Federal Register Vol. 81, No.86,

Federal Register Volume 81, Issue 86 (May 4, 2016)

Page Range26667-26996
FR Document

81_FR_86
Current View
Page and SubjectPDF
81 FR 26993 - Promoting Rehabilitation and Reintegration of Formerly Incarcerated IndividualsPDF
81 FR 26991 - Public Service Recognition Week, 2016PDF
81 FR 26989 - National Teacher Appreciation Day and National Teacher Appreciation Week, 2016PDF
81 FR 26987 - National Small Business Week, 2016PDF
81 FR 26985 - National Charter Schools Week, 2016PDF
81 FR 26983 - Older Americans Month, 2016PDF
81 FR 26981 - National Building Safety Month, 2016PDF
81 FR 26977 - Asian American and Pacific Islander Heritage Month, 2016PDF
81 FR 26774 - Meeting of the United States Manufacturing CouncilPDF
81 FR 26864 - Culturally Significant Objects Imported for Exhibition Determinations: “Splendor, Myth and Vision: Nudes From the Prado” ExhibitionPDF
81 FR 26832 - Government in the Sunshine Act Meeting NoticePDF
81 FR 26668 - Enterprise Housing Goals and MissionPDF
81 FR 26769 - Endangered and Threatened Wildlife and Plants; Revisions to the Regulations for Candidate Conservation Agreements With AssurancesPDF
81 FR 26817 - Candidate Conservation Agreements With Assurances PolicyPDF
81 FR 26835 - National Science Board Sunshine Act MeetingsPDF
81 FR 26863 - 30-Day Notice of Proposed Information Collection: Overseas Schools-Grant Status ReportPDF
81 FR 26864 - Overseas Schools Advisory Council Notice of MeetingPDF
81 FR 26834 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
81 FR 26863 - Main Street Mezzanine Fund, L.P., License No. 06/06-0326; Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of InterestPDF
81 FR 26862 - Texas Disaster #TX-00468PDF
81 FR 26861 - Announcement of Growth Accelerator Fund CompetitionPDF
81 FR 26759 - Notice of Demonstration To Test Proposed New Method of Assessing the Physical Conditions of Voucher-Assisted HousingPDF
81 FR 26815 - Request for Specific Policy Proposals and Methods of Research and Evaluation for MTW Demonstration Expansion; Extension of Comment PeriodPDF
81 FR 26767 - Safety Zone; Tall Ships Challenge Great Lakes 2016, Fairport Harbor, OH, Bay City, MI, Chicago, IL, Green Bay, WI, Duluth, MN, Erie, PAPDF
81 FR 26816 - 30-Day Notice of Proposed Information Collection: FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports by FHA-Approved LendersPDF
81 FR 26777 - Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for Exempted Fishing PermitsPDF
81 FR 26798 - Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)PDF
81 FR 26843 - New Postal ProductPDF
81 FR 26817 - 30-Day Notice of Proposed Information Collection: Screening and Eviction for Drug Abuse and Other Criminal ActivityPDF
81 FR 26776 - Fisheries of the Exclusive Economic Zone Off Alaska; Stock Assessment of Eastern Bering Sea Pollock; Peer Review MeetingPDF
81 FR 26745 - Fisheries of the Economic Exclusive Zone Off Alaska; Deep-Water Species Fishery by Vessels Using Trawl Gear in the Gulf of AlaskaPDF
81 FR 26668 - Special Conditions: Gulfstream Aerospace Corporation Model GVII-G500 Airplane, Technical Criteria for Approving Side-Facing SeatsPDF
81 FR 26727 - Fisheries of the Northeastern United States; Atlantic Sea Scallop Fishery; Framework Adjustment 27PDF
81 FR 26844 - Notice of Applications for Deregistration Under Section 8(f) of the Investment Company Act of 1940PDF
81 FR 26851 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of a Proposed Rule Change Consisting of Proposed Amendments to Rules G-12 and G-15 To Define Regular-Way Settlement for Municipal Securities Transactions as Occurring on a Two-Day Settlement Cycle and Technical Conforming AmendmentsPDF
81 FR 26857 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to FLEX Options Pilot ProgramPDF
81 FR 26792 - Notice of Agreements FiledPDF
81 FR 26813 - Notice of Kidney Interagency Coordinating Committee MeetingPDF
81 FR 26793 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
81 FR 26793 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
81 FR 26811 - Meeting of the National Preparedness and Response Science BoardPDF
81 FR 26838 - STP Nuclear Operating Company, South Texas Project, Units 1 and 2PDF
81 FR 26837 - Dominion Virginia Power; North Anna, Unit 3PDF
81 FR 26747 - Energy Conservation Program: Energy Conservation Standards for Commercial Packaged BoilersPDF
81 FR 26776 - Endangered and Threatened Species; Take of Anadromous FishPDF
81 FR 26787 - H2 Refuel H-Prize Schedule UpdatePDF
81 FR 26797 - Request for Nominations of Candidates To Serve on the Healthcare Infection Control Practices Advisory Committee (HICPAC)PDF
81 FR 26794 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial ReviewPDF
81 FR 26794 - Request for Nominations of Candidates To Serve on the Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC)PDF
81 FR 26794 - Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)PDF
81 FR 26773 - Submission for OMB Review; Comment RequestPDF
81 FR 26832 - Polyethylene Terephthalate Resin From Canada, China, India, and OmanPDF
81 FR 26865 - Commercial Driver's License Standards: Application for Exemption; Daimler Trucks North America (Daimler)PDF
81 FR 26866 - Commercial Driver's License Standards: Application for Exemption; Daimler Trucks North America (Daimler)PDF
81 FR 26780 - National Advisory Committee on Institutional Quality and Integrity MeetingPDF
81 FR 26788 - Combined Notice of FilingsPDF
81 FR 26692 - Financial Assistance and Social Services Programs; Burial AssistancePDF
81 FR 26826 - Indian Entities Recognized and Eligible To Receive Services From the United States Bureau of Indian AffairsPDF
81 FR 26851 - SEC Advisory Committee on Small and Emerging CompaniesPDF
81 FR 26835 - Agency Information Collection Activities: Comment RequestPDF
81 FR 26779 - Notice of Intent To Prepare an Environmental Impact Statement for the Presidential Aircraft Recapitalization Program at Joint Base Andrews-Naval Air Facility, Washington, MarylandPDF
81 FR 26832 - Notice of Public Meeting, Idaho Falls District Resource Advisory Council MeetingPDF
81 FR 26795 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
81 FR 26803 - Natural History Studies for Rare Disease Product Development: Orphan Products Research Project Grant (R01)PDF
81 FR 26804 - Quantitative Assessment of Assumptions To Support Extrapolation of Efficacy in Pediatrics; Public WorkshopPDF
81 FR 26807 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Market Claims in Direct-to-Consumer Prescription Drug Print AdsPDF
81 FR 26856 - Submission for OMB Review; Comment RequestPDF
81 FR 26799 - Special Protocol Assessment; Draft Guidance for Industry; AvailabilityPDF
81 FR 26805 - Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Draft Guidance for Industry; AvailabilityPDF
81 FR 26722 - Mefenoxam; Pesticide TolerancesPDF
81 FR 26802 - Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet FormatPDF
81 FR 26800 - Determination That LEUCOVORIN CALCIUM (Leucovorin Calcium) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or EffectivenessPDF
81 FR 26753 - Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Companion to Direct Final RulePDF
81 FR 26687 - Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological ProductsPDF
81 FR 26763 - Self-Employment Tax Treatment of Partners in a Partnership That Owns a Disregarded EntityPDF
81 FR 26693 - Self-Employment Tax Treatment of Partners in a Partnership That Owns a Disregarded EntityPDF
81 FR 26764 - Identification Markings Placed on Firearm Silencers and Firearm MufflersPDF
81 FR 26667 - Environmental Policies and Procedures; CorrectionsPDF
81 FR 26775 - Endangered and Threatened Species; Take of Anadromous Fish; Reopening of Comment PeriodPDF
81 FR 26826 - Agency Information Collection Activities: Request for CommentsPDF
81 FR 26774 - Notice of Public Meeting of the Illinois Advisory Committee To Discuss Approval of a Draft Advisory Memorandum Regarding Civil Rights and Environmental Justice in the StatePDF
81 FR 26667 - Environmental Policies and Procedures; CorrectionPDF
81 FR 26775 - Notice of Intent To Grant Exclusive LicensePDF
81 FR 26844 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Update Public Disclosure of Exchange Usage of Market DataPDF
81 FR 26846 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Nasdaq Rule 7023PDF
81 FR 26850 - Submission for OMB Review; Comment RequestPDF
81 FR 26854 - Submission for OMB Review; Comment RequestPDF
81 FR 26853 - Proposed Collection; Comment RequestPDF
81 FR 26849 - Submission for OMB Review; Comment RequestPDF
81 FR 26857 - Submission for OMB Review; Comment RequestPDF
81 FR 26833 - Advisory Committee on Veterans' Employment, Training and Employer Outreach (ACVETEO): MeetingPDF
81 FR 26833 - All Items Consumer Price Index for All Urban Consumers, United States City AveragePDF
81 FR 26789 - Agency Information Collection Activities OMB ResponsesPDF
81 FR 26870 - Proposed Collection of Information: FS Form 2001-ReleasePDF
81 FR 26812 - Center For Scientific Review; Notice of Closed MeetingsPDF
81 FR 26738 - Fisheries of the Exclusive Economic Zone Off Alaska; Western Alaska Community Development Quota ProgramPDF
81 FR 26790 - Senior Executive Service Performance Review BoardPDF
81 FR 26790 - Information Collections Being Submitted for Review and Approval to the Office of Management and BudgetPDF
81 FR 26791 - Information Collection Being Submitted for Review and Approval to the Office of Management and BudgetPDF
81 FR 26815 - Agency Information Collection Activities: Submission for Review; Information Collection Request for the Department of Homeland Security Science & Technology Technology Acceptance and Evaluation SurveyPDF
81 FR 26867 - Notice of Receipt of Petition for Decision That Nonconforming Model Year 2008 Aston Martin Vantage V8 Passenger Cars Are Eligible for ImportationPDF
81 FR 26869 - Notice of Receipt of Petition for Decision That Nonconforming Model Year 2009 Mercedes-Benz G Class Long Wheelbase (463 Chassis) Multipurpose Passenger Vehicle Are Eligible for ImportationPDF
81 FR 26780 - Application for New Awards; Data Disaggregation Initiative ProgramPDF
81 FR 26836 - Information Collection: Criteria and Procedures for Determining Eligibility for Access to or Control Over Special Nuclear MaterialPDF
81 FR 26793 - Notice of Filing of Complaint and AssignmentPDF
81 FR 26792 - Notice of Filing of Complaint and AssignmentPDF
81 FR 26814 - National Institute of Neurological Disorders and Stroke; Notice of Closed MeetingPDF
81 FR 26812 - National Institute of Environmental Health Sciences; Notice of Closed MeetingPDF
81 FR 26814 - National Institute on Aging; Notice of Closed MeetingsPDF
81 FR 26812 - National Institute on Aging; Notice of Closed MeetingsPDF
81 FR 26814 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 26695 - Safety Zone, Cape Fear River; Southport, NCPDF
81 FR 26903 - U.S. Citizenship and Immigration Services Fee SchedulePDF
81 FR 26675 - Airworthiness Directives; Turbomeca S.A. Turboshaft EnginesPDF
81 FR 26941 - Protection of Visibility: Amendments to Requirements for State PlansPDF
81 FR 26685 - Amendment of Class D and Class E Airspace; Walla Walla, WAPDF
81 FR 26673 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 26682 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 26871 - Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care FacilitiesPDF
81 FR 26825 - Marianas Trench Marine National Monument, Commonwealth of the Northern Mariana Islands; Northern Islands Submerged Lands Transfer to the Commonwealth of the Northern Mariana Islands Draft Environmental AssessmentPDF
81 FR 26750 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 26747 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 26697 - Determinations of Attainment by the Attainment Date, Extensions of the Attainment Date, and Reclassification of Several Areas for the 2008 Ozone National Ambient Air Quality StandardsPDF
81 FR 26677 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 26680 - Airworthiness Directives; Airbus AirplanesPDF

Issue

81 86 Wednesday, May 4, 2016 Contents Agriculture Agriculture Department See

Farm Service Agency

See

Rural Business-Cooperative Service

See

Rural Housing Service

See

Rural Utilities Service

AIRFORCE Air Force Department NOTICES Environmental Impact Statements; Availability, etc.: Presidential Aircraft Recapitalization Program at Joint Base Andrews-Naval Air Facility, Washington, Maryland, 26779 2016-10401 Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau PROPOSED RULES Identification Markings Placed on Firearm Silencers and Firearm Mufflers, 26764-26767 2016-10382 Fiscal Bureau of the Fiscal Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26870 2016-10358 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26795-26797 2016-10399 Meetings: Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health, 26794 2016-10420 Disease, Disability, and Injury Prevention and Control Special Emphasis Panel, 26794 2016-10422 Requests for Nominations: Breast and Cervical Cancer Early Detection and Control Advisory Committee, 26794-26795 2016-10421 Healthcare Infection Control Practices Advisory Committee, 26797-26798 2016-10423 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare and Medicaid Programs: Fire Safety Requirements for Certain Health Care Facilities, 26872-26901 2016-10043 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26798-26799 2016-10448 Civil Rights Civil Rights Commission NOTICES Meetings: Illinois Advisory Committee, 26774 2016-10378 Coast Guard Coast Guard RULES Safety Zones: Cape Fear River, Southport, NC, 26695-26697 2016-10310 PROPOSED RULES Safety Zones: Tall Ships Challenge Great Lakes 2016: Fairport Harbor, OH; Bay City, MI; Chicago, IL; Green Bay, WI; Duluth, MN; Erie, PA, 26767-26769 2016-10453 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Defense Department Defense Department See

Air Force Department

Education Department Education Department NOTICES Applications for New Awards: Data Disaggregation Initiative Program, 26780-26787 2016-10345 Meetings: National Advisory Committee on Institutional Quality and Integrity Meeting, 26780 2016-10414 Energy Department Energy Department See

Energy Efficiency and Renewable Energy Office

See

Federal Energy Regulatory Commission

PROPOSED RULES Energy Conservation Program: Energy Conservation Standards for Commercial Packaged Boilers, 26747 2016-10427
Energy Efficiency Energy Efficiency and Renewable Energy Office NOTICES H2 Refuel H-Prize Schedule Update, 26787-26788 2016-10425 Environmental Protection Environmental Protection Agency RULES Determinations of Attainment by the Attainment Date, Extensions of the Attainment Date, and Reclassifications of Several Areas for the 2008 Ozone National Ambient Air Quality Standards, 26697-26722 2016-09729 Pesticide Tolerances: Mefenoxam, 26722-26727 2016-10389 PROPOSED RULES Protection of Visibility; Amendments to Requirements for State Plans, 26942-26976 2016-10228 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26789-26790 2016-10361 Farm Service Farm Service Agency RULES Environmental Policies and Procedures; Corrections, 26667-26668 2016-10377 2016-10381 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Airbus Airplanes, 26677-26682 2016-08532 2016-08956 Boeing Company Airplanes, 26673-26675, 26682-26685 2016-10158 2016-10160 Turbomeca S.A. Turboshaft Engines, 26675-26677 2016-10279 Amendments of Class D and Class E Airspace: Walla Walla, WA, 26685-26686 2016-10179 Special Conditions: Gulfstream Aerospace Corporation Model GVII-G500 Airplane, Technical Criteria for Approving Side-Facing Seats, 26668-26673 2016-10440 PROPOSED RULES Airworthiness Directives: Boeing Company Airplanes, 26747-26753 2016-09795 2016-09801 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26790-26792 2016-10353 2016-10354 Senior Executive Service Performance Review Board, 26790 2016-10355 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 26788-26789 2016-10411 Federal Housing Finance Agency Federal Housing Finance Agency RULES Enterprise Housing Goals and Mission; CFR Correction, 26668 2016-10521 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 26792-26793 2016-10435 Complaints and Assignments: Landers Brothers Auto Group, Inc., et al. v. Nippon Yusen Kabushiki Kaisha, et al., 26793 2016-10341 Rush Truck Centers of Arizona, Inc., et al. v. Nippon Yusen Kabushiki Kaisha, et al., 26792 2016-10340 Federal Motor Federal Motor Carrier Safety Administration NOTICES Commercial Driver's License Standards; Exemption Applications: Daimler Trucks North America (Daimler), 26865-26867 2016-10415 2016-10416 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 26793 2016-10433 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 26793-26794 2016-10432 Fish Fish and Wildlife Service PROPOSED RULES Endangered and Threatened Wildlife and Plants: Candidate Conservation Agreements with Assurances, 26769-26772 2016-10483 NOTICES Candidate Conservation Agreements with Assurances Policy, 26817-26825 2016-10479 Environmental Assessments; Availability, etc.: Marianas Trench Marine National Monument, Commonwealth of the Northern Mariana Islands; Northern Islands Submerged Lands Transfer to the Commonwealth of the Northern Mariana Islands, 26825-26826 2016-09955 Food and Drug Food and Drug Administration RULES Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products, 26687-26692 2016-10385 PROPOSED RULES Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products, 26753-26759 2016-10386 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Market Claims in Direct-to-Consumer Prescription Drug Print Ads, 26807-26811 2016-10396 Determination that Drug Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness: LEUCOVORIN CALCIUM (Leucovorin Calcium) Injectable, 26800-26802 2016-10387 Funding Availability: Natural History Studies for Rare Disease Product Development: Orphan Products Research Project Grant (R01), 26803-26804 2016-10398 Guidance for Industry: Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment, 26805-26806 2016-10390 Guidance: Special Protocol Assessment, 26799-26800 2016-10391 Medical Devices; Exemption from Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format, 26802-26803 2016-10388 Meetings: Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics; Public Workshop, 26804-26805 2016-10397 Geological Geological Survey NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26826 2016-10379 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

National Institutes of Health

NOTICES Meetings: National Preparedness and Response Science Board, 26811-26812 2016-10430
Homeland Homeland Security Department See

Coast Guard

PROPOSED RULES U.S. Citizenship and Immigration Services Fee Schedule, 26904-26940 2016-10297 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26815 2016-10352
Housing Housing and Urban Development Department PROPOSED RULES Demonstration to Test Proposed New Method of Assessing the Physical Conditions of Voucher-Assisted Housing, 26759-26763 2016-10460 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports by FHA-Approved Lenders, 26816 2016-10450 Screening and Eviction for Drug Abuse and Other Criminal Activity, 26817 2016-10446 Request for Specific Policy Proposals and Methods of Research and Evaluation for MTW Demonstration Expansion, 26815-26816 2016-10454 Indian Affairs Indian Affairs Bureau RULES Financial Assistance and Social Services Programs; Burial Assistance, 26692-26693 2016-10409 NOTICES Indian Entities Recognized and Eligible to Receive Services, 26826-26832 2016-10408 Interior Interior Department See

Fish and Wildlife Service

See

Geological Survey

See

Indian Affairs Bureau

See

Land Management Bureau

Internal Revenue Internal Revenue Service RULES Self-Employment Tax Treatment of Partners in a Partnership That Owns a Disregarded Entity, 26693-26695 2016-10383 PROPOSED RULES Self-Employment Tax Treatment of Partners in a Partnership That Owns a Disregarded Entity, 26763-26764 2016-10384 International Trade Adm International Trade Administration NOTICES Meetings: United States Manufacturing Council, 26774-26775 2016-10545 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Polyethylene Terephthalate Resin from Canada, China, India, and Oman, 26832-26833 2016-10417 Meetings; Sunshine Act, 26832 2016-10540 Justice Department Justice Department See

Alcohol, Tobacco, Firearms, and Explosives Bureau

Labor Department Labor Department NOTICES Meetings: Advisory Committee on Veterans' Employment, Training and Employer Outreach, 26833-26834 2016-10363 United States City Average All Items Consumer Price Index for All Urban Consumers, 26833 2016-10360 2016-10362 Land Land Management Bureau NOTICES Meetings: Idaho Falls District Resource Advisory Council Meeting, 26832 2016-10400 National Archives National Archives and Records Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26834-26835 2016-10470 National Highway National Highway Traffic Safety Administration NOTICES Petitions for Import Eligibility: Nonconforming Model Year 2008 Aston Martin Vantage V8 Passenger Cars, 26867-26869 2016-10350 Nonconforming Model Year 2009 Mercedes-Benz G Class Long Wheelbase (463 Chassis) Multipurpose Passenger Vehicle, 26869-26870 2016-10349 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 26812-26814 2016-10335 2016-10357 Kidney Interagency Coordinating Committee Meeting, 26813-26814 2016-10434 National Institute of Environmental Health Sciences, 26812 2016-10338 National Institute of Neurological Disorders and Stroke, 26814 2016-10339 National Institute on Aging, 26812, 26814-26815 2016-10336 2016-10337 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Economic Exclusive Zone Off Alaska: Deep-Water Species Fishery by Vessels Using Trawl Gear in the Gulf of Alaska, 26745-26746 2016-10444 Fisheries of the Exclusive Economic Zone Off Alaska: Western Alaska Community Development Quota Program, 26738-26745 2016-10356 Fisheries of the Northeastern United States: Atlantic Sea Scallop Fishery; Framework Adjustment 27, 26727-26738 2016-10439 NOTICES Candidate Conservation Agreements with Assurances Policy, 26817-26825 2016-10479 Endangered and Threatened Species: Take of Anadromous Fish, 26775-26776 2016-10380 Environmental Impact Statements; Availability, etc.: Endangered and Threatened Species; Take of Anadromous Fish, 26776-26777 2016-10426 Exclusive Licenses, 26775 2016-10372 General Provisions for Domestic Fisheries: Application for Exempted Fishing Permits, 26777-26779 2016-10449 Meetings: Fisheries of the Exclusive Economic Zone off Alaska Stock Assessment of Eastern Bering Sea Pollock, 26776 2016-10445 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26835-26836 2016-10403 Meetings; Sunshine Act, 26835 2016-10478 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Criteria and Procedures for Determining Eligibility for Access to or Control over Special Nuclear Material, 26836-26837 2016-10342 Combined Licenses: Dominion Virginia Power; North Anna, Unit 3, 26837-26838 2016-10428 Environmental Assessments; Availability, etc.: STP Nuclear Operating Co., South Texas Project, Units 1 and 2, 26838-26843 2016-10429 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 26843-26844 2016-10447 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Asian American and Pacific Islander Heritage Month (Proc. 9434), 26977-26980 2016-10643 National Building Safety Month (Proc. 9435), 26981-26982 2016-10648 National Charter Schools Week (Proc. 9437), 26985-26986 2016-10653 National Small Business Week (Proc. 9438), 26987-26988 2016-10657 National Teacher Appreciation Day and National Teacher Appreciation Week (Proc. 9439), 26989-26990 2016-10660 Older Americans Month (Proc. 9436), 26983-26984 2016-10649 Public Service Recognition Week (Proc. 9440), 26991-26992 2016-10661 ADMINISTRATIVE ORDERS Rehabilitation and Reintegration of Formerly Incarcerated Individuals; Promotion Efforts (Memorandum of April 29, 2016), 26993-26996 2016-10662 Rural Business Rural Business-Cooperative Service RULES Environmental Policies and Procedures; Corrections, 26667-26668 2016-10377 2016-10381 Rural Housing Service Rural Housing Service RULES Environmental Policies and Procedures; Corrections, 26667-26668 2016-10377 2016-10381 Rural Utilities Rural Utilities Service RULES Environmental Policies and Procedures; Corrections, 26667-26668 2016-10377 2016-10381 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26773 2016-10419 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26849-26851, 26853-26857 2016-10364 2016-10365 2016-10366 2016-10367 2016-10368 2016-10369 2016-10395 Applications for Deregistration, 26844 2016-10438 Meetings: Advisory Committee on Small and Emerging Companies, 26851 2016-10406 Self-Regulatory Organizations; Proposed Rule Changes: Chicago Board Options Exchange, Inc., 26857-26861 2016-10436 Municipal Securities Rulemaking Board, 26851-26853 2016-10437 NASDAQ Stock Market, LLC, 26844-26849 2016-10370 2016-10371 Small Business Small Business Administration NOTICES 2016 Growth Accelerator Fund Competition, 26861-26862 2016-10467 Conflict of Interest Exemptions: Main Street Mezzanine Fund, LP, 26863 2016-10469 Disaster Declarations: Texas, 26862-26863 2016-10468 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Overseas Schools - Grant Status Report, 26863-26864 2016-10477 Culturally Significant Objects Imported for Exhibition: Splendor, Myth and Vision: Nudes from the Prado, 26864 2016-10543 Meetings: Overseas Schools Advisory Council, 26864 2016-10475 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department See

Bureau of the Fiscal Service

See

Internal Revenue Service

Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 26872-26901 2016-10043 Part III Homeland Security Department, 26904-26940 2016-10297 Part IV Environmental Protection Agency, 26942-26976 2016-10228 Part V Presidential Documents, 26977-26984, 26985-26996 2016-10643 2016-10648 2016-10653 2016-10657 2016-10660 2016-10649 2016-10661 2016-10662 Reader Aids

Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.

81 86 Wednesday, May 4, 2016 Rules and Regulations DEPARTMENT OF AGRICULTURE Rural Housing Service Rural Business-Cooperative Service Rural Utilities Service Farm Service Agency 7 CFR Parts 1924 and 1980 RIN 0575-AC56 Environmental Policies and Procedures; Corrections AGENCY:

Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, Farm Service Agency, USDA.

ACTION:

Final rule; correction.

SUMMARY:

This document corrects errors in the final rule that appeared in the Federal Register of March 2, 2016, entitled “Environmental Policies and Procedures.” The rule replaced two existing rules relating to the Agency's procedures for implementing NEPA.

DATES:

This rule is effective May 4, 2016.

FOR FURTHER INFORMATION CONTACT:

Kellie M. Kubena, Director, Engineering and Environmental Staff, Rural Utilities Service, Stop 1571, 1400 Independence Ave. SW., Washington, DC 20250-1571; email: [email protected]; telephone: (202) 720-1649.

SUPPLEMENTARY INFORMATION:

In FR Doc. 2016-03433 of March 2, 2016 (81 FR 11000), make the following correcting amendments:

Exhibit I to Subpart A of Part 1924—[Corrected] 1. On page 11029, in the third column, at the fourteenth line, in amendatory instruction 65, remove “300-1” and add “301-1” in its place.
§ 1980.451 [Corrected]
2. On page 11047, in the third column, at the seventh line from the bottom, in amendatory instruction 101, remove “(h)(3)” and add “(i)(3)” in its place.
3. On page 11048, in the first column, at the first line, remove “(h)” and add “(i)” in its place. Appendix K to Subpart E of Part 1980—[Corrected] 4. On page 11048, in the first column, at the 12th through 14th lines from the bottom, in amendatory instruction 104, remove “and paragraph C.12. of Section IX. Servicing”. 5. On page 11048, in the second column, below the table, remove lines four (“IX. Servicing.”) through fourteen (“* * * * *”). Dated:April 20, 2016. Lisa Mensah, Under Secretary, Rural Development. April 26, 2016. Alexis Taylor, Deputy Under Secretary, Farm and Foreign Agricultural Services.
[FR Doc. 2016-10381 Filed 5-3-16; 8:45 am] BILLING CODE 3410-XV-P
DEPARTMENT OF AGRICULTURE Rural Housing Service Rural Business-Cooperative Service Rural Utilities Service Farm Service Agency 7 CFR Part 1955 RIN 0575-AC56 Environmental Policies and Procedures; Correction AGENCY:

Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, Farm Service Agency, USDA.

ACTION:

Correcting amendment.

SUMMARY:

The Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, and Farm Service Agency published a document in the Federal Register on March 2, 2016 (81 FR 11000), entitled “Environmental Policies and Procedures.” The rule replaced two existing rules related to the Agency's procedures for implementing NEPA. This correction will replace the introductory text to paragraph (a) of § 1955.136.

DATES:

This rule is effective May 4, 2016.

FOR FURTHER INFORMATION CONTACT:

Kellie M. Kubena, Director, Engineering and Environmental Staff, Rural Utilities Service, Stop 1571, 1400 Independence Ave. SW., Washington, DC 20250-1571; email: [email protected]; telephone: (202) 720-1649.

SUPPLEMENTARY INFORMATION:

The Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, and Farm Service Agency published a document in the Federal Register on March 2, 2016 (81 FR 11000), entitled “Environmental Policies and Procedures.” This correction will replace the introductory text to paragraph (a) of § 1955.136.

List of Subjects in 7 CFR Part 1955

Government acquired property, Government property management, Sale of government acquired property, Surplus government property.

For the reasons set forth in the preamble, chapter XVIII, title 7, Code of Federal Regulations is amended as follows:

PART 1955—PROPERTY MANAGEMENT 1. The authority citation for part 1955 continues to read as follows: Authority:

5 U.S.C. 301; 7 U.S.C. 1989; 42 U.S.C. 1480.

Subpart C—Disposal of Inventory Property 2. In § 1955.136, revise the section heading and the introductory text of paragraph (a) to read as follows:
§ 1955.136 Environmental review requirements.

(a) Prior to a final decision on some disposal actions, the action must comply with the environmental review requirements in accordance with each agency's environmental policies and procedures. For Farm Service Agency actions the environmental policies and procedures are found in subpart G of part 1940 of this chapter and for Rural Development programs the environmental policies and procedures are found in 7 CFR part 1970. Assessments must be made for those proposed conveyances that meet one of the following criteria:

April 20, 2016. Lisa Mensah, Under Secretary, Rural Development. April 26, 2016. Alexis Taylor, Deputy Under Secretary, Farm and Foreign Agricultural Services.
[FR Doc. 2016-10377 Filed 5-3-16; 8:45 am] BILLING CODE 3410-XV-P
FEDERAL HOUSING FINANCE AGENCY 12 CFR Part 1282 Enterprise Housing Goals and Mission CFR Correction

In Title 12 of the Code of Federal Regulations, Part 1100 to End, revised as of January 1, 2016, on page 400, in § 1282.1, the definition of “Very low income” is reinstated to read as follows:

§ 1282.1 Definitions.

(b) * * *

Very low-income means:

(i) In the case of owner-occupied units, income not in excess of 50 percent of area median income; and

(ii) In the case of rental units, income not in excess of 50 percent of area median income, with adjustments for smaller and larger families in accordance with this part.

[FR Doc. 2016-10521 Filed 5-3-16; 8:45 am] BILLING CODE 1505-01-D
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2016-1085; Special Conditions No. 25-618-SC] Special Conditions: Gulfstream Aerospace Corporation Model GVII-G500 Airplane, Technical Criteria for Approving Side-Facing Seats AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final special conditions; request for comments.

SUMMARY:

These special conditions are issued for the Gulfstream Aerospace Corporation (Gulfstream) Model GVII-G500 airplane. This airplane will have a novel or unusual design feature associated with side-facing seats. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

The effective date of these special conditions is May 4, 2016. We must receive your comments by June 20, 2016.

ADDRESSES:

Send comments identified by docket number FAA-2016-1085 using any of the following methods:

Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending your comments electronically.

Mail: Send comments to Docket Operations, M-30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140, West Building Ground Floor, Washington, DC, 20590-0001.

Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Fax: Fax comments to Docket Operations at 202-493-2251.

Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket Web site, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.

Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Dan Jacquet, Airframe and Cabin Safety, ANM-115, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-2676; facsimile 425-227-1149.

SUPPLEMENTARY INFORMATION:

The substance of these special conditions has been subject to the public-comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance.

Comments Invited

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

Background

On March 29, 2012, Gulfstream Aerospace Corporation applied for a type certificate for their new Model GVII-G500 airplane. The Model GVII-G500 airplane will be a business jet capable of accommodating up to 19 passengers. It will incorporate a low, swept-wing design with winglets and a T-tail. The powerplant will consist of two aft-fuselage-mounted Pratt & Whitney turbofan engines.

Type Certification Basis

Under Title 14, Code of Federal Regulations (14 CFR) 21.17, Gulfstream must show that the Model GVII-G500 airplane meets the applicable provisions of 14 CFR part 25, as amended by Amendments 25-1 through 25-129.

If the Administrator finds that the applicable airworthiness regulations (i.e., part 25) do not contain adequate or appropriate safety standards for the Model GVII-G500 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, Model GVII-G500 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36. The FAA must issue a finding of regulatory adequacy under section 611 of Public Law 92-574, the “Noise Control Act of 1972.”

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17(a)(2).

Novel or Unusual Design Features

The Model GVII-G500 airplane will incorporate the following novel or unusual design feature:

Gulfstream wants the option to include side-facing seats in their new Model GVII-G500 airplane. Side-facing seats (i.e., seats positioned in the airplane with the occupant facing 90 degrees to the direction of airplane travel) are considered a novel design for transport-category airplanes that include Amendment 25-64 in their certification basis, and were not considered when those airworthiness standards were issued. The FAA has determined that the existing regulations do not provide adequate or appropriate safety standards for occupants of side-facing seats. To provide a level of safety that is equivalent to that afforded to occupants of forward- and aft-facing seats, additional airworthiness standards in the form of special conditions are necessary.

Discussion

On June 16, 1988, 14 CFR part 25 was amended to revise the emergency-landing conditions that must be considered in the design of transport-category airplanes. Amendment 25-64 revised the static-load conditions in § 25.561, and added a new § 25.562 that required dynamic testing for all seats approved for occupancy during takeoff and landing. The intent of Amendment 25-64 was to provide an improved level of safety for occupants on transport-category airplanes. However, because most seating on transport-category airplanes is forward-facing, the pass/fail criteria developed in Amendment 25-64 focused primarily on these seats.

For some time, the FAA granted exemptions for the multiple-place side-facing-seat installations because the existing test methods and acceptance criteria did not produce a level of safety equivalent to the level of safety provided for forward-and aft-facing seats. These exemptions were subject to many conditions that reflected the injury-evaluation criteria and mitigation strategies available at the time of the exemption issuance. The FAA also issued special conditions to address single-place side-facing seats because we believed that those conditions provided the same level of safety as for forward- and aft-facing seats.

Continuing concerns regarding the safety of side-facing seats prompted the FAA to conduct research to develop an acceptable method of compliance with §§ 25.562 and 25.785(b) for side-facing seat installations. That research has identified injury considerations and evaluation criteria in addition to those previously used to approve side-facing seats (see published report DOT/FAA/AR-09/41, July 2011). One particular concern that was identified during the FAA's research program, but not addressed in the previous special conditions, was the significant leg injuries that can occur to occupants of both single- and multiple-place side-facing seats. Because this type of injury does not occur on forward- and aft-facing seats, the FAA determined that, to achieve the level of safety envisioned in Amendment 25-64, additional requirements would be needed as compared to previously issued special conditions. Nonetheless, the research has now allowed the development of a single set of special conditions that is applicable to all fully side-facing seats.

On November 5, 2012, the FAA released PS-ANM-25-03-R1, “Technical Criteria for Approving Side-Facing Seats,” to update existing FAA certification policy on §§ 25.562 and 25.785(a) at Amendment 25-64 for single- and multiple-place side-facing seats. This policy addresses both the technical criteria for approving side-facing seats and the implementation of those criteria. The FAA methodology detailed in PS-ANM-25-03-R1 has been used in establishing a new set of proposed special conditions. Some of the conditions issued for previous exemptions are still relevant and are included in these new special conditions. However, others have been replaced by different criteria that reflect current research findings.

Applicability

As discussed above, these special conditions are applicable to the Gulfstream Model GVII-G500 airplane. Should Gulfstream apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

Conclusion

This action affects only a certain novel or unusual design feature on one model series of airplane. It is not a rule of general applicability.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon publication in the Federal Register.

The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

The authority citation for these special conditions is as follows: Authority:

49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Gulfstream Aerospace Corporation Model GVII-G500 airplane.

In addition to the airworthiness standards in §§ 25.562 and 25.785, the FAA issues the following special conditions (based on Policy Statement PS-ANM-25-03-R1) as part of the type certification basis for the Gulfstream Model GVII series airplanes. Items 1 and 2 are applicable to all side-facing seat installations, whereas items 3 through 16 represent additional requirements applicable to side-facing seats equipped with an airbag system in the shoulder belt.

1. Additional requirements applicable to tests or rational analysis conducted to show compliance with §§ 25.562 and 25.785 for side-facing seats:

a. The longitudinal test(s) conducted in accordance with § 25.562(b)(2), to show compliance with the seat-strength requirements of § 25.562(c)(7) and (8) and these special conditions, must have an ES-2re anthropomorphic test dummy (ATD) (49 CFR part 572 subpart U) or equivalent, or a Hybrid II ATD (49 CFR part 572, subpart B as specified in § 25.562) or equivalent, occupying each seat position and including all items (e.g., armrest, interior wall, or furnishing) contactable by the occupant if those items are necessary to restrain the occupant. If included, the floor representation and contactable items must be located such that their relative position, with respect to the center of the nearest seat place, is the same at the start of the test as before floor misalignment is applied. For example, if floor misalignment rotates the centerline of the seat place nearest the contactable item 8 degrees clockwise about the airplane x-axis, then the item and floor representations must be rotated by 8 degrees clockwise also, to maintain the same relative position to the seat place, as shown in Figure 1. Each ATD's relative position to the seat after application of floor misalignment must be the same as before misalignment is applied. To ensure proper occupant seat loading, the ATD pelvis must remain supported by the seat pan, and the restraint system must remain on the pelvis and shoulder of the ATD until rebound begins. No injury-criteria evaluation is necessary for tests conducted only to assess seat-strength requirements.

ER04MY16.001

b. The longitudinal test(s) conducted in accordance with § 25.562(b)(2), to show compliance with the injury assessments required by § 25.562(c) and these special conditions, may be conducted separately from the test(s) to show structural integrity. In this case, structural-assessment tests must be conducted as specified in paragraph 1a, above, and the injury-assessment test must be conducted without yaw or floor misalignment. Injury assessments may be accomplished by testing with ES-2re ATD (49 CFR part 572 subpart U) or equivalent at all places. Alternatively, these assessments may be accomplished by multiple tests that use an ES-2re ATD at the seat place being evaluated, and a Hybrid II ATD (49 CFR part 572, subpart B, as specified in § 25.562) or equivalent used in all seat places forward of the one being assessed, to evaluate occupant interaction. In this case, seat places aft of the one being assessed may be unoccupied. If a seat installation includes adjacent items that are contactable by the occupant, the injury potential of that contact must be assessed. To make this assessment, tests may be conducted that include the actual item, located and attached in a representative fashion. Alternatively, the injury potential may be assessed by a combination of tests with items having the same geometry as the actual item, but having stiffness characteristics that would create the worst case for injury (injuries due to both contact with the item and lack of support from the item).

c. If a seat is installed aft of structure (e.g., an interior wall or furnishing) that does not have a homogeneous surface contactable by the occupant, additional analysis and/or test(s) may be required to demonstrate that the injury criteria are met for the area that an occupant could contact. For example, different yaw angles could result in different injury considerations and may require additional analysis or separate test(s) to evaluate.

d. To accommodate a range of occupant heights (5th percentile female to 95th percentile male), the surface of items contactable by the occupant must be homogenous 7.3 inches (185 mm) above and 7.9 inches (200 mm) below the point (center of area) that is contacted by the 50th percentile male size ATD's head during the longitudinal test(s) conducted in accordance with paragraphs a, b, and c, above. Otherwise, additional head-injury criteria (HIC) assessment tests may be necessary. Any surface (inflatable or otherwise) that provides support for the occupant of any seat place must provide that support in a consistent manner regardless of occupant stature. For example, if an inflatable shoulder belt is used to mitigate injury risk, then it must be demonstrated by inspection to bear against the range of occupants in a similar manner before and after inflation. Likewise, the means of limiting lower-leg flail must be demonstrated by inspection to provide protection for the range of occupants in a similar manner.

e. For longitudinal test(s) conducted in accordance with § 25.562(b)(2) and these special conditions, the ATDs must be positioned, clothed, and have lateral instrumentation configured as follows:

(1) ATD positioning:

Lower the ATD vertically into the seat while simultaneously (see Figure 2 for illustration):

(a) Aligning the midsagittal plane (a vertical plane through the midline of the body; dividing the body into right and left halves) with approximately the middle of the seat place.

(b) Applying a horizontal x-axis direction (in the ATD coordinate system) force of about 20 lb (89 N) to the torso at approximately the intersection of the midsagittal plane and the bottom rib of the ES-2re or lower sternum of the Hybrid II at the midsagittal plane, to compress the seat back cushion.

(c) Keeping the upper legs nearly horizontal by supporting them just behind the knees.

ER04MY16.002

(d) After all lifting devices have been removed from the ATD:

(i) Rock it slightly to settle it into the seat.

(ii) Separate the knees by about 4 inches (100 mm).

(iii) Set the ES-2re ATD's head at approximately the midpoint of the available range of z-axis rotation (to align the head and torso midsagittal planes).

(iv) Position the ES-2re ATD's arms at the joint's mechanical detent that puts them at approximately a 40-degree angle with respect to the torso. Position the Hybrid II ATD hands on top of its upper legs.

(v) Position the feet such that the centerlines of the lower legs are approximately parallel to a lateral vertical plane (in the airplane coordinate system).

(2) ATD clothing: Clothe each ATD in form-fitting, mid-calf-length (minimum) pants and shoes (size 11E) weighing about 2.5 lb (1.1 Kg) total. The color of the clothing should be in contrast to the color of the restraint system. The ES-2re jacket is sufficient for torso clothing, although a form-fitting shirt may be used in addition if desired.

(3) ES-2re ATD lateral instrumentation: The rib-module linear slides are directional, i.e., deflection occurs in either a positive or negative ATD y-axis direction. The modules must be installed such that the moving end of the rib module is toward the front of the airplane. The three abdominal-force sensors must be installed such that they are on the side of the ATD toward the front of the airplane.

f. The combined horizontal/vertical test, required by § 25.562(b)(1) and these special conditions, must be conducted with a Hybrid II ATD (49 CFR part 572 subpart B as specified in § 25.562), or equivalent, occupying each seat position.

g. Restraint systems:

(1) If inflatable restraint systems are used, they must be active during all dynamic tests conducted to show compliance with § 25.562.

(2) The design and installation of seat-belt buckles must prevent unbuckling due to applied inertial forces or impact of the hands or arms of the occupant during an emergency landing.

2. Additional performance measures applicable to tests and rational analysis conducted to show compliance with §§ 25.562 and 25.785 for side-facing seats:

a. Body-to-body contact: Contact between the head, pelvis, torso, or shoulder area of one ATD with the adjacent-seated ATD's head, pelvis, torso, or shoulder area is not allowed. Contact during rebound is allowed.

b. Thoracic: The deflection of any of the ES-2re ATD upper, middle, and lower ribs must not exceed 1.73 inches (44 mm). Data must be processed as defined in Federal Motor Vehicle Safety Standards (FMVSS) 571.214.

c. Abdominal: The sum of the measured ES-2re ATD front, middle, and rear abdominal forces must not exceed 562 lbs (2,500 N). Data must be processed as defined in FMVSS 571.214.

d. Pelvic: The pubic symphysis force measured by the ES-2re ATD must not exceed 1,350 lbs (6,000 N). Data must be processed as defined in FMVSS 571.214.

e. Leg: Axial rotation of the upper-leg (femur) must be limited to 35 degrees in either direction from the nominal seated position.

f. Neck: As measured by the ES-2re ATD and filtered at Channel Frequency Class 600 as defined in SAE J211, “Instrumentation for Impact Test—Part 1—Electronic Instrumentation.”

(1) The upper-neck tension force at the occipital condyle (O.C.) location must be less than 405 lb (1,800 N).

(2) The upper-neck compression force at the O.C. location must be less than 405 lb (1,800 N).

(3) The upper-neck bending torque about the ATD x-axis at the O.C. location must be less than 1,018 in-lb (115 Nm).

(4) The upper-neck resultant shear force at the O.C. location must be less than 186 lb (825 N).

g. Occupant (ES-2re ATD) retention: The pelvic restraint must remain on the ES-2re ATD's pelvis during the impact and rebound phases of the test. The upper-torso restraint straps (if present) must remain on the ATD's shoulder during the impact.

h. Occupant (ES-2re ATD) support:

(1) Pelvis excursion: The load-bearing portion of the bottom of the ATD pelvis must not translate beyond the edges of its seat's bottom seat-cushion supporting structure.

(2) Upper-torso support: The lateral flexion of the ATD torso must not exceed 40 degrees from the normal upright position during the impact.

3. For seats with an airbag system in the shoulder belts, show that the airbag system in the shoulder belt will deploy and provide protection under crash conditions where it is necessary to prevent serious injury. The means of protection must take into consideration a range of stature from a 2-year-old child to a 95th percentile male. The airbag system in the shoulder belt must provide a consistent approach to energy absorption throughout that range of occupants. When the seat system includes an airbag system, that system must be included in each of the certification tests as it would be installed in the airplane. In addition, the following situations must be considered:

a. The seat occupant is holding an infant.

b. The seat occupant is a pregnant woman.

4. The airbag system in the shoulder belt must provide adequate protection for each occupant regardless of the number of occupants of the seat assembly, considering that unoccupied seats may have an active airbag system in the shoulder belt.

5. The design must prevent the airbag system in the shoulder belt from being either incorrectly buckled or incorrectly installed, such that the airbag system in the shoulder belt would not properly deploy. Alternatively, it must be shown that such deployment is not hazardous to the occupant, and will provide the required injury protection.

6. It must be shown that the airbag system in the shoulder belt is not susceptible to inadvertent deployment as a result of wear and tear, or inertial loads resulting from in-flight or ground maneuvers (including gusts and hard landings), and other operating and environmental conditions (vibrations, moisture, etc.) likely to occur in service.

7. Deployment of the airbag system in the shoulder belt must not introduce injury mechanisms to the seated occupant, or result in injuries that could impede rapid egress. This assessment should include an occupant whose belt is loosely fastened.

8. It must be shown that inadvertent deployment of the airbag system in the shoulder belt, during the most critical part of the flight, will either meet the requirement of § 25.1309(b) or not cause a hazard to the airplane or its occupants.

9. It must be shown that the airbag system in the shoulder belt will not impede rapid egress of occupants 10 seconds after airbag deployment.

10. The airbag system must be protected from lightning and high-intensity radiated fields (HIRF). The threats to the airplane specified in existing regulations regarding lighting, § 25.1316, and HIRF, § 25.1317, are incorporated by reference for the purpose of measuring lightning and HIRF protection.

11. The airbag system in the shoulder belt must function properly after loss of normal aircraft electrical power, and after a transverse separation of the fuselage at the most critical location. A separation at the location of the airbag system in the shoulder belt does not have to be considered.

12. It must be shown that the airbag system in the shoulder belt will not release hazardous quantities of gas or particulate matter into the cabin.

13. The airbag system in the shoulder-belt installation must be protected from the effects of fire such that no hazard to occupants will result.

14. A means must be available for a crewmember to verify the integrity of the airbag system in the shoulder-belt activation system prior to each flight, or it must be demonstrated to reliably operate between inspection intervals. The FAA considers that the loss of the airbag-system deployment function alone (i.e., independent of the conditional event that requires the airbag-system deployment) is a major-failure condition.

15. The inflatable material may not have an average burn rate of greater than 2.5 inches/minute when tested using the horizontal flammability test defined in part 25, appendix F, part I, paragraph (b)(5).

16. The airbag system in the shoulder belt, once deployed, must not adversely affect the emergency-lighting system (i.e., block floor proximity lights to the extent that the lights no longer meet their intended function).

Issued in Renton, Washington, on April 27, 2016. Dionne Palermo, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-10440 Filed 5-3-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-3982; Directorate Identifier 2015-NM-098-AD; Amendment 39-18503; AD 2016-09-05] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 717-200 airplanes. This AD was prompted by multiple reports of the vertical stabilizer leading edge showing signs of fastener distress. This AD requires a detailed inspection for any distress of the vertical stabilizer leading edge skin, and related investigative and corrective actions if necessary. This AD also requires, for certain airplanes, repetitive detailed inspections of the spar cap for any loose and missing fasteners, repetitive eddy current testing high frequency (ETHF) and radiographic testing (RT) inspections of the spar cap for any crack, and related investigative and corrective actions if necessary. We are issuing this AD to detect and correct any crack in the vertical stabilizer leading edge and front spar cap, which may result in the structure becoming unable to support limit load, and may lead to the loss of the vertical stabilizer.

DATES:

This AD is effective June 8, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of June 8, 2016.

ADDRESSES:

For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Data & Services Management, 3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001; telephone: 206-544-5000, extension 2; fax: 206-766-5683; 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-2015-3982.

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-2015-3982; 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 AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Eric Schrieber, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5348; fax: 562-627-5210; email: [email protected]

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 717-200 airplanes. The NPRM published in the Federal Register on October 6, 2015 (80 FR 60307) (“the NPRM”). The NPRM was prompted by multiple reports of the vertical stabilizer leading edge showing signs of fastener distress. The NPRM proposed to require a detailed inspection for any distress of the vertical stabilizer leading edge skin, and related investigative and corrective actions if necessary. The NPRM also proposed to require, for certain airplanes, repetitive detailed inspections of the spar cap for any loose and missing fasteners, repetitive ETHF and RT inspections of the spar cap for any crack, and related investigative and corrective actions if necessary. We are issuing this AD to detect and correct any crack in the vertical stabilizer leading edge and front spar cap, which may result in the structure becoming unable to support limit load, and may lead to the loss of the vertical stabilizer.

Comments

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment. Boeing and an anonymous commenter indicated their support for the NPRM.

Request To Add Credit for Previous Actions

Boeing requested that we add a “Credit for Previous Actions” paragraph to the proposed AD that would give credit for prior accomplishment of the initial inspection in paragraph (g) of the NPRM. Boeing stated that operator structural inspection credit has been incorporated as a precedent in previous ADs.

We agree with the commenter's request. Boeing MOM-MOM-14-0437-01B(R1), dated July 3, 2014, provides the same action and level of safety for the initial inspection specified in this AD. We have revised this AD by adding new paragraph (j) of this AD to give credit for the initial inspection in paragraph (g) of this AD, if that inspection was performed before the effective date of this AD using Boeing MOM-MOM-14-0437-01B(R1), dated July 3, 2014. We have redesignated the remaining paragraphs accordingly.

Conclusion

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the change described previously and minor editorial changes. We have determined that these minor changes:

• Αre consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

We reviewed Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015. The service information describes procedures for a detailed inspection for any distress of the vertical stabilizer leading edge skin, a detailed inspection for any loose and missing fasteners of the spar cap, ETHF and RT inspections of the spar cap for any crack, and related investigative and corrective actions. 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.

Costs of Compliance

We estimate that this AD affects 106 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

Estimated Costs Action Labor cost Parts cost Cost per product Cost on U.S.
  • operators
  • Inspections for distress 11 work-hours × $85 per hour = $935 per inspection cycle $0 $935 per inspection cycle $99,110 per inspection cycle. Repetitive inspections for cracking and loose and missing fasteners 7 work-hours × $85 per hour = $595 per inspection cycle 0 595 per inspection cycle 63,070 per inspection cycle.

    We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.

    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

    This AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:

    (1) Is not a “significant regulatory action” under Executive Order 12866,

    (2) Is not a “significant rule” under 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.

    Adoption of the Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA amends 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): 2016-09-05 The Boeing Company: Amendment 39-18503; Docket No. FAA-2015-3982; Directorate Identifier 2015-NM-098-AD. (a) Effective Date

    This AD is effective June 8, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to The Boeing Company Model 717-200 airplanes, certificated in any category, as specified in Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015.

    (d) Subject

    Air Transport Association (ATA) of America Code 55, Stabilizers.

    (e) Unsafe Condition

    This AD was prompted by multiple reports of the vertical stabilizer leading edge showing signs of fastener distress. We are issuing this AD to detect and correct any crack in the vertical stabilizer leading edge and front spar cap, which may result in the structure becoming unable to support limit load, and may lead to the loss of the vertical stabilizer.

    (f) Compliance

    Comply with this AD within the compliance times specified, unless already done.

    (g) Initial Inspection

    Except as required by paragraph (i)(1) of this AD, at the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015: Do a detailed inspection for any distress of the vertical stabilizer leading edge skin and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015, except as required by paragraph (i)(2) of this AD. Do all applicable related investigative and corrective actions before further flight.

    (h) Repetitive Inspections

    For all airplanes on which no cracking was found during any related investigative action required by paragraph (g) of this AD: At the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015, do the actions specified in paragraphs (h)(1) and (h)(2) of this AD and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015, except as required by paragraph (i)(2) of this AD. Do all applicable related investigative and corrective actions before further flight. Repeat the applicable inspection thereafter at the intervals specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015.

    (1) Do detailed inspections for any loose and missing fasteners of the vertical stabilizer leading edge as specified in “Part 4” of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015.

    (2) Do eddy current testing high frequency (ETHF) and radiographic testing (RT) inspections for any crack of the vertical stabilizer spar cap as specified in “Part 2” of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015; or do ETHF inspections for any crack of the vertical stabilizer spar cap as specified in “Part 3” of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015.

    (i) Exceptions to the Service Information

    (1) Where Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015 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.

    (2) If any crack is found during any inspection required by this AD, and Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015, specifies to contact Boeing for appropriate action: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (k) of this AD.

    (j) Credit for Previous Actions

    This paragraph provides credit for the initial inspection specified in paragraph (g) of this AD, if that inspection was performed before the effective date of this AD using Boeing MOM-MOM-14-0437-01B(R1), dated July 3, 2014, which is not incorporated by reference in this AD.

    (k) 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 (l) 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.

    (l) Related Information

    For more information about this AD, contact Eric Schrieber, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles ACO, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5348; fax: 562-627-5210; email: [email protected]

    (m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.

    (i) Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015.

    (ii) Reserved.

    (3) For Boeing service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, 3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001; telephone: 206-544-5000, extension 2; fax: 206-766-5683; Internet: https://www.myboeingfleet.com.

    (4) You may view this 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.

    (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on April 20, 2016. John P. Piccola, Jr., Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-10160 Filed 5-3-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-7490; Directorate Identifier 2015-NE-40-AD; Amendment 39-18500; AD 2016-09-02] RIN 2120-AA64 Airworthiness Directives; Turbomeca S.A. Turboshaft Engines AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain Turbomeca S.A. Astazou XIV B and H turboshaft engines. This AD requires a one-time inspection of the front surface of the 3rd stage turbine for a groove. This AD was prompted by a report of a crack on the 3rd stage turbine wheel. We are issuing this AD to prevent cracks in the 3rd stage turbine wheel, failure of the engine, in-flight shutdown, and loss of control of the helicopter.

    DATES:

    This AD becomes effective June 8, 2016.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of June 8, 2016.

    ADDRESSES:

    For service information identified in this final rule, contact Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; fax: 33 (0)5 59 74 45 15. You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-7490.

    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-2015-7490; 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 AD, the mandatory continuing airworthiness information (MCAI), the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Wego Wang, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7134; fax: 781-238-7199; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to the specified products. The NPRM was published in the Federal Register on February 2, 2016 (81 FR 5395). The NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

    During the overhaul of an ASTAZOU XIV engine, a crack was detected on the front face of the third stage turbine wheel between two balancing lugs. The cause of the crack is probably linked to a geometric singularity, likely caused by the transformation operation aimed at introducing expansion slots between the blades during embodiment of Turbomeca mod AB 173. Although there is only one known case of this type of crack, and although it was detected, the possibility exists that additional parts have the same geometric singularity.

    This condition, if not detected and corrected, may lead to failure of a turbine blade and its associated piece of rim, possibly resulting in an uncommanded in-flight shut-down and/or release of high energy debris.

    You may obtain further information by examining the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-7490.

    Comments

    We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (81 FR 5395, February 2, 2016).

    Conclusion

    We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed.

    Related Service Information Under 1 CFR Part 51

    Turbomeca S.A. has issued Service Bulletin (SB) No. 283 72 0811, Version A, dated August 25, 2015. The SB describes procedures for inspection of the 3rd stage turbine wheel. 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.

    Costs of Compliance

    We estimate that this AD affects 9 engines installed on helicopters of U.S. registry. We also estimate that it will take about 5 hours per engine to comply with this AD. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $3,825.

    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 AD will not have federalism implications under Executive Order 13132. This AD will 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 AD:

    (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 to the extent that it justifies making a regulatory distinction, 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.

    Adoption of the Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA amends 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): 2016-09-02 Turbomeca S.A.: Amendment 39-18500; Docket No. FAA-2015-7490; Directorate Identifier 2015-NE-40-AD. (a) Effective Date

    This AD becomes effective June 8, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all Astazou XIV B and XIV H turboshaft engines with 3rd stage turbine wheel, part number (P/N) 0 265 25 700 0 or P/N 0 265 25 706 0, installed, if the engine incorporates Turbomeca modification AB-173 or AB-208.

    (d) Reason

    This AD was prompted by a report of a crack on the 3rd stage turbine wheel. We are issuing this AD to prevent cracks in the 3rd stage turbine wheel, failure of the engine, in-flight shutdown, and loss of control of the helicopter.

    (e) Actions and Compliance

    Comply with this AD within the compliance times specified, unless already done.

    (1) At the next piece part exposure of the 3rd stage turbine wheel or within 1,000 engine hours after the effective date of this AD whichever comes first, perform a one-time inspection for a groove on the front surface of the 3rd stage turbine wheel. Use Accomplishment Instructions, paragraph 4.4.2, of Turbomeca S.A. Service Bulletin (SB) No. 283 72 0811, Version A, dated August 25, 2015 to perform the inspection.

    (2) If the 3rd stage turbine wheel passes inspection required by paragraph (e)(1) of this AD, no further action is required.

    (3) If the 3rd stage turbine wheel fails inspection required by paragraph (e)(1) of this AD, remove the part and replace with a part eligible for installation.

    (f) Installation Prohibition

    After the effective date of this AD, do not install any 3rd stage turbine wheel, P/N 0 265 25 700 0 or P/N 0 265 25 706 0, unless it was inspected per the Accomplishment Instructions, paragraph 4.4.2, of Turbomeca S.A. SB No. 283 72 0811, Version A, dated August 25, 2015.

    (g) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request. You may email your request to: [email protected]

    (h) Related Information

    (1) For more information about this AD, contact Wego Wang, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7134; fax: 781-238-7199; email: [email protected]

    (2) Refer to MCAI European Aviation Safety Agency AD 2015-0223, dated November 16, 2015, for more information. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-7490-0001.

    (i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.

    (i) Turbomeca S.A. Service Bulletin No. 283 72 0811, Version A, dated August 25, 2015.

    (ii) Reserved.

    (3) For Turbomeca S.A. service information identified in this AD, contact Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; fax: 33 (0)5 59 74 45 15.

    (4) You may view this service information at FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.

    (5) You may view this service information at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on April 21, 2016. Colleen M. D'Alessandro, Manager, Engine & Propeller Directorate, Aircraft Certification Service.
    [FR Doc. 2016-10279 Filed 5-3-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-5811; Directorate Identifier 2014-NM-158-AD; Amendment 39-18489; AD 2016-08-13] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

    Federal Aviation Administration (FAA), Department of Transportation (DOT).

    ACTION:

    Final rule.

    SUMMARY:

    We are superseding Airworthiness Directive (AD) 2004-19-11 for certain Airbus Model A320 series airplanes. AD 2004-19-11 required modification of the inner rear spar web of the wing, cold expansion of the attachment holes of the forward pintle fitting and the actuating cylinder anchorage of the main landing gear (MLG), repetitive ultrasonic inspections for cracking of the rear spar of the wing, and corrective action if necessary. AD 2004-19-11 also provided optional terminating action for the repetitive inspections. This new AD retains the requirements of AD 2004-19-11, and requires the previously optional terminating action. This AD was prompted by a determination that the previously optional terminating action is necessary to address the unsafe condition. We are issuing this AD to prevent fatigue cracking of the inner rear spar, which may lead to reduced structural integrity of the wing and the MLG.

    DATES:

    This AD becomes effective June 8, 2016.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of June 8, 2016.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of November 5, 2004 (69 FR 58828, October 1, 2004).

    The Director of the Federal Register approved the incorporation by reference of certain other publications listed in this AD as of June 30, 2000 (65 FR 34069, May 26, 2000).

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of February 14, 1994 (59 FR 1903, January 13, 1994).

    The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of June 11, 1993 (58 FR 27923, May 12, 1993).

    ADDRESSES:

    For service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email [email protected]; Internet http://www.airbus.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-2015-5811.

    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-2015-5811; 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 AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (telephone 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.

    SUPPLEMENTARY INFORMATION:

    Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2004-19-11, Amendment 39-13805 (69 FR 58828, October 1, 2004) (“AD 2004-19-11”). AD 2004-19-11 applied to certain Airbus Model 320 series airplanes. The NPRM published in the Federal Register on November 27, 2015 (80 FR 74058) (“the NPRM”). The NPRM was prompted by a determination that the previously optional terminating action is necessary to address the unsafe condition. The NPRM proposed to retain the requirements of AD 2004-19-11, and requires the previously optional terminating action. We are issuing this AD to prevent fatigue cracking of the inner rear spar, which may lead to reduced structural integrity of the wing and the MLG.

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0169, dated July 17, 2014, corrected July 22, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on certain Airbus Model 320 series airplanes. The MCAI states:

    During centre fuselage certification full scale fatigue test, cracks were found on the inner rear spar at holes position 52 on the right hand wing due to fatigue aspects.

    This condition, if not detected and corrected, could affect the structural integrity of the aeroplane.

    To prevent such cracks, Airbus developed modifications, which were introduced in production and in service through several Airbus Service Bulletins (SB).

    DGAC France issued * * * [an earlier AD], which was subsequently superseded by [DGAC] AD 2001-249 [which corresponds with FAA AD 2004-19-11, Amendment 39-13805 (69 FR 58828, October 1, 2004)], to require modification of the rear spar on some aeroplanes, post-modification repetitive inspections and, depending on findings, accomplishment of a repair. DGAC France AD 2001-249 also specified that modification in accordance with Airbus SB A320-57-1089 (in-service equivalent to Airbus mod 24591) constituted (optional) terminating action for the repetitive inspections.

    Since that [DGAC] AD [2001-249] was issued, in the framework of the A320 Extended Service Goal (ESG), it has been determined that Airbus mod 24591 is necessary to allow aeroplanes to operate up to the new ESG limit.

    For the reasons described above, this [EASA] AD retains the requirements of DGAC France AD 2001-249, which is superseded, and requires modification of all pre-mod 24591 aeroplanes.

    The modification includes modifying all specified fastener holes in the inner rear spar of the wing. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-5811.

    Comments

    We gave the public the opportunity to participate in developing this AD. We considered the comment received. United Airlines provided its support for the content of the NPRM.

    Explanation of Changes Made to This AD

    We have added a new paragraph (l)(1) to this AD to provide credit for actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-57-1060, Revision 1, dated April 26, 1993. We have redesignated paragraphs (l)(1) and (l)(2) of the proposed AD as paragraphs (l)(2) and (l)(3) of this AD.

    Conclusion

    We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:

    • Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

    • Do not add any additional burden upon the public than was already proposed in the NPRM.

    Related Service Information Under 1 CFR Part 51

    Airbus has issued Airbus Service Bulletin A320-57-1089, Revision 03, dated February 9, 2001. This service information describes procedures for modification of the airplane by accomplishing cold re-expansion of the holes in the inner rear spar for the attachment of gear rib 5, forward pintle fitting, and actuating cylinder anchorage; and the installation of interference fit fasteners in the rear spar and gear rib 5. 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.

    Costs of Compliance

    We estimate that this AD affects 84 airplanes of U.S. registry.

    The actions required by AD 2004-19-11, and retained in this AD take about 684 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $13,644 per product. Based on these figures, the estimated cost of the actions that were required by AD 2004-19-11 is $71,784 per product.

    We also estimate that it takes about 980 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $32,727 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $9,746,268, or $116,027 per product.

    We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.

    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 AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:

    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.

    Adoption of the Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA amends 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 removing Airworthiness Directive (AD) 2004-19-11, Amendment 39-13805 (69 FR 58828, October 1, 2004), and adding the following new AD: 2016-08-13 Airbus: Amendment 39-18489. Docket No. FAA-2015-5811; Directorate Identifier 2014-NM-158-AD. (a) Effective Date

    This AD becomes effective June 8, 2016.

    (b) Affected ADs

    This AD replaces AD 2004-19-11, Amendment 39-13805 (69 FR 58828, October 1, 2004) (“AD 2004-19-11”).

    (c) Applicability

    This AD applies to Airbus Model A320-211, -212, -214, -231, -232, and -233 airplanes, certificated in any category, all manufacturer serial numbers, except those on which Airbus modification (mod) 24591 has been embodied in production.

    (d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

    (e) Reason

    This AD was prompted by reports of fatigue cracking of the inner rear spar of the wing and also by a determination that the modification of the inner rear spar is necessary to address the unsafe condition. We are issuing this AD to prevent fatigue cracking of the inner rear spar, which may lead to reduced structural integrity of the wing and the main landing gear (MLG).

    (f) Compliance

    Comply with this AD within the compliance times specified, unless already done.

    (g) Retained Modification of Inner Rear Spar Web of the Wing, With Change to Acceptable Service Information

    This paragraph restates the requirements of paragraph (a) of AD 2004-19-11, with a change to acceptable service information. For airplanes having manufacturer's serial numbers (MSNs) 003 through 008 inclusive, and 010 through 021 inclusive, except airplanes modified as specified in Airbus Service Bulletin A320-57-1089, dated December 22, 1996; Revision 01, dated April 17, 1997; Revision 02, dated November 6, 1998; or Revision 03, dated February 9, 2001: Prior to the accumulation of 12,000 total flight cycles, or within 500 flight cycles after June 11, 1993 (the effective date of AD 93-08-15, Amendment 39-8563 (58 FR 27923, May 12, 1993)), whichever occurs later, modify the inner rear spar web of the wing in accordance with Airbus Service Bulletin A320-57-1004, Revision 1, dated September 24, 1992; or Revision 2, dated June 14, 1993. As of the effective date of this AD, only Airbus Service Bulletin A320-57-1004, Revision 2, dated June 14, 1993, may be used for the actions required by this paragraph.

    (h) Retained Cold Expansion of Holes at Forward Pintle Fitting and Actuating Cylinder Anchorage of the Main Landing Gear, With Change to Acceptable Service Information

    This paragraph restates the requirements of paragraph (b) of AD 2004-19-11, with a change to acceptable service information. For airplanes having MSNs 002 through 051 inclusive, except airplanes modified as specified in Airbus Service Bulletin A320-57-1089, dated December 22, 1996; Revision 01, dated April 17, 1997; Revision 02, dated November 6, 1998; or Revision 03, dated February 9, 2001: Prior to the accumulation of 12,000 total flight cycles, or within 2,000 flight cycles after February 14, 1994 (the effective date of AD 93-25-13, Amendment 39-8777 (59 FR 1903, January 13, 1994)), whichever occurs later, accomplish the requirements of paragraphs (h)(1) and (h)(2) of this AD in accordance with Airbus Service Bulletin A320-57-1060, dated December 8, 1992; Revision 1, dated April 26, 1993; or Revision 2, dated December 16, 1994. As of the effective date of this AD, only Airbus Service Bulletin A320-57-1060, Revision 2, dated December 16, 1994, may be used for the actions required by this paragraph.

    (1) Perform a cold expansion of all the attachment holes for the forward pintle fitting of the main landing gear (MLG), except for the holes that are for taper-lok bolts.

    (2) Perform a cold expansion of the holes at the actuating cylinder anchorage of the MLG.

    (i) Retained Repetitive Ultrasonic Inspections for Cracking of the Rear Spar of the Wing, With No Changes

    This paragraph restates the requirements of paragraphs (c), (d), and (e) of AD 2004-19-11, with no changes. Except for airplanes modified as specified in Airbus Service Bulletin A320-57-1089, dated December 22, 1996; Revision 01, dated April 17, 1997; Revision 02, dated November 6, 1998; or Revision 03, dated February 9, 2001: Do the actions specified in paragraphs (i)(1) and (i)(2) of this AD.

    (1) Do an ultrasonic inspection for cracking of the rear spar of the wing, in accordance with Airbus Service Bulletin A320-57-1088, Revision 04, dated August 6, 2001. Inspect at the applicable time specified in paragraph 1.E. of Airbus Service Bulletin A320-57-1088, Revision 04, dated August 6, 2001, except as required by paragraphs (i)(1)(i) and (i)(1)(ii) of this AD.

    (i) For any airplane that has not been inspected but has exceeded the applicable specified compliance time in paragraph 1.E. of Airbus Service Bulletin A320-57-1088, Revision 04, dated August 6, 2001, as of November 5, 2004 (the effective date of AD 2004-19-11): Inspect within 18 months after November 5, 2004.

    (ii) For any airplane that has been inspected before November 5, 2004 (the effective date of AD 2004-19-11): Repeat the inspection within 3,600 flight cycles after the most recent inspection.

    (2) Repeat the inspection required by paragraph (i)(1) of this AD at intervals not to exceed 3,600 flight cycles or 6,700 flight hours, whichever occurs first, until the requirements of paragraph (k) of this AD have been done.

    (j) Retained Corrective Action for Inspections Required by Paragraphs (i)(1) and (i)(2) of This AD, With Specific Delegation Approval Language

    This paragraph restates the requirements of paragraph (f) of AD 2004-19-11, with specific delegation approval language. If any crack is found during any inspection required by paragraph (i)(1) or (i)(2) of this AD: Before further flight, repair in accordance with a method approved by either the Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate; or the Direction Générale de l'Aviation Civile (or its delegated agent); or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA). Accomplishment of a repair as required by this paragraph does not constitute terminating action for the repetitive inspections required by paragraph (i)(2) of this AD.

    (k) New Requirement of This AD: Modification of the Inner Rear Spar

    Before exceeding 48,000 flight cycles or 96,000 flight hours, whichever occurs first since first flight of the airplane: Modify all specified fastener holes in the inner rear spar of the wing, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1089, Revision 03, dated February 9, 2001; except, where Airbus Service Bulletin A320-57-1089, Revision 03, dated February 9, 2001, specifies to contact Airbus for certain conditions, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA. Modification of all specified fastener holes in the rear spar of the wing terminates the initial and repetitive inspections required by paragraphs (i)(1) and (i)(2) of this AD. If the modification is done both before the airplane accumulates 12,000 total flight cycles and before the effective date of this AD, the modification also terminates the actions required by paragraphs (g) and (h) of this AD.

    (l) Credit for Previous Actions

    (1) This paragraph provides credit for actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-57-1060, Revision 1, dated April 26, 1993. This service information is not incorporated by reference in this AD.

    (2) This paragraph provides credit for actions required by paragraph (i) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-57-1088, Revision 02, dated July 29, 1999; or Revision 03, dated February 9, 2001. This service information is not incorporated by reference in this AD.

    (3) This paragraph provides credit for actions required by paragraph (k) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-57-1089, Revision 02, dated November 6, 1998. This service information is not incorporated by reference in this AD.

    (m) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149. Information may be emailed to: [email protected]

    (i) 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. The AMOC approval letter must specifically reference this AD.

    (ii) AMOCs approved previously in accordance with AD 2004-19-11 are approved as AMOCs for the corresponding provisions of paragraphs (g) through (j) of this AD.

    (2) Contacting the Manufacturer: As of the effective date of this AD, for any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA. If approved by the DOA, the approval must include the DOA-authorized signature.

    (n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0169, dated July 17, 2014, corrected July 22, 2014, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-5811.

    (2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (o)(8) and (o)(9) of this AD.

    (o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.

    (3) The following service information was approved for IBR on June 8, 2016.

    (i) Airbus Service Bulletin A320-57-1089, Revision 03, dated February 9, 2001.

    (ii) Reserved.

    (4) The following service information was approved for IBR on November 5, 2004 (69 FR 58828, October 1, 2004).

    (i) Airbus Service Bulletin A320-57-1088, Revision 04, dated August 6, 2001.

    (ii) Reserved.

    (5) The following service information was approved for IBR on June 30, 2000 (65 FR 34069, May 26, 2000).

    (i) Airbus Service Bulletin A320-57-1004, Revision 2, dated June 14, 1993. This service bulletin contains the following list of effective pages: Pages 1, 4, 12, 14, 17 through 20, 22, 23, 28, 29, Revision 2, dated June 14, 1993; page 15, Revision 1, dated September 24, 1992; and pages 2, 3, 5 through 11, 13, 16, 21, 24 through 27, 30, Original Issue, dated July 9, 1991.

    (ii) Airbus Service Bulletin A320-57-1060, Revision 2, dated December 16, 1994.

    (6) The following service information was approved for IBR on February 14, 1994 (59 FR 1903, January 13, 1994).

    (i) Airbus Service Bulletin A320-57-1060, dated December 8, 1992.

    (ii) Reserved.

    (7) The following service information was approved for IBR on June 11, 1993 (58 FR 27923, May 12, 1993).

    (i) Airbus Service Bulletin A320-57-1004, Revision 1, dated September 24, 1992. This service bulletin contains the following list of effective pages: Pages 1, 4, 12, 14 through 15, 17 through 18, 20, Revision 1, dated September 24, 1992; and pages 2 through 3, 5 through 11, 13, 16, 19, 21 through 30, Original Issue, dated July 9, 1991.

    (ii) Reserved.

    (8) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email [email protected]; Internet http://www.airbus.com.

    (9) You may view this 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.

    (10) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on April 8, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-08956 Filed 5-3-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-3990; Directorate Identifier 2014-NM-255-AD; Amendment 39-18478; AD 2016-08-02] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

    Federal Aviation Administration (FAA), Department of Transportation (DOT).

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain Airbus Model A320-214, -232, and -233 airplanes; and Airbus Model A321-211 and -231 airplanes. This AD was prompted by reports of incorrect installation of jiffy joint connectors on cables connected to certain passenger service units (PSUs), which could cause the passenger oxygen container to malfunction if the connector becomes disengaged during flight due to vibration. This AD requires identification of the affected PSUs, and depending on findings, doing applicable related investigative and corrective actions. We are issuing this AD to prevent failure of the door of the passenger oxygen container to open in the event of airplane decompression, resulting in lack of oxygen supply and consequent injury to occupants.

    DATES:

    This AD becomes effective June 8, 2016.

    The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of June 8, 2016.

    ADDRESSES:

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-3990; or in person at the Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

    For Airbus service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email [email protected]; Internet http://www.airbus.com.

    For Airbus Operations GmbH service information identified in this final rule, contact Airbus Operations GmbH, Cabin Electronics, Lueneburger Schanze 30, 21614 Buxtehude, Germany; telephone +49 40 7437 46 32; telefax +49 40 7437 16 80; email [email protected]

    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-2015-3990.

    FOR FURTHER INFORMATION CONTACT:

    Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.

    SUPPLEMENTARY INFORMATION:

    Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A320-214, -232, and -233 airplanes; and Airbus Model A321-211 and -231 airplanes. The NPRM published in the Federal Register on October 19, 2015 (80 FR 63134) (“the NPRM”).

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0256, dated November 26, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A320-214, -232, and -233 airplanes; and Airbus Model A321-211 and -231 airplanes. The MCAI states:

    A quality issue was reported regarding incorrect installation of jiffy joint connectors on cables connected to certain Passenger Service Units (PSU), which may lead to a malfunction of the passenger oxygen container in case of connector disengagement during flight due to vibrations. All the aeroplanes that had a potentially affected PSU installed were identified. Most of those aeroplanes were corrected during a specific quality inspection on the final assembly line prior to customer delivery. Unfortunately, a limited number of aeroplanes were delivered before the quality inspection was implemented.

    This condition, if not detected and corrected, could lead to failure of the door of the passenger oxygen container and open in case of aeroplane decompression, possibly resulting in lack of oxygen supply and consequent injury to occupants.

    For the reasons described above, this [EASA] AD requires identification of the affected PSU and, depending on the findings, * * * related investigative and corrective actions.

    Related investigative actions include a detailed inspection to determine if the jiffy joint connector works properly. Corrective actions include rework or replacement of the jiffy joint connectors.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3990.

    Comments

    We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

    Conclusion

    We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed, except for minor editorial changes. We have determined that these minor changes:

    • Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

    • Do not add any additional burden upon the public than was already proposed in the NPRM.

    Related Service Information Under 1 CFR Part 51

    Airbus has issued the following service information.

    • Airbus Service Bulletin A320-25-1B20, dated October 9, 2014. This service information describes procedures for inspecting for affected PSU part numbers and serial numbers, and depending on findings, doing applicable related investigative and corrective actions. Related investigative actions include a detailed inspection to determine if the jiffy joint connector works properly. Corrective actions include rework or replacement of the jiffy joint connectors.

    • Airbus Operations GmbH Vendor Service Bulletin Z315H-25-004, dated September 26, 2014, including Attachment 1, “List of affected PSU PNR and S/N” (the attachment is not numbered or dated). This service information describes procedures for inspecting for the connection of the jiffy joint connectors, and depending on findings, doing rework or replacement of the jiffy joint connectors.

    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.

    Costs of Compliance

    We estimate that this AD affects 7 airplanes of U.S. registry.

    We also estimate that it takes about 5 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost $0 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $2,975, or $425 per product.

    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 AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:

    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.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-3990; 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 AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

    List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

    Adoption of the Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA amends 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): 2016-08-02 Airbus: Amendment 39-18478. Docket No. FAA-2015-3990; Directorate Identifier 2014-NM-255-AD. (a) Effective Date

    This AD becomes effective June 8, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Airbus Model A320-214, -232, and -233 airplanes; and Airbus Model A321-211 and -231 airplanes, certificated in any category, having manufacturer serial numbers (MSNs) 5583, 5598, 5602, 5604, 5608, 5610, 5613 through 5622 inclusive, 5624 through 5627 inclusive, 5629 through 5632 inclusive, 5634 through 5636 inclusive, 5638, 5640 through 5644 inclusive, 5646 through 5649 inclusive, 5651 through 5653 inclusive, 5655, 5657 through 5661 inclusive, 5663, 5665, 5667, 5670, 5672, 5673, and 5675.

    (d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/Furnishings.

    (e) Reason

    This AD was prompted by reports of incorrect installation of jiffy joint connectors on cables connected to certain passenger service units (PSU), which could cause the passenger oxygen container to malfunction if the connector becomes disengaged during flight due to vibration. We are issuing this AD to prevent failure of the door of the passenger oxygen container to open in the event of airplane decompression, resulting in lack of oxygen supply and consequent injury to occupants.

    (f) Compliance

    Comply with this AD within the compliance times specified, unless already done.

    (g) Inspection and Related Investigative and Corrective Actions

    Within 7,500 flight hours or 26 months after the effective date of this AD, whichever occurs first, do an inspection to identify the part number and serial number of each PSU, and if an affected part number or serial number is found, do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-25-1B20, dated October 9, 2014. Do all applicable related investigative and corrective actions within 7,500 flight hours or 26 months after the effective date of this AD, whichever occurs first. An affected PSU part number or serial number is one listed in Attachment 1, “List of affected PSU PNR and S/N,” of Airbus Operations GmbH Vendor Service Bulletin Z315H-25-004, dated September 26, 2014. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number and serial number of the PSU can be conclusively determined from that review.

    (h) Clarification of Vendor Service Information

    On page 13 of Airbus Operations GmbH Vendor Service Bulletin Z315H-25-004, dated September 26, 2014, Table 4 (“List of Attachments”) under the heading “APPENDIX” identifies “Attachment 1, `List of affected PSU PNR and S/N.' ” The attachment is not numbered or dated.

    (i) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149. Information may be emailed to: [email protected] 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. The AMOC approval letter must specifically reference this AD.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

    (3) Required for Compliance (RC): If any service information contains procedures or tests that are identified as RC, those procedures and tests must be done to comply with this AD; any procedures or tests that are not identified as RC are recommended. Those procedures and tests that are not identified 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 procedures and tests identified as RC can be done and the airplane can be put back in an airworthy condition. Any substitutions or changes to procedures or tests identified as RC require approval of an AMOC.

    (j) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0256, dated November 26, 2014, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3990.

    (k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.

    (i) Airbus Operations GmbH Vendor Service Bulletin Z315H-25-004, dated September 26, 2014, including Attachment 1, “List of affected PSU PNR and S/N.” No page of the attachment to this document provides a document number, revision level, or date.

    (ii) Airbus Service Bulletin A320-25-1B20, dated October 9, 2014.

    (3) For Airbus service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email [email protected]; Internet http://www.airbus.com.

    (4) For Airbus Operations GmbH service information identified in this final rule, contact Airbus Operations GmbH, Cabin Electronics, Lueneburger Schanze 30, 21614 Buxtehude, Germany; telephone +49 40 7437 46 32; telefax +49 40 7437 16 80; email r[email protected]

    (5) You may view this 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.

    (6) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on March 31, 2016. Victor Wicklund, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-08532 Filed 5-3-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6147; Directorate Identifier 2016-NM-021-AD; Amendment 39-18506; AD 2016-09-08] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule; request for comments.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 747-8 series airplanes. This AD requires a detailed inspection for correct installation of the flex hose clamp of the occupant backup air supply and a general visual inspection for damage of the flex hose, and related investigative and corrective actions if necessary. This AD was prompted by a report indicating that flex hoses of the occupant backup air supply were found disconnected from the adjacent fiberglass duct on two airplanes. We are issuing this AD to detect and correct an incorrect clamp installation on the inboard end of the flex hose, which allows the flex hose to slowly become disconnected from the adjacent fiberglass duct, and damage to the hose. This condition, in conjunction with a cargo fire event, can potentially lead to decreased airflow to the main deck, possibly resulting in smoke and/or toxic fumes penetrating into the main deck passenger compartment, which could result in injury to the passengers or cabin crew.

    DATES:

    This AD is effective May 19, 2016.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of May 19, 2016.

    We must receive comments on this AD by June 20, 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: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    For service information identified in this final rule, 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-2016-6147.

    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-2016-6147; 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 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:

    Stanley Chen, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6585; fax: 425-917-6590; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Discussion

    We have received a report indicating that an operator, while on a maintenance visit, found a flex hose of the occupant backup air supply disconnected from the adjacent fiberglass duct on two airplanes. One of the flex hoses had a tear on the disconnected edge. A Boeing investigation found that these incidents were caused by the incorrect clamp installation on the inboard end of the flex hose, which is a quality control problem that allowed the flex hose to slowly become disconnected from the adjacent fiberglass duct. No related system faults were reported. We are issuing this AD to detect and correct an incorrect clamp installation on the inboard end of the flex hose, which allows the flex hose to slowly become disconnected from the adjacent fiberglass duct, and damage to the hose. This condition, in conjunction with a cargo fire event, can potentially lead to decreased airflow to the main deck, possibly resulting in smoke and/or toxic fumes penetrating into the main deck passenger compartment, which could result in injury to the passengers or cabin crew.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 747-21A2571, dated December 4, 2015. The service information describes procedures for a detailed visual inspection of the clamp installation on the inboard end of the flex hose and general visual inspection of the flex hose for damage, and related investigative and corrective actions 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 issuing 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.

    AD Requirements

    This AD requires accomplishing the actions specified in the service information described previously.

    The phrase “related investigative actions” is used in this AD. Related investigative actions are follow-on actions that (1) are related to the primary action, and (2) further investigate the nature of any condition found. Related investigative actions in an AD could include, for example, inspections.

    The phrase “corrective actions” is used in this AD. Corrective actions correct or address any condition found. Corrective actions in an AD could include, for example, repairs.

    FAA's Justification and Determination of the Effective Date

    There are currently no domestic operators of this product. Therefore, we find that notice and opportunity for prior public comment are unnecessary and that good cause exists for making this amendment effective in less than 30 days.

    Comments Invited

    This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2016-6147 and Directorate Identifier 2016-NM-021-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this 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 AD.

    Costs of Compliance

    Currently, there are no affected airplanes on the U.S. Register. However, if an affected airplane is imported and placed on the U.S. Register in the future, we estimate the following costs to comply with this AD:

    Estimated Costs Action Labor cost Cost per product Inspection of inboard end of the flex hose 3 work-hours × $85 per hour = $255 per inspection cycle $255 per inspection cycle

    We estimate the following costs to do any necessary repairs that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need this repair:

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Repair or replacement of inboard end of the flex hose Up to 3 work-hours × $85 per hour = $255 $65 per flex hose $320
    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

    This AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:

    (1) Is not a “significant regulatory action” under Executive Order 12866,

    (2) Is not a “significant rule” under 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.

    Adoption of the Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA amends 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): 2016-09-08 The Boeing Company: Amendment 39-18506; Docket No. FAA-2016-6147; Directorate Identifier 2016-NM-021-AD. (a) Effective Date

    This AD is effective May 19, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to The Boeing Company Model 747-8 series airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin 747-21A2571, dated December 4, 2015.

    (d) Subject

    Air Transport Association (ATA) of America Code 21, Air conditioning.

    (e) Unsafe Condition

    This AD was prompted by a report indicating that flex hoses of the occupant backup air supply were found disconnected from the adjacent fiberglass duct on two airplanes. We are issuing this AD to detect and correct an incorrect clamp installation on the inboard end of the flex hose, which allows the flex hose to slowly become disconnected from the adjacent fiberglass duct, and damage to the hose. This condition, in conjunction with a cargo fire event, can potentially lead to decreased airflow to the main deck, possibly resulting in smoke and/or toxic fumes penetrating into the main deck passenger compartment, which could result in injury to the passengers or cabin crew.

    (f) Compliance

    Comply with this AD within the compliance times specified, unless already done.

    (g) Inspection and Repair of Backup Air Supply Clamp and Flex Hose

    Except as required by paragraph (h) of this AD, at the applicable time in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-21A2571, dated December 4, 2015, do a detailed inspection for correct installation of the backup air supply clamp, and before further flight, do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-21A2571, dated December 4, 2015.

    (h) Exception to the Service Information

    Where paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-21A2571, dated December 4, 2015, 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.

    (i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle 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) 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, Seattle 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. 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

    For more information about this AD, contact Stanley Chen, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6585; fax: 425-917-6590; email: [email protected]

    (k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.

    (i) Boeing Alert Service Bulletin 747-21A2571, dated December 4, 2015.

    (ii) Reserved.

    (3) 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.

    (4) You may view this 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.

    (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on April 21, 2016. John P. Piccola, Jr., Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-10158 Filed 5-3-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2015-3675; Airspace Docket No. 15-ANM-19] Amendment of Class D and Class E Airspace; Walla Walla, WA AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This action modifies Class D airspace, Class E surface area airspace, Class E surface area airspace designated as an extension, and Class E airspace extending upward from 700 feet above the surface at Walla Walla Regional Airport, Walla Walla, WA. After a review of the airspace, the FAA found it necessary to amend the airspace areas for the safety and management of Instrument Flight Rules (IFR) operations for arriving and departing aircraft at the airport. This action also updates the geographic coordinates of Walla Walla Regional Airport in the respective Class D and E airspace areas above.

    DATES:

    Effective 0901 UTC, July 21, 2016. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.

    ADDRESSES:

    FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.9Z at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

    FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4511.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Walla Walla, WA.

    History

    On November 27, 2015, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to modify Class D airspace, Class E surface area airspace, Class E surface area airspace designated as an extension, and Class E airspace extending upward from 700 feet above the surface at Walla Walla Regional Airport, Walla Walla, WA, (80 FR 74063) Docket No. FAA-2015-3675. The FAA found these modifications necessary to ensure the safety and management of Instrument Flight Rules (IFR) operations for arriving and departing aircraft at the airport. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

    Class D and Class E airspace designations are published in paragraph 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1.

    Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class D airspace, Class E surface area airspace, Class E surface area airspace designated as an extension, and Class E airspace extending upward from 700 feet above the surface at Walla Walla Regional Airport, Walla Walla, WA. Class D airspace and all Class E airspace areas are modified to correct geographic latitude and longitude (lat./long.) errors in the legal description. Class E airspace designated as an extension is modified to include that area within 2.7 miles each side of the Walla Walla Airport 215° bearing extending from the 4.3-mile radius to 7.5 miles southwest of the airport, and that airspace within 4.1 miles each side of the airport 035° bearing extending from the 4.3-mile radius to 13.4 miles northeast of the airport. Class E airspace extending upward from 700 feet above the surface is modified to include that area bounded by a line beginning at lat. 45°52′29″ N., long. 118°23′027″ W.; to lat. 45°49′51″ N., long. 118°26′02″ W.; to lat. 45°57′17″ N., long. 118°40′49″ W.; to lat. 46°10′22″ N., long. 118°27′48″ W.; to lat. 46°08′46″ N., long. 118°24′32″ W.; to lat. 46°14′38″ N., long. 118°18′44″ W.; to lat. 46°16′07″ N., long. 118°21′47″ W.; to lat. 46°29′20″ N., long. 118°08′35″ W.; to lat. 46°22′02″ N., long. 117°53′24″ W.; to lat. 46°14′25″ N., long. 118°01′11″ W.; and that airspace within a 13.4-mile radius of point in space coordinates at lat. 46°03′27″ N., long. 118°12′20″ W., from the 052° bearing from the Walla Walla Regional Airport clockwise to the 198° bearing.

    Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    Environmental Review

    The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

    PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for Part 71 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015, is amended as follows: Paragraph 5000 Class D Airspace. ANM WA D Walla Walla, WA Walla Walla Regional Airport, WA (Lat. 46°05′43″ N., long. 118°17′09″ W.)

    That airspace extending upward from the surface to and including 3,700 feet MSL within a 4.3-mile radius of the Walla Walla Regional Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.

    Paragraph 6002 Class E Airspace Designated as Surface Areas. ANM WA E2 Walla Walla, WA Walla Walla Regional Airport, WA (Lat. 46°05′43′ N., long. 118°17′09″ W.)

    That airspace extending upward from the surface within a 4.3-mile radius of the Walla Walla Regional Airport.

    Paragraph 6004 Class E Airspace Areas Designated as an Extension to a Class D or Class E Surface Area. ANM WA E4 Walla Walla, WA Walla Walla Regional Airport, WA (Lat. 46°05′43″ N., long. 118°17′09″ W.)

    That airspace extending upward from the surface within 2.7 miles each side of the Walla Walla 215° bearing from the airport extending from the 4.3-mile radius of Walla Walla Regional Airport to 7.5 miles southwest of the airport, and within 4.1 miles each side of the Walla Walla 35° bearing from the airport extending from the 4.3-mile radius of Walla Walla Regional Airport to 13.4 miles northeast of the airport.

    Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ANM WA E5 Walla Walla, WA Walla Walla Regional Airport, WA (Lat. 46°05′43″ N., long. 118°17′09″ W.) Walla Walla Regional Airport, point in space coordinates (Lat. 46°03′27″ N., long. 118°12′20″ W.)

    That airspace extending upward from 700 feet above the surface bounded by a line beginning at lat. 45°52′29″ N., long. 118°23′027″ W.; to lat. 45°49′51″ N., long. 118°26′02″ W.; to lat. 45°57′17″ N., long. 118°40′49″ W.; to lat. 46°10′22″ N., long. 118°27′48″ W.; to lat. 46°08′46″ N., long. 118°24′32″ W.; to lat. 46°14′38″ N., long. 118°18′44″ W.; to lat. 46°16′07″ N., long. 118°21′47″ W.; to lat. 46°29′20″ N., long. 118°08′35″ W.; to lat. 46°22′02″ N., long. 117°53′24″ W.; to lat. 46°14′25″ N., long. 118°01′11″ W.; and that airspace within a 13.4-mile radius of point in space coordinates at lat. 46°03′27″ N., long. 118°12′20″ W., from the 052° bearing from the Walla Walla Regional Airport clockwise to the 198° bearing.

    Issued in Seattle, Washington, on April 21, 2016. Tracey Johnson, Manager, Operations Support Group, Western Service Center.
    [FR Doc. 2016-10179 Filed 5-3-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 610 [Docket No. FDA-2016-N-1170] Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Direct final rule.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency or we) is amending the general biological products standards relating to dating periods and also removing certain standards relating to standard preparations and limits of potency. FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This action is part of FDA's retrospective review of its regulations in response to an Executive order. FDA is issuing these amendments directly as a final rule because the Agency believes they are noncontroversial and FDA anticipates no significant adverse comments.

    DATES:

    This rule is effective September 16, 2016. Submit either electronic or written comments on this direct final rule or its companion proposed rule by July 18, 2016. If FDA receives no significant adverse comments within the specified comment period, the Agency intends to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule within 30 days after the comment period on this direct final rule ends.

    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-1170 for “Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products.” 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:

    Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Executive Summary A. Purpose of Direct Final Rule

    FDA is issuing this direct final rule because revision and removal of certain general biological products standards will update outdated requirements and accommodate new and evolving technology and testing capabilities without diminishing public health protections. FDA is taking this action because the existing codified requirements are duplicative of requirements that are also specified in biologics license applications (BLAs) or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products.

    B. Summary of the Major Provisions of the Direct Final Rule

    This direct final rule removes the requirements contained in § 610.20 (21 CFR 610.20) from the regulations. FDA is taking this action because the standard preparations listed in the regulation are obsolete, no longer available, or described on a product specific basis in BLAs. In addition, FDA believes that it is no longer necessary to restrict the source of standard preparations to the Center for Biologics Evaluation and Research (CBER), since appropriate standard preparations can often be obtained from other sources. Section 610.21 is removed because these potency limits are either obsolete or best described on a product specific basis in the BLA. Section 610.50 is amended to remove references to §§ 610.20 and 610.21 and official potency tests and to reflect FDA's updated approach to establishing dates of manufacture. Section 610.53 is amended to remove products no longer manufactured and products for which dating information is identified in the BLA of each individual product, and to reflect updated practices for the remaining products.

    C. Legal Authority

    FDA is taking this action under the biological products provisions of the Public Health Service Act (PHS Act), and the drugs and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

    D. Costs and Benefits

    Because this direct final rule does not impose any additional regulatory burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal.

    II. Direct Final Rulemaking

    In the document entitled “Guidance for FDA and Industry: Direct Final Rule Procedures,” announced and provided in the Federal Register of November 21, 1997 (62 FR 62466), FDA described its procedures on when and how the Agency will employ direct final rulemaking. The guidance may be accessed at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm. We have determined that this rule is appropriate for direct final rulemaking because we believe that it includes only noncontroversial amendments and we anticipate no significant adverse comments. Consistent with our procedures on direct final rulemaking, FDA is also publishing elsewhere in this issue of the Federal Register a companion proposed rule proposing to amend the general biological products standards relating to dating periods and to remove those relating to standard preparations and limits of potency. The companion proposed rule provides a procedural framework within which the rule may be finalized in the event that the direct final rule is withdrawn because of any significant adverse comments. The comment period for the direct final rule runs concurrently with the companion proposed rule. Any comments received in response to the companion proposed rule will be considered as comments regarding the direct final rule.

    We are providing a comment period on the direct final rule of 75 days after the date of publication in the Federal Register. If we receive any significant adverse comments, we intend to withdraw this direct final rule before its effective date by publication of a notice in the Federal Register. A significant adverse comment is defined as a comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants terminating a direct final rulemaking, we will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process. Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. A comment recommending a regulation change in addition to those in this direct final rule would not be considered a significant adverse comment unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to part of this rule and that part can be severed from the remainder of the rule (e.g., where, as here, a direct final rule deletes several unrelated regulations), we may adopt as final those provisions of the rule that are not the subject of the significant adverse comment.

    If any significant adverse comments are received during the comment period, FDA will publish, before the effective date of this direct final rule, a document withdrawing the direct final rule. If we withdraw the direct final rule, any comments received will be applied to the proposed rule and will be considered in developing a final rule using the usual notice-and-comment procedures.

    If FDA receives no significant adverse comments during the specified comment period, FDA intends to publish a document confirming the effective date within 30 days after the comment period ends.

    III. Background

    On January 18, 2011, President Barack Obama issued Executive Order 13563, “Improving Regulation and Regulatory Review” (76 FR 3821, January 21, 2011). One of the provisions in the Executive Order requires Agencies to consider how best to promote the retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned (76 FR 3821 at 3822). As one step in implementing the Executive Order, FDA published a notice in the Federal Register of April 27, 2011 (76 FR 23520) entitled “Periodic Review of Existing Regulations; Retrospective Review Under E.O. 13563.” In that notice, FDA announced that it was conducting a review of existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of, and support, advances in innovation that have occurred since those regulations took effect. As part of this initiative, FDA is updating outdated regulations as specified in this rule.

    FDA's general biological products standards in part 610 are intended to help ensure the safety, purity, and potency of biological products administered to humans. The revision and removal of certain general biological products standards are designed to update outdated requirements and accommodate new and evolving manufacturing and control testing technology. The rule provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.

    A. Sections 610.20 and 610.21

    Standard preparations are generally used to perform lot release testing or other specific product characterization assays. Under the current standard preparations, § 610.20, FDA requires specific standard preparations to be used for a small number of the biological products FDA regulates unless a modification is permitted under § 610.9. Specifically, according to current § 610.20 Standard preparations, standard preparations, made available by CBER, are required to be used in the testing of potency or opacity of certain biological products, mostly biological products that were initially licensed several decades ago. Most of these standard preparations requirements are now obsolete, because either CBER no longer provides the listed standard preparations, or the specific biological products are no longer manufactured, or both. In addition, standard preparations to help ensure the safety, purity, and potency of particular biological products can often be obtained from sources other than CBER now, including international sources, or can be developed internally by the applicant. Thus, FDA believes it is no longer necessary to specify CBER as the source of standard preparations in § 610.20. For these reasons, FDA is removing § 610.20. Consistent with current practice and BLAs, CBER will continue to make and supply standard preparations when appropriate, as well as continue to collaborate with external organizations in the development and assessment of physical standard preparations for biological products.

    Under the current § 610.21 Limits of potency, FDA specifies minimal potency limits to be met for the antibodies and antigens listed. However, most of the biological products subject to the specified potency limits are no longer manufactured. In addition, for those that are still manufactured, or for anyone wanting to manufacture the listed products, FDA's updated practice is to have the potency limit also be specified in the BLA. For this reason, FDA is removing § 610.21. As a result of removing §§ 610.20 and 610.21, part 610, subpart C is removed and reserved.

    In addition to sometimes being duplicative of information provided in the BLA and unnecessarily restrictive regarding the source of standard preparations, the codification by regulation of many of the standard preparations and limits of potency for certain biological products sometimes does not keep abreast of technological advances in science related to manufacturing and testing. For many years, because of the potential for impeding scientific progress, FDA has not codified additional specific standard preparations and limits of potency for licensed biological products, but instead the standards are established in the BLA. Failure to conform to applicable standards established in the license is grounds for revocation under § 601.5(b)(1)(iv) (21 CFR 601.5(b)(1)(iv)). Notwithstanding the changes in this rule, FDA will continue to require that each biological product meet standards to assure that the product is safe, pure, and potent, and will continue to require that each lot demonstrate conformance with the standards applicable to that product (see § 610.1) through appropriate testing. Therefore, we expect that standard preparations and potency limits will be established in the BLA and may be changed only in accordance with regulations for reporting post-approval changes (see § 601.12). Furthermore, no lot of any licensed product may be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such product (see § 610.1).

    FDA is therefore amending its regulations to remove §§ 610.20 and 610.21 because appropriate standard preparations and potency limits for any listed product are specified during the licensing process on a product specific basis. The removal of §§ 610.20 and 610.21 will also increase regulatory flexibility by allowing industry and FDA to more readily use and incorporate current scientific technology and other appropriate reference materials in the manufacture and regulation of licensed biological products.

    B. Sections 610.50 and 610.53

    A biological product is expected to remain stable and retain its identity, strength, quality, and purity for a period of time after manufacture when it is properly stored. The dating period limitations regulations provided at §§ 610.50 and 610.53 specify how the date of manufacture for biological products will be determined, when the dating begins, and dating periods for certain biological products. The existing § 610.50 prescribes how the date of manufacture is determined for biological products and relies in part upon §§ 610.20 and 610.21 or official standards of potency (i.e., a specific test method described in regulation). With the removal of §§ 610.20 and 610.21 for reasons described in this document, FDA is revising § 610.50 to reflect FDA's updated approach to establishing dates of manufacture.

    In addition, current § 610.50(b) does not provide FDA or applicants with flexibility to consider the variety of manufacturing situations and technologies that exist today and which may occur in the future. Since 1977, when the regulation was last amended, new methods of manufacture and testing often associated with new biological products have been developed. The revisions to § 610.50 provided in this direct final rule therefore allow additional manufacturing activities other than those currently listed to be used to determine the date of manufacture.

    Under the revised regulation, the date of manufacture must be identified in the approved BLA. FDA recommends that applicants discuss a suitable date of manufacture with FDA during late clinical development and propose a date of manufacture in the BLA. We consider the underlying science and manufacturing process testing methods in determining the date of manufacture for each specific product. The approved BLA will specify how the date of manufacture is determined. A paragraph is being added, § 610.50(c), specifying how the date of manufacture for Whole Blood and blood components is determined. This will assist in complying with the dating periods prescribed for Whole Blood and blood components in the revised table in redesignated § 610.53(b).

    The current table at § 610.53(c) lists dating periods, manufacturer's storage periods, and storage conditions for many biological products. The table in § 610.53(c) (which is redesignated as § 610.53(b)) is revised to remove products where storage conditions and dating periods are established to help ensure the continued safety, potency, and purity of each individual product, based upon information submitted in the relevant BLA. The dating period and storage conditions for these products will be identified in the BLA. The table in § 610.53(c) is also revised to delete those products that are no longer manufactured. We are retaining those products, specifically Whole Blood and blood components, whose dating periods are based upon data relating to the anticoagulant or preservative solution in the product, usage, clinical experience, laboratory testing, or further processing. The list is updated to include currently licensed Whole Blood and blood component products with their applicable storage temperatures and dating periods.

    In listing the dating periods for Whole Blood and blood component products, we took into account existing regulations, guidance documents, package inserts for solutions used for manufacture or storage of Whole Blood and blood components, and operator instruction manuals for devices used in the manufacture of Whole Blood and blood component products. Because we understand from these materials that these dating periods are in current use, and because blood establishments can request an exception under § 640.120 (21 CFR 640.120), we do not anticipate significant objections to codifying this information. Similarly, we are removing § 610.53(d) because it is duplicative of § 640.120. In addition, we recognize that future scientific understanding and new technology, such as the implementation of pathogen reduction technology or the approval of extended storage systems, could affect what dating periods would be necessary, as a scientific matter, for Whole Blood and blood components. For this reason, the rule allows for changes to the dating periods specified in § 610.53(b) when the dating period is otherwise specified in the instructions for use by the blood collection, processing, and storage system approved or cleared for such use by FDA.

    In conclusion, the amendments to the regulations provided by this rule are designed to be consistent with updated practices in the biological product industry and to remove unnecessary or outdated requirements. FDA is taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations to provide flexibility without diminishing public health protection. Given the additional flexibility provided by these revised regulations, FDA does not anticipate that applicants for licensed biological products will need to revise information in BLAs in order to conform to the revised regulations.

    IV. Highlights of the Direct Final Rule

    FDA is revising the general biological products standards relating to dating periods and removing certain standard preparations and limits of potency. These changes are designed to remove unnecessary or outdated requirements, and accommodate new and evolving technology and testing capabilities without diminishing public health protections. FDA is issuing these revisions directly as a final rule because the Agency believes they include only noncontroversial amendments and FDA anticipates no significant adverse comments.

    FDA is removing § 610.20 because the standard preparations listed are obsolete or no longer available; standard preparations to ensure the safety, purity, and potency of a product can best be determined on a product specific basis; and standard preparations may be obtained from other sources. Applicants for biological product licenses currently identify standard preparations in the BLA, and the proposed standard preparations and their purpose are reviewed by FDA during the regulatory process. The standard preparations may include standard preparations developed by the applicant as well as appropriate standard preparations that can be obtained from other sources. Consistent with current practice, CBER will continue to make and supply standard preparations when appropriate, as well as continue to collaborate with external organizations in the development and assessment of physical standard preparations for licensed biological products.

    We are removing § 610.21 because these potency limits are best described in the BLAs on a product specific basis. Applicants for biological product licenses already identify standards for potency to help ensure the safety, purity, and potency of the product within their BLA, and the proposed standards are reviewed by FDA during the regulatory process. The use of a potency limit is suitably described in the specific product's BLA and allows for its continued and appropriate use in the absence of § 610.21.

    We are revising § 610.50 by making a minor amendment to the section heading, removing the current language, redesignating § 610.53(b) as § 610.50(a) with edits, revising § 610.50(b), and adding new § 610.50(c). Current § 610.53(b), which applies to all biological products, has been moved to § 610.50(a) and edits have been made for better organization and clarification. Section 610.50(b) is being revised and § 610.50(c) is being added to clarify how the date of manufacture is set for purposes of determining the dating period for general biological products and for Whole Blood and blood components, respectively.

    We are amending the section heading of § 610.53 to reflect that it only addresses dating periods for Whole Blood and blood components. We are revising § 610.53(a) since this section only applies to the dating periods for Whole Blood and blood components. We are redesignating § 610.53(c) as § 610.53(b) and revising the text to provide an explanation on using the table and to correspond with 21 CFR 606.121(c)(7). We are revising the text and table to eliminate those products for which storage periods, storage conditions, and dating periods are better established by data submitted in the BLA, and to delete those products which are no longer manufactured. The dating period and storage conditions for these products are identified in the BLA. We are including an updated list of Whole Blood and blood component products with their applicable storage temperatures and dating periods, which are based upon available information, including data relating to the anticoagulant or preservative solution in the product, usage, clinical experience, laboratory testing, or further processing. The table contains a list of storage temperatures and dating periods for Whole Blood and blood components that FDA has reviewed and determined to be necessary to help ensure the safety, potency, and purity of these products. In listing the dating periods for the Whole Blood and blood component products, we took into account existing guidance documents, package inserts for solutions used for manufacture or storage of Whole Blood and blood components, and operator instruction manuals for devices used in the manufacture of Whole Blood and blood component products. We are redesignating § 610.53(c) as § 610.53(b) and removing all products regulated by FDA's Center for Drug Evaluation and Research (CDER) from the table. Finally, we are removing § 610.53(d) because it is duplicative of § 640.120.

    V. Legal Authority

    FDA is issuing this rule under the biological products provisions of the PHS Act (42 U.S.C. 216, 262, 263, 263a and 264) and the drugs and general administrative provisions of the FD&C Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, and 381). Under these provisions of the PHS Act and the FD&C Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, and potent, and prevent the introduction, transmission, and spread of communicable disease.

    VI. Economic Analysis of Impacts

    We have examined the impacts of the direct final rule under Executive Order 12866, Executive Order 13563, and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this direct final rule is not a significant regulatory action as defined by Executive Order 12866.

    The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the direct final rule is removing regulations and revising regulations to be consistent with updated practice, we certify that this direct final rule will not have a significant economic impact on a substantial number of small entities.

    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This direct final rule would not result in an expenditure in any year that meets or exceeds this amount.

    VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.31(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    VIII. Federalism

    We have analyzed this direct final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies 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. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

    IX. Paperwork Reduction Act of 1995

    This direct final rule contains collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collections of information in part 610 have been approved under OMB control number 0910-0338. The removal of § 610.53(d) impacts OMB control number 0910-0338. We are removing § 610.53(d) because it is duplicative of § 640.120, which is also approved under the same collection of information. While there is no net change in the burden estimate, the current approved collection of information will be updated to reflect this removal. The actions taken by this direct final rule do not create a substantive or material modification to this approved collection of information. Therefore, FDA concludes that OMB has already approved this information collection and the requirements in this document are not subject to additional review by OMB.

    List of Subjects in 21 CFR Part 610

    Biologics, Labeling, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 610 is amended as follows:

    PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS 1. The authority citation for part 610 continues to read as follows:

    Authority:

    21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.

    Subpart C [Removed and Reserved] 2. Remove and reserve subpart C, consisting of §§ 610.20 and 610.21. 3. Revise § 610.50 to read as follows:
    § 610.50 Date of manufacture for biological products.

    (a) When the dating period begins. The dating period for a product must begin on the date of manufacture as described in paragraphs (b) and (c) of this section. The dating period for a combination of two or more products must be no longer than the dating period of the component with the shortest dating period.

    (b) Determining the date of manufacture for biological products other than Whole Blood and blood components. The date of manufacture for biological products, other than Whole Blood and blood components, must be identified in the approved biologics license application as one of the following, whichever is applicable: The date of:

    (1) Potency test or other specific test as described in a biologics license application or supplement to the application;

    (2) Removal from animals or humans;

    (3) Extraction;

    (4) Solution;

    (5) Cessation of growth;

    (6) Final sterile filtration of a bulk solution;

    (7) Manufacture as described in part 660 of this chapter; or

    (8) Other specific manufacturing activity described in a biologics license application or supplement to the biologics license application.

    (c) Determining the date of manufacture for Whole Blood and blood components. (1) The date of manufacture for Whole Blood and blood components must be one of the following, whichever is applicable:

    (i) Collection date and/or time;

    (ii) Irradiation date;

    (iii) The time the red blood cell product was removed from frozen storage for deglycerolization;

    (iv) The time the additive or rejuvenation solution was added;

    (v) The time the product was entered for washing or removing plasma (if prepared in an open system);

    (vi) As specified in the instructions for use by the blood collection, processing, and storage system approved or cleared for such use by FDA; or

    (vii) As approved by the Director, Center for Biologics Evaluation and Research, in a biologics license application or supplement to the application.

    (2) For licensed Whole Blood and blood components, the date of manufacture must be identified in the approved biologics license application or supplement to the application.

    4. Revise § 610.53 to read as follows:
    § 610.53 Dating periods for Whole Blood and blood components.

    (a) General. Dating periods for Whole Blood and blood components are specified in the table in paragraph (b) of this section.

    (b) Table of dating periods. In using the table in this paragraph, when a product in column A is stored at the storage temperature prescribed in column B, storage of a product must not exceed the dating period specified in column C, unless a different dating period is specified in the instructions for use by the blood collection, processing and storage system approved or cleared for such use by FDA. Container labels for each product must include the recommended storage temperatures.

    Whole Blood and Blood Components Storage Temperatures and Dating Periods A Product B Storage temperature C Dating period Whole Blood ACD, CPD, CP2D Between 1 and 6 °C 21 days from date of collection. CPDA-1 do 1 35 days from date of collection. Red Blood Cells ACD, CPD, CP2D Between 1 and 6 °C 21 days from date of collection. CPDA-1 do 35 days from date of collection. Additive solutions do 42 days from date of collection. Open system
  • (e.g., deglycerolized, washed)
  • do 24 hours after entering bag.
    Deglycerolized in closed system with additive solution added do 14 days after entering bag. Irradiated do 28 days from date of irradiation or original dating, whichever is shorter. Frozen −65 °C or colder 10 years from date of collection. Platelets Platelets Between 20 and 24 °C 5 days from date of collection. Platelets Other temperatures according to storage bag instructions As specified in the instructions for use by the blood collection, processing and storage system approved or cleared for such use by FDA. Plasma Fresh Frozen Plasma −18 °C or colder 1 year from date of collection. Plasma Frozen Within 24 Hours After Phlebotomy do 1 year from date of collection. Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up To 24 Hours After Phlebotomy do 1 year from date of collection. Plasma Cryoprecipitate Reduced do 1 year from date of collection. Plasma do 5 years from date of collection. Liquid Plasma Between 1 and 6 °C 5 days from end of Whole Blood dating period. Source Plasma (frozen injectable) −20 °C or colder 10 years from date of collection. Source Plasma Liquid (injectable) 10 °C or colder According to approved biologics license application. Source Plasma (noninjectable) Temperature appropriate for final product 10 years from date of collection. Therapeutic Exchange Plasma −20 °C or colder 10 years from date of collection. Cryoprecipitated AHF Cryoprecipitated AHF −18 °C or colder 1 year from date of collection of source blood or from date of collection of oldest source blood in pre-storage pool. Source Leukocytes Source Leukocytes Temperature appropriate for final product In lieu of expiration date, the collection date must appear on the label. 1 The abbreviation “do.” for ditto is used in the table to indicate that the previous line is being repeated.
    Dated: April 27, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-10385 Filed 5-3-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [167A2100DD/AAKC001030/A0A501010.999900 253G] 25 CFR Part 20 RIN 1076-AF29 Financial Assistance and Social Services Programs; Burial Assistance AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Final rule; confirmation.

    SUMMARY:

    The Bureau of Indian Affairs (BIA) is confirming the interim final rule published on March 1, 2016, extending the deadline for filing an application for burial assistance to 180 days to address hardships resulting from the current short timeframe. The Department of the Interior (Department) did not receive any significant adverse comments during the public comment period on the interim final rule, and therefore confirms the rule without change.

    DATES:

    Effective May 4, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth Appel, Director, Office of Regulatory Affairs and Collaborative Action, Office of the Assistant Secretary—Indian Affairs; telephone (202) 273-4680, [email protected]

    SUPPLEMENTARY INFORMATION:

    On March 1, 2016, the Department published an interim final rule (81 FR 10475) to extend the deadline by which a relative of a deceased Indian can apply for burial assistance for the deceased Indian from 30 days following death to 180 days following death.

    The Department received three comments on the rule, all of which were supportive of the rule. None of the comments requested changes to the rule. Consequently, the Department did not make any change to the interim final rule as a result of this comment. For these reasons, the Department confirms the interim rule published March 1, 2016 (81 FR 10475), as final without change.

    Dated: April 26, 2016. Lawrence S. Roberts, Acting Assistant Secretary—Indian Affairs.
    [FR Doc. 2016-10409 Filed 5-3-16; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 301 [TD 9766] RIN 1545-BM87 Self-Employment Tax Treatment of Partners in a Partnership That Owns a Disregarded Entity AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Final and temporary regulations.

    SUMMARY:

    This document contains final and temporary regulations that clarify the employment tax treatment of partners in a partnership that owns a disregarded entity. These regulations affect partners in a partnership that owns a disregarded entity. The text of these temporary regulations serves as the text of proposed regulations (REG-114307-15) published in the Proposed Rules section in this issue of the Federal Register.

    DATES:

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

    Applicability date: For date of applicability, see § 301-7701-2T(e)(8).

    FOR FURTHER INFORMATION CONTACT:

    Andrew K. Holubeck at (202) 317-4774 (not a toll-free number).

    SUPPLEMENTARY INFORMATION:

    Background

    Section 301.7701-2(c)(2)(i) states that, except as otherwise provided, a business entity that has a single owner and is not a corporation under § 301.7701-2(b) is disregarded as an entity separate from its owner (a disregarded entity). However, § 301.7701-2(c)(2)(iv)(B) provides that an entity that is a disregarded entity is treated as a corporation for purposes of employment taxes imposed under subtitle C of the Internal Revenue Code (Code). Therefore, the disregarded entity, rather than the owner, is considered to be the employer of the entity's employees for purposes of employment taxes imposed by subtitle C.

    While § 301.7701-2(c)(2)(iv)(B) treats a disregarded entity as a corporation for employment tax purposes, this rule does not apply for self-employment tax purposes. Specifically, § 301.7701-2(c)(2)(iv)(C)(2) provides that the general rule of § 301.7701-2(c)(2)(i) applies for self-employment tax purposes. After setting forth this general rule, the regulation applies this rule in the context of a single individual owner by stating that the owner of an entity that is treated in the same manner as a sole proprietorship is subject to tax on self-employment income. The regulation, at § 301.7701-2(c)(2)(iv)(D), also includes an example that specifically illustrates the mechanics of the rule. In the example, the disregarded entity is subject to employment tax with respect to employees of the disregarded entity. The individual owner, however, is subject to self-employment tax on the net earnings from self-employment resulting from the disregarded entity's activities. The regulations do not include a separate example in which the disregarded entity is owned by a partnership.

    It has come to the attention of the Treasury Department and the IRS that even though the regulations set forth a general rule that an entity is disregarded as a separate entity from the owner for self-employment tax purposes, some taxpayers may have read the current regulations to permit the treatment of individual partners in a partnership that owns a disregarded entity as employees of the disregarded entity because the regulations did not include a specific example applying the general rule in the partnership context. Under this reading, which was not intended, some taxpayers have permitted partners to participate in certain tax-favored employee benefit plans. The Treasury Department and the IRS note that the regulations did not create a distinction between a disregarded entity owned by an individual (that is, a sole proprietorship) and a disregarded entity owned by a partnership in the application of the self-employment tax rule. Rather, § 301.7701-2(c)(2)(iv)(C)(2) provides that the general rule of § 301.7701-2(c)(2)(i) applies for self-employment tax purposes for any owner of a disregarded entity without carving out an exception regarding a partnership that owns such a disregarded entity. In addition, the Treasury Department and the IRS do not believe that the regulations alter the holding of Rev. Rul. 69-184, 1969-1 CB 256, which provides that: (1) Bona fide members of a partnership are not employees of the partnership within the meaning of the Federal Insurance Contributions Act, the Federal Unemployment Tax Act, and the Collection of Income Tax at Source on Wages (chapters 21, 23, and 24, respectively, subtitle C, Internal Revenue Code of 1954), and (2) such a partner who devotes time and energy in the conduct of the trade or business of the partnership, or in providing services to the partnership as an independent contractor, is, in either event, a self-employed individual rather than an individual who, under the usual common law rules applicable in determining the employer-employee relationship, has the status of an employee.

    To address this issue, the Treasury Department and the IRS clarify in these temporary regulations that the rule that a disregarded entity is treated as a corporation for employment tax purposes does not apply to the self-employment tax treatment of any individuals who are partners in a partnership that owns a disregarded entity. The rule that the entity is disregarded for self-employment tax purposes applies to partners in the same way that it applies to a sole proprietor owner. Accordingly, the partners are subject to the same self-employment tax rules as partners in a partnership that does not own a disregarded entity.

    Explanation of Provisions

    This document contains amendments to the Procedure and Administration Regulations (26 CFR part 301) under section 7701 of the Code to clarify that a disregarded entity that is treated as a corporation for purposes of employment taxes imposed under subtitle C of the Code is not treated as a corporation for purposes of employing its individual owner, who is treated as a sole proprietor, or employing an individual that is a partner in a partnership that owns the disregarded entity. Rather, the entity is disregarded as an entity separate from its owner for this purpose. Existing regulations already provide that the entity is disregarded for self-employment tax purposes and specifically note that the owner of an entity treated in the same manner as a sole proprietorship under § 301.7701-2(a) is subject to tax on self-employment income. These temporary regulations apply this existing general rule to illustrate that, if a partnership is the owner of a disregarded entity, the partners in the partnership are subject to the same self-employment tax rules as partners in a partnership that does not own a disregarded entity.

    While these temporary regulations provide that a disregarded entity owned by a partnership is not treated as a corporation for purposes of employing any partner of the partnership, these regulations do not address the application of Rev. Rul. 69-184 in tiered partnership situations. Several commenters have requested that the IRS provide additional guidance on the application of Rev. Rul. 69-184 to tiered partnership situations, and have also suggested modifying the holding of Rev. Rul. 69-184 to allow partnerships to treat partners as employees in certain circumstances, such as, for example, employees in a partnership who obtain a small ownership interest in the partnership as an employee compensatory award or incentive. However, these commenters have not provided detailed analyses and suggestions as to how the employee benefit and employment tax rules would apply in such situations. The Treasury Department and the IRS request comments on the appropriate application of the principles of Rev. Rul. 69-184 to tiered partnership situations, the circumstances in which it may be appropriate to permit partners to also be employees of the partnership, and the impact on employee benefit plans (including, but not limited to, qualified retirement plans, health and welfare plans, and fringe benefit plans) and on employment taxes if Rev. Rul. 69-184 were to be modified to permit partners to also be employees in certain circumstances.

    In order to allow adequate time for partnerships to make necessary payroll and benefit plan adjustments, these temporary regulations will apply on the later of: (1) August 1, 2016, or (2) the first day of the latest-starting plan year following May 4, 2016, of an affected plan (based on the plans adopted before, and the plan years in effect as of, May 4, 2016) sponsored by an entity that is disregarded as an entity separate from its owner for any purpose under § 301.7701-2. For these purposes, an affected plan includes any qualified plan, health plan, or section 125 cafeteria plan if the plan benefits participants whose employment status is affected by these regulations. For rules that apply before the applicability date of these regulations, see 26 CFR part 301 revised as of April 1, 2016.

    Special Analysis

    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 has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. For applicability of the Regulatory Flexibility Act (5 U.S.C. chapter 6), please refer to the Special Analysis section in the preamble to the cross-referenced notice of proposed rulemaking in the Proposed Rules section of this issue of the Federal Register. Pursuant to section 7805(f) of the Code, these regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

    Drafting Information

    The principal author of these regulations is Andrew Holubeck of the Office of the Division Counsel/Associate Chief Counsel (Tax Exempt and Government Entities). However, other personnel from the IRS and the Treasury Department participated in their development.

    List of Subjects in 26 CFR Part 301

    Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordkeeping requirements.

    Amendments to the Regulations

    Accordingly, 26 CFR part 301 is amended as follows:

    PART 301—PROCEDURE AND ADMINISTRATION Paragraph 1. The authority citation for part 301 continues to read in part as follows: Authority:

    26 U.S.C. 7805 * * *

    Par. 2. Section 301.7701-2 is amended by: 1. Revising paragraph (c)(2)(iv)(C)(2). 2. Adding paragraph (e)(8).

    The revision and addition reads as follows:

    § 301.7701-2 Business entities; definitions.

    (c) * * *

    (2) * * *

    (iv) * * *

    (C) * * *

    (2) [Reserved]. For further guidance, see § 301.7701-2T(c)(2)(iv)(C)(2).

    (e)(8) [Reserved]. For further guidance, see § 301.7701-2T(e)(8).

    Par. 3. Section 301.7701-2T is added to read as follows:
    § 301.7701-2T Business entities; definitions (temporary).

    (a) through (c)(2)(iv)(C)(1) [Reserved]. For further guidance, see § 301.7701-2(a) through (c)(2)(iv)(C)(1).

    (2) Section 301.7701-2(c)(2)(i) applies to taxes imposed under subtitle A, including Chapter 2—Tax on Self-Employment Income. Thus, an entity that is treated in the same manner as a sole proprietorship under § 301.7701-2(a) is not treated as a corporation for purposes of employing its owner; instead, the entity is disregarded as an entity separate from its owner for this purpose and is not the employer of its owner. The owner will be subject to self-employment tax on self-employment income with respect to the entity's activities. Also, if a partnership is the owner of an entity that is disregarded as an entity separate from its owner for any purpose under § 301.7701-2, the entity is not treated as a corporation for purposes of employing a partner of the partnership that owns the entity; instead, the entity is disregarded as an entity separate from the partnership for this purpose and is not the employer of any partner of the partnership that owns the entity. A partner of a partnership that owns an entity that is disregarded as an entity separate from its owner for any purpose under § 301.7701-2 is subject to the same self-employment tax rules as a partner of a partnership that does not own an entity that is disregarded as an entity separate from its owner for any purpose under § 301.7701-2.

    (c)(2)(iv)(D) through (e)(7) [Reserved]. For further guidance, see § 301.7701-2(c)(2)(iv)(D) through (e)(7).

    (8)(i) Effective/applicability date. Paragraph (c)(2)(iv)(C)(2) of this section applies on the later of—

    (A) August 1, 2016, or

    (B) The first day of the latest-starting plan year following May 4, 2016, of an affected plan (based on the plans adopted before, and the plan years in effect as of, May 4, 2016) sponsored by an entity that is disregarded as an entity separate from its owner for any purpose under § 301.7701-2. For rules that apply before the applicability date of these regulations, see 26 CFR part 301 revised as of April 1, 2016. For these purposes—

    (1) An affected plan includes any qualified plan, health plan, or section 125 cafeteria plan if the plan benefits participants whose employment status is affected by paragraph (c)(2)(iv)(C)(2),

    (2) A qualified plan means a plan, contract, pension, or trust described in paragraph (A) or (B) of section 219(g)(5) (other than paragraph (A)(iii)), and

    (3) A health plan means an arrangement described under § 1.105-5 of this chapter.

    (ii) Expiration date. The applicability of paragraph (c)(2)(iv)(C)(2) of this section expires on or before May 3, 2016, or such earlier date as may be determined under amendments to the regulations issued after May 3, 2016.

    John M. Dalrymple, Deputy Commissioner for Services and Enforcement. Approved: April 20, 2016. Mark J. Mazur, Assistant Secretary of the Treasury (Tax Policy).
    [FR Doc. 2016-10383 Filed 5-3-16; 8:45 am] BILLING CODE 4830-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2016-0306] RIN 1625-AA00 Safety Zone, Cape Fear River; Southport, NC AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone on the navigable waters of the Cape Fear River near Southport, North Carolina. This temporary safety zone is intended to restrict vessels from a portion of the Cape Fear River during the Barrier Island Challenge Stand Up Paddle Board Race. This action is necessary to protect the safety of race participants when they cross the Lower Swash Channel of the Cape Fear River. Entry into or movement within the safety zone during the enforcement period is prohibited without approval of the Captain of the Port.

    DATES:

    This rule is effective on May 7, 2016, from 9:30 a.m. through 11:30 a.m.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0306 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 on this rule, call or email LCDR Derek J. Burrill, Waterways Management Division Chief, Sector North Carolina, Coast Guard; telephone (910) 772-2230, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security E.O. Executive Order FR Federal Register NPRM Notice of proposed rulemaking Pub. L. Public Law § Section U.S.C. United States Code II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary 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 final details of this event were not provided until April 12, 2016, making it impracticable to publish an NPRM.

    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. Delaying the effective date of this rule would be contrary to public interest because immediate action is needed to protect race participants and spectators from the hazards associated with a paddleboard race.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port North Carolina (COTP) has determined that potential hazards associated with the Barrier Island Challenge Paddle Board Race on May 07, 2016 will be a safety concern when race participants cross the Lower Swash Channel on the Cape Fear River, Southport, North Carolina, a major shipping channel. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone.

    IV. Discussion of the Rule

    The Coast Guard is establishing a temporary safety zone on the navigable waters of the Lower Swash Channel on the Cape Fear River. The safety zone will encompass all waters within a shape bounded by the following coordinates: 33°55′05″ N., 078°00′04″ W.; 33°54′57″ N., 078°00′04″ W.; 33°54′56″ N., 078°00′54″ W.; 33°55′04″ N., 078°00′54″ W.; thence back to the point of origin (NAD 83) in Southport, North Carolina. This safety zone will be established in the interest of public safety due to the participants crossing the Cape Fear River. This rule will be enforced on May 07, 2016 during the times of 9:30 a.m. through 11:30 a.m., unless otherwise cancelled earlier by the COTP.

    Except for vessels authorized by the Captain of the Port or her Representative, no person or vessel may enter or remain in the safety zone during the time frame listed. The Captain of the Port will give notice of the enforcement of the safety zone by all appropriate means to provide the widest dissemination of notice among the affected segments of the public. This will include publication in the Local Notice to Mariners and Marine Information Broadcasts.

    V. Regulatory Analyses

    We developed this rule after considering numerous statutes and Executive Orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.

    A. Regulatory Planning and Review

    E.O.s 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 primary impact of these regulations will be on limiting all vessels wishing to transit the affected waterways during enforcement of the safety zone on the Cape Fear River within all waters within a shape bounded by the following coordinates: 33°55′05″ N., 078°00′04″ W.; 33°54′57″ N., 078°00′04″ W.; 33°54′56″ N., 078°00′54″ W.; 33°55′04″ N., 078°00′54″ W.; thence back to the point of origin (NAD 83) in Southport, North Carolina on May 07, 2016 from 9:30 a.m. through 11:30 a.m., unless otherwise cancelled by the COTP. Although these regulations prevent traffic from transiting a portion of the Cape Fear River during this event, that restriction is limited in duration, affects only a limited area, and will be well publicized to allow mariners to make alternative plans for transiting the affected area.

    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.

    While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A. above, this rule will not have a significant economic impact on any vessel owner or operator.

    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 would 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.

    Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). 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 does 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 above.

    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 an 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 determined 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 safety zone to limit vessels within all waters within a shape bounded by the following coordinates: 33°55′05″ N., 078°00′04″ W.; 33°54′57″ N., 078°00′04″ W.; 33°54′56″ N., 078°00′54″ W.; 33°55′04″ N., 078°00′54″ W.; thence back to the point of origin (NAD 83) in Southport, North Carolina on May 07, 2016 from 9:30 a.m. through 11:30 a.m. to protect life and property of mariners from the hazards associated with the event. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. 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 temporarily 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 § 100.35-T05-0306 to read as follows:
    § 100.35-T05-0306 Safety Zone, Cape Fear River; Southport, North Carolina

    (a) Definitions. For the purposes of this section, Captain of the Port means the Commander, Sector North Carolina.

    Representative means any Coast Guard commissioned, warrant or petty officer who has been authorized to act on the behalf of the Captain of the Port.

    (b) Location. The following area is a safety zone: Specified waters of the Captain of the Port Sector North Carolina zone, as defined in 33 CFR 3.25-10, all waters of the Cape Fear River within a shape bounded by the following coordinates: 33°55′05″ N., 078°00′04″ W.; 33°54′57″ N., 078°00′04″ W.; 33°54′56″ N., 078°00′54″ W.; 33°55′04″ N., 078°00′54″ W.; thence back to the point of origin (NAD 83) in Southport, North Carolina.

    (c) Regulations. (1) In accordance with the general regulations in 165.23 of this part, entry into this zone is prohibited unless authorized by the Captain of the Port, North Carolina or her designated representatives.

    (2) The operator of any vessel in the immediate vicinity of this safety zone shall:

    (i) If on scene proceed as directed by any commissioned, warrant or petty officer on shore or on board a vessel that is displaying a U.S. Coast Guard Ensign.

    (3) The Captain of the Port, North Carolina can be reached through the Sector North Carolina Command Duty Officer at Sector North Carolina in Wilmington, North Carolina at telephone number (910) 343-3882.

    (4) The Coast Guard Representatives enforcing the safety zone can be contacted on VHF-FM marine band radio channel 13 (165.65 Mhz) and channel 16 (156.8 Mhz).

    (d) Enforcement period. This section will be enforced on May 07, 2016, from 9:30 a.m. through 11:30 a.m., unless otherwise cancelled by the COTP.

    Dated: April 19, 2016. J.S. Dufresne, Captain, U.S. Coast Guard, Captain of the Port North Carolina.
    [FR Doc. 2016-10310 Filed 5-3-16; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 81 [EPA-HQ-OAR-2015-0468; FRL-9945-17-OAR] Determinations of Attainment by the Attainment Date, Extensions of the Attainment Date, and Reclassification of Several Areas for the 2008 Ozone National Ambient Air Quality Standards AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action on three separate and independent types of determinations for each of the 36 areas that are currently classified as “Marginal” for the 2008 ozone National Ambient Air Quality Standards (NAAQS). First, the EPA is determining that 17 areas attained the 2008 ozone NAAQS by the applicable attainment date of July 20, 2015, based on complete, quality-assured and certified ozone monitoring data for 2012-2014. Second, the EPA is granting 1-year attainment date extensions for eight areas on the basis that the requirements for such extensions under the Clean Air Act (CAA) and the EPA's implementing regulations have been met. Third, the EPA is determining that 11 areas failed to attain the 2008 ozone NAAQS by the applicable attainment date of July 20, 2015, and thus are reclassified by operation of law as “Moderate” for the 2008 ozone NAAQS. States containing any or any portion of these new Moderate areas must submit State Implementation Plan (SIP) revisions that meet the statutory and regulatory requirements that apply to 2008 ozone nonattainment areas classified as Moderate by January 1, 2017.

    DATES:

    This rule is effective on June 3, 2016.

    ADDRESSES:

    The EPA has established docket number EPA-HQ-OAR-2015-0468 for this action. All documents in the docket are listed on http://www.regulation.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 form. Publicly available docket materials are available electronically through http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Cecil (Butch) Stackhouse or Mr. H. Lynn Dail, Office of Air Quality Planning and Standards, Air Quality Policy Division, Mail Code C539-01, Research Triangle Park, NC 27711. Telephone Mr. Stackhouse at (919) 541-5208 or Mr. Dail at (919) 541-2363; or both at fax number: (919) 541-5315; email addresses: [email protected], or [email protected]

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Proposed Actions A. Determinations of Attainment B. Extensions of Marginal Area Attainment Dates C. Determinations of Failure To Attain and Reclassification D. Moderate Area SIP Revision Submission Deadline E. Rescission of Clean Data Determination and Proposed SIP Call for the 1997 8-Hour Ozone NAAQS for the New York-N. New Jersey-Long Island (NY-NJ-CT) Nonattainment Area II. Final Actions A. Determinations of Attainment B. Extensions of Marginal Area Attainment Dates C. Determinations of Failure To Attain and Reclassification D. Moderate Area SIP Revision Submission Deadline E. Rescission of Clean Data Determination and Final SIP Call for the 1997 8-Hour Ozone NAAQS for the New York-N. New Jersey-Long Island (NY-NJ-CT) Nonattainment Area III. Environmental Justice Considerations IV. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Paperwork Reduction Act (PRA) C. Regulatory Flexibility Act (RFA) D. Unfunded Mandates Reform Act (UMRA) E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act (CRA) L. Judicial Review I. Proposed Actions

    On August 27, 2015, the EPA proposed to find that 17 Marginal areas attained the 2008 NAAQS by the applicable attainment date of July 20, 2015, based on complete, quality-assured and certified ozone monitoring data for 2012-2014. See 80 FR 51992. The EPA also proposed to find that eight areas met the criteria, as provided in CAA section 181(a)(5) and 40 Code of Federal Regulations (CFR) 51.1107, to qualify for a 1-year attainment date extension for the 2008 ozone NAAQS even though they did not attain the NAAQS by the applicable deadline. Finally, the EPA proposed to find that 11 areas failed to attain the 2008 ozone NAAQS by the applicable Marginal attainment date and that they did not qualify for a 1-year attainment date extension. Under CAA section 181(b)(2)(A), if the EPA determines that an area failed to attain a given NAAQS by the applicable attainment date, the area shall be reclassified to a higher classification. In the EPA's August 2015 proposal, the EPA specified those 11 areas would be reclassified to Moderate. The reclassified areas must attain the standard as expeditiously as practicable, but in any event no later than July 20, 2018.

    The EPA proposed two options for establishing a deadline for states to submit the SIP revisions required for Moderate areas once their areas are reclassified from Marginal. The first option would have required state air agencies to submit the required SIP revisions as expeditiously as practicable, but no later than the beginning of the ozone season in 2017 for each respective area. The second option would have required state air agencies to submit the required SIP revisions as expeditiously as practicable, but no later than January 1, 2017. After consideration of the comments received on these proposed options, the EPA is finalizing a due date of no later than January 1, 2017, for all Moderate area SIP requirements that apply to newly reclassified areas.

    A. Determinations of Attainment

    In the proposal, the EPA evaluated data from air quality monitors in the 36 areas classified as Marginal for the 2008 ozone NAAQS in order to determine each area's attainment status as of the applicable attainment date of July 20, 2015. Seventeen of the 36 nonattainment areas' monitoring sites with valid data had a design value 1 equal to or less than 0.075 parts per million (ppm) based on 2012-2014 monitoring period.2 Thus, the EPA proposed to determine, in accordance with section 181(b)(2)(A) of the CAA and the EPA's implementing regulations at 40 CFR 51.1103, that the 17 areas listed in the following Table 1 attained the standard by the applicable attainment date for Marginal areas for the 2008 ozone NAAQS.

    1 Design value is a statistic that describes the air quality status of a given location relative to the level of the NAAQS. Design values for a site are the 3-year average annual fourth-highest daily maximum 8-hour average ozone concentrations.

    2 These determinations were based upon 3 years of complete, quality-assured and certified 2012-2014 data, in accordance with 40 CFR part 58 and recorded in EPA's Air Quality Statistics (AQS) database. Some areas attained the standard earlier with 2011, 2012 and 2013 data and maintained the standard in 2014, i.e., Knoxville, TX attained the standard with 2011-2013 ozone data and continued to attain with 2012-2014 data.

    Table 1—Marginal Nonattainment Areas That Attained the 2008 Ozone NAAQS by the July 20, 2015, Attainment Date 2008 ozone NAAQS
  • nonattainment area
  • 2012-2014 design value
  • (ppm)
  • Allentown-Bethlehem-Easton, PA 0.070 Baton Rouge, LA 0.072 Calaveras County, CA 0.071 Charlotte-Rock Hill, NC-SC 0.073 Chico (Butte County), CA 0.074 Cincinnati, OH-KY-IN 0.075 Columbus, OH 0.075 Dukes County, MA 0.068 Jamestown, NY 0.071 Knoxville, TN 0.067 Lancaster, PA 0.071 Memphis, TN-MS-AR 0.073 Reading, PA 0.071 San Francisco Bay Area, CA 0.072 Seaford, DE 0.074 Tuscan Buttes, CA 0.075 Upper Green River Basin Area, WY 0.064
    B. Extensions of Marginal Area Attainment Dates

    Of the 36 Marginal nonattainment areas for the 2008 ozone NAAQS, there are eight areas for which the EPA proposed to grant a 1-year attainment date extension based on determinations that these areas met the requirements for an extension under CAA section 181(a)(5), including compliance with all commitments and requirements in the applicable implementation plan and “clean” data in the year preceding the attainment year. In addition, for each of these areas, at least one state with jurisdiction over all or part of the area requested such an extension.

    The EPA proposed that eight Marginal nonattainment areas for the 2008 ozone NAAQS failed to attain the NAAQS by July 20, 2015, but met the attainment date extension criteria of CAA section 181(a)(5), as interpreted in 40 CFR 51.1107. The EPA proposed to find that all implicated states were meeting the obligations and commitments of their applicable implementation plans, in accordance with CAA section 181(a)(5)(A), and that, per CAA section 181(a)(5)(B) and the implementing regulations, the 4th highest daily maximum 8-hour average concentrations for all monitors in each area were not greater than 0.075 ppm for 2014, the year preceding the attainment year (see 40 CFR 51.1107). The EPA, therefore, proposed to grant a 1-year extension of the applicable Marginal area attainment date from July 20, 2015, to July 20, 2016, for the nonattainment areas listed in Table 2.

    Table 2—Marginal Nonattainment Areas That Qualify for a 1-Year Attainment Date Extension for the 2008 Ozone NAAQS 2008 ozone NAAQS nonattainment area 2012-2014 design value (ppm) 2014
  • 4th highest
  • daily
  • maximum 8-hr
  • average (ppm)
  • Cleveland-Akron-Lorain, OH 0.078 0.075 Houston-Galveston-Brazoria, TX 0.080 0.072 Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE 0.077 0.074 Pittsburgh-Beaver Valley, PA 0.077 0.071 San Luis Obispo (Eastern San Luis Obispo), CA 0.076 0.073 Sheboygan County, WI 0.081 0.072 St. Louis-St. Charles-Farmington, MO-IL 0.078 0.072 Washington, DC-MD-VA 0.076 0.069
    C. Determinations of Failure To Attain and Reclassification

    Lastly, the EPA proposed to determine that 11 areas (listed in Table 3) failed to attain the 2008 ozone NAAQS by the applicable attainment date of July 20, 2015 and were not eligible for a 1-year attainment date extension. For each of these areas, the 4th highest daily maximum 8-hour average for at least one monitor in each area was greater than 0.075 ppm for 2014. CAA section 181(b)(2)(A) provides that a Marginal nonattainment area shall be reclassified by operation of law upon a determination by the EPA that such area failed to attain the relevant NAAQS by the applicable attainment date. The new classification proposed for each of these 11 areas would be the next higher classification of “Moderate” under the CAA statutory scheme.3

    3 The 2012-2014 design values for the 11 areas did not exceed 0.100 ppm, which is the threshold for reclassifying an area to Serious per CAA section 181(b)(2)(A)(ii) and 40 CFR 51.1103.

    Table 3—Marginal Nonattainment Areas To Be Reclassified as Moderate Because They Did Not Attain the 2008 Ozone NAAQS by the July 20, 2015, Attainment Date 2008 ozone NAAQS nonattainment area 2012-2014 design value
  • (ppm)
  • 2014
  • 4th highest
  • daily
  • maximum 8-hr
  • average
  • (ppm)
  • Atlanta, GA 0.077 0.079 Chicago-Naperville, IL-IN-WI 0.081 0.076 Denver-Boulder-Greeley-Ft. Collins-Loveland, CO 0.082 0.077 Greater Connecticut, CT 0.080 0.077 Imperial County, CA 0.080 0.078 Kern County (Eastern Kern), CA 0.084 0.089 Mariposa County, CA 0.078 0.077 Nevada County (Western part), CA 0.079 0.082 New York-N. New Jersey-Long Island, NY-NJ-CT 0.085 0.081 Phoenix-Mesa, AZ 0.080 0.080 San Diego County, CA 0.079 0.079
    D. Moderate Area SIP Revision Submission Deadline

    The EPA also proposed to apply the Administrator's discretion, per CAA section 182(i), to adjust the statutory deadlines for submitting required SIP revisions for reclassified Moderate ozone nonattainment areas. CAA section 182(i) requires that reclassified areas meet the applicable plan submission requirements “according to the schedules prescribed in connection with such requirements, except that the Administrator may adjust any applicable deadlines (other than attainment dates) to the extent such adjustment is necessary or appropriate to assure consistency among the required submissions.” Under the Moderate area plan requirements of CAA section 182(b)(1) and 40 CFR 51.1108, states with ozone nonattainment areas classified as Moderate are provided 3 years (or 36 months) from the date of designation to submit a SIP revision complying with the Moderate ozone nonattainment plan requirements. For areas designated nonattainment for the 2008 ozone NAAQS and originally classified as Moderate, that deadline was July 20, 2015, a date that has already passed. The EPA, therefore, interpreted CAA section 182(i) as providing the authority to adjust the applicable deadlines “as necessary or appropriate to assure consistency among the required submissions” for the 11 reclassified 2008 Marginal ozone nonattainment areas. The CAA neither provides authority for the EPA to adjust the deadline to provide the full 3 years from the date of reclassification nor provides that the EPA may adjust the attainment date. In determining an appropriate deadline for the states with jurisdiction for these 11 reclassified nonattainment areas to submit their Moderate area SIP revisions, the EPA proposed two options for deadlines. The first proposed option would require that states submit the required SIP revisions as expeditiously as practicable, but no later than the beginning of the ozone season in 2017 for each state. We believed that this option would provide states additional time that may be needed to accomplish planning, administrative and SIP revision processes. Of the 11 areas proposed for reclassification to Moderate, four areas have ozone seasons that begin later than January 1 (based on ozone monitoring season changes finalized with the 2015 ozone NAAQS) 4 and this option would provide 2 additional months past January 2017 for those four areas. The second proposed option would require states submit the SIP revisions as expeditiously as practicable, but no later than January 1, 2017. We believed that setting a single specific submittal date would establish a consistent deadline for all 11 nonattainment areas, similar to the single uniform SIP submission deadline that would have applied to all areas if they had been initially classified as Moderate. This option would provide states with approximately 9 months after these reclassifications are finalized to develop complete SIP submissions and it is the latest SIP submittal date that would be compatible with the date by when Moderate area reasonably available control measures (RACM) and reasonably available control technology (RACT) must be in place (i.e., begin no later than January 1 of the 5th year after the effective date of designation for the 2008 ozone NAAQS, which is, in this case, January 1, 2017).

    4See Table D-3 of appendix D to 40 CFR part 58.

    E. Rescission of Clean Data Determination and Proposed SIP Call for the 1997 8-Hour Ozone NAAQS for New York-N. New Jersey-Long Island (NY-NJ-CT) Nonattainment Area

    On June 18, 2012, the EPA issued a clean data determination (CDD) for the NY-NJ-CT nonattainment area, suspending the three states' obligations to submit attainment-related planning requirements, including the obligation to submit attainment demonstrations, RACM and reasonable further progress (RFP) plans, and contingency measures, with respect to the 1997 8-hour ozone standard. On May 15, 2014 (79 FR 27830), the EPA proposed to rescind the CDD for the area based on the fact that the area was no longer attaining the 1997 8-hour ozone standard, and the EPA proposed a SIP Call for submittal of a new ozone attainment demonstration for the NY-NJ-CT area for the 1997 ozone NAAQS. As an alternative to submitting a new attainment demonstration for the 1997 ozone NAAQS, the EPA proposed to permit the relevant states to respond to the SIP Call by voluntarily requesting to be reclassified to Moderate for the 2008 ozone standard (see CAA section 181(b)(3)) and to prepare SIP revisions demonstrating how they would attain the more stringent 2008 standard as expeditiously as practicable, but no later than the Moderate area attainment date in 2018. The EPA explained in the May 2014 proposal that, because the 2008 standard is more stringent than the 1997 standard, the area would necessarily attain the 1997 standard once the area adopted a control strategy designed to achieve the tighter standard. Moreover, where state planning resources were constrained, those resources were better used focused on attaining the more stringent standard.

    In the agency's August 27, 2015, proposal regarding determinations of attainment of the 2008 Marginal ozone areas, the EPA discussed how its proposed actions affected the May 2014 proposed options for responding to a SIP Call for the 1997 8-hour ozone NAAQS. Specifically, the proposed option to permit the relevant states to respond to the final SIP Call by requesting reclassification to Moderate for the 2008 ozone standard [see CAA section 181(b)(3)] would consequently require that the states submit SIPs demonstrating how they would attain the more stringent 2008 standard as expeditiously as practicable. We explicitly noted in the August 2015 proposal that, if we were to finalize the determination that the NY-NJ-CT area failed to attain the 2008 ozone NAAQS by the Marginal area attainment date, the area would be reclassified by operation of law, and thus effectively eliminating the need for the three states to voluntarily request reclassification. The area would then be subject to Moderate nonattainment area planning requirements, and the subsequent submission of Moderate area attainment plans for the 2008 ozone standard would necessarily satisfy a final SIP Call for the NY-NJ-CT area on the 1997 ozone standard, because an approvable plan would demonstrate attainment of a more stringent NAAQS. We also noted that either of the proposed 2008 ozone attainment plan due dates would meet the statutory timeframe for the SIP revision due subsequent to a SIP Call for the 1997 ozone NAAQS for the area.

    II. Final Actions

    The publication of the EPA's proposed rule on August 27, 2015, (80 FR 51992) started a public comment period that ended on September 28, 2015.5 The comments received during this period may be found in the electronic docket for this action. A majority of commenters supported the EPA's actions as proposed to determine that certain areas attained the 2008 ozone NAAQS by the applicable attainment date, to provide 1-year attainment date extensions to the identified areas, and to reclassify to Moderate the non-attaining areas that do not qualify for an attainment date extension. Additional significant comments pertinent to each proposed action are addressed in the following appropriate sections. Included in the docket for this action is a full summary of significant comments received on the EPA's proposal and our responses to those comments. To access comments and the Response to Comment document, please go to http://www.regulations.gov and search for Docket No. EPA-HQ-OAR-2015-0468, or contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

    5 The EPA offered to hold a public hearing on the proposed actions, but no one requested such a hearing.

    Table 4—2008 Ozone Marginal Nonattainment Area Final Action Summary Nonattainment area Determination of attainment by the
  • attainment date
  • Determination of failure to
  • attain by the
  • attainment date
  • Extension of the marginal area attainment date to July 20, 2016
    Allentown-Bethlehem-Easton, PA X Atlanta, GA X Baton Rouge, LA X Calaveras County, CA X Charlotte-Rock Hill, NC-SC a X Chicago-Naperville, IL-IN-WI X Chico (Butte County), CA X Cincinnati, OH-KY-IN X Cleveland-Akron-Lorain, OH X Columbus, OH X Denver-Boulder-Greeley-Ft. Collins-Loveland, CO X Dukes County, MA X Greater Connecticut, CT X Houston-Galveston-Brazoria, TX X Imperial County, CA X Jamestown, NY X Kern County (Eastern Kern), CA X Knoxville, TN b X Lancaster, PA X Mariposa County, CA X Memphis, TN-MS-AR c X Nevada County (Western part), CA X New York, N. New Jersey-Long Island, NY-NJ-CT X Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE X Phoenix-Mesa, AZ X Pittsburgh-Beaver Valley, PA X Reading, PA X San Diego County, CA X San Francisco Bay Area, CA X San Luis Obispo (Eastern San Luis Obispo), CA X Seaford, DE X Sheboygan County, WI X St. Louis-St. Charles-Farmington, MO-IL X Tuscan Buttes, CA X Upper Green River Basin Area, WY X Washington, DC-MD-VA X a On July 28, 2015, the EPA redesignated to attainment the North Carolina portion of the Charlotte-Rock Hill, NC-SC, nonattainment area for the 2008 8-hour ozone NAAQS, effective August 27, 2015. See 80 FR 44873. On December 11, 2015, the EPA redesignated to attainment the South Carolina portion of the Charlotte-Rock Hill, NC-SC, nonattainment area for the 2008 8-hour ozone NAAQS, effective January 11, 2016. See 80 FR 76865. The EPA is herein determining that this area attained the 2008 ozone NAAQS by the applicable attainment date in order to satisfy the agency's obligation under CAA section 181(b)(2)(A). b On July 13, 2015, the EPA redesignated to attainment the Knoxville, TN, nonattainment area for the 2008 8-hour ozone NAAQS, effective August 12, 2015. See 80 FR 39970. Given that this area was still designated nonattainment as of July 20, 2015, the EPA is herein determining that this area attained the 2008 ozone NAAQS by the applicable attainment date in order to satisfy the agency's obligation under CAA section 181(b)(2)(A). c On February 10, 2016, the EPA proposed to redesignate to attainment the Arkansas portion of the Memphis, TN-MS-AR, nonattainment area for the 2008 8-hour ozone NAAQS. See 81 FR 7046. On February 11, 2016, the EPA proposed to redesignate to attainment the Mississippi portion of the Memphis, TN-MS-AR, nonattainment area for the 2008 8-hour ozone NAAQS. See 81 FR 7269.
    A. Determinations of Attainment

    Pursuant to section 181(b)(2)(A) of the CAA and 40 CFR 51.1103, the EPA is making a final determination that the 17 Marginal nonattainment areas listed in Table 1 attained the 2008 ozone NAAQS by the applicable attainment date of July 20, 2105. We received no adverse comments on this proposal.

    Once effective, this action satisfies the EPA's obligation pursuant to CAA section 181(b)(2)(A) to determine, based on an area's air quality as of the attainment date, whether the area attained the standard by that date. The effect of a final determination of attainment by the area's attainment date is to discharge the EPA's obligation under CAA section 181(b)(2)(A), and to establish that, in accordance with CAA section 181(b)(2)(A), the areas will not be reclassified for failure to attain by the applicable attainment date. These determinations of attainment do not constitute a redesignation to attainment. Redesignations require states to meet a number of additional statutory criteria, including the EPA approval of a state plan demonstrating maintenance of the air quality standard for 10 years after redesignation. As for all NAAQS, the EPA is committed to working with states that choose to submit redesignation requests for the 2008 ozone NAAQS.

    B. Extensions of Marginal Area Attainment Dates

    Pursuant to CAA section 181(a)(5), the EPA is making a final determination to grant 1-year attainment date extensions of the applicable attainment date from July 20, 2015, to July 20, 2016, for the 8 Marginal nonattainment areas listed in Table 2. The EPA received a number of comments on its proposal to extend the Marginal area attainment dates for the areas listed in Table 2. We summarize and respond to some of the key comments. The docket for this action contains a more detailed Response to Comment document.

    Comment: One commenter claimed that the EPA's proposed 1-year extension of the attainment date for the Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE area is unlawful and arbitrary because the state of Delaware did not request an extension of the attainment date. The commenter argued that granting an attainment date extension to a multi-state area when all states have not requested the extension is inconsistent with the EPA's failure to grant the state of New York's most recent voluntary reclassification request with regard to the 1997 8-hour ozone NAAQS.6 The commenter stated that there, the EPA refused to grant New York's request because the agency's position was that voluntarily reclassifying the area required all states with jurisdiction over the multi-state area to request the reclassification. The commenter noted that in that case the EPA interpreted CAA section 182(j)(1) “to require coordination and unanimity among the affected states,” and the commenter stated that the provision “seemingly has equal bearing” on a request to extend the attainment date.

    6 Letter from Joseph J. Martens, Commissioner, New York Department of Environmental Conservation, addressed to the EPA Administrator Lisa Jackson. June 20, 2012.

    Response: The EPA disagrees with the commenter that a request for voluntary reclassification under CAA section 181(b)(3) and a request for an extension of the attainment date under CAA section 181(a)(5) both require “unanimity” among the affected states. The EPA also does not agree that granting an extension of the attainment date to all states with jurisdiction over the Philadelphia multi-state nonattainment area is inconsistent with its prior reading of CAA section 182(j)(1).

    The statutory provisions governing voluntary reclassifications and requests for 1-year attainment date extensions differ in key respects regarding the question of whether all states in a nonattainment area need to request the action before the EPA may grant such requests. CAA section 181(b)(3), which governs voluntary reclassifications, states that “the Administrator shall grant the request of any State to reclassify a nonattainment area in that State [in accordance with the area's design value] to a higher classification” (emphasis added). The EPA reads that provision, and specifically the words “in that state,” to mean that although any state may request a reclassification, it can only do so on behalf of its own state. The same limiting phrase does not appear in the statutory provision governing 1-year attainment date extensions. That provision, CAA section 181(a)(5), states, “Upon application by any State, the Administrator may extend for 1 additional year” the attainment date, provided that the state has complied with all requirements and commitments pertaining to the area in its applicable implementation plan and the area meets certain air quality criteria. Because the statute grants the EPA the discretion to extend an attainment date “upon application by any State” and establishes limiting conditions that can be demonstrated as satisfied by either a state or by the EPA, CAA section 181(a)(5) by its terms does not require the consent of every state within a multi-state nonattainment area. The EPA does, however, interpret that provision as requiring all states with jurisdiction over the nonattainment area to substantively meet the two statutory conditions, although we note that the provision does not specify who must make the demonstration that the conditions have been met.

    Interpreting these two provisions to permit differing thresholds of state “unanimity” is particularly reasonable given the consequence of the EPA's action in each case. In extending an attainment date, the EPA imposes no additional obligation upon any state, but rather grants areas that are close to achieving the air quality standard 1 additional year to come into compliance, provided that the states governing that area meet certain criteria. A voluntary reclassification, on the other hand, can impose significant new attainment planning and emission reduction obligations. Had Congress intended to allow one state to request a reclassification on behalf of another state, and, therefore, to impose upon another state, without that state's consent, all of the resource-intensive consequences potentially associated with that action, it could have clearly stated so.

    The EPA further disagrees with the commenter that its prior interpretation of CAA section 182(j)(1)—requiring all states in a multi-state ozone nonattainment area to agree to a voluntary reclassification—is inconsistent with not requiring such consensus in the case of an attainment date extension. CAA section 182(j)(1)(A) directs states to “take all reasonable steps to coordinate, substantively and procedurally, the revisions and implementation of [SIPs] applicable to the nonattainment area concerned.” This provision on its face does not apply to an attainment date extension under CAA section 181(a)(5). Extending the attainment date by 1 year does not change an area's SIP submission requirements. Therefore, CAA section 182(j)(1)(A)'s directive to states governing a multi-state area to coordinate SIP submissions plainly does not have bearing on a provision that does not alter or affect SIP submissions. By contrast, as the EPA has stated, the coordination required by CAA section 182(j)(1)(A) is relevant to a voluntary reclassification, which establishes upon the states with jurisdiction over the nonattainment area new obligations to prepare and submit revisions to SIPs.

    Comment: One commenter stated that the states of Delaware and New Jersey did not make any claim or demonstration that they have complied with all requirements and commitments in the SIP, and, therefore, granting an extension to the multi-state area is not warranted. The commenter alleged that the EPA implied that an analysis of Delaware's compliance with the CAA section 181(a)(5)(A) criteria was conducted but that the EPA failed to provide any evidence or showing that Delaware did in fact comply with all requirements and commitments in the applicable implementation plan pertaining to the Philadelphia nonattainment area.

    Response: Given the state and federal partnership in implementing the CAA, it is not unreasonable for the EPA to interpret CAA section 181(a)(5)(A), in the absence of a state submitting a certification of compliance, for the EPA to exercise discretion and conduct an independent review of the applicable SIP in order to, in this case, determine whether Delaware and New Jersey are in compliance with the requirements and commitments of the federally-approved SIP. CAA section 302(q) defines “applicable implementation plan” as the portion (or portions) of the implementation plan, or most recent revision thereof, which has been approved under CAA section 110, or promulgated under CAA section 110(c), or promulgated or approved pursuant to regulations promulgated under CAA section 201(d) and which implements the relevant requirements of the CAA. The Act does not specify what type of review is required in order for the states or the EPA to demonstrate that the condition under CAA section 181(a)(5)(A) has been met; therefore, the EPA reasonably interprets the condition to require a review of the relevant, applicable approved implementation plan provisions, and an application of its own knowledge and expertise with regard to whether the state is meeting those obligations, including a review of whether the agency or outside parties has identified state noncompliance with the obligations. Therefore, in proposing to grant a 1-year extension of the attainment date for the Philadelphia area, and in conjunction with EPA Headquarters, the EPA Regional Offices, which have particular expertise and knowledge of the contents and implementation of SIPs, conducted reviews of whether Delaware and New Jersey are in compliance with their applicable implementation plans.

    The EPA reviewed New Jersey's applicable ozone implementation plan found at 40 CFR 52.1570 and the most recent actions related to New Jersey's applicable ozone implementation plan, which include the following EPA approvals: 74 FR 22837—“Approval and Promulgation of Implementation plans, New Jersey Reasonable Further Progress Plans, Reasonable Available Control Technology, Reasonably Available Control Measures and Conformity Budgets”; 75 FR 45483—“Approval and Promulgation of Implementation Plans; Implementation Plan Revision; State of New Jersey”; and 75 FR 80340—“Approval and Promulgation of Implementation Plans; New Jersey; 8-hour Ozone Control Measure.” Since the adoption of these measures, New Jersey has also amended its SIP to adopt and implement additional emission reductions as part of its SIPs to reduce regional haze and to meet the NAAQS for fine particles. The EPA has reviewed the contents of New Jersey's applicable SIPs and notes that there are no pending enforcement actions by the EPA or outside parties alleging that New Jersey has failed to implement its applicable plan.

    Similarly, the EPA reviewed Delaware's applicable ozone implementation plan found at 40 CFR 52.420. In our August 2015 proposal, we noted a recent proposal to disapprove a revision to Delaware's New Source Review (NSR) preconstruction permitting program regulation, see 80 FR 30015 (May 26, 2015). Despite this proposed disapproval of a SIP revision, we did not believe this proposal to disapprove a SIP revision was a bar to the EPA granting a 1-year attainment date extension for the Philadelphia area because there is an underlying approved nonattainment NSR SIP. The EPA has examined its own internal database of the notices required under 40 CFR 51.161(a), (b) and (d) (relating to a notice providing for public and the EPA comment on permit applications) and information posted by the state of Delaware. For the period after September 11, 2013 (the date on which Delaware's newly expanded offset area provisions under state law were effective), the EPA has identified no permits which triggered the requirement for lowest achievable emission rate (LAER) and offsets under Delaware's Regulation 1125 relating to ozone precursors of volatile organic compounds and nitrogen oxides (NOX). The EPA found that Delaware had undertaken a number of permitting actions since September 11, 2013, but none of these were subject to sections 2.5.5 and 2.5.6 of Delaware's Regulation 1125. The EPA also did not find any incidences of enforcement actions by the agency or outside parties alleging that Delaware is not meeting its SIP obligations.

    Moreover, the commenter has not presented any evidence or made any demonstration that suggests either New Jersey or Delaware is not in compliance with their applicable SIP and is, thus, unqualified to receive an attainment date extension. Based on its review of the states' applicable implementation plans and its knowledge and expertise of state actions with regard to those plans, the EPA is making a final determination that both New Jersey and Delaware are meeting the conditional requirement of CAA section 181(a)(5)(A).

    Comment: One commenter requested that the EPA deny Wisconsin's request for a 1-year extension to their attainment year for the Sheboygan County Marginal ozone nonattainment area. The commenter argued that 2015 preliminary air quality monitoring data for the Sheboygan area indicates that the area will not attain the standard in 2016, and, moreover, that the data also will not support a second 1-year extension of the attainment date for the Sheboygan area. The commenter maintained that even if a state meets the two conditions provided in CAA section 181(a)(5), the EPA retains the discretion to deny a request for a 1-year extension, and the commenter urged that the EPA should exercise its discretion in this case. In support, the commenter provided a citation to a 1994 EPA memo (Berry Memorandum) 7 that cautions states to consider whether an attainment date extension will ultimately be helpful if the area is not likely to attain the NAAQS by the extended attainment date. The commenter further pointed out that Wisconsin has an “inflexible and lengthy process for rulemaking,” which could further hinder the state's ability to meet the attainment date in the future, if the state delays planning and implementing additional control measures now. The commenter also pointed out that the Sheboygan area has not made considerable progress towards attaining the standard, and that the area backslid into nonattainment for the 1997 8-hour ozone NAAQS in 2012 and 2013. The commenter suggested that, rather than granting a 1-year extension of the attainment date, the EPA should determine that the Sheboygan area failed to meet its Marginal area attainment date of July 20, 2015, and, therefore, the EPA should reclassify the area to Moderate, which will allow the state of Wisconsin adequate time to achieve emissions reductions to meet the new attainment date for a Moderate area.

    7See memorandum signed by D. Kent Berry, Acting Director, Air Quality Management Division, “Procedures for Processing Bump Ups and Extension Requests for Marginal Ozone Nonattainment Areas.” U.S. EPA, February 3, 1994.

    Response: CAA section 181(a)(5) of the CAA, as interpreted by the EPA in 40 CFR 51.1107, authorizes the EPA to grant a 1-year attainment date extension upon application by a state if: (1) The state has complied with all requirements and commitments in the applicable SIP, and (2) all monitors in the area have a fourth highest daily maximum 8-hour average of 0.075 ppm or less for the last full year of air quality data prior to the attainment date (i.e., 2014 for an attainment date of July 20, 2015). Here, Wisconsin has clearly met both of the conditions for the Sheboygan area. Wisconsin submitted a request to the EPA for a 1-year extension of the attainment date for the Sheboygan area, certifying that Wisconsin had complied with all requirements and commitments pertaining to the area in the applicable implementation plan and that all monitors in the area have a fourth highest daily maximum 8-hour average of 0.075 ppm or less for 2014, the most recent complete year of quality-assured and certified data preceding the July 20, 2015, attainment date.8 The EPA has also evaluated the quality-assured and certified air quality monitoring data for 2014 and determined that Sheboygan met the air quality requirements of CAA section 181(a)(5)(B) and 40 CFR 51.1107. Although the EPA agrees with the commenter that the Administrator retains the discretion to deny a state's request for an attainment date extension even if the state has met both criteria in CAA section 181(a)(5), the agency is declining to exercise that discretion here. The commenter relies primarily upon preliminary air quality data for 2015 that has not been quality assured and certified to contend that the Administrator should deny Wisconsin's request here.9 Given that the state meets the extension criteria, the Administrator is disinclined to deny the state's request based on preliminary data. Moreover, the citation from the Berry Memorandum that the commenter relies upon is directed at cautioning states, in deciding whether to request an extension, to consider whether a 1-year attainment date extension will be helpful in achieving the NAAQS and is not directed at the Administrator's decision to grant or deny such request. The EPA does, however, agree with the commenter that, given the air quality trends and data presented by the commenter, it would be prudent for the state to begin preparing for the possibility that the area may not attain by the July 20, 2016, attainment date, and also may fail to meet the requirements to get an additional 1-year attainment date extension. However, the agency does not believe that those possibilities are reason enough to deny the state's request for this first 1-year attainment date extension, given that Wisconsin has met the two statutory criteria. Therefore, the EPA declines to grant the commenter's request to find that the area failed to attain by July 20, 2015, and to subsequently reclassify the area accordingly. The Sheboygan nonattainment area will remain classified as Marginal for the 2008 ozone NAAQS until the EPA (1) determines, based on quality assured and certified air quality data for 2013-2015, that the area did not attain the 2008 ozone NAAQS by July 20, 2016, and does not qualify for an additional 1-year extension10 and (2) reclassifies the area based on this determination. We expect Wisconsin to be taking the necessary steps to achieve timely attainment and will continue to work with the state toward that end.

    8See letter signed by Bart Sponseller, Deputy Division Administrator, Air, Waste and Remediation & Redevelopment Division, Wisconsin Department of Natural Resources addressed to Ms. Susan Hedman, Regional Administrator, U.S. EPA Region 5. RE: Request for 1-year extension to the attainment date for the Sheboygan, WI nonattainment area, May 12, 2015. Docket EPA-HQ-OAR-2015-0468-0022 at http://www.regulations.gov.

    9 These data are subject to the EPA's date certification requirements of 40 CFR 58.15, which require a state to submit its annual data certification letter by May 1.

    10 The area will qualify for a second 1-year extension if, and only if, the average of annual fourth-high daily maximum 8-hour ozone concentrations for 2014 and 2015 is at or below 0.075 ppm at all monitors in Sheboygan County.

    Comment: One commenter maintained that, in evaluating whether a state is in compliance with all requirements and commitments pertaining to an area pursuant to CAA section 181(a)(5)(A), the EPA may not rely on a letter from the state certifying that the state is meeting this requirement. The commenter argued that there must be a factual and rational basis for the agency to grant 1-year extensions and that assertions by the states that they are in compliance with all requirements and commitments does not provide a factual or rational basis when there is no evidence that the assertion was based on a systematic review of compliance or noncompliance.

    Response: The EPA disagrees with the commenter's assertion. CAA section 181(a)(5) does not specify who must make the demonstration as to whether a state is complying with all requirements and commitments to the area in the applicable implementation plan. Nothing in the provision explicitly prohibits the EPA from relying on certified statements from state officials that the requirement of CAA section 181(a)(5)(A) has been met, and nothing in the provision supports the commenter's suggestion that the EPA is independently required to perform a “systematic review of compliance or noncompliance” of the state's SIP regardless of whether a state official has made a certified statement to that effect in order to grant an attainment date extension. Given the state and federal partnership in implementing the CAA, it is not unreasonable for the EPA to interpret CAA section 181(a)(5)(A) as permitting the agency to rely upon the certified statements of its state counterparts, and the EPA has long interpreted the provision to be satisfied by such statements.11 In practice, in conjunction with a request for an extension, a state air agency's Executive Officer, or other senior individual with equivalent responsibilities, signs and affirms that their state is complying with their applicable federally-approved SIP. The commenter argues that the certifications lack rational or factual bases, but has not presented any evidence or made any demonstration that suggests any of the states receiving an attainment date extension are not in compliance with their SIPs. Absent such a showing, the EPA is disinclined to invalidate the certifications made by the states.

    11See Berry Memorandum.

    C. Determinations of Failure To Attain and Reclassification

    Pursuant to CAA section 181(b)(2), the EPA is finalizing its proposed determinations that the 11 Marginal nonattainment areas listed in Table 3 have failed to attain the 2008 ozone NAAQS by the applicable attainment date of July 20, 2015. Therefore, upon the effective date of this rule, these 11 Marginal 2008 ozone nonattainment areas will be reclassified by operation of law to Moderate for the 2008 ozone standard. The EPA received a number of adverse comments on its proposal to find that certain Marginal nonattainment areas failed to attain and to reclassify those areas. We summarize and respond to some of the key comments later. The docket for this action contains a more detailed Response to Comments document.

    Comment: A number of commenters, while conceding that air quality monitoring data factually required the EPA to determine that an area failed to attain by its attainment date, alleged that certain nonattainment areas' failure to attain by the Marginal area attainment date was due in large part to the influence of transported emissions from upwind states. These commenters alleged that the EPA has not done enough to enforce CAA section 110(a)(2)(D), which requires states to eliminate emissions that significantly contribute to, or interfere with maintenance of the NAAQS in other states. One commenter further noted that the EPA's current strategy with regard to ozone transport addresses only the revoked 85 parts per billion (ppb) standard, and that the EPA has no strategy to reduce transport after 2017.

    Response: The agency's mandatory duty to make determinations of attainment or failure to attain the NAAQS exists regardless of the nature or effect of transported emissions on monitored air quality data in a given nonattainment area.12 Nonetheless, the EPA readily acknowledges the role interstate transport of precursors to ozone pollution plays in the efforts of downwind areas to attain and maintain the NAAQS. To that end, as commenters have alluded to, the agency has taken a number of steps to fulfill its statutory obligation to enforce CAA section 110(a)(2)(D), or the “good neighbor” provision, including the NOX SIP Call, the Clean Air Interstate Rule, and the Cross-State Air Pollution Rule (CSAPR). most recently, the EPA has proposed to update CSAPR specifically to address the 2008 ozone NAAQS with tightened NOX budgets designed to achieve emission reductions in upwind states before the Moderate area attainment date of July 2018.

    12See Sierra Club v. EPA, 294 F.3d 155, 160-62 (D.C. Cir. 2002) (holding that the EPA is not permitted to relax mandatory statutory requirements for downwind areas on the basis of interstate transport).

    D. Moderate Area SIP Revision Submission Deadline

    The EPA received a number of comments on its two proposed options for establishing the Moderate area SIP due date that would apply to areas newly reclassified under this final action. After full consideration of those comments and pursuant to CAA section 182(i), the EPA is finalizing that SIP revisions required for the newly reclassified Moderate areas must be submitted as expeditiously as practicable, but no later than January 1, 2017. The EPA acknowledges that for some states with Moderate nonattainment areas reclassified from Marginal, meeting this SIP submittal deadline may be challenging. The EPA is committed to working closely with these states to help them prepare their SIP revisions in a timely manner.

    We summarize and provide responses to the most significant comments on this issue later; however, all comments received on the proposed options and the EPA's responses are available in the Response to Comment document located in the docket for this final rule.

    Comment: One commenter contended that the EPA failed to provide a legal basis for extending the SIP submittal deadlines for Moderate nonattainment areas. The commenter believed that the EPA made no claim that the 2017 SIP submittal deadlines are necessary or appropriate to assure consistency among the required submissions. The commenter also believed that the EPA's proposed extension would interfere with the attainment date and contravene CAA section 110(l). The commenter pointed out that if the EPA finalized the SIP submission deadline to coincide with the area's beginning of the ozone monitoring season, the consequence would be that the EPA would have less than 18 months to take action on state SIP submittals, as late as July 2018, which is very near the attainment date. The commenter believed that would be far too late for the EPA to require timely corrections of SIPs that fail to satisfy the requirements and fail to assure timely attainment.

    Response: The EPA disagrees with the commenter on all aspects of these comments. First, we believe that CAA section 182(i) clearly provides the Administrator the discretion to adjust any applicable deadline for reclassified areas (other than attainment dates) to the extent such adjustment is necessary or appropriate to assure consistency among the required submissions.

    The EPA disagrees with the implication of the comment that the default assumption upon reclassification is that the EPA would not adjust the Moderate area SIP submission deadlines. The fact that Congress included CAA section 182(i) in the statute indicates that it envisioned that upon reclassification, deadlines would be adjusted by the Administrator in a reasonable fashion. This is a particularly reasonable interpretation under the facts at issue here: The attainment date for Marginal areas under the statute and regulations was July 20, 2015, and the Moderate area SIP submission date for areas initially classified as Moderate for the 2008 ozone NAAQS was also July 20, 2015. Under CAA section 181(b)(2)(A), the EPA must make determinations of attainment and necessary reclassifications within 6 months of the statutory attainment date. Therefore, under the commenter's interpretation of the CAA, upon reclassification 6 months after July 20, 2015, states would immediately be found to be in default of the obligation to submit a Moderate area plan, a deadline that had passed 6 months prior, even though that obligation did not apply until the moment of reclassification. We do not agree that Congress would have intended the draconian and absurd result of providing states initial notice of an obligation and in the same action finding them at fault for already failing to have met that obligation. Therefore, the EPA believes that it is reasonable to read CAA section 182(i) in the context of the 11 reclassified 2008 Marginal ozone areas to provide the Administrator the authority to adjust the applicable deadline for Moderate area attainment plans “as necessary or appropriate to assure consistency among the required submissions.”

    Moreover, failing to establish new Moderate area SIP submission deadlines for the 11 areas that we are reclassifying in this rulemaking would lead to potential inconsistency in required submissions among those areas. Under the commenter's interpretation, these areas would all have missed their deadline to submit a Moderate area plan on July 20, 2015. The commenter would, therefore, have the EPA begin issuing findings of failure to submit under CAA section 110(k), which are required by statute 6 months following the statutory deadline to submit a SIP, simultaneously with this action, that is, the EPA's determination that the areas failed to attain and reclassification of those areas. Following the EPA's issuance of findings of failure to submit for the 11 areas, there would be no defined statutory or regulatory deadline by which to remedy the states' failures to make submittals, except the outside limit of 2 years, the deadline for EPA's obligation to implement a Federal Implementation Plan (FIP). Additionally, if the EPA had not affirmatively determined that a state had made a complete SIP submittal for an area within 18 months from the issuance of a finding of failure to submit, the offset sanction identified in CAA section 179(b)(2) would apply to the affected nonattainment area.

    The EPA also disagrees with the commenter that establishing a new SIP submittal deadline for the reclassified areas is in contravention of CAA section 110(l). CAA section 110(l) requires that plan revisions must go through notice and public hearing at the state level before submission to the EPA, and that “the Administrator shall not approve a revision of a plan if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress . . . or any other applicable requirement of this chapter.” In order for the EPA's proposed SIP submittal date to be in contravention of CAA section 110(l), one has to assume that the states will submit deficient SIPs and that the EPA will not take any kind of corrective action on those SIPs until after the maximum possible time period permitted under the statue to take action on such submittals (18 months) has passed. Only then could a SIP submittal date of more than 18 months prior to the attainment date be interpreted as interfering with the attainment of the NAAQS. The EPA does not believe this is a reasonable reading of CAA section 110(l) or the circumstances of these reclassifications and SIP deadline adjustments. While the EPA acknowledges that the timeline for preparation and submittal of SIPs must be compressed in order for measures to be in place to ensure areas attain by their new Moderate area attainment date, in establishing the new SIP submittal deadlines for these reclassified areas, the agency is also taking into account the time required for states to identify measures, complete the public notice and hearing process at the state level, and prepare SIP submissions.

    Comment: Several commenters supported the EPA's proposed option to align the deadline for SIP revisions with the start of the respective nonattainment area's 2017 ozone season. They cited a number of reasons this option was preferred, including that more time would be provided to states to accomplish planning, administrative and SIP revisions processes in order to meet the deadline. They also cited that this option would be consistent among states in that they would need to submit their SIP revisions by their respective ozone seasons. However, another commenter pointed out that finalizing this option would result in SIP submittal dates that would be varied among the states and, therefore, inconsistent. The same commenter also stated that setting the SIP deadline for the beginning of each area's ozone season would not be compatible with ensuring implementation of RACT by January 1, 2017, which is the deadline established in 40 CFR 51.1112(a)(3).

    Response: As noted earlier, of the 11 areas being reclassified to Moderate, there are only four areas located in states with ozone seasons that begin later than January 1 that could potentially benefit from an extra 2 months to submit their SIP revisions. While the EPA recognizes the value of additional time (beyond January 1, 2017) to these states to develop an attainment demonstration, an RFP plan, and contingency measures, the EPA also recognizes the value in establishing a single due date for Moderate area SIP submissions—including RACT—that does not extend beyond the deadline for implementing such controls. Thus, the EPA is finalizing its second proposed option, which requires that states submit the required Moderate area SIP revisions as expeditiously as practicable, but no later than January 1, 2017. This approach aligns the SIP submittal deadline with the January 1, 2017, deadline for implementing RACT pursuant to 40 CFR 51.1112(a)(3), for each area, and would also ensure that SIPs requiring control measures needed for attainment, including RACM, would be submitted prior to when those controls are required to be implemented. This option also treats states consistently, in keeping with CAA section 182(i). The EPA recognizes the challenges posed by these very short deadlines and is committed to working closely with all states to help them prepare their SIP revisions, including parallel processing, in a timely manner.

    E. Rescission of Clean Data Determination and Final SIP Call for the 1997 8-Hour Ozone NAAQS for the New York-N. New Jersey-Long Island (NY-NJ-CT) Nonattainment Area

    This action finalizes the EPA's determination that the NY-NJ-CT nonattainment area failed to attain the 2008 standard by the Marginal area attainment date of July 20, 2015, and must be reclassified to Moderate by operation of law in accordance with CAA section 181(b)(2)(A). In addition, the EPA is also finalizing in this rulemaking the proposed rescission of its prior CDD for the NY-NJ-CT nonattainment area with regard to the 1997 8-hour ozone NAAQS, as well as the accompanying SIP Call proposed with that rescission. As noted previously, in the May 2014 proposal, the EPA proposed that one way the affected states could respond to the SIP Call would be to voluntarily request a reclassification under the 2008 ozone NAAQS and to submit a SIP that meets the Moderate area requirements for that standard.

    By reclassifying the area by operation of law, this final action effectively eliminates the need for the three affected states to request reclassification under this option. However, as explained in the agency's August 27, 2015, proposal and reiterated later, the EPA believes it is appropriate for the three states involved to be able to meet their obligations under the SIP Call for the 1997 ozone NAAQS with their Moderate area SIP submittal for the 2008 ozone standard. This final action also supersedes the 18 months, which is the maximum period allowed under CAA section 110(k)(5), that EPA proposed to provide the states of New York, New Jersey and Connecticut from the effective date of a final SIP Call to develop and submit to the EPA the relevant SIPs for the 1997 or 2008 ozone NAAQS. As discussed previously, the EPA is finalizing that the required SIP revisions for these areas shall be submitted as expeditiously as practicable, but no later than January 1, 2017. We also note that this deadline meets the statutory timeframe for a SIP revision under CAA section 110(k)(5).

    The EPA did not receive adverse comments on its August 27, 2015, proposal to reclassify the NY-NJ-CT nonattainment area to Moderate, nor did the EPA receive comments about its statement that submitting an attainment plan for the 2008 ozone standard would satisfy a final SIP Call on the 1997 ozone standard. We received a number of comments on the May 15, 2014, proposal (79 FR 27830) to rescind the CDD for the NY-NJ-CT 1997 8-hour ozone nonattainment area and the accompanying SIP Call for attainment plans. We summarize later some of the significant comments submitted in response to the May 15, 2014, proposal and our responses. Additionally, we have made available a more detailed summary of comments and responses in a document titled, “Response to Comments: Proposed Rule: Rescission of Determination of Attainment and Call for Attainment Plans for New York, New Jersey and Connecticut for the 1997 8-Hour Ozone National Ambient Air Quality Standards for the NY-NJ-CT 1997 Ozone Nonattainment Area,” which is available in the docket associated with this rulemaking.

    Comment: One commenter believed that CAA section 110(k)(5) either compels or provides the EPA the authority necessary to expand the proposed SIP Call to include any state that is shown to significantly contribute to the failure of the NY-NJ-CT area to attain because these states have failed to meet their obligations under CAA section 110(a)(2)(D)(i)(I).13 The commenter further believed that CAA section 110(k)(5) allows the EPA to issue a SIP Call to address states' SIPs that are inadequate in mitigating transport as described in CAA sections 176A and 184. The commenter believed that the U.S. Supreme Court decision in EPA v. EME Homer City (134 S. Ct. 1584 (2014)), compels the EPA to immediately issue FIPs for upwind states that have failed to take all necessary steps to make it feasible for any nonattainment area significantly impacted by interstate air pollution to attain and maintain both the 1997 and 2008 8-hour ozone NAAQS. Finally, the commenter noted that the “CSAPR modeling shows that Connecticut receives no more than a 0.2 ppb total benefit from the CSAPR remedy, which is entirely inadequate given the overwhelming scope of transport.”

    13 The commenter refers to states' interstate transport obligations under CAA section 110(a)(2)(D)(ii), but the EPA understands these citations to in fact refer to the good neighbor provision, which is CAA section 110(a)(2)(D)(i)(I).

    Response: CAA section 110(a)(2)(D)(i)(I) requires states to prohibit emissions that contribute significantly to nonattainment in, or interfere with maintenance by any other state with respect to primary and secondary NAAQS. In the CSAPR promulgated on August 8, 2011 (76 FR 48207), the EPA found that emissions of sulfur dioxide and NOX in 27 eastern, midwestern, and southern states contribute significantly to nonattainment or interfere with maintenance in one or more downwind states with respect to one or more of three air quality standards—the annual PM2.5 NAAQS promulgated in 1997, the 24-hour PM2.5 NAAQS promulgated in 2006, and, as relevant here, the ozone NAAQS promulgated in 1997.

    For the 1997 ozone NAAQS specifically, twenty states are required under CSAPR to reduce NOX emissions during the ozone season (May through September) because they contribute to downwind states' ozone pollution. The emission reductions under CSAPR in these upwind states will improve ozone air quality in downwind states and help them attain and maintain the 1997 8-hour ozone standard.

    The timing of CSAPR's implementation was initially affected by litigation over the rule. On December 30, 2011, the D.C. Circuit stayed the effectiveness of CSAPR pending resolution of judicial review. On August 21, 2012, the D.C. Circuit vacated CSAPR,14 but on April 29, 2014, the U.S. Supreme Court issued an opinion reversing the D.C. Circuit's 2012 decision and remanded the case to the D.C. Circuit.15 Following the remand, on October 23, 2014, the D.C. Circuit granted the EPA's motion to lift the CSAPR stay and toll the CSAPR compliance deadlines by 3 years. Accordingly, CSAPR Phase 1 implementation began on January 1, 2015, with Phase 2 beginning in 2017. See CSAPR interim final rule at 81 FR 13275 (March 14, 2016). Subsequently, the D.C. Circuit issued its final ruling as to CSAPR, affirming it in most respects but invalidating without vacating several of the rule's state-specific budgets, including some of the rule's Phase 2 ozone-season NOX budgets.16 The EPA has since proposed a rulemaking to update to the CSAPR ozone-season NOX budgets in order to address the more stringent 2008 ozone NAAQS and to respond to the D.C. Circuit's remand of the Phase 2 ozone-season NOX budgets.17 As proposed, the CSAPR Update ozone-season NOX budgets would be effective starting in 2017, effectively replacing CSAPR Phase 2.

    14EME Homer City Generation, L.P. v. EPA, 696 F.3d 7, 38 (D.C. Circuit 2012).

    15EPA v. EME Homer City Generation, L.P., 134 S. Ct. 1584 (2014).

    16EME Homer City Generation, L.P. v. EPA, 795 F.3d 118 (D.C. Circuit 2015).

    17 80 FR 75706 (December 3, 2015).

    The EPA disagrees with the commenter that the Supreme Court's decision in EPA v. EME Homer City compels the agency to issue new FIPs or to expand the scope of the proposed SIP Call to address the 1997 and 2008 8-hour ozone NAAQS. The Supreme Court did, however, confirm that the EPA properly issued the CSAPR FIPs in response to disapprovals of SIPs or findings of failure to submit SIPs implementing states' 110(a)(2)(D)(i)(I) obligations with regard to the 1997 ozone NAAQS. Those FIPs took effect and began implementation on January 1, 2015 pursuant to the D.C. Circuit's grant of the EPA's motion requesting lifting of the stay, so we note that at the time the NY-NJ-CT area fell back into nonattainment of the 1997 standard, it did not have the benefit of CSAPR reductions. While the commenter points out that modeling conducted for the CSAPR rulemaking projected that the remedy would provide “no more than a 0.2 ppb total benefit,” the same modeling also predicted that those reductions, once implemented, would fully resolve nonattainment and maintenance problems for the 1997 ozone NAAQS in the receptors identified in the NY-NJ-CT nonattainment area. For upwind states that were linked only to receptors where downwind nonattainment and maintenance problems were fully resolved under the remedy, the EPA found that CSAPR quantified the full reduction responsibility for the 1997 ozone NAAQS under CAA section 110(a)(2)(D)(i)(I).18 Therefore, the EPA could not expand the scope of the SIP Call being issued on the basis that upwind states had not fulfilled their 110(a)(2)(D)(i)(I) obligations as to the 1997 ozone NAAQS when the EPA has already issued a FIP that fully resolves the obligations of those states with respect to that standard.

    18See 76 FR 48210, Federal Implementation Plans: Interstate Transport of Fine Particulate Matter and Ozone and Correction of SIP Approvals (August 8, 2011).

    The EPA also does not agree that it would be appropriate in this action to more broadly apply its 110(k)(5) authority to include additional states in this SIP Call to address interstate pollutant transport as described in sections 176A and 184 of the CAA. The EPA acknowledges that a number of states, including Connecticut and New York, submitted a petition under CAA section 176A requesting that the EPA add additional states to the Ozone Transport Region (OTR) that was established under section 184 of the CAA. The EPA is reviewing that petition separately and is not acting on that petition in this action. In addition, the EPA's authority to require SIP revisions under 110(k)(5) as they relate to additional control measures required by CAA section 184 applies to only states that are currently part of the OTR.

    III. Environmental Justice Considerations

    The CAA requires that states with areas designated as nonattainment submit to the Administrator the appropriate SIP revisions and implement specified control measures by certain dates applicable to the area's classification. By requiring additional planning and implementation requirements for the 11 nonattainment areas that we determined failed to attain the 2008 ozone NAAQS standard, the part of this action reclassifying those 11 areas from Marginal to Moderate will protect all those residing, working, attending school, or otherwise present in those areas regardless of minority or economic status.

    IV. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

    This action is exempt from review by the Office of Management and Budget (OMB) because it makes determinations if designated 2008 ozone nonattainment areas are either attaining or failing to attain the 2008 ozone NAAQS by the attainment date along with resulting reclassifications or determination to grant 1-year attainment date extensions.

    B. Paperwork Reduction Act (PRA)

    This rule does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0695. This action to find that the Marginal ozone nonattainment areas listed in Table 3 failed to attain the 2008 NAAQS by the applicable attainment date, to reclassify those areas as Moderate ozone nonattainment areas, and to adjust any applicable deadlines, does not establish any new information collection burden that has not already been identified in the existing 2008 ozone NAAQS Information Collection Request number 2347.01.

    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 will not impose any requirements on small entities. Determinations of nonattainment and the resulting reclassification of nonattainment areas by operation of law under section 181(b)(2) of the CAA do not in and of themselves create any new requirements. Instead, this rulemaking only makes a factual determination, and does not directly regulate any entities. This action also establishes the deadline by which states will need to submit revisions to their SIPs to address the new Moderate area requirements, and that deadline, if based on the statute, would otherwise be more stringent. In this final action, the EPA is exercising discretion under CAA section 182(i) which allows the Administrator to provide state air agencies additional time to comply with those requirements.

    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. This 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. No tribal areas are implicated in the 11 areas that we are finding to have failed to meet their attainment date. The CAA and the Tribal Authority Rule establish the relationship of the federal government and tribes in developing plans to attain the NAAQS, and this rule does nothing to modify that relationship. Thus, Executive Order 13175 does not apply to this action.

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

    The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the 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 this action determines that 11 areas, identified in Table 3, did not attain the 2008 ozone standard by their applicable attainment date and to reclassify these areas as Moderate ozone nonattainment areas and to adjust applicable deadlines.

    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

    The 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. The results of this evaluation are contained in the section of the preamble titled “Environmental Justice Considerations.”

    K. Congressional Review Act (CRA)

    This rule is exempt from the CRA because it is a rule of particular applicability that names specific entities where this rule makes factual determinations and does directly regulate any entities. The determinations of attainment and failure to attain the 2008 ozone NAAQS (and resulting reclassifications), and the determination to grant 1-year attainment date extensions do not in themselves create any new requirements beyond what is mandated by the CAA.

    L. Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review of final actions that are locally and regionally applicable may be filed only in the United States Court of Appeals for the appropriate circuit. However, the statute also provides that notwithstanding that general rule, “a petition for review of any action . . . may be filed only in the United States Court of Appeals for the District of Columbia if such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.” 42 U.S.C. 7607(b)(1). See also Dalton Trucking v. EPA, 808 F.3d 875 (D.C. Circuit 2015). Because this final action makes findings with regard to nonattainment areas across the country, interprets the CAA and applies such interpretations to states and nonattainment areas across the country, and establishes SIP deadlines for newly reclassified areas in different states in a consistent fashion, the Administrator finds that this action has nationwide scope and effect. Therefore, in accordance with CAA section 307(b)(1), petitions for review of this final action may be filed only in the United States Court of Appeals for the District of Columbia Circuit by July 5, 2016. Note, under CAA section 307(b)(2), the requirements established by this final rule may not be challenged separately in any civil or criminal proceedings for enforcement.

    List of Subjects 40 CFR Part 52

    Environmental protection, Administrative practice and procedure, Air pollution control, Designations and classifications, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

    40 CFR Part 81

    Environmental protection, Administrative practice and procedure, Air pollution control, Designations and classifications, Intergovernmental relations, Nitrogen oxides, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: April 11, 2016. Gina McCarthy, Administrator.

    For the reasons stated in the preamble, parts 52 and 81, title 40, chapter I of the Code of Federal Regulations are 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 E—Arkansas 2. Add § 52.174 to read as follows:
    § 52.174 Control strategy and regulations: Ozone.

    (a) The EPA has determined that the Crittenden County Marginal 2008 ozone NAAQS nonattainment area attained the NAAQS by the applicable attainment date of July 20, 2015.

    (b) [Reserved]

    Subpart F—California
    3. Section 52.282 is amended by revising paragraphs (e) introductory text and (e)(1) and (2) to read as follows:
    § 52.282 Control strategy and regulations: Ozone.

    (e) Determinations of attainment. Effective June 3, 2016.

    (1) Approval of applications for extensions of applicable attainment dates. Under section 181(a)(5) of the Clean Air Act, the EPA is approving the applications submitted by the California Air Resources Board dated June 1, 2015, referencing the District's letter of May 19, 2015, for extensions of the applicable attainment date for the San Luis Obispo (Eastern San Luis Obispo), CA 2008 8-hour ozone nonattainment areas from July 20, 2015 to July 20, 2016.

    (2) Determinations of attainment. The EPA has determined that the Calaveras County, Chico (Butte County), San Francisco Bay Area and Tuscan Buttes 2008 8-hour ozone nonattainment areas in California have attained the 2008 8-hour ozone standard by the July 20, 2015 applicable attainment date, based upon complete quality-assured data for 2012-2014. Therefore, the EPA has met its obligation pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality data as of the attainment date, whether the area attained the standard. As a result of these determinations, the Calaveras County, Chico (Butte County), San Francisco Bay Area and Tuscan Buttes 2008 8-hour ozone nonattainment areas in California will not be reclassified for failure to attain by their July 20, 2015, applicable attainment date under section 181(b)(2)(A).

    Subpart H—Connecticut
    4. Section 52.377 is amended by adding paragraph (p) to read as follows:
    § 52.377 Control strategy: Ozone.

    (p) Rescission of clean data determination for the 1997 eight-hour ozone standard. Effective June 3, 2016, the EPA is determining that complete quality-assured and certified ozone monitoring data for 2012-2014 show the NY-NJ-CT 1997 eight-hour ozone nonattainment area did not meet 1997 eight-hour ozone standard. Therefore, the EPA is rescinding the clean data determination for the 1997 eight-hour ozone standard only. The prior determination (see paragraph k of this section) is in accordance with 40 CFR 51.918. The prior determination suspended the requirements for this area to submit an attainment demonstration, associated reasonably available control measures, a reasonable further progress plan, contingency measures, and other planning SIPs related to attainment of the standard for as long as this area continues to meet the 1997 annual eight-hour ozone NAAQS. This rescission of the clean data determination will result in a SIP Call for a new ozone attainment demonstration, associated reasonably available control measures, a reasonable further progress plan, contingency measures, and other planning SIPs related to attainment of the standard, for this area only. If the revised plan is approved by the EPA as demonstrating reasonable further progress and attainment for the more stringent 2008 NAAQS by the Moderate area attainment date, and is approved by the EPA as containing adequate contingency measures for the 2008 NAAQS, then the plan would be deemed to have also satisfied requirements of the SIP Call associated with violations for the 1997 NAAQS.

    Subpart I—Delaware
    5. Section 52.425 is amended by adding paragraph (c) to read as follows:
    § 52.425 Determinations of attainment.

    (c) The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Seaford, DE 2008 ozone Marginal nonattainment area has attained the 2008 ozone NAAQS by the applicable attainment date of July 20, 2015. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality data as of the attainment date, whether the area attained the standard. The EPA also determined that the Seaford nonattainment area will not be reclassified for failure to attain by its applicable attainment date under section 181(b)(2)(A).

    Subpart P—Indiana
    6. Section 52.777 is amended by adding paragraph (tt) to read as follows:
    § 52.777 Control strategy: photochemical oxidants (hydrocarbons).

    (tt) Determination of attainment. As required by section 181(b)(2)(A) of the Clean Air Act, the EPA has determined that the Cincinnati, OH-KY-IN Marginal 2008 ozone nonattainment area has attained the 2008 ozone NAAQS by the applicable attainment date of July 20, 2015.

    Subpart S—Kentucky
    7. Section 52.930 is amended by adding paragraph (m) to read as follows:
    § 52.930 Control strategy: Ozone.

    (m) Determination of attainment. The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Cincinnati, OH-KY-IN 2008 ozone Marginal nonattainment area has attained the 2008 ozone NAAQS. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality data as of the attainment date, whether the area attained the standard. The EPA also determined that the Cincinnati, OH-KY-IN nonattainment area will not be reclassified for failure to attain by its applicable attainment date under section 181(b)(2)(A).

    Subpart T—Louisiana
    8. Section 52.977 is amended by adding paragraph (f) to read as follows:
    § 52.977 Control strategy and regulations: Ozone.

    (f) The EPA has determined that the Baton Rouge Marginal 2008 ozone NAAQS nonattainment area attained the NAAQS by the applicable attainment date of July 20, 2015.

    Subpart W—Massachusetts
    9. Section 52.1129 is amended by adding paragraph (k) to read as follows:
    § 52.1129 Control strategy: Ozone.

    (k) Determination of attainment for the eight-hour ozone standard. Effective June 3, 2016, the EPA is determining that complete quality-assured and certified ozone monitoring data for 2012 to 2014 show the Dukes County, Massachusetts eight-hour ozone nonattainment area attained the 2008 eight-hour ozone standard by its July 20, 2015 attainment deadline. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality data as of the attainment date, whether the area attained the standard. The EPA also determined that the Dukes County nonattainment area will not be reclassified for failure to attain by its applicable attainment date under section 181(b)(2)(A).

    Subpart Z—Mississippi
    10. Add § 52.1273 to read as follows:
    § 52.1273 Control strategy: Ozone.

    (a) Determination of attainment. The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Memphis, TN-MS-AR 2008 ozone Marginal nonattainment area has attained the 2008 ozone NAAQS. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality data as of the attainment date, whether the area attained the standard. The EPA also determined that the Memphis, TN-MS-AR nonattainment area will not be reclassified for failure to attain by its applicable attainment date under section 181(b)(2)(A).

    (b) [Reserved]

    Subpart FF—New Jersey
    § 52.1576 [Amended]
    11. Section 52.1576 is amended by remove paragraph (d). 12. Section 52.1582 is amended by adding paragraph (p) to read as follows:
    § 52.1582 Control strategy and regulations: Ozone.

    (p) Rescission of clean data determination for the 1997 eight-hour ozone standard. Effective June 3, 2016, the EPA is determining that complete quality-assured and certified ozone monitoring data for 2012-2014 show the New York-Northern New Jersey-Long Island, NY-NJ-CT 1997 eight-hour ozone nonattainment area did not meet 1997 eight-hour ozone standard. Therefore, the EPA is rescinding the clean data determination for the 1997 eight-hour ozone standard only. The prior determination (see paragraph (n)(2)) is in accordance with 40 CFR 51.918. The prior determination suspended the requirements for this area to submit an attainment demonstration, associated reasonably available control measures, a reasonable further progress plan, contingency measures, and other planning SIPs related to attainment of the standard for as long as this area continues to meet the 1997 annual eight-hour ozone NAAQS. This rescission of the clean data determination will result in a SIP Call for a new ozone attainment demonstration, associated reasonably available control measures, a reasonable further progress plan, contingency measures, and other planning SIPs related to attainment of the standard, for this area only. If the revised plan is approved by the EPA as demonstrating reasonable further progress and attainment for the more stringent 2008 NAAQS by the Moderate area attainment date, and is approved by the EPA as containing adequate contingency measures for the 2008 NAAQS, then the plan would be deemed to have also satisfied requirements of the SIP Call associated with violations for the 1997 NAAQS.

    Subpart HH—New York
    13. Section 52.1679 is amended by revising paragraph (b) to read as follows:
    § 52.1679 Determinations of attainment.

    (b) Determination of attainment. The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Jamestown, NY 2008 ozone Marginal nonattainment area has attained the 2008 ozone NAAQS. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality data as of the attainment date, whether the area attained the standard. The EPA also determined that the Jamestown, NY nonattainment area will not be reclassified for failure to attain by its applicable attainment date under section 181(b)(2)(A).

    14. Section 52.1683 is amended by revising paragraph (f)(2)(v) and adding paragraph (n) to read as follows:
    § 52.1683 Control strategy: Ozone.

    (f) * * *

    (2) * * *

    (v) Jamestown (consisting of Chautauqua County) as of June 3, 2016.

    (n) Rescission of clean data determination for the 1997 eight-hour ozone standard. Effective June 3, 2016, the EPA is determining that complete quality-assured and certified ozone monitoring data for 2012 to 2014 show the New York-Northern New Jersey-Long Island, NY-NJ-CT 1997 eight-hour ozone nonattainment area did not meet the 1997 eight-hour ozone standard. Therefore, the EPA is rescinding the clean data determination for the 1997 eight-hour ozone standard only. The prior determination (see paragraph (f)(2)(viii) of this section) is in accordance with 40 CFR 51.918. The prior determination suspended the requirements for this area to submit an attainment demonstration, associated reasonably available control measures, a reasonable further progress plan, contingency measures, and other planning SIPs related to attainment of the standard for as long as this area continues to meet the 1997 annual eight-hour ozone NAAQS. This rescission of the clean data determination will result in a SIP Call for a new ozone attainment demonstration, associated reasonably available control measures, a reasonable further progress plan, contingency measures, and other planning SIPs related to attainment of the standard, for this area only. If the revised plan is approved by the EPA as demonstrating reasonable further progress and attainment for the more stringent 2008 NAAQS by the Moderate area attainment date, and is approved by the EPA as containing adequate contingency measures for the 2008 NAAQS, then the plan would be deemed to have also satisfied requirements of the SIP Call associated with violations for the 1997 NAAQS.

    Subpart II—North Carolina
    15. Section 52.1779 is amended by adding paragraph (c) to read as follows:
    § 52.1779 Control strategy: Ozone.

    (c) Determination of attainment. The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Charlotte-Rock Hill, NC-SC 2008 ozone Marginal nonattainment area has attained the 2008 ozone NAAQS. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality data as of the attainment date, whether the area attained the standard. The EPA also determined that the Charlotte-Rock Hill, NC-SC nonattainment area will not be reclassified for failure to attain by its applicable attainment date under section 181(b)(2)(A).

    Subpart KK—Ohio
    16. Section 52.1885 is amended by adding paragraph (nn) to read as follows:
    § 52.1885 Control strategy: Ozone.

    (nn) Determination of attainment. As required by section 181(b)(2)(A) of the Clean Air Act, the EPA has determined that the Cincinnati, OH-KY-IN and Columbus, OH Marginal 2008 ozone nonattainment areas have attained the NAAQS by the applicable attainment date of July 20, 2015.

    Subpart NN—Pennsylvania
    17. Section 52.2056 is amended by adding paragraphs (k), (l), and (m) to read as follows:
    § 52.2056 Determinations of attainment.

    (k) The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Allentown-Bethlehem-Easton, PA 2008 ozone Marginal nonattainment area has attained the 2008 8-hour ozone NAAQS by the applicable attainment date of July 20, 2015. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the 2008 8-hour ozone NAAQS. The EPA also determined that the Allentown-Bethlehem-Easton, PA marginal nonattainment area will not be reclassified for failure to attain by its applicable attainment date pursuant to section 181(b)(2)(A).

    (l) The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Lancaster, PA 2008 ozone Marginal nonattainment area has attained the 2008 8-hour ozone NAAQS by the applicable attainment date of July 20, 2015. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the 2008 8-hour ozone NAAQS. The EPA also determined that the Lancaster, PA Marginal nonattainment area will not be reclassified for failure to attain by its applicable attainment date pursuant to section 181(b)(2)(A).

    (m) The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Reading, PA 2008 ozone Marginal nonattainment area has attained the 2008 8-hour ozone NAAQS by the applicable attainment date of July 20, 2015. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality as of the attainment date, whether the area attained the 2008 8-hour ozone NAAQS. The EPA also determined that the Reading, PA Marginal nonattainment area will not be reclassified for failure to attain by its applicable attainment date pursuant to section 181(b)(2)(A).

    Subpart PP—South Carolina
    18. Section 52.2125 is amended by adding paragraph (c) to read as follows:
    § 52.2125 Control strategy: Ozone.

    (c) Determination of attainment. The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Charlotte-Rock Hill, NC-SC 2008 ozone Marginal nonattainment area has attained the 2008 ozone NAAQS. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality data as of the attainment date, whether the area attained the standard. The EPA also determined that the Charlotte-Rock Hill, NC-SC nonattainment area will not be reclassified for failure to attain by its applicable attainment date under section 181(b)(2)(A).

    Subpart RR—Tennessee
    19. Section 52.2235 is amended by adding paragraph (d) to read as follows:
    § 52.2235 Control strategy: Ozone.

    (d) Determination of attainment. The EPA has determined, as of June 3, 2016, that based on 2011 to 2013 ambient air quality data, the Knoxville, TN and Memphis, TN-MS-AR 2008 ozone Marginal nonattainment areas have attained the 2008 ozone NAAQS. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on an area's air quality data as of the attainment date, whether the areas attained the standard. The EPA also determined that the Knoxville, TN and Memphis, TN-MS-AR nonattainment areas will not be reclassified for failure to attain by their applicable attainment date under section 181(b)(2)(A).

    Subpart ZZ—Wyoming
    20. Add § 52.2623 to read as follows:
    § 52.2623 Control strategy and regulations: Ozone.

    (a) Determination of attainment. The EPA has determined, as of June 3, 2016, that based on 2012 to 2014 ambient air quality data, the Upper Green River Basin Area, WY 2008 ozone Marginal nonattainment area has attained the 2008 ozone NAAQS. Therefore, the EPA has met the requirement pursuant to CAA section 181(b)(2)(A) to determine, based on the area's air quality data as of the attainment date, whether the area attained the standard. The EPA also determined that the Upper Green River Basin Area, WY nonattainment area will not be reclassified for failure to attain by its applicable attainment date under section 181(b)(2)(A).

    (b) [Reserved]

    PART 81—DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES 21. The authority citation for part 81 continues to read as follows: Authority:

    42 U.S.C. 7401, et seq.

    Subpart C—Section 107 Attainment Status Designations 22. Section 81.303 is amended in the table for “Arizona-2008 8-Hour Ozone NAAQS (Primary and secondary)” by revising the heading entry for “Phoenix-Mesa, AZ” and the entries for “Maricopa County (part)” to read as follows:
    § 81.303 Arizona.
    Arizona—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type Phoenix-Mesa, AZ: 2 Nonattainment 6/3/16 Moderate. Maricopa County (part) T1N, R1E (except that portion in Indian Country); T1N, R2E; T1N, R3E; T1N, R4E; T1N, R5E; T1N, R6E; T1N, R7E; T1N, R1W; T1N, R2W; T1N, R3W; T1N, R4W; T1N, R5W; T1N, R6W; T1N, R7W; T1N, R8W; T2N, R1E; T2N, R2E; T2N, R3E; T2N, R4E; T2N, R5E; T2N, R6E; T2N, R7E; T2N, R8E; T2N, R9E; T2N, R10E; T2N, R11E; T2N, R12E (except that portion in Gila County); T2N, R13E (except that portion in Gila County); T2N, R1W; T2N, R2W; T2N, R3W; T2N, R4W; T2N, R5W; T2N, R6W; T2N, R7W; T2N, R8W; T3N, R1E; T3N, R2E; T3N, R3E; T3N, R4E; T3N, R5E; T3N, R6E; T3N, R7E; T3N, R8E; T3N, R9E; T3N, R10E (except that portion in Gila County); T3N, R11E (except that portion in Gila County); T3N, R12E (except that portion in Gila County); T3N, R1W; T3N, R2W; T3N, R3W; T3N, R4W; T3N, R5W; T3N, R6W; T4N, R1E; T4N, R2E; T4N, R3E; T4N, R4E; T4N, R5E; T4N, R6E; T4N, R7E; T4N, R8E; T4N, R9E; T4N, R10E (except that portion in Gila County); T4N, R11E (except that portion in Gila County); T4N, R12E (except that portion in Gila County); T4N, R1W; T4N, R2W; T4N, R3W; T4N, R4W; T4N, R5W; T4N, R6W; T5N, R1E; T5N, R2E; T5N, R3E; T5N, R4E; T5N, R5E; T5N, R6E; N, R8E; T5N, R9E (except that portion in Gila County); T5N, R10E (except that portion in Gila County); T5N, R1W; T5N, R2W; T5N, R3W; T5N, R4W; T5N, R5W; T6N, R1E (except that portion in Yavapai County); T6N, R2E; T6N, R3E; T6N, R4E; T6N, R5E; T6N, R6E; T6N, R7E; T6N, R8E; T6N, R9E (except that portion in Gila County); T6N, R10E (except that portion in Gila County); T6N, R1W (except that portion in Yavapai County); T6N, R2W; T6N, R3W; T6N, R4W; T6N, R5W; T7N, R1E; (except that portion in Yavapai County); T7N, R2E (except that portion in Yavapai County);  T7N, R3E; T7N, R4E; T7N, R5E; T7N, R6E; T7N, R7E; T7N, R8E; T7N, R9E (except that portion in Gila County); T7N, R1W (except that portion in Yavapai County); T7N, R2W (except that portion in Yavapai County); T8N, R2E (except that portion in Yavapai County); T8N, R3E (except that portion in Yavapai County); T8N, R4E (except that portion in Yavapai County); T8N, R5E (except that portion in Yavapai County); T8N, R6E (except that portion in Yavapai County); T8N, R7E (except that portion in Yavapai County); T8N, R8E (except that portion in Yavapai and Gila Counties); T8N, R9E (except that portion in Yavapai and Gila Counties); T1S, R1E (except that portion in Indian Country); T1S, R2E (except that portion in Pinal County and in Indian Country); T1S, R3E; T1S, R4E; T1S, R5E; T1S, R6E; T1S, R7E; T1S, R1W; T1S, R2W; T1S, R3W; T1S, R4W; T1S, R5W; T1S, R6W; T2S, R1E (except that portion in Indian Country); T2S, R5E; T2S, R6E; T2S, R7E; T2S, R1W; T2S, R2W; T2S, R3W; T2S, R4W; T2S, R5W; T3S, R1E; T3S, R1W; T3S, R2W; T3S, R3W; T3S, R4W; T3S, R5W; T4S, R1E; T4S, R1W; T4S, R2W; T4S, R3W; T4S, R4W; T4S, R5W; T5S, R4W (Sections 1 through 22 and 27 through 34) *         *         *         *         *         *         * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. 23. Section 81.305 is amended in the table for “California-2008 8-Hour Ozone NAAQS (Primary and secondary)” by revising the entries for “Imperial County, CA”, “Kern County (Eastern Kern), CA”, “Mariposa County, CA”, “Nevada County (Western part), CA”, and “San Diego County, CA”, and “San Luis Obispo (Eastern San Luis Obispo), CA” and adding a footnote “5” to read as follows:
    § 81.305 California. California—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type *         *         *         *         *         *        * Imperial County, CA: 2 Nonattainment 6/3/16 Moderate. Imperial County Quechan Tribe of the Fort Yuma Indian Reservation 3 Torres Martinez Desert Cahuilla Indians 3 Kern County (Eastern Kern), CA: 2 Nonattainment 6/3/16 Moderate. Kern County (part) That portion of Kern County (with the exception of that portion in Hydrologic Unit Number 18090205—the Indian Wells Valley) east and south of a line described as follows: Beginning at the Kern-Los Angeles County boundary and running north and east along the northwest boundary of the Rancho La Liebre Land Grant to the point of intersection with the range line common to Range 16 West and Range 17 West, San Bernardino Base and Meridian; north along the range line to the point of intersection with the Rancho El Tejon Land Grant boundary; then southeast, northeast, and northwest along the boundary of the Rancho El Tejon Grant to the northwest corner of Section 3, Township 11 North, Range 17 West; then west 1.2 miles; then north to the Rancho El Tejon Land Grant boundary; then northwest along the Rancho El Tejon line to the southeast corner of Section 34, Township 32 South, Range 30 East, Mount Diablo Base and Meridian; then north to the northwest corner of Section 35, Township 31 South, Range 30 East; then northeast along the boundary of the Rancho El Tejon Land Grant to the southwest corner of Section 18, Township 31 South, Range 31 East; then east to the southeast corner of Section 13, Township 31 South, Range 31 East; then north along the range line common to Range 31 East and Range 32 East, Mount Diablo Base and Meridian, to the northwest corner of Section 6, Township 29 South, Range 32 East; then east to the southwest corner of Section 31, Township 28 South, Range 32 East; then north along the range line common to Range 31 East and Range 32 East to the northwest corner of Section 6, Township 28 South, Range 32 East, then west to the southeast corner of Section 36, Township 27 South, Range 31 East, then north along the range line common to Range 31 East and Range 32 East to the Kern-Tulare County boundary *         *         *         *         *         *        * Mariposa County, CA: 2 Mariposa County Nonattainment 6/3/16 Moderate. Nevada County (Western part), CA: 2 Nonattainment 6/3/16 Moderate. Nevada County (part) That portion of Nevada County, which lies west of a line, described as follows: Beginning at the Nevada-Placer County boundary and running north along the western boundaries of Sections 24, 13, 12, 1, Township 17 North, Range 14 East, Mount Diablo Base and Meridian, and Sections 36, 25, 24, 13, 12, Township 18 North, Range 14 East to the Nevada-Sierra County boundary *         *         *         *         *         *        * San Diego County, CA: 2 Nonattainment 6/3/16 Moderate. San Diego County Barona Group of Capitan Grande Band of Mission Indians of the Barona Reservation 3 Campo Band of Diegueno Mission Indians of the Campo Indian Reservation 3 Capitan Grande Band of Diegueno Mission Indians of California 3 Ewiiaapaayp Band of Kumayaay Indians 3 Iipay Nation of Santa Ysabel 3 Inaja Band of Diegueno Mission Indians of the Inaja and Cosmit Reservation 3 Jamul Indian Village of California 3 La Jolla Band of Luiseno Indians 3 La Posta Band of Diegueno Mission Indians of the La Posta Indian Reservation 3 Los Coyotes Band of Cahuilla and Cupeno Indians 3 Manzanita Band of Diegueno Mission Indians of the Manzanita Reservation 3 Mesa Grande Band of Diegueno Mission Indians of the Mesa Grande Reservation 3 Pala Band of Luiseno Mission Indians of the Pala Reservation 3 Pauma Band of Luiseno Mission Indians of the Pauma and Yuima Reservation 3 Rincon Band of Luiseno Mission Indians of the Rincon Reservation 3 San Pasqual Band of Diegueno Mission Indians of California 3 Sycuan Band of the Kumeyaay Nation 3 Viejas (Baron Long) Group of Capitan Grande Band of Mission Indians 3 *         *         *         *         *         *        * San Luis Obispo (Eastern San Luis Obispo), CA: 2 Nonattainment 6/3/16 Marginal.5 San Luis Obispo County (part) That portion of San Luis Obispo County that lies east of a line described as follows: Beginning at the San Luis Obispo County/Santa Barbara County boundary and running north along 120 degrees 24 minutes longitude to the intersection with 35 degrees 27 minutes latitude; east along 35 degrees 27 minutes latitude to the intersection with 120 degrees 18 minutes longitude; then north along 120 degrees 18 minutes longitude to the San Luis Obispo County/Monterey County boundary *         *         *         *         *         *        * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. 3 Includes Indian country of the tribe listed in this table located in the identified area. Information pertaining to areas of Indian country in this table is intended for CAA planning purposes only and is not an EPA determination of Indian country status or any Indian country boundary. EPA lacks the authority to establish Indian country land status, and is making no determination of Indian country boundaries, in this table. 4 Attainment date is extended to July 20, 2016.
    24. Section 81.306 is amended in the table for “Colorado—2008 8-Hour Ozone NAAQS (Primary and secondary)” by revising the entries for “Denver-Boulder-Greeley-Ft. Collins-Loveland, CO” to read as follows:
    § 81.306 Colorado. Colorado—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type Denver-Boulder-Greeley-Ft. Collins-Loveland, CO: 2 Nonattainment 6/3/16 Moderate. Adams County Arapahoe County Boulder County Broomfield County Denver County Douglas County Jefferson County Larimer County (part) That portion of the county that lies south of a line described as follows: Beginning at a point on Larimer County's eastern boundary and Weld County's western boundary intersected by 40 degrees, 42 minutes, and 47.1 seconds north latitude, proceed west to a point defined by the intersection of 40 degrees, 42 minutes, 47.1 seconds north latitude and 105 degrees, 29 minutes, and 40.0 seconds west longitude, thence proceed south on 105 degrees, 29 minutes, 40.0 seconds west longitude to the intersection with 40 degrees, 33 minutes and 17.4 seconds north latitude, thence proceed west on 40 degrees, 33 minutes, 17.4 seconds north latitude until this line intersects Larimer County's western boundary and Grand County's eastern boundary Weld County (part) That portion of the county that lies south of a line described as follows: Beginning at a point on Weld County's eastern boundary and Logan County's western boundary intersected by 40 degrees, 42 minutes, 47.1 seconds north latitude, proceed west on 40 degrees, 42 minutes, 47.1 seconds north latitude until this line intersects Weld County's western boundary and Larimer County's eastern boundary *         *         *         *         *         *        * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted.
    25. Section 81.307 is amended by revising the table for “Connecticut—2008 8-Hour Ozone NAAQS (Primary and secondary)” to read as follows:
    § 81.307 Connecticut. Connecticut—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type Greater Connecticut, CT: 2 Nonattainment 6/3/16 Moderate. Hartford County Litchfield County New London County Tolland County Windham County Mashantucket Pequot Tribe of Connecticut 3 Mohegan Indian Tribe of Connecticut 3 New York-N. New Jersey-Long Island, NY-NJ-CT: 2 Nonattainment 6/3/16 Moderate. Fairfield County Middlesex County New Haven County 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. 3 Includes Indian country of the tribe listed in this table located in the identified area. Information pertaining to areas of Indian country in this table is intended for CAA planning purposes only and is not an EPA determination of Indian country status or any Indian country boundary. EPA lacks the authority to establish Indian country land status, and is making no determination of Indian country boundaries, in this table.
    26. Section 81.308 is amended by revising the table for “Delaware—2008 8-Hour Ozone NAAQS (Primary and secondary)” to read as follows:
    § 81.308 Delaware. Delaware—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE: 2 Nonattainment 6/3/16 Marginal.4 New Castle County Seaford: 2 Sussex County Nonattainment Marginal. Rest of State: 3 Southern Delaware Intrastate AQCR: (remainder) Kent County Unclassifiable/Attainment 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. 3 Includes any Indian country in each county or area, unless otherwise specified. 4 Attainment date is extended to July 20, 2016.
    27. Section 81.309 is amended by revising the table for “District of Columbia—2008 8-Hour Ozone NAAQS (Primary and secondary)” to read as follows:
    § 81.309 District of Columbia. District of Columbia—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type Washington, DC-MD-VA: District of Columbia 2 Nonattainment 6/3/16 Marginal.3 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. 3 Attainment date is extended to July 20, 2016.
    28. Section 81.311 is amended in the table for “Georgia—2008 8-Hour Ozone NAAQS (Primary and secondary)” by revising the entries for “Atlanta, GA” to read as follows:
    § 81.311 Georgia. Georgia—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type Atlanta, GA: 2 Nonattainment 6/3/16 Moderate. Bartow County Cherokee County Clayton County Cobb County Coweta County DeKalb County Douglas County Fayette County Forsyth County Fulton County Gwinnett County Henry County Newton County Paulding County Rockdale County *         *         *         *         *         *         * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted.
    29. Section 81.314 is amended in the table for “Illinois—2008 8-Hour Ozone NAAQS (Primary and secondary)” by: a. Revising the entries for “Chicago-Naperville, IL-IN-WI”; b. Revising the heading entry “St. Louis-St. Charles-Farmington, MO-IL” and the entries “Madison County”, “Monroe County”, and “St. Clair County”; and c. Adding a footnote “4”.

    The revisions and addition read as follows:

    § 81.314 Illinois. Illinois—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type Chicago-Naperville, IL-IN-WI: 2 Nonattainment 6/3/16 Moderate. Cook County DuPage County Grundy County (part) Aux Sable Township Goose Lake Township Kane County Kendall County (part) Oswego Township Lake County McHenry County Will County St. Louis-St. Charles-Farmington, MO-IL: 2 Nonattainment 6/3/16 Marginal.4 Madison County Monroe County St. Clair County *         *         *         *         *         *         * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. * * * 4 Attainment date is extended to July 20, 2016.
    30. Section 81.315 is amended in the table for “Indiana—2008 8-Hour Ozone NAAQS (Primary and secondary)” by revising the entries for “Chicago-Naperville, IL-IN-WI” to read as follows:
    § 81.315 Indiana. Indiana—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type Chicago-Naperville, IL-IN-WI: 2 Nonattainment 6/3/16. Moderate. Lake County Porter County *         *         *         *         *         *         * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted.
    31. Section 81.321 is amended in the table for “Maryland—2008 8-Hour Ozone NAAQS (Primary and secondary)” by: a. Revising the entries for “Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE”; b. Revising the heading entry “Washington, DC-MD-VA”; and c. Adding a footnote “4”.

    The revisions and addition read as follows:

    § 81.321 Maryland. Maryland—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type *         *         *         *         *         *         * Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE: 2 Nonattainment 6/3/16 Marginal.4 Cecil County Washington, DC-MD-VA: 2 Nonattainment 6/3/16 Marginal. 4 *         *         *         *         *         *         * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. * * * 4 Attainment date is extended to July 20, 2016.
    32. Section 81.326 is amended in the table for “Missouri—2008—8-Hour Ozone NAAQS (Primary and secondary)” by revising the heading entry for “St. Louis-St. Charles-Farmington, MO-IL” and adding a footnote “4” to read as follows:
    § 81.326 Missouri. Missouri—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type St. Louis-St. Charles-Farmington, MO-IL: 2 Nonattainment 6/3/16 Marginal.4 *         *         *         *         *         *         * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. * * * 4 Attainment date is extended to July 20, 2016.
    33. Amend § 81.331 by revising the table for “New Jersey—2008 8-Hour Ozone NAAQS (Primary and secondary)” to read as follows:
    § 81.331 New Jersey. New Jersey—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type New York-N. New Jersey-Long Island, NY-NJ-CT: 2 Nonattainment 6/3/16 Moderate. Bergen County Essex County Hudson County Hunterdon County Middlesex County Monmouth County Morris County Passaic County Somerset County Sussex County Union County Warren County Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE: 2 Nonattainment 6/3/16 Marginal.3. Atlantic County Burlington County Camden County Cape May County Cumberland County Gloucester County Mercer County Ocean County Salem County 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. 3 Attainment date is extended to July 20, 2016.
    34. Section 81.333 is amended in the table for “New York—2008 8-Hour Ozone NAAQS (Primary and secondary)” by revising the entries for “New York-N. New Jersey-Long Island, NY-NJ-CT” to read as follows:
    § 81.333 New York. New York—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type *         *         *         *         *         *         * New York-N. New Jersey-Long Island, NY-NJ-CT: 2 Nonattainment 6/3/16 Moderate. Bronx County Kings County Nassau County New York County Queens County Richmond County Rockland County Suffolk County Westchester County Shinnecock Indian Nation 3 *         *         *         *         *         *         * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. 3 Includes Indian country of the tribe listed in this table located in the identified area. Information pertaining to areas of Indian country in this table is intended for CAA planning purposes only and is not an EPA determination of Indian country status or any Indian country boundary. EPA lacks the authority to establish Indian country land status, and is making no determination of Indian country boundaries, in this table.
    35. Section 81.336 is amended in the table for “Ohio—2008 8-Hour Ozone NAAQS (Primary and secondary)” by revising the entries for “Cleveland-Akron-Lorain, OH” and adding a footnote “4” to read as follows:
    § 81.336 Ohio. Ohio—2008—8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type *         *         *         *         *         *         * Cleveland-Akron-Lorain, OH: 2 Nonattainment 6/3/16 Marginal.4 Ashtabula County Cuyahoga County Geauga County Lake County Lorain County Medina County Portage County Summit County *         *         *         *         *         *         * 1 This date is July 20, 2012, unless otherwise noted. 2Excludes Indian country located in each area, unless otherwise noted. * * * 4 Attainment date is extended to July 20, 2016.
    36. Section 81.339 is amended in the table for “Pennsylvania—2008 8-Hour Ozone NAAQS (Primary and secondary)” by revising the entries for “Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE” and “Pittsburgh-Beaver Valley, PA” and adding a footnote “4” to read as follows:
    § 81.339 Pennsylvania. Pennsylvania—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date1 Type Classification Date1 Type *         *         *         *         *         *         * Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE 2 Nonattainment 6/3/16 Marginal.4 Bucks County Chester County Delaware County Montgomery County Philadelphia County Pittsburgh-Beaver Valley, PA 2 Nonattainment 6/3/16 Marginal.4 Allegheny County Armstrong County Beaver County Butler County Fayette County Washington County Westmoreland County *         *         *         *         *         *         * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. * * * 4 Attainment date is extended to July 20, 2016.
    37. Section 81.344 is amended in the table for “Texas—2008 8-Hour Ozone NAAQS (Primary and secondary)” by revising the entries for “Houston-Galveston-Brazoria, TX” and adding a footnote “4” to read as follows:
    § 81.344 Texas. Texas—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date1 Type Classification Date1 Type *         *         *         *         *         *         * Houston-Galveston-Brazoria, TX:2 Nonattainment 6/3/16 Marginal.4 Brazoria County Chambers County Fort Bend County Galveston County Harris County Liberty County Montgomery County Waller County *         *         *         *         *         *         * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. * * * 4 Attainment date is extended to July 20, 2016.
    38. Section 81.347 is amended in the table for “Virginia—2008 8-Hour Ozone NAAQS (Primary and secondary)” by revising the entries for “Washington, DC-MD-VA” and adding a footnote “4” to read as follows:
    § 81.347 Virginia. Virginia—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area 1 Designation Date 2 Type Classification Date 2 Type Washington, DC-MD-VA: 2 Nonattainment 6/3/16 Marginal.4 Arlington County Fairfax County Loudoun County Prince William County Alexandria City Fairfax City Falls Church City Manassas City Manassas Park City *         *         *         *         *         *         * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. * * * 4 Attainment date is extended to July 20, 2016.
    39. Section 81.350 is amended in the table for “Wisconsin—2008 8-Hour Ozone NAAQS (Primary and secondary)” by: a. Revising the heading entry for “Chicago-Naperville, IL-IN-WI” and the entries for “Sheboygan County, WI”; and b. Adding a footnote “4”.

    The revisions and addition read as follows:

    § 81.350 Wisconsin. Wisconsin—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type Chicago-Naperville, IL-IN-WI: 2 Nonattainment 6/3/16 Moderate. *         *         *         *         *         *         * Sheboygan County, WI: 2 Nonattainment 6/3/16 Marginal.4 Sheboygan County *         *         *         *         *         *         * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted. * * * 4 Attainment date is extended to July 20, 2016.
    [FR Doc. 2016-09729 Filed 5-3-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0014; FRL-9944-82] Mefenoxam; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of mefenoxam in or on rapeseed subgroup 20A. Syngenta Crop Protection, LLC., requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective May 4, 2016. Objections and requests for hearings must be received on or before July 5, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0014, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

    B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

    C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0014 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before July 5, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0014, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924-00), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4F8323) by Syngenta Crop Protection, LLC., 410 Swing Road, Greensboro, NC 27419. The petition requested that 40 CFR 180.546 be amended by establishing tolerances for residues of the fungicide mefenoxam, methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate, in or on rapeseed crop subgroup 20A at 0.05 parts per million (ppm). That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

    III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

    Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for mefenoxam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with mefenoxam follows.

    A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Mefenoxam is the enriched R-enantiomer of metalaxyl which is a racemic mixture that contains approximately 50% each of the R- and S-enantiomers. EPA conducted side-by-side comparison of the available toxicity data for mefenoxam and metalaxyl and concluded that mefenoxam has similar toxicity to that of metalaxyl. Therefore, the metalaxyl data may be used to support regulatory actions for mefenoxam.

    The Agency reassessed the toxicity databases for metalaxyl and mefenoxam in accordance with current policies and determined that many of the effects previously noted in several toxicological studies are no longer considered to be adverse (i.e. body weight gain without changes in absolute body weight; hepatocyte hypertrophy without necrosis; enzyme leakage to bloodstream or disruption of lipid homeostasis). In rat and dog repeat dose (i.e., subchronic and chronic) oral toxicity studies, there were no indications of adverse effects up to the highest dose tested (HDT).

    Adverse effects were only observed from acute exposure to rats. In the rat developmental toxicity study of metalaxyl, maternal toxicity consisted of dose-related increased incidence of convulsions that occurred shortly after dosing, as well as other clinical signs. In a range-finding acute neurotoxicity study of mefenoxam, females showed abnormal functional observation battery (FOB) findings at lower doses than males. However, there was no indication of toxicity up to the HDT in the mefenoxam subchronic neurotoxicity study, which confirms the lack of adverse effects observed in all other repeated-dose studies.

    There was no indication of developmental toxicity in studies of mefenoxam or metalaxyl. There was no indication of immunotoxicity in a mouse immunotoxicity study of mefenoxam. Metalaxyl and mefenoxam have been classified as “not likely to be carcinogenic in humans” based on the results for metalaxyl in the carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in rats.

    Specific information on the studies received and the nature of the adverse effects caused by mefenoxam as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Mefenoxam, Human Health Risk Assessment” at pages 14-17 in docket ID number EPA-HQ-OPP-2015-0014.

    B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

    A summary of the toxicological endpoints for mefenoxam used for human risk assessment is shown in Table 1 of this unit.

    Table 1—Summary of Toxicological Doses and Endpoints for Mefenoxam for Use in Human Health Risk Assessment Exposure/Scenario Point of departure and uncertainty/safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Acute dietary (General population including infants, children, and females 13-50 years of age NOAEL = 50 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Acute RfD = 0.5 mg/kg/day
  • aPAD = 0.5 mg/kg/day
  • Metalaxyl Prenatal Developmental Toxicity—Rat
  • LOAEL = 250 mg/kg/day based on dose-related increases in clinical signs of toxicity (e.g., post-dosing convulsions).
  • Chronic dietary (All populations) No endpoint was identified. No systemic toxicity was observed in any toxicity study where the animals were administered metalaxyl or mefenoxam in the diet. Acute dietary assessment is protective of all other durations of exposure. Incidental oral short-term (1 to 30 days) and intermediate-term (1 to 6 months) NOAEL = 50 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = 100 Metalaxyl Prenatal Developmental Toxicity—Rat
  • LOAEL = 250 mg/kg/day based on dose-related increases in clinical signs of toxicity (e.g., post-dosing convulsions).
  • Dermal short-term (1 to 30 days) and intermediate-term (1 to 6 months) No endpoint was identified. No systemic toxicity was observed at the limit dose (1,000 mg/kg/day) in rabbits treated with metalaxyl during a 21-day dermal toxicity study.
  • For converting oral to dermal doses for risk assessment, the Dermal Absorption Factor (DAF) = 35%.
  • Inhalation short-term (1 to 30 days) and intermediate-term (1 to 6 months) NOAEL = 50 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Note: Toxicity via the inhalation and oral routes are assumed to be equivalent.
  • LOC for MOE = 100 Metalaxyl Prenatal Developmental Toxicity—Rat
  • LOAEL = 250 mg/kg/day based on dose-related increases in clinical signs of toxicity (e.g., post-dosing convulsions).
  • Cancer (Oral, dermal, inhalation) Classification: “Not Likely to be Carcinogenic to Humans” based on the absence of treatment-related increases in tumor incidence in adequately conducted carcinogenicity studies in rats and mice treated with metalaxyl. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to mefenoxam, EPA considered exposure under the petitioned-for tolerances as well as all existing mefenoxam tolerances in 40 CFR 180.546 and metalaxyl tolerances 40 CFR 180.408. EPA assessed dietary exposures from mefenoxam/metalaxyl in food as follows:

    i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

    Such effects were identified for mefenoxam. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA conducted a somewhat refined acute dietary exposure assessment for the proposed food use of mefenoxam on the rapeseed subgroup 20A and the existing uses of both metalaxyl and mefenoxam. Residues were assumed to be present at tolerance levels in plant commodities, with additional factors applied to certain plant commodities to include all residues of concern for risk assessment. Tolerance-level residues adjusted upward to account for metalaxyl/mefenoxam residues of concern in livestock commodities were used and based on data from metabolism studies on goats and hens. DEEM default and empirical processing factors were used as available. It was assumed that 100% of the crops were treated (100% CT).

    ii. Chronic exposure. No such effects were identified in the toxicological studies for mefenoxam; therefore, a quantitative chronic dietary exposure assessment is unnecessary.

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that mefenoxam does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

    iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for mefenoxam. Tolerance-level residues and/or 100% CT were assumed for all food commodities

    2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for mefenoxam in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of mefenoxam. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

    Based on the Surface Water Concentration Calculator (SWCC) and the Pesticide Root Zone Model-Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of mefenoxam for acute exposures are estimated to be 741 parts per billion (ppb) for surface water and 3,700 ppb for ground water. These modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

    Mefenoxam is currently registered for the following uses that could result in residential exposures: Residential turf and ornamentals, including nonbearing citrus trees. EPA assessed residential exposure using the following assumptions: Residential handler exposure is expected to be short-term in duration. Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. Residential post-application exposure was assessed based on short-term incidental oral risk estimates for children 1 < 2 years old. Dermal post-application risk assessments were not conducted because an adverse systemic dermal hazard was not identified for mefenoxam. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

    4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found mefenoxam to share a common mechanism of toxicity with any other substances, and mefenoxam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that mefenoxam does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides

    D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

    2. Prenatal and postnatal sensitivity. There is no evidence that mefenoxam results in increased susceptibility from in utero exposure to rats or rabbits in the prenatal developmental studies or exposure to young rats in the 2-generation reproduction study.

    3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

    i. The toxicity database for metalaxyl and mefenoxam is complete.

    ii. In the rat prenatal developmental toxicity with metalaxyl, maternal animals exhibited clinical signs indicative of neurobehavioral effects as previously discussed.

    In the range-finding acute neurotoxicity study with mefenoxam, females exhibited abnormal functional observation battery (FOB) findings at doses lower than in males. In the subchronic neurotoxicity study with mefenoxam, there were no indications of neurotoxicity up to the HDT. In metalaxyl and mefenoxam treated adult animals, clinical signs and abnormal FOB findings were noted. However, a developmental neurotoxicity (DNT) study is not required for metalaxyl or mefenoxam because (1) there are no indications of increased susceptibility for infants or children; (2) the convulsions observed in the rat prenatal developmental toxicity study occurred in the maternal animals with no effects being observed in the young; (3) the convulsions occurred only after a bolus dose; (4) the available developmental and range-finding acute neurotoxicity studies provided clear NOAELs and LOAELs for evaluating effects; (5) the current POD is below the level at which any effects were seen in either study, and (6) there were no other indications of neurotoxicity in the mefenoxam or metalaxyl databases, which include a subchronic (adult rat) neurotoxicity study for mefenoxam. Therefore, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

    iii. In metalaxyl and mefenoxam treated animals, there was no evidence of increased susceptibility following pre-/postnatal exposure in the prenatal developmental toxicity studies or the reproduction and fertility effects study. There is no evidence that mefenoxam results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

    iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance levels or upper bound residue estimates. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to mefenoxam in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by mefenoxam.

    E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

    1. Acute risk. The acute aggregate risk assessment considers exposure estimates from dietary consumption of mefenoxam (food and drinking water). Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to mefenoxam will occupy 95% of the aPAD for children <1 years old, the population group receiving the greatest exposure, but this is below the level of concern.

    2. Chronic risk. A chronic aggregate risk assessment takes into account chronic exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from repeated exposure was identified and no chronic dietary endpoint was selected. Therefore, mefenoxam is not expected to pose a chronic risk.

    3. Short-term and Intermediate-term risk. Short-term and intermediate-term aggregate exposure takes into account both short-term and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Mefenoxam is currently registered for uses that could result in short-term and intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate short-term and intermediate-term residential exposures to mefenoxam. Using the exposure assumptions described in this unit for short-term and intermediate-term exposures, EPA has concluded the combined short-term and intermediate-term food, water, and residential exposures result in aggregate MOEs of 79,000 for adult; and 1,000 for children 1 < 2 years old. Because EPA's level of concern for mefenoxam is a MOE of 100 or below, these MOEs are not of concern.

    4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, mefenoxam is not expected to pose a cancer risk to humans.

    5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to mefenoxam residues.

    IV. Other Considerations A. Analytical Enforcement Methodology

    Several methods are available for enforcing tolerances: (1) A gas-liquid chromatography procedure employing an alkali flame ionization detector (GLC/AFID); (2) a method using GLC/nitrogen phosphorus detection; and (3) a multi-residue method in PAM, Vol 1.

    The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]

    B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

    The Codex has not established a MRL for mefenoxam for the rapeseed crop subgroup 20A.

    V. Conclusion

    Therefore, tolerances are established for residues of mefenoxam, methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate, in or on rapeseed subgroup 20A at 0.05 ppm.

    VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

    This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

    VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule 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. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: April 21, 2016. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

    PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority:

    21 U.S.C. 321(q), 346a and 371.

    2. In § 180.546, add alphabetically the entry for “Rapeseed subgroup 20A” to the table in paragraph (a) to read as follows:
    § 180.546 Mefenoxam; tolerances for residues.

    (a) * * *

    Commodity Parts per million *    *    *    *    * Rapeseed subgroup 20A 0.05 *    *    *    *    *
    [FR Doc. 2016-10389 Filed 5-3-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No.: 151210999-6348-02] RIN 0648-BF59 Fisheries of the Northeastern United States; Atlantic Sea Scallop Fishery; Framework Adjustment 27 AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Final rule.

    SUMMARY:

    NMFS approves and implements through regulations the measures included in Framework Adjustment 27 to the Atlantic Sea Scallop Fishery Management Plan, which the New England Fishery Management Council adopted and submitted to NMFS for approval. The purpose of Framework 27 is to prevent overfishing, improve yield-per-recruit, and improve the overall management of the Atlantic sea scallop fishery. Framework 27 sets specifications for the scallop fishery for fishing year 2016, including days-at-sea allocations, individual fishing quotas, and sea scallop access area trip allocations; creates a new rotational closed area south of Closed Area 2 to protect small scallops; opens the northern portion of the Nantucket Lightship Access Area to the Limited Access General Category fleet; transfers 19 percent of the Limited Access General Category access area trips from the Mid-Atlantic Access Area to the northern portion of the Nantucket Lightship Access Area; and implements an accountability measure to the fishing year 2016 Northern Gulf of Maine Total Allowable Catch as a result of a fishing year 2015 catch overage.

    DATES:

    Effective May 4, 2016.

    ADDRESSES:

    The Council developed an environmental assessment (EA) for this action that describes the action and other considered alternatives and provides a thorough analysis of the impacts of these measures. Copies of the Framework, the EA, and the Initial Regulatory Flexibility Analysis (IRFA), are available upon request from Thomas A. Nies, Executive Director, New England Fishery Management Council, 50 Water Street, Newburyport, MA 01950. The EA/IRFA is also accessible via the Internet at: http://www.nefmc.org/scallops/index.html or http://www.greateratlantic.fisheries.noaa.gov/sustainable/species/scallop/.

    Copies of the small entity compliance guide are available from John K. Bullard, Regional Administrator, NMFS, Greater Atlantic Regional Fisheries Office, 55 Great Republic Drive, Gloucester, MA 01930-2298, or available on the internet at: http://www.greateratlantic.fisheries.noaa.gov/sustainable/species/scallop/.

    FOR FURTHER INFORMATION CONTACT:

    Travis Ford, Fishery Policy Analyst, 978-281-9233.

    SUPPLEMENTARY INFORMATION:

    Background

    The Council adopted Framework 27 on December 3, 2015, and submitted a draft of the framework to NMFS on December 22, 2015, that presented Council recommended measures, rationale, impacts for review, and a draft EA. NMFS published a proposed rule, including a reference on how to obtain the framework and the draft final EA, for approving and implementing Framework 27 on February 24, 2016 (81 FR 9151). The proposed rule included a 30-day public comment period that closed on March 25, 2016. The Council submitted a final EA to NMFS on March 14, 2016, for approval. This annual action includes catch, effort, and quota allocations and adjustments to the rotational area management program for fishing year 2016. Framework 27 specifies measures for fishing year 2016, and includes fishing year 2017 measures that will go into place as a default should the next specifications-setting framework be delayed beyond the start of fishing year 2017. NMFS has approved all of the measures recommended by the Council and described below. The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) permits NMFS to approve, partially approve, or disapprove measures proposed by the Council based only on whether the measures are consistent with the fishery management plan, the Magnuson-Stevens Act and its National Standards, and other applicable law. We must defer to the Council's policy choices unless there is a clear inconsistency with the law or the FMP. Details concerning the development of these measures were contained in the preamble of the proposed rule and are not repeated here.

    Specification of Scallop Overfishing Limit (OFL), Acceptable Biological Catch (ABC), Annual Catch Limits (ACLs), Annual Catch Targets (ACTs), and Set-Asides for the 2016 Fishing Year and Default Specifications for Fishing Year 2017

    Table 1 outlines the scallop fishery catch limits derived from the ABC values.

    Table 1—Scallop Catch Limits (mt) for Fishing Years 2016 and 2017 for the Limited Access and Limited Access General Category (LAGC) Individual Fishing Quota (IFQ) Fleets 2016 2017
  • (default)
  • OFL 68,418 68,418 ABC/ACL (discards removed) 37,852 37,852 Incidental Catch 23 23 Research Set-Aside (RSA) 567 567 Observer Set-Aside 379 379 ACL for fishery 36,884 36,884 Limited Access ACL 34,855 34,855 LAGC ACL 2,029 2,029 LAGC IFQ 1,845 1,845 Limited Access with LAGC IFQ 184 184 Limited Access ACT 18,290 18,290

    This action deducts 1.25 million lb (567 mt) of scallops annually for 2016 and 2017 from the ABC and sets it aside as the Scallop RSA to fund scallop research and to compensate participating vessels through the sale of scallops harvested under RSA projects. As of March 1, 2016, this set-aside has been available for harvest by RSA-funded projects in open areas. Framework 27 allows RSA to be harvested from the Mid-Atlantic Access Area (MAAA), but prevents RSA harvesting from access areas under 2017 default measures. Of this 1.25 million-lb (567-mt) allocation, NMFS has already allocated 3,393 lb (1.5 mt) to multi-year projects it previously funded as part of the 2015 RSA awards process. NMFS reviewed proposals submitted for consideration of 2016 RSA awards and announced project selections on April 7, 2016. Details on the 2016 RSA awards can be found on our Web site here: http://www.nefsc.noaa.gov/coopresearch/news/scallop-rsa-2016.html.

    This action sets aside 1 percent of the ABC for the industry-funded observer program to help defray the cost of scallop vessels that carry an observer. The observer set-aside is 379 mt for fishing year 2016 and 379 mt for fishing year 2017. In fishing year 2016, the compensation rates for limited access vessels in open areas fishing under days-at-sea (DAS) is 0.11 DAS per DAS fished. For access area trips, the compensation rate is 175 lb (79 kg), in addition to the vessel's possession limit for the trip for each day or part of a day an observer is onboard. LAGC IFQ vessels may possess an additional 175 lb (79 kg) per trip in open areas when carrying an observer. NMFS may adjust the compensation rate throughout the fishing year, depending on how quickly the fleets are using the set aside. The Council may adjust the 2017 observer set-aside when it develops specific, non-default measures for 2017.

    Open Area DAS Allocations

    This action implements vessel-specific DAS allocations for each of the three limited access scallop DAS permit categories (i.e., full-time, part-time, and occasional) for 2016 and 2017 (Table 2). Fishing year 2016 DAS allocations are higher than those allocated to the limited access fleet in 2015 (30.86 DAS for full-time, 12.94 DAS for part-time, and 2.58 DAS for occasional vessels). Framework 27 also sets a 2017 DAS allocations equal to fishing year 2016 as a default measure in the event the 2017 specifications action is delayed past the start of the 2017 fishing year. The 2016 level default measure is expected to be more precautionary than the 2017 projected level. The allocations in Table 2 exclude any DAS deductions that are required if the limited access scallop fleet exceeded its 2015 sub-ACL. In addition, these DAS values take into account a 0.14-DAS per vessel reduction necessary to compensate for a measure implemented in Framework Adjustment 26 to the FMP (80 FR 22119; April 21, 2015) that allows vessel to transit to ports south of 39° N Lat. while not on DAS.

    Table 2—Scallop Open Area DAS Allocations for 2016 and 2017 Permit category 2016 2017 Full-Time 34.55 34.55 Part-Time 13.82 13.82 Occasional 2.88 2.88 LA Allocations and Trip Possession Limits for Scallop Access Areas

    For fishing year 2016 and the start of 2017, Framework 27 keeps all three Georges Bank Access Areas (i.e., Nantucket Lightship, Closed Area 1, and Closed Area 2 Access Areas) closed and keeps the MAAA open to the limited access fleet. This action closes a new area, the Closed Area 2 Extension, to protect small scallops located south of the current Closed Area 2 boundary. The Council will reconsider opening this closure area to scallop fishing in a future framework action when the scallops are larger and ready for harvest.

    Table 3 outlines the limited access allocations that can be fished from the MAAA, which each vessel can take in as many trips as needed, so long as the trip possession limits (also in Table 3) are not exceeded.

    Table 3—Scallop Access Area Limited Access Vessel Poundage Allocations and Trip Possession Limits for 2016 and 2017 Permit category Possession limits 2016 Vessel allocation 2017 Vessel allocation Full-Time 17,000 lb (7,711 kg) 51,000 lb (23,133 kg) 17,000 lb (7,711 kg). Part-Time 10,200 lb (4,627 kg) 20,400 lb (9,253 kg) 10,200 lb (4,627 kg). Occasional 1,420 lb (644 kg) 4,250 lb (1,928 kg) 1,420 lb (644 kg). Additional Measures To Reduce Impacts on Scallops

    1. Delayed Harvesting of Default 2017 MAAA Allocations. Although the Framework includes default access area allocations for the 2017 fishing year (see 2017 allocations in Table 3), vessels have to wait to fish these allocations until April 1, 2017. This measure is precautionary to help to protect scallops when scallop meat weights are lower than other times of the year (generally, this change in meat-weight is a physiological change in scallops due to spawning). However, if a vessel has not fully harvested its 2016 scallop access area allocation in fishing year 2016, it may still fish the remainder of its allocation in the first 60 days of 2017 (i.e., March 1, 2017, through April 29, 2017).

    2. 2017 RSA Harvest Restrictions. This action prohibits vessels participating in RSA projects from harvesting RSA in access areas while default 2017 measures are in place. If default measures are in place at the start of 2017, RSA can only be harvested from open areas. The Council will re-evaluate this measure in the framework action that would set final 2017 specifications.

    LAGC Measures

    1. ACL for LAGC vessels with IFQ permits. For LAGC vessels with IFQ permits, this action implements a 1,845-mt ACL for 2016 and an initial ACL of 1,845 mt for 2017 (see Table 1). The Council and NMFS calculate IFQ allocations by applying each vessel's IFQ contribution percentage to these ACLs. IFQ allocations for each vessel assume that LAGC IFQ fleet does not trigger any accountability measures (AMs). The AM dictates that if a vessel exceeds its IFQ in a given fishing year, its IFQ for the subsequent fishing year is reduced by the amount of the overage.

    Because Framework 27 will go into effect after the March 1 start of fishing year 2016, the default 2016 IFQ allocations went into place automatically on March 1, 2016. This action implements IFQ allocations greater than the default allocations. NMFS sent a letter to IFQ permit holders providing both March 1, 2016, IFQ allocations and Framework 27 IFQ allocations so that vessel owners know what mid-year adjustments will occur now that Framework 27 is approved.

    2. ACL for Limited Access Scallop Vessels with IFQ Permits. For limited access scallop vessels with IFQ permits, this action implements a 184-mt ACL for 2016 and a default 184-mt ACL for 2017 (see Table 1). We calculate IFQ allocations by applying each vessel's IFQ contribution percentage to these ACLs. IFQ allocations for each vessel assume that the LAGC IFQ fleet doesn't trigger any AMs. The AM dictates that if a vessel exceeds its IFQ in a given fishing year, its IFQ for the subsequent fishing year would be reduced by the amount of the overage.

    3. LAGC IFQ Trip Allocations and Possession Limits for Scallop Access Areas. Framework 27 allocates LAGC IFQ vessels a fleetwide number of trips in the MAAA and a fleetwide number of trips in the northern portion of the Nantucket Lightship Access Area (NLSN). This action does not grant the limited access fleet access to the NLSN.

    Framework 27 allocates 2,068 and 602 trips in 2016 and the same default amounts for 2017, respectively, to the MAAA. Under default 2017 measures, LAGC IFQ vessels must wait to fish these trips until April 1, 2017. It also allocates 485 trips to the NLSN for fishing year 2016. The total number of trips for both areas combined (2,553) for fishing year 2016 is equivalent to the overall proportion of total catch from access areas compared to total catch. Framework 27 does not allocate any trips to either fleet category in NLSN for the 2017 fishing year.

    4. NGOM Total Allowable Catch (TAC). The Framework 27 proposed rule proposed a 70,000-lb (31,751-kg) annual NGOM TAC for fishing years 2016 and 2017. However, the year-end analysis of the fishing year 2015 NGOM fishery shows a 2,546-lb (1,155-kg) overage in the NGOM TAC. The regulations implementing the Scallop FMP require that we implement an AM that reduces the NGOM TAC by the amount of the overharvest. Therefore, as a result of the fishing year 2015 catch overage, this action implements that AM, reducing the fishing year 2016 NGOM TAC to 67,454 lb (30,597 kg).

    5. Scallop Incidental Catch Target TAC. This action allocates a 50,000-lb (22,680-kg) scallop incidental catch target TAC for fishing years 2016 and a default target TAC for 2017 to account for mortality from this component of the fishery, and to ensure that F targets are not exceeded. The Council and NMFS may adjust this target TAC in a future action if vessels catch more scallops under the incidental target TAC than predicted.

    Despite the comments opposing the action, we find that the justification and analysis support the Council's recommendations, and that the Council process, in adopting Framework 27, followed up by the proposed and final rulemaking process, provided Council members and the public sufficient analysis to consider the proposed alternatives, including opening NLSN to LAGC vessels only, and adequate opportunity to comment on such alternatives. We have determined the Council's recommendations are consistent with law and we intend to approve all measures. Under the Magnuson-Stevens Act we can only disapprove a Council measure if it is not consistent with all applicable law. Otherwise, we give deference to the Council's policy recommendations.

    Regulatory Corrections Under Regional Administrator Authority

    This action includes several revisions to the regulatory text to address text that is unnecessary, outdated, unclear, or NMFS could otherwise improve. NMFS proposed these changes consistent with section 305(d) of the Magnuson-Stevens Act, which provides that the Secretary of Commerce may promulgate regulations necessary to ensure that amendments to an FMP are carried out in accordance with the FMP and the Magnuson-Stevens Act. The first revision, at § 648.14(i)(2)(ii)(B)(7), clarifies that the crew member restrictions, specified in § 648.51(c) and § 648.51(e)(3)(i), apply in all access areas. The second revision, at § 648.14(i)(3)(v)(C), clarifies that LAGC IFQ vessels must be declared into the Sea Scallop Access Area Program if they fish for, possess, or land scallops in or from any Sea Scallop Access Area. The third revision, at § 648.51(e)(2), clarifies that vessels participating in the small dredge program may carry component parts on board the vessel such that they do not conform with the definition of “dredge or dredge gear.” The fourth revision, at § 648.52(f), clarifies that LAGC IFQ vessels are permitted to possess no more than 75 bu (26.4 hL) of in-shell scallops outside of the Access Areas. Finally, the fifth revision, at § 648.60(g)(2), clarifies that LAGC IFQ vessels may fish with trawl gear in the MAAA.

    Comments and Responses

    NMFS received several comments on Framework 27 after the Council voted to submit the action but prior to the publication of the proposed rule. The majority of these comments objected to the alternative to allow exclusive LAGC effort in the NLSN, but we also received comments supporting this alternative. We considered these comments when preparing the proposed rule, but they did not present sufficient legal concerns that would require us to discuss possible disapproval of the measure in the proposed rule. Because these comments were mostly mirrored in comments on the proposed rule, we have not summarized them here.

    We received 17 comment letters on the proposed rule during the public comment period, including letters from 14 individuals; the Associated Fisheries of Maine (AFM); the Virginia Department of Environmental Quality; and Fisheries Survival Fund (FSF). The following summarizes the issues raised in the comments and NMFS's responses.

    Comment 1: Thirteen individuals wrote in support approving of the measure that allocates LAGC trips in the NLSN. These commenters were LAGC IFQ vessel owners and/or operators from New England. They believe that access to the NLSN will be extremely beneficial to their businesses and will allow them to fish closer to their homeports. They urged NMFS to approve this measure.

    Response: NMFS has approved all of the measures recommended by the Council, as supported by these commenters.

    Comment 2: Regarding the measure that allocates LAGC trips in the NLSN, AFM highlighted that the biological and economic analysis could not identify any negative impacts to the scallop resource or human communities because the amount of proposed harvest would be very small. It also highlighted that the Council has moved LAGC access area trips from Closed Area 2 to areas closer to shore in previous actions. AFM views the alternative to provide LAGC access to NLSN as a similar accommodation for a fleet comprised primarily of small vessels.

    Response: NMFS agrees that accommodating one specific fleet, whether the Limited Access fleet or LAGC fleet, with area-specific allocations is consistent with the Scallop FMP and with prior Council actions.

    Comment 3: The Virginia Department of Environmental Quality commented that it has no concerns with the proposed rule, and it believes the action is unlikely to have adverse impacts on fisheries resources under its jurisdiction.

    Response: We appreciate Virginia Department of Environmental Quality's comment.

    Comment 4: An individual was concerned that Framework 27 will adversely affect the income of the fishermen involved. He stated that the open area cannot withstand the increased effort due to an increase in the LAGC ACL. He asserts that vessels will target small scallops and prices will drop as a result of this increase. He also stated that the IFQ fleet will have a large amount of carryover because of poor catch rates in fishing year 2015, and that the LAGC fleet was caught off guard by this unforeseen anticipated increase.

    Response: We disagree with the commenter's concern about small scallops. Scallop dredges are required to have 4-inch rings that are designed to allow smaller scallops to pass through the gear, which should reduce the ability of vessel operators to target small scallops. Further, because larger scallops draw a higher price per pound there is generally an incentive to target larger scallops. Therefore, it is not likely to be in a vessel's best interest to target small scallops. In any event, because this substantial increase is only applicable to 5.5 percent of the fleet, analysis shows that it would not have a meaningful effect on price. The estimated ex-vessel price for the preferred alternative is $11.50, which is equal to or similar to the ex-vessel price in all of the other viable alternatives. Regarding carryover, LAGC IFQ vessels are limited to carrying over 15 percent of their available catch from fishing year 2015. However, despite this additional 15 percent that the LAGC fleet could carry over into fishing year 2016, that 15 percent carryover is unlikely to cause unexpected negative impacts resulting from additional catch on top of an already-increased sub-ACL. Finally, we projected an increase in the LAGC IFQ ACL during the fishing year 2015 specifications process in Framework 26. Because the LAGC ACL is formulaic, the magnitude of this increase was dependent on the result of the 2015 summer surveys. Once the surveys were completed, Council staff presented the potential increase in the LAGC ACL to the public in September of 2015. Therefore, this increase was not unforeseen. The quota allocations for fishing years 2016 and 2017 are based on the best scientific information available and are consistent with the control rules outlined in the ACL process established under Amendment 15 to the FMP.

    Comment 5: FSF, which represents a majority of the limited access scallop fleet, commented generally in favor of the Framework 27 measures, but, in a comment, recommended we disapprove the measure that allocates only LAGC effort in the NLSN. FSF stated in its comment its opinion that approval of this alternative is not legally permissive because of procedural flaws by the Council and NMFS. FSF contends that because the analysis was not included in the draft Framework until the day the Council voted on preferred alternatives (December 3, 2015), we cannot approve this measure because approval would violate the National Environmental Policy Act (NEPA) and the Administrative Procedure Act (APA). In support of this comment FSF notes, that, “alternatives considered by the Council must be `encompassed by the range of alternatives discussed in the relevant environmental documents,' ” citing NEPA and Agency Planning regulations at 40 CFR 1501.1(e).

    Response: FSF conflates the Council process with legal requirements on NMFS mandated by NEPA and APA. The legal adequacy of the relevant documents subject to NEPA and APA are not the draft documents considered by the Council at the December meeting because the Council is not a federal agency subject to these laws. Rather, the relevant documents are the final EA prepared after the December Council meeting and the proposed rule proposing to adopt the framework. The final EA encompasses a range of alternatives, including the NLSN measure, which are thoroughly analyzed for environmental and socioeconomic impacts and address the concerns raised by FSF. Further, the proposed rule provided ample opportunity for the public in general, and FSF in particular, to comment on the Framework, the EA analysis completed after the December Council meeting and referenced in the proposed rule, and the NLSN measure in particular.

    Comment 6: FSF cites 50 CFR 648.55(f) and states that the biological analysis for the measure allowing only LAGC vessels in the NLSN was conducted during the December Council meeting and not prior to, as required by law, and that the Council did not “provide the public with advance notice of the availability of both the proposals and the analyses, and opportunity to comment on them prior to and at the second Council meeting.” FSF cites the regulations at § 648.55(f) which state: “After considering the PDT's findings and recommendations, or at any other time, if the Council determines that adjustments to, or additional management measures are necessary, it shall develop and analyze appropriate management actions over the span of at least two Council meetings . . . The Council shall provide the public with advance notice of the availability of both the proposals and the analyses, and opportunity to comment on them prior to and at the second Council meeting . . .” FSF comments that any public notice deficiencies or, procedural irregularities at the Council level cannot be remedied by this rulemaking process. FSF goes on to state that the addition of the NSLN alternative could not be approved as a “logical outgrowth” of other alternatives.

    Response: We disagree with FSF's comment that we cannot approve the NLSN alternative because it is inconsistent with § 648.55(f) by failing to provide sufficient public notice and analysis before the Council voted on the alternative. First, there was sufficient public notice, analysis and full discussion before the Council voted to adopt the alternative. Although this specific alternative was not explicitly incorporated into the draft EA for Framework 27 at the beginning of the Council meeting, the public, and FSF in particular, were aware of this alternative well before the Council meeting and at the very least it is a logical outgrowth of measures that were being considered by the Council during the development of the framework. The Council initiated Framework 27 at its June 18, 2015, meeting and developed alternatives over several meetings including its September and December meetings, as well as the September 17, 2015, and the November 19, 2015, Scallop Oversight Committee meetings. Based on a Committee motion from its September 17, 2015, meeting, the concept of an alternative to allow fishing by all scallopers in NSLN was first included in a draft framework document for the September Council meeting. Members of the Scallop Advisory Panel, on which members of FSF sit, first suggested limiting scallop fishing in the NLSN to LAGC vessels only as an alternative at their meeting on November 18, 2015. The Advisory Panel suggested this alternative only after the Advisory Panel suggested a new alternative, created and raised by FSF, which proposed to have all access area effort in the MAAA. The next day, the Committee, in its meeting attended by representatives of FSF, requested that the Scallop Plan Development Team (PDT) analyze both the restricted NSLN alternative and the FSF sponsored alternative for the December Council meeting. Once analysis was complete, the PDT held a conference call on December 1, 2015. The notice for this call was posted on the Council Web site on November 23, 2015, and an automatic email was sent out on November 24, 2015, to anyone who registered to be informed on Council scallop issues. Members of the public, including representatives from FSF, attended the call. The next day, the Council summarized the details of that call in a PDT memo dated December 2, 2015, and made the memo available to the public at the Council meeting prior to the scallop discussion on December 3, 2015. The PDT memo provided both a biological and an economic analysis of the alternative.

    The Council heard public comment during the discussion of this measure both against and in support of this alternative, including comments against the measure from different representatives of FSF. The analyses included in the PDT memo, in combination with the public comment solicited at the meeting, and other analyses in Framework 27, allowed the Council to make an informed decision on this alternative. While this timing was tight, the process was consistent with the intent of the cited regulation in that it gave advance notice and analysis to the public over the course of two meetings (the November Committee meeting and the December Council meeting) before the measure was adopted. The Council frequently adjusts specific management alternatives that are logical outgrowths in the actions it is considering at or just before the final Council meeting. This provides the Council with the flexibility to consider sensible solutions or adjustments to these logical outgrowth alternatives without postponing action. Indeed, FSF was pushing for the adoption of its own sponsored proposed alternative even though it was subject to the same sequence of events and given the same analysis and consideration as the NSLN alternative. Therefore, we conclude that the Council and the public, including FSF, had more than adequate opportunity to consider and comment on the NLSN measure. Further, the adoption of this measure by the Council was consistent with the Council's procedural requirements to ensure that measures it adopts are sufficiently analyzed and the public is sufficiently aware of the analysis and propose alternatives before it adopts such a measure. Even if the Council's activity marginally infringed its established procedures because of the tight timing, courts, including those cited by FSF, have held that if there were procedural irregularities, they would not necessarily invalidate a regulation if such irregularities resulted in only “harmless error,” or there is no evidence that our decision to approve the alternative was materially affected by the Council's procedural irregularities (for which there is no evidence in this instance). Indeed, the Ninth U.S. Circuit Court of Appeals has held that “[i]if the Secretary has followed the appropriate rulemaking procedures and has established a rational basis for this action in promulgating regulations based on the submitted amendment, procedural challenges for irregularities at the Council level will not provide a justification for invalidating the regulations.” Atlantic Factory Trawler Association, et al. v. Baldridge, et al., 831 F. 2d 1456,1464 (9th Cir. 1987). FSF's comments that there was not adequate or sufficient understanding of and discussion about the alternative at the Council meeting is not supported by the facts as discussed above. There can be no doubt that there was a rational basis for the Council and NMFS adopting this alternative and nothing in the Council process materially affected our decision regarding this framework. Therefore any inconvenience FSF or the public may have experienced was at worst “harmless error,” which has been cured through notice and comment rulemaking.

    Comment 7: FSF alleges that the alternative that allocates LAGC trips in the NLSN violates the Scallop FMP access area guidelines, claiming that Amendment 10 to the Scallop FMP (69 FR 35194; June 23, 2004), “describes access area policies in terms that plainly anticipate that such areas are either open proportionally to both fleets or to neither.” FSF also cites a section of Amendment 11 to the Scallop FMP (73 FR 20090; April 14, 2008) referring to access area allocations for LAGC vessels that states that once an area is designated as controlled access, “it is understood that a specific percentage of the TAC per access area would be allocated to the General Category fleet.” FSF further contends that the Scallop FMP does not provide for decoupling of limited access and LAGC access to access areas, and the Council has never embarked on this path before. Finally, FSF quotes the Regional Administrator, who commented at the December Council meeting that he was concerned this alternative, “[takes] a chink out of this rotational closure and allows one group in early.”

    Response: There is nothing in the guidelines or policy underlying the Scallop FMP that prohibits this type of measure. Granting increased access area allocation to one part of the scallop fleet and not the other is not only contemplated by the Scallop FMP, it has been done in the past. The Environmental Impact Statement (EIS) to Amendment 11 acknowledges the possibility of differential allocations of area access specifically where it was determined that “it may not be effective to allocate the same percent per access area to the general category fishery. About 2 percent of the total TAC has been allocated to the general category fishery in previous access programs, but it was noted during this process that it may be most effective to consider variable percents for different access areas. For example, the 2 percent allocated in Closed Area 2 has never been caught by the general category fishery. It was discussed that these decisions are best considered in future framework actions that set specifications and allocations for the access area program and there is nothing in current regulations to prevent different percentages from being considered.” (EIS for Amendment 11 to the Scallop FMP; pg. 65). FSF's citation to Amendment 11 action comes from the description of a considered but rejected alternative. The rationale for rejection provides the same analysis as stated above that “it was discussed that it may not be effective to allocate the same percent per access area to the general category fishery.” FSF's reference to Amendment 10's intent is not specifically documented, and, in any event, Amendment 11 clearly allows for variable allocations among the Limited Access and LAGC fleets. Framework Adjustment 25 to the Scallop FMP (79 FR 26690; May 9, 2014) serves as the most recent example of the Council deciding to differentially allocate harvesting opportunities to one group of scallopers and not the other without any objection from FSF. In that framework, the Council allowed access to Closed Area 2 to the limited access fleet only, while permitting the LAGC fleet trips to another area based on a determination of equivalency of the LAGC fleet fishing in Closed Area 2. The fact that the Regional Administrator both spoke and voted against this measure at the December Council meeting does not by itself justify disapproval of the measure. The Regional Administrator's comments expressed policy, but not legal, concerns about the measure. Under the Magnuson-Stevens Act, even though the Regional Administrator may not be in favor of this measure on policy grounds, we can only disapprove a Council measure if it is not consistent with all applicable law, which is not the case here.

    Comment 8: FSF was concerned that the alternative that allocates LAGC trips in the NLSN differentially affects LAGC vessels homeported in New England differently than those homeported in the Mid-Atlantic, and the Council did not hold any meetings or hearings on this issue in the Mid-Atlantic region.

    Response: The Framework 27 EA discusses that this alternative may have a different impact on vessels regionally. Analysis in the EA suggests that allowing LAGC access to the NLSN may reduce the number of New England vessels traveling to the MAAA to fish, therefore increasing the total number of MAAA trips available to the Mid-Atlantic LAGC fleet. Furthermore, industry members from all regions had an equal opportunity to comment on the proposed rule, and there are members of the Advisory Panel, the Committee, and the Council that have LAGC and/or Mid-Atlantic interests. The fact that meetings were not held in an affected region does not mean that the framework is invalid, particularly when there was adequate opportunity for different regional fishers to comment.

    Comment 9: FSF asserts that “required analyses were inadequate or entirely lacking both prior to and at the meeting during which the Council took its vote.” It goes on to cite NEPA requirements for an EIS and they extend these requirements to the EA that the Council prepared for Framework 27.

    Response: NEPA regulations at 40 CFR 1508.9 state that an EA, “Shall include brief discussions of the need for the proposal, of alternatives as required by section 102(2)(E), of the environmental impacts of the proposed action and alternatives, and a listing of agencies and persons consulted.” The final EA includes these requirements. As stated above, the Council is not required to have a completed EA during the development of an action because it is not a Federal agency. In fact, it is impossible to analyze the action as a whole until after the Council selects preferred alternatives. While this regulation imposes a requirement ultimately of NMFS, the Council uses a draft EA as a means to present and analyze alternatives, and, in turn, submits that as part of the Council's recommendation to NMFS on the action. NMFS adopts the draft document prepared by the Council and works with the Council to finalize it. Nevertheless, we disagree with FSF's comment that there was inadequate analysis at the Council meeting before the Council took its vote. The analysis of the alternative that allocates LAGC trips in the NLSN that was available to the Council at the December meeting (the December 2, 2015, PDT memo) before any vote was taken was on par with other alternatives in the document. This analysis contained detailed images describing where fishing would occur and the condition of the resource in that area, both biological and economic projections of the impacts of the alternative, and a comparative analysis of those impacts compared to alternatives already in the document. This analysis found that the allowing LAGC access into the NLSN had the highest total benefits of any alternative in 2016 and no noticeable biological impact. Once the Council chose preferred alternatives, Council staff worked with NMFS to fully analyze all the alternatives and meet NEPA requirements for Framework 27.

    Comment 10: FSF believes that Framework 27 failed to sufficiently analyze economic impacts such as regional variation in lease prices.

    Response: FSF is incorrect. Framework 27 includes an economic and social analysis of all of the considered alternatives in Section 5.4 and it specifically analyzes regional variation in leasing in Section 5.4.3.12.3. Framework 27 concludes that “the distribution of access area allocations could have some impacts on (lease) prices, however, those impacts would be uncertain given that not only the size of scallops but several other factors, including the distance to each area from the homeports of IFQ holders, the fuel and trip costs, total amount of IFQ available, distribution of IFQ holdings among the active vessels, relative price of scallops by market category have an influence on lease prices.” Furthermore, as stated above, the PDT analysis available to the Council during its December meeting found that the allowing LAGC access into the NLSN had the highest total benefits of any alternative in 2016.

    Comment 11: FSF also claims that the alternative that allocates LAGC trips in the NLSN is an allocative measure and requires an amendment, as opposed to a framework, and also an EIS versus an EA. They cite NMFS' Operational Guidelines that limit a framework action, by definition, to “a mechanism for implementing recurrent, routine, or foreseeable actions in an expedited manner.”

    Response: This measure is not fundamentally allocative in the way suggested by FSF. The NLSN provision is only a one-year specification that does not increase total allocations or take away any allocations from the limited access fleet. The provision merely shifts around how LAGC scallopers can harvest their allocations based on their particular circumstances, not the amount they are allocated. This type of specification is a regular annual action that is foreseeable and consistent with the Scallop FMP, as discussed in the response to comment 7, which allows for differential access to access areas for the limited access and LAGC fleets depending on the annual needs of each fleet. Thus, although controversial, this action was a routine specifications action that is appropriate for a Framework. 50 CFR 648.55(f) describes the types of measures that the Council can decide to adjust. It allows for adjustments to area-specific trip allocations, specifications for IFQs for limited access general category vessels, and any other management measures currently included in the FMP. The controversiality of a measure in terms of its desirability is not justification to conduct an EIS. Only when the analysis of an action is controversial in terms of its validity is an EIS required. Finally, there is no law or provision of the Magnuson-Stevens Act that requires an amendment for allocative issues. Nor does NEPA require an EIS because of significant economic impacts as suggested by FSF.

    Comment 12: FSF says that the Council made the decision that NLSN was not ready to be opened as a biological matter. FSF states that the alternative that allocates LAGC trips in the NLSN violates National Standard 2 requiring that “conservation and management measures shall be based upon the best scientific information available.” FSF asserts that the Council made their decision to allow LAGC effort in the NLSN area based on politics and not the best available science.

    Response: This is not true as even acknowledged by FSF. In fact, alternatives in the document considered access to NLSN. The PDT determined that the NLSN area could handle a small amount of limited access effort (52 trips at 17,000 lb (400 mt)) and this alternative was included in Framework 27. Allowing the LAGC trips in the NLSN included in this final rule will result in approximately 132 mt of harvest. The Council's non-selected alternative to open the NLSN to both fleets at a very limited level would have resulted in approximately 400 mt of scallop harvest. The reason the broader NLSN alternative was not selected was not biological, but rather it was not supported by the limited access fleet because only 16.6 percent of the full-time limited access fleet would receive a trip in NLSN.

    The best available science shows that allowing access to the LAGC fleet will not harm the resource. Indeed, the analysis in the draft and final EA and the PDT memo concludes that the alternative allowing three times more access (400 mt) by limited access vessels and LAGC vessels would not jeopardize sustainability of the scallop resource. The decision was a policy decision of how much to allocate between the two fleets. The Council has the right to make these types of decisions, and we can only disapprove if it is inconsistent with Magnuson-Stevens Act requirements and the applicable law, not on whether we disagree with the policy underlying the measure. The Council made its decision based on the scientific analysis provided in the December 2, 2015, PDT memo, public and Council member testimony, and other analyses in the Framework 27 EA. FSF has not offered any other science or biological analysis to contradict the scientific information upon which the Council made its decision. FSF even notes that the PDT analysis in the memo could not identify negative biological impacts to the scallop resource because the amount of proposed harvest would be very small. Also, the draft and final EA concluded that there would be overall positive economic impacts for the scallop fleet, with relatively higher positive economic impacts for LAGC vessels homeported in the New England states. The Advisory Panel, including members of FSF preferred access to MAAA over NSLN in part because it allowed the entire limited access fleet into the area. It was only when the limited access fleet requested this alternative, that members of the LAGC fleet requested that 19 percent of their MAAA trip allocation be moved into the NLSN.

    Comment 13: FSF claims that the alternative that allocates LAGC trips in the NLSN violates National Standard 8 because it analyzed only impacts on the LAGC fleet that fished from ports closer to the access area rather than how it affects the entire LAGC fleet.

    Response: National Standard 8 requires that “Conservation and management measures shall . . . take into account the importance of fishery resources to fishing communities by utilizing economic and social data . . . in order to (A) provide for the sustained participation of such communities, and (B) to the extent practicable, minimize adverse economic impacts on such communities.” (16 U.S.C. 1851, Sec 301(a)(8)). The final version of the Framework, the expanded draft EA available when the proposed rule was published, and the final EA specifically analyze the differential impacts and conclude that because fewer northern vessels will go down to the MAAA, the Mid-Atlantic vessels, i.e., those farther from the NLSN, may have more quota to fish. While this analysis was not specifically available at the time the Council approved the NLSN measure there was a general mention of possible differential impacts in the PDT report that was available during the Council meeting and a self-evident understanding by Council members and the public that area-based allocations are, by their very nature, going to have more benefits to regions that are closer to areas open to fishing. As discussed above, the public had additional opportunity to comment on the draft EA which was made available for review at the time of the publication of the proposed rule. Ultimately, the adequacy of the NEPA analysis is determined by the final EA not the draft NEPA analysis available at the Council meeting. This level of analysis alerting the public and FSF to the differential impacts to communities as required by National Standard 8, followed up by more complete analysis in the draft and final EA is consistent with Magnuson-Stevens Act and NEPA requirements.

    Changes From Proposed Rule to Final Rule

    We included changes to the regulatory text to § 648.62 to implement an AM due to the overage of the NGOM TAC.

    Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with the FMP, other provisions of the Magnuson-Stevens Act, the ESA, and other applicable law.

    The Office of Management and Budget (OMB) has determined that this rule is not significant pursuant to Executive Order (E.O.) 12866.

    This final rule does not contain policies with federalism or “takings” implications, as those terms are defined in E.O. 13132 and E.O. 12630, respectively.

    This action does not contain any collection-of-information requirements subject the Paperwork Reduction Act (PRA).

    The Assistant Administrator for Fisheries has determined that the need to implement these measures in an expedited manner in order to help achieve conservation objectives for the scallop fishery and certain fish stocks constitutes good cause, under authority contained in 5 U.S.C. 553(d)(3), to waive the 30-day delay in effectiveness and to make the Framework 27 final measures effective upon publication in the Federal Register.

    Because Framework 27 has not yet been approved and implemented, certain default measures, including access area designations and DAS, IFQ, research set-aside and observer set-aside allocations, are automatically put into place. These default allocations were purposely set to be more conservative than what would eventually be implemented under Framework 27. Under default measures, each full-time vessel has 26 DAS and one access area 17,000-lb (7,711-kg) trip in the MAAA. We have good cause to waive the 30-day delay in effectiveness because this action provides full-time vessels with an additional 8.55 DAS (34.55 DAS total) and 34,000 lb (15,422 kg) in access area allocation (51,000 lb (23,133 kg) total) into the MAAA. Further, LAGC IFQ vessels will receive an additional 330 mt (2,029 mt total) of allocation and 1,466 trips into the MAAA (2,068 trips total) and 485 trips in the NLSN. Framework 27 could not have been put into place sooner to allow for a 30-day delayed effectiveness because the information and data necessary for the Council to develop the framework was not available in time. We received the final submission of the EA from the Council on March 14, 2016. We published the proposed rule on February 24, 2016, and the comment period did not close until March 25, 2016. Delaying the implementation of Framework 27 for 30 days would delay positive economic benefits to the scallop fleet and could negatively impact the access area rotation program by delaying fishing in access areas that should be available. There are no new measures that implement additional burdens on the fleet, and we do not expect that any members of the scallop industry will be aggrieved by waiving this delay.

    NMFS, pursuant to section 604 of the Regulatory Flexibility Act (RFA), has completed a final regulatory flexibility analysis (FRFA) in support of Framework 27 in this final rule. The FRFA incorporates the IRFA, a summary of the significant issues raised by the public comments in response to the IRFA, NMFS responses to those comments, a summary of the analyses completed in the Framework 27 EA, and this portion of the preamble. A summary of the IRFA was published in the proposed rule for this action and is not repeated here. A description of why this action was considered, the objectives of, and the legal basis for this rule is contained in Framework 27 and in the preamble to the proposed and this final rule, and is not repeated here. All of the documents that constitute the FRFA are available from NMFS and a copy of the IRFA, the Regulatory Impact Review (RIR), and the EA are available upon request (see ADDRESSES).

    A Summary of the Significant Issues Raised by the Public in Response to the IRFA, a Summary of the Agency's Assessment of Such Issues, and a Statement of Any Changes Made in the Final Rule as a Result of Such Comments

    There were no specific comments on the IRFA. The Comments and Responses section summarizes the comments that highlight concerns about the economic impacts and implications of impacts on small businesses (i.e., comments 4, 8, 9, 10, and 13).

    Description and Estimate of Number of Small Entities to Which the Rule Would Apply

    The regulations affect all vessels with limited access and LAGC scallop permits. The Framework 27 EA provides extensive information on the number and size of vessels and small businesses that will be affected by the regulations, by port and state (see ADDRESSES). There were 313 vessels that obtained full-time limited access permits in 2014, including 250 dredge, 52 small-dredge, and 11 scallop trawl permits. In the same year, there were also 34 part-time limited access permits in the sea scallop fishery. No vessels were issued occasional scallop permits. NMFS issued 220 LAGC IFQ permits in 2014 and 128 of these vessels actively fished for scallops that year (the remaining permits likely leased out scallop IFQ allocations with their permits in Confirmation of Permit History). The RFA defines a small business in shellfish fishery as a firm that is independently owned and operated and not dominant in its field of operation, with receipts of up to $5.5 million annually. Individually-permitted vessels may hold permits for several fisheries, harvesting species of fish that are regulated by several different fishery management plans, even beyond those impacted by this action. Furthermore, multiple permitted vessels and/or permits may be owned by entities with various personal and business affiliations. For the purposes of this analysis, “ownership entities” are defined as those entities with common ownership as listed on the permit application. Only permits with identical ownership are categorized as an “ownership entity.” For example, if five permits have the same seven persons listed as co-owners on their permit applications, those seven persons would form one “ownership entity,” that holds those five permits. If two of those seven owners also co-own additional vessels, that ownership arrangement would be considered a separate “ownership entity” for the purpose of this analysis.

    Ownership data from 2014 result in 166 distinct ownership entities for the limited access fleet and 106 distinct ownership entities for the LAGC IFQ fleet. Of these, and based on the Small Business Administration (SBA) guidelines, 152 of the limited access distinct ownership entities and 102 of the LAGC IFQ entities are categorized as small. The remaining 14 of the limited access and 4 of the LAGC IFQ entities are categorized as large entities, all of which are shellfish businesses.

    Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements of the Proposed Rule

    This action contains no new collection-of-information, reporting, or recordkeeping requirements.

    Description of the Steps the Agency Has Taken To Minimize the Significant Economic Impact on Small Entities Consistent With the Stated Objectives of Applicable Statutes

    During the development of Framework 27, NMFS and the Council considered ways to reduce the regulatory burden on, and provide flexibility for, the regulated entities in this action. For example, they opened the NLSN to LAGC vessels to provide vessels homeported in Massachusetts an opportunity to fish in an access area without traveling to the MAAA. This measure addresses safety and economic concerns for smaller northern LAGC vessels when fishing in an access area. Final actions and alternatives are described in detail in Framework 27, which includes an EA, RIR, and IRFA (available at ADDRESSES). The measures implemented by this final rule minimize the long-term economic impacts on small entities to the extent practicable. The only alternatives for the prescribed catch limits that were analyzed were those that met the legal requirements to implement effective conservation measures. Catch limits are fundamentally a scientific calculation based on the Scallop FMP control rules and SSC approval, and therefore are legally limited to the numbers contained in this rule. Moreover, the limited number of alternatives available for this action must be evaluated in the context of an ever-changing fishery management plan that has considered numerous alternatives over the years and have provided many mitigating measures applicable every fishing year.

    Overall, this rule minimizes adverse long-term impacts by ensuring that management measures and catch limits result in sustainable fishing mortality rates that promote stock rebuilding, and as a result, maximize yield. The measures implemented by this final rule also provide additional flexibility for fishing operations in the short-term. This final rule implements measures that enable small entities to offset some portion of the estimated economic impacts. These measures include allocating about 19 percent of LAGC IFQ access area trips (or 300,000 lb (136 mt)) to the NLSN which is open to LAGC vessels only. Because of the proximity of the LAGC vessels, which are smaller in size and homeported in Massachusetts to NLSN, this option will reduce fishing costs and have positive impacts on their profits; and allowing about 1.5 million lb (680 mt) of the total LAGC allocation of 4.4 million lb (1,996 mt) to be harvested from access areas.

    List of Subjects 50 CFR Part 648

    Fisheries, Fishing, Recordkeeping and reporting requirements.

    Dated: April 28, 2016. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 648 is amended as follows:

    PART 648—FISHERIES OF THE NORTHEAST UNITED STATES 1. The authority citation for part 648 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq.

    2. In § 648.14, paragraphs (i)(2)(ii)(B)(7) and (i)(3)(v)(B) are revised, and paragraph (i)(3)(v)(C) is added to read as follows:
    § 648.14 Prohibitions.

    (i) * * *

    (2) * * *

    (ii) * * *

    (B) * * *

    (7) Fish in a Sea Scallop Access Area, as described in § 648.59, with more persons on board the vessel than the number specified in § 648.51(c) or § 648.51(e)(3)(i), unless otherwise authorized by the Regional Administrator.

    (3) * * *

    (v) * * *

    (B) Declare into or leave port for an area specified in § 648.59(a) through (d) after the effective date of a notification published in the Federal Register stating that the number of LAGC trips have been taken, as specified in § 648.60.

    (C) Fish for or land per trip, or possess in excess of 40 lb (18.1 kg) of shucked scallops at any time in or from any Sea Scallop Access Area specified at § 648.59, unless declared into the Sea Scallop Access Area Program.

    3. In § 648.51, paragraph (e)(2) is revised to read as follows:
    § 648.51 Gear and crew restrictions.

    (e) * * *

    (2) The vessel may not use or have more than one dredge on board. However, component parts may be on board the vessel such that they do not conform with the definition of “dredge or dredge gear” in § 648.2, i.e., the metal ring bag and the mouth frame, or bail, of the dredge are not attached, and no more than one complete spare dredge could be made from these component's parts.

    4. In § 648.52, paragraph (f) is revised to read as follows:
    § 648.52 Possession and landing limits.

    (f) A limited access vessel or an LAGC vessel that is declared into the Sea Scallop Area Access Program as described in § 648.60, may not possess more than 50 bu (17.6 hL) or 75 bu (26.4 hL), respectively, of in-shell scallops outside of the Access Areas described in § 648.59(a) through (e).

    5. In § 648.53, paragraphs (a), (b)(1), (b)(4), and (g)(1) are revised, and paragraph (h)(5)(iv)(D) is removed and reserved to read as follows:
    § 648.53 Acceptable biological catch (ABC), annual catch limits (ACL), annual catch targets (ACT), DAS allocations, and individual fishing quotas (IFQ).

    (a) Scallop fishery ABC. The ABC for the scallop fishery shall be established through the framework adjustment process specified in § 648.55 and is equal to the overall scallop fishery ACL minus discards. The ABC/ACL, after discards are removed, shall be divided as sub-ACLs between limited access vessels, limited access vessels that are fishing under a LAGC permit, and LAGC vessels as specified in paragraphs (a)(3) and (4) of this section, after deducting the scallop incidental catch target TAC specified in paragraph (a)(2) of this section, observer set-aside specified in paragraph (g)(1) of this section, and research set-aside specified in § 648.56(d). The ABC/ACL for the 2017 fishing year is subject to change through a future framework adjustment.

    (1) ABC/ACL for fishing years 2016 through 2017, excluding discards, shall be:

    (i) 2016: 37,852 mt.

    (ii) 2017: 37,852 mt.

    (2) Scallop incidental catch target TAC. The annual incidental catch target TAC for vessels with incidental catch scallop permits is 22.7 mt.

    (3) Limited access fleet sub-ACL and ACT. The limited access scallop fishery shall be allocated 94.5 percent of the ACL specified in paragraph (a)(1) of this section, after deducting incidental catch, observer set-aside, and research set-aside, as specified in this paragraph (a)(3). ACT for the limited access scallop fishery shall be established through the framework adjustment process described in § 648.55. DAS specified in paragraph (b) of this section shall be based on the ACTs specified in paragraph (a)(3)(ii) of this section. The limited access fleet sub-ACL and ACT for the 2017 fishing year are subject to change through a future framework adjustment.

    (i) The limited access fishery sub-ACLs for fishing years 2016 and 2017 are:

    (A) 2016: 36,884 mt.

    (B) 2017: 36,884 mt.

    (ii) The limited access fishery ACTs for fishing years 2016 and 2017 are:

    (A) 2016: 18,290 mt.

    (B) 2017: 18,290 mt.

    (4) LAGC fleet sub-ACL. The sub-ACL for the LAGC IFQ fishery shall be equal to 5.5 percent of the ACL specified in paragraph (a)(1) of this section, after deducting incidental catch, observer set-aside, and research set-aside, as specified in this paragraph (a)(4). The LAGC IFQ fishery ACT shall be equal to the LAGC IFQ fishery's ACL. The ACL for the LAGC IFQ fishery for vessels issued only a LAGC IFQ scallop permit shall be equal to 5 percent of the ACL specified in paragraph (a)(1) of this section, after deducting incidental catch, observer set-aside, and research set-aside, as specified in this paragraph (a)(4). The ACL for the LAGC IFQ fishery for vessels issued only both a LAGC IFQ scallop permit and a limited access scallop permit shall be 0.5 percent of the ACL specified in paragraph (a)(1) of this section, after deducting incidental catch, observer set-aside, and research set-aside, as specified in this paragraph (a)(4).

    (i) The ACLs for fishing years 2016 and 2017 for LAGC IFQ vessels without a limited access scallop permit are:

    (A) 2016: 1,845 mt.

    (B) 2017: 1,845 mt.

    (ii) The ACLs for fishing years 2016 and 2017 for vessels issued both a LAGC and a limited access scallop permits are:

    (A) 2016: 184 mt.

    (B) 2017: 184 mt.

    (b) * * *

    (1) Landings per unit effort (LPUE). LPUE is an estimate of the average amount of scallops, in pounds, that the limited access scallop fleet lands per DAS fished. The estimated LPUE is the average LPUE for all limited access scallop vessels fishing under DAS, and shall be used to calculate DAS specified in paragraph (b)(4) of this section, the DAS reduction for the AM specified in paragraph (b)(4)(ii) of this section, and the observer set-aside DAS allocation specified in paragraph (g)(1) of this section. LPUE shall be:

    (i) 2016 fishing year: 2,316 lb/DAS (1.051 kg/DAS).

    (ii) 2017 fishing year: 2,690 lb/DAS (1,220 kg/DAS).

    (iii) [Reserved]

    (4) Each vessel qualifying for one of the three DAS categories specified in the table in this paragraph (b)(4) (full-time, part-time, or occasional) shall be allocated the maximum number of DAS for each fishing year it may participate in the open area limited access scallop fishery, according to its category, excluding carryover DAS in accordance with paragraph (d) of this section. DAS allocations shall be determined by distributing the portion of ACT specified in paragraph (a)(3)(ii) of this section, as reduced by access area allocations specified in § 648.59, and dividing that amount among vessels in the form of DAS calculated by applying estimates of open area LPUE specified in paragraph (b)(1) of this section. Allocation for part-time and occasional scallop vessels shall be 40 percent and 8.33 percent of the full-time DAS allocations, respectively. The annual open area DAS allocations for each category of vessel for the fishing years indicated are as follows:

    Scallop Open Area DAS Allocations Permit
  • category
  • 2016 2017
    Full-Time 34.55 34.55 Part-Time 13.82 13.82 Occasional 2.88 2.88

    (g) * * *

    (1) To help defray the cost of carrying an observer, 1 percent of the ABC/ACL specified in paragraph (a)(1) of this section shall be set aside to be used by vessels that are assigned to take an at-sea observer on a trip. The total TAC for observer set aside is 379 mt in fishing year 2016, and 379 mt in fishing year 2017.

    6. In § 648.58 paragraphs (b), (c), and (e) are revised to read as follows:
    § 648.58 Rotational Closed Areas.

    (b) Closed Area II—(1) Closed Area II Closed Area. No vessel may fish for scallops in, or possess or land scallops from, the area known as the Closed Area II Closed Area. No vessel may possess scallops in the Closed Area II Closed Area. The Closed Area II Closed Area is defined by straight lines, except where noted, connecting the following points in the order stated (copies of a chart depicting this area are available from the Regional Administrator upon request):

    Point Latitude Longitude Note CAIIA1 41°00′ N. 67°20′ W. CAIIA2 41°00′ N. 66°35.8′ W. CAIIA3 41°18.45′ N. (1) (2) CAIIA4 41°30′ N. (3) (2) CAIIA5 41°30′ N. 67°20′ W. CAIIA1 41°00′ N. 67°20′ W. 1 The intersection of 41°18.45′ N. lat. and the U.S.-Canada Maritime Boundary, approximately 41°18.45′ N. lat. and 66°24.89′ W. long. 2 From Point CAIIA3 connected to Point CAIIA4 along the U.S.-Canada Maritime Boundary. 3 The intersection of 41°30′ N. lat. and the U.S.-Canada Maritime Boundary, approximately 41°30′ N. lat., 66°34.73′ W. long.

    (2) Closed Area II Extension Closed Area. No vessel may fish for scallops in, or possess or land scallops from, the area known as the Closed Area II Extension Closed Area. No vessel may possess scallops in the Closed Area II Extension Closed Area. The Closed Area II Extension Closed Area is defined by straight lines, except where noted, connecting the following points in the order stated (copies of a chart depicting this area are available from the Regional Administrator upon request):

    Point Latitude Longitude Note CAIIE1 40°30′ N. 67°20′ W. CAIIE2 41°00′ N. 67°20′ W. CAIIE3 41°00′ N. 66°35.8′ W. CAIIE4 41°18.45′ N. (1) (2) CAIIE5 40°30′ N. (3) (2) CAIIE1 40°30′ N. 67°20′ W. 1 The intersection of 41°18.45′ N. lat. and the U.S.-Canada Maritime Boundary, approximately 41°18.45′ N. lat. and 66°24.89′ W. long. 2 From Point CAIIE4 to Point CAIIE5 following the U.S.-Canada Maritime Boundary. 3 The intersection of 40°30′ N. lat. and the U.S.-Canada Maritime Boundary, approximately, 65°44.34′ W. long.

    (c) Nantucket Lightship Closed Area. No vessel may fish for scallops in, or possess or land scallops from, the area known as the Nantucket Lightship Closed Area. No vessel may possess scallops in the Nantucket Lightship Closed Area, unless such vessel is an IFQ LAGC vessel participating in, and complying with the requirements of, the IFQ LAGC area access program described in § 648.60(g)(3), or the vessel is only transiting the area as provided in paragraph (e) of this section. The Nantucket Lightship Closed Area is defined by straight lines connecting the following points in the order stated (copies of a chart depicting this area are available from the Regional Administrator upon request),

    Point Latitude Longitude NLAA1 40°50′ N. 69°30′ W. NLAA2 40°50′ N. 69°00′ W. NLAA3 40°33′ N. 69°00′ W. NLAA4 40°33′ N. 68°48′ W. NLAA5 40°20′ N. 68°48′ W. NLAA6 40°20′ N. 69°30′ W. NLAA1 40°50′ N. 69°30′ W.

    (e) Transiting. No vessel possessing scallops may enter or be in the area(s) specified in paragraphs (a) and (c) of this section unless the vessel is transiting the area and the vessel's fishing gear is stowed and not available for immediate use as defined in § 648.2, or there is a compelling safety reason to be in such areas without such gear being stowed. A vessel may only transit the Closed Area II Closed Area or the Closed Area II Extension Closed Area, as described in paragraph (b) of this section, or the Elephant Trunk Closed Area, as described in paragraph (d) of this section, if there is a compelling safety reason for transiting the area and the vessel's fishing gear is stowed and not available for immediate use as defined in § 648.2.

    7. In § 648.59, paragraphs (a)(1), (b)(1), (c)(1), and (d)(1) are revised and paragraph (a)(2)(i) is removed and reserved to read as follows:
    § 648.59 Sea Scallop Access Areas.

    (a) * * *

    (1) Beginning March 1, 2016, through February 28, 2018 (i.e., fishing years 2016 and 2017), a vessel issued a scallop permit may not fish for, possess, or land scallops in or from the area known as the Mid-Atlantic Access Area unless the vessel is participating in, and complies with the requirements of, the area access program described in § 648.60 or the vessel is transiting pursuant to paragraph (f) of this section. The Mid-Atlantic Access Area is comprised of the following scallop access areas: The Delmarva Scallop Access Area, as described in paragraph (a)(2) of this section; the Elephant Trunk Scallop Access Area, as described in paragraph (a)(3) of this section; and the Hudson Canyon Scallop Access Area, as described in paragraph (a)(4) of this section.

    (b) * * *

    (1) From March 1, 2016, through February 28, 2018 (i.e., fishing years 2016 and 2017), a vessel issued a scallop permit may not fish for, possess, or land scallops in or from, the area known as the Closed Area I Scallop Access Area, described in paragraph (b)(3) of this section, unless transiting in accordance with paragraph (f) of this section. A vessel issued both a NE multispecies permit and an LAGC scallop permit may not fish in an approved SAP under § 648.85 and under multispecies DAS in the scallop access area, unless it complies with restrictions in paragraph (b)(5)(ii)(C) of this section.

    (c) * * *

    (1) From March 1, 2016, through February 28, 2018 (i.e., fishing years 2016 and 2017), a vessel issued a scallop permit may not fish for, possess, or land scallops in or from, the area known as the Closed Area II Access Area, described in paragraph (c)(3) of this section, unless transiting in accordance with paragraph (f) of this section. A vessel issued both a NE multispecies permit and an LAGC scallop permit may not fish in an approved SAP under § 648.85 and under multispecies DAS in the scallop access area, unless it complies with restrictions in paragraph (c)(5)(ii)(C) of this section.

    (d) * * *

    (1) From March 1, 2016, through February 28, 2018 (i.e., fishing years 2016 and 2017), a vessel issued a scallop permit may not fish for, possess, or land scallops in or from the area known as the Nantucket Lightship Access Area, described in paragraph (d)(3) of this section, unless the vessel is an IFQ LAGC vessel participating in, and complying with the requirements of, the IFQ LAGC area access program described in § 648.60(g)(3), or the vessel is transiting pursuant to paragraph (f) of this section. A vessel issued both a NE multispecies permit and an LAGC scallop permit may not fish in an approved SAP under § 648.85 and under multispecies DAS in the scallop access area, unless it complies with restrictions in paragraph (d)(5)(ii)(C) of this section.

    8. In § 648.60, paragraphs (a)(3)(i), (a)(5)(i), (c), (e), and (g)(1), (g)(2), and (g)(3) are revised to read as follows:
    § 648.60 Sea scallop access area program requirements.

    (a) * * *

    (3) Sea Scallop Access Area Allocations—(i) Limited access vessel allocations. (A) Except as provided in paragraph (c) of this section, paragraphs (a)(3)(i)(B) through (E) of this section specify the total amount of scallops, in weight, that a limited access scallop vessel may harvest from Sea Scallop Access Areas during applicable seasons specified in § 648.59. A vessel may not possess or land in excess of its scallop allocation assigned to specific Sea Scallop Access Areas, unless authorized by the Regional Administrator, as specified in paragraph (d) of this section, unless the vessel owner has exchanged an area-specific scallop allocation with another vessel owner for additional scallop allocation in that area, as specified in paragraph (a)(3)(ii) of this section. A vessel may harvest its scallop allocation, as specified in paragraph (a)(3)(i)(B) of this section, on any number of trips in a given fishing year, provided that no single trip exceeds the possession limits specified in paragraph (a)(5) of this section, unless authorized by the Regional Administrator, as specified in paragraphs (c) and (d) of this section,

    (B) Full-time scallop vessels. (1) In fishing year 2016, each full-time vessel shall have a total of 51,000 lb (23,133 kg) of scallops that may be harvested from the Mid-Atlantic Access Area, as defined in § 648.59(a).

    (2) For the 2017 fishing year, each full-time vessel shall have a total of 17,000 lb (7,711 kg) of scallops that may be harvested from the Mid-Atlantic Access Area, as defined in § 648.59(a), starting on April 1, 2017.

    (C) Part-time scallop vessels. (1) For the 2016 fishing year, each part-time scallop vessel shall have a total of 20,400 lb (9,253 kg) of scallop that may be harvested from the Mid-Atlantic Access Area, as defined in § 648.59(a).

    (2) For the 2016 fishing year, each part-time scallop vessel shall have a total of 10,200 lb (4,627 kg) of scallop that may be harvested from the Mid-Atlantic Access Area, as defined in § 648.59(a), starting on April 1, 2017.

    (D) Occasional scallop vessels. (1) For the 2016 fishing year, each occasional scallop vessel shall have a total of 4,250 lb (1,928 kg) of scallop that may be harvested from the Mid-Atlantic Access Area, as defined in § 648.59(a).

    (2) For the 2017 fishing year, each occasional scallop vessel shall have a total of 1,420 lb (644 kg) of scallop that may be harvested from the Mid-Atlantic Access Area, as defined in § 648.59(a), starting on April 1, 2017.

    (5) Possession and landing limits—(i) Scallop possession limits. Unless authorized by the Regional Administrator, as specified in paragraph (d) of this section, after declaring a trip into a Sea Scallop Access Area, a vessel owner or operator of a limited access scallop vessel may fish for, possess, and land, per trip, scallops, up to the maximum amounts specified in the table in this paragraph (a)(5). No vessel declared into the Access Areas as described in § 648.59(a) through (e) may possess more than 50 bu (17.62 hL) of in-shell scallops outside of the Access Areas described in § 648.59(a) through (e).

    Fishing year Permit category possession limit Full-time Part-time Occasional 2016 17,000 lb (57,711 kg) 10,200 lb (4,627 kg) 1,420 lb (644 kg). 2017 17,000 lb (57,711 kg) 10,200 lb (4,627 kg) 1,420 lb (644 kg).

    (c) Access area scallop allocation carryover. Unless otherwise specified in § 648.59, a limited access scallop vessel operator may fish any unharvested Scallop Access Area allocation from a given fishing year within the first 60 days of the subsequent fishing year if the Access Area is open. For example, if a full-time vessel has 7,000 lb (3,175 kg) remaining in the Mid-Atlantic Access Area at the end of fishing year 2016, that vessel may harvest 7,000 lb (3,175 kg) from its 2017 fishing year scallop access area allocation during the first 60 days that the Mid-Atlantic Access Area is open in fishing year 2017 (March 1, 2017, through April 29, 2018). Unless otherwise specified in § 648.59, if an Access Area is not open in the subsequent fishing year, then the unharvested scallop allocation would expire at the end of the fishing year that the scallops were allocated.

    (e) Sea Scallop Research Set-Aside Harvest in Access Areas—(1) Access Areas available for harvest of research set-aside (RSA). Unless otherwise specified, RSA may be harvested in any access area that is open in a given fishing year, as specified through a framework adjustment and pursuant to § 648.56. The amount of scallops that can be harvested in each access area by vessels participating in approved RSA projects shall be determined through the RSA application review and approval process. The access areas open for RSA harvest for fishing years 2016 and 2017 are:

    (i) 2016: The Mid-Atlantic Scallop Access Area, as specified in § 648.59(a).

    (ii) 2017: None.

    (2) [Reserved]

    (g) Limited Access General Category Gear restrictions. (1) An LAGC scallop vessel may only fish in the scallop access areas specified in § 648.59(a) through (e) or in (g)(3)(iv) of this section, subject to the seasonal restrictions specified in § 648.59(b)(4), (c)(4), and (d)(4), and subject to the possession limit specified in § 648.52(a), and provided the vessel complies with the requirements specified in paragraphs (a)(1), (a)(2), (a)(6) through (9), (d), (e), (f), and (g) of this section. A vessel issued both a NE multispecies permit and an LAGC scallop permit may fish in an approved SAP under § 648.85 and under multispecies DAS in the Closed Area I, Closed Area II, and Nantucket Lightship Sea Scallop Access Areas specified in § 648.59(b) through (d), provided the vessel complies with the requirements specified in § 648.59(b)(5)(ii), (c)(5)(ii), and (d)(5)(ii), and this paragraph (g), but may not fish for, possess, or land scallops on such trips.

    (2) Limited Access General Category Gear restrictions. An LAGC IFQ scallop vessel authorized to fish in the Access Areas specified in § 648.59(b) through (e) must fish with dredge gear only. The combined dredge width in use by, or in possession on board of, an LAGC scallop vessel fishing in Closed Area I, Closed Area II, and Nantucket Lightship Access Areas may not exceed 10.5 ft (3.2 m). The combined dredge width in use by, or in possession on board of, an LAGC scallop vessel fishing in the remaining Access Areas described in § 648.59 may not exceed 31 ft (9.4 m). Dredge width is measured at the widest point in the bail of the dredge.

    (3) LAGC IFQ Access Area Trips. (i) An LAGC scallop vessel authorized to fish in the Access Areas specified in § 648.59(a) through (e) or in paragraph (g)(3)(iv) of this section may land scallops, subject to the possession limit specified in § 648.52(a), unless the Regional Administrator has issued a notice that the number of LAGC IFQ access area trips have been or are projected to be taken. The total number of LAGC IFQ trips in a specified Access Area for fishing year 2016 and 2017 are:

    Access area 2016 2017 Mid-Atlantic Access Area 2,068 602 Closed Area 1 0 0 Closed Area 2 0 0 Nantucket Lightship 0 0 Nantucket Lightship North 485 0

    (ii) Scallops landed by each LAGC IFQ vessel on an access area trip shall count against the vessel's IFQ.

    (iii) Upon a determination from the Regional Administrator that the total number of LAGC IFQ trips in a specified Access Area have been or are projected to be taken, the Regional Administrator shall publish notification of this determination in the Federal Register, in accordance with the Administrative Procedure Act. Once this determination has been made, an LAGC IFQ scallop vessel may not fish for, possess, or land scallops in or from the specified Access Area after the effective date of the notification published in the Federal Register.

    (iv) Nantucket Lightship North Sea Scallop Access Area. (A) From March 1, 2016, through February 28, 2018 (i.e., fishing years 2016 and 2017), a vessel issued an LAGC IFQ scallop permit may not fish for, possess, or land scallops in or from the area known as the Nantucket Lightship North Access Area, described in paragraph (g)(3)(iv)(B) of this section, unless the vessel is participating in, and complying with the requirements of, the area access program described in this section or the vessel is transiting pursuant to § 648.59(f). A vessel issued both a NE multispecies permit and an LAGC scallop permit may not fish in an approved SAP under § 648.85 and under multispecies DAS in the scallop access area, unless it complies with restrictions in paragraph (d)(5)(ii)(C) of this section.

    (B) The Nantucket Lightship North Sea Scallop Access Area is defined by straight lines connecting the following points in the order stated (copies of a chart depicting this area are available from the Regional Administrator upon request):

    Point Latitude Longitude NLNAA1 40°50′ N. 69°00′ W. NLNAA2 40°30′ N. 69°00′ W. NLNAA3 40°30′ N. 69°30′ W. NLNAA4 40°50′ N. 69°30′ W. NLNAA1 40°50′ N. 69°00′ W.
    9. In § 648.62, paragraph (b)(1) is revised to read as follows:
    § 648.62 Northern Gulf of Maine (NGOM) Management Program.

    (b) * * *

    (1) NGOM annual hard TACs. The annual hard TAC for the NGOM is 67,454 lb (30,597 kg) for the 2016 fishing year and 70,000 lb (31,413 kg) for the 2017 fishing year.

    [FR Doc. 2016-10439 Filed 5-3-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150430410-6340-02] RIN 0648-BF05 Fisheries of the Exclusive Economic Zone Off Alaska; Western Alaska Community Development Quota Program AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Final rule.

    SUMMARY:

    NMFS issues a final rule to implement Amendment 109 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI FMP). This final rule amends regulations governing the Western Alaska Community Development Quota (CDQ) Program to support increased participation in the groundfish CDQ fisheries (primarily Pacific cod) by catcher vessels less than or equal to 46 feet (ft) (14.0 meters (m)) length overall (LOA) using hook-and-line gear. Specifically, this final rule exempts operators of registered catcher vessels greater than 32 ft (9.8 m) LOA and less than or equal to 46 ft LOA using hook-and-line gear from the requirement to obtain and carry a License Limitation Program (LLP) license when groundfish CDQ fishing. This final rule also reduces observer coverage requirements for catcher vessels less than or equal to 46 ft LOA when groundfish CDQ fishing, and implements new in-season management and catch accounting requirements to properly account for the harvest of groundfish and halibut and the accrual of halibut prohibited species catch in these fisheries. In addition to the regulations necessary to implement Amendment 109, this final rule removes from the regulations a table and some explanatory text that are no longer necessary. This final rule is intended to facilitate increased participation by residents of CDQ communities in the groundfish fisheries in the Bering Sea and Aleutian Islands management area (BSAI), and to support economic development in western Alaska. This final rule also is intended to promote the goals of the CDQ Program, the goals and objectives of the BSAI FMP, the Magnuson-Stevens Fishery Conservation and Management Act, and other applicable laws.

    DATES:

    Effective June 3, 2016.

    ADDRESSES:

    Electronic copies of the Regulatory Impact Review/Environmental Assessment (RIR/EA) and the Initial Regulatory Flexibility Analysis (IRFA) prepared for this action are available from http://www.regulations.gov or from the NMFS Alaska Region Web site at http://alaskafisheries.noaa.gov.

    Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this final rule may be submitted to NMFS Alaska Region, P.O. Box 21668, Juneau, AK 99802, Attn: Ellen Sebastian, Records Officer; in person at NMFS Alaska Region, 709 West 9th Street, Room 420A, Juneau, AK; and by email to [email protected] or faxed to 202-395-5806.

    FOR FURTHER INFORMATION CONTACT:

    Sally Bibb, 907-586-7389.

    SUPPLEMENTARY INFORMATION: Background

    This final rule implements Amendment 109 to the BSAI FMP. NMFS published a notice of availability (NOA) for Amendment 109 in the Federal Register on January 21, 2016 (81 FR 3374), with comments invited through March 21, 2016. The Secretary of Commerce approved Amendment 109 on April 15, 2016, after considering information from the public, and determining that Amendment 109 is consistent with the BSAI FMP, the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), and other applicable law. NMFS published a proposed rule to implement Amendment 109 and the regulatory amendments on February 8, 2016 (81 FR 6489). The comment period on the proposed rule ended on March 9, 2016. NMFS received one letter of comment on proposed Amendment 109 and one letter of comment on the proposed rule. NMFS responds to these comments in the section titled Comments and Responses. No changes were made from the proposed rule in response to these comments. Several minor editorial revisions are made in the amendatory instructions of this final rule to be consistent with two final rules that were implemented since the proposed rule for Amendment 109 was published. These revisions are described in the section titled Changes from the Proposed Rule.

    Summary of Amendment 109

    This section summarizes background information about the CDQ Program and the regulatory constraints on the small catcher vessel hook-and-line halibut and groundfish CDQ fisheries that led the North Pacific Fishery Management Council (Council) to recommend Amendment 109 and this final rule. Additional background is included in the proposed rule (81 FR 6489; February 8, 2016) and is not repeated here.

    The CDQ Program is an economic development program associated with federally managed fisheries in the BSAI. The purpose of the CDQ Program is to provide western Alaska communities with the opportunity to participate and invest in BSAI fisheries, to support economic development in western Alaska, to alleviate poverty and provide economic and social benefits for residents of western Alaska, and to achieve sustainable and diversified local economies in western Alaska. The CDQ Program also is a catch share program that allocates a portion of the BSAI total allowable catch limits for specific target crab and groundfish species, a portion of the commercial catch limits for halibut, and portions of certain prohibited species catch (PSC) limits to the CDQ Program. These amounts are then further allocated among the six CDQ groups as allocations that may be transferred among the CDQ groups. The primary focus of Amendment 109 is on the halibut CDQ allocations, the Pacific cod CDQ allocations, and the halibut PSC in the groundfish CDQ fisheries.

    The successful harvest of CDQ Program allocations is integral to achieving the goals of the CDQ Program and the community development plans of each CDQ group. One of the most effective ways the CDQ groups provide benefits to residents of their CDQ communities is to use the CDQ allocations to create local small-scale commercial fisheries. For purposes of this final rule, “local small-scale” means CDQ fisheries prosecuted by catcher vessels that are less than or equal to 46 ft LOA, using hook-and-line gear, and homeported or operated from CDQ communities. These local small-scale fisheries provide opportunities for residents of the CDQ communities to earn income from the sale of the commercially harvested fish.

    Certain Federal regulations have restricted the ability of fishermen in CDQ communities to harvest allocations of Pacific cod CDQ with small hook-and-line catcher vessels. In particular, requirements for full observer coverage and an LLP license limit the ability of CDQ community fishermen to retain Pacific cod CDQ when participating in the halibut CDQ fisheries or to develop separate local small-scale directed fisheries for Pacific cod CDQ. These regulatory constraints are described in more detail in the preamble to the proposed rule (81 FR 6489; February 8, 2016).

    This final rule amends regulations governing the CDQ Program to support increased participation in the groundfish CDQ fisheries (primarily Pacific cod) by catcher vessels less than or equal to 46 ft LOA using hook-and-line gear as intended by Amendment 109. Specifically, this final rule:

    • Exempts operators of registered catcher vessels greater than 32 ft LOA and less than or equal to 46 ft LOA using hook-and-line gear from the requirement to obtain and carry an LLP license when groundfish CDQ fishing (catcher vessels less than or equal to 32 ft LOA already are exempt from the LLP requirements in the BSAI under existing regulations);

    • Implements new in-season management and catch accounting procedures to properly account for the harvest of groundfish and halibut and the accrual of halibut PSC by operators of catcher vessels less than or equal to 46 ft LOA using hook-and-line gear when halibut or groundfish CDQ fishing;

    • Allows halibut caught by operators of catcher vessels less than or equal to 46 ft LOA using hook-and-line gear when groundfish CDQ fishing to accrue as either halibut CDQ, halibut individual fishing quota (IFQ), or halibut PSC, on a trip-by-trip basis; and

    • Places catcher vessels less than or equal to 46 ft LOA using hook-and-line gear in the partial observer coverage category when they are groundfish CDQ fishing. In addition to these changes for Amendment 109, the final rule removes a table and some explanatory text from observer program regulations at § 679.51(f) that are no longer necessary.

    This final rule is intended to facilitate increased participation by residents of CDQ communities in the BSAI groundfish CDQ fisheries and to support economic development in western Alaska. This final rule benefits the six CDQ groups and the operators of the small hook-and-line catcher vessels that the CDQ groups authorize to fish on their behalf by reducing the costs of participating in the groundfish CDQ fisheries. More information about the Council's and NMFS' rationale for this final rule and its expected impacts are provided in the proposed rule (81 FR 6489; February 8, 2016). The elements of this final rule are summarized in the following section of this preamble.

    The Final Rule LLP Exemption

    Regulations exempting specific vessels from LLP license requirements are codified at § 679.4(k)(2). This final rule adds a new paragraph (vi) to § 679.4(k)(2) to establish an LLP exemption for registered catcher vessels greater than 32 ft LOA and less than or equal to 46 ft LOA using hook-and-line gear when groundfish CDQ fishing. The operators of catcher vessels eligible for the LLP exemption are not required to obtain and carry an LLP license when they are groundfish CDQ fishing provided that certain vessel registration requirements are met prior to groundfish CDQ fishing.

    This final rule adds a new paragraph at § 679.5(m) that includes the vessel registration requirements that must be met to receive an LLP exemption. To receive an LLP exemption, a CDQ group representative must register each eligible catcher vessel through NMFS' online CDQ vessel registration system (“the CDQ vessel registration system”). To successfully register a catcher vessel, the CDQ group representative must log into the CDQ vessel registration system using the CDQ group's existing NMFS ID and password and provide the information required on the computer screen. NMFS will add each catcher vessel successfully registered to the CDQ vessel registration list, and NMFS will post that list on the NMFS Alaska Region Web site at http://alaskafisheries.noaa.gov. The CDQ group representative may add eligible catcher vessels to the CDQ vessel registration list at any time during the groundfish fishing year (January 1 through December 31); there is no deadline for vessel registration with NMFS.

    With each successful registration, the CDQ vessel registration system will provide the CDQ group representative with an LLP exemption letter documenting that the vessel is eligible for the LLP exemption when groundfish CDQ fishing. The CDQ group representative must provide a copy of the LLP exemption letter to the vessel operator. NMFS will not provide the LLP exemption letter directly to vessel operators. The vessel operator must maintain a legible copy of the LLP exemption letter on board the named vessel at all times when that vessel is groundfish CDQ fishing. Because registered vessels must have a legible copy of the LLP exemption letter on board the vessel before the vessel operator starts groundfish CDQ fishing, the CDQ group representative and the vessel operator must allow sufficient time to complete the registration process prior to the start of groundfish CDQ fishing by the vessel.

    The LLP exemption letter also will provide printable confirmation to the CDQ group of a successfully completed vessel registration. Once registered, a vessel will remain on the CDQ vessel registration list until removed by the CDQ group. The CDQ groups are not required to re-register vessels annually.

    A CDQ group representative may remove a vessel from the CDQ vessel registration list at any time by logging into the CDQ vessel registration system and following the applicable instructions. To remove a vessel from the CDQ vessel registration list, the CDQ group representative must certify to NMFS that 1) the vessel operator has been given notice by the CDQ group that the vessel is being removed from the list, and 2) the vessel operator is not groundfish CDQ fishing at the time of removal. The CDQ vessel registration system will provide a printable confirmation that a vessel has been removed from the CDQ vessel registration list. Once a vessel is removed from the CDQ vessel registration list, that vessel is no longer exempt from the LLP requirements, even if the operator still possesses the LLP exemption letter. This final rule does not require a CDQ group representative to remove registered vessels from the CDQ vessel registration list when they are participating in a non-CDQ fishery.

    To further clarify the vessel operator's responsibility, this final rule adds a new prohibition at § 679.7(d)(9) to prohibit the operator of a vessel eligible for the LLP exemption from conducting groundfish CDQ fishing without having a legible copy of the LLP exemption letter issued to a CDQ group for that vessel on board the vessel. In addition, this final rule adds a new prohibition at § 679.7(d)(10) to prohibit a CDQ group representative from removing a vessel from the CDQ vessel registration list without first providing notice to the operator of the registered vessel that the vessel is being removed from the CDQ vessel registration list, or when the vessel is groundfish CDQ fishing.

    Catch Accounting and Fishery Monitoring Requirements

    This final rule adds a new paragraph at § 679.32(c)(3)(iii) to establish the catch accounting and fishery monitoring requirements that apply to catcher vessels less than or equal to 46 ft LOA using hook-and-line gear when groundfish CDQ fishing and to the CDQ groups authorizing these vessels. Current regulations at § 679.32(c)(3)(i)(D) and (c)(3)(ii)(D) will continue to apply to catcher vessels greater than 46 ft LOA using hook-and-line gear when groundfish CDQ fishing.

    This final rule also establishes catch accounting procedures in § 679.32(c)(3)(iii) that provide CDQ groups and vessel operators with the opportunity to retain halibut CDQ or halibut IFQ when groundfish CDQ fishing. If the vessel operator is relying on halibut CDQ from a CDQ group to support the retained catch of legal-size halibut during a fishing trip, the CDQ group must provide adequate halibut CDQ to this vessel operator to account for all the legal-size halibut caught by the vessel during the entire fishing trip. A CDQ group's halibut prohibited species quota (PSQ) will not be reduced if halibut is present in the landing. Landed halibut CDQ or halibut IFQ will accrue to the account balance of the permit holder identified by the processor in the landing report based on the permits held by the vessel operator or persons on board the vessel.

    The operator of a hook-and-line catcher vessel less than or equal to 46 ft LOA who retains any halibut CDQ or halibut IFQ during the groundfish CDQ fishing trip must retain all legal-size halibut caught during that fishing trip. NMFS will continue to consider sub-legal-size halibut as wastage associated with the halibut fishery. As long as at least one halibut (IFQ or CDQ) is included in the groundfish CDQ landing, NMFS will not accrue any estimates of halibut PSC from the small catcher vessel groundfish CDQ fisheries to the CDQ group's halibut PSQ or to any component of the BSAI halibut PSC limit.

    If no halibut are included in a groundfish CDQ landing, NMFS will accrue an estimate of halibut PSC to the CDQ group's small catcher vessel halibut PSC limit (described below). NMFS will estimate the halibut PSC associated with these types of groundfish CDQ fishing trips using halibut PSC rates as calculated by NMFS, and apply the halibut PSC rates when halibut fishing is closed or when halibut fishing is open but no halibut are included in a landing.

    Under this final rule, NMFS will create a new quota category available to each CDQ group called the “small catcher vessel halibut PSC limit.” If a CDQ group wants to have a small hook-and-line catcher vessel groundfish CDQ fishery, the CDQ group must transfer halibut PSQ from its halibut PSQ to its small catcher vessel halibut PSC limit through a CDQ Transfer Request. The CDQ Transfer Request requirements are described under § 679.5(n). CDQ groups that do not want to have a local small-scale groundfish CDQ fishery do not have to transfer any halibut PSQ to this account. Each CDQ group will, in collaboration with NMFS, decide the appropriate amount of halibut PSQ to transfer to the small catcher vessel halibut PSC limit based on the amount of groundfish CDQ it wants to allocate to its small hook-and-line catcher vessel groundfish CDQ fishery and the expected use of halibut PSC in that fishery.

    With the exception of sablefish CDQ fishing, which will continue to be managed under § 679.32(c)(1), this final rule will prohibit groundfish CDQ fishing by catcher vessels less than or equal to 46 ft LOA using hook-and-line gear unless NMFS publishes notification in the Federal Register authorizing a CDQ group to conduct such fishing. In deciding whether to authorize groundfish CDQ fishing by these vessels, NMFS will consider whether a CDQ group has sufficient halibut in its small catcher vessel halibut PSC limit to support groundfish CDQ fishing by these catcher vessels.

    If NMFS determines that a CDQ group's small catcher vessel halibut PSC limit has been or will be reached, NMFS will issue a notice in the Federal Register prohibiting groundfish CDQ fishing by the small hook-and-line catcher vessels fishing for that CDQ group. NMFS will be responsible for issuing fishing closures to the small hook-and-line catcher vessel groundfish CDQ fisheries to maintain halibut PSC by these vessels within the small catcher vessel halibut PSC limit established by a CDQ group. NMFS will manage these fisheries to stay within the applicable CDQ groups' halibut PSC amount to the best of its ability, and will manage the small hook-and-line catcher vessel groundfish CDQ fishery conservatively to ensure that these PSC limits are not exceeded.

    Even with conservative management, it is possible that a small catcher vessel halibut PSC limit could be exceeded due to the high degree of variability in halibut PSC rates that can occur in hook-and-line fisheries. If NMFS is unable to close a CDQ group's small catcher vessel groundfish CDQ fishery before it exceeds the amount of halibut PSC allocated to the small catcher vessel halibut PSC limit, NMFS will not consider this a violation, and NMFS will not require the CDQ group to transfer an amount of halibut PSQ needed to cover the negative balance. However, this final rule will allow a CDQ group to voluntarily choose to transfer additional halibut PSQ to bring the balance of its small catcher vessel halibut PSC limit to zero.

    If a CDQ group's small catcher vessel halibut PSC limit has a negative balance at the end of the groundfish fishing year (December 31), and if the CDQ group has remaining halibut PSQ on that date, NMFS will transfer an amount of halibut PSQ into the CDQ group's small catcher vessel halibut PSC limit to bring the balance of the small catcher vessel halibut PSC limit to zero. NMFS will make this administrative transfer only after all fishing by a CDQ group is completed for the year, after data from the fishing year is finalized, and if the CDQ group has sufficient remaining halibut PSQ.

    This final rule also will permit a CDQ group to transfer halibut from its small catcher vessel halibut PSC limit back to the CDQ group's halibut PSQ. In reviewing a request to transfer halibut from the small catcher vessel halibut PSC limit back to the CDQ group's halibut PSQ, NMFS will consider the status of CDQ fisheries through the end of the year and anticipated halibut PSC rates for any remaining groundfish CDQ fishing by vessels managed under the small catcher vessel halibut PSC limit for the requesting CDQ group.

    Observer Coverage

    This final rule adds paragraph (a)(1)(i)(D) to § 679.51 and revises § 679.51(a)(2)(i)(C)(2) to place catcher vessels less than or equal to 46 ft LOA that are using hook-and-line gear when groundfish CDQ fishing in the partial observer coverage category. Under current regulations, the owners or operators of vessels in the partial observer coverage category are placed in an observer selection pool based on the requirements of the Annual Deployment Plan (ADP). Since implementation of the ADP process in 2013, vessels less than 40 ft (12.2 m) LOA have been placed in the “no selection pool.” These vessels are not required to carry observers or register fishing trips with NMFS. Vessels 40 ft LOA or greater are in the “trip selection pool” and must log all of their fishing trips in the Observer Declare and Deploy System (ODDS). This is an online system for registering fishing trips and receiving information about whether a particular trip is selected for observer coverage. If selected for observer coverage, the catcher vessel is required to carry an observer. Operators of vessels selected for observer coverage are required to comply with all vessel responsibilities in § 679.51(e)(1). More information about logging trips in ODDS is on the NMFS Alaska Region Web site under “Frequently Asked Questions” about the Observer Program (http://alaskafisheries.noaa.gov/sustainablefisheries/observers/).

    Other Regulatory Change

    This final rule removes the table in § 679.51(f) that summarizes the observer coverage requirements for different management programs and industry sectors, and the introductory text about the table that is at the beginning of § 679.51. Prior to Observer Program Restructuring (77 FR 70062, November 21, 2012), this table was located at the beginning of subpart E as a table of contents or guide to observer coverage requirements. However, with the reorganization of observer coverage requirements in 2012 and the placement of this table at the end of § 679.51, it no longer serves its previous function as a table of contents for the section. Therefore, this table is removed.

    Comments and Responses

    During the public comment periods for the NOA for Amendment 109 and the proposed rule to implement Amendment 109, NMFS received one letter of comment on the NOA and one letter of comment on the proposed rule. Both of these letters were from one member of the public. NMFS' responses to these comments are presented below.

    Comment 1: Both letters of comment expressed concern about overfishing and opposition to the overall management of the BSAI groundfish fisheries, including allocations to the CDQ Program to support economic development in Western Alaska and any regulations to increase participation in the CDQ fisheries.

    Response: This final rule does not change the overall harvest levels or allocations in the BSAI groundfish fisheries, or the total amount of groundfish, halibut, or PSC allocated to the CDQ Program. Therefore, the comments expressing concern about overfishing, or expressing opposition about the overall management of the BSAI groundfish fisheries are outside of the scope of the NOA and proposed rule. As for the comments in opposition to increased participation in the CDQ Program, NMFS supports the Council's and CDQ groups' efforts to increase participation in the CDQ fisheries by owners and operators of small catcher vessels using hook-and-line gear. Participation in the CDQ Program by small, local fishing fleets is consistent with the goals and objectives of the CDQ Program in the Magnuson-Stevens Act and the BSAI FMP. Any increased participation by small, local hook-and-line catcher vessels in the groundfish CDQ fisheries will be conducted within the existing allocations to the CDQ Program and to the CDQ groups, and within other applicable conservation and management regulations.

    Changes From the Proposed Rule

    The paragraph numbers for two additions to prohibitions at § 679.7(d) are renumbered from paragraphs (d)(8) and (d)(9) to paragraphs (d)(9) and (d)(10), respectively, because a new paragraph (d)(8) was recently added to § 679.7 under the cost recovery program final rule (81 FR 150, January 5, 2016).

    The final rule includes three revisions to § 679.51(a)(1)(i) to insert additional punctuation and make minor wording changes (moving placement of the word “or”) to the list of vessels that are in the partial observer coverage category. These minor changes are needed to reflect the addition of paragraph (a)(1)(i)(C) in § 679.51 through the final rule for Amendment 112 to the BSAI FMP and Amendment 102 to the Fishery Management Plan for Groundfish of the Gulf of Alaska (81 FR 17403; March 29, 2016).

    Classification

    The Administrator, Alaska Region, NMFS, determined that Amendment 109 and this final rule are necessary for the conservation and management of the BSAI groundfish fisheries and that they are consistent with the Magnuson-Stevens Act and other applicable law.

    Regulations governing the U.S. fisheries for Pacific halibut are developed by the International Pacific Halibut Commission (IPHC), the Pacific Fishery Management Council, the North Pacific Fishery Management Council (Council), and the Secretary of Commerce. Section 5 of the Northern Pacific Halibut Act of 1982 (Halibut Act, 16 U.S.C. 773c) allows the Regional Council having authority for a particular geographical area to develop regulations governing the allocation and catch of halibut in U.S. Convention waters as long as those regulations do not conflict with IPHC regulations. The final rule is consistent with the Council's authority to allocate halibut catches among fishery participants in the waters in and off Alaska.

    This final rule has been determined to be not significant for purposes of Executive Order 12866.

    Small Entity Compliance Guide

    Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a final regulatory flexibility analysis, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. The preamble to the proposed rule (81 FR 6489; February 8, 2016) and the preamble to this final rule serve as the small entity compliance guide. This rule does not require any additional compliance from small entities that is not described in the preamble to the proposed rule and this final rule. Copies of the proposed rule and this final rule are available from NMFS at the following Web site: http://alaskafisheries.noaa.gov.

    Final Regulatory Flexibility Analysis (FRFA)

    Section 604 of the Regulatory Flexibility Act (RFA) requires an agency to prepare a FRFA after being required by that section or any other law to publish a general notice of proposed rulemaking and when an agency promulgates a final rule under section 553 of Title 5 of the U.S. Code. The following paragraphs constitute the FRFA for this action.

    Section 604 describes the required contents of a FRFA: (1) A statement of the need for, and objectives of, the rule; (2) a statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments; (3) the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments; (4) a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available; (5) a description of the projected reporting, recordkeeping, and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and (6) a description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.

    Need for and Objectives of the Rule

    A description of the need for, and objectives of, the rule is contained in the preamble to the proposed rule and this final rule and is not repeated here. This FRFA incorporates the Initial Regulatory Flexibility Analysis (IRFA) (see ADDRESSES) and the summary of the IRFA in the proposed rule (81 FR 6489; February 8, 2016).

    Summary of Significant Issues Raised During Public Comment

    NMFS published a proposed rule to implement Amendment 109 and the regulatory amendments on February 8, 2016 (81 FR 6489). An IRFA was prepared and summarized in the Classification section of the preamble to the proposed rule. The comment period on the proposed rule ended on March 9, 2016. NMFS received one letter of comment on the proposed rule. This letter did not address the IRFA or the economic impacts of the rule more generally. The Chief Counsel for Advocacy of the Small Business Administration did not file any comments on the proposed rule.

    Number and Description of Small Entities Regulated by the Action

    This final rule will directly regulate two classes of small entities: (1) The six CDQ groups, which are non-profit corporations that represent the 65 western Alaska communities that are eligible to participate in the CDQ Program; and (2) the owners and operators of small hook-and-line catcher vessels who are authorized by a CDQ group to harvest groundfish or halibut CDQ allocations.

    The RFA recognizes and defines three kinds of small entities: (1) Small businesses, (2) small non-profit organizations, and (3) small government jurisdictions. The CDQ groups are considered small entities due to their status as non-profit corporations. The Small Business Administration has established size standards for all major industry sectors in the United States. A business primarily involved in finfish harvesting is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual gross receipts not in excess of $20.5 million, for all its affiliated operations worldwide.

    It is difficult to predict how many small hook-and-line catcher vessels may participate in the future under this final rule because no catcher vessels less than or equal to 46 ft LOA using hook-and-line gear currently are conducting directed fishing for groundfish CDQ. The best estimate of the upper bound of the number of future participants in the small catcher vessel Pacific cod CDQ fisheries is the maximum of 278 vessels less than or equal to 46 ft LOA that participated in the halibut CDQ fisheries from 2000 through 2013. NMFS assumes that all of the vessels that could be directly regulated by this action would be small entities based on estimated revenues of less than $20.5 million for all vessels and their known affiliations.

    Recordkeeping, Reporting, and Other Compliance Requirements

    This final rule contains three new reporting and recordkeeping requirements that affect small entities. First, each CDQ group that authorizes catcher vessels greater than 32 ft LOA and less than or equal to 46 ft LOA using hook-and-line gear to fish for groundfish CDQ with an exemption from the LLP must register the vessel in an online CDQ vessel registration system developed and maintained by NMFS. All six CDQ groups will be subject to the vessel registration requirement if they have vessels participating.

    Second, the operator of any registered catcher vessels greater than 32 ft LOA and less than or equal to 46 ft LOA using hook-and-line gear that is exempt from the LLP license requirements must maintain a legible copy of an LLP exemption letter on board the vessel at all times when groundfish CDQ fishing. The LLP exemption letter is generated through the CDQ vessel registration system when a CDQ group registers an eligible vessel. The CDQ group representative must provide this letter to the registered vessel operator. Depending on the level of participation, all six CDQ groups and all vessel operators could be subject to this requirement.

    Third, small catcher vessels fishing for groundfish CDQ under this final rule will be placed in the partial observer coverage category. Vessels subject to observer coverage are determined annually through the Observer Program's ADP. Since inception of the ADP process in 2013, vessels less than 40 ft LOA have been placed in the “no selection pool” and have had no additional reporting or recordkeeping requirements. Vessels 40 ft LOA or greater are in the “trip selection pool” and must log all of their fishing trips in ODDS. This is an online system for registering fishing trips and receiving information about whether a particular trip is selected for observer coverage.

    Vessels between 40 ft LOA and 46 ft LOA already log their halibut CDQ and halibut IFQ fishing trips in ODDS. Therefore, if these vessels are combining groundfish CDQ fishing with halibut CDQ or halibut IFQ fishing, they will not incur any additional reporting requirements associated with placement in the partial observer coverage category because the halibut trips already are in partial observer coverage. However, if any of these vessels start fishing for groundfish CDQ separate from their halibut CDQ or halibut IFQ fishing trips, then those additional fishing trips must be logged in ODDS. The cost of logging trips in ODDS represents an additional cost associated with the new small catcher vessel groundfish CDQ fisheries.

    Description of Significant Alternatives to the Final Action That Minimize Adverse Impacts on Small Entities

    The RFA requires identification of any significant alternatives to the final rule that would accomplish the stated objectives of the proposed action, consistent with applicable statutes, and that would minimize any significant economic impact of the proposed rule on small entities. As noted in the IRFA, this final rule is expected to create a net benefit for the directly regulated small entities. The benefits of this action are expected to outweigh the reporting, recordkeeping, and other compliance costs described in the previous section.

    The Council considered a status quo alternative (Alternative 1), and two action alternatives (Alternatives 2 and 3) in addition to this final rule (which was Alternative 4, the Council's preferred alternative). Neither Alternative 2 nor 3 would have provided more benefits to the directly regulated small entities or reduced reporting, recordkeeping, or compliance costs more than the preferred alternative that is implemented by this final rule.

    Under Alternative 2, the maximum retainable amount (MRA) of Pacific cod in the halibut CDQ fisheries would have been increased so the operators of the small hook-and-line vessels could retain more Pacific cod when halibut CDQ fishing and still be considered directed fishing for halibut rather than directed fishing for Pacific cod. Alternative 2 was considered because the more costly LLP license requirements, observer coverage requirements, and vessel monitoring system (VMS) requirements do not apply to vessels halibut CDQ fishing in the BSAI (except that the VMS requirements apply to vessels halibut fishing in the Aleutian Islands). Increasing the MRAs for Pacific cod when halibut CDQ fishing would allow the small vessels to retain more Pacific cod without triggering requirements that apply to vessels directed fishing for Pacific cod. The Council did not select Alternative 2 because this final rule accomplishes a similar outcome to Alternative 2 without creating a situation where vessels with the same catch composition are defined as fishing for halibut in the CDQ fisheries and fishing for Pacific cod in the non-CDQ fisheries. Also, Alternative 2 would have increased monitoring and enforcement costs relative to this final rule.

    Alternative 3 would have created a new type of LLP license specific to the small CDQ vessels in contrast to this final rule which provides an exemption to the LLP. However, Alternative 3 would not have resulted in a reduction in reporting, recordkeeping, and compliance costs in comparison to this final rule. Issuing a new CDQ LLP license would have required applications to NMFS and the issuance of a CDQ LLP license with certain conditions. Alternative 3 would have increased costs relative to this final rule.

    Collection-of-Information Requirements

    This final rule contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA) which have been approved by the Office of Management and Budget (OMB) under control numbers 0648-0269, 0648-0318, and 0648-0334. The information collections are presented by OMB control number.

    OMB Control No. 0648-0269

    Public reporting burden for CDQ Vessel Registration to add or remove vessels online that are exempt from the LLP license requirements is estimated to average five minutes per individual response and five minutes for maintenance of the LLP exemption letter on board a vessel that is groundfish CDQ fishing.

    The Groundfish/Halibut CDQ and Prohibited Species Quota (PSQ) Transfer Request is mentioned in this final rule, but no changes occur in the individual response for each requirement.

    OMB Control No. 0648-0318

    The Observer Declare and Deploy System is mentioned in this final rule, but the individual response for each requirement is not changed.

    OMB Control No. 0648-0334

    The individual response for each requirement of the LLP mentioned in this final rule is not changed.

    These estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding these burden estimates or any other aspect of these collections, including suggestions for reducing the burden, to NMFS (see ADDRESSES), and by email to [email protected], or fax to 202-395-5806.

    Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at: http://www.cio.noaa.gov/services_programs/prasubs.html.

    List of Subjects in 50 CFR Part 679

    Alaska, Fisheries, Reporting and recordkeeping requirements.

    Dated: April 28, 2016. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 679 is amended as follows:

    PART 679—FISHERIES OF THE EXCLUSIVE ECONOMIC ZONE OFF ALASKA 1. The authority citation for part 679 continues to read as follows: Authority:

    16 U.S.C. 773 et seq.; 1801 et seq.; 3631 et seq.; Pub. L. 108-447; Pub. L. 111-281.

    2. In § 679.4: a. In paragraph (k)(2)(iv), remove the words “license; or” and add in their place “license;” and in paragraph (k)(2)(v), remove “Area.” and add in its place “Area; or”; and b. Add paragraph (k)(2)(vi).

    The addtion reads as follows:

    § 679.4 Permits.

    (k) * * *

    (2) * * *

    (vi) The operator of a catcher vessel that is greater than 32 ft (9.8 m) LOA, that does not exceed 46 ft (14.0 m) LOA, and that is registered by a CDQ group following the procedures described in § 679.5(m) may use hook-and-line gear to conduct groundfish CDQ fishing without a groundfish license.

    3. In § 679.5, add paragraph (m) to read as follows:
    § 679.5 Recordkeeping and reporting (R&R).

    (m) CDQ Vessel Registration—(1) Registration. The representative for a CDQ group must register each vessel that is to receive the exemption from the LLP license requirements at § 679.4(k)(2)(vi) through the CDQ vessel registration system available on the NMFS Alaska Region Web site (http://alaskafisheries.noaa.gov). The CDQ group representative must log into the CDQ vessel registration system and provide the information required on the computer screen. NMFS will add each vessel successfully registered to the CDQ vessel registration list on the NMFS Alaska Region Web site at http://alaskafisheries.noaa.gov.

    (2) Responsibility. The CDQ group representative must successfully complete vessel registration through the CDQ vessel registration system before the vessel may be used to conduct groundfish CDQ fishing under § 679.32(c)(3)(iii) without an LLP license. By using the CDQ group's NMFS ID and password and submitting the vessel registration request, the CDQ group representative certifies that all information is true, correct, and complete.

    (3) LLP exemption letter. The CDQ vessel registration system will provide the CDQ group representative with an LLP exemption letter documenting that the registered vessel is exempt from the LLP when groundfish CDQ fishing. The CDQ group representative must provide a copy of the LLP exemption letter to the operator of the registered vessel named in the LLP exemption letter. The operator of the registered vessel named in the LLP exemption letter must maintain a legible copy of the LLP exemption letter on board the registered vessel at all times when that vessel is groundfish CDQ fishing.

    (4) Removing a vessel from the CDQ vessel registration list. A CDQ group representative may remove a vessel from the CDQ vessel registration system by logging into the online system and following the applicable instructions. A CDQ group representative may remove a registered vessel from the CDQ vessel registration list at any time but must certify at the time of removal that the vessel operator had been given notice by the CDQ group that the vessel is going to be removed from the list and that the vessel is not groundfish CDQ fishing at the time of removal. A vessel that is successfully removed from the CDQ vessel registration list is no longer exempt from the LLP requirements under § 679.4(k).

    4. In § 679.7, add paragraphs (d)(9) and (10) to read as follows:
    § 679.7 Prohibitions.

    (d) * * *

    (9) For an operator of a catcher vessel greater than 32 ft (9.8 m) LOA and less than or equal to 46 ft (14.0 m) LOA using hook-and-line gear and that is registered by a CDQ group under § 679.5(m), to conduct groundfish CDQ fishing without a legible copy of the LLP exemption letter issued to a CDQ group for that vessel on board the vessel.

    (10) For a CDQ group representative, to remove a vessel from the CDQ vessel registration list under § 679.5(m)(4) without first providing notice to the operator of the registered vessel that the vessel is being removed from the CDQ vessel registration list or when the vessel operator is groundfish CDQ fishing.

    5. In § 679.32, add a new first sentence to paragraphs (c)(3)(i)(D) and (c)(3)(ii)(D) and add paragraph (c)(3)(iii) to read as follows:
    § 679.32 Groundfish and halibut CDQ catch monitoring.

    (c) * * *

    (3) * * *

    (i) * * *

    (D) Observed catcher vessels using nontrawl gear. This paragraph applies to all observed catcher vessels using nontrawl gear, except those catcher vessels regulated under paragraph (c)(3)(iii) of this section. * * *

    (ii) * * *

    (D) Observed catcher vessels using nontrawl gear. This paragraph applies to all observed catcher vessels using nontrawl gear, except those catcher vessels regulated under paragraph (c)(3)(iii) of this section. * * *

    (iii) Groundfish CDQ fishing by catcher vessels less than or equal to 46 ft LOA using hook-and-line gear—(A) Applicability. Regulations in this paragraph apply to the operators of catcher vessels less than or equal to 46 ft (14.0 m) LOA using hook-and-line gear when groundfish CDQ fishing and to the CDQ groups authorizing the operators of these vessels to harvest groundfish CDQ or halibut CDQ.

    (B) Halibut CDQ or halibut IFQ. If any halibut CDQ or halibut IFQ are retained during a fishing trip on board a vessel described in paragraph (c)(3)(iii)(A) of this section, the following requirements apply:

    (1) The vessel operator must retain all legal-size halibut caught during that entire fishing trip.

    (2) The vessel operator must have sufficient halibut IFQ or halibut CDQ available to account for the catch of all legal-size halibut caught during the entire fishing trip.

    (3) If the vessel operator is relying on halibut CDQ from a CDQ group to support the retained catch of legal-size halibut during a fishing trip, the CDQ group must provide adequate halibut CDQ to this vessel operator to account for all of the legal-size halibut caught by the vessel during the entire fishing trip.

    (C) Halibut PSC. If halibut CDQ or halibut IFQ are not retained during a fishing trip on board a vessel described in paragraph (c)(3)(iii)(A) of this section, the following requirements apply:

    (1) The vessel operator must discard all halibut caught during the fishing trip.

    (2) Small catcher vessel halibut PSC limit. The CDQ group representative may transfer halibut from a CDQ group's halibut PSQ to its small catcher vessel halibut PSC limit. To do so, the CDQ representative must submit a transfer request using the procedures described in § 679.5(n). In reviewing a request to transfer halibut PSQ to a CDQ group's small catcher vessel halibut PSC limit, NMFS will consider whether the amount of halibut to be transferred to the small catcher vessel halibut PSC limit is sufficient to support groundfish CDQ fishing by the catcher vessels that the CDQ group plans to authorize to conduct groundfish CDQ fishing. The transfer is not effective until approved by NMFS. The CDQ group representative also may transfer halibut from a CDQ group's small catcher vessel halibut PSC limit back to its halibut PSQ by submitting a transfer request using the procedures described in § 679.5(n). In reviewing a request to transfer halibut from the small catcher vessel halibut PSC limit back to the CDQ group's halibut PSQ, NMFS will consider the status of CDQ fisheries through the end of the year and anticipated halibut PSC rates for any remaining groundfish CDQ fishing by vessels managed under the small catcher vessel halibut PSC limit for the requesting CDQ group.

    (3) Fishery closures. Directed fishing for groundfish CDQ, except sablefish CDQ managed under paragraph (c)(1) of this section, by catcher vessels less than or equal to 46 ft LOA using hook-and-line gear is prohibited unless the Regional Administrator publishes notification in the Federal Register authorizing such directed fishing. In deciding whether to authorize directed fishing, NMFS will consider whether a CDQ group has sufficient halibut in its small catcher vessel halibut PSC limit to support directed fishing for groundfish CDQ by these catcher vessels. Upon determining that a CDQ group's small catcher vessel halibut PSC limit has been or will be reached, the Regional Administrator will publish notification in the Federal Register prohibiting directed fishing for all groundfish CDQ species, except sablefish CDQ, by catcher vessels less than or equal to 46 ft LOA using hook-and-line gear fishing for that CDQ group. If the estimated halibut PSC by vessels described in paragraph (c)(3)(iii)(A) of this section exceeds the balance of the small catcher vessel halibut PSC limit on December 31 of any year, and if the CDQ group has remaining halibut PSQ on that date, NMFS will transfer an amount of halibut PSQ into the CDQ group's small catcher vessel halibut PSC limit to bring the balance of the small catcher vessel halibut PSC limit to zero. NMFS will make the determination about whether such an administrative transfer is necessary after data from the fishing year is finalized.

    6. In § 679.51: a. Remove the introductory text; b. In paragraphs (a)(1)(i)(A) and (B) remove “or” and in paragraph (a)(1)(i)(C) remove the period and add in its place “; or”; c. Add paragraph (a)(1)(i)(D); d. Revise paragraph (a)(2)(i)(C)(2); and e. Remove paragraph (f).

    The addition and revision read as follows:

    § 679.51 Observer requirements for vessels and plants.

    (a) * * *

    (1) * * *

    (i) * * *

    (D) A catcher vessel less than or equal to 46 ft LOA using hook-and-line gear when groundfish CDQ fishing under § 679.32(c)(3)(iii).

    (2) * * *

    (i) * * *

    (C) * * *

    (2) Using trawl gear or hook-and-line gear when groundfish CDQ fishing (see § 679.2), except for catcher vessels less than or equal to 46 ft LOA using hook-and-line gear when groundfish CDQ fishing under § 679.32(c)(3)(iii); or

    [FR Doc. 2016-10356 Filed 5-3-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150818742-6210-02] RIN 0648-XE604 Fisheries of the Economic Exclusive Zone Off Alaska; Deep-Water Species Fishery by Vessels Using Trawl Gear in the Gulf of Alaska AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS is prohibiting directed fishing for species that comprise the deep-water species fishery by vessels using trawl gear in the Gulf of Alaska (GOA). This action is necessary because the second seasonal apportionment of the Pacific halibut bycatch allowance specified for the deep-water species fishery in the GOA has been reached.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), April 30, 2016, through 1200 hours, A.l.t., May 15, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Josh Keaton, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (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 second seasonal apportionment of the Pacific halibut bycatch allowance specified for the deep-water species fishery in the GOA is 256 metric tons as established by the final 2016 and 2017 harvest specifications for groundfish of the GOA (81 FR 14740, March 18, 2016), for the period 1200 hours, A.l.t., April 1, 2016, through 1200 hours, A.l.t., July 1, 2016.

    In accordance with § 679.21(d)(6)(i), the Administrator, Alaska Region, NMFS, has determined that the second seasonal apportionment of the Pacific halibut bycatch allowance specified for the trawl deep-water species fishery in the GOA has been reached. Consequently, NMFS is prohibiting directed fishing for the deep-water species fishery by vessels using trawl gear in the GOA. The species and species groups that comprise the deep-water species fishery include sablefish, rockfish, deep-water flatfish, rex sole, and arrowtooth flounder. This closure does not apply to fishing by vessels participating in the cooperative fishery in the Rockfish Program for the Central GOA.

    After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

    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) as such 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 closure of the deep-water species fishery by vessels using trawl gear in the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of April 28, 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.

    This action is required by § 679.21 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: April 29, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-10444 Filed 4-29-16; 4:15 pm] BILLING CODE 3510-22-P
    81 86 Wednesday, May 4, 2016 Proposed Rules DEPARTMENT OF ENERGY 10 CFR Part 431 [Docket Number EERE-2013-BT-STD-0030] RIN 1904-AD01 Energy Conservation Program: Energy Conservation Standards for Commercial Packaged Boilers AGENCY:

    Office of Energy Efficiency and Renewable Energy, Department of Energy.

    ACTION:

    Extension of public comment period.

    SUMMARY:

    On March 24, 2016, the U.S. Department of Energy (DOE) published in the Federal Register a notice of proposed rulemaking (NOPR) for commercial packaged boiler energy conservation standards. This document announces an extension of the public comment period for submitting comments on the NOPR or any other aspect of the rulemaking for commercial packaged boilers. The comment period is extended to June 22, 2016.

    DATES:

    The comment period for the proposed rule published on March 24, 2016 (81 FR 15836), is extended. DOE will accept comments, data, and information regarding this rulemaking received no later than June 22, 2016.

    ADDRESSES:

    Interested persons may submit comments, identified by docket number EERE-2013-BT-STD-0030 and/or Regulation Identifier Number (RIN) 1904-AD01, by any of the following methods:

    Federal eRulemaking Portal: www.regulations.gov. Follow the instructions for submitting comments.

    Email: [email protected]. Include the docket number EERE-2013-BT-STD-0030 and/or RIN 1904-AD01 in the subject line of the message.

    Mail: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Program, Mailstop EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. If possible, please submit all items on a compact disc (CD), in which case it is not necessary to include printed copies. [Please note that comments and CDs sent by mail are often delayed and may be damaged by mail screening processes.]

    Hand Delivery/Courier: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Program, 950 L'Enfant Plaza SW., Suite 600, Washington, DC 20024. Telephone (202) 586-2945. If possible, please submit all items on CD, in which case it is not necessary to include printed copies.

    Docket: The docket is available for review at www.regulations.gov, including Federal Register notices, framework documents, public meeting attendee lists and transcripts, comments, and other supporting documents/materials. All documents in the docket are listed in the www.regulations.gov index. However, not all documents listed in the index may be publicly available, such as information that is exempt from public disclosure.

    The rulemaking Web page can be found at: https://www1.eere.energy.gov/buildings/appliance_standards/standards.aspx?productid=8The Web page contains a link to the docket for this notice on the regulation.gov site. The www.regulations.gov Web page contains instructions on how to access all documents in the docket, including public comments.

    FOR FURTHER INFORMATION CONTACT:

    Mr. James Raba, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-8654. Email: [email protected]

    In the Office of the General Counsel, contact Mr. Peter Cochran, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-9496. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    On March 24, 2016, DOE published in the Federal Register a notice of proposed rulemaking (NOPR) for Commercial Packaged Boilers. 81 FR 15836. The notice provided for submitting written comments, data, and information by May 23, 2016. DOE has received three requests to suspend the rulemaking until DOE completes a companion rulemaking addressing test procedures for commercial package boilers. (See: AHRI, No. 51, Laclede, No. 52, and AGA/APGA, No. 53). At this time, DOE denies the request to suspend the rulemaking for an undefined period of time, as requested. However, in oral comments at the April 21 public meeting regarding proposed energy conservation standards, a representative from the Air-Conditioning, Heating, & Refrigeration Institute (AHRI) requested an extension of the comment period for the NOPR, if DOE did not grant the suspension previously requested. An extension of the comment period would allow additional time for AHRI and other interested parties to examine the data, information, and analysis presented in the Commercial Packaged Boilers Technical Support Document, gather any additional data and information to address the proposed standards, and submit comments to DOE. The TSD can be found at: https://www1.eere.energy.gov/buildings/appliance_standards/standards.aspx?productid=8.

    In view of the alternative request and oral comments presented by AHRI during the April 21 public meeting, DOE has determined that a 30-day extension of the public comment period is appropriate. The comment period would be extended to June 22, 2016.

    Issued in Washington, DC, on April 26, 2016. Kathleen B. Hogan, Deputy Assistant Secretary for Energy Efficiency, Energy Efficiency and Renewable Energy.
    [FR Doc. 2016-10427 Filed 5-3-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6141; Directorate Identifier 2015-NM-048-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 certain The Boeing Model 767 airplanes. This proposed AD was prompted by fuel system reviews conducted by the manufacturer. This proposed AD would require modifying the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. This proposed AD would also provide optional actions for cargo airplanes. We are proposing this AD to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.

    DATES:

    We must receive comments on this proposed AD by June 20, 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-2016-6141.

    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-2016-6141; 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:

    Jon Regimbal, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6506; fax: 425-917-6590; 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-2016-6141; Directorate Identifier 2015-NM-048-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

    The FAA has examined the underlying safety issues involved in fuel tank explosions on several large transport airplanes, including the adequacy of existing regulations, the service history of airplanes subject to those regulations, and existing maintenance practices for fuel tank systems. As a result of those findings, we issued a regulation titled “Transport Airplane Fuel Tank System Design Review, Flammability Reduction and Maintenance and Inspection Requirements” (66 FR 23086, May 7, 2001). In addition to new airworthiness standards for transport airplanes and new maintenance requirements, this rule included Special Federal Aviation Regulation No. 88 (“SFAR 88”), Amendment 21-78. Subsequently, SFAR 88 was amended by: Amendment 21-82 (67 FR 57490, September 10, 2002; corrected at 67 FR 70809, November 26, 2002) and Amendment 21-83 (67 FR 72830, December 9, 2002; corrected at 68 FR 37735, June 25, 2003, to change “21-82” to “21-83”).

    Among other actions, SFAR 88 requires certain type design (i.e., type certificate (TC) and supplemental type certificate (STC)) holders to substantiate that their fuel tank systems can prevent ignition sources in the fuel tanks. This requirement applies to type design holders for large turbine-powered transport airplanes and for subsequent modifications to those airplanes. It requires them to perform design reviews and to develop design changes and maintenance procedures if their designs do not meet the new fuel tank safety standards. As explained in the preamble to the rule, we intended to adopt airworthiness directives to mandate any changes found necessary to address unsafe conditions identified as a result of these reviews.

    In evaluating these design reviews, we have established four criteria intended to define the unsafe conditions associated with fuel tank systems that require corrective actions. The percentage of operating time during which fuel tanks are exposed to flammable conditions is one of these criteria. The other three criteria address the failure types under evaluation: Single failures, combination of failures, and unacceptable (failure) experience. For all three failure criteria, the evaluations included consideration of previous actions taken that may mitigate the need for further action.

    We have determined that the actions identified in this proposed AD are necessary to reduce the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane.

    767 FQIS Design

    The design of the in-tank FQIS components and wiring has the potential for latent faults that could cause arcs, sparks, or resistive heating in the event of a hot short of an FQIS tank circuit to power wiring. The wiring of the FQIS is in some areas cobundled or closely adjacent to power wiring. An ignition source combined with flammable conditions in a center fuel tank could result in ignition of flammable vapor in the fuel tank, causing a structural failure of the wing and inflight breakup of the airplane.

    Under the policy contained in FAA Policy Memo PS-ANM100-2003-112-15 SFAR 88—Mandatory Action Decision Criteria, dated February 25, 2003 (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgPolicy.nsf/0/dc94c3a46396950386256d5e006aed11/$FILE/Feb2503.pdf), the FAA determined that this ignition source risk combined with the fleet average flammability for the center wing tank on most Model 767 airplanes created an unsafe condition for the center fuel tank. Applying that same policy, the FAA determined that, due to a lower fleet average flammability, that same unsafe condition does not exist in the main (wing) tanks of Model 767 airplanes. The FAA has also determined that the unsafe condition does not exist in the center wing tanks of certain Model 767-200 airplanes that do not carry fuel within the center wing structural box. For those Model 767-200 airplanes, the center tank consists of rib bays in the wing root area between the side of the fuselage and the engine nacelles. Those areas are subject to cooling from air flow over the wing in flight, and Boeing has shown that the center fuel tank on those airplanes meets the FAA's definition of a low-flammability fuel tank contained in the policy memo mentioned previously.

    Related Rulemaking

    On March 21, 2016, we issued AD 2016-07-07, Amendment 39-18452 (81 FR 19472, April 5, 2016), for certain Boeing Model 757-200, -200PF, -200CB, and -300 series airplanes. AD 2016-07-07 requires similar actions to those proposed in this NPRM. AD 2016-07-07 addressed the numerous public comments that were submitted on the proposal.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Service Bulletin 767-28-0118, dated July 15, 2014. The service information describes procedures for a BITE check (check of built-in test equipment) of the FQIS. 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 modifying the FQIS to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. As an alternative for cargo airplanes, this proposed AD would provide the option to modify the airplane by separating FQIS wiring routed between the FQIS processor and the center fuel tank, provided repetitive BITE checks (checks of built-in test equipment) of the FQIS are also performed. Refer to the service information identified previously for details on the procedures and compliance times.

    Costs of Compliance

    We estimate that this proposed AD affects 133 airplanes of U.S. registry. This estimate includes 127 cargo airplanes; 4 private, business/corporate/executive, or government airplanes; and 2 experimental airplanes. We estimate the following costs to comply with this proposed AD:

    Estimated Costs—Required Actions Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S. operators
    Modification 1,200 work-hours × $85 per hour = $102,000 $200,000 $302,000 $40,166,000
    Estimated Costs—Alternative Actions Action Labor cost Parts cost Cost per product BITE check 18 work-hours × $85 per hour = $1,530 per check $0 $1,530 per check. Wire separation 230 work-hours × $85 per hour = $19,550 $10,000 $29,550. 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-2016-6141; Directorate Identifier 2015-NM-048-AD. (a) Comments Due Date

    We must receive comments by June 20, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to The Boeing Company Model 767-200, -300, -300F, and -400ER series airplanes, certificated in any category, excluding airplanes identified in paragraphs (c)(1) and (c)(2) of this AD.

    (1) Airplanes on which the center auxiliary tank consists only of the spaces between the side of body rib 0 and rib 3 of the left and right wings (i.e., the wing center structural box is a dry bay and is not part of the fuel tank).

    (2) Airplanes equipped with a flammability reduction means (FRM) approved by the FAA as compliant with the Fuel Tank Flammability Reduction (FTFR) rule (73 FR 42444, July 21, 2008) requirements of section 25.981(b) or section 26.33(c)(1) of the Federal Aviation Regulations (14 CFR 25.981(b) or 14 CFR 26.33(c)(1)).

    (d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

    (e) Unsafe Condition

    This AD was prompted by fuel system reviews conducted by the manufacturer. We are issuing this AD to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.

    (f) Compliance

    Comply with this AD within the compliance times specified, unless already done.

    (g) Modification

    Within 60 months after the effective date of this AD, modify the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions, using a method approved in accordance with the procedures specified in paragraph (i) of this AD.

    (h) Alternative Actions for Cargo Airplanes

    For airplanes used exclusively for cargo operations: As an alternative to the requirements of paragraph (g) of this AD, do the actions specified in paragraphs (h)(1) and (h)(2) of this AD. To exercise this option, operators must perform the first inspection required under paragraph (h)(1) of this AD within 6 months after the effective date of this AD. To exercise this option for airplanes returned to service after conversion of the airplane from a passenger configuration to an all-cargo configuration more than 6 months after the effective date of this AD, operators must perform the first inspection required under paragraph (h)(1) of this AD prior to further flight after the conversion.

    (1) Within 6 months after the effective date of this AD, record the existing fault codes stored in the FQIS processor and then do a BITE check (check of built-in test equipment) of the FQIS, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 767-28-0118, dated July 15, 2014. If any nondispatchable fault code is recorded prior to the BITE check or as a result of the BITE check, before further flight, do all applicable repairs and repeat the BITE check until a successful test is performed with no nondispatchable faults found, in accordance with Boeing Service Bulletin 767-28-0118, dated July 15, 2014. Repeat these actions thereafter at intervals not to exceed 650 flight hours. Modification as specified in paragraph (h)(2) of this AD does not terminate the repetitive BITE check requirement of this paragraph.

    (2) Within 60 months after the effective date of this AD, modify the airplane by separating FQIS wiring that runs between the FQIS processor and the center tank wing spar penetrations, including any circuits that might pass through a main fuel tank, from other airplane wiring that is not intrinsically safe, using methods approved in accordance with the procedures specified in paragraph (i) of this AD.

    (i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle 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) 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, Seattle 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) 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. 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

    For more information about this AD, contact Jon Regimbal, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6506; fax: 425-917-6590; email: [email protected]

    Issued in Renton, Washington, on April 15, 2016. Victor Wicklund, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-09795 Filed 5-3-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6140; Directorate Identifier 2015-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 certain The Boeing Company Model 777 airplanes. This proposed AD was prompted by fuel system reviews conducted by the manufacturer. This proposed AD would require modifying the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. This proposed AD would also provide alternative actions for cargo airplanes. We are proposing this AD to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.

    DATES:

    We must receive comments on this proposed AD by June 20, 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.

    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-2016-6140; 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:

    Jon Regimbal, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6506; fax: 425-917-6590; 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-2016-6140; Directorate Identifier 2015-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

    The FAA has examined the underlying safety issues involved in fuel tank explosions on several large transport airplanes, including the adequacy of existing regulations, the service history of airplanes subject to those regulations, and existing maintenance practices for fuel tank systems. As a result of those findings, we issued a regulation titled “Transport Airplane Fuel Tank System Design Review, Flammability Reduction and Maintenance and Inspection Requirements” (66 FR 23086, May 7, 2001). In addition to new airworthiness standards for transport airplanes and new maintenance requirements, this rule included Special Federal Aviation Regulation No. 88 (“SFAR 88”), Amendment 21-78. Subsequently, SFAR 88 was amended by: Amendment 21-82 (67 FR 57490, September 10, 2002; corrected at 67 FR 70809, November 26, 2002) and Amendment 21-83 (67 FR 72830, December 9, 2002; corrected at 68 FR 37735, June 25, 2003, to change “21-82” to “21-83”).

    Among other actions, SFAR 88 requires certain type design (i.e., type certificate (TC) and supplemental type certificate (STC)) holders to substantiate that their fuel tank systems can prevent ignition sources in the fuel tanks. This requirement applies to type design holders for large turbine-powered transport airplanes and for subsequent modifications to those airplanes. It requires them to perform design reviews and to develop design changes and maintenance procedures if their designs do not meet the new fuel tank safety standards. As explained in the preamble to the rule, we intended to adopt airworthiness directives to mandate any changes found necessary to address unsafe conditions identified as a result of these reviews.

    In evaluating these design reviews, we have established four criteria intended to define the unsafe conditions associated with fuel tank systems that require corrective actions. The percentage of operating time during which fuel tanks are exposed to flammable conditions is one of these criteria. The other three criteria address the failure types under evaluation: Single failures, combination of failures, and unacceptable (failure) experience. For all three failure criteria, the evaluations included consideration of previous actions taken that may mitigate the need for further action.

    We have determined that the actions identified in this proposed AD are necessary to reduce the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane.

    Model 777 FQIS Design

    The design of the in-tank FQIS components and wiring has the potential for latent faults that could cause arcs, sparks, or resistive heating in the event of a hot short of an FQIS tank circuit to power wiring. The wiring of the FQIS is in some areas cobundled or closely adjacent to power wiring. An ignition source combined with flammable conditions in a center fuel tank could result in ignition of flammable vapor in the fuel tank, causing a structural failure of the wing and inflight breakup of the airplane.

    Under the policy contained in FAA Policy Memo PS-ANM100-2003-112-15 (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgPolicy.nsf/0/DC94C3A46396950386256D5E006AED11?OpenDocument&Highlight=sfar), the FAA determined that this ignition source risk combined with the fleet average flammability for the center wing tank on Model 777 airplanes created an unsafe condition for the center fuel tank. Applying that same policy, the FAA determined that, due to a lower fleet average flammability, that same unsafe condition does not exist in the main (wing) tanks of Model 777 airplanes, in the center auxiliary fuel tank of Model 777-200 series airplanes with a center auxiliary fuel tank capacity of less than 12,500 U.S. gallons (i.e, airplanes on which the wing center structural box is a dry bay and is not part of the center fuel tank), or in the body auxiliary tank of Model 777-200LR series airplanes.

    Related Rulemaking

    On March 21, 2016, we issued AD 2016-07-07, Amendment 39-18452 (81 FR 19472, April 5, 2016), for certain Boeing Model 757-200, -200PF, -200CB, and -300 series airplanes. AD 2016-07-07 requires similar actions to those proposed in this NPRM. AD 2016-07-07 addressed the numerous public comments that were submitted on the proposal.

    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 modifying the FQIS to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. As an alternative for cargo airplanes, this proposed AD would provide the alternative to modify the airplane by separating FQIS wiring routed between the FQIS processor and the center fuel tank, provided repetitive BITE checks (checks of built-in test equipment) of the FQIS are also performed.

    Costs of Compliance

    We estimate that this proposed AD affects 187 airplanes of U.S. registry. This estimate includes 29 cargo airplanes. Currently, there are no experimental, private, business/corporate/executive, or government aircraft registered in the United States that would be affected by the proposed airworthiness directive. The 158 affected U.S. air-carrier passenger airplanes are already required by applicable FAA operating regulations to be modified to include flammability reduction measures (FRM), so the proposed AD would not apply to those airplanes. However, to address the potential for those airplanes to be converted to cargo airplanes before the compliance deadline for the operating rule FRM requirement, we provide the following cost estimates to comply with this proposed AD:

    Estimated Costs—Required Actions Action Labor cost Parts cost Cost per
  • product
  • Modification 600 work-hours × $85 per hour = $51,000 $150,000 $201,000
    Estimated Costs—Alternative Actions Action Labor cost Parts cost Cost per product BITE check 1 work-hours × $85 per hour = $85 per check $0 $85 per check. Wire separation 230 work-hours × $85 per hour = $19,550 $10,000 $29,550. 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-2016-6140; Directorate Identifier 2015-NM-059-AD. (a) Comments Due Date

    We must receive comments by June 20, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to The Boeing Company Model 777-200, 777-200LR, 777-300, 777-300ER, and 777F series airplanes, certificated in any category, excluding airplanes identified in paragraphs (c)(1) and (c)(2) of this AD.

    (1) Airplanes on which the center tank consists only of the inboard structural box of the left and right wings (i.e., the wing center structural box is a dry bay and is not part of the fuel tank).

    (2) Airplanes equipped with a flammability reduction means (FRM) approved by the FAA as compliant with the Fuel Tank Flammability Reduction (FTFR) rule (73 FR 42444, July 21, 2008) requirements of section 25.981(b) or section 26.33(c)(1) of the Federal Aviation Regulations (14 CFR 25.981(b) or 14 CFR 26.33(c)(1)).

    (d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

    (e) Unsafe Condition

    This AD was prompted by fuel system reviews conducted by the manufacturer. We are issuing this AD to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.

    (f) Compliance

    Comply with this AD within the compliance times specified, unless already done.

    (g) Modification

    Within 60 months after the effective date of this AD, modify the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions, using a method approved in accordance with the procedures specified in paragraph (i) of this AD.

    (h) Alternative Actions for Cargo Airplanes

    For airplanes used exclusively for cargo operations: As an alternative to the requirements of paragraph (g) of this AD, do the actions specified in paragraphs (h)(1) and (h)(2) of this AD, using methods approved in accordance with the procedures specified in paragraph (i) of this AD. To exercise this alternative, operators must perform the first inspection required under paragraph (h)(1) of this AD within 6 months after the effective date of this AD. To exercise this alternative for airplanes returned to service after conversion of the airplane from a passenger configuration to an all-cargo configuration more than 6 months after the effective date of this AD, operators must perform the first inspection required under paragraph (h)(1) of this AD prior to further flight after the conversion.

    (1) Within 6 months after the effective date of this AD, record the existing fault codes stored in the FQIS processor and then do a BITE check (check of built-in test equipment) of the FQIS. If any nondispatchable fault code is recorded prior to the BITE check or as a result of the BITE check, before further flight, do all applicable repairs and repeat the BITE check until a successful test is performed with no nondispatchable faults found, using a method approved in accordance with the procedures specified in paragraph (i) of this AD. Repeat these actions thereafter at intervals not to exceed 650 flight hours. Modification as specified in paragraph (h)(2) of this AD does not terminate the repetitive BITE check requirement of this paragraph.

    (2) Within 60 months after the effective date of this AD, modify the airplane by separating FQIS wiring that runs between the FQIS processor and the center tank wing spar penetrations, including any circuits that might pass through a main fuel tank, from other airplane wiring that is not intrinsically safe, using methods approved in accordance with the procedures specified in paragraph (i) of this AD.

    (i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle 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) 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, Seattle 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.

    (j) Related Information

    For more information about this AD, contact Jon Regimbal, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6506; fax: 425-917-6590; email: [email protected]

    Issued in Renton, Washington, on April 15, 2016. Victor Wicklund, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-09801 Filed 5-3-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 610 [Docket No. FDA-2016-N-1170] Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Companion to Direct Final Rule AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency or we) is proposing to amend the general biological products standards relating to dating periods and also to remove certain standards relating to standard preparations and limits of potency. FDA is proposing this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This proposed action is part of FDA's retrospective review of its regulations in response to an Executive order.

    DATES:

    Submit either electronic or written comments on this proposed rule or its companion direct final rule by July 18, 2016. If FDA receives any timely significant adverse comments on the direct final rule with which this proposed rule is associated, the Agency will publish a document withdrawing the direct final rule within 30 days after the comment period ends. FDA will apply any significant adverse comments received on the direct final rule to the proposed rule in developing the final rule. FDA will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures.

    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-1170 for “Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products.” 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:

    Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION: I. Executive Summary A. Purpose of the Proposed Rule

    The proposed rule would revise and remove certain general biological products standards, which would update outdated requirements and accommodate new and evolving technology and testing capabilities without diminishing public health protections. FDA is proposing this action because the existing codified requirements are duplicative of requirements that are also specified in biologics license applications (BLAs) or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products.

    B. Summary of the Major Provisions of the Proposed Rule

    This proposed rule would remove the requirements contained in § 610.20 (21 CFR 610.20) from the regulations. FDA is proposing this action because the standard preparations listed in the regulation are obsolete, no longer available, or described on a product specific basis in BLAs. In addition, FDA believes that it would no longer be necessary to restrict the source of standard preparations to the Center for Biologics Evaluation and Research (CBER), since appropriate standard preparations can often be obtained from other sources. Furthermore, FDA is proposing to remove § 610.21 because these potency limits are either obsolete or best described on a product specific basis in the BLA. FDA is proposing to revise § 610.50 to remove references to §§ 610.20 and 610.21 and official potency tests and to reflect FDA's updated approach to establishing dates of manufacture. FDA is proposing to amend § 610.53 to remove products no longer manufactured and products for which dating information is identified in the BLA of each individual product, and to reflect updated practices for the remaining products.

    C. Legal Authority

    FDA is proposing this action under the biological products provisions of the Public Health Service Act (PHS Act), and the drugs and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

    D. Costs and Benefits

    Because this proposed rule would not impose any additional regulatory burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal.

    II. Companion Document to Direct Final Rulemaking

    This proposed rule is a companion to the direct final rule published in the rules section of this issue of the Federal Register. This companion proposed rule provides the procedural framework to finalize the rule in the event that the direct final rule receives any significant adverse comment and is withdrawn. The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. Any comments received in response to this companion proposed rule will also be considered as comments regarding the direct final rule. FDA is publishing the direct final rule because we believe the rule contains noncontroversial changes and there is little likelihood that there will be significant adverse comments opposing the rule.

    A significant adverse comment is defined as a comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants terminating a direct final rulemaking, we will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process. Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. A comment recommending a regulation change in addition to those in the direct final rule would not be considered a significant adverse comment unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to a part of the direct final rule and that part can be severed from the remainder of the rule (e.g., where, as here, a direct final rule deletes several unrelated regulations), we may adopt as final those provisions of the rule that are not the subject of the significant adverse comment.

    If any significant adverse comments to the direct final rule are received during the comment period, FDA will publish, within 30 days after the comment period ends, a document withdrawing the direct final rule. If we withdraw the direct final rule, any comments received will be considered comments on the proposed rule and will be considered in developing a final rule using the usual notice-and-comment procedures.

    If no significant adverse comment is received in response to the direct final rule, no further action will be taken related to this proposed rule. Instead, we will publish a document confirming the effective date within 30 days after the comment period ends. Additional information about direct final rulemaking procedures is set forth in the document entitled “Guidance for FDA and Industry: Direct Final Rule Procedures,” announced and provided in the Federal Register of November 21, 1997 (62 FR 62466). The guidance may be accessed at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.

    III. Background

    On January 18, 2011, President Barack Obama issued Executive Order 13563, “Improving Regulation and Regulatory Review” (76 FR 3821, January 21, 2011). One of the provisions in the Executive Order requires Agencies to consider how best to promote the retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned (76 FR 3821 at 3822). As one step in implementing the Executive Order, FDA published a notice in the Federal Register of April 27, 2011 (76 FR 23520), entitled “Periodic Review of Existing Regulations; Retrospective Review Under E.O. 13563.” In that notice, FDA announced that it was conducting a review of existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of, and support, advances in innovation that have occurred since those regulations took effect. As part of this initiative, FDA is proposing to update outdated regulations as specified in this proposed rule.

    FDA's general biological products standards in part 610 (21 CFR part 610) are intended to help ensure the safety, purity, and potency of biological products administered to humans. The proposed revision and removal of certain general biological products standards are designed to update outdated requirements and accommodate new and evolving manufacturing and control testing technology. The proposed rule provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.

    A. Sections 610.20 and 610.21

    Standard preparations are generally used to perform lot release testing or other specific product characterization assays. Under the current standard preparations, § 610.20, FDA requires specific standard preparations to be used for a small number of the biological products FDA regulates unless a modification is permitted under § 610.9. Specifically, according to current § 610.20 Standard preparations, made available by CBER, are required to be used in the testing of potency or opacity of certain biological products, mostly biological products that were initially licensed several decades ago. Most of these standard preparations requirements are now obsolete, because either CBER no longer provides the listed standard preparations, or the specific biological products are no longer manufactured, or both. In addition, standard preparations to help ensure the safety, purity, and potency of particular biological products can often be obtained from sources other than CBER now, including international sources, or can be developed internally by the applicant. Thus, FDA believes it is no longer necessary to specify CBER as the source of standard preparations in § 610.20. For these reasons, FDA proposes to remove § 610.20. Consistent with current practice and BLAs, CBER will continue to make and supply standard preparations when appropriate, as well as continue to collaborate with external organizations in the development and assessment of physical standard preparations for biological products.

    Under the current § 610.21 Limits of potency, FDA specifies minimal potency limits to be met for the antibodies and antigens listed. However, most of the biological products subject to the specified potency limits are no longer manufactured. In addition, for those that are still manufactured, or for anyone wanting to manufacture the listed products, FDA's updated practice is to have the potency limit also be specified in the BLA. For this reason, FDA proposes to remove § 610.21. As a result of removing §§ 610.20 and 610.21, we are proposing to remove and reserve part 610, subpart C.

    In addition to sometimes being duplicative of information provided in the BLA and unnecessarily restrictive regarding the source of standard preparations, the codification by regulation of many of the standard preparations and limits of potency for certain biological products sometimes does not keep abreast of technological advances in science related to manufacturing and testing. For many years, because of the potential for impeding scientific progress, FDA has not codified additional specific standard preparations and limits of potency for licensed biological products, but instead the standards are established in the BLA. Failure to conform to applicable standards established in the license is grounds for revocation under § 601.5(b)(1)(iv) (21 CFR 601.5(b)(1)(iv)). If the changes proposed in this proposed rule go into effect, FDA will continue to require that each biological product meet standards to assure that the product is safe, pure, and potent, and will continue to require that each lot demonstrate conformance with the standards applicable to that product (see § 610.1) through appropriate testing. Therefore, we expect that standard preparations and potency limits will be established in the BLA and may be changed only in accordance with regulations for reporting post-approval changes (see § 601.12). Furthermore, no lot of any licensed product may be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such product (see § 610.1).

    FDA is therefore proposing to amend its regulations to remove §§ 610.20 and 610.21 because appropriate standard preparations and potency limits for any listed product are specified during the licensing process on a product specific basis. The removal of §§ 610.20 and 610.21 will also increase regulatory flexibility by allowing industry and FDA to more readily use and incorporate current scientific technology and other appropriate reference materials in the manufacture and regulation of licensed biological products.

    B. Sections 610.50 and 610.53

    A biological product is expected to remain stable and retain its identity, strength, quality, and purity for a period of time after manufacture when it is properly stored. The dating period limitations regulations provided at §§ 610.50 and 610.53 specify how the date of manufacture for biological products will be determined, when the dating begins, and dating periods for certain biological products. The existing § 610.50 prescribes how the date of manufacture is determined for biological products and relies in part upon §§ 610.20 and 610.21 or official standards of potency (i.e., a specific test method described in regulation). With the proposed removal of §§ 610.20 and 610.21 for reasons described in this document, and as official potency tests no longer exist, FDA is proposing to revise § 610.50 to reflect FDA's updated approach to establishing dates of manufacture.

    In addition, current § 610.50(b) does not provide FDA or applicants with flexibility to consider the variety of manufacturing situations and technologies that exist today and which may occur in the future. Since 1977, when the regulation was last amended, new methods of manufacture and testing often associated with new biological products have been developed. The proposed revision to § 610.50 would allow additional manufacturing activities other than those currently listed to be used to determine the date of manufacture.

    The proposed regulatory provision would require the date of manufacture to be identified in the approved BLA. FDA recommends that applicants discuss a suitable date of manufacture with FDA during late clinical development and propose a date of manufacture in the BLA. We consider the underlying science and manufacturing process testing methods in determining the date of manufacture for each specific product. The approved BLA would specify how the date of manufacture would be determined. A proposed paragraph, § 610.50(c), would be added, specifying how the date of manufacture for Whole Blood and blood components would be determined. This provision would assist in complying with the dating periods prescribed for Whole Blood and blood components in the proposed table in redesignated § 610.53(b).

    The current table at § 610.53(c) lists dating periods, manufacturer's storage periods, and storage conditions for many biological products. FDA is proposing to revise the current table in § 610.53(c) (which would be redesignated as § 610.53(b)) to remove products where storage conditions and dating periods are established to help ensure the continued safety, potency, and purity of each individual product, based upon information submitted in the relevant BLA. The dating period and storage conditions for these products would be identified in the BLA. FDA is also proposing to revise the current table in § 610.53(c) to delete those products that are no longer manufactured. We are proposing to retain those products, specifically Whole Blood and blood components, whose dating periods are based upon data relating to the anticoagulant or preservative solution in the product, usage, clinical experience, laboratory testing, or further processing. The proposed list has been updated to include currently licensed Whole Blood and blood component products with their applicable storage temperatures and dating periods.

    In listing the dating periods for Whole Blood and blood component products, we took into account existing regulations, guidance documents, package inserts for solutions used for manufacture or storage of Whole Blood and blood components, and operator instruction manuals for devices used in the manufacture of Whole Blood and blood component products. Because we understand from these materials that these dating periods are in current use, and because blood establishments can request an exception under § 640.120 (21 CFR 640.120), we do not anticipate significant objections to codifying this information. Similarly, we are proposing to remove § 610.53(d) because it is duplicative of § 640.120. In addition, we recognize that future scientific understanding and new technology, such as the implementation of pathogen reduction technology or the approval of extended storage systems, could affect what dating periods would be necessary, as a scientific matter, for Whole Blood and blood components. For this reason, the proposed rule would allow for changes to the dating periods specified in proposed § 610.53(b) when the dating period is otherwise specified in the instructions for use by the blood collection, processing, and storage system approved or cleared for such use by FDA.

    In conclusion, the proposed amendments to the regulations are designed to be consistent with updated practices in the biological product industry and to remove unnecessary or outdated requirements. FDA is proposing this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations to provide flexibility without diminishing public health protection. If finalized, FDA does not anticipate that applicants for licensed biological products would need to revise information in BLAs in order to conform to the proposed revised regulations. Applicants must inform the Agency of any change to an approved application in accordance with § 601.12.

    IV. Highlights of the Proposed Rule

    FDA is proposing to revise the general biological products standards relating to dating periods and proposing to remove certain standard preparations and limits of potency. These proposed changes are designed to remove unnecessary or outdated requirements, and accommodate new and evolving technology and testing capabilities without diminishing public health protections.

    FDA is proposing to remove § 610.20 because the standard preparations listed are obsolete or no longer available; standard preparations to ensure the safety, purity, and potency of a product can best be determined on a product specific basis; and standard preparations may be obtained from other sources. Applicants for biological product licenses currently identify standard preparations for the product and purpose (e.g., potency) in the BLA, and the proposed standard preparations are reviewed by FDA during the regulatory process. The standard preparations may include standard preparations developed by the applicant as well as appropriate standard preparations that can be obtained from other sources. Consistent with current practice, CBER will continue to make and supply standard preparations when appropriate, as well as continue to collaborate with external organizations in the development and assessment of physical standard preparations for licensed biological products.

    We are proposing to remove § 610.21 because these potency limits are best described in the BLAs on a product specific basis. Applicants for biological product licenses already identify standards for potency to help ensure the safety, purity, and potency of the product and purpose within their BLA, and the proposed standards are reviewed by FDA during the regulatory process. The use of a potency limit is suitably described in the specific product's BLA and allows for its continued and appropriate use in the absence of § 610.21.

    We are proposing to revise § 610.50 by making a minor amendment to the section heading, removing the current language, redesignating § 610.53(b) as § 610.50(a) with edits, revising § 610.50(b), and adding new § 610.50(c). Current § 610.53(b), which applies to all biological products, would be moved to § 610.50(a) and edits will be made for better organization and clarification. Section 610.50(b) would be revised and § 610.50(c) would be added to clarify how the date of manufacture is set for purposes of determining the dating period for general biological products and for Whole Blood and blood components, respectively.

    We are proposing to amend the section heading of § 610.53 to reflect that it would only address dating periods for Whole Blood and blood components. We are proposing to revise § 610.53(a) since this section would only apply to the dating periods for Whole Blood and blood components. We are proposing to redesignate current § 610.53(c) as § 610.53(b) and revise the text to provide an explanation on using the table and to correspond with 21 CFR 606.121(c)(7). We are proposing to revise the text and table to eliminate those products for which storage periods, storage conditions, and dating periods are better established by data submitted in the BLA, and to delete those products which are no longer manufactured. The dating period and storage conditions for these products would be identified in the BLA. We are proposing to include an updated list of Whole Blood and blood component products with their applicable storage temperatures and dating periods, which are based upon available information, including data relating to the anticoagulant or preservative solution in the product, usage, clinical experience, laboratory testing, or further processing. The proposed table contains a list of storage temperatures and dating periods for Whole Blood and blood components that FDA has reviewed and determined to be necessary to help ensure the safety, potency, and purity of these products. In listing the dating periods for the Whole Blood and blood component products, we took into account existing guidance documents, package inserts for solutions used for manufacture or storage of Whole Blood and blood components, and operator instruction manuals for devices used in the manufacture of Whole Blood and blood component products. We are proposing to redesignate § 610.53(c) as § 610.53(b) and to remove all products regulated by FDA's Center for Drug Evaluation and Research (CDER) from the table. Finally, we are proposing to remove § 610.53(d) because it is duplicative of § 640.120.

    V. Legal Authority

    FDA is issuing this proposed rule under the biological products provisions of the PHS Act (42 U.S.C. 216, 262, 263, 263a, and 264) and the drugs and general administrative provisions of the FD&C Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, and 381). Under these provisions of the PHS Act and the FD&C Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, and potent, and prevent the introduction, transmission, and spread of communicable disease.

    VI. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.

    The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the proposed rule would remove regulations and revise regulations to be consistent with updated practice, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.

    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

    VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.31(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    VIII. Federalism

    We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule does not contain policies 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. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

    IX. Paperwork Reduction Act of 1995

    This proposed rule contains collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collections of information in part 610 have been approved under OMB control number 0910-0338. The proposed removal of § 610.53(d) would impact OMB control number 0910-0338. We would remove § 610.53(d) because it is duplicative of § 640.120, which is also approved under the same collection of information. While there would be no net change in the burden estimate, the current approved collection of information would be updated to reflect this removal. The actions that we propose to take in this proposed rule would not create a substantive or material modification to this approved collection of information. Therefore, FDA tentatively concludes that OMB has already approved the information collection proposed here and the proposed requirements in this document are not subject to additional review by OMB.

    List of Subjects in 21 CFR Part 610

    Biologics, Labeling, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 610 be amended as follows:

    PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS 1. The authority citation for part 610 continues to read as follows: Authority:

    21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.

    Subpart C [Removed and Reserved] 2. Remove and reserve subpart C, consisting of §§ 610.20 and 610.21. 3. Revise § 610.50 to read as follows:
    § 610.50 Date of manufacture for biological products.

    (a) When the dating period begins. The dating period for a product must begin on the date of manufacture as described in paragraphs (b) and (c) of this section. The dating period for a combination of two or more products must be no longer than the dating period of the component with the shortest dating period.

    (b) Determining the date of manufacture for biological products other than Whole Blood and blood components. The date of manufacture for biological products, other than Whole Blood and blood components, must be identified in the approved biologics license application as one of the following, whichever is applicable: The date of:

    (1) Potency test or other specific test as described in a biologics license application or supplement to the application;

    (2) Removal from animals or humans

    (3) Extraction;

    (4) Solution;

    (5) Cessation of growth;

    (6) Final sterile filtration of a bulk solution;

    (7) Manufacture as described in part 660 of this chapter; or

    (8) Other specific manufacturing activity described in a biologics license application or supplement to the biologics license application.

    (c) Determining the date of manufacture for Whole Blood and blood components. (1) The date of manufacture for Whole Blood and blood components must be one of the following, whichever is applicable:

    (i) Collection date and/or time;

    (ii) Irradiation date;

    (iii) The time the red blood cell product was removed from frozen storage for deglycerolization;

    (iv) The time the additive or rejuvenation solution was added;

    (v) The time the product was entered for washing or removing plasma (if prepared in an open system);

    (vi) As specified in the instructions for use by the blood collection, processing, and storage system approved or cleared for such use by FDA; or

    (vii) As approved by the Director, Center for Biologics Evaluation and Research, in a biologics license application or supplement to the application.

    (2) For licensed Whole Blood and blood components, the date of manufacture must be identified in the approved biologics license application or supplement to the application.

    4. Revise § 610.53 to read as follows:
    § 610.53 Dating periods for Whole Blood and blood components.

    (a) General. Dating periods for Whole Blood and blood components are specified in the table in paragraph (b) of this section.

    (b) Table of dating periods. In using the table in this paragraph, when a product in column A is stored at the storage temperature prescribed in column B, storage of a product must not exceed the dating period specified in column C, unless a different dating period is specified in the instructions for use by the blood collection, processing, and storage system approved or cleared for such use by FDA. Container labels for each product must include the recommended storage temperatures.

    Whole Blood and Blood Components Storage Temperatures and Dating Periods A Product B Storage temperature C Dating period Whole Blood ACD, CPD, CP2D Between 1 and 6 °C 21 days from date of collection. CPDA-1 ......do 1 35 days from date of collection. Red Blood Cells ACD, CPD, CP2D Between 1 and 6 °C 21 days from date of collection. CPDA-1 ......do 35 days from date of collection. Additive solutions ......do 42 days from date of collection. Open system (e.g., deglycerolized, washed) ......do 24 hours after entering bag. Deglycerolized in closed system with additive solution added ......do 14 days after entering bag. Irradiated ......do 28 days from date of irradiation or original dating, whichever is shorter. Frozen −65 °C or colder 10 years from date of collection. Platelets Platelets Between 20 and 24 °C 5 days from date of collection. Platelets Other temperatures according to storage bag instructions As specified in the instructions for use by the blood collection, processing, and storage system approved or cleared for such use by FDA. Plasma Fresh Frozen Plasma −18 °C or colder 1 year from date of collection. Plasma Frozen Within 24 Hours After Phlebotomy ......do 1 year from date of collection. Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up To 24 Hours After Phlebotomy ......do 1 year from date of collection. Plasma Cryoprecipitate Reduced ......do 1 year from date of collection. Plasma ......do 5 years from date of collection. Liquid Plasma Between 1 and 6 °C 5 days from end of Whole Blood dating period. Source Plasma (frozen injectable) −20 °C or colder 10 years from date of collection. Source Plasma Liquid (injectable) 10 °C or colder According to approved biologics license application. Source Plasma (noninjectable) Temperature appropriate for final product 10 years from date of collection. Therapeutic Exchange Plasma −20 °C or colder 10 years from date of collection. Cryoprecipitated AHF Cryoprecipitated AHF −18 °C or colder 1 year from date of collection of source blood or from date of collection of oldest source blood in pre-storage pool. Source Leukocytes Source Leukocytes Temperature appropriate for final product In lieu of expiration date, the collection date must appear on the label. 1 The abbreviation “do.” for ditto is used in the table to indicate that the previous line is being repeated.
    Dated: April 27, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-10386 Filed 5-3-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 982 [Docket No. FR-5928-N-01] Notice of Demonstration To Test Proposed New Method of Assessing the Physical Conditions of Voucher-Assisted Housing AGENCY:

    Office of the Assistant Secretary for Public and Indian Housing, HUD.

    ACTION:

    Notice.

    SUMMARY:

    Through this document, HUD solicits comment on a demonstration designed to test a new method of assessing the physical condition of housing assisted by HUD vouchers (voucher-assisted housing). In the Joint Explanatory Statement accompanying the act appropriating funds for HUD in Fiscal Year (FY 2016), Congress directed HUD to implement a single inspection protocol for public housing and voucher units. This demonstration would commence the process for implementing a single inspection protocol.

    DATES:

    Comments Due Date: July 5, 2016.

    ADDRESSES:

    Interested persons are invited to submit comments to the Office of the General Counsel, Regulations Division, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500. Communications should refer to the above docket number and title and should contain the information specified in the “Request for Comments” section. There are two methods for submitting public comments.

    1. Submission of Comments by Mail. Comments may be submitted by mail to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500. Due to security measures at all federal agencies, however, submission of comments by mail often results in delayed delivery. To ensure timely receipt of comments, HUD recommends that comments submitted by mail be submitted at least two weeks in advance of the public comment deadline.

    2. Electronic Submission of Comments. Interested persons may submit comments electronically through the Federal eRulemaking Portal at http://www.regulations.gov. HUD strongly encourages commenters to submit comments electronically. Electronic submission of comments allows the commenter maximum time to prepare and submit a comment, ensures timely receipt by HUD, and enables HUD to make comments immediately available to the public. Comments submitted electronically through the http://www.regulations.gov Web site can be viewed by other commenters and interested members of the public. Commenters should follow instructions provided on that site to submit comments electronically.

    Note:

    To receive consideration as public comments, comments must be submitted using one of the two methods specified above. Again, all submissions must refer to the docket number and title of the notice.

    No Facsimile Comments. Facsimile (fax) comments are not acceptable.

    Public Inspection of Comments. All comments and communications submitted to HUD will be available, for public inspection and copying between 8 a.m. and 5 p.m. weekdays at the above address. Due to security measures at the HUD Headquarters building, an advance appointment to review the public comments must be scheduled by calling the Regulations Division at (202) 708-3055 (this is not a toll-free number). Copies of all comments submitted are available for inspection and downloading at http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Daniel R. Williams, Real Estate Assessment Center, Office of Public and Indian Housing, Department of Housing and Urban Development, 550 12th Street SW., Suite 100, Washington DC 20410-4000; telephone number 202-475-8586 (this is not a toll-free number). Persons with hearing or speech impairments may contact this number via TTY by calling the toll-free Federal Relay Service at 800-877-8339.

    SUPPLEMENTARY INFORMATION:

    I. Structure of the Notice

    The following four sections discuss the background through the solicitation of comments. Section II below provides background information on oversight of the Housing Choice Voucher inspection program and explains the origins of the Uniform Physical Condition Standards for Vouchers (UPCS-V), an alternative approach for ensuring safe, habitable voucher-assisted housing. In Section III, the notice explains the three main areas that will be evaluated during the demonstration, which are: The objective condition standards including a list of life threatening and emergency items that must be addressed, the revised information technology (IT) processes, and the new oversight approach. Also in Section III, HUD discusses the general public housing agency (PHA) participation criteria it will use to select a representative mix of volunteer PHAs. In Section IV, HUD describes the process by which HUD will assess the results of the demonstration. In the last section of this notice, Section V, HUD solicits public comment generally as well as on several questions of specific interest.

    II. Background

    HUD's Housing Choice Voucher (HCV) program serves approximately 2.2 million households nationwide. The HCV program is administered by PHAs at the State and local levels and allows participants the opportunity to rent from private landlords in the neighborhood of their choosing. The goal of the HCV program is to enable access to decent, safe and sanitary affordable housing for low-income families. In the 1970's HUD established housing quality standards (HQS) in accordance with the U.S. Housing Act of 1937 (1937 Act) (42 U.S.C. 1437 et seq.). Section 8(o)(8)(B) of the 1937 Act (42 U.S.C. 1437f(o)(8)(B)), directs HUD to establish standards for safe and habitable housing. These standards are codified in HUD regulations at 24 CFR 982.401. PHAs use these standards to determine if housing meets the minimum criteria necessary for the safety and habitability of occupants assisted under the program.

    The HUD Office of Inspector General (OIG) has released several audit reports and evaluations that identified weakness in the HCV inspection program.1 These OIG reports and other factors led to the report of the Senate Committee on Appropriations, Report 113-045, that accompanied the Senate bill for HUD's 2014 appropriations, and directed HUD to “. . . move to a consistent inspection standard across housing assistance programs, as well as [for] oversight of Section 8 units.” 2 In response to this directive, HUD conducted a quality assurance review of HCV units using its current HQS inspection model.3 The results of these inspections showed that the current HQS protocol lacked objective, well-defined deficiency descriptions, was unable to capture granular unit conditions, and relied on a paper inspection form. In addition, there was an absence of modern health standards such as carbon monoxide detectors and sprinkler systems, and an absence of a universal list of life threatening or emergency deficiencies. HUD determined that these factors resulted in inconsistent application of HQS standards, and there was potential for inconsistent housing outcomes and exposure of families to health and safety hazards.

    1 See e.g., HUD OIG Reports: 2008-AT-003; 2012-BO-1005.

    2 See page 100 of https://www.thefederalregister.org/fdsys/pkg/CRPT-113srpt45/pdf/CRPT-113srpt45.pdf.

    3 See http://portal.hud.gov/hudportal/HUD?src=/program_offices/public_indian_housing/reac/oed.

    At the conclusion of the quality control review, HUD accelerated the search for a replacement to the Housing Quality Standards, leading to the eventual development of UPCS-V. In the Joint Explanatory Statement accompanying the Consolidated Appropriations Act of 2016, Public Law 114-113, approved December 18, 2015, Congress directed HUD to implement a single inspection protocol for public housing and voucher units.4 This demonstration would commence the process for implementing a single inspection protocol by soliciting PHAs to voluntarily move to the single inspection protocol, conduct field testing, and participate in oversight and monitoring activities related to the new standard. In addition to improving outcomes for families and aligning program standards, this demonstration will provide valuable feedback to HUD about how to efficiently and effectively implement UPCS-V at all PHAs. Congress has provided HUD with funding to improve its oversight of the HCV inspection program and to move the inspection standard for the HCV program to one that is consistent with other affordable housing programs and that incorporates modern health and safety practices.5

    4 See page 41 of Division L of the FY2016 Joint Explanatory Statement. See https://rules.house.gov/bill/114/hr-2029-sa.

    5 See Title II of Division K of the FY2015 Joint Explanatory Statement. See https://www.congress.gov/congressional-record/2014/12/11/house-section/article/H9307-1.

    III. The Demonstration A. Overview

    In response to Congressional direction and HUD's own goal to improve the effectiveness of the inspection of public and assisted housing while minimizing burdens, HUD is developing a new inspection and oversight approach called UPCS-V. UPCS-V incorporates housing health and safety constructs, concepts from the Uniform Physical Condition Standard (UPCS), codified in HUD regulations at 24 CFR 5.703, and HQS, codified at 24 CFR 982.401. The new UPCS-V will include deficiency definitions and decision criteria, and tailored standards and protocols to better meet HCV program needs. The UPCS protocol is currently recognized by industry stakeholders as the benchmark for government-assisted and affordable housing inspections. This Demonstration is the first step in implementing an aligned inspection protocol for public housing/multi-family housing and voucher programs, and will test the UPCS-V inspection model's ability to assess the physical condition of assisted housing, improve service delivery, enhance oversight and risk management capabilities, and better identify health and safety hazards in the home.

    B. The New Inspection Model and Demonstration Protocols

    Under this Demonstration, HUD will test, for up to three years, with up to 250 PHAs, the UPCS-V model as a new method of assessing the physical condition of voucher-assisted housing.

    In addition to hands-on training and technical assistance that will be provided by HUD to participating PHAs, some additional benefits of participating in the Demonstration include the opportunity to provide input to HUD on further refining the UPCS-V standards and processes, and the ability to evaluate, test, and refine internal PHA systems and processes.

    There are three components to the Demonstration, each of which may run concurrently:

    • Evaluation of Revised Inspection Model (UPCS-V) • Data Standardization and Information Exchange • Oversight and Performance Improvement Component 1: Evaluation of the Revised Inspection Model (UPCS-V)

    For the past 17 years, HUD has used the UPCS protocol when conducting over 310,000 physical inspections of public housing (PH) and subsidized multifamily housing (MFH) developments, solidifying UPCS as the industry standard for government-assisted and affordable housing inspections. HUD leveraged its experience with UPCS and developed a product tailored to the objectives of the HCV program. The scope of the inspection, the procedural guidelines, and the individual deficiencies have been modified to emphasize those areas that present the highest risk of harm to the family living in the HCV assisted unit.

    UPCS-V seeks to utilize well-defined and objective deficiency descriptions that can be used consistently within and across PHAs. The following table summarizes some of the high-level similarities and differences between UPCS-V and HQS.

    Item HQS UPCS-V Provides standardized list of deficiencies and measurable criteria X Defined standardized list of Life Threatening and Emergency items X Up-to-date health and safety standards X Designed as a unit-based inspection standard for federally assisted units X X Inspection standard aligned with other federally assisted programs X Pass/Fail results for all deficiencies X X PHA ability to adopt HUD-approved variances X X Uniform inspector training and registration X Includes guidance through the use of decision trees that lead to more consistent observations X Captures level of severity for line item deficiencies X Unit and room acceptability criteria X X Standardized criteria for PHA submission of electronic inspection data to HUD X Customized unit condition index to provide value added analytics of inspection data to PHAs and stakeholders X Photo requirements for fail deficiencies X Allow PHAs the use photo and document evidence to ensure all fail deficiencies have been mitigated X

    Like UPCS, HUD anticipates that the new inspection model will enable a PHA inspector to more consistently identify and accurately describe those items that pose a risk to tenant health and safety in the home. The new inspection model developed by HUD has updated standards and a well-defined list of itemized deficiencies enabling inspectors to make more accurate and objective decisions on a consistent basis. The new inspection model differs from the current HQS inspection model in that it incorporates standards based on UPCS and uses a classification system that collects a more detailed level of data resulting in a better representation of the condition of the unit.

    The new inspection protocol will capture levels of severity for line item deficiencies on an escalating scale of severity (L1, L2, L3). The classifications of minor (L1), major (L2) or significant (L3) would be used to determine the level of severity for each deficiency and to develop a unit condition index score. When considered in conjunction with a Pass/Fail determination, the unit condition index score would give residents, owners, PHAs, and HUD better insight into the overall condition of the unit. In addition to capturing a level of severity for all deficiencies, HUD will create a minimum, standardized list of life threatening items that PHAs participating in the demonstration must treat as “24 Hour” deficiencies.

    When an inspector finds Life Threatening or Emergency (LTE) deficiencies during an inspection, the inspector is to provide a list of such deficiencies to the responsible party—either tenant or owner—for repair within 24 hours. A specific set of deficiencies that must be addressed within 24 hours is not currently defined in HQS. UPCS-V will provide a list of LTE categories to use when inspecting HCV units during the Demonstration. PHAs will be responsible for additional items to this list.

    General Categories of Life Threatening and Emergency Items Life threatening ☐ Natural or Liquid Petroleum (LP) gas leak or fumes ☐ Electrical problems which could result in shock or fire ☐ Inoperable/missing smoke or carbon monoxide detector ☐ Gas/Oil Fired Water Heater/HVAC with missing or misaligned chimney ☐ Fire extinguishers expired or missing ☐ Building lacks an alternate means of exit in case of fire/blocked egress Emergency ☐ Missing entry door ☐ The HVAC system fails to meet established criteria for emergency heating or cooling with consideration for ambient temperature range and ventilation ☐ Absence of at least one functioning sink and toilet in unit ☐ No working refrigerator ☐ No working stove/oven or other method of heating/preparing food ☐ Waterlogged/damaged ceilings, floor or walls in imminent danger of potential collapse ☐ Major plumbing leaks or flooding ☐ Utilities not in service (e.g., electricity, gas (LP/natural), water or oil) ☐ No running hot water ☐ Structural integrity condition where the building, or a component of the building, is in imminent danger of potential collapse

    With the inclusion of a level of severity classification and a standardized list of life threatening items, the inspection report will be able to provide a more detailed description of the unit.

    As part of the Demonstration, HUD will conduct extensive field tests of the standards and protocol with a representative sample of HCV units to verify that the UPCS-V model consistently, accurately, and objectively evaluates housing conditions. The feasibility of implementing the protocol will also be evaluated to identify potential barriers that would prevent PHAs from successfully implementing UPCS-V. After HUD's initial round of testing has been completed, PHAs participating in this component of the Demonstration will conduct a portion, depending on the PHA's capabilities, of up to 100 percent of their required HCV physical inspections using UPCS-V in place of HQS. This component will continue throughout the up to three-year duration of the Demonstration until HUD has sufficient information to evaluate the success of PHAs using UPCS-V and assurance that the new method is achieving consistent results.

    Component 2: Data Standardization and Information Exchange of UPCS-V Inspections

    UPCS-V is designed as an electronic inspection model. This component of the Demonstration will test the transition from a paper-based to an electronic inspection approach. Initially, the UPCS-V inspections will be performed electronically using HUD-provided software, and all inspections will include photos of the most severe deficiencies. For PHAs with their own IT systems, including PHA-produced or provided inspection software, HUD also will test the feasibility of different methods of transferring physical inspection information between PHA and HUD systems.

    PHAs participating in this component will be required to document and submit to HUD all UPCS-V inspections electronically. HUD anticipates that it will then review, analyze, and where appropriate, transform the inspection data into value-added information, such as a scoring report, healthy homes report, and relative risk reports, for electronic transmission back to the PHA for its use.

    PHAs participating in this component of the Demonstration and that use non-HUD provided software will be required to have and maintain the information technology resources and support necessary to interface with HUD's systems using industry standard file transfer protocols such as Simple Object Access Protocol (SOAP) and Representational State Transfer (REST) standards. Some data exchange may be via transfer of flat files.

    Component 3: Oversight and Performance Improvement

    In this component of the Demonstration, HUD seeks to ensure PHAs are consistently identifying substandard housing, remedying such cases appropriately and in a timely manner, and accurately reporting HCV unit-based inspection outcomes to HUD. Selected PHAs will be required to participate in quality assurance and internal controls reviews, technical assistance, and training activities. As part of the Demonstration, HUD will analyze PHAs' capacity, competencies, inspection processes and systems that are in place to effectively manage and evaluate HCV units as decent, safe, and sanitary. Further, HUD will test the capacity of the UPCS-V model to identify properties that are at risk of falling into non-compliance before the next regularly scheduled biennial inspection.

    To develop an inspector performance baseline, HUD seeks to determine the acceptable variation between inspectors. HUD will conduct quality assurance inspections on HCV units to ensure inspector adherence to UPCS-V inspection standards and provide technical assistance where needed. HUD also will test both PHA and its own management controls to provide reasonable assurance that the process for planning, organizing, directing, and controlling the HCV unit-based inspection program will meet the requirements prescribed by UPCS-V.

    C. Selection Criteria and General Participation Requirements General Participation Requirements

    To participate in this Demonstration, a PHA must administer a housing choice voucher program. PHAs participating in any aspect of the Demonstration will be required to participate in focus groups, conference calls, and training sessions on policies and procedures. HUD will train each participating PHA's inspectors, administrators, and quality control staff on the new inspection protocol, including how to use the inspection software. The PHAs will be responsible for scheduling inspections with all the participants, assigning inspectors, and conducting inspections. The PHA must conduct at least 10 inspections per week, and the geographic spread of those inspections should be such that 90 percent of inspections are accessible within a 30 mile (or 1 hour) driving range.

    If selected, the PHA must participate in the Demonstration throughout the duration of the testing period for at least one (1) calendar year with the possibility of an extension, as determined by HUD, for a maximum total of three (3) years. PHAs that participate will also need to provide an internet connected, internet operating system (iOS) or Android based electronic handheld device (smart phone or tablet) for each PHA staff inspector participating with capability to download the required HUD-provided inspection software.

    Selection Criteria

    All PHAs must meet, at minimum, the general participation requirements described above. The strategic objectives for the Demonstration are for HUD to identify a diverse set of participants that will be representative of the different types of PHAs, properties and tenants found nationwide. HUD will use the following criteria to consider PHAs that have expressed an interest in participating in the Demonstration to ensure that participants represent the universe of PHAs that run HCV programs.

    Participants will be selected based on the characteristics of the organization (PHA) and the type of properties and tenants it administers:

    1. Characteristics of the PHA:

    • Is the PHA a local or state agency?

    • What percentage of HQS inspections are conducted annually? Biennially?

    • What percentage of the HCV housing stock is urban and what percentage is rural?

    • What percentage of the PHAs inspections are HCV inspections?

    • What is the number of monthly HCV inspections conducted?

    2. Characteristics of the Properties & Tenants:

    • What is the number of HCV voucher holders?

    • What is the average rent amount?

    • What is the percentage of PHA's HCV program that is Veterans Affairs Supportive Housing (VASH), Family Unification Program (FUP), and Non-Elderly Disabled (NED) participants?

    • What is the average HCV family size?

    • What type of housing is leased by HCV participants (single family, apartment, condo, high-rise, row house, duplex, townhouse, etc.)?

    • What is the average age of the housing stock?

    • What is the HCV tenant mix (by age, disability, elderly, family type, children, income level/hap amount)?

    The criteria are designed to capture the variation in PHAs and market characteristics that could affect the implementation of UPCS-V. Depending on the applications for participation received and the characteristics of the PHAs applying, the criteria may be adjusted to more accurately represent the diversity of PHAs. Not all 250 participants may be selected in the first round of testing. Accordingly, as the Demonstration proceeds, HUD may expand the number of participating PHAs, revise the selection criteria, or both, to reflect HUD's experience in implementing the Demonstration.

    IV. Evaluating the Demonstration

    The Demonstration will provide HUD insight into the UPCS-V model, including its ability to expand HUD's oversight and risk management capabilities through a reliable, repeatable inspection process that better identifies health and safety risks to families, before implementing such a program nationwide. The Demonstration is anticipated to begin 60 days following the date of publication of this notice, with PHAs being added on a rolling basis until a representative sample has been reached. At the conclusion of the demonstration, HUD will assess its success and determine whether to implement UPCS-V on a permanent basis throughout the country.

    In the evaluation of the Demonstration, HUD will assess such factors as whether the use of the new UPCS-V protocol produces (1) more consistent and accurate results, (2) data standardization and a reliable method for information exchange, and (3) increased oversight and administration of the HCV Program. The demonstration also will review the feasibility of a PHA to implement the UPCS-V protocol, a factor HUD considers necessary for an accurate evaluation of the Demonstration's success.

    V. Solicitation of Public Comment

    In accordance with section 470 of the Housing and Urban-Rural Recovery Act of 1983 (42 U.S.C. 3542), HUD is seeking comment on the Demonstration. Section 470 provides that HUD may not begin a demonstration program not expressly authorized by statute until a description of the demonstration program is published in the Federal Register and a 60-day period expires following the date of publication, during which time HUD solicits public comment and considers the comments submitted. HUD has established a public comment period of 60 days. The public comment period provided allows HUD the opportunity to consider those comments during the 60-day period, and be in a position to commence implementation of the demonstration following the conclusion of the 60-day period.

    While HUD solicits comment on all aspects of the Demonstration, HUD specifically solicits comment on the following:

    1. HUD is considering selecting for participation only PHAs that do not utilize contract inspectors. Are there any instances where an exception to this criterion might be useful?

    2. Will utilizing commercial, off-the-shelf hardware, such as internet connected tablets or smartphones, reduce the barriers to participation for PHAs as opposed to having PHAs use more specific devices such as those required for other HUD UPCS inspections?

    3. Are there other PHA characteristics that HUD should consider in selecting PHAs to participate in the demonstration?

    4. Are there other revisions outside of the UPCS criteria that HUD should consider when moving toward a single inspection protocol?

    HUD requests that PHAs interested in participating in the Demonstration notify HUD by the public comment deadline for this Demonstration notice by emailing HUD at [email protected], and providing the PHA name, PHA address, contact name, contact phone number, and email address.

    Dated: April 28, 2016. Lourdes Castro Ramírez, Principal Deputy Assistant Secretary for Public and Indian Housing.
    [FR Doc. 2016-10460 Filed 5-3-16; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 301 [REG-114307-15] RIN 1545-BM77 Self-Employment Tax Treatment of Partners in a Partnership That Owns a Disregarded Entity AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Notice of proposed rulemaking by cross-reference to temporary regulations.

    SUMMARY:

    In the Rules and Regulations section of this issue of the Federal Register, the IRS is issuing temporary regulations that clarify the employment tax treatment of partners in a partnership that owns a disregarded entity. These regulations affect partners in a partnership that owns a disregarded entity. The text of those temporary regulations serves as the text of these proposed regulations.

    DATES:

    Comments and requests for a public hearing must be received by August 2, 2016.

    ADDRESSES:

    Send submissions to: CC:PA:LPD:PR (REG-114307-15), 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-114307-15), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC 20224 or sent electronically, via the Federal eRulemaking Portal at http://www.regulations.gov/ (IRS REG-114307-15).

    FOR FURTHER INFORMATION CONTACT:

    Concerning the proposed regulations, Andrew K. Holubeck at (202) 317-4774; concerning submission of comments, or a request for a public hearing please contact Regina Johnson at (202) 317-6901 (not toll-free numbers).

    SUPPLEMENTARY INFORMATION:

    Background and Explanation of Provisions

    Temporary regulations in the Rules and Regulations section of this issue of the Federal Register amend the Procedure and Administration Regulations (26 CFR part 301) relating to section 7701. The temporary regulations clarify that an entity disregarded as separate from its owner (a disregarded entity), that is treated as a corporation for purposes of employment taxes imposed under subtitle C, is not treated as a corporation for purposes of employing its individual owner (who is treated as a sole proprietor) or for purposes of employing an individual that is a partner in a partnership that owns the disregarded entity. Rather, the entity is disregarded as an entity separate from its owner for this purpose. The partners are subject to the same self-employment tax rules as partners in a partnership that does not own an entity that is disregarded as separate from its owner. The text of those regulations also serves as the text of these proposed regulations. The preamble to the temporary regulations explains the amendments.

    Special Analysis

    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 has also 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 Internal Revenue Code, this notice of proposed rulemaking will be submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business.

    Comments and Requests for Public Hearing

    Before these proposed regulations are adopted as final regulations, consideration will be given to any comments that are submitted timely to the IRS as prescribed in this preamble under the ADDRESSES heading. The Treasury Department and the IRS request comments on all aspects of the proposed rules. All comments will be available at www.regulations.gov or upon request. A public hearing will be scheduled if requested in writing by any person that timely submits written comments. If a public hearing is scheduled, notice of the date, time, and place for the hearing will be published in the Federal Register.

    Drafting Information

    The principal author of these regulations is Andrew Holubeck of the Office of the Division Counsel/Associate Chief Counsel (Tax Exempt and Government Entities). However, other personnel from the IRS and the Treasury Department participated in their development.

    List of Subjects in 26 CFR Part 301

    Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordingkeeping requirements.

    Proposed Amendments to the Regulations

    Accordingly, 26 CFR part 301 is proposed to be amended as follows:

    PART 301—PROCEDURE AND ADMINISTRATION Paragraph 1. The authority citation for part 301 continues to read in part as follows: Authority:

    26 U.S.C. 7805 * * *

    Par. 2. Section 301.7701-2 is amended by revising paragraphs (c)(2)(iv)(C)(2) and adding paragraph (e)(8)(i) to read as follows:
    § 301.7701-2 Business entities; definitions

    (c) * * *

    (2) * * *

    (iv) * * *

    (C) * * *

    (2) [The text of the proposed amendment to § 301.7701-2(c)(2)(iv)(C)(2) is the same as the text of § 301.7701-2T(c)(2)(iv)(C)(2) published elsewhere in this issue of the Federal Register].

    (e) * * *

    (8)(i) [ The text of the proposed amendments to § 301.7701-2(e)(8)(i) is the same as the text of § 301.7701-2T(e)(8)(i) published elsewhere in this issue of the Federal Register].

    John Dalrymple, Deputy Commissioner for Services and Enforcement.
    [FR Doc. 2016-10384 Filed 5-3-16; 8:45 am] BILLING CODE 4830-01-P
    DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms, and Explosives 27 CFR Parts 478 and 479 [Docket No. ATF 29P] RIN 1140-AA33 Identification Markings Placed on Firearm Silencers and Firearm Mufflers AGENCY:

    Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF), Department of Justice.

    ACTION:

    Advance notice of proposed rulemaking.

    SUMMARY:

    The Department of Justice is considering amending the regulations of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) to require licensed manufacturers, licensed importers, and nonlicensed makers to place identification markings on the outer tube of firearm silencers and firearm mufflers. The Department wishes to gather information and comments from the public and industry concerning whether or not the regulations should be amended.

    DATES:

    Written comments must be postmarked and electronic comments must be submitted on or before August 2, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after Midnight Eastern Time on the last day of the comment period.

    ADDRESSES:

    You may submit comments, identified by docket number (ATF 29P), by any of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Fax: (202) 648-9741.

    Mail: Shermaine Kenner, Mailstop 6N-518, Office of Regulatory Affairs, Enforcement Programs and Services, Bureau of Alcohol, Tobacco, Firearms, and Explosives, 99 New York Avenue NE., Washington, DC 20226: ATTN: ATF29P.

    Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received will be posted without change to the Federal eRulemaking portal, http://www.regulations.gov, including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process, see the “Public Participation” heading of the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Shermaine Kenner, Office of Regulatory Affairs, Enforcement Programs and Services, Bureau of Alcohol, Tobacco, Firearms, and Explosives, U.S. Department of Justice, 99 New York Avenue NE., Washington, DC 20226; telephone: (202) 648-7070.

    SUPPLEMENTARY INFORMATION: I. Background

    Section 923(i) of the Gun Control Act of 1968 (GCA), as amended (18 U.S.C. chapter 44), requires licensed importers and licensed manufacturers to identify, by means of a serial number, each firearm imported or manufactured by such importer or manufacturer. The serial number must be engraved or cast on the receiver or frame of the weapon in such manner as the Attorney General prescribes by regulation. As defined in section 921(a)(3) of the GCA, the term “firearm” includes any firearm muffler or firearm silencer. The terms “firearm silencer” and “firearm muffler” are also defined in section 921(a)(24), as follows:

    [A]ny device for silencing, muffling, or diminishing the report of a portable firearm, including any combination of parts, designed or redesigned, and intended for use in assembling or fabricating a firearm silencer or firearm muffler, and any part intended only for use in such assembly or fabrication.

    With respect to certain firearms subject to the National Firearms Act (NFA) (26 U.S.C. chapter 53) (e.g., machine guns, any silencer (as defined in section 921(a)(24) of the GCA)), 26 U.S.C. 5842(a) requires each manufacturer and importer and anyone making a firearm to identify by a serial number each firearm manufactured, imported, or made. The serial number may not be readily removed, obliterated, or altered. Section 5842(a) also requires the firearm to be identified by the name of the manufacturer, importer, or maker, and such other identification as the Attorney General may prescribe by regulation.

    Regulations that implement 18 U.S.C. 923(i) are set forth in 27 CFR 478.92. In general, § 478.92(a)(1)(i) requires licensed manufacturers and licensed importers of firearms to legibly identify each firearm manufactured or imported by engraving, casting, stamping (impressing), or otherwise conspicuously placing on the frame or receiver an individual serial number. The serial number must be placed in a manner not susceptible of being readily obliterated, altered, or removed and must not duplicate any serial number placed by a licensed importer or manufacturer on any other firearm. For firearms manufactured or imported on and after January 30, 2002, the engraving, casting, or stamping (impressing) of the serial number must be to a minimum depth of .003 inch and in a print size no smaller than 1/16 inch.

    In addition, § 478.92(a)(1)(ii) requires licensed manufacturers and licensed importers to conspicuously place additional identification markings on the frame, receiver, or barrel of each firearm imported or manufactured in a manner not susceptible of being readily obliterated, altered, or removed. For firearms manufactured or imported on and after January 30, 2002, the engraving, casting, or stamping (impressing) of this information must be to a minimum depth of .003 inch. The additional information includes:

    1. The model, if such designation has been made;

    2. The caliber or gauge;

    3. The name of the licensed manufacturer or licensed importer (or recognized abbreviation) and, when applicable, the name of the foreign manufacturer;

    4. In the case of a domestically made firearm, the city and State (or recognized abbreviation thereof) where the licensed manufacturer maintains his place of business; and

    5. In the case of an imported firearm, the name of the country in which it was manufactured and the city and State (or recognized abbreviation thereof) where the licensed importer maintains his place of business.

    The same marking requirements apply to manufacturers, importers or makers of NFA firearms pursuant to 27 CFR 479.102(a).

    The current regulations do not specify the placement of required identification markings on firearm silencers and firearm mufflers. However, ATF has provided the industry with some guidance on this issue. In its “Frequently Asked Questions—Silencers,” dated April 17, 2008, ATF stated the following:

    The silencer must be marked in accordance with 27 CFR 478.92 and 479.102. The regulations require that the markings be conspicuous and legible, meaning that the markings may be placed on any external part, such as the outer tube or end cap. ATF strongly recommends that manufacturers place all required markings on the outer tube of the silencer, as this is the accepted industry standard. Moreover, this practice eliminates the need to remark in the event an end cap bearing the markings is damaged and requires replacement.

    II. National Firearms Act Trade and Collectors Association Petition

    On April 27, 2008, ATF received a petition filed on behalf of the National Firearms Act Trade and Collectors Association (NFATCA). NFATCA is a trade group representing the firearms and import community. Some of its members primarily manufacture, transport, and possess silencers for lawful use.

    Although in its April 2008 guidance ATF recommended that manufacturers place all required markings on the outer tube of the silencer, it stated that the required markings could also be placed on any external part of the silencer, including the end cap, provided the required markings are conspicuous and legible. According to the petitioner, the industry's response to ATF's guidance was not favorable:

    There has been an overwhelmingly negative response from the members of our trade to this particular guidance . . . there is strong policy agreement between ATF and our trade that only the silencer [outer] tube should be marked in accordance with the marking requirements of Parts 478 and 479 of Title 27 of the Code of Federal Regulations. . . . Allowing end caps to be the possible marking location for silencers does constitute a serious public safety issue in the areas of diversion, tracing, and evasion of other NFA rules.

    In addition, the petitioner stated that “[w]e have also been further advised that the Bureau does not see how they would be able to take any adverse legal action against a person or entity that should decide to mark the end caps of a silencer without promulgating a change in the regulations.”

    Accordingly, the petitioner requested that the relevant regulations be amended to require that a silencer be marked on the outer tube (as opposed to other locations), unless a variance is granted by the Director on a case-by-case basis for good cause. ATF finds that the petitioner has raised valid concerns and it believes that an amendment of the regulations is warranted. Therefore, based upon the statutory language and the facts as outlined below, ATF seeks to address the marking requirements of silencers to ensure that the serial numbers are placed on the part of the silencer that is least likely to be destroyed or removed, and therefore most likely to ensure that law enforcement are able to identify and trace a particular firearm silencer or firearm muffler.

    III. Discussion

    ATF is requesting information from industry members, trade associations, consumers, and all other interested parties to determine whether to require placement of identification markings on the outer tube of firearm silencers and firearm mufflers. Along with industry members, ATF considers the term “outer tube” to mean the largest external part of a silencer and is that portion of a silencer which encapsulates all components of the silencing unit and which contains and controls the expansion of the escaping gases.

    As indicated, placing all required markings on the outer tube of a completed firearm silencer or firearm muffler is the accepted industry standard. In addition, requiring identification markings to be placed on a single part provides consistency of markings throughout the industry and eliminates the need to remark a device in the event an end cap bearing the markings is damaged and requires replacement. If a silencer is not aligned with the barrel, the end cap might be damaged when a projectile passes through it. Outer tubes are rarely damaged in this way. Such damage often requires replacement of the end cap. Further, end caps are often removable so that processors may access the internal components within the silencer. Permitting serialization of a removable and fungible component may facilitate trafficking or illegal transfer of silencers by permitting registrants to use the serialized end cap of a registered silencer with an otherwise unregistered silencer.

    Although ATF is soliciting comments on the following specific questions, it is also requesting any relevant information on the subject.

    1. What percentage of manufacturers mark the end cap? If an outer tube is present, why do manufacturers mark the end cap instead of the outer tube of the silencer?

    2. If there is an additional cost (fixed or variable) between marking the end cap instead of the outer tube, how would ATF estimate such costs across the entire industry?

    3. Are there other parts or locations where the markings may be placed and still meet the requirements? If so, where?

    4. Are there silencer designs for a completed device for which marking the outer tube would be impossible? If so, what are those designs?

    5. When there are multiple outer tubes that make up one complete device, how should they be marked?

    IV. Statutory and Executive Order Review

    This advance notice of proposed rulemaking (ANPRM) has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review,” section 1(b), The Principles of Regulation, and in accordance with Executive Order 13563, “Improving Regulation and Regulatory Review,” section 1(b), General Principles of Regulation.

    The Department of Justice has determined that this ANPRM is a “significant regulatory action” under Executive Order 12866, section 3(f), and accordingly this ANPRM has been reviewed by the Office of Management and Budget. However, this action does not propose or impose any requirements. The ANPRM is being published to seek information from the public about the feasibility of marking silencer tubes.

    Furthermore, the requirements of section 603 of the Regulatory Flexibility Act do not apply to this action because, at this stage, it is an ANPRM and not a “rule” as defined in section 601 of the Regulatory Flexibility Act. Following review of the comments received in response to this ANPRM, if ATF promulgates a notice or notices of proposed rulemaking regarding this matter, ATF will conduct all analyses required by the Regulatory Flexibility Act, Executive Order 12866, and any other statutes or Executive Orders relevant to those rules and in effect at the time of promulgation.

    Public Participation A. Comments Sought

    ATF requests comments on this ANPRM from all interested persons. ATF specifically requests comments on the clarity of this ANPRM and how easy it is to understand. Additional comments are sought on the costs or benefits of the proposal in this ANPRM and on the appropriate methodology and data for calculating those costs and benefits.

    All comments must reference the docket number (ATF 29P), be legible, and include the commenter's complete first and last name and full mailing address. ATF will not consider, or respond to, comments that do not meet these requirements or comments containing profanity. In addition, if ATF cannot read your comment due to technical difficulties and cannot contact you for clarification, ATF may not be able to consider your comment.

    ATF will carefully consider all comments, as appropriate, received on or before the closing date, and will give comments received after that date the same consideration if it is practical to do so, but assurance of consideration cannot be given except as to comments received on or before the closing date.

    ATF will not acknowledge receipt of comments.

    B. Confidentiality

    ATF will make all comments meeting the requirements of this section available for public viewing at ATF and on the Internet as part of the eRulemaking initiative, and subject to the Freedom of Information Act. ATF will not redact personal identifying information that appears within the comment and it will appear on the Internet.

    The commenter should not include material that is considered confidential or inappropriate for disclosure to the public. Any person submitting a comment containing confidential material shall specifically designate that portion of the comment that contains material that is confidential under law (e.g., trade secrets, processes). The commenter shall place any portion of a comment that is confidential under law on pages separate from the balance of the comment with each page prominently marked “confidential” at the top of the page.

    Confidential information will be included in the rulemaking administrative record but will not be disclosed to the public. Any comments containing material that is not confidential under law may be disclosed to the public. In any event, a commenter's full first and last name and complete mailing address are not exempt from disclosure.

    C. Submitting Comments

    Submit comments in any of three ways (but do not submit the same comments multiple times or by more than one method).

    Federal eRulemaking Portal: We strongly recommend that you submit your comments to ATF via the Federal eRulemaking portal. Visit http://www.regulations.gov and follow the instructions for submitting comments. Comments will be posted within a few days of being submitted. However, if large volumes of comments are being processed simultaneously, your comment may not be viewable for up to several weeks. Please keep the comment tracking number that regulations.gov provides after you have successfully uploaded your comment.

    Mail: Send written comments to the address listed in the ADDRESSES section of this document. Written comments must appear in minimum 12 point font size (.17 inches), include the commenter's complete first and last name and full mailing address, be signed, and may be of any length.

    Facsimile: Submit comments by facsimile transmission to (202) 648-9741. Faxed comments must:

    (1) Be legible and appear in minimum 12-point font size (.17 inches);

    (2) Be on 81/2″ x 11″ paper;

    (3) Be signed and contain the commenter's complete first and last name and full mailing address; and

    (4) Be no more than five pages long.

    D. Request for Hearing

    Any interested person who desires an opportunity to comment orally at a public hearing should submit his or her request, in writing, to the Director of ATF within the 90-day comment period. The Director, however, reserves the right to determine, in light of all circumstances, whether a public hearing is necessary.

    Disclosure

    Copies of the petition, this advance notice, and the comments received will be available at http://www.regulations.gov (search for Docket No. ATF 29P) and for public inspection by appointment during normal business hours at: ATF Reading Room, Room 1E-063, 99 New York Avenue NE., Washington, DC 20226; telephone: (202) 648-8740.

    Drafting Information

    The author of this document is Shermaine Kenner, Office of Regulatory Affairs, Enforcement Programs and Service; Bureau of Alcohol, Tobacco, Firearms, and Explosives.

    List of Subjects 27 CFR Part 478

    Administrative practice and procedure, Arms and munitions, Customs duties and inspection, Exports, Imports, Intergovernmental relations, Law enforcement officers, Military personnel, Penalties, Reporting and recordkeeping requirements, Research, Seizures and forfeitures, Transportation.

    27 CFR Part 479

    Administrative practice and procedure, Arms and munitions, Customs duties and inspection, Excise taxes, Exports, Imports, Military personnel, Penalties, Reporting and recordkeeping requirements, Seizures and forfeitures, Transportation.

    Authority and Issuance

    This notice is issued under the authority of 5 U.S.C. 552(a); 18 U.S.C. 847, 921-931; and 44 U.S.C. 3504(h).

    Dated: April 28, 2016. Thomas E. Brandon, Deputy Director.
    [FR Doc. 2016-10382 Filed 5-3-16; 8:45 am] BILLING CODE 4410-FY-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2016-0267] RIN 1625-AA00 Safety Zone; Tall Ships Challenge Great Lakes 2016, Fairport Harbor, OH, Bay City, MI, Chicago, IL, Green Bay, WI, Duluth, MN, Erie, PA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to create safety zones around each tall ship visiting the Great Lakes during the Tall Ships Challenge 2016 race series. These safety zones will provide for the regulation of vessel traffic in the vicinity of each tall ship in the navigable waters of the United States. The Coast Guard is taking this action to safeguard participants and spectators from the hazards associated with the limited maneuverability of these tall ships and to ensure public safety during tall ships events. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before June 3, 2016.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2016-0267 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this proposed rulemaking, call or email Mark Bobal, Ninth District Inspections and Investigations Branch, Passenger Vessel Safety Specialist, U.S. Coast Guard; telephone 216-902-6052, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

    During the Tall Ships Challenge Great Lakes 2016, tall ships will be participating in parades and then mooring in the harbors of Fairport Harbor, OH, Bay City, MI, Chicago, IL, Green Bay, WI, Duluth, MN, and Erie, PA. This is a tri-annual event that teaches character building and leadership through sail training. The Tall Ships event seeks to educate the public about both the historical aspects of sailing ships as well as their current use as training vessels for students. Tall ships are large, traditionally-rigged sailing vessels. The event will consist of festivals at each port of call, sail training cruises, tall ship parades, and races between the ports. More information regarding the Tall Ships Challenge 2016 and the participating vessels can be found at http://www.sailtraining.org/tallships/2016greatlakes/TSC2016index.php.

    At 12:01 a.m. July 6, 2016, a safety zone will be established around each tall ship participating in this event. The safety zone around each ship will remain in effect as the tall ships travel throughout the Great Lakes. The safety zones will terminate at 12:01 a.m. on September 12, 2016.

    These safety zones are necessary to protect the tall ships from potential harm and to protect the public from the hazards associated with the limited maneuverability of tall sailing ships. When operating under sail they require a substantial crew to manually turn the rudder and adjust the sails, therefore they cannot react as quickly as modern ships. Additionally, during parades of sail the tall ships will be following a set course through a crowded harbor, it is imperative that spectator craft stay clear since maneuvering the tall ships to avoid large crowds of spectator craft would not be possible. Due to the high profile nature and extensive publicity associated with this event, each Captain of the Port (COTP) expects a large number of spectators in confined areas adjacent to the tall ships. The combination of large numbers of recreational boaters, congested waterways, boaters crossing commercially transited waterways and low maneuverability of the tall ships could easily result in serious injuries or fatalities. Therefore, the Coast Guard will enforce a safety zone around each ship to ensure the safety of both participants and spectators in these areas. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231.

    III. Discussion of Proposed Rule

    The Coast Guard proposes to establish safety zones from 12:01 a.m. on July 6, 2016 until 12:01 a.m. on September 12, 2016. The safety zones would cover all navigable waters within 100 yards of a tall ship in the Great Lakes. The duration of the zone is intended to ensure the safety of vessels and these navigable waters during the 2016 Tall Ships Challenge. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. If the tall ships are operating in a confined area such as a small harbor and there is not adequate room for vessels to stay out of the safety zone because of a lack of navigable water, then vessels will be permitted to operate within the safety zone and shall travel at the minimum speed necessary to maintain a safe course. The navigation rules shall apply at all times within the safety zone. The regulatory text we are proposing appears at the end of this document.

    IV. Regulatory Analyses

    We developed this proposed 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 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. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget.

    This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic would be able to safely transit around this safety zone or through it at slow speed in congested areas. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

    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 proposed rule would not have a significant economic impact on a substantial number of small entities.

    While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.

    If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

    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 proposed rule. If the rule would 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 proposed rule or any policy or action of the Coast Guard.

    C. Collection of Information

    This proposed rule would 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 Executive Order 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 proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

    Also, this proposed rule does not have tribal implications under Executive Order 13175, 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. If you believe this proposed 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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

    F. Environment

    We have analyzed this proposed 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 proposed rule involves a safety zone lasting more than one week. Normally such actions are categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. A preliminary 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 proposed 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.

    V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

    We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

    Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

    List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:

    PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority:

    33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

    2. Add § 165.T09-0073 to Ninth Coast Guard District to read as follows:
    § 165.T09-0073 Safety Zone; Tall Ships Challenge Great Lakes 2016; Fairport Harbor, OH, Bay City, MI, Chicago, IL, Green Bay, WI, Sturgeon Bay, WI, Duluth, MN, Erie, PA.

    (a) Definitions. The following definitions apply to this section:

    (1) Navigation rules means the Navigation Rules, International and Inland (See, 1972 COLREGS and 33 U.S.C. 2001 et seq.).

    (2) Official patrol means those persons designated by Captain of the Port Buffalo, Detroit, Sault Ste. Marie, Duluth and Lake Michigan to monitor a tall ship safety zone, permit entry into the zone, give legally enforceable orders to persons or vessels within the zone, and take other actions authorized by the cognizant Captain of the Port.

    (3) Public vessel means vessels owned, chartered, or operated by the United States or by a State or political subdivision thereof.

    (4) Tall ship means any sailing vessel participating in the Tall Ships Challenge 2016 in the Great Lakes.

    (b) Location. The following areas are safety zones: All navigable waters of the United States located in the Ninth Coast Guard District within a 100 yard radius of any tall ship.

    (c) Regulations. (1) No person or vessel is allowed within the safety zone unless authorized by the cognizant Captain of the Port, their designated representative, or the on-scene official patrol.

    (2) Persons or vessels operating within a confined harbor or channel, where there is not sufficient navigable water outside of the safety zone to safely maneuver are allowed to operate within the safety zone and shall travel at the minimum speed necessary to maintain a safe course. Vessels operating within the safety zone shall not come within 25 yards of a tall ship unless authorized by the cognizant Captain of the Port, their designated representative, or the on-scene official patrol.

    (3) When a tall ship approaches any vessel that is moored or anchored, the stationary vessel must stay moored or anchored while it remains within the tall ship's safety zone unless ordered by or given permission from the cognizant Captain of the Port, their designated representative, or the on-scene official patrol to do otherwise.

    (d) Effective period. This rule is effective from 12:01 a.m. on Wednesday, July 6, 2016 through 12:01 a.m. on Monday September 12, 2016.

    (e) Navigation Rules. The Navigation Rules shall apply at all times within a tall ships safety zone.

    Dated: April 8, 2016. J.E. Ryan, Rear Admiral, U.S. Coast Guard, Commander, Ninth Coast Guard District.
    [FR Doc. 2016-10453 Filed 5-3-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-HQ-ES-2015-0171; FF09E40000 167 FXES11150900000] RIN 1018-BB25 Endangered and Threatened Wildlife and Plants; Revisions to the Regulations for Candidate Conservation Agreements With Assurances AGENCY:

    U.S. Fish and Wildlife Service (FWS), Interior.

    ACTION:

    Proposed rule.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (FWS), propose changes to the regulations concerning enhancement of survival permits issued under the Endangered Species Act of 1973, as amended (ESA), associated with Candidate Conservation Agreements with Assurances. We propose to add the term “net conservation benefit” to the Candidate Conservation Agreements with Assurances regulations, and to eliminate references to “other necessary properties” to clarify the level of conservation effort we require each agreement to include in order for us to approve a Candidate Conservation Agreement with Assurances. We are also proposing these changes to the Candidate Conservation Agreement with Assurances policy in a separate document published in today's Federal Register.

    DATES:

    We will accept comments that we receive on or before July 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.

    ADDRESSES:

    You may submit comments by one of the following methods:

    Electronically: Go to the Federal eRulemaking Portal: http://www.regulations.gov. In the Search box, enter the docket number for this proposed rule, which is FWS-HQ-ES-2015-0171. Then click on the Search button. 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!” Please ensure that you have found the correct document before submitting your comment.

    By hard copy: Submit by U.S. mail or hand delivery to: Public Comments Processing, Attn: Docket No. FWS-HQ-ES-2015-0171, U.S. Fish and Wildlife Service, MS: BPHC, 5275 Leesburg Pike, Falls Church, VA 22041-3803.

    We will post all comments on http://www.regulations.gov. This generally means that we will post any personal information you provide us (see the Request for Information section, below, for more information).

    FOR FURTHER INFORMATION CONTACT:

    Jim Serfis, Chief, Branch of Conservation and Communications, U.S. Fish and Wildlife Service Headquarters, MS: ES, 5275 Leesburg Pike, Falls Church, VA 22041-3803; telephone 703-358-2171. If you use a telecommunications device for the deaf (TDD), call the Federal Information Relay Service (FIRS) at 800-877-8339.

    SUPPLEMENTARY INFORMATION: Background

    Through its Candidate Conservation program, one of the FWS's goals is to encourage the public to take specific conservation actions for declining species prior to them being listed under the ESA (16 U.S.C. 1531 et seq.). The cumulative outcome of such conservation actions may result in not needing to list a species; or may result in listing a species as threatened instead of endangered, and provide the basis for the species' recovery and eventual removal from the Federal List of Endangered and Threatened Wildlife. The Service put in place a voluntary conservation program for non-Federal property owners to help accomplish this goal: Candidate Conservation Agreements with Assurances (CCAAs). On June 17, 1999, the policy for this type of agreement (64 FR 32726) and implementing regulations in part 17 of title 50 of the Code of Federal Regulations (CFR) (64 FR 32706) were made final. On May 3, 2004, we published a final rule (69 FR 24084) to revise the CCAA regulations to make them easier to understand and implement by, among other things, defining “property owner” and by clarifying several points, including the transfer of permits, permit revocation, and advanced notification of take.

    To participate in a CCAA, non-Federal property owners agree to implement specific conservation actions on their land that reduce or eliminate threats to the species that are covered under the agreement. An ESA section 10(a)(1)(A) Enhancement of Survival permit is issued to the agreement participant providing a specific level of incidental take coverage should the property owner's agreed-upon conservation actions and routine property management actions (e.g., agricultural, ranching, or forestry activities) result in take of the covered species if listed. Property owners receive assurances that they will not be required to undertake any conservation actions other than those agreed to if new information indicates that additional or revised conservation measures are needed for the species, and they will not be subject to additional resource use or land use restrictions.

    Based on our experience reviewing and approving CCAAs over the past 16 years, we are proposing changes to the regulations that will clarify the level of conservation effort each agreement needs to include in order for FWS to approve an agreement and issue a permit.

    Purpose of Proposed Changes to Current Regulations at 50 CFR 17.22 and 17.32

    We are proposing changes to the CCAA regulations at 50 CFR 17.22(d) and 17.32(d) consistent with the proposed revisions to the CCAA policy published separately in today's Federal Register. The regulation changes are to (1) include the term “net conservation benefit” to clarify the level of conservation effort that is necessary in order to issue a permit associated with a CCAA and (2) eliminate references to “other necessary properties.”

    Under the current policy and regulations, to approve a CCAA we must “determine that the benefits of the conservation measures implemented by a property owner under a CCAA, when combined with those benefits that would be achieved if it is assumed that conservation measures were also to be implemented on other necessary properties, would preclude or remove any need to list the covered species.” The confusion created by the hypothetical concept of conservation measures needing to be implemented on “other necessary properties” is why we are clarifying and revising the CCAA standard to require a net conservation benefit to the covered species specifically on the property to be enrolled and eliminating references to “other necessary properties.”

    In concert with the proposed revisions to our CCAAs policy, published elsewhere in today's Federal Register, these changes to the regulations would help reassure landowners participating in CCAAs that additional conservation measures above and beyond those contained in the CCAA would not be required, and that additional land, water, or resource use restrictions would not be imposed upon them should a species that resides on their property become listed in the future.

    Request for Information

    Any final rule based on this proposal will consider information and recommendations submitted in a timely manner from all interested parties. We solicit comments, information, and recommendations from governmental agencies, Native American tribes, the scientific community, industry groups, environmental interest groups, and any other interested parties on this proposed rule. All comments and materials we receive by the date listed in DATES, above, will be considered prior to the approval of a final rule.

    You may submit your information concerning this proposed rule by one of the methods listed 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 personal identifying 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.

    Information and supporting documentation that we receive in response to this proposed rule will be available for you to review at http://www.regulations.gov, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service Headquarters (see FOR FURTHER INFORMATION CONTACT).

    Required Determinations Regulatory Planning and Review (Executive Orders 12866 and 13563)

    Executive Order 12866 provides that the Office of Management and Budget's Office of Information and Regulatory Affairs will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.

    Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements. This proposed rule is consistent with Executive Order 13563, and in particular with the requirement of retrospective analysis of existing rules, designed “to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.”

    Regulatory Flexibility Act

    Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 601 et seq.), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency, or his or her designee, certifies that the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We certify that, if adopted as proposed, this proposed rule would not have a significant economic effect on a substantial number of small entities.

    The proposed rule would revise the regulations governing issuance of an enhancement of survival permit in conjunction with a CCAA to clarify but not change current practice and does not place any new requirements on any non-Federal property owner that may seek to apply for approval of a CCAA.

    Paperwork Reduction Act of 1995 (PRA)

    This proposed rule does not contain any new collections of information that require approval by the Office of Management and Budget (OMB) under the PRA (44 U.S.C. 3501 et seq.). This proposed rule will not impose new recordkeeping or reporting requirements on State, local, or tribal governments; individuals; businesses; or organizations. OMB has reviewed and approved the application form that property owners use to apply for approval of a CCAA and associated enhancement of survival permit (Form 3-200-54) and assigned OMB Control Number 1018-0094, which expires January 31, 2017. We 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.

    Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.)

    In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.): (a) On the basis of information contained in the Regulatory Flexibility Act section above, this proposed rule would not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502, that this rule would not impose a cost of $100 million or more in any given year on local or State governments or private entities. A Small Government Agency Plan is not required. As explained above, small governments would not be affected because the proposed rule would not place additional requirements on any city, county, or other local municipalities.

    (b) This proposed rule would not produce a Federal mandate on State, local, or tribal governments or the private sector of $100 million or greater in any year; that is, this proposed rule is not a “significant regulatory action” under the Unfunded Mandates Reform Act. This proposed rule would impose no obligations on State, local, or tribal governments.

    Takings (E.O. 12630)

    In accordance with Executive Order 12630, this proposed rule would not have significant takings implications. This proposed rule would not pertain to “taking” of private property interests, nor would it directly affect private property. A takings implication assessment is not required because this proposed rule (1) would not effectively compel a property owner to suffer a physical invasion of property and (2) would not deny all economically beneficial or productive use of the land or aquatic resources. This proposed rule would substantially advance a legitimate government interest (conservation and recovery of endangered and threatened species) and would not present a barrier to all reasonable and expected beneficial use of private property.

    Federalism (E.O. 13132)

    In accordance with Executive Order 13132, we have considered whether this proposed rule would have significant Federalism effects and have determined that a federalism summary impact statement is not required. This proposed rule pertains only to approving enhancement of survival permits in conjunction with a CCAA under the ESA, and would not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government.

    Civil Justice Reform (E.O. 12988)

    This proposed rule does not unduly burden the judicial system and meets the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988. This proposed rule would clarify the issuance criteria for an enhancement of survival permit associated with a CCAA under the ESA.

    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, 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. We have considered possible effects on federally recognized Indian tribes and have preliminarily determined that there are no potential adverse effects of issuing this proposed rule. Our intent is to provide clarity in regard to the net conservation benefit requirements for a CCAA to be approved, including any agreements in which Tribes may choose to participate. We will continue to keep our tribal obligations in mind as we finalize this proposed rule.

    National Environmental Policy Act

    We analyzed the proposed regulations in accordance with the criteria of the National Environmental Policy Act (NEPA) (42 U.S.C. 4332(c)), the Council on Environmental Quality's Regulations for Implementing the Procedural Provisions of NEPA (40 CFR 1500-1508), and the Department of the Interior's NEPA procedures (516 DM 2 and 8; 43 CFR part 46) and determined that the proposed regulations are categorically excluded from NEPA documentation requirements consistent with 40 CFR 1508.4 and 43 CFR 46.210(i). This categorical exclusion applies to policies, directives, regulations, and guidelines that are “of an administrative, financial, legal, technical, or procedural nature.” This action does not trigger an extraordinary circumstance, as outlined in 43 CFR 46.215, applicable to the categorical exclusion. Therefore, the proposed regulations do not constitute a major Federal action significantly affecting the quality of the human environment.

    Energy Supply, Distribution or Use (E.O. 13211)

    Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This proposed rule, if made final, is not expected to affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.

    Clarity of This Proposed 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 or policy we publish must:

    (a) Be logically organized;

    (b) Use the active voice to address readers directly;

    (c) Use clear language rather than jargon;

    (d) Be divided into short sections and sentences; and

    (e) 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 proposed rule, your comments should be as specific as possible. For example, you should tell us 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.

    List of Subjects in 50 CFR Part 17

    Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.

    Accordingly, we propose to amend part 17, subchapter A of chapter IV, 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; 1531-1544; and 4201-4245, unless otherwise noted.

    2. Amend § 17.22 by revising paragraph (d)(8) to read as follows:
    § 17.22 Permits for scientific purposes, enhancement of propagation or survival, or for incidental taking.

    (d) * * *

    (8) Duration of the Candidate Conservation Agreement. The duration of a Candidate Conservation Agreement covered by a permit issued under this paragraph (d) must be sufficient to achieve a net conservation benefit, which is defined as the cumulative benefits of specific conservation measures designed to improve the status of a covered species by removing or minimizing threats, stabilizing populations, and increasing its numbers and improving its habitat.

    (i) The benefit would be measured by the projected increase in the species' population or improvement of the species' habitat, taking into account the duration of the Agreement and any off-setting adverse effects attributable to the incidental taking allowed by the enhancement of survival permit.

    (ii) The conservation measures and management activities covered by the agreement must be designed to reduce or eliminate those current and future threats on the property that are under the property owner's control, in order to increase the species populations or improve its habitat.

    (iii) In the case where the species and habitat is already adequately managed to the benefit of the species, a net conservation benefit will be achieved when the property owner commits to manage the species for a specified period of time with the anticipation that the population will increase or habitat quality will improve.

    3. Amend § 17.32 by revising paragraph (d)(8) to read as follows:
    § 17.32 Permits—general.

    (d) * * *

    (8) Duration of the Candidate Conservation Agreement. The duration of a Candidate Conservation Agreement covered by a permit issued under this paragraph (d) must be sufficient to achieve a net conservation benefit, which is defined as the cumulative benefits of specific conservation measures designed to improve the status of a covered species by removing or minimizing threats, stabilizing populations, and increasing its numbers and improving its habitat.

    (i) The benefit would be measured by the projected increase in the species' population or improvement of the species' habitat, taking into account the duration of the Agreement and any off-setting adverse effects attributable to the incidental taking allowed by the enhancement of survival permit.

    (ii) The conservation measures and management activities covered by the agreement must be designed to reduce or eliminate those current and future threats on the property that are under the property owner's control, in order to increase the species populations or improve its habitat.

    (iii) In the case where the species and habitat is already adequately managed to the benefit of the species, a net conservation benefit will be achieved when the property owner commits to manage the species for a specified period of time with the anticipation that the population will increase or habitat quality will improve.

    Dated: April 13, 2016. Noah Matson, Acting Director, U.S. Fish and Wildlife Service.
    [FR Doc. 2016-10483 Filed 5-3-16; 8:45 am] BILLING CODE 4333-15-P
    81 86 Wednesday, May 4, 2016 Notices DEPARTMENT OF AGRICULTURE Rural Utility Service Submission for OMB Review; Comment Request April 28, 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 June 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: Operating Reports for Telecommunications and Broadband Borrowers.

    OMB Control Number: 0572-0031.

    Summary of Collection: The Rural Utilities Service's (RUS) is a credit agency of the Department of Agriculture. The Rural Electrification Act of 1936, as amended (RE Act) (7 U.S.C. 901 et seq) authorizes the Secretary to make mortgage loans and loan guarantees to finance electric, telecommunications, broadband, and water and waste facilities in rural areas. In addition to providing loans and loan guarantees, one of RUS' main objectives is to safeguard loan security until the loan is repaid. The RE Act also authorizes the Secretary to make studies, investigations, and reports concerning the progress of borrowers' furnishing of adequate telephone service and publish and disseminate this information.

    Need and Use of the Information: Information from the Operating Report for both telecommunication and broadband borrowers provides RUS with vital financial information needed to ensure the maintenance of the security for the Government's loans and service data which enables RUS to ensure the provision of quality telecommunications and broadband service as mandated by the RE Act of 1936. Form 674, “Certificate of Authority to Submit or Grant Access to Data” will allow telecommunication and broadband borrowers to file electronic Operating Reports with the agency using the new USDA Data Collection System. Accompanied by a Board Resolution, it will identify the name and USDA e-Authentication ID for a certifier and security administrator that will have access to the system for purposes of filing electronic Operating Reports.

    Description of Respondents: Business or other for-profit; Not-for-profit institutions.

    Number of Respondents: 647.

    Frequency of Responses: Reporting: On occasion; Quarterly; Annually.

    Total Burden Hours: 8,525.

    Rural Utilities Service

    Title: Request for Release of Lien and/or Approval of Sale.

    OMB Control Number: 0572-0041.

    Summary of Collection: The Rural Utilities Service (RUS) is a credit agency of the U.S. Department of Agriculture (USDA) that makes mortgage loans and loan guarantees to finance electric, telecommunications, and water and waste facilities in rural areas. RUS manages loan programs in accordance with the Rural Electrification Act (RE Act) of 1936, 7 U.S.C. 901 et seq., as amended (RE Act). A 1949 amendment to the RE Act established the telephone program in RUS with the purpose of making loans to furnish and improve rural telephone service. Section 201 of the RE Act provides that loans shall not be made unless RUS finds and certifies that the security for the loan is reasonably adequate and that the loan will be repaid within the time agreed. In addition to providing loans and loan guarantees, one of RUS main objectives is to safeguard loan security until the loan is repaid.

    Need and Use of the Information: A borrower's assets provide the security for a Government loan. The selling of assets reduces the security and increases the risk of loss to the Government. A borrower seeking permission to sell some of its assets uses RUS Form 793. The form contains detailed information regarding the proposed sale. If the information in Form 793 is not collected when capital assets are sold, the capital assets securing the Government's loans could be liquidated and the Government's security either eliminated entirely or diluted to an undesirable level. This increases the risk of loss to the Government in the case of a default.

    Description of Respondents: Not-for-profit institutions; State, Local or Tribal Government.

    Number of Respondents: 40.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 100.

    Charlene Parker, Departmental Information Collection Clearance Officer.
    [FR Doc. 2016-10419 Filed 5-3-16; 8:45 am] BILLING CODE 3410-15-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Illinois Advisory Committee To Discuss Approval of a Draft Advisory Memorandum Regarding Civil Rights and Environmental Justice in the State AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Illinois Advisory Committee (Committee) will hold a meeting on Friday, May 06, 2016, at 12:00 p.m. CDT. The purpose of this meeting is to review and discuss approval of an advisory memorandum to be issued to the Commission regarding civil rights and environmental justice in the State. This memorandum is in support of the Commission's nationally focused 2016 statutory enforcement study.

    This meeting is available to the public through the following toll-free call-in number: 888-427-9419, conference ID: 7143536. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement at the end of the meeting. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.

    Member of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at [email protected] Persons who desire additional information may contact the Regional Programs Unit at (312) 353-8311.

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https://database.faca.gov/committee/meetings.aspx?cid=246. Click on the “Meeting Details” and “Documents” links to download. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

    Agenda Welcome and Introductions Review and Discussion of Advisory Memorandum: Environmental Justice in Illinois Open Comment Future Plans and Actions Adjournment

    Date: The meeting will be held on Friday, May 06, 2016, at 12:00 p.m. CDT.

    Public Call Information:

    Dial: 888-427-9419

    Conference ID: 7143536.

    Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstances of providing expedited information to the Commission for use in the agency's 2016 statutory enforcement report. Given the exceptional urgency of the events, the agency and advisory committee deem it important for the advisory committee to meet on the date given.

    FOR FURTHER INFORMATION CONTACT:

    Melissa Wojnaroski at [email protected] or 312-353-8311.

    Dated: April 28, 2016. David Mussatt, Chief, Regional Programs Unit.
    [FR Doc. 2016-10378 Filed 5-3-16; 8:45 am] BILLING CODE 6335-01-P
    DEPARTMENT OF COMMERCE International Trade Administration Meeting of the United States Manufacturing Council AGENCY:

    International Trade Administration, U.S. Department of Commerce.

    ACTION:

    Notice of an open meeting.

    SUMMARY:

    The United States Manufacturing Council (Council) will hold an open meeting via teleconference on Wednesday, May 18, 2016. The Council was established in April 2004 to advise the Secretary of Commerce on matters relating to the U.S. manufacturing industry. The purpose of the meeting is for Council members to review and deliberate on proposed recommendations by the Trade, Tax Policy, and Export Growth Subcommittee focused on tax policy and the Trans-Pacific Partnership and a proposed recommendation by the Workforce Subcommittee focused on career pathways to the manufacturing sector. The final agenda will be posted on the Department of Commerce Web site for the Council at http://www.trade.gov/manufacturingcouncil/, at least one week in advance of the meeting.

    DATES:

    Wednesday, May 18, 12 p.m.-1 p.m. The deadline for members of the public to register, including requests to make comments during the meeting and for auxiliary aids, or to submit written comments for dissemination prior to the meeting, is 5 p.m. EDT on May 11, 2016.

    ADDRESSES:

    The meeting will be held by conference call. The call-in number and passcode will be provided by email to registrants. Requests to register (including to speak or for auxiliary aids) and any written comments should be submitted to: U.S. Manufacturing Council, U.S. Department of Commerce, Room 4043, 1401 Constitution Avenue NW., Washington, DC, 20230; email: [email protected] Members of the public are encouraged to submit registration requests and written comments via email to ensure timely receipt.

    FOR FURTHER INFORMATION CONTACT:

    Archana Sahgal, U.S. Manufacturing Council, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230, telephone: 202-482-4501, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background: The Council advises the Secretary of Commerce on matters relating to the U.S. manufacturing industry.

    Public Participation: The meeting will be open to the public and will be accessible to people with disabilities. All guests are required to register in advance by the deadline identified under the DATES caption. Requests for auxiliary aids must be submitted by the registration deadline. Last minute requests will be accepted, but may be impossible to fill. There will be fifteen (15) minutes allotted for oral comments from members of the public joining the call. To accommodate as many speakers as possible, the time for public comments may be limited to three (3) minutes per person. Individuals wishing to reserve speaking time during the meeting must submit a request at the time of registration, as well as the name and address of the proposed speaker. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, the International Trade Administration may conduct a lottery to determine the speakers. Speakers are requested to submit a written copy of their prepared remarks by 5 p.m. EDT on May 11, 2016, for inclusion in the meeting records and for circulation to the members of the U.S. Manufacturing Council.

    In addition, any member of the public may submit pertinent written comments concerning the Council's affairs at any time before or after the meeting. Comments may be submitted to Archana Sahgal at the contact information indicated above. To be considered during the meeting, comments must be received no later than 5 p.m. EDT on May 11, 2016, to ensure transmission to the Council prior to the meeting. Comments received after that date and time will be distributed to the members but may not be considered on the call. Copies of Council meeting minutes will be available within 90 days of the meeting.

    Dated: April 29, 2016. Archana Sahgal, Executive Secretary, U.S. Manufacturing Council.
    [FR Doc. 2016-10545 Filed 5-2-16; 4:15 pm] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Notice of Intent To Grant Exclusive License AGENCY:

    National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).

    ACTION:

    Notice of intent.

    SUMMARY:

    Notice is hereby given that the U.S. Department of Commerce, National Oceanic and Atmospheric Administration (NOAA), intends to grant to Picarro, Inc. of Santa Clara, California, an exclusive global license to its rights in “Methods For Rapid Gas Sampling With High Horizontal Spatial Resolution In A Manner Suitable For Subsequent Constituent Gas Analysis”.

    DATES:

    Comments must be received on or before May 31, 2016.

    ADDRESSES:

    Send comments to NOAA Technology Partnerships Office, SSMC4 Room 7606, 1305 East West Highway, Silver Spring, Maryland 20910.

    FOR FURTHER INFORMATION CONTACT:

    Derek Parks, NOAA Technology Transfer Program Manager, at: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Federal Government's rights in this invention are assigned to the United States of America, as represented by the Secretary of Commerce. It is in the public interest to so license this invention, as Picarro, Inc. of Santa Clara, California, is a co-developer and co-patent holder for this technology. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published Notice, the NOAA Technology Partnerships Office receives written evidence and argument which establishes the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

    Dated: April 28, 2016. Jason Donaldson, Chief Financial Officer, Office of Oceanic and Atmospheric Research, National Oceanic and Atmospheric Administration.
    [FR Doc. 2016-10372 Filed 5-3-16; 8:45 am] BILLING CODE 3510-KD-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE525 Endangered and Threatened Species; Take of Anadromous Fish; Reopening of Comment Period AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.

    ACTION:

    Notice; availability of hatchery plan and request for comment; reopening of public comment period.

    SUMMARY:

    On March 28, 2016, the National Marine Fisheries Service (NMFS) announced the availability of a Hatchery and Genetic Management Plan (HGMP) pursuant to the protective regulations promulgated for Pacific salmon and steelhead under the Endangered Species Act (ESA). The HGMP, provided by the California Department of Fish and Wildlife, specifies the operation of a hatchery program rearing steelhead in the Mad River subbasin within the State of California. The announcement opened a 30-day public comment period on the HGMP and associated draft environmental assessment (EA). In response to a request received from the public, NMFS is reopening the comment period for an additional 15 days. This action reopens the comment period for the notice that published March 28, 2016.

    DATES:

    The comment period for the notice that published on March 28, 2016 (81 FR 17143) is reopened. Comments must be received at the appropriate address or fax number (see ADDRESSES) no later than 5:00 p.m. Pacific time on May 19, 2016.

    ADDRESSES:

    Written comments on the application should be addressed to the NMFS NOAA Fisheries West Coast Region California Coastal Office, 1655 Heindon Road, Arcata, California 95521, or faxed to 707-825-4840. Comments may be submitted by email. The mailbox address for providing email comments is: [email protected] Include in the subject line of the email comment the following identifier: Comments on the Mad River hatchery plan. The HGMP and associated draft EA are available on the Internet at www.westcoast.fisheries.noaa.gov.

    FOR FURTHER INFORMATION CONTACT:

    Dan Free, at phone number: (707) 825-5164, or via email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Reopening

    The notice (81 FR 17143) published in the Federal Register on March 28, 2016, with a 30-day comment period that closed on April 27, 2016. In response to a request received from the public, NMFS is reopening the comment period for an additional 15 days.

    Species Covered in This Notice

    Chinook salmon (Oncorhynchus tshawytscha): threatened, naturally produced and artificially propagated California Coastal.

    Coho salmon (O. kisutch): threatened, naturally produced and artificially propagated Southern Oregon/Northern California (SONCC).

    Steelhead (O. mykiss): threatened, naturally produced and artificially propagated Northern California.

    Background

    CDFW has submitted to NMFS an HGMP describing a hatchery program that releases steelhead into the Mad River, in northern California, for consideration pursuant to limit 5 of the ESA 4(d) rule for salmon and steelhead.

    The hatchery program that is the subject of the NMFS evaluation would operate to provide steelhead for harvest in freshwater recreational fisheries in the Mad River. The program would propagate steelhead that are derived from the local steelhead population in the Mad River, ensuring that at least half of the MRH winter-run steelhead spawning pairs are hatchery spawned natural-origin and to match natural-origin steelhead with their natural counterparts whenever possible. Measures would be applied in the hatchery program to reduce the risk of incidental adverse genetic, ecological, and demographic effects on natural-origin steelhead and salmon populations.

    As specified in the July 10, 2000, ESA 4(d) rule for salmon and steelhead (65 FR 42422) and updated June 28, 2005 (70 FR 37160), NMFS may approve an HGMP if it meets criteria set forth in 50 CFR 223.203(b)(5)(i)(A) through (K). Prior to final approval of an HGMP, NMFS must publish notification announcing its availability for public review and comment.

    Authority

    Under section 4 of the ESA, the Secretary of Commerce is required to adopt such regulations as she deems necessary and advisable for the conservation of species listed as threatened. The ESA salmon and steelhead 4(d) rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005) specifies categories of activities that contribute to the conservation of listed salmonids and sets out the criteria for such activities. Limit 5 of the updated 4(d) rule (50 CFR 223.203(b)(5)) further provides that the prohibitions of paragraph (a) of the updated 4(d) rule (50 CFR 223.203(a)) do not apply to activities associated with artificial propagation programs provided that an HGMP has been approved by NMFS to be in accordance with the salmon and steelhead 4(d) rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005).

    Dated: April 28, 2016. Angela Somma, Chief, Endangered Species Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-10380 Filed 5-3-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE581 Fisheries of the Exclusive Economic Zone Off Alaska; Stock Assessment of Eastern Bering Sea Pollock; Peer Review Meeting AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    NMFS has requested the Center for Independent Experts (CIE) to conduct a peer review of the agency's stock assessment of Eastern Bering Sea walleye pollock (Theragra chalcogramma). The CIE is a group affiliated with the University of Miami that provides independent peer reviews of NMFS science nationwide, including reviews of stock assessments for fish and marine mammals. The Eastern Bering Sea pollock stock assessment is reviewed annually by the Alaska Fisheries Science Center, the North Pacific Fishery Management Council (NPFMC) Plan Team, and the NPFMC Scientific and Statistical Committee. The CIE review will examine whether the assessment incorporates the best available scientific information and provides a reasonable approach to understanding the population dynamics and stock status of Eastern Bering Sea pollock. The public is invited to attend and observe the presentations and discussions between the CIE panel and the NMFS scientists who collected and processed the data, and designed the underlying model.

    DATES:

    The public meeting will be held from May 16 through May 19, 2016, 9 a.m. to 5 p.m. Pacific Daylight Time.

    ADDRESSES:

    The review will be held at the NMFS Alaska Fisheries Science Center, 7600 Sand Point Way NE., Building 4, Seattle, WA 98115. Photo identification is required to enter this facility.

    FOR FURTHER INFORMATION CONTACT:

    James Ianelli, 206-526-6510.

    SUPPLEMENTARY INFORMATION:

    The CIE panel will consist of three peer reviewers who will assess materials related to the topic, participate in a review workshop with the NMFS scientists who developed the model and the analytical approach, and produce a report. This review will be highly technical in nature and will cover mathematical details of the analytical approach. More information about the CIE is available on its Web site at www.ciereviews.org.

    Members of the public are invited to observe, and will be provided opportunities to contribute each day from May 16 through May 19, 2016. The final report will be available prior to the September NPFMC Plan Team meetings and will consist of individual reports from each panelist and a summary report. The results of the review will be presented during the September 2016 NPFMC Plan Team meeting, which will be announced at a later time in the Federal Register.

    Special Accommodations

    These workshops will be physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Ron Felthoven, 206-526-4114, at least 10 working days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: April 29, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-10445 Filed 5-3-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE592 Endangered and Threatened Species; Take of Anadromous Fish AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice of intent to prepare an Environmental Impact Statement; request for comments.

    SUMMARY:

    Pursuant to the National Environmental Policy Act (NEPA), this notice announces that NMFS intends to obtain information necessary to prepare an Environmental Impact Statement (EIS) for 10 Hatchery and Genetic Management Plans (HGMPs) for salmon and steelhead hatchery programs jointly submitted by the Washington Department of Fish and Wildlife (WDFW) with the Muckleshoot Indian Tribe and the Suquamish Tribe (referred to as the co-managers), for NMFS's evaluation and determination under Limit 6 of the Endangered Species Act (ESA) 4(d) Rule for threatened salmon and steelhead. The HGMPs specify the propagation of salmon and steelhead in the Duwamish-Green River basin in Washington State.

    NMFS provides this notice to advise other agencies and the public of its plans to analyze effects related to the action, and obtain suggestions and information that may be useful to the scope of issues and alternatives to include in the EIS.

    DATES:

    Written or electronic scoping comments must be received at the appropriate address or email mailbox (see ADDRESSES) no later than 5 p.m. Pacific Time June 3, 2016.

    ADDRESSES:

    Written comments may be sent by any of the following methods:

    Email to the following address: [email protected] with the following identifier in the subject line: Green Hatcheries EIS.

    • Mail or hand-deliver to NMFS Sustainable Fisheries Division, 510 Desmond Drive SE., Suite 103, Lacey, WA 98503.

    • Fax to (360) 753-9517.

    Comments received will be available for public inspection, by appointment, during normal business hours at the above address. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.

    FOR FURTHER INFORMATION CONTACT:

    Steve Leider, NMFS, by phone at (360) 753-4650, or email to [email protected]

    SUPPLEMENTARY INFORMATION:

    ESA-Listed Species Covered in This Notice

    Steelhead (Oncorhynchus mykiss): threatened, naturally and artificially produced in Puget Sound.

    Chinook salmon (O. tshawytscha): threatened, naturally and artificially produced in Puget Sound.

    Chum salmon (O. keta): threatened, naturally and artificially produced Hood Canal summer-run.

    Bull trout (Salvelinus confluentus): threatened Puget Sound/Washington Coast.

    Background

    The WDFW, Muckleshoot Indian Tribe, and Suquamish Tribe have jointly submitted to NMFS HGMPs for 10 hatchery programs in the Duwamish-Green River basin in Washington State. The HGMPs were submitted to NMFS from 2013 to 2015, pursuant to limit 6 of the 4(d) Rule for salmon and steelhead. The hatchery programs include releases of ESA-listed Chinook salmon and winter-run steelhead into the Duwamish-Green River basin. The hatchery programs also release non-listed coho and fall-run chum salmon and summer-run steelhead into the Duwamish-Green River basin. One hatchery program releases coho salmon into marine waters adjacent to the Duwamish-Green River basin. Seven of the programs are currently operating, and three are new.

    NEPA requires Federal agencies to conduct environmental analyses of their proposed major actions to determine if the actions may affect the human environment. NMFS's action of determining under Limit 6 of the 4(d) Rule for salmon and steelhead that implementation of the co-managers' HGMPs would not appreciably reduce the likelihood of survival and recovery of affected threatened ESUs is a major Federal action subject to environmental review under NEPA. Therefore, NMFS is seeking public input on the scope of the required NEPA analysis, including the range of reasonable alternatives, recommendations for relevant analysis methods, and information associated with impacts of the alternatives to the resources listed below or other relevant resources.

    NMFS will perform an environmental review of the HGMPs and prepare an EIS that will identify potentially significant direct, indirect, and cumulative impacts on the following resources identified to have a potential for effect from the proposed action:

    • Listed and Non-listed Species and their habitats • Water Quantity • Socioeconomics • Environmental Justice • Cumulative Impacts

    NMFS will rigorously explore and objectively evaluate a full range of reasonable alternatives in the EIS, including the proposed action and a no-action alternative. Other alternatives may include a decreased production alternative.

    For all potentially significant impacts, the EIS will identify measures to avoid, minimize, and mitigate the impacts, where feasible.

    Request for Comments

    NMFS provides this notice to: (1) Advise other agencies and the public of its plans to analyze effects related to the action, and (2) obtain suggestions and information that may be useful to the scope of issues and the full range of alternatives to include in the EIS.

    NMFS invites comment from all interested parties to ensure that the full range of issues related to the 10 salmon and steelhead HGMPs is identified. Comments should be as specific as possible.

    Written comments concerning the proposed action and the environmental review should be directed to NMFS as described above (see ADDRESSES). All comments and materials received, including names and addresses, will become part of the administrative record and may be released to the public.

    Authority

    The environmental review of the 10 salmon and steelhead HGMPs in the Duwamish-Green River basin of Washington State will be conducted in accordance with requirements of the NEPA of 1969 as amended (42 U.S.C. 4321 et seq.), NEPA Regulations (40 CFR parts 1500 through 1508), other appropriate Federal laws and regulations, and policies and procedures of NMFS for compliance with those regulations. This notice is being furnished in accordance with 40 CFR 1501.7 to obtain suggestions and information from other agencies and the public on the scope of issues and alternatives to be addressed in the EIS.

    Dated: April 29, 2016. Angela Somma, Chief, Endangered Species Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-10426 Filed 5-3-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE601 Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for Exempted Fishing Permits AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice; request for comments.

    SUMMARY:

    The Assistant Regional Administrator for Sustainable Fisheries, Greater Atlantic Region, NMFS, has made a preliminary determination that an Exempted Fishing Permit application contains all of the required information and warrants further consideration. This Exempted Fishing Permit would allow eight commercial fishing vessels to fish outside of the limited access sea scallop regulations in support of a study on seasonal bycatch distribution and optimal scallop meat yield on Georges Bank.

    Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed Exempted Fishing Permits.

    DATES:

    Comments must be received on or before May 19, 2016.

    ADDRESSES:

    You may submit written comments by any of the following methods:

    Email: [email protected] Include in the subject line “DA16-024 CFF Georges Bank Optimization Study EFP.”

    Mail: John K. Bullard, Regional Administrator, NMFS, Greater Atlantic Regional Fisheries Office, 55 Great Republic Drive, Gloucester, MA 01930. Mark the outside of the envelope “DA16-024 CFF Georges Bank Optimization Study EFP.”

    FOR FURTHER INFORMATION CONTACT:

    Shannah Jaburek, Fisheries Management Specialist, 978-282-8456.

    SUPPLEMENTARY INFORMATION:

    Coonamesset Farm Foundation (CFF) has submitted a proposal titled “Optimizing the Georges Bank Scallop Fishery by Maximizing Meat Yield and Minimizing Bycatch,” that has been favorably reviewed and is pending final approval by NOAA's Grants Management Division under the 2016 Atlantic Sea Scallop Research Set-Aside (RSA) Program.

    CFF submitted a complete application for an exempted fishing permit (EFP) on March 7, 2016. The project would look primarily at seasonal distribution of bycatch on the northern part of Georges Bank in relation to sea scallop meat weight yield while minimizing impacts to other stocks. Additional objectives include continued testing of a modified scallop dredge bag design to reduce flatfish bycatch and collecting biological samples to examine scallop meat quality and yellowtail flounder liver disease. Project investigators working on this project would also work in cooperation with New Hampshire Fish and Game (NHFG) and the Atlantic Offshore Lobstermen's Association (AOLA) to tag lobsters. CFF is requesting exemptions that would exempt eight commercial fishing vessels from the Atlantic sea scallop days-at-sea (DAS) allocations at 50 CFR 648.53(b); crew size restrictions at § 648.51(c); observer program requirements at § 648.11(g); Closed Area II (CAII) scallop gear restrictions specified at 648.81(b); and access area program requirements at § 648.60(a)(4). It would also exempt vessels from possession limits and minimum size requirements specified in 50 CFR part 648, subsections B and D through O, and 50 CFR 697.20 for sampling and tagging purposes only.

    Vessels would conduct scallop dredging in a year-round seasonal study on a total of eight 7-day trips, for a total of 56 DAS. Each trip would complete approximately 70 paired tows per trip for an overall total of 520 tows for the project. Closed Area II tows would take place in the central portion situated below the Closed Area II Habitat Closure Area, including the northern portion of Atlantic Sea Scallop Closed Area II Rotational Closed Area. Open area tows would be conducted on the northern half of Georges Bank, west of the boundary of Closed Area II. Although the proposed project included tow locations inside the Closed Area II Habitat Closure Area, we will not be authorizing tows in that area, consistent with previous requests by CFF to conduct dredging in this area. We will not grant access to the Habitat Closure Area for this project until a final outcome from the Omnibus Habitat Amendment II is determined.

    There is a potential for gear conflict with lobster gear in the central portion of Closed Area II. In an effort to help mitigate gear interactions, the project coordinator would distribute the time and location of stations to the lobster industry, work only during daylight hours, post an extra lookout to avoid gear, and conduct fishing operations in a way that avoids tangling in stationary gear. We do not expect the DAS, crew size, possession limits, or minimum size exemptions to generate any controversy or concern about the potential catch of egg-bearing female lobsters in this area during the months of June-October. The project would work in cooperation with NHFG and AOLA to tag lobsters with the primary goal of documenting their movement on and off Georges Bank. CFF would like to use data from the tagging project to provide data on the discard mortality of lobsters in the scallop fishery.

    All tows would be conducted with two tandem 15-foot (4.6-m) turtle deflector dredges for a duration of 30 minutes using an average tow speed of 4.8 knots. One dredge would be rigged with a 7-row apron and twine top hanging ratio of 2:1, while the other dredge would be rigged with a 5-row apron and 1.5:1 twine top hanging ratio. Both dredge frames would be rigged with identical rock and tickler chain configurations, 10-inch (25.4-cm) twine top, and 4-inch (10.2-cm) ring bag.

    For all tows the entire sea scallop catch would be counted into baskets and weighed. One basket from each dredge would be randomly selected and the scallops would be measured in 5-milimeter increments to determine size selectivity. All finfish catch would be sorted by species and then counted and measured. Weight, sex, and reproductive state would be determined for a random subsample (n = 10) of yellowtail, winter, and windowpane flounders. Lobsters would be measured, sexed, and evaluated for damage and shell disease. With the exception of samples retained for further processing, no catch would be retained for longer than needed to conduct sampling and no catch would be landed for sale. All catch estimates for the project are listed in the table below.

    Project Catch Estimates Species lb kg Scallops 7,500 3,402 Yellowtail Flounder 1,600 726 Winter Flounder 2,500 1,134 Windowpane Flounder 6,300 2,858 Summer Flounder 2,800 1,270 Fourspot Flounder 400 181 American Plaice Flounder 50 23 Witch Flounder 100 45 Haddock 100 45 Atlantic Cod 100 45 Monkfish 9,600 4,354 Spiny Dogfish 300 136 Barndoor Skate 2,800 1,270 Northeast Skate Complex 140,000 63,503 American Lobster 900* * American lobster value is number of individuals.

    CFF needs these exemptions to allow them to conduct experimental dredge towing without being charged DAS, as well as deploy gear in areas that are currently closed to scallop fishing. Participating vessels need crew size waivers to accommodate science personnel. Possession waivers would enable researchers to sample finfish and lobster catch that exceeds possession limits or prohibitions. The project would be exempt from the sea scallop observer program requirements because activities conducted on the trip are not consistent with normal fishing operations.

    If approved, the applicant may request minor modifications and extensions to the EFP throughout the year. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate completion of the proposed research and have minimal impacts that do not change the scope or impact of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: April 28, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-10449 Filed 5-3-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Department of the Air Force Notice of Intent To Prepare an Environmental Impact Statement for the Presidential Aircraft Recapitalization Program at Joint Base Andrews-Naval Air Facility, Washington, Maryland AGENCY:

    United States Air Force, Department of Defense.

    ACTION:

    Notice of intent.

    SUMMARY:

    The United States Air Force (Air Force) is issuing this notice to advise the public of its intent to prepare an Environmental Impact Statement (EIS) for the Presidential Aircraft Recapitalization (PAR) Program at Joint Base Andrews-Naval Air Facility, Washington, Maryland (JBA). The EIS will assess the potential environmental consequences of the proposal to beddown versions of the Boeing 747-8 passenger aircraft at JBA as replacements to the two existing VC-25A aircraft currently used to transport the President of the United States (POTUS).

    DATES:

    The Air Force plans to hold one daytime and one nighttime public scoping meeting, at the locations and times below:

    1. Daytime Scoping Meeting: Veterans of Foreign Wars Post 9619, 6527 Suitland Road, Morningside, MD 20746, on Tuesday, May 24th, 2016 from 9:00- 11:00 a.m.

    2. Nighttime Scoping Meeting: Veterans of Foreign Wars Post 9619, 6527 Suitland Road, Morningside, MD 20746, on Monday, May 23rd, 2016 from 6:00-8:00 p.m.

    ADDRESSES:

    Additional information on the PAR Program and the EIS/EIAP process can be accessed at the project Web site at www.parprogrameis.com, and the JBA Web site at www.andrews.af.mil. Inquiries and comments-by-mail regarding the USAF proposal should be directed to AFCEC/CZN, 2261 Hughes Ave., Ste. 155, JBSA-Lackland, TX 78236-9853, ATTN: Mr. John Guerra.

    The project Web site can also be used to submit scoping comments and scoping comments may also be submitted by mail to the address listed below. Comments will be accepted at any time during the Environmental Impact Analysis Process (EIAP). However, to ensure the Air Force has sufficient time to consider public input in the preparation of the Draft EIS, scoping comments should be submitted to the Web site or the address listed below by May 28th, 2016.

    SUPPLEMENTARY INFORMATION:

    The aircraft replacement was requested by the White House in April 2006 and was approved by the Secretary of the Air Force in a Strategic Basing decision on June 12, 2012. The EIS will assess the potential environmental consequences of bedding down the new aircraft, including construction of a new Presidential Complex with a multi-bay hangar facility, other necessary facility improvements and relocation of select facilities displaced by PAR activities. Facilities potentially requiring relocation include the Hazardous Cargo Pad (HCP), the Explosive Ordnance Disposal (EOD) Proficiency Range, the Joint Air Defense Operations Center (JADOC) Satellite Site, areas of the existing golf course, and the Military Working Dog (MWD) Kennel. The EIS will analyze various alternatives for implementing the Proposed Action at JBA (beddown and operations of a new aircraft) including a No Action Alternative. The Air Force is preparing this EIS in accordance with National Environmental Policy Act (NEPA) of 1969; 40 Code of Federal Regulations (CFR), Parts 1500-1508, the Council on Environmental Quality (CEQ) regulations implementing NEPA; and the USAF Environmental Impact Analysis Process (EIAP) [32 CFR part 989].

    Scoping and Agency Coordination: To effectively define the full range of issues and concerns to be evaluated in the EIS, the Air Force is soliciting scoping comments from interested local, state and federal agencies and interested members of the public. This NOI also serves to provide early notice of compliance with Executive Order (EO) 11990, “Protection of Wetlands” and EO 11988, “Floodplain Management.” State and federal regulatory agencies with special expertise in wetlands and floodplains have been contacted to request comment. The Air Force will hold two scoping meetings to inform the public as well as to solicit comments and concerns about the proposal. Scoping meetings will be held in the local community. Scheduled dates, locations, and addresses for each meeting will be published in the Washington Post, Prince George's County Gazette, and the Andrews Gazette newspapers a minimum of fifteen (15) days prior to each meeting.

    Anh Trinh, Air Force Federal Register Liaison Officer.
    [FR Doc. 2016-10401 Filed 5-3-16; 8:45 am] BILLING CODE 5001-10-P
    DEPARTMENT OF EDUCATION National Advisory Committee on Institutional Quality and Integrity Meeting AGENCY:

    National Advisory Committee on Institutional Quality and Integrity (NACIQI), Office of Postsecondary Education, U.S. Department of Education.

    ACTION:

    Announcement of the time and location of a meeting.

    SUMMARY:

    This meeting notice is an update to the previous notice published in the Federal Register (81 FR 14846) on March 18, 2016, and sets forth the time and location for the June 22-24, 2016 meeting of the National Advisory Committee on Institutional Quality and Integrity (NACIQI). The notice of this meeting is required under Section 10(a)(2) of the Federal Advisory Committee Act (FACA) and Section 114(d)(1)(B) of the Higher Education Act of 1965 (HEA), as amended.

    DATES:

    The NACIQI meeting will be held on June 22-24, 2016, from 8:30 a.m. to 5:30 p.m., at the DoubleTree by Hilton Washington DC Crystal City, 300 Army Navy Drive, Arlington, VA 22202.

    ADDRESSES:

    U.S. Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW., Room 6W250, Washington, DC 20202.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Hong, Executive Director/Designated Federal Official, NACIQI, U.S. Department of Education, 400 Maryland Avenue SW., Room 6W250, Washington, DC 20202, telephone: (202) 453-7805, or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    NACIQI's Statutory Authority and Function: The NACIQI is established under Section 114 of the HEA of 1965, as amended, 20 U.S.C. 1011c. The NACIQI advises the Secretary of Education about:

    • The establishment and enforcement of the criteria for recognition of accrediting agencies or associations under Subpart 2, Part H, Title IV, of the HEA, as amended.

    • The recognition of specific accrediting agencies or associations or a specific State approval agency.

    • The preparation and publication of the list of nationally recognized accrediting agencies and associations.

    • The eligibility and certification process for institutions of higher education under Title IV, of the HEA, together with recommendations for improvement in such process.

    • The relationship between (1) accreditation of institutions of higher education and the certification and eligibility of such institutions, and (2) State licensing responsibilities with respect to such institutions.

    • Any other advisory function relating to accreditation and institutional eligibility that the Secretary may prescribe.

    Access to Records of the Meeting: The Department will post the official report of the meeting on the NACIQI Web site 90 days after the meeting. Pursuant to the FACA, the public may also inspect the materials at 400 Maryland Avenue SW., Washington, DC 20202, by emailing [email protected] or by calling (202) 453-7110 to schedule an appointment.

    Reasonable Accommodations: The meeting site is accessible to individuals with disabilities. If you will need an auxiliary aid or service to participate in the meeting (e.g., interpreting service, assistive listening device, or materials in an alternate format), notify the contact person listed in this notice at least two weeks before the scheduled meeting date. Although we will attempt to meet a request received after that date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.

    Electronic Access to this Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Authority:

    20 U.S.C. 1011c.

    Lynn B. Mahaffie, Deputy Assistant Secretary for Planning, Policy, and Innovation, delegated the duties of the Assistant Secretary for Postsecondary Education.
    [FR Doc. 2016-10414 Filed 5-3-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION Application for New Awards; Data Disaggregation Initiative Program AGENCY:

    Office of English Language Acquisition (OELA), Department of Education.

    ACTION:

    Notice.

    Overview Information: Title III National Activities—Asian American and Pacific Islander Data Disaggregation Initiative. Notice inviting applications for new awards for fiscal year (FY 2016).

    Catalog of Federal Domestic Assistance (CFDA) Number: 84.365D.

    Dates:

    Applications Available: May 4, 2016.

    Deadline for Notice of Intent to Apply: May 24, 2016.

    Deadline for Transmittal of Applications: July 5, 2016.

    Deadline for Intergovernmental Review: September 1, 2016.

    Full Text of Announcement I. Funding Opportunity Description

    Purpose of Program: In FY 2016, the Department will, from the Elementary and Secondary Education Act Title III National Activities funds, award grants on a competitive basis for the Asian American and Pacific Islander (AAPI) Data Disaggregation (D2) program. The grants will be awarded to State educational agencies (SEAs) in consortia with local educational agencies (LEAs) to obtain and evaluate disaggregated data on English Learner (EL) AAPI subpopulations beyond the existing seven racial and ethnic categories 1 within the school community.

    1 In 1997, the Office of Management and Budget created five categories for data on race: American Indian or Alaska Native; Asian; Black or African American; Native Hawaiian or Other Pacific Islander; and White; and two categories for data on ethnicity: “Hispanic or Latino” and “Not Hispanic or Latino.” These data standards stemmed in large measure from new responsibilities to enforce civil rights laws. Data are needed to monitor equal access in housing, education, employment, and other areas, for populations that historically had experienced discrimination and differential treatment because of their race or ethnicity.

    Background: There has been ongoing and increasing interest among States in using data to identify effective practices that can be used by educators to improve student outcomes in our education system and in disseminating those practices. Comprehensive data collection systems are integral to enabling States to identify and disseminate such practices.

    In addition, a number of States have found that disaggregated data on student performance is critical for identifying and developing strategies for closing educational opportunity gaps among different student groups. These efforts have included collecting additional data about K-12 students, disaggregating these data, and making this information available to educators and the public. Based on the educational gaps highlighted by disaggregated data, States, universities, and colleges have created programs to improve the college and career readiness of K-12 students who previously were underrepresented among those enrolled in higher education institutions.

    The AAPI population is one of the fastest 2 growing groups of students and includes a significant number of ELs. Some public universities have identified AAPI subgroups by socioeconomic characteristics and educational attainment. Using these disaggregated AAPI data has helped SEAs and LEAs identify barriers certain groups of underserved students face in K-12 and postsecondary education. Additional granular data on the AAPI subgroup, as shown by existing State and postsecondary efforts, enable SEAs and LEAs to make strategic and informed decisions on interventions for underserved populations that include ELs. Data that show disparities within subpopulations of the AAPI population can help demonstrate the need for differentiated instructional approaches and other effective intervention approaches for different components of the AAPI population—all with the result of improving outcomes for high-need EL students.

    2 Cox, W. (January 12, 2015). Asians: America's Fastest Growing Minority. www.newgeography.com/content/004825-asians-americas-fastest-growing-minority.

    To better serve all ELs, this competition encourages SEAs to partner with LEAs to further disaggregate the data beyond the seven racial and ethnic categories and analyze and evaluate that data, or analyze and evaluate already-disaggregated data as a first step to inform targeted services and instructional support for underserved students, and to increase transparency in order to spotlight hidden achievement and opportunity gaps for AAPI ELs.

    The Department is establishing two absolute priorities for this competition. Applicants must address one of the two absolute priorities: One for applications proposing to further disaggregate and evaluate data regarding AAPI EL students, and the other for applications proposing to identify improvements to instructional programs, initiatives, or other services for AAPI EL students based on an analysis of already disaggregated data.

    The Department also has included one invitational priority for projects that will establish sustained partnerships with non-profit organizations and other private entities. An applicant may address the invitational priority regardless of which absolute priority it addresses.

    To improve the quality of data available to inform the future activities of SEAs and LEAs to improve student learning outcomes, D2-funded projects must use a portion of their budgets to conduct a project evaluation. The detailed requirements for this evaluation can be found in the Program Requirements section of this notice.

    Priorities: We are establishing these priorities for the FY 2016 grant competition and any subsequent year in which we make awards from the list of unfunded applications from this competition, in accordance with section 437(d)(1) of the General Education Provisions Act (GEPA), 20 U.S.C. 1232(d)(1).

    Absolute Priorities: These priorities are absolute priorities. Under 34 CFR 75.105(c)(3) we consider only applications that meet one of these priorities. Under this competition, each absolute priority constitutes its own funding category. The Secretary intends to award grants under each absolute priority for which applications of sufficient quality are submitted. Applicants must choose one of the two absolute priorities, and must clearly identify the specific absolute priority that the proposed project addresses.

    These priorities are:

    Absolute Priority 1:

    The purpose of this priority is to fund projects proposed by SEAs that do not currently disaggregate AAPI data on EL AAPI subpopulations beyond the existing seven racial and ethnic categories. Applicants must propose projects that will, consistent with applicable privacy requirements, improve the SEA's system of data collection by further disaggregating the AAPI subgroup and other subgroups as determined by the applicant, beyond the existing seven racial and ethnic categories and report, analyze, and evaluate the results of this effort for underserved populations including EL AAPI students.

    Absolute Priority 2:

    The purpose of this priority is to fund projects proposed by SEAs whose data systems, consistent with applicable privacy requirements, currently disaggregate AAPI data on EL AAPI subpopulations beyond the existing seven racial and ethnic categories inclusive of other subgroups, if applicable. Applicants must propose projects that will analyze and evaluate the data to identify opportunity gaps, interventions, improvements to instructional programs, and other initiatives that will improve outcomes for underserved populations including EL AAPI students.

    Invitational Priority: For FY 2016 and any subsequent year in which we make awards from the list of unfunded applications from this competition, this priority is an invitational priority. Under 34 CFR 75.105(c)(1) we do not give an application that meets this invitational priority a competitive or absolute preference over other applications.

    This priority is:

    Invitational Priority:

    Projects that will establish sustained partnerships with non-profits or other private entities, including philanthropic organizations, to sustain the project beyond the life of the grant.

    Program Requirements:

    Applicants must provide a high-quality plan for disseminating the evaluative findings from their projects to inform educators, parents, families, and other stakeholders and to highlight lessons learned that may be used by other SEAs that undertake similar disaggregation efforts. SEA applicants must apply as part of a consortium with one or more LEAs, and also must identify the LEAs they intend to partner with for the purposes of this program.

    In addition, grantees funded under Absolute Priority 1 must, by the end of the five-year award period, conduct, complete, and report the findings of an evaluation of the project that includes the elements described in paragraphs 1 through 7, below. Grantees funded under Absolute Priority 2 must address the elements described in paragraphs 1 through 9, below, even though some of the described activities may have been conducted prior to the D2 award or may have otherwise been conducted with other funds not connected to the D2 project.

    This evaluation must be submitted within 90 days of the end of the project period.

    Required elements for both Absolute Priority 1 and 2:

    1. A description of the activities the project has undertaken.

    2. A description, including documentation, of the steps the SEA or partner LEA(s) took to identify the additional disaggregations for students in the AAPI subgroup as well as any other disaggregations that were undertaken.

    3. A description of how the SEA or partner LEA(s) identified the achievement and opportunity gaps between students in the AAPI subgroups and students in other racial/ethnic groups, including the source(s) of the data used for the comparison.

    4. A description of how achievement and opportunity gaps between ELs and non-ELs were identified, including the source of the data. (The SEA or partner LEA(s) must use the most recent available data for all public schools in the jurisdiction.)

    5. A discussion of the likely cause(s) of the identified achievement and opportunity gaps.

    6. A description of how the SEA or partner LEA(s) will publicly report on the identified achievement and opportunity gaps and causes, including timelines for this reporting.

    7. A plan for how the SEA or partner LEA(s) will use the information to eliminate the identified achievement and opportunity gaps, including how the SEA determined that these strategies will be effective. The plan must justify these proposed activities by tying them back to State/local needs and explain how ELs will be supported, in particular, through these activities.

    Additionally, grantees funded under Absolute Priority 2 must include the following elements:

    8. A description of the measures that the SEA or partner LEA(s) will use to evaluate the progress toward eliminating the identified achievement and opportunity gaps including the method and timeline for the evaluation and how the continued evaluation of this progress will be built into existing strategic plans (or other guidance documents).

    9. A description of how the SEA or partner LEA(s) will publicly report on its progress in eliminating the identified gaps, including timelines for this reporting.

    Definitions: The following definitions are from 34 CFR 77.1, section 8101 of the ESEA, as amended by the Every Student Succeeds Act (ESSA) (20 U.S.C. 7801), or 2 CFR 200.90, except that the definition for Asian American and Pacific Islander is being established under the waiver of rulemaking for this program.3 These definitions apply to the priorities and selection criteria in this notice. The source of each definition is noted in parentheses following the text of the definition.

    3 The definition for “Asian American and Pacific Islander” included in this notice also was set forth in Executive Order 13515, October 14, 2009 and can also be found on the White House Initiative for Asian American and Pacific Islanders Web site at: www.whitehouse.gov/aapi.

    Asian American and Pacific Islander means persons within the jurisdiction of the United States having ancestry of any of the original peoples of East Asia, Southeast Asia, or South Asia, or any of the aboriginal, indigenous, or native peoples of Hawaii and other Pacific Islands.

    Baseline means the starting point from which performance is measured and targets are set. (34 CFR 77.1)

    English learner, when used with respect to an individual, means an individual—

    (a) Who is aged 3 through 21;

    (b) Who is enrolled or preparing to enroll in an elementary school or secondary school;

    (c)(i) Who was not born in the United States or whose native language is a language other than English;

    (ii)(I) Who is a Native American or Alaska Native, or a Native resident of the outlying areas; and

    (II) Who comes from an environment where a language other than English has had a significant impact on the individual's level of English language proficiency; or

    (iii) Who is migratory, whose native language is a language other than English, and who comes from an environment where a language other than English is dominant; and

    (d) Whose difficulties in speaking, reading, writing, or understanding the English language may be sufficient to deny the individual—

    (i) The ability to meet the State's challenging State academic standards;

    (ii) The ability to successfully achieve in classrooms where the language of instruction is English; or

    (iii) The opportunity to participate fully in society. (Section 8101 of the ESEA, as amended by the ESSA)

    Local educational agency means:

    (a) In General. A public board of education or other public authority legally constituted within a State for either administrative control or direction of, or to perform a service function for, public elementary schools or secondary schools in a city, county, township, school district, or other political subdivision of a State, or of or for a combination of school districts or counties that is recognized in a State as an administrative agency for its public elementary schools or secondary schools.

    (b) Administrative Control and Direction. The term includes any other public institution or agency having administrative control and direction of a public elementary school or secondary school.

    (c) Bureau of Indian Education Schools. The term includes an elementary school or secondary school funded by the Bureau of Indian Education but only to the extent that including the school makes the school eligible for programs for which specific eligibility is not provided to the school in another provision of law and the school does not have a student population that is smaller than the student population of the local educational agency receiving assistance under this Act with the smallest student population, except that the school shall not be subject to the jurisdiction of any State educational agency other than the Bureau of Indian Education. (Section 8101 of the ESEA, as amended by the ESSA)

    Outlying area means:

    (a) American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and the United States Virgin Islands;

    (b) The Republic of Palau, to the extent permitted under section 105(f)(1)(B)(ix) of the Compact of Free Association Amendments Act of 2003 (Pub. L. 108-188; 117 Stat. 2751) and until an agreement for the extension of United States education assistance under the Compact of Free Association becomes effective for the Republic of Palau; and

    (c) The Republic of the Marshall Islands and the Federated States of Micronesia, to the extent permitted under section 105(f)(1)(B)(viii) of the Compact of Free Association Amendments Act of 2003 (Pub. L. 108-188; 117 Stat. 2751). (Section 8101 of the ESEA, as amended by the ESSA)

    State means each of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and each of the outlying areas. (Section 8101 of the ESEA, as amended by the ESSA)

    Waiver of Proposed Rulemaking: Under the Administrative Procedure Act (5 U.S.C. 553) the Department generally offers interested parties the opportunity to comment on proposed priorities, requirements, and definitions. Section 437(d)(1) of GEPA, however, allows the Secretary to exempt from rulemaking requirements, regulations governing the first grant competition under a new or substantially revised program authority. This is the first grant competition for this program under section 3111(c)(1)(C) of the ESEA, as reauthorized by the No Child Left Behind Act, 20 U.S.C. 6821(c)(1)(C), and therefore qualifies for this exemption. In order to ensure timely grant awards, the Secretary has decided to forego public comment on the priorities, requirements, and definition under section 437(d)(1) of GEPA. These priorities, and definition will apply to the FY 2016 grant competition and any subsequent year in which we make awards from the list of unfunded applications from this competition.

    Program Authority: 20 U.S.C. 6821.

    Applicable Regulations: (a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 75, 77, 79, 81, 82, 84, 97, 98, and 99. (b) The Office of Management and Budget Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted and amended in 2 CFR part 3474.

    II. Award Information

    Type of Award: Discretionary grants.

    Estimated Available Funds: $1,000,000.

    Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2017 or later years from the list of unfunded applications from this competition.

    Estimated Range of Awards: Absolute Priority 1: $200,000-$400,000; Absolute Priority 2: $100,000-$250,000.

    Estimated Average Size of Awards: Absolute Priority 1: $300,000; Absolute Priority 2: $175,000

    Estimated Number of Awards: Up to 4 total.

    Note: The Department is not bound by any estimates in this notice.

    Project Period: Up to 60 months.

    III. Eligibility Information

    1. Eligible Applicants: SEAs in consortia with one or more LEAs. (20 U.S.C. 6821)

    2. Cost Sharing or Matching: This program does not require cost sharing or matching.

    IV. Application and Submission Information

    1. Address to Request Application Package: You can obtain an application package via the Internet or from the Education Publications Center (ED Pubs). To obtain a copy via the Internet, use the following address: www.ed.gov/fund/grant/apply/grantapps/index.html. To obtain a copy from ED Pubs, write, fax, or call: ED Pubs, U.S. Department of Education, P.O. Box 22207, Alexandria, VA 22304. Telephone, toll free: 1-877-433-7827. FAX: (703) 605-6794. If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call, toll free: 1-877-576-7734.

    You can contact ED Pubs at its Web site, also: www.EDPubs.gov or at its email address: [email protected]

    If you request an application package from ED Pubs, be sure to identify this program or competition as follows: CFDA 84.365D.

    Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the person listed under Accessible Format in section VIII of this notice.

    2. a. Content and Form of Application Submission: Requirements concerning the content of an application, together with the forms you must submit, are in the application package for this competition.

    Notice of Intent To Apply: May 24, 2016.

    We will be able to develop a more efficient process for reviewing grant applications if we know the approximate number of applicants that intend to apply for funding under this competition. Therefore, the Secretary strongly encourages each potential applicant to notify us of the applicant's intent to submit an application by emailing [email protected] with the subject line “Intent to Apply” and include in the content of the email the following information: (1) The applicant organization's name and address, (2) the absolute priority the applicant is planning to address in the application, and (3) whether the applicant plans to address the invitational priority. In addition, applicants should identify the LEA(s) they intend to partner with. Applicants that do not provide notice of their intent to apply may still submit an application. Page Limit: The application narrative (Part III of the application) is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. We strongly recommend that you limit the application narrative to no more than 35 pages. Applicants are also strongly encouraged not to include lengthy appendices that contain information that they were unable to include within the page limits for the narrative.

    Applicants must use the following standards:

    • A “page” is 8.5″; x 11″, on one side only, with 1” margins at the top, bottom, and both sides.

    • Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions.

    • Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).

    • Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.

    The page limit for the application does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the one-page abstract, the bibliography, or the letters of support of the application. However, the page limit does apply to all of the application narrative section of the application.

    b. Submission of Proprietary Information: Given the types of projects that may be proposed in applications for the D2 program, your application may include business information that you consider proprietary. In 34 CFR 5.11 we define “business information” and describe the process we use in determining whether any of that information is proprietary and, thus, protected from disclosure under Exemption 4 of the Freedom of Information Act (5 U.S.C. 552, as amended).

    Consistent with the process followed in the prior OELA competitions, we may post the project narrative section of funded D2 applications on the Department's Web site. Therefore, you may wish to request confidentiality of business information. Identifying proprietary information in the submitted application will help facilitate this public disclosure process.

    Consistent with Executive Order 12600, please designate in your application any information that you believe is exempt from disclosure under Exemption 4. In the appropriate Appendix section of your application, under “Other Attachments Form,” please list the page number or numbers on which we can find this information. For additional information please see 34 CFR 5.11(c).

    3. Submission Dates and Times:

    Applications Available: May 4, 2016.

    Deadline for Notice of Intent to Apply: May 24, 2016.

    Informational Meetings: The D2 program intends to hold Webinars designed to provide technical assistance to interested applicants. Detailed information regarding these meetings will be provided on the D2 Web site at http://www2.ed.gov/programs/d2/index.html.

    Deadline for Transmittal of Applications: July 5, 2016.

    Applications for grants under this competition must be submitted electronically using the Grants.gov application site. For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to Other Submission Requirements in section IV of this notice.

    We do not consider an application that does not comply with the deadline requirements.

    Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice. If the Department provides an accommodation or auxiliary aid to an individual with a disability in connection with the application process, the individual's application remains subject to all other requirements and limitations in this notice.

    Deadline for Intergovernmental Review: September 1, 2016.

    4. Intergovernmental Review: This competition is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this competition.

    5. Funding Restrictions: We reference regulations outlining funding restrictions in the Applicable Regulations section of this notice.

    6. Data Universal Numbering System Number, Taxpayer Identification Number, and System for Award Management: To do business with the Department of Education, you must—

    a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);

    b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry), the Government's primary registrant database;

    c. Provide your DUNS number and TIN on your application; and

    d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.

    You can obtain a DUNS number from Dun and Bradstreet at the following Web site: http://fedgov.dnb.com/webform. A DUNS number can be created within one to two business days.

    If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.

    The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.

    Note: Once your SAM registration is active, it may be 24 to 48 hours before you can access the information in, and submit an application through, Grants.gov.

    If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.

    Information about SAM is available at www.SAM.gov. To further assist you with obtaining and registering your DUNS number and TIN in SAM or updating your existing SAM account, we have prepared a SAM.gov Tip Sheet, which you can find at: www2.ed.gov/fund/grant/apply/sam-faqs.html.

    In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page: www.grants.gov/web/grants/register.html.

    7. Other Submission Requirements:

    Applications for grants under this program must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.

    a. Electronic Submission of Applications.

    Applications for grants under the D2 program, CFDA number 84.365D, must be submitted electronically using the Governmentwide Grants.gov Apply site at www.Grants.gov. Through this site, you will be able to download a copy of the application package, complete it offline, and then upload and submit your application. You may not email an electronic copy of a grant application to us.

    We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement and submit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section under Exception to Electronic Submission Requirement.

    You may access the electronic grant application for the D2 program at www.Grants.gov. You must search for the downloadable application package for this competition by the CFDA number. Do not include the CFDA number's alpha suffix in your search (e.g., search for 84.365, not 84.365D).

    Please note the following:

    • When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.

    • Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.

    • The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.

    • You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at www.G5.gov. In addition, for specific guidance and procedures for submitting an application through Grants.gov, please refer to the Grants.gov Web site at: www.grants.gov/web/grants/applicants/apply-for-grants.html.

    • You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.

    • You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.

    • You must upload any narrative sections and all other attachments to your application as files in a read-only, non-modifiable Portable Document Format (PDF). Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF (e.g., Word, Excel, WordPerfect, etc.) or submit a password-protected file, we will not review that material. Please note that this could result in your application not being considered for funding because the material in question—for example, the project narrative—is critical to a meaningful review of your proposal. For that reason it is important to allow yourself adequate time to upload all material as PDF files. The Department will not convert material from other formats to PDF.

    • Your electronic application must comply with any page-limit requirements described in this notice.

    • After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. This notification indicates receipt by Grants.gov only, not receipt by the Department. Grants.gov will also notify you automatically by email if your application met all the Grants.gov validation requirements or if there were any errors (such as submission of your application by someone other than a registered Authorized Organization Representative, or inclusion of an attachment with a file name that contains special characters). You will be given an opportunity to correct any errors and resubmit, but you must still meet the deadline for submission of applications.

    Once your application is successfully validated by Grants.gov, the Department will retrieve your application from Grants.gov and send you an email with a unique PR/Award number for your application.

    These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by Grants.gov, it must also meet the Department's application requirements as specified in this notice and in the application instructions. Disqualifying errors could include, for instance, failure to upload attachments in a read-only, non-modifiable PDF; failure to submit a required part of the application; or failure to meet applicant eligibility requirements. It is your responsibility to ensure that your submitted application has met all of the Department's requirements.

    • We may request that you provide us original signatures on forms at a later date.

    Application Deadline Date Extension in Case of Technical Issues with the Grants.gov System: If you are experiencing problems submitting your application through Grants.gov, please contact the Grants.gov Support Desk, toll free, at 1-800-518-4726. You must obtain a Grants.gov Support Desk Case Number and must keep a record of it.

    If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.

    If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice and provide an explanation of the technical problem you experienced with Grants.gov, along with the Grants.gov Support Desk Case Number. We will accept your application if we can confirm that a technical problem occurred with the Grants.gov system and that the problem affected your ability to submit your application by 4:30:00 p.m., Washington, DC time, on the application deadline date. We will contact you after we determine whether your application will be accepted.

    Note: The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.

    Exception to Electronic Submission Requirement: You qualify for an exception to the electronic submission requirement, and may submit your application in paper format, if you are unable to submit an application through the Grants.gov system because—

    • You do not have access to the Internet; or

    • You do not have the capacity to upload large documents to the Grants.gov system;

    and

    • No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.

    If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.

    Address and mail or fax your statement to: Melissa Escalante, U.S. Department of Education, 400 Maryland Avenue SW., Room 5C153, Washington, DC 20202-6510. FAX: (202) 205-1229.

    Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.

    b. Submission of Paper Applications by Mail.

    If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.365D), LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.

    You must show proof of mailing consisting of one of the following:

    (1) A legibly dated U.S. Postal Service postmark.

    (2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.

    (3) A dated shipping label, invoice, or receipt from a commercial carrier.

    (4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.

    If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:

    (1) A private metered postmark.

    (2) A mail receipt that is not dated by the U.S. Postal Service.

    Note: The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.

    We will not consider applications postmarked after the application deadline date.

    c. Submission of Paper Applications by Hand Delivery.

    If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address:

    U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.365D), 550 12th Street SW., Room 7039, Potomac Center Plaza, Washington, DC 20202-4260.

    The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.

    Note for Mail or Hand Delivery of Paper Applications: If you mail or hand deliver your application to the Department—

    (1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and

    (2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.

    V. Application Review Information

    1. Selection Criteria: The selection criteria for this competition are from 34 CFR 75.210. The maximum score for all of these criteria is 100 points. The maximum score for each criterion is indicated in parentheses.

    (a) Quality of the project design. (Up to 45 points)

    The Secretary considers the quality of the design of the proposed project. In determining the quality of the design of the proposed project, the Secretary considers:

    (1) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable.

    (2) The extent to which the design for implementing and evaluating the proposed project will result in information to guide possible replication of project activities or strategies including information about the effectiveness of the approach or strategies employed by the project.

    (b) Quality of project personnel. (Up to 10 points)

    The Secretary considers the quality of the personnel who will carry out the proposed project. In determining the quality of project personnel, the Secretary considers:

    (1) The extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.

    (2) The qualifications, including relevant training and experience, of key project personnel.

    (c) Quality of the management plan. (Up to 20 points)

    The Secretary considers the quality of the management plan for the proposed project. In determining the quality of the management plan for the proposed project, the Secretary considers:

    (1) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks.

    (2) The extent to which the time commitments of the project director and principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project.

    (d) Quality of the project evaluation. (Up to 25 points) The Secretary considers the quality of the evaluation to be conducted of the proposed project. In determining the quality of the evaluation, the Secretary considers:

    (1) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project.

    (2) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes.

    2. Review and Selection Process: The Department will screen applications that are submitted for D2 grants in accordance with the requirements in this notice and determine which applications meet the eligibility and other requirements. Reviewers will review all eligible applications for D2 grants that are submitted by the established deadline.

    Applicants should note, however, that the Department may screen for eligibility at multiple points during the competition process, including before and after peer review; applicants that are determined to be ineligible will not receive a grant award regardless of peer reviewer scores or comments. If we determine that a D2 grant application does not meet a D2 requirement, the application will not be considered for funding.

    For D2 grant applications, the Department intends to conduct a process to review and score all eligible applications. Reviewers will review and score all eligible applications on the following four selection criteria: (a) Quality of the project design; (b) Quality of project personnel; (c) Quality of the management plan; and (d) Quality of evaluation.

    We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

    In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

    3. Risk Assessment and Special Conditions: Consistent with 2 CFR 200.205, before awarding grants under this program the Department conducts a review of the risks posed by applicants. Under 2 CFR 3474.10, the Secretary may impose special conditions and, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

    VI. Award Administration Information

    1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN); or we may send you an email containing a link to access an electronic version of your GAN. We may notify you informally, also.

    If your application is not evaluated or not selected for funding, we notify you.

    2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice.

    We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

    3. Reporting: (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

    (b) Within 90 days of the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. The elements of the report are detailed in the Program Requirements section of this notice above.

    If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to www.ed.gov/fund/grant/apply/appforms.html.

    (c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.

    4. Performance Reporting: All grantees must submit an annual performance report that should contain the following elements on the project's progress: Preface, introduction, background, and data information/explanation; and a final performance report (see the section on Program Requirements) that includes performance measures established by the grantee. The Department will consider this data in making annual continuation awards. 34 CFR 75.110(b).

    Consistent with 34 CFR 75.591, grantees funded under this program shall comply with the requirements of any evaluation of the program conducted by the Department or an evaluator selected by the Department.

    5. Continuation Awards: In making a continuation award under 34 CFR 75.253, the Secretary considers, among other things: Whether a grantee has made substantial progress in achieving the goals and objectives of the project; whether the grantee has expended funds in a manner that is consistent with its approved application and budget; and, if the Secretary has established performance measurement requirements, the performance targets in the grantee's approved application.

    In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

    VII. Agency Contact FOR FURTHER INFORMATION CONTACT:

    Melissa Escalante, U.S. Department of Education, 400 Maryland Avenue SW., Room 5C153, Washington, DC 20202. Telephone: (202) 401-4300. FAX: (202) 205-1229 or by email at [email protected]

    If you use a TDD or a TTY, call the Federal Relay Service, toll free, at 1-800-877-8339.

    VIII. Other Information

    Accessible Format: Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or PDF. To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Dated: April 28, 2016. Libia S. Gil, Assistant Deputy Secretary and Director for the Office of English Language Acquisition.
    [FR Doc. 2016-10345 Filed 5-3-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy H2 Refuel H-Prize Schedule Update AGENCY:

    Office of Energy Efficiency and Renewable Energy, Department of Energy (DOE).

    ACTION:

    Notice of Schedule Update to the H2 Refuel H-Prize Competition Guidelines.

    SUMMARY:

    In this notice, DOE is extending the completion schedule for its H2 Refuel H-Prize competition. On October 28, 2014, the Department of Energy (DOE) announced the $1 million competition in the Federal Register, allowing teams from across the United States to compete to develop systems that generate and dispense hydrogen from resources commonly available to residences (electricity or natural gas) for use in homes, community centers, businesses or similar locations, to supplement the current infrastructure roll-out and reduce barriers to using hydrogen fuel cell electric vehicles. These Guidelines were updated in a September 3, 2015, Federal Register notice. Both the original and updated guidelines included a competition schedule. A delay in announcing the finalist selection significantly reduced the period for system construction before the start of the originally planned testing period. The announcement was originally planned for December 2015 to provide seven months for the system build as described by the guidelines. However, the announcement was delayed until January 29, 2016. Therefore, DOE is updating the completion schedule to allow a reasonable construction period.

    DATES:

    Key Upcoming Dates.

    —Summer 2016: Finalist system testing begins —Fall 2016: Competition ends, data will be analyzed to determine winner —Early 2017: Anticipated award of $1 million prize, if the Panel of Judges determines that there is a winning entry. ADDRESSES:

    The H-Prize Web site is http://hydrogenprize.org, where updates and announcements will be posted throughout the competition.

    FOR FURTHER INFORMATION CONTACT:

    Questions may be directed to—Technical information: Katie Randolph at 240-562-1759 or by email at [email protected]

    Prize contest: Emanuel Wagner, Contest Manager, Hydrogen Education Foundation, at 202-457-0868 x360 or by email at [email protected].

    SUPPLEMENTARY INFORMATION:

    The Department of Energy (DOE) announced the $1 million H2 Refuel H-Prize competition in the Federal Register on October 28, 2014 (79 FR 64179). The Guidelines were updated in a September 3, 2015 Federal Register notice (80 FR 53286). The competition opened on October 29, 2014. The preliminary data submission date was October 29, 2015. In this notice, DOE updates the completion schedule for the competition, as described in the DATES section.

    Issued in Washington, DC, on April 28, 2016. Sunita Satyapal, Fuel Cell Technology Office Director.
    [FR Doc. 2016-10425 Filed 5-3-16; 8:45 am] BILLING CODE 6450-01-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: RP16-838-000.

    Applicants: Natural Gas Pipeline Company of America.

    Description: § 4(d) Rate Filing: Calpine Energy Services to be effective 5/1/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5201.

    Comments Due: 5 p.m. ET 4/25/16.

    Docket Numbers: RP16-839-000.

    Applicants: Alliance Pipeline L.P.

    Description: § 4(d) Rate Filing: Daily Service April 13-30 2016 to be effective 4/13/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5236.

    Comments Due: 5 p.m. ET 4/25/16.

    Docket Numbers: RP16-840-000.

    Applicants: Southeast Supply Header, LLC.

    Description: Compliance filing SESH RP16-511 Compliance Filing to be effective 4/1/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5245.

    Comments Due: 5 p.m. ET 4/25/16.

    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: RP16-415-001.

    Applicants: Florida Gas Transmission Company, LLC.

    Description: Compliance filing Compliance with RP16-415-000 NAESB Order to be effective 4/1/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5080.

    Comments Due: 5 p.m. ET 4/25/16.

    Docket Numbers: RP16-436-001.

    Applicants: Sea Robin Pipeline Company, LLC.

    Description: Compliance filing Compliance with RP16-436-000 NAESB Order to be effective 4/1/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5081.

    Comments Due: 5 p.m. ET 4/25/16.

    Docket Numbers: RP16-444-001.

    Applicants: Leaf River Energy Center LLC.

    Description: Compliance filing Leaf River Energy Center LLC—Order No. 587-W Directed Changes to be effective 4/1/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5148.

    Comments Due: 5 p.m. ET 4/25/16.

    Docket Numbers: RP16-471-001.

    Applicants: Gulf States Transmission LLC.

    Description: Compliance filing Compliance with RP16-471 NAESB Order to be effective 4/1/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5084.

    Comments Due: 5 p.m. ET 4/25/16.

    Docket Numbers: RP16-546-001.

    Applicants: Dominion Transmission, Inc.

    Description: Compliance filing DTI—RP16-546 NAESB Compliance to be effective 4/1/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5083.

    Comments Due: 5 p.m. ET 4/25/16.

    Docket Numbers: RP16-547-001.

    Applicants: Dominion Cove Point LNG, LP.

    Description: Compliance filing DCP—(RP16-547) NAESB Compliance to be effective 4/1/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5079.

    Comments Due: 5 p.m. ET 4/25/16.

    Docket Numbers: RP16-550-001.

    Applicants: Transwestern Pipeline Company, LLC.

    Description: Compliance filing Compliance with RP16-550 NAESB Order to be effective 4/1/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5082.

    Comments Due: 5 p.m. ET 4/25/16.

    Docket Numbers: RP16-559-001.

    Applicants: Horizon Pipeline Company, L.L.C.

    Description: Compliance filing Compliance Filing to be effective 4/1/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5123.

    Comments Due: 5 p.m. ET 4/25/16.

    Docket Numbers: RP16-560-001.

    Applicants: Kinder Morgan Louisiana Pipeline LLC.

    Description: Compliance filing Compliance Filing to be effective 4/1/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5127.

    Comments Due: 5 p.m. ET 4/25/16.

    Docket Numbers: RP16-564-001.

    Applicants: Natural Gas Pipeline Company of America.

    Description: Compliance filing Compliance Filing to be effective 4/1/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5124.

    Comments Due: 5 p.m. ET 4/25/16.

    Docket Numbers: RP16-568-001.

    Applicants: Kinder Morgan Illinois Pipeline LLC.

    Description: Compliance filing Compliance Filing Substitute Sheets for Order 587-W to be effective 4/1/2016.

    Filed Date: 4/13/16.

    Accession Number: 20160413-5096.

    Comments Due: 5 p.m. ET 4/25/16.

    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: April 14, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-10411 Filed 5-3-16; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9941-83-OEI] Agency Information Collection Activities OMB Responses AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    This document announces the Office of Management and Budget (OMB) responses to Agency Clearance requests, in compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). 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. The OMB control numbers for EPA regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

    FOR FURTHER INFORMATION CONTACT:

    Courtney Kerwin (202) 566-1669, or email at [email protected] and please refer to the appropriate EPA Information Collection Request (ICR) Number.

    SUPPLEMENTARY INFORMATION:

    OMB Responses to Agency Clearance Requests OMB Approvals

    EPA ICR Number 2449.02; Water Quality Standards Regulatory Clarifications (Final Rule); 40 CFR part 131; was approved without change on 12/31/2015; OMB Number 2040-0286; expires on 12/31/2018.

    EPA ICR Number 1039.14; Monthly Progress Reports (Renewal); 48 CFR part 1552.211; was approved with change on 12/30/2015; OMB Number 2030-0005; expires on 12/31/2018.

    EPA ICR Number 2137.07; NESHAP for Coal- and Oil-fired Electric Utility Steam Generating Units (Renewal); 40 CFR part 63, subparts A and UUUUU; was approved without change on 12/23/2015; OMB Number 2060-0567; expires on 12/31/2018.

    EPA ICR Number 2268.04; NESHAP for Paint Stripping and Miscellaneous Surface Coating at Area Sources (Renewal); 40 CFR part 63, subparts HHHHHH and A; was approved without change on 12/22/2015; OMB Number 2060-0607; expires on 12/31/2018.

    EPA ICR Number 1983.07; NESHAP for Carbon Black, Ethylene, Cyanide, and Spandex (Renewal); 40 CFR part 63, subparts A and YY; was approved without change on 12/22/2015; OMB Number 2060-0489; expires on 12/31/2018.

    EPA ICR Number 1055.11; NSPS for Kraft Pulp Mills (Renewal); 40 CFR part 60, subparts A and BB; was approved without change on 12/22/2015; OMB Number 2060-0021; expires on 12/31/2018.

    EPA ICR Number 1831.06; NESHAP for Ferroalloys Production: Ferromanganese and Silicomanganese (Renewal); 40 CFR part 63, subpart XXX; was approved without change on 12/22/2015; OMB Number 2060-0391; expires on 12/31/2018.

    EPA ICR Number 2237.04; NESHAP for Gasoline Distribution Bulk Terminals, Bulk Plants, Pipeline Facilities and Gasoline Dispensing Facilities (Renewal); 40 CFR part 63, subparts A, BBBBBB and CCCCCC; was approved without change on 12/22/2015; OMB Number 2060-0620; expires on 12/31/2018.

    EPA ICR Number 2152.05; Clean Air Interstate Rule to Reduce Interstate Transport of Fine Particle Matter and Ozone (Renewal); 40 CFR parts 51 and 96; was approved without change on 12/22/2015; OMB Number 2060-0570; expires on 12/31/2018.

    EPA ICR Number 2385.06; Emission Guidelines for Commercial and Industrial Solid Waste Incineration (CISWI) units (Renewal); 40 CFR part 60, subpart DDDD; was approved without change on 12/22/2015; OMB Number 2060-0664; expires on 12/31/2018.

    EPA ICR Number 2170.06; Revisions to the Air Emissions Reporting Requirements: Revisions to Lead (Pb) Reporting Threshold and Clarifications to Technical Reporting Details (Final Rule); 40 CFR part 51; was approved without change on 12/22/2015; OMB Number 2060-0580; expires on 12/31/2018.

    EPA ICR Number 1748.10; State Small Business Stationary Source Technical and Environmental Compliance Assistance Programs (SBTCP) Annual Reporting Form (Renewal); was approved without change on 12/21/2015; OMB Number 2060-0337; expires on 12/31/2018.

    EPA ICR Number 1676.06; Clean Air Act Tribal Authority (Renewal); 40 CFR parts 9, 35, 49, 50, and 81; was approved without change on 12/18/2015; OMB Number 2060-0306; expires on 12/31/2018.

    EPA ICR Number 1617.08; Servicing of Motor Vehicle Air Conditioners (Renewal); 40 CFR part 82; was approved without change on 12/17/2015; OMB Number 2060-0247; expires on 12/31/2018.

    EPA ICR Number 1395.09; Emergency Planning and Release Notification Requirements under Emergency Planning and Community Right-to-Know Act Sections 302, 303, and 304 (Renewal); 40 CFR part 355; was approved without change on 12/16/2015; OMB Number 2050-0092; expires on 12/31/2018.

    EPA ICR Number 1352.13; Community Right-to-Know Reporting Requirements Under Sections 311 and 312 of the Emergency Planning and Community Right-to-Know Act (EPCRA) (Renewal); 40 CFR part 370; was approved with change on 12/16/2015; OMB Number 2050-0072; expires on 12/31/2018.

    EPA ICR Number 0370.25; Underground Injection Control (UIC) Program (Renewal); 40 CFR parts 144, 145, 146, 147, 148, and 124; was approved with change on 12/8/2015; OMB Number 2040-0042; expires on 12/31/2018.

    EPA ICR Number 1506.12; NSPS for Municipal Waste Combustors (Renewal); 40 CFR part 60, subparts A, Ea, and Eb; was approved with change on 12/1/2015; OMB Number 2060-0210; expires on 12/31/2018.

    EPA ICR Number 1985.06; NESHAP for Leather Finishing Operations (Renewal); 40 CFR part 63, subparts A and TTTT; was approved with change on 12/1/2015; OMB Number 2060-0478; expires on 12/31/2018.

    EPA ICR Number 0982.11; NSPS for Metallic Mineral Processing Plants (Renewal); 40 CFR part 60, subparts A and LL; was approved with change on 12/1/2015; OMB Number 2060-0016; expires on 12/31/2018.

    EPA ICR Number 1964.06; NESHAP for Wet-Formed Fiberglass Mat Production (Renewal); 40 CFR part 63, subparts A and HHHH; was approved with change on 12/1/2015; OMB Number 2060-0496; expires on 12/31/2018.

    EPA ICR Number 1807.08; NESHAP for Pesticide Active Ingredient Production (Renewal); 40 CFR part 63, subparts A and MMM; was approved without change on 12/1/2015; OMB Number 2060-0370; expires on 12/31/2018.

    Comment Filed

    EPA ICR Number 2519.01; Hazardous Waste Export-Import Revisions (Proposed Rule); 40 CFR part 262, subparts E, H, F; OMB filed comment on 12/15/2015.

    EPA ICR Number 1692.08; NESHAP for Petroleum Refineries (Proposed Rule); 40 CFR part 63, subpart CC; OMB filed comment on 12/15/2015.

    Courtney Kerwin, Acting Director, Collections Strategies Division.
    [FR Doc. 2016-10361 Filed 5-3-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION Senior Executive Service Performance Review Board

    As required by the Civil Service Reform Act of 1978 (Pub. L. 95-454), Chairman Thomas Wheeler appointed the following executive to the Senior Executive Service Performance Review Board (PRB): Jon S. Wilkins, Jr.

    Federal Communications Commission.

    Marlene H. Dortch, Secretary.
    [FR Doc. 2016-10355 Filed 5-3-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0292, 3060-0719] Information Collections Being Submitted for Review and Approval to the Office of Management and Budget 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 Office of Management and Budget (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 comments should be submitted on or before June 3, 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 contacts below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicholas A. Fraser, OMB, via email [email protected]; and to Nicole Ongele, FCC, via email [email protected] and to [email protected] Include in the comments the OMB control number as shown in the SUPPLEMENTARY INFORMATION section below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page http://www.reginfo.gov/public/do/PRAMain, (2) look for the section of the Web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of FCC ICRs currently under review appears, look for the OMB control number of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0292.

    Title: Section 69.605, Reporting and Distribution of Pool Access Revenues, Part 69—Access Charges.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit.

    Number of Respondents and Responses: 1,064 respondents; 12,757 responses.

    Estimated Time per Response: 0.75 hours—1 hour.

    Frequency of Response: Annual and monthly reporting requirements and third party disclosure requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154, 201, 202, 203, 205, 218 and 403 of the Communications Act of 1934, as amended.

    Total Annual Burden: 9,568 hours.

    Total Annual Cost: No cost.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality.

    Needs and Uses: The Commission is requesting approval for an extension (no change in the reporting and/or third party disclosure requirements).

    Due to consolidation in the telecommunications marketplace, there is a decrease in the Commission's burden estimates. Section 69.605 requires that access revenues and cost data shall be reported by participants in association tariffs to the association for computation of monthly pool revenues distributions. The association shall submit a report on or before February 1 of each calendar year describing the associations' cost study review process for the preceding calendar year as well as the results of that process. For any revisions to the cost study results made or recommended by the association that would change the respective carrier's calculated annual common line or traffic sensitive revenue requirement by ten percent or more, the report shall include the following information:

    (1) Name of the carrier;

    (2) A detailed description of the revisions;

    (3) The amount of the revisions;

    (4) The impact of the revisions on the carrier's calculated common line and traffic sensitive revenue requirements; and

    (5) The carrier's total annual common line and traffic sensitive revenue requirement. The information is used to compute charges in tariffs for access service (or origination and termination) and to compute revenue pool distributions. Neither process could be implemented without the information.

    OMB Control Number: 3060-0719.

    Title: Quarterly Report of Local Exchange Carriers Listing Payphone Automatic Number Identifications (ANIs).

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents and Responses: 400 respondents; 1,600 responses.

    Estimated Time per Response: 3.5 hours (8 hours for the initial submission; 2 hours per subsequent submission—for an average of 3.5 hours per response).

    Frequency of Response: Quarterly reporting requirement, recordkeeping requirement and third party disclosure requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151, 154, 201-205, 215, 218, 219, 220, 226 and 276 of the Communications Act of 1934, as amended.

    Total Annual Burden: 5,600 hours.

    Total Annual Cost: No cost.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: The Commission is not requesting respondents to submit confidential information to the Commission. If the respondents wish confidential treatment of their information, they may request confidential treatment under 47 CFR 0.459 of the Commission's rules.

    Needs and Uses: The Commission adopted rules and policies governing the payphone industry under section 276(b)(1)(A) of the Telecommunications Act of 1996 (the Act) and established “a per call compensation plan to ensure that all payphone service providers are fairly compensated for each and every completed intrastate and interstate call.” Pursuant to this mandate, and as required by section 64.1310(d) of the Commission's rules, Local Exchange Carriers (LECs) must provide to carriers required to pay compensation pursuant to section 64.1300(a), a quarterly report listing payphone ANIs. Without provision of this report, resolution of disputed ANIs would be rendered very difficult. Carriers would not be able to discern which ANIs pertain to payphones and therefore would not be able to ascertain which dial-around calls were originated by payphones for compensation purposes. There would be no way to guard against possible fraud. Without this collection, lengthy investigations would be necessary to verify claims. The report allows carriers to determine which dial-around calls are made from payphones. The information must be provided to third parties. The requirement would be used to ensure that LECs and the carriers required to pay compensation pursuant to 47 CFR 64.1300(a) of the Commission's rules comply with their obligations under the Telecommunications Act of 1996.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2016-10354 Filed 5-3-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0537] Information Collection Being Submitted for Review and Approval to the Office of Management and Budget 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 Office of Management and Budget (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 comments should be submitted on or before June 3, 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 contacts below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicholas A. Fraser, OMB, via email [email protected]; and to Cathy Williams, FCC, via email [email protected] and to [email protected] Include in the comments the OMB control number as shown in the Supplementary Information section below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page http://www.reginfo.gov/public/do/PRAMain, (2) look for the section of the Web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of FCC ICRs currently under review appears, look for the OMB control number of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0537.

    Title: Sections 13.9(c), 13.13(c), 13.17(b), 13.211(e) and 13.217, Commercial Operator License Examination Managers (COLEM) Records.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents: 659 respondents; 659 responses.

    Estimated Time per Response: .44 hours to 30 hours.

    Frequency of Response: Recordkeeping requirement and on occasion reporting requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information

    collection is contained in 47 U.S.C. 154 and 303 of the Communications Act of 1934.

    Total Annual Burden: 14,796 hours.

    Total Annual Cost: No cost.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Needs and Uses: The Commission will submit this expiring information collection after this comment period to obtain the full, three year clearance from the Office of Management and Budget (OMB). The Commission is requesting approval for a three year extension. The rule sections approved under this collections are 47 CFR 13.9, 13.13, 13.17 13.211 and 13.217. If the information collection requirements were not kept or fulfilled it is conceivable that examinees could be overcharged and that fraud and deceit could be used for unjust enrichment of the examiners.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2016-10353 Filed 5-3-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL MARITIME COMMISSION [Docket No. 16-10] Notice of Filing of Complaint and Assignment

    Rush Truck Centers of Arizona, Inc., Rush Truck Centers of California, Inc., Rush Truck Centers of Colorado, Inc., Rush Truck Centers of Florida, Inc., Rush Truck Centers of Georgia, Inc., Rush Truck Centers of Idaho, Inc., Rush Truck Centers of Kansas, Inc., Rush Truck Centers of North Carolina, Inc., Rush Truck Centers of Ohio, Inc., Rush Truck Centers of Oklahoma, Inc., Rush Truck Centers of Texas, LP., Rush Truck Centers of Utah, Inc., On Behalf of Themselves and All others similarly situated V. Nippon Yusen Kabushiki Kaisha, Nyk Line (North America) Inc., Mitsui O.S.K. Lines, Ltd., Mitsui O.S.K. Bulk Shipping (USA), Inc., World Logistics Service (USA) Inc., Höegh Autoliners as, Höegh Autoliners, Inc., Nissan Motor Car Carriers Co. Ltd., Kawasaki Kisen Kaisha, Ltd., “K” Line America, Inc., Wallenius Wilhelmsen Logistics as, Wallenius Wilhelmsen Logistics Americas LLC, Eukor Car Carriers Inc., CompaÑíA Sud Americana De Vapores S.A., and CSAV Agency North America, LLC.

    Notice is given that a Complaint has been filed with the Federal Maritime Commission (Commission) by the above named Complainants, “on behalf of themselves and all others similarly situated, hereinafter “Complainants,” against the above named “providers of Vehicle Carrier Services”, hereinafter “Respondents.” The Complaint is brought as a proposed class action. Complainants “seek to represent classes of truck and heavy equipment dealers in approximately 30 states . . . who purchased new Vehicles . . . that included in their prices Vehicle Carrier Services from any Respondent, unnamed co-conspirator, or any current or former subsidiary or affiliate thereof . . . . ” Complainants allege that Respondents “transport large numbers of cars, medium- and heavy-duty trucks, and other new, assembled motor vehicles including buses, commercial vehicles, construction equipment, mining equipment, and agricultural equipment . . . across oceans and other large bodies of water using specialized cargo ships known as Roll On-Roll Off vessels (“RoRos”).”

    Complainants allege that Respondents violated provisions of the Shipping Act of 1984, including 46 U.S.C. 40302(a), 41102(b)(1), 41102(c), 41103(a)(1) and (2), 41104(10), 41105(1) and (6), and the Commission's regulations at 46 CFR 535.401 et seq., because they “participated in a combination and conspiracy to suppress and eliminate competition in the Vehicle Carrier Services market by agreeing to fix, raise, stabilize and/or maintain the prices of, and allocation [sic] the market and customers for Vehicle Carrier Services sold to Vehicle manufacturers (“OEMs”) in the United States and elsewhere for the import and export of new, assembled Vehicles to and from the United States.”

    Complainants request the following relief:

    “(1) That Respondents be required to answer the charges herein;

    (2) That after due investigation and hearing Respondents be found to have violated 46 U.S.C. 40302(a), 41102(b)(l), 41102(c), 41103(a)(l) and (2), 41104(10), 41105(1) and (6), and 46 CFR 535.401, et seq., and such other provisions as to which violations may be proved hereunder;

    (3) The FMC determine that this action may be maintained as a class action under Rule 23(a), (b)(2) and (b)(3) of the Federal Rules of Civil Procedure, and direct that reasonable notice of this action, as provided by Rule 23(c)(2) of the Federal Rules of Civil Procedure, be given to each and every member of the Truck and Equipment Dealer Class;

    (4) That Complainants be awarded reparations in a sum to be proven under 46 U.S.C. 41305, with interest (46 U.S.C. 41305(a)) and reasonable attorneys' fees (46 U.S.C. 41305(b));

    (5) That Complainants be awarded double its proven actual injury under 46 U.S.C. 41305(c) because Respondents and their co-conspirators violated 46 U.S.C. 41102(b) and 41105(1);

    (6) That Respondents be found jointly and severally liable for the conduct alleged herein, including that of their co-conspirators; and

    (7) That such other and further order or orders be made as the FMC determines to be proper.

    The full text of the complaint can be found in the Commission's Electronic Reading Room at www.fmc.gov/16-10.

    This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by April 28, 2017 and the final decision of the Commission shall be issued by November 13, 2017.

    Karen V. Gregory, Secretary.
    [FR Doc. 2016-10340 Filed 5-3-16; 8:45 am] BILLING CODE 6731-AA-P
    FEDERAL MARITIME COMMISSION Notice of Agreements Filed

    The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the Federal Register. Copies of the agreements are available through the Commission's Web site (www.fmc.gov) or by contacting the Office of Agreements at (202)-523-5793 or [email protected]

    Agreement No.: 012405.

    Title: Crowley/Hoegh Space Charter Agreement.

    Parties: Crowley Latin America Services, LLC and Hoegh Autoliners AS.

    Filing Party: Wayne R. Rohde, Esq.; Cozen O'Connor LLP; 1200 Nineteenth St. NW., Washington, DC 20036.

    Synopsis: The Agreement authorizes Hoegh to charter space to Crowley in the trade between the U.S. Atlantic Coast and ports in Panama.

    Agreement No.: 012406.

    Title: COSCON/PIL Slot Exchange Agreement Asia—USWC.

    Parties: COSCO Container Lines Company, Limited and Pacific International Lines (PTE) Ltd.

    Filing Party: Eric. C. Jeffrey, Esq.; Nixon Peabody LLP; 799 9th Street NW., Suite 500, Washington, DC 20001.

    Synopsis: The agreement provides for the exchange of slots between COSCON and PIL on their respective services in the trade between the United States West Coast and China (including Hong Kong), Korea, Malaysia, Singapore, Vietnam, Sri Lanka, Togo, Ghana, Ivory Coast, and Nigeria.

    By Order of the Federal Maritime Commission.

    Dated: April 29, 2016. Rachel E. Dickon, Assistant Secretary.
    [FR Doc. 2016-10435 Filed 5-3-16; 8:45 am] BILLING CODE 6731-AA-P
    FEDERAL MARITIME COMMISSION [Docket No. 16-11] Notice of Filing of Complaint and Assignment

    Landers Brothers Auto Group, Inc. D/B/A Landers Honda (Jonesboro), Landers Brothers Auto No. 4, LLC D/B/A/Landers Honda (Pine Bluff), Individually and on Behalf of Others Similarly Situated v. Nippon Yusen Kabushiki Kaisha, NYK Line (North America) Inc., Mitsui O.S.K. Lines, Ltd., Mitsui O.S.K. Bulk Shipping (USA), Inc., World Logistics Service (USA) Inc., Höegh Autoliners AS, Höegh Autoliners, Inc., Nissan Motor Car Carriers Co. Ltd., Kawasaki Kisen Kaisha, Ltd., “K” Line America, Inc., Wallenius Wilhelmsen Logistics AS, Wallenius Wilhelmsen Logistics Americas LLC, Eukor Car Carriers Inc., Compañía SUD Americana De Vapores S.A., and CSAV Agency North America, LLC

    Notice is given that a Complaint has been filed with the Federal Maritime Commission (Commission) by the above named Complainants, “on behalf of themselves and all others similarly situated, hereinafter “Complainants,” against the above named “providers of Vehicle Carrier Services”, hereinafter “Respondents.” The Complaint is brought as a proposed class action. Complainants “seek to represent all Automobile Dealers in the United States who purchased motor vehicles incorporating a Vehicle Carrier Service charge charged by any Respondent or any current or former subsidiary or affiliate thereof, or any co-conspirator . . . .” Complainants allege that Respondents “transport large numbers of cars, trucks, and other automotive vehicles including agriculture and construction equipment . . . across large bodies of water using specialized cargo ships known as Roll On-Roll Off vessels (“RoRos”).”

    Complainants allege that Respondents violated provisions of the Shipping Act of 1984, including 46 U.S.C. 40302(a), 41102(b)(1), 41102(c), 41103(a)(1) and (2), 41104(10), 41105(1) and (6), and the Commission's regulations at 46 CFR 535.401 et seq., because they “participated in a combination and conspiracy to suppress and eliminate competition in the Vehicle Carrier Services market by agreeing to fix, raise, stabilize and/or maintain the prices of, and allocation [sic] the market and customers for Vehicle Carrier Services sold to automobile manufacturers and others in the United States, and elsewhere, for the import and export of motor vehicles to and from the United States.”

    Complainants request the following relief:

    (1) That Respondents be required to answer the charges herein;

    (2) That after due investigation and hearing Respondents be found to have violated 46 U.S.C. 40302(a), 41102(b)(l), 41102(c), 41103(a)(l) and (2), 41104(10), 41105(1) and (6), and 46 CFR 535.401, et seq., and such other provisions as to which violations may be proved hereunder;

    (3) The FMC determine that this action may be maintained as a class action under Rule 23(a), (b)(2) and (b)(3) of the Federal Rules of Civil Procedure, and direct that reasonable notice of this action, as provided by Rule 23(c)(2) of the Federal Rules of Civil Procedure, be given to each and every member of the Class;

    (4) That Complainants be awarded reparations in a sum to be proven under 46 U.S.C. 41305, with interest (46 U.S.C. 41305(a)) and reasonable attorneys' fees (46 U.S.C. 41305(b));

    (5) That Complainants be awarded double its proven actual injury under 46 U.S.C. 41305(c) because Respondents and their co-conspirators violated 46 U.S.C. 41102(b) and 41105(1);

    (6) That Respondents be found jointly and severally liable for the conduct alleged herein, including that of their co-conspirators; and

    (7) That such other and further order or orders be made as the FMC determines to be proper.

    The full text of the complaint can be found in the Commission's Electronic Reading Room at www.fmc.gov/16-11

    This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by April 28, 2017 and the final decision of the Commission shall be issued by November 13, 2017.

    Karen V. Gregory, Secretary.
    [FR Doc. 2016-10341 Filed 5-3-16; 8:45 am] BILLING CODE 6731-AA-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than May 16, 2016.

    A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:

    1. Henry Katz, Ada, Oklahoma and Sandra Beth Katz Sherry, Prairie Village, Kansas, Co-Trustees of the Barbara Katz Cobin Trust, Woodland Hills, California; Sandra Beth Sherry Trust, Prairie Village, Kansas; Marsha Katz Rothpan Trust, West Hills, California and Ronald D Lane Trust, Ada, Oklahoma, and all as members of the Vision Bancshares, Inc. Shareholders Agreement; to retain voting shares of Vision Bancshares, Inc., and thereby indirectly retain voting shares of Vision Bank, N.A., both in Ada, Oklahoma.

    Board of Governors of the Federal Reserve System, April 29, 2016. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2016-10433 Filed 5-3-16; 8:45 am] BILLING CODE 6210-01-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 May 31, 2016.

    A. Federal Reserve Bank of Minneapolis (Jacquelyn K. Brunmeier, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:

    1. Ascent Bancorp, Helena, Montana; to become a bank holding company by acquiring 100 percent of the voting shares of First Security Bank of Helena, Helena, Montana.

    Board of Governors of the Federal Reserve System, April 29, 2016. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2016-10432 Filed 5-3-16; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)

    In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention announces the following meeting of the aforementioned committee:

    Time and Date 11:00 a.m.-2:00 p.m. EDT, Wednesday, May 25, 2016

    Place: Audio Conference Call via FTS Conferencing.

    Status: Open to the public. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference at the USA toll-free, dial-in number, 1-866-659-0537 and the passcode is 9933701.

    Background: The Advisory Board was established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the new compensation program. Key functions of the Advisory Board include providing advice on the development of probability of causation guidelines, which have been promulgated by the Department of Health and Human Services (HHS) as a final rule; advice on methods of dose reconstruction, which have also been promulgated by HHS as a final rule; advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program; and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC).

    In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to the CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, rechartered on March 22, 2016 pursuant to Executive Order 13708, and will expire on September 30, 2017.

    Purpose: This Advisory Board is charged with (a) providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179; (b) providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and (c) upon request by the Secretary, HHS, advising the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class.

    Matters for Discussion: The agenda for the conference call includes: Work Group and Subcommittee Reports; SEC Petitions Update for the August 2016 Advisory Board Meeting; Plans for the August 2016 Advisory Board Meeting; and Advisory Board Correspondence.

    Contact Person for More Information: Theodore M. Katz, M.P.A., Designated Federal Officer, NIOSH, CDC, 1600 Clifton Rd. NE., Mailstop: E-20, Atlanta, GA 30333, Telephone (513) 533-6800, Toll Free 1-800-CDC-INFO, Email [email protected]

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Catherine Ramadei, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2016-10420 Filed 5-3-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

    The meeting announced below concerns Health Promotion and Disease Prevention Research Centers: Special Interest Project Competitive Supplements (SIPS), DP16-006, initial review.

    Summary: This document corrects a notice that was published in the Federal Register on April 21, 2016, Volume 81, Number 77, page 23497. This meeting is cancelled in its entirety.

    Contact Person for More Information: Brenda Colley Gilbert, Ph.D., M.S.P.H., Director, Extramural Research Program Operations and Services, CDC, 4770 Buford Highway NE., Mailstop F-80, Atlanta, Georgia 30341, Telephone: (770) 488-6295, [email protected]

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Catherine Ramadei, Acting Director, Management Analysis and Services Office Centers for Disease Control and Prevention.
    [FR Doc. 2016-10422 Filed 5-3-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Request for Nominations of Candidates To Serve on the Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC)

    The Centers for Disease Control and Prevention (CDC) is soliciting nominations for membership on the BCCEDCAC. The committee provides advice and guidance to the Secretary, HHS, and the Director, CDC, regarding the early detection and control of breast and cervical cancer. The committee makes recommendations regarding national program goals and objectives; implementation strategies; program priorities, including surveillance, epidemiologic investigations, education and training, information dissemination, professional interactions and collaborations, and policy.

    Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. The Secretary, HHS, acting through the Director, CDC, shall appoint to the advisory committee nominees with expertise in breast cancer, cervical cancer, medicine, public health, behavioral science, epidemiology, radiology, pathology, clinical medical care, health education, and surveillance. Two members may be representatives of the general public with personal experience in issues related to breast or cervical cancer early detection and control. Members may be invited to serve for up to four years.

    The next cycle of selection of candidates will conclude in the Summer of 2016, for selection of potential nominees to replace members whose terms will end on March 31, 2017.

    Selection of members is based on candidates' qualifications to contribute to the accomplishment of BCCEDCAC objectives. The U.S. Department of Health and Human Services will give close attention to equitable geographic distribution and to minority and female representation so long as the effectiveness of the Committee is not impaired. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, HIV status, disability, and cultural, religious, or socioeconomic status. Consideration is given to a broad representation of geographic areas within the U.S., with diverse representation of both genders, ethnic and racial minorities, and persons with disabilities. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government.

    Candidates should submit the following items:

    Current curriculum vitae or resume, including complete contact information (name, affiliation, mailing address, telephone numbers, fax number, email address);

    A 150 word biography for the nominee;

    At least one letter of recommendation from a person(s) not employed by the U.S. Department of Health and Human Services. Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by HHS.

    Nominations should be submitted (postmarked or received) by June 24, 2016:

    Electronic submissions: You may submit nominations, including attachments, electronically to [email protected]

    Regular, Express or Overnight Mail: Written nominations may be submitted to the following addressee only: Ms. Jameka Reese Blackmon, MBA, CMP c/o BCCEDCAC Secretariat, Centers for Disease Control and Prevention, 3719 North Peachtree Road, Building 100, Chamblee, Georgia 30341.

    Telephone and facsimile submissions cannot be accepted.

    Contact Person for More Information: Jameka R. Blackmon, MBA, CMP, Designated Federal Officer, National Center for Chronic Disease Prevention and Health Promotion, CDC, 4770 Buford Hwy. NE., Mailstop F76, Atlanta, Georgia 30341, Telephone (770) 488-4880; Fax (770) 488-4760; Email: [email protected].

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and the Agency for Toxic Substances and Disease Registry.

    Catherine Ramadei, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2016-10421 Filed 5-3-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-16AHI; Docket No. CDC-2016-0041] 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 information collection project entitled “Community-Based Organization Outcome Monitoring Projects for CBO HIV Prevention Services Clients”.

    DATES:

    Written comments must be received on or before July 5, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2016-0041 by any of the following methods:

    Federal eRulemaking Portal: Regulation.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

    “Community-Based Organization Outcome Monitoring Projects for CBO HIV Prevention Services Clients”—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Community-Based Organizations (CBOs) play an essential role in reaching persons at high risk of transmitting and acquiring HIV infection. Through Cooperative Agreement #CDC-RFA-PS15-1502 (CBO-HPS), CDC funds 90 CBOs to provide comprehensive HIV prevention services to HIV-positive persons and high-risk HIV-negative persons. However, the CBO-HIV Prevention Services (HPS) awardees are not required to monitor or report on critical outcomes such as whether HIV-positive persons who are linked to HIV medical care were retained in care or prescribed ART, and whether high-risk HIV-negative persons who were referred to Pre-Exposure Prophylaxis (PrEP) initiated its use. Also, CBO-HPS CBOs are not required to collect and report data about clients' perceived barriers to accessing HIV prevention services.

    CBO-OMP will fund a subset of CBO-HPS awardees to collect and report data to CDC about the utilization and outcomes of the HIV prevention and support services. This will increase understanding of HIV prevention and support services received by CBO-HPS clients, the outcomes of these services, and successes and challenges related to service provision and utilization.

    The respondent universe will comprise clients at 15-18 CBOs funded by CBO-HPS. CBO-OPM is organized in two categories: Category 1—HIV-positive clients and Category 2—high-risk HIV-negative clients.

    This information collection will evaluate HIV-prevention services over time through participant interviews, record/chart review, CBO-HPS staff interviews, and focus groups. Participant interviews will include questions for participants living with HIV-positive and high-risk HIV-negative clients at CBOs funded by CBO-HPS about demographics, HIV-related risk behaviors, HIV prevention and support services received, service outcomes, and experiences with services over time; staff interviews about strategies for and barriers to recruiting and engaging clients in HIV prevention and support services; and focus groups with clients who are receiving HIV prevention services at CBOs.

    For Category 1, self-reported client interview data will be collected at baseline, 3, 6, 9 and 15 months. For Category 2, self-reported client level data will be collected at baseline, 3, 6, and 9 months. Participants will complete a 30-minute, staff-facilitated interview at baseline and 20-minute staff-facilitated interviews at each follow-up, to assess the outcomes of HIV-prevention services they receive.

    This project will also collect information from CBO-HPS Staff. Two CBO-HPS staff interviews will be conducted for Category 1 and two staff interviews will be conducted for Category 2. All interviews are expected to last 2.5 hours.

    This project will also collect information from participant focus groups. Respondents will also complete a short demographic questionnaire. Focus groups will occur twice during the project period and will last approximately 90 minutes.

    All electronic data will be password protected and accessible only to project staff and direct supervisors. Data will be stored on network drives which are regularly backed up by staff. Participation in this project is strictly voluntary. The consent process will be implemented according to the local/state policies of the funded agencies. Consent forms are provided. The consent process for CBO-OMP involves the agency staff providing an overview of the project that includes a description of the benefits of as well as the risks and discomforts to participation as well as the protections for the respondent's privacy. Participants must sign the consent form prior to enrolling into the project.

    The information collected by each funded agency may include personally identifiable information, such as name and contact information, in order to provide continuity of service, follow-up of referrals, schedule follow-up interviews and other outreach activities. Personally identifiable information will be kept in a locked file cabinet and will be accessible only to appropriate agency staff. Any individually identifiable information collected by funded agencies will not be submitted to CDC.

    The category 1 information collection will occur over 33 months and will involve up to 15 CBOs. The population targeted by Category 1 are HIV-positive clients who are receiving CBO-HPS services and have been provided a CBO-HPS referral to HIV medical care. They will be screened, interviewed and CBO staff will collect their medical records related to their HIV-medical care visits, CD4 count and viral loads, and prescription to ART.

    The Category 2 information collection will occur over 21 months and involve up to 3 CBOs who will target high-risk HIV-negative clients who are receiving CBO-HPS services. CBOs will screen 225 persons each year. CBO staff will collect their medical records about medical care visits, PrEP prescriptions and information about which CBO-HPS referrals. Participants will be administered a baseline interview as well as interviews at 3 months, 6 months, and 9 months. Each CBO will also conduct two focus groups over the project period, one in each year of the evaluation.

    Each of the CBOs funded to participate in this project will be required to submit data they've collected each month to CDC, including the screener, medical records and CBO-HPS referrals, baseline interview, 3-month follow-up interview, 6-month follow-up interview, 9-month follow-up interview, focus groups, and staff interviews, respectively. There is no cost to respondents other than their time. Total burden hours are 1,125.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per respondent
  • Average
  • burden
  • response
  • (hours)
  • Total burden
  • (hours)
  • General public Screener Participant Interview Category 1 175 1 3/60 9 Facility office staff Medical records abstraction Category 1 120 3 3/60 18 CBO-HPS grantees CBO-HPS Referrals Category 1 120 3 3/60 18 General public Baseline Interview Category 1 150 1 40/60 100 General public 3,6,9, and 15 Month Follow-up Interview Category 1 120 4 30/60 240 General public Screener Focus Group Category 1 150 1 3/60 8 General Public Focus Group Questionnaire Category 1 90 1 2/60 3 General public Focus Group Category 1 90 1 1.5 135 CBO-HPS grantees Staff Interview Category 1 30 1 2.5 75 CBO-OMP CBOs Data submission Category 1 and 2 18 12 10/60 36 General public Screener Participant Interview Category 2 225 1 3/60 12 Facility office staff Medical records abstraction Category 2 168 2 3/60 17 CBO-HPS grantees CBO-HPS Referrals Category 2 168 2 3/60 17 General public Baseline Interview Category 2 210 1 40/60 140 General public 3,6, and 9 Month Follow-up Interview Category 2 168 3 30/60 252 General Public Screener Focus group Category 2 30 1 3/60 2 General Public Focus Group Questionnaire Category 2 18 1 2/60 1 General public Focus Group Category 2 18 1 1.5 27 CBO-HPS grantees Staff Interview Category 2 6 1 2.5 15 Total 1,125
    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. 2016-10399 Filed 5-3-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Request for Nominations of Candidates To Serve on the Healthcare Infection Control Practices Advisory Committee (HICPAC)

    The Centers for Disease Control and Prevention (CDC) is soliciting nominations for possible membership on the Healthcare Infection Control Practices Advisory Committee (HICPAC).

    The Committee provides advice and guidance to the Secretary, Department of Health and Human Services (HHS); the Director, Centers for Disease Control and Prevention (CDC); the Deputy Director, Office of Infectious Diseases (OID), CDC; the Director, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), CDC; and the Director, Division of Healthcare Quality Promotion (DHQP), NCEZID, CDC, regarding the practice of infection control and strategies for surveillance, prevention, and control of healthcare-associated infections, antimicrobial resistance, and related events in settings where healthcare is provided, including hospitals, outpatient settings, long-term-care facilities, and home health agencies.

    Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishment of HICPAC objectives.

    The Secretary, HHS, acting through the Director, CDC, shall appoint to the advisory committee nominees with expertise to provide advice regarding the practice of healthcare infection control, strategies for surveillance and prevention and control of healthcare-associated infections in United States healthcare facilities. Consideration is given to professional training and background, points of view represented, and upcoming issues to be addressed by the committee. Nominees may be invited to serve for four-year terms. The next cycle of selection of candidates will begin in the spring of 2016, for selection of potential nominees to replace members whose terms will end on June 30, 2017.

    Selection of members is based on candidates' qualifications to contribute to the accomplishment of HICPAC's objectives (http://www.cdc.gov/hicpac/about.html). The U.S. Department of Health and Human Services will give close attention to equitable geographic distribution and to minority and female representation so long as the effectiveness of the Committee is not impaired.

    Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, HIV status, disability, and cultural, religious, or socioeconomic status. Consideration is given to a broad representation of geographic areas within the U.S., with diverse representation of both genders, ethnic and racial minorities, and persons with disabilities. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Candidates should submit the following items:

    Current curriculum vitae or resume, including complete contact information (name, affiliation, mailing address, telephone numbers, fax number, email address) ; At least one letter of recommendation stating the qualifications of the candidate from person(s) not employed by the U.S. Department of Health and Human Services. Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by HHS.

    Nominations should be submitted (postmarked or received) by August 15, 2016.

    Electronic submissions: You may submit nominations, including attachments, electronically to [email protected]

    Regular, Express or Overnight Mail: Written nominations may be submitted to the following addressee only: Erin Stone, M.S., HICPAC, Division of Healthcare Quality Promotion, NCEZID, CDC, l600 Clifton Road NE., Mailstop A-07, Atlanta, Georgia 30333.

    Telephone and facsimile submissions cannot be accepted. Nominations may be submitted by the candidate or by the person/organization recommending the candidate.

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Catherine Ramadei, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2016-10423 Filed 5-3-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10615] Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB) AGENCY:

    Centers for Medicare & Medicaid Services, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on an information collection concerning CMS' Healthy Indiana Program (HIP) 2.0 Beneficiaries Survey. We are also announcing that the proposed information collection had been submitted to OMB and was approved under control number 0938-1300 through September 30, 2016. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA) we requested emergency review under 5 CFR 1320.13(a)(2)(i) because public harm is reasonably likely to result if the regular clearance procedures were followed.

    More specifically, the regular PRA clearance process would jeopardize the timely completion of CMS' evaluation of the State's upcoming non-emergency medical transportation (NEMT) waiver and other important waivers. Most importantly, it would potentially cause significant harm by depriving Medicaid beneficiaries—especially those affected by the NEMT waiver—of appropriate medical services and needed care.

    Although we have already received OMB approval to test/develop the survey instruments, we are now soliciting public comment for 30-days prior to implementing the survey in order to meet the conditions of OMB's Terms of Clearance that were issued on March 21, 2016.

    Under the PRA, federal agencies are required to publish notice in the Federal Register concerning each proposed information collection request (ICR). Interested persons are invited to send comments regarding our burden estimates or any other aspect of this ICR, including any of the following subjects: (1) The necessity and utility of the proposed ICR for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments must be received by June 3, 2016.

    ADDRESSES:

    When commenting, please reference the document identifier (CMS-10615) or OMB control number (0938-1300). To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

    1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

    2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: CMS-10615/OMB Control Number 0938-1300, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected].

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    Reports Clearance Office at (410) 786-1326.

    SUPPLEMENTARY INFORMATION: Contents

    This notice sets out a summary of the use and burden associated with the following ICR. More detailed information can be found in the collection's supporting statement and associated materials (see ADDRESSES).

    CMS-10615 Healthy Indiana Program (HIP) 2.0 Beneficiaries Survey

    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. The term “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. In compliance with the requirement of section 3506(c)(2)(A) of the PRA, we submitted to OMB our request for emergency processing of this information collection. OMB approved the emergency ICR for testing/developing the survey on March 21, 2016. This iteration seeks emergency approval for fielding the survey and for conducting interviews and focus groups.

    Information Collection

    1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Healthy Indiana Program (HIP) 2.0 Beneficiaries Survey; Use: This is a request for emergency approval to field the surveys and to conduct key informant interviews and focus groups. The surveys were tested during the first week of April 2016, and there was a week-long public comment period that was announced in the Federal Register on March 29, 2016 (81 FR 17460). This ICR contains the revised surveys based on testing and public comments provided during the survey testing period.

    Emergency OMB approval is being sought, as permitted under 5 CPR 1320.13(a)(2)(i), since public harm is reasonably likely to occur if the regular nonemergency PRA clearance procedures are followed. Potential harm may result due to insufficient information to adequately support decision making that is required in November 2016. The clearance is particularly important for decisions about the renewal of precedent-setting waivers of Medicaid policy that assure important beneficiary protections regarding coverage and access to care; e.g., the NEMT waiver. That waiver ends or will be extended by no later than December 1, 2016. The survey effort is critical to supply more detail and information on HIP 2.0 beneficiary understanding and experiences (current and new enrollees as well as disenrollees/lockouts). Other information on other key policies under the Indiana HIP 2.0 demonstration, such as the 60 day beneficiary lock-out period, is also included in this information collection. Including this other information, as well as the interviews and focus groups, with the NEMT related information allows all this information to be collected during the same period of time; this will improve the efficiency of resources when compared to fielding separate surveys, interviews and focus groups at a later time which would be needed under the regular PRA process. Form Number: CMS-10615 (OMB control number: 0938-1300); Frequency: Once; Affected Public: Individuals and households, Private sector (Business or other for-profits and Not-for-profits institutions), and State, Local, or Tribal Governments; Number of Respondents: 5,240; Total Annual Responses: 5,240; Total Annual Hours: 1,442. (For policy questions regarding this collection contact Teresa DeCaro at 202-384-6309).

    Written comments and recommendations will be considered from the public if received by the date and address noted above.

    Dated: April 29, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2016-10448 Filed 5-3-16; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1174] Special Protocol Assessment; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Special Protocol Assessment.” This draft guidance provides information about the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA). This draft guidance is intended to improve the quality of Requests for SPAs and accompanying submission materials, and the quality of the resulting interaction between sponsors and FDA. This draft guidance revises the guidance for industry entitled “Special Protocol Assessment” issued May 17, 2002.

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 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-D-1174 for “Special Protocol Assessment; Draft Guidance for Industry; Availability.” 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.

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building., 4th Floor, Silver Spring, MD 20993-0002, or Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Amalia Himaya, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301-796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Special Protocol Assessment.” SPA is a process by which sponsors may request to meet with FDA to reach agreement on the design and size of certain trials, clinical studies, or animal trials to determine if they adequately address scientific and regulatory requirements. After completing the SPA review, FDA issues a letter including an assessment of the protocol, agreement or nonagreement with the proposed protocol, and answers to the sponsor's relevant questions. Section 119 of the Food and Drug Administration Modernization Act of 1997 amended section 505(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(b)) and directed FDA to meet with sponsors who request to meet, provided certain conditions are met, to reach agreement on the design and size of the well-controlled clinical trials intended to form the primary basis for a demonstration of effectiveness in a marketing application submitted under section 505(b) of the FD&C Act or section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262). These provisions subsequently were amended in section 7002(d)(1) of the Biologics Price Competition and Innovation Act of 2009 to include any necessary clinical study or studies for biosimilar biological product applications under section 351(k) of the PHS Act. In 2013, the Pandemic and All Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) further amended the SPA provisions to provide for SPA agreements regarding animal and associated clinical trials conducted in support of applications for products developed under 21 CFR part 314 subpart I, and 21 CFR part 601 subpart H (the animal rule). Such marketing applications include new drug applications (NDAs), biologics license applications (BLAs), and efficacy supplements to approved NDAs and BLAs.

    In conjunction with the Prescription Drug User Fee Amendments of 2012 (PDUFA V), enacted as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), and with the Biosimilar User Fee Act of 2012 (BsUFA), enacted as part of FDASIA, FDA agreed to specific performance goals (PDUFA V goals and BsUFA goals, respectively) for SPA. Per section 505(b)(5)(B) of the FD&C Act, the PDUFA V goals, and the BsUFA goals, the following protocols are eligible for SPA: (1) Animal carcinogenicity protocols; (2) drug substance and drug product stability protocols; (3) animal efficacy protocols for studies intended to provide primary evidence of effectiveness required for approval or for licensure for products developed under the animal rule; (4) protocols for clinical trials or studies intended to form the primary basis of an efficacy claim; and (5) protocols for clinical studies necessary to prove biosimilarity and/or interchangeability.

    This draft guidance revises the guidance of the same name issued in May 2002. After it has been finalized, this guidance will replace the May 2002 guidance. Significant changes from the 2002 version include the following: (1) Clarifying which protocols are eligible for SPA; (2) adding animal rule efficacy protocols intended to support approval under part 314 subpart I, and part 601 subpart H, for drugs and biological products, respectively; (3) adding protocols intended to support approval of a biosimilar biological product; (4) providing greater detail about the content of an SPA submission; and (5) clarifying the process for rescinding an SPA agreement. FDA seeks comments to aid in finalizing this draft guidance.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the procedural aspects of SPA. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information referred to in the guidance entitled “Special Protocol Assessment” have been approved under OMB control number 0910-0470. The collections of information for FDA Form 1571 have been approved under OMB control number 0910-0014.

    III. Electronic Access

    Persons with access to the Internet may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: April 28, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-10391 Filed 5-3-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-P-1654] Determination That LEUCOVORIN CALCIUM (Leucovorin Calcium) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

    FOR FURTHER INFORMATION CONTACT:

    Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363, [email protected]

    SUPPLEMENTARY INFORMATION:

    In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

    The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

    Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.

    FDA has become aware that the drug products listed in the table in this document are no longer being marketed.

    Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant NDA 008107 LEUCOVORIN CALCIUM Leucovorin Calcium Equivalent to (EQ) 3 milligrams (mg) base/milliliter (mL); EQ 50 mg base/vial; EQ 100 mg base/vial; EQ 350 mg base/vial Injectable; Injection Hospira, Inc. NDA 009986 DELTASONE Prednisone 2.5 mg; 5 mg; 10 mg; 20 mg; 50 mg Tablet; Oral Pharmacia & Upjohn Co. NDA 010392 ATARAX Hydroxyzine Hydrochloride 10 mg; 25 mg; 50 mg; 100 mg Tablet; Oral Pfizer Inc. NDA 016727 PROLIXIN DECANOATE Fluphenazine Decanoate 25 mg/mL Injectable; Injection Bristol-Myers Squibb NDA 018031 INDERIDE-40/25 and INDERIDE 80/20 Hydrochlorothiazide; Propranolol Hydrochloride25 mg; 40 mg and 25 mg; 80 mg Tablet; Oral Wyeth Pharmaceuticals Inc. NDA 019279 DIMETANE-DX Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride 2 mg/5 mL; 10 mg/5 mL; 30 mg/5 mL Syrup; Oral A.H. Robins Company NDA 050007 VIBRAMYCIN Doxycycline Hyclate EQ 50 mg base Capsule; Oral Pfizer Inc. ANDA 061639 E.E.S. 200 and E.E.S. 400 Erythromycin Ethylsuccinate EQ 200 mg base/5 mL; EQ 400 mg base/5 mL Suspension; Oral Arbor Pharmaceuticals, LLC ANDA 062736 BACTOCILL Oxacillin Sodium EQ 1 gram (g) base/vial; EQ 2 g base/vial Injectable; Injection GlaxoSmithKline ANDA 065012 CEFOXITIN Cefoxitin Sodium EQ 1 g base/vial; EQ 2 g base/vial Injectable; Injection Fresenius Kabi USA

    FDA has reviewed its records and, under § 314.161, and has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.

    Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

    Dated: April 27, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-10387 Filed 5-3-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-P-0159] Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). Method, metallic reduction, glucose (urinary, non-quantitative) test systems in a reagent tablet format are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

    DATES:

    Submit either electronic or written comments by June 3, 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-P-0159 for “Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format.” 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:

    Ana Loloei Marsal, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4552, Silver Spring, MD 20993-0002, 301-796-8774, [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 safety and effectiveness. 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.

    Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of the FD&C Act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as postamendments devices), are classified through the premarket notification process under section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of the FD&C Act and the implementing regulations, 21 CFR part 807, require persons who intend to market a new device to submit a premarket no