Federal Register Vol. 81, No.112,

Federal Register Volume 81, Issue 112 (June 10, 2016)

Page Range37485-38059
FR Document

81_FR_112
Current View
Page and SubjectPDF
81 FR 37521 - Suspension of Community EligibilityPDF
81 FR 37594 - Sunshine Act MeetingPDF
81 FR 37582 - Sunshine Act MeetingPDF
81 FR 37664 - Pipeline Safety: Public Workshop on Public AwarenessPDF
81 FR 37596 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 37586 - Charter Re-Establishment of Department of Defense Federal Advisory CommitteesPDF
81 FR 37520 - Alpha-2,4,6-Tris[1-(phenyl)ethyl]-Omega-hydroxypoly(oxyethylene) poly(oxypropylene) Copolymer; Tolerance Exemption; Technical CorrectionPDF
81 FR 37564 - Mandatory Deposit of Electronic Books and Sound Recordings Available Only OnlinePDF
81 FR 37626 - Final Flood Hazard DeterminationsPDF
81 FR 37665 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 37627 - Proposed Flood Hazard DeterminationsPDF
81 FR 37621 - Changes in Flood Hazard DeterminationsPDF
81 FR 37502 - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability.PDF
81 FR 37500 - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; AvailabilityPDF
81 FR 37611 - Determination of Regulatory Review Period for Purposes of Patent Extension; TANZEUMPDF
81 FR 37606 - Determination of Regulatory Review Period for Purposes of Patent Extension; POMALYSTPDF
81 FR 37565 - Hazardous Waste Management System; Tentative Denial of Petition To Revise the RCRA Corrosivity Hazardous CharacteristicPDF
81 FR 37588 - Proposed Consent Decree, Clean Air Act Citizen Suit; Request for Public CommentPDF
81 FR 37592 - Environmental Impact Statements; Notice of AvailabilityPDF
81 FR 37602 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License ApplicationPDF
81 FR 37605 - Oncology Drugs for Companion Animals; Draft Guidance for Industry; AvailabilityPDF
81 FR 37499 - Medical Devices; Ophthalmic Devices; Classification of Nasolacrimal Compression DevicePDF
81 FR 37603 - Dissemination of Patient-Specific Information From Devices by Device Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
81 FR 37589 - Notice of Availability: Draft Protective Action Guide (PAG) for Drinking Water After a Radiological IncidentPDF
81 FR 37616 - Solicitation of Nominations for Appointment to the Advisory Committee on Minority HealthPDF
81 FR 37612 - Reproductive and Environmental Health NetworkPDF
81 FR 37513 - Special Local Regulations; Harborfest Dragon Boat Race, South Haven, MIPDF
81 FR 37562 - Special Local Regulation; Cumberland River, Mile 190.0 to 191.5; Nashville, TNPDF
81 FR 37514 - Security Zone; Military Ocean Terminal Concord (MOTCO); Concord, CaliforniaPDF
81 FR 37510 - Special Local Regulation; On Water Activities Associated With the 2016 Macy's 4th of July Fireworks, East River, Manhattan, NYPDF
81 FR 37504 - Guidance Under Section 108(a) Concerning the Exclusion of Section 61(a)(12) Discharge of Indebtedness Income of a Grantor Trust or a Disregarded EntityPDF
81 FR 37667 - Proposed Collection; Comment Request for Form 1099-HPDF
81 FR 37514 - Drawbridge Operation Regulation; Isle of Wight (Sinepuxent) Bay, Ocean City, MDPDF
81 FR 37585 - Privacy Act of 1974; System of RecordsPDF
81 FR 37574 - United States Travel and Tourism Advisory Board: Meeting of the United States Travel and Tourism Advisory BoardPDF
81 FR 37662 - Parts and Accessories Necessary for Safe Operation, Lamps and Reflective Devices; Application for an Exemption From STEMCO LPPDF
81 FR 37635 - Notice of Realty Action: Direct Sale of Reversionary Interest in San Bernardino County, CaliforniaPDF
81 FR 37636 - Notice of Intent To Solicit Nominations for the Dominguez-Escalante National Conservation Area Advisory Council, ColoradoPDF
81 FR 37637 - Call for Nominations for the California Desert District Advisory CouncilPDF
81 FR 37581 - Procurement List; DeletionsPDF
81 FR 37581 - Procurement List; Proposed Additions and DeletionPDF
81 FR 37614 - National Advisory Council on Migrant Health Request for Nominations for Voting MembersPDF
81 FR 38050 - Migratory Bird Hunting; Proposed 2017-18 Migratory Game Bird Hunting Regulations (Preliminary) With Requests for Indian Tribal Proposals; Notice of MeetingsPDF
81 FR 37580 - Patent and Trademark Public Advisory CommitteesPDF
81 FR 37579 - Grant of Interim Extension of the Term of U.S. Patent No. 5,912,231; LOCILEX® (pexiganan)PDF
81 FR 37639 - Notice of Application for a Recordable Disclaimer of Interest for Lands Owned by the Corporation of the Catholic Archbishop of Anchorage, AKPDF
81 FR 37634 - Notice of Proposed Withdrawal and Notification of a Public Meeting for the Johnny Behind the Rocks Recreation Zone, WyomingPDF
81 FR 37595 - Scientific Information Request on Treatment Strategies for Patients With Lower Extremity Chronic Venous Disease (LECVD)PDF
81 FR 37567 - Sanders Resource Advisory CommitteePDF
81 FR 37568 - Sanders Resource Advisory CommitteePDF
81 FR 37637 - Notice of Final Supplementary Rules for the Killpecker Sand Dunes Recreation Site, WyomingPDF
81 FR 37569 - Notice of Public Meeting of the Wisconsin Advisory Committee To Discuss Preparations for a Hearing on Hate Crimes in the StatePDF
81 FR 37598 - Medicare Program; Pre-Claim Review Demonstration for Home Health ServicesPDF
81 FR 37660 - Union Pacific Railroad Company-Trackage Rights Exemption-BNSF Railway CompanyPDF
81 FR 37661 - Agency Information Collection Activities; Extension of a Currently-Approved Information Collection: Unified Registration System, FMCSA Registration/UpdatesPDF
81 FR 37588 - Messalonskee Stream Hydro, LLC-Maryland; Messalonskee Stream Hydro, LLC-Maine; Notice of Application for Partial Transfer of License and Soliciting Comments, Motions To Intervene, and ProtestsPDF
81 FR 37633 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Kodiak National Wildlife Refuge Bear Viewing SurveyPDF
81 FR 37567 - Northeast Oregon Forests Resource Advisory CommitteePDF
81 FR 37575 - Proposed Information Collection; Comment Request; Pacific Coast Groundfish Trawl Rationalization Program Permit and License Information CollectionPDF
81 FR 37568 - Notice of New Fee Site; Federal Lands Recreation Enhancement Act, (Title VIII, Pub. L. 108-447)PDF
81 FR 37507 - Special Local Regulation; Midwest Masters Sprints; Maumee River; Toledo, OHPDF
81 FR 37566 - Uinta-Wasatch-Cache Resource Advisory CommitteePDF
81 FR 37557 - Evidence From Statutorily Excluded Medical SourcesPDF
81 FR 37568 - Black Hills Resource Advisory CommitteePDF
81 FR 37561 - Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition; CorrectionPDF
81 FR 37641 - Agency Information Collection Activities; Proposed eCollection; eComments Requested;Notice of Appeal From a Decision of an Immigration Judge (EOIR-26)PDF
81 FR 37643 - Civil Rights Division; Agency Information Collection Activities; Proposed eCollection; eComments Requested; Requirement That Movie Theaters Provide Notice as to the Availability of Closed Movie Captioning and Audio DescriptionPDF
81 FR 37615 - Agency Information Collection Activities: Proposed Collection: Public Comment RequestPDF
81 FR 37613 - Agency Information Collection Activities: Proposed Collection: Public Comment RequestPDF
81 FR 37608 - Request for Nominations for Individuals and Consumer Organizations for Advisory CommitteesPDF
81 FR 37644 - Derricks; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) RequirementsPDF
81 FR 37628 - Office for Interoperability and Compatibility Seeks Nominations for the Project 25 Compliance Assessment Program Advisory Panel-Single PositionPDF
81 FR 37587 - Charter Renewal of Department of Defense Federal Advisory CommitteesPDF
81 FR 37578 - Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for Exempted Fishing PermitsPDF
81 FR 37620 - National Institute of General Medical Sciences; Notice of Closed MeetingPDF
81 FR 37621 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
81 FR 37617 - National Cancer Institute; Notice of Closed MeetingsPDF
81 FR 37618 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 37619 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 37620 - Submission for OMB Review; 30-Day Comment Request: Autism Spectrum Disorder (ASD) Research Portfolio Analysis, NIMHPDF
81 FR 37573 - Certain Cased Pencils From the People's Republic of China: Preliminary Results of Antidumping Duty New Shipper Review; 2014-2015PDF
81 FR 37570 - Subzone 230D; Authorization of Limited Production Activity; Klaussner Furniture Industries, Inc. (Upholstered Furniture); Asheboro and Candor, North CarolinaPDF
81 FR 37571 - Foreign-Trade Zone 233-Dothan, Alabama, Application for Subzone, Next Level Apparel, Ashford, AlabamaPDF
81 FR 37583 - Government-Industry Advisory Panel; Notice of Federal Advisory Committee MeetingPDF
81 FR 37654 - Ramius Archview Credit and Distressed Fund and Ramius Advisors, LLC; Notice of ApplicationPDF
81 FR 37659 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change, as Modified by Amendment No. 5, To Adopt Initial and Continued Listing Standards for the Listing of Equity Investment Tracking Stocks and Adopt Listing Fees Specific to Equity Investment Tracking StocksPDF
81 FR 37656 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt Business Continuity Plan Requirements for ParticipantsPDF
81 FR 37578 - Marine Mammals; File Nos. 18978 and 19768PDF
81 FR 37576 - Endangered Species; File No. 20114PDF
81 FR 37570 - [Authorization of Production Activity, Foreign-Trade Subzone 279A, Thoma-Sea Marine Constructors, L.L.C. (Shipbuilding), Houma, LouisianaPDF
81 FR 37605 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of MeetingPDF
81 FR 37601 - Arthritis Advisory Committee; Notice of MeetingPDF
81 FR 37593 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
81 FR 37570 - Foreign-Trade Zone 119-Minneapolis, Minnesota; Notification of Proposed Production Activity; SICK, Inc.; Subzone 119G; (Electronic Industrial Sensors, Encoders, Optical Readers and Monitoring Systems); Savage, MinnesotaPDF
81 FR 37571 - Certain Steel Nails From the United Arab Emirates: Preliminary Results of Antidumping Duty Administrative Review; 2014-2015PDF
81 FR 37566 - National Advisory Council on Maternal, Infant and Fetal Nutrition; Notice of MeetingPDF
81 FR 37582 - Proposed Information Collection; Comment RequestPDF
81 FR 37517 - Air Plan Approval; Illinois; NAAQS UpdatesPDF
81 FR 37600 - Announcing the Intent To Award Single-Source Expansion Supplement Grants to Two Personal Responsibility Education Program Innovative Strategies (PREIS) GranteesPDF
81 FR 37534 - Fisheries of the Exclusive Economic Zone Off Alaska; Bycatch Management in the Bering Sea Pollock FisheryPDF
81 FR 37592 - Next Meeting of the North American Numbering CouncilPDF
81 FR 37564 - Air Plan Approval; Illinois; NAAQS UpdatePDF
81 FR 37513 - Drawbridge Operation Regulation; Sloop Channel and Long Creek, Nassau, NYPDF
81 FR 37621 - Center for Substance Abuse Treatment; Notice of MeetingPDF
81 FR 37594 - Notice of Termination; 10242 Bank of Florida-Southwest; Naples, FloridaPDF
81 FR 37640 - Certain Recombinant Factor VIII ProductsPDF
81 FR 37594 - Notice of Termination 10328 CommunitySouth Bank and Trust Easley, South CarolinaPDF
81 FR 37600 - Submission for OMB Review; Comment RequestPDF
81 FR 37660 - In the Matter of the Designation of Yarmouk Martyrs Brigade, aka Katibah Shuhada' al-Yarmouk, aka Liwa' Shuhada' al-Yarmouk, aka Yarmouk Brigade, aka Brigade of the Yarmouk Martyrs, aka Martyrs of Yarmouk, aka Al Yarmuk Brigade, aka Shuhda al-Yarmouk, aka Shohadaa al-Yarmouk Brigade, aka Suhada'a al-Yarmouk Brigade, aka Shuhada al Yarmouk Brigade, aka YMB, aka LSY as a Specially Designated Global TerroristPDF
81 FR 37576 - RIN 0648-BA21PDF
81 FR 37950 - Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial CalculationsPDF
81 FR 37642 - Notice of Public Comment Period on Proposed Uniform Language for Testimony and ReportsPDF
81 FR 38020 - Expatriate Health Plans, Expatriate Health Plan Issuers, and Qualified Expatriates; Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration InsurancePDF
81 FR 37485 - Airworthiness Directives; Fokker Services B.V. AirplanesPDF
81 FR 37496 - Airworthiness Directives; Various Aircraft Equipped With BRP-Powertrain GmbH & Co KG 912 A Series EnginePDF
81 FR 37521 - National Highway-Rail Crossing Inventory Reporting RequirementsPDF
81 FR 37645 - Privacy Act of 1974; Systems of RecordsPDF
81 FR 37629 - Federal Property Suitable as Facilities To Assist the HomelessPDF
81 FR 37494 - Airworthiness Directives; PILATUS AIRCRAFT LTD. AirplanesPDF
81 FR 37492 - Airworthiness Directives; B/E Aerospace Protective Breathing Equipment Part Number 119003-11PDF
81 FR 37894 - Control of Alcohol and Drug Use: Coverage of Maintenance of Way (MOW) Employees and Retrospective Regulatory Review-Based AmendmentsPDF
81 FR 37840 - Railroad Workplace Safety; Roadway Worker Protection Miscellaneous Revisions (RRR)PDF
81 FR 37488 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 37670 - Incentive-Based Compensation ArrangementsPDF

Issue

81 112 Friday, June 10, 2016 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 37596-37598 2016-13841 Requests for Scientific Information: Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease, 37595-37596 2016-13761 Agriculture Agriculture Department See

Food and Nutrition Service

See

Forest Service

Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare Program: Medicare Shared Savings Program; Accountable Care Organizations--Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial Calculations, 37950-38017 2016-13651 NOTICES Medicare Program: Pre-Claim Review Demonstration for Home Health Services, 37598-37600 2016-13755 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 37600-37601 2016-13682 Intent to Award Single-Source Expansion Supplement Grants: Two Personal Responsibility Education Program Innovative Strategies Grantees, 37600 2016-13698 Civil Rights Civil Rights Commission NOTICES Meetings: Wisconsin Advisory Committee, 37569 2016-13756 Coast Guard Coast Guard RULES Drawbridge Operations: Isle of Wight (Sinepuxent) Bay, Ocean City, MD, 37514 2016-13777 Sloop Channel and Long Creek, Nassau, NY, 37513-37514 2016-13692 Security Zones: Military Ocean Terminal Concord, Concord, CA, 37514-37517 2016-13781 Special Local Regulations: Harborfest Dragon Boat Race, South Haven, MI, 37513 2016-13783 Midwest Masters Sprints; Maumee River; Toledo, OH, 37507-37510 2016-13746 Water Activities Associated with the Macy's 4th of July Fireworks, East River, Manhattan, NY, 37510-37513 2016-13780 PROPOSED RULES Special Local Regulations: Cumberland River, Mile 190.0 to 191.5; Nashville, TN, 37562-37563 2016-13782 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

Patent and Trademark Office

Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 37581-37582 2016-13768 2016-13769 Comptroller Comptroller of the Currency PROPOSED RULES Incentive-Based Compensation Arrangements, 37670-37838 2016-11788 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 37665-37667 2016-13810 Consumer Product Consumer Product Safety Commission NOTICES Meetings; Sunshine Act, 37582 2016-13855 Copyright Office Copyright Office, Library of Congress PROPOSED RULES Mandatory Deposit of Electronic Books and Sound Recordings Available Only Online, 37564 2016-13814 Corporation Corporation for National and Community Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 37582-37583 2016-13702 Defense Department Defense Department NOTICES Charter Renewals: Department of Defense Federal Advisory Committees, 37586-37588 2016-13729 2016-13838 Meetings: Government-Industry Advisory Panel; Notice of Federal Advisory Committee, 37583-37585 2016-13718 Privacy Act; Systems of Records, 37585-37586 2016-13776 Employee Benefits Employee Benefits Security Administration PROPOSED RULES Expatriate Health Plans, Expatriate Health Plan Issuers, and Qualified Expatriates; Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance, 38020-38048 2016-13583 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Illinois; NAAQS Updates, 37517-37520 2016-13700 Tolerance Exemptions; Technical Correction, 37520-37521 2016-13816 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Illinois; NAAQS Update, 37564 2016-13695 Hazardous Waste Management System: Tentative Denial of Petition to Revise the RCRA Corrosivity Hazardous Characteristic, 37565 2016-13793 NOTICES Draft Protective Action Guide for Drinking Water after a Radiological Incident, 37589-37592 2016-13786 Environmental Impact Statements; Availability, etc.; Weekly Receipts, 37592 2016-13791 Proposed Consent Decree under the Clean Air Act Citizen Suit, 37588-37589 2016-13792 Executive Office Executive Office for Immigration Review NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Appeal from a Decision of an Immigration Judge, 37641-37642 2016-13738 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Airbus Airplanes, 37488-37492 2016-12324 B/E Aerospace Protective Breathing Equipment Part Number 119003-11, 37492-37494 2016-13250 Fokker Services B.V. Airplanes, 37485-37488 2016-13545 Pilatus Aircraft LTD. Airplanes, 37494-37496 2016-13372 Various Aircraft Equipped with BRP-Powertrain GmbH and Co KG 912 A Series Engine, 37496-37499 2016-13542 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 37593-37594 2016-13708 Meetings: North American Numbering Council, 37592-37593 2016-13696 Federal Deposit Federal Deposit Insurance Corporation PROPOSED RULES Incentive-Based Compensation Arrangements, 37670-37838 2016-11788 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 37665-37667 2016-13810 Terminations of Receiverships: Bank of Florida—Southwest, Naples, FL, 37594 2016-13689 CommunitySouth Bank and Trust, Easley, SC, 37594 2016-13683 Federal Emergency Federal Emergency Management Agency RULES Suspension of Community Eligibility, 37521 C1--2016--12123 NOTICES Flood Hazard Determinations, 37626-37627 2016-13812 Flood Hazard Determinations; Changes, 37621-37626 2016-13807 Flood Hazard Determinations; Proposals, 37627-37628 2016-13808 Federal Energy Federal Energy Regulatory Commission NOTICES License Transfer Applications: Messalonskee Stream Hydro, LLC—MD; Messalonskee Stream Hydro, LLC—ME, 37588 2016-13751 Federal Housing Finance Agency Federal Housing Finance Agency PROPOSED RULES Incentive-Based Compensation Arrangements, 37670-37838 2016-11788 Federal Mine Federal Mine Safety and Health Review Commission NOTICES Meetings; Sunshine Act, 37594 2016-13879 2016-13880 Federal Motor Federal Motor Carrier Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Unified Registration System, FMCSA Registration/Updates, 37661-37662 2016-13752 Parts and Accessories Necessary for Safe Operation, Lamps and Reflective Devices; Exemption Applications: STEMCO LP, 37662-37664 2016-13774 Federal Railroad Federal Railroad Administration RULES Control of Alcohol and Drug Use: Coverage of Maintenance of Way Employees and Retrospective Regulatory Review-Based Amendments, 37894-37948 2016-13058 National Highway-Rail Crossing Inventory Reporting Requirements, 37521-37534 2016-13516 Railroad Workplace Safety: Roadway Worker Protection Miscellaneous Revisions, 37840-37892 2016-13057 Federal Reserve Federal Reserve System PROPOSED RULES Incentive-Based Compensation Arrangements, 37670-37838 2016-11788 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 37665-37667 2016-13810 Fish Fish and Wildlife Service PROPOSED RULES Migratory Bird Hunting: Proposed 2017-18 Migratory Game Bird Hunting Regulations (Preliminary) With Requests for Indian Tribal Proposals; Meetings, 38050-38059 2016-13766 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Kodiak National Wildlife Refuge Bear Viewing Survey, 37633-37634 2016-13750 Food and Drug Food and Drug Administration RULES Guidance for Industry: Interim Policy on Compounding Using Bulk Drug Substances under the Federal Food, Drug, and Cosmetic Act, 37500-37504 2016-13798 2016-13799 Medical Devices: Ophthalmic Devices; Classification of Nasolacrimal Compression Device, 37499-37500 2016-13788 PROPOSED RULES Petitions for Rulemaking: Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, et al.; Correction, 37561-37562 2016-13739 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medicated Feed Mill License Application, 37602-37603 2016-13790 Guidance for Industry: Dissemination of Patient-Specific Information from Devices by Device Manufacturers, 37603-37604 2016-13787 Oncology Drugs for Companion Animals, 37605-37606 2016-13789 Meetings: Arthritis Advisory Committee, 37601-37602 2016-13709 Dermatologic and Ophthalmic Drugs Advisory Committee, 37605 2016-13710 Patent Extension Regulatory Review Periods: POMALYST, 37606-37608 2016-13796 TANZEUM, 37611-37612 2016-13797 Requests for Nominations: Individuals and Consumer Organizations for Advisory Committees, 37608-37611 2016-13733 Food and Nutrition Food and Nutrition Service NOTICES Meetings: National Advisory Council on Maternal, Infant and Fetal Nutrition, 37566 2016-13703 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activity Authorizations: Klaussner Furniture Industries, Inc., Subzone 230D, Asheboro and Candor, NC, 37570 2016-13720 Thoma-Sea Marine Constructors, LLC, Foreign-Trade Subzone 279A, Houma, LA, 37570 2016-13712 Proposed Production Activities: SICK, Inc., Foreign-Trade Zone 119—Minneapolis, MN, 37570 2016-13706 Subzone Applications: Next Level Apparel, Foreign-Trade Zone 233, Dothan, AL, 37571 2016-13719 Forest Forest Service NOTICES Meetings: Black Hills Resource Advisory Committee, 37568 2016-13743 Northeast Oregon Forests Resource Advisory Committee, 37567-37568 2016-13749 Sanders Resource Advisory Committee, 37567-37569 2016-13758 2016-13759 Uinta-Wasatch-Cache Resource Advisory Committee, 37566 2016-13745 New Fee Sites: Federal Lands Recreation Enhancement Act, 37568 2016-13747 Health and Human Health and Human Services Department See

Agency for Healthcare Research and Quality

See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

PROPOSED RULES Expatriate Health Plans, Expatriate Health Plan Issuers, and Qualified Expatriates; Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance, 38020-38048 2016-13583 NOTICES Requests for Nominations: Advisory Committee on Minority Health, 37616-37617 2016-13785
Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 37613-37616 2016-13735 2016-13736 Requests for Nominations: National Advisory Council on Migrant Health, 37614-37615 2016-13767 Single-Award Deviation from Competition Requirements: Reproductive and Environmental Health Network, 37612-37613 2016-13784 Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

NOTICES Requests for Nominations: Office for Interoperability and Compatibility: Project 25 Compliance Assessment Program Advisory Panel; Single Position, 37628-37629 2016-13730
Housing Housing and Urban Development Department NOTICES Federal Property Suitable as Facilities to Assist the Homeless, 37629-37633 2016-13428 Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

Internal Revenue Internal Revenue Service RULES Guidance Concerning the Exclusion of Discharge of Indebtedness Income of a Grantor Trust or a Disregarded Entity, 37504-37507 2016-13779 PROPOSED RULES Expatriate Health Plans, Expatriate Health Plan Issuers, and Qualified Expatriates; Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance, 38020-38048 2016-13583 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 37667-37668 2016-13778 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Cased Pencils from the People's Republic of China, 37573-37574 2016-13721 Certain Steel Nails from the United Arab Emirates, 37571-37573 2016-13704 Meetings: United States Travel and Tourism Advisory Board, 37574-37575 2016-13775 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Recombinant Factor VIII Products, 37640-37641 2016-13688 Justice Department Justice Department See

Executive Office for Immigration Review

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Requirement that Movie Theaters Provide Notice as to the Availability of Closed Movie Captioning and Audio Description, 37643-37644 2016-13737 Proposed Uniform Language for Testimony and Reports, 37642-37643 2016-13635
Labor Department Labor Department See

Employee Benefits Security Administration

See

Occupational Safety and Health Administration

Land Land Management Bureau NOTICES Applications for a Recordable Disclaimer of Interest for Lands Owned: Corporation of the Catholic Archbishop, Anchorage, AK, 37639-37640 2016-13763 Final Supplementary Rules for the Killpecker Sand Dunes Recreation Site, WY, 37637-37639 2016-13757 Meetings: Proposed Land Withdrawal; Johnny Behind the Rocks Recreation Zone, WY, 37634-37635 2016-13762 Realty Actions: Direct Sale of Reversionary Interest in San Bernardino County, CA, 37635-37636 2016-13773 Requests for Nominations: California Desert District Advisory Council, 37637 2016-13771 Dominguez-Escalante National Conservation Area Advisory Council, Colorado, 37636-37637 2016-13772 Library Library of Congress See

Copyright Office, Library of Congress

National Credit National Credit Union Administration PROPOSED RULES Incentive-Based Compensation Arrangements, 37670-37838 2016-11788 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Autism Spectrum Disorder (ASD) Research Portfolio Analysis, 37620-37621 2016-13722 Meetings: Center for Scientific Review, 37617-37620 2016-13723 2016-13724 2016-13725 National Institute of Allergy and Infectious Diseases, 37621 2016-13726 National Institute of General Medical Sciences, 37620 2016-13727 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Bycatch Management in the Bering Sea Pollock Fishery, 37534-37556 2016-13697 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Pacific Coast Groundfish Trawl Rationalization Program Permit and License Information Collection, 37575-37576 2016-13748 Environmental Impact Statements; Availability, etc.: Proposed Expansion for the Flower Garden Banks National Marine Sanctuary; Public Meetings, 37576-37578 2016-13661 Exempted Fishing Permits; Applications: General Provisions for Domestic Fisheries, 37578-37579 2016-13728 Permits: Endangered Species; File No. 20114, 37576 2016-13713 Marine Mammals; File Nos. 18978 and 19768, 37578 2016-13714 National Science National Science Foundation NOTICES Privacy Act; Systems of Records, 37645-37654 2016-13452 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Derricks, 37644-37645 2016-13732 Patent Patent and Trademark Office NOTICES Grants of Interim Extension of the Term of a U.S. Patent, 37579-37580 2016-13764 Requests for Nominations: Patent and Trademark Public Advisory Committees, 37580-37581 2016-13765 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Meetings: Public Awareness; Public Workshop, 37664-37665 2016-13845 Securities Securities and Exchange Commission PROPOSED RULES Incentive-Based Compensation Arrangements, 37670-37838 2016-11788 NOTICES Applications: Ramius Archview Credit and Distressed Fund and Ramius Advisors, LLC, 37654-37656 2016-13717 Self-Regulatory Organizations; Proposed Rule Changes: Chicago Stock Exchange, Inc., 37656-37659 2016-13715 New York Stock Exchange LLC, 37659-37660 2016-13716 Social Social Security Administration PROPOSED RULES Evidence from Statutorily Excluded Medical Sources, 37557-37561 2016-13744 State Department State Department NOTICES Designations as Global Terrorists: Yarmouk Martyrs Brigade, aka Katibah Shuhada' al-Yarmouk, aka Liwa' Shuhada' al-Yarmouk, et al., 37660 2016-13676 Substance Substance Abuse and Mental Health Services Administration NOTICES Meetings: Center for Substance Abuse Treatment National Advisory Council, 37621 2016-13690 Surface Transportation Surface Transportation Board NOTICES Trackage Rights Exemptions: Union Pacific Railroad Company; BNSF Railway Company, 37660-37661 2016-13754 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

See

Federal Railroad Administration

See

Pipeline and Hazardous Materials Safety Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Internal Revenue Service

Separate Parts In This Issue Part II Federal Deposit Insurance Corporation, 37670-37838 2016-11788 Federal Housing Finance Agency, 37670-37838 2016-11788 Federal Reserve System, 37670-37838 2016-11788 National Credit Union Administration, 37670-37838 2016-11788 Securities and Exchange Commission, 37670-37838 2016-11788 Treasury Department, Comptroller of the Currency, 37670-37838 2016-11788 Part III Transportation Department, Federal Railroad Administration, 37840-37892 2016-13057 Part IV Transportation Department, Federal Railroad Administration, 37894-37948 2016-13058 Part V Health and Human Services Department, Centers for Medicare & Medicaid Services, 37950-38017 2016-13651 Part VI Health and Human Services Department, 38020-38048 2016-13583 Labor Department, Employee Benefits Security Administration, 38020-38048 2016-13583 Treasury Department, Internal Revenue Service, 38020-38048 2016-13583 Part VII Interior Department, Fish and Wildlife Service, 38050-38059 2016-13766 Reader Aids

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81 112 Friday, June 10, 2016 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-8138; Directorate Identifier 2014-NM-112-AD; Amendment 39-18552; AD 2016-12-03] RIN 2120-AA64 Airworthiness Directives; Fokker Services B.V. Airplanes AGENCY:

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

ACTION:

Final rule.

SUMMARY:

We are superseding Airworthiness Directive (AD) 2011-17-10, for all Fokker Services B.V. Model F.28 Mark 1000, 2000, 3000, and 4000 airplanes. AD 2011-17-10 required inspecting for a by-pass wire between the housing of each in-tank fuel quantity indication (FQI) cable plug and the cable shield, and corrective actions if necessary. AD 2011-17-10 also required revising the airplane maintenance program. This new AD removes certain airplanes from the applicability. This new AD applies only to Model F.28 Mark 1000 airplanes and also requires revising the airplane maintenance or inspection program by incorporating the instructions in revised service information. This AD was prompted by the issuance of revised service information to update the critical design configuration control limitations (CDCCLs) that address potential ignition sources inside fuel tanks. We are issuing this AD to prevent potential ignition sources inside the fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane.

DATES:

This AD becomes effective July 15, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of July 15, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of September 16, 2011 (76 FR 50111, August 12, 2011).

ADDRESSES:

For service information identified in this final rule, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email [email protected]; Internet http://www.myfokkerfleet.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 Number FAA-2015-8138.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket Number FAA-2015-8138; 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.

FOR FURTHER INFORMATION CONTACT:

Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1149.

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2011-17-10, Amendment 39-16774 (76 FR 50111, August 12, 2011) (“AD 2011-17-10”). AD 2011-17-10 applied to all Model F.28 Mark 1000, 2000, 3000, and 4000 airplanes. The NPRM published in the Federal Register on January 4, 2016 (81 FR 34) (“the NPRM”). The NPRM was prompted by the issuance of revised service information to update the CDCCLs that address potential ignition sources inside fuel tanks. The NPRM proposed to retain the requirements of AD 2011-17-10, and to require revising the airplane maintenance or inspection program by incorporating the instructions in the revised service information. The NPRM also proposed to remove certain airplanes from the applicability. We are issuing this AD to prevent potential ignition sources inside the fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0111, dated May 8, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on certain Model F.28 Mark 1000 airplanes. The MCAI states:

[T]he FAA published Special Federal Aviation Regulation (SFAR) 88 [Amendment 21-78 (66 FR 23086, May 7, 2001). 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”)], and the Joint Aviation Authorities (JAA) published Interim Policy INT/POL/25/12.

The review conducted by Fokker Services on the F28 design, in response to these regulations, revealed that on certain aeroplanes, an interrupted shield contact may exist or develop between the housing of an in-tank Fuel Quantity Indication (FQI) cable plug and the cable shield of the shielded FQI system cables in the main and collector fuel tanks, which can, under certain conditions, form a spark gap.

This condition, if not detected and corrected, may create an ignition source in the fuel tank vapour space, possibly resulting in a wing fuel tank explosion and consequent loss of the aeroplane.

To address and correct this unsafe condition, Fokker Services published Service Bulletin (SB) SBF28-28-053 which provides instructions, for early production aeroplanes, for a one-time inspection to check for the presence of a by-pass wire between the housing of each in-tank FQI cable plug and the cable shield and, depending on findings, for the installation of a by-pass wire. In addition, SBF28-28-053 provides a Critical Design Configuration Control Limitation (CDCCL) item to make certain that the by-pass wire remains installed on these aeroplanes.

On later production aeroplanes, an improved plug Part Number (P/N) 20P227-2 was introduced with a better shield connection to the housing of the plug. Therefore, SBF28-28-053 (original issue and Revision 1) also provided a CDCCL item to ensure that this type of plug remains installed on those aeroplanes.

EASA issued AD 2010-0217 [which corresponds to FAA AD 2011-17-10, Amendment 39-16774 (76 FR 50111, August 12, 2011)] to require accomplishment of the instructions related to the by-pass wire and implementation of the CDCCL items as specified in Fokker Services SBF28-28-053 Revision 1, as applicable to aeroplane s/n.

Since EASA AD 2010-0217 was issued, it was identified that P/N 20P227-1 and 20P228-1 plugs are also approved and can therefore be installed on the later production aeroplanes. Prompted by this finding, Fokker Services issued SBF28-28-055 to address the implementation of a CDCCL item to make certain that only approved plug types remain installed on the later production aeroplanes, while SBF28-28-053 Revision 2 was issued for early production aeroplanes to address the by-pass wire related actions only.

Consequently, EASA issued AD 2011-0184, retaining the requirements of EASA AD 2010-0217, which was superseded, to require implementation of the related CDCCL items as specified in Fokker Services SBF28-28-053 Revision 2, or SBF28-28-055, as applicable to aeroplane s/n.

More recently, Fokker Services published Revision 3 of SBF28-28-053, to eliminate the use of a heat gun in or near to the fuel tank, and prompted by a change to the definition of the related CDCCL item. Fokker Services also cancelled SBF28-28-055, due to the introduction of a revised definition of the CDCCL item that has been published in Fokker Services SBF28-28-050, Revision 2.

For the reason described above, this [EASA] AD retains the requirements related to SBF28-28-053 of EASA AD 2011-0184, which is superseded, but requires those actions to be accomplished in accordance with the instructions of Fokker Services SBF28-28-053, Revision 3 (R3).

All the actions related to SBF28-28-055, as previously required through paragraphs (5) and (6) of EASA AD 2011-0184, are now addressed by EASA AD 2014-0110 [http://ad.easa.europa.eu/ad/2014-0110_1.pdf].

The CDCCL requirement in AD 2011-17-10 for Model F.28 Mark 2000, 3000, and 4000 airplanes is now addressed in other related rulemaking. Therefore, this AD does not include Model F.28 Mark 2000, 3000, and 4000 airplanes in the applicability.

This AD also removes airplanes having serial numbers 11993 and 11994 from the applicability because those airplanes were scrapped and removed from the type certificate data sheet.

The unsafe condition is the potential of ignition sources inside fuel tanks. Such ignition sources, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2015-8138.

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

Fokker Services B.V. has issued Fokker Service Bulletin SBF28-28-053, Revision 3, dated January 9, 2014. The service information describes procedures for inspecting for a by-pass wire between the housing of each in-tank FQI cable plug and the cable shield, and installing a by-pass wire if necessary. The service information also describes CDCCL Item 1.7 for fuel quantity indicating system (FQIS) wiring in wing tanks. 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 5 airplanes of U.S. registry. This AD adds a requirement to revise the airplane maintenance or inspection program by incorporating the instructions in revised service information. The current costs associated with this AD are repeated as follows for the convenience of affected operators:

The actions required by AD 2011-17-10 will take about 6 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $0 per product. Based on these figures, the estimated cost of the actions that were required by AD 2011-17-10 is $510 per product.

In addition, we estimate that any necessary follow-on actions required by AD 2011-17-10 take about 7 work-hours and require parts costing $308, for a cost of $903 per product. We have no way of determining the number of products that may need these actions.

We also estimate that it takes about 1 work-hour per product to revise the maintenance or inspection program. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $425, or $85 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.

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) 2011-17-10, Amendment 39-16774 (76 FR 50111, August 12, 2011), and adding the following new AD: 2016-12-03 Fokker Services B.V.: Amendment 39-18552. Docket No. FAA-2015-8138; Directorate Identifier 2014-NM-112-AD. (a) Effective Date

This AD becomes effective July 15, 2016.

(b) Affected ADs

This AD replaces AD 2011-17-10, Amendment 39-16774 (76 FR 50111, August 12, 2011) (“AD 2011-17-10”).

(c) Applicability

This AD applies to Fokker Services B.V. Model F.28 Mark 1000 airplanes; certificated in any category; serial numbers (S/Ns) 11003 through 11041 inclusive, and S/Ns 11991 and 11992.

(d) Subject

Air Transport Association (ATA) of America Code 28, Fuel.

(e) Reason

This AD was prompted by the issuance of revised service information to update the critical design configuration control limitations (CDCCLs) that address potential ignition sources inside fuel tanks. We are issuing this AD to prevent potential ignition sources inside the fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane.

(f) Compliance

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

(g) Retained Inspection and Installation, With Revised Service Information

This paragraph restates the requirements of paragraph (g) of AD 2011-17-10, with revised service information. At a scheduled opening of the fuel tanks, but not later than 84 months after September 16, 2011 (the effective date of AD 2011-17-10), do a general visual inspection for the presence of a by-pass wire between the housing of each in-tank fuel quantity indication (FQI) cable plug and the cable shield, in accordance with Part 1 of the Accomplishment Instructions of Fokker Service Bulletin SBF28-28-053, Revision 1, dated September 20, 2010; or Fokker Service Bulletin SBF28-28-053, Revision 3, dated January 9, 2014. As of the effective date of this AD, only Fokker Service Bulletin SBF28-28-053, Revision 3, dated January 9, 2014, may be used.

(h) Retained Corrective Actions, With Revised Service Information

This paragraph restates the requirements of paragraph (h) of AD 2011-17-10, with revised service information. If during the general visual inspection required by paragraph (g) of this AD, it is found that a by-pass wire is not installed: Before the next flight, install the by-pass wire between the housing of the in-tank FQI cable plug and the cable shield, in accordance with Part 2 of the Accomplishment Instructions of Fokker Service Bulletin SBF28-28-053, Revision 1, dated September 20, 2010; or Fokker Service Bulletin SBF28-28-053, Revision 3, dated January 9, 2014. As of the effective date of this AD, only Fokker Service Bulletin SBF28-28-053, Revision 3, dated January 9, 2014, may be used.

(i) Retained Maintenance Program Revision To Add Fuel Airworthiness Limitation, With a New Exception

This paragraph restates the requirements of paragraph (i) of AD 2011-17-10, with a new exception. Except as required by paragraph (k) of this AD, concurrently with the actions required by paragraph (g) of this AD, revise the airplane maintenance program by incorporating CDCCL-1 specified in paragraph 1.L.(1)(c) of Fokker Service Bulletin SBF28-28-053, Revision 1, dated September 20, 2010.

(j) Retained Requirement for No Alternative Actions, Intervals, and/or CDCCLs, With a New Exception

This paragraph restates the requirements of paragraph (k) of AD 2011-17-10 with a new exception. Except as required by paragraph (k) of this AD: After accomplishing the revision required by paragraph (i) of this AD, no alternative actions (e.g., inspection, interval) and/or CDCCLs may be used unless the actions, intervals, and/or CDCCLs are approved as an alternative methods of compliance (AMOC) in accordance with the procedures specified in paragraph (n)(1) of this AD.

(k) New Maintenance or Inspection Program Revision To Add Fuel Airworthiness Limitation

Within 30 days after the effective date of this AD: Revise the airplane maintenance or inspection program, as applicable, by incorporating CDCCL Item 1.7 as specified in paragraph 1.L.(1)(c) of Fokker Service Bulletin SBF28-28-053, Revision 3, dated January 9, 2014. Accomplishing the revision required by this paragraph terminates the revision required by paragraph (i) of this AD.

(l) No Alternative CDCCLs

After the maintenance or inspection program has been revised as required by paragraph (k) of this AD, no alternative CDCCLs may be used unless the CDCCLs are approved as an AMOC in accordance with the procedures specified in paragraph (n)(1) of this AD.

(m) Credit for Previous Actions

This paragraph provides credit for the applicable actions required by paragraph (k) of this AD, if those actions were performed before the effective date of this AD using Fokker Service Bulletin SBF28-28-053, Revision 2, dated June 22, 2011. This document is not incorporated by reference in this AD.

(n) 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: Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; 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.

(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 the European Aviation Safety Agency (EASA); or Fokker B.V. Service's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

(o) Related Information

(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0111, dated May 8, 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-2015-8138.

(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (p)(5) and (p)(6) of this AD.

(p) 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 July 15, 2016.

(i) Fokker Service Bulletin SBF28-28-053, Revision 3, dated January 9, 2014.

(ii) Reserved.

(4) The following service information was approved for IBR on September 16, 2011 (76 FR 50111, August 12, 2011).

(i) Fokker Service Bulletin SBF28-28-053, Revision 1, dated September 20, 2010.

(ii) Reserved.

(5) For service information identified in this AD, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email [email protected]; Internet http://www.myfokkerfleet.com.

(6) 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.

(7) 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 May 31, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-13545 Filed 6-9-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-4813; Directorate Identifier 2013-NM-161-AD; Amendment 39-18532; AD 2016-11-05] 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) 99-16-01 for certain Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes). AD 99-16-01 required repetitive inspections of certain bolt holes where parts of the main landing gear (MLG) are attached to the wing rear spar, and repair if necessary. Since we issued AD 99-16-01, we have determined that the risk of cracking in the wing rear spar is higher than initially determined. This new AD adds airplanes to the applicability, reduces the compliance times and repetitive intervals for the inspections, and changes the inspection procedures. This AD was prompted by a determination that the risk of cracking in the wing rear spar is higher than initially determined. We are issuing this AD to detect and correct cracking of the rear spar of the wing, which could result in reduced structural integrity of the airplane.

DATES:

This AD becomes effective July 15, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of July 15, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of November 9, 1995 (60 FR 52618, October 10, 1995).

ADDRESSES:

For service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EAW, 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-2015-4813.

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-2015-4813; 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:

Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-227-2125; fax: 425-227-1149.

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 99-16-01, Amendment 39-11236 (64 FR 40743, July 28, 1999) (“AD 99-16-01”). AD 99-16-01 superseded AD 95-20-02, Amendment 39-9380 (60 FR 52618, October 10, 1995). AD 99-16-01 applied to certain Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes). The NPRM published in the Federal Register on November 17, 2015 (80 FR 71751) (“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 2013-0180, dated August 9, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes). The MCAI states:

During full-scale fatigue testing, cracks were found on the rear spar from certain bolt holes at the attachment of the Main Landing gear (MLG) forward pick-up fitting and the MLG Rib 5 aft.

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

DGAC [Direction Générale de l'Aviation Civile] France issued * * * [an AD] (later revised) to require High Frequency Eddy Current (HFEC) or Ultrasonic (U/S) inspections of certain fastener holes where the MLG forward pick-up fitting and MLG Rib 5 aft are attached to the rear spar.

Since DGAC France * * * [issued a revised AD, which corresponded to FAA AD 99-16-01, Amendment 39-11236 (64 FR 40743, July 28, 1999), which superseded FAA AD 95-20-02, Amendment 39-9380 (60 FR 52618, October 10, 1995)] * * *, a fleet survey and updated Fatigue and Damage Tolerance analyses have been performed in order to substantiate the second A300-600 Extended Service Goal (ESG2) exercise. The results of these analyses have shown that the threshold and interval must be reduced to allow timely detection of these cracks and accomplishment of an applicable corrective action.

For the reasons described above, this [EASA] AD retains the requirements of [the revised DGAC France AD], which is superseded, but reduces the related compliance times.

The new, reduced threshold for the initial inspection ranges between 8,900 total flight cycles/20,000 total flight hours, and 34,600 total flight cycles/77,800 total flight hours, depending on the modification. The grace periods (750 or 1,500 landings) for airplanes that have exceeded the specified thresholds are unchanged from those provided in AD 99-16-01. The new, reduced intervals for the repetitive inspections range between 4,000 flight cycles/9,000 flight hours (whichever occurs first), and 8,900 flight cycles/20,000 flight hours (whichever occurs first), depending on the modification. 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-2015-4813. 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

We reviewed Airbus Service Bulletin A300-57-6017, Revision 04, including Appendix 1, dated February 4, 2011. This service information describes procedures for repetitive inspections of certain bolt holes where parts of the MLG are attached to the wing rear spar, and repair. 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 71 airplanes of U.S. registry.

The actions required by AD 99-16-01 and retained in this AD, take about 226 work-hours per product, at an average labor rate of $85 per work hour. Required parts cost about $0 per product. Based on these figures, the estimated cost of the actions that are required by AD 99-16-01 is $19,210 per product, per inspection cycle.

We also estimate that it will take about 226 work-hours per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $1,363,910, or $19,210 per product.

We have received no definitive data that will 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) 99-16-01, Amendment 39-11236 (64 FR 40743, July 28, 1999), and adding the following new AD: 2016-11-05 Airbus: Amendment 39-18532; Docket No. FAA-2015-4813; Directorate Identifier 2013-NM-161-AD. (a) Effective Date

This AD becomes effective July 15, 2016.

(b) Affected ADs

This AD replaces AD 99-16-01, Amendment 39-11236 (64 FR 40743, July 28, 1999) (“AD 99-16-01”).

(c) Applicability

This AD applies to Airbus Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes; Model A300 B4-605R and B4-622R airplanes; Model A300 F4-605R airplanes; and Model A300 C4-605R Variant F airplanes; certificated in any category; all manufacturer serial numbers.

(d) Subject

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

(e) Reason

This AD was prompted by the results of a full-scale fatigue test when cracking was found on the rear spar of the wing, and the subsequent determination that the risk of such cracking is higher than initially determined. We are issuing this AD to detect and correct cracking of the rear spar of the wing, which could result in reduced structural integrity of the airplane.

(f) Compliance

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

(g) Retained Inspections and Corrective Actions, With Revised Service Information

This paragraph restates the requirements of paragraphs (a), (b), (c), (d), (e), and (f) of AD 99-16-01 with revised service information and reduced thresholds and repetitive intervals, for Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes; manufacturer serial numbers (MSNs) 252 through 553 inclusive; except those airplanes on which Airbus Modification 07601 has been accomplished prior to delivery.

(1) Perform a high frequency eddy current (HFEC) rototest inspection to detect cracks in certain bolt holes where the main landing gear (MLG) forward pick-up fitting and MLG rib 5 aft are attached to the rear spar, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6017, Revision 01, including Appendix 1, dated July 25, 1994; or Airbus Service Bulletin A300-57-6017, Revision 04, including Appendix 1, dated February 24, 2011. As of the effective date of this AD, only Airbus Service Bulletin A300-57-6017, Revision 04, including Appendix 1, dated February 24, 2011, may be used for the actions required by this paragraph.

(i) For airplanes that have accumulated 17,300 total landings or less as of November 9, 1995 (the effective date of AD 95-20-02, Amendment 39-9380 (60 FR 52618, October 10, 1995)) (“AD 95-20-02”): Inspect prior to the accumulation of 17,300 total landings, or within 1,500 landings after November 9, 1995, whichever occurs later.

(ii) For airplanes that have accumulated 17,301 or more total landings, but less than 19,300 total landings as of November 9, 1995 (the effective date of AD 95-20-02): Inspect within 1,500 landings after November 9, 1995.

(iii) For airplanes that have accumulated 19,300 or more total landings as of November 9, 1995 (the effective date of AD 95-20-02): Inspect within 750 landings after November 9, 1995 (the effective date of AD 95-20-02).

(2) If no crack is found during the inspection required by paragraph (g)(1) of this AD, repeat that inspection thereafter at the time specified in either paragraph (g)(2)(i) or (g)(2)(ii) of this AD, as applicable.

(i) For airplanes on which Airbus Modification 07716 (as specified in Airbus Service Bulletin A300-57-6020) has not been accomplished: Inspect at the time specified in paragraph (g)(2)(i)(A) or (g)(2)(i)(B) of this AD, as applicable.

(A) For airplanes having MSNs 465 through 553 inclusive: Repeat the inspection at intervals not to exceed 13,000 landings, until the inspection required by paragraph (g)(4)(ii)(A)(1) of this AD has been accomplished.

(B) For airplanes having MSNs 252 through 464 inclusive: Repeat the inspection at intervals not to exceed 8,400 landings, until the inspection required by paragraph (g)(4)(ii)(A)(2) of this AD has been accomplished.

(ii) For airplanes on which Airbus Modification 07716 has been accomplished: Inspect at the time specified in either paragraph (g)(2)(ii)(A) or (g)(2)(ii)(B) of this AD, as applicable.

(A) For airplanes having MSNs 465 through 553 inclusive: Repeat the inspection at intervals not to exceed 11,800 landings, until the inspection required by paragraph (g)(4)(i)(B) of this AD has been accomplished.

(B) For airplanes having MSNs 252 through 464 inclusive: Repeat the inspection within 10,700 landings following the initial inspection required by paragraph (g)(1) of this AD, and thereafter at intervals not to exceed 7,500 landings, until the inspection required by paragraph (g)(4)(ii)(B)(2) has been accomplished.

(3) If any crack is found during the inspection required by either paragraph (g)(1) or (g)(2) of this AD, prior to further flight, accomplish the requirements of either paragraph (g)(3)(i) or (g)(3)(ii) of this AD, as applicable.

(i) For airplanes on which Airbus Modification 07716 has not been accomplished: Oversize the bolt hole by 1/32 inch and repeat the HFEC inspection required by paragraph (g)(1) of this AD, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6017, Revision 01, including Appendix 1, dated July 25, 1994. After accomplishing the oversizing and HFEC inspection, repeat the inspection, as required by paragraph (g)(2) of this AD, at the applicable schedule specified in that paragraph, until the inspection required by paragraph (g)(4)(ii)(B)(1) or (g)(4)(ii)(B)(2) of this AD has been accomplished.

(A) If no cracking is detected, install the second oversize bolt in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6017, Revision 01, including Appendix 1, dated July 25, 1994.

(B) If any cracking is detected, repair in accordance with a method approved by the Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate.

(ii) For airplanes on which Airbus Modification 07716 has been accomplished: Repair in accordance with a method approved by the Manager, International Branch, ANM-116. After repair, repeat the inspections as required by paragraph (g)(2) of this AD at the applicable schedule specified in that paragraph, until the inspection required by paragraph (g)(4)(ii)(B)(1) or (g)(4)(ii)(B)(2) of this AD has been accomplished.

(4) Perform an ultrasonic inspection to detect cracks in certain bolt holes where the MLG forward pick-up fitting and MLG rib 5 aft are attached to the rear spar, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6017, Revision 03, dated November 19, 1997; or Revision 04, including Appendix 1, dated February 24, 2011; at the time specified in paragraph (g)(4)(i) or (g)(4)(ii) of this AD, as applicable. As of the effective date of this AD, only Airbus Service Bulletin A300-57-6017, Revision 04, including Appendix 1, dated February 24, 2011, may be used for the actions in this paragraph.

(i) For airplanes not inspected prior to September 1, 1999 (the effective date of AD 99-16-01), as specified in Airbus Service Bulletin A300-57-6017, dated November 22, 1993; or Revision 01, including Appendix 1, dated July 25, 1994: Inspect at the time specified in paragraph (g)(4)(i)(A), (g)(4)(i)(B), or (g)(4)(i)(C) of this AD, as applicable. Accomplishment of this inspection terminates the requirements of paragraph (g)(1) of this AD.

(A) For airplanes that have accumulated 17,300 total landings or fewer as of the effective date of this AD: Inspect prior to the accumulation of 17,300 total landings, or within 1,500 landings after September 1, 1999 (the effective date of AD 99-16-01), whichever occurs later.

(B) For airplanes that have accumulated 17,301 total landings or more but fewer than 19,300 total landings as of September 1, 1999 (the effective date of AD 99-16-01): Inspect within 1,500 landings after September 1, 1999 (the effective date of AD 99-16-01).

(C) For airplanes that have accumulated 19,300 total landings or more as of September 1, 1999 (the effective date of AD 99-16-01): Inspect within 750 landings after September 1, 1999 (the effective date of AD 99-16-01).

(ii) For airplanes on which an HFEC inspection was performed prior to September 1, 1999 (the effective date of AD 99-16-01), in accordance with the requirements of paragraph (g)(1) of this AD, or in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6017, dated November 22, 1993: Inspect at the time specified in paragraph (g)(4)(ii)(A) or (g)(4)(ii)(B) of this AD, as applicable.

(A) If no cracking was detected during any HFEC inspection accomplished prior to September 1, 1999 (the effective date of AD 99-16-01), and if Airbus Modification 07716 has not been accomplished: Inspect at the time specified in paragraph (g)(4)(ii)(A)(1) or (g)(4)(ii)(A)(2) of this AD, as applicable.

(1) For airplanes having MSNs 465 through 553 inclusive: Inspect within 13,000 landings after the most recent HFEC inspection, and thereafter at intervals not to exceed 8,900 landings. Accomplishment of this inspection constitutes terminating action for the repetitive inspection requirement of paragraph (g)(2)(i)(A) of this AD.

(2) For airplanes having MSNs 252 through 464 inclusive: Inspect within 8,400 landings after the most recent HFEC inspection, and thereafter at intervals not to exceed 5,500 landings. Accomplishment of this inspection constitutes terminating action for the repetitive inspection requirement of paragraph (g)(2)(i)(B) of this AD.

(B) If any cracking was detected during any HFEC inspection performed prior to the effective date of this AD, regardless of the method of repair, or if Airbus Modification 07716 has been accomplished: Inspect at the time specified in paragraph (g)(4)(ii)(B)(1) or (g)(4)(ii)(B)(2) of this AD, as applicable.

(1) For airplanes having MSNs 465 through 553 inclusive: Inspect within 11,800 landings after the most recent HFEC inspection, and thereafter at intervals not to exceed 8,200 landings. Accomplishment of this inspection constitutes terminating action for the repetitive inspection requirement of paragraph (g)(3)(i) or (g)(3)(ii) of this AD, as applicable.

(2) For airplanes having MSNs 252 through 464 inclusive: Inspect within 10,700 landings after the initial inspection in accordance with paragraph (g)(1) of this AD, or within 7,500 landings after the most recent HFEC inspection, whichever occurs later, and thereafter at intervals not to exceed 4,900 landings. Accomplishment of this inspection constitutes terminating action for the repetitive inspection requirement of paragraph (g)(3)(i) or (g)(3)(ii) of this AD, as applicable.

(5) If no cracking is detected during the ultrasonic inspection required by paragraph (g)(4)(i) of this AD, repeat that inspection thereafter at the time specified in paragraph (g)(5)(i) or (g)(5)(ii) of this AD, as applicable, until the initial ultrasonic inspection required by paragraph (h) of this AD is done.

(i) For airplanes having MSNs 465 through 553 inclusive: Repeat the inspection at intervals not to exceed 8,900 landings.

(ii) For airplanes having MSNs 232 through 464 inclusive: Repeat the inspection at intervals not to exceed 5,500 landings.

(6) If any cracking is detected during any inspection performed in accordance with the requirements of paragraph (g)(4) or (g)(5) of this AD: Prior to further flight, repair in accordance with a method approved by the Manager, International Branch, ANM-116; 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).

Note 1 to paragraph (g) of this AD:

Airbus Service Bulletin A300-57-6017, Revision 01, including Appendix 1, dated July 25, 1994; and Airbus Service Bulletin A300-57-6017, Revision 04, including Appendix 1, dated February 24, 2011; also reference Airbus Service Bulletin A300-57-6020, dated November 22, 1993, as an additional source of service information for installation of oversize studs in the bolt holes.

(h) New Repetitive Inspections

At the applicable times specified in paragraph 1.B.(5), “Accomplishment Timescale,” of Airbus Service Bulletin A300-57-6017, Revision 04, including Appendix 1, dated February 24, 2011: Do ultrasonic inspections to detect cracks in the MLG attachment fitting holes on the wing rear spar, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6017, Revision 04, including Appendix 1, dated February 24, 2011. Repeat the inspections thereafter at the applicable intervals specified in paragraph 1.B.(5), “Accomplishment Timescale,” of Airbus Service Bulletin A300-57-6017, Revision 04, including Appendix 1, dated February 24, 2011. For airplanes modified as specified in Airbus Service Bulletin A300-57-6073, the initial inspection threshold is counted from the completion date of the modification. Clarification of compliance time terminology used in table 1, “Structural Inspection Program,” of Airbus Service Bulletin A300-57-6017, Revision 04, including Appendix 1, dated February 24, 2011, is provided in paragraphs (h)(1) through (h)(4) of this AD. Accomplishment of the initial inspection terminates the repetitive inspections required by paragraph (g)(5) of this AD.

(1) For pre-Airbus Modification 07716 or pre-Airbus Modification 11440 airplanes:

(i) The term “flight cycles” in the “Inspection Threshold” column is total flight cycles accumulated by the airplane.

(ii) The term “flight hours” in the “Inspection Threshold” column is total flight hours accumulated by the airplane.

(2) For post-Airbus Modification 07716 airplanes:

(i) The term “flight cycles” in the “Inspection Threshold” column is total flight cycles accumulated by the airplane.

(ii) The term “flight hours” in the “Inspection Threshold” column is total flight hours accumulated by the airplane.

(3) For post-Airbus Modification 11440 (Airbus Service Bulletin A300-57-6073) airplanes:

(i) The term “flight cycles” in the “Inspection Threshold” column is flight cycles accumulated by the airplane after the modification was done.

(ii) The term “flight hours” in the “Inspection Threshold” column is flight hours accumulated by the airplane after the modification was done.

(4) For post-Airbus Modification 07601 airplanes:

(i) The term “flight cycles” in the “Inspection Threshold” column is total flight cycles accumulated by the airplane.

(ii) The term “flight hours” in the “Inspection Threshold” column is total flight hours accumulated by the airplane.

(i) Repairs

If any crack is found during any inspection required by paragraph (h) of this AD: Before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; or Airbus's EASA DOA.

(j) Non-Terminating Repair

Accomplishment of any repair as required by paragraph (i) of this AD is not terminating action for the repetitive inspections required by paragraph (g) or (h) of this AD.

(k) Credit for Previous Actions

This paragraph provides credit for actions required by paragraphs (g) and (h) of this AD, if those actions were performed before the effective date of this AD using any of the following service information.

(1) Airbus Service Bulletin A300-57-6017, dated November 22, 1993, which is not incorporated by reference in this AD.

(2) Airbus Service Bulletin A300-57-6017, Revision 01, including Appendix 1, dated July 25, 1994, which was incorporated by reference in AD 95-20-02 and is retained in this AD.

(3) Airbus Service Bulletin A300-57-6017, Revision 02, dated January 14, 1997, including Appendix 1, dated July 25, 1994, which is not incorporated by reference in this AD.

(4) Airbus Service Bulletin A300-57-6017, Revision 03, including Appendix 1, dated November 19, 1997, which was incorporated by reference in AD 99-16-01, but is not retained in this AD.

(l) 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: Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-227-2125; 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 for AD 99-16-01 are approved as AMOCs for the corresponding provisions 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.

(m) Related Information

(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2013-0180, dated August 9, 2013, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov searching for and locating Docket No. FAA-2015-4813.

(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (n)(5) and (n)(6) of this AD.

(n) 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 July 15, 2016.

(i) Airbus Service Bulletin A300-57-6017, Revision 04, including Appendix 1, dated February 24, 2011.

(ii) Reserved.

(4) The following service information was approved for IBR on November 9, 1995 (60 FR 52618, October 10, 1995).

(i) Airbus Service Bulletin A300-57-6017, Revision 01, including Appendix 1, dated July 25, 1994.

(ii) Reserved.

(5) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 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.

(6) 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.

(7) 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 May 18, 2016. Dionne Palermo, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-12324 Filed 6-9-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-2134; Directorate Identifier 2015-CE-012-AD; Amendment 39-18547; AD 2016-11-20] RIN 2120-AA64 Airworthiness Directives; B/E Aerospace Protective Breathing Equipment Part Number 119003-11 AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain B/E Aerospace protective breathing equipment (PBE) that is installed on airplanes. This AD was prompted by a report of a PBE catching fire upon activation by a crewmember. This AD requires replacing the PBE. We are issuing this AD to correct the unsafe condition on these products.

DATES:

This AD is effective July 15, 2016.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of July 15, 2016.

ADDRESSES:

For service information identified in this final rule, contact B/E Aerospace, Inc., Commercial Aircraft Products Group, 10800 Pflumm Road, Lenexa, Kansas 66215; phone: (913) 338-9800; fax: (913) 338-8419; Internet: www.beaerospace.com. You may view this referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-2134.

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-2015-2134; 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 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:

David Enns, Aerospace Engineer, Wichita Aircraft Certification Office, FAA, 1801 S. Airport Road, Room 100, Wichita, Kansas 67209; phone: (316) 946-4147; fax: (316) 946-4107; email: [email protected]

SUPPLEMENTARY INFORMATION:

Discussion

We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain B/E Aerospace protective breathing equipment (PBE) that is installed on airplanes. The SNPRM published in the Federal Register on January 15, 2016 (81 FR 2131). We preceded the SNPRM with a notice of proposed rulemaking (NPRM) that published in the Federal Register on June 16, 2015 (80 FR 34330). The NPRM proposed to require inspecting the PBE to determine if the pouch has the proper vacuum seal and replacing if necessary. The NPRM was prompted by a report of a PBE catching fire upon activation by a crewmember. The SNPRM proposed to require replacement of the PBE following newly issued service information, regardless of inspection results. We are issuing this AD to correct the unsafe condition on these products.

Comments

We gave the public the opportunity to participate in developing this AD. We have considered the comments received. We received one anonymous comment in support of the SNPRM (81 FR 2131, January 15, 2016).

Request To Change Compliance Time

Penney Baudin of United Airlines requested a change to the PBE replacement compliance time.

The commenter requested a 12-month repetitive inspection with a 36-month terminating replacement action. The commenter stated that the change would alleviate restrictive shipping means and complex distribution of the PBEs since the units contain oxygen generators.

We do not agree with the commenter. We believe that the replacement compliance time of 18 months after the effective date of this AD is sufficient time since we are allowing even more time than specified in the related service information. Also, the public has been aware of this safety issue since we first published the first NPRM on June 16, 2015 (80 FR 34330). We have not changed the final rule AD action based on this comment.

Request To Correct Service Information

John Barker of B/E Aerospace stated that Service Bulletin 119003-35-009, dated November 9, 2015, is incorrectly referenced as Rev. 009 instead of Rev. 000 in the preamble of the SNPRM (81 FR 2131, January 15, 2016). The commenter requested the reference to the revision number be corrected.

We agree with the commenter. However, on April 12, 2016, Rev. 001 of B/E Aerospace Service Bulletin 119003-35-009 was released. We are incorporating the Revision 001, dated April 12, 2016, into the final rule AD action because the procedures for doing the inspection and replacement of the PBE have not changed.

We have changed the final rule AD action to include the newly revised service bulletin and to give credit to owners/operators who may have already done the required replacement following B/E Aerospace Service Bulletin No. 119003-35-009, Rev. 000, dated November 9, 2015, which was correctly referenced in paragraph (h) of the regulatory text in the SNPRM (81 FR 2131, January 15, 2016).

Conclusion

We reviewed the relevant data, considered the comments received, 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 SNPRM (81 FR 2131, January 15, 2016) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the SNPRM (81 FR 2131, January 15, 2016).

Related Service Information Under 1 CFR Part 51

We reviewed B/E Aerospace Service Bulletin No. 119003-35-011, Rev. 000, dated February 4, 2015, and B/E Aerospace Service Bulletin 119003-35-009, Rev. 001, dated April 12, 2016. B/E Aerospace Service Bulletin No. 119003-35-011, Rev. 000, dated February 4, 2015, describes procedures for inspecting PBE, part number (P/N) 119003-11, to determine if the vacuum seal of the pouch containing the PBE is compromised. B/E Aerospace Service Bulletin 119003-35-009, Rev. 001, dated April 12, 2016, describes procedures for replacing PBE P/N 119003-11 with P/N 119003-21. 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.

Differences Between This AD and the Service Information

B/E Aerospace Service Bulletin No. 119003-35-011, Rev. 000, dated February 4, 2015, applies to all PBE with P/N 119003-11 and P/N 119003-21. We have determined that this AD will apply only to a PBE P/N 119003-11 with regard to the inspection requirement of paragraph (g) of this AD. B/E Aerospace Service Bulletin 119003-35-009, Rev. 001, dated April 12, 2016, includes instructions for disposal. In this AD, we are requiring only the replacement action.

Costs of Compliance

We estimate that this AD affects 9,000 products installed on 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
  • Inspecting the pouch containing the PBE for proper vacuum seal .5 work-hour × $85 per hour = $42.50 Not applicable $42.50 $382,500 Replace the PBE P/N 119003-11 with a PBE P/N 119003-21 .5 work-hour × $85 per hour = $42.50 1,510 1,552.50 13,972,500
    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): 2016-11-20 B/E Aerospace: Amendment 39-18547; FAA-2015-2134; Directorate Identifier 2015-CE-012-AD. (a) Effective Date

    This AD is effective July 15, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to B/E Aerospace Protective Breathing Equipment (PBE), part number (P/N) 119003-11, that is installed on airplanes.

    (d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 35; Oxygen.

    (e) Unsafe Condition

    This AD was prompted by a report of a PBE, P/N 119003-11, catching fire upon activation by a crewmember. We are issuing this AD to correct the unsafe condition on these products.

    (f) Compliance

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

    (g) Inspection

    Within 3 months after July 15, 2016 (the effective date of this AD), while still in the stowage box, physically inspect the PBE pouch to determine if it has an intact vacuum seal. Do this inspection following paragraph III.A.1. of the Accomplishment Instructions in B/E Aerospace Service Bulletin No. 119003-35-011, Rev. 000, dated February 4, 2015.

    (h) Replacement

    (1) If a PBE pouch is found that does not have an intact vacuum seal during the inspection required in paragraph (g) of this AD: Before further flight or following existing minimum equipment list (MEL) procedures, replace the PBE with a PBE, P/N 119003-21, following paragraphs III.C., III.D.(4), III.D.(6), and III.D.(7) of the Accomplishment Instructions in B/E Aerospace Service Bulletin No. 119003-35-009, Rev. 001, dated April 12, 2016, or replace it with another FAA-approved serviceable PBE.

    (2) If a PBE pouch is found during the inspection required in paragraph (g) of this AD where the vacuum seal is intact: Within 18 months after July 15, 2016 (the effective date of this AD), remove PBE, P/N 119003-11, and replace the PBE with PBE, P/N 119003-21, following paragraphs III.C., III.D.(4), III.D.(6), and III.D.(7) of the Accomplishment Instructions in B/E Aerospace Service Bulletin No. 119003-35-009, Rev. 001, dated April 12, 2016, or replace it with another FAA-approved serviceable PBE.

    (i) Credit for Actions Done Following Previous Service Information

    If you performed the replacement action required in paragraphs (h)(1) and (2) of this AD before July 15, 2016 (the effective date of this AD) using B/E Aerospace Service Bulletin No. 119003-35-009, Rev. 000, dated November 9, 2015, you met the requirements of those paragraphs of this AD.

    (j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (k) of this AD.

    (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.

    (k) Related Information

    For more information about this AD, contact David Enns, Aerospace Engineer, Wichita ACO, FAA, 1801 S. Airport Road, Room 100, Wichita, Kansas 67209; phone: (316) 946-4147; fax: (316) 946-4107; email: [email protected]

    (l) 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) B/E Aerospace Service Bulletin No. 119003-35-009, Rev. 001, dated April 12, 2016.

    (ii) B/E Aerospace Service Bulletin No. 119003-35-011, Rev. 000, dated February 4, 2015.

    (3) For B/E Aerospace, Inc. service information identified in this AD, contact B/E Aerospace, Inc., 10800 Pflumm Road, Commercial Aircraft Products Group, Lenexa, Kansas 66215; phone: (913) 338-9800; fax: (913) 338-8419; Internet: www.beaerospace.com.

    (4) You may view this service information at FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-2134.

    (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 Kansas City, Missouri, on May 25, 2016. Pat Mullen, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-13250 Filed 6-9-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5284; Directorate Identifier 2016-CE-006-AD; Amendment 39-18550; AD 2016-12-01] RIN 2120-AA64 Airworthiness Directives; PILATUS AIRCRAFT LTD. Airplanes AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for PILATUS AIRCRAFT LTD. Models PC-12, PC-12/45, PC-12/47, and PC-12/47E airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as incorrect installation instructions of the torlon plates in the airplane maintenance manual resulting in the incorrect installation of the torlon plates in the forward wing-to-fuselage attachment. We are issuing this AD to require actions to address the unsafe condition on these products.

    DATES:

    This AD is effective July 15, 2016.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of July 15, 2016.

    ADDRESSES:

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5284; or in person at 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 service information identified in this AD, contact PILATUS AIRCRAFT LTD., Customer Support Manager, CH-6371 STANS, Switzerland; phone: +41 (0)41 619 33 33; fax: +41 (0)41 619 73 11; email: [email protected]; internet: http://www.pilatus-aircraft.com. You may view this referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the Internet at http://www.regulations.gov by searching for Docket No. FAA-2016-5284.

    FOR FURTHER INFORMATION CONTACT:

    Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4059; fax: (816) 329-4090; 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 PILATUS AIRCRAFT LTD. Models PC-12, PC-12/45, PC-12/47, and PC-12/47E airplanes. The NPRM was published in the Federal Register on March 28, 2016 (81 FR 17107). The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:

    Incorrect installations of torlon plates in the forward lower wing-to-fuselage attachment were reported on aeroplanes in service. Investigation determined that wrong torlon plate installation instructions were published in June 2007 in Revision (Rev.) 18 to 27 of the Aircraft Maintenance Manual (AMM) 02049, Data Module (DM) 12-A-57-00-00A-520A-A and DM 12-A-57-00-00A-720A-A, for the PC-12, PC-12/45 and PC-12/47 aeroplanes, and in the initial issue to Rev. 10 of AMM 02300, in DM 12-B-57-00-00A-520A-A and DM 12-B-57-00-00A-720A-A, for PC-12/47E aeroplanes.

    This condition, if not corrected, could lead to additional loads at the wing-to-fuselage interface, which detrimentally affects the fatigue life of the structural joint.

    To address this potential unsafe condition, Pilatus issued Service Bulletin (SB) No. 57-007 to provide inspection instructions to verify the correct installation of torlon plates in the wing-to-fuselage attachments, and the rectification instructions for incorrect installed torlon plates.

    For the reason described above, this AD requires a one-time inspection of the forward lower wing-to-fuselage attachments, both left hand (LH) and right hand (RH) sides and, depending on findings, accomplishment of applicable corrective action(s).

    The MCAI can be found in the AD docket on the Internet at: https://www.regulations.gov/#!documentDetail;D=FAA-2016-5284-0002. Comments

    We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (81 FR 17107, March 28, 2016) or on the determination of the cost to the public.

    Conclusion

    We reviewed the relevant data and determined that air safety and the public interest require adopting the 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 (81 FR 17107, March 28, 2016) for correcting the unsafe condition; and

    • Do not add any additional burden upon the public than was already proposed in the NPRM (81 FR 17107, March 28, 2016).

    Related Service Information Under 1 CFR Part 51

    We reviewed PILATUS AIRCRAFT LTD. PC-12 Service Bulletin No: 57-007, dated September 29, 2015. The service information describes procedures for inspection, and if necessary realignment or replacement of the torlon plates in the forward lower wing-to-fuselage attachments. 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 of the AD.

    Costs of Compliance

    We estimate that this AD will affect 268 products of U.S. registry. We also estimate that it would take about 1 work-hour per wing per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour.

    Based on these figures, we estimate the cost of the AD on U.S. operators to be $45,560, or $170 per product.

    In addition, we estimate that any necessary follow-on actions would take about 3 work-hours per wing and require parts costing $1,000 per wing, for a total cost of $2,510 per product. We have no way of determining the number of products that may need these actions.

    According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

    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, 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 by searching for and locating Docket No. FAA-2016-5284; 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 the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    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 AD: 2016-12-01 Pilatus Aircraft LTD.: Amendment 39-18550; Docket No. FAA-2016-5284; Directorate Identifier 2016-CE-006-AD. (a) Effective Date

    This airworthiness directive (AD) becomes effective July 15, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to PILATUS AIRCRAFT LTD. PC-12, PC-12/45, PC-12/47, and PC-12/47E airplanes, all serial numbers delivered before January 1, 2015, certificated in any category.

    Note 1 to paragraph (c) of this AD: The date of delivery may be found as the issue date of the EASA Form 52, which is part of the airplane records.

    (d) Subject

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

    (e) Reason

    This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as incorrect installation instructions of the torlon plates in the airplane maintenance manual resulting in the incorrect installation of the torlon plates in the forward wing-to-fuselage attachment. We are issuing this AD to identify and correct incorrectly installed torlon plates which could cause additional loads affecting the fatigue life at the wing-to-fuselage interface.

    (f) Actions and Compliance

    Do the actions in paragraphs (f)(1) through (4) of this AD. If paragraphs (f)(1), (2), and (3) of this AD have already been done before July 15, 2016 (the effective date of this AD), then only paragraph (f)(4) of this AD applies.

    (1) For any airplane that has had a wing removed and reinstalled or replaced between June 2007 and July 15, 2016 (the effective date of this AD): Within the next 12 months after July 15, 2016 (the effective date of this AD), inspect the torlon plates in the forward lower wing-to-fuselage attachments (both left hand (LH) and right hand (RH) sides) for correct installation following the accomplishment instructions in PILATUS AIRCRAFT LTD. PC-12 Service Bulletin No: 57-007, dated September 29, 2015.

    (2) For any airplane that has had a wing removed and reinstalled or replaced, between June 2007 and July 15, 2016 (the effective date of this AD): If an incorrect installation of the torlon plates is found during the inspection required in paragraph (f)(1) of this AD, remove the affected torlon plates, visually inspect the torlon plates and the affected lugs using a mirror and light source (if necessary) for any damage, and reinstall the torlon plates in the correct sequence, following the accomplishment instructions in paragraph 3.C. of PILATUS AIRCRAFT LTD. PC-12 Service Bulletin No: 57-007, dated September 29, 2015.

    (3) For any airplane that has had a wing removed and reinstalled or replaced, between June 2007 and July 15, 2016 (the effective date of this AD): If any damage is found during the inspection of the torlon plates and lugs required in paragraph (f)(2) of this AD, before further flight, contact PILATUS AIRCRAFT LTD. for FAA-approved repair instructions and accomplish those instructions accordingly. You may find contact information for PILATUS AIRCRAFT LTD. in paragraph (h) of this AD.

    (4) For all airplanes: As of July 15, 2016 (the effective date of this AD), do not install or re-install a wing on any airplane, unless concurrent with the wing installation, the torlon plates of the forward lower wing-to-fuselage attachment (both LH and RH sides) of the airplane are inspected and found to be installed correctly in accordance with the accomplishment instructions in paragraph 3.B. of PILATUS AIRCRAFT LTD. PC-12 Service Bulletin No: 57-007, dated September 29, 2015.

    Note 2 to paragraph (f)(4) of this AD:

    Installation of a wing on an airplane in accordance with the instructions of PILATUS aircraft maintenance manual (AMM) 02049, Revision 28 or later, or AMM 02300, Revision 11 or later, is an acceptable alternative method to comply with this inspection requirement.

    (g) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4059; fax: (816) 329-4090; email: [email protected] Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.

    (2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.

    (3) Reporting Requirements: For any reporting requirement in this AD, a federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately 5 minutes per response, including the time for reviewing instructions, completing and reviewing the collection of information. All responses to this collection of information are mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn: Information Collection Clearance Officer, AES-200.

    (h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.: 2016-0037, dated February 26, 2016, for related information. The MCAI can be found in the AD docket on the Internet at: https://www.regulations.gov/#!documentDetail;D=FAA-2016-5284-0002.

    (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) PILATUS AIRCRAFT LTD. PC-12 Service Bulletin No: 57-007, dated September 29, 2015.

    (ii) Reserved.

    (3) For PILATUS AIRCRAFT LTD. service information identified in this AD, contact PILATUS AIRCRAFT LTD., Customer Support Manager, CH-6371 STANS, Switzerland; phone: +41 (0)41 619 33 33; fax: +41 (0)41 619 73 11; email: [email protected]; Internet: http://www.pilatus-aircraft.com.

    (4) You may view this service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. In addition, you can access this service information on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5284.

    (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 Kansas City, Missouri, on June 1, 2016. Pat Mullen, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-13372 Filed 6-9-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-4878; Directorate Identifier 2016-CE-001-AD; Amendment 39-18551; AD 2016-12-02] RIN 2120-AA64 Airworthiness Directives; Various Aircraft Equipped With BRP-Powertrain GmbH & Co KG 912 A Series Engine AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for various aircraft equipped with a BRP-Powertrain GmbH & Co KG (formerly Rotax Aircraft Engines) 912 A series engine. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as a design change of the engine cylinder head temperature sensor without a concurrent revision of the engine model designation, the engine part number, or the cockpit indication to the pilot. We are issuing this AD to require actions to address the unsafe condition on these products.

    DATES:

    This AD is effective July 15, 2016.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of July 15, 2016.

    ADDRESSES:

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-4878; or in person at 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 service information identified in this AD, contact BRP-Powertrain GmbH & Co. KG, Welser Strasse 32, A-4623 Gunskirchen, Austria; phone: +43 7246 601 0; fax: +43 7246 601 9130; Internet: www.rotax-aircraft-engines.com. You may view this referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the Internet at http://www.regulations.gov by searching for Docket No. FAA-2016-4878.

    FOR FURTHER INFORMATION CONTACT:

    Jim Rutherford, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4165; fax: (816) 329-4090; 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 various aircraft equipped with a BRP-Powertrain GmbH & Co KG (formerly Rotax Aircraft Engines) 912 A series engine. The NPRM was published in the Federal Register on March 28, 2016 (81 FR 17109). The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:

    A design change of the engine cylinder heads was introduced by BRP-Powertrain in March 2013 which modifies the engine/aircraft interfaces by substituting the previous cylinder head temperature (CHT) measurement (limit temperature 135 °C/150 °C) with a coolant temperature (CT) measurement (limit temperature 120 °C). The design change was communicated on 15 May 2013 by BRP-Powertrain Service Instruction (SI) 912-020R7/914-022R7 (single document) but was not identified by a change of the engine model designation or of the engine P/N, but only through the cylinder head P/N and the position of the temperature sensor.

    Consequently, engines with the new cylinder heads (installed during production or replaced in-service during maintenance) may be installed on an aircraft without concurrent modification of that aircraft, instructions for which should be provided by the Type Certificate (TC) holder or Supplemental Type Certificate (STC) holder, as applicable. In this case, the coolant temperature with a maximum engine operating limit of 120 °C (valid for engines operated with water diluted glycol coolant) is displayed on a CHT indicator with a typical limit marking (red radial/range) of more than 120 °C.

    This condition, if not detected and corrected, will prevent the pilot to identify coolant limit exceedances, with subsequent loss of coolant (120 °C is the boiling temperature of the coolant), which could lead to engine in-flight shut-down, possibly resulting in a forced landing, with consequent damage to the aircraft and injury to occupants.

    BRP-Powertrain published revised SI-912-020R8/914-022R8 to clarify that, on the new cylinder heads, the coolant temperature, instead of the cylinder head temperature in the aluminum, is measured. EASA issued SIB 2014-34 to raise awareness that installation of affected engines and spare parts, without concurrent incorporation of aircraft TC/STC holder approved modifications, and even if unintended and unnoticed by production or maintenance, constitutes an unapproved aircraft modification.

    Since EASA published the SIB, further investigation has finally determined that sufficient reason exists to warrant AD action.

    For the reason stated above, this AD requires a one-time inspection to determine the actual engine configuration and, depending on findings, engine reidentification and (depending on TC or STC holder installation) modification of the affected aircraft. This also affects engines that are operated with waterless coolant.

    The MCAI can be found in the AD docket on the Internet at https://www.regulations.gov/#!documentDetail;D=FAA-2016-4878-0002. Comments

    We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (81 FR 17109, March 28, 2016) or on the determination of the cost to the public.

    Conclusion

    We reviewed the relevant data and determined that air safety and the public interest require adopting the 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 (81 FR 17109, March 28, 2016) for correcting the unsafe condition; and

    • Do not add any additional burden upon the public than was already proposed in the NPRM (81 FR 17109, March 28, 2016).

    Related Service Information Under 1 CFR Part 51

    We reviewed BRP-Powertrain GmbH & CO KG issued Rotax Aircraft Engines BRP Service Bulletin SB-912-068 and SB-914-049 (co-published as one document), dated April 16, 2015. The service information describes procedures for re-identifying the engine that has new cylinder heads, part numbers 413235 and 413236 installed. 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 of the AD.

    Costs of Compliance

    We estimate that this AD will affect 65 products of U.S. registry.

    We also estimate that it will take about 1 work-hour per product to comply with the engine re-identification requirement of this AD. The average labor rate is $85 per work-hour.

    Based on these figures, we estimate the cost of this portion of this AD on U.S. operators to be $5,525, or $85 per product.

    We also estimate that it will take about 1 work-hour per product to comply with the engine installation modification to indicate a Maximum Coolant Temperature requirement of this AD. The average labor rate is $85 per work-hour.

    Based on these figures, we estimate the cost of this portion of this AD on U.S. operators to be $5,525, or $85 per product.

    We also estimate that it will take about 1.5 work-hours per product to comply with the cylinder head replacement option of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $2,500 to replace a single engine cylinder head.

    Based on these figures, we estimate the cost of this portion of this AD on U.S. operators to be $2,627.50 per engine cylinder head.

    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, 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 AD: 2016-12-02 Various Aircraft: Amendment 39-18551; Docket No. FAA-2016-4878; Directorate Identifier 2016-CE-001-AD. (a) Effective Date

    This airworthiness directive (AD) becomes effective July 15, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all serial numbers of the airplanes listed in table 1 of paragraph (c) of this AD, that are:

    (1) equipped with a BRP-Powertrain GmbH & Co KG (formerly Rotax Aircraft Engines) 912 A series engine with a part number (P/N) 413235 or 413236 cylinder head installed in position 2 or 3; and

    (2) certificated in any category.

    Table 1 of Paragraph (c)—Affected Airplanes Type certificate holder Aircraft model Engine model Aeromot-Indústria Mecânico-Metalúrgica Ltda AMT-200 912 A2 Diamond Aircraft Industries HK 36 R “SUPER DIMONA” 912 A DIAMOND AIRCRAFT INDUSTRIES GmbH HK 36 TS and HK 36 TC 912 A3 Diamond Aircraft Industries Inc. DA20-A1 912 A3 HOAC-Austria DV 20 KATANA 912 A3 Iniziative Industriali Italiane S.p.A. Sky Arrow 650 TC 912 A2 SCHEIBE-Flugzeugbau GmbH SF 25C 912 A2, 912 A3 (d) Subject

    Air Transport Association of America (ATA) Code 72: Engine—Reciprocating.

    (e) Reason

    This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. This AD was prompted by design change of the engine cylinder head temperature sensor without a concurrent revision of the engine model designation, the engine part number, or the cockpit indication to the pilot. The sensor now measures the coolant temperature rather than the cylinder head temperature. If the engine coolant temperature with a maximum engine operating limit of 120 °C is displayed on a Cylinder Head Temperature indicator with a typical limit marking greater than 120 °C, the pilot will be unable to identify coolant temperature limit exceedances. This could result in loss of coolant, which could cause an inflight engine shutdown and forced landing.

    (f) Actions and Compliance

    Unless already done, do the following actions:

    (1) Within 6 months after July 15, 2016 (the effective date of this AD), for engines with cylinder heads listed in paragraph (c)(1) of this AD installed on both position 2 and position 3, change the engine model designation on the engine type data plate to include a “-01” suffix following paragraph 3.1.1) of the Accomplishment/Instructions in Rotax Aircraft Engines BRP Service Bulletin SB-912-068 and SB-914-049 (co-published as one document), dated April 16, 2015.

    (2) Within 6 months after July 15, 2016 (the effective date of this AD), for engines with only one cylinder head listed paragraph (c)(1) of this AD installed in a position 2 or 3, in order to keep such cylinder installed, you must replace the cylinder head installed on the unchanged position (2 or 3, as applicable) with a cylinder head having a P/N listed in paragraph (c)(1) of this AD, and change the engine model designation on the engine type data plate to include a “-01” suffix following paragraph 3.1.1) of the Accomplishment/Instructions in Rotax Aircraft Engines BRP Service Bulletin SB-912-068 and SB-914-049 (co-published as one document), dated April 16, 2015.

    (3) Before further flight after doing the required actions in paragraphs (f)(1) or (f)(2) of this AD as applicable, modify the aircraft and related documentation to indicate a Maximum Coolant Temperature limit of 120 °C using FAA-approved procedures.

    (i) Such procedures can be found by contacting your aircraft type certificate holder or the FAA contact specified in paragraph (g)(1) of this AD. The service documents referenced in paragraph (h) of this AD are examples of FAA-approved procedures for the applicable aircraft.

    (ii) These re-identified engines remain eligible for installation on approved aircraft-engine combinations.

    (4) As of July 15, 2016 (the effective date of this AD), do not install any other P/N cylinder head unless that installation is done following approved instructions provided by BRP-Powertrain at the address provided in paragraph (i)(3) of this AD.

    (g) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Jim Rutherford, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4165; fax: (816) 329-4090; email: [email protected] Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.

    (2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.

    (h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.: 2015-0240, dated December 18, 2015; Rotax Aircraft Engines BRP Service Bulletin SB-912-066 R1/SB-914-047 R1 (published as one document), Revision 1, dated April 23, 2015; Diamond Aircraft Industries GmbH Optional Service Bulletin OSB 36-111, dated September 17, 2015; Diamond Aircraft Industries GmbH Work Instruction WI-OSB 36-111, dated September 17, 2015; Diamond Aircraft Service Bulletin No.: DA20-72-04, dated January 22, 2015; Diamond Aircraft Industries GmbH Optional Service Bulletin OSB 20-066, dated September 17, 2015; Diamond Aircraft Industries GmbH Work Instruction WI-OSB 20-066, dated September 17, 2015; and Scheibe Aircraft GmbH Service Information 02/14-1, dated December 15, 2014, for related information. You may examine the MCAI on the Internet at https://www.regulations.gov/#!documentDetail;D=FAA-2016-4878-0002. For information on the availability of the service documents above, contact the FAA, Small Airplane Directorate, at 816-329-4148.

    (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) Rotax Aircraft Engines BRP Service Bulletin SB-912-068 and SB-914-049 (co-published as one document), dated April 16, 2015.

    (ii) Reserved.

    (3) For BRP-Powertrain GmbH & CO KG service information identified in this AD, contact BRP-Powertrain GmbH & Co. KG, Welser Strasse 32, A-4623 Gunskirchen, Austria; phone: +43 7246 601 0; fax: +43 7246 601 9130; Internet: www.rotax-aircraft-engines.com.

    (4) You may view this service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. In addition, you can access this service information on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-4878.

    (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 Kansas City, Missouri, on June 1, 2016. Pat Mullen, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-13542 Filed 6-9-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 [Docket No. FDA-2016-N-1308] Medical Devices; Ophthalmic Devices; Classification of Nasolacrimal Compression Device AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA) is classifying the nasolacrimal compression device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

    DATES:

    This order is effective June 10, 2016. The classification was applicable on April 20, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Daniel Fedorko, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2414, Silver Spring, MD 20993-0002, 301-796-6620.

    SUPPLEMENTARY INFORMATION: I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1) of the FD&C Act. Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

    In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device.

    On June 27, 2014, Innovatex, Inc., submitted a request for classification of the Tear Duct Occluder (originally referred to as the Glaucoma Companion Nasolacrimal Compression Device) under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class I (Ref. 1).

    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. FDA classifies devices into class I if general controls by themselves are sufficient to provide reasonable assurance of safety and effectiveness of the device for its intended use. After review of the information submitted in the de novo request, FDA determined that the device can be classified into class I. FDA believes general controls will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on April 20, 2016, FDA issued an order to the requestor classifying the device into class I. FDA is codifying the classification of the device by adding 21 CFR 886.5838.

    The device is assigned the generic name nasolacrimal compression device, and it is identified as a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.

    The risks to health that may be associated with use of the nasolacrimal compression device are improper fit of the device (extended or aggressive use of this device may cause sequelae such as bruising and/or soreness) and improper use of the device (for the uncoordinated, a corneal abrasion may occur inadvertently). General controls of the FD&C Act, including compliance with the labeling requirements in 21 CFR part 801 and the Quality System Regulation (21 CFR part 820), are sufficient to mitigate these risks and reasonably assure safety and effectiveness. FDA believes that the general controls provide reasonable assurance of safety and effectiveness.

    The nasolacrimal compression device is not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109, Prescription devices).

    Section 510(l) of the FD&C Act provides that a class I device is not subject to the premarket notification requirements under section 510(k) of the FD&C Act, unless the device is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury. FDA has determined that the device does meet these criteria and, therefore, premarket notification is not required for the device. Thus, persons who intend to market this device need not submit a premarket notification containing information on the nasolacrimal compression device they intend to market prior to marketing the device, subject to the limitations on exemptions in 21 CFR 886.9.

    II. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) 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.

    III. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of information found in other FDA regulations. These collections of information 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 in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding the quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

    IV. Reference

    The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov.

    1. DEN140022: De novo request from Innovatex, Inc., dated June 27, 2014.

    List of Subjects in 21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 886 is amended as follows:

    PART 886—OPHTHALMIC DEVICES 1. The authority citation for 21 CFR part 886 continues to read as follows: Authority:

    21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Add § 886.5838 to subpart F to read as follows:
    § 886.5838 Nasolacrimal compression device.

    (a) Identification. A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.

    (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

    Dated: June 6, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-13788 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2015-D-3539] Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

    DATES:

    Submit electronic or written comments on Agency guidances at any time.

    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-2015-D-3539 for “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act”. 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 this 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993-0002, 301-796-3110.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a guidance for industry entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” A new section 503B (21 U.S.C. 353b), added to the FD&C Act by the Drug Quality and Security Act in 2013, describes the conditions that must be satisfied for human drug products compounded by an outsourcing facility to be exempt from the following three sections of the FD&C Act: Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications); section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements). One of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for these exemptions is that the outsourcing facility does not compound drug products using a bulk drug substance unless: It appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need (see section 503B(a)(2)(A)(i) of the FD&C Act); or the drug compounded from such bulk drug substances appears on the drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) at the time of compounding, distribution, and dispensing (see section 503B(a)(2)(A)(ii) of the FD&C Act).

    This guidance describes the conditions under which FDA does not intend to take action against an outsourcing facility for compounding a drug product from a bulk drug substance that does not appear on a list of bulk drug substances that can be used in compounding and is not used to compound a drug product that appears on the FDA drug shortage list at the time of compounding, distribution, and dispensing, while FDA develops the list of bulk drug substances that can be used in compounding pursuant to section 503B(a)(2)(A)(i) of the FD&C Act (503B bulks list).1

    1 Elsewhere in this issue of the Federal Register, the Agency is making available a guidance entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act,” which describes the conditions under which FDA does not intend to take action against a licensed pharmacist in a State-licensed pharmacy or Federal facility, or a licensed physician, for compounding a drug product from a bulk drug substance that cannot otherwise be used in compounding under section 503A of the FD&C Act while FDA develops the list of bulk drug substances that can be used in compounding under section 503A(b)(1)(A)(i)(III).

    The guidance also describes FDA's process to establish the 503B bulks list, and it describes categories of substances that were nominated for inclusion on the 503B bulks list. These categories include:

    • 503B Category 1—Bulk Drug Substances Under Evaluation: These bulk drug substances may be eligible for inclusion on the 503B bulks list, were nominated with sufficient supporting information for FDA to evaluate them, and do not appear on any other list.

    • 503B Category 2—Bulk Drug Substances That Raise Significant Safety Risks: These bulk drug substances were nominated with sufficient supporting information to permit FDA to evaluate them and they may be eligible for inclusion on the 503B bulks list. However, FDA has identified significant safety risks relating to the use of these bulk substances in compounding, and therefore does not intend to adopt the policy described for the bulk substances in Category 1.

    • 503B Category 3—Bulk Drug Substances Nominated Without Adequate Support: These bulk drug substances may be eligible for inclusion on the 503B bulks list but were nominated with insufficient supporting information for FDA to evaluate them. These substances can be re-nominated with sufficient supporting information through a docket that FDA has established.

    In the Federal Register of October 27, 2015 (80 FR 65768), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on December 28, 2015. FDA received 11 comments on the draft guidance. In response to received comments or on its own initiative, FDA made several changes to the guidance to clarify particular points. In addition, FDA has made the following updates to the lists on its Web site of bulk drug substances that were nominated for inclusion on the 503A bulks list: 2

    2 In the future, if FDA makes changes to the categories of bulk drug substances on its Web site, we intend to follow the procedure identified in the guidance.

    • 503B Category 2: FDA has added one bulk drug substances to Category 2, germanium sesquioxide, because FDA identified significant safety risks relating to the use of this bulk drug substance in compounding.

    • 503B Category 4: The draft interim guidance included a fourth category of bulk drug substances that would have identified substances that FDA evaluated for inclusion on the 503B bulks list but, after obtaining and considering public comments, decided not to place on the 503B bulks list. In the final interim guidance, FDA removed this fourth category because the Agency intends to identify the bulk drug substances that will not be placed on the 503B bulks list in the Federal Register notice that establishes the 503B bulks list. Therefore, we do not believe it is necessary to also include them in the categories identified in this guidance.

    II. Electronic Access

    Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 7, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-13798 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2015-D-3517] Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability. AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” The guidance describes FDA's interim regulatory policy regarding the use of bulk drug substances by licensed pharmacists in State-licensed pharmacies or Federal facilities and by licensed physicians to compound human drug products while FDA develops the list of bulk drug substances that can be used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

    DATES:

    Submit electronic or written comments on Agency guidances at any time.

    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-2015-D-3517 for “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” 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 this 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993-0002, 301-796-3110.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a guidance for industry entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Section 503A of the FD&C Act (21 U.S.C. 353a) describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act:

    • Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications);

    • Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and

    • Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice requirements).

    One of the conditions that must be met for a compounded drug product to qualify for these exemptions is that a licensed pharmacist, or licensed physician, compounds the drug product using bulk drug substances that:

    (1) Comply with the standards of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the USP chapter on pharmacy compounding;

    (2) If such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or

    (3) If such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appears on a list developed by the Secretary through regulations issued by the Secretary under subsection (c) of section 503A (503A bulks list).

    (See section 503A(b)(1)(A)(i) of the FD&C Act).

    This guidance describes the conditions under which FDA does not intend to take action against a licensed pharmacist or licensed physician for compounding a drug product from a bulk drug substance that is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved drug, or does not appear on the list of bulk drug substances that can be used in compounding under section 503A(b)(1)(A)(i)(III) of the FD&C Act while FDA is developing the 503A bulks list.1 The guidance also describes FDA's process to establish the 503A bulks list and describes categories of substances that were nominated for inclusion on the 503A bulks list. The guidance includes a link to FDA's Web site listing bulk drug substances in each of the following categories:

    1 Elsewhere in this issue of the Federal Register, the Agency is making available a final guidance entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which describes the conditions under which FDA does not intend to take action against an outsourcing facility for compounding a drug product from certain bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under section 503B(a)(2)(A)(i) of the FD&C Act.

    503A Category 1—Bulk Drug Substances Under Evaluation: These bulk drug substances may be eligible for inclusion on the 503A bulks list, were nominated with sufficient supporting information for FDA to evaluate them, and do not appear on any other list.

    503A Category 2—Bulk Drug Substances That Raise Significant Safety Risks: These bulk drug substances were nominated with sufficient supporting information to permit FDA to evaluate them and they may be eligible for inclusion on the 503A bulks list. However, FDA has identified significant safety risks relating to the use of these bulk substances in compounding, and therefore does not intend to adopt the policy described for the bulk substances in Category 1.

    503A Category 3—Bulk Drug Substances Nominated Without Adequate Support: These bulk drug substances may be eligible for inclusion on the 503A bulks list, but were nominated with insufficient supporting information for FDA to evaluate them. These substances can be re-nominated with sufficient supporting information through a docket that FDA has established.

    In the Federal Register of October 27, 2015 (80 FR 65781), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on December 28, 2015. FDA received 14 comments on the draft guidance. In response to received comments or on its own initiative, FDA made several changes to the guidance to clarify particular points. In addition, FDA has made the following updates to the lists on its Web site of bulk drug substances that were nominated for inclusion on the 503A bulks list: 2

    2 In the future, if FDA makes changes to the categories of bulk drug substances on its Web site, we intend to follow the procedure identified in the guidance.

    1. 503A Category 2: FDA has added two bulk drug substances to Category 2, quinacrine hydrochloride for intrauterine administration and germanium sesquioxide, because FDA identified significant safety risks relating to the use of these bulk substances in compounding.

    2. 503A Category 3: FDA removed bulk drug substances from Category 3 that the Agency previously included on this list in error. Many of these substances are components of FDA-approved drugs or the subject of an applicable USP or NF monograph, and, therefore, can be used in compounding under section 503A without being placed on the 503A bulks list.

    3. 503A Category 4: The draft interim guidance included a fourth category of bulk drug substances that would have identified substances that FDA evaluated for inclusion on the 503A bulks list but, after notice-and-comment rulemaking, decided not to place on the 503A bulks list. In the final interim guidance, FDA removed this fourth category because the Agency intends to identify the bulk drug substances that will not be placed on the 503A bulks list in the final rule that establishes the 503A bulks list. Therefore, we do not believe it is necessary to also include them in the categories identified in this guidance.

    In this document, FDA is also announcing a Level 2 change to the final guidance, “Pharmacy Compounding of Human Drug Products Under Section 503A of the FD&C Act,” (503A Final Guidance) published in 2014 (79 FR 37742) and revised in 2015 (80 FR 65781). That guidance stated, “Until a bulk drug substances list is published in the Federal Register as a final rule, human drug products should be compounded using only bulk drug substances that are components of drugs approved under section 505 of the FD&C Act, or are the subject of USP or NF monographs.”

    When FDA issued the interim guidance concerning compounding using certain bulk drug substances under section 503A (Interim 503A Bulks Guidance) as a draft guidance for public comment, FDA announced in the notice of availability that because this draft interim guidance proposed to change the Agency's policy relating to compounding with bulk drug substances while FDA develops a list of bulk drug substances that can be used in compounding, FDA was adding a footnote to the 503A final guidance referencing this draft interim guidance. FDA stated that once this Interim 503A Bulks Guidance is finalized, FDA would remove that footnote from the 503A final guidance and cross-reference the final Interim 503A Bulks Guidance as establishing the policy for compounding with bulk drug substances during the development of the 503A bulks list.

    Therefore, concurrent with the issuance of the final Interim 503A Bulks Guidance, FDA is removing the sentence in the 503A final guidance referenced previously and is replacing it with the following statement, which the Agency proposed for public comment in the draft Interim 503A Bulks Guidance: “FDA's interim policy concerning bulk drug substances that are not components of drugs approved under section 505 of the FD&C Act or that are not the subject of applicable USP or NF monographs can be found in the guidance, ‘Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug and Cosmetic Act.' ” This change is a Level 2 change under 21 CFR 10.115, and comments on the proposed change in policy were solicited as part of the notice of availability of the draft Interim 503A Bulks Guidance.

    II. Electronic Access

    Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 7, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-13799 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9771] RIN 1545-BJ14 Guidance Under Section 108(a) Concerning the Exclusion of Section 61(a)(12) Discharge of Indebtedness Income of a Grantor Trust or a Disregarded Entity AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Final regulation.

    SUMMARY:

    This document contains final regulations relating to the exclusion from gross income of discharge of indebtedness income of a grantor trust or an entity that is disregarded as an entity separate from its owner. These final regulations provide rules regarding the term “taxpayer” for purposes of applying the exclusion from gross income of discharge of indebtedness income of a grantor trust or a disregarded entity. These final regulations affect grantor trusts, disregarded entities, and their owners.

    DATES:

    Effective Date: These regulations are effective on June 10, 2016.

    Applicability Date: These regulations apply to discharge of indebtedness income occurring on or after June 10, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Frank J. Fisher or Amy Chang, (202) 317-6850 (not a toll-free number).

    SUPPLEMENTARY INFORMATION:

    Background

    These final regulations contain amendments to the Income Tax Regulations (26 CFR part 1) under section 108 of the Internal Revenue Code (Code). Section 61(a)(12) provides that income from the discharge of indebtedness is includible in gross income. However, such income may be excludable from gross income under section 108 in certain circumstances. Section 108(a)(1)(A) and (B) exclude from gross income any amount that would be includible in gross income by reason of the discharge of indebtedness of the taxpayer if the discharge occurs in a title 11 case or when the taxpayer is insolvent. Section 108(d)(1) through (3) provide the meaning of the terms “indebtedness of the taxpayer,” “title 11 case,” and “insolvent,” for purposes of applying section 108, and each definition uses the term “taxpayer.” Section 7701(a)(14) defines “taxpayer” as any person subject to any internal revenue tax.

    On April 13, 2011, the Treasury Department and the IRS published in the Federal Register (76 FR 20593) a notice of proposed rulemaking (REG-154159-09) (the proposed regulations) to provide rules under section 108(a) regarding the term “taxpayer” for purposes of applying section 108 to the discharge of indebtedness income of a grantor trust or an entity that is disregarded as an entity separate from its owner (disregarded entity). The proposed regulations provide that, for purposes of applying section 108(a)(1)(A) and (B) to the discharge of indebtedness income of a grantor trust or a disregarded entity, the term “taxpayer,” as used in section 108(a)(1) and (d)(1) through (3), refers to the owner of the grantor trust or the disregarded entity. The proposed regulations also provide that, in the case of a partnership, the owner rules apply at the partner level to the partners to whom the discharge of indebtedness is allocable. For example, if a partnership holds an interest in a grantor trust or a disregarded entity, the applicability of section 108(a)(1)(A) and (B) to the discharge of indebtedness income is tested by looking to each partner to whom the income is allocable. Lastly, the proposed regulations clarify that, subject to the special rule for partnerships under section 108(d)(6), the insolvency exclusion is available only if the owner is insolvent and the bankruptcy exclusion is available only if the owner is under the bankruptcy court's jurisdiction.

    The Treasury Department and the IRS received written comments responding to the notice of proposed rulemaking. The comments are available for public inspection at www.regulations.gov. No public hearing was requested or held. The comments are discussed in this preamble.

    Summary of Comments and Explanation of Revisions

    After consideration of all the comments, the final regulations adopt the proposed regulations as modified by this Treasury decision. The purpose and scope of the proposed regulations and these final regulations are primarily limited to defining the term “taxpayer” for purposes of applying the bankruptcy and the insolvency exclusions from gross income, under section 108(a)(1)(A) and (B), to the discharge of indebtedness income of a grantor trust or a disregarded entity. These final regulations are not intended to address section 108 in general and are not intended to address liabilities in general.

    1. Other Exclusions Under Section 108(a)

    Two commenters recommended that the final regulations apply the provisions of the proposed regulations to all exclusions in section 108(a), not only to the bankruptcy and the insolvency exclusions. Guidance on the other exclusions in section 108(a) is beyond the scope of these regulations.

    2. Whether, Under Section 108(d)(2), the Owner Is “Under the Jurisdiction” of the Court in a Title 11 Case

    Section 108(a)(1)(A) provides, in part, that gross income does not include any amount which would be includible in gross income by reason of the discharge of the indebtedness of the taxpayer if the discharge occurs in a title 11 case. Section 108(d)(2) defines “title 11 case” as a case under title 11 of the United States Code (relating to bankruptcy), but only if the taxpayer is under the jurisdiction of the court in such case and the discharge of indebtedness is granted by the court or is pursuant to a plan approved by the court.

    Consistent with the proposed regulations, these regulations provide that the bankruptcy exclusion is available only if the owner of the grantor trust or the owner of the disregarded entity is under the jurisdiction of the court in a title 11 case. It is insufficient for the grantor trust or the disregarded entity to be under the jurisdiction of the court in a title 11 case. These regulations further clarify that the owner of the grantor trust or the owner of the disregarded entity must be under the jurisdiction of the court in a title 11 case of that owner as the “debtor,” as that term is defined in title 11 of the United States Code (the title 11 debtor).

    The commenters suggested that section 108(d)(2) does not require that the taxpayer be a title 11 debtor to be considered under the jurisdiction of the court in a title 11 case. One commenter recommended that an owner of a grantor trust or a disregarded entity be considered under the jurisdiction of the court in a title 11 case when that owner is indirectly liable for the debt of the grantor trust or the disregarded entity and the court in a title 11 case eliminates the owner's liability in conjunction with the cancellation of the debt of the grantor trust or disregarded entity. Another commenter recommended that an owner of a grantor trust or a disregarded entity be considered under the jurisdiction of the court in a title 11 case when either the owner has taken affirmative actions, such as filing a proof of claim or a proof of interest, that place the owner under the court's jurisdiction in a title 11 case, or the court otherwise asserts jurisdiction over the owner in connection with a title 11 case. A third commenter recommended that the owner of a disregarded entity be considered under the jurisdiction of the court in a title 11 case when: (1) The court asserts jurisdiction over that owner during the title 11 proceeding of the disregarded entity; (2) the owner's liability on the discharged debt had been previously established (by contract or otherwise); (3) the owner is liable for all, or substantially all, of the discharged debt; and (4) qualifying for the bankruptcy exclusion was not a principal purpose of the owner's undertaking of such liability.

    The Treasury Department and the IRS have not adopted these recommendations because extending the bankruptcy exclusion to the owner of a grantor trust or a disregarded entity when that owner is not itself in bankruptcy would be inconsistent with the intended purpose of section 108(a)(1)(A), as reflected in the legislative history of that provision. Congress added the bankruptcy exclusion to the Code to allow insolvent debtors a “fresh start” after they have liquidated their assets to pay off creditors. S. Rep. No. 1035, 96th Cong., 2d Sess. 9-10 (1980), 1980-2 CB 620, 624, provides:

    The rules of the [Bankruptcy Tax Act of 1980, Public Law 96-589, 94 Stat. 3389 (1980)] concerning income tax treatment of debt discharge in bankruptcy are intended to accommodate bankruptcy policy and tax policy. To preserve the debtor's “fresh start” after bankruptcy, the bill provides that no income is recognized by reason of debt discharge in bankruptcy, so that a debtor coming out of bankruptcy (or an insolvent debtor outside bankruptcy) is not burdened with an immediate tax liability.

    Here, Congress was referring to “debtor” as that term is defined in title 11. See 11 U.S.C. 101(12) (1980) (defining “debtor” as a person or municipality concerning which a case under title 11 has been commenced).

    The Bankruptcy Tax Act of 1980 was enacted to supplement the Bankruptcy Reform Act of 1978, Public Law 95-598, 92 Stat. 2549 (1978). See S. Rep. No. 1035, 96th Cong., 2d Sess. 9 (1980), 1980-2 CB 620, 624. As indicated in the legislative history of the Bankruptcy Reform Act of 1978, the debtor's “fresh start” is conditioned upon the debtor committing all of its nonexempt assets to the jurisdiction of the bankruptcy court, either for sale by the trustee or to determine an appropriate plan to repay creditors. See H.R. Rep. No. 595, 95th Cong., 1st Sess. 118, 125-26, 176 (1977). Congress did not intend that a solvent, non-debtor owner of a grantor trust or a disregarded entity, which has committed some but not all of its nonexempt assets to the bankruptcy court's jurisdiction, have an exclusion from discharge of indebtedness income merely by virtue of having some of its assets subject to the jurisdiction of the bankruptcy court.

    The commenters' recommendations are thus inconsistent with the Congressional intent underlying the Bankruptcy Tax Act of 1980 because those recommendations would provide a non-debtor owner that conducts only some of its activities through the grantor trust or disregarded entity with an unwarranted benefit when that owner is not a title 11 debtor and is able to pay its tax liability.

    Accordingly, these regulations clarify that the owner of the grantor trust or disregarded entity must itself be under the jurisdiction of the court in a title 11 case as the title 11 debtor to qualify for the bankruptcy exclusion.

    3. The Gracia Cases and the Application of the Bankruptcy Exclusion at the Partner Level

    A commenter noted uncertainty under existing law as to whether the holding in certain case law would be followed by the IRS. See Gracia v. Commissioner, T.C. Memo. 2004-147; Mirarchi v. Commissioner, T.C. Memo. 2004-148; Price v. Commissioner, T.C. Memo. 2004-149; Estate of Martinez v. Commissioner, T.C. Memo. 2004-150 (collectively, the Gracia Cases). Because the bankruptcy court had asserted jurisdiction over non-debtor partners for certain matters, the Tax Court in the Gracia Cases upheld the application of the bankruptcy exclusion to the partners of a partnership that was a title 11 debtor, despite the fact that the partners were not title 11 debtors. The IRS's position is that the Gracia Cases failed to interpret correctly the limited scope of section 108(a)(1)(A), which applies only to partners that are also title 11 debtors. See Action on Decision 2015-01 (2015-6 IRB 579) (nonacquiescence in the Gracia Cases).

    These regulations provide that, in the case of a partnership that holds an interest in a grantor trust or a disregarded entity, the owner rules apply at the level of the partners to whom the income is allocable. These regulations provide that the owner must be under the jurisdiction of the court in a title 11 case as the title 11 debtor to qualify for the bankruptcy exclusion. Accordingly, when the owner of the grantor trust or disregarded entity is a partnership, the partner to whom the income is allocable must be under the jurisdiction of the court in a title 11 case of that partner as the title 11 debtor to qualify for the bankruptcy exclusion.

    4. Whether a Grantor Trust Can Be a Debtor in a Title 11 Case

    One commenter noted that a trust cannot generally be a debtor in a title 11 case. On the other hand, a business trust can be a debtor in a title 11 case but is generally treated as a business entity for both bankruptcy and Federal tax purposes. As such, the commenter noted uncertainty as to whether these regulations concerning the bankruptcy exclusion could ever apply to the bankruptcy of a grantor trust.

    These regulations account for the possibility that a trust that is treated as a grantor trust for Federal tax purposes may be treated as a business trust for purposes of eligibility to be a debtor in a title 11 case. To provide comprehensive guidance, the Treasury Department and the IRS have retained references in these regulations to grantor trusts in the provisions concerning the bankruptcy exclusion.

    5. Multiple-Owner Grantor Trusts

    A grantor trust is any portion of a trust that is treated, under subpart E of part I of subchapter J of chapter 1, as being owned by a grantor or another person. One commenter recommended that future guidance specify how a grantor's share of a multiple-owner grantor trust's liability should be determined for purposes of determining insolvency under section 108(d)(3). Specifically, that commenter recommended that future guidance or tax forms provide that a grantor trust is required to report the owner's share of the trust's liabilities. These regulations do not address these issues but the Treasury Department and the IRS invite comments regarding the application of section 108(d)(3) to the owners of a multiple-owner grantor trust. Submissions should be submitted to:

    In the case of submissions to the IRS submitted by U.S. Mail: Internal Revenue Service, Attn: Frank J. Fisher, CC:PSI:1, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044.

    In the case of submissions to the IRS submitted by a private delivery service: Internal Revenue Service, Attn: Frank J. Fisher, CC:PSI:1, 1111 Constitution Ave. NW., Washington, DC 20224.

    6. Extent to Which Indebtedness of a Grantor Trust or a Disregarded Entity Is Treated as Indebtedness of the Owner, Whether Indebtedness Is Recourse or Nonrecourse Debt of the Owner, and the Effect on Insolvency

    For purposes of section 108, section 108(d)(1) defines the term “indebtedness of the taxpayer” as any indebtedness for which the taxpayer is liable or subject to which the taxpayer holds property. One commenter recommended that the final regulations clarify that, for purposes of section 108(d)(1), indebtedness of a disregarded entity is indebtedness of the owner. In addition, a commenter recommended that the Treasury Department and the IRS clarify whether debt of a disregarded entity should be treated as recourse or nonrecourse debt of the owner for purposes of determining the amount of cancellation of debt income realized by the owner. That commenter suggested that the Treasury Department and the IRS issue guidance, in the form of an example in a regulation or a revenue ruling, as to whether the indebtedness of a grantor trust or a disregarded entity is recourse or nonrecourse indebtedness of the owner.

    In addition, commenters recommended approaches for determining the extent to which liabilities of a grantor trust or a disregarded entity are taken into account in measuring the owner's insolvency under section 108(d)(3) for purposes of the insolvency exclusion under section 108(a)(1)(B), including applying the principles of Revenue Ruling 92-53 (1992-2 CB 48). For purposes of the insolvency exclusion, section 108(d)(3) defines “insolvency” as the excess of liabilities over the fair market value of assets. Revenue Ruling 92-53 provides that the amount by which a nonrecourse debt exceeds the fair market value of the property securing the debt (excess nonrecourse debt) is taken into account in determining whether a taxpayer is insolvent within the meaning of section 108(d)(3) only to the extent that the excess nonrecourse debt is discharged.

    Comprehensive guidance on these issues is beyond the scope of these regulations. However, the Treasury Department and the IRS are of the view that indebtedness of a grantor trust or a disregarded entity is indebtedness of the owner for purposes of section 108(d)(1); assuming the owner has not guaranteed the indebtedness and is not otherwise liable for the indebtedness under applicable law, such indebtedness should generally be treated as nonrecourse indebtedness for purposes of applying the section 108(a)(1)(B) insolvency exclusion; and accordingly the principles of Revenue Ruling 92-53 apply to determine the extent to which such indebtedness is taken into account in determining the owner's insolvency under section 108(d)(3). The Treasury Department and the IRS continue to study these issues and anticipate publishing additional guidance providing further clarification. Accordingly, the Treasury Department and the IRS invite comments on these issues. Submissions should be submitted to:

    In the case of submissions to the IRS submitted by U.S. Mail: Internal Revenue Service, Attn: Seoyeon Sharon Park, CC:ITA:5, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044.

    In the case of submissions to the IRS submitted by a private delivery service: Internal Revenue Service, Attn: Seoyeon Sharon Park, CC:ITA:5, 1111 Constitution Ave. NW., Washington, DC 20224.

    7. Valuation Discounts for Purposes of Section 108(d)(3)

    One commenter requested that the Treasury Department and the IRS clarify whether valuation discounts, if applicable to the owner's interest in a disregarded entity, could apply to the valuation of the assets and liabilities held by a disregarded entity for purposes of determining insolvency under section 108(d)(3). Guidance on this issue is beyond the scope of these regulations.

    8. Effective/Applicability Date

    These final regulations apply to the discharge of indebtedness income occurring on or after the date these final regulations are published in the Federal Register.

    Some commenters requested that the Treasury Department and the IRS permit taxpayers to apply the final regulations retroactively to taxable years for which the period of limitations remain open. Another commenter requested that the final regulations specifically provide that the IRS will not challenge positions taken by taxpayers that apply the rules in the proposed regulations. The proposed regulations and these regulations are consistent with the existing statute. Accordingly, the IRS will not challenge return positions consistent with the proposed regulations, as clarified in these final regulations, for the period prior to the effective/applicability date of these final regulations.

    Availability of IRS Documents

    For copies of recently issued Revenue Procedures, Revenue Rulings, notices, and other guidance published in the Internal Revenue Bulletin, please visit the IRS Web site at http://www.irs.gov.

    Special Analyses

    Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It 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 Code, these regulations have been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business, and no comments were received.

    Drafting Information

    The principal authors of these regulations are Frank J. Fisher and Amy Chang, Office of the Associate Chief Counsel (Passthroughs and Special Industries). However, other personnel from the Treasury Department and the IRS participated in the development of these regulations.

    List of Subjects in 26 CFR Part 1

    Income taxes, Reporting and recordkeeping requirements.

    Adoption of Amendments to the Regulations

    Accordingly, 26 CFR part 1 is amended as follows:

    PART 1—INCOME TAXES Paragraph 1. The authority citation for part 1 continues to read in part as follows: Authority:

    26 U.S.C. 7805 * * *

    Par. 2. Section 1.108-9 is added to read as follows:
    § 1.108-9 Application of the bankruptcy and the insolvency provisions of section 108 to grantor trusts and disregarded entities.

    (a) General rule—(1) Owner is the taxpayer. For purposes of applying section 108(a)(1)(A) and (B) to discharge of indebtedness income of a grantor trust or a disregarded entity, neither the grantor trust nor the disregarded entity shall be considered to be the “taxpayer,” as that term is used in section 108(a)(1) and (d)(1) through (3). Rather, for purposes of section 108(a)(1)(A) and (B) and (d)(1) through (3) and subject to section 108(d)(6), the owner of the grantor trust or the owner of the disregarded entity is the “taxpayer.”

    (2) The bankruptcy exclusion. If indebtedness of a grantor trust or a disregarded entity is discharged in a title 11 case, section 108(a)(1)(A) applies to that discharged indebtedness only if the owner of the grantor trust or the owner of the disregarded entity is under the jurisdiction of the court in a title 11 case as the title 11 debtor. If the grantor trust or the disregarded entity is under the jurisdiction of the court in a title 11 case as the title 11 debtor, but the owner of the grantor trust or the owner of the disregarded entity is not, section 108(a)(1)(A) does not apply to the discharge of indebtedness income.

    (3) The insolvency exclusion. Section 108(a)(1)(B) applies to the discharged indebtedness of a grantor trust or a disregarded entity only to the extent the owner of the grantor trust or the owner of the disregarded entity is insolvent. If the grantor trust or the disregarded entity is insolvent, but the owner of the grantor trust or the owner of the disregarded entity is solvent, section 108(a)(1)(B) does not apply to the discharge of indebtedness income.

    (b) Application to partnerships. Under section 108(d)(6), in the case of a partnership, section 108(a)(1)(A) and (B) applies at the partner level. If a partnership holds an interest in a grantor trust or a disregarded entity, the applicability of section 108(a)(1)(A) and (B) to the discharge of indebtedness income is tested by looking to each partner to whom the income is allocable.

    (c) Definitions—(1) Disregarded entity. For purposes of this section, a disregarded entity is an entity that is disregarded as an entity separate from its owner for Federal income tax purposes. See § 301.7701-2(c)(2)(i) of this chapter, the Procedure and Administration Regulations. Examples of disregarded entities include a domestic single-member limited liability company that does not elect to be classified as a corporation for Federal income tax purposes pursuant to § 301.7701-3 of this chapter, a corporation that is a qualified REIT subsidiary (within the meaning of section 856(i)(2)), and a corporation that is a qualified subchapter S subsidiary (within the meaning of section 1361(b)(3)(B)).

    (2) Grantor trust. For purposes of this section, a grantor trust is any portion of a trust that is treated under subpart E of part I of subchapter J of chapter 1 of subtitle A of title 26 of the United States Code as being owned by the grantor or another person.

    (3) Owner. Notwithstanding any other provision of this section to the contrary, neither a grantor trust nor a disregarded entity shall be considered an owner for purposes of this section.

    (4) Title 11 debtor. For purposes of this section, a title 11 debtor is a debtor in a case under title 11 of the United States Code, as defined in 11 U.S.C. 101(13).

    (d) Applicability date. The rules of this section apply to discharge of indebtedness income occurring on or after June 10, 2016.

    John Dalrymple, Deputy Commissioner for Services and Enforcement. Approved: May 25, 2016. Mark J. Mazur, Assistant Secretary of the Treasury (Tax Policy).
    [FR Doc. 2016-13779 Filed 6-9-16; 8:45 am] BILLING CODE 4830-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2016-0463] RIN 1625-AA08 Special Local Regulation; Midwest Masters Sprints; Maumee River; Toledo, OH AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary special local regulation controlling movement of vessels for certain waters of the Maumee River. This action is necessary and is intended to ensure safety of life on navigable waters to be used for a rowing event immediately prior to, during, and immediately after this event. This regulation requires vessels to maintain a minimum speed for safe navigation and maneuvering.

    DATES:

    This temporary final rule is effective from 5 a.m. until 2:30 p.m. on June 11, 2016. For the purposes of enforcement, actual notice will be used on June 11, 2016.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0463 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary final rule, call or email Petty Officer Brett Kreigh, Marine Safety Unit Toledo, Coast Guard; telephone 419-418-6046, email [email protected] If you have questions on viewing the docket, call Cheryl Collins, Program Manager, Docket Operations, telephone 202-366-9826.

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations COTP Captain of the Port DHS Department of Homeland Security E.O. Executive Order NAD 83 North American Datum of 1983 NPRM Notice of Proposed Rulemaking II. Background History and Regulatory Information

    On June 11, 2016, the Toledo Rowing Club is holding a rowing regatta in which at least 200 rowers will participate in a race on the Maumee River. Due to the projected amount of human-powered watercraft on the water, there is a need to require vessels in the affected waterways to maintain a minimum speed for safe navigation. The rowing regatta will occur between 5 a.m. and 2:30 p.m. on June 11, 2016. This event is taking place under the same sponsorship in the same location as last year.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231, 33 CFR 1.05-1 and 160.5; and Department of Homeland Security Delegation No. 0170.1. Having reviewed the application for a marine event submitted by the sponsor on January 11, 2016, the Captain of the Port Detroit (COTP) has determined that the likely combination of recreation vessels, commercial vessels, and an unknown number of spectators in close proximity to a rowing regatta along the water pose extra and unusual hazards to public safety and property. Therefore, the COTP is establishing a Special Local Regulation around the event location to help minimize risks to safety of life and property during this event.

    The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking with respect to this rule because waiting for a notice and comment period to run would be impracticable, unnecessary, and contrary to the public interest. Although an initial marine event application was submitted on January 11, 2016, final details regarding event area and patrol parameters were not known to the Coast Guard with sufficient time for the Coast Guard to solicit public comments before the start of the event. Thus, delaying the effective date of this rule to wait for a notice and comment period to run would be impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect the public from the hazards associated with this power boat race.

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

    IV. Discussion of Rule

    This rule establishes a temporary special local regulation from 5 a.m. until 2:30 p.m. on June 11, 2016. In light of the aforementioned hazards, the COTP has determined that a special local regulation is necessary to protect spectators, vessels, and participants. The special local regulation will encompass the following waterway: All waters of the Maumee River, Toledo, OH from the Veterans Glass Memorial Bridge at River Mile 3.25 to the Norfolk Southern Railroad Bridge at River Mile 5.76.

    An on-scene representative of the COTP or event sponsor representatives may permit vessels to transit the area when no race activity is occurring. The on-scene representative may be present on any Coast Guard, state or local law enforcement vessel assigned to patrol the event. Vessel operators desiring to transit through the regulated area must contact the Coast Guard Patrol Commander to obtain permission to do so. The COTP or his designated on-scene representative may be contacted via VHF Channel 16.

    The COTP or his designated on-scene representative will notify the public of the enforcement of this rule by all appropriate means, including a Broadcast Notice to Mariners and Local Notice to Mariners.

    V. Regulatory Analyses

    We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes or executive orders (E.O.).

    A. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f) of E.O. 12866, Regulatory Planning and Review, as supplemented by E.O. 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of E.O. 12866 or under section 1 of E.O. 13563. The Office of Management and Budget has not reviewed it under those Orders.

    We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues.

    The Coast Guard's use of this special local regulation will be of relatively small size and only nine and a half hours in duration, and it is designed to minimize the impact on navigation. Moreover, vessels may transit through the area affected by this special local regulation at a minimum speed for safe navigation. Overall, the Coast Guard expects minimal impact to vessel movement from the enforcement of this special local regulation.

    B. Impact on Small Entities

    As per the Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, we have considered the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

    This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in this portion of the Maumee River, in the vicinity of Toledo, OH between 5 a.m. and 2:30 p.m. on June 11, 2016.

    This special local regulation will not have a significant economic impact on a substantial number of small entities for the reasons cited in the Regulatory Planning and Review section. Additionally, before the enforcement of the regulation, Coast Guard Sector Detroit will issue a local Broadcast Notice to Mariners so vessel owners and operators can plan accordingly.

    C. Assistance for Small Entities

    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 so that they can better evaluate its effects on them. If this 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 above.

    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 entities that question or complain about this rule or any policy or action of the Coast Guard.

    D. 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).

    E. Federalism

    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 determined that this rule does not have implications for federalism.

    F. 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.

    G. Unfunded Mandates Reform Act

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

    H. Taking of Private Property

    This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

    I. Civil Justice Reform

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

    J. Protection of Children

    We have analyzed this rule under E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

    K. Indian Tribal Governments

    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.

    L. Energy Effects

    This action is not a “significant energy action” under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

    M. Technical Standards

    This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

    N. 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 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a special local regulation and is therefore categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

    List of Subjects in 33 CFR Part 100

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

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

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

    33 U.S.C. 1233.

    2. Add § 100.35T09-0463 to read as follows:
    § 100.35T09-0463 Special Local Regulation; Midwest Masters Sprints; Maumee River; Toledo, OH.

    (a) Regulated area. A regulated area is established to encompass the following waterway: all waters of the Maumee River, from the Veterans Glass Memorial Bridge at River Mile 3.25 to the Norfolk Southern Railroad Bridge at River Mile 5.76.

    (b) Effective period. This section is effective and will be enforced from 5 a.m. until 2:30 p.m. on June 11, 2016.

    (c) Regulations. (1) Consistent with § 100.901 of this part, vessels transiting within the regulated area shall travel at a no-wake speed and remain vigilant at all times. Additionally, vessels within the regulated area must yield right-of-way for event participants and event safety craft. Commercial vessels will have right-of-way over event participants, and event safety craft.

    (2) Vessel operators desiring to operate in the regulated area must contact the Coast Guard Patrol Commander to obtain permission to do so. The Captain of the Port Detroit (COTP) or his on-scene representative may be contacted via VHF Channel 16. Vessel operators given permission to operate within the regulated area must comply with all directions given to them by the COTP or his on-scene representative.

    (3) The “on-scene representative” of the COTP is any Coast Guard commissioned, warrant or petty officer or a Federal, State, or local law enforcement officer designated by or assisting the COTP to act on his behalf.

    Dated: June 6, 2016. Raymond Negron, Commander, U.S. Coast Guard, Acting Captain of the Port Detroit.
    [FR Doc. 2016-13746 Filed 6-9-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2016-0377] RIN 1625-AA08 Special Local Regulation; On Water Activities Associated With the 2016 Macy's 4th of July Fireworks, East River, Manhattan, NY AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary special local regulation on the navigable waters of the East River and Upper New York Bay Manhattan and Brooklyn, NY for on water vessel management associated with the Macy's 4th of July fireworks show. This Special Local Regulation allows the Coast Guard to enforce spectator vessel movement and prohibit all vessel traffic from entering the fireworks barge buffer zone during times when the associated event could pose an imminent hazard to persons and vessels operating in the area. This rule is necessary to provide for the safety of life on the navigable waters and to establish public viewing areas during the event.

    DATES:

    This rule is effective from 6 p.m. through 11 p.m. on July 4, 2016.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0377 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 Lieutenant Junior Grade Kathleen Kane, Vessel Traffic Services Division, Sector New York, U.S. Coast Guard; telephone (718) 354-4010, email [email protected]

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

    The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM with respect to this rule because doing so would be impracticable and contrary to the public interest. The Coast Guard was provided the final details for this event on March 31, 2016. Macy's is unable to move their event to a later date because of the highly publicized nature of this 4th of July event. Due to a major change in the location of the event from the Hudson, to East River, the Coast Guard was unable to use the safety zone established by the recurring Macy's 4th of July fireworks regulation published in Table 1 of 33 CFR 165.160.

    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. Any delay in this rule becoming effective would be contrary to public interest since immediate action is needed to provide for the safety of life and property on the navigable waters due to the inherent hazards created by the high concentration of spectator vessels expected in attendance for the event.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. This Special Local Regulation is necessary to ensure the safety of spectators and vessels from hazards associated with the anticipated concentration of vessels, before, during, and after the scheduled event.

    IV. Discussion of Comments, Changes, and the Rule

    The Coast Guard is establishing a Special Local Regulation on the navigable waters of the East River and Upper New York Bay along Manhattan and Brooklyn, NY for the on water management of vessels associated with the 2016 Macy's 4th of July event. The Special Local Regulation is necessary to ensure the safety of spectators from hazards associated with the anticipated concentration of vessels for the event.

    The event is scheduled to occur from 9:20 p.m. through 9:50 p.m. and the COTP New York anticipates a large number of vessels will congregate to view the fireworks display. This rule will be enforced from 6 p.m. through 11 p.m. on July 4, 2016 in order to ensure that the area is clear of persons and vessels before the fireworks display begins, and to ensure that no hazards remain after the fireworks display ends. If the event is cancelled due to inclement weather, then this regulation will be enforced from 6 p.m. through 11 p.m. on July 5, 2016.

    The COTP New York will establish seven limited access areas within the boundary of the regulated area. Access to these areas will be restricted to vessels of a certain size. The seven limited access areas are: (1) A “spectator area” designated ALFA in which access is limited to vessels greater than or equal to 20 meters in length (65.6ft); (2) a “spectator area” designated BRAVO in which access is limited to vessels less than 20 meters in length (65.6ft); (3) a “buffer zone” around the fireworks launch barges, designated area CHARLIE, limited to all vessels tending the fireworks launch barges; (4) a “spectator area” designated DELTA in which access is limited to vessels greater than 20 meters in length (65.6ft); (5) a “spectator area” designated ECHO in which access is limited to vessels less than or equal to 20 meters in length (65.6ft); (6) a “buffer zone” around the fireworks launch barge, designated area FOXTROT, limited to all vessels tending the fireworks launch barges; (7) a “spectator area” designated GOLF in which access is open to all vessels all lengths.

    Based on the inherent hazards associated with large concentrations of vessels in tight confines, the COTP New York has determined that the event poses a significant risk to public safety and property. The combination of an increased number of recreational vessels, congested waterways, and darkness has the potential to result in serious injuries or fatalities. The buffer zone along with the designated viewing areas will restrict vessels from a portion of the East River around the location of the fireworks launch platform before, during, and immediately after the event. All persons and vessels shall comply with the instructions of the COTP New York or a designated representative during the enforcement of the Special Local Regulation.

    Consistent with 33 CFR 165.7, the Coast Guard will notify the public and local mariners of this Special Local Regulation through appropriate means, which may include, but are not limited to, publication in the Federal Register, the Local Notice to Mariners, and Broadcast Notice to Mariners.

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

    Executive Orders 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 rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it 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 will only be restricted from the regulated area for a limited duration, and the Special Local Regulation is in effect during late night hours when vessel traffic is low. Advanced public notifications will also be made to local mariners through appropriate means, which may include, but would not be limited to, Local Notice to Mariners and Broadcast Notice to Mariners.

    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 received no comments from the Small Business Administration on this rulemaking. 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 enter or transit within the Special Local Regulation 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 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 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 rule does not have tribal implications under Executive Order 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.

    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 temporary rule involves restricting vessel movement within a Limited Access Area established by a Special Local Regulation. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination will be available in the docket where indicated under ADDRESSES, though due to the short timeline it may be made available after publication of this rule in the FR. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 100

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

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

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

    33 U.S.C. 1233.

    2. Add § 100.35T01-0481 to read as follows:
    § 100.35T01-0481 Special Local Regulation; On Water Activities Associated with the 2016 Macy's 4th of July Fireworks, East River, Manhattan, NY.

    (a) Regulated area. The regulated area includes all navigable waters of the East River and Upper New York Bay bounded by a line drawn from position 40°45′20″ N., 073°57′21″ W. (57th Street, New York, NY to 43rd Ave., Long Island City, NY), south along the East River to position 40°40′55″ N., 074°01′21″ W. (Southern tip of Governors Island, NY to Red Hook Point, NY), bounded West by a line drawn from position 40°41′47″ N., 074°00′37″ W. (Southern tip of Downtown Manhattan Heliport, NY to Governors Island Ventilator, NY). All geographic coordinates are North American Datum of 1983 (NAD 83). Within the overall regulated area defined above, the following are individually defined areas subject to specific requirements:

    (1) Area ALPHA. All navigable waters of the East River south of a line drawn from position 40°45′20″ N., 073°57′21″ W. (57th Street, New York, to 43rd Ave, Long Island City, New York) to a line drawn from position 40°44′58″ N. 073°57′41″ W. (47th Street, New York, NY to N Basin Rd., Long Island City, NY) between the east shore of Manhattan and west shore of Roosevelt Island.

    (2) Area BRAVO. All navigable waters of the East River south of a line drawn from position 40°45′20″ N., 073°57′21″ W. (57th Street, New York, to 43rd Ave, Long Island City, New York) to a line drawn from position 40°44′58″ N. 073°57′41″ W., (47th Street, New York, NY to N Basin Rd., Long Island City, NY) between the east shore of Roosevelt Island and west shore of Long Island City. (NAD 83)

    (3) Area CHARLIE. All navigable waters of the East River bound by a line drawn from position 40°44′58″ N. 073°57′41″ W. (47th Street, New York, NY to N Basin Rd., Long Island City, NY), south along the East River to position 40°43′40″ N., 073°57′59″ W. (15th Street, New York, NY to Noble Street, Brooklyn, NY), (NAD 83).

    (4) Area DELTA. All navigable waters of the East River by a line drawn from position 40°43′40″ N., 073°57′59″ W. (15th Street, New York, NY to Noble Street, Brooklyn, NY), south to a line drawn from position 40°43′19″ N., 073°58′04″ W. (7th Street, New York, NY to Bushwick Inlet Park), (NAD 83).

    (5) Area ECHO. All navigable waters of the East River by a line drawn from position 40°43′19″ N., 073°58′04″ W. (7th Street, New York, NY to Bushwick Inlet Park), south to position 40°42′52″ N., 073°58′18″ W. (East River Park, New York, NY to S 4th Street), (NAD 83).

    (6) Area FOXTROT. All navigable waters of the East River by a line drawn from position 40°42′52″ N., 073°58′18″ W. (East River Park, New York, NY to S 4th Street), south to position 40°41′58″ N., 074°00′16″ W. (Downtown Manhattan Heliport to Pier 3 Brooklyn, NY).

    (7) Area GOLF. All navigable waters of the Upper Bay, New York Harbor, NY, south of a line drawn from position 40°41′58″ N., 074°00′16″ W. to a line drawn from position 40°41′29″ N., 074°00′31″ W. (Governors Island Ventilator to Pier 7 Brooklyn, NY), south. West by a line drawn from position 40°41′47″ N., 074°00′37″ W. (Downtown Manhattan Heliport to Governors Island Ventilator).

    (b) Definitions. The following definitions apply to this section:

    (1) Designated representative. A “designated representative” is any Coast Guard commissioned, warrant or petty officer of the U.S. Coast Guard who has been designated by the Captain of the Port (COTP) New York, to act on his or her behalf.

    (2) Official patrol vessels. Official patrol vessels may consist of any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement vessels assigned or approved by the COTP New York.

    (3) Spectators. All persons and vessels not registered with the event sponsor as participants or official patrol vessels.

    (c) Special local regulations. (1) In accordance with the general regulations in § 100.35, entry into, transiting, or anchoring within the regulated areas is prohibited, unless authorized by the COTP or a designated representative.

    (2) Vessels are authorized by the COTP or a designated representative to enter areas of this special location regulation in accordance with the following restrictions:

    (i) Area ALPHA access is limited to vessels greater than or equal to 20 meters (65.6ft) in length.

    (ii) Area BRAVO access is limited to vessels less than 20 meters (65.6ft) in length.

    (iii) All vessels are prohibited from entering area CHARLIE without permission from the COTP or a designated representative.

    (iv) Area DELTA access is limited to vessels less than 20 meters (65.6ft) in length.

    (v) Area ECHO access is limited to vessels greater than or equal to 20 meters (65.6ft) in length.

    (vi) All vessels are prohibited from entering area FOXTROT without permission from the COTP or a designated representative.

    (vii) Area GOLF access is not limited by vessel length.

    (3) All persons and vessels in the regulated areas shall comply with the instructions of the COTP or a designated representative. Vessels shall be present in the corresponding areas by 7:30 p.m.

    (4) Upon being hailed by a U.S. Coast Guard vessel or a designated representative, by siren, radio, flashing light or other means, the operator of the vessel shall proceed as directed. A designated representative may be on an official patrol vessel or may be on shore and will communicate with vessels via VHF-FM radio or loudhailer. In addition, members of the Coast Guard Auxiliary may be present to inform vessel operators of this regulation. Failure to comply with a lawful direction may result in expulsion from the area, citation for failure to comply, or both.

    (5) Vessel operators desiring to enter or operate within the regulated area should contact the COTP New York at (718) 354-4356 (Sector NY Command Center) or a designated representative via VHF channel 16 to obtain permission to do so.

    (6) Spectators or other vessels shall not anchor, block, loiter, or impede the transit of event participants or official patrol vessels in the regulated areas during the effective dates and times unless authorized by COTP New York or a designated representative.

    (7) The COTP New York or a designated representative may delay or terminate any marine event in this subpart at any time if it is deemed necessary to ensure the safety of life or property.

    (d) Enforcement period. This regulation will be enforced from 6 p.m. until 11 p.m. on July 4, 2016, and if the fireworks display is postponed due to inclement weather, it will be enforced from 6 p.m. until 11 p.m. on July 5, 2016.

    Dated: May 23, 2016. M.H. Day, Captain, U.S. Coast Guard, Captain of the Port New York.
    [FR Doc. 2016-13780 Filed 6-9-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2013-0327] RIN 1625-AA00 Special Local Regulations; Harborfest Dragon Boat Race, South Haven, MI AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of enforcement of regulation.

    SUMMARY:

    The Coast Guard will enforce the special local regulation on the Black River in South Haven, Michigan for the Harborfest Dragonboat Race on June 18 and 19, 2016. This action is necessary and intended to ensure safety of life on navigable waters immediately prior to, during, and after the Dragonboat race. During the aforementioned period, the Coast Guard will enforce restrictions upon, and control movement of, vessels in the special regulated area.

    DATES:

    The regulations in 33 CFR 100.903 will be enforced from 6 a.m. until 7 p.m. on each day of June 18 and 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this notice of enforcement, call or email CWO Mark Stevens, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI at (414) 747-7188, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Coast Guard will enforce the special local regulation listed in 33 CFR 100.903 from 6 a.m. until 7 p.m. on each day of June 18 and 19, 2016. This special local regulation encompasses the waters of the Black River in South Haven, MI within the following coordinates starting at 42°24′13.6″ N., 086°16′41″ W.; then southeast 42°24′12.6″ N., 086°16′40″ W.; then northeast to 42°24′19.2″ N., 086°16′26.5″ W.; then northwest to 42°24′20.22″ N., 086°16′27.4″ W.; then back to point of origin (NAD 83). As specified in 33 CFR 100.903, no vessel may enter, transit through, or anchor within the regulated area without the permission of the Coast Guard Patrol Commander. Furthermore, the regulations in § 100.901 apply. Vessels desiring to transit the regulated area may do so only with prior approval of the Patrol Commander and when so directed by that officer. Vessels will be operated at a no wake speed to reduce the wake to a minimum, and in a manner which will not endanger participants in the event or any other craft. The rules contained in the above two sentences shall not apply to participants in the event or vessels of the patrol operating in the performance of their assigned duties. The Patrol Commander may direct the anchoring, mooring, or movement of any boat or vessel within the regatta area. A succession of sharp, short signals by whistle or horn from vessels patrolling the area under the direction of the U.S. Coast Guard Patrol Commander shall serve as a signal to stop. Vessels so signaled shall stop and shall comply with the orders of the Patrol Commander. Failure to do so may result in expulsion from the area, citation for failure to comply, or both.

    This notice of enforcement is issued under authority of 33 CFR 165.903, Harborfest Dragon Boat Race; South Haven, MI, and 5 U.S.C. 552(a). In addition to this notice of enforcement in the Federal Register, the Coast Guard plans to provide the maritime community with advance notification for the enforcement of this regulation via Broadcast Notice to Mariners or Local Notice to Mariners. The Patrol Commander may be contacted via Channel 16, VHF-FM.

    Dated: May 18, 2016. A.B. Cocanour, Captain, U.S. Coast Guard, Captain of the Port Lake Michigan.
    [FR Doc. 2016-13783 Filed 6-9-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0405] Drawbridge Operation Regulation; Sloop Channel and Long Creek, Nassau, NY AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Loop Parkway Bridge, mile 0.7, across Long Creek and the Meadowbrook State Parkway Bridge, mile 12.8, across Sloop Channel, at Nassau, New York. This temporary deviation is necessary to facilitate public safety during a public event, the Annual Salute to Veterans and Fireworks Display.

    DATES:

    This deviation is effective from 9:30 p.m. on June 25, 2016, to 11:59 p.m. June 26, 2016.

    ADDRESSES:

    The docket for this deviation, [USCG-2016-0405] is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Ms. Judy K. Leung-Yee, Project Officer, First Coast Guard District, telephone (212) 514-4330, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Town of Hempstead Department of Public Safety requested and the bridge owner of both bridges, the State of New York Department of Transportation, concurred with this temporary deviation from the normal operating schedule to facilitate a public event, the Annual Salute to Veterans and Fireworks Display.

    The Loop Parkway Bridge, mile 0.7, across Long Creek has a vertical clearance in the closed position of 21 feet at mean high water and 25 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.799(f).

    The Meadowbrook State Parkway Bridge, mile 12.8, across Sloop Channel has a vertical clearance in the closed position of 22 feet at mean high water and 25 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.799(h).

    Long Creek and Sloop Channel are transited by commercial fishing and recreational vessel traffic.

    Under this temporary deviation, the Loop Parkway and the Meadowbrook State Parkway Bridges may remain in the closed position between 9:30 p.m. and 11:59 p.m. on June 25, 2016 (rain date: June 26, 2016 between 9:30 p.m. and 11:59 p.m.).

    Vessels able to pass under the bridge in the closed position may do so at anytime. The bridges will not be able to open for emergencies and there are no immediate alternate routes for vessels to pass.

    The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

    In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

    Dated: June 6, 2016. C.J. Bisignano, Supervisory Bridge Management Specialist, First Coast Guard District.
    [FR Doc. 2016-13692 Filed 6-9-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0484] Drawbridge Operation Regulation; Isle of Wight (Sinepuxent) Bay, Ocean City, MD AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulations.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the US 50 (Harry W. Kelly Memorial) Bridge across the Isle of Wight (Sinepuxent) Bay, mile 0.5, at Ocean City, MD. The deviation is necessary to accommodate the increased vehicular traffic of the 2016 Ocean City Air Show. This deviation allows the bridge to remain in the closed-to-navigation position.

    DATES:

    The deviation is effective from 3:55 p.m. on Saturday June 18, 2016, to 4:55 p.m. Sunday June 19, 2016.

    ADDRESSES:

    The docket for this deviation, [USCG-2016-0484] is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Mr. Michael Thorogood, Bridge Administration Branch Fifth District, Coast Guard, telephone 757-398-6557, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Town of Ocean City, on behalf of the Maryland State Highway Administration, who owns the US 50 (Harry W. Kelly Memorial) Bridge, has requested a temporary deviation from the current operating regulations set out in 33 CFR 117.559, to accommodate increased vehicular traffic of the 2016 Ocean City Air Show.

    Under this temporary deviation, the bridge will be closed-to-navigation from 3:55 p.m. to 4:55 p.m. on June 18, 2016, and from 3:55 p.m. to 4:55 p.m. on June 19, 2016. The bridge is a double bascule bridge and has a vertical clearance in the closed-to-navigation position of 13 feet above mean high water.

    The Isle of Wight (Sinetuxent) Bay is used by a variety of vessels including small fishing vessels and recreational vessels. The Coast Guard has carefully considered the nature and volume of vessel traffic on the waterway in publishing this temporary deviation.

    Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local Notice and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

    In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

    Dated: June 7, 2016. Hal R. Pitts, Bridge Program Manager, Fifth Coast Guard District.
    [FR Doc. 2016-13777 Filed 6-9-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2015-0330] RIN 1625-AA87 Security Zone; Military Ocean Terminal Concord (MOTCO); Concord, California AGENCY:

    Coast Guard, DHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Coast Guard is revising the existing conditional security zone regulation currently in place in the navigable waters of Suisun Bay, California, near Concord, California around each of the three piers at the Military Ocean Terminal Concord (MOTCO), California (formerly United States Naval Weapons Center Concord, California). This action is intended to clarify responsibilities and authorities for enforcement of the security zone.

    DATES:

    This rule is effective from July 11, 2016.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2015-0330 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 Lieutenant Marcia Medina, Sector San Francisco, U.S. Coast Guard; telephone (415) 399-7443, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port San Francisco DHS Department of Homeland Security E.O. Executive Order FR Federal Register MOTCO Military Ocean Terminal Concord NPRM Notice of Proposed Rulemaking Pub. L. Public Law § Section U.S.C. United States Code II. Background Information and Regulatory History

    On August 27, 1996, the Department of the Army, Corps of Engineers published a final rule in the Federal Register (61 FR 43969) establishing a restricted area 1 around the MOTCO piers (33 CFR 334.1110). Although the restricted area prohibits public access to the piers at all times, it lacks a conditional boundary extension to be enforced during the presence of munitions laden vessels and/or military onload/offload activities. Prior to January 24, 2005, the Coast Guard would address this lack of a conditional boundary by publishing a temporary security zone of sufficient size in the area for each operation at MOTCO (see e.g., 68 FR 33382).

    1 A “restricted area” is defined in § 334.2 as a defined water area for the purpose of prohibiting or limiting public access to the area that generally provides security for Government property and/or protection to the public from the risks of damage or injury arising from the Government's use of that area.

    On January 24, 2005, to address this issue on a more permanent basis, the Coast Guard published a final rule in the Federal Register (70 FR 3299) establishing a conditional 500-yard security zone around MOTCO's piers to be enforced during military onload/offload operations (33 CFR 165.1199). The security zone provides necessary security for military operations by providing a standoff distance for blast and collision, a surveillance and detection perimeter, and a margin of response time for security personnel.

    On July 1, 2015, the Coast Guard published a NPRM (80 FR 48787), with proposed changes to clarify responsibilities and authorities for enforcement of the security zone. There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this security zone. During the comment period that ended on September 14, 2015, we received 0 comments.

    III. Legal Authority and Need for Rule

    The legal basis for this rule is 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, which collectively authorize the Coast Guard to establish security zones. This authority is separate from the Department of the Army, Corps of Engineers authority to provide appropriate security in defense of their waterfront facilities and for vessels moored thereto in accordance with the restricted area in 33 CFR 334.1110.

    The purpose of this rulemaking is to advance the Coast Guard's efforts to thwart potential terrorist activity through security measures on U.S. ports and waterways.

    IV. Discussion of Comments, Changes, and the Rule

    The current regulation at § 165.1199 contains several items that are the subject of the revisions in this FR. The revisions to § 165.1199 will clarify the regulations in a concise, understandable format.

    First, the Coast Guard revises § 165.1199(c) by clarifying the Coast Guard's enforcement role during active loading operations, and the ability of the COTP to designate other representatives as having authority to enforce the security zone. The Coast Guard proposes to replace the existing term “patrol personnel,” in favor of a more appropriate term, “designated representative,” which includes federal, state and local officials designated by the COTP. This revision clarifies that the COTP may designate law enforcement officials other than Coast Guard personnel to patrol and enforce the security zone.

    The Coast Guard also revises the security zone so that it is enforceable at any time a vessel loaded with munitions is present at a pier (in addition to during military onload/offload operations). Without this revision, the existing security zone is enforceable during military onload or offload operations only.

    Additionally, the Coast Guard proposes to remove the existing provision regarding “Local Notice to Mariners” as a means of notifying the public that the security zone will be enforced. The security concern related to providing advance notification of the presence of an explosive load at a military base outweighs the benefit of advance notice of the security zone. Instead, the Coast Guard would notify the public of security zone enforcement (and suspensions of enforcement) via Broadcast Notice to Mariners and/or actual notice on-scene during military onloads or offloads. This revision would better align the notification method of this security zone with the notification method for the existing safety zone in the area (see § 165.1198).

    No changes in the regulatory text of the rule in the NPRM.

    V. Regulatory Analyses

    We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes or executive orders.

    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.

    Security zone enforcement would be limited in duration, and limited to a narrowly tailored geographic area. In addition, although this rule would restrict access to the waters encompassed by the security zone, the effect of this rule would not be significant because the local waterway users will be notified via Broadcast Notice to Mariners and/or actual notice on-scene during military onloads or offloads. The entities most likely to be affected are waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities.

    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 received 0 comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

    This rule may affect owners and operators of waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities and sightseeing. The security zone would not have a significant economic impact on a substantial number of small entities for the following reasons. The security zone would be activated, and thus subject to patrol and enforcement, for a limited duration. When the security zone is activated, vessel traffic would be directed to pass safety around the security zone. The maritime public would be advised when transiting near the activated zone.

    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 a security zone of limited size and duration. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends 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. Revise § 165.1199 to read as follows:
    § 165.1199 Security Zones; Military Ocean Terminal Concord (MOTCO), Concord, California.

    (a) Location. The security zone(s) reside(s) within the navigable waters of Suisun Bay, California, extending from the surface to the sea floor, within 500 yards of the three Military Ocean Terminal Concord (MOTCO) piers in Concord, California.

    (b) Definitions. As used in this section, “designated representative” means any Coast Guard commissioned, warrant, or petty officer or any Federal, state, or local law enforcement officer who has been designated by the Captain of the Port San Francisco (COTP) to act on the COTP's behalf. The COTP's representative may be on a Coast Guard vessel, a Coast Guard Auxiliary vessel, a Federal, state, or local law enforcement vessel, or a location on shore.

    (c) Regulations. (1) The security zone(s) described in paragraph (a) of this section will be in force during active military onloading and/or offloading operations and at any time a vessel loaded with munitions is present at a pier.

    (2) When one or more piers are involved in onload or offload operations at the same time, there will be a 500-yard security zone for each involved pier.

    (3) Under the general regulations in subpart D of this part, entry into, transiting or anchoring within the security zone(s) described in paragraph (a) of this section is prohibited during times of enforcement unless authorized by the COTP or a designated representative.

    (4) Vessel operators desiring to enter or operate within the security zone(s) during times of enforcement must contact the COTP or a designated representative on VHF-16 or through the 24-hour Command Center at telephone (415) 399-3547 to obtain permission to do so. Vessel operators given permission to enter or operate in the security zone(s) must comply with all directions given to them by the COTP or a designated representative.

    (5) Upon being hailed by the COTP or designated representative by siren, radio, flashing light, or other means, the operator of a vessel approaching the security zone(s) must proceed as directed to avoid entering the security zone(s).

    (d) Notice of enforcement or suspension of enforcement of security zone(s). During periods that one or more security zones are enforced, the COTP or a designated representative will issue a Broadcast Notice to Mariners and/or notify mariners via actual notice on-scene. In addition, COTP maintains a telephone line that is maintained 24 hours a day, 7 days a week. The public can contact COTP at (415) 399-3547 to obtain information concerning enforcement of this section. When the security zones are no longer needed, the COTP or designated representative will cease enforcement of the security zones. Upon suspension of enforcement, all persons and vessels are granted general permissions to enter, move within, and exit the security zones, but should remain cognizant of the applicable restricted area designated in 33 CFR 334.1110.

    Dated: May 20, 2016. Gregory G. Stump, Captain, U.S. Coast Guard, Captain of the Port San Francisco.
    [FR Doc. 2016-13781 Filed 6-9-16; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2015-0009; EPA-R05-OAR-2015-0314; FRL-9946-80-Region 5] Air Plan Approval; Illinois; NAAQS Updates AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Direct final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving revised rules submitted by the State of Illinois as State Implementation Plan (SIP) revisions. The submitted rules update Illinois' ambient air quality standards to include the 2012 primary National Ambient Air Quality Standard (NAAQS) for fine particulate matter (PM2.5), add EPA-promulgated monitoring methods, and address the “sunset provisions” in our regulations. In addition, the revised rules contain the timing requirements for the “flagging of exceptional events” and the submitting of documentation supporting the determination of exceptional events for the 2012 primary annual PM2.5 standard.

    DATES:

    This direct final rule will be effective August 9, 2016, unless EPA receives adverse comments by July 11, 2016. If adverse comments are received by EPA, EPA will publish a timely withdrawal of the direct final rule in the Federal Register informing the public that the rule will not take effect.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R05-OAR-2015-0009 or EPA-R05-OAR-2015-0314 at http://www.regulations.gov or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Edward Doty, Attainment Planning and Maintenance Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6057, [email protected].

    SUPPLEMENTARY INFORMATION:

    Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This SUPPLEMENTARY INFORMATION section is arranged as follows:

    I. When and why did the State make these submittals? II. What are the State rule revisions? A. April 23, 2015, Submittal—Rule Revision Group R14-06 B. December 18, 2014, Submittal—Rule Revision Group R14-17 III. Did the State hold public hearings for these submittals? IV. What is EPA's analysis of the State's submittals? V. What action is EPA taking? VI. Incorporation by Reference VII. Statutory and Executive Order Reviews I. When and why did the State make these submittals?

    Section 109 of the Clean Air Act (CAA) requires EPA to establish national primary (protective of human health) and secondary (protective of human welfare) air quality standards for pollutants for which air quality criteria have been issued under Section 108 of the CAA (the criteria pollutants 1 ). Individually and collectively these standards are referred to as NAAQS. Section 109(d)(1) of the CAA requires EPA to review, and if necessary, based on accumulated health and welfare data, to revise each NAAQS every five years. If a NAAQS is revised, states whose rules include state air quality standards may revise their rules to address the revised NAAQS and associated monitoring requirements, and submit them to EPA as SIP revision requests. See, e.g., 415 ILCS 5/10(H).

    1 The criteria pollutants are ozone (O3), nitrogen oxides (represented by nitrogen dioxide (NO2)), sulfur oxides (represented by sulfur dioxide (SO2)), carbon monoxide (CO), particulate matter (represented by total suspended particulates (TSP), particulates (PM10), and fine particulates (PM2.5)), and lead (Pb). Note that Illinois also has air quality standard and monitoring rules for “coarse particulate matter” (PM2.5-10), although this is not a criteria pollutant and is generally considered to be included in PM10.

    On December 18, 2014, the Illinois Environmental Protection Agency (IEPA) submitted to EPA for approval as SIP revisions updates to the methods used by Illinois to monitor air quality for several NAAQS. These updates correspond to EPA's revised monitoring methods promulgated during the period of July 1, 2013, through December 31, 2013. The Illinois Pollution Control Board (IPCB) adopted these rule revisions on June 5, 2014, as rule revision group R14-17.

    On April 23, 2015, IEPA submitted to EPA for approval as SIP revisions an additional update to include the 2012 primary annual and 24-hour PM2.5 NAAQS and a provision incorporating by reference EPA-promulgated monitoring methods. These rule updates correspond to the NAAQS and monitoring methods promulgated by EPA during the period of January 1, 2013, through June 30, 2013, and on July 3, 2013, and August 5, 2013. This state submittal also addressed the “sunset provisions” of 40 CFR 50.4(e), finding that the 1971 NAAQS for sulfur dioxide (SO2) no longer applies to the Lemont and Pekin areas in Illinois. Finally, the revised rules contain the timing requirements for the “flagging of exceptional events” and the submitting of documentation supporting the determination of exceptional events for the 2012 primary annual PM2.5 standard. The IPCB adopted these rule revisions on September 5, 2013, as rule revision group R14-6.

    II. What are the State rule revisions? A. April 23, 2015, Submittal—Rule Revision Group R14-06

    The rule revisions contained in the April 23, 2015 submittal are summarized below.

    35 IAC 243.107. Reference Conditions

    Illinois amended this section to apply applicable monitoring requirements to the 2012 primary annual and 24-hour PM2.5 NAAQS, which Illinois codified at 35 IAC 243.120(d). Volume 35 of the Illinois Administrative Code section 243.107 (35 IAC 243.107) sets forth the reference air temperature and reference pressure measurements to determine air quality concentrations of monitored air pollutants, and mirrors the requirements of title 40 of the Code of Federal Regulations (CFR) 50.3. Among other things, this section requires that measurements of PM2.5 must be reported based on actual ambient air volume measured at actual temperature and pressure at the monitoring site. See also the discussion of 35 IAC 243.120(d), below.

    35 IAC 243.108. Incorporations by Reference

    Illinois updated 35 IAC 243.108 to incorporate by reference the 2013 versions of appendices A-1, A-2, B, C, D, F, G, H, I, J, K, L, N, O, P, Q, R, S, and T of 40 CFR part 50. These appendices contain the reference monitoring methods for and the “interpretation” of (i.e., data handling conventions and computations) the ambient standards for the criteria air pollutants.

    EPA made two changes in the 2013 versions of these appendices relative to the 2012 versions. First, EPA revised the appendix G reference method for the determination of lead in suspended particulate matter (78 FR 40000, July 3, 2013). Second, EPA revised appendix N for the data handling conventions and computations necessary for determining when the primary and secondary NAAQS for PM2.5 are met. 78 FR 3086, 3277-3281 (January 15, 2013). Illinois' rule revisions incorporate by reference these amended CFR appendices.

    Additionally, Illinois references an August 5, 2013, (78 FR 47191) EPA Federal Register document as revising appendix N of 40 CFR part 50. However, EPA's August 5, 2013 Federal Register document establishes area designations for the 2010 SO2 primary NAAQS, and does not address or relate to appendix N. Therefore, this rule revision contains an incorrect reference to EPA rulemaking, and is further discussed in Section IV, below.

    35 IAC 243.120. PM10 and PM2.5

    Illinois added Subsection (d) to incorporate EPA's 2012 primary annual and 24-hour NAAQS for PM2.5. These revised PM2.5 standards include an annual average level of 12 micrograms per cubic meter and a 24-hour average level of 35 micrograms per cubic meter. See 78 FR 3086 (January 15, 2013).

    Consistent with 40 CFR 50.13, this section also requires that the revised PM2.5 standards be measured by either a Federal Reference Method (FRM) based on appendix L of 40 CFR part 50, incorporated by reference in 35 IAC 243.108, or a Federal Equivalent Method (FEM) designated by EPA in accordance with 40 CFR part 53 and listed in EPA's “List of Designated Reference and Equivalent Methods,” which is also incorporated by reference in 35 IAC 243.108.2 See http://www3.epa.gov/ttnamti1/files/ambient/criteria/reference-equivalent-methods-list.pdf.

    2 The “List of Designated Reference and Equivalent Methods” is an EPA Web page that lists all FRMs and FEMs by pollutant and documents the Federal rulemakings that promulgated the monitoring methods. Other than the Federal Register notices for these rulemakings, it is the only comprehensive source of FEMS designated by EPA.

    35 IAC 243.122. Sulfur Oxides (Sulfur Dioxide)

    Illinois amended the IPCB Board Note in subsection (a)(5) to address the “sunset provisions” in 40 CFR 50.4(e). Under 40 CFR 50.4(e), the 1971 primary annual and 24-hour NAAQS for SO2 no longer apply to the Lemont and Pekin areas, effective October 4, 2014, because: (1) One year has passed since EPA designated these areas as nonattainment for the 2010 primary 1-hour SO2 NAAQS, effective October 3, 2013; (2) these areas were not designated as nonattainment for the 1971 SO2 NAAQS as of June 22, 2010; and (3) there has not been a SIP call for the 1971 SO2 NAAQS for these areas. See 75 FR 47191 (August 5, 2013). The 1971 SO2 NAAQS continues to apply for other areas in Illinois until these areas meet the sunset provisions specified in 40 CFR 50.4(e).

    35 IAC 243. Table A. Schedule of Exceptional Event Flagging and Documentation Submission for New or Revised NAAQS

    Illinois has amended Table A to add the flagging deadlines by year for the 2012 annual PM2.5 standard adopted in 2012 and promulgated on January 15, 2013 (78 FR 3086). For PM2.5 data collected in 2010 and 2011, the exceptional events were required to be flagged and described by July 1, 2013, and supported by complete documentation by December 12, 2013. For PM2.5 data collected in 2012, the exceptional events were required to be flagged and described by July 1, 2013, and supported by complete documentation by December 12, 2013. For PM2.5 data collected in 2013, the exceptional events were required to be flagged and described by July 1, 2014, and supported by complete documentation by August 1, 2014. The flagging and demonstration submittal deadlines are the same as the deadlines provided in Table 1 in 40 CFR 50.14.

    Table A lists the deadlines for exceptional event flagging and documentation of such flagging by pollutant standard. Under 40 CFR 50.14, a state may request that EPA exclude data showing violations or exceedances of the NAAQS from air quality determinations if the state can demonstrate to EPA's satisfaction that these violations or exceedances were due to exceptional events unlikely to reoccur and cause additional violations of the NAAQS at any monitoring site. Where such an event has occurred, the state may flag air quality data affected by the event and request that EPA approve the exclusion of these data from further air quality determinations, including designation of nonattainment areas and assessment of air quality data used for purposes of redesignation to attainment. The criteria for approval of exceptional event exclusion are given in 40 CFR 50.14(b) and the schedule and procedures for data flagging by the state are discussed in 40 CFR 50.14(c).

    B. December 18, 2014, Submittal—Rule Revision Group R14-17

    The rule revisions contained in the December 18, 2014, submittal are summarized below.

    35 IAC 243.108. Incorporations by Reference

    Illinois revised this section to incorporate by reference EPA's updated “List of Designated Reference and Equivalent Methods” from June 27, 2013, to December 17, 2013. On December 17, 2013, EPA issued an updated version of the “List of Designated Reference and Equivalent Methods” that includes five new FEMs for monitoring of PM10, PM2.5-10, PM2.5, and oxides of nitrogen (NOx) promulgated by EPA. See 78 FR 67360 (November 12, 2013). More specifically, EPA promulgated the following FEMs: (1) For PM2.5-10, Automated Equivalent Method EQPM-1013-207 (“Thermo Scientific TEOM® 1405-Dichotomous Ambient Particulate Monitor with FDMS”); (2) for PM10, Automated Equivalent Method EQPM-1013-208 (“Thermo Scientific TEOM® 1405-Dichotomous Ambient Particulate Monitor with FDMS”); (3) for PM2.5, Automated Equivalent Method EQPM-1013-209 (“Met One BAM-1022 Real Time Beta Attenuation Mass Monitor-Outdoor PM2.5 FEM Configuration”) and Automated Equivalent Method EQNA-1013-210 (“Environment S.A. Model MP101M PM2.5 Beta Attenuation Monitor”); and (4) for NOx, Automated Equivalent Method EQNA-1013-210 (“Environment S.A. Model AS32M cavity attenuated phase shift spectroscopy Nitrogen Dioxide Analyzer”). Illinois also added a statement to 35 IAC 243.108 that the incorporation by reference of EPA's promulgated monitoring methods “does not include USEPA methods approvals that occurred after December 17, 2013.”

    III. Did the State hold public hearings for these submittals?

    Illinois held a public hearing for the rule changes discussed in the December 18, 2014, submittal (R14-17) on May 7, 2014. Illinois held a public hearing for the rule revisions discussed in the April 23, 2015, submittal (R14-6) on October 31, 2013. The state received one comment for the R14-6 rule revisions in support of adoption of the proposed rule revisions.

    IV. What is EPA's analysis of the State's submittals?

    EPA finds the state's requested SIP revisions to be acceptable because the state's rule revisions make the state's air quality standards and associated monitoring requirements identical-in-substance to EPA's promulgated NAAQS and monitoring methods, as revised through December 17, 2013.

    Additionally, EPA finds that the specified exceptional event flagging and demonstration submittal deadlines are acceptable because they are consistent with the deadlines in 40 CFR 50.14.

    EPA also agrees with Illinois' application of the “sunset provisions” in 40 CFR 50.4(e) to the Lemont and Pekin areas. EPA has designated the Lemont and Pekin areas as nonattainment for the 2010 SO2 NAAQS, which means that Illinois must submit a regulation for SIP approval that meets Federal requirements and that provides for attainment of the 2010 SO2 NAAQS in these areas no later than October 4, 2018. The 1971 SO2 NAAQS no longer applies to the Lemont and Pekin areas because EPA designated the Lemont and Pekin areas as nonattainment for the 2010 SO2 NAAQS, these areas were not designated as nonattainment for the 1971 SO2 NAAQS as of June 22, 2010, and there has not been a SIP call for the 1971 SO2 NAAQS. See 78 FR 47192.

    Finally, as discussed above, the state's rule revisions to 35 IAC 243.108 incorrectly cite an August 5, 2013 EPA rulemaking at 78 FR 47191 as amending appendix N to 40 CFR part 50. Appendix N sets forth the data handling and computational requirements needed to demonstrate compliance with the 2012 PM2.5 NAAQS. The August 5, 2013, EPA rulemaking establishes area designations for the 2010 SO2 NAAQS, but does not amend appendix N to 40 CFR part 50. Although this citation is incorrect, we are still approving the submission because Illinois has also incorporated by reference the 2013 version of appendix N to 40 CFR part 50 at 35 IAC 243.108. Appendix N, as codified in the CFR, contains the reference monitoring methods for SO2 under the 2010 NAAQS and does not contain a citation to the August 5, 2013, EPA rulemaking. Therefore, it is unlikely that the public would be confused when determining the applicable data handling and computational requirements to demonstrate compliance with the 2012 PM2.5 NAAQS. Illinois should correct this incorrect citation in a subsequent rule revision, but it does not appear to present any implementation or enforcement issues for the state or EPA.

    V. What action is EPA taking?

    EPA is approving the submitted rule revisions as revisions of the Illinois SIP. Specifically, we are approving 35 IAC sections 243.107, 243.108, 243.120, 243.122, and 243.Table A revised as discussed above, and we are incorporating by reference these revised rules into the Illinois SIP.

    We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the state plan if relevant adverse written comments are filed. This rule will be effective August 9, 2016 without further notice unless we receive relevant adverse written comments by July 11, 2016. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that, if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. If we do not receive any comments, this action will be effective August 9, 2016.

    VI. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Illinois Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

    VII. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

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

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

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 9, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide.

    Dated: May 10, 2016. Robert A. Kaplan, Acting Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    2. Section 52.720 is amended by adding paragraph (c)(208) to read as follows:
    § 52.720 Identification of plan.

    (c) * * *

    (208) On December 18, 2014, and April 23, 2015, Illinois submitted amendments to its State Implementation Plan at 35 Illinois Administrative Code part 243, which updates Illinois air quality standards to reflect National Ambient Air Quality Standards promulgated by EPA through December 17, 2013, and incorporates Federal test procedures for these pollutants.

    (i) Incorporation by Reference. (A) Illinois Administrative Code Title 35: Environmental Protection; Subtitle B: Air Pollution; Chapter I: Pollution Control Board; Subchapter I: Air Quality Standards And Episodes; Part 243: Air Quality Standards; Sections 243.107 Reference Conditions, 243.120 p.m.10 and PM2.5, 243.122 Sulfur Oxides (Sulfur Dioxide), and 243.Table A Schedule of Exceptional Event Flagging and Documentation Submission for New or Revised NAAQS, effective November 27, 2013.

    (B) Illinois Administrative Code Title 35: Environmental Protection; Subtitle B: Air Pollution; Chapter I: Pollution Control Board; Subchapter I: Air Quality Standards And Episodes; Part 243: Air Quality Standards; Section 243.108 Incorporation by Reference, effective June 9, 2014.

    [FR Doc. 2016-13700 Filed 6-9-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0485; FRL-9946-43] Alpha-2,4,6-Tris[1-(phenyl)ethyl]-Omega-hydroxypoly(oxyethylene) poly(oxypropylene) Copolymer; Tolerance Exemption; Technical Correction AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule; technical correction.

    SUMMARY:

    EPA issued a final rule in the Federal Register of March 2, 2016, concerning Alpha-2,4,6-Tris[1-(phenyl)ethyl]-Omega-hydroxypoly(oxyethylene) poly(oxypropylene) copolymer; Tolerance Exemption. This document corrects typographical errors.

    DATES:

    This final rule correction is effective June 10, 2016.

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0485, 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; telephone number: (703) 308-8009; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Does this action apply to me?

    The Agency included in the March 2, 2016 final rule a list of those who may be potentially affected by this action.

    II. What does this technical correction do?

    EPA issued a final rule in the Federal Register of March 2, 2016 (81 FR 10776) (FRL-9942-48) that increases the poly(oxyethylene) content from 16-30 moles to 16-60 moles. EPA inadvertently mistyped the final ratio of poly(oxyethylene) ratio as 16-30 moles instead of 16-60 moles.

    The preamble for FR Doc. 2016-04599 published in the Federal Register issue of Wednesday, March 2, 2016 (81 FR 10776) (FRL-9942-48) is corrected as follows:

    1. On page 10776, second column, under the heading Summary, paragraph one, line 9 and line 23, correct 16-30 to read 16-60.

    2. On page 10777, first column, paragraph 6, line 17 is corrected to read: 16-60 moles.

    3. On page 10778, second column, paragraph two, line 7 is corrected to read: 16-60 moles.

    III. Why is this correction issued as a final rule?

    Section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)(3)(B)) provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making this technical correction final without prior proposal and opportunity for comment, because it does not affect or change the Agency's original regulatory decision nor does it adversely affect human or environmental health. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

    IV. Do any of the statutory and executive order reviews apply to this action?

    No. For a detailed discussion concerning the statutory and executive order review, refer to Unit X of the March 2, 2016 final rule.

    V. 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: June 1, 2016. Susan Lewis, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR Chapter 1 is corrected 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 §  180.960, revise the following entry in the table to read as follows:
    §  180.960 Polymers; exemptions from the requirement of a tolerance. Polymer CAS No. *         *         *         *         *         *         * Alpha-[2,4,6-Tris[1-(phenyl)ethyl]phenyl]-Omega-hydroxy poly(oxyethylene) poly(oxypropylene) copolymer, the poly(oxypropylene) content averages 2-8 moles, the poly(oxyethylene) content averages 16-60 moles. Minimum number-average molecular weight (in amu) of 1,500 70880-56-7 *         *         *         *         *         *         *
    [FR Doc. 2016-13816 Filed 6-9-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket ID FEMA-2016-0002; Internal Agency Docket No. FEMA-8435] Suspension of Community Eligibility Correction
    § 64.6 [Corrected]

    In rule document 2016-12123, appearing on pages 32660-32664, in the issue of Tuesday, May 24, 2016, make the following correction:

    On page 32661, in the first column of the table, the entry “Region III” should read “Region I”.

    [FR Doc. C1-2016-12123 Filed 6-8-16; 8:45 am] BILLING CODE 1505-01-D
    DEPARTMENT OF TRANSPORTATION Federal Railroad Administration 49 CFR Part 234 [Docket No. FRA-2011-0007, Notice No. 6] RIN 2130-AC55 National Highway-Rail Crossing Inventory Reporting Requirements AGENCY:

    Federal Railroad Administration (FRA), Department of Transportation (DOT).

    ACTION:

    Final rule; response to petition for reconsideration.

    SUMMARY:

    This document responds to a petition for reconsideration of FRA's January 6, 2015, final rule addressing U.S. DOT National Highway-Rail Crossing Inventory (Crossing Inventory or Inventory) Reporting Requirements. This document amends and clarifies the final rule in response to the petition for reconsideration and makes certain additional amendments to the rule to address practical implementation problems that arose after publication of the final rule.

    DATES:

    The amendments in this final rule are effective June 10, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Ronald Ries, Staff Director, Highway-Rail Crossing and Trespasser Prevention Programs Division, Office of Railroad Safety, FRA, 1200 New Jersey Avenue SE., Mail Stop 25, Washington, DC 20590 (telephone: 202-493-6299), [email protected]; or Kathryn Shelton Gresham, Office of Chief Counsel, FRA, 1200 New Jersey Avenue SE., Mail Stop 13, Washington, DC 20590 (telephone: 202-493-6063), [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    On October 18, 2012, FRA published a notice of proposed rulemaking (NPRM) as a first step towards the agency's promulgation of Crossing Inventory regulations per the Congressional mandate contained in Section 204(a) of the Rail Safety Improvement Act of 2008 (RSIA) (codified at 49 U.S.C. 20160). See 77 FR 64077. After careful consideration of comments received in response to the NPRM and testimony received at a February 19, 2013, public hearing, FRA published a final rule on January 6, 2015, requiring railroads that operate one or more trains through highway-rail or pathway crossings to submit initial reports to the Crossing Inventory, including current information about warning devices and signs for previously unreported and new highway-rail and pathway crossings through which they operate. The final rule also requires railroads to periodically update the data in the Crossing Inventory, including the prompt reporting of a crossing sale, crossing closure, or changes in certain crossing characteristics. See 80 FR 746.

    The Association of American Railroads (AAR) filed a petition for reconsideration (Petition) of the final rule. In its Petition, AAR asks FRA: (1) For additional time to comply with the final rule; (2) to reconsider the rule's requirement that railroads, in certain instances, submit data to the Crossing Inventory that State agencies have historically submitted voluntarily. Specifically, AAR asks FRA to amend 49 CFR 234.405 and 234.407 to address that issue and issues associated with the assignment of inventory numbers to certain crossings located in private companies', ports', and docks' areas; (3) to amend those same sections, and § 234.409, to remove the requirement that railroads operating trains through highway-rail or pathway crossings, that are not the “primary operating railroad” for those crossings, ensure information the relevant primary operating railroad provides to the Crossing Inventory is submitted and updated; and (4) to revise the Inventory Guide 1 to disallow states from reporting crossing closures to the Crossing Inventory.

    1 Federal Railroad Administration, Office of Railroad Safety, “Guide for Preparing U.S. DOT Crossing Inventory Forms” (initially published January 6, 2015).

    The specific issues AAR raised, and FRA's responses to those issues, are discussed in detail in the “Section-by-Section Analysis” below. The Section-by-Section Analysis also contains a discussion of each provision of the final rule which FRA is amending or clarifying in response to practical implementation issues it has discovered since it promulgated the final rule. These amendments also allow greater flexibility in complying with the rule. These amendments are within the scope of the issues and options discussed, considered, or raised in the NPRM.

    II. Section-by-Section Analysis A. Amendments to 49 CFR Part 234 Section 234.401 Definitions

    FRA is adding definitions of “general railroad system of transportation” and “general system railroad” to this section because these terms are used in the revised definition of “primary operating railroad”, which is discussed below. For purposes of this subpart, FRA is defining a general railroad system of transportation as the network of standard gage track over which goods may be transported throughout the nation and passengers may travel between cities and within metropolitan and suburban areas. Consistent with the definition of “general railroad system of transportation”, FRA is defining general system railroad as a railroad that operates on track, which is part of the general railroad system of transportation. Thus, a general system railroad is not a plant railroad, as defined in § 234.5 of this part.

    As applied to highway-rail and pathway crossings located within private companies', ports', or docks' areas, the final rule defines “primary operating railroad” as “each railroad that owns track leading to the private company, port, or dock area.” After FRA issued the final rule, at least one regulated entity expressed concern about a private company where a railroad owns track leading into the private company, but does not actually operate on track within the company. Because the railroad does not operate over any crossings within the company's area, the railroad stated it does not have ready access to the information the rule requires it to report to the Crossing Inventory for crossings within the private company.

    FRA did not intend to require railroads merely owning track leading to a private company, port, or dock area, where the only railroad that operates through crossings within the area is a plant railroad, as defined in § 234.5, to report to the Crossing Inventory information on the crossings within the private area. Accordingly, FRA is revising the definition of “primary operating railroad” to clarify that mere ownership of track leading to a private company, port, or dock area does not make a railroad a primary operating railroad for crossings within that area, if no general system railroad operates over that track and through at least one crossing within the private area.

    If a general system railroad operates over track leading to a private area and through at least one highway-rail or pathway crossing within the private area, the railroad that owns the track leading to the area and over which the general system railroad operates, is responsible for reporting to the Crossing Inventory information on all the crossings within the private area. The railroad owning the track leading to the private area should be able to obtain access to the information required to be submitted to the Crossing Inventory (e.g., number and speed of train movements through the crossings within the area) through the railroad operating over the track it owns.

    For example, if one general system railroad (Railroad A) owns a track leading to a private company, port, or dock area and operates over that track and through at least one crossing within the private area, that Railroad (Railroad A) is the primary operating railroad for all crossings within the private area. Similarly, if Railroad A owns track leading to a private company, port, or dock area, but does not operate over that track or any crossings within the private area but instead allows another general system railroad (Railroad B) to operate over its track leading to the private area and Railroad B also operates through at least one crossing within the private area, Railroad A (the railroad that owns the track leading to the private area) is considered the primary operating railroad for all of the crossings within the private area—even though it does not actually operate over the track.

    On the other hand, if two general system railroads (e.g., Railroad C and Railroad D) own separate tracks leading to a private company, port, or dock area, and Railroad C operates over its own track leading to the private area and through at least one crossing within that area (and Railroad D does not operate over its track leading to the private area or through any crossings within the area), Railroad C (the general system railroad that owns and operates over its track leading to the private area and through at least one crossing within that area) is considered the primary operating railroad for all of the crossings within that area.

    Likewise, if Railroads C and D each own track leading to a private company, port, or dock area, and Railroad E (another general system railroad) operates over one of their tracks leading to the private area and through at least one crossing within the area, the owner of the track leading to the area over which Railroad E operates is the primary operating railroad for all crossings within the private area. If both Railroads C and D own track leading to a private company, port, or dock area, and they each operate over their owned track into the area and through at least one crossing within the area, they both will be considered primary operating railroads for all crossings within the private area.

    Finally, if in any scenario a general system railroad (or more than one railroad) owns track leading to a private company, port, or dock area, but neither that railroad nor any other general system railroad operates over that track and through at least one crossing within the area, then the crossings in the private area do not need to be reported to the Crossing Inventory. For example, if a general system railroad owns track leading up to the entrance of a private area and operates over that track (or allows another general system railroad to operate over that track), but does not operate over any crossing within the area, that railroad is not considered a primary operating railroad for purposes of the crossings within the private area.

    Section 234.403 Submission of Data to the Crossing Inventory, Generally

    Section 234.403 of the final rule contains the general requirements for submission of information to the Crossing Inventory. Paragraph (e) of that section of the final rule allows a parent corporation to submit crossing data to the Crossing Inventory on behalf of one or more of its subsidiaries, if the parent corporation and subsidiary railroad(s): (1) Provide written notice (signed by the chief executive officer of the parent corporation) to FRA that the parent corporation is assuming the reporting and updating responsibility; and (2) operate as a “single, seamless, integrated” railroad system. Since publication of the final rule, numerous railroads that voluntarily submitted crossing data in the past on behalf of their subsidiaries notified FRA they would like to continue to do so. However, because they do not operate as a “single, seamless, integrated” railroad system they cannot report on behalf of their subsidiaries under the final rule. Railroads also questioned the need for the chief executive officer, as opposed to any railroad official, to sign the written notice the parent corporation submits. After considering these concerns, which could inadvertently prevent parent corporations from reporting crossing data on behalf of their subsidiaries, FRA is amending § 234.403(e) by removing the requirement that parent corporations and their subsidiary railroads operate as a “single, seamless, integrated” railroad system. As a result, all railroad parent corporations can now report on behalf of their subsidiaries under paragraph (e).

    This final rule also simplifies the notification process a parent corporation must follow if it wants to submit Crossing Inventory data on behalf of one or more of its subsidiary railroads. At least one regulated entity raised concerns about current paragraph (e)(1) of this section of the final rule that requires the chief executive officer of the parent corporation to sign the required notice to FRA that the parent corporation is assuming reporting and updating responsibility for its subsidiaries. In response to those concerns, FRA is amending paragraph (e)(1) to allow any appropriate management official with authority to bind the company to sign the notice. This notice must include a statement that the parent corporation is agreeing to (1) submit and update crossing data for the named subsidiaries and the parent corporation, and (2) be subject to enforcement action for noncompliance with the final rule. FRA is also amending paragraph (e)(1) to require only the parent corporation, instead of the parent corporation and the named subsidiary, to submit the required written notice to FRA.

    Section 234.405 Submission of Initial Data to the Crossing Inventory for Previously Unreported Crossings Assignment of Inventory Numbers to Previously Unreported Crossings Located in a Private Company, Port, or Dock Area

    Current paragraph (a)(1)(ii) of § 234.405 requires each primary operating railroad that operates through at least one previously unreported crossing within a private company, port, or dock area to assign one or more Inventory Numbers to those crossings. AAR asserts that (1) this requirement is contrary to current practice that allows a single Inventory Number to be assigned to all crossings in these areas, and (2) this new requirement could create reporting confusion if an accident were to occur at a crossing within a private company, port, or dock area. AAR requests that FRA amend this requirement to allow multiple primary operating railroads to share an assigned Inventory Number for one or more previously unreported highway-rail and pathway crossings located within a private company, port, or dock area.

    After careful consideration, FRA is not adopting AAR's request to modify the language of § 234.405(a)(1)(ii) for two reasons. First, for purposes of enforcement of this rule's reporting requirements, if the railroads share a single Inventory Number, FRA will not know which railroad is responsible for misreporting or failure to report. Second, if a reportable accident/incident occurs at a previously unreported highway-rail or pathway crossing located within a private company, port, or dock area, it benefits both FRA and the railroads involved for the railroad responsible for reporting the accident/incident under 49 CFR part 225 to have its own unique Inventory Number it can use in the accident/incident report it files with FRA.2

    2 FRA is aware that some primary operating railroads already share a single Inventory Number for highway-rail and pathway crossings located within a private company, port, or dock area that have already been reported to the Crossing Inventory. See discussion of § 234.409 below for how to submit periodic updates in such situations.

    FRA disagrees with AAR's argument that assigning multiple Inventory Numbers to the same highway-rail or pathway crossing could create reporting confusion. It is possible that a railroad that operates over its own track into a private company, port, or dock area may not know if another railroad with its own track leading into the area assigned an Inventory Number to the crossings within the area. By requiring each railroad to assign its own Inventory Number to the crossings within a private company, port, or dock area, a railroad involved in a crossing collision inside the area will not have to rely on another railroad to provide the Inventory Number so it can report the accident as required under part 225.

    FRA also disagrees with AAR's assertion that requiring each primary operating railroad to assign one or more Inventory Numbers to crossings located within a private company, port, or dock area could result in multiple railroads having multiple signs at each vehicular entrance that provide multiple Inventory Numbers and emergency notification information for the same crossings. However, FRA regulations do not require railroads to post emergency notification signs (ENS signs) at crossings located within a private company. As for port and dock areas, subpart E of 49 CFR part 234 (subpart E) requires railroads to post at least one ENS sign only at each vehicular entrance if any highway-rail and/or pathway crossings are located within that area (and provided the port or dock area does not meet the definition of “plant railroad” in § 234.5.) See 49 CFR 234.311(a)(2)(ii). Subpart E does not require railroads to post signs at each crossing within such an area. The track owner or lessee that maintains the highway-rail or pathway grade crossing (the “maintaining railroad” under 49 CFR 234.301) is responsible for the placement and maintenance of ENS signs at each vehicular entrance. See 49 CFR 234.311(a)(2)(ii). Under subpart E, if the primary dispatching railroad under 49 CFR 234.306 and the maintaining railroad are not the same entity, the primary dispatching railroad must provide the emergency telephone number to display on the ENS sign to the maintaining railroad. See 49 CFR 234.309(a).

    If there is more than one primary operating railroad that operates through highway-rail or pathway crossings in a port or dock area, subpart E does not require multiple signs at each vehicular entrance with multiple Inventory Numbers and emergency notification information for the crossings. Instead, under subpart E, the maintaining railroad (not the primary operating railroad under this final rule) is responsible for posting ENS signs that display the emergency telephone number and the Inventory Number assigned to the crossings in the port or dock area by the primary dispatching railroad.

    Submission of Completed Inventory Forms for Previously Unreported Highway-Rail and Pathway Crossings

    Paragraph (a)(3) of § 234.405 of the final rule requires primary operating railroads to submit to the Crossing Inventory “accurate and complete [U.S. DOT Crossing] Inventory Forms, or their electronic equivalent,” for previously unreported highway-rail and pathway crossings through which the railroads operate. AAR requests that FRA amend this provision (and the corresponding provision in § 234.407(a)(3) addressing new highway-rail and pathway crossings) by removing the requirement that primary operating railroads submit “completed” U.S. DOT Crossing Inventory Forms (Inventory Forms) for such crossings.

    AAR also objects to the voluntary process in paragraph 234.405(d) (and the corresponding provision in § 234.407(d) (addressing new highway-rail and pathway crossings). Section 234.405(d) provides that if a railroad requests data necessary to complete an Inventory Form from a State agency, but does not timely receive that information from the State agency, the railroad may notify FRA in writing of the State's non-responsiveness. AAR asserts that railroads should not be held responsible for supplying state-controlled information not maintained by the railroads. AAR urges FRA to revise this requirement to limit primary operating railroads' reporting responsibilities to crossing data within their control.

    FRA acknowledges that State agencies generally maintain the crossing data in Parts III, IV, and V of the Inventory Form. However, the RSIA, as amended by sec. 11316(g) of the Fixing America's Surface Transportation Act (FAST Act), specifically requires railroads to report “[n]ot later than 1 year after the date of enactment of the RSIA or 6 months after a new crossing becomes operational, whichever occurs later . . . current information, including information about warning devices and signage, as specified by the Secretary, concerning each previously unreported crossing through which it operates with respect to the trackage over which it operates.” 49 U.S.C. 20160. Crossing data about warning devices and signage is primarily in Part III of the Inventory Form, under the heading “Highway or Pathway Traffic Control Device Information.” Thus, in addition to the crossing data in Parts I and II of the Inventory Form, which railroads have historically collected and maintained in the Crossing Inventory, the RSIA specifically requires railroad carriers to submit additional crossing data “about warning devices and signage” for previously unreported and new crossings.

    The RSIA also contains language granting the Secretary of Transportation (and by delegation, FRA) the authority to exercise discretion in determining the scope of the crossing data railroads must submit to the Crossing Inventory. In the final rule, FRA determined that submission of complete Inventory Forms for previously unreported and new public highway-rail grade crossings is needed to increase the accuracy and utility of the Crossing Inventory. FRA continues to maintain that position. Railroads generally work closely with the State agency responsible for grade crossing safety before any new public highway-rail grade crossings become operational. Therefore, any burden associated with obtaining State-maintained crossing data for new public highway-rail grade crossings should be minimal.

    Nevertheless, to clarify this requirement, FRA is revising § 234.405(a)(3) (and the corresponding provision in § 234.407(a)(3) on new highway-rail and pathway crossings) to require primary operating railroads to submit “accurate Inventory Forms, or their electronic equivalent,” (as opposed to “accurate and complete” Inventory Forms) to the Crossing Inventory for previously unreported highway-rail and pathway crossings through which they operate. Primary operating railroads must fill out these accurate Inventory Forms as the Inventory Guide requires. In other words, primary operating railroads are only required to complete the entire Inventory Form for new and previously unreported public highway-rail grade crossings. The Inventory Guide only requires primary operating railroads to complete Parts I and II of the Inventory Form for new and previously unreported pathway grade crossings and new and previously unreported private highway-rail grade crossings.

    State-Maintained Crossing Data

    Since the final rule requires primary operating railroads to complete Inventory Forms (or their electronic equivalent) for new and previously unreported public highway-rail grade crossings, those railroads may need to obtain crossing data from the State agency responsible for maintaining highway-rail and pathway crossing data to complete the Inventory Form (or its electronic equivalent). Current § 234.405(d) of the final rule explains how a primary operating railroad that requests State-maintained crossing data from the appropriate State agency responsible for maintaining the data, but does not timely receive the requested data, may notify FRA in writing that the railroad requested the required data, but did not receive the data. Under the final rule, if a railroad properly submits such notification, FRA would not hold the primary operating railroad responsible for failing to complete and submit accurate Inventory Forms (or their electronic equivalent) for previously unreported public highway-rail grade crossings.

    In its Petition, AAR asserts that “FRA has taken a relatively straightforward process, whereby primary operating railroads could provide the data which they possess and state agencies could provide the remaining highway traffic and other non-railroad data, and has made it burdensome and complex.” Noting that a primary operating railroad may operate in dozens of states, AAR further asserts that contacting each relevant State agency, tracking the responses of those agencies, and creating a certification process would be an unmerited burden on the industry.

    As noted previously, FRA continues to maintain its position that submission of complete Inventory Forms for previously unreported and new public highway-rail grade crossings is needed to increase the accuracy and utility of the Crossing Inventory. To achieve this goal, FRA is requiring primary operating railroads to provide the crossing data they possess and to request any additional required crossing data from the State agency responsible for maintaining that data. FRA anticipates that State agencies will generally respond promptly to railroad requests for State-maintained crossing data. However, primary operating railroads may submit copies of their written requests for State-maintained crossing data to FRA and to each operating railroad that operates through the crossing. This is not mandatory, but, if FRA audits the Crossing Inventory, FRA would know the primary operating railroad made an effort to obtain State data for one or more previously unreported public highway-rail grade crossings.

    After considering AAR's request, FRA is simplifying the written notification process in § 234.405(d). Instead of providing written notice to FRA certifying that State-maintained crossing data was requested at least 60 days earlier and has not yet been received, a primary operating railroad can send a copy of its written request for State-maintained crossing data to FRA and to each operating railroad that operates through the crossing. As long as the primary operating railroad submits the State-maintained crossing data within 60 days of receipt, FRA will consider the written request for State-maintained crossing data to be an affirmative defense to potential liability for failure to timely submit an Inventory Form (or its electronic equivalent) to the Crossing Inventory for a previously unreported public highway-rail grade crossing.

    Deadline for the Submission of Crossing Data for Previously Unreported Highway-Rail and Pathway Crossings

    Paragraphs (a)(3) and (b) of § 234.405 of the final rule provide a deadline of March 7, 2016, for operating railroads and primary operating railroads to submit the required Inventory Forms, or their electronic equivalent, for previously unreported highway-rail and pathway crossings. AAR requests that FRA extend the deadline to three years from the final rule's effective date (i.e., until March 9, 2018). AAR asserts this additional time will allow railroads to hire and train additional staff to physically locate and inspect tens of thousands of previously unreported private crossings. AAR also asserts that railroads need this additional time to add newly acquired information to the Crossing Inventory and to modify their IT systems to meet the new requirements.

    After careful consideration, FRA is not adopting AAR's request to extend the reporting deadline for new and previously unreported highway-rail and pathway crossings to three years from the final rule's effective date. However, FRA acknowledges that railroads may need additional time to incorporate the changes that FRA is making in this amendment to the final rule as a result of AAR's Petition. Therefore, FRA is revising § 234.405(a)(3) to extend the deadline for primary operating railroads to submit crossing data to the Crossing Inventory for previously unreported highway-rail and pathway crossings to August 9, 2016. Consistent with this extension of time, FRA is also extending the deadline for operating railroads that operate on separate tracks to submit crossing data to the Crossing Inventory to August 9, 2016. FRA is not adjusting any other deadlines in § 234.405(a) and (b).

    Duty of Operating Railroads To Ensure New and Previously Unreported Highway-Rail and Pathway Crossings Are Reported to the Crossing Inventory

    Paragraph (c) of § 234.405 requires operating railroads (railroads other than the primary operating railroad that operate through a crossing) to notify FRA if a primary operating railroad has not submitted a completed Inventory Form, or its electronic equivalent, to the Crossing Inventory consistent with the rule for a new or previously unreported crossing the railroad operates through. AAR requests that FRA amend this requirement (along with the corresponding requirement in § 234.407(c) related to new crossings) so operating railroads will not be liable for a primary operating railroad's failure to submit the required crossing data. AAR asserts this provision imposes a significant burden on operating railroads and constitutes an inappropriate shift of regulatory compliance policing responsibility to a private business. AAR asserts that the final rule requires operating railroads to include and validate data for other railroads' crossings in their databases on an ongoing basis to ensure the primary operating railroad properly submitted required crossing data to the Crossing Inventory. AAR further asserts it is unrealistic to require railroads to audit the crossing data of other railroads, in addition to their own crossing data, all within 14 months.

    After careful consideration of AAR's request, with respect to the initial reporting of new and previously unreported highway-rail and pathway crossings, FRA cannot legally adopt AAR's request. Paragraph (c) of § 234.405 (and paragraph (c) of § 234.407 related to new crossings) implements the RSIA mandate that each railroad carrier ensure current information about each previously unreported highway-rail or pathway crossing is reported to the Crossing Inventory. See 49 U.S.C. 20160(a). Congress left FRA no discretion to ignore this mandate. Clearly, Congress thought operating railroads that operate over new and unreported highway-rail and pathway crossings are in the best position to identify crossings that have not been reported to the Crossing Inventory.

    Section 234.407 Submission of Initial Data to the Crossing Inventory for new Crossings

    Paragraph (b) of this section of the final rule requires operating railroads that operate on separate tracks through a new highway-rail or pathway crossing to submit crossing data to the Crossing Inventory by March 7, 2016, but erroneously fails to provide a future deadline for highway-rail and pathway crossings that become operational after the final rule's effective date. This document corrects this technical error by amending § 234.407(b) to require operating railroads that operate on separate tracks through a new highway-rail or pathway crossing to submit crossing data no later than six months after the crossing becomes operational or August 9, 2016, whichever occurs later.

    FRA is also making a technical amendment to correct a typographical error in the second sentence of paragraph (d)(1)(i) of this section in this final rule. The original version of this sentence in the final rule contained an erroneous reference to § 234.405(a)(3).

    Assignment of Inventory Numbers to New Crossings Located in a Private Company, Port, or Dock Area

    Paragraph (a)(1)(ii) of § 234.407 of the final rule requires each primary operating railroad to assign one or more Inventory Numbers to new highway-rail and pathway crossings within a private company, port, or dock area and through which the railroad operates. See discussion of § 234.405 above. AAR requests that FRA amend this requirement to allow multiple primary operating railroads to assign a shared Inventory Number to new highway-rail and pathway crossings that are located within a private company, port, or dock area. AAR asserts that as drafted, § 234.407(a)(1)(ii) is contrary to current practice. AAR also asserts that this new requirement could create reporting confusion if an accident were to occur at a crossing within a private company, port, or dock area. After careful consideration, FRA is not adopting AAR's request to modify § 234.407(a)(1)(ii) for the reasons explained in the Section-by-Section analysis of § 234.405(a)(1)(ii) above.

    Submission of Completed Inventory Forms for New Highway-Rail and Pathway Crossings

    Paragraph (a)(3) of § 234.407 requires primary operating railroads to submit to the Crossing Inventory “accurate and complete [U.S. DOT Crossing] Inventory Forms, or their electronic equivalent,” for new highway-rail and pathway crossings through which railroads operate. As discussed in the Section-by-Section Analysis of § 234.405 above, under the heading “Submission of Completed Inventory Forms for Previously Unreported Highway-Rail Grade Crossings”, AAR requests that FRA amend § 234.407(a)(3) to remove the requirement that primary operating railroads submit “completed” Inventory Forms for new highway-rail and pathway crossings. AAR also objects to the voluntary process in paragraph (d) of this section which provides that if a railroad requests data necessary to complete an Inventory Form from a State agency and that agency does not timely respond, the railroad may notify FRA in writing of the State's non-responsiveness.

    After careful consideration, FRA is revising § 234.407(a)(3) consistent with the revisions to § 234.405(a)(3), to clarify that primary operating railroads must submit “accurate Inventory Forms, or their electronic equivalent,” (as opposed to “accurate and complete” Inventory Forms) to the Crossing Inventory for new highway-rail and pathway crossings through which they operate. The primary operating railroad must fill out these accurate Inventory Forms consistent with the Inventory Guide, which requires completion of the entire Inventory Form only for new public highway-rail grade crossings.

    Deadline for the Submission of Crossing Data for New Highway-Rail and Pathway Crossings

    The final rule provides that “[e]ach primary operating railroad shall submit accurate and complete Inventory Forms, or their electronic equivalent, to the Crossing Inventory for new highway-rail and pathway crossings through which it operates, no later than six (6) months after the crossing becomes operational or March 7, 2016, whichever occurs later.” 49 CFR 234.407(a)(3). The final rule also provides that “[f]or each new highway-rail and pathway crossing where operating railroads operate trains on separate tracks through the crossing, each operating railroad (other than the primary operating railroad) shall submit accurate crossing data specified in the Inventory Guide to the Crossing Inventory no later than March 7, 2016.” 49 CFR 234.407(b).

    AAR requests that FRA amend § 234.407(a)(3) to establish a deadline three years from the final rule effective date for operating railroads and primary operating railroads to submit crossing data for new highway-rail and pathway crossings to the Crossing Inventory. AAR asserts that railroads need this additional time to add newly acquired information to the Inventory and to modify their IT systems to meet the new requirements. For the reasons explained in the Section-by-Section analysis of § 234.405(a)(3) above, FRA is not adopting the AAR's request to extend the reporting deadline for new highway-rail and pathway crossings to March 9, 2018 (three years from the final rule effective date). However, with respect to new crossings (highway-rail and pathway crossings that become operational on or after June 10, 2016), primary operating railroads will have six (6) months from the date on which the highway-rail or pathway crossing becomes operational to report the new crossing to the Crossing Inventory, consistent with § 234.403 and the Inventory Guide. Similarly, operating railroads that operate on separate tracks through a new highway-rail or pathway crossing will have six (6) months from the date on which the highway-rail or pathway crossing becomes operational to submit crossing data to the Crossing Inventory, consistent with § 234.403 and the Inventory Guide.

    Duty of Operating Railroads To Ensure New Highway-Rail and Pathway Crossings Are Reported to the Crossing Inventory

    Paragraph (c) of § 234.407 requires operating railroads (railroads other than the primary operating railroad that operate through a crossing) to notify FRA if a completed Inventory Form, or its electronic equivalent, has not been submitted to the Crossing Inventory consistent with the final rule for a new crossing that the railroad operates through. Consistent with its request to amend § 234.405(c) regarding previously unreported crossings, AAR requests that FRA amend § 234.407(c), so operating railroads will not be held liable for the primary operating railroad's failure to timely report a new highway-rail or pathway crossing to the Crossing Inventory. For the reasons discussed in the Section-by-Section analysis of § 234.405(c), FRA is not adopting AAR's request to amend § 234.407(c).

    State-Maintained Crossing Data

    As explained in the Section-by-Section analysis of § 234.405(d), primary operating railroads are required to complete Inventory Forms (or their electronic equivalent) for new public highway-rail grade crossings. Therefore, primary operating railroads may need to obtain crossing data from the State agency responsible for maintaining highway-rail and pathway crossing data to complete the Inventory Form (or its electronic equivalent). Like paragraph (d) of § 234.405, current paragraph (d) of § 234.407 of the final rule explains how a primary operating railroad may submit written notification to the FRA Associate Administrator that they requested certain crossing data from the appropriate State agency responsible for maintaining highway-rail and pathway crossing data, which the State has not yet provided. As long as the primary operating railroad submits the State-maintained crossing data within 60 days of receipt, FRA will consider a properly filed written notification to be an affirmative defense to potential violations for failure to timely submit an Inventory Form (or its electronic equivalent) to the Crossing Inventory for a new public highway-rail grade crossing.

    FRA is revising the written notification process in § 234.407(d). FRA is no longer asking primary operating railroads to provide their written notifications by certified mail, return receipt requested. Instead, a primary operating railroad can send copies of its request for State-maintained crossing data to the FRA Associate Administrator and to each operating railroad that operates through the new public highway-rail grade crossing. As long as the primary operating railroad: (1) Sends copies of its written request for State-maintained crossing data to the FRA Associate Administrator and to each operating railroad that operates through the new public highway-rail grade crossing no later than six (6) months after the crossing becomes operational; and (2) submits the State-maintained crossing data within 60 days of receipt, FRA will consider the written request for State-maintained crossing data to be an affirmative defense to potential liability for failure to timely submit an Inventory Form (or its electronic equivalent) to the Crossing Inventory for a new public highway-rail grade crossing.

    Section 234.409 Submission of Periodic Updates to the Crossing Inventory.

    AAR's Petition states that some primary operating railroads share a single Inventory Number for highway-rail and pathway crossings located within a private company, port, or dock area that have already been reported to the Crossing Inventory. (As explained in the definition of “primary operating railroad” in § 234.401 above, each railroad that owns track leading to a private company, port, or dock area is considered a primary operating railroad for the crossings within that area, if a general system railroad operates over the track owned by that railroad and through at least one crossing within that private area.)

    Paragraph (a) of § 234.409 requires each primary operating railroad to submit periodic updates to the Crossing Inventory. To comply with this requirement, primary operating railroads that currently share Inventory Numbers for highway-rail and pathway crossings located within a private company, port, or dock area must exercise one of two options.

    First, each primary operating railroad that operates through the crossing(s) may choose to assign a new unique Inventory Number (or set of Inventory Numbers) to the crossing(s) located within a private company, port, or dock area through which it operates. Each primary operating railroad (except the primary operating railroad that assigned the original Inventory Number to the crossing(s)) would then use its new Inventory Number(s) to submit crossing data to the Crossing Inventory as a new crossing record. After the new crossing record is established, each primary operating railroad can submit periodic updates to the Crossing Inventory for the highway-rail and pathway crossing(s) located within a private company, port, or dock area using the Inventory Number(s) it assigned to the crossing(s).

    Second, FRA will accommodate primary operating railroads that wish to continue sharing a single Inventory Number which has already been used to report highway-rail and pathway crossings located within a private company, port, or dock area to the Crossing Inventory. As explained in Frequently Asked Question (FAQ) number 37 in Appendix E to the Inventory Guide, the primary operating railroad of record in the Crossing Inventory can submit an up-to-date and accurate periodic update to the Crossing Inventory for all of the railroad-assigned data fields in Appendix B to the Inventory Guide (“Responsibility Table for Periodic Updates to the Crossing Inventory”). As part of this update, the primary operating railroad of record must check the “Yes” box in Part I, item 7 (“Do Other Railroads Operate a Separate Track at Crossing”) of the Inventory Form (or its electronic equivalent) and provide railroad codes for all of the other primary operating railroads.

    The other primary operating railroads that share the Inventory Number can satisfy the periodic updating requirement in § 234.409 by using the shared Inventory Number to submit up-to-date and accurate crossing data for the data fields specified in Appendix C to the Inventory Guide (“Reporting Crossings that have Multiple Operating Railroads”). This method for submitting periodic updates is identical to the method operating railroads that operate on separate tracks through a crossing use, under paragraph (b) of § 234.409.

    This second option is only available for new or previously unreported highway-rail and pathway crossings located within a private company, port, or dock area that have already been reported to the Crossing Inventory and assigned one or more Inventory Numbers that are shared by multiple primary operating railroads.

    Submission of Periodic Updates

    The final rule requires primary operating railroads to submit, consistent with the Inventory Guide, “up-to-date and accurate crossing data” to the Crossing Inventory for each highway-rail and pathway crossing through which it operates. Paragraph (a) of § 234.409 of the final rule requires primary operating railroads to submit updated data at least every three (3) years from the date of the primary operating railroad's most recent submission of data (or most recent submission on behalf of the primary operating railroad) for the crossing or by March 7, 2016. Paragraph (b) requires operating railroads that operate trains on separate tracks through a crossing to similarly update the data required by the Inventory Guide.

    As it did for §§ 234.405 and 234.407, AAR requests that FRA amend the compliance deadlines in paragraphs (a) and (b) of § 234.409 for three years from the final rule's effective date. This would allow railroads to submit updated crossing data for highway-rail and pathway grade crossings at least every three (3) years from the date of the most recent submission of data by that railroad for the crossing or by March 7, 2018, whichever occurs later.

    Consistent with FRA's responses to AAR's requests to amend the compliance deadlines in §§ 234.405 and 234.407 discussed above, FRA is not adopting AAR's request to extend the compliance deadlines for railroads in paragraphs (a) and (b) of § 234.409 by three years. As with the compliance deadlines in §§ 234.405 and 234.407, however, FRA acknowledges that railroads may need additional time to incorporate the changes that are being made in these amendments to the final rule being made as a result of AAR's Petition. Therefore, FRA is revising § 234.409(a) and (b) to extend the deadline for primary operating railroads and operating railroads to submit updated crossing data to the Crossing Inventory for highway-rail and pathway crossings over which they operate to every three (3) years from the date of the most recent submission of data by the railroad (or on behalf of the railroad) for the crossing or August 9, 2016, whichever occurs later.

    Duty of Operating Railroads To Ensure Up-to-Date Crossing Data Is Reported to the Crossing Inventory

    Paragraph (c) of § 234.409 requires operating railroads (other than primary operating railroads), that operate through a highway-rail or pathway crossing for which up-to-date information has not been timely submitted to the Crossing Inventory to notify FRA of this oversight. Written notification the operating railroad provides must include, at a minimum, the Inventory Number for each highway-rail or pathway crossing that has not been updated.

    AAR requests that FRA amend § 234.409(c), so that operating railroads will not be held liable for the primary operating railroad's failure to timely submit updated crossing data to the Crossing Inventory. AAR asserts that this provision imposes a significant burden on operating railroads, which will need to include and validate data for other railroads' crossings in their databases on an ongoing basis to ensure that the primary operating railroad has properly submitted required crossing data to the Crossing Inventory. AAR further asserts that this language constitutes an inappropriate shift of regulatory compliance policing responsibility to a private business and that it is unrealistic to require railroads to audit the crossing data of other railroads, in addition to their own crossing data, within 14 months.

    After considering AAR's request, FRA is removing § 234.409(c). The RSIA requires each railroad carrier to ensure that periodic updates are submitted to the Crossing Inventory for each highway-rail and pathway crossing through which it operates. See 49 U.S.C. 20160(b). However, unlike previously unreported and new crossings that have not yet been reported to the Crossing Inventory, FRA can use the Grade Crossing Inventory System (GCIS) to generate reports that identify out-of-date highway-rail and pathway crossing data. FRA can use these reports to verify that primary operating railroads (and any operating railroads that operate on separate tracks through the crossing) are timely submitting periodic updates to the Crossing Inventory, as required by § 234.409(a) and (b). Therefore, FRA is revising the final rule to remove the requirement that operating railroads monitor the Crossing Inventory and provide the agency written notification if a primary operating railroad fails to timely submit updates to the highway-rail and pathway crossing data for which it is responsible.

    Section 234.411 Changes Requiring Submission of Updated Information to the Crossing Inventory

    Consistent with the extended deadline by which railroads are required to report new and previously unreported highway-rail and pathway crossings to the Crossing Inventory, this final rule revises § 234.411 to clarify the primary operating railroad is required to report the following events to the Crossing Inventory within three (3) months, if they occur on or after June 10, 2016: (1) The sale of all or part of a crossing; (2) the closure of a highway-rail or pathway crossings; or (3) a change in crossing surface or warning device at a public highway-rail grade crossing.

    Current paragraph (a) of § 234.411 requires any railroad that sells all or part of a highway-rail or pathway crossing to report the crossing sale to the Crossing Inventory within three (3) months of the date of sale or March 7, 2016, whichever occurs later. However, with respect to railroads, GCIS is primarily designed to accept crossing data from the primary operating railroad, unless other operating railroads operate on separate tracks through the crossing (or the primary operating railroad delegates reporting and updating responsibility to another entity). (As stated in the Inventory Guide, GCIS will accept partial data submissions from other operating railroads once the primary operating railroad submits an Inventory Form, or its electronic equivalent, which indicates that one or more operating railroads operate on separate tracks through the crossing.) Therefore, FRA is also amending § 234.411(a)(1) to require a selling railroad that is not the primary operating railroad to notify the primary operating railroad of the sale of all or part of a highway-rail or pathway crossing within three (3) months of the date of sale.

    Under new § 234.411(a)(2)(i), if the primary operating railroad sells all or part of a highway-rail or pathway crossing for which it has reporting and updating responsibility under this subpart, it would be required to submit an Inventory Form, or its electronic equivalent, which reflects the crossing sale to the Crossing Inventory consistent with § 234.403 and the Inventory Guide within three (3) months of the date of sale. However, under new § 234.411(a)(2)(ii), if a primary operating railroad is notified of the sale of all or part of a highway-rail or pathway crossing under paragraph (a)(1) of this section, then it would be required to submit an Inventory Form, or its electronic equivalent, which reflects the crossing sale to the Crossing Inventory consistent with § 234.403 and the Inventory Guide within three (3) months of the date of notification.

    Section 234.413 Recordkeeping

    This document makes a technical amendment to the heading of this section to correct a typographical error.

    Appendix A to Part 234—Schedule of Civil Penalties

    This document revises the civil penalty schedule in appendix A to this part to reflect changes that were made to individual sections in these final rule amendments. FRA is revising the civil penalty schedule to reflect violations may be assessed under §§ 234.405(a) and 234.407(a) if the primary operating railroad fails to timely submit an accurate Inventory Form (or electronic equivalent) to the Crossing Inventory for a new or previously unreported crossing. (Previously, the civil penalty schedule indicated that violations may be assessed under these sections if the primary operating railroad fails to timely submit an accurate and complete Inventory Form or the electronic equivalent to the Crossing Inventory for a new or previously unreported crossing. However, as discussed above, primary operating railroads are only required to submit complete Inventory Forms or their electronic equivalent for public highway-rail grade crossings.) FRA is also revising the civil penalty schedule to remove the recommended civil penalty associated with § 234.409(c) because this provision has been removed.

    B. Amendments to Inventory Guide Instructions for Completing the U.S. DOT Crossing Inventory Form

    FRA is clarifying a statement made in the final rule preamble discussion of the “Crossing Type” data field in Part I of the Inventory Form. Specifically, in the preamble to the final rule, FRA stated that it

    will defer to the determination of the relevant State agency for the public/private classification of highway-rail (and pathway) crossings. Accordingly, we are asking State agencies to submit voluntary updates to the Crossing Type data field in Part I of the Inventory Form, as stated in Appendix B to the Inventory Guide. 80 FR at 767. FRA intended to ask State agencies to submit voluntary updates to the “Crossing Type” data field only for public highway-rail and pathway crossings. Appendix B to the Inventory Guide states that primary operating railroads are required to submit updates to the “Crossing Type” data field for private highway-rail and pathway crossings. Appendix E to the Inventory Guide, Frequently Asked Questions (FAQs) Who Can Report Closed Crossing Status in the Crossing Inventory

    FAQ number 22 in Appendix E to the Inventory Guide states that “[t]he primary operating railroad must report the closure of a highway-rail or pathway crossing to the Crossing Inventory, but the State may also report the closure of a public crossing.” AAR requests that FRA amend this FAQ to state that only railroads can report the closure of a crossing to the Crossing Inventory. AAR asserts that allowing dual reporting is problematic because a State may close crossings in the Crossing Inventory on the basis of inaccurate information and without informing the operating railroad, which causes railroads to incur additional research and effort to address and resolve the discrepancy.

    FRA declines to adopt AAR's recommendation to modify FAQ number 22 in Appendix E to the Inventory Guide. While the primary operating railroad is the only entity that can report the closure of a private highway-rail or pathway crossing to the Inventory, both railroads and States collect and maintain data related to public highway-rail and pathway crossings. Both entities have an interest in ensuring that the Crossing Inventory reflects up-to-date and accurate data related to crossing status. By allowing States to report the closure of public highway-rail and pathway crossings to the Crossing Inventory, States can provide needed updates to crossing status in the event that the primary operating railroad ceases to operate.

    Reporting Crossing Sales That Result in a New Primary Operating Railroad

    FRA is revising FAQ number 24 in Appendix E to the Inventory Guide to incorporate an FRA recommendation when railroads report crossing sales that result in a new primary operating railroad. As stated in revised FAQ number 24, if the sale of a highway-rail or pathway crossing results in a new primary operating railroad, FRA strongly recommends that the new primary operating railroad submit updated crossing data to the Crossing Inventory for all of the railroad-assigned data fields on the Inventory Form (or its electronic equivalent) within six (6) months of the date of sale.

    III. Regulatory Impact and Notices A. Executive Order 12866 and 13563 and DOT Regulatory Policies and Procedures

    FRA analyzed the potential costs and benefits of the amendments to the final rule adopted in this document. FRA estimates that the amendments will not materially impact the findings of the previously published regulatory evaluation. The extension of time for compliance with changes that are being made in these final rule amendments will grant some relief to railroads. However, the twenty-year analysis is still valid.

    FRA evaluated both the final rule and these amendments under existing policies and procedures and determined both to be non-significant under both Executive Order 12866 and 13563 and DOT policies and procedures. See 44 FR 11034, Feb. 26, 1979. FRA previously placed in the docket a regulatory evaluation addressing the economic impact of the final rule. The primary purpose of the Crossing Inventory is to provide a uniform inventory database that can be merged with highway-rail crossing collision files and used to analyze information for planning and implementation of crossing improvement programs by public and private agencies responsible for highway-rail crossing safety, as well as the railroad industry and academia.

    FRA has determined these amendments to the final rule do not change FRA's position that the anticipated benefits justify the costs.

    B. Regulatory Flexibility Act and Executive Order 13272

    To ensure the impact of this rulemaking on small entities is properly considered, FRA developed these final rule amendments consistent with Executive Order 13272 (“Proper Consideration of Small Entities in Agency Rulemaking”) and DOT's procedures and policies to promote compliance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.).

    The Regulatory Flexibility Act requires an agency to review regulations to assess their impact on small entities. FRA certified that this final rule will not have a significant economic impact on a substantial number of small entities. Although a substantial number of small railroads will be affected by the final rule, none of these entities will be significantly impacted. The amendments to this final rule will grant some relief to small entities by granting them additional time to comply with changes that are being made in these the final rule amendments. However, the amendments to the final rule will not change the overall impact on small entities. Therefore, FRA is confident that its previous certification for the final rule is still valid.

    C. Federalism

    Executive Order 13132, “Federalism” (64 FR 43255, Aug. 10, 1999), requires FRA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” are defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, the agency may not issue a regulation with federalism implications that imposes substantial direct compliance costs and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or the agency consults with State and local government officials early in the process of developing the regulation. Where a regulation has federalism implications and preempts State law, the agency seeks to consult with State and local officials in the process of developing the regulation.

    FRA analyzed this amended final rule in accordance with the principles and criteria contained in Executive Order 13132. Based on this analysis, FRA concluded that this rule will not have a substantial effect on the States or their political subdivisions; it will not impose any compliance costs; and it will not affect the relationships between the Federal government and the States or their political subdivisions, or the distribution of power and responsibilities among the various levels of government. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply and FRA determined that preparation of a federalism summary impact statement for this amended final rule is not required. This amended final rule could have preemptive effect by operation of law under a provision of the former Federal Railroad Safety Act of 1970 (repealed and recodified at 49 U.S.C. 20106). Section 20106 provides that States may not adopt or continue in effect any law, regulation, or order related to railroad safety or security that covers the subject matter of a regulation prescribed or order issued by the Secretary (with respect to railroad safety matters) or the Secretary of Homeland Security (with respect to railroad security matters), except when the State law, regulation, or order qualifies under the “essentially local safety or security hazard” exception to sec. 20106.

    D. Paperwork Reduction Act

    The information collection requirements in this amended final rule are being submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq. The sections that contain new information collection requirements and the estimated time to fulfill each requirement are as follows:

    CFR Section Respondent universe Total annual
  • responses
  • Average time per response Total annual burden hours
    234.403(a-c)—Submission of Data to the U.S. DOT Highway-Rail Crossing Inventory: Completion of Inventory Form 51 States/entities & 618 railroads 4,212 forms 30 minutes 2,106 hours —Mass Update Lists of Designated Data Submitted by Railroads/States 51 States/entities & 618 railroads 257 lists 30 minutes 129 hours —Excel Lists of Submitted Data 51 States/entities & 618 railroads 1,234 lists 30 minutes 617 hours —Changes/Corrections to Crossing Inventory Data Submitted via GX 32 Computer Program 51 States/entities & 618 railroads 35,845 records 6 minutes 3,585 hours —Written Requests by States/Railroads for FRA Crossing Inventory Guide 51 States/entities & 618 railroads 10 requests 15 minutes 3 hours (d)—Reporting Crossing Inventory Data by State Agencies on Behalf of Railroads: Written Notices to FRA 51 States/entities & 618 railroads 20 notices 30 minutes 10 hours —(e)(1)—Consolidated Reporting by Parent Corporation on Behalf of Its Subsidiary Railroads: Written Notice to FRA 51 States/entities & 618 railroads 250 notices 30 minutes 125 hours —(e)(2)—Immediate Notification to FRA by Parent Corporation of Any Changes in the List of Subsidiary Railroads for Which It Reports 51 States/entities & 618 railroads 75 notices 30 minutes 38 hours 234.405(a)(1)—Initial Submission of Previously Unreported Highway-Rail and Pathway Crossings through which They Operate by Primary Operating Railroads: Providing Assigned Crossing Inventory Number to Each Railroad that Operates One or More Trains Through Crossing + Assignee Inventory Numbers for Highway-Rail and Pathway Crossing Located in Rail Yard, Passenger Station, within Private Company, Port, or Dock Area 51 States/entities & 618 railroads 5,300 assigned numbers + 10,600 provided assigned numbers 5 minutes +
  • 5 minutes
  • 1,325 hours
    (a)(2)(i)—Completed Inventory Forms for Each Previously Unreported Crossing 51 States/entities & 618 railroads 5,300 forms 30 minutes 2,650 hours (c)—Duty of All Operating Railroads: Notification to FRA of Previously Unreported Crossing through Which It Operates 51 States/entities & 618 railroads 450 notices/Notifications 30 minutes 225 hours (d)—State-maintained Crossing Data: Written Copy of Request for Such Data to FRA (Revised Requirement) 51 States/entities & 618 railroads 35 copies of written request 2 minutes 1 hour —Copies of Written Request for State-maintained Data to Each Operating Railroad Transiting Crossing (Revised Requirement) 51 States/entities & 618 railroads 105 copies of written request 2 minutes 4 hours 234.407(a)—Submission of Initial Data to the Crossing Inventory for New Crossings: Providing Assigned Inventory Numbers for New Highway-Rail and Pathway Crossings through which They Operate by Primary Operating Railroads to Each Railroad that Operates One or More Trains Through the Crossing 51 States/entities & 618 railroads 100 assigned numbers + 100 provided assigned numbers 5 minutes + 5 minutes 16 hours (a)(2)(i)—Completed Inventory Forms for Each New Highway-Rail and Pathway Crossing 51 States/entities & 618 railroads 100 forms 90 minutes 150 hours 234.409(a)—Submission of Periodic Updates to the Crossing Inventory 51 States/entities & 618 railroads 80,775 crossing inventory updates 2.5025 minutes 3,369 hours (c) Duty of All Operating Railroads: Written Notification to FRA of that Up-to-date and Accurate Information has Not Been Timely Submitted to the Crossing Inventory 51 States/entities & 618 railroads 950 written notices 20 minutes 317 hours 234.411(a)—Crossing Sale: Submission of Crossing Inventory Form by Any Operating Railroad that Sells All or Part of Highway-Rail and Pathway Crossing 51 States/entities & 618 railroads 650 reports/updated crossing inventory form 2 hours 1,300 hours (b)—Crossing Closure: Submission of Crossing Inventory Form by Primary Operating Railroad that Closes Highway-Rail and Pathway Crossing 51 States/entities & 618 railroads 85 crossing inventory forms (closures) 5 minutes 7 hours (c)—Primary Operating RR Submission of Inventory form for Any Surface/Warning Device Changes at Crossing 51 States/entities & 618 railroads 650 forms 30 minutes 325 hours 234.413(a&b)(1)—Recordkeeping: Duplicate Copy of Each Inventory Form Submitted in Hard Copy 51 States/entities & 618 railroads 5,901 duplicate copies 1 minute 98 hours (a&b)(2)—Railroad Copy of FRA Confirmation after Electronic Submission of Crossing Data to the Crossing Inventory 51 States/entities & 618 railroads 80,775 copies 1 minute 1,346 hours (c)—Railroad List of Establishment Locations Where Any Required Records are Kept 51 States/entities & 618 railroads 618 lists 5 minutes 52 hours

    Organizations and individuals desiring to submit comments on the collection of information requirements should direct them to the Office of Management and Budget, Office of Information and Regulatory Affairs, Washington, DC 20503, Attention: FRA Desk Officer. Comments may also be sent via email to OMB at the following address: [email protected]

    OMB is required to make a decision concerning the collection of information requirements contained in this amended final rule between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication.

    FRA cannot impose a penalty on persons for violating information collection requirements which do not display a current OMB control number, if required. FRA intends to obtain current OMB control numbers for any new information collection requirements resulting from this rulemaking action on the effective date of this amended final rule. The OMB control number, when assigned, will be announced by separate notice in the Federal Register.

    E. Environmental Impact

    FRA has evaluated this rule under its “Procedures for Considering Environmental Impacts” (FRA's Procedures) (64 FR 28545, May 26, 1999) as required by the National Environmental Policy Act (42 U.S.C. 4321 et seq.), other environmental statutes, Executive Orders, and related regulatory requirements. FRA has determined that this amended final rule is not a major FRA action (requiring the preparation of an environmental impact statement or environmental assessment) because it is categorically excluded from detailed environmental review under section 4(c)(20) of FRA's Procedures. See 64 FR 28547, May 26, 1999.

    Under section 4(c) and (e) of FRA's Procedures, the agency has further concluded that no extraordinary circumstances exist with respect to this regulation that might trigger the need for a more detailed environmental review. As a result, FRA finds that this amended final rule is not a major Federal action significantly affecting the quality of the human environment.

    F. Unfunded Mandates Reform Act of 1995

    Under Section 201 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency “shall, unless otherwise prohibited by law, assess the effects of Federal regulatory actions on State, local, and tribal governments, and the private sector (other than to the extent that such regulations incorporate requirements specifically set forth in law).” Section 202 of the Act (2 U.S.C. 1532) further requires that before promulgating any general notice of proposed rulemaking that is likely to result in the promulgation of any rule that includes any Federal mandate that may result in expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year, and before promulgating any final rule for which a general notice of proposed rulemaking was published, the agency shall prepare a written statement detailing the effect on State, local, and tribal governments and the private sector. This amended final rule will not result in the expenditure, in the aggregate, of $155,000,000 or more (as adjusted annually for inflation) in any one year, and thus preparation of such a statement is not required.

    G. Energy Impact

    Executive Order 13211 requires Federal agencies to prepare a Statement of Energy Effects for any “significant energy action.” 66 FR 28355, May 22, 2001. Under the Executive Order, a “significant energy action” is defined as any action by an agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking: (1)(i) That is a significant regulatory action under Executive Order 12866 or any successor order, and (ii) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (2) that is designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. FRA evaluated this amended final rule consistent with Executive Order 13211. FRA determined that this amended final rule is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Consequently, FRA determined that this regulatory action is not a “significant energy action” within the meaning of Executive Order 13211.

    H. Trade Impact

    The Trade Agreements Act of 1979 (TAA) (Pub. L. 96-39, 19 U.S.C. 2501 et seq.) prohibits Federal agencies from engaging in any standards setting or related activities that create unnecessary obstacles to the foreign commerce of the United States. Legitimate domestic objectives, such as safety, are not considered unnecessary obstacles. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. FRA assessed the potential effect of this amended final rule on foreign commerce and believes that its requirements are consistent with the TAA. The requirements imposed are safety standards which, as noted, are not considered unnecessary obstacles to trade.

    I. Privacy Act

    Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). See http://www.regulations.gov/#!privacyNotice for the privacy notice of regulations.gov or interested parties may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

    List of Subjects in 49 CFR Part 234

    Highway safety, Penalties, Railroad safety, Reporting and recordkeeping requirements, State and local governments.

    For the reasons discussed in the preamble, FRA amends part 234 of chapter II, subtitle B of title 49, Code of Federal Regulations as follows:

    PART 234—[AMENDED] 1. The authority citation for part 234 continues to read as follows: Authority:

    49 U.S.C. 20103, 20107, 20152, 20160, 21301, 21304, 21311, 22501 note; Pub. L. 110-432, Div. A., Sec. 202, 28 U.S.C. 2461, note; and 49 CFR 1.89.

    2. Section 234.401 is amended by adding definitions of “General railroad system of transportation” and “General system railroad” in alphabetical order and revising the definition of “Primary operating railroad” to read as follows:
    § 234.401 Definitions.

    General railroad system of transportation means the network of standard gage track over which goods may be transported throughout the nation and passengers may travel between cities and within metropolitan and suburban areas.

    General system railroad means a railroad that operates on track which is part of the general railroad system of transportation.

    Primary operating railroad means the operating railroad that either owns or maintains the track through the highway-rail or pathway crossing, unless the crossing is located within a private company, port, or dock area. If more than one operating railroad either owns or maintains the track through the highway-rail or pathway crossing, or if no operating railroad owns or maintains the track through the highway-rail or pathway crossing, then the operating railroad that operates the highest number of trains through the crossing is the primary operating railroad. In the event that there is only one operating railroad that operates one or more trains through a highway-rail or pathway crossing, that operating railroad is the primary operating railroad. For highway-rail and pathway crossings that are located within a private company, port, or dock area (“private area”), each railroad that owns track leading to the private company, port, or dock area will be considered a primary operating railroad for all crossings within the private area if a general system railroad operates over the railroad's track leading to the private area and through at least one crossing within that area.

    3. Revise § 234.403(e) to read as follows:
    § 234.403 Submission of data to the Crossing Inventory, generally.

    (e) Reporting by the parent corporation on behalf of subsidiary railroads. (1) To satisfy the reporting requirements of this section, a parent corporation may submit crossing data to the Crossing Inventory on behalf of one or more of its subsidiary railroads. The parent corporation shall provide written notice to the FRA Associate Administrator that it has assumed reporting and updating responsibility for all of the subsidiary railroad's highway-rail and pathway crossings. The written notification shall include the following:

    (i) A list of all subsidiary railroads for which the parent corporation will submit and update highway-rail and pathway crossing data;

    (ii) A statement signed by an official of the parent corporation affirming that the parent corporation agrees to submit and update all of the highway-rail and pathway crossing data for the named subsidiary railroad(s); and

    (iii) A statement that the parent corporation agrees to be subject to enforcement action for noncompliance with the reporting or updating requirements of this subpart.

    (2) The parent corporation shall provide immediate written notification to the FRA Associate Administrator of any change in the list of subsidiary operating railroads for which it has assumed reporting and updating responsibility.

    (3) The parent corporation shall submit the data required by paragraph (a) of this section to the Crossing Inventory electronically.

    4. In § 234.405, revise paragraphs (a)(1) and (3), (b), and (d) to read as follows:
    § 234.405 Submission of initial data to the Crossing Inventory for previously unreported crossings.

    (a) Duty of primary operating railroad. (1)(i) With the exception of highway-rail and pathway crossings located in a railroad yard, passenger station, or within a private company, port, or dock area, each primary operating railroad shall assign an Inventory Number to each previously unreported highway-rail and pathway crossing through which it operates.

    (ii) A primary operating railroad shall assign one or more Inventory Numbers to previously unreported highway-rail and pathway crossings through which it operates, which are located in a railroad yard, passenger station, or within a private company, port, or dock area.

    (3) Each primary operating railroad shall submit accurate Inventory Forms, or their electronic equivalent, to the Crossing Inventory for the previously unreported highway-rail and pathway crossings through which it operates, no later than August 9, 2016. The Inventory Form, or its electronic equivalent, shall reference the assigned Inventory Number for the crossing(s) and shall be completed and submitted consistent with § 234.403 and the Inventory Guide.

    (b) Duty of operating railroad when operating railroads operate on separate tracks. For each previously unreported highway-rail and pathway crossing where operating railroads operate trains on separate tracks through the crossing, each operating railroad (other than the primary operating railroad) shall submit accurate crossing data specified in the Inventory Guide to the Crossing Inventory no later than August 9, 2016. The Inventory Form, or its electronic equivalent, which contains this crossing data shall reference the Inventory Number assigned to the crossing by the primary operating railroad and shall be completed and submitted in accordance with § 234.403.

    (d) State-maintained crossing data. If a primary operating railroad requests State-maintained crossing data from the appropriate State agency responsible for maintaining highway-rail and pathway crossing data, the primary operating railroad may send a copy of its written request for State-maintained crossing data to the FRA Associate Administrator and to each operating railroad that operates through the crossing. FRA will consider the written request to be an affirmative defense to potential liability for failure to timely submit an accurate Inventory Form, or its electronic equivalent, as required by paragraph (a)(3) of this section if the primary operating railroad:

    (1) Provides a copy of its written request for State-maintained crossing data to the FRA Associate Administrator and to each operating railroad that operates through the crossing; and

    (2) Submits the requested State-maintained crossing data to the Crossing Inventory within 60 days of receipt.

    5. In § 234.407, revise paragraphs (a)(3), (b) and (d) to read as follows:
    § 234.407 Submission of initial data to the Crossing Inventory for new crossings.

    (a) * * *

    (3) Each primary operating railroad shall submit accurate Inventory Forms, or their electronic equivalent, to the Crossing Inventory for new highway-rail and pathway crossings through which it operates, no later than six (6) months after the crossing becomes operational. The Inventory Form, or its electronic equivalent, shall reference the assigned Inventory Number for the crossing(s) and shall be completed and submitted in accordance with § 234.403.

    (b) Duty of Operating Railroad when operating railroads operate on separate tracks. For each new highway-rail and pathway crossing where operating railroads operate trains on separate tracks through the crossing, each operating railroad shall submit accurate crossing data specified in the Inventory Guide to the Crossing Inventory no later than six (6) months after the crossing becomes operational. The Inventory Form, or its electronic equivalent, which contains this crossing data shall reference the Inventory Number assigned to the crossing by the primary operating railroad and shall be completed and submitted consistent with § 234.403 and the Inventory Guide.

    (d) State-maintained crossing data. If a primary operating railroad requests State-maintained crossing data from the appropriate State agency responsible for maintaining highway-rail and pathway crossing data, the primary operating railroad may send a copy of its written request for State-maintained crossing data to the FRA Associate Administrator and to each operating railroad that operates through the crossing. FRA will consider the written request to be an affirmative defense to potential liability for failure to timely submit an accurate Inventory Form, or its electronic equivalent, as required by paragraph (a)(3) of this section if the primary operating railroad:

    (1) Provides a copy of its written request for State-maintained crossing data to the FRA Associate Administrator and to each operating railroad that operates through the crossing no later than six (6) months after the crossing becomes operational; and

    (2) Submits the requested State-maintained crossing data to the Crossing Inventory within 60 days of receipt.

    6. Revise § 234.409 to read as follows:
    § 234.409 Submission of periodic updates to the Crossing Inventory.

    (a) Duty of primary operating railroad. Each primary operating railroad shall submit up-to-date and accurate crossing data to the Crossing Inventory for each highway-rail and pathway crossing (except for a grade-separated or closed highway-rail or pathway crossing) through which it operates, consistent with the Inventory Guide. Updated crossing data shall be submitted to the Crossing Inventory at least every three (3) years from the date of the most recent submission of data by the primary operating railroad (or on behalf of the primary operating railroad) for the crossing or August 9, 2016, whichever occurs later. For hard-copy submissions to Crossing Inventory, this three-year period shall be measured from mailing date of the most recent submission of data by the primary operating railroad (or on behalf of the primary operating railroad).

    (b) Duty of operating railroad when operating railroads operate on separate tracks. For each highway-rail and pathway crossing where operating railroads operate trains on separate tracks through the crossing, each operating railroad shall submit up-to-date and accurate crossing data for certain specified data fields on the Inventory Form, or its electronic equivalent, to the Crossing Inventory at least every three (3) years from the date of the most recent submission of data by that operating railroad (or on behalf of that operating railroad) for the crossing or August 9, 2016, whichever occurs later. For hard-copy submissions to Crossing Inventory, this three-year period shall be measured from mailing date of the most recent submission of data by the operating railroad (or on behalf of the operating railroad). The Inventory Form, or its electronic equivalent, shall be completed and submitted consistent with § 234.403 and the Inventory Guide.

    7. Revise § 234.411 to read as follows:
    § 234.411 Changes requiring submission of updated information to the Crossing Inventory.

    (a) Crossing sale. (1) If a railroad that is not a primary operating railroad sells all or part of a highway-rail or pathway crossing on or after June 10, 2016, it shall report the crossing sale to the primary operating railroad within three (3) months of the date of sale.

    (2) If the primary operating railroad:

    (i) Sells all or part of a highway-rail or pathway crossing on or after June 10, 2016 for which it has reporting and updating responsibility under this subpart; or

    (ii) Is notified of the sale of all or part of a highway-rail or pathway crossing on or after June 10, 2016 under paragraph (a)(1) of this section, then the primary operating railroad shall submit an Inventory Form, or its electronic equivalent, which reflects the crossing sale to the Crossing Inventory consistent with § 234.403 and the Inventory Guide within three (3) months of the date of sale or three months of notification, respectively.

    (b) Crossing closure. The primary operating railroad shall report the closure of any highway-rail or pathway crossing that occurs on or after June 10, 2016 to the Crossing Inventory within three (3) months of the date on which the crossing is closed. The primary operating railroad shall submit an Inventory Form, or its electronic equivalent, that reflects closure of the crossing to the Crossing Inventory consistent with § 234.403 and the Inventory Guide.

    (c) Changes in crossing characteristics. (1) The primary operating railroad shall report any change in crossing surface or change in warning device at a public highway-rail grade crossing that occurs on or after June 10, 2016 to the Crossing Inventory within three (3) months of the date of the change. The primary operating railroad shall submit an Inventory Form, or its electronic equivalent, that reflects up-to-date and accurate crossing data for the crossing (including the change in crossing surface or change in warning device) to the Crossing Inventory consistent with § 234.403 and the Inventory Guide.

    (2) For purposes of this subpart, a “change in warning device” means the addition or removal of a crossbuck, yield or stop sign, flashing lights, or gates at a public highway-rail grade crossing. The installation of a crossbuck, yield or stop sign, flashing lights, or gates that will be in place for less than six months does not constitute a “change in warning device” for purposes of this subpart.

    8. The heading of § 234.413 is revised to read as follows:
    § 234.413 Recordkeeping.
    9. In Appendix A to Part 234, place the entry for subpart F in alphabetical order, and revise the entries under subpart F to read as follows: Appendix A to Part 234—Schedule of Civil Penalties 1 Section Violation Willful violation *         *         *         *         *         *         * Subpart F—Highway-Rail and Pathway Crossing Inventory Reporting § 234.403 Submission of data to the Crossing Inventory: (b) Failure to complete Inventory Form (or electronic equivalent) in accordance with the Inventory Guide $1,000 $2,000 (c) Class I railroad failure to submit crossing data to the Crossing Inventory electronically 1,000 2,000 § 234.405 Submission of initial data to the Crossing Inventory for previously unreported crossings (a) Primary operating railroad failure to timely submit an accurate Inventory Form (or electronic equivalent) to the Crossing Inventory for previously unreported crossing 2,500 5,000 (b) Operating railroad failure to timely submit accurate partial crossing data to the Crossing Inventory for previously unreported crossing 2,500 5,000 (c) Operating railroad failure to provide written notification to FRA that the primary operating railroad failed to timely report previously unreported crossing 1,000 2,000 § 234.407 Submission of initial data to the Crossing Inventory for new crossings: (a) Primary operating railroad failure to timely submit an accurate Inventory Form (or electronic equivalent) to the Crossing Inventory for new crossing 2,500 5,000 (b) Operating railroad failure to timely submit accurate partial crossing data to the Crossing Inventory for new crossing 2,500 5,000 (c) Operating railroad failure to provide written notification to FRA that the primary operating railroad failed to timely report new crossing 1,000 2,000 § 234.409 Submission of periodic updates to the Crossing Inventory: (a) Primary operating railroad failure to timely submit up-to-date and accurate crossing data to the Crossing Inventory for highway-rail or pathway crossing 2,500 5,000 (b) Operating railroad failure to timely submit up-to-date and accurate partial crossing data to the Crossing Inventory for highway-rail or pathway crossing 2,500 5,000 § 234.411 Changes requiring submission of updated information to the Crossing Inventory: (a) Failure to timely report crossing sale to the Crossing Inventory 2,500 5,000 (b) Primary operating railroad failure to timely report crossing closure to the Crossing Inventory 2,500 5,000 (c) Primary operating railroad failure to timely submit up-to-date and accurate crossing data to the Crossing Inventory after change in crossing characteristics 2,500 5,000 § 234.413 Recordkeeping 1,000 2,000 § 234.415 Electronic Recordkeeping 1,000 2,000 1 A penalty may be assessed against an individual only for a willful violation. The Administrator reserves the right to assess a penalty of up to $105,000 for any violation where circumstances warrant. See 49 CFR part 209, appendix A. To facilitate the assessment of penalty amounts, the specific types of violations of a given section are sometimes designated by the paragraph of the section (e.g., “(a)”) and a code not corresponding to the legal citation for the violation (e.g., “(1)”), so that the complete citation in the penalty schedule is e.g., “(a)(1).” FRA reserves the right to revise the citation of the violation in the Summary of Alleged Violations issued by FRA in the event of litigation. Issued in Washington, DC, on May 20, 2016, under the authority set forth in 49 CFR 1.89(b). Sarah E. Feinberg, Administrator.
    [FR Doc. 2016-13516 Filed 6-9-16; 8:45 am] BILLING CODE 4910-06-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150629562-6447-02] RIN 0648-BF25 Fisheries of the Exclusive Economic Zone Off Alaska; Bycatch Management in the Bering Sea Pollock Fishery AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    NMFS issues this final rule to implement Amendment 110 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands management area (FMP). Amendment 110 and this final rule improve the management of Chinook and chum salmon bycatch in the Bering Sea pollock fishery by creating a comprehensive salmon bycatch avoidance program. This action is necessary to minimize Chinook and chum salmon bycatch in the Bering Sea pollock fishery to the extent practicable while maintaining the potential for the full harvest of the pollock total allowable catch (TAC) within specified prohibited species catch (PSC) limits. Amendment 110 is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the FMP, and other applicable laws.

    DATES:

    Effective July 11, 2016.

    ADDRESSES:

    Electronic copies of Amendment 110 and the Environmental Assessment (EA)/Regulatory Impact Review (RIR) prepared for this action (collectively the “Analysis”), and the Environmental Impact Statement (EIS) prepared for Amendment 91 to the FMP may be obtained from www.regulations.gov or from the NMFS Alaska Region Web site at http://alaskafisheries.noaa.gov. All public comments submitted during the comment periods may be obtained from www.regulations.gov.

    Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this rule may be submitted by mail to NMFS Alaska Region, P.O. Box 21668, Juneau, AK 99802-1668, Attn: Ellen Sebastian, Records Officer; in person at NMFS Alaska Region, 709 West 9th Street, Room 420A, Juneau, AK; by email to [email protected]; or by fax to 202-395-5806.

    FOR FURTHER INFORMATION CONTACT:

    Gretchen Harrington or Alicia Miller, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fisheries in the exclusive economic zone of the Bering Sea and Aleutian Islands Management Area (BSAI) under the FMP. The North Pacific Fishery Management Council (Council) prepared the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801 et seq. Regulations governing U.S. fisheries and implementing the FMP appear at 50 CFR parts 600 and 679.

    NMFS published the Notice of Availability for Amendment 110 in the Federal Register on January 8, 2016 (81 FR 897), with comments invited through March 8, 2016. NMFS published the proposed rule to implement Amendment 110 on February 3, 2016 (81 FR 5681), with comments invited through March 4, 2016. The Secretary of Commerce approved Amendment 110 on March 29, 2016. NMFS received 15 comment letters containing 27 unique substantive comments on the FMP amendment and proposed rule. A summary of these comments and the responses by NMFS are provided under the heading Response to Comments below.

    A detailed review of the provisions of Amendment 110, the proposed regulations to implement Amendment 110, and the rationale for these regulations is provided in the preamble to the proposed rule (81 FR 5681, February 3, 2016) and is briefly summarized in this final rule. The preamble to the proposed rule describes 1) the Bering Sea pollock fishery, 2) salmon bycatch in the Bering Sea pollock fishery, 3) the importance of salmon in western Alaska, 4) management of salmon bycatch in the BSAI, 5) objectives of and rationale for Amendment 110 and the implementing regulations, 6) proposed salmon bycatch management measures, 7) proposed changes to monitoring and enforcement requirements, and 8) other regulatory changes in the proposed rule.

    Amendment 110 and this final rule apply to owners and operators of catcher vessels, catcher/processors, motherships, inshore processors, and the six Western Alaska Community Development Quota (CDQ) Program groups participating in the pollock (Gadus chalcogrammus) fishery in the Bering Sea. The Bering Sea pollock fishery is managed under the American Fisheries Act (AFA) (16 U.S.C. 1851 note) and the Magnuson-Stevens Act. The AFA defines the sectors of the Bering Sea pollock fishery, determines which vessels and processors are eligible to participate in each sector, establishes allocations of Bering Sea pollock total TAC to each sector as directed fishing allowances, and establishes excessive share limits for harvesting pollock. As required by section 206(b) of the AFA, NMFS allocates a specified percentage of the Bering Sea pollock TAC to each of the three AFA fishery sectors: 1) 50 percent to catcher vessels delivering to inshore processors, called the “inshore sector”; 2) 40 percent to catcher/processors and catcher vessels delivering to those catcher/processors, called the “catcher/processor sector”; and 3) 10 percent to catcher vessels harvesting pollock for processing by motherships, called the “mothership sector.”

    Pollock is harvested with trawl vessels that tow large nets through the water. Pollock can occur in the same locations as Chinook salmon and chum salmon. Consequently, Chinook salmon and chum salmon are incidentally caught in the nets as fishermen target pollock.

    Section 3 of the Magnuson-Stevens Act defines bycatch as fish that are harvested in a fishery, which are not sold or kept for personal use. Therefore, Chinook salmon and chum salmon caught in the pollock fishery are considered bycatch under the Magnuson-Stevens Act, the FMP, and NMFS regulations at 50 CFR part 679. Bycatch of any species, including discard or other mortality caused by fishing, is a concern of the Council and NMFS. National Standard 9 and section 303(a)(11) of the Magnuson-Stevens Act require the Council to recommend, and NMFS to implement, conservation and management measures that, to the extent practicable, minimize bycatch and bycatch mortality.

    The bycatch of culturally and economically valuable species like Chinook salmon and chum salmon, which are fully allocated and, in some cases, facing conservation concerns, are categorized as prohibited species under the FMP. They are the most regulated and closely managed category of bycatch in the groundfish fisheries off Alaska, and specifically in the pollock fishery. In addition to Pacific salmon, other species including steelhead trout, Pacific halibut, king crab, Tanner crab, and Pacific herring are also classified as prohibited species in the groundfish fisheries off Alaska. Fishermen must avoid salmon bycatch and any salmon caught must either be donated to the Prohibited Species Donation (PSD) Program (see § 679.26), or returned to Federal waters as soon as practicable, with a minimum of injury, after an observer has determined the amount of salmon bycatch and collected any scientific data or biological samples.

    The Council and NMFS have been concerned about the potential impact of Chinook and chum salmon bycatch on returns to western Alaska given the relatively large proportion of bycatch from western Alaska that occurs in the pollock fishery. Chinook salmon and chum salmon destined for western Alaska support commercial, subsistence, sport, and personal use fisheries. The State of Alaska (State) manages the salmon commercial, subsistence, sport, and personal use fisheries. The Alaska Board of Fisheries adopts regulations through a public process to conserve salmon and to allocate salmon to the various users. The first management priority is to meet spawning escapement goals to sustain salmon resources for future generations. The next priority is for subsistence use under both State and Federal law. Salmon is a primary subsistence food in some areas. Subsistence fisheries management includes coordination with U.S. Federal agencies where Federal rules apply under the Alaska National Interest Lands Conservation Act. Section 3.4 of the Analysis describes the State and Federal management process. Appendix A-4 of the Analysis provides an overview of the importance of subsistence salmon harvests and commercial salmon harvests.

    Over the last 20 years, the Council and NMFS have adopted and implemented several management measures to limit salmon bycatch in the BSAI trawl fisheries, and particularly in the pollock fishery. Most recently, NMFS implemented Amendment 84 to the FMP to enhance the effectiveness of salmon bycatch measures (72 FR 61070, October 29, 2007) and Amendment 91 to the FMP to provide incentives to minimize Chinook salmon bycatch to the extent practicable (75 FR 53026, August 30, 2010).

    Amendment 84 exempted pollock vessels from Chinook Salmon Savings Area and Chum Salmon Savings Area closures in the Bering Sea if they participate in an intercooperative agreement (ICA) to reduce salmon bycatch. Amendment 84 also exempted vessels participating in non-pollock trawl fisheries in the Bering Sea from area closures because these fisheries intercept minimal amounts of salmon. Additional information on the provisions of Amendment 84 is provided in the final rule prepared for that action (72 FR 61070, October 29, 2007).

    Amendment 91 was implemented to manage Chinook salmon bycatch in the pollock fishery. Amendment 91 combined a limit on the amount of Chinook salmon that may be caught incidentally with a novel approach designed to minimize bycatch to the extent practicable in all years and prevent bycatch from reaching the limit in most years, while providing the fleet the flexibility to harvest the total allowable catch (TAC) of Bering Sea pollock. Amendment 91 removed Chinook salmon from the Amendment 84 regulations, and established two Chinook salmon PSC limits for the pollock fishery—60,000 and 47,591 Chinook salmon. Under Amendment 91, the PSC limit is 60,000 Chinook salmon if some, or all, of the pollock fishery participates in an industry-developed contractual arrangement, called an incentive plan agreement (IPA). An IPA establishes a program to minimize bycatch at all levels of Chinook salmon abundance. Participation in an IPA is voluntary; however, any vessel or CDQ group that chooses not to participate in an IPA is subject to a restrictive opt-out allocation (also called a backstop cap). Since Amendment 91 was implemented, all AFA vessels (i.e., vessels authorized to directed fish for Bering Sea pollock) have participated in an IPA. Additional information on the provisions of Amendment 91 is provided in the final rule prepared for that action (75 FR 53026, August 30, 2010).

    The following sections describe 1) the salmon bycatch management measures implemented with Amendment 110 and this final rule, 2) the changes from proposed to final rule, and 3) response to comments.

    Amendment 110 and This Final Rule

    The objective of Amendment 110 and this final rule is to create a comprehensive salmon bycatch avoidance program that works more effectively than current management to avoid Chinook salmon bycatch and Alaska-origin chum salmon bycatch in the pollock fishery. The Council and NMFS recognize that salmon are an extremely important resource to Alaskans who depend on local fisheries for their sustenance and livelihood.

    Amendment 110 and this final rule adjust the existing Chinook salmon bycatch program to incorporate revised chum salmon bycatch measures into the existing IPAs. Amendment 110 and this final rule are designed to consider the importance of continued production of critical chum salmon runs in western Alaska by focusing on bycatch avoidance of Alaskan chum salmon runs. Historically, western Alaska chum salmon run strength has varied substantially and chum salmon are important to the subsistence lifestyle of Alaskans. Amendment 110 and this final rule also provide additional protections to chum salmon stocks other than those from western Alaska, recognizing that most of the non-western Alaska chum salmon are likely from Asian hatcheries.

    In addition, the Council and NMFS sought to provide greater incentives to avoid Chinook salmon by strengthening existing incentives during times of historically low Chinook salmon abundance in western Alaska. Thus, the management measures included in Amendment 110 focus on retaining the incentives to avoid Chinook salmon bycatch at all levels of abundance as intended by Amendment 91. Multiple years of historically low Chinook salmon abundance have resulted in significant restrictions for subsistence users in western Alaska and failure to achieve conservation objectives. While Chinook salmon bycatch impact rates have been low under Amendment 91, the Council and NMFS determined that there is evidence that improvements could be made to ensure the program is reducing Chinook salmon bycatch at low levels of salmon abundance. An analysis of the possible improvements is provided in Section 3.5.3 of the Analysis.

    Amendment 110 and this final rule—

    • incorporate chum salmon avoidance into the IPAs established under Amendment 91 to the FMP, and remove the non-Chinook salmon bycatch reduction ICA previously established under Amendment 84 to the FMP;

    • modify the requirements for the content of the IPAs to increase the incentives for fishermen to avoid Chinook salmon;

    • change the seasonal apportionments of the pollock TAC to allow more pollock to be harvested earlier in the year when Chinook salmon PSC use tends to be lower;

    • reduce the Chinook salmon PSC limit and performance standard in years with low Chinook salmon abundance in western Alaska; and

    • improve the monitoring of salmon bycatch in the pollock fishery.

    Incorporate Chum Salmon Avoidance Into the Incentive Plan Agreements (IPAs)

    Amendment 110 and this final rule incorporate chum salmon avoidance, and the important chum salmon avoidance features of the Amendment 84 ICAs, into the IPAs established under Amendment 91. This final rule removes the Amendment 84 implementing regulations at § 679.21(g). However, Amendment 110 and this final rule maintain the current non-Chinook salmon PSC limit of 42,000 fish and the closure of the Chum Salmon Savings Area to the pollock fishery when the 42,000 non-Chinook salmon PSC limit has been reached. Vessels that participate in an IPA are exempt from the Chum Salmon Savings Area closure. The purpose of maintaining the non-Chinook salmon PSC limit and the Chum Salmon Savings Area closure is to provide additional incentives for vessels to join an IPA, and to serve as back-stop chum salmon bycatch management measures for those vessels that choose not to participate in an IPA.

    To incorporate chum salmon into the IPAs, this final rule modifies the required contents of the IPAs at § 679.21(f)(12), to include the following eight provisions.

    • Incentives for the operator of each vessel to avoid Chinook salmon and chum salmon bycatch under any condition of pollock and Chinook salmon abundance in all years.

    • An explanation of how the incentives to avoid chum salmon do not increase Chinook salmon bycatch.

    • Rewards for avoiding Chinook salmon, penalties for failure to avoid Chinook salmon at the vessel level, or both.

    • An explanation of how the incentive measures in the IPA are expected to promote reductions in a vessel's Chinook salmon and chum salmon bycatch rates relative to what might have occurred in absence of the incentive program.

    • An explanation of how the incentive measures in the IPA promote Chinook salmon savings and chum salmon savings in any condition of pollock abundance or Chinook salmon abundance and influence the vessel operator's decisions to avoid Chinook salmon and chum salmon.

    • An explanation of how the IPA ensures that the operator of each vessel governed by the IPA will manage that vessel's Chinook salmon bycatch to keep total bycatch below the performance standard for the sector in which the vessel participates.

    • An explanation of how the IPA ensures that the operator of each vessel governed by the IPA will manage that vessel's chum salmon bycatch to avoid areas and times where the chum salmon are likely to return to western Alaska.

    • The rolling hot spot program for salmon bycatch avoidance and the agreement to provide notifications of closure areas and any violations of the rolling hot spot program to at least one third party group representing western Alaskans who depend on salmon and do not directly fish in a groundfish fishery.

    This final rule also adds reporting requirements to the IPA Annual Report at § 679.21(f)(13) to require the IPA representative to describe how the IPA addresses the goals and objectives in the IPA provisions related to chum salmon. Section 3.5.2 of the Analysis provides more detail on adding elements of chum salmon bycatch management.

    Modify the IPAs To Increase the Incentives To Avoid Chinook Salmon

    Amendment 110 and this final rule modify the IPAs to increase the incentives to reduce Chinook salmon bycatch within the IPAs. To incorporate additional incentives for Chinook salmon savings into the IPAs, this final rule modifies the required contents of the IPAs at § 679.21(f)(12) to include the following six provisions.

    • Restrictions or penalties targeted at vessels that consistently have significantly higher Chinook salmon PSC rates relative to other vessels fishing at the same time.

    • Requirement that vessels enter a fishery‐wide in‐season salmon PSC data sharing agreement.

    • Requirement for a rolling hotspot program that operates throughout the entire pollock A season (January 20 through June 10) and B season (June 10 through November 1).

    • Requirement for the use of salmon excluder devices, with recognition of contingencies, from January 20 through March 31 and from September 1 until the end of the B season.

    • For savings-credit-based IPAs, limitation on the salmon savings credits to maximum of three years.

    • Restrictions or performance criteria to ensure that Chinook salmon PSC rates in October are not significantly higher than those achieved in the preceding months, thereby avoiding late-season spikes in salmon PSC.

    Revise the Bering Sea Pollock Seasonal Allocations

    This final rule changes the allocation of the Bering Sea pollock TAC between the A and B seasons at § 679.20(a)(5)(i)(B)(1). This final rule allocates five percent of the pollock allocation from the B season to the A season, resulting in new seasonal apportionments of 45 percent of the TAC in the A season and 55 percent of the TAC in the B season. This final rule maintains the rollover of any remaining pollock from the A season to the B season. The revised season allocation works in conjunction with the new IPA requirements to shift effort out of the late B season and provide fishery participants more flexibility to avoid Chinook salmon PSC when it tends to be higher in the late B season.

    Reduce the Chinook Salmon Performance Standard and PSC Limit in Years of Low Chinook Salmon Abundance in Western Alaska

    Amendment 110 and this final rule add a new lower Chinook salmon performance standard and PSC limit for the pollock fishery in years of low Chinook salmon abundance in western Alaska. The Council and NMFS determined that a lower performance standard and PSC limit would be appropriate at low levels of Chinook salmon abundance in western Alaska because most of the Chinook salmon bycatch comes from western Alaska. These provisions work in conjunction with the changes to the IPA requirements to ensure that Chinook salmon bycatch is avoided at all times, particularly at low abundance levels.

    Each year, NMFS will determine whether Chinook salmon is at low abundance based on information provided by the State. By October 1 of each year, the State will provide a Chinook salmon abundance using the 3-System Index for western Alaska based on the post-season in-river Chinook salmon run size for the Kuskokwim, Unalakleet, and Upper Yukon aggregate stock grouping. When this index is less than or equal to 250,000 Chinook salmon, NMFS will apply the new lower performance standard and low PSC limit for the following year.

    If NMFS determines it is a low Chinook salmon abundance year, NMFS will set the performance standard at 33,318 Chinook salmon and the PSC limit at 45,000 Chinook salmon for the following fishing year. NMFS will publish the lower PSC limit and performance standard in the annual harvest specifications. In years with no determination of a low Chinook salmon abundance, NMFS will manage under the current 47,591 Chinook salmon performance standard and 60,000 Chinook salmon PSC limit.

    The inclusion of a lower PSC limit and performance standard is based on the need to reduce bycatch when these Chinook salmon stocks are low in order to minimize the impact of the pollock fishery on the stocks. Any additional Chinook salmon returning to Alaska rivers improves the ability to meet the State's spawning escapement goals, which is necessary for long-term sustainability of Chinook salmon and the people reliant on salmon fisheries. While the performance standard is the functional limit in the IPAs, the Council and NMFS determined that the 60,000 PSC limit should also be reduced given the potential for decreased bycatch reduction incentives should a sector exceed its performance standard before the PSC limit is reached. The reduced PSC limit is intended to encourage vessels to avoid bycatch to a greater degree in years of low abundance, and to set a maximum permissible PSC limit that reduces the risk of adverse impact on stocks in western Alaska during periods of low abundance.

    Changes to Monitoring and Enforcement Requirements

    This final rule amends the monitoring and enforcement regulations to clarify and strengthen those implemented under Amendment 91. These changes—

    • revise salmon retention and handling requirements on catcher vessels;

    • improve observer data entry and transmission requirements aboard catcher vessels;

    • clarify the requirements applicable to viewing salmon in a storage container; and

    • clarify the requirements for the removal of salmon from an observer sampling station at the end of a haul or delivery.

    This final rule also makes a number of other revisions to the regulations for clarity and efficiency. All of these regulatory changes are detailed in the preamble to the proposed rule (81 FR 5681, February 3, 2016).

    Change From Proposed to Final Rule

    NMFS made no changes to the final rule in response to comments received on the proposed rule.

    NMFS made three minor changes in this final rule to reflect final rules published after NMFS published the proposed rule for Amendment 110. First, this final rule removed the definition of prohibited species quota (PSQ) reserve because that definition was corrected in the final rule to implement halibut PSC limit reductions under Amendment 111 to the FMP (81 FR 24714, April 27, 2016). Second, this final rule revises the heading for § 679.21(e) that was modified under regulations that implemented Amendment 111 to the FMP to clarify that paragraph (e) applies to PSC limits for BSAI crab and herring. Third, this final rule adds the parenthetical phrase “(except for a catcher/processor placed in the partial observer coverage category under paragraph (a)(3) of this section)” to § 679.51(e)(1)(iii)(B) to be consistent with the final rule to allow qualifying small catcher/processors to be in the partial observer coverage category under the North Pacific Groundfish and Halibut Observer Program (81 FR 17403, March 29, 2016).

    Additionally, this final rule makes a minor editorial clarification to revise § 679.21(f)(2) to clarify that the State will provide to NMFS an estimate of Chinook salmon abundance using a the 3-System Index for western Alaska based on the Kuskokwim, Unalakleet, and Upper Yukon aggregate stock grouping.

    Response to Comments

    NMFS received 15 comment letters containing 27 specific comments, which are summarized and responded to below. The commenters consisted of individuals, representatives of the pollock fishery participants, a representative of groundfish fishery participants, Alaska Native organizations, and the State.

    Comment 1: We support the comprehensive salmon bycatch avoidance program outlined in the proposed rule for Amendment 110 and believe it will be more effective in meeting the Council's objectives, including minimizing salmon bycatch, responding to changing conditions of abundance, and avoiding Alaska-origin salmon stocks.

    Response: NMFS acknowledges the comment.

    Comment 2: Consistent genetic stock composition data show that Alaska-origin stocks continue to comprise a majority of the Chinook salmon bycatch and almost a quarter of the chum salmon bycatch in the Bering Sea pollock fishery. Recognizing the importance of these stocks to western Alaska commercial and subsistence users, and our increased understanding of the areas and times of year in which Alaska Chinook and chum salmon stocks are more predominate in the bycatch, Amendment 110 provides the necessary flexibility to respond to and incorporate new information in the bycatch avoidance program.

    Response: NMFS acknowledges the comment.

    Comment 3: Reducing salmon bycatch in the Bering Sea pollock fishery is critical to the future of Chinook salmon runs. Amendment 110 is urgently needed because of the dire status of Chinook salmon stocks in western Alaska. Amendment 110 and the proposed regulations are an important step in further reducing salmon bycatch in the pollock fishery. Amendment 110 will continue to lower Chinook salmon bycatch, however, constant vigilance is required to ensure that the Chinook salmon PSC limits established in regulation are never actually met.

    Response: NMFS acknowledges the comment.

    Comment 4: It is essential to integrate chum salmon bycatch measures into the IPAs and include the accountability and transparency measures.

    Response: Amendment 110 and this final rule incorporate chum salmon avoidance measures into the IPAs established for Chinook salmon bycatch management under Amendment 91. Incorporating chum salmon into the IPAs provides measures to prevent high chum salmon bycatch, while also giving participants in the pollock fishery the flexibility to use coordinated management under the IPAs to adapt quickly to changing conditions. The Council determined and NMFS agreed that Amendment 110 and this final rule strike an appropriate balance between regulatory requirements and adaptive management necessary for chum salmon bycatch management.

    Comment 5: Make sure the theoretical salmon avoidance schemes proposed do not make matters worse for Chinook salmon in the attempt to avoid chum salmon.

    Response: The chum salmon-specific requirements in the Amendment 84 implementing regulations sometimes prevented fishery participants from making decisions to avoid Chinook salmon when vessels encountered both chum salmon and Chinook salmon. Adding chum salmon measures to the IPAs provides vessel operators with the flexibility to respond to changing conditions and provides greater incentives to reduce bycatch of both salmon species, thereby making salmon bycatch management more effective, comprehensive, and efficient.

    Comment 6: The measures designed to reduce Chinook salmon bycatch in the proposed rule provide useful tools to fine-tune the IPAs to mandate greater bycatch reduction.

    Response: NMFS agrees. Amendment 110 and this final rule modify the IPAs to increase the incentives for fishermen to avoid Chinook salmon. The Council and NMFS recognize that the IPAs were effective at providing incentives for each vessel operator to avoid Chinook salmon, but that additional measures were necessary to address higher Chinook salmon PSC rates observed in October (the last month when the pollock fishery is authorized to operate). Amendment 110 and this final rule also address concerns with individual vessels that consistently have significantly higher Chinook salmon PSC rates relative to other vessels fishing at the same time. The Council and NMFS want to ensure the use of salmon excluder devices (i.e., gear modifications that are designed to exclude salmon bycatch while retaining pollock) and a rolling hotspot program. These new provisions increase the incentives to reduce Chinook salmon bycatch within the IPAs, provide an opportunity for IPAs to increase vessels' responsiveness in October, and improve performance of individual vessels.

    Comment 7: The entire history of the Bering Sea pollock fishery and its impacts on western Alaska salmon has been a disaster and it is within this context that we remain opposed to the allowance of any salmon bycatch during the pollock fishery. Driving bycatch continuously lower, with an ultimate goal of zero, is essential. NMFS should prioritize its responsibilities based on moral and ethical obligations, in addition to its legal obligations, to those tribal communities whose very survival depends on a future of salmon returning in sufficient numbers to their rivers.

    Response: The Council recommended and NMFS approved Amendment 110 because it best balances the need to minimize salmon bycatch to the extent practicable while providing the pollock fleet the flexibility to harvest the pollock TAC. NMFS has complied with all applicable laws, executive orders, and international obligations in approving and implementing Amendment 110. Preventing all salmon bycatch would not meet the purpose and need for this action and would not meet NMFS' obligations under the Magnuson-Stevens Act.

    While salmon bycatch in the pollock fishery may be a contributing factor in the decline of salmon, NMFS expects the numbers of the ocean bycatch that would have returned to western Alaska would be relatively small due to ocean mortality and the large number of other river systems contributing to the total Chinook or chum salmon bycatch. For Chinook salmon, Section 3.5.1 of the Analysis explains that the Chinook salmon bycatch expected to have returned to western Alaska rivers is approximately 2.3 percent of coastal western Alaska run size in recent years. For chum salmon, Section 3.5.1 of the Analysis explains that the chum salmon bycatch expected to have returned to western Alaska rivers is approximately 0.5 percent of the coastal western Alaska run size in recent years. Under Amendment 110 and this final rule, these impact rates are anticipated to be further reduced as the pollock fleet improves its ability to avoid salmon at all times.

    Although the reasons for the decline of Chinook salmon and some runs of chum salmon are not completely understood, scientists believe they are predominately natural. Changes in ocean and river conditions, including unfavorable shifts in temperatures and food sources, likely cause poor survival of Chinook salmon and some runs of chum salmon. The EIS prepared for Amendment 91 provides more detail on the decline of salmon in western Alaska (see ADDRESSES). Section 3.4 of the Analysis describes the stocks status of Chinook and chum salmon.

    Comment 8: A key component of Amendment 110 and the proposed rule is to reduce the performance standard and PSC limit in years of low Chinook salmon abundance in western Alaska. The limits set in Amendment 91 were far too high to ensure a healthy future for western Alaska salmon runs. The mechanism to lower these limits in times of low Chinook salmon abundance is the minimum step NMFS must take at this time to fulfill numerous legal responsibilities to reduce the allowable salmon bycatch in the pollock fishery. Taking action now to lower the PSC limit and performance standard in years of extremely low abundance is a critical step to ensure that bycatch is reduced in the years when every source of mortality must be reduced.

    Response: Amendment 110 and this final rule add a new lower Chinook salmon performance standard and PSC limit for the pollock fishery in years of low Chinook salmon abundance in western Alaska. These provisions work in conjunction with the changes to the IPA requirements to ensure that Chinook salmon bycatch is avoided at all times, particularly at low abundance levels.

    Each year, NMFS will determine whether Chinook salmon is at low abundance based on information provided by the State using the 3-System Index. When this index is less than or equal to 250,000 Chinook salmon, NMFS will apply the new lower performance standard and reduced PSC limit for the following year. If NMFS determines it is a low Chinook salmon abundance year, NMFS will set the performance standard at 33,318 Chinook salmon and the PSC limit at 45,000 Chinook salmon for the following fishing year. The reduced PSC limit is intended to encourage vessels to avoid bycatch to a greater degree in years of low abundance, and to set a maximum permissible PSC limit that reduces the risk of adverse impact on stocks in western Alaska during periods of low abundance.

    In years with no determination of low Chinook salmon abundance, NMFS will manage under the current 47,591 Chinook salmon performance standard and 60,000 Chinook salmon PSC limit. The Council determined, and NMFS agrees, that these limits are appropriate given that the IPAs maintain bycatch well below these limits. Average Chinook salmon bycatch has been approximately 16,647 Chinook salmon per year since implementation of Amendment 91 in 2011.

    Comment 9: Amendment 110 reduces the number of Chinook salmon that can be taken as bycatch in years of very low Chinook salmon abundance in western Alaska, which is critical to maintaining objectives under National Standard 9. In years of very low Chinook salmon abundance, the State struggles to meet salmon escapement goals in important western Alaska systems, and only does so by prohibiting any directed Chinook salmon harvest for subsistence, as well as restricting subsistence harvest of other species, such as chum salmon, to minimize Chinook salmon mortalities.

    Response: NMFS acknowledges the comment.

    Comment 10: Amendment 110 links bycatch limits to a broad index of Chinook salmon abundance based on the Kuskokwim, Unalakleet, and Upper Yukon aggregate stock grouping — the 3-System Index. The 3-System Index includes significant river systems for subsistence fisheries in Alaska and provides a broad regional representation of western Alaska Chinook salmon stocks. Any additional fish returning to these rivers in years of very low abundance improves the State's ability to meet escapement goals.

    The Analysis clearly outlined the objectives that proposed indices were evaluated against, and the 3-System Index was identified as the most robust and appropriate index for this purpose. The primary component of the 3-System Index is preliminary escapement information from total run reconstruction using methods outlined in State publications. The State will provide the 3-System Index estimate to NMFS annually by October 1 and is committed to maintaining a transparent and accessible process for stakeholders as the State improves its understanding of these systems. The State will present any substantive changes to the methods used in developing the 3-System Index to the Council and its Scientific and Statistical Committee (SSC).

    Response: NMFS acknowledges the comment.

    Comment 11: The provision to reduce the PSC limit and performance standard in years of low Chinook salmon abundance based on the State's 3-System Index is unwarranted, unnecessary, not sound science, and not responsible management. It unfairly targets and penalizes the pollock fishery for circumstances beyond its control. Science has shown that there is not a relationship between Chinook salmon bycatch in the pollock fishery and the size of the runs in coastal western Alaska.

    Response: NMFS disagrees. The provisions to reduce the Chinook salmon PSC limit and performance standard in years of low abundance are necessary to achieve the program goals. The Council and NMFS determined that a lower performance standard and PSC limit are appropriate at low levels of Chinook salmon abundance in western Alaska because most of the Chinook salmon bycatch in the pollock fishery comes from western Alaska. These provisions work in conjunction with the changes to the IPA requirements to ensure that Chinook salmon bycatch is avoided at all times, particularly at low abundance levels.

    The Council and State conducted an extensive analysis about the appropriate index to use to indicate a low Chinook salmon abundance year. Low Chinook salmon abundance years are characterized by difficulty meeting escapement goals and severely restricted or fully closed in-river salmon fisheries. Section 2.6 of the Analysis evaluates various indices and shows that the 3-System Index (Unalakleet, Upper Yukon, and Kuskokwim river systems) meets the objectives. The Analysis also shows a clear natural break in the data analyzed indicating that when the index is less than 250,000 Chinook salmon, the index is strongly correlated to years with historically low run sizes. These river systems provide a broad regional representation of stocks and signify very important river systems and subsistence fisheries in western Alaska. Subsistence harvests from these three river systems account for up to 87 percent of the statewide subsistence harvest of Chinook salmon. As shown in the Analysis, having more than one system in the index and having broad regional representation makes the index more robust and able to account for changing environmental conditions.

    The inclusion of a lower PSC limit and performance standard is based on the need to reduce bycatch when the abundance of Chinook salmon stocks in western Alaska is low, in order to minimize the impact of the pollock fishery on the stocks. Any additional Chinook salmon returning to Alaska rivers improves the ability to meet the State's spawning escapement goals, which is necessary for long-term sustainability of Chinook salmon, and to meet subsistence management objectives for the people reliant on salmon fisheries. While the performance standard is the functional limit in the IPAs, the Council and NMFS determined that the 60,000 PSC limit should also be reduced given the potential for decreased bycatch reduction incentives if a sector exceeds its performance standard before the PSC limit is reached. The reduced PSC limit is intended to encourage vessels to avoid bycatch to a greater degree in years of low Chinook salmon abundance, and to set a maximum permissible PSC limit that reduces the risk of adverse impact on stocks in western Alaska during periods of low abundance.

    See the response to Comment 7 for a discussion of the relationship between Chinook salmon bycatch in the pollock fishery and the size of the runs in coastal western Alaska.

    Comment 12: The dramatic changes the Council made to the Chinook salmon abundance index, Chinook salmon PSC limit, and the performance standard between initial review in December 2014 and final action in April 2015 are hard to track and are not well documented in the final Analysis.

    Response: Sections 2.6.3 and 2.6.4 of the Analysis discuss the management measures to reduce the PSC limit and performance standard in years of low Chinook salmon abundance (see ADDRESSES). Section 2.6.4 explains the history of the 3-System Index and the analysis the State undertook to develop the appropriate Chinook salmon abundance index for determining low Chinook salmon abundance in western Alaska.

    Comment 13: There is no discussion in the EA about the methods used to determine a “natural break.” The EA identifies 250,000 Chinook as a natural break in the “data”. However, the data presented is actually the output of a model used to assess Chinook salmon run size. A formal definition for this threshold is required, as there is no guarantee that future models, or revisions to input data, will result in the same natural break in the model output. Instead of the 250,000 Chinook salmon threshold, NMFS should define (in probabilistic terms) a threshold to set the performance standard and PSC limit, rather than identifying an arbitrary natural break in future model output.

    Response: Section 2.6.4 of the Analysis provides a description of the methods for use of in-river run reconstructions with the 3-System Index and rationale for this choice of index and for the 250,000 Chinook salmon threshold. The evaluation of the estimated Chinook salmon run size by year is included in the Analysis and represents the best available scientific information.

    In-river run reconstructions represent an estimate of all fish harvested in the river and respective coastal areas plus escapement. The relationship upon which the threshold was determined is the relationship between final in-river run abundance of the 3-System Index and the bycatch of adult equivalent Chinook salmon attributed to all western Alaska stocks. In Section 2.6.4.2 of the Analysis, each point in Figure 8 represents a single year showing this relationship during the years analyzed. The years were referred to in the Analysis as data points for purposes of describing the clustering of these years below a breakpoint which falls above 200,486 Chinook salmon and below 286,692 Chinook salmon (see Table 6 in Section 2.6.4.5 of the Analysis).

    The clustering of years below 200,486 Chinook salmon also matches years which have been categorized as low abundance years for all three systems due to documented failures to meet escapement goals, restrictions on subsistence harvests, or declarations of Federal fishery resource disasters under the provisions of section 312 of the Magnuson-Stevens Act (Section 2.6.4 of the Analysis). Based on this information, the Council determined that a threshold of 250,000 Chinook salmon was an appropriate value within this range to represent a year when Chinook salmon were in a low abundance and as a threshold to determine that the lower PSC limit and lower performance standard would be in place for the subsequent year.

    This information was also used by the Council to select the 3-System Index. As explained in Section 2.6.4 of the Analysis, the 3-System index is a transparent and annually updated index that relies on easily accessible information from reports published by the State.

    The management measure to reduce the PSC limit and performance standard is tied to the selected threshold of 250,000 Chinook salmon based on the 3-System Index. No re-estimation of the threshold is planned on an annual basis or in subsequent years.

    Comment 14: Many comments expressed concerned over a letter the State had sent to NMFS on September 17, 2015, before Amendment 110 was approved and implemented. In this letter, the State provided an index estimate of 252,000 Chinook salmon to provide NMFS, the Council, and the public with a preview of Chinook salmon abundance using the 3-System Index for 2016. Commenters are concerned that this estimate reflected changes the State made in how it modeled abundance from the methods outlined in the Analysis. The State subsequently sent another letter on March 3, 2016, revising the index estimate to 279,000 Chinook salmon. The State made this revision to the index estimate based largely on the public review of the 3-System Index used to inform the State's September 17, 2015, letter.

    Response: In their March 3, 2016, letter, the State explains that the September 2015 letter's post-season run size estimate for the 3-System Index used a Kuskokwim River run reconstruction estimate that employed a modification to the model that had not yet been reviewed by the Council. As such, the State amended the 2015 post-season run size estimate to reflect the original version of the model and has committed to using the original model in the 3-System Index until the Council determines the modification is appropriate to use.

    Further, the State explains in their comment letter submitted on the proposed rule (see ADDRESSES) that the primary components of the post-season run index are preliminary escapement information and the total run reconstruction methods outlined in State publications. The State is committed to maintaining a transparent and accessible process for stakeholders, and the State will present any substantive changes to the methods used in developing the 3-System Index to the Council and its SSC.

    Comment 15: Clarify in the final rule a transparent public process for ensuring that the State provides the data, assumptions, and methods it uses to generate the 3-System Index to NMFS, the public, and the Council.

    Response: NMFS agrees that a transparent public process is necessary for ensuring that the 3-System Index represents the best available scientific information. NMFS is committed to working with the Council and the State to define a transparent process to ensure that the data, assumptions, and methods used in the 3-System Index continue to incorporate the best available scientific information and provide a reliable indicator of Chinook salmon abundance necessary to reduce the PSC limit and performance standard. NMFS will work with the State and the Council to refine this process before the State provides the index for the 2017 fishing year on October 1, 2016.

    Comment 16: The State must use the 3-System Index and associated methods and models described the Analysis and recommended by the Council in April 2015. Any changes to the 3-System Index and associated methods and models should be vetted through the Council and its SSC. Other models and methods may produce different run size estimates and a different threshold of low abundance. Structural changes to the run-reconstruction model would have resulted in a different “natural break” in the data that was used to determine the threshold for the 3-System Index. There are no provisions in the proposed rule to accommodate changes in the threshold that are associated with future changes to the run-reconstruction model, or revisions to the historical input data.

    Response: The Council and State conducted an extensive analysis about the appropriate index to indicate a low Chinook salmon abundance year. Low Chinook salmon abundance years are characterized by difficulty meeting escapement goals and in-river salmon fisheries being severely restricted or fully closed. Section 2.6 of the Analysis evaluates various indices and shows that the 3-System Index (Unalakleet, Upper Yukon, and Kuskokwim river systems) meets the objectives. These river systems provide a broad regional representation of stocks and signify very important river systems and subsistence fisheries in western Alaska. Subsistence harvests from these three river systems account for up to 87 percent of the statewide subsistence harvest of Chinook salmon. As shown in the Analysis, having more than one system in the index and having broad regional representation makes the index more robust. The Analysis also shows a clear natural break in the data such that index sizes less than 250,000 Chinook salmon correspond to years with historically low run sizes.

    NMFS agrees that any changes to the 3-System Index or the methods used should have a transparent review process by the Council and its SSC. Scientific methods change over time based on the best available scientific information. NMFS is committed to working with the State and the Council to define a transparent process for review of the State's 3-System Index and associated scientific methods. However, neither Amendment 110 nor the proposed rule prescribes the process to review the State's scientific methods on an ongoing basis, or that the State must use the same scientific methods that were used to develop the 3-System Index. NMFS does not prescribe scientific methods for stock assessments in Federal regulations. To do so would preclude NMFS, the Council, and the State from incorporating the best scientific information available into the stock assessment.

    In recommending Amendment 110, the Council chose a threshold of 250,000 Chinook salmon on which to determine when Chinook salmon are at low abundance. In order to change that threshold amount, the Council would need to amend the FMP and NMFS would need to amend the regulations. The process for changing the 250,000 Chinook salmon threshold would be the same as for any FMP amendment with implementing regulations.

    Comment 17: NMFS does not have the latitude to just receive and apply the State's estimate of Chinook salmon abundance from the 3-System Index without analysis to independently verify the estimates. Applying the State's estimate would constitute delegation of management to the State of vessels fishing for pollock in the exclusive economic zone, which cannot occur because the FMP does not authorize delegation to the State. The proposed rule grants the State sole authority over the annual run size estimate and does not contemplate independent verification of the estimate by NMFS. NMFS compares the estimate to the low abundance threshold fixed in the regulations to determine whether or not a year is one of low Chinook salmon abundance, which in turn determines the following year's Chinook salmon PSC limit and performance standard applicable to vessels participating in the Federal pollock fishery. That determination does not involve any discretion on the part of NMFS.

    Response: Each year, NMFS will rely on a Chinook salmon abundance estimate from the State using the established 3-System Index as the best available scientific information on Chinook salmon abundance in western Alaska. The 3-System Index was reviewed by the Council's SSC and recommended by the Council. NMFS relies on the State for this abundance estimate because the State has management authority over salmon in western Alaska and collects and analyzes the scientific data necessary to estimate Chinook salmon abundance. Relying on the State to provide this type of scientific information is not the same as delegating management authority of the pollock fishery to the State. NMFS manages, and will continue to manage, the pollock fishery. In furtherance of that effort, NMFS will use information collected by the State. Specifically, NMFS will use the 3-System Index for Chinook salmon abundance to apply the appropriate PSC limit and performance standard. The PSC limit and performance standard are the measures the Council and NMFS determined were required in low Chinook salmon abundance years to achieve the program goals. NMFS will publish the PSC limit and performance standard in the annual harvest specifications. That is clearly a management action undertaken by NMFS, and not the State.

    Under Amendment 110, it is each pollock vessel's responsibility to avoid salmon bycatch at all times. If fishery participants maintain their bycatch below their PSC limit, then these measures achieve their purpose without closing the pollock fishery. Alternatively, the Council could have recommended to permanently reduce the performance standard and PSC limit in order to achieve the goals of encouraging vessels to avoid bycatch to a greater degree in years of low abundance and reducing the risk of adverse impact on stocks in western Alaska during periods of low abundance. Instead, by using the 3-System Index, the Council recommended a reduced PSC limit and performance standard only during years of low Chinook salmon abundance.

    Comment 18: To avoid unauthorized delegation, the proposed rule should be revised to require that NMFS annually confirm that the State estimate was calculated using the Council-approved index and models from April 2015 and reproduce the estimate using the data provided by the State. These standards would address the requirement that, when a core agency function—such as PSC management—is involved, there must be Federal standards in place and a process for NMFS to review the application of those standards.

    Response: NMFS did not change this final rule in response to this comment. The Council designed, and this final rule implements, a program where the State provides NMFS an estimate of Chinook salmon abundance using the 3-System Index for western Alaska. Neither Amendment 110 nor the proposed rule constrains the State to use the methods, data sources, and models developed for Council final action in April 2015. To do so would be inconsistent with the manner in which science develops generally, and would result in an index that may fail to incorporate the best scientific information available.

    NMFS relies on the State to produce the 3-System Index annually because the State has management authority over salmon and collects and analyzes the scientific data necessary to estimate Chinook salmon abundance. While NMFS will review the 3-System Index provided each October 1, NMFS will not recalculate the State's Chinook salmon abundance estimate each year.

    Comment 19: What action would NMFS take if the State is unable to provide an estimate of Chinook salmon abundance by October 1? NMFS should not determine low abundance if the State does not timely deliver an estimate, whether because of difficulty obtaining relevant data, budget restrictions, or other reason. The final rule should specify that NMFS will not determine it is a year of low Chinook salmon abundance if the State does not provide a Chinook salmon abundance estimate by October 1. If no such determination is made, the 60,000 Chinook salmon PSC limit and 47,591 Chinook salmon performance standard would apply.

    Response: Absent a letter from the State showing Chinook salmon abundance under the 3-System Index is equal to or below the 250,000 Chinook salmon threshold, the 60,000 PSC limit and 45,591 performance standard will remain in effect. The State's reporting of the 3-System Index by October 1 is necessary to determine if it is a low Chinook salmon abundance year and to reduce the PSC limit and performance standard in the next fishing year. A change to this final rule is not necessary.

    Comment 20: Change the text of Amendment 110 to state that NMFS will verify the State's estimate of abundance and that the State must use the index approved by the Council at its April 2015 meeting.

    Response: NMFS cannot change amendment text after it has been transmitted by the Council and NMFS as published in the Notice of Availability. Under section 304(a) of the Magnuson-Stevens Act, NMFS is limited to approval, disapproval, or partial approval of a fishery management plan amendment. If NMFS disapproves or partially approves an amendment, NMFS has to notify the Council and specify the applicable law with which the amendment is inconsistent, the nature of such inconsistencies, and make recommendations to conform to applicable law. The Council may then submit a revised amendment to the Secretary of Commerce. Amendment 110 and the provision to reduce the PSC limit and performance standard are consistent with applicable law, and the commenter did not recommend disapproval or partial disapproval of Amendment 110.

    NMFS responds to the issue of verifying the State's Chinook salmon abundance index in the response to Comment 17. NMFS responds to the issue of requiring the State to use the index approved by the Council at its April 2015 meeting in the response to Comment 16.

    Comment 21: Commenters made a number of technical comments on the State's 3-System Index and the methods and models that the State used to develop the index and to generate the September 17, 2015, index estimate of 252,000 Chinook salmon.

    Response: The State can modify the 3-System Index over time to represent the best available scientific information. These comments concerning the intricacies of the State's scientific methods are important for that process. However, they are outside of the scope of Amendment 110 and this final rule.

    Comment 22: Good fisheries management calls for a reduction in salmon bycatch. The pollock fishery should be managed in a way that rewards those fishermen that successfully avoid salmon and other bycatch and reduces quota and opportunity for those fishermen that have significant salmon or other bycatch.

    Response: Amendment 110 and this final rule improve the IPAs implemented under Amendment 91 to include chum salmon avoidance measures and to increase the ability for each vessel to avoid Chinook salmon. The IPA component is an innovative approach that is designed to provide incentives for each vessel to avoid bycatch at all times with the goal of bringing bycatch to minimum achievable levels. The requirements for an IPA are performance based (i.e., they address what an IPA should accomplish); any number of different incentive plans could meet these objectives. The requirements for the IPA are performance based because fishery participants have more tools available to them to create incentives to minimize bycatch at the vessel level than could be prescribed through Federal regulation. As designed, an IPA can be more responsive and adaptive than Federal regulations. IPAs are flexible in allowing the pollock fleet to modify the IPAs as performance information becomes available to ensure that the IPAs meet the goal to provide incentives for each vessel to avoid bycatch at all times in Amendment 91 and Amendment 110.

    Additionally, this final rule requires the IPA representative to submit an annual report to the Council that is the primary tool through which the Council will evaluate whether the IPAs meet the goal for each vessel to avoid salmon bycatch at all times.

    Comment 23: Include a well thought-out plan for this Chinook salmon bycatch avoidance program and outline the possible increased incentives to achieve maximum effectiveness. Without this, the program could have little to no impact on Chinook salmon bycatch. It is ideal to have the IPA incentives visible to the public in order to have complete transparency of industry.

    Response: The Council analyzed a number of specific incentive measures in Section 3.5.3 of the Analysis. The Analysis describes the new IPA requirements implemented with this final rule and provides examples of ways the fishery participants could modify their IPAs to meet those requirements. Regulations establish the performance based requirements that each IPA must accomplish. Any number of different incentive plans could meet these regulatory requirements. The requirements for the IPA are performance based because fishery participants have more tools available to them to create incentives to minimize bycatch at the vessel level than could be prescribed through Federal regulation. As designed, an IPA can be more responsive and adaptive than Federal regulations and can use tools not available to managers, such as fees and penalties.

    Additionally, Federal regulations include a number of provisions to ensure transparency of the IPAs. First, regulations require the IPA representative to submit an annual report so the Council can evaluate whether its goals for the IPAs are being met (§ 679.21(f)(13)). Second, existing regulations require vessel owners to submit an annual economic data report to provide quantitative information so the Council can evaluate how the IPA influences a vessel's operational decisions to avoid Chinook salmon bycatch (§ 679.65). Third, this final rule adds additional requirements for IPA transparency, including a requirement that IPA representatives notify at least one third party group representing western Alaskans of closure areas and any violations of the rolling hot spot program. Finally, the final rule requires the IPA representative to describe in the IPA annual report how the IPA addresses the goals and objectives in the IPA provisions related to chum salmon (§ 679.21(f)).

    Comment 24: Research should be done on Chinook salmon bycatch in the pollock fishery to determine which stock they are from since there are some stocks where the State has limited commercial and subsistence harvests. If Chinook salmon from those stocks are being taken by the pollock fishery, then the pollock fishery should have to wait to fish until those Chinook salmon leave the areas in which pollock are taken.

    Response: NMFS conducts research on the Chinook salmon caught in the pollock fishery. Amendment 91 improved the collection of Chinook salmon information by increasing observer coverage to full coverage for all vessels and shoreside processing facilities and by requiring a census of Chinook salmon in every haul or fishing trip. NMFS also collects and analyzes scientific data and biological samples from the Chinook salmon bycatch. NMFS conducts a genetic analysis of samples from the Chinook salmon bycatch in the pollock fishery to determine the overall stock composition of the bycatch. The most recent analysis is available from the NMFS Alaska Fisheries Science Center (http://www.afsc.noaa.gov/Publications/AFSC-TM/NOAA-TM-AFSC-310.pdf).

    However, this genetic analysis takes time and the results are not available in time to delay or move the pollock fishery. Instead, the IPAs use a rolling hotspot program to provide real-time Chinook salmon bycatch information so that the fleet can avoid areas of high Chinook salmon bycatch rates. A Chinook salmon rolling hotspot program is a component of the current IPAs, however, it is not a mandatory requirement. The catcher/processor IPA and the mothership IPA have a rolling hotspot program in place throughout the year. The inshore IPA has a rolling hotspot program that can be suspended during the season. Amendment 110 and this final rule require all IPAs to have a rolling hot spot program throughout the A and B seasons. This provision also requires notifications of closure areas and any violations of the rolling hot spot program to at least one third-party group representing western Alaskans, consistent with the requirement for the chum salmon rolling hotspot program. Section 3.5.3.3 of the Analysis provides more detail on this addition to the IPA requirements (see ADDRESSES).

    Comment 25: The over allocation of pollock has ruined the livelihoods of all that depend on it for a living. A two-thirds reduction in the Bering Sea pollock TAC would increase escapement to the Yukon River system and raise the price of the pollock products. We have been giving pollock away at the expense of traditional Alaskan salmon fisheries. Everything that swims in the Bering Sea eats pollock and every fishery and northern fur seals have declined due to the over allocation of pollock.

    Response: The process for assessing and specifying the Bering Sea pollock TAC is outside the scope of this action. There is no evidence that a two-thirds reduction in the pollock TAC would measurably increase salmon escapement to the Yukon River system. While salmon bycatch in the pollock fishery may be a contributing factor in the decline of salmon, NMFS expects the numbers of the ocean bycatch that would have returned to western Alaska would be relatively small due to ocean mortality and the large number of other river systems contributing to the total Chinook or chum salmon bycatch. For Chinook salmon, Section 3.5.1 of the Analysis explains that the Chinook salmon bycatch expected to have returned to western Alaska rivers is approximately 2.3 percent of coastal western Alaska run size in recent years. For chum salmon, Section 3.5.1 of the Analysis explains that the chum salmon bycatch expected to have returned to western Alaska rivers is approximately 0.5 percent of the coastal western Alaska run size in recent years. Under Amendment 110 and this final rule, these impact rates will be reduced further as the pollock fleet improves its ability to avoid salmon at all times.

    NMFS is actively pursuing research on northern fur seals to help us understand the reasons for the decline and potential threats to the population. A description of past and ongoing research is available on the National Marine Mammal Laboratory's Web site (http://www.afsc.noaa.gov/nmml/species/species_nfs.php). The research projects investigate a broad range of topics related to fisheries interactions around the Pribilof Islands, including studies to quantify area-specific food habits and animal conditions, describe foraging behavior in different environments, delineate foraging habitats, and model habitat suitability in relation to fur seals and commercial fisheries.

    Comment 25: The Analysis did not fully describe the potential impacts to the pollock fishery under the lower PSC performance standard and limits in years of low Chinook salmon abundance. The Analysis compared the impacts only to current Chinook salmon bycatch levels and not to potential or historical levels. Little to no forgone pollock harvest was noted under any scenario. Amendment 110 and the proposed rule are a potential threat that could suspend fishing operations in one of the largest fisheries in the world. Large juvenile Chinook salmon year classes persist in the marine environment for multiple years before returning as mature fish to the river systems. Recent unpredictability in the BSAI ecosystem likely only increases the probability of constraining the pollock fishery in future years based on management decisions made today. The Analysis should have attempted to quantify the probability of the limit shutting the fishery down in a given year.

    Response: The purpose of a RIR is to analyze the potential costs and benefits associated with a regulatory change. To do so, the RIR must compare potential effects of the alternatives being considered with the regulatory status quo condition. In this case, the status quo is defined by the incentive-based Chinook salmon PSC avoidance structure established under Amendment 91. Since Amendment 91, Chinook salmon PSC has been much lower than the “potential or historical” levels the commenter presumably is referring to and these lower levels, as properly considered in the analysis, represent the regulatory status quo condition. Historically higher levels of bycatch occurred under differing regulatory conditions, do not represent status quo conditions, and are not appropriate to consider in the Analysis. Note that historical bycatch was considered in the EIS prepared for Amendment 91 (see ADDRESSES).

    Amendment 110 and this final rule provide further incentives for industry to avoid Chinook salmon PSC, particularly in years of low Chinook salmon abundance. As explained in Section 4.8.2 of the Analysis, economic analysis has demonstrated the ability of a catcher-processor fleet to adapt their behavior to reduce PSC when faced with individual vessel caps. The reduced individual vessel caps that could result under this final rule during times of low Chinook abundance in western Alaska are not intended to close the pollock fishery. They are intended to alter fishing behavior to further avoid Chinook PSC. The flexibility given to industry to self-regulate PSC avoidance, provided in Amendment 91, remains and is augmented by this rule. Thus, the probability of the limit shutting down the fishery in a given year is dependent on changes in fishing activity that are not presently known and are dependent on the actions of the fishing fleet.

    Comment 26: Revise the Regulatory Flexibility Act (RFA) analysis to determine the number of directly regulated entities that are defined as small entities without applying affiliations among directly regulated entities based on their participation in a pollock harvesting cooperative. NMFS considers a vessel owner's membership in a harvesting cooperative to be an affiliation; this shows a misunderstanding of the nature of harvesting cooperatives. Harvesting cooperatives in Alaska are not large vertically or horizontally integrated businesses. Cooperative members are joined by simple rules to help remove the race for fish by coordinating selected fishing activities, but each catcher vessel (or collection of commonly owned catcher vessels) is a distinct business unit. The fact that cooperatives coordinate harvests in a manner that allows for more complete harvest of the quota should not be interpreted as creating a single business unit in the manner intended for defining a small business that is appropriate for protection by the RFA.

    Response: When NMFS calculates the size of an entity to determine if it is a small entity, NMFS must include the annual receipts and the employees of affiliates. Affiliation is determined by the ability to control. Control may arise through ownership, management, or other relationships or interactions between the parties. When the ability to control exists, even if it is not exercised, affiliation exists. The Small Business Administration (SBA) has a specific set of rules that explain when another person, business, or entity is considered an affiliate for size purposes in its Small Business Size Regulations (13 CFR 121.103). NMFS has applied these rules in the evaluation it conducted in this RFA analysis.

    Harvesting cooperatives meet the definition of affiliation because cooperatives have the ability to control member vessels. Cooperatives are predicated on collective agreements among their members, to abide by the terms and practices set out for membership. That is, the entity formed by creation of the cooperative is, by definition, a third party that controls or has the power to control its members. Cooperatives coordinate harvests, which is operational control of the input side of the business. The small entity standard is “independently owned and operated.” Cooperative members may be independently owned but still not be considered small entities because the cooperative has enough operational control that its members are not considered to be independently operated for purposes of the definition of affiliation.

    Cooperative membership does not automatically mean an entity is large (not small). A cooperative may be a small entity if the combined annual gross receipts of all cooperative members meet the size standard used by the SBA or, after July 1, 2016, NMFS' small business size standard for RFA compliance at 50 CFR 200.2(a). For more information on NMFS' small business size standard for RFA compliance, see 80 FR 81194 (December 29, 2015). NMFS's RFA analysis to estimate the number of small entities directly regulated by this action is correct.

    Comment 27: NMFS' aggregation of cooperative member's gross earnings eliminates a fishing business's access to the benefits of SBA review and runs against the intent of the RFA.

    Response: The RFA is primarily concerned with ensuring that Federal agency decision-makers seriously and systematically consider disproportionate economic impacts on small entities that may result from their actions. To comply with the RFA, NMFS has prepared an IRFA and a FRFA following the required contents specified in the RFA. The IRFA was prepared and summarized in the “Classification” section of the preamble to the proposed rule (81 FR 5681, February 3, 2016). The FRFA is in the “Classification” section of the preamble to this final rule.

    If a specific business applies to the SBA to participate in an SBA program, the SBA conducts an independent review of that business to determine if that business qualifies as a small business for purposes of participating in an SBA program. That business must satisfy SBA's definition of a business concern, along with SBA's size standards for small businesses. The SBA does not rely on the analysis conducted by NMFS under the RFA to determine whether a particular entity satisfies SBA's definition of a small business. See https://www.sba.gov/ for more information on SBA's assessment of a small business.

    Classification

    The NMFS Assistant Administrator has determined that Amendment 110 to the FMP and this rule are necessary for the conservation and management of the groundfish fishery and that they are consistent with the Magnuson-Stevens Act and other applicable law.

    This rule has been determined to be not significant for the purposes of Executive Order (E.O.) 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 FRFA, 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 preambles to the proposed rule and this final rule serve as the small entity compliance guide. This action does not require any additional compliance from small entities that is not described in the preambles. Copies of the proposed rule and this final rule are available from the NMFS Web site at http://alaskafisheries.noaa.gov.

    Final Regulatory Flexibility Analysis

    This FRFA incorporates the IRFA, a summary of the significant issues raised by the public comments, NMFS' responses to those comments, and a summary of the analyses completed to support the action.

    Section 604 of the Regulatory Flexibility Act requires that, when an agency promulgates a final rule under section 553 of Title 5 of the U.S. Code, after being required by that section or any other law to publish a general notice of proposed rulemaking, the agency shall prepare a FRFA. 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 SBA 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, This Rule

    A statement of the need for, and objectives of, this rule is contained earlier in this preamble and is not repeated here.

    Public and Chief Counsel for Advocacy Comments on the Proposed Rule

    NMFS published a proposed rule on February 3, 2016 (81 FR 5681). An IRFA was prepared and summarized in the “Classification” section of the preamble to the proposed rule. The comment period closed on March 4, 2016. NMFS received 15 letters of public comment on the proposed rule and Amendment 110. The Chief Counsel for Advocacy of the SBA did not file any comments on the proposed rule.

    Summary of Significant Issues Raised During Public Comment

    One comment letter was received with two comments on the IRFA. These are Comment 26 and Comment 27 under Response to Comments, above. No changes were made to this rule or the RFA analysis as a result of these comments on the IRFA.

    Comment 26 disagrees with NMFS using affiliation to determine whether a member of a fishery cooperative is a small entity in the IRFA. The comment requests NMFS to revise the analysis to determine whether the vessels that are directly regulated entities under this action are small entities without applying the cooperative affiliations. We disagree because when we calculate the size of an entity to determine if it is a small entity, we must include the annual receipts and the employees of affiliates, per the Small Business Size Regulations (13 CFR 121.103).

    Comment 27 is concerned that NMFS' aggregation of a cooperative member's gross earnings eliminates a fishing business's access to the benefits of SBA review and runs against the intent of the RFA. To comply with the RFA, agencies prepare an IRFA and a FRFA following the required contents specified in the RFA. NMFS has complied with the RFA for this action. NMFS has prepared an IRFA and a FRFA following the required contents specified in the RFA. If a specific business applies to the SBA to participate in an SBA program, the SBA conducts an independent review of that business to determine if that business qualifies as a small business for purposes of participating in an SBA program. That business must satisfy SBA's definition of a business concern, along with SBA's size standards for small businesses. The SBA does not rely on the analysis conducted by NMFS under the RFA to determine whether a particular entity satisfies SBA's definition of a small business.

    Number and Description of Directly Regulated Small Entities

    The action directly regulates those entities that participate in the directed pollock trawl fishery in the Bering Sea. These entities include vessels harvesting pollock under the AFA and the six CDQ groups that receive allocations of pollock.

    The SBA requires consideration of affiliations among entities for the purpose of assessing if an entity is small. The AFA pollock cooperatives are a type of affiliation. All the non-CDQ entities directly regulated by this action are members of AFA cooperatives and, therefore, NMFS considers them “affiliated” large (non-small) entities for RFA purposes. AFA cooperatives have gross annual revenues that are substantially greater than $20.5 million, the standard used by the SBA to define the annual gross revenue of a large (non-small) business engaged in finfish harvesting, such as pollock. Therefore, all the non-CDQ pollock fishery participants are defined as large (non-small) entities.

    Due to their status as non-profit corporations, the six CDQ groups are identified as “small” entities for RFA purposes. This action directly regulates the six CDQ groups. As described in regulations implementing the RFA (13 CFR 121.103), the CDQ groups' affiliations with other large entities do not define them as large entities.

    The six CDQ groups, formed to manage and administer the CDQ allocations, investments, and economic development projects, are the Aleutian Pribilof Island Community Development Association, the Bristol Bay Economic Development Corporation, the Central Bering Sea Fishermen's Association, the Coastal Villages Region Fund, the Norton Sound Economic Development Corporation, and the Yukon Delta Fisheries Development Association. The 65 communities, with approximately 27,000 total residents, that benefit from participation in the CDQ Program are not directly regulated by this action.

    Recordkeeping, Reporting, and Other Compliance Requirements

    This final rule revises some existing requirements and removes some requirements. The revised requirements are those related to—

    • Development and submission of proposed IPAs and amendments to approved IPAs;

    • An annual report from the participants in each IPA, documenting information and data relevant to the Bering Sea Chinook salmon bycatch management program; and

    • Salmon handling and storage on board a vessel, and obligations to facilitate observer data reporting.

    This final rule removes the requirements for an application form for a proposed IPA or amended IPA.

    Description of Significant Alternatives Considered to the Final Action That Minimize Adverse Impacts on Small Entities

    This action is a comprehensive program to minimize Chinook salmon and chum salmon bycatch in a manner that accomplishes the stated objectives and is consistent with applicable statutes. No alternatives were identified in addition to those analyzed in the IRFA that had the potential to further reduce the economic burden on small entities, while achieving the objectives of this action. Section 2.10 of the Analysis discusses alternatives considered and eliminated from detailed analysis (see ADDRESSES).

    This final rule includes performance standards to minimize Chinook salmon and chum salmon bycatch, while limiting the burden on CDQ groups. A system of transferable PSC allocations and a performance standard, even in years of low Chinook salmon abundance, will allow CDQ groups to decide how best to comply with the requirements of this action, given the other constraints imposed on the pollock fishery (e.g., pollock TAC, market conditions, area closures associated with other rules, gear restrictions, climate and oceanographic change).

    Based on the best available scientific data and information, none of the alternatives except the preferred alternative have the potential to accomplish the stated objectives of the Magnuson-Stevens Act and other applicable statutes (as reflected in this action), while minimizing any significant adverse economic impact on small entities.

    Tribal Summary Impact Statement (E.O. 13175)

    E.O. 13175 of November 6, 2000 (25 U.S.C. 450 note), the Executive Memorandum of April 29, 1994 (25 U.S.C. 450 note), the American Indian and Alaska Native Policy of the U.S. Department of Commerce (March 30, 1995), and the Tribal Consultation and Coordination Policy of the U.S. Department of Commerce (May 21, 2013), outline the responsibilities of NMFS in matters affecting tribal interests. Section 161 of Public Law 108-199 (188 Stat. 452), as amended by section 518 of Public Law 108-447 (118 Stat. 3267), extends the consultation requirements of E.O. 13175 to Alaska Native corporations. Under the E.O. and agency policies, NMFS must ensure meaningful and timely input by tribal officials and representatives of Alaska Native corporations in the development of regulatory policies that have tribal implications.

    Section 5(b)(2)(B) of E.O. 13175 requires NMFS to prepare a tribal summary impact statement as part of the final rule. This statement must contain (1) a description of the extent of the agency's prior consultation with tribal officials, (2) a summary of the nature of their concerns, (3) the agency's position supporting the need to issue the regulation, and (4) a statement of the extent to which the concerns of tribal officials have been met.

    A Description of the Extent of the Agency's Prior Consultation With Tribal Officials

    The consultation process for this action began during the Council process when the Council started developing Amendment 110 in 2012. A number of tribal representatives and tribal organizations provided written public comments and oral public testimony to the Council during Council outreach meetings on Amendment 110 and at the numerous Council meetings at which Amendment 110 was discussed.

    NMFS conducted two tribal consultations, one in December 2014 and one in April 2015, with representatives from the Tanana Chiefs Conference; the Association of Village Council Presidents; the Yukon River Drainage Fisheries Association; the Kawerak, Inc.; and the Bering Sea Fishermen's Association. These organizations prepared letters for the Council and requested the consultations to discuss the salmon bycatch management measures under consideration by the Council. NMFS posted reports from these consultations on the NMFS Alaska Region Web site at https://alaskafisheries.noaa.gov/tribal-consultations.

    NMFS continued the consultation process by sending a letter to Alaska tribal governments, Alaska Native corporations, and related organizations (“Alaska Native representatives”) when the Notice of Availability for Amendment 110 published in the Federal Register in March 2016. The letter included a copy of the Notice of Availability and notified representatives of the opportunity to comment and consult. NMFS received 4 letters of comment on Amendment 110 and the proposed rule from tribal members and representatives of tribal governments, tribal organizations, or Alaska Native corporations. The comment summaries and NMFS' responses are provided in this preamble under Response to Comments and are summarized below.

    A Summary of the Nature of Tribal Concerns

    The concerns expressed in consultations and reflected in written comments from tribal representatives and members center on four themes. First, Chinook salmon is vitally important to tribal members, and they suffer great hardships when Chinook salmon abundance is low. Second, tribal representatives attribute low Chinook salmon in-river returns directly to bycatch in the Bering Sea pollock fishery. Third, tribal members want Chinook salmon bycatch greatly curtailed. Fourth, NMFS should exercise its trust responsibilities by advocating for Alaska native interests on the Council.

    The comment letter from Tanana Chiefs Conference; the Association of Village Council Presidents; the Yukon River Drainage Fisheries Association; the Kawerak, Inc.; and the Bering Sea Fishermen's Association supported Amendment 110 and the implementing regulations as an important step in further reducing salmon bycatch but urged NMFS and the pollock industry to continue working towards greater bycatch reduction, with an ultimate goal of zero bycatch. In particular, these comments support the provision to reduce the PSC limit and performance standard in years of low Chinook salmon abundance in western Alaska as critical to ensuring Chinook salmon bycatch is reduced in the years when every source of mortality must be reduced.

    The comment from the Native Village of Kotzebue expressed concern that although Amendment 110 is going in the right direction towards zero salmon bycatch, the bycatch limits are still too high.

    The comment from Ahtna, Incorporated, encourages the Secretary of Commerce to take all reasonable measures to reduce Chinook salmon bycatch in the Bering Sea and Gulf of Alaska.

    The comment from the Aleut Corporation supports Amendment 110, but is strongly opposed to the provision to reduce the PSC limit and performance standard in low Chinook salmon abundance years because it is unwarranted, unnecessary, not sound science, and not responsible management. The Aleut Corporation believes this provision unfairly restricts the pollock fishery when science has shown that there is not a relationship between salmon bycatch and the size of the salmon runs in coastal western Alaska.

    NMFS' Position Supporting the Need To Issue the Regulation

    This final rule is needed to implement Amendment 110, a complex and innovative program to minimize salmon bycatch to the extent practicable in the pollock fishery. This final rule is also needed to create a comprehensive salmon bycatch avoidance program that works more effectively than the current salmon bycatch programs to avoid Chinook salmon bycatch and Alaska-origin chum salmon bycatch. The Council and NMFS recognize that salmon are an extremely important resource to Native Alaskans who depend on local fisheries for their sustenance and livelihood.

    Amendment 110 and this final rule adjust the existing Chinook salmon bycatch program to, among other things, incorporate revised chum salmon bycatch measures into the existing IPAs. Amendment 110 and this final rule are designed to consider the importance of continued production of critical chum salmon runs in western Alaska by focusing on bycatch avoidance of Alaskan chum salmon runs. These runs have substantial variation in run sizes over time, and are of historic importance in the subsistence lifestyle of Native Alaskans. Additional protections to other chum stocks from outside of Alaska are embedded in the objective to avoid the high bycatch of chum salmon overall, recognizing that most non-Alaska chum salmon are likely from Asian hatcheries.

    In addition, the Council and NMFS sought to provide greater incentives to avoid Chinook salmon by strengthening incentives during times of historically low Chinook salmon abundance in western Alaska. Thus, the management measures included in Amendment 110 focus on retaining the incentives to avoid Chinook salmon bycatch at all levels of abundance as intended by Amendment 91. Multiple years of historically low Chinook salmon abundance have resulted in significant restrictions for subsistence users in western Alaska and failure to achieve conservation objectives. While Chinook salmon bycatch impact rates have been low under Amendment 91, the Council and NMFS have determined that there is evidence that improvements could be made to ensure the program is reducing Chinook salmon bycatch at low levels of salmon abundance.

    A Statement of the Extent to Which the Concerns of Tribal Officials Have Been Met

    One of the primary factors in initiating this action was concern over the potential impacts of Chinook salmon and chum salmon bycatch in the Bering Sea pollock fishery on the return of these salmon to western Alaska river systems and the recognition of the importance of salmon to the people in western Alaska. While the final program is not as restrictive on the pollock fishery as advocated by some Alaska Native representatives, it will minimize salmon bycatch to the extent practicable.

    Collection-of-Information Requirements

    This rule contains collection-of-information requirements subject the Paperwork Reduction Act (PRA) and which have been approved by OMB. The collections are listed below by OMB control number.

    OMB Control Number 0648-0731

    Public reporting burden is estimated to average 5 minutes per individual response for use of a vessel's computer, software, and data transmission; 5 minutes per individual response for notification of observer before handling the vessel's Bering Sea pollock catch; and 5 minutes for notification of crew person responsible for ensuring all sorting, retention, and storage of salmon.

    OMB Control Number 0648-0393

    Public reporting burden is estimated to average 8 hours per individual response for the Application to Receive Transferable Chinook Salmon PSC Allocations, including the contract; 4 hours for the amendment to the contract; and 15 minutes for the Application for the Transfer of Chinook Salmon PSC Allocations.

    OMB Control Number 0648-0401

    Public reporting burden is estimated to average 40 hours per individual response for the Salmon Bycatch IPA; and 8 hours for the IPA Annual Report.

    Public reporting burden includes 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 on this data collection, including suggestions for reducing the burden, to NMFS Alaska Region (see ADDRESSES), or 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, nor shall any person be subject to a 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, Recordkeeping and reporting requirements.

    Dated: June 2, 2016. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, NMFS amends 50 CFR part 679 as follows:

    PART 679—FISHERIES OF THE EXCLUSIVE ECONOMIC ZONE OFF ALASKA 1. The authority citation for 50 CFR part 679 continues to read as follows: Authority:

    16 U.S.C. 773 et seq.; 1801 et seq.; 3631 et seq.; Public Law 108-447; Public Law 111-281.

    2. In § 679.2: a. Remove the definitions for “Chinook salmon bycatch incentive plan agreement (IPA)”; b. Revise the definitions for “Chum Salmon Savings Area of the BSAI CVOA”, and paragraph (6) of “Fishing trip”; c. Remove the definition for “Non-Chinook salmon bycatch reduction intercooperative agreement (ICA)”; and d. Add a definition for “Salmon bycatch incentive plan agreement (IPA)” in alphabetical order to read as follows:
    § 679.2 Definitions.

    Chum Salmon Savings Area of the BSAI CVOA (See § 679.21(f)(14) and Figure 9 to this part).

    Fishing trip means: * * *

    (6) For purposes of § 679.7(d)(5)(ii)(C)(2) for CDQ groups and § 679.7(k)(8)(ii) for AFA entities, the period beginning when a vessel operator commences harvesting any pollock that will accrue against a directed fishing allowance for pollock in the BS or against a pollock CDQ allocation harvested in the BS and ending when the vessel operator offloads or transfers any processed or unprocessed pollock from that vessel.

    Salmon bycatch incentive plan agreement (IPA) is a voluntary private contract, approved by NMFS under § 679.21(f)(12), that establishes incentives for participants to avoid Chinook salmon and chum salmon bycatch while directed fishing for pollock in the BS.

    3. In § 679.7: a. Revise paragraphs (d)(5)(ii)(B), (d)(5)(ii)(C)(5), and the paragraph (k)(8) heading; b. Redesignate paragraph (k)(8)(iv) as (k)(8)(v); and c. Add new paragraph (k)(8)(iv).

    The revisions and addition read as follows:

    § 679.7 Prohibitions.

    (d) * * *

    (5) * * *

    (ii) * * *

    (B) Non-Chinook salmon. For the operator of a vessel, to use trawl gear to harvest pollock CDQ in the Chum Salmon Savings Area between September 1 and October 14 after the CDQ group's non-Chinook salmon PSQ is attained, unless the vessel is participating in an approved IPA under § 679.21(f)(12).

    (C) * * *

    (5) For the operator of a catcher vessel delivering pollock CDQ catch to a shoreside processor or stationary floating processor to:

    (i) Deliver pollock CDQ to a processor that does not have a catch monitoring and control plan approved under § 679.28(g).

    (ii) Handle, sort, or discard catch without notifying the observer 15 minutes prior to handling, sorting, or discarding catch as described in § 679.21(f)(15)(ii)(B)(2).

    (iii) Fail to secure catch after the completion of catch handling and the collection of scientific data and biological samples as described in § 679.21(f)(15)(ii)(B)(3).

    (k) * * *

    (8) Salmon PSC.

    (iv) Catcher vessels. (A) For the operator of a catcher vessel, to handle, sort, or discard catch without notifying the observer 15 minutes prior to handling, sorting, or discarding catch as described in § 679.21(f)(15)(ii)(B)(2).

    (B) For the operator of a catcher vessel to fail to secure catch after the completion of catch handling and the collection of scientific data and biological samples as described in § 679.21(f)(15)(ii)(B)(3).

    4. In § 679.20, revise paragraph (a)(5)(i)(B)(1) to read as follows:
    § 679.20 General limitations.

    (a) * * *

    (5) * * *

    (i) * * *

    (B) * * *

    (1) Inshore, catcher/processor, mothership, and CDQ sectors. The portions of the BS subarea pollock directed fishing allowances allocated to each sector under sections 206(a) and 206(b) of the AFA and the CDQ allowance in the BSAI will be divided into two seasonal allowances corresponding to the two fishing seasons set out at § 679.23(e)(2), as follows:

    (i) A Season, 45 percent;

    (ii) B Season, 55 percent.

    5. In § 679.21: a. Remove and reserve paragraph (c); b. Revise the paragraph (e) heading; c. Remove paragraphs (e)(1)(vi) through (viii), (e)(3)(i)(A)(3), and (e)(7)(vii) through (ix); and d. Revise paragraphs (f) and (g).

    The revisions read as follows:

    § 679.21 Prohibited species bycatch management.

    (e) BSAI PSC limits for crab and herring. * * *

    (f) Salmon Bycatch Management in the BS Pollock Fishery—(1) Applicability. This paragraph contains regulations governing the bycatch of salmon in the BS pollock fishery.

    (2) Chinook salmon prohibited species catch (PSC) limit. Each year, NMFS will allocate to AFA sectors listed in paragraph (f)(3)(ii) of this section a portion of the applicable Chinook salmon PSC limit. NMFS will publish the applicable Chinook salmon PSC limit in the annual harvest specifications after determining if it is a low Chinook salmon abundance year. NMFS will determine that it is a low Chinook salmon abundance year when abundance of Chinook salmon in western Alaska is less than or equal to 250,000 Chinook salmon. By October 1 of each year, the State of Alaska will provide to NMFS an estimate of Chinook salmon abundance using the 3-System Index for western Alaska based on the Kuskokwim, Unalakleet, and Upper Yukon aggregate stock grouping.

    (i) An AFA sector will receive a portion of the 47,591 Chinook salmon PSC limit, or, in a low Chinook salmon abundance year, the 33,318 Chinook salmon PSC limit, if —

    (A) No Chinook salmon bycatch incentive plan agreement (IPA) is approved by NMFS under paragraph (f)(12) of this section; or

    (B) That AFA sector has exceeded its performance standard under paragraph (f)(6) of this section.

    (ii) An AFA sector will receive a portion of the 60,000 Chinook salmon PSC limit, or, in a low Chinook salmon abundance year, the 45,000 Chinook salmon PSC limit, if—

    (A) At least one IPA is approved by NMFS under paragraph (f)(12) of this section; and

    (B) That AFA sector has not exceeded its performance standard under paragraph (f)(6) of this section.

    (3) Allocations of the Chinook salmon PSC limits—(i) Seasonal apportionment. NMFS will apportion the Chinook salmon PSC limits annually 70 percent to the A season and 30 percent to the B season, which are described in § 679.23(e)(2).

    (ii) AFA sectors. Each year, NMFS will make allocations of the applicable Chinook salmon PSC limit to the following four AFA sectors:

    AFA Sector: Eligible participants are: (A) Catcher/processor AFA catcher/processors and AFA catcher vessels delivering to AFA catcher/processors, all of which are permitted under § 679.4(l)(2) and (l)(3)(i)(A), respectively. (B) Mothership AFA catcher vessels harvesting pollock for processing by AFA motherships, all of which are permitted under § 679.4(l)(3)(i)(B) and (l)(4), respectively. (C) Inshore AFA catcher vessels harvesting pollock for processing by AFA inshore processors, all of which are permitted under § 679.4(l)(3)(i)(C). (D) CDQ Program The six CDQ groups authorized under section 305(i)(1)(D) of the Magnuson-Stevens Act to participate in the CDQ Program.

    (iii) Allocations to each AFA sector. NMFS will allocate the Chinook salmon PSC limits to each AFA sector as follows:

    (A) If a sector is managed under the 60,000 Chinook salmon PSC limit, the maximum amount of Chinook salmon PSC allocated to each sector in each season and annually is—

    AFA sector A season % Allocation # of Chinook B season % Allocation # of Chinook Annual total % Allocation # of Chinook (1) Catcher/processor 32.9 13,818 17.9 3,222 28.4 17,040 (2) Mothership 8.0 3,360 7.3 1,314 7.8 4,674 (3) Inshore 49.8 20,916 69.3 12,474 55.6 33,390 (4) CDQ Program 9.3 3,906 5.5 990 8.2 4,896

    (B) If the sector is managed under the 45,000 Chinook salmon PSC limit, the sector will be allocated the following amount of Chinook salmon PSC in each season and annually:

    AFA sector A season % Allocation # of Chinook B season % Allocation # of Chinook Annual total % Allocation # of Chinook (1) Catcher/processor 32.9 10,363 17.9 2,415 28.4 12,780 (2) Mothership 8.0 2,520 7.3 987 7.8 3,510 (3) Inshore 49.8 15,687 69.3 9,355 55.6 25,020 (4) CDQ Program 9.3 2,930 5.5 743 8.2 3,690

    (C) If the sector is managed under the 47,591 Chinook salmon PSC limit, the sector will be allocated the following amount of Chinook salmon PSC in each season and annually:

    AFA sector A season % Allocation # of Chinook B season % Allocation # of Chinook Annual total % Allocation # of Chinook (1) Catcher/processor 32.9 10,906 17.9 2,556 28.4 13,516 (2) Mothership 8.0 2,665 7.3 1,042 7.8 3,707 (3) Inshore 49.8 16,591 69.3 9,894 55.6 26,485 (4) CDQ Program 9.3 3,098 5.5 785 8.2 3,883

    (D) If the sector is managed under the 33,318 Chinook salmon PSC limit, the sector will be allocated the following amount of Chinook salmon PSC in each season and annually:

    AFA sector A season % Allocation # of Chinook B season % Allocation # of Chinook Annual total % Allocation # of Chinook (1) Catcher/processor 32.9 7,673 17.9 1,789 28.4 9,462 (2) Mothership 8.0 1,866 7.3 730 7.8 2,599 (3) Inshore 49.8 11,615 69.3 6,926 55.6 18,525 (4) CDQ Program 9.3 2,169 5.5 550 8.2 2,732

    (iv) Allocations to the AFA catcher/processor and mothership sectors. (A) NMFS will issue transferable Chinook salmon PSC allocations under paragraph (f)(3)(iii) of this section to entities representing the AFA catcher/processor sector and the AFA mothership sector if these sectors meet the requirements of paragraph (f)(8) of this section.

    (B) If no entity is approved by NMFS to represent the AFA catcher/processor sector or the AFA mothership sector, then NMFS will manage that sector under a non-transferable Chinook salmon PSC allocation under paragraph (f)(10) of this section.

    (v) Allocations to inshore cooperatives and the AFA inshore open access fishery. NMFS will further allocate the inshore sector's Chinook salmon PSC allocation under paragraph (f)(3)(iii) of this section among the inshore cooperatives and the inshore open access fishery based on the percentage allocations of pollock to each inshore cooperative under § 679.62(a). NMFS will issue transferable Chinook salmon PSC allocations to inshore cooperatives. Any Chinook salmon PSC allocated to the inshore open access fishery will be as a non-transferable allocation managed by NMFS under the requirements of paragraph (f)(10) of this section.

    (vi) Allocations to the CDQ Program. NMFS will further allocate the Chinook salmon PSC allocation to the CDQ Program under paragraph (f)(3)(iii) of this section among the six CDQ groups based on each CDQ group's percentage of the CDQ Program pollock allocation. NMFS will issue transferable Chinook salmon PSC allocations to CDQ groups.

    (vii) Accrual of Chinook salmon bycatch to specific PSC allocations.

    If a Chinook salmon PSC allocation is: Then all Chinook salmon bycatch: (A) A transferable allocation to a sector-level entity, inshore cooperative, or CDQ group under paragraph (f)(8) of this section By any vessel fishing under a transferable allocation will accrue against the allocation to the entity representing that vessel. (B) A non-transferable allocation to a sector or the inshore open access fishery under paragraph (f)(10) of this section By any vessel fishing under a non-transferable allocation will accrue against the allocation established for the sector or inshore open access fishery, whichever is applicable. (C) The opt-out allocation under paragraph (f)(5) of this section By any vessel fishing under the opt-out allocation will accrue against the opt-out allocation.

    (viii) Public release of Chinook salmon PSC information. For each year, NMFS will release to the public and publish on the NMFS Alaska Region Web site (http://alaskafisheries.noaa.gov/):

    (A) The Chinook salmon PSC allocations for each entity receiving a transferable allocation;

    (B) The non-transferable Chinook salmon PSC allocations;

    (C) The vessels fishing under each transferable or non-transferable allocation;

    (D) The amount of Chinook salmon bycatch that accrues towards each transferable or non-transferable allocation;

    (E) Any changes to these allocations due to transfers under paragraph (f)(9) of this section, rollovers under paragraph (f)(11) of this section, and deductions from the B season non-transferable allocations under paragraphs (f)(5)(v) or (f)(10)(iii) of this section; and

    (F) Tables for each sector that provide the percent of the sector's pollock allocation, numbers of Chinook salmon associated with each vessel in the sector used to calculate the opt-out allocation and annual threshold amounts, and the percent of the pollock allocation associated with each vessel that NMFS will use to calculate IPA minimum participation assigned to each vessel.

    (4) Reduction in allocations of the Chinook salmon PSC limit—(i) Reduction in sector allocations. NMFS will reduce the seasonal allocation of the Chinook salmon PSC limit to the catcher/processor sector, the mothership sector, the inshore sector, or the CDQ Program under paragraph (f)(3)(iii)(A) or (B) of this section, if the owner of any permitted AFA vessel in that sector, or any CDQ group, does not participate in an approved IPA under paragraph (f)(12) of this section. NMFS will subtract the amount of Chinook salmon from each sector's allocation associated with each vessel not participating in an approved IPA.

    (ii) Adjustments to the inshore sector and inshore cooperative allocations. (A) If some members of an inshore cooperative do not participate in an approved IPA, NMFS will reduce the allocation to the cooperative to which those vessels belong, or the inshore open access fishery.

    (B) If all members of an inshore cooperative do not participate in an approved IPA, the amount of Chinook salmon that remains in the inshore sector's allocation, after subtracting the amount of Chinook salmon associated with the non-participating inshore cooperative, will be reallocated among the inshore cooperatives participating in an approved IPA based on the proportion each participating cooperative represents of the Chinook salmon PSC initially allocated among the participating inshore cooperatives that year.

    (iii) Adjustment to CDQ group allocations. If a CDQ group does not participate in an approved IPA, the amount of Chinook salmon that remains in the CDQ Program's allocation, after subtracting the amount of Chinook salmon associated with the non-participating CDQ group, will be reallocated among the CDQ groups participating in an approved IPA based on the proportion each participating CDQ group represents of the Chinook salmon PSC initially allocated among the participating CDQ groups that year.

    (iv) All members of a sector do not participate in an approved IPA. If all members of a sector do not participate in an approved IPA, the amount of Chinook salmon that remains after subtracting the amount of Chinook salmon associated with the non-participating sector will not be reallocated among the sectors that have members participating in an approved IPA. This portion of the PSC limit will remain unallocated for that year.

    (5) Chinook salmon PSC opt-out allocation. The following table describes requirements for the opt-out allocation:

    (i) What is the amount of Chinook salmon PSC that will be allocated to the opt-out allocation in the A season and the B season? The opt-out allocation will equal the sum of the Chinook salmon PSC deducted under paragraph (f)(4)(i) of this section from the seasonal allocations of each sector with members not participating in an approved IPA. (ii) Which participants will be managed under the opt-out allocation? Any AFA-permitted vessel or any CDQ group that is a member of a sector eligible under paragraph (f)(2)(ii) of this section to receive allocations of the 60,000 PSC limit or the 45,000 PSC limit, but that is not participating in an approved IPA. (iii) What Chinook salmon bycatch will accrue against the opt-out allocation? All Chinook salmon bycatch by participants under paragraph (f)(5)(ii) of this section. (iv) How will the opt-out allocation be managed? All participants under paragraph (f)(5)(ii) of this section will be managed as a group under the seasonal opt-out allocations. If the Regional Administrator determines that the seasonal opt-out allocation will be reached, NMFS will publish a notice in the Federal Register closing directed fishing for pollock in the BS, for the remainder of the season, for all vessels fishing under the opt-out allocation. (v) What will happen if Chinook salmon bycatch by vessels fishing under the opt-out allocation exceeds the amount allocated to the A season opt-out allocation? NMFS will deduct from the B season opt-out allocation any Chinook salmon bycatch in the A season that exceeds the A season opt-out allocation. (vi) What will happen if Chinook salmon bycatch by vessels fishing under the opt-out allocation is less than the amount allocated to the A season opt-out allocation? If Chinook salmon bycatch by vessels fishing under the opt-out allocation in the A season is less than the amount allocated to the opt-out allocation in the A season, this amount of Chinook salmon will not be added to the B season opt-out allocation. (vii) Is Chinook salmon PSC allocated to the opt-out allocation transferable? No. Chinook salmon PSC allocated to the opt-out allocation is not transferable.

    (6) Chinook salmon bycatch performance standard. If the total annual Chinook salmon bycatch by the members of a sector participating in an approved IPA is greater than that sector's annual threshold amount of Chinook salmon in any three of seven consecutive years, that sector will receive an allocation of Chinook salmon under the 47,591 PSC limit in all future years, except in low Chinook salmon abundance years when that sector will receive an allocation under the 33,318 Chinook salmon PSC limit.

    (i) Annual threshold amount. Prior to each year, NMFS will calculate each sector's annual threshold amount. NMFS will post the annual threshold amount for each sector on the NMFS Alaska Region Web site (http://alaskafisheries.noaa.gov/). At the end of each year, NMFS will evaluate the Chinook salmon bycatch by all IPA participants in each sector against that sector's annual threshold amount.

    (ii) Calculation of the annual threshold amount. A sector's annual threshold amount is the annual number of Chinook salmon that would be allocated to that sector under the 47,591 Chinook salmon PSC limit, as shown in the table in paragraph (f)(3)(iii)(C) of this section, or the 33,318 Chinook salmon PSC limit in low Chinook salmon abundance years, as shown in the table in paragraph (f)(3)(iii)(D) of this section. If any vessels in a sector do not participate in an approved IPA, NMFS will reduce that sector's annual threshold amount by the number of Chinook salmon associated with each vessel not participating in an approved IPA. If any CDQ groups do not participate in an approved IPA, NMFS will reduce the CDQ Program's annual threshold amount by the number of Chinook salmon associated with each CDQ group not participating in an approved IPA.

    (iii) Exceeding the performance standard. If NMFS determines that a sector has exceeded its performance standard by exceeding its annual threshold amount in any three of seven consecutive years, NMFS will issue a notification in the Federal Register that the sector has exceeded its performance standard. In all subsequent years, NMFS will allocate to that sector either the amount of Chinook salmon in the table in paragraph (f)(3)(iii)(C) of this section or, in low Chinook salmon abundance years, the amount of Chinook salmon in the table in paragraph (f)(3)(iii)(D) of this section. All members of the affected sector will fish under this lower PSC allocation regardless of whether a vessel or CDQ group within that sector participates in an approved IPA.

    (7) Replacement vessels. If an AFA-permitted vessel is no longer eligible to participate in the BS pollock fishery or if a vessel replaces a currently eligible vessel, NMFS will assign the portion and number of Chinook salmon associated with that vessel to the replacement vessel or distribute it among other eligible vessels in the sector based on the procedures in the law, regulation, or private contract that accomplishes the vessel removal or replacement action.

    (8) Entities eligible to receive transferable Chinook salmon PSC allocations. (i) NMFS will issue transferable Chinook salmon PSC allocations to the following entities, if these entities meet all the applicable requirements of this section.

    (A) Inshore cooperatives. NMFS will issue transferable Chinook salmon PSC allocations to the inshore cooperatives permitted annually under § 679.4(l)(6). The representative and agent for service of process (see definition at § 679.2) for an inshore cooperative is the cooperative representative identified in the application for an inshore cooperative fishing permit issued under § 679.4(l)(6), unless the inshore cooperative representative notifies NMFS in writing that a different person will act as its agent for service of process for purposes of this paragraph (f). An inshore cooperative is not required to submit an application under paragraph (f)(8)(ii) of this section to receive a transferable Chinook salmon PSC allocation.

    (B) CDQ groups. NMFS will issue transferable Chinook salmon PSC allocations to the CDQ groups. The representative and agent for service of process for a CDQ group is the chief executive officer of the CDQ group, unless the chief executive officer notifies NMFS in writing that a different person will act as its agent for service of process. A CDQ group is not required to submit an application under paragraph (f)(8)(ii) of this section to receive a transferable Chinook salmon PSC allocation.

    (C) Entity representing the AFA catcher/processor sector. NMFS will authorize only one entity to represent the catcher/processor sector for purposes of receiving and managing transferable Chinook salmon PSC allocations on behalf of the catcher/processors eligible to fish under transferable Chinook salmon PSC allocations. NMFS will issue transferable Chinook salmon allocations under the Chinook salmon PSC limit to the entity representing the catcher/processor sector if that entity represents all the owners of AFA-permitted vessels in this sector that are participants in an approved IPA.

    (D) Entity representing the AFA mothership sector. NMFS will authorize only one entity to represent the mothership sector for purposes of receiving and managing transferable Chinook salmon PSC allocations on behalf of the vessels eligible to fish under transferable Chinook salmon PSC allocations. NMFS will issue transferable Chinook salmon allocations under the Chinook salmon PSC limit to an entity representing the mothership sector if that entity represents all the owners of AFA-permitted vessels in this sector that are participants in an approved IPA.

    (ii) Request for approval as an entity eligible to receive transferable Chinook salmon PSC allocations. A representative of an entity representing the catcher/processor sector or the mothership sector may request approval by NMFS to receive transferable Chinook salmon PSC allocations on behalf of the members of the sector. The application must be submitted to NMFS at the address in paragraph (b)(6) of this section. A completed application consists of the application form and a contract, described below.

    (A) Application form. The applicant must submit a paper copy of the application form with all information fields accurately filled in, including the affidavit affirming that each eligible vessel owner, from whom the applicant received written notification requesting to join the sector entity, has been allowed to join the sector entity subject to the same terms and conditions that have been agreed on by, and are applicable to, all other parties to the sector entity. The application form is available on the NMFS Alaska Region Web site (http://alaskafisheries.noaa.gov/) or from NMFS at the address in paragraph (b)(6) of this section.

    (B) Contract. A contract containing the following information must be attached to the completed application form:

    (1) Information that documents that all vessel owners party to the contract agree that the entity, the entity's representative, and the entity's agent for service of process named in the application form represent them for purposes of receiving transferable Chinook salmon PSC allocations.

    (2) A statement that the entity's representative and agent for service of process are authorized to act on behalf of the vessel owners party to the contract.

    (3) Signatures, printed names, and date of signature for the owners of each AFA-permitted vessel identified in the application form.

    (C) Contract duration. Once submitted, the contract attached to the application form is valid until amended or terminated by the parties to the contract.

    (D) Deadline. An application form and contract must be received by NMFS no later than 1700 hours, A.l.t., on October 1 of the year prior to the year for which the Chinook salmon PSC allocations are effective.

    (E) Approval. If more than one entity application form is submitted to NMFS, NMFS will approve the application form for the entity that represents the most eligible vessel owners in the sector.

    (F) Amendments to the sector entity. (1) An amendment to the sector entity contract, with no change in entity participants, may be submitted to NMFS at any time and is effective upon written notification of approval by NMFS to the entity representative. To amend a contract, the entity representative must submit a complete application, as described in paragraph (f)(8)(ii) of this section.

    (2) To make additions or deletions to the vessel owners represented by the entity for the next year, the entity representative must submit a complete application, as described in paragraph (f)(8)(ii) of this section, by December 1.

    (iii) Entity representative. (A) The entity's representative must —

    (1) Act as the primary contact person for NMFS on issues relating to the operation of the entity;

    (2) Submit on behalf of the entity any applications required for the entity to receive a transferable Chinook salmon PSC allocation and to transfer some or all of that allocation to and from other entities eligible to receive transfers of Chinook salmon PSC allocations;

    (3) Ensure that an agent for service of process is designated by the entity; and

    (4) Ensure that NMFS is notified if a substitute agent for service of process is designated. Notification must include the name, address, and telephone number of the substitute agent in the event the previously designated agent is no longer capable of accepting service on behalf of the entity or its members within the 5-year period from the time the agent is identified in the application to NMFS under paragraph (f)(8)(ii) of this section.

    (B) Any vessel owner that is a member of an inshore cooperative, or a member of the entity that represents the catcher/processor sector or the mothership sector, may authorize the entity representative to sign a proposed IPA submitted to NMFS, under paragraph (f)(12) of this section, on his or her behalf. This authorization must be included in the contract submitted to NMFS, under paragraph (f)(8)(ii)(B) of this section, for the sector-level entities and in the contract submitted annually to NMFS by inshore cooperatives under § 679.61(d).

    (iv) Agent for service of process. The entity's agent for service of process must—

    (A) Be authorized to receive and respond to any legal process issued in the United States with respect to all owners and operators of vessels that are members of an entity receiving a transferable allocation of Chinook salmon PSC or with respect to a CDQ group. Service on or notice to the entity's appointed agent constitutes service on or notice to all members of the entity.

    (B) Be capable of accepting service on behalf of the entity until December 31 of the year five years after the calendar year for which the entity notified the Regional Administrator of the identity of the agent.

    (v) Absent a catcher/processor sector or mothership sector entity. If the catcher/processor sector or the mothership sector does not form an entity to receive a transferable allocation of Chinook salmon PSC, the sector will be managed by NMFS under a non-transferable allocation of Chinook salmon PSC under paragraph (f)(10) of this section.

    (9) Transfers of Chinook salmon PSC. (i) A Chinook salmon PSC allocation issued to eligible entities under paragraph (f)(8)(i) of this section may be transferred to any other entity receiving a transferable allocation of Chinook salmon PSC by submitting to NMFS an application for transfer described in paragraph (f)(9)(iii) of this section. Transfers of Chinook salmon PSC allocations among eligible entities are subject to the following restrictions:

    (A) Entities receiving transferable allocations under the 60,000 PSC limit may only transfer to and from other entities receiving allocations under the 60,000 PSC limit.

    (B) Entities receiving transferable allocations under the 45,000 PSC limit may only transfer to and from other entities receiving allocations under the 45,000 PSC limit.

    (C) Entities receiving transferable allocations under the 47,591 PSC limit may only transfer to and from other entities receiving allocations under the 47,591 PSC limit.

    (D) Entities receiving transferable allocations under the 33,318 PSC limit may only transfer to and from other entities receiving allocations under the 33,318 PSC limit.

    (E) Chinook salmon PSC allocations may not be transferred between seasons.

    (ii) Post-delivery transfers. If the Chinook salmon bycatch by an entity exceeds its seasonal allocation, the entity may receive transfers of Chinook salmon PSC to cover overages for that season. An entity may conduct transfers to cover an overage that results from Chinook salmon bycatch from any fishing trip by a vessel fishing on behalf of that entity that was completed or is in progress at the time the entity's allocation is first exceeded. Under § 679.7(d)(5)(ii)(C)(2) and (k)(8)(v)(B), vessels fishing on behalf of an entity that has exceeded its Chinook salmon PSC allocation for a season may not start a new fishing trip for pollock in the BS on behalf of that same entity for the remainder of that season.

    (iii) Application for transfer of Chinook salmon PSC allocation—(A) Completed application. NMFS will process a request for transfer of Chinook salmon PSC provided that a paper or electronic application is completed, with all information fields accurately filled in. Application forms are available on the NMFS Alaska Region Web site (http://alaskafisheries.noaa.gov/) or from NMFS at the address in paragraph (b)(6) of this section.

    (B) Certification of transferor—(1) Non-electronic submittal. The transferor's designated representative must sign and date the application certifying that all information is true, correct, and complete. The transferor's designated representative must submit the paper application as indicated on the application.

    (2) Electronic submittal. The transferor's designated entity representative must log onto the NMFS online services system and create a transfer request as indicated on the computer screen. By using the transferor's NMFS ID, password, and Transfer Key, and submitting the transfer request, the designated representative certifies that all information is true, correct, and complete.

    (C) Certification of transferee—(1) Non-electronic submittal. The transferee's designated representative must sign and date the application certifying that all information is true, correct, and complete.

    (2) Electronic submittal. The transferee's designated representative must log onto the NMFS online services system and accept the transfer request as indicated on the computer screen. By using the transferee's NMFS ID, password, and Transfer Key, the designated representative certifies that all information is true, correct, and complete.

    (D) Deadline. NMFS will not approve an application for transfer of Chinook salmon PSC after June 25 for the A season or after December 1 for the B season.

    (10) Non-transferable Chinook salmon PSC allocations. (i) All vessels belonging to a sector that is ineligible to receive transferable allocations under paragraph (f)(8) of this section, any catcher vessels participating in an inshore open access fishery, and all vessels fishing under the opt-out allocation under paragraph (f)(5) of this section will fish under specific non-transferable Chinook salmon PSC allocations.

    (ii) All vessels fishing under a non-transferable Chinook salmon PSC allocation, including vessels fishing on behalf of a CDQ group, will be managed together by NMFS under that non-transferable allocation. If, during the fishing year, the Regional Administrator determines that a seasonal non-transferable Chinook salmon PSC allocation will be reached, NMFS will publish a notice in the Federal Register closing the BS to directed fishing for pollock by those vessels fishing under that non-transferable allocation for the remainder of the season or for the remainder of the year.

    (iii) For each non-transferable Chinook salmon PSC allocation, NMFS will deduct from the B season allocation any amount of Chinook salmon bycatch in the A season that exceeds the amount available under the A season allocation.

    (11) Rollover of unused A season allocation—(i) Rollovers of transferable allocations. NMFS will add any Chinook salmon PSC allocation remaining at the end of the A season, after any transfers under paragraph (f)(9)(ii) of this section, to an entity's B season allocation.

    (ii) Rollover of non-transferable allocations. For a non-transferable allocation for the mothership sector, catcher/processor sector, or an inshore open access fishery, NMFS will add any Chinook salmon PSC remaining in that non-transferable allocation at the end of the A season to that B season non-transferable allocation.

    (12) Salmon bycatch incentive plan agreements (IPAs)—(i) Minimum participation requirements. More than one IPA may be approved by NMFS. Each IPA must have participants that represent the following:

    (A) Minimum percent pollock. Parties to an IPA must collectively represent at least 9 percent of the BS pollock quota.

    (B) Minimum number of unaffiliated AFA entities. Parties to an IPA must represent any combination of two or more CDQ groups or corporations, partnerships, or individuals who own AFA-permitted vessels and are not affiliated, as affiliation is defined for purposes of AFA entities in § 679.2.

    (ii) Membership in an IPA. (A) No vessel owner or CDQ group is required to join an IPA.

    (B) For a vessel owner in the catcher/processor sector or mothership sector to join an IPA, that vessel owner must be a member of the entity representing that sector under paragraph (f)(8).

    (C) For a CDQ group to be a member of an IPA, the CDQ group must sign the IPA and list in that IPA each vessel harvesting BS pollock CDQ, on behalf of that CDQ group, that will participate in that IPA.

    (D) Once a member of an IPA, a vessel owner or CDQ group cannot withdraw from the IPA during a fishing year.

    (iii) Request for approval of a proposed IPA. The IPA representative must submit a proposed IPA to NMFS at the address in paragraph (b)(6) of this section. The proposed IPA must contain the following information:

    (A) Affidavit. The IPA must include the affidavit affirming that each eligible vessel owner or CDQ group, from whom the IPA representative received written notification requesting to join the IPA, has been allowed to join the IPA subject to the same terms and conditions that have been agreed on by, and are applicable to, all other parties to the IPA.

    (B) Name of the IPA.

    (C) Representative. The IPA must include the name, telephone number, and email address of the IPA representative who submits the proposed IPA on behalf of the parties and who is responsible for submitting proposed amendments to the IPA and the annual report required under paragraph (f)(13) of this section.

    (D) Third party group. The IPA must identify at least one third party group. Third party groups include any entities representing western Alaskans who depend on salmon and have an interest in salmon bycatch reduction but do not directly fish in a groundfish fishery.

    (E) Description of the incentive plan. The IPA must contain a description of the following—

    (1) The incentive(s) that will be implemented under the IPA for the operator of each vessel participating in the IPA to avoid Chinook salmon and chum salmon bycatch under any condition of pollock and Chinook salmon abundance in all years.

    (2) How the incentive(s) to avoid chum salmon do not increase Chinook salmon bycatch.

    (3) The rewards for avoiding Chinook salmon, penalties for failure to avoid Chinook salmon at the vessel level, or both.

    (4) How the incentive measures in the IPA are expected to promote reductions in a vessel's Chinook salmon and chum salmon bycatch rates relative to what would have occurred in absence of the incentive program.

    (5) How the incentive measures in the IPA promote Chinook salmon and chum salmon savings in any condition of pollock abundance or Chinook salmon abundance in a manner that is expected to influence operational decisions by vessel operators to avoid Chinook salmon and chum salmon.

    (6) How the IPA ensures that the operator of each vessel governed by the IPA will manage that vessel's Chinook salmon bycatch to keep total bycatch below the performance standard described in paragraph (f)(6) of this section for the sector in which the vessel participates.

    (7) How the IPA ensures that the operator of each vessel governed by the IPA will manage that vessel's chum salmon bycatch to avoid areas and times where the chum salmon are likely to return to western Alaska.

    (8) The rolling hot spot program for salmon bycatch avoidance that operates throughout the entire A season and B season and the agreement to provide notifications of closure areas and any violations of the rolling hot spot program to the third party group.

    (9) The restrictions or penalties targeted at vessels that consistently have significantly higher Chinook salmon PSC rates relative to other vessels fishing at the same time.

    (10) The requirement for vessels to enter a fishery‐wide in‐season salmon PSC data sharing agreement.

    (11) The requirement for the use of salmon excluder devices, with recognition of contingencies, from January 20 to March 31, and from September 1 until the end of the B season.

    (12) The requirement that salmon savings credits are limited to a maximum of three years for IPAs with salmon savings credits.

    (13) The restrictions or performance criteria used to ensure that Chinook salmon PSC rates in October are not significantly higher than those achieved in the preceding months.

    (F) Compliance agreement. The IPA must include a written statement that all parties to the IPA agree to comply with all provisions of the IPA.

    (G) Signatures. The names and signatures of the owner or representative for each vessel and CDQ group that is a party to the IPA. The representative of an inshore cooperative, or the representative of the entity formed to represent the AFA catcher/processor sector or the AFA mothership sector under paragraph (f)(8) of this section may sign a proposed IPA on behalf of all vessels that are members of that inshore cooperative or sector level entity.

    (iv) Deadline and duration—(A) Deadline for proposed IPA. A proposed IPA must be received by NMFS no later than 1700 hours, A.l.t., on October 1 of the year prior to the year for which the IPA is proposed to be effective.

    (B) Duration. Once approved, an IPA is effective starting January 1 of the year following the year in which NMFS approves the IPA, unless the IPA is approved between January 1 and January 19, in which case the IPA is effective starting in the year in which it is approved. Once approved, an IPA is effective until December 31 of the first year in which it is effective or until December 31 of the year in which the IPA representative notifies NMFS in writing that the IPA is no longer in effect, whichever is later. An IPA may not expire mid-year. No party may join or leave an IPA once it is approved, except as allowed under paragraph (f)(12)(v)(C) of this section.

    (v) NMFS review of a proposed IPA—(A) Approval. An IPA will be approved by NMFS if it meets the following requirements:

    (1) Meets the minimum participation requirements in paragraph (f)(12)(i) of this section;

    (2) Is submitted in compliance with the requirements of paragraphs (f)(12)(ii) and (iv) of this section; and

    (3) Contains the information required in paragraph (f)(12)(iii) of this section.

    (B) IPA identification number. If approved, NMFS will assign an IPA identification number to the approved IPA. This number must be used by the IPA representative in amendments to the IPA.

    (C) Amendments to an IPA. Amendments to an approved IPA may be submitted to NMFS at any time and will be reviewed under the requirements of this paragraph (f)(12). An amendment to an approved IPA is effective upon written notification of approval by NMFS to the IPA representative.

    (D) Disapproval. (1) NMFS will disapprove a proposed IPA or a proposed amendment to an IPA for either of the following reasons:

    (i) If the proposed IPA fails to meet any of the requirements of paragraphs (f)(12)(i) through (iii) of this section, or

    (ii) If a proposed amendment to an IPA would cause the IPA to no longer be consistent with the requirements of paragraphs (f)(12)(i) through (iv) of this section.

    (2) Initial Administrative Determination (IAD). If, in NMFS' review of the proposed IPA, NMFS identifies deficiencies in the proposed IPA that require disapproval of the proposed IPA, NMFS will notify the applicant in writing. The IPA representative will be provided one 30-day period to address, in writing, the deficiencies identified by NMFS. Additional information or a revised IPA received by NMFS after the expiration of the 30-day period specified by NMFS will not be considered for purposes of the review of the proposed IPA. NMFS will evaluate any additional information submitted by the applicant within the 30-day period. If the Regional Administrator determines that the additional information addresses deficiencies in the proposed IPA, the Regional Administrator will approve the proposed IPA under paragraphs (f)(12)(iv)(B) and (f)(12)(v)(A) of this section. However, if, after consideration of the original proposed IPA and any additional information submitted during the 30-day period, NMFS determines that the proposed IPA does not comply with the requirements of paragraph (f)(12) of this section, NMFS will issue an initial administrative determination (IAD) providing the reasons for disapproving the proposed IPA.

    (3) Administrative Appeals. An IPA representative who receives an IAD disapproving a proposed IPA may appeal under the procedures set forth at § 679.43. If the IPA representative fails to file an appeal of the IAD pursuant to § 679.43, the IAD will become the final agency action. If the IAD is appealed and the final agency action is a determination to approve the proposed IPA, then the IPA will be effective as described in paragraph (f)(12)(iv)(B) of this section.

    (4) Pending appeal. While appeal of an IAD disapproving a proposed IPA is pending, proposed members of the IPA subject to the IAD that are not currently members of an approved IPA will fish under the opt-out allocation under paragraph (f)(5) of this section. If no other IPA has been approved by NMFS, NMFS will issue all sectors allocations of the 47,591 Chinook salmon PSC limit as described in paragraph (f)(3)(iii)(C) of this section, or, in low Chinook salmon abundance years, allocations of the 33,318 Chinook salmon PSC limit as described in paragraph (f)(3)(iii)(D) of this section.

    (vi) Public release of an IPA. NMFS will make all proposed IPAs and all approved IPAs and the list of participants in each approved IPA available to the public on the NMFS Alaska Region Web site (http://alaskafisheries.noaa.gov/).

    (13) IPA Annual Report. The representative of each approved IPA must submit a written annual report to the Council at the address specified in § 679.61(f). The Council will make the annual report available to the public.

    (i) Submission deadline. The IPA Annual Report must be received by the Council no later than March 15.

    (ii) Information requirements. The IPA Annual Report must contain the following information:

    (A) A comprehensive description of the incentive measures, including the rolling hot spot program and salmon excluder use, in effect in the previous year;

    (B) A description of how these incentive measures affected individual vessels;

    (C) An evaluation of whether incentive measures were effective in achieving salmon savings beyond levels that would have been achieved in absence of the measures, including the effectiveness of—

    (1) Measures to ensure that chum salmon were avoided in areas and at times where chum salmon are likely to return to western Alaska;

    (2) Restrictions or penalties that target vessels that consistently have significantly higher Chinook salmon PSC rates relative to other vessels; and

    (3) Restrictions or performance criteria used to ensure that Chinook PSC rates in October are not significantly higher than in previous months.

    (D) A description of any amendments to the terms of the IPA that were approved by NMFS since the last annual report and the reasons that the amendments to the IPA were made.

    (E) The sub-allocation to each participating vessel of the number of Chinook salmon PSC and amount of pollock (mt) at the start of each fishing season, and number of Chinook salmon PSC and amount of pollock (mt) caught at the end of each season.

    (F) The following information on in-season transfer of Chinook salmon PSC and pollock among AFA cooperatives, entities eligible to receive Chinook salmon PSC allocations, or CDQ groups:

    (1) Date of transfer;

    (2) Name of transferor;

    (3) Name of transferee;

    (4) Number of Chinook salmon PSC transferred; and

    (5) Amount of pollock (mt) transferred.

    (G) The following information on in-season transfers among vessels participating in the IPA:

    (1) Date of transfer;

    (2) Name of transferor;

    (3) Name of transferee;

    (4) Number of Chinook salmon PSC transferred; and

    (5) Amount pollock (mt) transferred.

    (14) Non-Chinook salmon prohibited species catch (PSC) limit and Chum Salmon Savings Area. (i) The PSC limit for non-Chinook salmon caught by vessels using trawl gear from August 15 through October 14 in the Catcher Vessel Operational Area, as defined under § 679.22(a)(5) and in Figure 2 to this part, is 42,000 fish.

    (ii) 10.7 percent of the non-Chinook PSC limit is allocated to the CDQ Program as a PSQ reserve.

    (iii) If the Regional Administrator determines that 42,000 non-Chinook salmon have been caught by vessels using trawl gear during the period August 15 through October 14 in the Catcher Vessel Operational Area, NMFS will prohibit fishing for pollock for the remainder of the period September 1 through October 14 in the Chum Salmon Savings Area as defined in Figure 9 to this part.

    (iv) Trawl vessels participating in directed fishing for pollock and operating under an IPA approved by NMFS under paragraph (f)(12) of this section are exempt from closures in the Chum Salmon Savings Area.

    (15) Salmon handling. Regulations in this paragraph apply to vessels directed fishing for pollock in the BS, including pollock CDQ, and processors taking deliveries from these vessels.

    (i) Salmon discard. The operator of a vessel and the manager of a shoreside processor or SFP must not discard any salmon or transfer or process any salmon under the PSD Program at § 679.26 if the salmon were taken incidental to a directed fishery for pollock in the BS until the number of salmon has been determined by the observer and the observer's collection of any scientific data or biological samples from the salmon has been completed.

    (ii) Salmon retention and storage. (A) Operators of catcher/processors or motherships must—

    (1) Sort and transport all salmon bycatch from each haul to an approved storage container located adjacent to the observer sampling station that allows an observer free and unobstructed access to the salmon (see § 679.28(d)(2)(i) and (d)(7)). The salmon storage container must remain in view of the observer from the observer sampling station at all times during the sorting of the haul.

    (2) If, at any point during sorting of a haul or delivery, the salmon are too numerous to be contained in the salmon storage container, cease all sorting and give the observer the opportunity to count the salmon in the storage container and collect scientific data or biological samples. Once the observer has completed all counting and sampling duties for the counted salmon, the salmon must be removed by vessel personnel from the approved storage container and the observer sampling station, in the presence of the observer.

    (3) Before sorting of the next haul may begin, give the observer the opportunity to complete the count of salmon and the collection of scientific data or biological samples from the previous haul. When the observer has completed all counting and sampling duties for a haul or delivery, vessel personnel must remove the salmon, in the presence of the observer, from the salmon storage container and the observer sampling station.

    (4) Ensure no salmon of any species pass the observer sample collection point, as identified in the scale drawing of the observer sampling station (see § 679.28(d)(2)(i) and (d)(7)).

    (B) Operators of vessels delivering to shoreside processors or stationary floating processors must—

    (1) Retain all salmon taken incidental to a directed fishery for pollock in the BS until the salmon are delivered to the processor receiving the vessel's BS pollock catch.

    (2) Notify the observer at least 15 minutes before handling catch on board the vessel, including, but not limited to, moving catch from one location to another, sorting, or discard of catch prior to the delivery of catch to the processor receiving the vessel's BS pollock catch. This notification requirement is in addition to the notification requirements in § 679.51(e).

    (3) Secure all salmon and catch after the observer has completed the collection of scientific data and biological samples and after the vessel crew has completed handling the catch. All salmon and any other catch retained on board the vessel must be made unavailable for sorting and discard until the delivery of catch to the processor receiving the vessel's BS pollock catch. Methods to make salmon or retained catch unavailable for sorting or discard include but are not limited to securing the catch in a completely enclosed container above or below deck, securing the catch in an enclosed codend, or completely and securely covering the fish on deck.

    (4) Comply with the requirements in paragraphs (f)(15)(ii)(B)(2) and (3) of this section, before handling the catch prior to delivery.

    (C) Shoreside processors or stationary floating processors must—

    (1) Comply with the requirements in § 679.28(g)(7)(vii) for the receipt, sorting, and storage of salmon from deliveries of catch from the BS pollock fishery.

    (2) Ensure no salmon of any species pass beyond the last point where sorting of fish occurs, as identified in the scale drawing of the plant in the Catch Monitoring Control Plan (CMCP).

    (3) Sort and transport all salmon of any species to the salmon storage container identified in the CMCP (see § 679.28 (g)(7)(vi)(C) and (g)(7)(x)(F)). The salmon must remain in that salmon storage container and within the view of the observer at all times during the offload.

    (4) If, at any point during the offload, salmon are too numerous to be contained in the salmon storage container, cease the offload and all sorting and give the observer the opportunity to count the salmon and collect scientific data or biological samples. The counted salmon then must be removed from the area by plant personnel in the presence of the observer.

    (5) At the completion of the offload, give the observer the opportunity to count the salmon and collect scientific data or biological samples.

    (6) Before sorting of the next offload of catch from the BS pollock fishery may begin, give the observer the opportunity to complete the count of salmon and the collection of scientific data or biological samples from the previous offload of catch from the BS pollock fishery. When the observer has completed all counting and sampling duties for the offload, plant personnel must remove the salmon, in the presence of the observer, from the salmon storage container and location where salmon are counted and biological samples or scientific data are collected.

    (iii) Assignment of crew to assist observer. Operators of vessels and managers of shoreside processors and SFPs that are required to retain salmon under paragraph (f)(15)(i) of this section must designate and identify to the observer aboard the vessel, or at the shoreside processor or SFP, a crew person or employee responsible for ensuring all sorting, retention, and storage of salmon occurs according to the requirements of (f)(15)(ii) of this section.

    (iv) Discard of salmon. Except for salmon under the PSD Program at § 679.26, all salmon must be returned to the sea as soon as is practicable, following notification by an observer that the number of salmon has been determined and the collection of scientific data or biological samples has been completed.

    (g) Chinook salmon bycatch management in the AI pollock fishery—(1) Applicability. This paragraph contains regulations governing the bycatch of Chinook salmon in the AI pollock fishery.

    (2) AI Chinook salmon PSC limit. (i) The PSC limit for Chinook salmon caught by vessels while harvesting pollock in the AI is 700 fish.

    (ii) 7.5 percent of the PSC limit is allocated to the CDQ Program as a PSQ reserve.

    (3) Area closures. If, during the fishing year, the Regional Administrator determines that catch of Chinook salmon by vessels using trawl gear while directed fishing for pollock in the AI will reach the PSC limit, NMFS, by notification in the Federal Register, will close the AI Chinook Salmon Savings Area, as defined in Figure 8 to this part, to directed fishing for pollock with trawl gear on the following dates:

    (i) From the effective date of the closure until April 15, and from September 1 through December 31, if the Regional Administrator determines that the annual limit of AI Chinook salmon will be attained before April 15.

    (ii) From September 1 through December 31, if the Regional Administrator determines that the annual limit of AI Chinook salmon will be attained after April 15.

    6. In § 679.22, revise paragraph (a)(10) to read as follows:
    § 679.22 Closures.

    (a) * * *

    (10) Chum Salmon Savings Area. Directed fishing for pollock by vessels using trawl gear is prohibited from August 1 through August 31 in the Chum Salmon Savings Area defined at Figure 9 to this part (see also § 679.21(f)(14)). Vessels directed fishing for pollock in the BS, including pollock CDQ, and operating under an approved IPA under § 679.21(f)(12) are exempt from closures in the Chum Salmon Savings Area.

    7. In § 679.28, revise paragraphs (d)(7)(i) through (iii) to read as follows:
    § 679.28 Equipment and operational requirements.

    (d) * * *

    (7) * * *

    (i) A salmon storage container must be located adjacent to the observer sampling station;

    (ii) The salmon storage container must remain in view of the observer at the observer sampling station at all times during the sorting of each haul; and

    (iii) The salmon storage container must be at least 1.5 cubic meters.

    8. In § 679.51, revise paragraphs (e)(1)(iii), (e)(2) introductory text, and (e)(2)(iii)(B)(3) to read as follows:
    § 679.51 Observer requirements for vessels and plants.

    (e) * * *

    (1) * * *

    (iii) Communications and observer data entry—(A) Observer use of equipment. Allow an observer to use the vessel's communications equipment and personnel, on request, for the confidential entry, transmission, and receipt of work-related messages, at no cost to the observer or the United States.

    (B) The operator of a catcher/processor (except for a catcher/processor placed in the partial observer coverage category under paragraph (a)(3) of this section), mothership, or catcher vessel 125 ft LOA or longer (except for a catcher vessel fishing for groundfish with pot gear) must provide the following equipment, software and data transmission capabilities:

    (1) Observer access to computer. Make a computer available for use by the observer.

    (2) NMFS-supplied software. Ensure that the most recent release of NMFS data entry software provided by the Regional Administrator or other approved software is installed on the computer described in paragraph (e)(1)(iii)(B)(1) of this section.

    (3) Data transmission. The computer and software described in paragraphs (e)(1)(iii)(B)(1) and (2) of this section must be connected to a communication device that provides a point-to-point connection to the NMFS host computer.

    (4) Functional and operational equipment. Ensure that the required equipment described in paragraph (e)(1)(iii)(B) of this section and that is used by an observer to enter or transmit data is fully functional and operational. “Functional” means that all the tasks and components of the NMFS-supplied, or other approved, software described in paragraph (e)(1)(iii)(B)(2) of this section and any required data transmissions to NMFS can be executed effectively aboard the vessel by the equipment.

    (C) The operator of a catcher vessel participating in the Rockfish Program or a catcher vessel less than 125 ft LOA directed fishing for pollock in the BS must comply with the computer and software requirements described in paragraphs (e)(1)(iii)(B)(1), (2), and (4) of this section.

    (2) Shoreside processor and stationary floating processor responsibilities. A manager of a shoreside processor or a stationary floating processor that is required to maintain observer coverage as specified under paragraph (b) of this section must:

    (iii) * * *

    (B) * * *

    (3) Functional and operational equipment. Ensuring that the communications equipment required under paragraph (e)(2)(iii)(B) of this section that is used by observers to enter and transmit data is functional and operational. “Functional” means that all the tasks and components of the NMFS-supplied, or other approved, software described at paragraph (e)(2)(iii)(B)(2) of this section and any data transmissions to NMFS can be executed effectively by the communications equipment.

    Tables 47a through 47d to Part 679 [Removed]
    9. Remove Tables 47a through 47d to part 679.
    [FR Doc. 2016-13697 Filed 6-9-16; 8:45 am] BILLING CODE 3510-22-P
    81 112 Friday, June 10, 2016 Proposed Rules SOCIAL SECURITY ADMINISTRATION 20 CFR Parts 404 and 416 [Docket No. SSA-2016-0015] RIN 0960-AH92 Evidence From Statutorily Excluded Medical Sources AGENCY:

    Social Security Administration.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    In accordance with section 812 of the Bipartisan Budget Act of 2015 (BBA section 812), we propose to revise our rules to explain how we would address evidence furnished by medical sources that meet one of BBA section 812's exclusionary categories (statutorily excluded medical sources). Under this proposed rule, we would not consider evidence furnished by a statutorily excluded medical source unless we find good cause to do so. We propose several circumstances in which we would find good cause, and we also propose to require statutorily excluded medical sources to notify us of their excluded status when they furnish evidence to us. These rules would allow us to fulfill obligations that we have under the Bipartisan Budget Act of 2015 (BBA).

    DATES:

    To ensure that we consider your comments, we must receive them by no later than August 9, 2016.

    ADDRESSES:

    You may submit comments by any one of three methods—Internet, fax, or mail. Do not submit the same comments multiple times or by more than one method. Regardless of which method you choose, please state that your comments refer to Docket No. SSA-2016-0015 so that we may associate your comments with the correct regulation.

    Caution: You should be careful to include in your comments only information that you wish to make publicly available. We strongly urge you not to include in your comments any personal information, such as Social Security numbers or medical information.

    1. Internet: We strongly recommend that you submit your comments via the Internet. Please visit the Federal eRulemaking portal at http://www.regulations.gov. Use the “Search” function to find docket number SSA-2016-0015. The system will issue a tracking number to confirm your submission. You will not be able to view your comment immediately because we must post each comment manually. It may take up to a week for your comment to be viewable.

    2. Fax: Fax comments to (410) 966-2830.

    3. Mail: Mail your comments to the Office of Regulations and Reports Clearance, Social Security Administration, 3100 West High Rise Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401.

    Comments and background documents are available for public viewing on the Federal eRulemaking portal at www.regulations.gov or in person, during regular business hours, by arranging with the contact person identified below.

    FOR FURTHER INFORMATION CONTACT:

    Dan O'Brien, Office of Disability Policy, Social Security Administration, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, (410) 597-1632. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213, or TTY 1-800-325-0778, or visit our Internet site, Social Security Online, at www.socialsecurity.gov.

    SUPPLEMENTARY INFORMATION: I. How BBA Section 812 Affects How We Consider Evidence

    We consider all evidence we receive when we determine whether an individual is blind or disabled under the Social Security Act (Act).1 We define evidence as anything you or anyone else submits to us, or that we obtain, that relates to your claim.2

    1 42 U.S.C. 416(i), 42 U.S.C. 423(d), and 42 U.S.C. 1382c(a).

    2 20 CFR 404.1512(b) and 416.912(b).

    The BBA was enacted on November 2, 2015.3 BBA section 812 amended section 223(d)(5) of the Act, 42 U.S.C. 423(d)(5), by adding a new paragraph “C.” Under this provision, when we make a disability determination or decision, or when we conduct a continuing disability review (CDR), under titles II or XVI of the Act, we cannot consider evidence furnished by certain sources, unless we have good cause.4

    3 Pub. L. 114-74, 129 Stat. 584.

    4 Public Law 114-74, sec. 812, 129 Stat. 584, 602. Excluding evidence under BBA section 812 does not constitute an exclusion of a medical source from Social Security programs under section 1136 of the Act, 42 U.S.C. 1320b-6.

    Specifically, we may not consider evidence from the following medical sources:

    • A medical source convicted of a felony under sections 208 or 1632 of the Act,5

    5 42 U.S.C. 408 and 1383a. These sections make it a felony to give false statements or omit information to cause an improper payment, convert a payment intended for someone else, provide us with false information we need for our records concerning the individual's true identity, or misuse a Social Security card or number for the purpose of obtaining or causing an increase in benefits to which the individual is not entitled or eligible.

    • a medical source excluded from participating in any Federal health care program under section 1128 of the Act,6 or

    6 42 U.S.C. 1320a-7. This section identifies four mandatory and 16 permissive bases for excluding a provider from participating in all Federal health care programs (as defined in section 1128B(f) of the Act). The four mandatory exclusions from participating in Federal health care programs are: (1) Conviction of program-related crimes, (2) conviction relating to patient abuse, (3) felony conviction relating to health care fraud, and (4) felony conviction relating to controlled substance. The 16 permissive exclusions from participating in Federal health care programs are: (1) Conviction relating to fraud, (2) conviction relating to obstruction of an investigation or audit, (3) misdemeanor conviction relating to controlled substance, (4) license revocation or suspension, (5) exclusion or suspension under federal or state health care program, (6) claims for excessive charges or unnecessary services and failure of certain organizations to furnish medically necessary services, (7) fraud, kickbacks, and other prohibited activities, (8) entities controlled by a sanctioned individual, (9) failure to disclose required information, (10) failure to supply requested information on subcontractors and suppliers, (11) failure to supply payment information, (12) failure to grant immediate access, (13) failure to take corrective action, (14) default on health education loan or scholarship obligations, (15) individuals controlling a sanctioned entity, and (16) making false statements or misrepresentation of a material fact. The Department of Health and Human Services' Office of Inspector General (HHS OIG), which administers section 1128 of the Act, may grant a waiver for all but one of these bases. A mandatory exclusion for a conviction related to patient abuse may not be waived.

    • a medical source imposed with a civil monetary penalty (CMP), assessment, or both, for submitting false evidence under section 1129 of the Act.7

    7 42 U.S.C. 1320a-8. This section permits the imposition of a CMP or assessment (or both) for certain offenses. One such offense is making a false statement or representation of a material fact for us to use in determining an initial or continuing right to Social Security disability benefits.

    We refer to the individuals and entities that fall into one or more of these exclusionary categories as statutorily excluded medical sources.

    Our Inspector General or the Secretary of Health and Human Services (HHS) will inform us about these statutorily excluded medical sources at such times and to the extent necessary for the effective implementation of this requirement.8 BBA section 812 requires us to issue regulations to carry out the amendments to the Act by November 2, 2016.9 BBA section 812 is effective on or after the effective date of the regulations, or by November 2, 2016, whichever is earlier.10

    8 Section 812(a) of Public Law 114-74, 129 Stat. at 602.

    9 Section 812(b) of Public Law 114-74, 129 Stat. at 602.

    10 Section 812(c) of Public Law 114-74, 129 Stat. at 602.

    II. Proposed Revisions to Our Rules

    We propose to implement BBA section 812 by adding new 20 CFR 404.1503b and 416.903b to state that we will not consider evidence from a statutorily excluded medical source under section 223(d)(5)(C) of the Act, unless we find good cause. Under our proposed rules, we may find good cause to consider evidence from an excluded medical source in the following five situations:

    • The evidence from the medical source consists of evidence of treatment that occurred before the date the source was convicted of a felony under section 208 or under section 1632 of the Act;

    • The evidence from the medical source consists of evidence of treatment that occurred during a period in which the source was not excluded from participation in any Federal health care program under section 1128 of the Act;

    • The evidence from the medical source consists of evidence of treatment that occurred before the date the source received a final decision imposing a CMP, assessment, or both, for submitting false evidence under section 1129 of the Act;

    • The sole basis for the medical source's exclusion under section 223(d)(5)(C) of the Act is that the source cannot participate in any Federal health care program under section 1128 of the Act, but the Office of Inspector General of the Department of Health and Human Services granted a waiver of the section 1128 exclusion; or

    • The evidence is a laboratory finding about a physical impairment and there is no indication that the finding is unreliable.

    We may find good cause to consider evidence from an excluded medical source in any of these five enumerated situations when we make a disability determination or decision or when we conduct a CDR.

    The first three good cause exceptions relate to evidence that pertains to periods prior to the event that would trigger exclusion under BBA section 812, or relate to a period during which the medical source was not excluded from participating in any Federal health care program. We believe that it would be consistent with the purpose of BBA section 812 to find good cause to consider evidence furnished by a medical source of treatment that occurred: (1) Before the source is convicted of a felony under section 208 or 1632 of the Act,11 (2) outside of the period the source cannot participate in Federal health care programs under section 1128 of the Act,12 or (3) before the source is issued a final decision imposing a CMP, assessment, or both, for submitting false evidence under section 1129 of the Act.13 We propose these good cause exceptions in order to protect the public interest. In our view, an undue hardship would be placed on our claimants, and the purposes of BBA section 812 would not be served, unless we include these exceptions. In this situation, there is little risk that the evidence would be tainted by the activity for which the source has been sanctioned or convicted, but a greater risk that we could make an incorrect determination or decision by excluding probative evidence.

    11 42 U.S.C. 408 and 42 U.S.C. 1383a.

    12 42 U.S.C. 1320a-7.

    13 42 U.S.C. 1320a-8.

    Specifically, it would be against the public interest if we barred claimants from ever using evidence furnished by statutorily excluded medical sources concerning treatment that occurred prior to the period those sources qualify for a BBA section 812 exclusion. For example, there may be instances where a statutorily excluded medical source provided treatment to a claimant prior to the period the source qualified for a BBA section 812 exclusion or performed the acts that led to the exclusion. In those instances, and others, we would determine whether to consider the source's evidence concerning such treatment on a case-by-case basis. In addition, section 1128 of the Act permits some medical sources to resume participating in Federal health care programs after a prescribed exclusion period if they successfully apply for reinstatement.14 We believe it would also be against the public interest for us to place an absolute bar on claimants from ever using evidence of treatment that occurred after termination of the exclusion under section 1128 when medical sources are permitted to resume their participation in Federal health care programs. We would determine whether to consider that evidence on a case-by-case basis as well.

    14 42 U.S.C. 1320a-7.

    The fourth good cause exception aligns our rules with those of HHS and provides a consistent approach regarding evidence from affected medical sources. HHS' Office of the Inspector General (HHS OIG) may waive a medical source's exclusion 15 from participating in any Federal health care program for three of the four mandatory exclusions contained in section 1128 of the Act if: (1) It receives a written waiver request from the program's administrator who has determined that the exclusion will pose a hardship to any beneficiary, and (2) the medical source is the sole community physician or sole source of essential specialized services in a community.16 HHS OIG may waive a medical source's exclusion for one of the permissive exclusions if it determines that imposing the exclusion would not be in the public interest.17 All waivers may be rescinded if the basis for the waiver ceases to exist.18 Because a waiver from HHS OIG permits an otherwise excluded medical source to participate in a Federal health care program, we may find good cause to consider evidence from such a medical source consistent with the particular terms of the waiver.

    15 42 U.S.C. 1320a-7(c)(3)(B); 42 CFR 1001.1801.

    16 42 U.S.C. 1320a-7(a), (c)(3)(B); 42 CFR 1001.1801(a). HHS OIG cannot waive an exclusion based on a conviction related to patient abuse.

    17 42 U.S.C. 1320a-7(b); 42 CFR 1001.1801(c).

    18 42 CFR 1001.1801(d), (e).

    The fifth good cause exception relies on the unique nature of laboratory findings about physical impairments.19 Laboratory findings about physical impairments are objective, reliable, and reproducible tests that require the least amount of subjective interpretation by a medical source. They are important to help us understand fundamental information about claimants' impairments and whether they are entitled to benefits, such as the onset date and duration of an impairment(s).20 If we would find that a laboratory finding about a physical impairment in a claim is not reliable, we would not apply the good cause exception.

    19 Laboratory findings related to a physical impairment include chemical tests (such as blood tests), electrophysiological studies (such as electrocardiograms and electroencephalograms), pathology reports, and medical imaging (such as x-rays). See 20 CFR 404.1528(c) and 416.928(c).

    20 See 20 CFR 404.130, 404.1509, and 416.909.

    III. Proposed Notification Process

    Our long-term solution to the administration of BBA section 812 is to implement automated evidence matching within our case processing system(s) to identify excludable evidence. As part of our efforts to comply with BBA section 812's implementation deadline of November 2, 2016, we propose to require that statutorily excluded medical sources inform us in writing of their BBA section 812 exclusion(s) each time they submit evidence to us that relates to a claim for Social Security disability benefits or payments.

    Regarding the content of the written statement, statutorily excluded medical sources would be required to include a heading that states,

    WRITTEN STATEMENT REGARDING SECTION 223(d)(5)(C) OF THE SOCIAL SECURITY ACT—DO NOT REMOVE. Immediately following this heading, sources would also need to include their name, title, and the applicable event(s) that triggered their statutory exclusion. Sources convicted of a felony under section 208 or 1632 of the Act 21 would also need to provide the date of their felony conviction. Similarly, sources imposed with a CMP, assessment, or both, for submitting false evidence under section 1129 of the Act,22 would need to provide the date of the final imposition of the CMP, assessment, or both. Sources that cannot participate in any Federal health care program under section 1128 of the Act 23 would need to include the basis for their exclusion, its effective date and anticipated length, and whether HHS' OIG waived it.

    As stated above, our proposed self-reporting requirement would apply only to statutorily excluded medical sources. This requirement applies when the statutorily excluded medical source submits evidence to us directly or indirectly through a representative, claimant, or other individual or entity. We further propose to require that no individual or entity be permitted to remove a statutorily excluded medical source's written statement of exclusion prior to submitting the source's evidence to us. We also seek to reserve the right to request that statutorily excluded medical sources provide us with additional information or clarify any information they submit regarding their exclusion under section 223(d)(5)(C) of the Act.

    If statutorily excluded medical sources do not inform us of their excluded status, we may refer the medical source to our Office of the Inspector General for any action it deems appropriate, including investigation and CMP pursuit.

    Executive Order 12866, as Supplemented by Executive Order 13563

    We consulted with the Office of Management and Budget (OMB) and determined that this NPRM does not meet the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB has not reviewed it.

    Regulatory Flexibility Act

    We certify that this NPRM would not have a significant economic impact on a substantial number of small entities. The only economic impact on small entities from this NPRM results from BBA section 812's requirement that we not consider evidence from statutorily excluded medical sources. As described above and in our Paperwork Reduction Act statement, below, we propose to require statutorily excluded medical sources to provide us with a brief self-report containing basic information each time they submit evidence related to a claim for benefits under titles II or XVI of the Act. Therefore, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended.

    Paperwork Reduction Act

    This proposed rule poses new public reporting burdens in the sections listed below. Because these requirements are not covered by an existing OMB-approved form, we provide burden estimates for them.

    Regulation
  • section
  • Description of public reporting requirement Number of
  • respondents
  • (annually)
  • Frequency of response Average
  • burden per
  • response
  • (minutes)
  • Estimated
  • annual burden
  • (hours)
  • 404.1503b(c) 416.903b(c) Statutorily excluded medical sources must inform us in writing that they are excluded under section 223(d)(5)(C) of the Act, as amended, each time they submit evidence related to a claim for benefits under titles II or XVI of the Act. The written statement must include: A heading stating that it is a written statement regarding section 223(d)(5)(C) of the Act; the name and title of the medical source; the applicable excluding event(s); the date of the medical source's felony conviction if applicable; the date of the imposition of a civil monetary penalty or assessment, or both, for the submission of false evidence if applicable; the basis, effective date, anticipated length of the exclusion, and whether the Office of Inspector General of the Department of Health and Human Services waived the exclusion 50 60 20 1000 Total 50 1000

    We submitted an Information Collection Request for clearance to OMB. We are soliciting comments on the burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize the burden on respondents, including the use of automated techniques or other forms of information technology. If you would like to submit comments, please send them to the following locations:

    Office of Management and Budget, Attn: Desk Officer for SSA, Fax Number: 202-395-6974, Email address: [email protected] Social Security Administration, Attn: Reports Clearance Officer, 1333 Annex, 6401 Security Blvd., Baltimore, MD 21235-0001, Fax Number: 410-965-6400, Email: [email protected]

    You can submit comments until August 9, 2016, which is 60 days after the publication of this notice. However, your comments will be most useful if you send them to SSA by July 11, 2016, which is 30 days after publication. To receive a copy of the OMB clearance package, contact our Reports Clearance Officer using any of the above contact methods. We prefer to receive comments by email or fax.

    (Catalog of Federal Domestic Assistance Program Nos. 96.001, Social Security—Disability Insurance; 96.002, Social Security—Retirement Insurance; and 96.004, Social Security—Survivors Insurance) List of Subjects 20 CFR Part 404

    Administrative practice and procedure, Blind, Disability benefits, Old-Age, Survivors, and Disability Insurance, Reporting and recordkeeping requirements, Social Security.

    20 CFR Part 416

    Administrative practice and procedure, Reporting and recordkeeping requirements, Supplemental Security Income (SSI).

    Dated: May 27, 2016. Carolyn W. Colvin, Acting Commissioner of Social Security.

    For the reasons set out in the preamble, we propose to amend 20 CFR part 404 subpart P and part 416 subpart I as set forth below:

    PART 404—FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Subpart P—Determining Disability and Blindness 1. The authority citation for subpart P of part 404 continues to read as follows: Authority:

    Secs. 202, 205(a)-(b) and (d)-(h), 216(i), 221(a), (i), and (j), 222(c), 223, 225, and 702(a)(5) of the Social Security Act (42 U.S.C. 402, 405(a)-(b) and (d)-(h), 416(i), 421(a), (i), and (j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 U.S.C. 902 note).

    2. Add § 404.1503b to read as follows:
    § 404.1503b Evidence from statutorily excluded medical sources.

    (a) General. We will not consider evidence from the following medical sources statutorily excluded under section 223(d)(5)(C) of the Social Security Act (Act), as amended, unless we find good cause under paragraph (b) of this section:

    (1) Any medical source that has been convicted of a felony under section 208 or under section 1632 of the Act;

    (2) Any medical source that has been excluded from participation in any Federal health care program under section 1128 of the Act; or

    (3) Any medical source that has received a final decision imposing a civil monetary penalty or assessment, or both, for submitting false evidence under section 1129 of the Act.

    (b) Good cause. We may find good cause to consider evidence from a statutorily excluded medical source under section 223(d)(5)(C) of the Act, as amended, if:

    (1) The evidence from the medical source consists of evidence of treatment that occurred before the date the source was convicted of a felony under section 208 or under section 1632 of the Act;

    (2) The evidence from the medical source consists of evidence of treatment that occurred during a period in which the source was not excluded from participation in any Federal health care program under section 1128 of the Act;

    (3) The evidence from the medical source consists of evidence of treatment that occurred before the date the source received a final decision imposing a civil monetary penalty or assessment, or both, for submitting false evidence under section 1129 of the Act;

    (4) The sole basis for the medical source's exclusion under section 223(d)(5)(C) of the Act, as amended, is that the source cannot participate in any Federal health care program under section 1128 of the Act, but the Office of Inspector General of the Department of Health and Human Services granted a waiver of the section 1128 exclusion; or

    (5) The evidence is a laboratory finding about a physical impairment and there is no indication that the finding is unreliable.

    (c) Statutorily excluded medical sources' reporting requirements. Statutorily excluded medical sources (as described in paragraph (a) of this section) must inform us in writing that they are excluded under section 223(d)(5)(C) of the Act, as amended, each time they submit evidence related to a claim for benefits under titles II or XVI of the Act. This reporting requirement applies to evidence that statutorily excluded medical sources submit to us either directly or through a representative, claimant, or other individual or entity.

    (1) Statutorily excluded medical sources must provide a written statement, which contains the following information:

    (i) A heading stating: “WRITTEN STATEMENT REGARDING SECTION 223(d)(5)(C) OF THE SOCIAL SECURITY ACT—DO NOT REMOVE”

    (ii) The name and title of the medical source;

    (iii) The applicable excluding event(s) stated in paragraphs (a)(1)-(a)(3) of this section;

    (iv) The date of the medical source's felony conviction under sections 208 or 1632 of the Act, if applicable;

    (v) The date of the imposition of a civil monetary penalty or assessment, or both, for the submission of false evidence, under section 1129 of the Act, if applicable; and

    (vi) The basis, effective date, anticipated length of the exclusion, and whether the Office of the Inspector General of the Department of Health and Human Services waived the exclusion, if the excluding event was the medical source's exclusion from participation in any Federal health care program under section 1128 of the Act.

    (2) The written statement provided by an excluded medical source may not be removed by any individual or entity prior to submitting evidence to us.

    (3) We may request that the excluded medical source provide us with additional information or clarify any information submitted that bears on the medical source's exclusion(s) under section 223(d)(5)(C) of the Act, as amended.

    PART 416—SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Subpart I—Determining Disability and Blindness 3. The authority citation for subpart I of part 416 continues to read as follows: Authority:

    Secs. 221(m), 702(a)(5), 1611, 1614, 1619, 1631(a), (c), (d)(1), and (p), and 1633 of the Social Security Act (42 U.S.C. 421(m), 902(a)(5), 1382, 1382c, 1382h, 1383(a), (c), (d)(1), and (p), and 1383(b); secs. 4(c) and 5, 6(c)-(e), 14(a), and 15, Pub. L. 98-460, 98 Stat. 1794, 1801, 1802, and 1808 (42 U.S.C. 421 note, 423 note, and 1382h note).

    4. Add § 416.903b to read as follows:
    § 416.903b Evidence from statutorily excluded medical sources.

    (a) General. We will not consider evidence from the following medical sources statutorily excluded under section 223(d)(5)(C) of the Social Security Act (Act), as amended, unless we find good cause under paragraph (b) of this section:

    (1) Any medical source that has been convicted of a felony under section 208 or under section 1632 of the Act;

    (2) Any medical source that has been excluded from participation in any Federal health care program under section 1128 of the Act; or

    (3) Any medical source that has received a final decision imposing a civil monetary penalty or assessment, or both, for submitting false evidence under section 1129 of the Act.

    (b) Good cause. We may find good cause to consider evidence from a statutorily excluded medical source under section 223(d)(5)(C) of the Act, as amended, if:

    (1) The evidence from the medical source consists of evidence of treatment that occurred before the date the source was convicted of a felony under section 208 or under section 1632 of the Act;

    (2) The evidence from the medical source consists of evidence of treatment that occurred during a period in which the source was not excluded from participation in any Federal health care program under section 1128 of the Act;

    (3) The evidence from the medical source consists of evidence of treatment that occurred before the date the source received a final decision imposing a civil monetary penalty or assessment, or both, for submitting false evidence under section 1129 of the Act;

    (4) The sole basis for the medical source's exclusion under section 223(d)(5)(C) of the Act, as amended, is that the source cannot participate in any Federal health care program under section 1128 of the Act, but the Office of Inspector General of the Department of Health and Human Services granted a waiver of the section 1128 exclusion; or

    (5) The evidence is a laboratory finding about a physical impairment and there is no indication that the finding is unreliable.

    (c) Statutorily excluded medical sources' reporting requirements. Statutorily excluded medical sources (as described in paragraph (a) of this section) must inform us in writing that they are excluded under section 223(d)(5)(C) of the Act, as amended, each time they submit evidence related to a claim for benefits under titles II or XVI of the Act. This reporting requirement applies to evidence that statutorily excluded medical sources submit to us either directly or through a representative, claimant, or other individual or entity.

    (1) Statutorily excluded medical sources must provide a written statement, which contains the following information:

    (i) A heading stating: “WRITTEN STATEMENT REGARDING SECTION 223(d)(5)(C) OF THE SOCIAL SECURITY ACT—DO NOT REMOVE”

    (ii) The name and title of the medical source;

    (iii) The applicable excluding event(s) stated in paragraphs (a)(1)-(a)(3) of this section;

    (iv) The date of the medical source's felony conviction under sections 208 or 1632 of the Act, if applicable;

    (v) The date of the imposition of a civil monetary penalty or assessment, or both, for the submission of false evidence, under section 1129 of the Act, if applicable; and

    (vi) The basis, effective date, anticipated length of the exclusion, and whether the Office of the Inspector General of the Department of Health and Human Services waived the exclusion, if the excluding event was the medical source's exclusion from participation in any Federal health care program under section 1128 of the Act.

    (2) The written statement provided by an excluded medical source may not be removed by any individual or entity prior to submitting evidence to us.

    (3) We may request that the excluded medical source provide us with additional information or clarify any information submitted that bears on the medical source's exclusion(s) under section 223(d)(5)(C) of the Act, as amended.

    [FR Doc. 2016-13744 Filed 6-9-16; 8:45 am] BILLING CODE 4191-02-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 175, 176, 177, and 178 [Docket No. FDA-2016-F-1253] Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition; Correction AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of petition; correction.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is correcting a notice entitled “Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition” that appeared in the Federal Register of May 20, 2016 (81 FR 31877). The document announced that Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council filed a petition proposing that we amend and/or revoke specified regulations to no longer provide for the food contact use of specified ortho-phthalates, but omitted two items. This document corrects that error.

    FOR FURTHER INFORMATION CONTACT:

    Kelly Randolph, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1188.

    SUPPLEMENTARY INFORMATION:

    In FR Doc. 2016-11866, appearing on page 31878 in the Federal Register of Friday, May 20, 2016, the following correction is made:

    On page 31878, in the third column, under the heading “§ 175.300 Resinous and Polymeric Coatings,” the document is corrected to add “Butyl phthalyl butyl glycolate (CAS No. 85-70-1)” and “Ethyl phthalyl ethyl glycolate (CAS No. 84-72-0)” in alphabetical order.

    Dated: June 7, 2016. Dennis M. Keefe, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.
    [FR Doc. 2016-13739 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2016-0169] RIN 1625-AA08 Special Local Regulation; Cumberland River, Mile 190.0 to 191.5; Nashville, TN AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to establish a special local regulation for all waters of the Cumberland River beginning at mile marker 190.0 and ending at mile marker 191.5 from 9 a.m. until noon on July 30, 2016. This proposed special regulation is necessary to provide safety for the participants in the “Music City SUP Race” marine event. This proposed rulemaking would prohibit persons and vessels from being in the special local regulated area unless authorized by the Captain of the Port Ohio Valley or a designated representative. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before June 27, 2016.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2016-0169 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 Petty Officer Ashley Schad, MSD Nashville, Nashville, TN, at 615-736-5421 or at [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, Purpose, and Legal Basis

    On January 28, 2016, the Nashville Paddle Company notified the Coast Guard that it will be conducting a race from 9 a.m. to noon on July 30, 2016. The event will consist of at least 75 participants on various sized stand up paddle boards and kayaks on the Cumberland River. The Captain of the Port Ohio Valley (COTP) has determined that additional safety measures are necessary to protect participants, spectators, and waterway users during this event. Therefore, the Coast Guard proposes to establish a special local regulation on specified waters of the Cumberland River. This proposed regulation would be in effect from 9 a.m. until noon on July 30, 2016.

    The purpose of this rulemaking is to ensure the safety of vessels and participants of the navigable waters before, during, and after the scheduled event. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1233, which authorizes the Coast Guard to establish and define special local regulations under 33 CFR 100.

    III. Discussion of Proposed Rule

    The Captain of the Port Ohio Valley proposes to establish a special local regulated area from 9 a.m.to noon on July 30, 2016 for all waters of the Cumberland River beginning at mile marker 190.0 and ending at mile marker 191.5. The duration of the special local regulated area is intended to ensure the safety of vessels, participants, and these navigable waters before, during, and after the scheduled event. No vessel or person would be permitted to enter the special local regulated area without obtaining permission from the COTP or a designated representative. 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 (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 NPRM has not been designated a “significant regulatory action,” under E.O. 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 special local regulated area.

    This proposed special local regulation restricts transit on the Cumberland River from mile 190.0 to 191.5, for a short duration of 3 hours for one day; Broadcast Notices to Mariners and Local Notices to Mariners will also inform the community of this special local regulation so that they may plan accordingly for this short restriction on transit. Vessel traffic may request permission from the COTP Ohio Valley or a designated representative to enter the restricted 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 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 special local regulated area 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 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 proposed 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 proposed rule does not have tribal implications under E.O. 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 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 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 special local regulated area that would prohibit entry to unauthorized vessels. Normally such actions are categorically excluded from further review under paragraph 34(h) 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 100

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

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

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

    33 U.S.C. 1233.

    2. Add § 100.35T08-0169 to read as follows:
    § 100.35T08-0169 Special Local Regulation; Cumberland River Mile 190.0 to 191.5; Nashville, TN

    (a) Location. All waters of the Cumberland River beginning at mile marker 190.0 and ending at mile marker 191.5 at Nashville, TN.

    (b) Regulations.

    (1) In accordance with the general regulations in § 100.801 of this part, entry into this area is prohibited unless authorized by the Captain of the Port Ohio Valley or a designated representative.

    (2) Persons or vessels requiring entry into or passage through the area must request permission from the Captain of the Port Ohio Valley or a designated representative. U.S. Coast Guard Sector Ohio Valley may be contacted on VHF Channel 13 or 16, or at 1-800-253-7465.

    Dated: May 10, 2016. R.V. Timme, Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
    [FR Doc. 2016-13782 Filed 6-9-16; 8:45 am] BILLING CODE 9110-04-P
    LIBRARY OF CONGRESS U.S. Copyright Office 37 CFR Part 202 [Docket No. 2016-3] Mandatory Deposit of Electronic Books and Sound Recordings Available Only Online AGENCY:

    U.S. Copyright Office, Library of Congress.

    ACTION:

    Extension of comment period.

    SUMMARY:

    The United States Copyright Office is extending the deadline for the submission of written comments in response to its May 17, 2016 Notice of Inquiry regarding the mandatory deposit of online-only electronic books and sound recordings.

    DATES:

    Written comments are now due no later than 11:59 p.m. Eastern Time on August 18, 2016.

    ADDRESSES:

    The Copyright Office is using the regulations.gov system for the submission and posting of public comments in this proceeding. All comments are therefore to be submitted electronically through regulations.gov. Specific instructions for submitting comments are available on the Copyright Office Web site at http://copyright.gov/policy/mandatorydeposit/. If electronic submission of comments is not feasible, please contact the Office using the contact information below for special instructions.

    FOR FURTHER INFORMATION CONTACT:

    Jacqueline C. Charlesworth, General Counsel and Associate Register of Copyrights, [email protected]; or Sarang V. Damle, Deputy General Counsel, [email protected] Both can be reached by telephone at 202-707-8350.

    SUPPLEMENTARY INFORMATION:

    The United States Copyright Office is undertaking an inquiry into the current interim rule regarding mandatory deposit of online-only electronic works, and the rule's potential expansion to cover electronic books and sound recordings. On May 17, 2016, the Copyright Office issued a Notice of Inquiry seeking public input on several questions related to that topic. See 81 FR 30505 (May 17, 2016). To ensure that commenters have sufficient time to respond, the Copyright Office is extending the deadline for the submission of initial comments in response to the Notice to August 18, 2016, at 11:59 p.m. Eastern Time.

    Dated: June 7, 2016. Jacqueline C. Charlesworth, General Counsel and Associate Register of Copyrights, U.S. Copyright Office.
    [FR Doc. 2016-13814 Filed 6-9-16; 8:45 am] BILLING CODE 1410-30-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2015-0009; EPA-R05-OAR-2015-0314; FRL-9946-79-Region 5] Air Plan Approval; Illinois; NAAQS Update AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve revised rules submitted by the State of Illinois as State Implementation Plan (SIP) revisions. The submitted rules update Illinois' ambient air quality standards to include the 2012 primary National Ambient Air Quality Standard (NAAQS) for fine particulate matter (PM2.5), add EPA-promulgated monitoring methods, and address the “sunset provisions” in our regulation, finding that the 1971 NAAQS for sulfur dioxide no longer applies to the Lemont and Pekin areas in Illinois. In addition, the revised rules contain the timing requirements for the “flagging of exceptional events” and the submitting of documentation supporting the determination of exceptional events for the 2012 primary annual averaged PM2.5 standard.

    DATES:

    Comments must be received on or before July 11, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R05-OAR-2015-0009 or EPA-R05-OAR-2015-0314 at http://www.regulations.gov or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Edward Doty, Air Programs Branch (AR-18J), Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6057, [email protected]

    SUPPLEMENTARY INFORMATION:

    In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittals as a direct final rule without prior proposal because the Agency views these as noncontroversial submittals and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that, if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the Rules section of this Federal Register.

    Dated: May 10, 2016. Robert A. Kaplan, Acting Regional Administrator, Region 5.
    [FR Doc. 2016-13695 Filed 6-9-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 261 [EPA-HQ-RCRA-2016-0040; FRL-9947-60-OLEM] Hazardous Waste Management System; Tentative Denial of Petition To Revise the RCRA Corrosivity Hazardous Characteristic AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Extension of comment period.

    SUMMARY:

    The Environmental Protection Agency (EPA or the Agency) is extending the comment period on the tentative denial of a petition to revise the Resource Conservation and Recovery Act (RCRA) corrosivity hazardous waste characteristic regulation, published in the Federal Register on April 11, 2016. EPA is tentatively denying the rulemaking petition because the materials submitted in support of the petition fail to demonstrate that the requested regulatory revisions are warranted, as further explained in the tentative denial. The Agency's review of additional materials it identified as relevant to the petition similarly did not demonstrate that any change to the corrosivity characteristic regulation is warranted at this time. The comment period is being extended to December 7, 2016.

    DATES:

    Comments must be received on or before December 7, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-RCRA-2016-0040, at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Gregory Helms, Materials Recovery and Waste Management Division, Office of Resource Conservation and Recovery, (5304P), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: 703-308-8855; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    This document extends the public comment period on the tentative denial of a petition to revise the Resource Conservation and Recovery Act (RCRA) corrosivity hazardous waste characteristic regulation, published in the Federal Register on April 11, 2016 (81 FR 21295). In that Federal Register notice, the Agency tentatively denied petitioners' requests that the Agency make two changes to the current RCRA corrosivity characteristic regulation: (1) Revise the regulatory value for defining waste as corrosive from the current value of pH 12.5, to pH 11.5; and (2) expand the scope of the RCRA corrosivity definition to include nonaqueous wastes in addition to the aqueous wastes currently regulated. Petitioner-Public Employees for Environmental Responsibility (“PEER”) has requested that the Agency extend the public comment period to allow additional time to evaluate the record supporting the tentative denial. EPA is hereby extending the comment period, which was set to end on June 10, 2016, to December 7, 2016. Late comments on this tentative denial may not be considered.

    To submit comments or access the docket, please follow the detailed instructions as provided under ADDRESSES. If you have questions, consult the individuals listed under FOR FURTHER INFORMATION CONTACT.

    Dated: June 3, 2016. Barnes Johnson, Director, Office of Resource Conservation and Recovery, Office of Solid Waste and Emergency Response.
    [FR Doc. 2016-13793 Filed 6-9-16; 8:45 am] BILLING CODE 6560-50-P
    81 112 Friday, June 10, 2016 Notices DEPARTMENT OF AGRICULTURE Food and Nutrition Service National Advisory Council on Maternal, Infant and Fetal Nutrition; Notice of Meeting AGENCY:

    Food and Nutrition Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act, 5 U.S.C. APP., this notice announces a meeting of the National Advisory Council on Maternal, Infant and Fetal Nutrition.

    Date and Time: July 12-14, 2016, 9:00 a.m.-5:30 p.m.

    Place: The meeting will be held at the Hilton Garden Inn Arlington/Shirlington, Environment Room, 4271 Campbell Avenue, Arlington, Virginia, 22206.

    SUPPLEMENTARY INFORMATION:

    The National Advisory Council on Maternal, Infant and Fetal Nutrition will meet to continue its study of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), and the Commodity Supplemental Food Program (CSFP). The agenda will include updates and a discussion of Breastfeeding Promotion and Support activities, the WIC food packages, WIC funding, Electronic Benefits Transfer, CSFP initiatives, and current research studies.

    Status: Meetings of the National Advisory Council on Maternal, Infant and Fetal Nutrition are open to the public. Members of the public may participate, as time permits. Members of the public may file written statements with the contact person named below before or after the meeting.

    Contact Person for Additional Information: Anne Bartholomew, Supplemental Food Programs Division, Food and Nutrition Service, Department of Agriculture, (703) 305-2746. If members of the public need special accommodations, please notify Anne Bartholomew by June 28, 2016, at (703) 305-2746, or email at [email protected]

    Dated: May 26, 2016. Audrey Rowe, Administrator, Food and Nutrition Service.
    [FR Doc. 2016-13703 Filed 6-9-16; 8:45 am] BILLING CODE 3410-30-P
    DEPARTMENT OF AGRICULTURE Forest Service Uinta-Wasatch-Cache Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Uinta-Wasatch-Cache Resource Advisory Committee (RAC) will meet in South Jordan, Utah. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with title II of the Act. RAC information can be found at the following Web site: http://www.fs.usda.gov/main/uwcnf/workingtogether/advisorycommittees.

    DATES:

    The meeting will be held on June 28, 2016, from 6:00 p.m.-8:00 p.m.

    All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Forest Service Office, Room #314, 857 West South Jordan Parkway, South Jordan, Utah. The meeting will also be available via conference call, for the conference line information, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at www.fs.usda.gov/uwcnf. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Loyal Clark, RAC Coordinator, by phone at 801-999-2113 or via email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to:

    1. Review the roles and responsibilities of the RAC,

    2. Develop operating guidelines,

    3. Elect a chair person, and

    4. Review and recommend project proposals.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by June 17, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Loyal Clark, RAC Coordinator, Uinta-Wasatch-Cache National Forest, 857 West South Jordan Parkway, South Jordan, Utah 84095; by email to [email protected], or via facsimile to 801-253-8118.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: June 3, 2016. David C. Whittekiend, Forest Supervisor.
    [FR Doc. 2016-13745 Filed 6-9-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Sanders Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Sanders Resource Advisory Committee (RAC) will meet in Thompson Falls, Montana. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. Additional RAC information, including the meeting agenda and the meeting summary/minutes can be found at the following Web site: http://cloudapps-usda-gov.force.com/FSSRS/RAC_Page?id=001t0000002JcwJAAS.

    DATES:

    The meeting will be held July 14, 2016, at 7:00 p.m.

    All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Sanders County Courthouse, 1111 Main Street, Thompson Falls, Montana.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at the Plains Ranger District, 408 Clayton Plains, Montana. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    John Gubel, Designated Federal Officer, by phone at 406-827-3533 or via email at jgu[email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is:

    1. Review and approve previous meeting minutes;

    2. Discuss project proposals and address project specific questions;

    3. Discuss project recommendations and rankings;

    4. Vote on projects to be recommended for approval; and

    5. Open forum for public discussion.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by July 1, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Robin Walker, RAC Coordinator, P.O. Box 429, Plains, Montana 59859; by email to [email protected], or via facsimile to 406-826-4358.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: May 23, 2016. John Gubel, Designated Federal Official, Sanders Resource Advisory Commitee.
    [FR Doc. 2016-13759 Filed 6-9-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Northeast Oregon Forests Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Northeast Oregon Forests Resource Advisory Committee (RAC) will meet in Baker City, Oregon. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site: http://www.fs.usda.gov/main/pts/specialprojects/racweb.

    DATES:

    The meeting will be held on the following dates:

    • July 14, 2016, from 9:30 a.m. to 4:00 p.m.; and

    • July 15, 2016, from 9:30 a.m. to 4:00 p.m.

    All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Whitman Ranger District, Baker Work Center, 3285 11th St., Baker City, Oregon.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at the Whitman Ranger District. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Jeff Tomac, Designated Federal Officer, by phone at 541-523-1301 or via email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to review and recommend 2016/2017 project proposals.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by July 7, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Jeff Tomac, Designated Federal Officer, Whitman Ranger District, 1550 Dewey Avenue, Suite A, Baker City, Oregon 97814; by email to [email protected], or via facsimile to 541-523-6395.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: May 31, 2016. Jeff Tomac, Desiganted Federal Official.
    [FR Doc. 2016-13749 Filed 6-9-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Black Hills Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Black Hills Resource Advisory Committee (RAC) will meet in Rapid City, South Dakota. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with title II of the Act. RAC information can be found at the following Web site: http://www.fs.usda.gov/main/blackhills/workingtogether/advisorycommittees.

    DATES:

    The meeting will be held on June 30, 2016, at 5:00 p.m. to 8:00 p.m.

    All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Mystic Ranger District, 8221 South Highway 16, Rapid City, South Dakota.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at the Mystic Ranger District. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Ruth Esperance, Designated Federal Officer, by phone at 605-343-1567 or via email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to review and recommend projects for funding under the Secure Rural School allocations to the Custer, Lawrence, and Pennington Counties for 2014 and 2015.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by June 24, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Ruth Esperance, Designated Federal Officer, 8221 South Highway 16, Rapid City, South Dakota; by email to [email protected]; or via facsimile to 605-343-7134.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: June 6, 2016. Ruth Esperance, Designated Federal Officer.
    [FR Doc. 2016-13743 Filed 6-9-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Notice of New Fee Site; Federal Lands Recreation Enhancement Act, (Title VIII, Pub. L. 108-447) AGENCY:

    Coronado National Forest, USDA Forest Service, USDA.

    ACTION:

    Notice of new fee site.

    SUMMARY:

    The Coronado National Forest is proposing to charge a $175 fee for the overnight rental of the Sollers Cabin, located on the Santa Catalina Ranger District. The Sollers Cabin has not been available for recreation use prior to this date. Rentals of other cabins on National Forests in Arizona have shown that the public appreciates the enhanced recreational opportunity afforded by these rehabilitated historic structures. Funds from the rental will be used for the continued operation and maintenance of this facility and other properties in the Arizona “Rooms with a View” Cabin Rental Program. This fee is only a proposal and will be determined upon further analysis and public comment.

    DATES:

    Please send any comments on this fee proposal by December, 2016, so comments can be complied, and analyzed and shared with the BLM—Arizona Recreation Resource Advisory Council. If the fee proposal is approved, the Sollers Cabin will likely be available for rent in the spring of 2017.

    ADDRESSES:

    Forest Supervisor, Coronado National Forest, 300 West Congress, Tucson, AZ 85701.

    FOR FURTHER INFORMATION CONTACT:

    Kathy Makansi, Archaeologist, 520-760-2502.

    SUPPLEMENTARY INFORMATION:

    The Federal Recreation Lands Enhancement Act (Title VII, Pub. L. 108-447) directed the Secretary of Agriculture to publish a six month advance notice in the Federal Register whenever new recreation fee areas are established. This new fee will be reviewed by the BLM—Arizona Recreation Resource Advisory Council prior to a final decision and implementation. The Coronado National Forest currently has seven other cabin rentals. These rentals are often fully booked throughout their rental season. Sollers is a large three bedroom (2-story) cabin located in a remote setting (at the end of a dirt road) approximately 20 miles from Tucson, Arizona. The cabin consists of 3 bedrooms, a living room, kitchen, and a bathroom. The cabin also has electricity and indoor plumbing. A business analysis of the Sollers Cabin has shown that people desire having this sort of recreation experience on the Coronado National Forest. A market analysis indicates that the $175.00/per night fee is both reasonable and acceptable for this sort of unique recreation experience.

    People wanting to rent the Sollers Cabin will need to do so through the National Recreation Reservation Service, at www.recreation.gov or by calling 1-877-444-6777. The National Recreation Reservation Service charges a $9 fee for reservations.

    Dated: June 2, 2016. Kerwin S. Dewberry, Coronado National Forest Supervisor.
    [FR Doc. 2016-13747 Filed 6-9-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Sanders Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Sanders Resource Advisory Committee (RAC) will meet in Thompson Falls, Montana. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site: http://cloudapps-usda-gov.force.com/FSSRS/RAC_Page?id=001t0000002JcwJAAS.

    DATES:

    The meeting will be held June 30, 2016, at 7:00 p.m.

    All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Sanders County Courthouse, 1111 Main Street, Thompson Falls, Montana.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at the Plains Ranger District. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    John Gubel, Designated Federal Officer, by phone at 406-827-3533 or via email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to:

    1. Review and approve previous meeting minutes;

    2. Discuss status of RAC and membership;

    3. Review status of approved projects and discuss monitoring;

    4. Review project proposals submitted; and

    5. Open forum for public discussion.

    The meeting is open to the public.

    The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by June 15, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Robin Walker, RAC Coordinator, P.O. Box 429, Plains, Montana 59859; by email to [email protected], or via facsimile to 406-826-4358.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: May 23, 2016. John Gubel, Designated Federal Official, Sanders Resource Advisory Committee.
    [FR Doc. 2016-13758 Filed 6-9-16; 8:45 am] BILLING CODE 3411-15-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Wisconsin Advisory Committee To Discuss Preparations for a Hearing on Hate Crimes 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 Wisconsin Advisory Committee (Committee) will hold a meeting on Friday, June 24, 2016, at 12:00 p.m. CDT for the purpose of preparing for a hearing on hate crime in the state.

    This meeting is open to the public through the following toll-free call-in number: 888-481-2877, conference ID: 4195513. Any interested member of the public may call this number and listen to 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. 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 invited to make statements to the Committee during the scheduled open comment period. In addition, members of the public may 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=282. 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: I. Welcome and Introductions—Naheed Bleecker, Chair II. Hearing Preparation: Hate Crimes and Civil Rights in Wisconsin • Panelists • Logistics (schedule, location, date) III. Open Comment—Public Participation IV. Adjournment DATES:

    The meeting will be held on Friday, June 24, 2016, at 12:00 p.m. CDT.

    Public Call Information:

    Dial: 888-481-2877.

    Conference ID: 4195513.

    FOR FURTHER INFORMATION CONTACT:

    Melissa Wojnaroski, DFO, at 312-353-8311 or [email protected]

    Dated: June 07, 2016. David Mussatt, Chief, Regional Programs Unit.
    [FR Doc. 2016-13756 Filed 6-9-16; 8:45 am] BILLING CODE 6335-01-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-5-2016] [Authorization of Production Activity, Foreign-Trade Subzone 279A, Thoma-Sea Marine Constructors, L.L.C. (Shipbuilding), Houma, Louisiana

    On February 3, 2016, the Houma-Terrebonne Airport commission, grantee of FTZ 279, submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board on behalf of Thoma-Sea Marine Constructors, L.L.C., operator of Subzone 279A, in Houma, Louisiana.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (81 FR 7500, February 12, 2016). The FTZ Board has determined that no further review of the activity is warranted at this time. The production activity described in the notification is authorized, subject to the FTZ Act and the FTZ Board's regulations, including Section 400.14, and the following special conditions:

    (1) Any foreign steel mill products admitted to the zone for the Thoma-Sea Marine Constructors, L.L.C., activity, including plate, angles, shapes, channels, rolled steel stock, bars, pipes and tubes, not incorporated into merchandise otherwise classified, and which is used in manufacturing, shall be subject to full customs duties in accordance with applicable law, unless the Executive Secretary determines that the same item is not then being produced by a domestic steel mill.

    (2) Thoma-Sea Marine Constructors, L.L.C., shall meet its obligation under 15 CFR 400.13(b) by annually advising the FTZ Board's Executive Secretary as to significant new contracts with appropriate information concerning foreign purchases otherwise dutiable, so that the FTZ Board may consider whether any foreign dutiable items are being imported for manufacturing in the zone primarily because of FTZ procedures and whether the FTZ Board should consider requiring customs duties to be paid on such items.

    Dated: June 2, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-13712 Filed 6-9-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-39-2016] Foreign-Trade Zone 119—Minneapolis, Minnesota; Notification of Proposed Production Activity; SICK, Inc.; Subzone 119G; (Electronic Industrial Sensors, Encoders, Optical Readers and Monitoring Systems); Savage, Minnesota

    The Greater Metropolitan Area Foreign Trade Zone Commission, grantee of FTZ 119, submitted a notification of proposed production activity to the FTZ Board on behalf of SICK, Inc. (SICK), operator of Subzone 119G, at its facility located in Savage, Minnesota. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on May 17, 2016.

    SICK already has authority to produce photo-electronic industrial automation sensors within Subzone 119G. The current request would add new finished products (encoders, zone control sensors, proximity sensors, integrated optical readers, data process monitoring/reporting systems) and certain foreign components and materials to the scope of authority. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

    Production under FTZ procedures could exempt SICK from customs duty payments on the foreign status components and materials used in export production. On its domestic sales, SICK would be able to choose the duty rates during customs entry procedures that apply to photo-electronic industrial automation sensors, encoders, zone control sensors, proximity sensors, integrated optical readers, and data process monitoring/reporting systems (free, 2.6% or 2.7%) for the foreign status inputs noted below and in the existing scope of authority. Customs duties also could possibly be deferred or reduced on foreign status production equipment.

    The components and materials sourced from abroad are: adhesives of polymers; plastic labels; plastic gaskets/washers/seals; corrugated cartons; steel screws/bolts/nuts/washers; steel and brass nuts/bolts/screws; steel brackets; inductors; electrical connectors; and, metal clamps and brackets (duty rate ranges from free to 6.5%).

    Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is July 20, 2016.

    A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via www.trade.gov/ftz.

    For further information, contact Pierre Duy at [email protected] or (202) 482-1378.

    Dated: June 2, 2016. Executive Secretary.
    [FR Doc. 2016-13706 Filed 6-9-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-1-2016] Subzone 230D; Authorization of Limited Production Activity; Klaussner Furniture Industries, Inc. (Upholstered Furniture); Asheboro and Candor, North Carolina

    On January 5, 2016, Klaussner Furniture Industries, Inc., operator of Subzone 230D, submitted a notification of proposed production activity to the Foreign Trade-Zones (FTZ) Board for its facilities within Subzone 230D, in Asheboro and Candor, North Carolina.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (81 FR 3100, January 20, 2016). The FTZ Board has determined that further review of part of the proposed activity is warranted at this time. The production activity described in the notification is authorized on a limited basis, subject to the FTZ Act and the FTZ Board's regulations, including Section 400.14, and further subject to a restriction requiring that foreign status upholstery leather including hides (classified within HTSUS Subheadings 4107.11, 4107.92, and 4107.99) be admitted to the subzone in privileged foreign status (19 CFR 146.41).

    Dated: June 2, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-13720 Filed 6-9-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-78-2016] Foreign-Trade Zone 233—Dothan, Alabama, Application for Subzone, Next Level Apparel, Ashford, Alabama

    An application has been submitted to the Foreign-Trade Zones Board (the Board) by the Dothan-Houston County Foreign Trade Zone, Inc., grantee of FTZ 233, requesting subzone status for the facility of Next Level Apparel located in Ashford, Alabama. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on June 1, 2016.

    The proposed subzone (22.27 acres) is located at 814 6th Avenue in Ashford. The proposed subzone would be subject to the existing activation limit of FTZ 233. No authorization for production activity has been requested at this time.

    In accordance with the Board's regulations, Camille Evans of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.

    Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is July 20, 2016. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to August 4, 2016.

    A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via www.trade.gov/ftz. For further information, contact Camille Evans at [email protected] or (202) 482-2350.

    Dated: June 1, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-13719 Filed 6-9-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-520-804] Certain Steel Nails From the United Arab Emirates: Preliminary Results of Antidumping Duty Administrative Review; 2014-2015 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on certain steel nails (nails) from the United Arab Emirates (UAE). The period of review (POR) is May 1, 2014, through April 30, 2015.1 We preliminarily find that ODS and Dubai Wire sold subject merchandise at less than normal value in the United States and that Oman Fasteners, OISI, and Precision had no shipments during the POR. Interested parties are invited to comment on these preliminary results.

    1 The review covers five producers/exporters of the subject merchandise, Dubai Wire FZE (Dubai Wire), Oman Fasteners LLC (Oman Fasteners), Overseas Distribution Services Inc. (ODS), Overseas International Steel Industry LLC (OISI), and Precision Fasteners LLC (Precision).

    DATES:

    Effective Date: June 10, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Bryan Hansen or Minoo Hatten, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3683, and (202) 482-1690, respectively.

    SUPPLEMENTARY INFORMATION:

    Scope of the Order

    The merchandise subject to the Order2 is nails from the UAE. The products are currently classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7317.00.55, 7317.00.65, and 7317.00.75. While the HTSUS subheadings are provided for convenience and customs purposes, the written product description remains dispositive. A full description of the scope of the order is contained in the Preliminary Decision Memorandum.3

    2See Certain Steel Nails from the United Arab Emirates: Amended Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order, 77 FR 27421 (May 10, 2012) (Order).

    3See the Memorandum from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, “Decision Memorandum for Preliminary Results of Antidumping Duty Administrative Review; 2014-2015: Certain Steel Nails from the United Arab Emirates” dated concurrently with and hereby adopted by this notice (Preliminary Decision Memorandum).

    Preliminary Determination of No Shipments

    Based on our analysis of U.S. Customs and Border Protection (CBP) information and information provided by Oman Fasteners, OISI, and Precision, we preliminarily determine that these companies had no shipments of the subject merchandise, and, therefore, no reviewable transactions, during the POR. For a full discussion of this determination, see the Preliminary Decision Memorandum.

    Methodology

    The Department is conducting this review in accordance with section 751(a)(2) of the Tariff Act of 1930, as amended (the Act). Export price is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions, see Preliminary Decision Memorandum.

    The Preliminary Decision Memorandum is a public document and is made available to the public via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and is available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be found at http://enforcement.trade.gov/frn/index.html. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content. A list of the topics discussed in the Preliminary Decision Memorandum is attached as an Appendix to this notice.

    Preliminary Results of Review

    As a result of this review, we preliminarily determine that the following weighted-average dumping margins exist for the period May 1, 2014, through April 30, 2015:

    Producer/exporter Weighted-
  • average
  • margin
  • (percent)
  • Overseas Distribution Services Inc. 7.80 Dubai Wire FZE 4 7.80

    4 Dubai Wire was not selected for individual examination in this review. Generally, we look to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the rate for respondents not selected for individual review. Section 735(c)(5)(A) of the Act instructs that we are not to calculate an all-others rate using any zero or de minimis margins or any margins based on total facts available. Accordingly, our usual practice has been to average the rates for the selected companies excluding zero, de minimis, and rates based entirely on facts available. In this review, we calculated a weighted-average dumping margin above zero or de minimis for the sole respondent selected for individual examination, ODS. Based on this, and analogous to the statutory provision concerning investigations, we preliminarily determine that a reasonable method for determining the weighted-average dumping margin for Dubai Wire in this review is to assign the rate calculated for ODS.

    Disclosure and Public Comment

    We intend to disclose the calculations performed to parties in this proceeding within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.5 Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.6

    5See 19 CFR 351.309(d).

    6See 19 CFR 351.303 (for general filing requirements).

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically filed document must be received successfully in its entirety by the Department's electronic records system, ACCESS, by 5 p.m. Eastern Time within 30 days after the date of publication of this notice.7 Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs. The Department intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, unless extended, pursuant to section 751(a)(3)(A) of the Act.

    7See 19 CFR 351.310(c).

    Assessment Rates

    Upon completion of the administrative review, the Department shall determine and CBP shall assess antidumping duties on all appropriate entries. If ODS' weighted-average dumping margin continues to be above de minimis in the final results of this review, we will calculate an importer-specific assessment rate on the basis of the ratio of the total amount of antidumping duties calculated for each importer's examined sales and the total entered value of the sales in accordance with 19 CFR 351.212(b)(1). If ODS' weighted-average dumping margin is zero or de minimis in the final results of review, we will instruct CBP not to assess duties on any of its entries in accordance with the Final Modification for Reviews, i.e., “{w}here the weighted-average margin of dumping for the exporter is determined to be zero or de minimis, no antidumping duties will be assessed.” 8

    8See Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101, 8102 (February 14, 2012).

    For entries of subject merchandise during the POR produced by ODS for which it did not know its merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.

    Consistent with our practice, if we continue to find that Oman Fasteners, OISI, and Precision had no shipments of subject merchandise to the United States in the final results of this review, we intend to instruct CBP to liquidate any existing entries of merchandise produced by Oman Fasteners, OISI, and Precision and exported by other parties at the all-others rate.

    For Dubai Wire, the company not selected for individual examination, we will instruct CBP to apply the rate assigned to it in the final results of this review, to all entries of subject merchandise produced and/or exported by Dubai Wire.

    We intend to issue instructions to CBP 15 days after publication of the final results of this review.

    Cash Deposit Requirements

    The following deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of nails from the UAE entered, or withdrawn from warehouse, for consumption on or after the date of publication as provided by section 751(a)(2) of the Act: (1) The cash deposit rates for ODS and Dubai Wire will be the rates established in the final results of this administrative review; (2) for merchandise exported by manufacturers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; (4) the cash deposit rate for all other manufacturers or exporters will continue to be 4.30 percent, the all-others rate established in the Order. These cash deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Importers

    This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

    Dated: June 3, 2016.

    Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    Appendix—List of Topics Discussed in the Preliminary Decision Memorandum Summary Background Scope of the Order Preliminary Determination of No Shipments Rate for Respondent Not Selected for Individual Examination Discussion of the Methodology A. Comparisons to Normal Value 1. Determination of Comparison Method 2. Results of Differential Pricing Analysis B. Product Comparisons C. Date of Sale D. U.S. Price E. Normal Value 1. Home Market Viability and Comparison Market 2. Level of Trade 3. Calculation of Normal Value Based on Constructed Value 4. Cost of Production F. Verification G. Currency Conversion Recommendation
    [FR Doc. 2016-13704 Filed 6-9-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-827] Certain Cased Pencils From the People's Republic of China: Preliminary Results of Antidumping Duty New Shipper Review; 2014-2015 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (the Department) is a conducting a new shipper review (NSR) of the antidumping duty order on certain cased pencils from the People's Republic of China (PRC). The NSR covers the exporter Wah Yuen Stationery Co., Ltd. and its affiliated producer, Shandong Wah Yuen Stationery Co., Ltd. (collectively, Wah Yuen). The period of review (POR) is December 1, 2014, through May 31, 2015. The Department preliminarily finds that Wah Yuen made a sale of subject merchandise at below normal value. Interested parties are invited to comment on these preliminary results.

    DATES:

    Effective Date: June 10, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Mary Kolberg, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-1785.

    Scope of the Order

    Imports covered by this order are shipments of certain cased pencils of any shape or dimension which are writing and/or drawing instruments that feature cores of graphite or other materials, encased in wood and/or man-made materials, whether or not decorated and whether or not tipped (e.g., with erasers, etc.) in any fashion, and either sharpened or unsharpened. The pencils subject to the order are currently classifiable under subheading 9609.10.00 of the Harmonized Tariff Schedule of the United States (HTSUS). A full description of the scope of the order is contained in the Preliminary Decision Memorandum.1 Although the HTSUS subheadings are provided for convenience and customs purposes, the written product description is dispositive.

    1See Memorandum to Paul Piquado, Assistant Secretary for Enforcement and Compliance, from Christian Marsh, Deputy Assistant Secretary, re: “Decision Memorandum for Preliminary Results of Antidumping Duty New Shipper Review: Certain Cased Pencils from the People's Republic of China,” dated June 2, 2016.

    Methodology

    The Department is conducting this review in accordance with section 751(a)(2)(B) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.214. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. A list of topics discussed in the Preliminary Decision Memorandum is in the attached Appendix to this notice.

    The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's centralized electronic service system (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and it is available to all parties in the Department's Central Records Unit, B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the Internet at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    Preliminary Results of New Shipper Review

    The Department preliminarily determines that the following weighted-average dumping margin exists for the POR December 1, 2014, through May 31, 2015:

    Exporter Producer Weighted average dumping margin
  • (percent)
  • Wah Yuen Stationery Co., Ltd. Shandong Wah Yuen Stationery Co., Ltd. 31.03
    Disclosure and Public Comment

    The Department will disclose the analysis performed for these preliminary results to the parties within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties may submit case briefs by no later than 30 days after the date of publication of these preliminary results of review.2 Rebuttals, limited to issues raised in the case briefs, may be filed by no later than five days after the case briefs are filed.3

    2See 19 CFR 351.309(c).

    3See 19 CFR 351.309(d).

    Any interested party may request a hearing within 30 days of publication of this notice.4 Hearing requests should contain the following information: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Oral presentations will be limited to issues raised in the briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing to be held at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.5

    4See 19 CFR 351.310(c).

    5See 19 CFR 351.310(d).

    Unless the deadline is extended pursuant to section 751(a)(2)(B)(iii), the Department intends to issue the final results of this new shipper review, which will include the results of its analysis of all issues raised in the case and rebuttal briefs, within 90 days of publication of these preliminary results, pursuant to section 751(a)(2)(B)(iv) of the Act.

    Assessment Rates

    Upon issuance of the final results, pursuant to 19 CFR 351.212(b), the Department will determine, and the U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries.6 The Department intends to issue assessment instructions to CBP 15 days after the date of publication of the final results of this new shipper review.

    6See 19 CFR 351.212(b)(1).

    If the respondent's weighted average dumping margin is not zero or de minimis (i.e., less than 0.50 percent) in the final results, the Department will calculate importer-specific assessment rates on the basis of the ratio of the total amount of dumping calculated for each importer's examined sales to the total entered value of those sales, in accordance with 19 CFR 351.212(b)(1). Where an importer-specific ad valorem rate is not zero or de minimis, the Department will instruct CBP to collect the appropriate antidumping duties at the time of liquidation.7 Where either a respondent's weighted average dumping margin is zero or de minimis, or an importer-specific ad valorem rate is zero or de minimis, the Department will instruct CBP to liquidate appropriate entries without regard to antidumping duties.8

    7See 19 CFR 351.212(b)(1).

    8See 19 CFR 351.106(c)(2).

    For entries that were not reported in the U.S. sales data submitted by Wah Yuen, the Department will instruct CBP to liquidate such entries at the rate for the PRC-wide entity.9 The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future cash deposits of estimated antidumping duties, where applicable.

    9 For a full discussion of this practice, see Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011).

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this new shipper review for shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: For merchandise produced by Shandong Wah Yuen Stationery Co., Ltd. and exported by Wah Yuen Stationery Co., Ltd., the cash deposit rates will be equal to the weighted-average dumping margin established in the final results of this review (except, if the rate is zero or de minimis, then zero cash deposit will be required). These cash deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Importers

    This notice also serves as a reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during the POR. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Notification Regarding Administrative Protective Orders

    This notice serves as a reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a violation subject to sanction.

    Notification to Interested Parties

    These preliminary results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.214 and 351.221(b)(4).

    Dated: June 2, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix—List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope of the Order IV. Discussion of the Methodology V. Date of Sale VI. Comparisons to Normal Value VII. Results of Differential Pricing Analysis VIII. U.S. Price IX. Normal Value X. Factor Valuations XI. Currency Conversion XII. Recommendation
    [FR Doc. 2016-13721 Filed 6-9-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration United States Travel and Tourism Advisory Board: Meeting of the United States Travel and Tourism Advisory Board AGENCY:

    International Trade Administration, U.S. Department of Commerce.

    ACTION:

    Notice of an open meeting.

    SUMMARY:

    The United States Travel and Tourism Advisory Board (Board) will hold the first meeting of its newly appointed members on Thursday, June 30, 2016. The Board was re-chartered in August 2015, to advise the Secretary of Commerce on matters relating to the travel and tourism industry. At the meeting, members will be sworn-in and will begin a discussion of the work they will undertake during their appointment term. They are expected to discuss issues impacting the travel and tourism industry, including travel promotion, visa policy, travel facilitation, data and research, sustainable tourism, and domestic travel and tourism issues, in addition to other topics. The agenda may change to accommodate Board business. The final agenda will be posted on the Department of Commerce Web site for the Board at http://trade.gov/ttab, at least one week in advance of the meeting.

    DATES:

    Thursday, June 30, 2016, 9 a.m.-12 p.m. EDT. 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 June 23, 2016.

    ADDRESSES:

    The meeting will be held at the Department of Commerce. Requests to register (including to speak or for auxiliary aids) and any written comments should be submitted to: U.S. Travel and Tourism Advisory Board, U.S. Department of Commerce, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230, [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:

    Li Zhou, the United States Travel and Tourism Advisory Board, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230, telephone: 202-482-4501, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background: The Board advises the Secretary of Commerce on matters relating to the U.S. travel and tourism 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 meeting. 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 5:00 p.m. EDT on Thursday, June 23, 2016, for inclusion in the meeting records and for circulation to the members of the Travel and Tourism Advisory Board.

    In addition, any member of the public may submit pertinent written comments concerning the Board's affairs at any time before or after the meeting. Comments may be submitted to Li Zhou at the contact information indicated above. To be considered during the meeting, comments must be received no later than 5:00 p.m. EDT on Thursday, June 23, 2016, to ensure transmission to the Board 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 Board meeting minutes will be available within 90 days of the meeting.

    Dated: June 6, 2016. Li Zhou, Executive Secretary, United States Travel and Tourism Advisory Board.
    [FR Doc. 2016-13775 Filed 6-9-16; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Pacific Coast Groundfish Trawl Rationalization Program Permit and License Information Collection AGENCY:

    National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, 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.

    DATES:

    Written comments must be submitted on or before August 9, 2016.

    ADDRESSES:

    Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at [email protected]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Sarah Towne, NMFS West Coast Region, 7600 Sand Point Way NE., Seattle, WA 98103, (206) 526-4140, or [email protected]

    SUPPLEMENTARY INFORMATION: I. Abstract

    The National Marine Fisheries Service (NMFS) requests comments on the extension of a currently approved information collection for the West Coast Region's Pacific Coast Groundfish Trawl Rationalization Program.

    The Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801 et seq., provides that the Secretary of Commerce is responsible for the conservation and management of marine fisheries resources in the Exclusive Economic Zone (3-200 miles) of the United States. NMFS West Coast Region manages the Pacific Coast Groundfish Fishery in the Exclusive Economic Zone (EEZ) off of Washington, Oregon, and California under the Pacific Coast Groundfish Fishery Management Plan.

    In January 2011, NMFS implemented a trawl rationalization program, which is a catch share program, for the Pacific Coast Groundfish Limited Entry Trawl Fishery. The program was implemented through Amendments 20 and 21 to the Pacific Coast Groundfish Fishery Management Plan and the corresponding implementing regulations at 50 CFR part 660. Amendment 20 established the trawl rationalization program that consists of: an individual fishing quota (IFQ) program for the shorebased trawl fleet (including whiting and nonwhiting sectors), and cooperative programs for the at-sea mothership and catcher/processor trawl fleets (whiting only). Amendment 21 set long-term allocations for the limited entry trawl sectors of certain groundfish species.

    Under the trawl rationalization program, new permits, accounts, endorsements and licenses were established. These consist of: Quota share (QS) permits/accounts, vessel accounts, first receiver site licenses, mothership endorsements on certain limited entry trawl permits, mothership catcher vessel endorsements on certain limited entry trawl permits, catcher/processor endorsements on certain limited entry trawl permits, a mothership cooperative permit, and a catcher/processor cooperative permit. NMFS collects information from program participants required to: (1) Establish new permits, accounts, and licenses; (2) renew permits, accounts, and licenses; (3) allow trading of QS percentages and quota pounds (QP) in online QS and vessel accounts, and allow transfer of catch history assignments between limited entry trawl permits; (4) track compliance with program control limits; and (5) implement other features of the regulations pertaining to permits and licenses. NMFS requests comments on the extension of these permit information collections.

    As part of this request, NMFS plans to remove the notary requirement on all of our forms in this collection, which will save time and money for permit, vessel, and license owners.

    II. Method of Collection

    Information is collected by mail and electronically.

    The following information is collected by mail: QS permit application forms; late QS permit renewals; vessel account registration requests; late vessel account renewals; trawl identification of ownership interest forms for new applicants, mothership catcher vessel endorsed limited entry permit owners, and mothership permit owners; first receiver site license application forms; mothership permit renewal forms; mothership permit change of vessel registration, permit owner, or vessel owner application forms; mothership cooperative permit application forms; change of mothership catcher vessel endorsement and catch history assignment registration forms; mutual agreement exception forms; mothership withdrawal forms; catcher/processor cooperative permit application forms; material change forms; and QS abandonment requests.

    The following information is collected electronically: QS permit renewals; QS percent transfers; QP transfers from a QS account to a vessel account; vessel account renewals; QP transfers from a vessel account to another vessel account; and trawl identification of ownership interest forms for online QS and vessel account renewals.

    III. Data

    OMB Control Number: 0648-0620.

    Form Number(s): None.

    Type of Review: Extension of a currently approved collection, with revision.

    Affected Public: Business or other for-profit organizations; Not-for-profit institutions; State, Local, or Tribal government.

    Estimated Number of Respondents: 410 unique respondents.

    Estimated Time per Response: QS permit/account application form—30 minutes; QS permit/account online renewal—10 minutes; QS permit/account late renewal form—15 minutes; QS transfer—10 minutes; QP transfer from QS account to vessel account—8 minutes; vessel account registration request—15 minutes; vessel account online renewal—10 minutes; vessel account late renewal form—15 minutes; QP transfer from vessel account to another vessel account—8 minutes; trawl identification of ownership interest form for new entrants—45 minutes; trawl identification of ownership interest form for renewals—5 minutes; first receiver site license application form for new entrants—210 minutes; first receiver site license application form for re-registering license holders—110 minutes; mothership permit renewal form—20 minutes; mothership permit change of vessel registration, permit owner, or vessel owner application form—45 minutes; mothership cooperative permit application form—240 minutes; change of mothership catcher vessel endorsement and catch history assignment registration form—45 minutes; mutual agreement exception—60 minutes; mothership withdrawal—120 minutes; catcher/processor cooperative permit application form—120 minutes; QS abandonment request—10 minutes.

    Estimated Total Annual Burden Hours: 640.

    Estimated Total Annual Cost to Public: $12,475.

    IV. Request for Comments

    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 (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

    Dated: June 7, 2016. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2016-13748 Filed 6-9-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE614 Endangered Species; File No. 20114 AGENCY:

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

    ACTION:

    Notice; receipt of application.

    SUMMARY:

    Notice is hereby given that Commonwealth of Northern Mariana Islands Department of Lands & Natural Resources, Sea Turtle Program, Caller Box 10007 Saipan, MP 96950 Northern Mariana Islands [Responsible Party: Richard B. Seman,], has applied in due form for a permit to take green (Chelonia mydas) and hawksbill (Eretmochelys imbricata) sea turtles for purposes of scientific research.

    DATES:

    Written, telefaxed, or email comments must be received on or before July 11, 2016.

    ADDRESSES:

    The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page, https://apps.nmfs.noaa.gov, and then selecting File No. 20114 from the list of available applications.

    These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to [email protected] Please include the File No. in the subject line of the email comment.

    Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.

    FOR FURTHER INFORMATION CONTACT:

    Arturo Herrera or Amy Hapeman (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    The subject permit is requested under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.) and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

    The applicant requests a five-year permit to research green and hawksbill sea turtles within the U.S. CNMI. The purpose of the project is to characterize the population structure, size class composition, foraging ecology, health, and migration patterns of green and hawksbill turtles in the region. Researchers would be authorized to capture 265 green and 40 hawksbill sea turtles annually by hand-capture and perform the following procedures: Examine; measure; photograph; video; weigh; flipper and Passive Integrated Transponder (PIT) tag; temporary carapace mark; oral swab, tissue, and blood sample. 235 green and 20 hawksbill sea turtles will receive scute sampling, while 30 captured hawksbills and 20 greens will have satellite transmitters attached by epoxy. In addition, dead carcasses, tissues and parts may be salvaged from up to 15 greens and 10 hawksbills annually.

    Dated: June 6, 2016. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-13713 Filed 6-9-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-BA21 Notice of Availability of a Draft Environmental Impact Statement for the Proposed Expansion for the Flower Garden Banks National Marine Sanctuary; Announcement of Public Meetings AGENCY:

    Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).

    ACTION:

    Notice of availability and public meetings.

    SUMMARY:

    The National Oceanic and Atmospheric Administration (NOAA) has prepared a draft environmental impact statement for the proposed actions of boundary expansion, and application of existing regulations and management plan actions to new geographic areas of the Flower Garden Banks National Marine Sanctuary (FGBNMS or sanctuary). The purpose of this action is to provide sanctuary protection for a number of nationally significant reefs and banks in the northcentral Gulf of Mexico. Five alternatives to implement these proposed actions are analyzed for potential effects on the human environment. NOAA is soliciting public comment on the draft environmental impact statement.

    DATES:

    Comments on this draft environmental impact statement will be considered if received by August 19, 2016. Public meetings will be held in the following locations and times as indicated below:

    (1) Galveston, Texas Date: July 12, 2016 Location: Flower Garden Banks National Marine Sanctuary Office Address: 4700 Avenue U, Building 216, Galveston, TX 77551 Time: 5:30-7:30 p.m. (2) Houston, Texas Date: July 13, 2016 Location: Trini Mendenhall Community Center Address: 1414 Wirt Rd., Houston, TX 77055 Time: 5:30-7:30 p.m. (3) New Orleans, Louisiana Date: July 19, 2016 Location: Hilton New Orleans Airport, Segnette Room Address: 901 Airline Drive, Kenner, LA 70062 Time: 5:30-7:30 p.m. (4) Mobile, Alabama Date: July 20, 2016 Location: Five Rivers Delta Center Address: 30945 Five Rivers Blvd., Spanish Fort, AL 36527 Time: 5:30-7:30 p.m. (5) Lafayette, Louisiana Date: July 21, 2016 Location: Estuarine Habitats and Coastal Fisheries Center Address: 646 Cajundome Blvd., Lafayette, LA 70506 Time: 5:30-7:30 p.m. ADDRESSES:

    You may submit comments on this document, identified by NOAA-NOS-2016-0059, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NOS-2016-0059, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Flower Garden Banks National Marine Sanctuary, NOAA, 4700 Avenue U, Building 216, Galveston, TX 77551, Attn: George Schmahl, Superintendent.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NOAA. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NOAA will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    FOR FURTHER INFORMATION CONTACT:

    Kelly Drinnen, Education and Outreach Specialist, Flower Garden Banks National Marine Sanctuary at 409-621-5151 ext. 102 or via email at [email protected].

    Copies of the draft environmental impact statement can be downloaded or viewed on the internet at www.regulations.gov (search for docket #NOAA-NOS-2016-0059) or at http://flowergarden.noaa.gov. Copies can also be obtained by contacting the person identified under FOR FURTHER INFORMATION CONTACT.

    SUPPLEMENTARY INFORMATION:

    I. Background Flower Garden Banks National Marine Sanctuary

    Located in the northwestern Gulf of Mexico, 70 to 115 miles off the coasts of Texas and Louisiana, Flower Garden Banks National Marine Sanctuary (FGBNMS or sanctuary) currently includes three separate undersea features: East Flower Garden Bank; West Flower Garden Bank; and Stetson Bank. The banks range in depth from 55 feet to nearly 500 feet and provide a wide range of habitat conditions that support several distinct biological communities, including the northernmost coral reefs in the continental United States. These and similar formations throughout the north central Gulf of Mexico provide the foundation for significant habitat for a variety of species. The combination of location and geology makes FGBNMS extremely productive and diverse, and presents a unique set of challenges for managing and protecting its natural wonders. East and West Flower Garden Banks were designated a national marine sanctuary in 1992 for purposes of protecting and managing the conservation, ecological, recreational, research, education, historic and aesthetic resources and qualities of these areas. Stetson Bank was added to the sanctuary by Congress in 1996 (Pub. Law 104-283).

    The Office of National Marine Sanctuaries (ONMS) is required to periodically review sanctuary management plans to ensure that sanctuary sites continue to best conserve, protect and enhance their nationally significant living and cultural resources. In 2012 NOAA updated and revised the 1991 Flower Garden Banks Management Plan to address recent scientific discoveries, advancements in managing marine resources, and new resource management issues. As a result of this review, the FGBNMS Advisory Council recommended expanding the sanctuary to provide similar protections to additional banks in the north central Gulf of Mexico.

    On February 3, 2015 NOAA initiated the public scoping process (80 FR 5699) to consider expanding FGBNMS to include additional areas in the Gulf of Mexico. The public scoping period ended on April 6, 2015, during which time three public hearings were held and NOAA received both written and oral comments on the concept of expanding the boundaries of the sanctuary. NOAA received approximately 200 comments during that scoping period, generally supportive of the concept to expand the sanctuary boundary. Some comments were supportive with conditions tied to specific issues such as access to oil and gas resources and fisheries concerns. This information was considered during the development of the range of alternatives in the expansion proposal.

    The expansion of the sanctuary to include additional nationally significant habitat is supported for a number of reasons. In general, the northern Gulf of Mexico is a heavily utilized and industrialized region, and there is a significant concern about impacts from bottom-disturbing activities (e.g. some activities related to oil and gas exploration and production, fishing with bottom tending gear, vessel anchoring, and salvage activities) on the sensitive biological resources and geological features associated with many reefs and banks in the area. Additional opportunities for research, exploration, and education related to these significant ocean resources is critical for understanding changes occurring in the environment, fostering a stewardship ethic, and developing an understanding of the ecosystem services these resources provide for communities throughout the Gulf of Mexico region.

    II. NOAA Proposed Action

    NOAA is releasing for public comment a DEIS that analyzes a proposed action to expand the FGBNMS boundary to include additional bank and reef areas in the northcentral Gulf of Mexico and to apply the existing sanctuary regulations and management regime to the expanded area. NOAA developed five alternatives for expanding the FGBNMS boundary. The alternatives range from taking no action to adding as much as an additional approximate 880 square miles.

    NOAA's preferred alternative (Alternative 3) is the expansion of the existing boundaries from ~56 square miles to an area that encompasses ~383 square miles of waters in the northwestern Gulf of Mexico. This alternative would add 15 additional banks ranging from 70 to 120 miles off-shore that are comprised of reefs and bottom features that provide habitat for fish and other biological resources that serve as engines of sustainability for much of the Gulf of Mexico.

    The proposed sanctuary expansion advances NOAA's mission to conserve and manage coastal and marine ecosystems and resources and furthers the FGBNMS mission to identify, protect, conserve, and enhance the natural and cultural resources, values, and qualities of FGBNMS and its regional environment for this and future generations. The need for the proposed sanctuary expansion is informed by widespread acute and chronic threats to marine habitat in the north central Gulf of Mexico that can most effectively be addressed through NOAA's evaluation and implementation of the comprehensive suite of habitat conservation and management actions made possible by FGBNMS expansion to ensure that valuable natural resources are available to future generations of Americans.

    NOAA is seeking public comment on the DEIS which is available at http://flowergarden.noaa.gov/ or may be obtained by contacting the individual listed under the heading FOR FURTHER INFORMATION CONTACT.

    Authority:

    16 U.S.C. 1431 et seq.

    Dated: June 1, 2016. John Armor, Acting Director, Office of National Marine Sanctuaries.
    [FR Doc. 2016-13661 Filed 6-9-16; 8:45 am] BILLING CODE 3510-NK-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE404 and 0648-XE486 Marine Mammals; File Nos. 18978 and 19768 AGENCY:

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

    ACTION:

    Notice; issuance of permits.

    SUMMARY:

    Notice is hereby given that permits have been issued to the following entities for research on marine mammal parts:

    File No. 18978: Pam Miller, Alaska Community Action on Toxics, 505 West Northern Lights Blvd., Suite 205, Anchorage, AK 99503; and

    File No. 19768: Evin Hildebrandt, Ph.D., University of Massachusetts Medical School, 55 Lake Avenue, S3-221, Worcester, MA 01655.

    ADDRESSES:

    The permits and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Skidmore or Amy Sloan, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    On March 8, 2016 (File No. 18978; 81 FR 12075) and March 11, 2016 (File No. 19768; 81 FR 12879), notices were published in the Federal Register that requests for permits to conduct research on marine mammal parts had been submitted by the above-named applicants. The requested permits have been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

    File No. 18978 (Miller) authorizes the receipt and export of subsistence hunted marine mammal parts. Researchers will work with Yupik households and local hunters on St. Lawrence Island, Alaska, to obtain samples from up to 8 animals per year from ringed seal (Pusa hispida); bearded seal (Erignathus barbatus); and ribbon seal (Histriophoca fasciata) and 9 animals per year from bowhead whale (Balaena mysticetus) and spotted seal (Phoca largha). Samples would be measured for contaminant levels to determine marine mammal exposure to polybrominated diphenyl ethers and perfluorinated compounds. No live animals would be affected. The permit is valid through April 30, 2021.

    File No. 19768 (Hildebrandt) authorizes the receipt of cell lines from other researchers and the creation of cell lines from animal tissues obtained from the stranding network under a regional authorization letter for scientific research purposes. Up to 15 cell lines would be received or created annually from certain cetacean species. These cell lines would be used to study the evolution of endogenous viruses (viruses that integrate into the genome of the host) using the DNA and RNA sequencing. No live animals would be affected. The permit is valid through May 31, 2021.

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), a final determination has been made that the activities proposed are categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    As required by the ESA, issuance of these permits was based on a finding that such permits: (1) Were applied for in good faith; (2) will not operate to the disadvantage of such endangered species; and (3) are consistent with the purposes and policies set forth in section 2 of the ESA.

    Dated: June 6, 2016. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-13714 Filed 6-9-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE619 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 (Assistant Regional Administrator), has made a preliminary determination that an exempted fishing permit application contains all of the required information and warrants further consideration. This permit would allow one commercial fishing vessel to test the economic viability of using electric rod and reel gear to target pollock in the Western Gulf of Maine Closure Area, and to temporarily retain undersized catch for measurement and data collection. The privately-funded study would be conducted by a commercial fisherman as a pilot demonstration project.

    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 June 27, 2016.

    ADDRESSES:

    You may submit written comments by any of the following methods:

    Email: [email protected] Include in the subject line “Comments on Rod and Reel Fishing in WGOM Closed Area 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 “Comments Rod and Reel Fishing in WGOM Closed Area EFP.”

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth Scheimer, Fisheries Management Specialist, 978-281-9236, [email protected]

    SUPPLEMENTARY INFORMATION:

    A commercial fisherman submitted a complete application for an exempted fishing permit (EFP) on May 4, 2016, to conduct commercial fishing activities that the regulations would otherwise restrict. The EFP would authorize one vessel to use electric rod and reel gear in the Western Gulf of Maine (GOM) Closure Area and to temporarily retain undersized catch for measurement and data collection.

    The project, titled “Utilization of Electric Rod and Reel to Target Pollock in WGOM Closed Area,” is privately funded by a commercial fisherman as a pilot study to test the economic viability of using electric rod and reel gear to target pollock while avoiding non-target catch. The study would take place in the Western GOM Closure Area, from June through August 2016, with one vessel planning to fish up to 5 days per month. The exemptions are necessary because groundfish vessels on commercial groundfish trips are prohibited from fishing in the Western GOM Closure Area and from retaining undersized groundfish. The vessel would use four electric rod and reels each day and fish for at least 4 to 6 hours, with an additional 5 to 6 hours of steaming, for a total trip of approximately 12 hours. Fishing would primarily occur within the Western GOM Closure Area, in the area known as “The Fingers,” with some effort being conducted outside the area. The researcher is requesting access to the Western GOM Closure Area based on his belief that pollock is concentrated in this area, and that they can be targeted with minimal catch of non-target species.

    A research technician would accompany all trips that occur under this EFP to measure and document fish caught (retained and discarded), document fishing gear, bait, location, and fishing conditions to evaluate gear performance. Undersized fish would be discarded as quickly as possible after sampling. All Northeast multispecies of legal size would be landed, with all catch being attributed to the sector vessel's annual catch entitlement. Proceeds from the sales would be retained by the vessel. The participating vessel would not be exempt from any sector monitoring or reporting requirements.

    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: June 6, 2016. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-13728 Filed 6-9-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE United States Patent and Trademark Office [Docket No.: PTO-P-2016-00014] Grant of Interim Extension of the Term of U.S. Patent No. 5,912,231; LOCILEX® (pexiganan) AGENCY:

    United States Patent and Trademark Office, Commerce.

    ACTION:

    Notice of Interim Patent Term Extension.

    SUMMARY:

    The United States Patent and Trademark Office has issued an order granting interim extension under 35 U.S.C. 156(d)(5) for a one-year interim extension of the term of U.S. Patent No. 5,912,231.

    FOR FURTHER INFORMATION CONTACT:

    Mary C. Till by telephone at (571) 272-7755; by mail marked to her attention and addressed to the Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273-7755; or by email to [email protected]

    SUPPLEMENTARY INFORMATION:

    Section 156 of Title 35, United States Code, generally provides that the term of a patent may be extended for a period of up to five years if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review, and that the patent may be extended for interim periods of up to one year if the regulatory review is anticipated to extend beyond the expiration date of the patent.

    On May 26, 2016, Scripps Research Institute, the patent owner of record, timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 5,912,231. The patent claims a composition of the active ingredient pexiganan of the human drug product LOCILEX®. The application for patent term extension indicates that New Drug Application (NDA) 29-930 was submitted to the Food and Drug Administration (FDA) on July 24, 1998.

    Review of the patent term extension application indicates that, except for permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for one year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory review period will continue beyond the original expiration date of the patent, June 15, 2016, interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.

    An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 5,912,231 is granted for a period of one year from the original expiration date of the patent.

    Dated: June 6, 2016. Robert Bahr, Deputy Commissioner for Patent Examination Policy, United States Patent and Trademark Office.
    [FR Doc. 2016-13764 Filed 6-9-16; 8:45 am] BILLING CODE 3510-16-P
    DEPARTMENT OF COMMERCE United States Patent and Trademark Office [Docket No. PTO-P-2016-0020] Patent and Trademark Public Advisory Committees AGENCY:

    United States Patent and Trademark Office, Commerce.

    ACTION:

    Notice and request for nominations for the Patent and Trademark Public Advisory Committees.

    SUMMARY:

    On November 29, 1999, the President signed into law the Patent and Trademark Office Efficiency Act (the “Act”), Public Law 106-113, which, among other things, established two Public Advisory Committees to review the policies, goals, performance, budget and user fees of the United States Patent and Trademark Office (USPTO) with respect to patents, in the case of the Patent Public Advisory Committee, and with respect to trademarks, in the case of the Trademark Public Advisory Committee, and to advise the Director on these matters (now codified at 35 U.S.C. 5). The America Invents Act Technical Corrections Act made several amendments to the 1999 Act, including the requirement that the terms of the USPTO Public Advisory Committee members be realigned by 2014, so that December 1 be used as the start and end date, with terms staggered so that each year three existing terms expire and three new terms begin on December 1. Through this Notice, the USPTO is requesting nominations for up to three (3) members of the Patent Public Advisory Committee, and for up to three (3) members of the Trademark Public Advisory Committee, for terms of three years that begin on December 1, 2016.

    DATES:

    Nominations must be postmarked or electronically transmitted on or before July 25, 2016.

    ADDRESSES:

    Persons wishing to submit nominations should send the nominee's resumé by postal mail to Vikrum D. Aiyer, Chief of Staff, Office of the Under Secretary of Commerce for Intellectual Property and Director of the USPTO, Post Office Box 1450, Alexandria, Virginia 22313-1450 or by electronic mail to: [email protected] for the Patent Public Advisory Committee, or [email protected] for the Trademark Public Advisory Committee.

    FOR FURTHER INFORMATION CONTACT:

    Vikrum D. Aiyer, Chief of Staff, Office of the Under Secretary of Commerce for Intellectual Property and Director of the USPTO, at (571) 272-8600.

    SUPPLEMENTARY INFORMATION:

    The Advisory Committees' duties include:

    • Review and advise the Under Secretary of Commerce for Intellectual Property and Director of the USPTO on matters relating to policies, goals, performance, budget, and user fees of the USPTO relating to patents and trademarks, respectively; and

    • Within 60 days after the end of each fiscal year: (1) Prepare an annual report on matters listed above; (2) transmit the report to the Secretary of Commerce, the President, and the Committees on the Judiciary of the Senate and the House of Representatives; and (3) publish the report in the Official Gazette of the USPTO.

    Advisory Committees

    The Public Advisory Committees are each composed of nine (9) voting members who are appointed by the Secretary of Commerce (the “Secretary”) and serve at the pleasure of the Secretary for three-year terms. Members are eligible for reappointment for a second consecutive three-year term. The Public Advisory Committee members must be citizens of the United States and are chosen to represent the interests of diverse users of the United States Patent and Trademark Office with respect to patents, in the case of the Patent Public Advisory Committee, and with respect to trademarks, in the case of the Trademark Public Advisory Committee. Members must represent small and large entity applicants located in the United States in proportion to the number of applications filed by such applicants. The Committees must include individuals with “substantial background and achievement in finance, management, labor relations, science, technology, and office automation.” 35 U.S.C. 5(b)(3). Each of the Public Advisory Committees also includes three (3) non-voting members representing each labor organization recognized by the USPTO. Administration policy discourages the appointment of federally registered lobbyists to agency advisory boards and commissions (Lobbyists on Agency Boards and Commissions, http://www.whitehouse.gov/blog/2009/09/23/lobbyist-agency-boards-and-commissions (Sept. 23, 2009)); cf. Exec. Order No. 13490, 74 FR 4673 (January 21, 2009) (While Executive Order 13490 does not specifically apply to federally registered lobbyists appointed by agency or department heads, it sets forth the Administration's general policy of decreasing the influence of special interests in the Federal Government).

    Procedures and Guidelines of the Patent and Trademark Public Advisory Committees

    Each newly appointed member of the Patent and Trademark Public Advisory Committees will serve for a three-year term that begins on December 1, 2015, and ends on December 1, 2018. As required by the 1999 Act, members of the Patent and Trademark Public Advisory Committees will receive compensation for each day (including travel time) while the member is attending meetings or engaged in the business of that Advisory Committee. The enabling statute states that members are to be compensated at the daily equivalent of the annual rate of basic pay in effect for level III of the Executive Schedule under section 5314 of Title 5, United States Code. Committee members are compensated on an hourly basis, calculated at the daily rate. While away from home or regular place of business, each member shall be allowed travel expenses, including per diem in lieu of subsistence, as authorized by Section 5703 of Title 5, United States Code.

    Applicability of Certain Ethics Laws

    Public Advisory Committee Members are Special Government Employees within the meaning of Section 202 of Title 18, United States Code. The following additional information includes several, but not all, of the ethics rules that apply to members, and assumes that members are not engaged in Public Advisory Committee business more than 60 days during any period of 365 consecutive days.

    • Each member will be required to file a confidential financial disclosure form within thirty (30) days of appointment. 5 CFR 2634.202(c), 2634.204, 2634.903, and 2634.904(b).

    • Each member will be subject to many of the public integrity laws, including criminal bars against representing a party in a particular matter that came before the member's committee and that involved at least one specific party. 18 U.S.C. 205(c); see also 18 U.S.C. 207 for post-membership bars. A member also must not act on a matter in which the member (or any of certain closely related entities) has a financial interest. 18 U.S.C. 208.

    • Representation of foreign interests may also raise issues. 35 U.S.C. 5(a)(1) and 18 U.S.C. 219.

    Meetings of the Patent and Trademark Public Advisory Committees

    Meetings of each Advisory Committee will take place at the call of the respective Committee Chair to consider an agenda set by that Chair. Meetings may be conducted in person, telephonically, on-line through the Internet, or by other appropriate means. The meetings of each Advisory Committee will be open to the public except each Advisory Committee may, by majority vote, meet in executive session when considering personnel, privileged, or other confidential information. Nominees must have the ability to participate in Committee business through the Internet.

    Dated: June 3, 2016. Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.
    [FR Doc. 2016-13765 Filed 6-9-16; 8:45 am] BILLING CODE 3510-16-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Deletions AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Deletions from the Procurement List.

    SUMMARY:

    The Committee is proposing to delete products and services from the Procurement List that were previously furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

    DATES:

    Effective July 10, 2016

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION: Deletions

    On 4/22/2016 (81 FR 23682), 5/6/2016 (81 FR 27419-27420), and 5/20/2016 (81 FR 31917-31918), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed deletions from the Procurement List.

    After consideration of the relevant matter presented, the Committee has determined that the products and services listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

    Regulatory Flexibility Act Certification

    I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

    1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

    2. The action may result in authorizing small entities to furnish the products and services to the Government.

    3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products and services deleted from the Procurement List.

    End of Certification

    Accordingly, the following products and services are deleted from the Procurement List:

    Products NSN(s)—Product Name(s): 8415-01-580-0038—Cover, Helmet, Advanced Combat, Multi Camouflage, Large/X-Large 8415-01-580-0064—Cover, Helmet, Advanced Combat, Multi Camouflage, Small/Medium 8415-01-580-0074—Cover, Helmet, Advanced Combat, Multi Camouflage, XX-Large Mandatory Source(s) of Supply: Mount Rogers Community Services Board, Wytheville, VA Lions Volunteer Blind Industries, Inc., Morristown, TN Contracting Activities: Army Contracting Command—Aberdeen Proving Ground, Natick Contracting Division, Natick, MA Defense Logistics Agency Troop Support, Philadelphia, PA NSN(s)—Product Name(s): 7510-01-463-1985—Jumbo Refill, Ballpoint Pen “Aristocrat” 7510-01-463-1987—Jumbo Refill, Ballpoint Pen “Aristocrat” 7510-01-463-1988—Jumbo Refill, Ballpoint Pen “Aristocrat” 7510-01-463-1989—Jumbo Refill, Ballpoint Pen “Aristocrat” 7520-01-446-4500—Pen, Retractable, Cushion Grip, Exec. “Aristocrat” 7520-01-446-4503—Pen, Retractable, Cushion Grip, Exec. “Aristocrat” 7520-01-446-4504—Pen, Retractable, Cushion Grip, Exec. “Aristocrat” 7520-01-446-4505—Pen, Retractable, Cushion Grip, Exec. “Aristocrat” Mandatory Source(s) of Supply: Industries of the Blind, Inc., Greensboro, NC Contracting Activity: General Services Administration, New York, NY NSN(s)—Product Name(s): 7530-01-555-2906—Paper, Tabulating Machine Mandatory Source(s) of Supply: Tarrant County Association for the Blind, Fort Worth, TX Contracting Activity: General Services Administration, New York, NY NSN(s)—Product Name(s): 7530-00-800-0996—Paper, Tabulating Machine Mandatory Source(s) of Supply: The Lighthouse for the Blind, St. Louis, MO Tarrant County Association for the Blind, Fort Worth, TX Contracting Activity: General Services Administration, New York, NY Services Service Type: Document Destruction Service Mandatory for: Internal Revenue Service: St. Paul Headquarters, Minneapolis, MN Mandatory Source(s) of Supply: AccessAbility, Inc., Minneapolis, MN Contracting Activity: Dept. of the Treasury, Washington, DC Service Type: Janitorial/Custodial Service Service Mandatory For: Middle River Depot, 2800 Eastern Blvd., Baltimore, MD Mandatory Source(s) of Supply: The Chimes, Inc., Baltimore, MD Contracting Activity: GSA/PBS/R03 Regional Contracts Support Services Section, Philadelphia, PA Barry S. Lineback, Director, Business Operations.
    [FR Doc. 2016-13769 Filed 6-9-16; 8:45 am] BILLING CODE 6353-01-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Proposed Additions and Deletion AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Proposed additions to and deletion from the procurement list.

    SUMMARY:

    The Committee is proposing to add products and services to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes a product previously furnished by such agency.

    Comments must be received on or before: 7/10/2016.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202-4149.

    FOR FURTHER INFORMATION OR TO SUBMIT COMMENTS CONTACT:

    Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

    Additions

    If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products and services listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.

    The following products and services are proposed for addition to the Procurement List for production by the nonprofit agencies listed:

    Products NSN(s)—Product Name(s): 5120-00-NIB-0163—Socket Set, Chrome, 1/4″ Drive Deep, Metric 6 Point Fasteners, 11 Pieces 5120-00-NIB-0164—Socket Set, Chrome 1/4″ Drive Shallow, Metric 6 Point Fasteners, 11 Pieces 5120-01-047-4356—Socket Set, Chrome 3/8″ Drive Shallow, Metric 12 Point Fasteners, 12 Pieces 5120-01-429-3550—Socket Set, Chrome 1/2″ Drive Deep, Metric 12 Point Fasteners, 13 Pieces 5120-01-429-3569—Socket Set, Chrome 1/2″ Drive Shallow, Metric 12 Point Fasteners, 13 Pieces 5120-01-429-3605—Socket Set, Chrome 3/8″ Drive Deep, Metric 6 Point Fasteners, 12 Pieces Mandatory Purchase For: Total Government Requirement Mandatory Source(s) of Supply: Beyond Vision, Inc., Milwaukee, WI Contracting Activity: General Services Administration, Kansas City, MO Distribution: B-List NSN(s)—Product Name(s): 8105-00-022-1319—Grocery Bag, Kraft Paper, Natural Brown, 1/6 Barrel, Heavy Duty, 12″ x 7″ x 161/2 8105-00-271-1485—Grocery Bag, Kraft Paper, Natural Brown, No. 12, 7″ x 41/2″ x 137/8 8105-00-281-1158—Grocery Bag, Kraft Paper, Natural Brown, No. 2, 41/4″ x 23/8″ x 81/8 8105-00-281-1425—Grocery Bag, Kraft Paper, Natural Brown, No. 8, 61/4″ x 33/4″ x 123/4 8105-00-281-1429—Grocery Bag, Kraft Paper, Natural Brown, No. 25, 81/4″ x 51/4″ x 177/8 8105-00-286-7308—Grocery Bag, Kraft Paper, Natural Brown, No. 20, 81/8″ x 6″ x 143/8 8105-00-543-7169—Grocery Bag, Kraft Paper, Natural Brown, 1/4 Barrel Bag, 11″ x 7″ x 231/4 8105-00-857-2250—Grocery Bag, Kraft Paper, Natural Brown, 1/6 Barrel, Heavy Duty, 17″ x 13″ x 7″ Mandatory Purchase For: Total Government Requirement Mandatory Source(s) of Supply: South Texas Lighthouse for the Blind, Corpus Christi, TX Contracting Activity: General Services Administration, New York, NY Distribution: A-List NSN(s)—Product Name(s): 8530-01-490-7372—Kit, Toiletries Mandatory Purchase For: Total Government Requirement Mandatory Source(s) of Supply: NewView Oklahoma, Inc., Oklahoma City, OK Contracting Activity: General Services Administration, Fort Worth, TX Distribution: B-List NSN(s)—Product Name(s): 6210-00-NIB-0006—Tube Light, LED, T8, Universal (Type A or B), 4100K, 2 Foot Mandatory Purchase For: Total Government Requirement Mandatory Source(s) of Supply: Central Association for the Blind and Visually Impaired, Utica, NY Industries for the Blind, Inc., Greensboro, NC Contracting Activity: Defense Logistics Agency Troop Support Distribution: B-List Services Service Type: Dormitory Support Service Mandatory for: US Air Force, Cannon Air Force Base, Dormitory Campus, CAFB Fire Department, Base Confinement Area, and Fire Department, Melrose AF Range, Cannon AFB, NM Mandatory Source(s) of Supply: ENMRSH, Inc., Clovis, NM Contracting Activity: US Air Force, 27th Special Operations Contracting Squadron, Cannon Air Force Base, NM Service Type: Laundry Service Mandatory for: US Army, Tripler Army Medical Center and Clinics Schofield Barracks, HI Mandatory Source(s) of Supply: Great Plains Enterprises, Inc., Las Vegas, NV Contracting Activity: US Army, US Army 0413 AQ HQ, KO Directorate of Contracting, Building 520 Pierce St., Fort Shafter, HI Service Type: Transcription Service Mandatory for: U.S. Navy, Naval Medical Logistics Command, Fort Detrick, MD Mandatory Source(s) of Supply: Lighthouse of Houston, Houston, TX Contracting Activity: Naval Medical Logistics Command, Fort Detrick, MD Deletion

    The following product is proposed for deletion from the Procurement List:

    Product NSN(s)—Product Name(s): 2510-01-063-3893—Floorboard, Wood Mandatory Source(s) of Supply: UNKNOWN Contracting Activity: Defense Logistics Agency Land and Maritime, Columbus, OH Barry S. Lineback, Director, Business Operations.
    [FR Doc. 2016-13768 Filed 6-9-16; 8:45 am] BILLING CODE 6353-01-P
    CONSUMER PRODUCT SAFETY COMMISSION Sunshine Act Meeting Time and Date:

    Wednesday June 15, 2016, 10:00 a.m.-4:00 p.m.

    Place:

    Hearing Room 420, Bethesda Towers, 4330 East-West Highway, Bethesda, Maryland.

    Status:

    Commission Meeting—Open to the Public.

    Matters To Be Considered:

    Hearing: Agenda and Priorities for Fiscal Years 2017 and 2018. A live webcast of the Meeting can be viewed at www.cpsc.gov/live.

    FOR FURTHER INFORMATION CONTACT:

    Todd A. Stevenson, Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, (301) 504-7923.

    Dated: June 7, 2016. Todd A. Stevenson, Secretary.
    [FR Doc. 2016-13855 Filed 6-8-16; 11:15 am] BILLING CODE 6355-01-P
    CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Proposed Information Collection; Comment Request AGENCY:

    Corporation for National and Community Service.

    ACTION:

    Notice.

    SUMMARY:

    The Corporation for National and Community Service (CNCS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. Sec. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirement on respondents can be properly assessed.

    Currently, CNCS is soliciting comments concerning its proposed renewal of its Senior Corps Project Progress Report (PPR)—OMB Control Number 3045-0033, with an expiration date of August 31, 2016. The Senior Corps PPR has two components: (1) Narratives and work plans, and (2) the Progress Report Supplement (PRS) which is an annual survey of volunteer demographics and grantee characteristics. The resulting data is used by grantees and CNCS to track performance and inform continued grant funding support, as well as to identify trends and to support management and analysis.

    Copies of the information collection request can be obtained by contacting the office listed in the Addresses section of this Notice.

    DATES:

    Written comments must be submitted to the individual and office listed in the ADDRESSES section by August 9, 2016.

    ADDRESSES:

    You may submit comments, identified by the title of the information collection activity, by any of the following methods:

    (1) By mail sent to: Corporation for National and Community Service, Corporation for National and Community Service, Senior Corps; Attention Ms. Jill Sears, Program Officer; 250 E Street SW., Washington, DC 20525.

    (2) By hand delivery or by courier to the CNCS mailroom on the 4th Floor at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except Federal holidays.

    (3) Electronically through www.regulations.gov.

    Individuals who use a telecommunications device for the deaf (TTY-TDD) may call 1-800-833-3722 between 8:00 a.m. and 8:00 p.m. Eastern Time, Monday through Friday.

    FOR FURTHER INFORMATION CONTACT:

    Jill Sears, (202) 606-7577, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    CNCS is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are expected to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (e.g., permitting electronic submissions of responses).

    Background

    The Progress Report (PPR) was designed to assure that grantees of the Senior Corps' programs (RSVP, Foster Grandparent and Senior Companion Programs) address and fulfill legislated program purposes; meet agency program management and grant requirements; track and measure progress to benefit the local project and its contributions to senior volunteers and the community; and to report progress toward work plan objectives agreed upon in the granting of the award. The resulting data is used by grantees and CNCS to track performance and inform continued grant funding support, as well as to identify trends and to support management and analysis.

    Current Action

    CNCS seeks to renew and revise the current OMB approved Progress Report. In August of 2015, Senior Corps revised its OMB approved Grant Application Instructions. The revised Grant Application Instructions incorporated a revised standard national performance measures framework for Senior Corps programs. The revised PPR will align to the national performance measures revisions and allow grantees to enter actual data relative to the revised framework.

    The revised PPR will be used in the same manner as the existing report. CNCS also seeks to continue using the current report until the revised report is approved by OMB. The current application is due to expire on August 31, 2016.

    Type of Review: Renewal.

    Agency: Corporation for National and Community Service.

    Title: Senior Corps Project Progress Report.

    OMB Number: 3045-0033.

    Agency Number: CNCS Form 1020.

    Affected Public: Sponsors of Senior Corps grants.

    Total Respondents: 1,250.

    Frequency: Work plans and narratives: Semi-Annual. Progress Report Supplement: Annual.

    Average Time per Response: Work plans and narratives: Four hours. Progress Report.

    Supplement: Eight hours.

    Estimated Total Burden Hours: 20,000 hours.

    Total Burden Cost (Capital/Startup): None.

    Total Burden Cost (Operating/Maintenance): None.

    Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.

    Dated: June 6, 2016. Mikel Herrington, Acting Director Senior Corps.
    [FR Doc. 2016-13702 Filed 6-9-16; 8:45 am] BILLING CODE 6050-28-P
    DEPARTMENT OF DEFENSE Office of the Secretary Government-Industry Advisory Panel; Notice of Federal Advisory Committee Meeting AGENCY:

    Office of the Under Secretary of Defense (Acquisition, Technology, and Logistics), Department of Defense (DoD).

    ACTION:

    Federal advisory committee meeting notice.

    SUMMARY:

    The Department of Defense is publishing this notice to announce the following Federal advisory committee meeting of the Government-Industry Advisory Panel. This meeting is open to the public.

    DATES:

    The meeting will be held from 1:00 p.m. to 5:00 p.m. on Tuesday, June 21, 2016. Public registration will begin at 12:30 p.m. For entrance into the meeting, you must meet the necessary requirements for entrance into the Pentagon. For more detailed information, please see the following link: http://www.pfpa.mil/access.html.

    ADDRESSES:

    Pentagon Library, Washington Headquarters Services, 1155 Defense Pentagon, Washington, DC 20301-1155. The meeting will be held in Room M2. The Pentagon Library is located in the Pentagon Library and Conference Center (PLC2) across the Corridor 8 bridge.

    FOR FURTHER INFORMATION CONTACT:

    LTC Andrew Lunoff, Office of the Assistant Secretary of Defense (Acquisition), 3090 Defense Pentagon, Washington, DC 20301-3090, email: [email protected], phone: 571-256-9004.

    SUPPLEMENTARY INFORMATION:

    Due to circumstances beyond the control of the Designated Federal Officer and the Department of Defense, the Government-Industry Advisory Panel was unable to provide public notification of its meeting of June 21, 2016, as required by 41 CFR 102-3.150(a). Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

    Purpose of the Meeting: This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (FACA) (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150. The Government-Industry Advisory Panel will review sections 2320 and 2321 of title 10, United States Code (U.S.C.), regarding rights in technical data and the validation of proprietary data restrictions and the regulations implementing such sections, for the purpose of ensuring that such statutory and regulatory requirements are best structured to serve the interest of the taxpayers and the national defense. The scope of the panel is as follows: (1) Ensuring that the Department of Defense (DoD) does not pay more than once for the same work, (2) Ensuring that the DoD contractors are appropriately rewarded for their innovation and invention, (3) Providing for cost-effective reprocurement, sustainment, modification, and upgrades to the DoD systems, (4) Encouraging the private sector to invest in new products, technologies, and processes relevant to the missions of the DoD, and (5) Ensuring that the DoD has appropriate access to innovative products, technologies, and processes developed by the private sector for commercial use.

    Agenda: This will be the second meeting of the Government-Industry Advisory Panel with a series of meetings planned through September 1, 2016. The panel will cover details of 10 U.S.C. 2320 and 2321, begin understanding the implementing regulations and detailed the necessary groups within the private sector and government to provide supporting documentation for their review of these codes and regulations during follow-on meetings. Agenda items for the second meeting will include the following: (1) Issues or concerns of 10 U.S.C. 2320 and 2321; (2) Implementing DFARS regulations (Subparts 227.71 and .72, and associated clauses); (3) Discussions on DoD's policy and guidance on Intellectual Property (IP) strategy and management; (4) Discussions on DoD personnel preparation for implementation of DoD's IP policy and guidance; (5) Discussion of regulation of extending and adapting the scheme of 10 U.S.C. 2320 and 2321 to apply to computer software; (6) Discussion on applicability of 10 U.S.C. 2320 and 2321, and implementing DFARS requirements and clauses, to contracts and subcontracts for commercial items; (7) Discussions on practices used by DoD in acquiring IP from non-traditional contractors, commercial contractors, and traditional contractors; (8) Discussion on DoD's policy, guidance and practices linking technical data management and other IP considerations with open systems architecture (OSA) and/or modular open systems approaches (MOSA); (9) Planning for follow-on meeting.

    Availability of Materials for the Meeting: A copy of the agenda or any updates to the agenda for the June 21, 2016 meeting will be available as requested or at the following site: http://www.facadatabase.gov/committee/meetings.aspx?cid=2561.

    Minor changes to the agenda will be announced at the meeting. All materials will be posted to the FACA database after the meeting.

    Public Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b, as amended, and 41 CFR 102-3.140 through 102-3.165, and subject to the availability of space, this meeting is open to the public. Registration of members of the public who wish to attend the meeting will begin upon publication of this meeting notice and end three business days (June 16) prior to the start of the meeting. All members of the public must contact LTC Lunoff at the phone number or email listed in the FOR FURTHER INFORMATION CONTACT section to make arrangements for Pentagon escort, if necessary. Public attendees should arrive at the Pentagon's Visitor's Center, located near the Pentagon Metro Station's south exit and adjacent to the Pentagon Transit Center bus terminal with sufficient time to complete security screening no later than 12:30 p.m. on June 21. To complete security screening, please come prepared to present two forms of identification of which one must be a pictured identification card. Government and military DoD CAC holders are not required to have an escort, but are still required to pass through the Visitor's Center to gain access to the Building. Seating is limited and is on a first-to-arrive basis. Attendees will be asked to provide their name, title, affiliation, and contact information to include email address and daytime telephone number to the Designated Federal Officer (DFO) listed in the FOR FURTHER INFORMATION CONTACT section. Any interested person may attend the meeting, file written comments or statements with the committee, or make verbal comments from the floor during the public meeting, at the times, and in the manner, permitted by the committee.

    Special Accommodations: The meeting venue is fully handicap accessible, with wheelchair access.

    Individuals requiring special accommodations to access the public meeting or seeking additional information about public access procedures, should contact LTC Lunoff, the committee DFO, at the email address or telephone number listed in the FOR FURTHER INFORMATION CONTACT section, at least five (5) business days prior to the meeting so that appropriate arrangements can be made.

    Written Comments or Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act, the public or interested organizations may submit written comments or statements to the Government-Industry Advisory Panel about its mission and/or the topics to be addressed in this public meeting. Written comments or statements should be submitted to LTC Lunoff, the committee DFO, via electronic mail, the preferred mode of submission, at the email address listed in the FOR FURTHER INFORMATION CONTACT section in the following formats: Adobe Acrobat or Microsoft Word. The comment or statement must include the author's name, title, affiliation, address, and daytime telephone number. Written comments or statements being submitted in response to the agenda set forth in this notice must be received by the committee DFO at least five (5) business days prior to the meeting so that they may be made available to the Government-Industry Advisory Panel for its consideration prior to the meeting. Written comments or statements received after this date may not be provided to the panel until its next meeting. Please note that because the panel operates under the provisions of the Federal Advisory Committee Act, as amended, all written comments will be treated as public documents and will be made available for public inspection.

    Verbal Comments: Members of the public will be permitted to make verbal comments during the meeting only at the time and in the manner allowed herein. If a member of the public is interested in making a verbal comment at the open meeting, that individual must submit a request, with a brief statement of the subject matter to be addressed by the comment, at least three (3) business days in advance to the committee DFO, via electronic mail, the preferred mode of submission, at the email address listed in the FOR FURTHER INFORMATION CONTACT section. The committee DFO will log each request to make a comment, in the order received, and determine whether the subject matter of each comment is relevant to the panel's mission and/or the topics to be addressed in this public meeting. A 30-minute period near the end of the meeting will be available for verbal public comments. Members of the public who have requested to make a verbal comment and whose comments have been deemed relevant under the process described in this paragraph, will be allotted no more than three (3) minutes during this period, and will be invited to speak in the order in which their requests were received by the DFO.

    Dated: June 6, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-13718 Filed 6-9-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2016-OS-0071] Privacy Act of 1974; System of Records AGENCY:

    Office of the Secretary of Defense, DoD.

    ACTION:

    Notice to alter a System of Records.

    SUMMARY:

    The Office of the Secretary of Defense proposes to alter a system of records, DPR 37, entitled “DoD Employer Support of Guard and Reserve Volunteer Rosters.” The system is used to maintain a roster of and facilitate communication between ESGR members; to track ESGR-related training, awards, and hours donated by ESGR DoD volunteer staff; and to identify federal employee and ESGR DoD volunteer emergency contact information.

    DATES:

    Comments will be accepted on or before July 11, 2016. This proposed action will be effective the date following the end of the comment period unless comments are received which result in a contrary determination.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

    * Federal Rulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    * Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name and docket number for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    Mrs. Luz D. Ortiz, Chief, Records, Privacy and Declassification Division (RPD2), 1155 Defense Pentagon, Washington, DC 20301-1155, or by phone at (571) 372-0478.

    SUPPLEMENTARY INFORMATION:

    The Office of the Secretary of Defense notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT or at the Defense Privacy and Civil Liberties Division Web site at http://dpcld.defense.gov/.

    The proposed systems reports, as required by 5 U.S.C. 552a(r) of the Privacy Act, as amended, were submitted on May 23, 2016, to the House Committee on Oversight and Government Reform, the Senate Committee on Homeland Security and Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4 of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” revised November 28, 2000 (December 12, 2000 65 FR 77677).

    Dated: June 7, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. DPR 37 SYSTEM NAME:

    DoD Employer Support of Guard and Reserve Volunteer Rosters (January 29, 2010, 75 FR 4788)

    CHANGES: SYSTEM ID:

    Delete entry and replace with “DHRA 17.”

    SYSTEM NAME:

    Delete entry and replace with “Employer Support of the Guard and Reserve Member Management System (MMS).”

    SYSTEM LOCATION:

    Delete entry and replace with “Defense Information Systems Agency (DISA), Computing Directorate Mechanicsburg, 5450 Carlisle Pike, Mechanicsburg, PA 17050-2411.”

    Backup: Iron Mountain, 1665 S 5350 W, Salt Lake City, UT 84104-4721.”

    CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:

    Delete entry and replace with “Federal employees and DoD volunteers who work for Employer Support of the Guard and Reserve (ESGR).”

    CATEGORIES OF RECORDS IN THE SYSTEM:

    Delete entry and replace with “Full name; role/position and ESGR affiliation (State Committee region or Headquarters); military base for volunteer activity; home address, home and/or mobile phone number, and personal email address; ESGR-related training completed; affiliated Service (if applicable); and emergency contact name, phone number, and relationship.

    Additional information collected on federal employees includes: work address, phone number, and email; assigned military unit and rank (where applicable); and official report and departure date.

    Additional information collected on DoD volunteers includes: volunteer hours performed; awards; mentor/mentee assignments; military experience (Component, rank, status, and years of service); civilian work experience (industry and position type); special skills or qualifications; and form of DoD identification (where applicable).”

    AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

    Delete entry and replace with “10 U.S.C. 136, Under Secretary of Defense for Personnel and Readiness; 10 U.S.C. 1588, Authority to accept certain voluntary services; DoDD 1250.01, National Committee for Employer Support of the Guard and Reserve (NCESGR); DoD Instruction (DoDI) 1205.22, Employer Support of the Guard and Reserve; DoDI 1100.21, Voluntary Services in the Department of Defense; and DoDI 3001.02, Personnel Accountability in Conjunction With Natural or Manmade Disasters.”

    PURPOSE(S):

    Delete entry and replace with “To maintain a roster of and facilitate communication between ESGR members; to track ESGR-related training, awards, and hours donated by ESGR DoD volunteer staff; and to identify federal employee and ESGR DoD volunteer emergency contact information for accountability during manmade disasters and other emergencies.”

    ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:

    Delete entry and replace with “In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, the records contained herein may be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

    Law Enforcement Routine Use: If a system of records maintained by a DoD Component to carry out its functions indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or by regulation, rule, or order issued pursuant thereto, the relevant records in the system of records may be referred, as a routine use, to the agency concerned, whether federal, state, local, or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute, rule, regulation, or order issued pursuant thereto.

    Congressional Inquiries Disclosure Routine Use: Disclosure from a system of records maintained by a DoD Component may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.

    Disclosure to the Department of Justice for Litigation Routine Use: A record from a system of records maintained by a DoD Component may be disclosed as a routine use to any component of the Department of Justice for the purpose of representing the Department of Defense, or any officer, employee or member of the Department in pending or potential litigation to which the record is pertinent.

    Disclosure of Information to the National Archives and Records Administration Routine Use: A record from a system of records maintained by a DoD Component may be disclosed as a routine use to the National Archives and Records Administration for the purpose of records management inspections conducted under authority of 44 U.S.C. 2904 and 2906.

    Data Breach Remediation Purposes Routine Use: A record from a system of records maintained by a Component may be disclosed to appropriate agencies, entities, and persons when (1) The Component suspects or has confirmed that the security or confidentiality of the information in the system of records has been compromised; (2) the Component has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Component or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Components efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.

    The DoD Blanket Routine Uses set forth at the beginning of the Office of the Secretary of Defense (OSD) compilation of systems of records notices apply to this system. The complete list of DoD Blanket Routine Uses can be found online at: http://dpcld.defense.gov/Privacy/SORNsIndex/BlanketRoutineUses.aspx.”

    RETRIEVABILITY:

    Delete entry and replace with “Full name and ESGR affiliation.”

    SAFEGUARDS:

    Delete entry and replace with “All personally identifiable information (PII) is maintained in a secure, password protected electronic system. The system utilizes security hardware and software to include physical controls such as combination locks, cipher locks, key cards, identification badges, closed circuit televisions, and controlled screenings. Technical controls include the use of user identifications and passwords, intrusion detection systems, encryption, Common Access Cards (CAC), firewalls, virtual private networks, role-based access controls, and two-factor authentication. Administrative controls include periodic security audits, regular monitoring of users' security practices, methods to ensure only authorized personnel access information, encryption of backups containing sensitive data, visitor registers, backups secured off-site, and use of visitor registers.”

    Retention and disposal:

    Delete entry and replace with “Headquarters Personnel Records: Destroy upon separation or transfer of employee.

    Volunteer Staff Records: Destroy/delete 4 years after volunteer departs program.”

    SYSTEM MANAGER(S) AND ADDRESS:

    Delete entry and replace with “Executive Director, Headquarters, Employer Support of the Guard and Reserve, 4800 Mark Center Drive, Alexandria, VA 22350-1200.”

    NOTIFICATION PROCEDURE:

    Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the Executive Director, Headquarters, Employer Support of the Guard and Reserve, 4800 Mark Center Drive, Alexandria, VA 22350-1200.

    Signed, written requests should contain the individual's full name, ESGR affiliation, and personal contact information (home address, phone number, and email).”

    RECORDS ACCESS PROCEDURES:

    Delete entry and replace with “Individuals seeking access to records about themselves contained in this system should address written inquiries to the Office of the Secretary of Defense/Joint Staff, Freedom of Information Act Requester Service Center, Office of Freedom of Information, 1155 Defense Pentagon, Washington, DC 20301-1155.

    Signed, written requests should contain the individual's full name, personal contact information (home address, phone number, email), and the number and name of this system of records notice.”

    [FR Doc. 2016-13776 Filed 6-9-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Charter Re-Establishment of Department of Defense Federal Advisory Committees AGENCY:

    Department of Defense.

    ACTION:

    Re-establishment of Federal Advisory Committee.

    SUMMARY:

    The Department of Defense (DoD) is publishing this notice to announce that it is re-establishing the Board of Advisors to the Presidents of the Naval Postgraduate School and the Naval War College (“the Board”).

    FOR FURTHER INFORMATION CONTACT:

    Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.

    SUPPLEMENTARY INFORMATION:

    The Board is being re-established in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(d). The Board's charter and contact information for the Board's Designated Federal Officer (DFO) can be found at http://www.facadatabase.gov/.

    The Board provides the Secretary of Defense and the Deputy Secretary of Defense, through the Secretary of the Navy, independent advice and recommendations on matters relating to the Naval Postgraduate School and the Naval War College. These matters include, but are not limited to, organizational management, curricula and methods of instructions, facilities, and other matters of interest.

    The Board is composed of no more than ten members who are eminent authorities in the fields of academia, business, national defense and security, the defense industry, and research and analysis. Membership appointments are authorized by the Secretary of Defense or the Deputy Secretary of Defense and administratively certified by the Secretary of the Navy for a term of service of one-to-four years, with annual renewals, in accordance with DoD policies and procedures. Board members, who are not full-time or permanent part-time Federal officers or employees, shall be appointed as experts or consultants pursuant to 5 U.S.C. 3109 to serve as special government employee members. Board members who are full-time or permanent part-time Federal officers or employees shall be appointed pursuant to 41 CFR 102-3.130(a) to serve as regular government employee members. No member, unless authorized by the Secretary of Defense or the Deputy Secretary of Defense, may serve more than two consecutive terms of service on the Board, including its subcommittees, or serve on more than two DoD federal advisory committees at one time. All members of the Board are appointed to provide advice on behalf of the Government on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Except for reimbursement of official Board-related travel and per diem, Board members serve without compensation. The DoD may establish subcommittees, task forces, or working groups to support the Board. Currently, the DoD has approved two permanent subcommittees to the Board—the Naval Postgraduate School Subcommittee, and the Naval War College Subcommittee. The Naval Postgraduate School Subcommittee, comprised of no more than 15 members, shall focus on the Naval Postgraduate School, and the Secretary of Defense has approved the following non-voting ex-officio appointments to the Naval Postgraduate School Subcommittee—the Chief of Naval Personnel/Deputy Chief of Naval Operations for Manpower, Personnel, Training and Education Command; the Commanding General USMC Training and Education Command; the Commandant Army War College; the Chief of Naval Research; and the Commander and President of the Air University. The Naval Postgraduate School Subcommittee shall meet a minimum of two times a year. The Naval War College Subcommittee, comprised of no more than ten members, shall focus on the Naval War College, and the Secretary of Defense has approved the following ex-officio non-voting member to the Naval War College Subcommittee—the Chief of Naval Personnel/Deputy Chief of Naval Operations for Manpower, Personnel, Training and Education. The Naval War College Subcommittee shall meet a minimum of two times a year.

    Subcommittees will not work independently of the Board and must report all recommendations and advice solely to the Board for full deliberation and discussion. Subcommittees, task forces, or working groups have no authority to make decisions and recommendations, verbally or in writing, on behalf of the Board. No subcommittee or any of its members can update or report, verbally or in writing, directly to the DoD or any Federal officers or employees. The Board's DFO, pursuant to DoD policy, must be a full-time or permanent part-time DoD employee, and must be in attendance for the duration of each and every Board/subcommittee meeting. The public or interested organizations may submit written statements to Board membership about the Board's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Board. All written statements shall be submitted to the DFO for the Board, and this individual will ensure that the written statements are provided to the membership for their consideration.

    Dated: June 7, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-13838 Filed 6-9-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Charter Renewal of Department of Defense Federal Advisory Committees AGENCY:

    Department of Defense.

    ACTION:

    Renewal of Federal Advisory Committee.

    SUMMARY:

    The Department of Defense (DoD) is publishing this notice to announce that it is renewing the charter for the Defense Business Board (“the Board”).

    FOR FURTHER INFORMATION CONTACT:

    Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.

    SUPPLEMENTARY INFORMATION:

    This committee's charter is being renewed in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(d). The charter and contact information for the Board's Designated Federal Officer (DFO) can be obtained at http://www.facadatabase.gov/.

    The Board provides the Secretary of Defense and the Deputy Secretary of Defense with independent advice and recommendations on critical matters concerning the Department of Defense (DoD). The Board shall be composed of no more than 35 members who must possess the following: (a) A proven track record of sound judgment and business acumen in leading or governing large, complex private sector corporations or organizations and (b) a wealth of top-level, global business experience in the areas of executive management, corporate governance, audit and finance, human resources, economics, technology, or healthcare. Members who are not full-time or permanent part-time Federal officers or employees are appointed as experts or consultants pursuant to 5 U.S.C. 3109 to serve as special government employee members. Members who are full-time or permanent part-time Federal officers or employees are appointed pursuant to 41 CFR 102-3.130(a) to serve as regular government employee members. Each member is appointed to provide advice on behalf of the Government on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Except for reimbursement of official Board-related travel and per diem, members serve without compensation. The DoD, as necessary and consistent with the Board's mission and DoD policies and procedures, may establish subcommittees, task forces, or working groups to support the Board, and all subcommittees must operate under the provisions of FACA and the Government in the Sunshine Act. Subcommittees will not work independently of the Board and must report all recommendations and advice solely to the Board for full deliberation and discussion. Subcommittees, task forces, or working groups have no authority to make decisions and recommendations, verbally or in writing, on behalf of the Board. No subcommittee or any of its members can update or report, verbally or in writing, directly to the DoD or any Federal officers or employees. The Board's DFO, pursuant to DoD policy, must be a full-time or permanent part-time DoD employee, and must be in attendance for the duration of each and every Board/subcommittee meeting. The public or interested organizations may submit written statements to the Board membership about the Board's mission and functions. Such statements may be submitted at any time or in response to the stated agenda of planned Board meetings. All written statements must be submitted to the Board's DFO who will ensure the written statements are provided to the membership for their consideration.

    Dated: June 6, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-13729 Filed 6-9-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2556-077] Messalonskee Stream Hydro, LLC—Maryland; Messalonskee Stream Hydro, LLC—Maine; Notice of Application for Partial Transfer of License and Soliciting Comments, Motions To Intervene, and Protests

    On May 20, 2016, Messalonskee Stream Hydro, LLC—Maryland (transferor) and Messalonskee Stream Hydro, LLC—Maine (transferee) filed an application for the transfer of license of the Messalonskee Project No. 2556. The project is located on Messalonskee Stream, a tributary of the Kennebec River, in Kennebec County, Maine. The project does not occupy Federal lands.

    The applicants seek Commission approval to transfer the license for the Messalonskee Project from the transferor to the transferee. This transfer of license reflects an internal corporate reorganization. The transferor will be merged into newly created transferee.

    Applicants Contact: Mr. Andrew Locke, Messalonskee Stream Hydro, LLC, c/o Essex Hydro Assets, 55 Union Street, Boston, MA 02108, Phone: 617-367-0032, Email: [email protected]

    FERC Contact: Patricia W. Gillis, (202) 502-8735, [email protected]

    Deadline for filing comments, motions to intervene, and protests: 30 days from the date that the Commission issues this notice. The Commission strongly encourages electronic filing. Please file comments, motions to intervene, and protests using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-2556-077.

    Dated: June 6, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-13751 Filed 6-9-16; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OGC-2016-0301; FRL-9947-57-OGC] Proposed Consent Decree, Clean Air Act Citizen Suit; Request for Public Comment AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of proposed consent decree.

    SUMMARY:

    In accordance with section 113(g) of the Clean Air Act, as amended (“CAA” or the “Act”), notice is hereby given of a proposed consent decree to address a lawsuit filed by Partnership for Policy Integrity (“Plaintiffs”) in the United States District Court for the Middle District of Georgia: Partnership for Policy Integrity v. McCarthy, Civil Action No. 5:16-cv-00038-CAR (M.D. G.A.). On January 25, 2016, Plaintiffs filed a complaint alleging that Gina McCarthy, in her official capacity as Administrator of the United States Environmental Protection Agency (“EPA”), failed to perform a non-discretionary duty to grant or deny within 60 days a petition submitted by Plaintiffs on May 26, 2015 requesting that EPA object to a CAA Title V permit issued by the Environmental Protection Division (“EPD”) of Georgia's Department of Natural Resources, to Piedmont Green Power, LLC, authorizing the operation of a 60.5 megawatt (MW) steam-turbine generator powered by a 700 million British thermal unit per hour (MMBtu) biomass boiler in Barnesville, Georgia. The proposed consent decree would establish a deadline for EPA to take such action.

    DATES:

    Written comments on the proposed consent decree must be received by July 11, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID number EPA-HQ-OGC-2016-0301, online at www.regulations.gov (EPA's preferred method); by email to [email protected]; by mail to EPA Docket Center, Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; or by hand delivery or courier to EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be formatted in Word or ASCII file, avoiding the use of special characters and any form of encryption, and may be mailed to the mailing address above.

    FOR FURTHER INFORMATION CONTACT:

    John Krallman, Air and Radiation Law Office (2344A), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone: (202) 564-0904; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Additional Information About the Proposed Consent Decree

    The proposed consent decree would resolve a lawsuit filed by the Plaintiffs seeking to compel the Administrator to take actions under CAA section 505(b)(2). Under the terms of the proposed consent decree, EPA would agree to sign its response granting or denying the petition filed by Plaintiffs regarding Piedmont Green Power's biomass boiler located in Barnesville, Georgia, pursuant to section 505(b)(2) of the CAA, on or before December 16, 2016.

    Under the terms of the proposed consent decree, EPA would expeditiously deliver notice of EPA's response to the Office of the Federal Register for review and publication following signature of such response. In addition, the proposed consent decree outlines the procedure for the Plaintiffs to request costs of litigation, including attorney fees.

    For a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the proposed consent decree from persons who are not named as parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree should be withdrawn, the terms of the consent decree will be affirmed.

    II. Additional Information About Commenting on the Proposed Consent Decree A. How can I get a copy of the consent decree?

    The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2016-0301) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center 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 OEI Docket is (202) 566-1752.

    An electronic version of the public docket is available through www.regulations.gov. You may use www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and access those documents in the public docket that are available electronically. Once in the system, key in the appropriate docket identification number then select “search.”

    It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing online at www.regulations.gov without change, unless the comment contains copyrighted material, confidential business information (CBI), or other information whose disclosure is restricted by statute. Information claimed as CBI and other information whose disclosure is restricted by statute is not included in the official public docket or in the electronic public docket. EPA's policy is that copyrighted material, including copyrighted material contained in a public comment, will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the EPA Docket Center.

    B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

    If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment and with any disk or CD ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

    Use of the www.regulations.gov Web site to submit comments to EPA electronically is EPA's preferred method for receiving comments. The electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, email address, or other contact information unless you provide it in the body of your comment. In contrast to EPA's electronic public docket, EPA's electronic mail (email) system is not an “anonymous access” system. If you send an email comment directly to the Docket without going through www.regulations.gov, your email address is automatically captured and included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

    Dated: June 1, 2016. Lorie J. Schmidt, Associate General Counsel.
    [FR Doc. 2016-13792 Filed 6-9-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2007-0268; FRL-9947-55-OW] Notice of Availability: Draft Protective Action Guide (PAG) for Drinking Water After a Radiological Incident AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of document availability; request for public comment.

    SUMMARY:

    As part of its mission to protect human health and the environment, the Environmental Protection Agency (EPA) publishes protective action guides to help federal, state, local and tribal emergency response officials make radiation protection decisions during emergencies. EPA, in coordination with a multi-agency working group within the Federal Radiological Preparedness Coordinating Committee, is proposing an addition to the 2013 revised interim Protective Action Guides and Planning Guidance for Radiological Incidents (“2013 revised PAG Manual” hereafter) to provide guidance on drinking water. The Draft Protective Action Guide for Drinking Water is now available in the EPA Docket, under ID No. EPA-HQ-OAR-2007-0268, and EPA is requesting comment on the draft guide.

    DATES:

    Comments must be received on or before July 25, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2007-0268, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Lisa M. Christ, Standards and Risk Management Division, Office of Ground Water and Drinking Water, Mail Code 4607M, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202) 564-8354; fax number: (202) 564-3758; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

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

    This action does not impose any requirements on anyone. It notifies interested parties of EPA's proposed, draft drinking water protective action guide (PAG) and requests public comment. The drinking water PAG will help federal, state, local, tribal officials and public water systems make decisions about use of water during radiological emergencies. The drinking water PAG is non-regulatory guidance.

    B. What authority does EPA have to provide Protective Action Guidance?

    The historical and legal basis of EPA's role in the 2013 PAG Manual begins with Reorganization Plan No. 3 of 1970, in which the Administrator of the EPA assumed all the functions of the Federal Radiation Council (FRC), including the charge to “. . . advise the President with respect to radiation matters, directly or indirectly affecting health, including guidance for all federal agencies in the formulation of radiation standards and in the establishment and execution of programs of cooperation with [s]tates.” (Reorg. Plan No. 3 of 1970, sec. 2(a)(7), 6(a)(2); § 274.h of the Atomic Energy Act of 1954, as amended (AEA), codified at 42 U.S.C. 2021(h)). Recognizing this role, the Federal Emergency Management Agency (FEMA) directed EPA, in its Radiological Emergency Planning and Preparedness Regulations, to “establish Protective Action Guides (PAGs) for all aspects of radiological emergency planning in coordination with appropriate federal agencies.” (44 CFR 351.22(a)). FEMA also tasked EPA with preparing “guidance for state and local governments on implementing PAGs, including recommendations on protective actions which can be taken to mitigate the potential radiation dose to the population.” (44 CFR 351.22(b)). All of this information was to “be presented in the Environmental Protection Agency (EPA) `Manual of Protective Action Guides and Protective Actions for Nuclear Incidents.' ”(44 CFR 351.22(b)).

    Additionally, section 2021(h) charged the Administrator with performing “such other functions as the President may assign to him [or her] by Executive Order.” Executive Order 12656 states that the Administrator shall “[d]evelop, for national security emergencies, guidance on acceptable emergency levels of nuclear radiation. . ..” (Executive Order No. 12656, sec. 1601(2)). EPA's role in PAGs development was reaffirmed by the National Response Framework, Nuclear/Radiological Incident Annex of June 2008.

    C. What is the PAG Manual: Protective Action Guides and Planning Guidance for Radiological Incidents?

    In 2013, EPA revised the PAG Manual to provide federal, state and local emergency management officials with guidance for responding to radiological emergencies (78 FR 22257, April 15, 2013). See the 2013 PAG Manual at https://www.epa.gov/radiation/protective-action-guides-pags. A protective action guide (PAG) is the projected dose to an individual from a release of radioactive material at which a specific protective action to reduce or avoid that dose is recommended. Emergency management officials use PAGs for making decisions regarding actions to protect the public from exposure to radiation during an emergency. Such actions include evacuation, shelter-in-place, temporary relocation, water and food restrictions.

    The PAGs are based on the following essential principles, which also apply to the selection of any protective action during an incident:

    • Prevent acute effects.

    • Balance protection with other important factors and ensure that actions result in more benefit than harm.

    • Reduce risk of chronic effects.

    The PAG Manual is not a legally binding regulation or standard and does not supersede any environmental laws; PAGs are not intended to define “safe” or “unsafe” levels of exposure or contamination. As indicated by the use of non-mandatory language such as “may,” “should” and “can,” the Manual only provides recommendations and does not confer any legal rights or impose any legally binding requirements upon any member of the public, states or any federal agency. Rather, the PAG Manual provides projected radiation dose levels at which specific actions are recommended in order to reduce or avoid that dose. The 2013 revised interim PAG Manual is designed to provide flexibility to be more or less restrictive as deemed appropriate by decision makers based on the unique characteristics of the incident and the local situation.

    D. What additional guidance is being proposed for the PAG Manual?

    The draft drinking water protective action guidance was developed by a multi-agency PAG Subcommittee of the Federal Radiological Preparedness Coordinating Committee and is published by the EPA with concurrence from the Department of Energy, the Department of Defense, the Department of Homeland Security (DHS), including the Federal Emergency Management Agency, the Nuclear Regulatory Commission, the Department of Health and Human Services, including both the Centers for Disease Control and Prevention and the Food and Drug Administration (FDA), the U.S. Department of Agriculture and the Department of Labor.

    A large scale radiation contamination incident could impact the United States, driving the need for a pre-established drinking water PAG. EPA is proposing a two-tiered intermediate phase drinking water PAG of 100 mrem projected dose in the first year for infants, children and pregnant or nursing women and 500 mrem projected dose in the first year for the general population. The proposed PAG is designed to work in concert with the other Protective Action Guides currently in place for other media in the intermediate phase (i.e., the Food and Drug Administration's 500 mrem PAG for ingestion of food) and provides an additional level of protection for the most sensitive life stages. Authorities have flexibility on how to apply the PAG. In some cases they may find it prudent to use a single PAG (e.g., 100 mrem) as a target for the whole population, while in other circumstances, authorities may find that it makes sense to use both targets simultaneously. For example, emergency managers can use a two-tiered approach to focus on protecting the most sensitive population with limited, alternate water resources. Because the water and food PAGs are designed to be used in concert, the appropriate protective actions will be influenced by the exposure scenario and factors that influence the viability of alternative approaches to reducing that dose.

    This proposed, additional draft guidance recommends protective actions when drinking water may be impacted by a radiological or nuclear incident. The two-tier approach seeks to balance the goal of keeping radiation doses as low as possible with the practical and logistical challenges of providing alternative drinking water during the response to a disaster. EPA has included examples of estimated costs for selected drinking water protective actions in the Docket, ID No. EPA-HQ-OAR-2007-0268. In developing the drinking water PAG, the Agency considered potential cumulative exposure from a radiation incident. Ultimately, a PAG does not represent an “acceptable” routine exposure; a PAG is a dose at which protective action is advised in order to reduce or avoid that dose. Every PAG is developed with the same three principles: prevent acute effects, balance protection with other important factors and ensure that actions result in more benefit than harm, and reduce risk of chronic effects. Emergency management officials should consider all exposure routes when making protective action decisions in an emergency.

    Under the Safe Drinking Water Act (SDWA), the Agency has established maximum contaminant levels (MCLs) for radiological contaminants in drinking water. The National Primary Drinking Water Regulations (NPDWR) for radionuclides are based on lifetime exposure criteria and assume 70 years of continued exposure to contaminants in drinking water. While the SDWA framework is appropriate for day-to-day normal operations, it may not provide the necessary tools to assist emergency responders with determining the need for an immediate protective action. EPA expects that any drinking water system adversely impacted during a radiation contamination incident will take action to return to compliance with MCLs as soon as practicable.

    E. How were comments received on the 2013 draft PAG Manual considered in developing this proposal?

    On April 15, 2013, EPA published a Federal Register notice requesting public comments on the appropriateness of developing and incorporating a drinking water PAG in the revised PAG Manual (78 FR 22257).

    Regarding the specific issue of drinking water, the Agency received about 50 comment letters from members of the public, state and local emergency response and health organizations, environmental advocates, industry associations, organizations opposed to nuclear power, and from national and international radiation protection organizations.

    Several commenters from state emergency management agencies and radiation control programs expressed an urgent need for EPA to establish a drinking water PAG, pointing out that drinking water is the only media not currently addressed in the PAG Manual. Commenters stated that a drinking water PAG is a critical aspect of a coordinated emergency response after a radiation contamination incident.

    Commenters representing states agencies from Ohio, Kansas, Pennsylvania, Illinois and Washington suggested that a drinking water PAG should be established at the 500 mrem level, to be consistent with the FDA food PAG and with the DHS guidance 1 for water. While EPA agrees with the need of establishing a drinking water PAG, which is consistent with currently available guidance, it is also important to note that EPA believes that when possible, PAG recommendations should provide an additional level of protection to sensitive life-stages. For short-term incidents, it is appropriate to consider a lower tier PAG level of 100 mrem for sensitive life-stages including pregnant women, nursing women and children 15 years old and under. This approach of setting a two-tier level of protection incorporates suggestions submitted by commenters regarding the adequate consideration of children and sensitive subpopulations. There is an abundant precaution built into the derivation of the drinking water PAG through a variety of assumptions, including amount of water consumed, exposure duration and dose-response modeling, using the dose-response for the most sensitive life stages to derive the PAG for children through age 15 years. Today's proposal ensures that protective measures are appropriate for all members of the public, including sensitive subpopulations.

    1 Guidance established by the Department of Homeland Security as an intermediate-level PAG for drinking water interdiction (73 FR 45029, April 1, 2008).

    In contrast, several commenters from environmental protection advocate organizations suggested that a drinking water PAG is not needed, and urged EPA to base any emergency response measures regarding drinking water solely on the NPDWR for Radionuclides MCLs. Some commenters expressed concerns that establishing a drinking water PAG would weaken existing environmental standards and regulations. However, the drinking water standards are legal limits designed to prevent health effects from everyday exposure to low levels of radiation over long periods and they are not changing with this proposal.

    Estimated risk of excess cancer cases for lifetime exposure (70 years) to radioactive contaminants in drinking water at 4 mrem/yr (the MCL) generally falls in a range of risks deemed acceptable by the Agency's regulations. Estimated risks associated with a shorter (one year) exposure to radioactivity in drinking water at the proposed PAG levels fall within a similar range. Emergency guides are temporary measures to minimize risk while enabling prioritization of limited resources during an emergency response.

    The PAG levels are guidance for emergency situations; they do not supplant any standards or regulations, nor do they affect the stringency or enforcement of any standards or regulations. The PAG levels are intended to be used only in an emergency when radiation levels have already exceeded environmental standards. EPA expects that any drinking water system adversely impacted during a radiation incident will take action to return to compliance with Safe Drinking Water Act levels as soon as practicable.

    F. When will the PAG Manual be finalized?

    Once comments on this proposed, additional draft action have been addressed, EPA will add drinking water guidance to the full PAG Manual, which will then be issued in final form for incorporation into state, local, tribal and federal emergency response plans over a one-year implementation timeframe.

    G. What should I consider as I prepare my comments for EPA?

    When submitting comments, remember to:

    • Identify the rulemaking by docket number, subject heading, Federal Register date and page number.

    • Follow directions—the EPA may ask you to respond to specific questions or organize comments by referencing the chapter number of the draft action guide

    • Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

    • Describe any assumptions and provide technical information and data that you used.

    • If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow it to be reproduced.

    • Illustrate your concerns with specific examples and suggest alternatives.

    • Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

    • Make sure to submit your comments by the comment period deadline identified.

    H. What specific comments are being sought?

    While all comments regarding any aspect of the draft drinking water PAG guidance will be considered, please comment on the following issues specifically:

    • Please comment on the appropriateness of the drinking water PAG and the guidance for advance planning.

    • Please comment on what implementation challenges might be associated with the two-tiered approach to the water PAG that EPA should consider, and suggest additional guidance that would be helpful.

    • Please comment on whether (and if so why) EPA should reconsider using a single-tier drinking water PAG rather than tiered approach proposed in the draft action guide.

    • Please suggest additional guidance that would aid pre-incident planning and implementation specific to your community's drinking water systems.

    • Please comment on how this guidance should be implemented in emergency response and recovery plans at all levels of government, including considerations for public communications during an emergency.

    In the future, calculations and derived response levels will be provided in the Federal Radiological Monitoring and Assessment Center (FRMAC) Assessment Manuals. Emergency planners are referred to FRMAC Monitoring and Sampling Methods to assess surface and drinking water impacts from a radiological emergency. See the Assessment and Monitoring & Sampling folders at http://www.nv.doe.gov/nationalsecurity/homelandsecurity/frmac/manuals.aspx. After considering public comments, EPA intends to issue a final PAG Manual, which will supersede the 1992 PAG Manual and the 2013 revised PAG Manual.

    Dated: June 3, 2016. Joel Beauvais, Deputy Assistant Administrator, Office of Water.
    [FR Doc. 2016-13786 Filed 6-9-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-9027-5] Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General Information (202) 564-7146 or http://www2.epa.gov/nepa.

    Weekly receipt of Environmental Impact Statements Filed 05/30/2016 Through 06/03/2016 Pursuant to 40 CFR 1506.9. Notice

    Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

    EIS No. 20160124, Final, FERC, AK, Sweetheart Lake Hydroelectric Project, Review Period Ends: 07/11/2016, Contact: John Matkowski 202-502-8576 EIS No. 20160125, Final, BIA, NV, Aiya Solar Project, Review Period Ends: 07/11/2016, Contact: Charles Lewis 602-379-6782 EIS No. 20160126, Draft, USA, AZ, Lone Star Ore Body Development Project, Comment Period Ends: 07/25/2016, Contact: Michael Langley 602-230-6953 EIS No. 20160127, Final, NPS, CA, Restoration of Native Species in High Elevation Aquatic Ecosystems Plan, Review Period Ends: 07/11/2016, Contact: Woody Smeck 559-565-3100 EIS No. 20160128, Final, USACE, NC, Morehead City Harbor Integrated Dredged Material Management Plan, Review Period Ends: 07/11/2016, Contact: Jennifer Owens 910-251-4757 EIS No. 20160129, Draft, USFS, CA, Los Padres Tamarisk Removal, Comment Period Ends: 07/25/2016, Contact: Lloyd Simpson 805-646-4348 ex. 316 EIS No. 20160130, Draft, NOAA, TX, Flower Garden Banks National Marine Sanctuary Boundary Expansion, Comment Period Ends: 08/19/2016, Contact: Kelly Drinnen 409-621-5151 Ext.105 EIS No. 20160131, Third Final Supplemental, USFS, MT, Beaverhead-Deerlodge National Forest Land and Resource Management Plan to comply with District of Mont Court Order, Review Period Ends: 07/20/2016, Contact: Jan Bowey 406-842-5432 EIS No. 20160132, Draft, FHWA, CO, US 50 Corridor East, Comment Period Ends: 07/29/2016, Contact: Patricia Sergeson 720-963-3073 EIS No. 20160133, Final, FTA, VA, Potomac Yard Metrorail Station, Review Period Ends: 07/11/2016, Contact: Dan Koenig 202-219-3528 EIS No. 20160134, Final, TVA, TN, PROGRAMMATIC—Ash Impoundment Closure, Review Period Ends: 07/11/2016, Contact: Ashley Farless 423-751-2361 Dated: June 7, 2016. Dawn Roberts, Management Analyst, NEPA Compliance Division, Office of Federal Activities.
    [FR Doc. 2016-13791 Filed 6-9-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION [CC Docket No. 92-237; DA 16-599] Next Meeting of the North American Numbering Council AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice.

    SUMMARY:

    In this document, the Commission released a public notice announcing the meeting and agenda of the North American Numbering Council (NANC). The intended effect of this action is to make the public aware of the NANC's next meeting and agenda.

    DATES:

    Thursday, June 30, 2016, 10:00 a.m.

    ADDRESSES:

    Requests to make an oral statement or provide written comments to the NANC should be sent to Carmell Weathers, Competition Policy Division, Wireline Competition Bureau, Federal Communications Commission, Portals II, 445 12th Street SW., Room 5-C162, Washington, DC 20554.

    FOR FURTHER INFORMATION CONTACT:

    Carmell Weathers at (202) 418-2325 or [email protected]. The fax number is: (202) 418-1413. The TTY number is: (202) 418-0484.

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's document in CC Docket No. 92-237, DA 16-599 released May 31, 2016. The complete text in this document is available for public inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. The document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street SW., Room CY-B402, Washington, DC 20554, telephone (800) 378-3160 or (202) 863-2893, facsimile (202) 863-2898, or via the Internet at http://www.bcpiweb.com. It is available on the Commission's Web site at http://www.fcc.gov.

    The North American Numbering Council (NANC) has scheduled a meeting to be held Thursday, June 30, 2016, from 10:00 a.m. until 2:00 p.m. The meeting will be held at the Federal Communications Commission, Portals II, 445 12th Street SW., Room TW-C305, Washington, DC. This meeting is open to members of the general public. The FCC will attempt to accommodate as many participants as possible. The public may submit written statements to the NANC, which must be received two business days before the meeting. In addition, oral statements at the meeting by parties or entities not represented on the NANC will be permitted to the extent time permits. Such statements will be limited to five minutes in length by any one party or entity, and requests to make an oral statement must be received two business days before the meeting.

    People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty). Reasonable accommodations for people with disabilities are available upon request. Include a description of the accommodation you will need, including as much detail as you can. Also include a way we can contact you if we need more information. Please allow at least five days advance notice; last minute requests will be accepted, but may be impossible to fill.

    Proposed Agenda: Thursday, June 30, 2016, 10:00 a.m.*

    1. Announcements and Recent News 2. Approval of Transcript—March 24, 2016 3. Report of the North American Numbering Plan Administrator (NANPA) 4. Report of the National Thousands Block Pooling Administrator (PA) 5. Report of the Toll Free Number Administrator (TFNA) 6. Report of the Numbering Oversight Working Group (NOWG) 7. Report of the North American Numbering Plan Billing and Collection (NANP B&C) Agent 8. Report of the Billing and Collection Working Group (B&C WG) 9. Report of the North American Portability Management LLC (NAPM LLC) 10. Report of the Local Number Portability Administration (LNPA) Transition Oversight Manager (TOM) 11. Report of the Local Number Portability Administration Working Group (LNPA WG) 12. Report of the Future of Numbering Working Group (FoN WG) 13. Report of the Internet Protocol Issue Management Group (IP IMG) 14. Status of the Industry Numbering Committee (INC) activities 15. Summary of Action Items 17. Public Comments and Participation (maximum 5 minutes per speaker) 18. Other Business Adjourn no later than 2:00 p.m.

    *The Agenda may be modified at the discretion of the NANC Chairman with the approval of the DFO.

    Federal Communications Commission. Marilyn Jones, Attorney, Wireline Competition Bureau.
    [FR Doc. 2016-13696 Filed 6-9-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0710] Information Collection Being Reviewed by the Federal Communications Commission 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 the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. 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 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 Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before August 9, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0710.

    Title: Policy and Rules Under Parts 1 and 51 Concerning the Implementation of the Local Competition Provisions in the Telecommunications Act of 1996—CC Docket No. 96-98.

    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: 15,282 respondents; 1,067,987 responses.

    Estimated Time per Response: .50 hours-4,000 hours.

    Frequency of Response: On occasion 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 sections 1-4, 201-205, 214, 224, 251, 252, and 303(r) of the Communications Act of 1934, as amended, and section 601 of the Telecommunications Act of 1996. 47 U.S.C. 151-154, 201-205, 224, 251, 252, 303 (r), and 601.

    Total Annual Burden: 645,798 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 to implement the First Report and Order on Reconsideration issued in CC Docket No. 96-98. That Order implemented parts of sections 251 and 252 of the Telecommunications Act of 1996 that affect local competition. Incumbent local exchange carriers (ILECs) are required to offer interconnection, unbundled network elements (UNEs), transport and termination, and wholesale rates for certain services to new entrants. Incumbent LECS must price such services and rates that are cost-based and just and reasonable and provide access to right-of-way as well as establish reciprocal compensation arrangements for the transport and termination of telecommunications traffic.

    Federal Communications Commission. Sheryl D. Todd, Deputy Secretary, Office of Secretary.
    [FR Doc. 2016-13708 Filed 6-9-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination 10328 CommunitySouth Bank and Trust Easley, South Carolina

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10328 CommunitySouth Bank and Trust, Easley, South Carolina (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of CommunitySouth Bank and Trust (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective June 01, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: June 6, 2016.

    Federal Deposit Insurance Corporation.

    Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-13683 Filed 6-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination; 10242 Bank of Florida—Southwest; Naples, Florida

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10242 Bank of Florida—Southwest, Naples, Florida (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Bank of Florida—Southwest (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective June 01, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: June 6, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-13689 Filed 6-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL MINE SAFETY AND HEALTH REVIEW COMMISSION [BAC 6735-01] Sunshine Act Meeting June 8, 2016. Time and Date:

    10:00 a.m., Tuesday, July 12, 2016.

    Place:

    The Richard V. Backley Hearing Room, Room 511N, 1331 Pennsylvania Avenue NW., Washington, DC 20004 (enter from F Street entrance).

    Status:

    Open.

    Matters to be Considered:

    The Commission will hear oral argument in the matter Secretary of Labor v. The American Coal Company, Docket No. LAKE 2011-13 (Issues include whether the Judge erred by denying the Secretary's motion to approve a proposed settlement because the Judge concluded that more information was needed.) Any person attending this oral argument who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and § 2706.160(d).

    Contact Person For More Information:

    Emogene Johnson (202) 434-9935/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free.

    Sarah L. Stewart, Deputy General Counsel.
    [FR Doc. 2016-13879 Filed 6-8-16; 4:15 pm] BILLING CODE P
    FEDERAL MINE SAFETY AND HEALTH REVIEW COMMISSION [BAC 6735-01] Sunshine Act Meeting June 8, 2016.

    Time and Date:

    10:00 a.m., Thursday, July 14, 2016.

    Place:

    The Richard V. Backley Hearing Room, Room 511N, 1331 Pennsylvania Avenue NW., Washington, DC 20004 (enter from F Street entrance).

    Status:

    Open.

    Matters to Be Considered:

    The Commission will consider and act upon the following in open session: Secretary of Labor v. The American Coal Company, Docket No. LAKE 2011-13 (Issues include whether the Judge erred by denying the Secretary's motion to approve a proposed settlement because the Judge concluded that more information was needed.) Any person attending this meeting who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and § 2706.160(d).

    Contact Person For More Information:

    Emogene Johnson (202) 434-9935/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free.

    Sarah L. Stewart, Deputy General Counsel.
    [FR Doc. 2016-13880 Filed 6-8-16; 4:15 pm] BILLING CODE P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Scientific Information Request on Treatment Strategies for Patients With Lower Extremity Chronic Venous Disease (LECVD) AGENCY:

    Agency for Healthcare Research and Quality (AHRQ), HHS.

    ACTION:

    Request for scientific information submissions.

    SUMMARY:

    The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease (LECVD), which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Programs. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

    DATES:

    Submission Deadline on or before July 11, 2016.

    ADDRESSES:

    Email submissions: [email protected].

    Print submissions:

    Mailing Address:Portland VA Research Foundation, Scientific Resource Center, Attn: Scientific Information Packet Coordinator, P.O. Box 69539, Portland, OR 97239.

    Shipping Address (FedEx, UPS, etc.):Portland VA Research Foundation, Scientific Resource Center, Attn: Scientific Information Packet Coordinator, 3710 SW. U.S. Veterans Hospital Road, Mail Code: R&D 71, Portland, OR 97239.

    FOR FURTHER INFORMATION CONTACT:

    Ryan McKenna, Telephone: 503-220-8262 ext. 51723 or Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Programs to complete a review of the evidence for Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease (LECVD). The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (e.g., details of studies conducted). We are looking for studies that report on Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease (LECVD), including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: http://www.AHRQ.gov/sites/default/files/wysiwyg/research/findings/ta/topicrefinement/lecvd_protocol.pdf.

    This notice is to notify the public that the EPC Program would find the following information on Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease (LECVD) helpful:

    ☐ A list of completed studies that your organization has sponsored for this indication. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.

    For completed studies that do not have results on ClinicalTrials.gov, please provide a summary, including the following elements: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.

    A list of ongoing studies that your organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.

    ☐ Description of whether the above studies constitute all Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file.

    Your contribution will be very beneficial to the ECP Program. The contents of all submissions will be made available to the public upon request. Materials submitted must be publicly available or can be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.

    The draft of this review will be posted on AHRQ's EPC Program Web site and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://subscriptions.ahrq.gov/accounts/USAHRQ/subscriber/new?topic_id=USAHRQ_18.

    The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions. The entire research protocol, is available online at: http://www.AHRQ.gov/sites/default/files/wysiwyg/research/findings/ta/topicrefinement/lecvd_protocol.pdf.

    KQ 1: Narrative review of the diagnostic methods and diagnostic criteria for all adult patients (symptomatic and asymptomatic) with LE varicose veins, LE chronic venous insufficiency/incompetence/reflux, and/or LE chronic venous thrombosis/obstruction (including post-thrombotic syndrome).

    KQ 2: Regarding treatments for all adult patients (symptomatic and asymptomatic) with LE varicose veins and/or LE chronic venous insufficiency/incompetence/reflux:

    I. What is the comparative effectiveness of exercise, medical therapy, weight reduction, mechanical compression therapy, and invasive procedures (i.e., surgical and endovascular procedures) on health outcomes?

    II. What diagnostic method(s) and criteria were used in each study?

    III. How does the comparative effectiveness of treatment vary by patient characteristics, including age, sex, risk factors, comorbidities, characteristics of disease, anatomic segment affected, and characteristics of the therapy (e.g., exercise intensity, type of mechanical compression)?

    IV. What are the comparative safety concerns associated with each treatment strategy (e.g., adverse drug reactions, bleeding)? Do the safety concerns vary by patient subgroup (age, sex, race, risk factors, comorbidities, anatomic segment, or disease severity)?

    KQ 3: Regarding treatments for all adult patients (symptomatic and asymptomatic) with LE chronic venous thrombosis/obstruction (including post-thrombotic syndrome):

    I. What is the comparative effectiveness of exercise, medical therapy, mechanical compression therapy, and invasive procedures (i.e., surgical and endovascular procedures) on health outcomes?

    II. What diagnostic method(s) and criteria were used in each study?

    III. How does the comparative effectiveness of treatment vary by patient characteristics, including age, sex, risk factors, comorbidities, characteristics of disease, anatomic segment affected, and characteristics of the therapy (e.g., exercise intensity, type of mechanical compression)?

    IV. What are the comparative safety concerns associated with each treatment strategy (e.g., adverse drug reactions, bleeding)? Do the safety concerns vary by patient subgroup (age, sex, race, risk factors, comorbidities, anatomic segment, or disease severity)?

    PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting) KQ 1: Diagnosis I. Population(s): A. Adults (over age 18) with the diagnosis of LE varicose veins, LE chronic venous insufficiency/incompetence/reflux, and/or LE chronic venous thrombosis/obstruction (including post-thrombotic syndrome) II. Diagnostic Measures: A. Air plethysmography, LE venous duplex ultrasonography (with and without compression), invasive venography, magnetic resonance venography, computed tomographic venography, serum D-dimer testing, Villalta score III. Comparators: A. Diagnostic modalities listed above (air plethysmography, LE duplex venous ultrasonography [with and without compression], invasive venography, magnetic resonance venography, computed tomographic venography, serum D-dimer testing, Villalta score) will be compared to one another IV. Outcomes: A. Sensitivity, specificity, positive predictive value, negative predictive value, inter -rater reliability, internal consistency, test -retest reliability, false positives, false negatives, and positive and negative likelihood ratios for each diagnostic measure listed above will be compared V. Timing: A. Not applicable VI. Settings: A. All clinical settings, including inpatient and outpatient KQs 2-3: Treatment I. Population(s): A. KQ 2: A symptomatic or symptomatic adults (over age 18) with the diagnosis of LE varicose veins and/or LE chronic venous insufficiency/incompetence/reflux: i. Subgroup analysis: age, race/ethnicity, sex, body weight, CEAP classification, VCSS classification, severity of disease, anatomic segment affected (e.g., iliofemoral, infrainguinal), known malignancy, presence of LE ulcer A. KQ 3: A symptomatic or symptomatic adults(over age 18) with the diagnosis of LE chronic venous thrombosis/obstruction (including post-thrombotic syndrome): i. Subgroup analysis: age, race/ethnicity, sex, body weight, CEAP classification, VCSS classification, Villalta score, severity of disease, anatomic segment affected (e.g., iliofemoral, infrainguinal), known malignancy, presence of LE ulcer II. Interventions: A. KQ 2: lifestyle interventions (e.g ., smoking cessation, leg elevation, weight reduction, exercise), medical therapy, local skin care/wound care, mechanical compression therapy, and invasive procedures (i.e., surgical and endovascular procedures) i. Medical therapies: diuretics, aspirin, pentoxifylline, prostacyclins, zinc sulfate ii. Invasive surgical/endovascular procedures: sclerotherapy (liquid, foam, glue), radiofrequency ablation, thermal ablation, chemical ablation, ambulatory phlebectomy, transilluminated powered phlebectomy, venous ligation, venous excision B. KQ 3: lifestyle interventions (e.g., smoking cessation, leg elevation, weight reduction, exercise), medical therapy, local skin care/wound care, mechanical compression therapy, and invasive procedures (i.e., surgical and endovascular procedures) i. Medical therapies: anticoagulants including warfarin, apixaban, rivaroxaban, edoxaban, and dabigatran; diuretics ii. Invasive surgical/endovascular procedures: endovenous angioplasty/stenting, ultrasound accelerated thrombolysis for chronic DVT (EkoSonic® endovascular system), surgical thromboembolectomy III. Comparators: A. Specific treatments will be compared to other included treatments as described above or to no treatment (placebo or usual care) IV. Outcomes: A. Changes on standardized symptom scores (Villalta score, CEAP classification, AVVQ score, and VCSS score); qualitative reduction in Ledema; qualitative reduction in LE pain; improvement in LE venous hemodynamics/reflux severity as measured by air plethysmography, duplex ultrasonography, or invasive venography; venous wound healing, recurrent ulceration, patient-reported quality of life (including AVVQ), repeat intervention, LE amputation E B. Adverse effects of treatment, including: adverse drug reactions; bleeding (including intracranial bleeding); venous wound infection; contrast nephropathy; radiation-related injuries; exercise-related harms; periprocedural complications (vessel dissection, vessel perforation, and AV fistula), thrombophlebitis, venous thrombosis (including stent thrombosis), venous thromboembolic events (including PE), and death V. Timing: A. Studies with all durations of followup will be included in the review; for symptomatic patients, we will attempt to categorize studies into those that evaluate short-term (≤30 days), intermediate-ter m (31 days to 6 months), and long-term (> 6 months) events. VI. Settings: A. Any Sharon B. Arnold, Deputy Director.
    [FR Doc. 2016-13761 Filed 6-9-16; 8:45 am] BILLING CODE 4160-90-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Agency for Healthcare Research and Quality, HHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Survey of Hospital Quality Leaders.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

    This proposed information collection was previously published in the Federal Register on February 10, 2016 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

    DATES:

    Comments on this notice must be received by July 11, 2016.

    ADDRESSES:

    Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by email at [email protected] (attention: AHRQ's desk officer).

    FOR FURTHER INFORMATION CONTACT:

    Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Proposed Project Survey of Hospital Quality Leaders

    The Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Hospital Survey (HCAHPS) was first implemented on a voluntary basis in 2006 to assess patients' experiences with care. Today, hospitals subject to the Inpatient Prospective Payment System (IPPS) annual payment update provisions are required to collect and submit HCAHPS data in order to receive their full annual payment update. In addition, HCAHPS performance was added to the calculation of the value-based incentive payment in the Hospital Value-Based Purchasing (Hospital VBP) program, beginning with discharges in October 2012. The FY 2015 Hospital VBP program links 30% of the Inpatient Prospective Payment System hospitals' payment from CMS to HCAHPS performance.

    Despite the high stakes associated with HCAHPS scores, little is known about the ways in which hospitals are using HCAHPS data and supplemental information about patient experience to understand and improve their patients' experiences.

    This research has the following goals:

    (1) To characterize the role of HCAHPS in hospitals' efforts to improve patient experiences

    (2) to identify the types of quality improvement activities that hospitals implement to improve their HCAHPS scores

    (3) to describe hospitals' perspectives on HCAHPS

    (4) to determine the types of information collected by hospitals beyond those required for Hospital VBP

    This study is being conducted by AHRQ through its contractor, the RAND Corporation, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).

    Method of Collection

    Survey of Hospital Quality Leaders: this survey will elicit information from approximately 500 hospital quality leaders in a variety of hospital settings, including high- and low-performing hospitals, facilities of varying sizes, and hospitals representing all nine geographic Census divisions. Hospital quality leaders will be asked to provide information about the use of HCAHPS in their hospital, with questions addressing all of the substantive areas identified in the goals section above.

    Characterizing hospitals' use of HCAHPS data will provide important insight into the activities hospitals conduct to improve patient experience scores. This information may be useful in supporting hospitals who lag behind their peers, learning from hospitals with outstanding records of patient experience, and providing recommendations that may be used to refine HCAHPS survey content.

    Estimated Annual Respondent Burden

    Table 1 shows the estimated annualized burden and cost for the respondents' time to participate in this data collection. These burden estimates are based on tests of data collection conducted on nine or fewer entities. As indicated below, the annual total burden hours are estimated to be 294 hours. The annual total cost associated with the annual total burden hours is estimated to be $14,708.

    Table 1 shows the estimated annualized burden for the respondents' time to participate in this data collection. The Survey of Hospital Quality Leaders will be administered to 500 individuals. Prior work suggests that 3-5 items can typically be completed per minute, depending on item complexity and respondent characteristics, (Hays & Reeve, 2010; Berry, 2009). We have calculated our burden estimate using a conservative estimate of 4.5 items per minute. The survey contains 159 items and is thus estimated to require an average administration time of 35 minutes. As indicated below, the annual total burden hours are estimated to be 294 hours.

    Table 1—Estimated Annualized Burden Hours and Cost Collection task Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Hours per
  • response
  • Total burden
  • hours
  • Average
  • hourly wage
  • rate *
  • Total cost
  • burden
  • Survey of Hospital Quality Leaders 500 1 .59 294 $49.96 $14,708 Totals 294 14,708 * Based upon mean hourly wages, “National Compensation Survey: All United States December 2009—January 2011,” U.S. Department of Labor, Bureau of Labor Statistics.
    Request for Comments

    In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

    Sharon B. Arnold, Deputy Director.
    [FR Doc. 2016-13841 Filed 6-9-16; 8:45 am] BILLING CODE 4160-90-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-6069-N] Medicare Program; Pre-Claim Review Demonstration for Home Health Services AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice announces a 3-year Medicare pre-claim review demonstration for home health services in the states of Illinois, Florida, Texas, Michigan, and Massachusetts where there have been high incidences of fraud and improper payments for these services.

    DATES:

    This demonstration will begin in Illinois no earlier than August 1, 2016, in Florida no earlier than October 1, 2016, and in Texas no earlier than December 1, 2016. The demonstration will begin in Michigan and Massachusetts no earlier than January 1, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer McMullen, (410) 786-7635.

    Questions regarding the Medicare Pre-Claim Review Demonstration for Home Health Services should be sent to [email protected].

    SUPPLEMENTARY INFORMATION: I. Background and Legislative Authority

    Section 402(a)(1)(J) of the Social Security Amendments of 1967 (42 U.S.C. 1395b-1(a)(1)(J)) authorizes the Secretary to develop demonstration projects that “develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services under the health programs established by the Social Security Act” (the Act). According to this authority, we will implement a Medicare demonstration that establishes a pre-claim review process for home health agencies (HHAs) to assist in developing improved procedures for the identification, investigation, and prosecution of Medicare fraud occurring among HHAs providing services to Medicare beneficiaries. The proposed demonstration will begin in Illinois not earlier than August 1, 2016, will begin in Florida not earlier than October 1, 2016, and will begin in Texas not earlier than December 1, 2016. The demonstration will begin in Michigan and Massachusetts not earlier than January 1, 2017. Providers in each state will be notified by the appropriate Medicare Administrative Contractor prior to the start of the demonstration in the state. Additionally, CMS will utilize other educational efforts to announce the program to stakeholders.

    This demonstration will evaluate an additional method that may assist with the investigation and prosecution of fraud in order to protect the Medicare Trust Funds from fraudulent actions and improper payments. We believe this demonstration will bolster the efforts that CMS and its partners have taken in implementing a series of anti-fraud initiatives in these states and will provide valuable data that CMS working with its law enforcement partners, can use to combat the submission of fraudulent claims to the Medicare program. One such anti-fraud initiative is the use of temporary moratoria on the enrollment of new home health providers that were put in place in the Miami and Chicago that and were subsequently expanded to the Fort Lauderdale, Detroit, Dallas, and Houston metropolitan areas. These temporary moratoria prohibit the new enrollment of home health providers to help CMS prevent and combat fraud, waste, and abuse in these locations.

    We also believe the data collected from this demonstration will assist with a second initiative, the Health Care Fraud Prevention and Enforcement Action Team (HEAT) Task Force, created by the Department of Health and Human Services and the Department of Justice (DOJ), and the Heat Task Force's ongoing fight against Medicare fraud. The HEAT Task Force uses resources across the government to help prevent and stop fraud, waste, and abuse in the Medicare and Medicaid programs. Since 2007, the HEAT Task Force of the DOJ has charged more than 2,300 defendants with defrauding Medicare of more than $7 billion and convicted approximately 1,800 defendants of felony health care fraud offenses. In addition, the data resulting from this demonstration could provide investigators and law enforcement with important information to determine how to focus their investigation activities to identify and combat home health fraud, and in so doing, protect the Medicare Trust Funds from fraudulent actions and improper payments.

    This demonstration may also help prevent improper payments in geographic areas where HHA providers are known to have a high incidence of fraud. The improper payment rate for HHA claims has been increasing over the past several years, and fraud is one factor contributing to the increase. It is important to note that while all payments made as a result of fraud are considered “improper payments,” not all improper payments constitute fraud. CMS' Comprehensive Error Rate Testing (CERT) program, which measures Medicare's improper payment rate, estimates the payments that did not meet Medicare coverage, coding, and billing rules. The fiscal year (FY) 2015 Department of Health and Human Services Agency Financial Report reported that the CERT program's calculated 2015 improper payment rate for HHA claims increased to 59.0 percent from the 2014 rate of 51.4 percent and the 2013 rate of 17.3 percent. The increase in the 2015 improper payment rate was primarily due to “insufficient documentation” errors, specifically, insufficient documentation to support the medical necessity of the services. Similar documentation errors have also occurred in previous years. For example, the 2014 CERT report found that the majority of home health payment errors occurred when the narrative portion of the face-to-face encounter documentation did not sufficiently describe how the clinical findings from the encounter supported the beneficiary's homebound status and need for skilled services.

    Due to the substantial increase in improper payments and concerns raised by the home health industry, relating to implementation of the face-to-face encounter documentation requirement, we made Medicare HHA payment policy changes in an effort to simplify the face-to-face encounter regulations. Specifically, as of January 1, 2015, a separate narrative is no longer required as part of the face-to-face documentation. Rather, the certifying physician's or the acute/post-acute care facility's medical record(s) for the patient must contain sufficient documentation to substantiate eligibility for home health services.

    Despite these recent changes, we continue to see cases in which the medical record does not support eligibility for the home health benefit, which constitute “insufficient documentation” errors. Moreover, we note that the recent regulatory changes do not address HHA errors in home health billing other than those related to the face-to-face narrative requirement. Therefore, we also plan to use this demonstration to help make sure that all coverage and clinical documentation requirements are met before claims are submitted for final payment.

    We also believe that this demonstration will enable us to—(1) test the level of resources needed to implement a permanent pre-claim review program for home health services; (2) determine the feasibility of performing pre-claim reviews to prevent payment for services that have historically had a high incidence of fraud; and (3) determine the return on investment of pre-claim review for home health claims. This demonstration will support our program integrity strategy of moving beyond a reactive “pay and chase” method toward a more effective, proactive strategy that identifies potential improper payments before payments are made. We will analyze data from the home health services pre-claim review demonstration to evaluate the impact on fraud in the demonstration states, which we believe will help assist in developing improved procedures for the identification, investigation, and prosecution of Medicare fraud occurring among HHAs providing services to Medicare beneficiaries and may consider if a more focused, risk based approach to pre-claim review is warranted in the future.

    The pre-claim review demonstration does not create new documentation requirements, but simply requires currently mandated documentation earlier in the claims payment process. In addition, there are no changes to the home health service benefit for Medicare fee-for service beneficiaries.

    II. Provisions of the Notice

    This demonstration will implement a 3-year pre-claim review process for home health services in Illinois, Florida, Texas, Michigan, and Massachusetts. Prior to and during the demonstration, we will conduct outreach to and education of home health providers and Medicare beneficiaries using media such as webinars, open door forums, frequently asked questions pages on our Web site, other Web site postings, and educational materials issued by the Medicare Administrative Contractors (MACs) to provide guidance on the pre-claim review process. Additional information about the implementation of the pre-claim review demonstration will be available on the CMS Web site at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Overview.html. Questions regarding the Medicare Pre-Claim Review Demonstration for Home Health Services should be sent to [email protected]. Under this demonstration, a HHA provider, the entity billing on behalf of the HHA, or the beneficiary (known as the “submitter”) will be encouraged to submit to the relevant MAC a request for pre-claim review, along with all relevant documentation to support Medicare coverage of the applicable home health level of service. After receipt of all relevant documentation, the MAC will review the pre-claim review request to determine whether the service level complies with applicable Medicare coverage and clinical documentation requirements. The HHA provider should submit the Request for Anticipated Payment (RAP) before submitting the pre-claim review request and begin providing services while waiting for the decision from the MAC.

    The MAC will communicate to the HHA and beneficiary a decision provisionally approving (or disapproving) payment after a submission of a request for pre-claim review. For the initial submission of a pre-claim review request, the MAC will make all reasonable efforts to make a determination and issue a notice of the decision within 10 business days.

    If the MAC declines payment after review, the submitter may amend and resubmit it. A pre-claim review request may be resubmitted an unlimited number of times. For subsequent pre-claim review requests, CMS or its agents will conduct a complex medical review and make all reasonable efforts to postmark and notify the HHA and the beneficiary of its decision within 20 business days. These timeframes are consistent with the Prior Authorization of Power Mobility Devices (PMDs) Demonstration. Meeting these timeframes will be part of the contract performance metrics for the MACs that are involved in this demonstration at the time their contracts are modified to incorporate the demonstration's work requirements (as well as the necessary funding).

    If an applicable claim is submitted for payment without a pre-claim review decision, it will be stopped for prepayment review and documentation will be requested. After the first 3 months of the demonstration in a particular state, we will apply a payment reduction for claims that, after such prepayment review, are deemed payable, but did not first receive a pre-claim review decision. As evidence of compliance, the HHA must submit the pre-claim review number on the claim in order to avoid a 25-percent payment reduction. The 25-percent payment reduction cannot be recouped from or otherwise charged to the beneficiary, and is not subject to appeal. The beneficiary would not be liable for more than he or she would otherwise be if the demonstration were not in place.

    The following explains the various pre-claim review scenarios:

    In each of the following scenarios, the HHA would conduct all required assessments, submit the RAP, and begin services for the beneficiaries.

    Scenario 1: When a submitter submits a pre-claim review request to the MAC with appropriate documentation, and all relevant Medicare coverage and documentation requirements are met for the home health service, the MAC will send a provisional affirmative pre-claim review decision to the HHA and the Medicare beneficiary. When the HHA submits the claim for payment to the MAC after delivering the home health level of service(s), the claim will include a unique tracking number that indicates it has been affirmed for pre-claim review and, as long as all Medicare coverage and documentation requirements continue to be met, the claim is paid.

    Scenario 2: When a submitter submits a pre-claim review request with documentation that does not meet all relevant Medicare coverage and clinical documentation requirements for the home health level of service, notification of a non-affirmative decision will be sent to the HHA and the beneficiary advising them that Medicare will not pay for the service. The submitter may then resubmit the request with additional documentation to support that the Medicare requirements have been met. Alternatively, the HHA could submit the claim to the MAC, at which point the MAC would deny the claim for lack of a provisional affirmative pre-claim review decision and recoup the payment made on the RAP following their standard procedures. Upon receiving the claim denial by the MAC, the HHA or the beneficiary would have the opportunity to appeal the claim denial if they believe Medicare coverage was denied inappropriately. Beneficiaries will continue to have the option of signing an Advance Beneficiary Notice of Noncoverage (ABN) in order to receive the services and be liable for payment.

    Scenario 3: When a submitter submits a pre-claim review request with incomplete documentation, the request, along with a detailed decision letter explaining what information is missing, is sent back to the submitter for resubmission. Both the HHA and the beneficiary are notified and the submitter can resubmit the request with appropriate supporting documentation.

    Scenario 4: When the HHA provides the treatment to the beneficiary and submits the claim to the MAC for payment without submitting a pre-claim review request, the home health claim will be stopped for prepayment review and documentation will be requested. If the claim is determined to be not medically necessary or not sufficiently documented, the claim will be denied and all current policies and procedures regarding liability for payment will apply. The HHA, the beneficiary, or both can appeal the claim denial if they believe the claim was payable. If the claim is determined to be payable on appeal, it will be paid. After the first 3 months of the demonstration, we will reduce payment by 25 percent for claims that after such prepayment review are deemed payable but did not first receive a pre-claim review decision. This payment reduction is not subject to appeal. After a claim is submitted, processed, and denied, appeal rights for the claim denial would become available in accordance with 42 CFR part 405, subpart I. The 25-percent payment reduction cannot be charged to the beneficiary. The beneficiary would not be liable for more than he or she would otherwise be if the demonstration were not in place.

    Additional information is available on the CMS' Web site at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Overview.html.

    III. Collection of Information Requirements

    We announced and solicited comments for the information collection requirements associated with the Medicare Prior Authorization of Home Health Services Demonstration in a 60-day Federal Register notice that published on February 5, 2016 (81 FR 6275). The information collection requirements do not take effect until they are approved by OMB and issued a valid OMB control number.

    Dated: May 26, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services.
    [FR Doc. 2016-13755 Filed 6-8-16; 4:15 pm] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [CFDA Number: 93.092] Announcing the Intent To Award Single-Source Expansion Supplement Grants to Two Personal Responsibility Education Program Innovative Strategies (PREIS) Grantees AGENCY:

    Family and Youth Services Bureau, ACYF, ACF.

    ACTION:

    This notice announces the intent to award single-source expansion supplement grants under the Personal Responsibility Education Program Innovative Strategies (PREIS) program to Children's Hospital of Los Angeles in Los Angeles, CA and Education Development Center, Inc. in Newton, MA.

    SUMMARY:

    The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Adolescent Pregnancy Prevention Program, announces its intent to award a single-source expansion supplement grant of up to $151,265 to Children's Hospital of Los Angeles and up to $55, 917.20 to Education Development Center, Inc.

    DATES:

    The period of support for the single-source expansion supplements is September 30, 2015, through September 29, 2016.

    FOR FURTHER INFORMATION CONTACT: LeBretia White, Program Manager, Adolescent Pregnancy Prevention Program, Division of Adolescent Development and Support, Family and Youth Services Bureau, 330 C Street SW., Washington, DC 20201. Telephone: 202-205-9605; Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    Children's Hospital of Los Angeles is funded under the Personal Responsibility Education Program Innovative Strategies (PREIS) program to adapt an existing evidence-based pregnancy prevention program for pregnant and parenting teens and rigorously evaluate the program for its impact on reducing repeat pregnancy. The supplemental award will be used to review, code, and analyze digital recordings, employ intensive tracking and follow up efforts with participants to administer the 36-month follow-up survey, conduct additional advanced analyses, develop manuscripts and briefs based on additional analyses, and disseminate study findings.

    Education Development Center, Inc. is funded under the Personal Responsibility Education Program Innovative Strategies (PREIS) program to implement a parent education program for Latino youth (Salud y Exito/Health and Success) and to rigorously evaluate the intervention to determine impact on reducing sexual risk-taking behavior. The supplement award will be used to augment dissemination efforts for the intervention by developing a social media campaign to promote the intervention Web site and to analyze social media data to determine the campaign's reach.

    Statutory Authority:

    The statutory authority for the award is Sec. 513 of the Social Security Act (42 U.S.C. 713). Sec. 2953 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) established PREP and funded it for FY 2010 through 2014. Sec. 206 of the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93) extended that funding through FY 2015. Sec. 215 of the Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10) extended funding through FY 2017.

    Christopher Beach, Senior Grants Policy Specialist, Division of Grants Policy, Office of Administration, Administration for Children and Families.
    [FR Doc. 2016-13698 Filed 6-9-16; 8:45 am] BILLING CODE 8414-37-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request

    Title: National Survey of Child and Adolescent Well-Being-Third Cohort (NSCAW III): Agency Recruitment.

    OMB No.: 0970-0202.

    Description: The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) intends to collect data on a third cohort of children and families for the National Survey of Child and Adolescent Well-Being (NSCAW). NSCAW is the only source of nationally representative, longitudinal, firsthand information about the functioning and well-being, service needs, and service utilization of children and families who come to the attention of the child welfare system. The first two cohorts of NSCAW were collected beginning in 1999 and 2008 and studied children who had been the subject of investigation by Child Protective Services. Children were sampled from child welfare agencies nationwide.

    The proposed data collection plan for the third cohort of NSCAW includes two phases: Phase 1 includes child welfare agency recruitment and collection of files for sampling children, and Phase 2 includes baseline data collection and an 18-month follow-up data collection. The current data collection plan calls for selecting a new cohort of 4,565 children and families and repeating similar data collection procedures as the previous two cohorts. This Notice is specific to Phase 1. The overall goal is to recruit child welfare agencies in 83 primary sampling units nationwide. Child welfare agencies will be selected with probability proportional to size, based on the current distributions in the child welfare system. Child welfare agency recruitment will include: mail, email, phone calls, and site visits with child welfare agency administrators.

    Respondents: Child welfare agency administrators and other personnel. Data collection will take place over a 2-year period.

    Annual Burden Estimates Instrument Total number of respondents Annual
  • number of
  • respondents
  • Number of
  • responses per respondent
  • Average
  • burden hours per response
  • Annual burden hours
    Information package for agency administrators 114 57 1 0.25 14 Initial call with agency staff 114 57 1 1 57 In-person visit with agency staff 20 10 1 1 10 Visit or call with agency staff explaining the sample file process 83 42 1 2 84 Agency staff monthly sample file generation and transmission 83 42 15 1 630

    Estimated Total Annual Burden Hours: 795.

    Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street, SW., Washington, DC 20201, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]

    OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected], Attn: Desk Officer for the Administration for Children and Families.

    Robert Sargis, ACF Certifying Officer.
    [FR Doc. 2016-13682 Filed 6-9-16; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

    DATES:

    The meeting will be held on July 13, 2016, from 7:30 a.m. to 5 p.m.

    ADDRESSES:

    FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    FOR FURTHER INFORMATION CONTACT:

    Moon Hee Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: The committee will discuss biologics license application 761042, for GP2015, a proposed biosimilar to Amgen Inc.'s ENBREL (etanercept) submitted by Sandoz, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (in combination with methotrexate (MTX) or used alone); (2) reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older; (3) reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (in combination with MTX in patients who do not respond adequately to MTX alone); (4) reducing signs and symptoms in patients with active ankylosing spondylitis; and (5) treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before June 28, 2016. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 3 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 20, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 21, 2016.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Moon Hee Choi at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: June 6, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs.
    [FR Doc. 2016-13709 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0511] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by July 11, 2016.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-0337. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Medicated Feed Mill License Application—21 CFR Part 515—OMB Control Number 0910-0337—Revision

    Feed manufacturers that seek to manufacture feed using Category II, Type A medicated articles or manufacture certain liquid and free-choice feed, using Category I, Type A medicated articles that must follow proprietary formulas or specifications are required to obtain a facility license under section 512 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b). Our regulations in part 515 (21 CFR part 515) establish the procedures associated with applying for a facility license. We require that a manufacturer seeking a facility license submit a completed medicated feed mill license application using Form FDA 3448 (21 CFR 515.10(b)). We use the information submitted to establish that the applicant has made the certifications required by section 512 of the FD&C Act, to register the mill, and to schedule a pre-approval inspection. We have made minor editorial revisions to Form FDA 3448, including the addition of a dedicated field for the submitter's email address in the contact information section. We estimate that the revisions will not change the amount of time necessary to complete the form.

    We require the submission of a supplemental medicated feed mill license application for a change in facility ownership or a change in facility address (§ 515.11(b)). If a licensed facility is no longer manufacturing medicated animal feed under § 515.23, a manufacturer may request voluntary revocation of a medicated feed mill license. An applicant also has the right to file a request for hearing under § 515.30(c) to give reasons why a medicated feed mill license should not be refused or revoked.

    In the Federal Register of March 9, 2016 (81 FR 12509), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment, which was not responsive to the comment request.

    We estimate the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 21 CFR section and activity Number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual responses Average burden per response Total hours
    Medicated Feed Mill License Application using Form FDA 3448 (515.10(b)) 20 1 20 0.25 (15 minutes) 5 Supplemental Feed Mill License Application using Form FDA 3448 (515.11(b)) 40 1 40 0.25 (15 minutes) 10 Voluntary Revocation of Medicated Feed Mill License
  • (515.23)
  • 40 1 40 0.25 (15 minutes) 10
    Filing a Request for a Hearing on Medicated Feed Mill License (515.30(c)) 1 1 1 4 4 Total 29 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 2—Estimated Annual Recordkeeping Burden 1 21 CFR section and activity Number of
  • recordkeepers
  • Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours
    Maintenance of Records for Approved Labeling for Each “Type B” and “Type C” Feed (510.305) 890 1 890 0.03 (2 minutes) 27 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    These estimates are based on our experience with medicated feed mill license applications. We estimate that we will receive 20 medicated feed mill license applications, 40 supplemental applications, 40 requests for voluntary revocation, and that these submissions will take approximately 15 minutes per response, as shown in table 1, rows 1 through 3. We estimate that preparing a request for a hearing under § 515.30(c) takes approximately 4 hours, as shown in table 1, row 4. In table 2, we estimate that 890 licensees will keep the records required by 21 CFR 510.305 expending a total of 27 hours annually.

    Dated: June 6, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-13790 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1264] Dissemination of Patient-Specific Information From Devices by Device Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Dissemination of Patient-Specific Information from Devices by Device Manufacturers.” The FDA developed this draft guidance to facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers to patients. This draft guidance provides recommendations to industry, healthcare providers, and FDA staff about the mechanisms and considerations for device manufacturers sharing such information with patients. This draft guidance is not final nor is it in effect at this time.

    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 of 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 August 9, 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-1264 for “Dissemination of Patient-Specific Information from Devices by Device Manufacturers.” 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.

    An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Sugato De, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5435, Silver Spring, MD 20993-0002, 301-796-6270, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    Increasingly, patients seek to play an active role in their own healthcare. FDA believes that manufacturers providing patients with accurate, useable information about their healthcare (including the medical products they use and patient-specific information these products generate) will improve healthcare by empowering patients to participate fully with their healthcare providers in making sound medical decisions. For purposes of this guidance, patient-specific information is defined as any information unique to an individual patient or unique to that patient's treatment or diagnosis that may be recorded, stored, processed, retrieved, and/or derived from a medical device. This information may include, but is not limited to, recorded patient data, device usage/output statistics, healthcare provider inputs, incidence of alarms, and/or records of device malfunctions or failures.

    FDA developed this draft guidance to convey FDA's policy regarding the dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from a medical device and provided by the manufacturer to the patient who is either treated or diagnosed with that specific device. This draft guidance document also outlines considerations for the form in which this information is communicated to help to ensure clarity of content and appropriate context.

    Manufacturers may share patient-specific information (recorded, stored, processed, retrieved, and/or derived from a medical device, consistent with the intended use of that medical device) with patients either on their own initiative or at the patient's request, without obtaining additional premarket review before doing so. Any labeling, as that term is defined in section 201(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), that is provided to the patient by the manufacturer is subject to applicable requirements in the FD&C Act and FDA regulations.

    II. Significance of 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 “Dissemination of Patient-Specific Information from Devices by Device Manufacturers.” 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.

    III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500067 to identify the guidance you are requesting.

    IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information found in FDA regulations and guidance. These collections of information 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 in 21 CFR parts 801 and 809, regarding device labeling, are approved under OMB control number 0910-0485.

    Dated: June 6, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-13787 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

    DATES:

    The meeting will be held on July 19, 2016, from 8 a.m. to 5 p.m.

    ADDRESSES:

    FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: The committee will discuss biologics license application (BLA) 761032, brodalumab injection, a human monoclonal antibody, submitted by Valeant Pharmaceuticals Luxembourg S.à.r.l, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before July 5, 2016. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 24, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 27, 2016.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Jennifer Shepherd at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: June 6, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs.
    [FR Doc. 2016-13710 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1248] Oncology Drugs for Companion Animals; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #237 entitled “Oncology Drugs for Companion Animals.” The guidance provides recommendations for sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses), discusses the contents of a new animal drug application (NADA) for certain oncology drugs, and provides recommendations on how to address human user safety concerns.

    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 August 9, 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-1248 for “Oncology Drugs for Companion Animals.” 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 guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 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:

    Christopher Loss, Center for Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 Standish Pl., Rm. N310, Rockville, MD 20855, 240-402-0619, [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a draft guidance for industry #237 entitled “Oncology Drugs for Companion Animals.” This guidance document makes recommendations to sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses). The guidance discusses the contents of the target animal safety, effectiveness, and labeling technical sections of an NADA for oncology drugs administered as single agents. The guidance also includes recommendations on how to address human user safety concerns.

    In the guidance, FDA recommends that sponsors of multi-drug regimens contact the Center for Veterinary Medicine (CVM) to discuss a product development plan. While sponsors may choose alternate pathways for approval, the Agency is recommending that sponsors first discuss their proposed study plans with CVM, especially if they choose to use an alternative pathway for approval. The Agency encourages sponsors to schedule a presubmission conference with CVM as they begin to make their investigational plans to ensure that they are completely informed on the requirements contained in the statute and regulations.

    II. Significance of Guidance

    This level 1 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 oncology drugs for companion animals. 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.

    III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: June 7, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-13789 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2014-E-1239; FDA-2015-E-0539] Determination of Regulatory Review Period for Purposes of Patent Extension; POMALYST AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) has determined the regulatory review period for POMALYST and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

    DATES:

    Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by August 9, 2016 Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 7, 2016. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    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 Nos. FDA-2014-E-1239 and FDA-2015-E-0539 for “Determination of Regulatory Review Period for Purposes of Patent Extension; POMALYST.” 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:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human drug product POMALYST (pomalidomide). POMALYST is indicated for treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of last therapy. Subsequent to this approval, the USPTO received patent term restoration applications for POMALYST (U.S. Patent Nos. 6,316,471 and 8,198,262) from Celgene Corporation, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 11, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of POMALYST represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for POMALYST is 3,716 days. Of this time, 3,411 days occurred during the testing phase of the regulatory review period, while 305 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: December 9, 2002. The applicant claims December 14, 2002, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was December 9, 2002, which was the first date after receipt of the IND that the investigational studies were allowed to proceed.

    2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: April 10, 2012. FDA has verified the applicant's claim that the new drug application (NDA) for POMALYST (NDA 204026) was initially submitted on April 10, 2012.

    3. The date the application was approved: February 8, 2013. FDA has verified the applicant's claim that NDA 204026 was approved on February 8, 2013.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 5 years or 241 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: June 3, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-13796 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Request for Nominations for Individuals and Consumer Organizations for Advisory Committees AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization.

    FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

    DATES:

    Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a letter or email stating that interest to FDA (see ADDRESSES) by July 11, 2016, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by July 11, 2016. Nominations will be accepted for current vacancies and for those that will or may occur through August 31, 2016.

    ADDRESSES:

    All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should be submitted electronically to [email protected], by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or by FAX: 301-847-8640.

    Consumer representative nominations should be submitted electronically by logging into the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or by FAX: 301-847-8640. Additional information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.

    FOR FURTHER INFORMATION CONTACT:

    For questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff (ACOMS), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, 301-796-8220 email: [email protected].

    For questions relating to specific advisory committees or panels, contact the appropriate Contact Person listed in table 1 in the SUPPLEMENTARY INFORMATION section:

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing (see table 1 for Contact Person).

    Table 1—Advisory Committee Contacts Contact person Committee/panel Janie Kim, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6129, Silver Spring, MD 20993-0002, Phone: 301-796-9016, Email: [email protected] Allergenic Products Advisory Committee. Shanika Craig, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002, Phone: 301-796-6639, Email: [email protected] Anesthesiology and Respiratory Therapy Devices Panel. Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993-0002, Phone: 301-796-6875, Email: [email protected] Gastroenterology and Urology Devices Panel; General and Plastic Surgery Devices Panel; Neurological Devices Panel. Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3354, Silver Spring, MD 20993-0002, Phone: 301-796-5290, Email: [email protected] Ophthalmic Devices Panel. Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, Phone: 301-796-6683, Email: [email protected] Molecular and Clinical Genetics Devices Panel. Cindy Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2430, Silver Spring, MD 20993-0002, Phone: 301-796-0889, Email: [email protected] Gastrointestinal Drugs Advisory Committee. Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993-0002, Phone: 301-796-4043, Email: [email protected] Medical Imaging Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Advisory Committee. Table 2—Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Committee/panel/areas of expertise needed Type of vacancy Approximate date needed Allergenic Products Advisory Committee—Knowledgeable in the fields of allergy, immunology, pediatrics, internal medicine, biochemistry, and related specialties 1—Voting August 31, 2016. Anesthesiology and Respiratory Therapy Devices Panel—Anesthesiologists, pulmonary medicine specialists, or other experts who have specialized interests in ventilator support, pharmacology, physiology, or the effects and complications of anesthesia 1—Non-Voting Immediately. Gastroenterology and Urology Devices Panel Science Advisory Board to the National Center for Toxicological Research—Knowledgeable in the fields related to toxicological research 1—Non-Voting Immediately. General and Plastic Surgery Devices Panel—Surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic and endoscopic); dermatologists; experts in biomaterials, lasers, wound healing, and quality of life; and biostatisticians 1—Non-Voting Immediately. Neurological Devices Panel—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians 1—Non-Voting Immediately. Ophthalmic Devices Panel—Ophthalmologists with expertise in corneal-external disease, vitreo-retinal surgery, glaucoma, ocular immunology, ocular pathology; optometrists; vision scientists; and ophthalmic professionals with expertise in clinical trial design, quality of life assessment, electrophysiology, low vision rehabilitation, and biostatistics 1—Non-Voting Immediately. Molecular and Clinical Genetics Devices Panel—Experts in human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. The Agency is also interested in considering candidates with training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology and related statistical training. Additionally, individuals with experience in genetic counseling, medical ethics as well as ancillary fields of study will be considered 1—Non-Voting Immediately. Gastrointestinal Drugs Advisory Committee—Knowledgeable in the fields of gastroenterology, endocrinology, surgery, clinical pharmacology, physiology, pathology, liver function, motility, esophagitis, and statistics 1—Voting June 30, 2016. Medical Imaging Advisory Committee—Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics and related specialties 1—Voting June 30, 2016. Pharmaceutical Science and Clinical Pharmacology Advisory Committee—Knowledgeable in the fields of pharmaceutical manufacturing, clinical pharmacology, pharmacokinetics, bioavailability and bioequivalence research, the design and evaluation of clinical trials, laboratory analytical techniques, pharmaceutical chemistry, physiochemistry, biochemistry, biostatistics and related biomedical and pharmacological specialties 1—Voting Immediately. II. Functions and General Description of the Committee Duties A. Allergenic Products Advisory Committee

    Reviews and evaluates available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease as well as the affirmation or revocation of biological product licenses, on the safety, effectiveness, and labeling of the product; on clinical and laboratory studies of such products; on amendments or revisions to regulations governing the manufacture, testing, and licensing of allergenic biological products; and on the quality and relevance of FDA's research programs.

    B. Certain Panels of the Medical Devices Advisory Committee

    Reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises on the classification or reclassification of devices into one of three regulatory categories; advises on any possible risks to health associated with the use of devices; advises on formulation of product development protocols; reviews premarket approval applications for medical devices; reviews guidelines and guidance documents; recommends exemption of certain devices from the application of portions of the Federal Food, Drug, and Cosmetic Act; advises on the necessity to ban a device; and responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner of Food and Drugs on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices.

    The Dental Products Panel also functions at times as a dental drug panel. The functions of the dental drug panel are to evaluate and recommend whether various prescription drug products should be changed to over-the-counter status and to evaluate data and make recommendations concerning the approval of new dental drug products for human use.

    The Medical Devices Dispute Resolution Panel provides advice to the Commissioner on complex or contested scientific issues between FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and Agency guidance and policies. The Panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to regular advisory panel proceedings or Agency decisions or actions.

    C. Gastrointestinal Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of gastrointestinal diseases.

    D. Medical Imaging Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology.

    E. Pharmaceutical Science and Clinical Pharmacology Advisory Committee

    Provide advice on scientific and technical issues concerning the safety and effectiveness of human generic drug products for use in the treatment of a broad spectrum of human diseases and, as required, any other product for which FDA has regulatory responsibility. The committee may also review Agency sponsored intramural and extramural biomedical research programs in support of FDA's generic drug regulatory responsibilities.

    III. Criteria for Members

    Persons nominated for membership as consumer representatives on committees or panels should meet the following criteria: (1) Demonstrate ties to consumer and community-based organizations, (2) be able to analyze technical data, (3) understand research design, (4) discuss benefits and risks, and (5) evaluate the safety and efficacy of products under review. The consumer representative should be able to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers.

    IV. Selection Procedures

    Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and public advocacy groups. These organizations recommend nominees for the Agency's selection. Representatives from the consumer health branches of Federal, State, and local governments also may participate in the selection process. Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests should send a letter stating that interest to FDA (see ADDRESSES) within 30 days of publication of this document.

    Within the subsequent 30 days, FDA will compile a list of consumer organizations that will participate in the selection process and will forward to each such organization a ballot listing at least two qualified nominees selected by the Agency based on the nominations received, together with each nominee's current curriculum vitae or resume. Ballots are to be filled out and returned to FDA within 30 days. The nominee receiving the highest number of votes ordinarily will be selected to serve as the member representing consumer interests for that particular advisory committee or panel.

    V. Nomination Procedures

    Any interested person or organization may nominate one or more qualified persons to represent consumer interests on the Agency's advisory committees or panels. Self-nominations are also accepted. Nominations should include a cover letter and current curriculum vitae or resume for each nominee, including a current business and/or home address, telephone number, and email address if available, and a list of consumer or community-based organizations for which the candidate can demonstrate active participation.

    Nominations should also specify the advisory committee(s) or panel(s) for which the nominee is recommended. In addition, nominations should include confirmation that the nominee is aware of the nomination, unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. Members will be invited to serve for terms up to 4 years.

    FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of qualified nominees. Names not selected will remain on a list of eligible nominees and be reviewed periodically by FDA to determine continued interest. Upon selecting qualified nominees for the ballot, FDA will provide those consumer organizations that are participating in the selection process with the opportunity to vote on the listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as voting or nonvoting consumer representatives will not participate in the selection process.

    This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: June 3, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs.
    [FR Doc. 2016-13733 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-2341] Determination of Regulatory Review Period for Purposes of Patent Extension; TANZEUM AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) has determined the regulatory review period for TANZEUM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

    DATES:

    Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by August 9, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 7, 2016. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    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-2014-E-2341

    For Determination of Regulatory Review Period for Purposes of Patent Extension; TANZEUM. 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:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human biological product TANZEUM (albiglutide). TANZEUM is indicated as an adjunct to diet and exercise to improve g