Federal Register Vol. 81, No.181,

Federal Register Volume 81, Issue 181 (September 19, 2016)

Page Range64049-64343
FR Document

81_FR_181
Current View
Page and SubjectPDF
81 FR 64060 - Revised Medical Criteria for Evaluating Respiratory System DisordersPDF
81 FR 64341 - Continuation of the National Emergency With Respect to Persons Who Commit, Threaten To Commit, or Support TerrorismPDF
81 FR 64226 - Sunshine Act MeetingPDF
81 FR 64142 - Sunshine Act; Notice of MeetingPDF
81 FR 64049 - National Hispanic Heritage Month, 2016PDF
81 FR 64182 - Submission for OMB Review; 30-Day Comment Request; National Institute of Neurological Disorders and Stroke Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Access RequestPDF
81 FR 64211 - Sunshine Act MeetingPDF
81 FR 64149 - Registration Review; Draft Ecological and/or Human Health Risk Assessments; Notice of AvailabilityPDF
81 FR 64256 - U.S. National Commission for UNESCO Notice of Teleconference MeetingPDF
81 FR 64142 - Notice of Availability of Revised Methodology for Determining Average Prime Offer RatesPDF
81 FR 64256 - E.O. 13224 Designation of Omar Diaby, aka Omar al-Diaby, aka Omar Omsen, aka Omar Oumsen, aka Oumar Diaby as a Specially Designated Global TerroristPDF
81 FR 64151 - Proposed Collection; Comment Request; Proposed Information Collection Request for the National Study of Nutrient Removal and Secondary Technologies: Publicly Owned Treatment Works (POTW) Screener QuestionnairePDF
81 FR 64256 - E.O. 13224 Designation of Fathi Ahmad Mohammad Hammad, aka Fathi Ahmad Hammad, aka Fathy Ahmed Hamad, aka Fathi Hamad as a Specially Designated Global TerroristPDF
81 FR 64184 - Louisiana; Amendment No. 6 to Notice of a Major Disaster DeclarationPDF
81 FR 64060 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Definition of Qualified Auditor; Announcement of Effective DatePDF
81 FR 64143 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS); Organizational Conflicts of Interest in Major Defense Acquisition ProgramsPDF
81 FR 64256 - U.S. Department of State Advisory Committee on Private International Law: Public Meeting on Micro-, Small-, and Medium Sized EnterprisesPDF
81 FR 64145 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Educational Opportunity Centers Program (EOC) Annual Performance ReportPDF
81 FR 64135 - U.S. Smart Grid Solutions ToolkitPDF
81 FR 64212 - Tennessee Valley Authority; Sequoyah Nuclear Plant, Units 1 and 2PDF
81 FR 64209 - Environmental Properties Management; Cimarron Facility; Decommissioning PlanPDF
81 FR 64204 - Proposed Information Collection Request Submitted for Public Comment and Recommendations Eligibility Data Form: Uniformed Services Employment and Reemployment Rights Act and Veteran's Preference (USERRA/VP)PDF
81 FR 64207 - Issuance of Updates to NUREG-1556 (Consolidated Guidance About Materials Licenses), Volumes 1 (Portable Gauges), 2 (Industrial Radiography), 3 (Sealed Sources and Devices), 4 (Fixed Gauges), 10 (Master Material Licenses), 15 (Changes of Control and Bankruptcy), and 19 (Reciprocity)PDF
81 FR 64141 - Agency Information Collection Activities Under OMB ReviewPDF
81 FR 64131 - Foreign-Trade Zone (FTZ) 7-Mayaguez, Puerto Rico; Notification of Proposed Production Activity; MSD International GMBH (Puerto Rico Branch) LLC; Subzone 7G (Pharmaceuticals) Las Piedras, Puerto RicoPDF
81 FR 64150 - National Advisory Council for Environmental Policy and TechnologyPDF
81 FR 64189 - Proposed Flood Hazard DeterminationsPDF
81 FR 64186 - Proposed Flood Hazard DeterminationsPDF
81 FR 64183 - Proposed Flood Hazard DeterminationsPDF
81 FR 64203 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Income and Eligibility Verification System ConfidentialityPDF
81 FR 64185 - Proposed Flood Hazard DeterminationsPDF
81 FR 64187 - Proposed Flood Hazard DeterminationsPDF
81 FR 64162 - International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4-Methylethcathinone and Eleven Other Substances; Request for CommentsPDF
81 FR 64164 - Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and WebcastPDF
81 FR 64177 - A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public DocketPDF
81 FR 64127 - Privacy Act System of Records, Amended System of RecordsPDF
81 FR 64144 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Student Aid Internet Gateway (SAIG) Enrollment DocumentPDF
81 FR 64183 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 64202 - Notice of Lodging of Proposed Consent Decree Under the Clean Water ActPDF
81 FR 64147 - Boulder Canyon ProjectPDF
81 FR 64066 - Security Zone; 22nd International Seapower Symposium, Goat Island, Newport, RIPDF
81 FR 64068 - Security Zone; 22nd International Seapower Symposium Special Events, Rosecliff Mansion and Newport Marriott Hotel, Newport, RIPDF
81 FR 64190 - Agency Information Collection Activities: Application for Asylum and for Withholding of Removal, Form I-589; Extension, Without Change, of a Currently Approved CollectionPDF
81 FR 64191 - Agency Information Collection Activities: Application for Waiver of Grounds of Inadmissibility, FormI-690; Extension, Without Change, of a Currently Approved CollectionPDF
81 FR 64139 - Multistakeholder Process on Internet of Things Security Upgradability and PatchingPDF
81 FR 64159 - RPG National Cross-Site Evaluation 30-Day NoticePDF
81 FR 64205 - Agency Information Collection Activities: Proposed Collection; Comment Request; Call Report and Credit Union ProfilePDF
81 FR 64206 - Submission for OMB Review; Comment RequestPDF
81 FR 64192 - Draft Environmental Impact Statement; Indiana Department of Natural Resources Habitat Conservation PlanPDF
81 FR 64257 - Qualification of Drivers; Exemption Applications; Diabetes MellitusPDF
81 FR 64110 - Endangered and Threatened Wildlife and Plants: Proposed Rule To List the Maui's Dolphin as Endangered and the South Island Hector's Dolphin as Threatened Under the Endangered Species ActPDF
81 FR 64094 - Endangered and Threatened Wildlife and Plants; Proposed Rule To List Two Guitarfishes as ThreatenedPDF
81 FR 64161 - Submission for OMB Review; Comment Request; Child Care and Development Fund Financial Report (ACF-696) for States and TerritoriesPDF
81 FR 64155 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
81 FR 64157 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
81 FR 64156 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 64270 - Solicitation of Nomination for Appointment to the Veterans' Advisory Committee on Education (VACOE)PDF
81 FR 64126 - Advisory Committee MeetingPDF
81 FR 64146 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Program for International Student Assessment (PISA 2018) Recruitment and Field TestPDF
81 FR 64171 - Biosimilar User Fee Act; Public MeetingPDF
81 FR 64175 - Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act; Public Meeting; Request for CommentsPDF
81 FR 64061 - Country-by-Country Reporting; CorrectionPDF
81 FR 64195 - National Register of Historic Places; Notification of Pending Nominations and Related ActionsPDF
81 FR 64168 - Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility TypesPDF
81 FR 64166 - Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug AdministrationPDF
81 FR 64083 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 64080 - Airworthiness Directives; Airbus Defense and Space S.A. (Formerly Known as Construcciones Aeronauticas, S.A.) AirplanesPDF
81 FR 64205 - NASA Advisory Council; Science Committee; Planetary Science Subcommittee; MeetingPDF
81 FR 64153 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 64196 - Certain Industrial Control System Software, Systems Using Same and Components Thereof; Institution of InvestigationPDF
81 FR 64143 - U.S. Strategic Command Strategic Advisory Group; Notice of Federal Advisory Committee Closed MeetingPDF
81 FR 64144 - Proposed Collection; Comment RequestPDF
81 FR 64230 - AB Private Credit Investors Corporation, et al.; Notice of ApplicationPDF
81 FR 64226 - OFS Capital Corporation, et al.; Notice of ApplicationPDF
81 FR 64197 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
81 FR 64247 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Deadline for Implementing Rule 6.61(a)(2) and (3) Until September 30, 2016PDF
81 FR 64249 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee Schedule on the BOX Market LLC (“BOX”) Options Facility To Change the Liquidity Fee and Credit Structure for PIP and COPIP TransactionsPDF
81 FR 64238 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Deadline for Implementing Rule 967.1NY(a)(2) and (3) Until September 30, 2016PDF
81 FR 64250 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee Schedule on the BOX Market LLC (“BOX”) Options Facility To Change the Fees and Credits for Facilitation and Solicitation TransactionsPDF
81 FR 64218 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee Schedule on the BOX Market LLC (“BOX”) Options Facility To Specify That All Complex Order Transactions Executed Through the Exchange's Auction Mechanisms Will Be Subject to Section I (Exchange Fees) and II (Liquidity Fees and Credits)PDF
81 FR 64215 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To Establish the MSRB Academic Historical Transaction Data ProductPDF
81 FR 64240 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Partial Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change Amending FINRA Rules 2210 (Communications With the Public), 2213 (Requirements for the Use of Bond Mutual Fund Volatility Ratings), and 2214 (Requirements for the Use of Investment Analysis Tools), as Modified by Partial Amendment No. 1PDF
81 FR 64234 - Self-Regulatory Organizations; Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 11.340 To Modify Certain Data Collection Requirements of the Regulation NMS Plan To Implement a Tick Size Pilot ProgramPDF
81 FR 64221 - Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Regarding Tiers Related to SPY OptionsPDF
81 FR 64321 - System Safeguards Testing Requirements for Derivatives Clearing OrganizationsPDF
81 FR 64092 - Privacy Act of 1974; ImplementationPDF
81 FR 64253 - Council on Underserved Communities Advisory Board: MeetingPDF
81 FR 64198 - Privacy Act of 1974; System of RecordsPDF
81 FR 64061 - Qualification Standards for Enlistment, Appointment, and InductionPDF
81 FR 64126 - Beginning Farmers and Ranchers Advisory CommitteePDF
81 FR 64254 - Request for Information on Strategies for Improving Work Outcomes for Individuals With Musculoskeletal DisabilitiesPDF
81 FR 64138 - Certain Cut-to-Length Carbon-Quality Steel Plate From the Republic of Korea: Final Results of Countervailing Duty Administrative Review and New Shipper Review; Calendar Year 2014PDF
81 FR 64206 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 64130 - Foreign-Trade Zone 122-Corpus Christi, Texas; Application for Expansion of Subzone 122J; Valero Refining Company; Nueces County, TexasPDF
81 FR 64070 - Partial Approval and Partial Disapproval of Air Quality Implementation Plans; NJ; Infrastructure SIP Requirements for 2008 Lead, 2008 Ozone, 2010 Nitrogen Dioxide, 2010 Sulfur Dioxide, and 2012 PM2.5PDF
81 FR 64130 - Foreign-Trade Zone (FTZ) 119-Minneapolis, Minnesota Authorization of Production Activity SICK, Inc.; (Electronic Industrial Sensors, Encoders, Optical Readers and Monitoring Systems) Savage, MinnesotaPDF
81 FR 64135 - Stainless Steel Sheet and Strip From the People's Republic of China: Preliminary Affirmative Determination of Sales at Less Than Fair Value and Preliminary Affirmative Determination of Critical CircumstancesPDF
81 FR 64257 - Twenty Fourth Meeting of SC-217 Aeronautical DatabasesPDF
81 FR 64154 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies; CorrectionPDF
81 FR 64181 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed MeetingsPDF
81 FR 64182 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Amended Notice of MeetingPDF
81 FR 64181 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
81 FR 64180 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
81 FR 64207 - Astronomy and Astrophysics Advisory Committee; Notice of MeetingPDF
81 FR 64134 - Solid Fertilizer Grade Ammonium Nitrate From the Russian Federation; Final Results of Antidumping Duty Administrative Review; Final Determination of No Shipments; 2014-2015PDF
81 FR 64131 - Certain Frozen Fish Fillets From the Socialist Republic of Vietnam: Preliminary Results and Partial Rescission of the Antidumping Duty Administrative Review; 2014-2015PDF
81 FR 64195 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
81 FR 64154 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
81 FR 64267 - Public Meeting Regarding NHTSA's Research PortfolioPDF
81 FR 64180 - Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar ApplicantPDF
81 FR 64178 - S9 Nonclinical Evaluation for Anticancer Pharmaceuticals-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; AvailabilityPDF
81 FR 64194 - Proposed Renewal of Information Collection: OMB Control Number 1084-0033, Private Rental SurveyPDF
81 FR 64072 - Air Plan Approval; Ohio; Infrastructure SIP Requirements for the 2012 PM2.5PDF
81 FR 64088 - Schedule of Fees for Consular Services, Department of State and Overseas Embassies and Consulates-Passport Services Fee ChangesPDF
81 FR 64051 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 64057 - Airworthiness Directives; Fokker Services B.V. AirplanesPDF
81 FR 64053 - Airworthiness Directives; Viking Air Limited AirplanesPDF
81 FR 64271 - System Safeguards Testing RequirementsPDF
81 FR 64265 - Reports, Forms, and Recordkeeping RequirementsPDF
81 FR 64266 - Reports, Forms, and Record Keeping RequirementsPDF
81 FR 64268 - Petition for Exemption From the Federal Motor Vehicle Theft Prevention Standard; Volkswagen Group of America, Inc.PDF
81 FR 64085 - Voluntary Disclosure Reporting ProgramPDF
81 FR 64063 - Access to Classified Information by Historical Researchers and Certain Former Government PersonnelPDF
81 FR 64075 - Small Business Investment Companies (SBIC); Early Stage InitiativePDF

Issue

81 181 Monday, September 19, 2016 Contents Agriculture Agriculture Department See

Grain Inspection, Packers and Stockyards Administration

NOTICES Meetings: Beginning Farmers and Ranchers Advisory Committee, 64126 2016-22406
Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Methodology for Determining Average Prime Offer Rates, 64142 2016-22504 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 64155-64159 2016-22446 2016-22447 2016-22448 Central Central Intelligence Agency RULES Access to Classified Information by Historical Researchers and Certain Former Government Personnel, 64063-64066 2016-21825 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Child Care and Development Fund Financial Report for States and Territories, 64161-64162 2016-22449 Regional Partnership Grants National Cross-Site Evaluation, 64159-64161 2016-22458 Coast Guard Coast Guard RULES Safety Zones: 22nd International Seapower Symposium Special Events, Rosecliff Mansion and Newport Marriott Hotel, Newport, RI, 64068-64070 2016-22463 22nd International Seapower Symposium, Goat Island, Newport, RI, 64066-64068 2016-22464 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

National Telecommunications and Information Administration

NOTICES Privacy Act; Systems of Records, 64127-64130 2016-22469
Commodity Futures Commodity Futures Trading Commission RULES System Safeguards Testing Requirements, 64272-64319 2016-22174 System Safeguards Testing Requirements for Derivatives Clearing Organizations, 64322-64340 2016-22413 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 64141 2016-22481 Consumer Product Consumer Product Safety Commission NOTICES Meetings; Sunshine Act, 64142 2016-22653 Defense Acquisition Defense Acquisition Regulations System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Defense Federal Acquisition Regulation Supplement; Organizational Conflicts of Interest in Major Defense Acquisition Programs, 64143 2016-22492 Defense Department Defense Department See

Defense Acquisition Regulations System

RULES Qualification Standards for Enlistment, Appointment, and Induction, 64061-64063 2016-22408 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 64144 2016-22428 Meetings: U.S. Strategic Command Strategic Advisory Group, 64143-64144 2016-22429
Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Educational Opportunity Centers Program Annual Performance Report, 64145-64146 2016-22490 Program for International Student Assessment Recruitment and Field Test, 64146-64147 2016-22443 Student Aid Internet Gateway Enrollment Document, 64144-64145 2016-22468 Energy Department Energy Department See

Western Area Power Administration

Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: New Jersey; Infrastructure SIP Requirements for 2008 Lead, 2008 Ozone, 2010 Nitrogen Dioxide, etc., 64070-64072 2016-22400 Ohio; Infrastructure Requirements for the 2012 PM2.5 National Ambient Air Quality Standards, 64072-64074 2016-22360 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Study of Nutrient Removal and Secondary Technologies: Publicly Owned Treatment Works Screener Questionnaire, 64151-64153 2016-22498 Meetings: National Advisory Council for Environmental Policy and Technology; Teleconference, 64150-64151 2016-22479 Registration Review: Draft Ecological and/or Human Health Risk Assessments, 64149-64150 2016-22506 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Airbus Airplanes, 64051-64053 2016-22191 Fokker Services B.V. Airplanes, 64057-64060 2016-22186 Viking Air Ltd. Airplanes, 64053-64057 2016-22183 PROPOSED RULES Airworthiness Directives: Airbus Airplanes, 64083-64085 2016-22435 Airbus Defense and Space S.A. (Formerly Known as Construcciones Aeronauticas, S.A.) Airplanes, 64080-64083 2016-22434 Voluntary Disclosure Reporting Program, 64085-64088 2016-21966 NOTICES Meetings: SC-217 Aeronautical Databases, 64257 2016-22396 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 64153-64154 2016-22431 Federal Emergency Federal Emergency Management Agency NOTICES Flood Hazard Determinations, 64189-64190 2016-22478 Flood Hazard Determinations; Correction, 64183-64187 2016-22476 2016-22477 Flood Hazard Determinations; Proposals, 64185-64189 2016-22473 2016-22474 Major Disaster Declarations: Louisiana; Amendment No. 6, 64184-64185 2016-22495 Federal Motor Federal Motor Carrier Safety Administration NOTICES Qualification of Drivers; Exemption Applications: Diabetes Mellitus, 64257-64265 2016-22452 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 64154 2016-22383 Formations of, Acquisitions by, and Mergers of Bank Holding Companies; Corrections, 64154 2016-22395 Fish Fish and Wildlife Service NOTICES Environmental Impact Statements; Availability, etc.: Indiana Department of Natural Resources Habitat Conservation Plan, 64192-64193 2016-22455 Food and Drug Food and Drug Administration RULES Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Food for Animals; Definition of Qualified Auditor, 64060-64061 2016-22494 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Data to Support Social and Behavioral Research as used by the Food and Drug Administration, 64166-64167 2016-22437 Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types, 64168-64171 2016-22438 Guidance: S9 Nonclinical Evaluation for Anticancer Pharmaceuticals—Questions and Answers; International Council for Harmonisation, 64178-64180 2016-22375 International Drug Scheduling; Convention on Psychotropic Substances, 64162-64164 2016-22472 List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics October 2007 to December 2015, 64177-64178 2016-22470 Meetings: Biosimilar User Fee Act, 64171-64175 2016-22442 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Health Canada and U.S. Food and Drug Administration Joint Public Consultation, 64164-64166 2016-22471 Progress toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act, 64175-64177 2016-22441 Receipt of Notice that a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant, 64180 2016-22376 Foreign Trade Foreign-Trade Zones Board NOTICES Applications for Subzone Expansion: Valero Refining Company, Foreign-Trade Zone 122, Corpus Christi, TX, 64130 2016-22401 Production Activities: SICK, Inc., Foreign-Trade Zone 119, Minneapolis, MN, 64130-64131 2016-22399 Proposed Production Activities: MSD International GMBH LLC, Foreign-Trade Zone 7, Mayaguez, PR, 64131 2016-22480 Grain Inspection Grain Inspection, Packers and Stockyards Administration NOTICES Meetings: Grain Inspection Advisory Committee, 64126-64127 2016-22444 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Children and Families Administration

See

Food and Drug Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

See

U.S. Citizenship and Immigration Services

Interior Interior Department See

Fish and Wildlife Service

See

National Park Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Private Rental Survey, 64194-64195 2016-22374
Internal Revenue Internal Revenue Service RULES Country-by-Country Reporting; Correction, 64061 2016-22440 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Frozen Fish Fillets from the Socialist Republic of Vietnam; Administrative Review; 2014-2015, 64131-64133 2016-22386 Cut-to-Length Carbon-Quality Steel Plate from the Republic of Korea, 64138-64139 2016-22403 Stainless Steel Sheet and Strip from the People's Republic of China, 64135-64138 2016-22397 Investigations; Determinations, Modifications, and Rulings, etc.: Solid Fertilizer Grade Ammonium Nitrate from the Russian Federation, 64134-64135 2016-22387 U.S. Smart Grid Solutions Toolkit, 64135 2016-22487 International Trade Com International Trade Commission NOTICES Complaints: Certain Integrated Circuits with Voltage Regulators and Products Containing Same, 64195-64196 2016-22384 Certain Silicon-on-Insulator Wafers, 64197-64198 2016-22425 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Industrial Control System Software, Systems Using Same and Components Thereof, 64196-64197 2016-22430 Justice Department Justice Department PROPOSED RULES Privacy Act; Systems of Records, 64092-64094 2016-22412 NOTICES Privacy Act; Systems of Records, 64198-64202 2016-22410 Proposed Consent Decrees Under the Clean Water Act, 64202-64203 2016-22466 Labor Department Labor Department See

Veterans Employment and Training Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Income and Eligibility Verification System Confidentiality, 64203-64204 2016-22475
NASA National Aeronautics and Space Administration NOTICES Meetings: Planetary Science Subcommittee of the NASA Advisory Council, 64205 2016-22433 National Credit National Credit Union Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 64206 2016-22456 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Call Report and Credit Union Profile, 64205-64206 2016-22457 National Highway National Highway Traffic Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 64265-64267 2016-22066 2016-22068 Federal Motor Vehicle Theft Prevention Standard; Exemption Approvals: Volkswagen Group of America, Inc., 64268-64269 2016-22060 Meetings: Vehicle and Behavioral Safety Research Portfolio, 64267-64268 2016-22382 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Institute of Neurological Disorders and Stroke Federal Interagency Traumatic Brain Injury Research Data Access Request, 64182 2016-22561 Meetings: Eunice Kennedy Shriver National Institute of Child Health and Human Development, 64181 2016-22394 National Institute of Allergy and Infectious Diseases, 64180-64181 2016-22389 2016-22391 2016-22392 National Institute of Child Health and Human Development; Amendment, 64182-64183 2016-22393 National Oceanic National Oceanic and Atmospheric Administration PROPOSED RULES Endangered and Threatened Wildlife and Plants: Listing of Maui's Dolphin as Endangered and South Island Hector's Dolphin as Threatened, 64110-64125 2016-22451 Listing of Two Guitarfishes as Threatened, 64094-64110 2016-22450 National Park National Park Service NOTICES National Register of Historic Places: Pending Nominations and Related Actions, 64195 2016-22439 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 64206-64207 2016-22402 Meetings: Astronomy and Astrophysics Advisory Committee, 64207 2016-22390 National Telecommunications National Telecommunications and Information Administration NOTICES Meetings: Internet of Things Security Upgradability and Patching, 64139-64141 2016-22459 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Consolidated Guidance on Materials Licenses, 64207-64209 2016-22482 Exemptions: Tennessee Valley Authority; Sequoyah Nuclear Plant, Units 1 and 2, 64212-64215 2016-22486 License Amendment Applications: Environmental Properties Management; Cimarron Facility; Decommissioning Plan, 64209-64211 2016-22485 Meetings; Sunshine Act, 64211-64212 2016-22546 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: National Hispanic Heritage Month (Proc. 9493), 64049-64050 2016-22578 ADMINISTRATIVE ORDERS Terrorism; Continuation of National Emergency With Respect to Persons Who Commit, Threaten to Commit, or Support (Notice of September 15, 2016), 64341-64343 2016-22691 Securities Securities and Exchange Commission NOTICES Applications: AB Private Credit Investors Corporation, et al., 64230-64234 2016-22427 OFS Capital Corporation, et al., 64226-64230 2016-22426 Meetings; Sunshine Act, 64226 2016-22659 Self-Regulatory Organizations; Proposed Rule Changes: BOX Options Exchange LLC, 64218-64221, 64249-64253 2016-22420 2016-22421 2016-22423 Financial Industry Regulatory Authority, Inc., 64240-64247 2016-22418 Investors Exchange LLC, 64234-64238 2016-22417 Municipal Securities Rulemaking Board, 64215-64218 2016-22419 NASDAQ BX, Inc., 64221-64226 2016-22416 NYSE Arca, Inc., 64247-64248 2016-22424 NYSE MKT LLC, 64238-64239 2016-22422 Small Business Small Business Administration PROPOSED RULES Small Business Investment Companies; Early Stage Initiative, 64075-64080 2016-21509 NOTICES Meetings: Council on Underserved Communities Advisory Board, 64253-64254 2016-22411 Social Social Security Administration RULES Medical Criteria for Evaluating Respiratory System Disorders, 64060 C1--2016--13275 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Strategies for Improving Work Outcomes for Individuals with Musculoskeletal Disabilities, 64254-64256 2016-22404 State Department State Department PROPOSED RULES Schedule of Fees for Consular Services, Department of State and Overseas Embassies and Consulates—Passport Services Fee Changes, 64088-64092 2016-22215 NOTICES Designations as Global Terrorists: Fathi Ahmad Mohammad Hammad, a.k.a. Fathi Ahmad Hammad, a.k.a. Fathy Ahmed Hamad, a.k.a. Fathi Hamad, 64256 2016-22497 Omar Diaby, a.k.a. Omar al-Diaby, a.k.a. Omar Omsen, a.k.a. Omar Oumsen, a.k.a. Oumar Diaby, 64256 2016-22500 Meetings: Advisory Committee on Private International Law, 64256-64257 2016-22491 National Commission for United Nations, Educational, Scientific, and Cultural Organization; Teleconference, 64256 2016-22505 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 64183 2016-22467 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department See

Internal Revenue Service

U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Asylum and for Withholding of Removal, 64190-64191 2016-22462 Application for Waiver of Grounds of Inadmissibility, 64191-64192 2016-22461 Veteran Affairs Veterans Affairs Department NOTICES Requests for Nominations: Veterans' Advisory Committee on Education, 64270 2016-22445 Veterans Employment Veterans Employment and Training Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Eligibility Data Form: Uniformed Services Employment and Reemployment Rights Act and Veteran's Preference, 64204-64205 2016-22484 Western Western Area Power Administration NOTICES Rate Orders: Boulder Canyon Project, 64147-64149 2016-22465 Separate Parts In This Issue Part II Commodity Futures Trading Commission, 64272-64319 2016-22174 Part III Commodity Futures Trading Commission, 64322-64340 2016-22413 Part IV Presidential Documents, 64341-64343 2016-22691 Reader Aids

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81 181 Monday, September 19, 2016 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5591; Directorate Identifier 2014-NM-193-AD; Amendment 39-18651; AD 2016-19-02] 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) 2005-15-07 for certain Airbus Model A320-111 airplanes and Model A320-200 series airplanes. AD 2005-15-07 required installing insulator and cable ties to the electrical cables of the S routes at the gaps in the raceway in the wing trailing edge and the wing tip and wing root areas. This new AD requires additional modifications in the trailing edges of both wings. This new AD also removes airplanes from the applicability. This AD was prompted by reports of wire chafing in the left-hand wing trailing edge. We are issuing this AD to prevent wire chafing in the trailing edge of the wings, which could result in a short circuit in the vicinity of the fuel tanks, consequently resulting in a potential source of ignition in a fuel tank vapor space and consequent fuel tank explosion.

DATES:

This AD is effective October 24, 2016.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of October 24, 2016.

ADDRESSES:

For service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email [email protected]; Internet http://www.airbus.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5591.

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-2016-5591; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (telephone 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2005-15-07, Amendment 39-14196 (70 FR 43024, July 26, 2005) (“AD 2005-15-07”). AD 2005-15-07 applied to certain Airbus Model A320-111 airplanes and Model A320-200 series airplanes. The NPRM published in the Federal Register on April 20, 2016 (81 FR 23199). The NPRM was prompted by reports of wire chafing in the left-hand wing trailing edge. The NPRM proposed to continue to require installing insulator and cable ties to the electrical cables of the S routes at the gaps in the raceway in the wing trailing edge and the wing tip and wing root areas. The NPRM proposed to require additional modifications in the trailing edges of both wings. The NPRM also proposed to remove airplanes from the applicability. We are issuing this AD to prevent wire chafing in the trailing edge of the wings, which could result in a short circuit in the vicinity of the fuel tanks, consequently resulting in a potential source of ignition in a fuel tank vapor space and consequent fuel tank explosion.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0198, dated September 5, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A320-211, -212, and -231 airplanes. The MCAI states:

Prompted by an accident * * *, the FAA published Special Federal Aviation Regulation (SFAR) 88 [(66 FR 23086, May 7, 2001)], and the Joint Aviation Authorities (JAA) published Interim Policy INT/POL/25/12.

Prompted by that regulation, the results of an Airbus review of the A320 type design identified, on certain aeroplanes, a possible ignition source in fuel tank vapour space(s). That condition, if not corrected, could result in a fuel tank explosion and consequent loss of the aeroplane.

It was, therefore, decided to modify the cable routes of the wing trailing edge, aft of the rear spar and wing tip of those aeroplanes, to be applied in service in accordance with the instructions of Airbus Service Bulletin (SB) A320-24-1062 Revision 05. Following that decision, DGAC France issued AD F-2004-173 (EASA approval number 2004-10570) to require that modification.

After that AD was issued, it was found that additional work, introduced by Airbus SB A320-24-1062 Revision 05, was not included as part of the normal accomplishment instructions, which meant that the additional work might not be accomplished. Consequently, EASA issued AD 2008-0051, retaining the requirements of DGAC France AD F-2004-173 [which corresponds to FAA AD 2005-15-07], which was superseded, and required the accomplishment of the additional work in accordance with the instructions of Airbus SB A320-24-1062 Revision 06. EASA AD 2008-0051 was revised to reduce the Applicability and to add a clarification to paragraph (2).

After EASA AD 2008-0051R1 was issued, some operators reported wire chafing in the left hand wing trailing edge. Investigation established that the wire chafing, initiated at raceway gaps, was either due to maintenance action(s), or to structure vibrations.

Prompted by these findings, Airbus developed two modifications to prevent any further wire chafing by introducing an additional protection at raceway gaps and a new cable standard in the trailing edges of both wings.

Airbus published SB A320-92-1049 and SB A320-92-1052 to make these modifications available for in-service application. At the time of incorporation of Airbus SB A320-24-1062, these two modifications were considered recommended only.

EASA recently determined that this condition, if not corrected, could lead to a short circuit on 115 volts in the vicinity of fuel tanks, consequently creating another risk of ignition source in a fuel tank vapour space.

For the reasons described above, this [EASA] AD retains the requirements of EASA AD 2008-0051R1, which is superseded, and requires modifications to install the additional anti-chafing protection and the new cable standard.

This AD also removes Model A320-214, -232, and -233 airplanes from the applicability because those airplane models have been modified in production or in service. This AD also removes Model A320-111 airplanes from the applicability because those airplanes are no longer on the U.S. type certificate data sheet (there are no more A320-111 airplanes in service in the U.S. and none in storage). 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-2016-5591.

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 Bulletins A320-92-1049, Revision 01, dated November 28, 2011; A320-92-1052, dated December 5, 2007; and A320-24-1062, Revision 07, dated November 28, 2011.

Airbus Service Bulletin A320-92-1049, Revision 01, dated November 28, 2011, describes procedures for installing the additional anti-chafing protection.

Airbus Service Bulletin A320-92-1052, dated December 5, 2007, describes procedures for replacing the current electrical cable with the new standard one.

Airbus Service Bulletin A320-24-1062, Revision 07, dated November 28, 2011, describes procedures for installing insulator and cable ties to the electrical cables of the S routes at the gaps in the raceway in the wing trailing edge and the wing tip and wing root areas.

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 47 airplanes of U.S. registry.

The actions required by AD 2005-15-07, and retained in this AD take about 35 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 2005-15-07 is $2,975 per product.

We also estimate that it would take about 76 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $13,000 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $914,620, or $19,460 per product.

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 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) 2005-15-07, Amendment 39-14196 (70 FR 43024, July 26, 2005), and adding the following new AD: 2016-19-02 Airbus: Amendment 39-18651; Docket No. FAA-2016-5591; Directorate Identifier 2014-NM-193-AD. (a) Effective Date

This AD is effective October 24, 2016.

(b) Affected ADs

This AD replaces AD 2005-15-07, Amendment 39-14196 (70 FR 43024, July 26, 2005) (“AD 2005-15-07”).

(c) Applicability

This AD applies to Airbus Model A320-211, -212, and -231 airplanes, certificated in any category, all manufacturer serial numbers except those on which Airbus Modification 22626 has been embodied in production.

(d) Subject

Air Transport Association (ATA) of America Code 24, Electrical Power; and Code 92.

(e) Reason

This AD was prompted by reports of wire chafing in the left-hand wing trailing edge. We are issuing this AD to prevent wire chafing in the trailing edge of the wings, which could result in a short circuit in the vicinity of the fuel tanks, consequently resulting in a potential source of ignition in a fuel tank vapor space and consequent fuel tank explosion.

(f) Compliance

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

(g) Retained Modification, With Revised Service Information

This paragraph restates the requirements of paragraph (f) of AD 2005-15-07, with revised service information. Within 60 months after August 30, 2005 (the effective date of AD 2005-15-07), install insulator and cable ties to the electrical cables of the S routes at the gaps in the raceway in the wing trailing edge and the wing tip and wing root areas, in accordance with Airbus Service Bulletin A320-24-1062, Revision 05, dated June 27, 2002; or the Accomplishment Instructions of Airbus Service Bulletin A320-24-1062, Revision 07, dated November 28, 2011. As of the effective date of this AD, only Airbus Service Bulletin A320-24-1062, Revision 07, dated November 28, 2011, may be used.

(h) New Requirement of This AD: Modification of Trailing Edges

Within 60 months after the effective date of this AD, modify the trailing edges of both wings by accomplishing the actions specified in paragraphs (h)(1) and (h)(2) of this AD.

(1) Install the additional anti-chafing protection in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-92-1049, Revision 01, dated November 28, 2011.

(2) Replace the current electrical cable with the new standard one in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-92-1052, dated December 5, 2007. During the replacement, ensure that the anti-chafing protection specified in Airbus Service Bulletin A320-92-1049, Revision 01, dated November 28, 2011, as required by paragraph (h)(1) of this AD, remains in place.

(i) New Additional Modification

For airplanes on which the installation specified in Airbus Service Bulletin A320-24-1062, Revision 05, dated June 27, 2002, has been done: Within 60 months after the effective date of this AD, install insulators and cable ties, in accordance with “Modification—Additional Work (Introduced at Revision No. 06)” of the Accomplishment Instructions of Airbus Service Bulletin A320-24-1062, Revision 07, dated November 28, 2011.

(j) Credit for Previous Actions

(1) This paragraph provides credit for actions required by paragraphs (g) and (i) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-24-1062, Revision 06, dated June 26, 2007, which is not incorporated by reference in this AD.

(2) This paragraph provides credit for actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-92-1049, dated July 23, 2007, which is not incorporated by reference in this AD.

(k) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

(2) Contacting the Manufacturer: 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 Airbus's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

(l) Related Information

(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0198, dated September 5, 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-2016-5591.

(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (m)(4) and (m)(5) of this AD.

(m) Material Incorporated by Reference

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

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

(3) The following service information was approved for IBR on October 24, 2016.

(i) Airbus Service Bulletin A320-24-1062, Revision 07, dated November 28, 2011.

(ii) Airbus Service Bulletin A320-92-1049, Revision 01, dated November 28, 2011.

(iii) Airbus Service Bulletin A320-92-1052, dated December 5, 2007. (4) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email [email protected]; Internet http://www.airbus.com.

(5) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

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

Issued in Renton, Washington, on September 6, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-22191 Filed 9-16-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-4229; Directorate Identifier 2015-CE-038-AD; Amendment 39-18657; AD 2016-19-08] RIN 2120-AA64 Airworthiness Directives; Viking Air Limited Airplanes AGENCY:

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

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for Viking Air Limited Models DHC-2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III 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 corrosion of the elevator control rod and of the elevator actuating lever on the control column. We are issuing this AD to detect and correct corrosion and/or cracking of the elevator control rod assemblies and the elevator actuating lever, which if not detected and corrected, could cause these components to fail. This failure could result in loss of control.

DATES:

This AD is effective October 24, 2016.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD as of October 24, 2016.

ADDRESSES:

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-4229; 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 Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; Fax: 250-656-0673; telephone: (North America) (800) 663-8444; email: [email protected]; Internet: http://www.vikingair.com/support/service-bulletins. 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-2016-4229.

FOR FURTHER INFORMATION CONTACT:

Aziz Ahmed, Aerospace Engineer, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone: (516) 228-7329; fax: (516) 794-5531; 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 all Viking Air Limited Models DHC-2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III airplanes. The NPRM was published in the Federal Register on March 3, 2016 (81 FR 11132). 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:

There have been a number of reports of corrosion and/or cracking at the elevator actuating lever on the control column, in the elevator control rod assemblies, and at the rod end plug.

Undetected corrosion and/or cracking of the elevator control rod assemblies or elevator actuating lever may lead to the failure of the components with consequent loss of aeroplane control.

The MCAI requires visually inspecting the elevator control rod assemblies, the elevator actuating lever on the control column, and the control column torque tube for corrosion, cracking, and/or other damages, and repairing or replacing damaged parts. The MCAI also requires incorporating revisions into the maintenance program and adds a life limit to certain elevator control rod assemblies. The MCAI can be found in the AD docket on the Internet at https://www.regulations.gov/document?D=FAA-2016-4229-0002. Comments

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (81 FR 11132, March 3, 2016) and the FAA's response to each comment.

Request To Change Inspection Procedure for the Elevator Control Rod

Roger Braun requested allowance for inspecting the elevator control rod without removing it from the airplane.

The commenter stated that even though the inspection procedure in Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision `C', dated July 17, 2015 (SB No. V2/0005, Rev. C), requires removing the elevator control rod, that doing so is excessively invasive and adds an increased risk of maintenance errors and/or damage to the part over simply inspecting it in place.

We do not agree with the commenter. The elevator control rod ends are not required to be removed from its assembly. Removal of the elevator control rod assembly is necessary to do the required inspections. Viking Air Limited and Transport Canada determined that removing the elevator control rod assembly is necessary to adequately do the inspection, and the process of removing the elevator control rod assembly does not pose additional risk to safety.

We have not changed the AD based on this comment.

Request To Rename/Revise the Airworthiness Limitations Section

Roger Braun requested to omit the requirement to revise the Airworthiness Limitation section and instead include the repetitive inspection in the final rule AD action. The commenter stated that it is very hard to find the compliance times for the repetitive inspections, which are embedded in the temporary revisions to be inserted into the Airworthiness Limitation section of the FAA-approved maintenance program. The commenter asked that instead of inserting continued airworthiness instructions into the manual, why not include the language “repeat inspection every 400 flight hours” in the AD actions?

We partially agree. We agree that the repetitive inspection requirements that are embedded in the temporary revisions are not clear or easy to understand. However, we disagree with writing the repetitive inspections into the AD because Viking Air Limited plans to have all the required inspections in their maintenance manual rather than dispersed over numerous other documents. We have determined that revising the Airworthiness Limitations section of the FAA-approved maintenance program to mandate the repetitive inspections is acceptable. To clarify the intent of the of the Airworthiness Limitations section, we have changed the heading of that section to Repetitive Inspection in order to make the repetitive inspections clear.

We have changed the AD based on this comment.

Request To Allow Minor Surface Corrosion

Roger Braun requested that the final rule AD action be changed to include an allowance for minor surface corrosion.

The commenter stated that the proposed AD and the related service information are vague in delineating what corrosion is considered unacceptable by stating if “any corrosion” is found, which would be an unrealistic standard. The commenter requested relief for minor surface corrosion.

We do not agree. Viking Air Limited and Transport Canada determined that all corrosion is unacceptable. Small surface corrosion must also be repaired following the SB No. V2/0005, Rev. C, dated July 17, 2015.

We have not changed the AD based on this comment.

Request for Clarification of Life Limit for Part Number (P/N) C2FC619A-11

Roger Braun requested clarification in the final rule AD action to clearly state that P/N C2FC619A-11 elevator control rod is not a life-limited part.

The commenter stated that it is not entirely clear in the proposed AD that elevator control rod, P/N C2FC619A-11, is not a life-limited part. The commenter requested further clarification in the final rule AD action specifying that there is no life limit on P/N C2FC619A-11.

We agree with the commenter and have added a statement in the AD to further clarify that the P/N C2CF619A-11 elevator control rod has no life limit.

We have changed the AD based on this comment.

Request To Extend Repetitive Inspection Compliance Times

Roger Braun requested relief for the repetitive inspection of the elevator control rods with a known date of manufacture, for example, 5 or 10 years.

We infer that the commenter wants the repetitive inspections changed from every 400 hours time-in-service (which is what is specified in the Temporary Revisions to the Airworthiness Limitations section) to a repetitive 5-year inspection.

We do not agree. Viking Air Limited and Transport Canada determined that damage can occur at any time. Therefore, no threshold is provided that will allow a certain period of time before the start of the repetitive inspection requirement.

We have not changed the AD based on this comment.

Request To Change Repetitive Inspection Compliance Time

Mark Henshaw requested the repetitive inspections be yearly/12-month inspections. The commenter stated that he operated his airplane 400-500 hours per summer season, as most operators do. The commenter stated that the 400-hour recurring inspection will require the operators to remove the airplane from service, remove the pilot floor panel, pilot side panels, oil cooler cowl, side after cowl, unbolt the control column bearings and the inboard control column mount then remove it, pull the elevator control rod out of the airplane, and then do the elevator control rod inspection. We infer that the commenter is making the point that the inspection is very labor intensive. The commenter stated that this inspection would fit nicely into a yearly/12-month inspection criteria instead of what probably will fall right in the middle of their busy season when a 100-hour inspection may or may not have been scheduled. This inspection will add at least 4-6 hours (on a good night) to a routine 100-hour inspection.

The commenter requested an alternative of yearly/every 12 months, that way all the elevator control rods get looked at every year and nobody has to stop their airplane right in the middle of their busy season for this inspection.

The commenter stated that there has never been a requirement to remove the elevator control rod, and does agree that doing the inspection is great idea, but not every 400 hours.

We do not agree that yearly/12 month inspections are an acceptable level of safety to address the unsafe condition. The 400-hour inspection should assure that any damage will be detected before it rises to an unsafe level. Additionally, Viking Air Limited informed us that there are existing inspections specified in the applicable maintenance manuals around the same affected area as this AD that requires lifting of floor boards.

We have not changed the AD based on this comment.

Conclusion

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

• Αre consistent with the intent that was proposed in the NPRM (81 FR 11132, March 3, 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 11132, March 3, 2016).

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

Related Service Information Under 1 CFR Part 51

We reviewed Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision `C', dated July 17, 2015; Temporary Revision No.: 2-38, dated March 4, 2015, of VIKING PSM NO.: 1-2-2, AIRCRAFT: DHC-2 BEAVER, SERIES: ALL, PUBLICATION: MAINTENANCE MANUAL; and Temporary Revision No.: 2T-14, dated March 4, 2015, of VIKING PSM NO.: 1-2T-2, AIRCRAFT: DHC-2 TURBO BEAVER, SERIES: ALL, PUBLICATION: MAINTENANCE MANUAL. The service information describes procedures for doing detailed visual inspections of the elevator control rod assemblies, the elevator actuating lever on the control column, and the control column torque tube for corrosion, cracking, and/or other damages. The service bulletin also describes procedures for repairing or replacing damaged parts. 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 135 products of U.S. registry. We also estimate that it will take about 11.5 work-hours per product to comply with the basic inspection requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of the basic inspection requirements of this AD on U.S. operators to be $131,962.50, or $977.50 per product.

In addition, we estimate that any necessary follow-on actions will take about 8 work-hours and require parts costing $1,859, for a cost of $2,539 per product. Contact Viking Air Limited at the address identified in the ADDRESSES section of this AD for current pricing and lead time. We have no way of determining the number of products that may need these actions.

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-2016-4229; 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: 2016-19-08 Viking Air Limited: Amendment 39-18657; Docket No. FAA-2016-4229; Directorate Identifier 2015-CE-038-AD. (a) Effective Date

This airworthiness directive (AD) becomes effective October 24, 2016.

(b) Affected ADs

None.

(c) Applicability

This AD applies to Viking Air Limited Models DHC-2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III airplanes, all serial numbers, certificated in any category.

(d) Subject

Air Transport Association of America (ATA) Code 27: Flight Controls.

(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 corrosion of the elevator control rod and of the elevator actuating lever on the control column. We are issuing this AD to detect and correct corrosion and/or cracking of the elevator control rod assemblies and the elevator actuating lever, which if not detected and corrected, could cause these components to fail. This failure could result in loss of control.

(f) Actions and Compliance

Comply with this AD within the compliance times specified in paragraphs (g) through (l) of this AD, including all subparagraphs, unless already done.

(g) Initial Inspections

Within the next 120 days after October 24, 2016 (the effective date of this AD) or within the next 100 hours time-in-service (TIS) after October 24, 2016 (the effective date of this AD), whichever occurs first, do the following inspections in accordance with section I. PLANNING INFORMATION, paragraph D. of Viking DHC-2 Beaver Service Bulletin Number: V2/0005, Revision “C”, dated July 17, 2015:

(1) For airplanes with an installed elevator control rod assembly, part number (P/N) C2CF619A, do a detailed visual inspection of P/N C2CF619A for corrosion, cracking, and/or other damages.

(2) For airplanes with an installed elevator control rod assembly, P/N CT2CF1021-1, do a detailed visual inspection of P/N CT2CF1021-1 for corrosion, cracking, and/or other damages.

(3) For all airplanes, do a detailed visual inspection of the elevator actuating lever on the control column and the control column torque tube for corrosion, cracking and/or other damages.

(h) Repetitive Inspections (Airworthiness Limitations)

Within the next 30 days after October 24, 2016 (the effective date of this AD), insert the following into the Airworthiness Limitations section of the FAA-approved maintenance program (e.g., maintenance manual). This revision to the Limitations section incorporates repetitive inspections of the elevator control rod assemblies, the elevator actuating lever, and the control column torque tube for corrosion, cracks, and/or other damage. Insert item 20A., of Part 3, in Appendix 2 of Temporary Revision No.: 2-38, dated March 4, 2015, into the VIKING PSM NO.: 1-2-2, AIRCRAFT: DHC-2 BEAVER, SERIES: ALL, PUBLICATION: MAINTENANCE MANUAL; and Insert item 20A., in Part 4, of Temporary Revision No.: 2T-14, dated March 4, 2015, into VIKING PSM NO.: 1-2T-2, AIRCRAFT: DHC-2 TURBO BEAVER, SERIES: ALL, PUBLICATION: MAINTENANCE MANUAL.

(i) Replacement/Repair for P/N C2CF619A

(1) Before further flight after the inspection required in paragraph (g)(1) of this AD, if corrosion, cracking, or other damages are found, replace P/N C2CF619A with P/N C2CF619A-11 following section I. PLANNING INFORMATION, paragraph D. of Viking DHC-2 Beaver Service Bulletin Number: V2/0005, Revision “C”, dated July 17, 2015, or contact Viking Air Limited at the address specified in paragraph (o) of this AD for an FAA-approved repair and incorporate the repair.

(2) Within the next 120 days after October 24, 2016 (the effective date of this AD) or within the next 100 hours TIS after October 24, 2016 (the effective date of this AD), whichever occurs first, you may replace P/N C2CF619A with P/N C2CF619A-11 instead of doing the inspection required in paragraph (g)(1) of this AD. Do the replacement following section I. PLANNING INFORMATION, paragraph D. of Viking DHC-2 Beaver Service Bulletin Number: V2/0005, Revision “C”, dated July 17, 2015.

(3) After replacing P/N C2CF619A with P/N C2CF619A-11, you must still do the repetitive inspections of the elevator control rod assemblies following the Airworthiness Limitations section of the FAA-approved maintenance program (e.g., maintenance manual) specified in paragraph (k)(1) of this AD.

(j) Replacement/Repair for P/N CT2CF1021-1

(1) Before further flight after the inspection required in paragraph (g)(2) of this AD, if corrosion, cracking, or other damages are found, replace the elevator control rod assembly with P/N CT2CF1021-1 that has been inspected and is free of corrosion, cracking, or other damages following section I. PLANNING INFORMATION, paragraph D. of Viking DHC-2 Beaver Service Bulletin Number: V2/0005, Revision “C”, dated July 17, 2015, or contact Viking Air Limited at the address specified in paragraph (o) of this AD for an FAA-approved repair and incorporate the repair.

(2) After replacing or repairing P/N CT2CF1021-1, you must still do the repetitive inspections of the elevator control rod assemblies following the Airworthiness Limitations section of the FAA-approved maintenance program (e.g., maintenance manual) specified in paragraph (k)(1) of this AD.

(k) Repair of the Elevator Actuating Lever

Before further flight after the inspection required in paragraph (g)(3) of this AD, if corrosion, cracking, or other damages are found, contact Viking Air Limited at the address specified in paragraph (o) of this AD for an FAA-approved repair and incorporate the repair.

(l) Restrictions

As of October 24, 2016 (the effective date of this AD), do not install P/N C2CF619A or C2CF619A-9 as a replacement part.

(m) Life Limit for P/N C2CF619A

As of October 24, 2016 (the effective date of this AD), elevator control rod assemblies, P/N C2CF619A, are life-limited to 15 years and must be replaced with P/N C2CF619A-11, which is not a life-limited part, at the following compliance time:

(1) If, as of October 24, 2016 (the effective date of this AD), the age of the installed P/N C2CF619A is known, it must be replaced before exceeding the life limit or within the next 12 months after October 24, 2016 (the effective date of this AD), whichever occurs later.

(2) If, as of October 24, 2016 (the effective date of this AD), the age of the installed P/N C2CF619A is not known, it must be replaced within the next 12 months after October 24, 2016 (the effective date of this AD).

(n) Credit for Actions Accomplished in Accordance With Previous Service Information

Credit will be given for the inspections required in paragraphs (g)(1) through (3) of this AD if they were done before October 24, 2016 (the effective date of this AD) following Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision `NC', dated March 26, 2012; Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision `A', dated November 7, 2014; or Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision `B', dated March 4, 2015.

(o) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, New York 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. Send information to ATTN: Aziz Ahmed, Aerospace Engineer, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone: (516) 228-7329; fax: (516) 794-5531; 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.

(p) Related Information

Refer to MCAI Transport Canada AD No. CF-2015-21, dated July 30, 2015; and Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision `NC', dated March 26, 2012; Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision `A', dated November 7, 2014; or Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision `B', dated March 4, 2015, for related information. You may examine the MCAI on the Internet at https://www.regulations.gov/document?D=FAA-2016-4229-0002.

(q) 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) Viking DHC-2 Beaver Service Bulletin Number: V2/0005, Revision “C”, dated July 17, 2015.

(ii) Item 20A., of Part 3, in Appendix 2 of Temporary Revision No.: 2-38, dated March 4, 2015, into the VIKING PSM NO.: 1-2-2, AIRCRAFT: DHC-2 BEAVER, SERIES: ALL, PUBLICATION: MAINTENANCE MANUAL.

(iii) Item 20A., in Part 4, of Temporary Revision No.: 2T-14, dated March 4, 2015, into VIKING PSM NO.: 1-2T-2, AIRCRAFT: DHC-2 TURBO BEAVER, SERIES: ALL, PUBLICATION: MAINTENANCE MANUAL.

(3) For Viking Air Limited service information identified in this AD, contact Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; Fax: 250-656-0673; telephone: (North America) (800) 663-8444; email: [email protected]; Internet: http://www.vikingair.com/support/service-bulletins.

(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-2016-4229.

(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 September 8, 2016. Pat Mullen, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-22183 Filed 9-16-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5035; Directorate Identifier 2015-NM-042-AD; Amendment 39-18650; AD 2016-19-01] 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 adopting a new airworthiness directive (AD) for all Fokker Services B.V. Model F28 Mark 0070 and Mark 0100 airplanes. This AD was prompted by reports of cracking in a certain area of the pressure bulkhead webplate and skin connection angle. This AD requires a one-time inspection of the affected pressure bulkhead webplate and skin connection angle, and corrective actions if necessary. We are issuing this AD to detect and correct cracking of the pressure bulkhead webplate and skin connection angle that could lead to sudden inflight decompression of the airplane, resulting in injury to occupants.

DATES:

This AD is effective October 24, 2016.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of October 24, 2016.

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 No. FAA-2016-5035.

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-2016-5035; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (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:

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 425-227-1139.

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 all Fokker Services B.V. Model F28 Mark 0070 and Mark 0100 airplanes. The NPRM published in the Federal Register on March 29, 2016 (81 FR 17417) (“the NPRM”). The NPRM was prompted by reports of cracking in a certain area of the pressure bulkhead webplate and skin connection angle. The NPRM proposed to require a one-time inspection of the affected pressure bulkhead webplate and skin connection angle, and corrective actions if necessary. We are issuing this AD to detect and correct cracking of the pressure bulkhead webplate and skin connection angle that could lead to sudden inflight decompression of the airplane, resulting in injury to occupants.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0024, dated February 19, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Fokker Services B.V. Model F28 Mark 0070 and Mark 0100 airplanes. The MCAI states:

Service experience with the Fokker 100 type design has shown that cracking can occur in the pressure bulkhead webplate and skin connection angle on the right hand (RH) side at station 14911 (station 12447 for F28 Mark 0070) at stringer 67 of fuselage section 2, before reaching the existing threshold for inspection per ALS [Airworthiness Limitations Section] task 533016-00-03 (F28 Mark 0100) or task 533016-01-03 (F28 Mark 0070). Any cracks in this area are not visible from the outside (covered by fairing) until they reach a critical length.

This condition, if not detected and corrected, could lead to sudden in-flight decompression of the aeroplane, possibly resulting in injury to occupants.

To address this potential unsafe condition, Fokker Services published Service Bulletin (SB) SBF100-53-128, which provides inspection instructions to detect any crack in the affected area.

For the reasons described above, this [EASA] AD requires a one-time inspection of the affected pressure bulkhead webplate and skin connection angle, and, depending on findings, accomplishment of applicable corrective action(s).

This [EASA] AD is considered to be an interim action and further AD action may follow, possibly to lower the current ALS task threshold, if justified by the inspection results.

Corrective actions include repair of cracking in the skin connection angle and pressure bulkhead webplate, as applicable.

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-2016-5035.

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 relevant 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 Fokker Service Bulletin SBF100-53-128, dated November 12, 2014; and Fokker Service Bulletin SBF100-53-129, dated February 16, 2015. The service information describes procedures for inspection of the affected pressure bulkhead webplate and skin connection angle, and corrective actions if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

We estimate that this AD affects 8 airplanes of U.S. registry.

We also estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD, and 1 work-hour per product for reporting. The average labor rate is $85 per work-hour. Required parts will cost about $0 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $1,360, or $170 per product.

In addition, we estimate that any necessary follow-on actions will take about 46 work-hours and require parts costing $2,000, for a cost of $5,910 per product. We have no way of determining the number of aircraft that might need these actions.

Paperwork Reduction Act

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to 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 control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is 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.

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 adding the following new airworthiness directive (AD): 2016-19-01 Fokker Services B.V.: Amendment 39-18650. Docket No. FAA-2016-5035; Directorate Identifier 2015-NM-042-AD. (a) Effective Date

This AD is effective October 24, 2016.

(b) Affected ADs

None.

(c) Applicability

This AD applies to Fokker Services B.V. Model F28 Mark 0070 and F28 Mark 0100 airplanes, certificated in any category, all serial numbers.

(d) Subject

Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

This AD was prompted by reports of cracking in the pressure bulkhead webplate and skin connection angle. We are issuing this AD to detect and correct cracking of the pressure bulkhead webplate and skin connection angle that could lead to sudden inflight decompression of the airplane, resulting in injury to occupants.

(f) Compliance

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

(g) Inspection

At the time specified in paragraph (h) of this AD: Do a detailed inspection of the pressure bulkhead webplate and skin connection angle on the right-hand side at station 14911 (for Model F28 Mark 0100 airplanes) or station 12447 (for Model F28 Mark 0070 airplanes) at stringer 67 of fuselage section 2, as applicable, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100-53-128, dated November 12, 2014. This AD does not require action for airplanes which, as of the effective date of this AD, have accumulated less than 30,000 flight cycles.

(1) If any crack is found in the skin connection angle, before further flight, repair the skin connection angle, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100-53-129, dated February 16, 2015.

(2) If any crack is found in the pressure bulkhead webplate, before further flight, repair the pressure bulkhead webplate, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100-53-129, dated February 16, 2015.

(h) Compliance Times

At the applicable time specified in paragraph (h)(1) or (h)(2) of this AD, do the actions required by paragraph (g) of this AD.

(1) For airplanes that have accumulated less than 40,000 total flight cycles as of the effective date of this AD, do the actions in paragraph (g) of this AD within 2,000 flight cycles after the effective date of this AD.

(2) For airplanes that have accumulated 40,000 or more total flight cycles as of the effective date of this AD, do the actions in paragraph (g) of this AD within 750 flight cycles after the effective date of this AD.

(i) Reporting

Submit a report of the findings (both positive and negative) of the inspection required by paragraph (g) of this AD to Fokker Services B.V. Engineering, Quality Department 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, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100-53-128, dated November 12, 2014, at the applicable time specified in paragraph (i)(1) or (i)(2) of this AD. The report must include the inspection results; the airplane serial number; the total number of flight cycles and flight hours on the airplane; a sketch or photo to show the location of the crack(s) and damaged part(s), if applicable; and the length of each crack, if applicable.

(1) If the inspection was done on or after the effective date of this AD: Submit the report within 30 days after the inspection.

(2) If the inspection was done before the effective date of this AD: Submit the report within 30 days after the effective date of this AD.

(j) 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: 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.

(3) Reporting Requirements: 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.

(k) Related Information

Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2015-0024, dated February 19, 2015, 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-2016-5035.

(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 this AD specifies otherwise.

(i) Fokker Service Bulletin SBF100-53-128, dated November 12, 2014.

(ii) Fokker Service Bulletin SBF100-53-129, dated February 16, 2015.

(3) 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.

(4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

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

Issued in Renton, Washington, on September 6, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-22186 Filed 9-16-16; 8:45 am] BILLING CODE 4910-13-P
SOCIAL SECURITY ADMINISTRATION 20 CFR Parts 404 and 416 [Docket No. SSA-2006-0149] RIN 0960-AF58 Revised Medical Criteria for Evaluating Respiratory System Disorders Correction

In rule document 2016-13275, appearing on pages 37138-37153, in the issue of Thursday, June 9, 2016, make the following correction:

PART 404—FEDERAL OLD AGE, SURVIVORS AND DISABILITY INSURANCE (1950) [CORRECTED] On page 37147, in the Table titled “TABLE II—FVC CRITERIA FOR 3.02B”, the column headings are corrected to read as set forth below: Height without shoes
  • (centimeters)
  • < means less than
  • Height without shoes
  • (inches)
  • < means less than
  • Table II-A Age 18 to attainment of age 20 Females FVC less than or equal to
  • (L, BTPS)
  • Males FVC less than or equal to
  • (L, BTPS)
  • Table II-B Age 20 or older Females FVC less than or equal to
  • (L, BTPS)
  • Males FVC less than or equal to
  • (L, BTPS)
  • [FR Doc. C1-2016-13275 Filed 9-16-16; 8:45 am] BILLING CODE 1505-01-D
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 117 and 507 [Docket Nos. FDA-2011-N-0920, FDA-2011-N-0922] Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Definition of Qualified Auditor; Announcement of Effective Date AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule; announcement of effective date.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is announcing the effective date for the definition of qualified auditor in the two final rules that appeared in the Federal Register of September 17, 2015.

    DATES:

    The effective date of paragraph (2) of the definition of qualified auditor in 21 CFR 117.3 and in 21 CFR 507.3, which published in the Federal Register of September 17, 2015 (80 FR 55908) and (80 FR 56170), is September 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    For questions relating to Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166.

    For questions relating to Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals: Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246.

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of September 17, 2015 (80 FR 55908), we published a final rule for “Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (preventive controls for human food rule). In § 117.3, we included the definition of a qualified auditor. In the definition, we provided examples of qualified auditors. Paragraph 2 of the definition reads “An audit agent of a certification body that is accredited in accordance with regulations in part 1, subpart M of this chapter.” At the time the final rule published, paragraph 2 referred to a provision in a future final rule: “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits to Issue Certifications” (third-party certification rule). In the preamble to the preventive controls for human food rule, we stated that we would publish a document in the Federal Register announcing the effective date of paragraph (2) once we finalized the third-party certification rule (80 FR 55908 at 55954).

    In the Federal Register of September 17, 2015 (80 FR 56170), we published a final rule for “Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (preventive controls for animal food rule). In § 507.3, we included the definition of a qualified auditor. In the definition, we provided examples of qualified auditors. Paragraph 2 of the definition reads “An audit agent of a certification body that is accredited in accordance with regulations in part 1, subpart M of this chapter.” At the time the final rule published, paragraph 2 referred to a provision in a future final rule: “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits to Issue Certifications” (third-party certification rule). In the preamble to the preventive controls for animal food rule, we stated that we would publish a document in the Federal Register announcing the effective date of paragraph (2) once we finalized the third-party certification rule (80 FR 55908 at 55954).

    The final third-party certification rule (80 FR 74569) published in the Federal Register on November 27, 2015, with an effective date of January 26, 2016. This document announces that the effective date for paragraph 2 in the definition of qualified auditor in § 117.3 (80 FR 55098 at 56147) and § 507.3 (80 FR 56170 at 56339) is September 19, 2016.

    Dated: September 14, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-22494 Filed 9-16-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9773] RIN 1545-BM70 Country-by-Country Reporting; Correction AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Correcting amendment.

    SUMMARY:

    This document contains corrections to final regulations (TD 9773) that were published in the Federal Register on Thursday, June 30, 2016 (81 FR 42482). This document contains final regulations that require annual country-by-country reporting by certain United States persons that are the ultimate parent entity of a multinational enterprise group.

    DATES:

    This correction is effective September 19, 2016 and is applicable on or after June 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Melinda E. Harvey of the Office of Associate Chief Counsel (International) at (202) 317-6934 (not a toll-free number).

    SUPPLEMENTARY INFORMATION:

    Background

    The final regulations (TD 9773) that are the subject of this correction are under section 1.6038-4 of the Internal Revenue Code.

    Need for Correction

    As published, the final regulations (TD 9773) contain errors that may prove to be misleading and are in need of clarification.

    List of Subjects in 26 CFR Part 1

    Income taxes, Reporting and recordkeeping requirements.

    Correction of Publication

    Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:

    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 1.6038-4 is amended by revising paragraph (d)(3)(iv) to read as follows:
    § 1.6038-4 Information returns required of certain United States persons with respect to such person's U.S. multinational enterprise group.

    (d) * * *

    (3) * * *

    (iv) Income tax paid and accrued tax expense of permanent establishment. In the case of a constituent entity that is a permanent establishment, the amount of income tax paid and the amount of accrued tax expense referred to in paragraphs (d)(2)(iv) and (v) of this section should not include the income tax paid or tax expense accrued by the business entity of which the permanent establishment would be a part, but for the third sentence of paragraph (b)(2) of this section, in that business entity's tax jurisdiction of residence on the income derived by the permanent establishment.

    Martin V. Franks, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, (Procedure and Administration).
    [FR Doc. 2016-22440 Filed 9-16-16; 8:45 am] BILLING CODE 4830-01-P
    DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 66 [Docket ID: DOD-2011-OS-0099] RIN 0790-AI78 Qualification Standards for Enlistment, Appointment, and Induction AGENCY:

    Office of the Under Secretary of Defense for Personnel and Readiness, DoD.

    ACTION:

    Final rule.

    SUMMARY:

    This rule updates policies and responsibilities for basic entrance qualification standards for enlistment, appointment, and induction into the Armed Forces and delegates the authority to specify certain standards to the Secretaries of the Military Departments. It establishes the age, aptitude, character/conduct, citizenship, dependents, education, medical, physical fitness, and other disqualifying conditions that are causes for rejection from military service. Other standards may be prescribed in the event of mobilization or national emergency. This rule sets standards designed to ensure that individuals under consideration for enlistment, appointment, and/or induction are able to perform military duties successfully, and to select those who are the most suitable for Service life.

    DATES:

    Effective Date: This rule is effective on October 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Dennis J. Drogo, (703) 697-9268.

    SUPPLEMENTARY INFORMATION:

    Public Comments and Responses

    On March 27, 2015 (80 FR 16269-16277), the Department of Defense published an interim final rule titled “Qualification Standards for Enlistment, Appointment, and Induction” for a 60-day public comment period. The comment period ended on May 26, 2015. Three public comments were received. This section addresses those comments.

    Comment 1: “Abstain: the area were I live is not for emergency personnel conducting business that should be known as unwanted security.”

    Response: The Department of Defense thanks the commenter for the comment. No changes were made to the final rule as a result.

    Comment 2: A 16-year veteran of the Air Force is in favor of having a qualified Armed Service to serve our country but, the commenter thinks interviews should be a part of the entrance process. The commenter says that being able to meet the proposed criteria does not guarantee a qualified member of the Armed Forces.

    Response: Prospective recruits are thoroughly vetted, to include multiple interviews at various stages of the entrance process, prior to taking the oath of service. No changes were made to the final rule.

    Comment 3: A male 40 years of age asked for help understanding why multiple recruiters in his area are stating that the current cut off age for non-prior service (NPS) is 39 for some Reserve and Guard branches. The commenter states that recruiters sent him away due to him being too old.

    Response: This part as further implemented by Department of Defense Instruction 1304.26, “Qualification Standards for Enlistment, Appointment, and Induction,” provides the Department of Defense's minimum acceptable standards for military Service. The Services can establish more restrictive standards based on the needs and requirements of that specific Service. The difference between these two sets of standards explains the challenges faced by the writer of this comment. No changes were made to the final rule.

    Although no changes were made to the final rule based on public comments received, a few edits were made due to reorganization, to provide clarification in the definition of “Dependent” and the waiver process, and to fix some grammatical issues.

    Executive Summary I. Purpose of This Regulatory Action

    This rule updates policies and responsibilities for basic entrance qualification standards for enlistment, appointment, and induction into the Armed Forces and delegates the authority to specify certain standards to the Secretaries of the Military Departments.

    II. Summary of the Major Provisions of This Regulatory Action

    This regulatory action establishes age, aptitude, character/conduct, citizenship, dependents, education, medical, physical fitness, and other disqualifying conditions that are causes for rejection from military service. Other standards may be prescribed in the event of mobilization or national emergency. This regulatory action also sets standards designed to ensure that individuals under consideration for enlistment, appointment, and/or induction are able to perform military duties successfully and to select those who are the most suitable for Service life; and removes provisions related to homosexual conduct.

    III. Costs and Benefits of This Regulatory Action

    Administrative costs are negligible. The benefit of publishing this final rule is that it establishes standards to ensure that those who are enlisted, appointed, or inducted are the best qualified to complete their prescribed training and the best able to adapt to the military life. Failure to maintain these standards would result in a high attrition of personnel and would significantly increase training costs. The success of today's All-volunteer military is dependent on this policy.

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

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

    Public Law 104-4, “Unfunded Mandates Reform Act” (2 U.S.C. Ch. 25)

    Section 1532 of title 2, United States Code requires agencies to assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2014, that threshold is approximately $141 million. This rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.

    Public Law 96-354, “Regulatory Flexibility Act” (5 U.S.C. 601)

    The Department of Defense certifies that this final rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

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

    It has been certified that 32 CFR part 66 does not impose additional reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995. The following existing clearances will be utilized:

    0701-0101—“Air Force ROTC College Scholarship Application” 0701-0150—“Air Force Recruiting Information Support System—Total Forces (AFRISS-TF)” 0702-0073—“U.S. Army ROTC 4-year College Scholarship Application” 0702-0111—“Army ROTC Referral Information” 0703-0020—“Enlistee Financial Statement” 0704-0006—“Request for Verification of Birth” 0704-0173—“Record of Military Processing—Armed Forces of the United States” 0704-0413—“Medical Screening of Military Personnel” 0704-0415, “Application for Department of Defense Common Access Card—DEERS Enrollment”

    The Department will continue to review its processes to identify collection instruments and consider how these collection tools may be improved and make revisions accordingly. The Department welcomes comments on how you think we can improve on our information collection activities.

    Executive Order 13132, “Federalism”

    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This final rule will not have a substantial effect on State and local governments.

    List of Subjects in 32 CFR Part 66

    Armed forces, Qualification standards.

    Accordingly, the interim final rule published at 80 FR 16269-16277 on March 27, 2015 is adopted as a final rule with the following changes:

    PART 66—[AMENDED] 1. The authority citation for part 66 continues to read as follows: Authority:

    10 U.S.C. 504, 505, 520, 532, 12102, 12201, and 12205.

    2. Amend § 66.3 by revising paragraphs (2) and (3) of the definition of “Dependent” to read as follows:
    § 66.3 Definitions.

    Dependent.

    (2) An unmarried step-child under the age of 18 living with the applicant.

    (3) An unmarried biological child or unmarried adopted child of the applicant under the age of 18.

    3. Amend § 66.5 by: a. Revising paragraph (a). b. Removing paragraph (c) and redesignating paragraph (d) as paragraph (c).

    The revision reads as follows:

    § 66.5 Responsibilities.

    (a) Under the authority, direction, and control of the Under Secretary of Defense for Personnel and Readiness (USD(P&R)), the Assistant Secretary of Defense for Manpower and Reserve Affairs (ASD(M&RA)):

    (1) Acts as an advisor to the USD(P&R) on the Reserve enlistment and appointment standards.

    (2) Acts as an advisor to the USD(P&R) on the height and weight requirements of the standards in § 66.6.

    (3) Ensures the U.S. Military Entrance Processing Command assists the Military Services in implementing the standards in § 66.6.

    § 66.6 [Amended]
    4. Amend § 66.6 by: a. In paragraph (b)(2)(ii), adding the words “,when not operating as a Service under the Navy” after “The Secretary of Defense (or the Secretary of Homeland Security for the Coast Guard.” b. In paragraph (b)(3)(ii), removing “Bearers of alternative credential” and adding in its place “Bearers of an alternative credential.” c. In paragraph (b)(8)(iii), adding a comma after the words “conviction” and “adjudication.” d. In paragraph (b)(8)(vi)(A), removing “(OPM)” and adding in its place “(Office of Personnel Management (OPM)).” e. In paragraph (b)(9)(ii), removing the comma after “The MEPS Chief Medical Officer.”
    § 66.7 [Amended]
    5. Amend § 66.7 by: a. At the end of paragraph (a) introductory text, adding the sentence “The waiver procedure is not automatic, and approval is based on each individual case.” b. In paragraph (a)(3), adding the sentence “Waivers are not authorized for cases noted in § 66.6(b)(8)(iii).” at the end of the paragraph. c. In paragraph (b)(1), removing “State or federal jurisdiction” and adding in its place “the appropriate State or federal jurisdiction.” Dated: September 13, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-22408 Filed 9-16-16; 8:45 am] BILLING CODE 5001-06-P
    CENTRAL INTELLIGENCE AGENCY 32 CFR Part 1909 Access to Classified Information by Historical Researchers and Certain Former Government Personnel AGENCY:

    Central Intelligence Agency.

    ACTION:

    Final rule.

    SUMMARY:

    Consistent with Executive Order 13526, the Central Intelligence Agency (CIA) is providing greater clarity about the procedures under which it may provide historical researchers and certain former Government personnel with access to classified CIA information. This rule is being issued as a final rule without prior notice of proposed rulemaking as allowed by the Administrative Procedure Act for rules of agency procedure and interpretation.

    DATES:

    Effective September 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Joseph W. Lambert, (703) 613-1379.

    SUPPLEMENTARY INFORMATION:

    Consistent with section 4.4 of Executive Order 13526, the CIA has revised its access regulations to more clearly set forth the procedures used to provide historical researchers and certain former Government personnel with access to classified CIA information. This rule is being issued as a final rule without prior notice of proposed rulemaking as allowed by the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(A) for rules of agency procedure and interpretation.

    List of Subjects in 32 CFR Part 1909

    Archives and records, Classified information, Historical records.

    Accordingly, the CIA is revising 32 CFR part 1909 as follows: PART 1909—ACCESS TO CLASSIFIED CIA INFORMATION BY HISTORICAL RESEARCHERS AND CERTAIN FORMER GOVERNMENT PERSONNEL PURSUANT TO SEC. 4.4 OF EXECUTIVE ORDER 13526 Sec. 1909.1 Authority and purpose. 1909.2 Definitions. 1909.3 Contact for general information and requests. 1909.4 Suggestions and complaints. 1909.5 Requirements as to who may apply. 1909.6 Designation of authority to waive need-to-know and grant historical access requests. 1909.7 Receipt, recording, and tasking. 1909.8 Determinations on requests for access by former Presidents and Vice Presidents, former Presidential and Vice Presidential appointees or designees, and historical researchers. 1909.9 Action by the ARP. 1909.10 Final CIA decision. 1909.11 Notification of decision. 1909.12 Termination of access. Authority:

    Executive Order 13526, 75 FR 707, 3 CFR 2010 Comp., p. 298-327 (or successor Orders).

    § 1909.1 Authority and purpose.

    (a) Authority. This part is issued under the authority of and in order to implement section 4.4 of Executive Order 13526, as amended (or successor Orders); section 1.6 of Executive Order 12333, as amended (or successor Orders); section 102A of the National Security Act of 1947, as amended; and section 6 of the Central Intelligence Agency Act of 1947, as amended.

    (b) Purpose. This part prescribes procedures for waiving the need-to-know requirement for access to classified information with respect to persons:

    (1) Requesting access to classified CIA information as historical researchers;

    (2) Requesting access to classified CIA information as a former Presidential or Vice Presidential appointee or designee; or

    (3) Requesting access to classified CIA information as a former President or Vice President.

    § 1909.2 Definitions.

    As used in this part:

    Agency Release Panel or Panel or ARP means the CIA Agency Release Panel established pursuant to part 1900 of this chapter.

    CIA means the Unites States Central Intelligence Agency.

    Control means ownership or the authority of the CIA pursuant to Federal statute or legal privilege to regulate official or public access to records.

    Coordinator means the CIA Information and Privacy Coordinator who serves as the CIA manager of the historical access process established pursuant to section 4.4 of the Order.

    Days means business days. Three (3) days may be added to any time limit imposed on a requester by this part if responding by U.S. domestic mail; ten (10) days may be added if responding by international mail;

    Director of Security means the CIA official responsible for making determinations regarding all security and access approvals and overseeing execution of the necessary secrecy, nondisclosure, and/or prepublication review agreements as may be required.

    Former Presidential or Vice Presidential appointee or designee means any person who has previously occupied a senior policy-making position in the Executive branch of the United States Government to which they were appointed or designated by the current or a former President or Vice President.

    Historical researcher means any individual with professional training in the academic field of history (or related fields such as journalism) engaged in a historical research project that is intended for publication (or any similar activity such as academic course development) and that is reasonably intended to increase the understanding of the American public regarding the operations and activities of the United States Government. This term also means anyone selected by a former President or Vice President, or by a former Presidential or Vice Presidential appointee or designee, to assist them in historical research as a research associate.

    Information means any knowledge that can be communicated or documentary material, regardless of its physical form that is owned by, produced by or for, or is under the control of the United States Government.

    Interested party means any official in the executive, congressional, or judicial branches of government, United States or foreign, or U.S. Government contractor who, in the sole discretion of the CIA, has a subject matter or physical interest in the documents or information at issue;

    Originator means the CIA officer who originated the information at issue, or successor in office, or a CIA officer who has been delegated declassification authority for the information at issue in accordance with the provisions of the Order.

    Order means Executive Order 13526 of December 29, 2009 and published at 75 FR 707 (or successor Orders).

    Senior Agency Official means the official designated by the DCIA under section 5.4(d) of the Order to direct and administer the CIA's program under which information is classified, safeguarded, and declassified.

    § 1909.3 Contact for general information and requests.

    For general information on this part, to inquire about access to CIA information under this part, or to make a formal request for such access, please direct your communication in writing to the Information and Privacy Coordinator, Central Intelligence Agency, Washington, DC 20505. Inquiries will also by accepted by facsimile at (703) 613-3007. For general information only, the telephone number is (703) 613-1287. Collect calls cannot be accepted.

    § 1909.4 Suggestions and complaints.

    The CIA welcomes suggestions, comments, or complaints with regard to its administration of the historical access provisions of Executive Order 13526. Members of the public shall address all such communications to the CIA Information and Privacy Coordinator. The CIA will respond as determined feasible and appropriate under the circumstances.

    § 1909.5 Requirements as to who may apply.

    (a) Historical researchers—(1) In general. Any historical researcher as defined above may submit a request in writing to the Coordinator to be given access to classified information for purposes of that research. Any such request shall indicate the nature, purpose, and scope of the research project.

    (2) Additional considerations. In light of the very limited Agency resources, it is the policy of the Agency to consider applications for access by historical researchers (other than research associates) only in those instances where the researcher's needs cannot be satisfied through requests for access to reasonably described records under the Freedom of Information Act or the mandatory declassification review provisions of Executive Order 13526, and where issues of internal resource availability and fairness to all members of the historical research community militate in favor of a particular grant.

    (b) Former Presidential and Vice Presidential appointees or designees. Any former Presidential or Vice Presidential appointee or designee as defined herein may also submit a request to be given access to any classified items which they originated, reviewed, signed, or received while serving in that capacity. Requests from such appointees or designees shall be in writing to the Coordinator and shall identify the records containing the classified information of interest. Such appointees or designees may also request approval for a research associate, but there is no entitlement to such enlargement of access and the decision in this regard shall be in the sole discretion of the Senior Agency Official.

    (c) Former Presidents and Vice Presidents. Any former President or Vice President may submit a request for access to classified CIA information. Requests from former Presidents or Vice Presidents shall be in writing to the Coordinator and shall identify the records containing the classified information of interest. A former President or Vice President may also request approval for a research associate, but there is no entitlement to such enlargement of access and the decision in this regard shall be in the sole discretion of the Senior Agency Official

    § 1909.6 Designation of authority to waive need-to-know and grant historical access requests.

    (a) The Agency Release Panel (ARP) is designated to review requests and shall issue a recommendation to the Senior Agency Official who shall issue the final CIA decision whether or not to waive the need-to-know and grant requests for access by historical researchers, by former Presidential and Vice Presidential appointees and designees, or by former Presidents and Vice Presidents under Executive Order 13526 (or successor Orders) and these regulations.

    (b) ARP Membership. The ARP is chaired by the Director, Information Management Services and composed of the Chief, Information Review and Release Group, the Chief, Classification Management Program Office, the Information Review Officers from the various Directorates and the DCIA area, as well as the representatives of the various release programs and offices within CIA. The Information and Privacy Coordinator also serves as Executive Secretary of the ARP.

    § 1909.7 Receipt, recording, and tasking.

    The Information and Privacy Coordinator shall within ten (10) days make a record of each request for access received under this part, acknowledge receipt to the requester in writing, and take the following actions:

    (a) Compliance with general requirements. The Coordinator shall review each request under this part and determine whether it meets the general requirements as set forth in § 1909.5 and notify the requester that the request has been accepted for consideration if it does. If it does not, the Coordinator shall so notify the requester and explain the basis for this decision and any steps that can be taken to perfect the request.

    (b) Action on requests meeting general requirements. For requests which meet the requirements of § 1909.5, the Coordinator shall thereafter task the Director, Center for the Study of Intelligence, the originator(s) of the information for which access is sought, and other interested parties to review the request and provide their input concerning whether or not the required determinations set forth in § 1909.8 can be made. Additional taskings may be directed as required during the review process.

    § 1909.8 Determinations on requests for access by former Presidents and Vice Presidents, former Presidential and Vice Presidential appointees or designees, and historical researchers.

    (a) Required determinations for former Presidents and Vice Presidents. In order to recommend approval of an access request made by a former President or Vice President, the ARP must make the following determinations in writing:

    (1) That the access is consistent with the interest of national security;

    (2) That a nondisclosure agreement has been or will be executed by the requester and other appropriate steps are taken to assure that classified information will not be disclosed or otherwise compromised;

    (3) That a CIA prepublication review agreement has been or will be executed by the requester which provides for a review of notes and any resulting manuscript; and,

    (4) That appropriate steps can be taken to ensure that the information is safeguarded in a manner consistent with Executive Order 13526.

    (b) Required determinations for former Presidential and Vice Presidential appointees or designees. In order to recommend approval of an access request made by a former Presidential or Vice Presidential appointee or designee, the ARP must make the following determinations in writing:

    (1) That the requester has previously occupied a senior policy-making position to which the requester was appointed or designated by the President or Vice President;

    (2) That the access is consistent with the interest of national security;

    (3) That a nondisclosure agreement has been or will be executed by the requester and other appropriate steps are taken to assure that classified information will not be disclosed or otherwise compromised;

    (4) That a CIA prepublication review agreement has been or will be executed by the requester which provides for a review of notes and any resulting manuscript;

    (5) That appropriate steps can be taken to ensure that the information is safeguarded in a manner consistent with Executive Order 13526; and,

    (6) That access will be limited to items that the person originated, reviewed, signed, or received while serving as a Presidential or Vice Presidential appointee or designee.

    (c) Required determinations for a research associate of a former President or Vice President, or of a former Presidential or Vice Presidential appointee or designee. In order to recommend approval of a request for historical access by a research associate, the ARP must make the following determinations in writing:

    (1) That the requester has been selected as a research associate of a former President or Vice President, or of a Presidential or Vice Presidential appointee or designee;

    (2) That the access is consistent with the interest of national security, and one factor in that determination is that an appropriate security check has been conducted and a security clearance or access has been issued by an appropriate U.S. Government agency;

    (3) That a nondisclosure agreement has been or will be executed by the requester and other appropriate steps are taken to assure that classified information will not be disclosed or otherwise compromised;

    (4) That a CIA prepublication review agreement has been or will be executed by the requester which provides for a review of notes and any resulting manuscript;

    (5) That appropriate steps can be taken to ensure that the information is safeguarded in a manner consistent with Executive Order 13526; and,

    (6) That, in the case of a former Presidential or Vice Presidential appointee or designee, access by the research associate will be limited to items that the Presidential or Vice Presidential appointee or designee who selected the research associate originated, reviewed, signed, or received while serving as a Presidential or Vice Presidential appointee or designee.

    (d) Required determinations for a historical researcher (other than a research associate). In order to recommend approval of an access request made by a historical researcher (other than a research associate to which paragraph (c) of this section applies) the ARP must make the following determinations in writing:

    (1) That a serious professional or scholarly research project by the requester is contemplated;

    (2) That the access is consistent with the interest of national security, and one factor in that determination is that an appropriate security check has been conducted and a security clearance or access has been issued by an appropriate U.S. Government agency;

    (3) That a nondisclosure agreement has been or will be executed by the requester, and other appropriate steps are taken to assure that classified information will not be disclosed or otherwise compromised;

    (4) That a CIA prepublication review agreement has been or will be executed by the requester, which provides for a review of notes and any resulting manuscript;

    (5) That the information requested is reasonably accessible and can be located and compiled with a reasonable effort;

    (6) That it is reasonably expected that substantial and substantive Government documents and/or information will be amenable to declassification and release and/or publication;

    (7) That sufficient resources are available for the administrative support of the historical researcher given current requirements; and,

    (8) That the request cannot be satisfied to the same extent through requests for access to reasonably described records under the Freedom of Information Act or the Mandatory Declassification Review provisions of Executive Order 13526.

    § 1909.9 Action by the ARP.

    The ARP shall meet on a regular schedule and may take action when a simple majority of the total membership is present. A recommendation to the Senior Agency Official concerning whether or not to grant requests for access to classified CIA information by former Presidents or Vice Presidents, by former Presidential or Vice Presidential appointees or designees, or by historical researchers shall be made by a majority vote of the members present.

    § 1909.10 Final CIA decision.

    (a) Upon receipt of a recommendation by the ARP concerning whether or not to grant access to classified CIA information under this part, the Senior Agency Official may, in his sole discretion, waive the need-to-know requirement and approve such access only if he or she:

    (1) Determines in writing that access is consistent with the interests of national security;

    (2) Takes appropriate steps to protect classified information from unauthorized disclosure or compromise and ensures that the information is safeguarded in a manner consistent with Executive Order 13526; and,

    (3) Limits any access granted to former Presidential or Vice Presidential appointees and designees (or any research associate they select) to the items that the former Presidential or Vice Presidential appointee or designee originated, reviewed, signed, or received while serving in that capacity.

    (b) The Director of the Central Intelligence Agency reserves the authority to make a superseding decision concerning whether or not to waive the need-to-know requirement and to grant access to classified CIA information under this part in any case only if he or she:

    (1) Determines in writing that access is consistent with the interests of national security;

    (2) Takes appropriate steps to protect classified information from unauthorized disclosure or compromise, and ensures that the information is safeguarded in a manner consistent with Executive Order 13526; and,

    (3) Limits any historical access granted to former Presidential or Vice Presidential appointees and designees (or any research associate they select) to the items that the former Presidential or Vice Presidential appointee or designee originated, reviewed, signed, or received while serving in that capacity.

    (c) The Senior Agency Official also may make a determination that a successive request for historical access falls within the scope of an earlier waiver of the “need-to-know” criterion under section 4.4 of the Order, so long as the extant waiver is no more than two years old.

    § 1909.11 Notification of decision.

    The Executive Secretary shall inform the requester of the final CIA decision and, if favorable, shall manage the access for such period of time as deemed required, but in no event for more than two years unless renewed by the Senior Agency Official, in accordance with the requirements of this part for waiving need-to-know and granting access in the first instance.

    § 1909.12 Termination of access.

    The Coordinator shall cancel any authorization and deny any further access whenever the Director of Security cancels the security clearance of any person who has been granted access to classified CIA information under the part; or whenever the Senior Agency Official, or the Director of the Central Intelligence Agency, determines that continued access would no longer be consistent with the requirements of this part; or at the conclusion of the authorized period of up to two years if there is no renewal under § 1909.11.

    Dated: August 30, 2016. Joseph W. Lambert, Director, Information Management Services.
    [FR Doc. 2016-21825 Filed 9-16-16; 8:45 am] BILLING CODE 6310-02-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [USCG-2016-0790] RIN 1625-AA87 Security Zone; 22nd International Seapower Symposium, Goat Island, Newport, RI AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary security zone along the western shore of Goat Island, Newport, Rhode Island, including the vicinity of Newport Harbor Light at the northeastern point of Goat Island to and around the Goat Island Connector between Goat Island and Newport, Rhode Island, in conjunction with the 22nd International Seapower Symposium. Entry into this zone by any vessel or persons is prohibited unless specifically authorized by the Captain of the Port (COTP), Southeastern New England or the COTP's designated on-scene representative.

    DATES:

    This rule is effective without actual notice from September 19, 2016 until September 23, 2016. For the purposes of enforcement, actual notice will be used from September 18, 2016 until September 19, 2016.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0790 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 temporary rule, call or email Mr. Edward G. LeBlanc at Sector Southeastern New England; telephone (401) 435-2351, email [email protected].

    SUPPLEMENTARY INFORMATION: I. Table of Acronyms CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section TFR Temporary Final Rule 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 a NPRM with respect to this rule. Because of the sensitive security issues related to these special events, the Coast Guard was not aware of the final details with sufficient time to solicit public comments. Thus, waiting for a full comment period to run would inhibit the Coast Guard's ability to keep senior military leaders and government officials, along with the general public, safe from subversive acts directed at these high visibility special events. Providing a prolonged public notice and comment period is contrary to the public interest due to national security concerns.

    We are issuing this rule, and 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. Any delay encountered in this temporary rule's effective date would be contrary to the public interest given the immediate need to ensure the safety and security of event attendees.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231; which authorizes the Coast Guard to define Security Zones.

    This action is intended to temporarily prohibit vessel traffic from transiting within 250 yards of the western shore of Goat Island and within a 250 yard radius of Newport Harbor Light at the northeastern point of Goat Island and extending to 250 yards on either side of the Goat Island Connector between Goat Island and Newport, Rhode Island, to ensure the security of attendees to the 22nd International Seapower Symposium by properly safeguarding against potential sabotage, subversive acts, or other threats.

    IV. Discussion of Comments, Changes, and the Rule

    The 22nd International Seapower Symposium is being held on Goat Island, Newport, RI, from September 18 through September 23, 2016. High level U.S. officials and delegates from over 125 countries are expected to attend. Goat Island, the site of the 22nd International Seapower Symposium, is waterfront property in Newport, Rhode Island, within the Captain of the Port, Southeastern New England zone.

    This rule establishes a temporary 250-yard security zone in the navigable waters adjacent to the western shore of Goat Island and in the vicinity of Newport Harbor Light at the northeastern point of Goat Island and extending to 250 yards on either side of the Goat Island Connector between Goat Island and Newport, Rhode Island, where the 22nd International Seapower Symposium is being held from September 18 through September 23, 2016. Vessels and persons will be prohibited from entering this security zone during the 22nd International Seapower Symposium. The perimeter of the security zone along the western shore and northeast point of Goat Island will be clearly marked by six special purpose white buoys with orange stripes. It has been determined that the necessary security enhancements provided by this rule greatly outweigh any potential negative impacts. Public notifications will be made prior to and during the entire effective period of this security zone via marine information broadcasts and local notice to mariners.

    V. Regulatory Analyses

    We developed this rule after considering numerous statutes and executive orders relating to rulemaking. Below we summarize our analyses based on 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, the rule has not been reviewed by the Office of Management and Budget.

    This regulatory action determination is based on the size, location, duration of the event. The effect of this rule will be small, as the duration of the security zone is for only six days. Additionally, vessels may be permitted to transit and navigate in waters adjacent to this security zone, minimizing any adverse impact. Maritime advisories will be broadcast. The Coast Guard anticipates negligible negative impact on vessel traffic from this temporary security zone. It will be in effect for only six days and will only affect waters adjacent to the western shore, northeast end of Goat Island, and the Goat Island Connector where there are no major channels, slips, marinas, or other waterfront facilities for recreational or commercial traffic. Additionally, the security zone is in effect in mid- to late-September when there is reduced vessel activity in the vicinity of Goat Island and vessels can transit safely around the security zone and in all other waters of Newport Harbor.

    B. Impact on Small Entities

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

    While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule would 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 (Public Law 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 calls for no 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 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 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 does not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a temporary 250-yard security zone in the navigable waters in the vicinity of Newport Harbor in conjunction with the 22nd International Seapower Symposium. Normally such actions are categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. An environmental analysis checklist and Categorical Exclusion Determination will be 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), Reports 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; Department of Homeland Security Delegation No. 0170.1.

    2. Add temporary § 165.T01-0790 to read as follows:
    § 165.T01-0790 Security Zone: Goat Island, Newport, Rhode Island.

    (a) Location. The following area is a security zone: All navigable waters, from surface to bottom, within 250 yards of the western shore of Goat Island, Newport, Rhode Island, marked at its southern boundary by Goat Island Southwest Buoy “1” (U.S. Coast Guard Light List No. 17825) in approximate position 41°28′56.869″ N., 71°19′45.865″ W., and extending north parallel to the western shore to where it meets and includes an arc extending in a 250 yard radius around Newport Harbor Light (U.S. Coast Guard Light List No. 17850) at position 41°29′36.000″ N., 071°19′37.800″ W. and extends to and includes waters within 250 yards on either side of the Goat Island Connector between Goat Island and Newport, Rhode Island.

    (b) Effective and enforcement period. This rule will be effective and enforced from 8:00 a.m. on September 18, 2016 to 8:00 p.m. on September 23, 2016.

    (c) Definitions. The following definitions apply to this section: “Designated on-scene patrol personnel” means any commissioned, warrant and petty officers of the Coast Guard operating Coast Guard vessels who have been authorized to act on the behalf of the Captain of the Port, Southeastern New England.

    (d) Regulations. (1) The general regulations contained in 33 CFR 165.33 apply.

    (2) In accordance with the general regulations in § 165.33 of this part, entry into or movement within this zone is prohibited unless authorized by the Captain of the Port, Southeastern New England.

    (3) All persons and vessels shall comply with the Coast Guard Captain of the Port or designated on-scene patrol personnel.

    (4) Upon being hailed by a Coast Guard vessel by siren, radio, flashing light or other means, the operator of the vessel shall proceed as directed.

    (5) Persons and vessels may request permission to enter the zone on VHF-16.

    Dated: August 31, 2016. J.A. Smith, Commander, U.S. Coast Guard, Acting Captain of the Port, Southeastern New England.
    [FR Doc. 2016-22464 Filed 9-16-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [USCG-2016-0813] RIN 1625-AA87 Security Zone; 22nd International Seapower Symposium Special Events, Rosecliff Mansion and Newport Marriott Hotel, Newport, RI AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary 500-yard security zone on the waters adjacent to Rosecliff Mansion and the Newport Marriott Hotel, in Newport, Rhode Island, in conjunction with special events of the U.S. Navy's 22nd International Seapower Symposium. Vessels and people are prohibited from entering these security zones.

    DATES:

    This rule is effective from 4 p.m. on September 20, 2016 through 11:30 p.m. on September 22, 2016.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0813 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 temporary rule, call or email Mr. Edward G. LeBlanc at Sector Southeastern New England, telephone (401) 435-2351, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Acronyms CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section TFR Temporary Final Rule U.S.C. United States Code II. Background, Purpose, and Legal Basis

    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 NPRM with respect to this rule. Because of the sensitive security issues related to these special events, the Coast Guard was not aware of the final details with sufficient time to solicit public comments. Thus, waiting for a full comment period to run would inhibit the Coast Guard's ability to keep senior military leaders and government officials, along with the general public, safe from subversive acts directed at these high visibility special events. Providing a prolonged public notice and comment period is contrary to the public interest due to national security concerns.

    We are issuing this rule, and 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, delaying the effective date of this rule would be contrary to the public interest.

    III. Legal Authority and Need for Rule

    The legal authority for this rule is 33 U.S.C. 1231 which authorizes the Coast Guard to define Security Zones.

    The 22nd International Seapower Symposium is being held on Goat Island, Newport, RI, from September 18 to September 23, 2016. High level U.S. officials and delegates from over 125 countries are expected to attend. As part of the Symposium, special events are being held on the evenings of Tuesday, September 20 and Thursday, September 22, 2016, at Rosecliff Mansion and the Newport Marriott Hotel, respectively, which are waterfront properties in Newport, Rhode Island, and within the COTP, Southeastern New England zone. The COTP has determined that it is necessary to temporarily prohibit vessel traffic from transiting within 500 yards of Rosecliff Mansion (approximate position 41°-27′54″ N., 071°-18′18″ W.) and the Newport Marriott Hotel (approximate position 41°-29′23″ N., 071°-19′04″ W.), Newport, RI, to safeguard the symposium attendees against potential sabotage, subversive acts, or other threats.

    IV. Discussion of the Rule

    For the reasons discussed above, this rule establishes temporary 500-yard security zones in the navigable waters adjacent to Rosecliff Mansion (approximate position 41°-27′54″ N., 071°-18′18″ W.) and the Newport Marriott Hotel (approximate position 41°-29′23″ N., 071°-19′04″ W.) respectively, in Newport, Rhode Island. These security zones will be effective and enforced at Rosecliff Mansion and the Newport Marriott Hotel from 4 p.m. to 11:30 p.m. on Tuesday, September 20 and Thursday, September 22, 2016, respectively. Vessels and persons will be prohibited from entering these security zones during this time.

    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 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, the rule has not been reviewed by the Office of Management and Budget.

    The Coast Guard expects the economic impact of this rule to be minimal, such that a full regulatory evaluation under the regulatory policies and procedures of DHS is unnecessary. The effect of this rule will be small, as the duration of the security zones is for only seven and a half hours on two separate evenings. Additionally, vessels may be permitted to transit and navigate in waters adjacent to this security zones, minimizing any adverse impact. Maritime advisories will be broadcasted.

    B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule 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 security zones may be small entities, for the reasons stated in section V.A above this 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 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 calls for no 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 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 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 does not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of temporary security zones for special events being held in conjunction with the 22nd International Seapower Symposium. Normally such actions are categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. An environmental analysis checklist and Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reports and recordkeeping requirements, Security measures, and 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. Add temporary § 165.T01-0813 to read as follows:
    § 165.T01-0813 Security Zones: Rosecliff Mansion and Newport Marriott Hotel, Newport, Rhode Island.

    (a) Location. The following areas are security zones: All navigable waters, from surface to bottom, within 500 yards of Rosecliff Mansion (approximate position 41°−27′54″ N., 071°−18′18″ W.) and the Newport Marriott Hotel (approximate position 41°−29′23″ N., 071°−19′04″ W.), Newport, Rhode Island.

    (b) Effective and enforcement period. This rule will be effective and enforced from 4 p.m. to 11:30 p.m. on Tuesday, September 20, 2016 at Rosecliff Mansion, and from 4 p.m. to 11:30 p.m. on Thursday, September 22, 2016, at the Newport Marriott Hotel.

    (c) Definitions. The following definitions apply to this section: “Designated on-scene patrol personnel” means any commissioned, warrant and petty officers of the U.S. Coast Guard operating Coast Guard vessels who have been authorized to act on the behalf of the Captain of the Port, Southeastern New England.

    (d) Regulations. (1) The general regulations contained in 33 CFR 165.30 and 165.33 apply.

    (2) In accordance with the general regulations in 33 CFR 165.33 of this part, entry into or movement within these zones is prohibited unless authorized by the Captain of the Port, Southeastern New England.

    (3) Any vessel permitted to enter these security zones shall comply with the Coast Guard Captain of the Port or designated on-scene patrol personnel.

    (4) Upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light or other means, the operator of the vessel shall proceed as directed.

    (5) Persons and vessels may request permission to enter the zone on VHF-16.

    Dated: August 31, 2016. J.A. Smith, Commander, U.S. Coast Guard, Acting Captain of the Port, Southeastern New England.
    [FR Doc. 2016-22463 Filed 9-16-16; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R02-OAR-2016-0389; FRL-9952-41-Region 2] Partial Approval and Partial Disapproval of Air Quality Implementation Plans; NJ; Infrastructure SIP Requirements for 2008 Lead, 2008 Ozone, 2010 Nitrogen Dioxide, 2010 Sulfur Dioxide, and 2012 PM2.5, 2006 PM10 and 2011 Carbon Monoxide NAAQS: Interstate Transport Provisions AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is partially approving and partially disapproving elements of a New Jersey State Implementation Plan (SIP) submittal pertaining to the infrastructure requirements of section 110(a)(1) and (2) of the Clean Air Act (CAA) for the 2008 Lead, 2008 Ozone, 2010 Nitrogen Dioxide (NO2), 2010 Sulfur Dioxide (SO2), 2011 Carbon Monoxide (CO), 2006 Particulate Matter of ten microns or less (PM10), and 2012 Particulate Matter of 2.5 microns or less (PM2.5) National Ambient Air Quality Standards (NAAQS). The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA. This action pertains specifically to infrastructure requirements relating to interstate transport provisions concerning the Prevention of Significant Deterioration of Air Quality (PSD) regulations, and visibility protection.

    DATES:

    This rule is effective on October 19, 2016.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R02-OAR-2016-0389. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy. Publicly available docket materials are available either electronically through http://www.regulations.gov or please contact the person identified in the FOR FURTHER INFORMATION CONTACT section for additional information.

    FOR FURTHER INFORMATION CONTACT:

    Kenneth Fradkin, 212-637-3702, [email protected]

    SUPPLEMENTARY INFORMATION:

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

    I. Background and Purpose II. What action is EPA taking? III. Statutory and Executive Order Reviews I. Background and Purpose

    This rulemaking addresses CAA section 110(a)(2)(D)(i) requirements in New Jersey's infrastructure SIP submitted on October 17, 2014 to address applicable infrastructure requirements with respect to the 2008 Lead, 2008 Ozone, 2010 NO2, 2010 SO2, and 2012 PM2.5, 2006 PM10 and 2011 CO NAAQS.

    The requirement for states to make a SIP submission of this type arises out of CAA section 110(a)(1). Pursuant to section 110(a)(1), states must make SIP submissions “within 3 years (or such shorter period as the Administrator may prescribe) after the promulgation of a national primary ambient air quality standard (or any revision thereof),” and these SIP submissions are to provide for the “implementation, maintenance, and enforcement” of such NAAQS. The statute directly imposes on states the duty to make these SIP submissions, and the requirement to make the submissions is not conditioned upon EPA's taking any action other than promulgating a new or revised NAAQS. Section 110(a)(2) includes a list of specific elements that “[e]ach such plan” submission must address. EPA commonly refers to such state plans as “infrastructure SIPs.” In particular, section 110(a)(2)(D)(i)(I) requires SIPs to include provisions prohibiting any source or other type of emissions activity in one state from contributing significantly to nonattainment of the NAAQS (commonly referred to as prong 1), or interfering with maintenance of the NAAQS (prong 2), in any another state. Section 110(a)(2)(D)(i)(II) requires SIPs to include provisions prohibiting any source or other type of emissions activity in one state from interfering with measures required to prevent significant deterioration (PSD) of air quality (prong 3) and to protect visibility (prong 4) in another state.

    This rulemaking pertains only to the portion of the SIP submittal addressing section 110(a)(2)(D)(i)(II)(prongs 3 and 4). On March 30, 2016, New Jersey withdrew the portion of the submittal addressing 110(a)(2)(D)(i)(I) (prongs 1 and 2) for the 2008 Ozone NAAQS. EPA subsequently issued a Finding of Failure to Submit to New Jersey.1 EPA will address the other portions of the October 17, 2014 infrastructure SIP submittal in a separate action.

    1 81 FR 38963 (June 15, 2016).

    EPA proposed action on the October 17, 2014 submittal on July 27, 2016 (81 FR 49205). In that action, EPA proposed to disapprove the portions of New Jersey's October 17, 2014 SIP submission addressing prong 3 and proposed to approve the portions addressing prong 4 regarding CAA section 110(a)(2)(D)(i) requirements. No comments were received on the proposal. The reader is referred to the July 27, 2016 proposed rulemaking for a detailed discussion of New Jersey's submittal and EPA's review and proposed actions.

    II. What action is EPA taking?

    EPA is approving the portion of the October 17, 2014 SIP submittal from New Jersey pertaining to the requirements of CAA section 110(a)(2)(D)(i)(II) requirement for visibility (or prong 4) for the 2008 Lead, 2008 Ozone, 2010 NO2, 2010 SO2, and 2012 p.m.2.5, 2006 p.m.10 and 2011 CO NAAQS.

    New Jersey has elected to comply with the Federal PSD requirements by accepting delegation of the Federal rules and has been successfully implementing this program for many years. However, EPA does not recognize a delegated PSD program as satisfying the Infrastructure SIP requirements. Therefore, EPA is disapproving New Jersey's submittal pertaining to the requirements of CAA section 110(a)(2)(D)(i)(II) requirement for PSD (or prong 3) for the 2008 Lead, 2008 Ozone, 2010 NO2, 2010 SO2, and 2012 PM2.5, 2006 p.m.10 and 2011 CO NAAQS. However, the disapprovals will not trigger any sanctions or additional Federal Implementation Plan obligation since a PSD Federal Implementation Plan is already in place.

    III. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review

    This final action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and was therefore not submitted to the Office of Management and Budget for review.

    B. Paperwork Reduction Act (PRA)

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

    C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This rule does not impose any requirements or create impacts on small entities. This partial SIP approval and partial SIP disapproval under CAA section 110 will not in-and-of itself create any new requirements but simply approves and disapproves certain state requirements for inclusion into the SIP.

    D. Unfunded Mandates Reform Act (UMRA)

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

    E. Executive Order 13132: Federalism

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

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

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

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

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

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

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

    I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

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

    EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations because it does not affect the level of protection provided to human health or the environment. This action merely partially approves and partially disapproves a SIP submittal from the State of New Jersey.

    K. Congressional Review Act (CRA)

    This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to 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).

    L. Judicial Review

    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 November 18, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2)).

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental relations, Incorporation by reference, Carbon monoxide, Lead, Nitrogen dioxide, Ozone, Particulate matter, Sulfur dioxide, Volatile organic compounds.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: September 6, 2016. Judith A. Enck, Regional Administrator, Region 2.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart FF—New Jersey 2. Section 52.1586 is amended by adding paragraph (b) and adding and reserving paragraph (c) to read as follows:
    § 52.1586 Section 110(a)(2) infrastructure requirements.

    (b) 2008 Lead, 2008 8-hour ozone, 2010 NO 2 , 2010 SO 2 , 2012 PM 2.5 , 2006 PM 10 and 2011 CO NAAQS—(1) Approval. Submittal from New Jersey dated October 17, 2014 to address the CAA infrastructure requirements of section 110(a)(2) for the 2008 Lead, 2008 8-hour ozone, 2010 NO2, 2010 SO2, 2012 PM2.5, 2006 PM10 and 2011 CO NAAQS is approved for (D)(i)(II) prong 4 (visibility).

    (2) Disapproval. Submittal from New Jersey dated October 17, 2014 to address the CAA infrastructure requirements of section 110(a)(2) for the 2008 Lead, 2008 8-hour ozone, 2010 NO2, 2010 SO2, 2012 PM2.5, 2006 PM10 and 2011 CO NAAQS is disapproved for (D)(i)(II) prong 3 (PSD program only). These requirements are being addressed by § 52.1603 which has been delegated to New Jersey to implement.

    (c) [Reserved]

    [FR Doc. 2016-22400 Filed 9-16-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2015-0824; FRL-9952-42-Region 5] Air Plan Approval; Ohio; Infrastructure SIP Requirements for the 2012 PM2.5 NAAQS AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving elements of the state implementation plan (SIP) submission from Ohio regarding the infrastructure requirements of section 110 of the Clean Air Act (CAA) for the 2012 fine particulate matter (PM2.5) National Ambient Air Quality Standards (NAAQS). The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA. The proposed rule associated with this final action was published on June 23, 2016, and we received no comments.

    DATES:

    This final rule is effective on October 19, 2016.

    ADDRESSES:

    EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2015-0824. All documents in the docket are listed on the www.regulations.gov Web site. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either through www.regulations.gov or at the Environmental Protection Agency, Region 5, Air and Radiation Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. We recommend that you telephone Joseph Ko, Environmental Engineer, at (312) 886-7947 before visiting the Region 5 office.

    FOR FURTHER INFORMATION CONTACT:

    Joseph Ko, Environmental Engineer, Attainment Planning and Maintenance, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-7947, [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. What did Ohio submit, and what is the scope of EPA's action? II. What action is EPA taking? III. Statutory and Executive Order Reviews I. What did Ohio submit, and what is the scope of EPA's action? A. What state SIP submission does this rulemaking address?

    This rulemaking addresses a submission from the Ohio Environmental Protection Agency (OEPA), describing its infrastructure SIP for the 2012 PM2.5 NAAQS, dated December 4, 2015.

    B. Why did the state make this SIP submission?

    Under sections 110(a)(1) and (2) of the CAA, states are required to submit infrastructure SIPs to ensure that their SIPs provide for implementation, maintenance, and enforcement of the NAAQS, including the 2012 PM2.5 NAAQS. These submissions must contain any revisions needed for meeting the applicable SIP requirements of section 110(a)(2), or certifications that their existing SIPs for the NAAQS already meet those requirements.

    EPA highlighted this statutory requirement in an October 2, 2007, guidance document entitled “Guidance on SIP Elements Required Under Sections 110(a)(1) and (2) for the 1997 8-hour Ozone and PM2.5 National Ambient Air Quality Standards” (2007 Memo) and has issued additional guidance documents, the most recent on September 13, 2013, “Guidance on Infrastructure State Implementation Plan (SIP) Elements under CAA Sections 110(a)(1) and (2)” (2013 Memo). The SIP submission referenced in this rulemaking pertains to the applicable requirements of section 110(a)(1) and (2), and addresses the 2012 PM2.5 NAAQS. To the extent that the prevention of significant deterioration (PSD) program is non-NAAQS specific, a narrow evaluation of other aspects of Ohio's submittal pertinent to the NAAQS will be included in the appropriate sections.

    C. What is the scope of this rulemaking?

    EPA is acting upon the SIP submission from OEPA that addresses the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the 2012 PM2.5 NAAQS. The requirement for states to make a SIP submission of this type is in CAA section 110(a)(1). Pursuant to section 110(a)(1), states must make SIP submissions “within 3 years (or such shorter period as the Administrator may prescribe) after the promulgation of a national primary ambient air quality standard (or any revision thereof),” and these SIP submissions are to provide for the “implementation, maintenance, and enforcement” of such NAAQS. The statute directly imposes on states the duty to make these SIP submissions, and the requirement to make the submissions is not conditioned upon EPA's taking any action other than promulgating a new or revised NAAQS. Section 110(a)(2) includes a list of specific elements that “[e]ach such plan” submission must address.

    EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of CAA sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Although the term “infrastructure SIP” does not appear in the CAA, EPA uses the term to distinguish this particular type of SIP submission from submissions that are intended to satisfy other SIP requirements under the CAA, such as “nonattainment SIP” or “attainment plan SIP” submissions to address the nonattainment planning requirements of part D of title I of the CAA, “regional haze SIP” submissions required by EPA rule to address the visibility protection requirements of CAA section 169A, and nonattainment new source review (NNSR) permit program submissions to address the permit requirements of CAA, title I, part D.

    This rulemaking will not cover four substantive areas that are not integral to acting on a state's infrastructure SIP submission: (i) Existing provisions related to excess emissions during periods of start-up, shutdown, or malfunction at sources, that may be contrary to the CAA and EPA's policies addressing such excess emissions (“SSM”); (ii) existing provisions related to “director's variance” or “director's discretion” that purport to permit revisions to SIP-approved emissions limits with limited public process or without requiring further approval by EPA, that may be contrary to the CAA (“director's discretion”); (iii) existing provisions for PSD programs that may be inconsistent with current requirements of EPA's “Final New Source Review (NSR) Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”); and (iv) transport provisions under section 110(a)(2)(D). Instead, EPA has the authority to, and plans to, address each one of these substantive areas in separate rulemakings. A detailed history and interpretation of infrastructure SIP requirements can be found in EPA's May 13, 2014, proposed rule entitled, “Infrastructure SIP Requirements for the 2008 Lead NAAQS” in the section, “What is the scope of this rulemaking?” (see 79 FR 27241 at 27242—27245).

    II. What action is EPA taking?

    EPA is approving most elements of the submission from OEPA certifying that its current SIP is sufficient to meet the required infrastructure elements under sections 110(a)(1) and (2) for the 2012 PM2.5 NAAQS. The proposed rulemaking associated with this final action was published on June 23, 2016 (81 FR 40827), and EPA received no comments during the comment period, which ended on July 25, 2016. For the reasons discussed in the proposed rulemaking, EPA is therefore taking final action to approve most elements, as proposed, of Ohio's submissions. EPA's final actions for the state's satisfaction of infrastructure SIP requirements, by element of section 110(a)(2) are contained in the table below.

    Element 2012
  • PM2.5
  • (A): Emission limits and other control measures A (B): Ambient air quality monitoring and data system A (C): Program for enforcement of control measures A (D) 1: Interstate Transport—Significant contribution NA (D) 2: Interstate Transport—interfere with maintenance NA (D) 3: PSD A (D) 4: Visibility NA (D) 5: Interstate and International Pollution Abatement A (E): Adequate resources A (E): State boards A (F): Stationary source monitoring system A (G): Emergency power A (H): Future SIP revisions A (I): Nonattainment area plan or plan revisions under part D + (J) 1: Consultation with government officials A (J) 2: Public notification A (J) 3: PSD A (J) 4: Visibility protection + (K): Air quality modeling and data A (L): Permitting fees A (M): Consultation and participation by affected local entities A In the above table, the key is as follows: A Approve. NA No Action/Separate Rulemaking. + Not germane to infrastructure SIPs.
    III. 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 November 18, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.

    Dated: August 30, 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. In § 52.1870, the table in paragraph (e) is amended by adding an entry for “Section 110(a)(2) Infrastructure Requirements for the 2012 PM2.5 NAAQS” after the entry “Section 110(a)(2) infrastructure requirements for the 2006 PM2.5 NAAQS” under “Infrastructure Requirements” to read as follows:
    § 52.1870 Identification of plan.

    (e) * * *

    EPA-Approved Ohio Nonregulatory and Quasi-Regulatory Provisions Title Applicable
  • geographical or
  • non-attainment area
  • State date EPA approval Comments
    *         *         *         *         *         *         * Infrastructure Requirements *         *         *         *         *         *         * Section 110(a)(2) infrastructure requirements for the 2012 PM2.5 NAAQS Statewide 12/2/2015 9/19/2016, [Insert Federal Register citation] Addresses the following CAA elements: 110(a)(2)(A)-(C), (D)(iii), (D)(v), (E)-(H), (J)(i), (J)(ii), (J)(iii), (K)-(M). *         *         *         *         *         *         *
    [FR Doc. 2016-22360 Filed 9-16-16; 8:45 am] BILLING CODE 6560-50-P
    81 181 Monday, September 19, 2016 Proposed Rules SMALL BUSINESS ADMINISTRATION 13 CFR Part 107 RIN 3245-AG68 Small Business Investment Companies (SBIC); Early Stage Initiative AGENCY:

    U.S. Small Business Administration.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    In this proposed rule, SBA is making changes to its Early Stage Small Business Investment Company (SBIC) initiative, which was launched in 2012 as a 5-year effort as part of President Obama's Startup America Initiative. The intent of the initiative was to license and provide SBA-guaranteed leverage to Early Stage SBICs that would focus on making investments in early stage small businesses. Although 62 investment funds applied to the program, few satisfied SBA's licensing criteria. To date, SBA has only licensed five Early Stage SBICs. In an attempt to attract more qualified early stage fund managers, this rule proposes changes to the initiative with respect to licensing, non-SBA borrowing, and leverage eligibility. These proposed changes are based in part on feedback SBA received on an Advance Notice of Proposed Rulemaking (ANPRM) that was published in March 2015. In addition, this rule reflects SBA's intention to continue licensing and providing SBA-guaranteed leverage to Early Stage SBICs beyond the 5-year term of the initiative, and proposes certain technical changes to SBA's Early Stage regulations.

    DATES:

    Comments on the proposed rule must be received on or before October 19, 2016.

    ADDRESSES:

    You may submit comments, identified by RIN 3245-AG68, by any of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail, Hand Delivery/Courier: Mark Walsh, Associate Administrator for the Office of Investment and Innovation, U.S. Small Business Administration, 409 Third Street SW., Washington, DC 20416.

    SBA will post comments on http://www.regulations.gov. If you wish to submit confidential business information (CBI) as defined in the User Notice at http://www.regulations.gov, please submit the information to Theresa Jamerson, Office of Investment and Innovation, 409 Third Street SW., Washington, DC 20416. Highlight the information that you consider to be CBI and explain why you believe this information should be held confidential. SBA will review the information and make the final determination of whether or not it will publish the information.

    FOR FURTHER INFORMATION CONTACT:

    Theresa Jamerson, Office of Investment and Innovation, (202) 205-7563.

    SUPPLEMENTARY INFORMATION:

    I. Public Participation

    SBA invites comments, data, and information from all interested parties, including but not limited to investors, small businesses, advocacy groups, nongovernmental organizations, and legal representatives with relevant expertise on any and all aspects of this proposed rule. Comments that will provide the most assistance to SBA in developing these procedures will reference a specific portion of the proposed rule, explain the reason for any recommended change, and include data, information, or authorities that support such recommended change. SBA is generally seeking comments on:

    A. Proposed licensing requirements for Early Stage SBICs;

    B. Proposed evaluation of Early Stage SBICs by SBA;

    C. Proposed treatment of third-party debt of Early Stage SBICs;

    D. Proposed maximum amount of leverage for Early Stage SBICs, both individually and annually in aggregate;

    E. Constraints of equity versus debenture financing as articulated in the proposed rule;

    F. Treatment of interest reserve, capital impairment, and cost of money in the proposed rule;

    G. Alternative financing terms compared with those in the proposed rule, such as discounted debentures and longer-maturity debentures;

    H. Access by non-leveraged SBICs to Early Stage SBIC leverage under the proposed rule;

    I. Alignment of the proposed rule with early stage investment strategies, including the relatively long time horizons of early-stage investors in capital-intensive technologies; and

    J. Other suggested changes that SBA has not included in this proposal.

    SBA also invites comments on the economic and financial analyses supporting this rule.

    II. Background Information

    In the Small Business Investment Act of 1958 (Act), Congress created the Small Business Investment Company (SBIC) program to “stimulate and supplement the flow of private equity capital and long-term loan funds which small-business concerns need for the sound financing of their business operations and for their growth, expansion, and modernization, and which are not available in adequate supply . . . .” 15 U.S.C. 661. Congress intended that the program “be carried out in such manner as to insure the maximum participation of private financing sources.” Id. In accordance with that policy, the U.S. Small Business Administration (SBA) does not invest directly in small businesses. Rather, through the SBIC program, SBA licenses and provides debenture leverage to SBICs. SBICs are privately-owned and professionally managed for-profit investment funds that make loans to, and investments in, qualified small businesses using a combination of privately raised capital and debenture leverage guaranteed by SBA. SBA will guarantee the repayment of debentures issued by an SBIC (Debentures) based on the amount of qualifying private capital raised by an SBIC up to a maximum amount of $150 million.

    The standard Debenture requires semi-annual interest payments. Consequently, most SBICs finance later stage small businesses with positive operating cash flow, and most structure their investments as loans or mezzanine debt in an amount that is at least sufficient to cover the SBIC's Debenture interest payments. Early stage companies typically do not have positive operating cash flow and therefore cannot make current interest or dividend payments. As a result, investments in early stage companies do not fit naturally with the structure of debenture leverage.

    Early stage businesses without the necessary assets or cash flow for traditional bank funding face difficult challenges accessing capital. As a result of this capital gap, and as part of President Obama's Startup America Initiative, on April 27, 2012, SBA published a final rule (77 FR 25042) to define a new sub-category of SBICs. SBA's intent was to license over a 5-year period (fiscal years 2012 through 2016) venture funds focused on early stage businesses. Because Early Stage SBICs present a higher credit risk than traditional SBICs, that rule authorized SBA to guarantee Debentures only in an amount equal to each Early Stage SBIC's Regulatory Capital (consisting of paid-in capital contributions from private investors plus binding capital commitments from Institutional Investors, as defined in existing § 107.50), up to a maximum guarantee amount of $50 million. SBA allocated $200 million per year ($1 billion total) of its SBIC Debenture authorization over these years to this effort.

    Since 2012, SBA has received 62 applications to the Early Stage SBIC program, but licensed only five Early Stage SBICs. Those applicants that were not licensed failed to meet SBA's licensing criteria. Many of these applicants had management teams with limited track records and few positive realizations. In order to determine the market need for SBA to continue licensing Early Stage SBICs past fiscal year 2016, SBA sought input from the public through an Advance Notice of Proposed Rule Making (ANPRM) on March 18, 2015 (80 FR 14034). In the ANPRM, SBA also sought input regarding what changes should be made to the program to attract qualified early stage fund managers.

    Comments on the ANPRM and additional discussions SBA held with industry participants indicated that the program should be continued because funding gaps, especially in certain geographic areas and industries, continue to pose challenges for early stage businesses. Based on SBA's analysis of the financing data available on the PricewaterhouseCoopers' Moneytree Web site (www.pwcmoneytree.com), although the venture capital industry provided over $81 billion in financings to U.S. businesses between January 2014 and June 2015, less than a third went to early stage or start-up businesses. Additionally, venture capital financings were geographically focused, with over three quarters of venture capital dollars going to three states: California, New York, and Massachusetts.

    In comparison, based on financing data Early Stage SBICs reported in SBA Form 1031 (Portfolio Financing Report), Early Stage SBICs reported that over 69% of their financing dollars through September 2015 were invested in states other than California, New York, or Massachusetts. Also, Early Stage SBICs reported that investments they have made in early stage small businesses have resulted in net job growth. SBA compared job data submitted by the existing Early Stage SBICs on SBA Form 1031 at the time of first financing to that submitted on SBA Form 468 (Annual Financial Report) for the reporting period as of December 31, 2014. This data indicated that Early Stage SBIC portfolio companies increased job growth on a net basis by 48% from the date of initial Early Stage SBIC investment through the reporting period.

    SBA received suggestions for program improvement both through the ANPRM and discussions with industry. This proposed rule incorporates some of those suggested changes.

    III. Section by Section Analysis Section 107.310—When and How To Apply for Licensing as an Early Stage SBIC

    The proposed rule would remove § 107.310 in its entirety. The current regulation sets forth two restrictions specific to the licensing of Early Stage SBICs. First, Early Stage SBIC applications may be submitted only during a limited timeframe identified in a Notice published in the Federal Register (which SBA has published on an annual basis since 2012). This restriction was put in place to enable SBA to manage the flow of applicants and properly allocate the $200 million annual Early Stage leverage among all successful applicants. Since the demand for Early Stage licenses from qualified fund managers has been well below capacity, the proposed rule would allow Early Stage applicants to apply at any time, similar to other SBIC applicants. SBA believes that if the demand for Early Stage licenses increases to such an extent that SBA becomes concerned about leverage availability, SBA will be able to manage the flow of applicants and leverage issued through § 107.320, an existing regulation that gives SBA the right to maintain diversification of Early Stage SBICs with respect to the year in which Early Stage SBICs commence operations.

    The second restriction set forth in current § 107.310 states that SBA will not consider an application from an applicant under Common Control with an existing Early Stage SBIC that has outstanding Debentures or Debenture commitments. This requirement was put in place to promote fund manager diversification and because the short term duration of the original initiative would not have given existing Early Stage SBICs time to realize investments sufficiently to qualify for a subsequent fund. Since the proposed rule would make the initiative an ongoing part of the SBIC program, SBA is proposing to remove this restriction. SBA would review requests for subsequent Early Stage licenses similar to other SBIC subsequent license requests, by considering such factors as the existing SBIC's investment cycle, operating and regulatory history of the existing SBIC, anticipated co-investment between the proposed and existing SBIC, realizations since the existing SBIC was licensed, forecasted realizations and repayment of leverage, and consistency of management teams and limited partners between the existing SBIC and applicant.

    One of SBA's strategic goals, as set forth in the FY2014-2018 Strategic Plan, is to ensure inclusive entrepreneurship by expanding access and opportunity to small businesses and entrepreneurs, including women, minorities, veterans and other entrepreneurs, in communities where market gaps remain. SBA encourages fund managers with early stage investment strategies that focus on these diverse communities to apply for licensing as an Early Stage SBIC.

    Section 107.320—Evaluation of Early Stage SBICs

    Current § 107.320 gives SBA the right to maintain diversification among Early Stage SBICs with respect to: (a) The year in which they commence operations, and (b) their geographic location. The proposed rule would clarify that diversification by geographic location would be with regard to where the fund would be investing rather than where the fund is located. Although SBA believes that Early Stage investors typically invest close to where they are located since they are often actively involved with their portfolio companies, this proposed change would clarify SBA's original intent.

    Section 107.565—Restrictions on Third-Party Debt of Early Stage SBICs

    Although current regulations allow standard SBICs to incur unsecured third party debt without SBA approval, current § 107.565 requires Early Stage SBICs to obtain prior SBA approval in order to have, incur or refinance any third party debt, whether secured or unsecured. This restriction was created because of the high risk profile of Early Stage SBICs. Even debt that is unsecured increases SBA's credit risk because SBA leverage is never senior to the claims of other unsecured creditors: Under § 107.560, the first $10 million of SBA leverage is generally subordinated to other unsecured debt of an SBIC, and leverage above $10 million is pari passu with other unsecured debt. Nonetheless, SBA recognizes that it is typical practice for investment funds, including those pursuing venture capital strategies, to use a line of credit to help bridge capital needs for financings—investment funds use lines of credit to fund financings and operations between capital calls, and can generally draw on a line of credit more quickly than investors pay in capital when called. To provide Early Stage SBICs access to this industry-standard tool while minimizing the credit risk to SBA, this proposed rule would allow current and future Early Stage SBICs to obtain an unsecured line of credit without SBA approval under the following conditions:

    (1) The line of credit is limited to the lesser of 20% of Regulatory Capital or total unfunded binding commitments from Institutional Investors minus any such commitments included in the Interest Reserve under § 107.1181. Since the line of credit will be used to bridge private capital calls to enable an Early Stage SBIC to finance a small business, SBA believes that the line of credit should not exceed the maximum amount that may be invested into a single portfolio company. Existing § 107.740 calculates the maximum amount an SBIC may invest in a single portfolio company based on certain changes to an SBIC's Regulatory Capital, but this amount is generally 20% of Regulatory Capital. For simplicity, the proposed rule would set the borrowing limit to be no greater than 20% of Regulatory Capital as determined by the Capital Certificates submitted from time to time by the SBIC. Additionally, the line of credit should be no greater than the amount of capital available for call from investors. Early Stage SBICs use unfunded binding commitments from investors for three primary purposes: (1) To call capital to finance small businesses, (2) to call capital to fund operations, and (3) to fund the Interest Reserve required under § 107.1181. Since Early Stage SBICs cannot call unfunded commitments associated with the Interest Reserve (unless they are using that capital to pay interest on SBA-guaranteed leverage or SBA annual charges), the line of credit should be no greater than unfunded binding commitments from Institutional Investors minus any commitments associated with the Interest Reserve.

    (2) The term of the line of credit does not exceed 24 months. Based on feedback from industry, SBA understands that most lines of credit are renewed on an annual basis. In this rule, SBA is proposing a 24 month limitation on the duration of the line of credit, which SBA believes should be sufficiently long so as to not impact the standard maturity dates in typical line of credit documentation. An Early Stage SBIC may renew the line of credit during its lifecycle as long as each renewal is no longer than 24 months and the Early Stage SBIC is in compliance with the requirements of this section.

    (3) The line of credit is held by a federally regulated financial institution. SBA proposes this requirement, that the lender be regulated by a federal financial institutions regulator (e.g., the FDIC, OCC, or NCUA) to ensure that the lender is creditworthy, that the credit terms are reasonable and customary, and that the lender will not seek unusual remedies in the event of a default.

    (4) All borrowings under the line of credit: (i) Are not secured third-party debt, as that term is defined under § 107.550(a); (ii) Are for the purpose of maintaining the Early Stage SBIC's operating liquidity or providing funds for a particular Financing of a Small Business; (iii) Must be fully repaid within 90 days after the date they are drawn; and (iv) Must be fully paid off for at least 30 consecutive days during the Early Stage SBIC's fiscal year. SBA proposes these requirements to ensure that such debt is unsecured, since secured third party debt presents a higher credit risk to SBA and must be approved by SBA under § 107.550. Further, the third party debt must be solely for the purpose of maintaining the SBIC's operating liquidity or providing funds for a particular financing of a small business. Finally, since such borrowings are temporary in nature, the line of credit should be repaid quickly and not continuously refinanced. SBA believes these requirements are typical for a line of credit and would provide Early Stage SBICs with access to a standard industry tool while minimizing SBA's credit risk.

    Section 107.1150 Maximum Amount of Leverage for a Section 301(c) Licensee

    Current § 107.1150(c) limits Early Stage SBICs to SBA-guaranteed leverage and leverage commitments of 100 percent of Regulatory Capital or $50 million, whichever is less. Originally, the $50 million maximum was set in order to provide increased diversity to the Early Stage SBIC portfolio. Comments to the Early Stage ANPRM indicated that a higher maximum would be more attractive to experienced early stage fund managers and suggested either $75 million or $100 million as a maximum leverage ceiling. Given that SBA's goal is still to keep the overall amount of Early Stage leverage to $200 million in any given year, SBA believes that $75 million is responsive to the feedback SBA has received and is a more appropriate amount than $100 million to help achieve diversification within the Early Stage program. This proposed maximum would be available to future Early Stage SBICs as well as existing Early Stage SBICs.

    The proposed rule would change the references to $50 million in both § 107.1150(c)(1) and § 107.1150(c)(3)(iii) to $75 million to reflect the increase in SBA-guaranteed leverage.

    It should be noted that SBA's approval of leverage commitments to, and draws by, Early Stage SBIC applicants would remain subject to SBA credit policies and SBA's overall SBIC Debenture leverage authorization. Also, as discussed above, under existing § 107.320, SBA will also continue to maintain the right to require diversification among Early Stage SBICs by year and geography as part of the evaluation of Early Stage SBICs in the licensing process.

    Compliance With Executive Orders 12866, 12988, 13132, 13563, the Paperwork Reduction Act (44 U.S.C. Ch. 35) and the Regulatory Flexibility Act (5 U.S.C. 601-612) Executive Order 12866

    The Office of Management and Budget has determined that this rule is a “significant” regulatory action under Executive Order 12866. The Regulatory Impact Analysis is set forth below.

    1. Necessity of Regulation

    As discussed above, early stage financing gaps remain, and SBA's Early Stage SBICs are financing these gaps and creating jobs. This proposed rule reflects SBA's intention to continue licensing and providing SBA-guaranteed leverage to Early Stage SBICs, and implements changes to improve the program and attract more qualified fund managers to continue to finance those gaps. Based on industry feedback, SBA believes that minor changes could improve the program without increasing credit risk to SBA. For example, removing the call process and accepting Early Stage SBIC applications on a rolling basis would allow fund managers to organize funds on their own timeline and allow fund managers to apply in a manner more conducive to their fundraising process. In addition, increasing the maximum leverage to $75 million would be more attractive to qualified managers that are able to raise higher amounts of capital and are seeking more capital to round out their fundraising. At the same time, maintaining a maximum one to one ratio of leverage to private capital would permit this increase to maximum leverage without increasing the risk to SBA. Moreover, allowing fund managers of existing Early Stage SBICs to apply for a subsequent license would help successful fund managers continue to fund early stage small businesses. Finally, allowing Early Stage SBICs to access a line of credit, similar to other venture funds and standard SBICs, would streamline Early Stage SBIC cash management and operations.

    2. Alternative Approaches to Regulation

    SBA considered making no changes to the Early Stage regulations and not issuing any further calls for Early Stage SBICs. However, based on industry feedback received through the ANPRM process, which is supported by industry statistics, gaps in the market place still remain for early stage financings. Because Early Stage SBICs are financing that gap and creating jobs, SBA decided to make the Early Stage program an ongoing part of the SBIC program and propose as part of this rule those changes suggested by industry that would not increase risk but would help to improve the program.

    As part of the ANPRM process and discussions with industry, SBA received several suggested changes that the Agency either could not implement or chose not to implement primarily due to cost and risk. These include the following:

    Implementing a true equity program. Although SBA agrees that an early stage investment strategy would be more ideally funded with equity capital than the currently structured Debenture, SBA is not authorized by the Act to take equity positions in SBICs or make direct equity investments in small businesses. SBA has tried to provide for a leverage structure that balances risk/cost and usability by venture investors.

    Lowering or removing the Interest Reserve. Early Stage SBICs currently have access to a Debenture that requires quarterly interest payments throughout its term. Current § 107.1181 requires that for each Debenture that requires periodic interest payments to SBA during the first five years of its term, an Early Stage SBIC must maintain a reserve (consisting of either unfunded commitments from Institutional Investors or restricted cash in a segregated account) sufficient to pay the interest and annual charge on such Debenture for the first 21 payment dates following the date of issuance. SBA modeled both lowering the number of years required for the Interest Reserve and removing the Interest Reserve completely to identify the impact to the annual charge. The annual charge is an amount that SBA formulates each year and is paid by SBICs with outstanding leverage to offset projected SBIC Debenture losses and keep the Debenture program at zero subsidy cost. The Interest Reserve decreases SBA's credit risk for Early Stage SBICs; therefore, making the proposed changes to the Interest Reserve would have required all SBICs to pay a higher annual charge. SBA received input on these impacts from three of its five Early Stage SBICs, all of which preferred a lower annual charge rather than changes to the Interest Reserve. SBA therefore decided not to pursue this option.

    Implementing an accruing Debenture with longer maturity. In addition to the Debenture discussed above, Early Stage SBICs have access to a Debenture that is issued at a discount and does not require interest payments during the first five years of its term. In response to industry suggestions to modify the Debenture to align better with early stage cash flows, SBA considered creating a Debenture that would not be issued at a discount and would not require interest payments over a 10 or even 15 year period, but would accrue interest that would be payable at maturity. Evaluation of this instrument must take into account the fact that SBA's guarantee includes both the leverage principal and accrued interest. Using such a non-discounted accruing Debenture, if an Early Stage SBIC with $75 million in Regulatory Capital were to issue $75 million in Debentures, the $75 million in Debenture proceeds plus the accrued interest would exceed both the 1 tier of leverage maximum and $75 million maximum leverage guarantee amount for the Early Stage SBIC. If an SBIC issued Debentures at the full face amount of $75 million with interest accruing at a 5% rate and an annual charge of 1%, this would accrue in 5 years to over $100 million, in 10 years to over $134 million, and in 15 years to over $179 million. At the 15 year point, the maximum leverage guarantee would exceed the maximum leverage allowed by statute. In this scenario, the Debentures must be issued at a discount, and extending the 5-year discount to a 10 or 15 year timeframe would decrease the amount of proceeds the Early Stage SBIC would receive at time of issuance. For example, a Debenture that would accrue in five years to $1 million may provide an Early Stage SBIC with only $750,000 in proceeds, based on a 4% interest rate and a 1% annual charge. Increasing the accrual period to 10 years would reduce those proceeds to less than $600,000. At a higher interest rate, these Debenture proceeds would be reduced even further. SBA believes this would make the instrument less attractive.

    Providing more flexibility with regard to capital impairment. One of the ANPRM comments indicated that Early Stage SBICs should be provided with more flexibility in regard to capital impairment, the primary financial metric SBA uses to evaluate SBIC financial performance. Most Early Stage SBICs have a 70% maximum allowable capital impairment percentage (CIP). CIP measures the amount of operating and investment losses against an SBIC's Regulatory Capital. If an Early Stage SBIC exceeds its maximum CIP, after notifying the SBIC and giving the SBIC a cure period of at least 15 days, SBA may invoke the remedies identified in § 107.1810(g), which include, among other things, declaring the Debentures and any accrued interest immediately due and payable. SBA has decided not to modify the maximum allowable CIP for Early Stage SBICs because SBA generally experiences leverage losses with SBICs whose CIPs are in excess of 70%.

    Furthermore, the existing Early Stage regulations already include adequate flexibility for Early Stage SBICs with respect to CIP. SBA previously operated a program that focused on equity investment called the Participating Securities program. That program generally allowed SBICs to have up to 85% maximum CIP in the first five years following the first issuance of leverage. In originally developing the Early Stage rule, SBA noted that SBA incurred leverage losses for most Participating Securities SBICs when the SBIC's CIP went over 85%. For the few Participating Securities SBICs that did fully repay SBA leverage, higher CIPs were often the result of the loss of “Class 2 Appreciation” on the SBIC's investments. Class 2 Appreciation, defined in § 107.1840(d)(3), relates to unrealized appreciation on securities that are non-public securities of a small business based on a new round of outside financing within the last 24 months. After 24 months, an SBIC's Class 2 Appreciation could “time out” and the SBIC would no longer receive credit for it in the CIP calculation. Current § 107.1845 allows Early Stage SBICs to request approval to extend the validity of Class 2 Appreciation beyond 24 months based on relevant information, including a third party valuation. SBA believes this provision provides sufficient flexibility for Early Stage SBICs with respect to CIP while properly limiting SBA's credit risk.

    Change cost of money rules for Early Stage SBICs. Current § 107.855 generally limits the interest an SBIC may charge a small business on Debt Securities to 14 percent and Loans to 19 percent. SBA received comments that Early Stage SBICs should be allowed greater flexibility with cost of money provisions. SBA does not believe that such changes would significantly help Early Stage SBICs, which are primarily making equity investments that are not subject to the cost of money limitations.

    Non-leveraged SBIC access to Early Stage leverage. SBA received comments in response to the ANPRM stating that SBA should allow non-leveraged SBICs that have an early stage strategy to access Early Stage leverage. In the licensing process for non-leveraged applicants, SBA does not perform the same level of financial review that it does for applicants that intend to use leverage. A request of this type would require SBA to undertake a substantive review of the non-leveraged SBIC's qualifications that would, in many ways, be equivalent to a new license application. Moreover, nothing in SBA's regulations prevents a non-leveraged SBIC with an early stage focus from applying for the Early Stage SBIC program if that SBIC wishes to access Early Stage leverage. Therefore, SBA does not propose to implement this suggestion.

    Increase the maximum leverage to $100 million. Although SBA received comments that indicated the maximum leverage for Early Stage SBICs should be increased to $100 million, SBA was concerned that, based on its expected $200 million annual allocation of Early Stage leverage, this could concentrate the limited Early Stage allocation to only two funds per year. SBA therefore chose to propose a maximum leverage ceiling of only $75 million per year. SBA also considered only approving a higher maximum for new Early Stage SBIC applicants, but believes that existing Early Stage SBICs should be able to benefit from this increase.

    3. Potential Benefits and Costs

    The proposed rule reflects SBA's intent to continue licensing and providing SBA-guaranteed leverage to Early Stage SBICs, and would make material improvements to the program. Even though currently licensed Early Stage SBICs are eligible for almost $220 million in commitments, Early Stage SBICs have requested and been approved for less than $113 million in leverage commitments and have issued less than $44 million in Debentures through September 2015. Most venture funds have a 5-year investment period with follow-on financings in later years, so it is not unusual that these funds have not applied for or drawn all available leverage. SBA expects Early Stage SBICs to draw additional capital and leverage over a 5 to 7 year period to support financings and operational expenses, commensurate with this investment cycle. Despite the relatively small amount of leverage drawn, Early Stage SBICs have made over $94 million in financings to 46 small businesses through September 2015, with over half of the financing dollars reported in FY 2015. Since most Early Stage SBICs did not start reporting financings until 2014, and venture funds typically have a 5 year investment period, SBA expects funds to continue to make $50 to $75 million in financings per year for the next 2 to 3 years and then decline, unless new Early Stage SBICs are licensed.

    As previously noted, the Early Stage program finances geographic funding gaps and creates jobs. Over 69% of Early Stage SBIC financing dollars went to states not in the traditional geographic hubs for venture capital financing. In addition, Early Stage SBIC financial reports filed with SBA for Early Stage SBICs' fiscal year 2014 showed a net gain in jobs of 48% in the small businesses Early Stage SBICs had invested in during 2014.

    In terms of cost, since fiscal year 2012, the SBIC Debenture subsidy formulation model has taken into account Early Stage SBICs. Early Stage SBICs have a higher expected loss rate than standard SBICs, so the more leverage SBA allocates to Early Stage SBICs results in a proportionally higher annual charge. As noted in the April 27, 2012 final rule that established Early Stage SBICs (77 FR 25042), SBA allocated $150 million in leverage commitments (i.e., 7% of SBA's total leverage authorization) to Early Stage SBICs for FY 2012. This allocation increased the FY 2012 annual charge for all SBICs by 13.7 basis points. For FY 2017, based on current demand, SBA has budgeted $100 million in Early Stage commitments (i.e., 4% of SBA's total leverage authorization). SBA expects this allocation to increase the annual charge paid by all SBICs by less than 7 basis points, which is smaller than the increase to the annual charge related to the $200 million allocation for each of FYs 2012-2016. After FY 2017, SBA expects to allocate no more than approximately $200 million in leverage commitments to Early Stage SBICs in any year, which would keep the increase in cost related to the Early Stage program to no more than approximately 14 basis points. Depending on demand, Early Stage SBIC performance, and other factors, SBA may modify this targeted allocation. SBA believes that none of the changes proposed in this rule would alter the risk profile of the Early Stage SBICs or increase the annual charge paid by SBICs. The program will remain a zero subsidy program.

    Executive Order 12988

    This action meets applicable standards set forth in section 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. The action does not have retroactive or presumptive effect.

    Executive Order 13132

    The rule will not have substantial direct effects on the States, or the distribution of power and responsibilities among the various levels of government. Therefore, for the purposes of Executive Order 13132, Federalism, SBA determines that this proposed rule has no federalism implications warranting the preparation of a federalism assessment.

    Executive Order 13563

    This proposed rule was developed based on comments received on the ANPRM SBA issued in March 2015 (80 FR 14034) and several discussions with Early Stage participants and others in the industry. SBA issued the ANPRM to solicit comments and ideas on the Early Stage SBIC program and considered each comment it received. The proposed changes are a result of those comments.

    Paperwork Reduction Act, 44 U.S.C. Ch. 35

    SBA has determined that this rule proposes no additional reporting or recordkeeping requirements as defined by the Paperwork Reduction Act.

    Regulatory Flexibility Act, 5 U.S.C. 601-612

    When an agency promulgates a rule, the Regulatory Flexibility Act requires the agency to prepare an initial regulatory flexibility analysis (IRFA), which describes the potential economic impact of the rule on small entities and alternatives that may minimize that impact. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an IRFA, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities.

    This proposed rule would affect the existing five Early Stage SBICs, as well as all potential applicants, all of which are small entities. Although SBA is seeking to expand the number of participants, because of the limited amount of available leverage, even with future growth, the number of affected small entities will still be relatively low. SBA has determined that the impact on entities affected by the rule will not be significant. Because SBA's subsidy model already takes into account Early Stage SBICs and the proposed rule does not impact the current annual fee needed to keep the Debenture program at a zero subsidy cost, no cost impacts are expected.

    List of Subjects in 13 CFR Part 107

    Examination fees, Investment companies, Loan programs-business, Licensing fees, Small businesses.

    For the reasons stated in the preamble, SBA proposes to amend part 107 of title 13 of the Code of Federal Regulations as follows:

    PART 107—SMALL BUSINESS INVESTMENT COMPANIES 1. The authority citation for part 107 is revised to read as follows: Authority:

    15 U.S.C. 681, 683, 687(c), 687b, 687d, 687g, and 687m.

    § 107.310 [Removed and Reserved]
    2. Remove and reserve § 107.310. 3. Revise § 107.320(b) to read as follows:
    § 107.320 Evaluation of Early Stage SBICs.

    (b) The geographic location of projected investments based on the applicant's business plan.

    4. Revise § 107.565 to read as follows:
    § 107.565 Restrictions on third-party debt of Early Stage SBICs.

    (a) General. If you are an Early Stage SBIC and you have outstanding Leverage or a Leverage commitment, you must get SBA's prior written approval to have, incur, or refinance any third-party debt other than accounts payable from routine business operations, unless such debt satisfies the conditions in paragraph (b) of this section.

    (b) Qualified line of credit. Without obtaining SBA's prior written approval, an Early Stage SBICs may have, incur, or refinance third party debt that meets all of the following conditions:

    (1) The third party debt is a line of credit with maximum availability limited to the lesser of:

    (i) 20% of Regulatory Capital; or

    (ii) Total unfunded binding commitments from Institutional Investors minus any such commitments used to fund the Interest Reserve under § 107.1181.

    (2) The term of the line of credit does not exceed 24 months, but may be renewable, provided that each renewal does not exceed 24 months and you are in compliance with the conditions of this paragraph (b).

    (3) The line of credit is held by a federally regulated financial institution.

    (4) All borrowings under the line of credit:

    (i) Are not secured third-party debt, as that term is defined in § 107.550(a);

    (ii) Are for the purpose of maintaining your operating liquidity or providing funds for a particular Financing of a Small Business;

    (iii) Must be fully repaid within 90 days after the date they are drawn; and

    (iv) Must be fully paid off for at least 30 consecutive days during your fiscal year.

    5. Amend § 107.1150 by revising paragraphs (c)(1) and (c)(3)(ii), to read as follows:
    § 107.1150 Maximum amount of Leverage for a Section 301(c) Licensee.

    (c) * * *

    (1) The total amount of any and all Leverage commitments you receive from SBA shall not exceed 100 percent of your highest Regulatory Capital or $75 million, whichever is less;

    (3) * * *

    (ii) $75 million.

    Dated: August 26, 2016. Maria Contreras-Sweet, Administrator.
    [FR Doc. 2016-21509 Filed 9-16-16; 8:45 am] BILLING CODE 8025-01-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-9109; Directorate Identifier 2016-NM-011-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Defense and Space S.A. (Formerly Known as Construcciones Aeronauticas, S.A.) Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to supersede Airworthiness Directive (AD) 2013-23-02, for all Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, CN-235-300, and C-295 airplanes. AD 2013-23-02 currently requires an inspection of the feeder cables of certain fuel booster pumps for damage (including, but not limited to, signs of electrical arcing and fuel leaks), and replacement if necessary. Since we issued AD 2013-23-02, we have determined that a modification is necessary to address the identified unsafe condition. This proposed AD would retain the requirements of AD 2013-23-02 and would also require modification of the electrical installation of the fuel booster pumps. We are proposing this AD to prevent damage to certain fuel booster pumps, which could create an ignition source in the fuel tank vapor space, and result in a fuel tank explosion and consequent loss of the airplane.

    DATES:

    We must receive comments on this proposed AD by November 3, 2016.

    ADDRESSES:

    You may send comments by any of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.

    Fax: 202-493-2251.

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

    Hand Delivery: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    For service information identified in this NPRM, contact EADS CASA (Airbus Defense and Space), Services/Engineering Support, Avenida de Aragón 404, 28022 Madrid, Spain; telephone: +34 91 585 55 84; fax: +34 91 585 31 27; email: [email protected] You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    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-2016-9109; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Shahram Daneshmandi, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-227-1112; fax: 425-227-1149.

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-9109; Directorate Identifier 2016-NM-011-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

    Discussion

    On October 31, 2013, we issued AD 2013-23-02, Amendment 39-17657 (78 FR 68688, November 15, 2013) (“AD 2013-23-02”). AD 2013-23-02 requires actions intended to address an unsafe condition on all Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, CN-235-300, and C-295 airplanes.

    Since we issued AD 2013-23-02, we have determined that a modification of the fuel booster pump is necessary to address the identified unsafe condition.

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2016-0014, dated January 14, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, CN-235-300, and C-295 airplanes. The MCAI states:

    An occurrence with a CN-235 aeroplane was reported, involving an in-flight problem with the fuel transfer system. The results of the subsequent investigation revealed damage on the fuel booster pump electrical feeding cable and some burn marks on the pump body and plate (fairing) at the external side of the fuel tank; confirmed electrical arcing between the wire and pump body; and revealed fuel leakage onto the affected wire.

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

    To address this potential unsafe condition, EADS CASA (Airbus Military) issued All Operators Letter (AOL) 235-025 and AOL 295-025, providing inspection instructions for the affected fuel booster pumps, Part Number (P/N) 1C12-34 and P/N 1C12-46.

    Consequently, EASA issued AD 2013-0186 [which corresponds to FAA AD 2013-23-02] to require a one-time [detailed visual] inspection of the affected fuel booster pumps to detect damage and, depending on findings, replacement of the fuel booster pump. That [EASA] AD also required reporting of all findings to EADS CASA for evaluation.

    Since that [EASA] AD was issued, Airbus Defence and Space (D&S) developed [a] modification of the fuel boost pump electrical installation, available for in-service application through Airbus D&S Service Bulletin (SB) 235-28-0023. That modification involves improved protection of the output of affected fuel pump harness avoiding undesired electrical contacts and preventing potential arcing between the affected harness and metallic parts of the fuel boost cover.

    For the reasons described above this [EASA] AD partially retains the requirements of EASA AD 2013-0186, which is superseded, and requires modification of the fuel pump electrical installation.

    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-2016-9109.

    Related Service Information Under 1 CFR Part 51

    EADS CASA has issued Airbus Defense and Space Service Bulletin SB-235-28-0023C, Revision 01, dated October 27, 2015. The service information describes procedures for modification of the fuel booster pumps. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.

    Clarification of Affected Airplanes for Paragraph (i) of This AD

    Paragraph (3) of the MCAI specifies a modification for all airplanes. However, the MCAI only specifies service information for Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, and CN-235-300 airplanes. We have determined that this modification only applies to Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, and CN-235-300 airplanes. Therefore, in paragraph (i) of this proposed AD we have identified Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, and CN-235-300 airplanes.

    Costs of Compliance

    We estimate that this proposed AD affects 35 airplanes of U.S. registry.

    The actions required by AD 2013-23-02, and retained in this proposed AD take about 4 work-hours per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the actions that are required by AD 2013-23-02 is $340 per product.

    We also estimate that it would take about 8 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $1,802 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $86,870, or $2,482 per product.

    In addition, we estimate that any necessary follow-on actions would take about 3 work-hours and require parts costing $16,080, for a cost of $16,335 per product. We have no way of determining the number of aircraft that might need this action.

    Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

    We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

    Regulatory Findings

    We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify this proposed regulation:

    1. Is not a “significant regulatory action” under Executive Order 12866;

    2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

    3. Will not affect intrastate aviation in Alaska; and

    4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

    PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by removing Airworthiness Directive (AD) 2013-23-02, Amendment 39-17657 (78 FR 68688, November 15, 2013), and adding the following new AD: Airbus Defense and Space S.A. (formerly known as Construcciones Aeronauticas, S.A.): Docket No. FAA-2016-9109; Directorate Identifier 2016-NM-011-AD. (a) Comments Due Date

    We must receive comments by November 3, 2016.

    (b) Affected ADs

    This AD replaces AD 2013-23-02, Amendment 39-17657 (78 FR 68688, November 15, 2013) (“AD 2013-23-02”).

    (c) Applicability

    This AD applies to Airbus Defense and Space S.A. (formerly known as Construcciones Aeronauticas, S.A.) Model CN-235, CN-235-100, CN-235-200, CN-235-300, and C-295 airplanes, certificated in any category, all manufacturer serial numbers.

    (d) Subject

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

    (e) Reason

    This AD was prompted by a report of an in-flight problem with the fuel transfer system. We are issuing this AD to prevent damage to certain fuel booster pumps, which could create an ignition source in the fuel tank vapor space, and result in a fuel tank explosion and consequent loss of the airplane.

    (f) Compliance

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

    (g) Retained Inspection of the Feeder Cables of Certain Fuel Booster Pumps With No Changes

    This paragraph restates the requirements of paragraph (g) of AD 2013-23-02, with no changes. Within the times specified in paragraph (g)(1) or (g)(2) of this AD, as applicable: Perform a detailed visual inspection for damage (including, but not limited to, signs of electrical arcing and fuel leaks) of the electrical feeder cables of each fuel booster pump having part number (P/N) 1C12-34 or 1C12-46, in accordance with the instructions of Airbus Military All Operator Letter 235-025, dated July 29, 2013 (for Model CN-235 airplanes); or Airbus Military All Operator Letter 295-025, Revision 01, dated August 1, 2013 (for Model C-295 airplanes).

    (1) For each fuel booster pump that has not been replaced as of December 2, 2013 (the effective date of AD 2013-23-02): Prior to the accumulation of 300 total flight hours or within 5 flight cycles after December 2, 2013, whichever occurs later.

    (2) For each fuel booster pump that has been replaced as of December 2, 2013 (the effective date of AD 2013-23-02): Within 300 flight hours since the most recent fuel booster pump replacement, or within 5 flight cycles after December 2, 2013, whichever occurs later.

    (h) Retained Replacement of Affected Fuel Boost Pumps With No Changes

    This paragraph restates the requirements of paragraph (h) of AD 2013-23-02, with no changes. If any damage (including, but not limited to, signs of electrical arcing and fuel leaks) is found during the inspection required by paragraph (g) of this AD: Within the time specified in paragraph (h)(1) or (h)(2) of this AD, replace the affected fuel booster pump with a serviceable pump, in accordance with Airbus Military All Operator Letter 235-025, dated July 29, 2013 (for Model CN-235 airplanes); or Airbus Military All Operator Letter 295-025, Revision 01, dated August 1, 2013 (for Model C-295 airplanes).

    (1) Before further flight.

    (2) Within 10 days following the inspection, provided that the airplane is operated under the conditions specified in Airbus Military All Operator Letter 235-025, dated July 29, 2013 (for Model CN-235 airplanes); or Airbus Military All Operator Letter 295-025, Revision 01, dated August 1, 2013 (for Model C-295 airplanes).

    (i) New Requirement of This AD: Modification of the Fuel Booster Pumps

    For Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, and CN-235-300 airplanes: Within 12 months after the effective date of this AD, modify the electrical installation of the fuel booster pumps, in accordance with the Accomplishment Instructions of Airbus Defense and Space Service Bulletin SB-235-28-0023C, Revision 01, dated October 27, 2015. Accomplishing the modification terminates the requirements of paragraphs (g) and (h) of this AD for that airplane.

    (j) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph (i) of this AD, if those actions were performed before the effective date of this AD using Airbus EADS CASA Service Bulletin SB-235-28-0023, dated March 14, 2014.

    (k) 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: Shahram Daneshmandi, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-227-1112; 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 EADS CASA's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

    (l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) European Aviation Safety Agency (EASA) AD 2016-0014, dated January 14, 2016, 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-2016-9109.

    (2) For service information identified in this AD, contact EADS CASA (Airbus Defense and Space), Services/Engineering Support, Avenida de Aragón 404, 28022 Madrid, Spain; telephone: +34 91 585 55 84; fax: +34 91 585 31 27; email: [email protected] 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.

    Issued in Renton, Washington, on September 12, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-22434 Filed 9-16-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-9110; Directorate Identifier 2015-NM-196-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A319-115, A319-132, A320-214, A320-232, A321-211, A321-213, and A321-231 airplanes. This proposed AD was prompted by a report of certain tie rod assemblies installed on the hinged fairing assembly of the main landing gear (MLG) with no cadmium plating on the rod end threads. This proposed AD would require a detailed inspection of certain tie rod assemblies installed on the hinged fairing assembly of the MLG for the presence of cadmium plating, and replacement of tie rod assemblies without cadmium plating. We are proposing this AD to detect and correct the absence of cadmium plating on the rod end threads of the tie rod assemblies. The absence of cadmium plating could lead to galvanic corrosion of the tie rod end threads, resulting in rod end failure, loss of a MLG door, and consequent damage to the airplane.

    DATES:

    We must receive comments on this proposed AD by November 3, 2016.

    ADDRESSES:

    You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.

    Fax: 202-493-2251.

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

    Hand Delivery: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    For service information identified in this NPRM, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email [email protected]; Internet http://www.airbus.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    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-2016-9110; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-9110; Directorate Identifier 2015-NM-196-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

    Discussion

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0234, dated December 8, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A319-115, A319-132, A320-214, A320-232, A321-211, A321-213, and A321-231 airplanes. The MCAI states:

    A production quality issue was identified concerning tie rod assemblies, having Part Number (P/N) starting with D52840212000 or D52840212002, which are installed on the main landing gear (MLG) hinged fairing assembly. This quality issue affects the cadmium plating surface treatment which was inadvertently omitted from the rod end threads of the assembly. The absence of cadmium plating reduces the corrosion protection scheme.

    This condition, if not detected and corrected, could lead to galvanic corrosion of the tie rod end threads, possibly resulting in rod end failure, loss of a MLG door, and consequent injury to persons on ground.

    To address this unsafe condition, Airbus identified the affected [manufacturer serial number] MSN and issued [service bulletin] SB A320-52-1167 to provide inspection instructions.

    For the reason described above, this [EASA] AD requires a one-time inspection of the affected MLG hinged fairing tie rod assemblies [for the presence of cadmium plating], and, depending on findings, replacement of the affected tie rod assembly.

    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-2016-9110. Related Service Information Under 1 CFR Part 51

    Airbus has issued Service Bulletin A320-52-1167, dated August 6, 2015. The service information describes procedures for a detailed inspection for the presence of cadmium plating on tie rod assemblies having certain part numbers, and procedures for replacement of tie rod assemblies with no cadmium plating on the rod end threads. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.

    Costs of Compliance

    We estimate that this proposed AD affects 20 airplanes of U.S. registry.

    We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Inspection 2 work-hours × $85 per hour = $170 $0 $170 $3,400

    We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We have no way of determining the number of airplanes that might need these replacements:

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Replacement 13 work-hours × $85 per hour = $1,105 Not available $1,105

    According to the manufacturer, some of the costs of this proposed 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 available 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 proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify this proposed regulation:

    1. Is not a “significant regulatory action” under Executive Order 12866;

    2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

    3. Will not affect intrastate aviation in Alaska; and

    4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

    PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Airbus: Docket No. FAA-2016-9110; Directorate Identifier 2015-NM-196-AD. (a) Comments Due Date

    We must receive comments by November 3, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Airbus Model A319-115, A319-132, A320-214, A320-232, A321-211, A321-213, and A321-231 airplanes, certificated in any category, as identified in Airbus Service Bulletin A320-52-1167, dated August 6, 2015.

    (d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

    (e) Reason

    This AD was prompted by a report of certain tie rod assemblies installed on the hinged fairing assembly of the main landing gear (MLG) with no cadmium plating on the rod end threads. We are issuing this AD to detect and correct the absence of cadmium plating on the rod end threads of the tie rod assemblies. The absence of cadmium plating could lead to galvanic corrosion of the tie rod end threads, resulting in rod end failure, loss of a MLG door, and consequent damage to the airplane.

    (f) Compliance

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

    (g) Inspection and Corrective Action

    Within 80 months after the airplane's first flight, do a detailed inspection of each tie rod assembly having a part number (P/N) D52840212000 or D52840212002 at the MLG hinged fairing for the presence of cadmium plating (gold colored threads), in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-52-1167, dated August 6, 2015. If during the inspection any tie rod assembly is found that does not have cadmium plating, before further flight, replace the tie rod assembly with a serviceable part having the same part number and cadmium plating, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-52-1167, dated August 6, 2015.

    (h) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

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

    (3) Required for Compliance (RC): If any service information contains procedures or tests that are identified as RC, those procedures and tests must be done to comply with this AD; any procedures or tests that are not identified as RC are recommended. Those procedures and tests that are not identified as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the procedures and tests identified as RC can be done and the airplane can be put back in an airworthy condition. Any substitutions or changes to procedures or tests identified as RC require approval of an AMOC.

    (i) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2015-0234, dated December 8, 2015, 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-2016-9110.

    (2) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email [email protected]; Internet http://www.airbus.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on September 12, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-22435 Filed 9-16-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 193 [Docket No. FAA-2006-24855] Voluntary Disclosure Reporting Program AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed order designating information as protected from disclosure.

    SUMMARY:

    This notice describes a proposed order through which the Federal Aviation Administration plans to designate a certain category of information as protected from public disclosure pursuant to a Voluntary Disclosure Reporting Program. The Federal Aviation Administration is required to protect the information from disclosure to the public, including disclosure required by statute, such as the Freedom of Information Act, following issuance of an order designating the information as protected. The instant designation is intended to encourage participation in the Voluntary Disclosure Reporting Program.

    DATES:

    Comments must be received on or before October 19, 2016.

    ADDRESSES:

    Send comments identified by Docket Number FAA-2006-24855 using any of the following methods:

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

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

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

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

    Privacy: In accordance with 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.

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

    FOR FURTHER INFORMATION CONTACT:

    For questions concerning this action, contact Scott Crosier, ASI/Manager, Voluntary Disclosure Reporting Program (VDRP), Air Carrier Training Systems and Voluntary Safety Programs Branch, AFS-280, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (703) 661-0278; email: [email protected] Or, Hillary Heintz, AIR Compliance and Enforcement Program Manager, Aircraft Certification Service, AIR-150, 950 L'Enfant Plaza N SW., Washington, DC 20024; telephone (202) 267-1446; email: [email protected]

    SUPPLEMENTARY INFORMATION: I. Authority for This Designation

    The FAA sets forth this designation pursuant to title 49 of the United States Code (49 U.S.C.) section 40123 and title 14, Code of Federal Regulations (14 CFR), part 193.

    II. Overview of Proposed Designation

    On August 17, 2006, the Federal Aviation Administration (FAA) issued FAA Order 8000.89, Designation of Voluntary Disclosure Reporting Program (VDRP) Information as Protected from Public Disclosure under part 193. The FAA published the Notice of Order in the Federal Register. 71 FR 54405 (Sept. 15, 2006).

    This Proposed Order Designating Information as Protected from Disclosure will retain the current protection provided for disclosures under FAA Order 8000.89 while also designating disclosures to the agency by entities as provided in Advisory Circular (AC) 00-68 as protected from public disclosure in accordance with the provisions of part 193. The comment period for the contents of AC 00-68 opened on June 12, 2015 and closed on August 7, 2015.

    III. Background

    Under 49 U.S.C. 40123, certain voluntarily provided safety and security information is protected from disclosure to encourage persons to provide the information to the FAA. The FAA must issue an order making certain findings before the information is protected from disclosure. The FAA's rules implementing that section are in part 193. If the Administrator issues an order designating information as protected under 49 U.S.C. 40123, that information will not be disclosed under the Freedom of Information Act (5 U.S.C. 552) or other laws except as provided in 49 U.S.C. 40123, 14 CFR part 193, and the order designating the information as protected. This proposed order is issued under § 193.11, which sets out the notice procedure for designating information as protected.

    IV. Discussion of the Proposal Summary of the VDRP Voluntary Information Sharing Program

    A. Who may participate: Regulated entities as provided in AC 00-58, as amended, AC 00-68, and AC 121-37.

    B. What voluntarily provided information would be protected from disclosure under this proposed designation: The content of all submissions by a regulated entity that are accepted under the VDRP, including, but not limited to, all of the items listed under Proposed Findings, Paragraph IV D(2) below.

    C. How persons would participate: Regulated entities participate by notification of an apparent violation to the FAA by the regulated entity in accordance with the VDRP reporting procedures, and completion of corrective actions in accordance with AC 00-58, as amended, AC 00-68, and AC 121-37.

    D. Duration of this information sharing program: This information sharing program would continue in effect indefinitely, unless the FAA terminates the VDRP, or until the order of designation under part 193 for the VDRP is withdrawn by the FAA.

    Proposed Findings

    The FAA proposes to designate information received under the VDRP as protected under 49 U.S.C. 40123 and 14 CFR 193.7 based on the following findings:

    (1) Summary of why the FAA finds that the information will be provided voluntarily.

    The FAA finds that the information will be provided voluntarily. No regulated entity is required to participate in the VDRP. Initiation of submissions under the VDRP are indicative of the willingness of regulated entities to identify and correct their own instances of regulatory noncompliance, develop long term comprehensive fixes or corrective action plans, and foster safe operating practices.

    (2) Description of the type of information that may be voluntarily provided under the program and a summary of why the FAA finds that the information is safety or security related.

    The information that would be voluntarily submitted under a VDRP is described in AC 00-58, as amended, AC 00-68, and AC 121-37. Because the Federal Aviation Regulations specify the minimum requirements for safety, and VDRP submissions entail violations of those regulations, the information is inherently safety related. It would include the following:

    (a) Information contained in an initial notification to the FAA:

    —A brief description of the apparent violation, including an estimate of the duration of time that it remained undetected, as well as how and when it was discovered; —Verification that noncompliance ceased after it was identified; —A brief description of the immediate action taken after the apparent violation was identified, the immediate action taken to terminate the conduct that resulted in the apparent violation, and the person responsible for taking the immediate action; —Verification that an evaluation is underway to determine if there are any systemic problems; —Identification of the person responsible for preparing the comprehensive fix for disclosures under AC 00-58, as amended, and AC 121-37, or the corrective action plan for disclosures under AC 00-68; and —Acknowledgment that a detailed written report will be provided to the designated FAA official within the timeframe specified in AC 00-58, as amended, AC 121-37, or AC 00-68, as amended.

    (b) Information contained in a detailed written report:

    —A list of the specific FAA regulations that may have been violated; —A description of the apparent violation, including the duration of time it remained undetected, as well as how and when it was detected; —A description of the immediate action taken to terminate the conduct that resulted in the apparent violation, including when it was taken, and who was responsible for taking the action; —An explanation that shows the apparent violation was inadvertent; —Evidence that demonstrates the seriousness of the apparent violation and the regulated entity's analysis of that evidence; —A detailed description of the proposed comprehensive fix or corrective action plan, outlining the planned corrective steps, the responsibilities for implementing those corrective steps, and a time schedule for completion of the fix; and —Identification of the company official responsible for monitoring the implementation and completion of the comprehensive fix.

    (c) FAA generated documentation and electronic information that is directly associated with an accepted VDRP submission, including, but not limited to:

    —Acknowledgment of receipt of a VDRP submission; —Notification of VDRP acceptance, request for modification, or rejection; —Routine correspondence directly associated with a VDRP submission; —FAA records directly associated with FAA monitoring of a comprehensive fix or corrective action plan; —FAA Letter of Correction in accordance with AC 121-37 or, written notification in accordance with AC 00-58, as amended, and AC 00-68, as amended, for an accepted VDRP submission; and —All FAA electronic databases of VDRP submissions and FAA responses.

    (d) Information contained in a report submitted to the FAA under the informal voluntary disclosure reporting process described in AC 00-68, as amended, including, but not limited to:

    —A description of the apparent noncompliance; —A causal analysis of the apparent noncompliance; —The corrective action(s) taken or planned; and —The date by which the regulated entity will complete the corrective action(s).

    (3) Summary of why the FAA finds that the disclosure of the information would inhibit persons from voluntarily providing that type of information.

    The FAA finds that disclosure of the information would inhibit the voluntary provision of that type of information. Regulated entities are reluctant to voluntarily disclose instances of regulatory noncompliance if such submissions might be subject to public disclosure. A significant impediment to participation in the VDRP is concern over public disclosure of the information, and, if disclosed, the potential for it to be used for other than the system safety enhancement purposes for which the VDRP was created. Withholding such information from disclosure is consistent with the FAA's safety and security responsibilities because, unless the FAA can provide assurance that it will not be disclosed, regulated entities will be reluctant to participate in the program. Information received under the VDRP will be identified as such in each FAA line of business's central database used to track submissions. To encourage continued use of the VDRP, the FAA will not keep the identity of persons reporting, or detailed information about disclosures, under that program in any central database.

    The FAA finds that by virtue of designating information provided under the VDRP as protected under part 193, the reluctance of regulated entities to participate due to concerns about possible disclosure of the information will be mitigated. In addition, FAA will be able to retain more information about the disclosures, including the identity of the reporters, in an FAA database, without negatively impacting participation in the VDRP. Disclosures under the VDRP enable the FAA to become aware of many more instances of regulatory noncompliance than it otherwise would and, moreover, the VDRP permits the FAA to assure that appropriate corrective action is taken. If regulated entities do not participate, the FAA and the public will be deprived of the opportunity to make the system safety improvements that receipt of the information otherwise enables.

    (4) Summary of why the receipt of that type of information aids in fulfilling the FAA's safety and security responsibilities.

    The FAA finds that receipt of VDRP information aids in fulfilling the FAA's safety and security responsibilities. A primary purpose of FAA regulations is to assure public safety. Because the VDRP identifies and corrects instances of regulatory noncompliance of which the FAA may be otherwise unaware, the program offers significant potential for enhancement of public safety. Receipt of this otherwise unavailable information would also provide the FAA with an improved basis for modifying procedures, policies, and regulations to improve safety and efficiency.

    (5) Summary of why withholding such information from disclosure would be consistent with the FAA's safety and security responsibilities, including a statement as to the circumstances under which, and a summary of why, withholding such information from disclosure would not be consistent with the FAA's safety and security responsibilities, as described in § 193.9.

    The FAA finds that withholding VDRP information provided to the FAA is consistent with the FAA's safety responsibilities. The VDRP specifically provides that appropriate corrective action must be taken by the regulated entity for all instances of regulatory noncompliance accepted under the program. To be accepted by the FAA, apparent violations disclosed under the program must be inadvertent, and, where applicable, must not indicate a lack, or reasonable question of a lack, of qualification of the regulated entity. Corrective action under the VDRP can be accomplished by the regulated entity and verified by the FAA without disclosure of the protected information. If the FAA determines that the steps taken by the entity are not those documented in the written report, the submission may be excluded from the VDRP, and appropriate legal enforcement action may be initiated.

    The FAA will release information submitted under a VDRP as specified in part 193 and this proposed order. The FAA may disclose de-identified summary information to explain the need for changes in FAA policies, procedures, and regulations. The term “de-identified” means that the identity of the source of the information and the names of the regulated entity, employees, and other persons, as well as any other information that could be used to ascertain the identity of the submitter have been redacted. The FAA may disclose de-identified, summarized VDRP information that identifies a systemic problem in the aviation system, when other persons need to be advised of the problem so that they can take corrective action. The FAA may disclose de-identified aggregate statistical information concerning VDRP submissions. The FAA may disclose independently obtained information relating to any event disclosed in a VDRP report, unless the FAA determines that in the case of an accepted VDRP submission, release of such independently obtained information would be inconsistent with the provisions of this order, or would otherwise be prohibited by public law or regulation. The FAA also may disclose information concerning enforcement action taken for a regulatory violation initially identified in a VDRP submission, when that submission is not accepted by the FAA, or, if accepted, it is later excluded by the FAA because of the regulated entity's failure to comply with the criteria of the VDRP. The FAA also may disclose any information about a disclosure initially submitted under the VDRP that is not accepted, or accepted but later excluded because of the regulated entity's failure to comply with the criteria of the VDRP.

    (6) Summary of how the FAA will distinguish information protected under part 193 from information the FAA receives from other sources.

    In accordance with AC 00-58, as amended, AC 00-68, and AC 121-37, all VRDP submissions must be clearly identified as such by the regulated entity making the submission. Any other information received by the FAA from the regulated entity concerning the content of a VDRP submission must be clearly labeled as follows to be eligible for protection under this designation: “WARNING: The Information in this Document is Protected from Disclosure under 49 U.S.C. 40123 and 14 CFR part 193.” If the information is submitted electronically, the warning notice must be appropriately embedded in the electronic submission in a fashion that assures the visibility of the warning to any viewer.

    Proposed Designation

    Accordingly, the FAA proposes to designate the above-described information submitted under a VDRP to be protected under 49 U.S.C. 40123 and part 193, when obtained by the FAA pursuant to an accepted VDRP submission.

    V. Additional information A. Comments Invited

    The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.

    B. Availability of This Proposed Designation

    An electronic copy of rulemaking documents may be obtained from the Internet by—

    1. Searching the Federal eRulemaking Portal (http://www.regulations.gov);

    2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies or

    3. Accessing the Government Printing Office's Web page at http://www.thefederalregister.org/fdsys/.

    Copies may also be obtained by sending a request to the Federal Aviation Administration, Aircraft Certification Office, AIR-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-8235. Commenters must identify the docket or notice number of this rulemaking.

    All documents the FAA considered in developing this proposed rule may be accessed from the Internet through the Federal eRulemaking Portal referenced in item (1) above.

    Issued under authority provided by 49 U.S.C. 106(f) and 40123 in Washington, DC, on September 7, 2016. David W. Hempe, Deputy Director, Aircraft Certification Service, AIR-1.
    [FR Doc. 2016-21966 Filed 9-16-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF STATE 22 CFR Part 22 [Public Notice: 9520] RIN 1400-AD81 Schedule of Fees for Consular Services, Department of State and Overseas Embassies and Consulates—Passport Services Fee Changes AGENCY:

    Department of State.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Department of State proposes an adjustment to the Schedule of Fees for Consular Services of the Department of State's Bureau of Consular Affairs (“Schedule of Fees” or “Schedule”) for the execution fee for passport books and cards. The Department is adjusting this fee in light of the findings of the most recent annual update to the Cost of Service Model to better align the fees for consular services with the costs of providing those services.

    DATES:

    The Department of State will accept comments on this proposed rule until November 18, 2016.

    ADDRESSES:

    Interested parties may submit comments to the Department by any of the following methods:

    • Visit the Regulations.gov Web site at: http://www.regulations.gov and search for the Regulatory Information Number (RIN) 1400-AD81 or docket number DOS-2016-0029.

    Mail paper document: U.S. Department of State, Office of the Comptroller, Bureau of Consular Affairs (CA/C), SA-17, 8th Floor, Washington, DC 20522-1707.

    Email: [email protected] You must include the RIN (1400-AD81) in the subject line of your message.

    • All comments should include the commenter's name, the organization the commenter represents, if applicable, and the commenter's address. If the Department is unable to read your comment for any reason, and cannot contact you for clarification, the Department may not be able to consider your comment. After the conclusion of the comment period, the Department will publish a Final Rule (in which it will address relevant comments) as expeditiously as possible.

    FOR FURTHER INFORMATION CONTACT:

    James McDaniel, Management Analyst, Office of the Comptroller, Bureau of Consular Affairs, Department of State; phone: 202-485-6694, telefax: 202-485-6826; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    The proposed rule makes a change to the Schedule of Fees. The Department sets and collects its fees based on the concept of full cost recovery. The Department completed its most recent review of current consular fees and will implement a change to the Schedule of Fees based on the costs of services calculated by the Fiscal Year 2014 update to the Cost of Service Model.

    What is the authority for this action?

    The Department of State derives the general authority to set fees based on the cost of the consular services it provides, and to charge those fees, from the general user charges statute, 31 U.S.C. 9701. See, e.g., 31 U.S.C. 9701(b)(2)(A) (“The head of each agency . . . may prescribe regulations establishing the charge for a service or thing of value provided by the agency . . . based on . . . the costs to the government.”). As implemented through Executive Order 10718 of June 27, 1957, 22 U.S.C. 4219 further authorizes the Department to establish fees to be charged for official services provided by U.S. embassies and consulates.

    Several statutes address specific fees relating to passports. For instance, 22 U.S.C. 214(a) authorizes the Secretary of State to set the passport execution fee by regulation, and to authorize state and local government officials and the U.S. Postal Service to collect and retain the execution fee for each application for a passport accepted by such officials or the U.S. Postal Service.

    Certain people are exempted by law or regulation from paying specific fees. They include, for instance, exemptions from the passport execution and application fees for officers or employees of the U.S. government proceeding abroad in the discharge of official duties and exemption from the passport execution fee if those officers or employees execute their application before a federal official. See 22 U.S.C. 214(a); 22 CFR 22.1; 22 CFR 51.52(b).

    The Department last changed fees for passport services in an interim final rule dated September 8, 2015. See Department of State Schedule of Fees for Consular Services, Department of State and Overseas Embassies and Consulates, 22 CFR part 22 (80 FR 53704). Those changes to the Schedule went into effect September 26, 2015. A final rule regarding those fees has not yet been published.

    Why is the Department adjusting fees at this time?

    With certain exceptions—such as the reciprocal nonimmigrant visa issuance fee—the Department of State generally sets consular fees at an amount calculated to achieve recovery of the costs to the U.S. government of providing the consular service, in a manner consistent with general user charges principles, regardless of the specific statutory authority under which the fees are authorized. As set forth in OMB Circular A-25, as a general policy, each recipient should pay a reasonable user charge for government services, resources, or goods from which he or she derives a special benefit, at an amount sufficient for the U.S. government to recover the full costs to it of providing the service, resource, or good. See OMB Circular No. A-25, sec. 6(a)(2)(a). The OMB guidance covers all Federal Executive Branch activities that convey special benefits to recipients beyond those that accrue to the general public. See id., sections 4(a), 6(a)(1).

    The Department reviews consular fees through an annual update to its Cost of Service Model to determine the appropriateness of each fee in light of OMB guidance. The Department proposes to make the change set forth below in the Schedule of Fees accordingly. The Cost of Service Model is an activity-based costing model that determines the current direct and indirect costs to the U.S. government associated with each consular good and service the Department provides. The model update identified the direct and indirect cost of the passport execution fee, and the update's results formed the basis of the change herein proposed to the Schedule.

    Activity-Based Costing

    To set fees in accordance with the general user charges principles, the Department must determine the true cost of providing consular services. Following guidance provided in “Managerial Cost Accounting Concepts and Standards for the Federal Government,” OMB's Statement #4 of Federal Accounting Standards (SFFAS #4), available at http://www.fasab.gov/pdffiles/sffas-4.pdf, the Department chose to develop and use an activity-based costing (ABC) model to determine the true cost of each of its consular services.

    The Government Accountability Office (GAO) defines activity-based costing as a “set of accounting methods used to identify and describe costs and required resources for activities within processes.” Because an organization can use the same staff and resources (computer equipment, production facilities, etc.) to produce multiple products or services, ABC models seek to identify and assign costs to processes and activities, and then to individual products and services through the identification of key cost drivers referred to as “resource drivers” and “activity drivers.” ABC models also seek to identify the amount of time an organization's personnel spend on each service and how much overhead cost (rent, utilities, facilities maintenance, etc.) is associated with delivering each service. ABC models require financial and accounting analysis, and modeling skills combined with a detailed understanding of an organization's business processes. ABC models require an organization to identify all activities required to produce a particular product or service (“activities”) and all resources consumed (costs) in the course of producing that product or service. An organization also must measure the quantity of resources consumed (“resource driver”); and the frequency and intensity of demand placed on activities to produce services (“activity driver”). SFFAS Statement #4 provides a detailed discussion of the use of cost accounting by the U.S. government.

    The Department's Cost of Service Model

    The Department conducted periodic Cost of Service Studies using ABC methods to determine the costs of its consular services through 2009. In 2010, the Department moved to adopt an annually updated Cost of Service Model (CoSM) that measures all of its consular operations and costs, including all of the activities needed to provide consular services, whether fee-based or not. This provides a comprehensive and detailed look at all consular services and all services that the Department performs for other agencies in connection with its consular operations. The CoSM now includes approximately 80 distinct activities, and enables the Department to model its consular-related costs with a high degree of precision.

    The Department uses three methods outlined in SFFAS Statement #4 (paragraph 149(2)) to assign resource costs to activities: (a) Direct tracing; (b) estimation based on surveys, interviews, or statistical sampling; and (c) allocations. The Department uses direct tracing to assign the cost of, for example, a physical passport book or the visa foil placed in a visa applicant's passport. Assigning costs to activities such as adjudicating a passport or visa application requires estimation based on surveys, interviews, or statistical sampling to determine who performs an activity and how long it takes. Indirect costs (overhead) in the CoSM are allocated according to the level of effort needed for a particular activity. Where possible, the model uses overhead cost pools to assign indirect costs only to related activities. For instance, the cost of rent for domestic passport agencies is assigned only to passport costs, not to visas or other services the Department provides only overseas. The Department allocates indirect support costs to each consular service by the portion of each cost attributable to consular activities. For example, the model allocates a portion of the cost of the Department's Bureau of Human Resources to consular services. The total amount of this allocation is based on the number of Bureau of Human Resources staff members who support Bureau of Consular Affairs personnel. In turn, this amount is allocated among the different consular services by the level of effort to provide them.

    To assign labor costs, the Department relies on a variety of industry-standard estimation methodologies. To document how consular staff divide their time overseas, the Department conducts the Consular Overseas Data Collection (CODaC) survey of a representative sample of posts each year. The Department uses CODaC survey data in conjunction with volume data from more than 200 individual consular sections in consulates and embassies worldwide, to develop resource drivers to assign labor costs to activities. For consular activities that take place in the United States, the Department collects volume data from periodic workload reports, including Passport Agency Task Reports pulled from management databases that include Passport's Management Information System. Financial information is gathered from reports by the Bureau of Consular Affairs' Office of the Comptroller. The Department converts the cost and workload data it collects into resource drivers and activity drivers for each resource and activity.

    Because approximately 70 percent of the workforce involved in providing consular services are full-time Federal employees, if demand for a service falls precipitously, the Department cannot shed employees as quickly as the private sector. Likewise, should demand rise precipitously, the Department cannot add employees quickly, because delivering the majority of consular services requires specially trained employees who cannot begin their training until they have completed the Federal hiring process and obtained a security clearance. Additionally, given government procurement rules and security requirements, the Department must commit to many of its facilities and infrastructure costs years before a facility becomes available. In spite of changes in demand, the Department is obligated to cover these costs. Given these and other constraints on altering the Department's cost structure in the short term, changes in service volumes can have dramatic effects on whether a fee is self-sustaining. Therefore, the CoSM includes two years of predictive data and three years of actual data. Predictive workloads are based on projections by the Office of Visa Services, the Office of Passport Services, and other parts of the Bureau of Consular Affairs that are consistent with Department budget documents prepared for Congress.

    The costs the Department enters into the CoSM include every line item of costs, including items such as physical material for making passports and visas, salaries, rent, supplies, and IT hardware and software. The Department then determines a resource driver (from, for example, the responses to the CODaC survey) for each of these costs, as discussed above and enters the resource drivers and assignments into the model. The Department then selects an activity driver, such as the volume data discussed above, for each activity, in order to assign these costs to each service type. This process allows the model to calculate a total cost for each of the Schedule of Fees' line items for visa services, passport services, and overseas citizens services, and services for other government agencies and no-fee services. The model then divides this total cost by the total volume of the service or product in question in order to determine a final unit cost for the service or product. Projected costs for predictive years also are included to take account of changes in the size of consular staff, workload, and similar factors. The resulting database constitutes the CoSM. The Department continues to refine and update the CoSM in order to set fees commensurate with the cost of providing consular services. Because the CoSM is a complex series of iterative computer processes incorporating more than a million calculations, it is not reducible to a tangible form such as a document. Inputs are formatted in spreadsheets for entry into the ABC software package. The ABC software package itself is an industry standard commercial off-the-shelf product, SAP Business Objects. The software's output includes spreadsheets with raw unit costs, validation reports, and management reports.

    A number of fees are set at levels other than cost. These include passport fees for minors, which are set below cost as a longstanding matter of policy, and the reduced Border Crossing Card Fee for Mexican Minors, which is set by law. The true cost of these services must be offset by other fees. These offsets are calculated on additional spreadsheets outside the model software. Final unit costs incorporate these offsets.

    Schedule of Fees Updates

    The last broad set of amendments to the Schedule of Fees occurred in 2014, though the Department has made some specific amendments to it since that time. Some fees, including the Immigrant Visa petition and the Immigrant Visa ineligibility waiver (items 31(a) and 35(c) respectively), are set by the Department of Homeland Security and were most recently updated by that agency on November 23, 2010. The change to the current Schedule of Fees is discussed below. The CoSM estimate discussed below is based on projected workload for Fiscal Year 2016, and the proposed fee has been rounded to make it easier to collect.

    Passport Execution Fee

    The Department proposes to increase the execution fee for passport books and cards from $25 to $35, excepting those persons who are exempted statutorily from paying the passport execution fee. The passport execution fee is applicable to all first-time passport applicants and certain other applicants who must apply in person, such as minors under the age of 16. Applicants apply in-person at post offices and other acceptance facilities, such as local clerks of court, and at the Department's passport offices. The passport execution fee includes the costs associated with accepting passport applications and fees in-person, including salaries, benefits, and an allocated portion of overhead including, but not limited to, rent, utilities, supplies, and equipment. The Department's CoSM showed that these costs were more than $33. The U.S. Postal Service—the acceptance agent for the majority of passport applications—regularly conducts a similar study and found that these costs were more than $34. See 22 U.S.C. 214(a); 22 CFR 51.51(b).

    The $10 increase in the passport execution fee will result in a $10 increase to the cost to first-time passport applicants and certain applicants who must appear at post offices and other acceptance facilities such as local clerks of court. Individuals who apply for a passport renewal by mail will not see a fee increase.

    Regulatory Findings Administrative Procedure Act

    The Department is publishing this rule as a proposed rule, with a 60-day provision for public comments.

    Regulatory Flexibility Act

    The Department reviewed this proposed rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities as defined in 5 U.S.C. 601(6).

    Unfunded Mandates Act of 1995

    This proposed rule will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501-1504.

    Small Business Regulatory Enforcement Fairness Act of 1996

    This proposed rule is a major rule as defined by 5 U.S.C. 804(2).

    Executive Order 12866

    The Department has reviewed this proposed rule to ensure its consistency with the regulatory philosophy and principles set forth in the Executive Orders. OMB determined that this rule is significant under Executive Order 12866, and the Department confirmed that it is economically significant as defined by the Executive Order.

    This proposed rule is necessary in light of the Department of State's CoSM finding that the cost of executing first-time passports is higher than the current fee. The Department is setting the fees in accordance with 31 U.S.C. 9701 and other applicable authority, as described in more detail above. See, e.g., 31 U.S.C. 9701(b)(2)(A) (“The head of each agency . . . may prescribe regulations establishing the charge for a service or thing of value provided by the agency . . . based on . . . the costs to the Government.”). This regulation generally sets the fee for passport executions at the amount required to recover the costs associated with providing this service.

    Details of the proposed fee change are as follows:

    Item No. Proposed fee Current fee Change in fee Percentage
  • increase
  • Estimated
  • annual
  • number of
  • applications 1
  • Estimated change in
  • annual fees
  • collected 1
  • SCHEDULE OF FEES FOR CONSULAR SERVICES *         *         *         *         *         *         * PASSPORT AND CITIZENSHIP SERVICES 1. Passport Book or Card Execution: Required for first-time applicants and others who must apply in person $35 $25 $10 40% 11,763,831 $117,638,310 Total $117,638,310 *         *         *         *         *         *         * 1 Based on projected FY 2016 workload.

    The Department of State does not anticipate that demand for passport services affected by this proposed rule will change significantly because of these fee changes, and welcomes public comment on that expectation.

    The Department does not believe that passport application fees are a significant determining factor when U.S. citizens decide to travel internationally. The price of a passport book or card remains minor in comparison with other costs associated with foreign travel, given that taxes and surcharges alone on an international airfare can easily surpass $100. As a result, the Department does not believe passport demand will be significantly affected by increases of the size proposed.

    Executive Orders 12372 and 13132

    This regulation will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on federal programs and activities do not apply to this regulation.

    Executive Order 13175

    The Department determined that this proposed rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.

    Paperwork Reduction Act

    This information collection contained in this proposed rule is pursuant to the Paperwork Reduction Act, 44 U.S.C. Chapter 35. Information Collection 1405-0004, form DS-11 is related to this proposed rule. The Notice of Proposed Rulemaking proposes an increase in the passport execution fee, from $25 to $35, based on the result of the Department CoSM, which found that the government's cost of executing a first-time passport is higher than the fee that the Department was charging an individual applicant. The CoSM is an activity-based costing model that determines the current direct and indirect costs to the U.S. government associated with each consular good and service the Department provides.

    This information collection was renewed on August 30, 2016, with an expiration date of August 31, 2019. This notice request comments as it pertains to the proposed fee increase from $25 to $35.

    (1) Title of Information Collection: Application for a U.S. Passport. (2) OMB Control Number: 1405-0004. (3) Type of Request: Revision of a Currently Approved Collection. (4) Form Number: DS-11. (5) Respondents: Individuals or Households. (6) Estimated Number of Respondents: 11,763,831. (7) Estimated Number of Responses: 11,763,831. (8) Average Time per Response: 85 Minutes. (9) Total Estimated Burden Time: 16,665,427 hours. (10) Frequency: On occasion. (11) Obligation to Respond: Required to Obtain a Benefit. (12) Submit comments to OMB by the following methods: Office of Management and Budget (OMB):

    • Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:

    Email: [email protected] You must include the DS form number, information collection title, and the OMB control number in the subject line of your message.

    Fax: 202-395-5806. Attention: Desk Officer for Department of State.

    Abstract of Proposed Collection

    The DS-11 solicits data necessary for Passport Services to issue a U.S. passport (book and/or card format) pursuant to authorities granted to the Secretary of State by 22 U.S.C. 211a et seq. and Executive Order (E.O.) 11295 (August 5, 1966) for the issuance of passports to U.S. nationals.

    The issuance of U.S. passports requires the determination of identity, nationality, and entitlement with reference to the provisions of Title III of the Immigration and Nationality Act (INA) (8 U.S.C. 1401-1504), the 14th Amendment to the Constitution of the United States, other applicable treaties and laws, and implementing regulations at 22 CFR parts 50 and 51. The specific regulations pertaining to the Application for a U.S. passport are at 22 CFR 51.20 through 51.28.

    Methodology

    The information collected on the DS-11 is used to facilitate the issuance of passports to U.S. citizens and nationals. The primary purpose of soliciting the information is to establish citizenship, identity, and entitlement to the issuance of the U.S. passport or related service, and to properly administer and enforce the laws pertaining to the issuance thereof.

    Passport Services collects information from U.S. citizens and non-citizen nationals when they complete and submit the Application for a U.S. passport. Passport applicants can either download the DS-11 from the Internet or obtain one from an Acceptance Facility/Passport Agency. The form must be completed and executed at an acceptance facility or passport agency, and submitted with evidence of citizenship and identity.

    List of Subjects in 22 CFR Part 22

    Consular services, Fees, Passports.

    Accordingly, for the reasons stated in the preamble, 22 CFR part 22 is proposed to be amended as follows:

    PART 22—SCHEDULE OF FEES FOR CONSULAR SERVICES—DEPARTMENT OF STATE AND FOREIGN SERVICE 1. The authority citation for part 22 is revised to read as follows: Authority:

    8 U.S.C. 1101 note, 1153 note, 1183a note, 1351, 1351 note, 1714, 1714 note; 10 U.S.C. 2602(c); 11 U.S.C. 1157 note; 22 U.S.C. 214, 214 note, 1475e, 2504(a), 2651a, 4201, 4206, 4215, 4219, 6551; 31 U.S.C. 9701; Exec. Order 10,718, 22 FR 4632 (1957); Exec. Order 11,295, 31 FR 10603 (1966).

    2. Revise item 1 in the table “Schedule of Fees for Consular Services” in § 22.1 to read as follows:
    § 22.1 Schedule of fees. Schedule of Fees for Consular Services Item No. Fee Passport and Citizenship Services 1. Passport Book or Card Execution: Required for first-time applicants and others who must apply in person (Applicants applying for both the book and card simultaneously on the same application pay only one execution fee.) $35 *         *         *         *         *         *         *
    Dated: July 31, 2016. Patrick F. Kennedy, Under Secretary for Management.
    [FR Doc. 2016-22215 Filed 9-16-16; 8:45 am] BILLING CODE 4710-13-P
    DEPARTMENT OF JUSTICE 28 CFR Part 16 [CPCLO Order No. 008-2016] Privacy Act of 1974; Implementation AGENCY:

    Federal Bureau of Investigation, United States Department of Justice.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    Elsewhere in this issue of the Federal Register, the Federal Bureau of Investigation (FBI), a component of the United States Department of Justice (“Department” or “DOJ”), has published a notice of a new Privacy Act system of records, “FBI Insider Threat Program Records (ITPR),” JUSTICE/FBI-023. In this notice of proposed rulemaking, the FBI proposes to exempt this system from certain provisions of the Privacy Act in order to avoid interference with efforts to detect, deter, and/or mitigate insider threats to national security or to the FBI and its personnel, facilities, resources, and activities. For the reasons provided below, the Department proposes to amend its Privacy Act regulations by establishing an exemption for records in this system from certain provisions of the Privacy Act pursuant to 5 U.S.C. 552a(j) and (k). Public comment is invited.

    DATES:

    Comments must be received by October 19, 2016.

    ADDRESSES:

    Address all comments to the U.S. Department of Justice, ATTN: Privacy Analyst, Office of Privacy and Civil Liberties, National Place Building, 1331 Pennsylvania Avenue NW., Suite 1000, Washington, DC 20530-0001 or facsimile 202-307-0693. To ensure proper handling, please reference the CPCLO Order No. on your correspondence. You may review an electronic version of the proposed rule at http://www.regulations.gov, and you may also comment by using that Web site's comment form for this regulation. When submitting comments electronically, you must include the CPCLO Order No. in the subject box.

    Please note that the Department is requesting that electronic comments be submitted before midnight Eastern Daylight Savings Time on the day the comment period closes because http://www.regulations.gov terminates the public's ability to submit comments at that time. Commenters in time zones other than Eastern Time may want to consider this so that their electronic comments are received. All comments sent via regular or express mail will be considered timely if postmarked on the day the comment period closes.

    Posting of Public Comments: Please note that all comments received are considered part of the public record and made available for public inspection online at http://www.regulations.gov and in the Department's public docket. Such information includes personally identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

    If you want to submit personally identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONALLY IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all personally identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.

    If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket.

    Personally identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be posted online and placed in the Department's public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency's public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.

    FOR FURTHER INFORMATION CONTACT:

    Richard R. Brown, Federal Bureau of Investigation, Assistant General Counsel, Privacy and Civil Liberties Unit, Office of the General Counsel, J. Edgar Hoover Building, 935 Pennsylvania Avenue NW., Washington, DC 20535-0001, telephone 202-324-3000.

    SUPPLEMENTARY INFORMATION:

    The Presidential Memorandum—National Insider Threat Policy and Minimum Standards for Executive Branch Insider Threat Programs (Nov. 21, 2012) states that an insider threat is the threat that any person with authorized access to any United States Government resources, to include personnel, facilities, information, equipment, networks or systems, will use her/his authorized access, wittingly or unwittingly, to do harm to the security of the United States through espionage, terrorism, unauthorized disclosure of national security information, or through the loss or degradation of departmental resources or capabilities.

    In the Notice section of today's Federal Register, the FBI has established a new Privacy Act system of records, “FBI Insider Threat Program Records (ITPR),” JUSTICE/FBI-023. The system serves as a repository for FBI information and for information lawfully received from other federal agencies or purchased from private companies and permits the comparison of data sets in order to provide a more complete picture of potential insider threats.

    In this rulemaking, the FBI proposes to exempt this Privacy Act system of records from certain provisions of the Privacy Act in order to avoid interference with the responsibilities of the FBI to detect, deter, and/or mitigate insider threats as established by federal law and policy. For an overview of the Privacy Act, see: https://www.justice.gov/opcl/privacy-act-1974.

    Regulatory Flexibility Act

    This proposed rule relates to individuals rather than small business entities. Pursuant to the requirements of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, therefore, the proposed rule will not have a significant economic impact on a substantial number of small entities.

    Small Entity Inquiries

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, 5 U.S.C. 801 et seq., requires the FBI to comply with small entity requests for information and advice about compliance with statutes and regulations within FBI jurisdiction. Any small entity that has a question regarding this document may contact the person listed in FOR FURTHER INFORMATION CONTACT: Persons can obtain further information regarding SBREFA on the Small Business Administration's Web page at http://www.sba.gov/advo/archive/sum_sbrefa.html.

    Paperwork Reduction Act

    The Paperwork Reduction Act of 1995, 44 U.S.C. 3507(d), requires that the FBI consider the impact of paperwork and other information collection burdens imposed on the public. There are no current or new information collection requirements associated with this proposed rule. The records that are contributed to this system may be provided by individuals covered by this system, the FBI, DOJ, and United States Government components, other domestic and foreign government entities, or purchased from private entities, and sharing of this information electronically will not increase the paperwork burden on the public.

    Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 103-3, 109 Stat. 48, requires Federal agencies to assess the effects of certain regulatory actions on State, local, and tribal governments, and the private sector. UMRA requires a written statement of economic and regulatory alternatives for proposed and final rules that contain Federal mandates. A “Federal mandate” is a new or additional enforceable duty, imposed on any State, local, or tribal government, or the private sector. If any Federal mandate causes those entities to spend, in aggregate, $100 million or more in any one year, the UMRA analysis is required. This proposed rule would not impose Federal mandates on any State, local, or tribal government or the private sector.

    List of Subjects in 28 CFR Part 16

    Administrative Practices and Procedures, Courts, Freedom of Information Act, and the Privacy Act.

    Pursuant to the authority vested in the Attorney General by 5 U.S.C. 552a and delegated to me by Attorney General Order 2940-2008, it is proposed to amend 28 CFR part 16 as follows:

    PART 16—[AMENDED] 1. The authority citation for part 16 continues to read as follows: Authority:

    5 U.S.C. 301, 552, 552a, 552b(g), 553; 18 U.S.C. 4203(a)(1); 28 U.S.C. 509, 510, 534; 31 U.S.C. 3717, 9701.

    Subpart E—Exemption of Records Systems Under the Privacy Act
    § 16.96 [AMENDED]
    2. Amend § 16.96 by adding paragraphs (x) and (y) to read as follows:
    § 16.96 Exemption of Federal Bureau of Investigation Systems—limited access.

    (x) The following system of records is exempt from 5 U.S.C. 552a(c)(3) and (4); (d)(1), (2), (3) and (4); (e)(1), (2) and (3); (e)(4)(G), (H) and (I); (e)(5) and (8); (f) and (g) of the Privacy Act:

    (1) FBI Insider Threat Program Records (JUSTICE/FBI-023).

    (2) These exemptions apply only to the extent that information in this system is subject to exemption pursuant to 5 U.S.C. 552a(j) or (k). Where compliance would not appear to interfere with or adversely affect the purpose of this system to detect, deter, and/or mitigate insider threats to national security or to the FBI, the applicable exemption may be waived by the FBI in its sole discretion.

    (y) Exemptions from the particular subsections are justified for the following reasons:

    (1) From subsection (c)(3), the requirement that an accounting be made available to the named subject of a record, because this system is exempt from the access provisions of subsection (d). Also, because making available to a record subject the accounting of disclosures from records concerning him/her would specifically reveal any insider threat-related interest in the individual by the FBI or agencies that are recipients of the disclosures. Revealing this information could compromise ongoing, authorized law enforcement and intelligence efforts, particularly efforts to identify and/or mitigate insider threats to national security or to the FBI. Revealing this information could also permit the record subject to obtain valuable insight concerning the information obtained during any investigation and to take measures to impede the investigation, e.g., destroy evidence or flee the area to avoid the investigation.

    (2) From subsection (c)(4) notification requirements because this system is exempt from the access and amendment provisions of subsection (d) as well as the accounting of disclosures provision of subsection (c)(3). The FBI takes seriously its obligation to maintain accurate records despite its assertion of this exemption, and to the extent it, in its sole discretion, agrees to permit amendment or correction of FBI records, it will share that information in appropriate cases.

    (3) From subsection (d)(1), (2), (3) and (4), (e)(4)(G) and (H), (e)(8), (f) and (g) because these provisions concern individual access to and amendment of law enforcement, intelligence and counterintelligence, and counterterrorism records and compliance could alert the subject of an authorized law enforcement or intelligence activity about that particular activity and the interest of the FBI and/or other law enforcement or intelligence agencies. Providing access could compromise information classified to protect national security; disclose information which would constitute an unwarranted invasion of another's personal privacy; reveal a sensitive investigative or intelligence technique; provide information that would allow a subject to avoid detection or apprehension; or constitute a potential danger to the health or safety of law enforcement personnel, confidential sources, or witnesses.

    (4) From subsection (e)(1) because it is not always possible to know in advance what information is relevant and necessary for law enforcement and intelligence purposes. The relevance and utility of certain information that may have a nexus to insider threats to national security or to the FBI may not always be fully evident until and unless it is vetted and matched with other sources of information that are necessarily and lawfully maintained by the FBI.

    (5) From subsections (e)(2) and (3) because application of these provisions could present a serious impediment to efforts to detect, deter and/or mitigate insider threats to national security or to the FBI and its personnel, facilities, resources, and activities. Application of these provisions would put the subject of an investigation on notice of the investigation and allow the subject an opportunity to engage in conduct intended to impede the investigative activity or avoid apprehension.

    (6) From subsection (e)(4)(I), to the extent that this subsection is interpreted to require more detail regarding the record sources in this system than has been published in the Federal Register. Should the subsection be so interpreted, exemption from this provision is necessary to protect the sources of law enforcement and intelligence information and to protect the privacy and safety of witnesses and informants and others who provide information to the FBI. Further, greater specificity of properly classified records could compromise national security.

    (7) From subsection (e)(5) because in the collection of information for authorized law enforcement and intelligence purposes, including efforts to detect, deter, and/or mitigate insider threats to national security or to the FBI and its personnel, facilities, resources, and activities, due to the nature of investigations and intelligence collection, the FBI often collects information that may not be immediately shown to be accurate, relevant, timely, and complete, although the FBI takes reasonable steps to collect only the information necessary to support its mission and investigations. Additionally, the information may aid in establishing patterns of activity and providing criminal or intelligence leads. It could impede investigative progress if it were necessary to assure relevance, accuracy, timeliness and completeness of all information obtained during the scope of an investigation. Further, some of the records in this system may come from other domestic or foreign government entities, or private entities, and it would not be administratively feasible for the FBI to vouch for the compliance of these agencies with this provision.

    Dated: September 2, 2016. Erika Brown Lee, Chief Privacy and Civil Liberties Officer, Department of Justice.
    [FR Doc. 2016-22412 Filed 9-16-16; 8:45 am] BILLING CODE 4410-02-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 223 [Docket No. 150211138-6789-01] RIN 0648-XD771 Endangered and Threatened Wildlife and Plants; Proposed Rule To List Two Guitarfishes as Threatened AGENCY:

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

    ACTION:

    Proposed rule; 12-month petition finding; request for comments.

    SUMMARY:

    We, NMFS, have completed a comprehensive status review under the Endangered Species Act (ESA) for the common guitarfish (Rhinobatos rhinobatos) and the blackchin guitarfish (Rhinobatos cemiculus). We have determined that, based on the best scientific and commercial data available, and after taking into account efforts being made to protect these species, both species meet the definition of a threatened species under the ESA. Therefore, we propose to list both species as threatened species under the ESA. We are not proposing to designate critical habitat for either of the species proposed for listing because the geographical areas occupied by these species are entirely outside U.S. jurisdiction. We are soliciting comments on our proposal to list these two foreign marine guitarfish species.

    DATES:

    Comments on this proposed rule must be received by November 18, 2016. Public hearing requests must be made by November 3, 2016.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2016-0082, by either of the following methods:

    Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal. Go to http://www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2016-0082. Click the “Comment Now” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Brendan Newell, NMFS Office of Protected Resources (F/PR3), 1315 East-West Highway, Silver Spring, MD 20910, USA.

    Instructions: You must submit comments by one of the above methods to ensure that we receive, document, and consider them. 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. All comments received are a part of the public record and will generally be posted for public viewing on http://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. We will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous). You can find the petition, status review report, Federal Register notices, and the list of references electronically on our Web site at http://www.nmfs.noaa.gov/pr/species/petition81.htm.

    FOR FURTHER INFORMATION CONTACT:

    Brendan Newell, NMFS, Office of Protected Resources (OPR), Telephone: (301) 427-7710 or Marta Nammack, NMFS, (OPR), Telephone: (301) 427-8469.

    SUPPLEMENTARY INFORMATION:

    Background

    On July 15, 2013, we received a petition from WildEarth Guardians to list 81 marine species as threatened or endangered under the ESA. This petition included species from many different taxonomic groups, and we prepared our 90-day findings in batches by taxonomic group. We found that the petitioned actions may be warranted for 27 of the 81 species and announced the initiation of status reviews for each of the 27 species (78 FR 63941, October 25, 2013; 78 FR 66675, November 6, 2013; 78 FR 69376, November 19, 2013; 79 FR 9880, February 21, 2014; and 79 FR 10104, February 24, 2014). This document addresses the findings for 2 of those 27 species: Common guitarfish (Rhinobatos rhinobatos) and blackchin guitarfish (Rhinobatos cemiculus). The status of, and relevant Federal Register notices for, the other 25 species can be found on our Web site at http://www.nmfs.noaa.gov/pr/species/petition81.htm.

    We are responsible for determining whether species are threatened or endangered under the ESA (16 U.S.C. 1531 et seq.). To make this determination, we consider first whether a group of organisms constitutes a “species” under the ESA, then whether the status of the species qualifies it for listing as either threatened or endangered. Section 3 of the ESA defines a “species” to include “any subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature.”

    On February 7, 1996, NMFS and the U.S. Fish and Wildlife Service (USFWS; together, the Services) adopted a policy describing what constitutes a distinct population segment (DPS) of a taxonomic species (the DPS Policy; 61 FR 4722). The DPS Policy identified two elements that must be considered when identifying a DPS: (1) The discreteness of the population segment in relation to the remainder of the species (or subspecies) to which it belongs; and (2) the significance of the population segment to the remainder of the species (or subspecies) to which it belongs. As stated in the DPS Policy, Congress expressed its expectation that the Services would exercise authority with regard to DPSs sparingly and only when the biological evidence indicates such action is warranted. Based on the scientific information available, we determined that the common guitarfish (Rhinobatos rhinobatos) and blackchin guitarfish (Rhinobatos cemiculus) are “species” under the ESA. There is nothing in the scientific literature indicating that either of these species should be further divided into subspecies or DPSs.

    Section 3 of the ESA defines an endangered species as “any species which is in danger of extinction throughout all or a significant portion of its range” and a threatened species as one “which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” We interpret an “endangered species” to be one that is presently in danger of extinction. A “threatened species,” on the other hand, is not presently in danger of extinction, but is likely to become so in the foreseeable future (that is, at a later time). In other words, the primary statutory difference between a threatened and endangered species is the timing of when a species may be in danger of extinction, either presently (endangered) or in the foreseeable future (threatened).

    When we consider whether a species might qualify as threatened under the ESA, we must consider the meaning of the term “foreseeable future.” It is appropriate to interpret “foreseeable future” as the horizon over which predictions about the conservation status of the species can be reasonably relied upon. The foreseeable future considers the life history of the species, habitat characteristics, availability of data, particular threats, ability to predict threats, and the reliability to forecast the effects of these threats and future events on the status of the species under consideration. Because a species may be susceptible to a variety of threats for which different data are available, or which operate across different time scales, the foreseeable future is not necessarily reducible to a particular number of years.

    Section 4(a)(1) of the ESA requires us to determine whether any species is endangered or threatened due to any of the following factors: the present or threatened destruction, modification, or curtailment of its habitat or range; overutilization for commercial, recreational, scientific, or educational purposes; disease or predation; the inadequacy of existing regulatory mechanisms; or other natural or manmade factors affecting its continued existence. Under section (4)(b)(1)(A), we are also required to make listing determinations based solely on the best scientific and commercial data available, after conducting a review of the species' status and after taking into account efforts being made by any state or foreign nation to protect the species.

    Status Review

    The status review for the two guitarfishes addressed in this finding was conducted by a NMFS biologist in the Office of Protected Resources. Henceforth, the status review report for these guitarfishes will be referenced in this preamble as “Newell (2016)”, and is available at http://www.nmfs.noaa.gov/pr/species/petition81.htm and on the respective species pages found on the Office of Protected Resources Web site (http://www.nmfs.noaa.gov/pr/species/index.htm). In order to complete the status review, information was compiled on each species' biology, ecology, life history, threats, and conservation status from information contained in the petition, our files, a comprehensive literature search, and consultation with experts. We also considered information submitted by the public in response to our petition finding.

    Newell (2016) provided an evaluation of the factors specified by section 4(a)(1)(A)-(E) of the ESA (16 U.S.C. 1533(a)(1)(A)-(E)) (Summary of Factors Affecting the Two Guitarfish Species), as well as the species' demographic risks, such as low productivity, and then synthesized this information to estimate the extinction risk of the species (Extinction Risk). For the complete threats assessment, demographic risks analysis, and risk of extinction analysis, see Newell (2016).

    The demographic risk analysis, mentioned above, is an assessment of the manifestation of past threats that have contributed to the species' current status and informs the consideration of the biological response of the species to present and future threats. For this analysis, Newell (2016) considered the demographic viability factors developed by McElhany et al., (2000). The approach of considering demographic risk factors to help frame the consideration of extinction risk has been used in many of our status reviews, including for Pacific salmonids, Pacific hake, walleye pollock, Pacific cod, Puget Sound rockfishes, Pacific herring, scalloped and great hammerhead sharks, and black abalone (see http://www.nmfs.noaa.gov/pr/species/ for links to these reviews). In this approach, the collective condition of individual populations is considered at the species level according to four demographic viability factors: abundance; growth rate/productivity; spatial structure/connectivity; and diversity. These viability factors reflect concepts that are well-founded in conservation biology, and that individually and collectively provide strong indicators of extinction risk.

    In conducting the threats assessment, Newell (2016) identified and summarized the section 4(a)(1) factors that are currently operating on the species and their likely impact on the biological status of the species. Newell (2016) also looked for future threats (where the impact on the species has yet to be manifested), and considered the reliability of forecasting the effects of these threats and future events on the status of these species. Using the findings from the demographic risk analysis and threats assessment, Newell (2016) evaluated the overall extinction risk of the species. Because species-specific information (such as current abundance) is sparse, qualitative “reference levels” of risk were used to describe extinction risk. The definitions of the qualitative “reference levels” of extinction risk were as follows: “Low Risk”—a species is at low risk of extinction if it is not at a moderate or high level of extinction risk (see “Moderate risk” and “High risk” below). A species may be at low risk of extinction if it is not facing threats that result in declining trends in abundance, productivity, spatial structure, or diversity. A species at low risk of extinction is likely to show stable or increasing trends in abundance and productivity with connected, diverse populations. “Moderate Risk”—a species is at moderate risk of extinction if it is on a trajectory that puts it at a high level of extinction risk in the foreseeable future (see description of “High Risk” below). A species may be at moderate risk of extinction due to projected threats or declining trends in abundance, productivity, spatial structure, or diversity. “High Risk”—a species with a high risk of extinction is at or near a level of abundance, productivity, spatial structure, and/or diversity that places its continued persistence in question. The demographics of a species at such a high level of risk may be highly uncertain and strongly influenced by stochastic or depensatory processes. (Stochastic processes are random processes evolving with time; depensatory processes are density-dependent processes where a decrease in a species' population leads to reduced reproductive success, such as by an increase in the rate of predation on eggs or young, or through the reduced likelihood of finding a mate.) Similarly, a species may be at high risk of extinction if it faces clear and present threats (e.g., confinement to a small geographic area; imminent destruction, modification, or curtailment of its habitat; or disease epidemic) that are likely to create present and substantial demographic risks.

    The draft status review report (Newell (2016)) was submitted to independent peer reviewers; comments and information received from peer reviewers were addressed and incorporated as appropriate before finalizing the draft report. The status review report is available on our Web site (see ADDRESSES section) and the peer review report is available at http://www.cio.noaa.gov/services_programs/prplans/PRsummaries.html. Below we summarize information from the report and our analysis of the status of the two guitarfish species. Further details can be found in Newell (2016).

    Species Descriptions

    Guitarfishes are cartilaginous fishes (class Chondrichthyes), in the subclass Elasmobranchii (which includes all cartilaginous fishes except chimaeras). They are part of the super order Batoidea, and members of the order Rajiformes, which also includes skates, sawfishes, electric rays, and rays. Rajiformes are characterized by a dorsoventrally depressed body with the anterior edge of the pectoral fin attached to the side of the head (Serena 2005). Guitarfishes are members of the family Rhinobatidae, which have a moderately depressed, elongated, shark-like body form, with pectoral fins barely enlarged (compared to other batoids except for sawfish), a subtriangular disk, two sub-equal, well-developed, and well-separated dorsal fins, and an elongated, wedge-shaped snout. Guitarfishes have a stouter tail than all other batoids except sawfishes and torpedo rays (Bigelow & Schroeder 1953; Serena 2005).

    Rhinobatos rhinobatos and Rhinobatos cemiculus are sympatric species with relatively wide, overlapping ranges in the subtropical waters of the eastern Atlantic and Mediterranean. In the Atlantic both species range from Northern Portugal south to Angola, with R. rhinobatos extending slightly farther north into the Bay of Biscay in south Atlantic France. Both species' historical ranges include all Mediterranean countries with the exception of Malta and France, which are only in the range of R. rhinobatos. Both species are primarily found in coastal and estuarine, sandy or muddy bottomed habitat from very shallow water to depths of approximately 100 m (Corsini-Foka 2009; Melendez & Macias 2007; Serena 2005). Both species feed on a variety of macrobenthic organisms, including crustaceans, fishes, and mollusks (Basusta et al.,, 2007; Enajjar et al.,, 2007; Lteif 2015; Patokina & Litvinov 2005).

    In terms of reproduction, Rhinobatos rhinobatos and Rhinobatos cemiculus are aplacental viviparous species (giving birth to live, free swimming young with embryo nutrition coming from a yolk sac rather than a placental connection). Both species aggregate seasonally to reproduce, with females visiting protected shallow waters to give birth (Capape & Zaouali 1994; Demirhan et al., 2010; Echwikhi et al., 2013; Ismen et al., 2007). As with many other elasmobranchs, females mature later and at greater sizes than males, females reach greater total length, and female fecundity increases with total length (TL) (Capape & Zaouali 1994; Cortés 2000; Demirhan et al., 2010; Enajjar et al., 2008; Ismen et al., 2007). Based on the limited available information, both species seem to be relatively fast growing compared to most elasmobranch species (Başusta et al., 2008; Enajjar et al., 2012)_ENREF_53. Additional species-specific descriptions are provided below.

    Common guitarfish (Rhinobatos rhinobatos) are khaki-brown colored on their dorsal surface with a white underside (Melendez & Macias 2007). R. rhinobatos have rostral ridges that are widely separated over their entire length with the anterior of their nasal lobe level with the inner corner of their nostril. They have a wide posterior nasal flap and spiracles with two moderately developed folds, with the outer fold more prominent. They have no dorsal or anal spines and relatively small thorns present around the inner margin of their orbits, between their spiracles, on their shoulders and along the midline of their discs and tails (Melendez & Macias 2007). There are regional variations in the maximum size and size at maturity of R. rhinobatos. TL ranges from 22-185 cm with the heaviest specimen recorded reaching 26.6 kg (Edelist 2014; Ismen et al., 2007). The best available information estimated that 50 percent of females and males reached maturity between 79-87 cm TL and 68-78 cm TL, respectively (Abdel-Aziz et al., 1993; Demirhan et al., 2010; Enajjar et al., 2008), and that gestation lasts 9-12 months with females giving birth to 1-14 pups in the late summer or early fall (see Newell (2016)). The maximum age recorded was 24 years old (Başusta et al., 2008) and R. rhinobatos likely matures between 2 and 4 years old (Başusta et al., 2008; Demirhan et al., 2010). For a more detailed discussion of size, age, and reproduction see Newell (2016).

    Blackchin guitarfish (Rhinobatos cemiculus) have a brown dorsal surface with a white underside and usually a blackish blotch on the snout, especially in juveniles. Their rostral ridges are narrowly separated and nearly join in the front. Their anterior nasal lobes extend little if any and their posterior nasal flaps are narrow. Their spiracle has two well-developed folds of about the same size. They have no anal or dorsal spine and have thorns present around the inner margin of their orbits, between their spiracles, on their shoulders, and along the midline of their disc and tail (Melendez & Macias 2007). There are regional variations in the maximum TL and size at maturity. TL ranges from 32-245 cm with the heaviest specimen recorded reaching 26 kg, although the maximum weight is likely much higher because the 26 kg specimen was only 202 cm TL (Capape & Zaouali 1994; Seck et al., 2004). Based on the best available information, 50 percent of females and males reached maturity between 138-153 cm TL and 112-138 cm TL, respectively (Enajjar et al., 2012; Valadou et al., 2006). The reported litter size varies greatly, but the reported range is 2-24 pups per litter with small litters typical (Capape & Zaouali 1994; Seck et al., 2004; Valadou et al., 2006). R. cemiculus is more prolific than R. rhinobatos, likely because it reaches a greater size than R. rhinobatos (Capape & Zaouali 1994). Gestation lasts between 5-12 months with parturition occurring in the later summer and early fall (Capape & Zaouali 1994; Seck et al., 2004; Valadou et al., 2006). Enajjar et al., (2012) found that males and females in the Gulf of Gabés, Tunisia, matured around 3 and 5 years of age, respectively, and that individuals of the species can live for at least 14 years. No other age data were found for this species. For a more detailed discussion of size, age, and reproduction, see Newell (2016).

    Historical and Current Distribution and Population Abundance Rhinobatos rhinobatos

    Historically the common guitarfish was known on all shores of the Mediterranean as well as the coastal eastern Atlantic from the Bay of Biscay (France) to Angola (Melendez & Macias 2007). Throughout its historical Mediterranean range this species has likely always been rare in most of the northwestern Mediterranean, and more common in the Levantine Sea and along the southern shore of the Mediterranean from southern Tunisia to Egypt (Abdel-Aziz et al., 1993; Capapé et al., 2004; Çek et al., 2009; Edelist 2014; Lteif 2015; Saad et al., 2006). Presently R. rhinobatos has been extirpated from the northwestern Mediterranean, including the coasts of Spain and France, as well as the Tyrrhenian, Ligurian, and Adriatic Seas (Bertrand et al., 2000; Capapé et al., 2006; Medits 2016a; Notarbartolo di Sciara et al., 2007b). In this now curtailed portion of its range, up until the early 20th century, R. rhinobatos was likely only common in the waters around Sicily (Doderlein 1884; Psomadakis et al., 2009) and the Balearic Islands of Spain (Notarbartolo di Sciara et al., 2007b).

    R. rhinobatos is present in all Tunisian waters, although less common than R. cemiculus. It is more abundant in the southeastern area around the Gulf of Gabès and the Bahiret el Biban, which are areas used by this species for reproduction (Capapé et al., 2004; Echwikhi et al., 2013; Echwikhi et al., 2012; Enajjar et al., 2008). In the Northern and Southern Lagoons near the City of Tunis in the Gulf of Tunis on the northwest coast of Tunisia, R. rhinobatos has become common since 2004, in response to environmental restoration of the lagoons (Mejri et al., 2004). Little information was available for the status of R. rhinobatos in Libyan waters beyond that they are targeted by fishers (Séret & Serena 2002). In a 2005 report, the Regional Activity Centre for Specially Protected Areas (RAC/SPA) proposed a research program that would focus on eight cartilaginous fishes of Libya, including R. rhinobatos, because of their commercial importance and interest in their conservation (RAC/SPA 2005). According to the proposal authors, some species, including guitarfishes, which are now rare or extirpated in other parts of the Mediterranean, are still common in Libyan waters. In neighboring Egypt, R. rhinobatos was common in commercial fishery catches in 1990 (Abdel-Aziz et al., 1993). Over the last 10 years, guitarfishes and other elasmobranchs have been increasingly exploited by Egyptian fishers as desirable bycatch species, and recent declines in landings indicate that these populations are currently being overexploited (A. Marbourk, NOS, pers. comm. to B. Newell, NMFS, 21 July, 2016).

    North of Egypt, R. rhinobatos was considered common in Israeli waters as of 2006, with the largest TL for the species recorded from a female specimen in the area (Edelist 2014; Golani 2006). Lernau and Golani (2004) state, “swarms of Rhinobatos rhinobatos are captured with purse seines.” Although this statement is not connected to a specific fishing area it appears the authors are either discussing fishing along the Israeli coast or in the nearby Bardawil Lagoon on the Egyptian Sinai Peninsula. R. rhinobatos is the most commonly observed elasmobranch in Lebanese fisheries (Lteif 2015). In a study of elasmobranch exploitation in Syria in the early 2000s, R. rhinobatos was characterized as a “moderate economically important species either for being caught in little quantities with high efforts in fishing, or for their little demand for human consumption. Or maybe for both reasons” (Saad et al., 2006). By comparison, R. cemiculus was characterized as a “very economically important species being caught in plentiful quantities and highly consumable” (Saad et al., 2006). No clarification was given as to whether there is low catch with high effort, or low demand. Regardless, the fact that R. rhinobatos was characterized as being of “moderate” economic importance indicates this fish is more than an occasional visitor to Syrian waters. In the Turkish portion of the Levantine Sea (off southeastern Turkey), R. rhinobatos is common in fisheries bycatch, including in İskenderun Bay, where, as of 2012, it was less common than R. cemiculus (Başusta et al., 2012; Çek et al., 2009). West of İskenderun Bay, based on samples collected in the early 1980s, R. rhinobatos is also common in Mersin Bay (Gücü & Bingel 1994), and it was collected in a 2002-2003 survey of the Karataş Coasts (located between İskenderun Bay and Mersin Bay). R. rhinobatos has also been recorded in the Gulf of Antalya, west of Mersin Bay (C. Mancusi, ARPAT, pers. comm. to B. Newell, NMFS, 23 March, 2016). Individuals of all life history stages, including large quantities of pregnant females, have been captured in the Gulf of Gabès and the Bahiret el Biban (Capapé et al., 2004), Alexandria, Egypt (Abdel-Aziz et al., 1993), and in İskenderun Bay (Çek et al., 2009). In the Aegean Sea, which is bound by the east coast of Turkey and the west coast of Greece, R. rhinobatos is rare (Corsini-Foka 2009). It was present on a checklist from 1969 (Bilecenoğlu et al., 2014), with one individual reported in 2008 and another in the 1970s (Corsini-Foka 2009), while no occurrences were detected during a 2006-2007 survey of Saroz Bay in the northeastern Aegean (Keskin et al., 2011).

    In the Atlantic, north of the strait of Gibraltar, the only records we found of this species were from checklists and museum records from Spain and Portugal (Bañón et al., 2010; Carneiro et al., 2014) and it not is reported in the International Council for the Exploration of the Sea (ICES) DATRAS data base, which is a collection of 45 years' worth of survey data including data collected off the Atlantic coasts of France, Spain, and Portugal (ICES 2016), indicating that they are likely historically rare North of the Strait of Gibraltar.

    Along the Atlantic coast of Africa, this species is found from Morocco to Angola. It is likely that this species is rare in Moroccan waters (Gulyugin et al., 2006; Serghini et al., 2008). In West Africa, R. rhinobatos has been one of the most common and widely distributed elasmobranchs in Mauritania, Gambia, Guinea, Guinea-Bissau, Senegal, and Sierra Leone, but has become scarce throughout most of this portion of its range in recent decades (Diop & Dossa 2011; M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016). In Mauritania, fishing pressure has driven declines in the average size of guitarfishes landed in the Banc d'Arguin National Park from 1998 to 2007 (Diop & Dossa 2011). Restrictions on elasmobranch fishing in the park have allowed guitarfishes to recover locally but they are still exploited throughout the rest of Mauritanian waters (M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016). In Senegal, guitarfishes are heavily targeted and this fishing pressure has caused local declines in both species, with substantial declines reported over the period of 1990 to 2005 (Diop & Dossa 2011; M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016; Notarbartolo di Sciara et al., 2007a; Notarbartolo di Sciara et al., 2007b).

    Rhinobatos rhinobatos occurs in the waters of Guinea-Bissau off the mainland and around the Bijagós Archipelago where it is targeted by fishers (Cross 2015; Fowler & Cavanagh 2005; Kasisi 2004; Tous et al., 1998). In the late 1990s, rapid and substantial declines of R. rhinobatos were reported in the Bijagós Archipelago, as specialized and sophisticated fishing teams targeting elasmobranchs for their fins migrated into the area, although previously the area had seen almost no elasmobranch fishing (Tous et al., 1998). In Guinea it is likely that this species is experiencing similar declines to those in Guinea-Bissau, Senegal, and Gambia (M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016). In Sierra Leone, this species is one of the most heavily exploited elasmobranchs (Diop & Dossa 2011). It was recorded from 2008-2010 in a survey by the Sierra Leone Ministry of Fisheries and Marine Resources as well as in industrial and artisanal fishery data (Sierra Leone Ministry of Fisheries and Marine Resources, pers. comm. to M. Miller, NMFS, 11 April, 2016). Rhinobatos rhinobatos is listed in an updated checklist of the marine fishes of Cape Verde, an island nation located about 600 km west of Dakar, Senegal. However, the authors of the checklist considered the record of R. rhinobatos invalid, stating that they did not know of any records of this species in the Cape Verde Islands (Wirtz et al., 2013).

    Little information about the status of R. rhinobatos was available throughout the rest of this species' Atlantic range. From January 2009 to December 2010, R. rhinobatos was recorded during a study of landings by artisanal fishers based in the Ghanaian villages of Ahwaim and Elmina (Nunoo & Asiedu 2013). Rhinobatos rhinobatos is present in Gabon, but is likely less abundant than R. cemiculus (G. De Bruyne, Wildlife Conservation Society, Mayumba, pers. comm. to B. Newell, NMFS, 26 June, 2016). Rhinobatos rhinobatos was not caught from March 2013 to May 2015 during a study of artisanal fisheries around Mayumba, Gabon (De Bruyne 2015). No information on this species was available from Ghana and Gabon prior to these periods of study. We found no data for R. rhinobatos in the following countries, which have coastline in this species' range: Liberia, Cote d'Ivoire, Togo, Benin, Nigeria, Cameroon, Equatorial Guinea, São Tomé and Príncipe, Republic of the Congo, Democratic Republic of the Congo, and Angola.

    Rhinobatos cemiculus

    Historically, the blackchin guitarfish had a distribution similar to, but slightly more restricted than, R. rhinobatos, with its range listed through most of the coastal Mediterranean, and in the eastern Atlantic from Portugal to Angola (Melendez & Macias 2007). In the Mediterranean, there are no records of this species off the coast of France (Capapé et al., 2006), and there are doubts about whether R. cemiculus occurred in the Adriatic Sea (Akyol & Capapé 2014). Throughout its historical Mediterranean range, this species has likely always been rare in most of the northwestern Mediterranean, and more common in the Levantine Sea and along the southern shore of the Mediterranean from southern Tunisia to Egypt (Rafrafi-Nouira et al., 2015). Presently all guitarfishes have been extirpated from the northwestern Mediterranean including the coast of Spain, as well as from the Tyrrhenian, Ligurian, and Adriatic Seas (Bertrand et al., 2000; Capapé et al., 2006; Medits 2016a; Notarbartolo di Sciara et al., 2007b). In this now curtailed portion of its range, up until the early 20th century, R. cemiculus may have been common in the waters around Sicily (Doderlein 1884; Psomadakis et al., 2009), and frequently occurred around the Balearic Islands of Spain (Notarbartolo di Sciara et al., 2007b).

    Rhinobatos cemiculus commonly occur in fishery landings, both as a target species and as bycatch from the waters of the east coast of Tunisia, the north coast of Africa, and the eastern Mediterranean from Israel to southeastern Turkey (Capape & Zaouali 1994; Lteif 2015; Saad et al., 2006). It is fished throughout all of Tunisian waters. It is considered rare along the north coast of Tunisa, although it may become more common in this area due to warming seas (Rafrafi-Nouira et al., 2015) and environmental restoration (Mejri et al., 2004). It has always been abundant in southeastern Tunisia around the Gulf of Gabès and the Bahiret el Biban, where it is more abundant than R. rhinobatos, and is known to use these areas during reproduction, including for parturition (Capapé et al., 2004; Echwikhi et al., 2013; Echwikhi et al., 2012; Enajjar et al., 2008).

    As with R. rhinobatos, little information is available on the status of R. cemiculus in Libyan waters beyond that they are targeted by fishers (Séret & Serena 2002), and that they are still common, relative to their occurrence in other parts of the Mediterranean (RAC/SPA 2005). Guitarfishes are consumed in Libya, and in a 2005 proposal for a research program focused on the cartilaginous fishes of Libya, R. cemiculus was selected as one of the eight priority species for research because of its commercial importance and interest in its conservation (RAC/SPA 2005). Capapé et al., (1981) reported that an Egyptian museum specimen of R. cemiculus originated from the Red Sea, but no other reference to this species occurring in the Red Sea was reported. We found no information on the distribution or abundance of R. cemiculus in Mediterranean Egyptian waters, but this fish likely occurs in this area (Capape & Zaouali 1994).

    North of Egypt, R. cemiculus is considered prevalent in Israeli waters (less common than R. rhinobatos), where it is caught as bycatch by commercial fishers (Golani 2006). From December 2012 to October 2014, R. cemiculus was the second most common elasmobranch in Lebanese fisheries catches after R. rhinobatos (Lteif 2015). In a study of elasmobranch exploitation in Syria in the early 2000s, R. cemiculus was characterized as a “very economically important species being caught in plentiful quantities and highly consumable” (Saad et al., 2006).

    North of Syria, R. cemiculus is one of the most common elasmobranchs in fisheries landings in İskenderun Bay, Turkey (and more abundant than R. rhinobatos) (Başusta et al., 2012; Keskin et al., 2011). West of İskenderun Bay, R. cemiculus was caught during a 2006 study of shrimp trawl bycatch in Mersin Bay sampling (Duruer et al., 2008). Rhinobatos rhinobatos, but not R. cemiculus, was collected in a 2002-2003 survey of the Karataş Coasts (Çiçek et al., 2014). In the Aegean Sea, R. cemiculus is rare (Corsini-Foka 2009; Filiz et al., 2016). In 2013, two large R. cemiculus were caught in trawls in İzmir Bay, Turkey (eastern-central Aegean), which the authors considered a range expansion for this species (Akyol & Capapé 2014). Further expanding the range of this species, in October 2012 one R. cemiculus was caught near Bursa, Turkey, in the Sea of Marmara, which connects the Aegean Sea and the greater Mediterranean to the Black Sea (C. Mancusi, ARPAT, pers. comm. to B. Newell, NMFS, 23 March, 2016), although this record has not been reported in peer-reviewed literature.

    In the Atlantic, north of the Strait of Gibraltar, the only records we found of this species were from checklists and museum records from Spain and Portugal (Bañón et al., 2010; Carneiro et al., 2014), although Rafrafi-Nouira et al., (2015) noted that north of the Strait of Gibraltar, R. cemiculus was only known off Portugal. This species was not reported in the DATRAS data base (ICES 2016), indicating that they have historically been rare north of the Strait of Gibraltar.

    Along the Atlantic coast of Africa, this species is found from Morocco to Angola. It is likely rare in Moroccan waters (Gulyugin et al., 2006; Serghini et al., 2008). In West Africa, R. cemiculus has been one of most common and widely distributed elasmobranchs in Mauritania, Gambia, Guinea, Guinea-Bissau, Senegal, and Sierra Leone, but it has become scarce throughout most of this portion of its range in recent decades (Diop & Dossa 2011; M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016). In Mauritania, fishing pressure has driven declines in the average size of guitarfishes landed in the Banc d'Arguin National Park from 1998 to 2007, resulting in 95 percent of the landed R. cemiculus being smaller than the size at 50 percent maturity (Diop & Dossa 2011). Restrictions on elasmobranch fishing in the park have allowed guitarfishes to recover locally, but they are still exploited throughout the rest of Mauritanian waters (M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016). In Senegal, guitarfishes are heavily targeted, and this has caused local declines in both species, with substantial declines reported over the period of 1990 to 2005 (Diop & Dossa 2011; M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016; Notarbartolo di Sciara et al., 2007a; Notarbartolo di Sciara et al., 2007b).

    Rhinobatos cemiculus occurs in the waters of Guinea-Bissau off the mainland and around the Bijagós Archipelago, where they are targeted by fishers (Cross 2015; Fowler & Cavanagh 2005; Kasisi 2004; Tous et al., 1998). Rhinobatos cemiculus was one of the elasmobranch species taken in the highest numbers in 1989 during experimental fishing trips (Diop & Dossa 2011). In the late 1990s, rapid and substantial declines of R. cemiculus were reported in the Bijagós Archipelago, as specialized and sophisticated fishing teams targeting elasmobranchs for their fins migrated into the area, although previously the area had seen almost no elasmobranch fishing (Tous et al., 1998). In Guinea, just south of Guinea-Bissau, R. cemiculus is one of the most important fishery species (Diop & Dossa 2011), and it is likely that this species is experiencing declines similar to those in Guinea, Senegal, and Gambia (M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016). In Sierra Leone, this species is one of the most heavily exploited elasmobranchs (Diop & Dossa 2011). It was recorded from 2008 to 2010 in a survey by the Sierra Leone Ministry of Fisheries and Marine Resources as well as in industrial and artisanal fishery data (Sierra Leone Ministry of Fisheries and Marine Resources, pers. comm. to M. Miller, NMFS, 11 April, 2016). Rhinobatos cemiculus is likely not common or exploited in the waters of Cape Verde (Diop & Dossa 2011). Little information about the status of R. cemiculus was available throughout the rest of this species' Atlantic range. From January 2009 to December 2010, R. cemiculus was not recorded in a study of landings by artisanal fishers based in the Ghanaian villages of Ahwaim and Elmina (Nunoo & Asiedu 2013). Rhinobatos cemiculus is present throughout Gabonese coastal waters (G. De Bruyne, Wildlife Conservation Society, Mayumba, pers. comm. to B. Newell, NMFS, 26 June, 2016), and it was reported as bycatch from March 2013 to May 2015 during a study of artisanal fisheries around Mayumba, Gabon (De Bruyne 2015). No information on this species was available from Ghana and Gabon prior to these periods of study. We found no data for R. cemiculus in the following countries with coastline in this species' range: Liberia, Cote d'Ivoire, Togo, Benin, Nigeria, Cameroon, Equatorial Guinea, São Tomé and Príncipe, Republic of the Congo, Democratic Republic of the Congo, and Angola.

    Summary of Factors Affecting the Two Guitarfish Species

    Available information regarding historical, current, and potential threats to these two guitarfishes was thoroughly reviewed (see Newell (2016)). We find that the main threat to these species is overutilization for commercial purposes. This threat is exacerbated by both species' reproductive behavior. Mature adults, including near-term pregnant females, congregate in shallow waters to breed and give birth. This behavior is well understood and exploited by fishers throughout these species' ranges and exposes both species to capture by most demersal fishing gear types (Diop & Dossa 2011; Echwikhi et al., 2013; Echwikhi et al., 2012). Although information on these species' age structure and reproductive capacity is incomplete, it is likely that their reproductive capacity, which may be high compared to some other elasmobranchs, but low compared to most fished species, increases the threat of commercial overutilization to both species. We find that current regulatory mechanisms contribute to the extinction risk of both species because they are inadequate to protect these species from further overutilization. In addition, pollution and development that modifies coastal habitat may be a threat to these species' survival, although the specific effects of these threats are not well studied, so there is significant uncertainty regarding the contribution of pollution and coastal development to the extinction risk of these guitarfishes. We summarize information regarding these threats and their interactions below, with species-specific information where available, and according to the factors specified in section 4(a)(1) of the ESA. Available information does not indicate that recreational fishing, disease, predation, or other natural or manmade factors are operative threats on these species; therefore, we do not discuss these factors further in this finding. See Newell (2016) for a full discussion of all ESA section 4(a)(1) threat categories.

    Present or Threatened Destruction, Modification, or Curtailment of Habitat or Range

    Both R. rhinobatos and R. cemiculus have likely been extirpated from the northwestern Mediterranean. Rhinobatos rhinobatos has likely been extirpated from the Mediterranean coasts of Spain and France, as well as the Tyrrhenian, Ligurian, and Adriatic Seas (Bertrand et al., 2000; Capapé et al., 2006; Medits 2016a). Rhinobatos cemiculus may never have occurred in the Mediterranean waters of France, but it has been extirpated from the Ligurian and Tyrrhenian Seas, the Balearic Islands, and possibly the Adriatic (it is uncertain if it ever occurred there) (Akyol & Capapé 2014; Medits 2016a; Notarbartolo di Sciara et al., 2007a). Throughout the area where both species have been extirpated, we found almost no information on the life-history of either species, including no mention of the presence of different maturity stages or pregnant females. Based on the lack of available information, it appears that both species were rare throughout much of the area where they have been extirpated, with the exception of the Balearic Islands and the waters off Sicily.

    Around the Balearic Islands, both R. rhinobatos and R. cemiculus were frequently observed until at least the early 20th century (Notarbartolo di Sciara et al., 2007a; Notarbartolo di Sciara et al., 2007b). In the Tyrrhenian Sea, especially around Sicily, Rhinobatos spp. was common in commercial trawls in the northern Tyrrhenian as late as the 1960s (Doderlein 1884; Fowler & Cavanagh 2005; Psomadakis et al., 2009). Both species were present daily at the Palermo (northwest Sicily) fish market in the late 19th century, where R. rhinobatos was likely more common than R. cemiculus (Doderlein 1884). The seasonal influx of R. rhinobatos in Sicilian waters (which may also apply to R. cemiculus) described by Doderlein (1884) is similar to the seasonal congregation of breeding adults reported in other portions of both species' ranges.

    Additionally, Doderlein (1884) reported specimens of R. cemiculus that were 170, 180, and 230 cm TL (the largest being male), indicating that these individuals were likely mature. However, there was no discussion of pregnant females, reproduction, or how R. rhinobatos and R. cemiculus used these areas, so there is significant uncertainty regarding how the loss of the populations in Sicilian and Balearic waters, as well as the loss of populations in the rest of the northwestern Mediterranean, could contribute to the extinction risk of either species.

    Although we found no other evidence of extirpations, the best available information indicates significant declines of elasmobranchs in West Africa, with R. rhinobatos and R. cemiculus, which were once common, becoming scarce. This region has already seen the total or near extirpation of sawfishes and the African wedgefish (Diop & Dossa 2011; Fowler & Cavanagh 2005). Given the similarity of these species (relatively large, dorsoventrally flattened, coastal elasmobranchs) to Rhinobatos spp., and the significant fishing pressure in the area, it is reasonable to conclude that R. rhinobatos and R. cemiculus could face the threat of range curtailment in West Africa in the foreseeable future.

    Throughout these species' ranges there is not much information available on the species-specific threats to R. rhinobatos and R. cemiculus habitat. However, in the Mediterranean, the decline of elasmobranch diversity and abundance is well documented, and is attributed in part to habitat destruction and pollution (Carlini et al., 2002; Cavanagh & Gibson 2007; Melendez & Macias 2007; Psomadakis et al., 2009). Mediterranean ecosystems have been shaped by human actions for millennia, perhaps more so than anywhere else on earth (Bradai et al., 2012). Large species that use coastal habitat, especially those species that use these areas as nursery areas (e.g., R. rhinobatos and R. cemiculus), are particularly vulnerable in areas of intensive human activity (Cavanagh & Gibson 2007). The semi-enclosed nature of the Mediterranean increases the effects of pollution and habitat degradation on elasmobranch species and, as a result, the status of elasmobranchs may be worse in the Mediterranean than in other regions of the world (Melendez & Macias 2007; Séret & Serena 2002).

    The Mediterranean Sea receives heavy metals, pesticides, excess nutrients, and other pollutants in the form of run-off (Melendez & Macias 2007; Psomadakis et al., 2009). As long-lived predators, large elasmobranchs are significant bioaccumulators of pollutants (Melendez & Macias 2007). No information is available on the bioaccumulation of pollutants in the tissues of Rhinobatos spp. in the Mediterranean Sea, but other elasmobranchs, such as the spiny dogfish and the gulper shark, have shown high concentrations of toxins (Melendez & Macias 2007). A study of the accumulation of trace metals cadmium, copper, and zinc in fish along the Mauritanian coast showed low levels of bioaccumulation of these metals in the tissues of R. cemiculus compared to bony fishes. It should be noted that three specimens of R. cemiculus were the only elasmobranchs collected in this study, and that, in contrast with the Mediterranean, the trace metals in the area of the study are thought to be primarily natural in origin (Sidoumou et al., 2005).

    Pollution, habitat degradation, and development in the coastal zone are also of concern in some African countries within these species' ranges (Diop & Dossa 2011; Kasisi 2004). While pollution is a concern in portions of both species' ranges, the effects of pollution on elasmobranchs and marine food webs are not well understood (Melendez & Macias 2007). We found no information describing how marine pollution affects Rhinobatos spp., so the contribution of marine pollution to these species' extinction risk is unknown.

    The significant demersal trawling that occurred and continues to occur throughout the Mediterranean range of the two Rhinobatos species (Edelist 2014; FAO 2016b; Sacchi 2008), and to a lesser extent throughout their Atlantic range (Diop & Dossa 2011), has likely altered seafloor morphology (Puig et al., 2012). In some important reproductive areas for Rhinobatos spp., such as the southeast coast of Turkey, intense trawling pressure has occurred over recent decades in depths less than 70 m (Çiçek et al., 2014). However, we found no information that this habitat modification has had a direct effect on the abundance or distribution of these two species. Additionally, trawl fishing within three nautical miles of the Mediterranean coast has been prohibited since 2012 in order to protect coastal elasmobranch species (FAO 2016e).

    Some information shows that these species are sensitive to habitat modification. Psomadakis et al., (2009) attributed the extirpation of Rhinobatos spp. from the northwestern Mediterranean to the combination of centuries of human development and fishing pressure. Additionally, both species returned to the Northern and Southern Tunis Lagoons in Tunisia after large scale restoration of the area (Mejri et al., 2004). Prior to restoration, the lagoons had undergone significant anthropogenic hydrological modification and been extremely polluted from sewage input and industrial waste (Noppen 2003). After restoration was completed in 2001, R. cemiculus was recorded for the first time, and R. rhinobatos, which had previously been rare, became common (Mejri et al., 2004). Based on the available information, it is likely that pollution and modification of habitat contribute to the risk of extirpation of both species from portions of their range. However, because of the lack of information on the pollution and habitat modification throughout their entire ranges, and because there is no information on the direct effects of these threats to either species, the degree of the contribution of these factors to the extinction risk of both species is unknown at this time.

    Overutilization for Commercial Purposes

    The primary threat to both of these species is commercial overutilization. This threat is difficult to quantify, as fisheries data on elasmobranch landings throughout both species' ranges has been drastically underreported (Clarke et al., 2006; Diop & Dossa 2011; FAO 2016a). When elasmobranch catches have been reported, it was generally not reported at the species level (Bradai et al., 2012; Echwikhi et al., 2012). However, based on surveys of fishers' knowledge, museum records, and analysis of scientific surveys of the northern Mediterranean, it appears that commercial overutilization has been the main driver of both species' extirpation from the northwestern Mediterranean, and their decline in abundance in other regions (Baino et al., 2001; Bertrand et al., 2000; Capapé et al., 2006; Carlini et al., 2002; Diop & Dossa 2011; Echwikhi et al., 2012; Psomadakis et al., 2009).

    The overutilization of these species is not concentrated in one area or fishery. Throughout portions of their ranges, they are, or were until recently, targeted for their fins, meat, or both (G. De Bruyne, Wildlife Conservation Society, Mayumba, pers. Comm. to B. Newell, NMFS, 26 June, 2016; Diop & Dossa 2011; Echwikhi et al., 2012). Throughout their ranges, there is great diversity in fisheries and in the types of gear used (Diop & Dossa 2011; FAO 2016b). As bycatch, R. cemiculus and R. rhinobatos are particularly exposed to fishing pressure from demersal trawl, gillnet, and longline fisheries (Cavanagh & Gibson 2007; Echwikhi et al., 2013; Echwikhi et al., 2012; FAO 2016d).

    In West Africa, both species have been targeted by the shark fin fishery, which has led to both species becoming scarce in this region after a few decades of targeted fishing (Diop & Dossa 2011; Fowler & Cavanagh 2005). The explosion of the Chinese middle class at the end of the last century led to a rapid increase in demand for shark fin soup, a traditional Chinese dish desired for its alleged tonic properties and, most importantly, because it has served as an indicator of high societal status for centuries. Shark fins are one of the highest value seafood products in the world, especially compared to shark meat, which is widely regarded as low value (Dulvy et al., 2014; Hareide et al., 2007b). The value and quality of shark fins are judged by the thickness and length of the ceratotrichia, or fin needles, and based on this valuation system, guitarfishes have some of the most valuable elasmobranch fins (Hareide et al., 2007b).

    The majority of the commercial harvest information available for these species in the Atlantic pertains to the FAO Subregional Fisheries Commission (SRFC) member countries: Mauritania, Senegal, Gambia, Guinea, Guinea-Bissau, Sierra Leone, and Cape Verde. Outside of the SRFC countries, we also found information on fisheries in Morocco, Ghana, and Gabon. We found no data for either species in the following countries, which have Atlantic coastline that is considered in one or both species' ranges: France, Spain, Portugal, Liberia, Cote d'Ivoire, Togo, Benin, Nigeria, Cameroon, Equatorial Guinea, São Tomé and Príncipe, Republic of the Congo, Democratic Republic of the Congo, and Angola.

    In the SRFC region, elasmobranchs, including R. rhinobatos and R. cemiculus, have historically been extremely abundant (Diop & Dossa 2011). Prior to the 1970s, elasmobranchs were primarily taken as bycatch and processed for sale to meet local demand. There was a small market for salted and dried elasmobranch meat, based in Ghana that fueled trade for elasmobranch bycatch through the SRFC region, including for guitarfishes caught in Senegal and Gambia. However, compared to other fishery products, shark meat had very low value, so there was little economic incentive to develop a targeted fishery. Elasmobranch fishing in the SRFC region began to grow in Senegal and Gambia in the 1970s, and then, fueled by the growing demand for shark fins, developed into a robust and unsustainable shark fishery by the early 1980s. To supply the shark fin export industry, specialized shark fishing teams became increasingly common in the SRFC region. These teams of artisanal fishers migrate into new areas along the west coast of Africa as local elasmobranch resources become locally overexploited (Diop & Dossa 2011; Ducrocq & Diop 2006). As the fishery became more migratory, the increase in fishing effort drove the need to maximize profits, further encouraging the unsustainable, wasteful practice of finning (Diop & Dossa 2011; Tous et al., 1998). In recent decades the demand for elasmobranch meat, which was once considered a low value product, has grown, which provided additional economic incentive for growth in the shark fishery in the SRFC region (Clarke et al., 2007; Dent & Clarke 2015).

    The SRFC subregion's international elasmobranch fishing industry is composed of industrial and artisanal fishing vessels, coastal processing facilities, and a robust trade network. Vessels are owned both by local fishermen and foreign investors (primarily Spanish). Owners have financed improvements in fishing technology (e.g. more advanced boats and nets) as yields have declined. Guitarfishes are also targeted from shore, such as by fishers using beach-based “`guitar lines” in Mauritania. In the SRFC region, elasmobranch fishing effort steadily increased since the 1970s, with landings peaking in the early 2000s, and then showing a significant and ongoing drop. Throughout the region (with the exception of Cape Verde, an offshore island nation where neither species are abundant), “resources seem to be fully exploited, if not overexploited, for almost all selachian1 species” (Diop & Dossa 2011; Ducrocq & Diop 2006). Because Rhinobatos spp. have also been heavily targeted for their highly valuable fins in the SRFC region for decades, this status of full or overexploitation likely also applies to guitarfishes in the SRFC region (Diop & Dossa 2011; M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016).

    1i.e. sharks.

    In the SRFC region, Diop and Dossa (2011) report the importance of one or both R. rhinobatos and R. cemiculus to local elasmobranch fisheries in all member countries except Gambia and Cape Verde. Fishers throughout this region time their fishing activities with the migration patterns and reproductive behavior of both species, targeting guitarfishes when they return to the shallows to give birth (Ducrocq & Diop 2006). In Mauritania, R. cemiculus is one of the three elasmobranch species taken in highest numbers (Diop & Dossa 2011; M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016). In Guinea-Bissau and Guinea, R. cemiculus is listed as one of the few species listed as “most important landings” and “taken in the highest numbers,” respectively. In Sierra Leone, “Rhinobatos spp. and Dasyatis spp. (stingrays) are found in the highest numbers, both in terms of weight and number.” In Senegal, both species, along with coastal sharks, are the main fisheries targets (Diop & Dossa 2011). Diatta et al., (2009) also found that guitarfishes were some of the primary elasmobranchs targeted by the robust artisanal fishery in Senegal, where finning is prevalent, and these fishes were caught when they returned to shallow waters to breed.

    While the shark fin industry has been the major driver for elasmobranch declines in the SRFC countries, it is not the sole driver of overutilization of R. rhinobatos and R. cemiculus. The region has also experienced heavy population shifts in recent decades, primarily from people migrating to the coast, and this has put increased demand on all marine resources. Additionally, fisheries reporting in the area is inadequate, and there is significant bycatch in the industrial fishing industry (Diop & Dossa 2011). In addition to reported harvest, since 1980, the African Atlantic coast has experienced extremely high rates of illegal, unreported, and unregulated (IUU) fishing, including in shallow areas where both guitarfish species are vulnerable to capture (Agnew et al., 2009; Greenpeace 2015).

    As a result of the decades of sustained and widespread targeting of guitarfishes and other elasmobranchs in the SRFC region, combined with the increasing overall fishing effort, there has been an overall decrease in catch, with some species, such as sawfishes, lemon sharks and the African wedgefish, almost completely disappearing (Diop & Dossa 2011), and some species, including guitarfishes, becoming scarce (Diop & Dossa 2011; M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016; Ducrocq & Diop 2006). Based on survey and fisher interview data collected by the IUCN Guinea-Bissau Programme and the National Centro de Investigacao Pesqueira Applicada, both guitarfishes were the main targets of specialized fishing teams in Guinea-Bissau, and landings had declined substantially as of the late 1990s (Fowler & Cavanagh 2005; Tous et al., 1998). This fishing pressure also drove down the average size of R. rhinobatos landed (Notarbartolo di Sciara et al., 2007b). According to unpublished data from the Senegalese Ministry of Maritime Economy and International Maritime Transportation, guitarfish landings in Senegal have decreased from 4,050 t in 1998 to 821 t in 2005, with a reduction in the overall size of specimens landed (Notarbartolo di Sciara et al., 2007a). Diop and Dossa (2011) reported that, because of overexploitation in the Banc d'Arguin National Park in Mauritania, 95 percent of landed R. cemiculus were smaller than their size-at-maturity, which was likely impacting their reproductive capacity. A ban on shark fishing in Banc d'Arguin National Park has allowed guitarfishes to recover within the park's boundaries, but both species are still heavily targeted outside of the park (M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016).

    While Diop and Dossa (2011) characterized one or both species as being important, or landed in high numbers, in fisheries in Senegal, Mauritania, and Guinea-Bissau, the authors did not state a time period for these characterizations. As just discussed, significant declines in the overall abundance of guitarfishes have been reported in all of these countries (Diop & Dossa 2011; M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016; Fowler & Cavanagh 2005; Notarbartolo di Sciara et al., 2007a; Notarbartolo di Sciara et al., 2007b) as well as substantial reported declines in landings of larger, more fecund, individuals of both species in Guinea-Bissau, Senegal (Notarbartolo di Sciara et al., 2007a; Notarbartolo di Sciara et al., 2007b) and Mauritania (Diop & Dossa 2011). Similar trends are likely in Guinea and Gambia (M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016). Because of the migratory fisheries in the SRFC countries, and the reported scarcity of guitarfishes throughout the area (Diop & Dossa 2011), it is reasonable to assume similar declines have occurred or will occur in Sierra Leone.

    In Morocco, both species are likely rare; they are not targeted, but at least R. rhinobatos occurs as demersal trawl bycatch (Notarbartolo di Sciara et al., 2007b). We found no information on the commercial exploitation of Rhinobatos spp. in Morocco but, in general, Moroccan fisheries are likely in a state of overexploitation after years of intense and extremely underreported fishing activity by foreign vessels (Belhabib et al., 2012b; Jouffre & Inejih 2005). In Ghana, where the artisanal fishing industry is an important and entrenched part of the economy, the demand for dried and salted elasmobranch meat was an early driver of the regional elasmobranch industry (Diop & Dossa 2011; Ducrocq & Diop 2006; Nunoo & Asiedu 2013), and R. rhinobatos, but not R. cemiculus, was recently reported in artisanal fisheries landings (Nunoo & Asiedu 2013). The demersal fisheries resources of Ghana have been “operating under stress during the last decades” (Nunoo & Asiedu 2013). Artisanal fishers from Ghana, as well as from neighboring Togo and Benin, have migrated to other countries' fishing grounds along the west coast of Africa, likely because fishing grounds in these fishers' countries have been overexploited, overcrowded, or both (De Bruyne 2015; Diop & Dossa 2011).

    In Gabon, both species are present in coastal waters, and are targeted by artisanal fishers using specialized gear for their meat and to supply the black market fin trade, which is connected to the West African fin trade. Both species are also targeted by recreational fishers (G. De Bruyne, Wildlife Conservation Society, Mayumba, pers. comm. to B. Newell, NMFS, 26 June, 2016). In the area of the village of Mayumba in southwest Gabon, R. cemiculus was the most frequent batoid species captured by artisanal fishers from 2014 to 2015 (R. rhinobatos is not mentioned). This catch included no mature females, which was noted by the author as an indicator that fishing has had a negative impact on the reproductive capacity of this species in the area. Although the author noted the absence of pregnant females, he did not discuss whether pregnant females had previously been recorded in the area. “Sea fishing” began around Mayumba in the 1950s with the arrival of fishers from Ghana, Benin, and Togo, many of whom had been crowded out of fishing grounds in the Republic of the Congo. Until recently, this area experienced unsustainable industrial and IUU fishing. In this area, there has also long been subsistence fishing by locals in the Banio Lagoon, where sharks and rays were prevalent 30 years ago, but today are almost impossible to catch (De Bruyne 2015). Based on this information, it appears that overutilization has caused a decline in abundance and reproductive capacity of R. cemiculus in at least part of Gabonese waters.

    In contrast with the relatively recent and rapid exploitation of guitarfishes in the African Atlantic, primarily driven by the demand for shark fins, finning is not widely practiced in the Mediterranean (Hareide et al., 2007a; Serena 2005). Instead, in the Mediterranean these species have been impacted by the centuries of sustained fishing pressure coupled with recent increases in fishing effort and fishing technology advances (Ferretti et al., 2008; Psomadakis et al., 2009). As evidence of both species' decline, R. rhinobatos and R. cemiculus have been listed on Annex II: List of Endangered or Threatened Species of the Protocol Concerning Specially Protected Areas and Biological Diversity in the Mediterranean (SPA/BD Protocol) of the Barcelona Convention since 2012. The SPA/BD Protocol prohibits the landing of these species in the Mediterranean and requires that they “must be released unharmed and alive to the highest extent possible.” We found no studies on the survival rates of guitarfishes after being released from fishing gear interactions, so the potential of this requirement to reduce fishing mortality is unknown.

    General Fisheries Commission for the Mediterranean (GFCM) recommendation GFCM/36/2012/3, which is associated with the SPA/BD Protocol (see Inadequacy of Existing Regulatory Mechanisms), also prohibits trawling within three nautical miles of the shoreline, greatly reducing the likelihood that these coastal fish will be caught as bycatch. Recommendation GFCM/36/2012/3 also prohibits finning and the landing of elasmobranchs without their heads and skins, thus protecting these fish from illegal sale (FAO 2016e)(Hareide et al., 2007a; Serena 2005). We found no information on the current level of IUU fishing on these species in the Mediterranean, so it is difficult to assess the impact of these prohibitions. Recent information from Tunisia, Lebanon, and Egypt indicates that the fisheries in these countries are inadequately regulated (Echwikhi et al., 2013; Echwikhi et al., 2012; Lteif 2015; A. Marbourk, NOS, pers. comm. to B. Newell, NMFS, 21 July, 2016; Samy-Kamal 2015).

    Regardless of the efficacy of the SPA/BD Protocol prohibitions, the historical fishing pressure on R. rhinobatos and R. cemiculus has driven declines in abundance throughout much of the Mediterranean (Baino et al., 2001; Bertrand et al., 2000; Capapé et al., 2006; Diop & Dossa 2011; Notarbartolo di Sciara et al., 2007a; Notarbartolo di Sciara et al., 2007b; Psomadakis et al., 2009). The area has a long history of fishing pressure, which has not abated in recent decades (Ferretti et al., 2008). Better technology and increased fishing effort, including increased benthic continental shelf and slope trawling over the last 50 years, has resulted in the decline of many elasmobranch species (Bradai et al., 2012). In the northwestern Mediterranean, sustained and intensive fishing pressure has been a main driver of the extirpation of Rhinobatos spp. (Bradai et al., 2012; Capapé et al., 2006; Psomadakis et al., 2009; Sacchi 2008). The highest concentration of fishing vessels in the Mediterranean occurs in the Eastern Mediterranean Sea and the Ionian Sea GFCM subregions, which make up the majority of the current Mediterranean ranges of Rhinobatos spp. Turkey, which appears to have some of the largest concentrations of R. cemiculus along its southern coast, also has the most fishing vessels with 16,447 vessels (17.74 percent of vessels in the Mediterranean). However, some of these vessels fish in the Black Sea, where neither species is found, or in the Aegean Sea, where these species are rare (FAO 2016b).

    Between 1970 and 1985, reported Mediterranean and Black Sea chondrichthyan landings (which includes both guitarfishes) grew from 10,000 t to 25,000 t, and then declined to about 7,000 t annually in 2008 despite growing fishing effort (Bradai et al., 2012; Cavanagh & Gibson 2007; Hareide et al., 2007). During this time, Tunisia and Turkey were two of the most prolific Mediterranean elasmobranch fishing countries. As of 2007, there were six Mediterranean elasmobranchs affected by targeted fisheries. Historically, many more species had been targeted or landed in large quantities, but this number has been reduced because these fisheries are no longer commercially viable (Cavanagh & Gibson 2007; FAO 2016d; Ferretti et al., 2008). In a few areas in the Mediterranean, R. rhinobatos and R. cemiculus are or were targeted or considered a valuable secondary catch. Additionally, the global demand for elasmobranch meat has grown rapidly in recent decades, with the reported production of meat and fillets growing from approximately 40,000 tons in 1985 to 121,641 tons in 2004 (Clarke et al., 2007; Dent & Clarke 2015), potentially providing economic incentive to retain these species as targeted or incidental catch.

    The primary Mediterranean area where R. rhinobatos and R. cemiculus have been fished is the waters of Tunisia, where seasonal artisanal fishers target elasmobranchs with gillnets and longlines when they move into shallow waters in the spring and summer (Echwikhi et al., 2013; Echwikhi et al., 2012). Rhinobatos spp. meat is sold in local markets and the skin is used for drumheads by local players (Capape & Zaouali 1994). In Tunisian waters R. cemiculus is landed in greater numbers than R. rhinobatos (Capape & Zaouali 1994; Echwikhi et al., 2013; Echwikhi et al., 2012), although species-specific data and reliable discard data are largely unavailable (Echwikhi et al., 2012). Data on fishing vessels are underreported, especially in Tunisia and Morocco. However, based on the available data, the Tunisian fleet is composed of 12,826 reported vessels, or 14.91 percent of the 92,734 vessels reported in the Mediterranean and Black Sea, making it the third largest Mediterranean and Black Sea fishing fleet. Since 1970, when total fisheries landings in Tunisia were about 25,000 tons, there has been a steady increase in landings, reaching an average of 101,400 t from 2000to 2013. Additionally, Tunisia has one of the youngest fishing fleets in terms of vessel age, indicating a relatively recent increase in fishing capacity. As is the case throughout the Mediterranean, the vast majority of the Tunisian fishery is composed of artisanal vessels (FAO 2016b). While elasmobranch landings have dropped overall in southern Tunisia (Echwikhi et al., 2013; Echwikhi et al., 2012), an assessment from the Workshop on Stock Assessment of Selected Species of Elasmobranchs in the GFCM area found that the southern Tunisian R. cemiculus stock was actually underfished from 2001-2007 (GFMC:SAC 2012).

    Targeted fishing for guitarfishes in Tunisia likely began in the 1970s to mid-1980s (Capapé et al., 2004; Echwikhi et al., 2013). The majority of Tunisian elasmobranch catches have been from the Gulf of Gabès (Bradaï et al., 2006; Echwikhi et al., 2013; Echwikhi et al., 2012), where general elasmobranch landings and batoid landings steadily increased during the 1990s, peaked in 2002, and decreased from 2003 to 2008 (trend data are not available after 2008) (Echwikhi et al., 2012). Guitarfishes were targeted with special gillnets called “garracia,” with catches peaking in the spring and summer when females move into shallow waters to gestate and give birth. Adults, juveniles, and neonates have also been caught as bycatch in demersal fish and shrimp trawls (Bradaï et al., 2006). In a study of elasmobranch gillnet fishing in the Gulf of Gabès from 2007 to 2008, R. cemiculus was the most abundant elasmobranch caught. R. cemiculus and R. rhinobatos were 52 percent and 6.81 percent of the total elasmobranch catch, respectively. Female R. cemiculus (40 percent mature) and R. rhinobatos (48 percent mature) were more common than males. The authors of this study noted that R. cemiculus is particularly susceptible to capture in bottom gillnets because of its shape and schooling behavior (Echwikhi et al., 2012).

    In recent years, Gulf of Gabès fishermen who had targeted grouper using demersal longlines have shifted to targeting elasmobranchs as grouper abundance has declined, although in this fishery elasmobranchs were still reported as bycatch (Echwikhi et al., 2013). The first study of elasmobranch catches in this longline fishery, conducted from 2007 to 2008, found that R. cemiculus was the most abundant elasmobranch, with R. cemiculus and R. rhinobatos composing 31.7 percent and 11.2 percent of the elasmobranch catch, respectively. Mature, pregnant females dominated the R. cemiculus catch, while males and females were about equal for R. rhinobatos, with slightly more mature individuals than juvenile individuals caught. This study found that longline fishing effort during this time period was “considerable” (Echwikhi et al., 2013). Enajjar et al., (2008) found a decrease in the overall TL and TL at 50 percent maturity for male and female R. rhinobatos in southern Tunisia, compared to the results reported by Capape et al., (1975, 1997). The reported decrease in R. rhinobatos, compared to the relatively recent GFCM:SAC (2012) stock assessment that found R. cemiculus was underfished in this area, may indicate that only the Tunisian population of R. rhinobatos is experiencing levels of fishing pressure that contribute to its risk of extinction. There is significant uncertainty with this conclusion because of the limited information available.

    Just east of the Tunisian border, there are artisanal gillnet and longline elasmobranch fisheries based in Tarwah, Libya, that, as of 2000, primarily targeted sharks of the family Carcharhinidae, with guitarfishes and angelsharks retained as associate target species (Lamboeuf et al., 2000). This information was reported in Appendix VI of Lamboeuf et al., (2000), which provided an example of the project's database printout, rather than a complete picture of guitarfish retention in Libya, and we found no additional information on guitarfish catch in this country. According to the RAC/SPA (2005) research proposal, guitarfishes have been traditionally consumed in Libya, and some species that have declined in the greater Mediterranean, including guitarfishes, are still relatively common in Libyan waters. The effects of targeted fishing in Libya on the extinction risk of these species are unknown at this time.

    Along the eastern Mediterranean, guitarfishes are illegally targeted in Lebanon by artisanal fishers. From December 2012 to October 2014, R. rhinobatos was the most common elasmobranch in Lebanese fisheries catches, followed by R. cemiculus, and both have had significant economic value. Fishing pressure in Lebanon is greatest in the north, where it has already impacted elasmobranch diversity (Lteif 2015). In a study of elasmobranch exploitation in Syria in the early 2000s, R. cemiculus was characterized as a “very economically important species being caught in plentiful quantities and highly consumable,” whereas R. rhinobatos was characterized as a “moderate economically important species either for being caught in little quantities with high efforts in fishing, or for their little demand for human consumption. Or maybe for both reasons” (Saad et al., 2006). It is unclear if R. cemiculus is more common or if there is a higher demand for its meat over that of R. rhinobatos, but these data indicate that both species were either targeted or welcomed as secondary catch in Syria. Overall fisheries landings in Lebanon and Syria increased since the 1970s, but their reported landings only make a small fraction of the overall Mediterranean catch (FAO 2016c).

    Throughout their entire Mediterranean ranges, R. cemiculus and R. rhinobatos have long been exposed to pressure as bycatch (Bradai et al., 2012). Rhinobatos cemiculus is one of the most commonly landed elasmobranchs in İskenderun Bay, Turkey (and more abundant than R. rhinobatos) (Başusta et al., 2012; Keskin et al., 2011), where the coastal area is heavily fished, exposing mature, breeding individuals to capture when they migrate to shallow waters (Başusta et al., 2008). Rhinobatos spp. are not commercially important species in Turkey (Keskin et al., 2011), but Çek et al., (2009) reported that R. rhinobatos has been exploited by bottom trawlers in İskenderun Bay since 1990, and it is consumed locally. The same is likely true for R. cemiculus. After Egypt, Turkey has the highest number of registered trawlers in the Eastern Mediterranean, with 599 vessels (FAO 2016b). While some of these trawlers are concentrated in the Black Sea (FAO 2016b), the southeastern waters of Turkey, including İskenderun Bay, have been intensely fished for decades and have shown obvious signs of decline in biodiversity and fish abundance (Çiçek et al., 2014).

    In Egypt, Mediterranean fisheries landings have generally been growing since the 1970s, as fishing technology has advanced and fishing effort has increased. There have been periods where landings dropped despite continued increases in fishing efforts (FAO 2016c; Samy-Kamal 2015). As a result there has been an increase in the landings of and demand for cartilaginous fishes bycatch, with guitarfishes (not reported at the species level) composing the majority of these landings, primarily as bycatch from shrimp trawls. Prior to 2005, shark and ray bycatch were usually discarded. From 2005 to 2006, landings of cartilaginous fishes jumped from around 500 tons to over 3,000 tons. Over the last 10 years, this production has remained high, although recently it decreased from over 3,000 tons annually in 2010 and 2011, to 1,843 tons in 2014 in spite of sustained fishing effort (A. Marbourk, NOS, pers. comm. to B. Newell, NMFS, 21 July, 2016). Most of the landings in Egypt occur in the Nile Delta region, which is highly suitable for trawling and includes Alexandria, where R. rhinobatos is known to aggregate in shallow waters to give birth (Abdel-Aziz et al., 1993; Samy-Kamal 2015). Within this region, almost 80 percent of the cartilaginous fish production is landed at two ports, Alexandria and Borg El Burullus (A. Marbourk, NOS, pers. comm. to B. Newell, NMFS, 21 July, 2016). Wild-caught fisheries in Egypt have been regulated for decades, but these regulations have been under-enforced, as the government has focused on developing the booming aquaculture industry. Additionally, regulations have not been updated to reflect the GFCM recommendations, which are apparently also not being enforced. This lack of enforcement has resulted in rampant IUU fishing in Egyptian waters, including unsustainable trawling and the use of illegal fishing gear (Samy-Kamal 2015). The lack of fishing regulations and enforcement has resulted in widespread declines in Egyptian fisheries, including in elasmobranch populations, and is likely also affecting neighboring countries, as Egyptian fishers are known to illegally fish in Libyan waters (A. Marbourk, NOS, pers. comm. to B. Newell, NMFS, 21 July, 2016).

    In the waters of Cyprus, there was a large increase in coastal trawl fishing effort in the late 1980s. From 1985 to 1990, there was a spike in elasmobranch capture, primarily of dogfish, skates, and rays, followed by a sharp decline in capture after 1990. In response to a government fishing permit buy-back program, trawling effort has reduced substantially since the early 2000s (Hadjichristophorou 2006). In Israel, reported landings are low, approximately at the levels reported for Syria and Lebanon, and have been decreasing for decades (FAO 2016c), although Edelist (2014) considered the soft-bottomed habitat off Israel to be under intensive fishing pressure. Guitarfish are caught as bycatch by local fishermen, but there is little market for elasmobranch products because they are not kosher, thus their consumption is forbidden by Jewish law. Elasmobranch species are primarily caught as bycatch by local fishermen using trawls and bottom long-lines, and also purse seines and trammel nets (Golani 2006). Rhinobatos rhinobatos are considered common in the area, while R. cemiculus is prevalent but less abundant than R. rhinobatos (Edelist 2014; Golani 2006).

    The magnitude of the threat to R. rhinobatos and R. cemiculus from commercial overharvest is impossible to fully assess because of the lack of fisheries data, especially at the species level, from all countries in which these species occur. However, the best available information shows (1) fishery driven extirpation of Rhinobatos spp. from the northwestern Mediterranean (Capapé et al., 2006; Psomadakis et al., 2009); (2) decreasing elasmobranch landings due to decades of technological advances and increased fishing effort (Cavanagh & Gibson 2007; Diop & Dossa 2011; Melendez & Macias 2007; Séret & Serena 2002); (3) substantial decreases in the abundance of both species in West Africa (Diop & Dossa 2011); (4) considerable fishing effort in demersal fisheries concentrated in coastal areas where both species, especially reproductive individuals, are particularly vulnerable to capture (Çiçek et al., 2014; Diop & Dossa 2011; Echwikhi et al., 2013; Echwikhi et al., 2012; Samy-Kamal 2015); (5) sustained targeting of these species as commercially important species (Diop & Dossa 2011; Echwikhi et al., 2013; Echwikhi et al., 2012; Lteif et al., 2016; Saad et al., 2006); and (6) evidence of fishery driven size reduction (Diop & Dossa 2011; Enajjar et al., 2012). Based on this information, we conclude that overharvest from industrial and artisanal commercial fisheries is contributing significantly to the extinction risk of both R. rhinobatos and R. cemiculus throughout their ranges.

    Inadequacy of Existing Regulatory Mechanisms

    There are some regional and national regulatory mechanisms that impact the conservation status of these species. In 2009, both species were listed on SPA/BD Protocol Annex III: List of Species Whose Exploitation is Regulated, which was adopted under the Barcelona Convention in 1995 (Bradai et al., 2012). In 2012, both species were uplisted to Annex II: List of Endangered or Threatened Species (S. de Benedictis, GFCM Secretariat, pers. comm. to B. Newell, 12, May, 2016). The protocol charges all parties with identifying and compiling lists of all endangered or threatened species in their jurisdiction, controlling or prohibiting (where appropriate) the taking or disturbance of wild protected species, and coordinating their protection and recovery efforts for migratory species, among other measures that are likely less relevant to these species (RAC/SPA 1996). Currently, all coastal Mediterranean countries where these species occur are contracting parties to the SPA/BD Protocol (European Commission 2016). Further, since 2012, both species have been protected by GFCM recommendation GFCM/36/2012/3. This recommendation prohibits the finning of elasmobranchs or the beheading or skinning of elasmobranchs before landing, and it prohibits trawling in the first three nautical miles off the coast or up to the 50 m isobaths (whichever comes first). Additionally, Annex II elasmobranch species cannot be retained on board, transshipped, landed, transferred, stored, sold or displayed or offered for sale, and must be released unharmed and alive to the extent possible (GFCM/36/2012/3). Any capture of these species in the GFCM area of competence, which includes all national and high seas waters of the Mediterranean and Black Seas (FAO 2016f), is considered IUU fishing (S. de Benedictis, GFCM Secretariat, pers. comm. to B. Newell, 12, May, 2016).

    In the Mediterranean, the efficacy of these and other protections is unclear, but it appears that countries have historically been slow to adopt and enforce the SPA/BD Protocol protections (Serena 2005). Italy, Greece, and Lebanon have promulgated regulations in accordance with the SPA/BD Protocol to protect species listed in Annex II (Bradai et al., 2012; Lteif 2015), Tunisia has restricted the retention of rays and skates less than 40cm, and all cartilaginous fishes are protected in Israel (Bradai et al., 2012). In Lebanon, these regulations are neither being followed nor enforced (Lteif 2015). Historically, monitoring of the Mediterranean fleet has been negligible (Séret & Serena 2002), and the data on cartilaginous fishes have not been reported at the species level (Echwikhi et al., 2012; Serena 2005). Vessel, bycatch, and discard data from artisanal fisheries, which primarily operate along the coast and make up 80 percent of the vessels in the Mediterranean, are difficult to obtain and likely underreported (FAO 2016c, 2016d). Echwikhi et al., (2012) and Echwikhi et al., (2013) describe the nature of artisanal gillnet and longline fisheries in Tunisia and the Mediterranean as “unregulated.” In Lebanon, Turkey, and Tunisia the artisanal sector makes up well over 80 percent of the total vessels, and no data were available for Syria (FAO 2016c), increasing the likelihood that fisheries in these important portions of Rhinobatos spp. range are underregulated and catches are underreported.

    In Egypt, which is also an important part of the range of at least R. rhinobatos, the wild catch fisheries are underregulated as the government has focused most of its resources on supporting the booming aquaculture industry (Samy-Kamal 2015). This lack of regulation and enforcement has led to widespread overfishing in Egyptian waters, where both guitarfish species have been retained as profitable bycatch species since 2005, and Egyptian fishers are known to illegally fish in Libyan waters because of the overexploited state of local Egyptian fisheries. Additionally, the focus on aquaculture production has resulted in the pollution of coastal brackish lakes, which degrades coastal ecosystems (A. Marbourk, NOS, pers. comm. to B. Newell, NMFS, 21 July, 2016).

    In the Atlantic African countries, as in the Mediterranean, artisanal fishing makes up a huge, growing proportion of the fishing activity. Until recently, this fishing sector has lacked species-specific data and strong management or regulations (De Bruyne 2015; Diop & Dossa 2011; Nunoo & Asiedu 2013). Along the Atlantic coast of Africa, all of the SRFC countries have passed regulations that offer some protection to either or both species. Cape Verde, Guinea, Gambia, and Sierra Leone have all banned finning. Mauritania has banned all elasmobranch fishing (except for houndshark) in Banc d'Arguin National Park since 2003. Guinea and Sierra Leone have introduced elasmobranch fishing licenses. Guinea-Bissau dismantled elasmobranch fishing camps in the Bijagos Archipelago and banned elasmobranch fishing in all marine protected areas (MPAs). Senegal established size limits for R. cemiculus (106 cm for males and 100 cm for females). However, all of the SRFC countries lack adequate technical and financial resources for monitoring and management, and regulations at the country level are not very strict and lack regional coordination (Diop & Dossa 2011). Whether these regulatory protections put in place in the SRFC countries are reducing the extinction risk of these species is unknown at this time.

    In Gabon, a national marine planning effort called “Gabon Bleu,” which was established in 2012, seeks to improve management of marine resources across different stakeholder groups, including artisanal and industrial fishing. The country's 2005 Fisheries Code had established regulations that were not being followed, with reported non-compliance including the disconnection of vessel monitoring systems and the use of illegal monofilament nets by artisanal fishers. In 2012, under Gabon Bleu, all fishing activity was suspended, and all fishers who wished to resume work were required to sign an agreement that clearly defined the regulations and required their participation in fisheries research. Several arrests were made as a result of a crackdown on IUU fishing that included increased surveillance (De Bruyne 2015). Additionally, both species are considered “sensitive species” and cannot be targeted by fishers. Unfortunately, these regulations have not eliminated the black market for fins, so guitarfishes are still being targeted by artisanal fishers and illegally finned by demersal trawl fishers (G. De Bruyne, Wildlife Conservation Society, Mayumba, pers. comm. to B. Newell, NMFS, 28 June, 2016). In Mayumba National Park, only artisanal fishers have been allowed to operate, and sharks are no longer targeted (De Bruyne 2015). Recent efforts to improve monitoring of artisanal catches have also been made in Ghana (Nunoo & Asiedu 2013). Republic of the Congo, which shares Gabon's southern border, banned all shark fishing along its entire coastline in 2001 (Marine Conservation Institute 2016), although we found no information on the enforcement of this ban.

    IUU fishing by foreign fleets is also a major challenge for sustainable fisheries management in Africa. The west coast of Africa has experienced some of the highest amounts of IUU fishing in the world for decades (Agnew et al., 2009). Historically, EU vessels had fished unsustainably off African countries (Agnew et al., 2009; Belhabib et al., 2012a), but recent regulatory updates, such as the reform for the European Union Common Fisheries Policy (CFP), have curbed these practices (Greenpeace 2015). Currently, the biggest source of IUU fishing in Atlantic African waters, in particular the SRFC region, is China, whose African distant water fishing fleet has swelled from 13 vessels in 1985, to 462 vessels in 2013 (Greenpeace 2015). Chinese vessels, which negotiate fishing agreements with African countries, have been documented trawling in shallow prohibited areas, underreporting catch, using illegal fishing gear, misreporting vessel specifications (including gross tonnage), and tampering with vessel monitoring systems (Greenpeace 2015). Currently, it appears that many West African coastal states lack the regulatory and enforcement capacity to adequately deal with this issue (Greenpeace 2015).

    We found no regulatory information for Morocco, Liberia, Cote d'Ivoire, Togo, Benin, Nigeria, Cameroon, Democratic Republic of the Congo, and Angola. Overall, we found little information on the effectiveness of the current regulations in countries along the west coast of Africa and the Mediterranean, so it is difficult to assess how these regulations are impacting the extinction risk of both species. However, we do know that in the African Atlantic there has been rapid growth of unregulated or underregulated exploitation of both species. In addition, throughout both species' ranges IUU fishing is still prevalent, and there is an abundance of coastal, artisanal fishers, who can be difficult to regulate because of the novelty of efforts to regulate and manage fishers that have long been undermanaged or not regulated at all. Because of these factors, as well as the high catchability and low reproductive potential of these species, we conclude that the inadequacy of existing regulatory mechanisms is likely contributing significantly to the extinction risk of both R. rhinobatos and R. cemiculus. Although the 2012 SPA/BD Protocol Annex II listing and other current regulations may, in time, provide sufficient protection to reduce these species' risk of extinction, the current uncertainty associated with the enforcement of these restrictions is too great to conclude these protections are adequate to prevent overutilization.

    Extinction Risk

    Although there is no quantitative analysis of either species' abundance over time, and data for many demographic characteristics of R. rhinobatos and R. cemiculus are lacking, the best available data indicate that these species currently face a moderate risk of extinction due to their inherent demographic vulnerabilities, coupled with commercial overutilization and the inadequacy of regulations of commercial fisheries in their ranges. As defined in the status review (see Newell (2016)), a species is considered to be at a moderate risk of extinction when it is on a trajectory that puts it at a high level of extinction risk in the foreseeable future. In this case, we define the foreseeable future as 15-20 years, which is a reasonable amount of time to project the continued threat of overutilization as countries throughout both species' ranges develop and begin to enforce relevant regulations. Additionally, given the relatively low productivity of these species, it will likely take more than one generation for these species to recover. This foreseeable future corresponds roughly to three generation times of R. cemiculus (Enajjar et al., 2012). In this case, because of the lack of life-history data, we simply define the generation time of R. cemiculus as the age when the average female reaches sexual maturity (5.09 years).

    Rhinobatos rhinobatos

    The common guitarfish faces demographic risks that significantly increase its risk of extinction in the foreseeable future. Although there is no species-specific quantitative analysis of R. rhinobatos abundance over time, the best available information (including survey data, interviews with fishers, and anecdotal accounts) indicates that this species has likely undergone significant declines throughout most of its range, with no evidence to suggest a reversal of these trends, with the exception of a few, extremely localized examples. Based on survey data and historical records, this species once occurred throughout the entire coastal northwestern Mediterranean, including as a common species off the Balearic Islands and Sicily, but it has been extirpated for decades throughout this entire area. In the Mediterranean, strong fishing pressure on this species, both as a targeted species and as bycatch, likely still occurs in Tunisia, Lebanon, southeast Turkey, Egypt, and Libya. In Africa, substantial and relatively recent declines have occurred in Mauritania, Senegal, Gambia, Guinea-Bissau, and Sierra Leone, all countries where this species was one of the most common elasmobranch species only a few decades ago. This species is also targeted illegally for its fins in Gabon, and IUU fishing is likely rampant throughout most of its African Atlantic range.

    The limited productivity data on R. rhinobatos suggests this species may be relatively fast-growing and productive compared to other elasmobranchs. However, compared to most fished species, such as bony fishes, this species is slow-growing and has low productivity. Additionally, aspects of this species' reproductive strategy make it inherently vulnerable to overexploitation. This species is long-lived, and larger, older individuals are the most productive. Because this species migrates into shallow waters to give birth and breed, the breeding population of this species is very vulnerable to fishing capture and, as a result, a decline of the average size at maturity and rate of maturity in catches has been reported in many of the portions of this species' range where data are available. Information on spatial structure, connectivity, and diversity is unavailable for this species. However, differences in maximum TL, size at maturity, and reproductive timing throughout this species' range, combined with evidence of extirpated populations from areas that have not been recolonized after decades, suggest there may be isolated populations that contribute to the genetic diversity of this species.

    In conclusion, although there is significant uncertainty regarding the current abundance of this species, the best available information indicates that the species has suffered substantial declines in many portions of its range where it was once common. Throughout almost all of this species' range, the threat of overutilization from industrial and artisanal fishing continues. Given the past evidence of fishery-driven extirpation in areas where this species was once common, and the still-practiced targeting of mature, breeding individuals, which has likely reduced the reproductive potential of these species, we find that continued fishing pressure poses a significant risk of endangering this species with extinction in the foreseeable future. Additionally, the regulations and conservation measures in place are likely inadequate to reverse the decline of this species. In summary, based on the best available information and the above analysis, we conclude that R. rhinobatos is presently at a moderate risk of extinction throughout its range.

    Rhinobatos cemiculus

    The blackchin guitarfish faces demographic risks that significantly increase its risk of extinction in the foreseeable future. Although there is no species-specific quantitative analysis of R. cemiculus abundance over time, the best available information (including survey data, interviews with fishers, and anecdotal accounts) indicates that this species has likely undergone significant declines throughout most of its range, with no evidence to suggest a reversal of these trends, with the exception of a few, extremely localized examples. Based on survey data and historical records, this species once occurred throughout much of the coastal northwestern Mediterranean, likely as a common species off the Balearic Islands and Sicily, but it has been extirpated for decades throughout this entire area. In the Mediterranean, strong fishing pressure on this species, both as a targeted species and as bycatch, likely still occurs in Tunisia, Lebanon, southeast Turkey, Egypt, and Libya. In Africa, substantial and relatively recent declines have occurred in Mauritania, Senegal, Gambia, Guinea-Bissau, and Sierra Leone, all countries where this species was one of the most common elasmobranch species only a few decades ago. This species is also targeted illegally for its fins in Gabon, and IUU fishing is likely rampant throughout most of its African Atlantic range.

    The limited productivity data on R. cemiculus suggests this species may be relatively fast-growing and productive compared to other elasmobranchs. However, compared to most fished species, such as bony fishes, this species is slow-growing and has low productivity. Additionally, aspects of this species' reproductive strategy make it inherently vulnerable to overexploitation. This species is long-lived and larger, older individuals are the most productive. Because this species migrates into shallow waters to give birth and breed, the breeding population of this species is very vulnerable to fishing capture and, as a result, a decline of the average size at maturity and rate of maturity in catches has been reported in many of the portions of this species' range where data are available. Information on spatial structure, connectivity, and diversity is unavailable for this species. However, differences in maximum TL, size at maturity, and reproductive timing throughout this species' range, combined with evidence of extirpated populations from areas that have not been recolonized after decades, suggest there may be isolated populations that contribute to the genetic diversity of this species.

    In conclusion, although there is significant uncertainty regarding the current abundance of this species, the best available information indicates that the species has suffered substantial declines in many portions of its range where it was once common. Throughout almost all of this species' range, the threat of overutilization from industrial and artisanal fishing continues. Given the past evidence of fishery driven extirpation in areas where this species was once common, and the still-practiced targeting of mature, breeding individuals, which has likely reduced the reproductive potential of this species, we find that continued fishing pressure poses a significant risk of endangering this species with extinction in the foreseeable future. Additionally, the regulations and conservation measures in place are likely inadequate to reverse the decline of this species. In summary, based on the best available information and the above analysis, we conclude that R. cemiculus is presently at a moderate risk of extinction throughout its range.

    Conservation Efforts

    Throughout the ranges of R. rhinobatos and R. cemiculus, we found no efforts that are dedicated specifically to the conservation of these species. However, there are some efforts in portions of their ranges that may have a positive effect on the status of these species. These include recently developed management plans and protections from harvest and habitat modification in national parks and MPAs.

    All SRFC countries except Gambia have adopted, or integrated into their fisheries management plans, a National Plan of Action for the Conservation and Management of Sharks (NPOA-Sharks) as part of the Sub-Regional Plan of Action for the Conservation of Sharks (SRPOA-Sharks) (Diop & Dossa 2011). With assistance from the International Union for the Conservation of Nature's Shark Specialist Group (IUCNSSG), these plans were developed under the recommendations of the FAO International Plan of Action for the Conservation and Management of Sharks (IPOA-SHARKS). IPOA-SHARKS seeks to ensure conservation and sustainable management of sharks with emphasis on quality data collection for management purposes (IUCNSSG 2016). In the SRFC, these plans are still in the early stage of implementation, and it remains to be seen how effective they will be in minimizing the extinction risk of R. rhinobatos and R. cemiculus. Additionally, all of the SRFC countries lack adequate technical and financial resources for monitoring and management, and regulations at the country level are not very strict and lack regional coordination (Diop & Dossa 2011). There are no NPOA-Sharks developed for the other African nations in these species' Atlantic ranges (IUCNSSG 2016). All European countries have adopted the EU Plan of Action (EUPOA Sharks) but we could find little information on conservation actions associated with this plan.

    The GFMC is one of the only FAO Regional Fisheries Management Organizations (RMFOs) with the competence to adopt spatial management measures in the high seas. However, many of these protections have focused on the deep sea (FAO 2016e), offering little conservation value to either species. In the early 2000s, Cyprus initiated a fishing license buy-back program, which likely reduced trawl impact on these species (Hadjichristophorou 2006), although we found little information on either species' status in Cyprian waters, so we cannot evaluate the conservation benefit of this action.

    The Regional Activity Centre for Specially Protected Areas (RAC/SPA) and the Network of Marine Protection Area Managers in the Mediterranean (MedPAN) have been working with a diverse network of partners to establish a network of well-connected, well-managed MPAs that protect at least 10 percent of the Mediterranean Sea while representing the sea's biodiversity (Gabrié et al., 2012). The Gabrié et al., (2012) report, entitled “The Status of Marine Protected Areas in the Mediterranean Sea,” found that, as of 2012, only 4.6 percent of the Mediterranean surface (114,600 km2) was protected by MPAs, with these areas mostly concentrated in the coastal zone, predominantly in the northern basin where these species are rare or have been extirpated. Two Mediterranean ecoregions that are important to both species, the Tunisian plateau and the Levantine Sea, were found to be “markedly under-represented.” Management of MPAs throughout the Mediterranean was found to be weak, with many MPAs lacking dedicated managers and management plans and financial resources, and having a low surveillance levels, with only northwestern MPAs reporting a sufficient budget to effectively manage. Additionally, the level of ecosystem protection varies throughout the Mediterranean MPAs. For example, most are not “no-take” zones, so artisanal and recreational fishers still have access to many protected areas.

    There are also MPAs on the West Coast of Africa that might impact or have already impacted the status of these two guitarfish species. In the Banc d'Arguin National Park in Mauritania, the use of specialized gear such as guitarfish nets as well as the targeting of shark and ray species has been prohibited since 2003 (Diop & Dossa 2011). This allowed the local guitarfish populations to recover, but both species are still targeted outside of the park (M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016). Guinea-Bissau has banned shark fishing in all of its MPAs, including the Bijagos Archipelago, which includes important areas for both species (Cross 2015; Diop & Dossa 2011). Mayumba National Park in Gabon, where at least R. cemiculus is found, has recently implemented gear restrictions and no longer allows industrial fishing (De Bruyne 2015). There are also other MPAs that dot the west coast of Africa, but they collectively cover only a small fraction of both species' ranges (MPAtlas 2016).

    Proposed Determination

    There is significant uncertainty regarding the status of the current populations of both R. rhinobatos and R. cemiculus, but both species may still be relatively common, although very likely below their historical population levels, in Tunisia, Israel, Lebanon, Syria, and southeastern Turkey. Based on this information, and the best available scientific and commercial information, as summarized here and in Newell (2015), we find that neither Rhinobatos species is currently at high risk of extinction throughout their entire ranges. However, both species are at moderate risk of extinction. We assessed the ESA section 4(a)(1) factors and conclude that R. rhinobatos and R. cemiculus face ongoing threats of overutilization by fisheries and inadequate existing regulatory mechanisms throughout their ranges. Both species have also suffered a curtailment of a large portion of their historical ranges. These species' natural biological vulnerability to overexploitation and present demographic risks (declining abundance, decreasing size of reproductive individuals, and low productivity) are currently exacerbating the negative effects of these threats. Further, ongoing conservation efforts are not adequate to improve the status of these species. Thus, both species are likely to become endangered throughout their ranges in the foreseeable future. We therefore propose to list both species as threatened under the ESA.

    Effects of Listing

    Conservation measures provided for species listed as endangered or threatened under the ESA include recovery plans (16 U.S.C. 1533(f)); concurrent designation of critical habitat, if prudent and determinable (16 U.S.C. 1533(a)(3)(A)) and consistent with implementing regulations; Federal agency requirements to consult with NMFS under section 7 of the ESA to ensure their actions do not jeopardize the species or result in adverse modification or destruction of critical habitat should it be designated (16 U.S.C. 1536); and, for endangered species, prohibitions on taking (16 U.S.C. 1538). Recognition of the species' plight through listing promotes conservation actions by Federal and state agencies, foreign entities, private groups, and individuals.

    Identifying Section 7 Conference and Consultation Requirements

    Section 7(a)(2) (16 U.S.C. 1536(a)(2)) of the ESA and NMFS/USFWS regulations require Federal agencies to consult with us to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of listed species or destroy or adversely modify critical habitat. Section 7(a)(4) (16 U.S.C. 1536(a)(4)) of the ESA and NMFS/USFWS regulations also require Federal agencies to confer with us on actions likely to jeopardize the continued existence of species proposed for listing, or that result in the destruction or adverse modification of proposed critical habitat of those species. It is unlikely that the listing of these species under the ESA will increase the number of section 7 consultations, because these species occur outside of the United States and are unlikely to be affected by Federal actions.

    Critical Habitat

    Critical habitat is defined in section 3 of the ESA (16 U.S.C. 1532(5)) as: (1) The specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the ESA, on which are found those physical or biological features (a) essential to the conservation of the species and (b) that may require special management considerations or protection; and (2) specific areas outside the geographical area occupied by a species at the time it is listed upon a determination that such areas are essential for the conservation of the species. “Conservation” means the use of all methods and procedures needed to bring the species to the point at which listing under the ESA is no longer necessary (16 U.S.C. 1532(3)). Section 4(a)(3)(A) of the ESA (16 U.S.C. 1533(a)(3)(A)) requires that, to the extent prudent and determinable, critical habitat be designated concurrently with the listing of a species. However, critical habitat shall not be designated in foreign countries or other areas outside U.S. jurisdiction (50 CFR 424.12(h)).

    The best available scientific and commercial data as discussed above identify the geographical areas occupied by R. rhinobatos and R. cemiculus as being entirely outside U.S. jurisdiction, so we cannot designate critical habitat for these species.

    Identification of Those Activities That Would Constitute a Violation of Section 9 of the ESA

    On July 1, 1994, NMFS and FWS published a policy (59 FR 34272) that requires NMFS to identify, to the maximum extent practicable at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the ESA. Because we are proposing to list the R. rhinobatos and R. cemiculus as threatened, no prohibitions of section 9(a)(1) of the ESA will apply to these species.

    Protective Regulations Under Section 4(d) of the ESA

    We are proposing to list R. rhinobatos and R. cemiculus as threatened under the ESA. In the case of threatened species, ESA section 4(d) leaves it to the Secretary's discretion whether, and to what extent, to extend the section 9(a) “take” prohibitions to the species, and authorizes us to issue regulations necessary and advisable for the conservation of the species. Thus, we have flexibility under section 4(d) to tailor protective regulations, taking into account the effectiveness of available conservation measures. The section 4(d) protective regulations may prohibit, with respect to threatened species, some or all of the acts which section 9(a) of the ESA prohibits with respect to endangered species. These section 9(a) prohibitions apply to all individuals, organizations, and agencies subject to U.S. jurisdiction. Because neither species has ever occupied U.S. waters, and the United States has no known commercial or management interest in either species, we propose to not apply any section 9(a) prohibitions to either species.

    Public Comments Solicited

    To ensure that any final action resulting from this proposed rule to list the R. rhinobatos and R. cemiculus as threatened will be as accurate and effective as possible, we are soliciting comments and information from the public, other concerned governmental agencies, the scientific community, industry, and any other interested parties on information in the status review and proposed rule. Comments are encouraged on these proposals (See DATES and ADDRESSES). We must base our final determination on the best available scientific and commercial information. We cannot, for example, consider the economic effects of a listing determination. Before finalizing this proposed rule, we will consider the comments and any additional information we receive, and such information may lead to a final regulation that differs from this proposal or result in a withdrawal of this listing proposal. We particularly seek:

    (1) Information concerning the threats to the Rhinobatos species proposed for listing;

    (2) Taxonomic information on the species;

    (3) Biological information (life history, genetics, population connectivity, etc.) on the species;

    (4) Efforts being made to protect the species throughout their current ranges;

    (5) Information on the commercial trade of the species;

    (6) Historical and current distribution and abundance and trends for the species; and

    (7) Any of the above information on either or both species from the following countries, from which we have very little information: Morocco, Liberia, Cote d'Ivoire, Ghana, Togo, Benin, Nigeria, Cameroon, Equatorial Guinea, São Tomé and Príncipe, Republic of the Congo, Democratic Republic of the Congo, Angola, Algeria, and Syria.

    We request that all information be accompanied by: (1) Supporting documentation, such as maps, bibliographic references, or reprints of pertinent publications; and (2) the submitter's name, address, and any association, institution, or business that the person represents.

    Role of Peer Review

    In December 2004, the Office of Management and Budget (OMB) issued a Final Information Quality Bulletin for Peer Review establishing a minimum peer review standard. We solicited peer review comments on the draft common guitarfish and blackchin guitarfish status review report (Newell (2016)) from three scientists familiar with both guitarfish species. We received and reviewed these peer review comments, and incorporated them into both the draft status review report for the common guitarfish and blackchin guitarfish and this proposed rule. Peer reviewer comments on the draft status review are summarized in the peer review report, which is available at: http://www.cio.noaa.gov/services_programs/prplans/PRsummaries.html.

    References

    A complete list of references used in this proposed rule is available upon request (see ADDRESSES).

    Classification National Environmental Policy Act

    The 1982 amendments to the ESA, in section 4(b)(1)(A), restrict the information that may be considered when assessing species for listing. Based on this limitation of criteria for a listing decision and the opinion in Pacific Legal Foundation v. Andrus, 675 F. 2d 825 (6th Cir. 1981), NMFS has concluded that ESA listing actions are not subject to the environmental assessment requirements of the National Environmental Policy Act (NEPA).

    Executive Order 12866, Regulatory Flexibility Act, and Paperwork Reduction Act

    As noted in the Conference Report on the 1982 amendments to the ESA, economic impacts cannot be considered when assessing the status of a species. Therefore, the economic analysis requirements of the Regulatory Flexibility Act are not applicable to the listing process. In addition, this proposed rule is exempt from review under Executive Order 12866. This proposed rule does not contain a collection-of-information requirement for the purposes of the Paperwork Reduction Act.

    Executive Order 13132, Federalism

    In accordance with E.O. 13132, we determined that this proposed rule does not have significant federalism effects and that a federalism assessment is not required. In keeping with the intent of the Administration and Congress to provide continuing and meaningful dialogue on issues of mutual state and Federal interest, this proposed rule will be given to the relevant governmental agencies in the countries in which the species occurs, and they will be invited to comment. We will confer with the U.S. Department of State to ensure appropriate notice is given to all foreign nations within the ranges of both species. As the process continues, we intend to continue engaging in informal and formal contacts with the U.S. State Department, giving careful consideration to all written and oral comments received.

    List of Subjects in 50 CFR Part 223

    Endangered and threatened species, Exports, Imports, Transportation.

    Dated: September 12, 2016. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, we propose to amend 50 CFR part 223 as follows:

    PART 223—THREATENED MARINE AND ANADROMOUS SPECIES 1. The authority citation for part 223 continues to read as follows: Authority:

    16 U.S.C. 1531-1543; subpart B, § 223.201-202 also issued under 16 U.S.C. 1361 et seq.; 16 U.S.C. 5503(d) for § 223.206(d)(9).

    2. In § 223.102, paragraph (e), add entries for two species in alphabetical order by common name under the “Fishes” table subheading to read as follows:
    § 223.102 Enumeration of threatened marine and anadromous species.

    (e) * * *

    Species 1 Common
  • name
  • Scientific
  • name
  • Description of
  • listed entity
  • Citation(s) for listing
  • determination(s)
  • Critical
  • habitat
  • ESA Rules
    *         *         *         *         *         *         * Fishes *         *         *         *         *         *         * Guitarfish, blackchin Rhinobatos cemiculus Entire species [Federal Register citation and date when published as a final rule] NA NA Guitarfish, common Rhinobatos rhinobatos Entire species [Federal Register citation and date when published as a final rule] NA NA *         *         *         *         *         *         * 1 Species includes taxonomic species, subspecies, distinct population segments (DPSs) (for a policy statement, see 61 FR 4722, February 7, 1996), and evolutionarily significant units (ESUs) (for a policy statement, see 56 FR 58612, November 20, 1991).
    [FR Doc. 2016-22450 Filed 9-16-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Parts 223 and 224 [Docket No. 160614520-6520-01] RIN 0648-XE686 Endangered and Threatened Wildlife and Plants: Proposed Rule To List the Maui's Dolphin as Endangered and the South Island Hector's Dolphin as Threatened Under the Endangered Species Act AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    We, NMFS, propose to list the Maui's dolphin (Cephalorhynchus hectori maui) as endangered and the South Island Hector's dolphin (C. hectori hectori) as threatened under the Endangered Species Act (ESA). We have reviewed the best available scientific and commercial data and completed a comprehensive status review for these two subspecies of Hector's dolphin (C. hectori). The Maui's dolphin faces serious demographic risks due to critically low abundance, a low population growth rate, a restricted range, low genetic diversity, and ongoing threats such as bycatch in commercial and recreational gillnets. We have determined Maui's dolphin is currently in danger of extinction throughout its range and, therefore, meets the definition of an endangered species. The relatively more abundant and more widely distributed South Island Hector's dolphin has experienced large historical declines and is expected to continue to slowly decline due to bycatch and other lesser threats, such as disease and impacts associated with tourism. We have determined that this subspecies is not currently in danger of extinction throughout all or a significant portion of its range, but is likely to become so within the foreseeable future; and therefore, it meets the definition of a threatened species. Both subspecies occur only in New Zealand. We are authorized to designate critical habitat within U.S. jurisdiction only, and we are not aware of any areas within U.S jurisdiction that may meet the definition of critical habitat under the ESA. Therefore, we are not proposing to designate critical habitat. We are soliciting public comments on our status review report and proposal to list these two subspecies.

    DATES:

    Comments on this proposed rule must be received by November 18, 2016. Public hearing requests must be made by November 3, 2016.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2016-0118, by either of the following methods:

    Electronic Submissions: Submit all electronic comments via the Federal eRulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2016-0118, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Lisa Manning, NMFS Office of Protected Resources (F/PR3), 1315 East West Highway, Silver Spring, MD 20910, USA.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter“N/A” in the required fields if you wish to remain anonymous).

    You can find the petition, status review report, Federal Register notices, and the list of references electronically on our Web site at http://www.nmfs.noaa.gov/pr/species/petition81.htm.

    FOR FURTHER INFORMATION CONTACT:

    Lisa Manning, NMFS, Office of Protected Resources, [email protected], (301) 427-8466.

    SUPPLEMENTARY INFORMATION:

    Background

    On July 15, 2013, we received a petition from WildEarth Guardians to list 81 marine species or populations as endangered or threatened species under the ESA. We determined that the petition had sufficient merit for further consideration, and status reviews were initiated for 27 of the 81 species or populations, including the Hector's dolphin (Cephalorhynchus hectori; 78 FR 63941, October 25, 2013; 78 FR 66675, November 6, 2013; 78 FR 69376, November 19, 2013; 79 FR 9880, February 21, 2014; and 79 FR 10104, February 24, 2014). This document addresses the proposed determination for the Hector's dolphin. The findings and relevant Federal Register notices for the other species and populations can be found on our Web site at http://www.nmfs.noaa.gov/pr/species/petition81.htm.

    Listing Determinations Under the ESA

    We are responsible for determining whether species are threatened or endangered under the ESA (16 U.S.C. 1531 et seq.). To make this determination, we first consider whether a group of organisms constitutes a “species” under the ESA, then whether the status of the species qualifies it for listing as either threatened or endangered. Section 3 of the ESA defines a “species” to include “any subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature.” Maui's dolphin, C. hectori maui, and the South Island (SI) Hector's dolphin, C. hectori hectori, have been formally recognized as subspecies (Baker et al. 2002, Pichler 2002); and thus, each meets the ESA definition of a “species.”

    Section 3 of the ESA defines an endangered species as “any species which is in danger of extinction throughout all or a significant portion of its range” and a threatened species as one “which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” We interpret an “endangered species” to be one that is presently in danger of extinction. A “threatened species,” on the other hand, is not presently in danger of extinction, but is likely to become so in the foreseeable future (that is, at a later time). In other words, the primary statutory difference between a threatened species and endangered species is the timing of when a species may be in danger of extinction, either presently (endangered) or in the foreseeable future (threatened).

    When we consider whether a species might qualify as threatened under the ESA, we must consider the meaning of the term “foreseeable future.” It is appropriate to interpret “foreseeable future” as the horizon over which predictions about the conservation status of the species can be reasonably relied upon. The foreseeable future considers the life history of the species, habitat characteristics, availability of data, particular threats, ability to predict threats, and the reliability to forecast the effects of these threats and future events on the status of the species under consideration. Because a species may be susceptible to a variety of threats for which different data are available regarding the species' response to that threat, or which operate across different time scales, the foreseeable future is not necessarily reducible to a particular number of years.

    Section 4(a)(1) of the ESA requires us to determine whether any species is endangered or threatened due to any one or a combination of the following five threat factors: The present or threatened destruction, modification, or curtailment of its habitat or range; overutilization for commercial, recreational, scientific, or educational purposes; disease or predation; the inadequacy of existing regulatory mechanisms; or other natural or manmade factors affecting its continued existence. We are also required to make listing determinations based solely on the best scientific and commercial data available, after conducting a review of the species' status and after taking into account efforts being made by any state or foreign nation to protect the species.

    In assessing the extinction risk of these two subspecies, we considered demographic risk factors, such as those developed by McElhany et al. (2000), to organize and evaluate the forms of risks. The approach of considering demographic risk factors to help frame the consideration of extinction risk has been used in many of our previous status reviews (see http://www.nmfs.noaa.gov/pr/species for links to these reviews). In this approach, the collective condition of individual populations is considered at the species level (or in this case, the subspecies level) according to four demographic viability factors: Abundance and trends, population growth rate or productivity, spatial structure and connectivity, and genetic diversity. These viability factors reflect concepts that are well-founded in conservation biology and that individually and collectively provide strong indicators of extinction risk.

    Scientific conclusions about the overall risk of extinction faced by Maui's dolphin and the SI Hector's dolphin under present conditions and in the foreseeable future are based on our evaluation of the subspecies' demographic risks and section 4(a)(1) threat factors. Our assessment of overall extinction risk considered the likelihood and contribution of each particular factor, synergies among contributing factors, and the cumulative impact of all demographic risks and threats on each subspecies.

    Section 4(b)(1)(A) of the ESA requires the Secretary, when making a listing determination for a species, to take into consideration those efforts, if any, being made by any State or foreign nation, or any political subdivision of a State or foreign nation, to protect the species. Therefore, prior to making a listing determination, we also assess such protective efforts to determine if they are adequate to mitigate the existing threats.

    Status Review

    Status reviews for Maui's dolphin and the SI Hector's dolphin were completed by NMFS staff from the Office of Protected Resources. To complete the status reviews, we compiled the best available data and information on the subspecies' biology, ecology, life history, threats, and conservation status by examining the petition and cited references, and by conducting a comprehensive literature search and review. We also considered information submitted to us in response to our petition finding. A single draft status review report was prepared for the two subspecies and submitted to three independent peer reviewers; comments and information received from peer reviewers were addressed and incorporated as appropriate into the draft report. The draft status review report (cited as Manning and Grantz 2016) is available on our Web site (see ADDRESSES section). In the sections below, we provide information from the report regarding threats to and the status of each subspecies.

    Subspecies Descriptions

    The Hector's dolphin is one of the world's smallest dolphins and occurs only in the coastal waters of New Zealand. Hector's dolphins have short and stocky bodies, no external beak, and a relatively large fluke. They are easily distinguished by their distinctive black, white, and gray color patterns and their rounded dorsal fin, which has a shallowly sloping anterior edge and a convex posterior edge, and is unique to the genus (Dawson 2009). Lifespan is thought to be about 20 years (Slooten 1991, Secchi et al. 2004b), and several dolphins have been aged to a minimum of 22 years based on photo-identification data (Rayment et al. 2009a, Webster et al. 2009). Hector's dolphins have a varied diet that includes cephalopods, crustaceans, and small fish species; however, relatively few prey species appear to comprise the bulk of their diet. Stomach content analysis indicates that common prey species include red cod (Pseudophycis bachus), ahuru (Auchenoceros punctatus), arrow squid (Nototodarus sp.), sprat (Sprattus sp.), sole (Peltorhamphus sp.), and stargazer (Crapatalus sp., Miller et al. 2013).

    Females typically have their first calf at 7-9 years of age, and males likely reach sexual maturity at 6-9 years of age (Slooten 1991, Gormley 2009). Calving occurs in the austral spring and early summer, generally from November to February (Slooten and Dawson 1988, Slooten and Dawson 1994). Calves remain with their mothers for 1 to 2 years, although 2 years appears to be more common (Slooten and Dawson 1994). Females typically produce single calves every 2 to 4 years (Slooten and Dawson 1994), which gives a yearly birth rate between 0.33 and 0.5. Fecundity (i.e., the number of female offspring per female per breeding season) has been estimated as ranging from 0.165 to 0.250 (Secchi et al. 2004b, Gormley 2009).

    Hector's dolphins make few audible sounds, and their repertoire consists mainly of high frequency (112-130k Hz) clicks of either one or two short pulses (i.e., usually less than 200 μs for single pulses and less than 400 μs for double pulses, Dawson 1988a). Analyses of recorded vocalizations suggest Hector's dolphins use their vocalizations for fine discrimination, locating prey, and communicating, rather than large-scale navigation, for which lower frequency echolocation is required (Dawson 1988a, Dawson 1991a).

    Available data indicates that Hector's dolphins have small home ranges and high site fidelity (Bedjer and Dawson 2001, Bräger et al. 2002, Rayment et al. 2009a, Oremus et al. 2012). Based on multiple analyses of photo-identification data and genetic recapture data, the along-shore home range appears to be similar for both subspecies and is typically less than 50 km (Bräger et al. 2002, Rayment et al. 2009a, Oremus et al. 2012). Home ranges also do not appear to differ between males and females (Bräger et al. 2002, Rayment et al. 2009a).

    Historically, Hector's dolphins are thought to have been present along almost the entire coastlines of both the North and South Islands of New Zealand (Cawthorn 1988, Russell 1999, Pichler 2002, MFish and DOC 2007a). The two subspecies probably became initially separated by the opening of Cook Strait during the late Pleistocene and Holocene interglacial periods, and this isolation was likely maintained through behavioral mechanisms such as natal philopatry and small home ranges (Pichler 2002, Baker et al., 2002, Dawson 2009). Currently, Maui's dolphins occur along the northwest coast of the North Island, between Maunganui Bluff in the north and Whanganui in the south (Currey et al. 2012). Occasional sightings and strandings have also been reported from areas farther south along the west coast as well as in areas such as Hawke Bay on the east coast of the North Island (Baker 1978, Russell 1999, Ferreira and Roberts 2003, Slooten et al. 2005, MFish and DOC 2007a, Du Fresne 2010). The SI Hector's dolphin currently has a fragmented distribution around the South Island (Dawson et al. 2004, Rayment et al. 2011b) and consists of at least three genetically distinct, regional populations (Pichler 2001, Pichler 2002, Hamner et al. 2012a). SI Hector's dolphins are most abundant around Banks Peninsula, Cloudy Bay, and Cliffords Bay on the east coast and along the central west coast. Distinct and localized populations also occur on the south coast in Te Waewae Bay, Toetoe Bay, and Porpoise Bay (Dawson and Slooten 1988b, Clement et al. 2011, Hamner et al. 2012a, Rodda 2014, Mackenzie and Clement 2014). The connectivity between these regional populations, especially the south coast populations, appears to be limited (Bejder and Dawson 2001, Hamner et al. 2012a). Hector's dolphins do not appear to occur offshore of or within the deep water fiords of Fiordland, although they have been sighted there on rare occasions (Dawson and Slooten 1988b, MFish and DOC 2007a).

    Hector's dolphins are typically sighted within about 20 nautical miles (nmi; 37.0 km) of the shore and in water less than 100 m deep (Slooten et al. 2005, Mackenzie and Clement 2014, Rayment et al. 2011b, Mackenzie and Clement 2016). For the North Island, an extensive review by Du Fresne (2010) of both published scientific surveys and unpublished opportunistic sightings data indicates that Maui's dolphins are most frequently found within 4 nmi (7.4 km) of the coast but do occasionally occur at least as far as 7 nmi (13.0 km) offshore. Off the South Island, differences in distribution patterns have been observed for the west and east coasts that may be driven in part by differences in bathymetry or location of the shelf break. On the west coast, the 100 m isobath is always within 13 nmi (24.1 km) of the coast, and in some places as close as 5 nmi (9.3 km); whereas, off Banks Peninsula on the east coast, the 100 m isobath is 16 to 30 nmi (29.6 to 55.6 km) offshore (Rayment et al. 2011b). SI Hector's dolphins are typically within 8 nmi (14.8 km) from shore on the east coast of the South Island and within 3 nmi (5.6 km) from shore on the west coast (Rayment et al. 2010b, 2011b, Mackenzie and Clement 2013, Mackenzie and Clement 2016). However, SI Hector's dolphins have been sighted at least occasionally as far as about 20 nmi (37.0 km) from shore on both coasts (Rayment et al. 2010b, 2011b, MacKenzie and Clement 2016).

    Seasonal changes in this nearshore distribution are evident for at least some populations of Hector's dolphins, with distributions often extending farther from shore in the winter relative to the warmer months. For example, based on aerial surveys that extended as far as 20 nmi offshore (37.0 km) of Banks Peninsula and were conducted over 3 years (2002, 2004, and 2005), Rayment et al. (2010b) found that winter sightings extended as far as 18.2 nmi (33.6 km) offshore, compared to 16.3 nmi (30.2 km) in summer; and, while only 7 percent of all dolphins were sighted beyond the 50 m isobath in summer, 44 percent of all dolphins were sighted beyond the 50 m isobath in winter. Slooten et al. (2005) report a similar change in distribution for Maui's dolphins between summer and winter aerial surveys conducted in 2004/2005. Similar seasonal changes in SI Hector's dolphin distribution relative to shore and water depth have also been detected in comparisons of summer and winter sightings data for the west coast of the South Island; however, the observed seasonal shift on the west coast is less dramatic relative to that on the east coast (Rayment et al. 2011b, Mackenzie and Clement 2014).

    Summary of ESA Section 4(a)(1) Factors Affecting Maui's Dolphin

    Available information regarding historical, current, and potential threats to Maui's dolphins was thoroughly reviewed and is discussed in detail in the status review report (Manning and Grantz 2016). We summarize information regarding these threats below according to the factors specified in section 4(a)(1) of the ESA.

    In August 2007, the New Zealand Department of Conservation (DOC) and the Ministry for Primary Industries (MPI, formerly called the Ministry of Fisheries or MFish) released a draft Threat Management Plan (TMP) for Hector's dolphins. This plan describes the nature and level of actual and potential threats to Maui's dolphins, as well as strategies to address those threats. In addition, in June 2012, DOC and MPI convened a risk assessment workshop to inform their review of the Maui's dolphin portion of the TMP. The results of this semi-quantitative risk assessment are available in the report by Currey et al. (2012). The report identifies, evaluates, and rates threats to Maui's dolphins based on scoring by an expert panel. Both the TMP and the risk assessment report greatly informed our assessment, as summarized below.

    The Present or Threatened Destruction, Modification, or Curtailment of Its Habitat or Range

    Threats to the habitat of Maui's dolphins include pollution, mining, oil and gas development activities, acoustic disturbance (Currey et al. 2012).

    Persistent chemical pollutants are a concern for many cetacean species, which theoretically can accumulate high concentrations of contaminants due to their longevity, high trophic-level, and naturally high blubber content (Stockin et al. 2010). Contaminants are also specifically a concern for Hector's dolphins due to the dolphins' coastal distribution and thus close proximity to agricultural and industrial activities. Toxicological studies of contaminants, such as polychlorinated biphenyls (PCBs) and organochlorine (OC) pesticides, are limited for Maui's dolphins, and studies on emerging contaminants, such as brominated flame retardant (PBDEs) and perfluorinated chemicals, have yet to be done. Numerous studies on other cetacean species have linked contaminants, such as heavy metals, PCBs, and OC pesticides, with biological impacts, including endocrine disruption, reproductive impairment, immune suppression, and elevated infectious disease (e.g., Fujise et al. 1988, Kuiken et al. 1994, Jepson et al. 2005, O'Hara and O'Shea 2001, Schwacke et al. 2002, Wells et al. 2005). Stockin et al. (2010) examined PCB and OC contaminant loads in stranded or entangled Hector's dolphins (n=27, SI Hector's dolphins; n=3, Maui's dolphins) sampled from 1997 to 2009. Results indicated high concentrations of these chemicals in both subspecies, and a roughly two-fold increase in levels of OC pesticides than had been previously reported for Hector's dolphins by Jones et al. (1999). However, as noted by Stockin et al. (2010), no PCB concentrations were above thresholds associated with reproductive and immunological effects (Stockin et al. 2010).

    Pollution in the form of plastic marine debris from both marine and land-based sources can accumulate in, and degrade, Maui's dolphins' habitat. Plastics and other synthetic, non-biodegradable materials in the marine environment create the potential for entanglement, injury, and ingestion. Although data are lacking to evaluate whether and the extent to which this threat is impacting Maui's dolphins, Currey et al. (2012) did identify plastics as being likely to affect population trends over the next 5 years. Plastic bags have been identified as a concern in particular, because they may be mistaken for squid, a common prey item for Maui's dolphins.

    Interest in marine minerals mining along the North Island of New Zealand has been growing in recent years, with prospecting and exploration occurring mainly from Manukua Harbor south to New Plymouth (Thompson 2012). Exploration activities have mainly targeted iron sands or titanomagnetite (Thompson 2012). According to New Zealand Petroleum and Minerals (NZPM), which is the government agency responsible for issuing mining permits for New Zealand's oil, gas and mineral resources, demand and exploration for petroleum (oil and gas) is also increasing, and multiple areas within the range of Maui's dolphins are covered under existing prospecting, exploration, and mining permits. Mineral mining activities involving the large scale removal of sediment from the seabed are likely to lead to relatively long term (3-10 year) changes to benthic community composition, thereby altering prey availability and benthic topography (Thompson 2012). Other potential, unintended side-effects include the mobilization and accidental spilling of contaminants and exposure to greater levels of vessel traffic (Thompson 2012). Acoustic disturbance, such as from seismic surveys, sonar, and drilling activities, also poses a potential threat to Maui's dolphins, because it may have negative physical or physiological effects, such as shifts in hearing thresholds, and may disrupt normal behaviors, including navigating, migrating, and feeding (Gordon et al. 2003; Thompson 2012).

    The extent to which Maui's dolphins are currently being impacted by these and other habitat-related threats is assumed to be small. These threats have been characterized as having mainly sub-lethal effects, and combined, may currently be responsible for less than 4.5 percent of all Maui's dolphin mortalities (Currey et al. 2012). However, it is probable that Maui's dolphin habitat will become increasingly degraded as a result of pollution and acoustic and benthic disturbances due to increasing human pressure and demand for mineral and petroleum resources (MFish and DOC 2007b).

    Overutilization for Commercial, Recreational, Scientific or Educational Purposes

    Overutilization of Maui's dolphins for commercial, recreational, scientific, or educational purposes does not appear to pose a significant threat to Maui's dolphin. Maui's dolphins have not been exploited commercially; although, Baker (1978, citing Abel et al. 1971) noted that, between 1969 and 1972, a few Hector's dolphins were taken for live exhibition at Marineland of New Zealand. It's not clear which subspecies was taken. Hector's dolphins have also apparently been taken for food, oil, and bait; however, the extent to which this occurred is unknown (Pichler et al. 2003).

    There is some evidence that commercial dolphin-watching vessels and swim-with-dolphin operations cause behavioral changes in Hector's dolphins (Bejder et al. 1999, Constantine 1999, Martinez et al. 2012). Such tourism activities, however, seem to occur at a relatively low intensity within the range of Maui's dolphins and instead are much more concentrated elsewhere—mainly the Bay of Islands and the Bay of Plenty on the east coast of the North Island and various locations of the South Island (Martinez 2010b). Although tourism and the potential related impacts of boat strike, noise, and displacement were identified as threats in the risk assessment completed by Currey et al. (2012), the expert panel did not think these threats were likely to affect population trends within the next 5 years.

    Disease or Predation

    Predation of Hector's dolphins by several shark species, such as seven-gill sharks (Notorhynchus cepedianus) and blue sharks (Prionace glauca), is known to occur; however, predation rates are not known (Slooten and Dawson 1988). Predation was not considered to be posing a threat to Maui's dolphins in the recent risk assessment by Currey et al. (2012).

    Disease is another known source of mortality for Hector's dolphins. In their evaluation, Currey et al. (2012) categorized natural disease, stress-induced disease, and domestic animal vectors as posing threats that are likely to have population level effects on Maui's dolphins within the next 5 years. Prevalence of infectious disease and associated behavioral impacts and mortality rates have not been well studied in Hector's dolphins, so the significance of this source of mortality remains unclear. Recently, Roe et al. (2013) found that 7 of 28 Hector's dolphins (25 percent), including 2 of 3 Maui's dolphins, collected between 2007 and 2011 and later necropsied had died as a result of Toxoplasma gondii infection. Of the 22 dolphins for which a definitive cause of death was established, a total of ten (45 percent) were found to have died from infectious disease (T. gondii infections, bacterial infection, or fungal infection). These findings suggest that infectious disease may be a significant source of mortality for Hector's dolphins. In addition, while toxoplasmosis is typically a secondary disease in cetaceans, resulting in symptoms in immunosuppressed individuals rather than healthy individuals, there was no evidence of immunosuppression in these cases (Roe et al. 2013). This finding suggests that Hector's dolphins may be particularly susceptible to toxoplasmosis. Roe et al. (2013) also note that toxoplasmosis may have other effects beyond direct mortality and could be an important cause of neonatal loss. The source of the T. gondii infection could not be determined in this study, but exposure may be occurring through freshwater run-off from terrestrial sources (Roe et al. 2013). Overall, while data remain limited for Maui's dolphins, the available data suggest that disease, especially toxoplasmosis, is posing a threat to Maui's dolphins.

    Inadequacy of Existing Regulatory Mechanisms

    A number of regulatory measures have been put in place to address bycatch of Maui's dolphins. Although data on bycatch of Maui's dolphins are limited, fishery-related mortality has been identified as posing a significant threat to Maui's dolphins. The risk assessment completed by Currey et al. (2012) attributed 95.5 percent of the estimated human-caused mortalities forecasted to occur over the next 5 years to legal and illegal fishing-related activities. This translated into an estimated median of 4.97 Maui's dolphin mortalities per year due to fishing activities (95 percent confidence interval (CI) = 0.28—8.04). To help inform the risk assessment of Currey et al. (2012), Wade et al. (2012) calculated the Potential Biological Removal (PBR) for Maui's dolphins and estimated it as one dolphin mortality every 10 to 23 years. PBR, which is a management tool specific to the U.S. Marine Mammal Protection Act (MMPA) is used to evaluate allowable levels of human-caused mortality (Wade 1998; Wade et al. 2012). (PBR is defined under section 3 of the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (16 U.S.C. 1362).) This analysis indicates that the estimated bycatch mortality of Maui's dolphins greatly exceeds PBR.

    The DOC maintains a database of reports from the public of dead and stranded Hector's dolphins, and between 1921 and 2008, 45 percent of the reports for Maui's dolphins (4 of 11 dolphins) for which cause of death could be determined were found to have died due to “possible,” “probable,” or “known” entanglement (http://www.doc.govt.nz/our-work/hectors-and-maui-dolphin-incident-database/1921-2008/). Between July 2008 and January 2016, the DOC Incident Database lists an additional four confirmed Maui's dolphins, and of the two with determinable causes of death, one was an adult female found dead in January 2012 from entanglement in a commercial net set (http://www.doc.govt.nz/our-work/hectors-and-maui-dolphin-incident-database/). (The other dolphin was recorded as having died due to natural causes.)

    Bycatch of Maui's dolphins occurs mainly in gillnet gear, but bycatch in trawl gear is likely also posing a threat (Bird and Palka 2013). Although commercial gillnetting had been practiced in New Zealand since 1930 (DOC and MFish 1994), fishing effort was low until the mid-1970s (Dawson 1991). By the 1980's, bycatch of dolphins in gillnets became a serious concern in New Zealand (Dawson and Slooten 2005). Eventually, in 2003, MFish began to address bycatch of Maui's dolphins by closing waters to set netting from Maunganui Bluff to Pariokariwa Point out to 4 nmi (7.4 km) and inside the entrance to the Manukau Harbor. Trawling was also prohibited out to 2 nmi (3.7 km) along most of this same stretch of coastline and out to 4 nmi within a short portion of the Maui's dolphin's core range (see Figure 7 in Manning and Grantz 2016). Commercial and recreational gillnetting continued within harbors and in the southern portion of the Maui's dolphin range.

    In 2007, when the draft TMP was released, the MPI and DOC concluded that bycatch was still the most serious threat to Hector's dolphins. In 2008, MFish expanded protection for Maui's dolphins by extending the set netting closure out to 7 nmi (13.0 km; instead of 4 nmi (7.4 km)) and farther into Manukau Harbor. Then, in 2012, following an entanglement of a Maui's dolphin off Cape Egmont, an interim ban was put in place from Pariokariwa Point south to Hawera for all set netting out to 2 nmi (Gazette, 28 June 2012) and for commercial set netting between two and seven nautical miles offshore unless an MPI observer was on board (see Figure 8 in Manning and Grantz 2016). In 2013, the MPI determined that their interim measures would be made permanent (MPI and DOC 2013).

    This steady expansion of area-based, bycatch-reduction measures along the west coast of the North Island has resulted in a substantial level of protection for Maui's dolphins. However, bycatch remains a concern for Maui's dolphins, because current fisheries restrictions do not extend throughout their range and certain forms of fishing still occur within the core portion of the subspecies' range. In particular, commercial and non-commercial set netting occur within all west coast harbors, with all areas within the harbors, from intertidal areas to the deeper channels, being fished for species like flounder, mullet, and rig (MFish and DOC 2007b). Sightings data (Slooten et al. 2005) and passive acoustic data (Rayment et al. 2011a) indicate that Maui's dolphins occur at least occasionally within west coast harbors and therefore may be at risk of entanglement in these areas (MFish and DOC 2007b). In addition, the southern extension of the gillnetting prohibitions that was put in place in 2012 only extends out to 2 nmi (3.7 km) from shore, as opposed to the 7 nmi (13 km) boundary elsewhere along the west coast. Beyond 2 nmi, gillnetting is permitted in this portion of the range if an MPI observer is on board. Furthermore, the extension of the closed area in the southern portion of the dolphin's range may not extend far enough southward. The risk assessment of Currey et al. (2012) used survey and non-survey sightings data to develop a distribution for Maui's dolphins that extends to Whanganui, which is about 70 km south of the current gillnet closed area boundary at Hawera. Trawling also continues in waters past the existing 2 nmi or 4 nmi offshore boundary for the trawling closed area—even in the core portion of the Maui's dolphin's range. Currey et al. (2012) concluded that trawling in this zone was a source of continued bycatch risk for Maui's dolphins.

    Before the protected area extensions in 2012, estimated bycatch was about 4.69 to 13.01 dolphins per year or about 75 times the PBR of 0.044-0.1 Maui's dolphins per year (Currey et al. 2012).). The recent extensions to the protection measures have reduced the estimated bycatch to 3.28−4.16 Maui's dolphin mortalities per year or about 54 times PBR (Slooten 2014).

    A series of regulations have been put in place to address some of the threats associated with mining and petroleum industry activities. The West Coast North Island Marine Mammal Sanctuary (WCNIMMS) was established in 2008 as part of the draft TMP, and restrictions were put in place on seabed mining and acoustic seismic surveys within the sanctuary. In particular, seabed mineral mining was prohibited out to 2 nmi (3.7 km) along the full length of the sanctuary and out to 4 nmi (7.4 km) south of Raglan Harbor to north of Manakau Harbor. However, a large swath of the sanctuary, which extends out 12 nmi (22.2 km) from the coast, remains open to mining. A range of operational requirements has been specified for seismic surveying within the sanctuary (Gazette: Gazette, 25 September 2008), including mandatory notification prior to conducting surveys and mandatory reporting of any interactions with dolphins. Qualified marine mammal observers are required on all survey ships to help ensure that no whales or dolphins are too close to the ship. When visibility is poor, hydrophones must be used to listen for whale and dolphin sounds (Gazette, 25 September 2008). In August 2012, the DOC Minister and the Minister of Energy and Resources developed a voluntary “Code of Conduct for Minimizing Acoustic Disturbance to Marine Mammals from Seismic Surveys Operations.” This voluntary guidance was intended to increase protections for Maui's dolphins, in part by identifying their entire historical range out to 100m water depth as an “Area of Ecological Significance,” which triggers additional mitigation requirements. Shortly thereafter, in November 2013, the DOC and MPI announced a decision to formally regulate seismic surveying and make the 2012 code of conduct a mandatory standard. The mandatory code of conduct applies to Territorial waters, the Exclusive Economic Zone (EEZ) of New Zealand, and within all marine mammal sanctuaries, and it continues to include requirements for planning, operations, monitoring, and reporting. The 2013 code of conduct is currently undergoing review and may be further augmented to increase protections for Maui's dolphins and other species of concern.

    As indicated in the discussion above, there are gaps in the current regulatory protections for Maui's dolphins. Population viability analyses performed under previous management scenarios have predicted continued declines in abundance of Maui's dolphins or failure to recover (Burkhart and Slooten 2003, Slooten 2007a), as do more recent analyses under the current fisheries management regime (Slooten 2013). More recent modelling work also indicates that recovery of this subspecies will occur only under circumstances where human-induced mortality is extremely minimal (Wade et al. 2012; Slooten 2013). Therefore, we conclude that while the protections for Maui's dolphins have gradually increased from 2003 to present, there is insufficient evidence to conclude that current regulatory measures are adequate in terms of addressing threats to this subspecies.

    Other Natural or Manmade Factors Affecting Its Continued Existence

    Other threats identified in the 2012 risk assessment and characterized as being likely to affect population trends within the next 5 years include fishing vessel noise, disturbance, and trophic effects of fishing; however, these threats were considered to collectively make very limited contributions to the overall level of human-caused mortality (Currey et al. 2012). Although vessel traffic and its associated impacts of disturbance and boat strikes were considered to contribute little to annual mortality of Maui's dolphins, mortality due to vessel traffic was rated as having a 47.8 percent chance of exceeding PBR (Currey et al. 2012). Due to their coastal distribution and apparent attraction to small boats (Baker 1978, Slooten and Dawson 1988), the potential for boat strikes could be considered relatively high, but reports of boat strikes have been extremely rare (Stone and Yoshinaga 2000a). None of the reports within the DOC Incident Database from July 2008 to April 2016 are listed with boat strike as the cause of death.

    Summary of ESA Section 4(a)(1) Factors Affecting SI Hector's Dolphin

    Available information regarding historical, current, and potential threats to SI Hector's dolphins was thoroughly reviewed and is discussed in detail in the status review report (Manning and Grantz 2016). We summarize information regarding these threats below according to the factors specified in section 4(a)(1) of the ESA.

    The Present or Threatened Destruction, Modification, or Curtailment of Its Habitat or Range

    As discussed earlier for Maui's dolphins, persistent chemical pollutants are a concern for SI Hector's dolphins, which can theoretically accumulate high concentrations of contaminants due to their longevity, high trophic-level, and naturally high blubber content (Stockin et al. 2010). In cetaceans, biological impacts resulting from accumulation of contaminants such as heavy metals, PCBs, and organochlorine (OC) pesticides include endocrine disruption, reproductive impairment, immune suppression, and elevated infectious disease (e.g., Fujise et al. 1988, Kuiken et al. 1994, O'Hara and O'Shea 2001, Schwacke et al. 2002, Jepson et al. 2005, Wells et al. 2005). As previously mentioned, Stockin et al. (2010) found high PCB and OC contaminant loads in Hector's dolphins (n=27, SI Hector's dolphins; n=3, Maui's dolphins) sampled from 1997 to 2009, and a roughly two-fold increase in levels of OC pesticides than had been previously reported for Hector's dolphins by Jones et al. (1999). However, no PCB concentrations were above thresholds associated with reproductive and immunological effects (Stockin et al. 2010). High levels of polychlorinated dibenzo-p-dioxins (PCDDs) and dibenzofurans (PCDFs), which are two related and ubiquitous chemical contaminants, were also found to occur at unexpected levels in the blubber of six SI Hector's dolphins (Buckland et al. 1990).

    Plastic marine debris is also a concern for SI Hector's dolphins. Plastics and other synthetic, non-biodegradable materials in the marine environment create the potential for entanglement, injury, and ingestion by various marine species. As with other marine mammals, Hector's dolphins may become entangled and subsequently wounded, or have impaired foraging ability, and/or increased susceptibility to predation. Ingestion of plastics by marine species has been associated with a multitude of impacts including blockage of the digestive tract, starvation, reduction in reproductive capacity, drowning, and possible accumulation of toxic compounds (Laist 1997, Gregory 2009). Plastic debris was found in the stomach of a SI Hector's dolphin that stranded along the coast of the Canterbury region, and there are anecdotal reports of SI Hector's dolphins off Banks Peninsula with fishing line or netting entangling the head or upper body and cutting into the blubber (MFish and DOC 2007b).

    Mining occurs along the west coast of the South Island where there are significant nearshore and beach deposits of ilmenite (mined mainly for titanium dioxide). The TMP for Hector's dolphins identified possible impacts of mining activity, including loss or reduction in prey species, noise, and vessel disturbance (MFish and DOC 2007b). Based on a search of the NZPM's map in June 2016 (http://data.nzpam.govt.nz/permitwebmaps?commodity=minerals), a large portion of the SI Hector's dolphin west coast range is included in a prospecting permit application, indicating the potential for continued mining activity in this region.

    Prospecting permits for petroleum cover large areas along the southeastern coast of the South Island (http://data.nzpam.govt.nz/permitwebmaps?commodity=petroleum, June 2016). Drill ships are also operated off Canterbury and along the west coast of the South Island. Potential habitat impacts from these activities include oil spills; increased vessel traffic; and acoustic disturbances from seismic surveys, sonar, and drilling activities. Contaminants in oil and gas may impact the health of the dolphins, and the associated noise may disrupt normal behaviors, such as navigating, migrating, and feeding (Gordon et al. 2003, Thompson 2012).

    Overall, it is clear that SI Hector's dolphins are exposed to multiple habitat-related threats. However, the extent to which SI Hector's dolphins are being impacted—both individually and at a population level—by these habitat-related threats is not yet established due to insufficient data (MFish and DOC 2007b). It is possible that SI Hector's dolphin habitat will become increasingly degraded in the future with increasing human use of the coastal zone and its resources (MFish and DOC 2007b).

    Overutilization for Commercial, Recreational, Scientific or Educational Purposes

    Hector's dolphins have not been systematically captured for any commercial, recreational, scientific, or educational purposes; although, as noted earlier, a few Hector's dolphins have been taken for live exhibition. While Hector's dolphins have also apparently been taken for food, oil, and bait, the extent to which this occurred is not known (Pichler et al. 2003).

    There is growing evidence that overutilization in the form of commercial dolphin-watching and swim-with-dolphin operations, which are increasingly popular tourist activities in New Zealand, are a concern for SI Hector's dolphins. The majority of the commercial viewing and encounter operations in New Zealand occur around the South Island and are especially popular along the east coast off Kaikoura and within Akaroa Harbor, which have become major eco-tourist destinations in New Zealand (Martinez 2010b). Within Akaroa Harbor, and as of 2010, there were up to about 18 daily `swim-with' trips and 14 dolphin-watching trips per day between November and March that specifically targeted Hector's dolphins (Martinez 2010b). In addition to permitted commercial operations, opportunistic viewing also occurs by both commercial and recreational boaters.

    Dolphin-watching and swim-with-dolphin operations have been shown to cause behavioral changes in Hector's dolphins (Bejder et al. 1999, Constantine 1999, Martinez et al. 2012). In a study of SI Hector's dolphins in Porpoise Bay, Bejder et al. (1999) found that while SI Hector's dolphins were not displaced by dolphin-watching tour boats, the dolphins did respond by approaching the boats, especially initially, and by forming significantly tighter groupings. A possible interpretation of the behavioral response of `bunching' is that the boat is perceived as some kind of threat and may in fact cause the animals some level of stress (Constantine 1999). In Akaroa Harbor, Martinez (2010b) found that both diving—which is considered a feeding behavior—and travelling were significantly disrupted by vessel interactions. Evidence also indicates that the use of sounds to attract Hector's dolphins to swimmers affects the behavior of the dolphins (Martinez et al. 2012). For example, both the number and the duration of close interactions or approaches by Hector's dolphins were significantly greater when a swimmer banged two rocks together underwater (Martinez et al. 2012). Such deliberate efforts to attract Hector's dolphins could have behavioral consequences such as disrupted or reduced foraging time, which in turn can have biological consequences (Martinez et al. 2012). For some regional dolphin populations, a relatively large portion of that population can be exposed to the tourist activities occurring in a particular harbor or area. For example, about 80 percent of the SI Hector's dolphins that were photo-identified in surveys around Banks Peninsula between 1985 and 2006 had alongshore home ranges that included Akaroa Harbor, and for half of these dolphins, Akaroa Harbor served as a core use or “hub” area (Rayment et al. 2009a).

    Longer-term impacts of these tourism activities on SI Hector's dolphins are not yet clear but could include physiological stress, reduced energy intake, and possibly even reduced calving success. Linkages between immediate behavioral responses to vessel traffic and longer-term biological consequences have already been established for other species (e.g., Tursiops sp.) and include declines in abundance and reduced reproductive success in females (Bejder et al. 2006a, 2006b, 2006c). Given this information and the fact that SI Hector's dolphin populations encounter dolphin-watching operations in multiple areas of their range (e.g., Porpoise Bay, Timaru, Akaroa Harbor, and Marlborough Sounds), dolphin-watching and `swim-with' activities are likely posing a significant but sub-lethal threat to this subspecies. The actual magnitude of this threat cannot yet be established, but this threat is likely to persist given the popularity and lucrativeness of the eco-tourism industry in New Zealand.

    Disease or Predation

    As previously mentioned, predation of Hector's dolphins by several shark species, such as broadnose seven-gill sharks (N. cepedianus) and blue sharks (P. glauca), is known to occur (Slooten and Dawson 1988). Although seven-gill sharks are particularly common around Banks Peninsula, predation rates are not known (Slooten and Dawson 1988), and there is no evidence to suggest predation is posing a threat to this subspecies.

    Prevalence of infectious disease and associated impacts have not yet been well studied in Hector's dolphins, but recent evidence suggests that infectious disease may be a significant source of mortality for SI Hector's dolphins. In particular, Roe et al. (2013) found that out of 22 dolphins collected between 2007 and 2011 for which a definitive cause of death was established, a total of ten (45 percent) had died due to infectious disease (Toxoplasma gondii infections, bacterial infection, or fungal infection). Five of the 22 SI Hector's dolphins (23 percent) were found to have died as a result of T. gondii infection (toxoplasmosis, Roe et al. 2013). While toxoplasmosis is typically a secondary disease in cetaceans, resulting in symptoms in immunosuppressed individuals rather than healthy individuals, there was no evidence of immunosuppression in these cases, suggesting that Hector's dolphins are particularly susceptible to toxoplasmosis (Roe et al. 2013). Beyond direct mortality, toxoplasmosis can also have other biological consequences, such as behavioral changes, reduced reproductive rate, and neonatal loss. Because the fatal cases of T. gondii infection in this study were distributed throughout almost the entire range of the SI Hector's dolphin, exposure is probably occurring over broad areas. Overall, the available data suggest that disease, especially toxoplasmosis, is posing a threat to SI Hector's dolphins.

    Inadequacy of Existing Regulatory Mechanisms

    As with Maui's dolphins, a number of regulatory measures have been put in place to address bycatch of SI Hector's dolphins. As previously noted, by the 1980's, bycatch of Hector's dolphins in commercial and recreational gillnets was recognized as a serious issue in New Zealand (Dawson and Slooten 2005). In the South Island, a region of particular concern was the Pegasus Bay and Canterbury Bight area along the east coast, where there was a known high degree of overlap between inshore gillnetting and a locally abundant population of SI Hector's dolphins. To begin to quantify the level of bycatch, Dawson (1991b) conducted fisherman interviews during 1984-1988 and found that at least 230 SI Hector's dolphins had died due to entanglement in commercial and recreational gillnets in the Pegasus Bay and Canterbury Bight region during this period. Ages of entangled dolphins that were physically examined (n=43) ranged from younger than 1 year to about 20 years old, but a high proportion (63 percent) were 3 years old or younger, suggesting that younger dolphins are especially vulnerable to entanglement (Dawson 1991b). Overall, this level of bycatch (i.e., 230 over 4 years or about 57.5 entanglement mortalities per year), greatly exceeded the estimated population growth rate for this regional population (1.8−4.9 percent or 13.3−36.3 individuals per year; Dawson and Slooten 1988b, Slooten and Lad 1991). Subsequent analyses based on observer data, suggested that bycatch rates during this period (1984−1988) were actually much higher, averaging 100 dolphins per year (Davies et al. 2007).

    Released in 2007, the TMP for Hector's dolphins identified set gillnetting as the greatest source of human-caused mortality of Hector's dolphins but also discussed how SI Hector's dolphins are incidentally captured in other gear types (MFish and DOC 2007b). Between 1921 and when the TMP was released, the DOC Incident Database indicates there had been 19 reports of Hector's dolphin mortalities due to trawls, which corresponds to 9 percent of the reported incidents with a known cause of death. All 19 of these reports occurred off the South Island within 2 nmi (3.7 km) of shore (MFish and DOC 2007b). Entanglement deaths of SI Hector's dolphins have also occurred in pot traps (e.g., rock lobster pots). Three such incidents were reported (in 1989, 1997, and 2004) and all occurred off Kaikoura, which is along the northeast coast of the South Island (MFish and DOC 2007b).

    In reaction to the growing concern over bycatch of Hector's dolphins, the DOC established the Banks Peninsula Marine Mammal Sanctuary (BPMMS) in 1988. When it was first established, the sanctuary extended from Sumner Head to the Rakaia River and out to 4 nmi (7.4 km), covering an area of about 1,140 sq km. All gillnetting within the sanctuary (with some harbor exceptions) was prohibited from November through February, and additional gear restrictions that applied throughout the remainder of the year essentially resulted in a year-round ban of commercial gillnetting within the sanctuary (Dawson and Slooten 1993). Additional restrictions on recreational gillnetting, such as limiting fishing to daylight hours only and requiring continuous tending of nets, were also enacted to help further reduce bycatch mortality. Based on fisheries observer data, bycatch in gillnets continued to occur to the immediate north and south of the sanctuary at unsustainable levels (Baird and Bradford 2000, Dawson and Slooten 2005), and there was little evidence of improved survival of SI Hector's dolphins within the sanctuary (Cameron et al. 1999). In recognition that further protection of SI Hector's dolphins was needed, the sanctuary boundaries were expanded in 2008 to the north and south and out to 12 nmi (22.2 km) offshore, but no restrictions on fishing activities were applied to the area beyond the original 4 nmi (7.4 km) sanctuary boundary (MFish and DOC 2007b, DOC 2008). The sanctuary currently encompasses about 4,130 sq. km and 389 km of coastline.

    In addition to the expansion of BPMMS, a series of fishing restrictions were put in place in 2008 to reduce bycatch of SI Hector's dolphins elsewhere around the South Island. Along the east and south coasts, from Cape Jackson in the Marlborough Sounds to Sandhill Point east of Fiordland, commercial gillnetting was banned out to 4 nmi (7.4 km) from shore, except at Kaikoura, where it was banned out to 1 nmi (1.9 km), and in Te Waewae Bay, where it is banned out to about 9 nmi (16.7 km) from shore (MFish 2008). Recreational gillnetting was allowed to continue in specified harbors and estuaries; and, in the case of flatfishing (e.g. for Rhombosolea spp.), gillnetting was permitted from April through September in the upper reaches of four harbors on Banks Peninsula, and in a similar area in Queen Charlotte Sound. Trawling was also prohibited along the east and south coasts from Cape Jackson to Sandhill Point out to 2 nmi (3.7 km), with an exception for trawls using a low headline net (used to target flatfish, MFish 2008). On the west coast of the South Island, again with some exceptions for certain harbors, inlets, estuaries, river mouths and lagoons, recreational set netting was banned year-round in waters out to 2 nmi (3.7 km) and from Cape Farewell on Farewell Spit to Awarua Point north of Fiordland; and commercial set netting was banned in the same area from December through February (MFish 2008). No trawling prohibitions were implemented for the west coast, and no fishing prohibitions were instituted along the north coast of the South Island. Since 2008, some amendments and changes to these fishery restrictions have been made for particular fishing activities and specific locations, but these changes are limited in scope and scale and are not discussed in detail here; see Manning and Grantz (2016) for additional detail.

    Recently, in 2013, the DOC established the Akaroa Harbor Marine Reserve at the mouth of Akaroa Harbor on Banks Peninsula. This reserve includes about 512 hectares of habitat or about 12 percent of the total harbor area (www.doc.govt.nz/parks-and-recreation/places-to-go/canterbury/places/banks-peninsula-area/akaroa-marine-reserve/). As a result of this designation, which provides protection to all marine life within the reserve, fishing and any other taking of living or non-living marine resources is prohibited.

    Despite the gradual increase in fishing restrictions around the South Island, exposure of SI Hector's dolphins to fishing activity remains fairly high throughout the South Island. On the west coast, where the dolphins are known to occur year-round and range to about 6.5 nmi (12.0 km) offshore (Mackenzie and Clement 2016), commercial gillnetting is prohibited only out to 2 nmi for just 3 months of the year, and there are no prohibitions on trawling. Survey sightings off the south coast indicate that the dolphins at least occasionally occur as far as 9.6 nmi (17.8 km) from shore and outside of protected areas (Clement et al. 2011). On the east coast, a substantial portion of the population is distributed well beyond the current closed areas, particularly in winter months (e.g., out to 18.2 nmi (33.7 km), Rayment et al. 2006, Rayment et al. 2010b); and gillnetting is still allowed within the BPMMS in waters between the original (4 nmi) and the extended offshore boundary (12 nmi).

    Evidence of continued bycatch around the South Island is available in the DOC Incident Database (www.doc.govt.nz/our-work/hectors-and-maui-dolphin-incident-database/), which lists 13 entanglement mortalities between May 2009 and April 2015; and, in 2012, two Hector's dolphins were found stranded and wrapped in a gillnet just north of Christchurch (Slooten 2013, 2016). Unfortunately, the actual level of bycatch since 2008 is unknown and the database records provide only a subset of the total bycatch (Slooten and Dawson 2016). The majority of mortalities captured in the database are also listed as having unknown or indeterminable causes. Pichler et al. (2003) reported that of the dolphins caught by commercial and recreational gillnet fishers and brought in for necropsies, only about half have discernable net markings, contributing further to the underestimation of bycatch rates. Some additional data are available from commercial gillnetting observer programs. For example, based on low observer coverage of commercial gillnet vessels from May 2009 through April 2010 (about 15.8 percent of fishing days and about 13 percent of total sets), three SI Hector's dolphin mortalities were recorded from the east coast of the South Island (ECSI; MPI 2011b, Slooten and Davies 2012). Slooten and Davies (2012) analyzed these data and estimated that 23 SI Hector's dolphins (range of 4−48, CV = 0.21) were caught off the ECSI in that year.

    Evidence from multiple modelling efforts suggests that SI Hector's dolphins will continue to decline due to bycatch under the current management measures. For example, for the most recent assessment of the BPMMS population, which has benefited from almost three decades of protection, Gormley et al. (2012) conducted a mark-recapture analysis of photographically identified dolphins (n=462) from 1986 to 2006 to compare annual survival rates before and after establishment of the sanctuary and associated gillnetting restrictions. Results indicated that between the two time periods, mean survival probability increased by 5.4 percent (from 0.863 to 0.917), which corresponds to a 6 percent increase in population growth. However, the population projections using the post-sanctuary survival rate also corresponded to a mean annual population decrease of 0.5 percent per year, with only 41 percent of the model simulations resulting in a population increase (Gormley et al. 2012). As noted by Gormley et al. (2012), this finding is consistent with other research indicating that the BPMMS is too small to allow recovery of this SI Hector's dolphin population (Rayment et al. 2006, Slooten et al. 2006b, Slooten and Dawson 2008, Rayment et al. 2010b, Slooten and Dawson 2010). A population viability analysis by Slooten and Dawson (2010), which relied on commercial gillnet observer data for a portion of the east coast to estimate bycatch (from Baird and Bradford 2000), projected that the west coast population would continue to decline (by just over 1,000 individuals by 2050), the Banks Peninsula population would continue to decline, and the remainder of the east coast population would slowly increase (by 450 individuals by 2050). In a review of risk assessments for SI Hector's dolphins, Slooten and Davies (2012) found that despite differing modelling approaches and assumptions applied, the risk assessments were highly consistent and were in general agreement that recovery of SI Hector's dolphins is unlikely under the current level of protections.

    Overall, based on the available information, the existing measures to address the threat of bycatch of SI Hector's dolphins appear inadequate, and we conclude that bycatch continues to pose a significant risk to this subspecies. The risk of bycatch in commercial and recreational trawl and gillnet fisheries remains high given the known distribution of the dolphins relative to areas closed to fishing, especially on the west and north coasts (Faustino et al. 2013, Slooten 2013). Although bycatch of SI Hector's dolphins has been slowed by the fisheries restrictions implemented in 2008, available risk analyses indicate that population decline is expected to continue (Slooten and Dawson 2010, Gormley et al. 2012, Slooten and Davies 2012). Finally, enforcement of the existing regulations may be insufficient. Illegal fishing has been reported for Banks Peninsula (Slooten and Davies 2012), and illegal fishing is discussed in the TMP (MFish and DOC 2007b). There are insufficient data available to evaluate the level of compliance with existing regulations.

    Several management measures have been implemented to address some of the threats associated with mining and petroleum industry activities. For both petroleum and minerals mining activities, a permit is generally required from local authorities under the Resource Management Act 1991 for mining activities within New Zealand's territorial sea (within 12 nmi from the coast). For mining activities beyond the territorial sea, the Environmental Protection Authority (EPA) manages the environmental effects of activity under the Exclusive Economic Zone and Continental Shelf (Environmental Effects) Act 2012 (EEZ Act) and its regulations, which establish which activities require permits and impact assessments. Seismic surveys are permitted under the EEZ Act if they adhere to the Code of Conduct for Minimizing Acoustic Disturbance to Marine Mammals from Seismic Survey Operations (DOC 2013). In 2013, the DOC and MPI updated their seismic survey guidelines and announced a decision to make the code of conduct a mandatory standard. The mandatory code of conduct applies to Territorial waters, the EEZ of New Zealand, and within all marine mammal sanctuaries, and includes requirements for planning, operations, monitoring, and reporting. The 2013 code of conduct is currently undergoing review and may be further augmented to increase protections for Hector's dolphins and other species of concern. Discharge management plans associated with mining activities also must be approved under the Maritime Rules Part 200, Maritime New Zealand prior to drilling.

    To help manage non-fishing-related threats to Hector's dolphins, the DOC expanded BPMMS in 2008 and established an additional three marine mammal sanctuaries- the Catlins Coast, Clifford and Cloudy Bay, and Te Waewae Bay Marine Mammal Sanctuaries (MMS). The Catlins Coast MMS lies along the south coast of the South Island (SCSI) between Three Brother's Point and Busy Point and extends 5 nmi to 6.9 nmi offshore. The sanctuary encompasses about 660 sq km of marine habitat and 161 km of coastline. The Clifford and Cloudy Bay MMS, which lies on the northeast coast, includes about 1,427 sq km and 338 km of coastline between Cape Campbell to Tory Channel, and extends 12 nmi offshore. The Te Waewae Bay MMS includes this entire SCSI bay and encompasses about 359 sq km of marine habitat and 113 km of coastline. Protections for SI Hector's dolphins that accompanied the expansion of BPMMS and the designation of these three additional sanctuaries were specific requirements for conducting seismic surveys. Included among the requirements for seismic surveys are mandatory notification prior to conducting surveys, mandatory reporting of any interactions with dolphins, and presence of qualified marine mammal observers on all survey ships (Gazette, 23 September 2008). There are no additional restrictions on mining activities within the sanctuaries.

    Overall, while there is a clear regulatory process in place for reviewing and permitting mining activities, given the existing information, it is not clear whether existing management measures are adequate to minimize acoustic and other impacts to SI Hector's dolphins such that these activities do not pose a threat to the subspecies.

    The dolphin-watching industry in New Zealand is regulated under the Marine Mammals Protection Regulations (MMPR), which were revised in 1992 in response to the growth in marine mammal-based tourism (Constantine (1999), citing Donoghue 1996). Among other provisions, these regulations govern the issuance of permits to commercial operators and, as discussed above, the behavior of vessels around dolphins. As a permit issuance criterion, commercial tour operators are required to ensure that their activities have “no significant adverse effect” on their targeted population (MMPR, 1992; Appendix 1.4). Given the high level of commercial dolphin watching operations in some portions of the SI Hector's dolphin's range, the repeat exposure of individual dolphins to vessels and/or `swim-with' activities, and the potential linkage to long-term biological consequences, it is possible that the current level of tourism is having a significant adverse impact on the subspecies. We find that there are insufficient data by which to verify that this permit issuance criterion is being met.

    Pursuant to the MMPR, all boaters, both recreational and commercial, must adhere to certain rules when operating around marine mammals. For example, no more than 3 vessels and/or aircraft are allowed within 300 m of any marine mammal at the same time; speeds must be kept to `no wake' speeds when within 300 m of any marine mammal; swimmers are prohibited from swimming with dolphin pods with very young calves; and boats are prohibited from circling, obstructing, or cutting through any group (MMPR 1992, part 3). Compliance monitoring is limited and sufficient quantitative data are not available to assess compliance by commercial and recreational boaters with these regulations (MFish and DOC 2007b). Thus, it is difficult to determine whether these regulations, and the associated education and enforcement, adequately address boat-related disturbance and boat strikes, which are discussed further in the section below.

    Other Natural or Manmade Factors Affecting Its Continued Existence

    Other potential threats to SI Hector's dolphins include vessel noise, trophic effects of fishing, and climate change; however, there are no data available to assess how or whether these factors are contributing to the overall level of human-caused mortality or population trends. Boat strikes, however, are a documented source of mortality for Hector's dolphins, and the TMP identifies vessel traffic as a threat that can result in disturbance and mortality (MFish and DOC 2007b). Vessel traffic has increased around the South Island, especially in areas more densely populated by people, and reports of cetaceans with propeller scars have increased (Martinez 2010b). Stone and Yoshinaga (2000) reported the death of two calves on consecutive days in Akaroa Harbor. In 1999, two calves, both estimated to be younger than 4 weeks old, were recovered on successive days from Akaroa Harbor, and autopsy results confirmed that one calf was killed by collision with a boat and the other calf by a propeller strike (Stone and Yoshinaga 2000). Stone and Yoshinaga (2000) suggest that mother and calf pairs may be less capable of evading boats if they are approached. Although the specific cause of death was unknown, the TMP also states that there were an additional nine cases from around the South Island in which cause of death was some form of trauma (MFish and DOC 2007b). Overall, data are too limited to assess the rate of boat strikes, but existing information clearly indicates that boat strikes are contributing to the total level of human-caused mortality.

    Demographic Risks Affecting Extinction Risk for Maui's Dolphins

    In our status review, data and information about demographic risks to Maui's dolphins were considered according to four categories—abundance and trends, population growth/productivity, spatial structure/connectivity, and genetic diversity. Each of these demographic threat categories was then rated according to the following qualitative scale:

    Very low risk: It is unlikely that this factor contributes significantly to risk of extinction, either by itself or in combination with other demographic factors.

    Low risk: It is unlikely that this factor contributes significantly to long-term or near future risk of extinction by itself, but there is some concern that it may, in combination with other demographic factors.

    Moderate risk: This factor is likely to contribute significantly to long-term risk of extinction, but does not by itself constitute a danger of extinction in the near future.

    High risk: This factor contributes significantly to long-term risk of extinction and is likely to contribute to short-term risk of extinction in the near future.

    Very high risk: This factor by itself indicates danger of extinction in the near future. (Note: The term “significantly” is used here as it is generally defined—i.e., in a sufficiently great or important way as to be worthy of attention.)

    In the sections below, we present information from Manning and Grantz (2016) to summarize the demographic risks facing Maui's dolphins.

    A. Abundance and Trends

    Based on line-transect aerial surveys conducted in January 2004, Slooten et al. 2006a estimated a total population size of 111 Maui's dolphins (95 percent CI = 48-252). A more recent abundance estimate, derived through genetic mark-recapture analysis of samples collected in 2010 and 2011, is 55 dolphins over 1 year of age (95 percent CI: 48−69, Hamner et al. 2012b). This estimate is based on a genetic mark-recapture analysis using 37 biopsy samples collected in 2010 and 36 biopsy samples collected in 2011, which were genotyped across 20 variable microsatellite loci and analyzed in a closed-sample model (Lincoln-Peterson estimator with Chapman correction, Chapman 1951; Hamner et al. 2012b). Both of these estimates indicate that the abundance of Maui's dolphins is critically low.

    Small populations can face higher risks of extinction from a range of factors, including stochastic demographic processes, genetic effects, and environmental catastrophes; and various theoretical abundance thresholds have been proposed as indicators of relative extinction risk (Gilpin and Soulé 1986, Allendorf et al. 1987, Mace et al. 2008). Both of the most recent abundance estimates for Maui's dolphins are well below commonly cited theoretical thresholds indicating a very high risk of extinction—e.g., 250 total individuals (Allendorf et al. 1987) and 250 mature individuals (Mace et al. 2008).

    Although historical abundance estimates are not available, Slooten (2007a) estimated population abundances for 1970 by back-calculating, using a population estimate of 117 dolphins (CV= 0.44) and estimates of fishing effort and rate of dolphin bycatch. Results suggest that the abundance of Maui's dolphins in 1970 was about 1,729 dolphins (CV= 0.51, Slooten 2007, Slooten and Dawson 2010). Martien et al. (1999) also projected numbers back to 1970 using an earlier abundance estimate published by Dawson and Slooten (1988; i.e., 134 dolphins), and estimated there were about 448 Maui's dolphins in 1970. Although there are differences in the models, assumptions, input data, and results of these two analyses, these estimated abundances for 1970 suggest the Maui's dolphin population has declined by about 90 percent or more when compared to the current abundance estimate of 55 dolphins over 1 year of age.

    Available evidence suggests that abundance of Maui's dolphins will continue to decline. For example, an annual rate of decline of 3.0 percent per year (95 percent CI: −11 percent to +6 percent) and an annual survival rate of 84 percent (95 percent CI = 0.75-0.90) was estimated by Hamner et al. (2012b). Although this result was somewhat equivocal given the large confidence interval, a projected decline is supported by the trend analysis conducted by Wade et al. (2012) using six different abundance estimates generated from 1985 to 2011. Wade et al. (2012) calculated a statistically significant declining trend of −3.2 percent per year from 1985 to 2011 (90 percent CI = −5.7 percent to −0.6 percent, p = 0.029).

    Given a population abundance of fewer than 100 dolphins over one year of age, evidence of a very large historical decline, and evidence of possible continued decline, this demographic risk category was rated as posing a “very high risk” for the subspecies.

    B. Population Growth

    Fecundity (i.e., the number of female offspring per female per breeding season) of Maui's dolphins is relatively low (0.165 to 0.25, Secchi et al. 2004b), with females having calves every two to four years after reaching maturity at about 7 years of age (Slooten and Dawson 1994, Dawson 2009). Due to an estimated lifespan of only about 22 years, later maturity, and low fecundity, Maui's dolphins are considered to have a low intrinsic rate of population growth (Dawson 2009). The annual mortality rate is estimated to be about 17 percent per year for dolphins 1 year of age and older (Hamner et al. 2012b), and, as mentioned above, modelling results suggest a declining population trend (Wade et al. 2012). Overall, this demographic factor was found to constitute a “high risk” for Maui's dolphin.

    C. Population Structure and Connectivity

    Maui's dolphins are thought to have once ranged along the entire coast of the North Island (Russell 1999, Dawson et al. 2001b, Baker et al. 2002, Du Fresne 2010). The dolphins now occur only off the west coast of the North Island. While there is no indication of spatial structuring within the subspecies, data do indicate that home ranges of individuals are probably small (e.g. 35.5 km (SE= 4.03), Oremus et al. 2012), and that movements over 100 km are probably rare (Hamner et al. 2012b). Overall, the available information indicates that substantial range contraction has already occurred, gene flow will be limited among populations of Hector's dolphins that are over 100 km apart, and any fragmentation of the remaining population would be a serious concern. Overall, this demographic factor was rated as posing a “moderate risk” for Maui's dolphins.

    D. Genetic Diversity

    Genetic diversity in Maui's dolphins is currently very low. Pichler (2002) analyzed microsatellite DNA for Maui's dolphins across six loci (n = 4 to 12) and reported an average of 1.5 alleles per locus, three of which were fixed (i.e., 1 allele), and an overall low heterozygosity (0.083−0.25). Analyses of contemporary mitochondrial DNA (mtDNA) samples also indicate a single maternal lineage (Pichler 2002, Hamner et al. 2012a). This level of haplotype diversity (i.e., h = 0) is well below the typical range of 0.70−0.92 for other more abundant odontocete species (Pichler and Baker 2000) and is only seen in several other rare marine mammals (e.g., vaquita (Phocoena sinus), north Atlantic right whale (Eubalaena glacialis), Dawson et al. 2001b).

    Maui's dolphins are reproductively isolated from SI Hector's dolphins, and there has been no recent gene flow between the subspecies (Pichler et al. 2001, Hamner et al. 2012a). Based on analyses of mtDNA, the North Island subspecies has been isolated from the South Island populations for up to 16,000 years (Pichler et al. 2001). Hamner et al. (2012a) noted that some degree of inbreeding is inevitable for such a small, isolated population and also suggested that the significant deviation from a 1:1 sex ratio they observed for stranded Maui's dolphins, due to an excess of females in their sample (41 females of 68 total Maui's dolphins), may be an indication of deleterious inbreeding effects.

    Overall, Maui's dolphins have very low genetic diversity, are genetically isolated, and are vulnerable to inbreeding depression and the accumulation of deleterious mutations, which are serious concerns that can hasten the extinction of small populations (Lunch et al. 1995, Frankham 2005, O'Grady et al. 2006). This demographic factor was rated as a “high risk” for Maui's dolphins.

    Demographic Risks Affecting Extinction Risk for SI Hector's Dolphins

    In the sections below, we present information from Manning and Grantz (2016) on the demographic risks facing SI Hector's dolphins. As with Maui's dolphins, demographic risks to SI Hector's dolphins were considered according to the same four categories (abundance and trends, population growth/productivity, spatial structure/connectivity, and genetic diversity) and rated according to the same qualitative scale as defined above.

    A. Abundance and Trends

    Various surveys have been completed for portions of the SI Hector's dolphin's range, each producing a separate, regional abundance estimate for the associated portion of the subspecies' range. (See Manning and Grantz (2016) for discussion of older surveys and abundance estimates.) The most recent abundance estimate for the west coast of the South Island (WCSI) is based on aerial surveys conducted by Mackenzie and Clement (2016) in 2014/2015 from Farewell Spit south to Milford Sound. These surveys included substantial effort in waters beyond 4 nmi (7.4 km) from shore and included an “outer” survey zone between 12 nmi and 20 nmi from shore (22.2-37.0 km, MacKenzie and Clement 2016). Based on these surveys, summer and winter abundance estimates of 5,490 dolphins (95% CI = 3,319-9,079) and 5,802 dolphins (95% CI = 3,879-8,679), respectively, were estimated using mark-recapture distance sampling after correcting for availability bias (or how “available” the dolphins are at or near the surface where they can be observed; Mackenzie and Clement 2016)). The most recent surveys of the north (NCSI) and east coasts (ECSI) of the South Island were conducted in the summer of 2012/2013 and winter 2013 and extended from Farewell Spit to Nugget Point and extended offshore to 20 nm (37.0 km; MacKenzie and Clement 2014). These intensive aerial surveys, which had a similar design as the WCSI surveys, produced an estimated summer abundance of 9,728 dolphins (95 percent CI= 7,001-13,517) and an estimated winter abundance of 8,208 dolphins (95 percent CI = 4,888-13,785, MacKenzie and Clement 2014, Mackenzie and Clement 2016). The most recent surveys of the SCSI produced an abundance estimate of 238 dolphins (95 percent CI = 113-503, Clement et al. 2011, Mackenzie and Clement 2016). This abundance estimate was based on two aerial surveys completed in March and August 2010 from Puysegur Point to Nugget Point and extended out to the 100-m depth contour (Clement et al. 2011). Following completion of the last of these three regional survey efforts, Mackenzie and Clement (2016) re-analyzed the data and, using the sum of the averages of the summer and winter abundance estimates from these surveys, calculated a total population estimate of 14,849 SI Hector's dolphins (95% CI = 11,923-18,492).

    Despite the large confidence intervals associated with some of these recent abundance estimates, the data indicate that the total abundance of SI Hector's dolphins is greater than commonly applied theoretical abundances used as indicators of a high risk of extinction—e.g., 2,500 total individuals (Allendorf et al. 1987) and 1,000 mature individuals (Mace et al. 2008)—suggesting that SI Hector's dolphins are not at high risk of extinction due to abundance alone.

    Populations of SI Hector's dolphins have, however, experienced substantial declines and available information suggests that the subspecies is likely to continue declining (Slooten and Lad 1991, Slooten et al. 1992, Burkhart and Slooten 2003). SI Hector's dolphin populations are estimated to have experienced declines of 20-73 percent since the 1970s following the expansion of commercial gillnetting in New Zealand (Slooten 2007, Davies et al. 2008, Slooten and Dawson 2010). Evidence of a historical decline is also provided by the findings of Pichler and Baker (2000), who detected a significant decline in mtDNA diversity (from h = 0.65 to h = 0.35, p<0.05) for ECSI Hector's dolphins in a comparison of contemporary (n=108) samples to historical samples (n=55) dating back to 1870. These authors suggest that the high rate of decline in mitochondrial DNA diversity reflects a high rate of population decline driven by unsustainable levels of bycatch mortality. While there is strong evidence that adult survival in the ECSI population has improved following the implementation of fishing restrictions at BPMMS (0.863 (95 percent CI = 0.647-0.971) pre-sanctuary versus 0.917 (95 percent CI = 0.802-0.984) post-sanctuary), the improved survival rate still corresponds to an estimated decline of 0.5 percent per year (Gormley et al. 2012). Results of modelling efforts by Slooten and Davies (2012) also suggest continued population declines over the next 50 years if fisheries management practices remain the same.

    Overall, this demographic factor was rated as posing a “moderate risk” for SI Hector's dolphins.

    B. Population Growth

    Given an estimated lifespan of about 22 years, relatively late maturity (at 7-9 years), and low fecundity (0.165 to 0.25), Hector's dolphins are considered to have a low intrinsic population growth rate (Slooten 1991, Slooten and Lad 1991, Secchi and Fletcher 2004, Secchi et al. 2004b, Dawson 2009). Females may produce only four to seven calves over their lifetime. Estimates of the survival rate of SI Hector's dolphins ≥ 1 year old have ranged from 0.77 to 0.89 (Slooten and Lad 1991, Slooten et al. 1992, Slooten and Dawson 1994, Cameron et al. 1999). Based on simple Leslie matrix models, Slooten and Ladd (1991) estimated a maximum population growth rate of 0.018 to 0.049; whereas, Secchi and Fletcher (2004) estimated a much lower population growth rate of 0.0065. Projections of population growth, given estimated levels of human-caused mortality, have varied depending on the modelling approach and the study population, but results are generally consistent in indicating a continuing population decline (Slooten and Dawson 2010, Slooten and Davies 2012). Essentially, the available information indicates that population growth is too low to compensate for current mortality rates, and that mortality needs to be reduced in order to allow populations around the South Island to recover from past declines due to bycatch (Slooten 2013).

    This demographic factor was rated as posing a “moderate risk” for SI Hector's dolphins.

    C. Population Structure and Connectivity

    Analyses of both mtDNA and microsatellite DNA indicate the existence of three distinct regional populations of SI Hector's dolphins—east, west, and south coast populations (Pichler et al. 1998, Pichler 2002, Hamner et al. 2012a). Each regional population is characterized by one or two high frequency mtDNA haplotypes, and hierarchical analyses of both mtDNA and microsatellite DNA data indicate strong genetic differentiation among the three regional populations (mtDNA FST = 0.321, p<0.001; Phi ST = 0.395; microsatellite FST = 0.058, p<0.001; Hamner et al. 2012a). There appears to be additional genetic structuring on the south coast, as samples from Te Wæwæ Bay and Toetoe Bay, locations separated by only about 100 km of coastline, were significantly differentiated based on both mtDNA (FST = 0.136, p = 0.03) and microsatellite DNA (FST = 0.043, p = 0.005). Fine-scale population structuring has also recently been detected in ECSI Hector's dolphins sampled from adjacent populations on either side of Kaikoura Canyon (Hamner et al. 2016). Analysis of both mtDNA (FST = 0.081, p<0.001) and microsatellite DNA (FST = 0.013, p<0.001) indicated a low but statistically significant level of genetic differentiation between these adjacent populations (Hamner et al. 2016).

    Estimated migration rates for males and females among the three main regional populations are low and appear to be asymmetrical (Pichler 2002, Hamner et al. 2012a). Based on mtDNA, Pichler (2002) estimated long-term migration rates of less than one female per generation among regions, except between the west and south coasts where female migration rates were estimated to be between 2.7 and 3.7 female migrants per generation. Based on analyses of both mtDNA and microsatellite DNA, there also appears to be a low level of male-mediated gene flow, with the highest exchange appearing to occur from the south coast to the east coast (Hamner et al. 2012a). Analysis of levels of genetic differentiation among sample locations within regions suggests a “stepping-stone” model of gene flow in which there are low levels of migration between neighboring populations over distances shorter than 100 km and much more limited gene flow among the three larger regional populations (Pichler 2002; Hamner et al. 2012a). Hamner et al. (2012a) concluded that very rare migration events are facilitating gene flow across the roughly 100-370 km distances separating the three larger regions. Overall, these findings are consistent with a priori expectations of low gene flow over larger spatial scales given the small estimated home ranges (typically 30 km-60 km) and high degree of site fidelity observed in SI Hector's dolphins (Bejder and Dawson 2001, Bräger et al. 2002, Rayment et al. 2009a). Although longer-range movements (> 400 km) of SI Hector's dolphins do appear to occur, at least on occasion, there is as yet no indication that such movements are associated with mating (Hamner et al. 2012b, Hamner et al. 2014a).

    How the existing population structure and connectivity of SI Hector's dolphin populations influence extinction risk is unclear. The current distribution of SI Hector's dolphins as multiple populations with a low level of connectivity could potentially provide protection from local extirpation (for example, by a catastrophic event) while allowing for local adaptation, which could ultimately benefit long-term survival (Franklin 1980). Alternatively, restricted and asymmetrical dispersal among populations may mean there is very limited potential for one population to buffer against the loss of another local population and prevent further fragmentation (Pichler et al. 1998, Pichler 2001). The ongoing human-caused mortality and the slow population growth rate of SI Hector's dolphins are factors that favor this latter interpretation.

    Overall, this demographic factor was rated as posing a “moderate risk” to SI Hector's dolphins.

    D. Genetic Diversity

    Relative to other abundant dolphin species, genetic diversity of SI Hector's dolphins is low (Pichler and Baker 2000; Pichler 2002). Pichler and Baker (2000) reported haplotype (h) and nucleotide (π) diversity estimates of 0.35 and 0.0030, respectively, for ECSI Hector's dolphins (n = 46) and 0.66 and 0.0040 for WCSI Hector's dolphins (n = 47), which are low compared to previously reported estimates for other, more abundant odontocetes (e.g., h = 0.70-0.92 and π > 0.01). Diversity estimates based on mtDNA analyses by Hamner et al. (2012a) were somewhat higher for both the ECSI (h = 0.51, π = 0.0039) and WCSI (h = 0.72, π = 0.0049, n = 154) populations, possibly as a consequence of larger sample sizes, but they are still relatively low. The low genetic diversity observed may reflect restricted gene flow among populations and a consequent increase in genetic drift within populations.

    As noted above, analysis of mtDNA samples for ECSI Hector's dolphins by Pichler and Baker (2000) indicated a significant decline in mitochondrial diversity between historical samples from 1870-1987 (h = 0.65 and π = 0.0084, n = 36) and more contemporary samples from 1988-1998 (h = 0.35 and π = 0.0030, n = 46). A trend analysis of mtDNA diversity also indicated full loss of diversity within the next 20 years (Pichler and Baker 2000).

    Guidelines commonly cited and applied in conservation biology are that, in a finite population and ignoring other ecological considerations, a minimum effective population size of at least 50 individuals is required to prevent the harmful effects of inbreeding, and an effective population size of at least 500 individuals is required to prevent the accumulation of deleterious recessive alleles and maintain genetic diversity over hundreds of years (Franklin 1980, Soulé 1980, Gilpin and Soulé 1986, Allendorf et al. 1987). Other theoretical analyses, however, suggests that these thresholds are too low and that well over 1,000 breeding adults per generation may instead be necessary to avoid extinction by “mutational meltdown” over time periods of 100 or more generations (Lynch et al. 1995). Given that effective population size is often about 1/5 to 1/3 of a population's total size (Frankham 1995), a conservative estimate of the effective population size for SI Hector's dolphins could be roughly estimated as 2,385 to 3,698 dolphins (calculated using 1/5 of the 95 percent CI abundance estimates). Because these rough estimates are well above the thresholds of 50, 500, and 1,000 associated with inbreeding, loss of genetic diversity, and mutational meltdown, we conclude that the SI Hector's dolphin is not at high risk of extinction in the near-term due to its current genetic health.

    Given the evidence of low and potentially declining genetic diversity, this demographic factor was rated as being a “moderate risk.”

    Protective Efforts

    In addition to the regulatory measures discussed above (e.g. fishing and boating regulations, sanctuary designations), we considered other efforts being made to protect Hector's dolphins. We considered whether such protective efforts, as summarized below, alter our findings regarding the status of Maui's and Hector's dolphins.

    To help raise awareness and educate boaters about the regulations governing the operation of vessels around marine mammals, the DOC recently initated the ‘Sustainable Marine Mammal Actions in Recreation and Tourism'—or SMART program. Commercial operators who participate in the training course through this program are labelled `SMART operators' and are promoted to tourists as such. A training course for recreational boaters is also available. While this proactive program has likely improved boater awareness and on-the-water behavior to some degree, we have no data to evaluate the extent to which boater-associated impacts on Hector's dolphins have been reduced, and the available information indicates that dolphin-watching and `swim-with' activities are not benign activities even when conducted according to the existing regulations.

    To help minimize fisheries interactions and bycatch, some voluntary practices have been used in some areas around the South Island since 2002. These measures include deployment of pingers and other modifications to fishing activities. However, the extent to which such voluntary measures are being implemented is unclear, and the efficacy of pingers in reducing bycatch of Hector's dolphins has not yet been clearly established (Dawson 1998, Stone et al. 2000b). The MPI also established a hotline for reporting violations of fishing restrictions; however, there are no data available to evaluate whether the hotline has contributed to improved enforcement or compliance with existing fishing regulations.

    Although these efforts may be providing measurable protection for Hector's dolphins, there is no indication that these efforts are ameliorating threats, particularly the threats of bycatch and disease, such that the extinction risk of either subspecies is reduced. Therefore, we conclude that these protective efforts do not alter the extinction risk for either Maui's or SI Hector's dolphins. We are not aware of any other conservation measures for these subspecies and are soliciting additional information on any relevant conservation efforts through the public comment process on this proposed rule (see Public Comments Solicited below).

    Proposed Listing Determinations

    Maui's dolphins are currently at critically low abundance, and face additional demographic risks due to greatly reduced genetic diversity and a low population growth rate. Past declines, on the order of about 90 percent, have been driven largely by bycatch in gillnets. Maui's dolphins continue to face threats of bycatch, disease, and mining and seismic disturbances; and available evidence suggests the population will continue to decline despite existing management protections. We conclude that Maui's dolphin is currently facing a high risk of extinction throughout its range and is likely to become extinct. Therefore, we find that this subspecies meets the definition of an endangered species under the ESA. This conclusion is consistent with previous risk assessments for Maui's dolphin, which have concluded this subspecies is facing an extremely high risk of extinction in the wild and will recover only if sources of anthropogenic mortality are eliminated (Slooten et al. 2006; MFish and DOC 2007b, Baker et al. 2010). Concern over abundance and trends for Maui's dolphin has previously led to its classification as “nationally critical” under the New Zealand Threat Classification System, which is the most threatened status within this classification system (Baker et al. 2010).

    Under the New Zealand Threat Classification System, the SI Hector's dolphin has been formally classified as “nationally endangered,” which is the second-most threatened status within this classification system (Baker et al. 2010). The qualifier “conservation dependent” is also applied to SI Hector's dolphins, meaning that the subspecies is likely to move to the higher category of “nationally critical” if current management were to cease (Townsend et al. 2008, Baker et al. 2010).

    Our review of the best available data indicates that the SI Hector's dolphin has experienced substantial population declines since the 1970s, has relatively low genetic diversity, a low intrinsic population growth rate, and a fragmented population structure. Although historical data are lacking, Slooten (2007a) estimated that the SI Hector's dolphin population has declined by about 73 percent between 1970 and 2007, and available population viability analyses indicate that the SI Hector's dolphin is likely to continue to decline unless bycatch mortality is reduced (Davies et al. 2008, Slooten and Davies 2012, Slooten 2013). Gormley et al. (2012) estimated that the Banks Peninsula population, which has benefited from almost three decades of protection, would continue to decline at a rate of about 0.5 percent per year despite significantly improved survival rates. Assuming an existing population abundance of about 14,849 dolphins (95 percent CI = 11,923-18,492), a constant rate of decline of 0.5 percent per year for the subspecies as a whole could result in a 50 percent decline in the population in about 138 years and an 80 percent decline in about 321 years. These are simply estimates based on the limited data available, however, and they do not establish any specific thresholds for determining when the subspecies may be in danger of extinction throughout all or a significant portion of its range. The actual rate of decline of the subspecies remains unclear given the very limited bycatch mortality data available. A trend analysis based on survey data is also confounded by the fact that surveys have covered different portions of the range and have dramatically increased in sophistication and geographical scope over time. Thus, a precise analysis of the rate of decline and projection of time to extinction given multiple threats and demographic considerations is not currently possible.

    Current levels of bycatch are contributing to the decline of this subspecies (Slooten and Davies 2012). Additional, lesser threats, such as disease and tourism impacts, are likely exacerbating the rate of decline and thereby contributing to the overall extinction risk of this subspecies. Given recent abundance estimates for the total population and evidence of a slowed rate of decline following expanded fisheries management measures, we find that this subspecies is not facing an imminent risk of extinction. However, historical declines and the projected decline for most populations, combined with a low population growth rate, low genetic diversity, limited population connectivity, and the ongoing threats of bycatch, disease, and tourism, provide a strong indication that this subspecies is likely to become an endangered species within the foreseeable future assuming a status quo in conservation. We therefore propose to list this subspecies as threatened under the ESA.

    Effects of Listing

    Conservation measures provided for species listed as endangered or threatened under the ESA include the development and implementation of recovery plans (16 U.S.C. 1533(f)); designation of critical habitat, if prudent and determinable (16 U.S.C. 1533(a)(3)(A)); a requirement that Federal agencies consult with NMFS under section 7 of the ESA to ensure their actions do not jeopardize the species or result in adverse modification or destruction of designated critical habitat (16 U.S.C. 1536); and prohibitions on “taking” (16 U.S.C. 1538). The prohibitions on “take,” including export and import, automatically apply to species listed as endangered. Prohibitions on take do not apply to species listed as threatened unless protective regulations are issued under section 4(d) of the ESA (16 U.S.C. 1533(d)). In the case of threatened species, section 4(d) of the ESA leaves it to the Secretary's discretion whether, and to what extent, to extend take prohibitions to the species. Section 4(d) protective regulations may prohibit, with respect to threatened species, some or all of the acts which section 9(a) of the ESA prohibits with respect to endangered species. We are not proposing such regulations at this time but may consider potential protective regulations pursuant to section 4(d) for the SI Hector's dolphin in a future rulemaking.

    Recognition of the species' imperiled status through listing may also promote conservation actions by Federal and state agencies, foreign entities, private groups, and individuals.

    Activities That Would Constitute a Violation of Section 9 of the ESA

    On July 1, 1994, NMFS and the U.S. Fish and Wildlife Service (USFWS) published a policy (59 FR 34272) that requires us to identify, to the maximum extent practicable at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the ESA. The intent of this policy is to increase public awareness of the potential effects of species listings on proposed and ongoing activities.

    If the Maui's dolphin is listed as endangered, all of the prohibitions of section 9(a)(1) of the ESA will apply to this subspecies. Section 9(a)(1) includes prohibitions against the import, export, use in foreign commerce, and “take” of the listed species. These prohibitions apply to all persons subject to the jurisdiction of the United States, including in the United States, its territorial sea, or on the high seas. Take is defined as “to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct.” Activities that could result in a violation of section 9 prohibitions for Maui's dolphins include, but are not limited to, the following:

    (1) Delivering, receiving, carrying, transporting, or shipping in interstate or foreign commerce any individual or part, in the course of a commercial activity;

    (2) Selling or offering for sale in interstate commerce any part, except antique articles at least 100 years old; and

    (3) Importing or exporting Maui's dolphins or any parts of these dolphins.

    Whether a violation results from a particular activity is entirely dependent upon the facts and circumstances of each incident. Further, an activity not listed here may in fact constitute a violation.

    Section 7 Conference and Consultation Requirements

    Section 7(a)(2) (16 U.S.C. 1536(a)(2)) of the ESA and joint NMFS/USFWS regulations require Federal agencies to consult with NMFS to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of listed species or destroy or adversely modify critical habitat. Section 7(a)(4) (16 U.S.C. 1536(a)(4)) of the ESA and NMFS/USFWS regulations also require Federal agencies to confer with us on actions likely to jeopardize the continued existence of species proposed for listing, or that are likely to result in the destruction or adverse modification of proposed critical habitat of those species. It is unlikely that the listing of these subspecies under the ESA will increase the number of section 7 consultations, because these subspecies occur outside of the United States and are unlikely to be affected by Federal actions.

    Critical Habitat

    Critical habitat is defined in section 3 of the ESA (16 U.S.C. 1532(5)) as: (1) The specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the ESA, on which are found those physical or biological features (a) essential to the conservation of the species and (b) that may require special management considerations or protection; and (2) specific areas outside the geographical area occupied by a species at the time it is listed if such areas are determined to be essential for the conservation of the species. Section 4(a)(3)(A) of the ESA (16 U.S.C. 1533(a)(3)(A)) requires that, to the extent prudent and determinable, critical habitat be designated concurrently with the listing of a species. However, critical habitat cannot be designated in foreign countries or other areas outside U.S. jurisdiction (50 CFR 424.12(g)). Maui's and SI Hector's dolphins are endemic to New Zealand and do not occur within areas under U.S. jurisdiction. There is no basis to conclude that any unoccupied areas under U.S. jurisdiction are essential for the conservation of either subspecies. Therefore, we do not intend to propose any critical habitat designations for either subspecies.

    Public Comments Solicited

    We must base our final listing determination on the best scientific and commercial data available. We cannot consider the economic effects of a listing determination. To help ensure that any final action resulting from this proposed rule will be accurate and based on the best available data, we are soliciting comments from the public, other concerned governmental agencies, the scientific community, industry, and any other interested parties on the draft status review report and proposed rule. See DATES and ADDRESSES for information on how to submit comments.

    Promulgation of any final regulation to list these subspecies will take into consideration the comments and any additional data we receive during the comment period, and this process may lead to a final regulation that differs from this proposal. We are especially seeking information regarding the following topics:

    (1) New or updated data regarding threats to Maui's and SI Hector's dolphins, especially bycatch rates in commercial and recreational fisheries, bycatch in fishing gear types other than gillnets, compliance with fishing regulations, and trends in disease prevalence;

    (2) New or updated population viability analyses that reflect the most recent abundance estimates for the subspecies;

    (3) Current or planned activities within the range of these subspecies and their possible impacts on these species; and,

    (4) Conservation efforts that are addressing threats to either subspecies.

    We request that all information be accompanied by: (1) Supporting documentation, such as maps, bibliographic references, or reprints of pertinent publications; and (2) the submitter's name, address, and any association, institution, or business that the person represents.

    Peer Review

    In December 2004, the Office of Management and Budget (OMB) issued a Final Information Quality Bulletin for Peer Review establishing a minimum peer review standard. We solicited peer review comments on the draft status review report (Manning and Gantz 2016) from three scientists with expertise on Hector's dolphins. We received and reviewed comments from these scientists, and their comments are incorporated into the draft status review report and this proposed rule. Their comments on the status review are summarized in the peer review report and available at www.cio.noaa.gov/services_programs/prplans/PRsummaries.html.

    References

    A complete list of the references used in this proposed rule is available upon request (see ADDRESSES).

    Classification National Environmental Policy Act

    Section 4(b)(1)(A) of the ESA restricts the information that may be considered when assessing species for listing and sets the basis upon which listing determinations must be made. Based on the requirements in section 4(b)(1)(A) of the ESA and the opinion in Pacific Legal Foundation v. Andrus, 675 F. 2d 825 (6th Cir. 1981), we have concluded that ESA listing actions are not subject to the environmental assessment requirements of the National Environmental Policy Act (NEPA).

    Executive Order 12866, Regulatory Flexibility Act, and Paperwork Reduction Act

    As noted in the Conference Report on the 1982 amendments to the ESA, economic impacts cannot be considered when assessing the status of a species. Therefore, the economic analysis requirements of the Regulatory Flexibility Act are not applicable to the listing process.

    In addition, this proposed rule is exempt from review under Executive Order 12866. This proposed rule does not contain a collection-of-information requirement for the purposes of the Paperwork Reduction Act.

    Executive Order 13132, Federalism

    In accordance with E.O. 13132, we determined that this proposed rule does not have significant federalism effects and that a federalism assessment is not required. In keeping with the intent of the Administration and Congress to provide continuing and meaningful dialogue on issues of mutual state and Federal interest, this proposed rule will be given to the relevant governmental agencies in New Zealand, and they will be invited to comment. We will confer with the U.S. Department of State to ensure appropriate notice is given to New Zealand. As the process continues, we intend to continue engaging in informal and formal contact with the U.S. State Department, giving careful consideration to all written and oral comments received.

    List of Subjects 50 CFR Part 223

    Endangered and threatened species, Exports, Transportation.

    50 CFR Part 224

    Endangered and threatened species, Exports, Imports, Transportation.

    Dated: September 13, 2016. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, we propose to amend 50 CFR parts 223 and 224 as follows:

    PART 223—THREATENED MARINE AND ANADROMOUS SPECIES 1. The authority citation for part 223 continues to read as follows: Authority:

    16 U.S.C. 1531-1543; subpart B, § 223.201-202 also issued under 16 U.S.C. 1361 et seq.; 16 U.S.C. 5503(d) for § 223.206(d)(9).

    2. In § 223.102, amend the table in paragraph (e) by adding an entry under “Marine Mammals” in alphabetical order, by common name, to read as follows:
    § 223.102 Enumeration of threatened marine and anadromous species.

    (e) * * *

    Species 1 Common name Scientific name Description of listed
  • entity
  • Citation(s) for listing
  • determination(s)
  • Critical habitat ESA rules
    Marine Mammals Dolphin, Hector's Cephalorhynchus hectori hectori Entire subspecies [Federal Register Citation and Date When Published as a Final Rule] NA NA *         *         *         *         *         *         * 1 Species includes taxonomic species, subspecies, distinct population segments (DPSs) (for a policy statement, see 61 FR 4722, February 7, 1996), and evolutionarily significant units (ESUs) (for a policy statement, see 56 FR 58612, November 20, 1991).
    PART 224—ENDANGERED MARINE AND ANADROMOUS SPECIES 3. The authority citation for part 224 continues to read as follows: Authority:

    16 U.S.C. 1531-1543 and 16 U.S.C 1361 et seq.

    4. In § 224.101, amend the table in paragraph (h) by adding an entry under “Marine Mammals” in alphabetical order, by common name, to read as follows:
    § 224.101 Enumeration of endangered marine and anadromous species.

    (h) * * *

    Species 1 Common name Scientific name Description of listed
  • entity
  • Citation(s) for listing
  • determination(s)
  • Critical habitat ESA rules
    Marine Mammals *         *         *         *         *         *         * Dolphin, Maui's Cephalorhynchus hectori maui Entire subspecies [Federal Register Citation and Date When Published as a Final Rule] NA NA *         *         *         *         *         *         * 1 Species includes taxonomic species, subspecies, distinct population segments (DPSs) (for a policy statement, see 61 FR 4722, February 7, 1996), and evolutionarily significant units (ESUs) (for a policy statement, see 56 FR 58612, November 20, 1991).
    [FR Doc. 2016-22451 Filed 9-16-16; 8:45 am] BILLING CODE 3510-22-P
    81 181 Monday, September 19, 2016 Notices DEPARTMENT OF AGRICULTURE Beginning Farmers and Ranchers Advisory Committee AGENCY:

    Office of Advocacy and Outreach, USDA.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act (FACA), the Office of Advocacy and Outreach (OAO) is announcing a meeting of the Beginning Farmers and Ranchers Advisory Committee (BFRAC). The committee is being convened to consider issues involving barriers for beginning farmers and ranchers, including lending and access to U.S. Department of Agriculture (USDA) programs, resources, and land. The members will deliberate on recommendations to be prepared for USDA Secretarial consideration.

    DATES:

    The committee meeting is scheduled for Thursday and Friday, September 29 and 30, 2016, from 8:30 a.m.-4:30 p.m. CST at the Cleveland Airport Marriott in Cleveland, Ohio. The meeting will be open to the public. All persons wishing to make comments during this meeting must check in between 8:30 a.m. and 9:30 a.m., and between 2:00 p.m. and 3:00 p.m. CST, on both days, at the registration table. All public commenters will be allowed a maximum of three minutes. If the number of registrants requesting to speak is greater than what can be reasonably accommodated during the scheduled open public meeting timeframe, speakers will be scheduled on a first-come basis. Public written comments for the committee's consideration may be submitted by close of business on September 22, 2016, to Mrs. Kenya Nicholas, Designated Federal Official, USDA OAO, 1400 Independence Avenue SW., Room 520-A, Washington, DC 20250-0170, Phone (202) 720-6350, Fax (202) 720-7704, Email: [email protected] Written submissions are encouraged to either be less than one page in length, or be accompanied by an executive summary and a summary of policy initiatives.

    A listen-only line will be available during the entire meeting for all who wish to listen in on the meeting or make public comments through the following telephone number: 1 (888) 790-3101 and enter passcode 6995865. Members of the public may also submit written comments for consideration to the committee via email at: [email protected] or fax to: (202) 720-7136.

    ADDRESSES:

    This public advisory committee meeting will be held at the Cleveland Airport Marriott, 4277 West 150th Street, Cleveland, Ohio 44135. There will also be signs directing attendees to the meeting room.

    FOR FURTHER INFORMATION CONTACT:

    Questions should be directed to Phyllis Morgan, Executive Assistant, OAO, 1400 Independence Avenue SW., Whitten Building, Room 520-A, Washington, DC 20250, Phone: (202) 720-6350; Fax: (202) 720-7704; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The BFRAC last met in Kansas City, Missouri, on August 3-4, 2015. The Secretary tasked the BFRAC with providing recommendations on access to land, farm business transition, and land tenure. They also considered issues around lending and credit in parsing statistics generated by USDA. Please visit our Web site at: http://www.outreach.usda.gov/smallbeginning/index.htm for additional information on the BFRAC.

    The public is asked to pre-register for the meeting by midnight on September 23, 2016. You may pre-register for the public meeting by submitting an email to [email protected] with your name, organization or affiliation, or any comments for the committee's consideration. You may also fax this information to (202) 720-7704. Members of the public who wish to make comments during the committee meeting must register at the check-in table.

    The agenda is as follows: Day 1: Committee discussions and public comments; Day 2: Committee discussions, public comments, and continued committee deliberations. Please visit the Beginning Farmers and Ranchers Advisory Committee Web site for the full agenda. All agenda topics and documents will be made available to the public by September 23, 2016, at: http://www.outreach.usda.gov/smallbeginning/index.htm. Copies of the agenda will also be distributed at the meeting.

    Meeting Accommodations: USDA is committed to ensuring that everyone is accommodated in our work environment, programs, and events. If you are a person with a disability and request reasonable accommodations to participate in this meeting, please note the request in your registration and you may contact Mrs. Kenya Nicholas in advance of the meeting by or before noon on September 23, 2016, by phone at (202) 720-6350, fax (202) 720-7704, or email: [email protected]

    Dated: September 13, 2016. Christian Obineme, Associate Director, Office of Advocacy and Outreach.
    [FR Doc. 2016-22406 Filed 9-16-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration Advisory Committee Meeting AGENCY:

    Grain Inspection, Packers and Stockyards Administration, USDA.

    ACTION:

    Notice of advisory committee meeting.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act, this constitutes notice of the upcoming meeting of the Grain Inspection, Packers and Stockyards Administration (GIPSA) Grain Inspection Advisory Committee (Advisory Committee). The Advisory Committee meets annually to advise the GIPSA Administrator on the programs and services that GIPSA delivers under the U.S. Grain Standards Act. Recommendations by the Advisory Committee help GIPSA better meet the needs of its customers who operate in a dynamic and changing marketplace.

    DATES:

    October 19, 2016, 8:00 a.m. to 4:30 p.m.; and October 20, 2016, 8:00 a.m. to Noon.

    ADDRESSES:

    The Advisory Committee meeting will take place at the Albers Mill Building, 1200 NW Naito Parkway, Suite 240, Portland, Oregon 97209.

    Requests to orally address the Advisory Committee during the meeting or written comments may be sent to: Administrator, GIPSA, U.S. Department of Agriculture, 1400 Independence Avenue, SW., STOP 3601, Washington, DC 20250-3601. Requests and comments may also be faxed to (202) 690-2173.

    FOR FURTHER INFORMATION CONTACT:

    Terri L. Henry by phone at (202) 205-8281 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    The purpose of the Advisory Committee is to provide advice to the GIPSA Administrator with respect to the implementation of the U.S. Grain Standards Act (7 U.S.C. 71-87k). Information about the Advisory Committee is available on the GIPSA Web site at http://www.gipsa.usda.gov/fgis/adcommit.html.

    The agenda will include service delivery overview, quality assurance and compliance updates, field management overview, international program updates as they relate to outreach, and technology and science initiatives.

    For a copy of the agenda please contact Terri L. Henry by phone at (202) 205-8281 or by email at [email protected]

    Public participation will be limited to written statements unless permission is received from the Committee Chairperson to orally address the Advisory Committee. The meeting will be open to the public.

    Persons with disabilities who require alternative means of communication of program information or related accommodations should contact Terri L. Henry at the telephone number listed above.

    Larry Mitchell, Administrator, Grain Inspection, Packers and Stockyards Administration.
    [FR Doc. 2016-22444 Filed 9-16-16; 8:45 am] BILLING CODE 3410-KD-P
    DEPARTMENT OF COMMERCE [Docket No. 160907830-6830-01] Privacy Act System of Records, Amended System of Records AGENCY:

    U.S. Department of Commerce, Office of the Secretary.

    ACTION:

    Notice of an Amended Privacy Act System of Records: “COMMERCE/DEPT-25, Access Control and Identity Management System.”

    SUMMARY:

    In accordance with the Privacy Act of 1974, as amended, Title 5 United States Code (U.S.C.) 552a(e)(4) and (11); and Office of Management and Budget (OMB) Circular A-130, Appendix I, Federal Agency Responsibilities for Maintaining Records About Individuals, the Department of Commerce proposes to amend the system of records entitled: “COMMERCE/DEPT-25, Access Control and Identity Management System.” Based on a review of the system of records notice, the Department is making necessary administrative updates to the sections entitled “SYSTEM LOCATION,” “SECURITY CLASSIFICATION,” and “NOTIFICATION PROCEDURE.”

    DATES:

    The system of records becomes effective on September 19, 2016.

    ADDRESSES:

    For a copy of the system of records please mail requests to: Michael J. Toland, Deputy Chief Freedom of Information Act (FOIA) Officer and Department Privacy Act Officer, Office of Privacy and Open Government, 1401 Constitution Ave. NW., Room 52010, Washington, DC 20230.

    FOR FURTHER INFORMATION CONTACT:

    Michael J. Toland, Deputy Chief FOIA Officer and Department Privacy Act Officer, Office of Privacy and Open Government, 1401 Constitution Ave. NW., Room 52010, Washington, DC 20230.

    SUPPLEMENTARY INFORMATION:

    On May 8, 2015, the Department published a proposed new Privacy Act system of records notice in the Federal Register (80 FR 26534) entitled: “COMMERCE/DEPT-25, Access Control and Identity Management System.” The system serves to provide electronic physical access control, intrusion detection and video management solutions to ensure the safety and security of the Department's assets to include people, facilities, information and property. The system controls access to only those authorized as well as aids in the monitoring, assessment and response to security and emergency related incidents.

    As a result of the Department's internal review of the notice covering this system of records, we became aware that the National Technical Information Service was not included under the “SYSTEM LOCATION” and “NOTIFICATION PROCEDURE” sections. We also became aware that incorrect information was provided for the “SECURITY CLASSIFICATION” section. For the aforementioned reasons, the Department publishes a notice of an amended system of records entitled: “COMMERCE/DEPT-25, Access Control and Identity Management System,” as published in the Federal Register on May 8, 2015 (80 FR 26534).

    OMB Circular A-130, Appendix I, indicates that minor changes to systems of records need not be reported. In this notice, we are making minor changes to the “COMMERCE/DEPT-25, Access Control and Identity Management System” system of records. Therefore, the Department has not filed a report describing the altered system of records covered by this notice with the Chair of the Senate Committee on Homeland Security and Governmental Affairs, the Chair of the House Committee on Oversight and Government Reform, or the Administrator of the Office of Information and Regulatory Affairs, OMB.

    COMMERCE/DEPT-25 SYSTEM NAME:

    Access Control and Identity Management System.

    SECURITY CLASSIFICATION:

    Unclassified, sensitive, for official use only, and classified.

    SYSTEM LOCATION:

    a. For Office of Security, Office of the Secretary, U.S. Department of Commerce, Room 1033, 1401 Constitution Avenue NW., Washington, DC 20230.

    b. For Office of Security, U.S. Census Bureau, Room 2J438, 4600 Silver Hill Road, Washington, DC 20233-3700.

    c. For Office of Security, U.S. Census Bureau Indiana, Room 104, Building 66, 1201 E. 10th Street, Jeffersonville, IN 47132.

    d. For Office of Security, National Institute of Standards and Technology, Room A-105, Building 318, 100 Bureau Drive, Gaithersburg, MD 20899.

    e. For Office of Security, National Oceanic and Atmospheric Administration, Room G-101, SSMC- OFA543, 1335 East-West Highway, Silver Spring, MD 20910.

    f. For Office of Security, National Oceanic and Atmospheric Administration, Western Region, Building 1, 7600 Sand Point Way NE., Seattle, WA 38115.

    g. For Office of Security, FirstNet, John W. Powell Federal Building, 12201 Sunrise Valley, Drive, Reston, VA 22091.

    h. For Office of Security, U.S. Patent and Trademark Office, 600 Dulany Street, Madison Building, West, Alexandria, VA 22313.

    i. For Office of the Secretary, Minority Business Development Agency, Economic and Statistics Administration, and Economic Development Administration: Office of the Secretary, Chief Information Officer, 1401 Constitution Avenue NW., Washington, DC 20230.

    j. For U.S. Census Bureau, Chief Information Officer, 4600 Silver Hill Road, Suitland, MD 20746.

    k. For Bureau of Industry and Security, Chief Information Officer, 1401 Constitution Avenue NW., Washington, DC 20230.

    l. For International Trade Administration, Chief Information Officer, 1401 Constitution Avenue NW., Washington, DC 20230.

    m. For National Institute of Standards and Technology, Chief Information Officer, 100 Bureau Drive, Gaithersburg, MD 20899.

    n. For National Telecommunications and Information Administration, Chief Information Officer, 1401 Constitution Avenue NW., Washington, DC 20230.

    o. For National Oceanic and Atmospheric Administration, Chief Information Officer, 1305 East-West Highway, SSMC3, Silver Spring, MD 20910.

    p. For U.S. Patent and Trademark Office, Chief Information Officer, 600 Dulany Street, Madison Building, Alexandria, VA 22314.

    q. For Office of Inspector General, Chief Information Officer, Chief Information Officer, 1401 Constitution Avenue NW., Washington, DC 20230.

    r. For National Technical Information Service, Office of the Chief Information Officer, Security Division, 5301 Shawnee Road., Alexandria, VA 22312.

    CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:

    Employees, contractors, and other affiliates requiring access to Department of Commerce electronic (including PKI-authenticated) and physical assets.

    CATAGORIES OF RECORDS IN THE SYSTEM:

    Records may include the individual's name; organization; work telephone number; cellular telephone number; home telephone number, work email; Federal agency Smart Card Number (FASC-N); social security number; employee number; status as an employee, contractor or other affiliation with the Department of Commerce; PIN number (encrypted); sign-in/out, badge-in/out, time-in/out, log-in/out data; computer transaction data to include, but not limited to, key stroke monitoring; IP address of access; logs of internet activity and records on the authentication of the access request; key fob identifier; token identifier; Personal Identity Verification (PIV) Card identifier; computer access login name; and any computer generated identifier assigned to a user.

    AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

    5 U.S.C. 301; 35 U.S.C. 2; the Electronic Signatures in Global and National Commerce Act, Public Law 106-229; 28 U.S.C. 533-535; 44 U.S.C. 1301; Homeland Security Presidential Directive 12 and IRS Publication-1075.

    PURPOSES:

    Records in this system are used by authorized personnel to improve security for Department of Commerce physical facilities for purposes including: Ensuring process integrity; enabling employees to carry out their lawful and authorized responsibilities; verifying individuals' authorization to access buildings and facilities; creating a record of individuals' access to buildings and facilities; facilitating the issuance and retrieval of visitor and temporary badges; and providing statistical data on building and facility access patterns including electronic and physical sign/badge-in and sign/badge-out data for resource planning and emergency management purposes.

    Records may also be used to secure electronic assets; to maintain accountability for issuance and disposition of security access; to maintain an electronic system to facilitate secure on-line communication between Federal automated systems, between Federal employees or contractors, and with the public, using digital signature technologies to authenticate and verify identity; to provide a means of access to electronic assets, desktops, and laptops; and to provide mechanisms for non- repudiation of personal identification and access to electronic systems, including but not limited to human resource, financial, procurement, travel and property systems, as well as systems containing information on intellectual property and other mission critical systems. The system also maintains records relating to the issuance of digital certificates utilizing public key cryptography to employees and contractors for the transmission of sensitive electronic material that requires protection.

    ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND PURPOSES OF SUCH USES:

    1. Records in this system are accessed on a daily basis by authorized personnel to verify individuals' authorized access to buildings and facilities; electronic systems and computers; facilitate the issuance and retrieval of visitor and temporary badges; determine whether administrative action (including disciplinary action) should be taken regarding any employee, contractor, or visitor; and provide statistical data on computer information systems, building and facility access patterns including electronic and physical sign/badge-in and sign/badge-out data for resource planning, emergency management purposes, assuring the security of computer information systems, and implementing Executive Order 13587.

    2. In the event that a system of records maintained by the Department to carry out its functions indicates or relates to a violation or potential violation of law or contract, whether civil, criminal or regulatory in nature, and whether arising by general statute or particular program statute or contract, or rule, regulation, or order issued pursuant thereto, or where necessary to protect an interest of the Department, the relevant records in the system of records may be referred, as a routine use, to the appropriate agency, whether Federal, state, local or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute or contract, or rule, regulation or order issued pursuant thereto, or protecting the interest of the Department.

    3. A record from this system of records may be disclosed to a Federal, state or local agency maintaining civil, criminal or other relevant enforcement information or other pertinent information, such as current licenses, if necessary to obtain information relevant to a Department decision concerning the assignment, hiring or retention of an individual, the issuance of a security clearance, the letting of a contract, or the issuance of a license, grant or other benefit.

    4. A record from this system of records may be disclosed to a Federal, state, local, or international agency, in response to its request, in connection with the assignment, hiring or retention of an individual, the issuance of a security clearance, the reporting of an investigation of an individual, the letting of a contract, or the issuance of a license, grant, or other benefit by the requesting agency, to the extent that the information is relevant and necessary to the requesting agency's decision on the matter.

    5. A record from this system of records may be disclosed in the course of presenting evidence to a court, magistrate or administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations.

    6. A record in this system of records may be disclosed to a Member of Congress submitting a request involving an individual when the individual has requested assistance from the Member with respect to the subject matter of the record.

    7. A record in this system of records may be disclosed to the Office of Management and Budget in connection with the review of private relief legislation as set forth in OMB Circular No. A-19 at any stage of the legislative coordination and clearance process as set forth in that Circular.

    8. A record in this system of records may be disclosed to the Department of Justice in connection with determining whether disclosure thereof is required by the Freedom of Information Act (5 U.S.C. 552).

    9. A record in this system of records may be disclosed to a contractor of the Department having need for the information in the performance of the contract, but not operating a system of records within the meaning of 5 U.S.C. 552a(m).

    10. A record in this system may be transferred to the Office of Personnel Management for personnel research purposes; as a data source for management information; for the production of summary descriptive statistics and analytical studies in support of the function for which the records are collected and maintained; or for related manpower studies.

    11. A record from this system of records may be disclosed to the Administrator, General Services, or his designee, during an inspection of records conducted by the General Services Administration as part of that agency's responsibility to recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this purpose, and any other relevant (i.e. GSA or Commerce) directive. Such disclosure shall not be used to make determinations about individuals.

    12. A record in this system of records may be disclosed to appropriate agencies, entities and persons when (1) it is suspected or determined that the security or confidentiality of information in the system of records has been compromised; (2) the DOC 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 whether systems or programs (whether maintained by the DOC 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 DOC's efforts to respond to the suspected or confirmed compromise and to prevent, minimize, or remedy such harm.

    13. A record in this system of records may be disclosed to appropriate agencies, entities and persons for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function.

    DISCLOSURE TO CONSUMER REPORTING AGENCIES:

    Not applicable.

    POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: Storage:

    Records in this system are on paper and/or in digital or other electronic form. Paper records are stored in secure rooms and storage cabinets and electronic records are stored as electronic/digital media and stored in secure file-servers within controlled environment. Both paper and electronic/digital records are accessed only by authorized personnel.

    RETRIEVABILITY:

    Records are retrieved by individual's name, employment status, organization and/or security access badge number, or other Department of Commerce identifier. Information may be retrieved from this system of records by automated search based on extant indices and automated capabilities utilized in the normal course of business.

    SAFEGUARDS:

    Entrance to data centers and support organization offices is restricted to those employees whose work requires them to be there for the system to operate. Identification cards are verified to ensure that records are in areas accessible only to authorized personnel who are properly screened, cleared, and trained. Disclosure of electronic information through remote terminals is restricted through the use of passwords and sign-on protocols that are periodically changed. Reports produced from the remote printers are subject to the same privacy controls as other documents of like sensitivity. Electronic and digital certificates ensure secure local and remote access and allow only authorized employees, contractor employees, or other affiliated individuals to gain access to federal information assets available through secured systems access.

    Access to sensitive records is available only to authorized employees and contractor employees responsible for the management of the system and/or employees of program offices who have a need for such information. Electronic records are password-protected or PKI-protected, consistent with the requirements of the Federal Information Security Management Act (Pub. L. 107-296), and associated OMB policies, standards and guidance from the National Institute of Standards and Technology, and the General Services Administration; all records are protected from unauthorized access through appropriate administrative, physical, and technical safeguards.

    Access is restricted on a “need to know” basis, utilization of PIV Card access, secure VPN for Web access, and locks on doors and approved storage containers. Buildings have security guards and secured doors. Entrances are monitored through electronic surveillance equipment.

    RETENTION AND DISPOSAL:

    Records are disposed of in accordance with the appropriate records disposition schedule approved by the Archivist of the United States.

    SYSTEM MANGER(S) AND ADDRESS:

    System managers are the same as stated in the System Location section above.

    NOTIFICATION PROCEDURE:

    An individual requesting notification of existence of records on himself or herself should send a signed, written inquiry to the locations listed below. The request letter should be clearly marked, “PRIVACY ACT REQUEST.” The written inquiry must be signed and notarized or submitted with certification of identity under penalty of perjury. Requesters should reasonably specify the record contents being sought.

    For records at locations a., g., and i.: Departmental Freedom of Information and Privacy Act Officer, Room 52010, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.

    For records at locations b., c., and j.: U.S. Census Bureau, Freedom of Information and Privacy Act Officer, Room 8H027, 4600 Silver Hill Road, Washington, DC 20233-3700.

    For records at locations d. and m.: National Institute of Standards and Technology, Freedom of Information and Privacy Act Officer, Room 1710, 100 Bureau Drive, Gaithersburg, MD 20899.

    For records at locations e., f., and o.: National Oceanic and Atmospheric Administration, Freedom of Information and Privacy Act Officer, Room 9719, SSMC3, 1315 East-West Highway, Silver Spring, MD 20910.

    For records at locations h. and p.: U.S. Patent and Trademark Office, Freedom of Information and Privacy Act Officer, 600 Dulany Street, Madison Building, East, Room 10B20, Alexandria, VA 22313.

    For records at location k.: Bureau of Industry and Security, Freedom of Information and Privacy Act Officer, Room 6622, 1401 Constitution Avenue NW., Washington, DC 20230.

    For records at location l.: International Trade Administration, Freedom of Information and Privacy Act Officer, Room 40003, 1401 Constitution Avenue NW., Washington, DC 20230.

    For records at location n.: National Telecommunications and Information Administration, Freedom of Information and Privacy Act Officer, Room 4713, 1401 Constitution Avenue NW., Washington, DC 20230.

    For records at location q.: Office of Inspector General, Freedom of Information and Privacy Act Officer, Room 7892, 1401 Constitution Avenue NW., Washington, DC 20230.

    For records at location r.: National Technical Information Service, Freedom of Information Act Officer, 5301 Shawnee Road, Alexandria, VA 22312.

    RECORD ACCESS PROCEDURES:

    An individual requesting access to records on himself or herself should send a signed, written inquiry to the same address as stated in the Notification Procedure section above. The request letter should be clearly marked, “PRIVACY ACT REQUEST.” The written inquiry must be signed and notarized or submitted with certification of identity under penalty of perjury. Requesters should specify the record contents being sought.

    CONTESTING RECORD PROCEDURES:

    An individual requesting corrections or contesting information contained in his or her records must send a signed, written request inquiry to the same address as stated in the Notification Procedure section above. Requesters should reasonably identify the records, specify the information they are contesting and state the corrective action sought and the reasons for the correction with supporting justification showing how the record is incomplete, untimely, inaccurate, or irrelevant. The Department's rules for access, for contesting contents, and for appealing initial determination by the individual concerned appear in 15 CFR part 4, Appendix B.

    RECORD SOURCE CATEGORIES:

    The information contained in these records is provided by or verified by: The subject individual of the record, supervisors, other personnel documents, other Department systems, access log records and sensors and non-Federal sources such as private employers and their agents, along with those authorized by the individuals to furnish information.

    EXEMPTIONS CLAIMED FOR THE SYSTEM:

    Pursuant to 5 U.S.C. 552a(j)(2), (k)(1), (k)(2), and (k)(5), all information and material in the record which meets the criteria of these subsections are exempted from the notice, access, and contest requirements under 5 U.S.C. 552a(c)3, (d), (e)(1), (e)(4)(G), (H), and (I), and (f) of the agency regulations because of the necessity to exempt this information and material in order to accomplish the law enforcement function of the agency, to prevent disclosure of classified information as required by Executive Order 12958, as amended by Executive Order 13292, to assure the protection of the President, to prevent subjects of investigation from frustrating the investigatory process, to prevent the disclosure of investigative techniques, to fulfill commitments made to protect the confidentiality of information, and to avoid endangering these sources and law enforcement personnel.

    Dated: September 14, 2016. Michael J. Toland, Department of Commerce, Deputy Chief FOIA Officer, Department Privacy Act Officer.
    [FR Doc. 2016-22469 Filed 9-16-16; 8:45 am] BILLING CODE 3510-BX-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-59-2016] Foreign-Trade Zone 122—Corpus Christi, Texas; Application for Expansion of Subzone 122J; Valero Refining Company; Nueces County, Texas

    An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Port of Corpus Christi Authority, grantee of FTZ 122, requesting an expansion of Subzone 122J on behalf of Valero Refining Company. 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 FTZ Board (15 CFR part 400). It was formally docketed on September 12, 2016.

    Subzone 122J was approved on December 21, 1988 (Board Order 414, 53 FR 53041, December 30, 1988). The subzone currently consists of three sites located in Nueces County: Site 1 (381 acres)—refinery complex located at 5900 Up River Road, Corpus Christi; Site 2 (230 acres)—refinery complex located at 1300 Cantwell Lane, Corpus Christi; and, Site 3 (16 acres)—coke pad located adjacent to Site 2.

    The applicant is requesting authority to expand Site 1 of the subzone to include an adjacent parcel (6.7 acres) located at 6601 Up River Road in Corpus Christi. No additional authorization for production activity has been requested at this time.

    In accordance with the FTZ Board's regulations, Camille Evans of the FTZ Staff is designated examiner to review the application and make recommendations to the FTZ Board.

    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 October 31, 2016. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to November 14, 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 FTZ 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: September 12, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-22401 Filed 9-16-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-39-2016] Foreign-Trade Zone (FTZ) 119—Minneapolis, Minnesota Authorization of Production Activity SICK, Inc.; (Electronic Industrial Sensors, Encoders, Optical Readers and Monitoring Systems) Savage, Minnesota

    On May 17, 2016, 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., within Subzone 119G, in Savage, Minnesota.

    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 37570, June 10, 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 Board's regulations, including Section 400.14.

    Dated: September 13, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-22399 Filed 9-16-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-60-2016] Foreign-Trade Zone (FTZ) 7—Mayaguez, Puerto Rico; Notification of Proposed Production Activity; MSD International GMBH (Puerto Rico Branch) LLC; Subzone 7G (Pharmaceuticals) Las Piedras, Puerto Rico

    MSD International GMBH (Puerto Rico Branch) LLC (MSD), operator of Subzone 7G, submitted a notification of proposed production activity to the FTZ Board for its facility within Subzone 7G, in Las Piedras, Puerto Rico. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on August 29, 2016.

    MSD currently has authority to produce certain pharmaceutical products and their intermediates within Subzone 7G. The current request would add a finished pharmaceutical product and foreign status materials/components to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status materials/components and specific finished product described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

    Production under FTZ procedures could exempt MSD from customs duty payments on the foreign-status materials/components used in export production. On its domestic sales, MSD would be able to choose the duty rate during customs entry procedures that applies to finished ertugliflozin/metformin pharmaceutical tablets for the treatment of type-2 diabetes (duty free) for the foreign-status materials/components noted below and in the existing scope of authority. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.

    The materials/components sourced from abroad include: Metformin hydrochloride and jet-milled ertugliflozin active ingredients (duty rates 3.7% and 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 October 31, 2016.

    A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via www.trade.gov/ftz.

    For further information, contact Diane Finver at [email protected] or (202) 482-1367.

    Dated: September 13, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-22480 Filed 9-16-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-552-801] Certain Frozen Fish Fillets From the Socialist Republic of Vietnam: Preliminary Results and Partial Rescission of the Antidumping Duty Administrative Review; 2014-2015 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department preliminarily determines that none of the mandatory respondents in this review qualify for a separate rate and are, therefore, considered a part of the Vietnam-Wide Entity for their exports of subject merchandise exported to the United States during the period of review (“POR”) August 1, 2014, through July 31, 2015. If these preliminary results are adopted in the final results, the Department will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on all appropriate entries of subject merchandise during the POR. Interested parties are invited to comment on these preliminary results.

    DATES:

    Effective September 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Kenneth Hawkins or Javier Barrientos, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone 202-482-6491 or 202-482-2243, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On September 30, 2014, the Department initiated the 12th administrative review of the antidumping duty order on fish fillets from Vietnam for the period August 1, 2014, through July 31, 2015.1 On May 4, 2016, the Department partially extended the deadline for issuing the preliminary results by 118 days.2 The revised deadline for the preliminary results of this administrative review is now September 6, 2016.

    1See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 80 FR 60356 (October 6, 2015).

    2See Memorandum to Christian Marsh, Deputy Assistant Secretary, Antidumping and Countervailing Duty Operations, through James C. Doyle, Director, Office V, Antidumping and Countervailing Duty Operations regarding, from, Kenneth Hawkins, International Trade Compliance Analyst, Antidumping and Countervailing Duty Operations, “Certain Frozen Fish Fillets from the Socialist Republic of Vietnam: Extension of Deadline for Preliminary Results of 2014-2015 Antidumping Duty Administrative Review,” dated May 4, 2016.

    Scope of the Order

    The product covered by the order is frozen fish fillets, including regular, shank, and strip fillets and portions thereof, whether or not breaded or marinated, of the species Pangasius Bocourti, Pangasius Hypophthalmus (also known as Pangasius Pangasius) and Pangasius Micronemus. These products are classifiable under tariff article code 0304.62.0020 (Frozen Fish Fillets of the species Pangasius, including basa and tra), and may enter under tariff article codes 0305.59.0000, 1604.19.2100, 1604.19.3100, 1604.19.4100, 1604.19.5100, 1604.19.6100 and 1604.19.8100 of the Harmonized Tariff Schedule of the United States (“HTSUS”).3 Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the order is dispositive.4

    3 Until June 30, 2004 these products were classifiable under HTSUS 0304.20.6030, 0304.20.6096, 0304.20.6043 and 0304.20.6057. From July 1, 2004 until December 31, 2006 these products were classifiable under HTSUS 0304.20.6033. From January 1, 2007 until December 31, 2011 these products were classifiable under HTSUS 0304.29.6033. On March 2, 2011 the Department added two HTSUS numbers at the request of U.S. Customs and Border Protection (“CBP”) that the subject merchandise may enter under: 1604.19.2000 and 1604 19.3000, which were changed to 1604.19.2100 and 1604.19.3100 on January 1, 2012. On January 1, 2012 the Department added the following HTSUS numbers at the request of CBP: 0304.62.0020, 0305.59.0000, 1604.19.4100, 1604.19.5100, 1604.19.6100 and 1604.19.8100.

    4 For a complete description of the scope of the order, see Memorandum to Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, from Gary Taverman, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations “Certain Frozen Fish Fillets from the Socialist Republic of Vietnam: Issues and Decision Memorandum for the Final Results of the 11th Antidumping Duty Administrative Review; 2013-2014,” at 2-3 (“Issues and Decision Memorandum”), dated concurrently with and hereby adopted by this notice.

    Partial Rescission of Administrative Review

    Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation. Between December 30, 2015 and January 4, 2016 we received timely withdrawal of review requests for 62 companies from Petitioner,5 Bien Dong Seafood Co., Ltd (“Bien Dong”), and Vinh Hoan Corporation (“Vinh Hoan”).6 Of these 62 companies, 38 do not have any review request outstanding. Therefore, in accordance with 19 CFR 351.213(d)(1), the Department is rescinding this review of the antidumping duty order on certain frozen fish fillets from the Socialist Republic of Vietnam with respect to these 38 companies.7 In addition the Department is rescinding the review for two additional companies.8 The review will continue with respect to the other firms for which a review was requested and initiated.

    5 Catfish Farmers of America and individual U.S. catfish processors America's Catch, Alabama Catfish Inc. dba Harvest Select Catfish, Inc., Heartland Catfish Company, Magnolia Processing, Inc. dba Pride of the Pond, and Simmons Farm Raised Catfish, Inc. (hereinafter, “Petitioner”).

    6See, e.g., Letter from Bien Dong Seafood regarding Frozen Fish Fillets from the Socialist Republic of Vietnam: Withdrawal of Request for Administrative Review—Bien Dong Seafood Co., Ltd., dated December 30, 2015; Letter from Petitioner regarding Certain Frozen Fish Fillets from the Socialist Republic of Vietnam: Partial Withdrawal of Request for Antidumping Duty Administrative Review, dated January 4, 2016; Letter from Vinh Hoan regarding Frozen Fish Fillets from the Socialist Republic of Vietnam: Withdraw of Request for Administrative Review—Vinh Hoan Corporation, dated January 4, 2016.

    7See Appendix II for a full list of rescinded companies.

    8See Issues and Decision Memorandum at 4.

    Preliminary Determination of No Reviewable Transactions

    The Department has preliminarily determined that Ben Tre Aquaproduct Import and Export Joint Stock Company, CADOVIMEX II Seafood Import Export and Processing Joint Stock Company, and Hoang Long Seafood Processing Company Limited had no reviewable transactions during the POR. Consistent with our practice in non-market economy (“NME”) cases, we will not to rescind the review, in part, in this circumstance, but rather, complete the review with respect to these companies and issue appropriate instructions to CBP based on the final results of the review.9

    9See Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694, 65694-65695 (October 24, 2011).

    Methodology

    The Department is conducting this review in accordance with sections 751(a)(1)(B) and 751(a)(2)(A) of the Tariff Act of 1930, as amended (“the Act”). Constructed export prices and export prices have been calculated in accordance with section 772 of the Act. Because Vietnam is an NME within the meaning of section 771(18) of the Act, NV has been calculated in accordance with section 773(c) of the Act.

    For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is on file electronically 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 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 Review

    The Department preliminarily determines that the following weighted-average dumping margins exist for the period August 1, 2013, through July 31, 2014:

    Exporter Weighted-
  • average
  • margin
  • (dollars/
  • kilogram) 10
  • Cuu Long Fish Joint Stock Company * 0. 69 GODACO Seafood Joint Stock Company * 0. 69 Green Farms Seafood Joint Stock Company * 0. 69 NTSF Seafoods Joint Stock Company * 0. 69 Vietnam-Wide Entity 11 2.39 * These companies are separate rate respondents not individually examined.
    Disclosure, Public Comment & Opportunity To Request a Hearing

    The Department will disclose the calculations used in our analysis to parties in this review within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

    10 In the third administrative review of this order, the Department determined that it would calculate per-unit assessment and cash deposit rates for all future reviews. See Certain Frozen Fish Fillets from the Socialist Republic of Vietnam: Final Results of Antidumping Duty Administrative Review and Partial Rescission, 73 FR 15479 (March 24, 2008).

    11 The Vietnam-wide entity includes mandatory respondents Golden Quality Seafood Corporation, Thuan An Production Trading and Service Co., Ltd. and Viet Phu Foods and Fish Corporation.

    Interested parties may submit case briefs within 30 days after the date of publication of these preliminary results of review in the Federal Register.12 Rebuttals to case briefs, which must be limited to issues raised in the case briefs, must be filed within five days after the time limit for filing case briefs.13 Parties who submit arguments are requested to submit with the argument (a) a statement of the issue, (b) a brief summary of the argument, and (c) a table of authorities.14 Parties submitting briefs should do so pursuant to the Department's electronic filing system, ACCESS.

    12See 19 CFR 351.309(c)(1)(ii).

    13See 19 CFR 351.309(d)(1)-(2).

    14See 19 CFR 351.309(c)(2), (d)(2).

    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 within 30 days of the date of publication of this notice. Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues parties intend to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, at a date and time to be determined. See 19 CFR 351.310(d). Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    The Department intends to issue the final results of this administrative review, which will include the results of our analysis of all issues raised in the case briefs, within 120 days of publication of these preliminary results in the Federal Register, pursuant to section 751(a)(3)(A) of the Act.

    Assessment Rates

    Upon issuance of the final results, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.15 The Department intends to issue assessment instructions to CBP 15 days after the publication date of the final results of this review.

    15See 19 CFR 351.212(b).

    For any individually examined respondent whose weighted average dumping margin is above de minimis (i.e., 0.50 percent) in the final results of this review, the Department will calculate importer-specific assessment rates on the basis of the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of sales, in accordance with 19 CFR 351.212(b)(1). Where an importer- (or customer-) specific ad valorem rate is greater than de minimis, the Department will instruct CBP to collect the appropriate duties at the time of liquidation.16 Where either a respondent's weighted average dumping margin is zero or de minimis, or an importer- (or customer-) specific ad valorem is zero or de minimis, the Department will instruct CBP to liquidate appropriate entries without regard to antidumping duties.17

    16See 19 CFR 351.212(b)(1).

    17See 19 CFR 351.106(c)(2).

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this review for shipments of the subject merchandise from Vietnam entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by sections 751(a)(2)(C) of the Act: (1) For the companies listed above that have a separate rate, the cash deposit rate will be that established in the final results of this review (except, if the rate is zero or de minimis, then zero cash deposit will be required); (2) for previously investigated or reviewed Vietnam and non-Vietnam exporters not listed above that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (3) for all Vietnam exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be that for the Vietnam-wide entity; and (4) for all non-Vietnam exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the Vietnam exporter that supplied that non-Vietnam exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Importers

    This notice also 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 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.

    This preliminary determination is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

    Dated: September 6, 2016. Christian Marsh, Deputy Assistant Secretary for Enforcement and Compliance. Appendix I List of Topics Discussed in the Preliminary Decision Memorandum 1. Summary 2. Case History 3. Scope of the Order 4. Discussion of the Methodology a. Partial Rescission b. Selection of Respondents c. Preliminary Determination of No Reviewable Transactions d. NME Country Status e. Separate Rates 5. Recommendation Appendix II (1) An Giang Fisheries Import and Export Joint Stock Company (also known as Agifish or AnGiang Fisheries Import and Export) (2) An My Fish Joint Stock Company (also known as Anmyfish or Anmyfishco) (3) An Phat Seafood Co. Ltd. (4) An Phu Seafood Corp. (also known as ASEAFOOD) (5) Anvifish Co., Ltd. (6) Asia Commerce Fisheries Joint Stock Company (also known as Acomfish JSC or Acomfish) (7) Asia Pangasius Company Limited (8) Bentre Forestry and Aquaproduct Import Export Joint Stock Company (also known as Ben Tre Forestry and Aquaproduct Import-Export Company or Ben Tre Forestry Aquaproduct Import-Export Company or Ben Tre Frozen Aquaproduct Export Company or Faquimex) (9) Binh An Seafood Joint Stock Co. (10) C.P. Vietnam Corporation (11) Cafatex Corporation (CAFATEX) (12) Can Tho Animal Fishery Products Processing Export Enterprise (also known as Cafatex) (13) Europe Joint Stock Company (14) Hiep Thanh Seafood Joint Stock Co. (15) Hoang Long Seafood Processing Co., Ltd. (HLS) (16) Hung Vuong Corporation (17) Hung Vuong Joint Stock Company (18) Hung Vuong Mascato Company Limited (19) Hung Vuong-Sa Dec Co. Ltd. (20) Hung Vuong-Vinh Long Co., Ltd. (21) International Development & Investment Corporation (IDI) (22) Lian Heng Investment Co., Ltd. (also known as Lian Heng) (23) Lian Hengg Trading Co., Ltd. (also known as Lian Heng) (24) Nam Viet Company Ltd. (25) Ngoc Ha Co., Ltd. Food Processing and Trading (26) Nha Trang Seafoods, Inc. (also known as Nha Trang Seafoods-F89 or Nha Trang Seafoods) (27) Quang Minh Seafood Co., Ltd. (28) Seafood Joint Stock Company No. 4-Branch Dong Tam Fisheries Processing Company (DOTASEAFOODCO) (29) Southern Fisheries Industries Company, Ltd. (also known as South Vina) (30) Southern Fishery Industries Company, Ltd. (also known as South Vina) (31) Sunrise Corporation (32) TG Fishery Holdings Corporation (also known as TG) (33) Thanh Hung Co., Ltd. (also known as Thanh Hung Frozen Seafood Processing Import Export Co., Ltd. or Thanh Hung) (34) Thien Ma Seafood Co., Ltd. (also known as THIMACO) (35) Thien Ma Seafoods Co., Ltd. (also known as THIMACO) (36) Thien Phat Seafood Co., Ltd. (37) Thuan An Production Trading and Services Co., Ltd. (TAFISHCO) (38) Thuan Hung Co., Ltd. (also known as THUFICO) (39) Vinh Long Import-Export Company (also known as Vinh Long or Imex Cuu Long) (40) Vinh Quang Fisheries Joint-Stock Company
    [FR Doc. 2016-22386 Filed 9-16-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-821-811] Solid Fertilizer Grade Ammonium Nitrate From the Russian Federation; Final Results of Antidumping Duty Administrative Review; Final Determination of No Shipments; 2014-2015 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    On May 13, 2016, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on solid fertilizer grade ammonium nitrate (ammonium nitrate) from the Russian Federation. We invited interested parties to comment; we received no comments or requests for a hearing. Therefore, for the final results, we continue to find that sales of subject merchandise by JSC Acron and its affiliate JSC Dorogobuzh (collectively, Acron) have not been made at prices below normal value (NV) during the period of review (POR). Further, we continue to find that MCC EuroChem and its affiliates OJSC NAK Azot and OJSC Nevinnomyssky Azot (collectively, EuroChem) made no shipments of subject merchandise during the POR.

    DATES:

    Effective September 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth Eastwood or David Crespo, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3874, or (202) 482-3693, respectively.

    SUPPLEMENTARY INFORMATION:

    On May 13, 2016, the Department published the Preliminary Results. 1 The POR is April 1, 2014, through March 31, 2015. We invited interested parties to comment on the Preliminary Results. We received no comments or requests for a hearing. The Department conducted this administrative review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).

    1See Solid Fertilizer Grade Ammonium Nitrate From the Russian Federation; Preliminary Results of Antidumping Duty Administrative Review; Preliminary Determination of No Shipments; 2014-2015, 81 FR 29839 (May 13, 2016) (Preliminary Results).

    Scope of the Order

    The merchandise subject to this order is solid, fertilizer grade ammonium nitrate products. The merchandise subject to this order is classified in the Harmonized Tariff Schedule of the United States (HTSUS) at subheadings 3102.30.00.00 and 3102.290000. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise within the scope is dispositive.2

    2 For a complete description of the scope of the order, see the memorandum from Gary Taverman, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, entitled, “Decision Memorandum for the Preliminary Results of the 2014-2015 Administrative Review of the Antidumping Duty Order on Solid Fertilizer Grade Ammonium Nitrate from the Russian Federation,” (Preliminary Decision Memorandum), dated May 5, 2016, which can be accessed directly at http://enforcement.trade.gov/frn/.

    Final Results of Review and Final Determination of No Shipments

    As noted above, the Department received no comments concerning the Preliminary Results on the record of this segment of the proceeding. As there are no changes from, or comments upon, the Preliminary Results, the Department finds that there is no reason to modify its analysis. Thus, we continue to find that sales of subject merchandise by Acron were not made at less than NV during the POR. Further, we continue to find that EuroChem made no shipments of subject merchandise during the POR. Accordingly, no decision memorandum accompanies this Federal Register notice. For further details of the issues addressed in this proceeding, see the Preliminary Results and the accompanying Preliminary Decision Memorandum. The final weighted-average dumping margin for the period April 1, 2014, through March 31, 2015 for Acron is as follows:

    Producer/exporter Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • JSC Acron/JSC Dorogobuzh 0.00
    Assessment Rates

    The Department will determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries in this review, in accordance with 19 CFR 351.212(b). The Department intends to issue assessment instructions directly to CBP 15 days after publication of these final results of review. Because we have calculated a zero margin for Acron, the only respondent with entries of subject merchandise during the POR, in the final results of this review, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

    The Department clarified its “automatic assessment” regulation on May 6, 2003.3 This clarification applies to entries of subject merchandise during the POR produced and exported by Acron or EuroChem for which Acron or EuroChem did not know that the merchandise was destined for the United States. In such instances, we will instruct CBP to liquidate unreviewed entries at the all-others rate effective during the POR if there is no rate for the intermediate company(ies) involved in the transaction.4

    3See Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003) (Assessment Policy Notice).

    4See Assessment Policy Notice for a full discussion of this clarification.

    Cash Deposit Requirements

    The Department notified CBP to discontinue the collection of cash deposits on entries of the subject merchandise, entered or withdrawn from warehouse, on or after August 20, 2016.5 Therefore, no cash deposit requirements will be imposed in response to these final results.

    5See Ammonium Nitrate From the Russian Federation: Final Results of Sunset Review and Revocation of Antidumping Duty Order, 81 FR 61185 (August 12, 2016).

    Reimbursement of Duties

    This notice also serves as a final 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.

    Administrative Protective Order

    This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation, which is subject to sanction.

    We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

    Dated: September 12, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-22387 Filed 9-16-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration U.S. Smart Grid Solutions Toolkit AGENCY:

    International Trade Administration, U.S. Department of Commerce.

    ACTION:

    Notice and request for public comment.

    SUMMARY:

    The U.S. Department of Commerce announces the development of a toolkit to promote the deployment of U.S. smart grid technologies and services to be launched in FY2017. Through this Notice, the Department of Commerce seeks broad input from all interested stakeholders regarding the most frequently requested “use cases” by electric utilities for inclusion in a web-based U.S. Smart Grid Solutions Toolkit. The U.S. Smart Grid Solutions Toolkit (“Toolkit”) is intended to be used by foreign energy officials and foreign end-users of smart grid technologies. The Toolkit will outline U.S. approaches to a series of electric utility use cases and highlight participating U.S. vendors of relevant U.S. smart grid technologies and services. The Toolkit will support the President's National Export Initiative by fostering export opportunities for the U.S. energy industry.

    DATES:

    Written comments must be received on or before 4:00 p.m. Eastern Daylight Time (EDT) on October 1, 2016.

    ADDRESSES:

    Written comments by be submitted by email to [email protected] Comments submitted by email should be machine-readable and should not be copy protected. Written comments should include contact information for the submitter including name, email, and phone number. Written comments also may be submitted by mail to Victoria Gunderson, Office of Energy & Environmental Industries, Room 4053, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.

    FOR FURTHER INFORMATION CONTACT:

    Victoria Gunderson, Office of Energy & Environmental Industries, Room 4053, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; phone 202-482-7890; fax 202-482-5665; email [email protected]

    SUPPLEMENTARY INFORMATION:

    The development of the U.S. Smart Grid Solutions Toolkit requires the identification of three elements: (1) The most frequently requested use cases by global electric utilities; (2) a framework logic to outline the structure of the U.S. smart grid industry; and (3) U.S. vendors capable of supplying relevant goods and services to foreign buyers. At this stage of development of the Toolkit, and through this Notice, the Department of Commerce invites comment to identify the most commonly requested “use cases,” requested by electric utilities. Smart grid use cases should be limited to those applications that can be addressed by transmission, distribution, and energy storage related technologies and services. Examples of use cases include, but are not limited to, the following: Arbitrage, distribution upgrades due to wind/solar, curtailment minimization, frequency regulation, improved customer engagement, non-technical loss reduction, outage detection, and peak demand reduction.

    Because input received will be publicly available upon request, businesses or individuals responding to this notice should not include any business confidential. Final selection of included use cases into the Toolkit will not be attributed.

    A subsequent Federal Register notice will be issued at a later date for U.S. vendors capable of supplying relevant goods and services to foreign buyers to express interest and provide relevant information to be listed in the Toolkit.

    Man Cho, Deputy Director, Office of Energy and Environmental Industries.
    [FR Doc. 2016-22487 Filed 9-16-16; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-042] Stainless Steel Sheet and Strip From the People's Republic of China: Preliminary Affirmative Determination of Sales at Less Than Fair Value and Preliminary Affirmative Determination of Critical Circumstances AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Department) preliminarily determines that imports of stainless steel sheet and strip (stainless sheet and strip) from the People's Republic of China (PRC) are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation is July 1, 2015, through December 31, 2015. The estimated dumping margins are shown in the “Preliminary Determination” section of this notice. We invite interested parties to comment on this preliminary determination.

    DATES:

    Effective September 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Toni Page at (202) 482-1398 or Lingjun Wang at (202) 482-2316, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.

    SUPPLEMENTARY INFORMATION: Background

    The Department published the notice of initiation of this investigation on March 10, 2016.1 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum dated concurrently with and hereby adopted by this notice.2 A list of topics included in the Preliminary Decision Memorandum is included as Appendix I. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov, and to all parties in the Central Records Unit located at Room B8024 of the Department's main building. In addition, a complete version of the Preliminary Decision Memorandum can be found at http://enforcement.trade.gov/frn. The signed Preliminary Decision Memorandum and electronic version of Preliminary Decision Memorandum are identical in content.

    1See Stainless Steel Sheet and Strip From the People's Republic of China: Initiation of Less Than Fair Value Investigation, 81 FR 12711 (March 10, 2016) (Initiation Notice).

    2See Memorandum from Gary Taverman, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, entitled “Decision Memorandum for the Preliminary Determination in the Antidumping Duty Investigation of Stainless Steel Sheet and Strip from the People's Republic of China” (Preliminary Decision Memorandum).

    Scope of the Investigation

    The product covered by this investigation is stainless sheet and strip. For a complete description of the scope of this investigation, see Appendix II.

    Scope Comments

    In accordance with the Preamble to the Department's regulations,3 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).4 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. For a summary of the product coverage comments and rebuttal response submitted to the record, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Memorandum.5 The Department is preliminarily not modifying the scope language as it appeared in the Initiation Notice.

    3See Antidumping Duties; Countervailing Duties, 62 FR 27296, 27323 (May 19, 1997) (Preamble).

    4See Initiation Notice.

    5See Stainless Steel Sheet and Strip from the People's Republic of China: Preliminary Scope Decision Memorandum (September 9, 2016) (Preliminary Scope Memorandum).

    Postponement of Deadline for the Preliminary Determination

    The Department published the notice of postponement of preliminary determination of this investigation on July 7, 2016.6 Pursuant to sections 733(c)(1)(B)(i) and (ii) of the Tariff Act of 1930, as amended (the Act), we postponed the preliminary determination by 50 days. As a result, the deadline for the preliminary determination of this investigation moved to September 9, 2016.

    6See Stainless Steel Sheet and Strip From the People's Republic of China: Postponement of Preliminary Determination of Antidumping Duty Investigation, 81 FR 44277 (July 7, 2016).

    Methodology

    The Department is conducting this investigation in accordance with section 731 of the Act. Furthermore, for purposes of this preliminary LTFV determination, the Department continues to treat the PRC as a non-market economy country within the meaning of section 771(18) of the Act. For a full discussion of the Department's methodology, see Preliminary Decision Memorandum.

    Preliminary Affirmative Determination of Critical Circumstances

    On May 6, 2015, pursuant to section 733(e)(1) of the Act and 19 CFR 351.206, Petitioners timely filed an allegation that critical circumstances exist with respect to imports of stainless sheet and strip from the PRC. We preliminarily determine that critical circumstances exist for the separate rate companies and the PRC-wide entity. For a full description of the methodology and results of our analysis, see the Preliminary Decision Memorandum.

    Combination Rates

    In the Initiation Notice, the Department stated that it would calculate combination rates for the respondents that are eligible for a separate rate in this investigation.7 Policy Bulletin 05.1 describes this practice.8

    7See Initiation Notice, 81 FR at 9438-39.

    8See Enforcement and Compliance's Policy Bulletin No. 05.1, regarding, “Separate-Rates Practice and Application of Combination Rates in Antidumping Investigations involving Non-Market Economy Countries,” dated April 5, 2005 (Policy Bulletin 05.1), available on the Department's Web site at http://enforcement.trade.gov/policy/bull05-1.pdf.

    Preliminary Determination

    The Department preliminarily determines that the following dumping margins exist:

    Exporter Producer Margin
  • (%)
  • Cash deposit
  • (%)
  • Taiyuan Ridetaixing Precision Stainless Steel Incorporated Co., Ltd Taiyuan Ridetaixing Precision Stainless Steel Incorporated Co., Ltd 63.86 63.12 Zhangjiagang Pohang Stainless Steel Co., Ltd Zhangjiagang Pohang Stainless Steel Co., Ltd 63.86 63.12 PRC-Wide Entity PRC-Wide Entity 76.64 75.90

    As detailed in the Preliminary Decision Memorandum, Shanxi Taigang Stainless Steel Co., Ltd. and Tianjin Taigang Daming Metal Product Co., Ltd., two mandatory respondents in this investigation, did not demonstrate that they were entitled to a separate rate. Accordingly, we consider them to be part of the PRC-wide entity.9

    9See Preliminary Decision Memorandum.

    Suspension of Liquidation

    In accordance with section 733(d)(2) of the Act, we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of stainless sheet and strip from the PRC as described in Appendix II, that are entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Section 733(e)(2) of the Act provides that given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of investigation was published. As described above, we preliminarily find that critical circumstances exist for the separate rate companies and the PRC-wide entity. Therefore, in accordance with section 733(e)(2)(A) of the Act, for the separate rate companies and the PRC-wide entity, the suspension of liquidation shall apply to unliquidated entries of merchandise entered, or withdrawn from warehouse, for consumption on or after 90 days prior to the date of publication of this notice in the Federal Register. The suspension of liquidation will remain in effect until further notice.

    We will also instruct CBP, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), to require a cash deposit as follows: 10 (1) The cash deposit rate for the exporter/producer combinations listed in the table above will be the rate identified in the table; (2) for all combinations of PRC exporters/producers of merchandise under consideration that have not received their own separate rate above, the cash-deposit rate will be the cash deposit rate established for the PRC-wide entity; and (3) for all non-PRC exporters of merchandise under consideration which have not received their own separate rate above, the cash-deposit rate will be the cash deposit rate applicable to the PRC exporter/producer combination that supplied that non-PRC exporter. The cash deposit rates were adjusted by the countervailing duty attributable to export subsidies.11

    10See Modification of Regulations Regarding the Practice of Accepting Bonds During the Provisional Measures Period in Antidumping and Countervailing Duty Investigations, 76 FR 61042 (October 3, 2011).

    11See Preliminary Decision Memorandum.

    Disclosure and Public Comment

    We will disclose the calculations performed to interested parties in this proceeding within five days of the date of announcement of this preliminary determination in accordance with 19 CFR 351.224(b). Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 30 days after the publication of this preliminary determination in the Federal Register.12 Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.13

    12See 19 CFR 351.309(b)(2)(c)(i).

    13See 19 CFR 351.309, see also 19 CFR 351.303 (for general filing requirements).

    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.14 This summary should be limited to five pages total, including footnotes.

    14See 19 CFR 351.309(c)(2) and (d)(2).

    Interested parties who wish to request a hearing must do so in writing within 30 days after the publication of this preliminary determination in the Federal Register.15 Requests should contain the party's name, address, and telephone number; the number of participants; and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, at a date, time, and location to be determined. Parties will be notified of the date, time, and location of any hearing.

    15See 19 CFR 351.310(c).

    Parties must file their case and rebuttal briefs, and any requests for a hearing, electronically using ACCESS.16 Electronically-filed documents must be received successfully in their entirety by 5:00 p.m. Eastern Time on the due dates established above.17

    16See 19 CFR 351.303(b)(2)(i).

    17See 19 CFR 351.303(b)(1).

    International Trade Commission Notification

    In accordance with section 733(f) of the Act, we are notifying the International Trade Commission (ITC) of our preliminary determination of sales at LTFV. If our final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after our final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

    This determination is issued and published in accordance with sections 733(f) and 777(i)(I) of the Act and 19 CFR 351.205(c).

    Dated: September 9, 2016. Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations. Appendix I List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Period of Investigation IV. Scope Comments V. Scope of the Investigation VI. Respondent Selection VII. Critical Circumstances A. Legal Framework B. Critical Circumstances Allegation C. Analysis VIII. Discussion of the Methodology A. Non-Market Economy Country B. Separate Rates C. The PRC-Wide Entity D. Application of Facts Available and Adverse Inferences IX. Adjustment Under Section 777A(F) of the Act X. Adjustment to Cash Deposit Rate for Export Subsidies XI. Verification XII. Conclusion Table of Authorities Appendix II Scope of the Investigation

    The merchandise covered by this investigation is stainless steel sheet and strip, whether in coils or straight lengths. Stainless steel is an alloy steel containing, by weight, 1.2 percent or less of carbon and 10.5 percent or more of chromium, with or without other elements. The subject sheet and strip is a flat-rolled product with a width that is greater than 9.5 mm and with a thickness of 0.3048 mm and greater but less than 4.75 mm, and that is annealed or otherwise heat treated, and pickled or otherwise descaled. The subject sheet and strip may also be further processed (e.g., cold-rolled, annealed, tempered, polished, aluminized, coated, painted, varnished, trimmed, cut, punched, or slit, etc.) provided that it maintains the specific dimensions of sheet and strip set forth above following such processing. The products described include products regardless of shape, and include products of either rectangular or non-rectangular cross-section where such cross-section is achieved subsequent to the rolling process, i.e., products which have been “worked after rolling” (e.g., products which have been beveled or rounded at the edges).

    For purposes of the width and thickness requirements referenced above: (1) Where the nominal and actual measurements vary, a product is within the scope if application of either the nominal or actual measurement would place it within the scope based on the definitions set forth above; and (2) where the width and thickness vary for a specific product (e.g., the thickness of certain products with non-rectangular cross-section, the width of certain products with non-rectangular shape, etc.), the measurement at its greatest width or thickness applies.

    All products that meet the written physical description, and in which the chemistry quantities do not exceed any one of the noted element levels listed above, are within the scope of this investigation unless specifically excluded.

    Subject merchandise includes stainless steel sheet and strip that has been further processed in a third country, including but not limited to cold-rolling, annealing, tempering, polishing, aluminizing, coating, painting, varnishing, trimming, cutting, punching, and/or slitting, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the stainless steel sheet and strip.

    Excluded from the scope of this investigation are the following: (1) Sheet and strip that is not annealed or otherwise heat treated and not pickled or otherwise descaled; (2) plate (i.e., flat-rolled stainless steel products of a thickness of 4.75 mm or more); and (3) flat wire (i.e., cold-rolled sections, with a mill edge, rectangular in shape, of a width of not more than 9.5 mm).

    The products under investigation are currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7219.13.0031, 7219.13.0051, 7219.13.0071, 7219.13.0081, 7219.14.0030, 7219.14.0065, 7219.14.0090, 7219.23.0030, 7219.23.0060, 7219.24.0030, 7219.24.0060, 7219.32.0005, 7219.32.0020, 7219.32.0025, 7219.32.0035, 7219.32.0036, 7219.32.0038, 7219.32.0042, 7219.32.0044, 7219.32.0045, 7219.32.0060, 7219.33.0005, 7219.33.0020, 7219.33.0025, 7219.33.0035, 7219.33.0036, 7219.33.0038, 7219.33.0042, 7219.33.0044, 7219.33.0045, 7219.33.0070, 7219.33.0080, 7219.34.0005, 7219.34.0020, 7219.34.0025, 7219.34.0030, 7219.34.0035, 7219.34.0050, 7219.35.0005, 7219.35.0015, 7219.35.0030, 7219.35.0035, 7219.35.0050, 7219.90.0010, 7219.90.0020, 7219.90.0025, 7219.90.0060, 7219.90.0080, 7220.12.1000, 7220.12.5000, 7220.20.1010, 7220.20.1015, 7220.20.1060, 7220.20.1080, 7220.20.6005, 7220.20.6010, 7220.20.6015, 7220.20.6060, 7220.20.6080, 7220.20.7005, 7220.20.7010, 7220.20.7015, 7220.20.7060, 7220.20.7080, 7220.90.0010, 7220.90.0015, 7220.90.0060, and 7220.90.0080. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this proceeding is dispositive.

    [FR Doc. 2016-22397 Filed 9-16-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-580-837] Certain Cut-to-Length Carbon-Quality Steel Plate From the Republic of Korea: Final Results of Countervailing Duty Administrative Review and New Shipper Review; Calendar Year 2014 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce

    SUMMARY:

    The Department of Commerce (the Department) completed the administrative review (AR) and new shipper review (NSR) of the countervailing duty (CVD) order on cut-to-length carbon-quality steel plate (CTL Plate) from the Republic of Korea for the January 1, 2014, through December 31, 2014, period of review (POR). Based on our analysis of the comments received, the Department determined that Dongkuk Steel Mill Co., Ltd. (DSM), the firm examined in the AR, and Hyundai Steel Company Ltd. (Hyundai Steel), the firm examined in the NSR, each received a de minimis net subsidy rate during the POR. The final net subsidy rates are listed below in the “Final Results of Review” section.

    DATES:

    Effective September 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    John Conniff at 202-482-1009 (for Hyundai Steel), or Jolanta Lawska at 202-482-8362 (for DSM), AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.

    SUPPLEMENTARY INFORMATION: Background

    On February 10, 2000, the Department published in the Federal Register the CTL Plate Order. 1 On March 14, 2016, the Department published its preliminary results of AR and NSR of the CVD order on CTL Plate from the Republic of Korea for the POR.2 For a discussion of the events following the Preliminary Results, see the Preliminary Decision Memorandum.

    1See Notice of Amended Final Determination: Certain Cut-to-Length Carbon-Quality Steel Plate From India and the Republic of Korea; and Notice of Countervailing Duty Orders: Certain Cut-to-Length Carbon-Quality Steel Plate from France, India, Indonesia, Italy, and the Republic of Korea, 65 FR 6587 (February 10, 2000) (CTL Plate Order).

    2See Certain Cut-to-Length Carbon-Quality Steel Plate from the Republic of Korea: Preliminary Results of Countervailing Duty Administrative Review and New Shipper Review; Calendar Year 2014, 81 FR 13330 (March 14, 2016) (Preliminary Results), and accompanying Preliminary Decision Memorandum.

    Scope of the Order

    The products covered by the order are certain hot-rolled carbon-quality steel: (1) Universal mill plates (i.e., flat-rolled products rolled on four faces or in a closed box pass, of a width exceeding 150 mm but not exceeding 1250 mm, and of a nominal or actual thickness of not less than 4 mm, which are cut-to-length (not in coils) and without patterns in relief), of iron or non-alloy-quality steel; and (2) flat-rolled products, hot-rolled, of a nominal or actual thickness of 4.75 mm or more and of a width which exceeds 150 mm and measures at least twice the thickness, and which are cut-to-length (not in coils).

    The merchandise subject to the order is currently classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings: 7208.40.3030, 7208.40.3060, 7208.51.0030, 7208.51.0045, 7208.51.0060, 7208.52.0000, 7208.53.0000, 7208.90.0000, 7210.70.3000, 7210.90.9000, 7211.13.0000, 7211.14.0030, 7211.14.0045, 7211.90.0000, 7212.40.1000, 7212.40.5000, 7212.50.0000, 7225.40.3050, 7225.40.7000, 7225.50.6000, 7225.99.0090, 7226.91.5000, 7226.91.7000, 7226.91.8000, 7226.99.0000.

    Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise covered by the order is dispositive.3

    3 For a complete description of the scope of the order, see Memorandum from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance, “Decision Memorandum for Final Results of 2014 Countervailing Duty Administrative Review and New Shipper Review: Cut-to-Length Carbon-Quality Steel Plate from the Republic of Korea,” (Issues and Decision Memorandum), dated concurrently and hereby adopted by this notice.

    Methodology

    The Department conducted this review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For the subsidy program found countervailable during the POR, we determine that there is a subsidy, i.e., a government-provided financial contribution that confers a benefit to the recipient, and that the subsidy is specific. See sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and section 771(5A) of the Act regarding specificity. For a complete description of the methodology, see the Issues and Decision Memorandum.

    Analysis of Comments Received

    All issues raised in interested parties' case briefs, submitted in this proceeding, are addressed in the Issues and Decision Memorandum. A list of the issues raised by interested parties and to which we responded in the Issues and Decision Memorandum, is attached to this notice as Appendix I. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov, and is available to all parties in the Central Records Unit, room B8024 of the main Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed Issues and Decision Memorandum and the electronic versions of the Issues and Decision Memorandum are identical in content.

    Final Results of Review

    In accordance with 19 CFR 351.221(b)(4)(i), we calculated an individual subsidy rate for DSM, the firm subject to the AR and Hyundai Steel, the firm subject to the NSR. For the period January 1, 2014, through December 31, 2014, we determine the total net countervailable subsidy rates for DSM and Hyundai are as follows:

    Company 2014 Ad Valorem rate Dongkuk Steel Mill Co., Ltd 0.01 percent ad valorem (de minimis). Hyundai Steel Company Ltd 0.23 percent ad valorem (de minimis). Disclosure

    We intend to disclose to parties in this proceeding the calculations performed for these final results within five days of the date of the publication of this notice in the Federal Register, in accordance with 19 CFR 351.224(b).

    Assessment Rates

    In accordance with 19 CFR 351.212(b)(2), the Department intends to issue assessment instructions to U.S. Customs and Border Protection (CBP) 15 days after the date of publication of these final results to liquidate shipments of subject merchandise produced by DSM and Hyundai Steel entered, or withdrawn form warehouse, for consumption on or after January 1, 2014, through December 31, 2014, without regard to CVDs because a de minimis subsidy rate was calculated for each company.

    Cash Deposit Instructions

    The Department also intends to instruct CBP to collect cash deposits of zero percent on shipments of the subject merchandise produced and/or exported by DSM and Hyundai Steel entered or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review. For all non-reviewed firms, we will instruct CBP to collect cash deposits of estimated countervailing duties at the most recent company-specific or all-others rate applicable to the company. These cash deposit requirements, when imposed, shall remain in effect until further notice.

    Return or Destruction of Proprietary Information

    This notice also serves as a reminder to parties subject to 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/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 sanctionable violation.

    We are issuing and publishing these final results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

    Dated: September 12, 2016. Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance. Appendix I. Summary II. Period of Review III. Scope of the Order IV. Attribution of Subsidies V. Bona Fides Analysis VI. Analysis of Programs VII. Analysis of Comments Comment 1: Whether the Department Should Initiate an Investigation into the GOK's Provision of Electricity for less than adequate remuneration (LTAR) Comment 2: Whether the Department Improperly Countervailed Acquisition Tax Exemptions Received By Hyundai Steel under the Restrictions of Special Taxation Act (RSTA) Article 120 in Connection with its Acquisition of HYSCO's Cold-Rolled Assets Comment 3: Whether the Department Improperly Countervailed Property Tax Exemptions Received by the Pohang Plant under the Restriction of Special Location Taxation Act (RSLTA) Comment 4: Whether the Department Should Initiate an Investigation into the GOK's Provision of Electricity for More than Adequate Remuneration (MTAR) VIII. Recommendation
    [FR Doc. 2016-22403 Filed 9-16-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Multistakeholder Process on Internet of Things Security Upgradability and Patching AGENCY:

    National Telecommunications and Information Administration, U.S. Department of Commerce.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    The National Telecommunications and Information Administration (NTIA) will convene meetings of a multistakeholder process concerning Internet of Things Security Upgradability and Patching. This Notice announces the first meeting, which is scheduled for October 19, 2016.

    DATES:

    The meeting will be held on October 19, 2016, from 10:00 a.m. to 4:00 p.m., Central Daylight Time.

    ADDRESSES:

    The meeting will be held in the Trinity Ballroom at the Renaissance Austin Hotel, 9721 Arboretum Boulevard, Austin, Texas 78759.

    FOR FURTHER INFORMATION CONTACT:

    Allan Friedman, National Telecommunications and Information Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Room 4725, Washington, DC 20230; telephone: (202) 482-4281; email: [email protected] Please direct media inquiries to NTIA's Office of Public Affairs: (202) 482-7002; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background: In March of 2015 the National Telecommunications and Information Administration issued a Request for Comment to “identify substantive cybersecurity issues that affect the digital ecosystem and digital economic growth where broad consensus, coordinated action, and the development of best practices could substantially improve security for organizations and consumers.” 1 We received comments from a range of stakeholders, including trade associations, large companies, cybersecurity startups, civil society organizations and independent computer security experts.2 The comments recommended a diverse set of issues that might be addressed through the multistakeholder process, including cybersecurity policy and practice in the emerging area of Internet of Things (IoT).

    1 U.S. Department of Commerce, Internet Policy Task Force, Request for Public Comment, Stakeholder Engagement on Cybersecurity in the Digital Ecosystem, 80 FR 14360, Docket No. 150312253-5253-01 (Mar. 19, 2015), available at: https://www.ntia.doc.gov/files/ntia/publications/cybersecurity_rfc_03192015.pdf.

    2 NTIA has posted the public comments received at https://www.ntia.doc.gov/federal-register-notice/2015/comments-stakeholder-engagement-cybersecurity-digital-ecosystem.

    In a separate but related matter in April 2016, NTIA, the Department's Internet Policy Task Force, and its Digital Economy Leadership Team sought comments on the benefits, challenges, and potential roles for the government in fostering the advancement of the Internet of Things.” 3 Over 130 stakeholders responded with comments addressing many substantive issues and opportunities related to IoT.4 Security was one of the most common topics raised.

    3 U.S. Department of Commerce, Internet Policy Task Force, Request for Public Comment, Benefits, Challenges, and Potential Roles for the Government in Fostering the Advancement of the Internet of Things, 81 FR 19956, Docket No. 160331306-6306-01 (April 5, 2016), available at: https://www.ntia.doc.gov/federal-register-notice/2016/rfc-potential-roles-government-fostering-advancement-internet-of-things.

    4 NTIA has posted the public comments received at https://www.ntia.doc.gov/federal-register-notice/2016/comments-potential-roles-government-fostering-advancement-internet-of-things.

    Many commenters emphasized the need for a secure lifecycle approach to IoT devices that considers the development, maintenance, and end-of-life phases and decisions for a device. On August 2, 2016, after reviewing these comments, NTIA announced that the next multistakeholder process on cybersecurity would be on IoT security upgradability and patching.5

    5 NTIA, Increasing the Potential of IoT through Security and Transparency (Aug. 2, 2016), available at: https://www.ntia.doc.gov/blog/2016/increasing-potential-iot-through-security-and-transparency.

    The matter of patching vulnerable systems is now an accepted part of cybersecurity.6 Unaddressed technical flaws in systems leave the users of software and systems at risk. The nature of these risks varies, and mitigating these risks requires various efforts from the developers and owners of these systems. One of the more common means of mitigation is for the developer or other maintaining party to issue a security patch to address the vulnerability. Patching has become more commonly accepted, even for consumers, as more operating systems and applications shift to visible reminders and automated updates. Yet as one security expert notes, this evolution of the software industry has yet to become the dominant model in IoT.7

    6See, e.g. Murugiah Souppaya and Karen Scarfone, Guide to Enterprise Patch Management Technologies, Special Publication 800-40 Revision 3, National Institute of Standards and Technology, NIST SP 800-40 (2013) available at: http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-40r3.pdf.

    7 Bruce Schneier, The Internet of Things Is Wildly Insecure—And Often Unpatchable, Wired (Jan. 6, 2014) available at: https://www.schneier.com/blog/archives/2014/01/security_risks_9.html.

    To help realize the full innovative potential of IoT, users need reasonable assurance that connected devices, embedded systems, and their applications will be secure. A key part of that security is the mitigation of potential security vulnerabilities in IoT devices or applications through patching and security upgrades.

    The ultimate objective of the multistakeholder process is to foster a market offering more devices and systems that support security upgrades through increased consumer awareness and understanding. Enabling a thriving market for patchable IoT requires common definitions so that manufacturers and solution providers have shared visions for security, and consumers know what they are purchasing. Currently, no such common, widely accepted definitions exist, so many manufacturers struggle to effectively communicate to consumers the security features of their devices. This is detrimental to the digital ecosystem as a whole, as it does not reward companies that invest in patching and it prevents consumers from making informed purchasing choices.

    The immediate goal of this process will be to develop a broad, shared definition or set of definitions around security upgradability for consumer IoT, as well as strategies for communicating the security features of IoT devices to consumers. One initial step will be to explore and map out the many dimensions of security upgradability and patching for the relevant systems and applications. A goal will be to design and explore definitions that are easily understandable, while being backed by technical specifications and organizational practices and processes. A final step will be to develop a strategy to share these definitions throughout the broader development community, and ultimately with consumers. This may include raising awareness in the consumer space to help consumers understand security options and drive market forces.

    Stakeholders will determine the shape of the conversation and the process. NTIA has announced that the scope of the discussion will be around consumer devices, but stakeholders will ultimately determine which technologies, sectors, and applications will be discussed in the process, and covered by the resulting definitions and framework.

    While we anticipate a technical discussion in the process of exploring security upgrades, NTIA does not expect this discussion to develop new technical standards. This multistakeholder process is not a formal standards development process. Stakeholders may wish to use existing standards in their discussion and definitions, or may wish to call for new standards or standards processes as part of their recommendations.

    Stakeholders will determine the exact nature of the outcome of this process. Because it is unlikely that a one-size-fits-all solution will be feasible in this dynamic space, stakeholders will need to determine how to scope and organize the work through sub-groups or other means. Success of the process will be evaluated by the extent to which stakeholders embrace and implement the consensus findings within their individual practices or organizations, and work to promulgate them throughout the community. Although the stakeholders determine the outcome of the process, it is important to note that the process will not result in a new law or regulation.

    Matters to Be Considered: The October 19, 2016, meeting will be the first in a series of NTIA-convened multistakeholder discussions concerning IoT security upgradability and patching. Subsequent meetings will follow on a schedule determined by those participating in the first meeting. Stakeholders will engage in an open, transparent, consensus-driven process to understand the range of issues in security upgradability, and develop a set of definitions useful to both industry and consumers. The multistakeholder process will involve hearing and understanding the perspectives of diverse stakeholders, including a range of IoT manufacturers, solution providers, security experts, and consumer advocates.

    The October 19, 2016, meeting is intended to bring stakeholders together to share the range of views on security upgradability and patching, and to establish more concrete goals and structure of the process. The objectives of this first meeting are to: (1) Briefly review the importance of patching and the challenges in the existing ecosystem; (2) briefly share different perspectives on existing technologies and practices; (3) engage stakeholders in a discussion of key security upgrade dimensions, features, and concerns; (4) engage stakeholders in a discussion of logistical issues, including internal structures such as a small drafting committee or various working groups, and the location and frequency of future meetings; and (5) identify concrete goals and stakeholder work following the first meeting.

    The main objective of further meetings will be to encourage and facilitate continued discussion among stakeholders to build out a mapping of the range of issues, and develop a consensus view of a consolidated set of potential definitions. Discussions will also cover best practices for sharing security information with consumers. This discussion may include circulation of stakeholder-developed strawman drafts and discussion of the appropriate scope of the initiative. Stakeholders may also agree on procedural work plans for the group, including additional meetings or modified logistics for future meetings. NTIA suggests that stakeholders consider setting clear deadlines for a working draft and a phase for external review of this draft, before reconvening to take account of external feedback.

    More information about stakeholders' work will be available at: https://www.ntia.doc.gov/other-publication/2016/multistakeholder-process-iot-security.

    Time and Date: NTIA will convene the first meeting of the multistakeholder process on IoT Security Upgradability and Patching on October 19, 2016, from 10:00 a.m. to 4:00 p.m., Central Daylight Time. Please refer to NTIA's Web site, https://www.ntia.doc.gov/other-publication/2016/multistakeholder-process-iot-security, for the most current information.

    Place: The meeting will be held in the Trinity Ballroom at the Renaissance Austin Hotel, 9721 Arboretum Boulevard, Austin, Texas 78759. The location of the meeting is subject to change. Please refer to NTIA's Web site, https://www.ntia.doc.gov/other-publication/2016/multistakeholder-process-iot-security, for the most current information.

    Other Information: The meeting is open to the public and the press on a first-come, first-served basis. Space is limited. To assist the agency in determining space and webcast technology requirements, NTIA requests that interested persons pre-register for the meeting at https://www.ntia.doc.gov/other-publication/2016/multistakeholder-process-iot-security.

    The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Allan Friedman at (202) 482-4281 or [email protected] at least seven (7) business days prior to each meeting. The meetings will also be webcast. Requests for real-time captioning of the webcast or other auxiliary aids should be directed to Allan Friedman at (202) 482-4281 or [email protected] at least seven (7) business days prior to each meeting. There will be an opportunity for stakeholders viewing the webcast to participate remotely in the meetings through a moderated conference bridge, including polling functionality. Access details for the meetings are subject to change. Please refer to NTIA's Web site, http://www.ntia.doc.gov/other-publication/2016/multistakeholder-process-iot-security, for the most current information.

    Dated: September 14, 2016. Kathy D. Smith, Chief Counsel, National Telecommunications and Information Administration.
    [FR Doc. 2016-22459 Filed 9-16-16; 8:45 am] BILLING CODE 3510-60-P
    COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities Under OMB Review AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995 (“PRA”), this notice announces that the Information Collection Request (“ICR”) abstracted below has been forwarded to the Office of Management and Budget (“OMB”) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.

    DATES:

    Comments must be submitted on or before October 19, 2016.

    ADDRESSES:

    Comments regarding the burden estimated or any other aspect of the information collection, including suggestions for reducing the burden, may be submitted directly to the Office of Information and Regulatory Affairs (“OIRA”) in OMB, within 30 days of the notice's publication, by email at [email protected] Please identify the comments by OMB Control No. 3038-0102. Please provide the Commodity Futures Trading Commission (“CFTC” or “Commission”) with a copy of all submitted comments at the address listed below. Please refer to OMB Control No. 3038-0102, found on http://reginfo.gov.

    Comments may also be mailed to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Commodity Futures Trading Commission, 725 17th Street NW., Washington, DC 20503, or submitted through the Commission's Web site at http://comments.cftc.gov. Follow the instructions for submitting comments through the Web site.

    Comments may also be mailed to: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581 or by Hand Delivery/Courier at the same address.

    A copy of the supporting statements for the collection of information discussed above may be obtained by visiting http://reginfo.gov. All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http://www.cftc.gov.

    FOR FURTHER INFORMATION CONTACT:

    Melissa D'Arcy, Special Counsel, Division of Clearing and Risk, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581; (202) 418-5086; email: [email protected], and refer to OMB Control No. 3038-0102.

    SUPPLEMENTARY INFORMATION:

    Title: “Clearing Exemption for Certain Swaps Entered into by Cooperatives,” (OMB Control No. 3038-0102). This is a request for extension of a currently approved information collection.

    Abstract: Section 2(h)(1)(A) of the Commodity Exchange Act requires certain entities to submit for clearing certain swaps if they are required to be cleared by the Commission. Commission regulation 50.51 permits certain cooperatives to elect not to clear certain swaps that otherwise would be required to be cleared, provided that they meet certain conditions. The rule further requires the reporting of certain information if the exemption for cooperatives is elected. This collection pertains to information the Commission needs to monitor use of the cooperative exemption and assess market risk in connection therewith. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    Burden Statement: The Commission is revising its estimate of the burden for this collection to reflect the current number of respondents and respondent burden. The respondent burden for this collection is estimated to be as follows:

    Respondents/Affected Entities: Parties electing the cooperative exemption under Commission regulation 50.51.

    Estimated Number of Respondents: 25.

    Estimated Average Burden Hours per Respondent: 1 hour.

    Estimated Total Annual Burden Hours on Respondents: 25 hours.

    Frequency of Collection: Annually; on occasion.

    There are no capital costs or operating and maintenance costs associated with this collection.

    Authority:

    44 U.S.C. 3501 et seq.

    Dated: September 14, 2016. Robert N. Sidman, Deputy Secretary of the Commission.
    [FR Doc. 2016-22481 Filed 9-16-16; 8:45 am] BILLING CODE 6351-01-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION Notice of Availability of Revised Methodology for Determining Average Prime Offer Rates AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Bureau of Consumer Financial Protection (Bureau) announces the availability of a revised methodology statement, entitled the “Methodology for Determining Average Prime Offer Rates.” The methodology statement describes the methodology used to calculate average prime offer rates for purposes of Regulation C and Regulation Z. The Bureau removed from the methodology statement the references to the sources of survey data used to calculate average prime offer rates.

    ADDRESSES:

    The revised methodology statement is available on the Web site of the Federal Financial Institutions Examination Council (FFIEC) at https://www.ffiec.gov/ratespread/newcalchelp.aspx#4.

    FOR FURTHER INFORMATION CONTACT:

    Terry J. Randall, Counsel, Office of Regulations, at 202-435-7700.

    SUPPLEMENTARY INFORMATION:

    The average prime offer rates (APORs) are annual percentage rates derived from average interest rates, points, and other loan pricing terms offered to borrowers by a representative sample of lenders for mortgage loans that have low-risk pricing characteristics. APORs have implications for data reporters under Regulation C and creditors under Regulation Z. Regulation C requires covered financial institutions to report, for certain transactions, the difference between a loan's annual percentage rate (APR) and the APOR for a comparable transaction.1 Under Regulation Z, a creditor may be subject to certain special provisions if the difference between a loan's APR and the APOR for a comparable transaction exceeds certain thresholds.2

    1 12 CFR 1003.4(a)(12)(i).

    2 12 CFR 1026.35(a) and 1026.32(a)(1)(i).

    The Bureau calculates APORs on a weekly basis according to a methodology statement that is available to the public and posts the APORs.3 To calculate APORs, survey data on four mortgage products are used and posted on the FFIEC Web site weekly: 30-year fixed rate mortgage, 15-year fixed rate mortgage, five-year variable rate mortgage, and one-year variable rate mortgage.4 Currently, both the methodology statement and the FFIEC Web page that lists the survey data used to calculate APORs identify the sources of the survey data used to calculate APORs.

    3See FFIEC, Average Prime Offer Rate Tables, available at https://www.ffiec.gov/ratespread/aportables.htm.

    4See FFIEC, Mortgage Rate Survey Data Used to Calculate Rate Spreads for Loans Reportable under HMDA, available at https://www.ffiec.gov/ratespread/mortgagerates.htm.

    The Freddie Mac Primary Mortgage Market Survey® (PMMS) previously provided survey data for all four of the mortgage products that were used to calculate the weekly APORs. Earlier this year, Freddie Mac discontinued publishing the result for the one-year variable rate mortgage product. However, it provided the Bureau with data on the one-year variable rate mortgage product obtained using the same survey and calculation techniques as the PMMS. Beginning on July 7, 2016, the Bureau started using data provided by a survey conducted by HSH Associates (HSH) for the one-year variable rate mortgage product together with PMMS data on 30-year fixed rate mortgage, 15-year fixed rate mortgage, and five-year variable rate mortgage products to calculate the weekly APORs. The Bureau updated both the methodology statement 5 and the FFIEC Web site to note the change in the source of survey data for the one-year variable rate mortgage product and continued to post the survey data used to calculate APORs on the FFIEC Web site on a weekly basis.6 The Bureau has learned that, this month, HSH will discontinue collecting mortgage survey data, including data on the one-year variable rate mortgage product. The Bureau has identified a replacement source of survey data on the one-year variable rate product: Data obtained from Freddie Mac using the same survey and calculation techniques as PMMS, although the official PMMS no longer publishes results for the one-year variable rate mortgage product. The Bureau will use these data to calculate APORs beginning on September 22, 2016.

    5 Notice of Availability of Revised Methodology for Determining Average Prime Offer Rates, 81 FR 52831 (Aug. 10, 2016).

    6See FFIEC, Mortgage Rate Survey Data Used to Calculate Rate Spreads for Loans Reportable under HMDA, available at https://www.ffiec.gov/ratespread/mortgagerates.htm.

    The Bureau will continue to post the survey data used to calculate APORs on the FFIEC Web site every week at https://www.ffiec.gov/ratespread/mortgagerates.htm and will continue to identify the source of the survey data on that Web page. However, to streamline how the Bureau provides notice of the sources of survey data, the Bureau will no longer revise the methodology statement each time it is necessary to change the source of survey data. Accordingly, the Bureau revised the methodology statement to remove the references to the sources of survey data. In addition to this change to the methodology statement, the Bureau corrected the methodology statement to clarify that the survey data reflect only points and do not include fees. There are no other substantive changes to the methodology statement.

    Dated: September 13, 2016. Richard Cordray, Director, Bureau of Consumer Financial Protection.
    [FR Doc. 2016-22504 Filed 9-16-16; 8:45 am] BILLING CODE 4810-AM-P
    CONSUMER PRODUCT SAFETY COMMISSION Sunshine Act; Notice of Meeting TIME AND DATE:

    Thursday September 22, 2016, 9:30 a.m.-11:30 a.m.

    PLACE:

    Hearing Room 420, Bethesda Towers, 4330 East-West Highway, Bethesda, Maryland.

    STATUS:

    Commission Meeting—Open to the Public.

    Matter to be Considered:

    Briefing Matter: Fiscal Year 2017 Operating Plan.

    A live webcast of the Meeting can be viewed at www.cpsc.gov/live.

    CONTACT PERSON FOR MORE INFORMATION:

    Todd A. Stevenson, Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, (301) 504-7923.

    Dated: September 15, 2016. Todd A. Stevenson, Secretariat.
    [FR Doc. 2016-22653 Filed 9-15-16; 4:15 pm] BILLING CODE 6355-01-P
    DEPARTMENT OF DEFENSE Defense Acquisition Regulations System [OMB Control Number 0704-0477; Docket Number DARS-2016-0037] Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS); Organizational Conflicts of Interest in Major Defense Acquisition Programs AGENCY:

    Defense Acquisition Regulations System, Department of Defense (DoD).

    ACTION:

    Notice and request for comments regarding a proposed revision of an approved information collection requirement.

    SUMMARY:

    In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), DoD announces the proposed revision of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (b) the accuracy of the estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection for use through March 31, 2017. DoD proposes that OMB extend its approval for use for three additional years beyond the current expiration date.

    DATES:

    DoD will consider all comments received by November 18, 2016.

    ADDRESSES:

    You may submit comments, identified by OMB Control Number 0704-0477, using any of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Email: [email protected]. Include OMB Control Number 0704-0477 in the subject line of the message.

    Fax: 571-372-6094.

    Mail: Defense Acquisition Regulations System, Attn: Ms. Amy Williams, OUSD(AT&L)DPAP(DARS), 3060 Defense Pentagon, Room 3B941, Washington, DC 20301-3060.

    Comments received generally will be posted without change to http://www.regulations.gov, including any personal information provided.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Amy Williams, at 571-372-6106. The information collection requirements addressed in this notice are available on the World Wide Web at: http://www.acq.osd.mil/dpap/dars/dfarspgi/current/index.html. Paper copies are available from Ms. Amy Williams, OUSD(AT&L)DPAP(DARS), 3060 Defense Pentagon, Room 3B941, Washington, DC 20301-3060.

    SUPPLEMENTARY INFORMATION:

    Title and OMB Number: Defense Federal Acquisition Regulation Supplement (DFARS) Subpart 209.5, Organizational and Consultant Conflicts of Interest, and related provision at DFARS 252.209-7008, Notice of Prohibition Relating to Organizational Conflict of Interest-Major Defense Acquisition Program; OMB Control Number 0704-0477.

    Needs and Uses: This information collection requires an offeror to submit a mitigation plan if requesting an exemption from the statutory limitation on future contracting. This information will be used to resolve organizational conflicts of interest arising in a systems engineering and technical assistance contract for an MDAP, as required by section 207 of Weapon Systems Acquisition Reform Act of 2009 (WSARA).

    Affected Public: Businesses or other for-profit and not-for-profit institutions.

    Number of Respondents: 22.

    Responses per Respondent: 3.

    Annual Responses: 67.

    Average Burden per Response: 40 hours.

    Annual Burden Hours: 2,680.

    Reporting Frequency: On occasion.

    Summary of Information Collection

    This information collection includes requirements relating to DFARS subpart 209.5, Organizational and Consultant Conflicts of Interest, and the related provision at DFARS 252.209-7008, Notice of Prohibition Relegating to Organizational Conflict of Interest—Major Defense Acquisition Program. DFARS subpart 209.5 implements section 207 of the Weapons system Acquisition Reform Act of 2009 (Pub. L. 111-23). The provision at DFARS 252.209-7008, paragraph (d), requires an offeror to submit a mitigation plan if requesting an exemption from the statutory limitation on future contracting.

    Jennifer L. Hawes, Editor, Defense Acquisition Regulations System.
    [FR Doc. 2016-22492 Filed 9-16-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary U.S. Strategic Command Strategic Advisory Group; Notice of Federal Advisory Committee Closed Meeting AGENCY:

    Department of Defense.

    ACTION:

    Notice of Federal Advisory Committee closed meeting.

    SUMMARY:

    The Department of Defense is publishing this notice to announce the following Federal Advisory Committee meeting of the U.S. Strategic Command Strategic Advisory Group. This meeting will be closed to the public.

    DATES:

    Wednesday, October 5, 2016, from 8:00 a.m. to 4:00 p.m. and Thursday, October 6, 2016, from 8:00 a.m. to 12:00 p.m.

    ADDRESSES:

    Dougherty Conference Center, Building 432, 906 SAC Boulevard, Offutt AFB, Nebraska 68113.

    FOR FURTHER INFORMATION CONTACT:

    Mr. John L. Trefz, Jr., Designated Federal Officer, (402) 294-4102, 901 SAC Boulevard, Suite 1F7, Offutt AFB, NE 68113-6030.

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. App 2, Section 1), the Government in Sunshine Act of 1976 (5 U.S.C. 552b), and 41 CFR 102-3.150.

    Purpose of the Meeting: The purpose of the meeting is to provide advice on scientific, technical, intelligence, and policy-related issues to the Commander, U.S. Strategic Command, during the development of the Nation's strategic war plans.

    Agenda: Topics include: Policy Issues, Space Operations, Nuclear Weapons Stockpile Assessment, Weapons of Mass Destruction, Intelligence Operations, Cyber Operations, Global Strike, Command and Control, Science and Technology, Missile Defense.

    Meeting Accessibility: Pursuant to 5 U.S.C. 552b, and 41 CFR 102-3.155, the Department of Defense has determined that the meeting shall be closed to the public. Per delegated authority by the Chairman, Joint Chiefs of Staff, Admiral C.D. Haney, Commander, U.S. Strategic Command, in consultation with his legal advisor, has determined in writing that the public interest requires that all sessions of this meeting be closed to the public because they will be concerned with matters listed in 5 U.S.C. 552b(c)(1).

    Written Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140, the public or interested organizations may submit written statements to the membership of the Strategic Advisory Group at any time or in response to the stated agenda of a planned meeting. Written statements should be submitted to the Strategic Advisory Group's Designated Federal Officer; the Designated Federal Officer's contact information can be obtained from the GSA's FACA Database—http://www.facadatabase.gov/. Written statements that do not pertain to a scheduled meeting of the Strategic Advisory Group may be submitted at any time. However, if individual comments pertain to a specific topic being discussed at a planned meeting, then these statements must be submitted no later than five business days prior to the meeting in question. The Designated Federal Officer will review all submitted written statements and provide copies to all the committee members.

    Dated: September 13, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-22429 Filed 9-16-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2015-OS-0058] Proposed Collection; Comment Request AGENCY:

    Office of Economic Adjustment, Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics, DoD.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the Office of Economic Adjustment announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by November 18, 2016.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at http://www.regulations.gov for submitting comments. Please submit comments on any given form identified by docket number, form number, and title.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Office of Economic Adjustment, Compliance and Integration, ATTN: Nia Hope, 2231 Crystal Drive, Suite 520, Arlington, VA 22202 at 703-697-2088.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Application Information Public Schools on Military Installations; SF 424; OMB Control Number 0790-0006.

    Needs and Uses: The information collection requirement is necessary to determine applicant and project compliance with legal and programmatic requirements of the program and will help the Federal Evaluation Team, in cooperation with the eligible invited Local Education Authorities, to establish an agreed upon project scope and budget to be considered for funding.

    Affected Public: State, Local, or Tribal Government.

    Annual Burden Hours: 264.

    Number of Respondents: 12.

    Responses per Respondent: 1.

    Annual Responses: 12.

    Average Burden per Response: 22 hours.

    Frequency: Annually.

    Dated: September 13, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-22428 Filed 9-16-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0084] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Student Aid Internet Gateway (SAIG) Enrollment Document AGENCY:

    Federal Student Aid (FSA), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before October 19, 2016.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2016-ICCD-0084. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 2E-347, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Student Aid Internet Gateway (SAIG) Enrollment Document.

    OMB Control Number: 1845-0002.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments; Private Sector.

    Total Estimated Number of Annual Responses: 65,071.

    Total Estimated Number of Annual Burden Hours: 14,720.

    Abstract: Enrollment in the Federal Student Aid (FSA) Student Aid Internet Gateway (SAIG) allows eligible entities to securely exchange Title IV, Higher Education Act (HEA) assistance programs data electronically with the Department of Education processors. Organizations establish Destination Point Administrators (DPAs) to transmit, receive, view and update student financial aid records using telecommunication software. Eligible respondents include, but are not limited to, the following institutions of higher education that participate in Title IV, HEA assistance programs, third-party servicers of eligible institutions, Guaranty Agencies, Federal Family Education Loan Program (FFELP) lenders, Federal Loan Servicers, and local educational agencies (LEAs). The Enrollment Form for Post-Secondary Schools and Servicers represents the full complement of questions that must be presented for an organization enrolling in SAIG. The Enrollment Form for State Grant Agencies is a subset of selected questions (from the full complement of questions) to streamline the form for ease of use. This request represents the full 3 year review.

    Dated: September 14, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-22468 Filed 9-16-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No. ED-2016-ICCD-0078] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Educational Opportunity Centers Program (EOC) Annual Performance Report AGENCY:

    Office of Postsecondary Education (OPE), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a reinstatement of a previously approved information collection.

    DATES:

    Interested persons are invited to submit comments on or before October 19, 2016.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2016-ICCD-0078. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 2E-347, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Rachael Couch, 202-453-6078.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Educational Opportunity Centers Program (EOC) Annual Performance Report.

    OMB Control Number: 1840-0830.

    Type of Review: A reinstatement of a previously approved information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments; Private Sector.

    Total Estimated Number of Annual Responses: 126.

    Total Estimated Number of Annual Burden Hours: 1,008.

    Abstract: The purposes of the EOC Program are to: Provide information regarding financial and academic assistance available for qualified adults who want to enter or continue to pursue a program of postsecondary education; provide assistance to those individuals in applying for admission to institutions at which a program of postsecondary education is offered, including preparing necessary applications for use by admissions and financial aid officers; and assist in improving the financial and economic literacy of program participants.

    An Educational Opportunity Centers project may provide the following services:

    (1) Public information campaigns designed to inform the community regarding opportunities for postsecondary education and training;

    (2) Academic advice and assistance in course selection;

    (3) Assistance in completing college admission and financial aid applications;

    (4) Assistance in preparing for college entrance examinations;

    (5) Education or counseling services designed to improve the financial literacy and economic literacy of students;

    (6) Guidance on secondary school reentry or entry to a general educational development (GED) program or other alternative education program for secondary school dropouts;

    (7) Individualized personal, career, and academic counseling;

    (8) Tutorial services;

    (9) Career workshops and counseling;

    (10) Mentoring programs involving elementary or secondary school teachers, faculty members at institutions of higher education (IHEs), students, or any combination of these persons; and

    (11) Programs and activities as described in items (1) through (10) that are specially designed for students who are limited English proficient, students from groups that are traditionally underrepresented in postsecondary education, students with disabilities, students who are homeless children and youths, students who are in foster care or are aging out of the foster care system, or other disconnected students.

    (12) Other activities designed to meet the purposes of the EOC Program.

    Dated: September 14, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-22490 Filed 9-16-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0102] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Program for International Student Assessment (PISA 2018) Recruitment and Field Test AGENCY:

    National Center for Education Statistics (NCES), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before October 19, 2016.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2016-ICCD-0102. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 2E-347, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact NCES Information Collections at [email protected]

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Program for International Student Assessment (PISA 2018) Recruitment and Field Test.

    OMB Control Number: 1850-0755.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 14,392.

    Total Estimated Number of Annual Burden Hours: 8,775.

    Abstract: We are announcing a second 30-day comment period for the Program for International Student Assessments (PISA) 2017 Field Test to include additional survey items in the field test questionnaires, as recently stipulated by the Organization for Economic Cooperation and Development (OECD).

    The Program for International Student Assessments (PISA) is an international assessment of 15-year-olds which focuses on assessing students' reading, mathematics, and science literacy. PISA was first administered in 2000 and is conducted every three years. The United States has participated in all of the previous cycles, and will participate in 2018 in order to track trends and to compare the performance of U.S. students with that of students in other education systems. PISA 2018 is sponsored by the Organization for Economic Cooperation and Development (OECD). In the United States, PISA is conducted by the National Center for Education Statistics (NCES), within the U.S. Department of Education. In each administration of PISA, one of the subject areas (reading, mathematics, or science literacy) is the major domain and has the broadest content coverage, while the other two subjects are the minor domains. PISA emphasizes functional skills that students have acquired as they near the end of mandatory schooling (aged 15 years), and students' knowledge and skills gained both in and out of school environments. PISA 2018 will focus on reading literacy as the major domain. Mathematics and science literacy will also be assessed as minor domains, with additional assessments of global competence and financial literacy. In addition to the cognitive assessments described above, PISA 2018 will include questionnaires administered to assessed students, school principals, and teachers. To prepare for the main study in 2018, NCES will conduct a PISA field test from April-May 2017 to evaluate newly developed assessment and questionnaire items, to test the assessment operations, and to test school recruitment, data collection, and data management procedures. The PISA main study will be conducted in the U.S. from September-November 2018. This submission requests approval for: Recruitment and pre-assessment activities for the 2017 field test sample; administration of the field test; and recruitment of schools for the 2018 main study sample.

    Dated: September 14, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-22443 Filed 9-16-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Western Area Power Administration Boulder Canyon Project AGENCY:

    Western Area Power Administration, DOE.

    ACTION:

    Notice of approval for Fiscal Year 2017 base charge and rates.

    SUMMARY:

    In this notice, the Western Area Power Administration (WAPA) establishes the Fiscal Year (FY) 2017 base charge and rates for Boulder Canyon Project (BCP) electric service, as approved by the Deputy Secretary of Energy (Deputy Secretary). The base charge will provide sufficient revenue to cover all annual costs, including interest expense, and to repay investments within the allowable period.

    DATES:

    The base charge and rates will be effective the first day of the first full billing period beginning on or after October 1, 2016, and will remain in effect through September 30, 2017, or until superseded.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Ronald E. Moulton, Regional Manager, Desert Southwest Region, Western Area Power Administration, P.O. Box 6457, Phoenix, AZ 85005-6457, (602) 605-2453, email [email protected], or Mr. Scott Lund, Rates Manager, Desert Southwest Region, Western Area Power Administration, P.O. Box 6457, Phoenix, AZ 85005-6457, (602) 605-2442, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Hoover Dam, authorized by the Boulder Canyon Project Act (45 Stat. 1057, December 21, 1928), sits on the Colorado River along the Arizona and Nevada border. The Hoover Dam power plant has 19 generating units (two for plant use) and an installed capacity of 2,078,800 kilowatts (kW) (4,800 kW for plant use). High-voltage transmission lines and substations connect BCP power to consumers in southern Nevada, Arizona, and southern California. Electric service rates are adjusted annually using an existing rate formula established on April 19, 1996. The rate formula requires BCP power customers to pay a base charge (expressed in dollars), rather than a rate, for their power. The base charge is calculated to generate sufficient revenue to cover all annual costs, including interest expense, and to repay investments within allowable time periods. The base charge is allocated to each BCP power customer in proportion to its allocation of Hoover power. The composite power rate, expressed in mills per kilowatt-hour (mills/kWh), is calculated by dividing the base charge by energy sales in a year. However, it is the base charge and not the power rate that is used to calculate BCP customers' bills.

    Rate Schedule BCP-F9 under Rate Order No. WAPA-171 was approved on an interim basis by the Deputy Secretary for a five-year period beginning October 1, 2015, and ending September 30, 2020.1 This rate schedule, which was approved by the Federal Energy Regulatory Commission (FERC) on a final basis on December 11, 2015, requires the base charge be calculated annually based on current financial and hydrological data.2 This notice sets forth the calculation for the FY 2017 BCP base charge.

    1 80 FR 44098 (July 24, 2015).

    2 Docket No. EF15-7-000 (153 FERC ¶ 62,189).

    The FY 2017 base charge for BCP electric service is $69,662,289, a 9.3 percent increase from the FY 2016 base charge of $63,735,856. The primary factors contributing to the change in the base charge are prior year carryover and total expenses. Prior year carryover, the difference between the previous year's base charge and expense, has decreased by $9 million, or 62.7 percent. Prior year carryover offset current year expenses, thereby reducing the base charge. In FY 2014, carryover increased significantly when customers repaid certain capitalized investments. Since that time carryover has steadily decreased, contributing to the increase in the FY 2017 base charge. Total expenses, which include operation, maintenance and replacement costs, increased by $6 million, or 9.2 percent, while other expenses such as the uprating credit program and Hoover Dam Visitor Center costs decreased by $10 million, or 37 percent. Despite the overall expense decrease of $4 million, the FY 2017 base charge is increasing due to the reduction of prior year carryover.

    The FY 2017 composite rate of 19.63 mills/kWh increased 7.11 percent compared to the FY 2016 composite rate of 18.33 mills/kWh. The FY 2017 energy rate of 9.82 mills/kWh increased 7.11 percent compared to the FY 2016 energy rate of 9.17 mills/kWh. The FY 2017 capacity rate of $1.89/kW-month increased 9.8 percent compared to the FY 2016 capacity rate of $1.72/kW-month. Energy sales are forecast to increase 2 percent from FY 2016 while FY 2017 capacity sales are expected to decrease 0.5 percent due to poor hydrological conditions. The increase in the FY 2017 base charge is the primary driver behind the increases in the composite, energy and capacity rates. The base charge and rates were calculated using WAPA's FY 2016 Final Master Schedule which provides FY 2017 energy and capacity sales projections.

    The following summarizes the steps taken by WAPA to ensure involvement of all interested parties in determining the base charge and rates:

    1. A Federal Register notice was published on April 4, 2016 (81 FR 19169), announcing the proposed rate adjustment process, initiating a public consultation and comment period, announcing public information and public comment forums, and presenting procedures for public participation.

    2. Discussion of the proposal occurred at two informal BCP Contractor meetings held April 5, 2016, in Phoenix, Arizona and April 12, 2016, via web conference. Representatives from WAPA and the Bureau of Reclamation (Reclamation) explained the basis for the estimates used to calculate the base charge and rates and held a question and answer session.

    3. At the public information forum held on April 27, 2016, in Phoenix, Arizona, WAPA and Reclamation representatives explained the proposed base charge and rates for FY 2017 and held a question and answer session at these informal meetings.

    4. A public comment forum held on May 25, 2016, in Phoenix, Arizona, provided the public with an opportunity to comment for the record.

    5. WAPA received several comments during the 90-day consultation and comment period ending July 5, 2016. Comments and responses, paraphrased for brevity when not affecting the meaning of the statement, are presented below.

    Comment: Commenters objected to the expense WAPA incurred to negotiate electric service contracts for the Post-2017 marketing period.

    Response: Department of Energy Order RA 6120.2 requires the recovery of all costs of operating and maintaining a power system. It was necessary and appropriate to incur costs associated with negotiating the Post-2017 electric service contracts and implementation agreement. During the negotiations, WAPA remained mindful of costs incurred and was prudent in managing travel and related expenses.

    Comment: A commenter questioned why the FY 2017 base charge has cost increases for power marketing when the negotiations for the Post-2017 electric service contracts have concluded.

    Response: The commenter is correct in pointing out that negotiations on the Post-2017 electric service contracts concluded in 2016. The increase in power marketing costs in the FY 2017 base charge is necessary to implement and support the 31 additional electric service contracts that will be in effect during the Post-2017 marketing period.

    Comment: A commenter expressed concern regarding changes to WAPA's General Western Allocation, which is a component of the Facility Expenses cost category.

    Response: WAPA provided a detailed explanation of cost allocation changes that affect the General Western Allocation during a customer meeting held on August 23, 2016. WAPA will continue to provide customers with detailed explanations of changes in BCP costs.

    Comment: A commenter encouraged Reclamation and WAPA to separately account for Post-Retirement Benefit (PRB) expenses collected during each marketing period in the event a refund is given for those expenses.

    Response: Reclamation and WAPA are able to identify the PRB expenses collected in each marketing period, inclusive of any refunds.

    Comment: A commenter asked for an update on a customer audit of the BCP and whether the audit will impact the FY 2017 base charge.

    Response: The BCP contractors designated an audit selection committee to oversee the selection process of a new audit firm. Southern California Public Power Authority plans to administer the contract. This audit will not affect the FY 2017 base charge and rates as any findings will not be identified until after the FY 2017 base charge and rates are in effect.

    Comment: A commenter requested that detailed presentations be made when the FY 2018 base charge is proposed so new contractors can better understand the proposal.

    Response: WAPA will increase the level of detail presented in future presentations and supporting documentation and work with new contractors to assist them in understanding the proposed base charge.

    Comment: A commenter requested the current Ten Year Operating Plan and supporting documentation for the FY 2017 base charge.

    Response: Reclamation has sent new and existing contractors the latest Ten Year Operating Plan. Supporting documentation for the base charge is available on WAPA's Web site at https://www.wapa.gov/regions/DSW/Rates/Pages/boulder-canyon-rates.aspx.

    Electric Service Rates

    The base charge and the resulting calculated rates for electric service are designed to recover expenses including operation and maintenance, payments to states, visitor services, the uprating program, replacements, investment repayment, and accumulated interest. WAPA's power repayment study (PRS) allocates the base charge for electric service equally between capacity and energy.

    Availability of Information

    Information about this base charge and rate adjustment, including the PRS, comments, letters, memorandums, and other supporting material developed or maintained by WAPA and used to develop the FY 2017 base charge and rates is available for public review at the Desert Southwest Region, Western Area Power Administration, 615 South 43rd Avenue, Phoenix, AZ 85009. The information is also available on WAPA's Web site at https://www.wapa.gov/regions/DSW/Rates/Pages/boulder-canyon-rates.aspx.

    Ratemaking Procedure Requirements

    BCP electric service rates are developed under the Department of Energy Organization Act (42 U.S.C. 7101-7352), through which the power marketing functions of the Secretary of the Interior under the Reclamation Act of 1902 (ch. 1093, 32 Stat. 388), as amended and supplemented by subsequent enactments, particularly section 9(c) of the Reclamation Project Act of 1939 (43 U.S.C. 485h(c)), and other acts that specifically apply to the project involved, were transferred to and vested in the Secretary of Energy, acting by and through WAPA.

    By Delegation Order No. 00-037.00A, effective October 25, 2013, the Secretary of Energy delegated: (1) The authority to develop power and transmission rates to the Administrator of WAPA; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary; and (3) the authority to confirm, approve, and place into effect on a final basis, to remand or to disapprove such rates to the FERC. Existing Department of Energy procedures for public participation in power rate adjustments (10 CFR part 903) were published on September 18, 1985 (50 FR 37835). Department of Energy procedures were followed by WAPA in developing the rate formula approved by FERC on December 11, 2015.3

    3 Docket No. EF15-7-000 (153 FERC ¶ 62,189).

    The Boulder Canyon Project Implementation Agreement (BCPIA) requires that WAPA determine the annual base charge and rates for the next fiscal year before October 1 of each rate year. The rates for the first rate year, and each fifth rate year thereafter, become effective provisionally upon approval by the Deputy Secretary subject to final approval by FERC. For all other rate years, as is the case for FY 2017, the rates become effective on a final basis upon approval by the Deputy Secretary.

    In accordance with 10 CFR part 904, effective June 1, 1987, and the BCPIA, the rates are reviewed annually and adjusted to assure sufficient revenues are collected to achieve payment of all costs and financial obligations associated with the project. Each fiscal year, WAPA prepares a PRS for the BCP to update actual revenues and expenses, including interest, estimates of future revenues, operating expenses, and capitalized costs.

    Consistent with procedures set forth in 10 CFR parts 903 and 904 and 18 CFR part 300, WAPA held a consultation and comment period. The notice of the proposed FY 2017 base charge and rates for electric service was published in the Federal Register on April 4, 2016 (81 FR 19169).

    Under Delegation Order Nos. 00-037.00A and 00-001.00F and in compliance with 10 CFR parts 903 and 904, I hereby approve the FY 2017 base charge and rates for BCP electric service on a final basis under Rate Schedule BCP-F9 through September 30, 2017.

    Dated: September 12, 2016. Elizabeth Sherwood-Randall, Deputy Secretary of Energy.
    [FR Doc. 2016-22465 Filed 9-16-16; 8:45 am] BILLING CODE 6450-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2015-0794; FRL-9947-88] Registration Review; Draft Ecological and/or Human Health Risk Assessments; Notice of Availability AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the availability of EPA's draft human health and ecological risk assessments for the registration review of carfentrazone-ethyl, copper compounds, mineral acids, spinosad, and spinetoram and opens a public comment period on these documents. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed comprehensive draft human health and/or ecological risk assessments for all chemicals listed in the Table of Unit III. After reviewing comments received during the public comment period, EPA will issue revised risk assessments, explain any changes to the draft risk assessments, and respond to comments and may request public input on risk mitigation before completing proposed registration review decisions for the chemicals listed in the Table of Unit III. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.

    DATES:

    Comments must be received on or before November 18, 2016.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2015-0794, by one of the following methods:

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

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

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    For pesticide specific information contact: The Chemical Review Manager listed in the Table of Unit III.

    For general questions on the registration review program, contact: Richard Dumas, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8015; email address:[email protected]

    SUPPLEMENTARY INFORMATION:

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

    This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the Chemical Review Manager listed in the Table of Unit III.

    B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.

    II. Authority

    EPA is conducting its registration review of the chemicals listed in the Table of Unit III pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.

    III. Registration Reviews

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide registrations for the chemicals listed in the Table in this Unit to ensure that they continue to satisfy the FIFRA standard for registration—that is, that these chemicals can still be used without unreasonable adverse effects on human health or the environment.

    Table—Draft Risk Assessments Being Made Available for Public Comment Registration review case name (and case No.) Docket ID No. Chemical review manager, email address, and telephone No. Carfentrazone-ethyl (7422) EPA-HQ-OPP-2010-0815 Matthew Manupella, [email protected], (703) 347-0411. Copper Compounds: Copper sulfate (0636), Copper compound group II (0649), Copper salts (4026), Copper and Oxides (4025) EPA-HQ-OPP-2010-0212 Jordan Page, [email protected], (703) 347-0467 Stephen Savage, [email protected], (703) 347-0345. Mineral Acids (4064) EPA-HQ-OPP-2008-0766 Stephen Savage, [email protected], (703) 347-0345 Matthew Manupella, [email protected], (703) 347-0411. Spinosad (7421) EPA-HQ-OPP-2011-0667 Roy Johnson, [email protected], (703) 347-0492. Spinetoram (7448) EPA-HQ-OPP-2011-0666 Roy Johnson [email protected], (703) 347-0492

    Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity, through this notice of availability, for interested parties to provide comments and input concerning the Agency's draft human health and/or ecological risk assessments for the chemicals listed in the Table in this Unit. Such comments and input could address, among other things, the Agency's risk assessment methodologies and assumptions, as applied to these draft risk assessments. The Agency will consider all comments received during the public comment period and make changes, as appropriate, to the draft ecological and/or human health risk assessments. EPA will then issue revised risk assessments, explain any changes to the draft risk assessments, and respond to comments. In the Federal Register notice announcing the availability of the revised risk assessments, if the revised risk assessment indicates risks of concern, the Agency may provide a comment period for the public to submit suggestions for mitigating the risk identified in the revised risk assessment before developing proposed registration review decisions for the chemicals listed in the Table in this Unit.

    1. Other related information. Additional information on the registration review status of the chemicals listed in the Table in this Unit, as well as information on the Agency's registration review program and on its implementing regulation is available at https://www.epa.gov/pesticide-reevaluation.

    2. Information submission requirements. Anyone may submit data or information in response to this document. To be considered during a pesticide's registration review, the submitted data or information must meet the following requirements:

    • To ensure that EPA will consider data or information submitted, interested persons must submit the data or information during the comment period. The Agency may, at its discretion, consider data or information submitted at a later date.

    • The data or information submitted must be presented in a legible and useable form. For example, an English translation must accompany any material that is not in English and a written transcript must accompany any information submitted as an audiographic or videographic record. Written material may be submitted in paper or electronic form.

    • Submitters must clearly identify the source of any submitted data or information.

    • Submitters may request the Agency to reconsider data or information that the Agency rejected in a previous review. However, submitters must explain why they believe the Agency should reconsider the data or information in the pesticide's registration review.

    As provided in 40 CFR 155.58, the registration review docket for each pesticide case will remain publicly accessible through the duration of the registration review process; that is, until all actions required in the final decision on the registration review case have been completed.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: September 9, 2016. Yu-Ting Guilaran, Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs.
    [FR Doc. 2016-22506 Filed 9-16-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9952-58-OA] National Advisory Council for Environmental Policy and Technology AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of advisory committee teleconference.

    SUMMARY:

    Under the Federal Advisory Committee Act, Public Law 92463, EPA gives notice of a public meeting of the National Advisory Council for Environmental Policy and Technology (NACEPT). NACEPT provides advice to the EPA Administrator on a broad range of environmental policy, technology, and management issues. NACEPT members represent academia, industry, non-governmental organizations, and state, local and tribal governments. The purpose of this meeting is for NACEPT to discuss the Council's draft report regarding actions that EPA should take in response to technological and sociological developments in the area of citizen science. A copy of the meeting agenda will be posted at http://www2.epa.gov/faca/nacept.

    DATES:

    NACEPT will hold a public teleconference on October 17, 2016, from 12:00 p.m. to 4:00 p.m. (EDT).

    ADDRESSES:

    The meeting will be held at the EPA Headquarters, William Jefferson Clinton Federal Building East, Room 1132, 1201 Constitution Avenue NW., Washington, DC 20004.

    FOR FURTHER INFORMATION CONTACT:

    Eugene Green, Designated Federal Officer, [email protected], (202) 564-2432, U.S. EPA, Office of Resources, Operations and Management; Federal Advisory Committee Management Division (MC1601M), 1200 Pennsylvania Avenue NW., Washington, DC 20460.

    SUPPLEMENTARY INFORMATION:

    Requests to make oral comments or to provide written comments to NACEPT should be sent to Eugene Green at [email protected] by October 10, 2016. The teleconference is open to the public, with limited seating available on a first-come, first-served basis. Members of the public wishing to participate in the teleconference should contact Eugene Green via email or calling (202) 564-2432 no later than October 10, 2016.

    Meeting Access: Information regarding accessibility and/or accommodations for individuals with disabilities should be directed to Eugene Green at the email address or phone number listed above. To ensure adequate time for processing, please make requests for accommodations at least 10 days prior to the meeting.

    Dated: September 7, 2016. Eugene Green, Designated Federal Officer.
    [FR Doc. 2016-22479 Filed 9-16-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OW-2016-0404; FRL-9952-57-OW] Proposed Collection; Comment Request; Proposed Information Collection Request for the National Study of Nutrient Removal and Secondary Technologies: Publicly Owned Treatment Works (POTW) Screener Questionnaire AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency is planning to submit an information collection request (ICR) for a mandatory survey, “Proposed Information Collection Request for the National Study of Nutrient Removal and Secondary Technologies: Publicly Owned Treatment Works (POTW) Screener Questionnaire” (EPA ICR No. 2553.01, OMB Control No. 2040-NEW). Before submitting the ICR to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Comments must be submitted on or before November 18, 2016.

    ADDRESSES:

    Submit your comments, referencing Docket ID No. EPA-HQ-OW-2016-0404 online using www.regulations.gov (our preferred method), by email to [email protected], Attention Docket ID No. EPA-HQ-OW-2016-0404, or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2016-0404. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through http://www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment along with any disk you submit. 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. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Paul Shriner, Engineering and Analysis Division (4303T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-566-1076; email address: [email protected].

    SUPPLEMENTARY INFORMATION:

    How can I access the docket and/or submit comments?

    EPA has established a public docket for this ICR under Docket ID No. EPA—EPA-HQ-OW-2016-0404, which is available at https://www.regulations.gov, or for in person viewing at the Water Docket in the EPA Docket Center, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. 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 Water Docket is (202) 566-2426.

    Use https://www.regulations.gov to obtain a copy of the draft collection of information supporting statement, obtain a draft of the screener, review the draft mailing list of screener respondents, submit or view public comments, view the index listing of the contents of the docket, and access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified in this document.

    What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically solicits comments and information to enable it to:

    (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

    (ii) Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    (iii) Enhance the accuracy, quality, utility, and clarity of the information to be collected; and

    (iv) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology (e.g., permitting electronic submission of responses). In particular, EPA is requesting comments from small POTWs (those that service a population of less than 50,000) on examples of specific additional ways EPA can reduce the paperwork burden on small facilities.

    What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your comments:

    1. Explain your views as clearly as possible and provide specific examples.

    2. Describe any assumptions that you used.

    3. Provide copies of any technical information and/or data you used that support your views.

    4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

    5. Offer alternative ways to improve the collection activity.

    6. Make sure to submit your comments by the deadline identified under DATES above.

    7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

    What information collection activity or ICR does this apply to?

    Affected entities: Entities potentially affected by this action are approximately 16,000 (but no more than 20,000) POTWs that meet the definition under 40 CFR 403.3(q), as well as up to 100 state and/or small municipal association contacts.

    Title: National Study of Nutrient Removal and Secondary Technologies: Publicly Owned Treatment Works (POTW) Screener Questionnaire Information Collection Request.

    ICR numbers: EPA ICR No. 2553.01, OMB Control No. 2040—NEW.

    ICR status: This ICR is for a new information collection activity. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's information collections are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable.

    Abstract: Nutrient pollution remains the single greatest challenge to our Nation's water quality, and presents a growing threat to public health and local economies—contributing to toxic harmful algal blooms, contamination of drinking water sources, and costly impacts on recreation, tourism and fisheries. The multi-phase study described here, when completed, will provide a rich database of nutrient removal performance at secondary treatment POTWs nationwide, and will help POTWs understand the range of nutrient removal performance and opportunities to optimize nutrient removals based on data from their peers. It will also serve as a major new resource for POTWs, states and stakeholders to evaluate the most cost effective approaches to nutrient reduction at the watershed scale. The EPA is collaborating with states to make greater progress in reducing nutrient loadings discharged into the Nation's waters from all sources. With this goal in mind, EPA's Office of Water is planning to collect data to evaluate the nutrient removals and related technology performance of POTWs with conventional secondary treatment. For the purposes of this study “conventional secondary treatment” are those processes used by industry to meet the regulatory requirements for secondary treatment. The goals of this study would be to establish a baseline of nutrient performance nationally for secondary treatment facilities and to document the capability of POTWs to reduce nutrient discharges by implementing changes to operations and maintenance, without making extensive capital investments.

    The full study would be conducted in multiple phases over the course of four to five years, allowing for interactions with stakeholders and experts in each phase. The first phase of the study is a screener questionnaire which is the focus of this ICR.

    To initiate this study, EPA first needs to update existing information on the universe of POTWs in the U.S., including tribally owned facilities, and collect basic information on the characteristics of these POTWs. There are no currently available datasets which identify all the POTWs in the country, or that identify which POTWs are conventional secondary treatment plants. These conventional secondary plants would then be the focus of study over the next four years to determine how efficiently these plants remove nutrients and how enhancements to operation and maintenance have improved that performance. EPA envisions conducting future surveys of a statistically representative sample of the population of secondary treatment plants but will not know the exact format of the collection until it receives data from this screener. Regardless of the method, EPA's objective is to create a database of the full population of POTWs in the U.S. and use that database for further statistical study of nutrient removal performance. EPA plans to make this database publically available—subject to confidentiality concerns that may arise. Currently only a small number of case studies are available documenting how secondary treatment plants can reduce nutrient discharges through enhanced operation and maintenance procedures. The study EPA is planning would provide statistically representative data on improved nutrient removal by secondary treatment plants resulting from changes in operation and maintenance. This study would help States and POTWs agree to and set well-informed and realistic nutrient load reduction targets for wastewater treatment facilities where appropriate, and provide information on the time and costs needed to make enhancements in operation and maintenance procedures.

    EPA's Office of Water plans to administer the initial survey as a mandatory census of POTWs in the U.S. Clean Water Act Section 308 authority constitutes a broad authority 1 to request information to carry out any objective under the Clean Water Act. 33 U.S.C. 1318(a). Any use of 308 authority is never taken lightly by EPA, and much deliberation went into this decision. Key to our decision are the goals of the overall study and the concern that voluntary submission or self-selection could result in a low or unrepresentative survey response rate. This census, the first phase of the study, is essential to the future phases of the study. Requiring facilities to participate is necessary to identify all of the secondary treatment or equivalent facilities in the U.S. EPA's Office of Water intends to use this information for research and statistical purposes only. Information is not being collected for purposes of enforcement or to compel facilities to submit information regarding activities that might be potential violations of their National Pollution Discharge Elimination System (NPDES) permits. This census will solicit basic facility identification, characterization, and technical information necessary to develop the future detailed questionnaire, to select the sample of secondary treatment plants planned for subsequent phases of the study, and to select POTWs where future influent and effluent sampling could be conducted to document performance. EPA would prepare a second ICR for the subsequent phases of the study after the first phase census is completed and the sample frame for the subsequent phases developed. EPA is considering utilizing pre-tests, pilots, or other techniques to obtain stakeholder input in the development of the subsequent phases of this study which may not need to be conducted using 308 authority.

    1See Natural Resources Defense Council, Inc. v. U.S. EPA, 822 F.2d 104, 119 (D.C. Cir. 1987) (“[i]n our view, the statute's sweep is sufficient to justify broad information disclosure requirements relating to the Administrator's duties, as long as the disclosure demands which he imposes are `reasonable.' ”)

    The rationale for conducting this effort as a mandatory census is two-fold. Currently there exist multiple, disparate databases containing information concerning various subsets of treatment facilities; however, each of these databases is incomplete with respect to identifying all facilities. In addition, each database has missing or incomplete data fields. Second, historic precedent indicates that voluntary survey designs have extremely low response rates and issues with bias. Both of these facts make getting an accurate, national profile of POTWs infeasible without making it mandatory to respond. EPA also intends to conduct up to 40 POTW site visits and up to 100 state and small municipality association phone contacts to solicit information on industry terminology, typical treatment trains and modes of operation, and nutrient removal technologies and operating practices, and this ICR addresses these activities as well.

    EPA is limiting the information requested by the census to that which is necessary to create a complete population of POTWs and to identify basic information about that population. Questions include those necessary to identify and stratify the universe of POTWs and, within that population, the secondary treatment POTWs not designed specifically to remove nitrogen and phosphorus. A draft of the screener is available at Docket ID No. EPA-HQ-OW-2016-0404 as part of today's request for comments (see Instructions section of this notice for further information).

    The draft screener makes use of multiple choice and yes/no questions, with the intention to use drop down menus and checkboxes from which respondents will choose the best answer. EPA is not including open-ended questions in the screener questionnaire which would likely be unwieldy due to the number and expected variation of responses and the extensive follow-up needed when entering the responses into a database. EPA intends to design the screener questionnaire as a web-based survey that POTWs can fill out and submit online. EPA intends to require the submittal of a signed certification form that will either be uploaded with the screener, or may be mailed directly to the Agency. EPA will provide a mechanism for POTWs to respond with a mailed response if they cannot access the internet. EPA is specifically soliciting comments on simplifying the census format. In addition, EPA is soliciting comments on EPA's approach to developing the mailing list, and has made a draft available in the Docket (see Instructions section of this notice for further information).

    Burden statement: This information collection is a one-time event. The total respondent reporting and recordkeeping burden for this collection of information is estimated to average 3.5 hours per response for 90 percent of the respondents and 1.5 hours per response for 10 percent of the respondents. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. The burden estimate includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

    The ICR provides a detailed explanation of the Agency's estimate, which is only briefly summarized here:

    Estimated total number of potential respondents: No more than 20,000 POTWs, 40 POTWs for site visits, 100 state or small municipal association contacts.

    Frequency of response: One-time data collection.

    Estimated total average burden for each respondent: POTW screener survey response—3.5 hours for 90 percent of the respondents ($147) and 1.5 hours for 10 percent of the respondents ($65); POTW site visit respondent—8 hours, $224; State/Small Municipal Association contact—1 hour, $55.

    Estimated total respondent burden hours: 66,420.

    Estimated total respondent costs: $2,792,713. This estimate reflects unit costs for labor and operational and maintenance costs.

    What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR, the screener questionnaire, and its approach as appropriate. During this public comment period, EPA will be working with stakeholders to refine the survey instrument and will revise the instrument as appropriate after considering the comments expressed during those interactions and in response to this notice. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. At that time, EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and a 30 day opportunity to submit comments to OMB on this ICR. If you have any questions about this ICR or the approval process, please contact the technical person listed above under FOR FURTHER INFORMATION CONTACT.

    Dated: September 12, 2016. Elizabeth Southerland, Director, Office of Science and Technology.
    [FR Doc. 2016-22498 Filed 9-16-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1021] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written PRA comments should be submitted on or before November 18, 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 Cathy Williams, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-1021.

    Title: Section 25.139, NGSO FCC Coordination and Information Sharing Between MVDDS Licensees in the 12.2 GHz to 12.7 GHz Band.

    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: 6 respondents; 6 responses.

    Estimated Time per Response: 6 hours.

    Frequency of Response: On occasion reporting requirement and third party disclosure requirement.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collections is contained in 47 U.S.C. 154(i), 157(a), 301, 303(c), 303(f), 303(g), 303(r), 308, and 309(j).

    Total Annul Burden: 36 hours.

    Total Annual Cost: None.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Needs and Uses: Section 25.139, which the Commission adopted in the 2002 Order in ET Docket No. 98-206, requires Non-Geostationary Satellite Orbit (NGSO) Fixed-Satellite Services (FSS) licensees to maintain a subscriber database in a format that can be readily shared to enable MVDDS licensees to determine whether a proposed Multichannel Video Distribution and Data Service (MVDDS) transmitting antenna meets the minimum spacing requirement relative to qualifying, existing NGSO FSS subscriber receivers (set forth in § 101.129, FCC Rules). The Commission will use Section 25.139 to ensure that NGSO FSS licensees provide MVDDS licensees with the data needed to determine whether a proposed MVDDS transmitting site meets the minimum spacing requirement relative to certain NGSO FSS receivers.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison. Office of Secretary.
    [FR Doc. 2016-22431 Filed 9-16-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 13, 2016.

    A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. Arbor Bancorp, Inc., Ann Arbor, Michigan; to merge with Birmingham Bloomfield Bancshares, Inc., and thereby indirectly acquire Bank of Birmingham, both in Birmingham, Michigan.

    2. Sullivan Bancshares, Inc., Sullivan, Illinois; to merge with Moultrie Bancorp, Inc., and thereby indirectly acquire Hardware State Bank, both in Lovington, Illinois.

    3. Sullivan BancShares, Inc. Employee Savings & Retirement Plan, Sullivan, Illinois; to become a bank holding company by acquiring up to 32.90 percent of Sullivan Bancshares, Inc., and thereby acquire shares of First National Bank of Sullivan, both in Sullivan, Illinois, and Hardware State Bank, Lovington, Illinois.

    B. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:

    1. Durant Bancorp, Inc., Durant, Oklahoma; to acquire 100 percent of the voting shares of North American Bancshares, Inc., Sherman, Texas, and thereby indirectly acquire the American Bank of Texas, Sherman, Texas.

    Board of Governors of the Federal Reserve System, September 13, 2016. Michele T. Fennell, Assistant Secretary of the Board.
    [FR Doc. 2016-22383 Filed 9-16-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies; Correction

    This notice corrects notice FR Doc. 2016-20773 published on page 59624 of the Federal Register on August 30, 2016.

    Under the Federal Reserve Bank of Chicago heading, the entry for Mid Illinois Bancorp, Inc., Employee Stock Ownership Plan, Peoria, Illinois, to increase its ownership of Mid Illinois Bancorp, Inc., Peoria, Illinois, from 25.24 percent to 30 percent, and thereby increase its indirect ownership of South Side Trust and Savings Bank, Peoria, Illinois, is revised to read as follows:

    Comments on this application must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than September 23, 2016.

    Board of Governors of the Federal Reserve System, September 13, 2016. Michele T. Fennell, Assistant Secretary of the Board.
    [FR Doc. 2016-22395 Filed 9-16-16; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-1015; Docket No. CDC-2016-0091] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the National Electronic Health Records Survey (NEHRS), formerly approved as the National Ambulatory Medical Care Survey (NAMCS) National Electronic Health Records Survey (NEHRS). This three year revision request includes an update to the currently approved questionnaire, the addition of a follow-up survey, and a survey name change deleting the National Ambulatory Medical Care Survey (NAMCS) from the title. The purpose of NEHRS is to meet the needs and demands for statistical information about EHR adoption in physician offices in the United States.

    DATES:

    Written comments must be received on or before November 18, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2016-0091 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Proposed Project

    The National Electronic Health Records Survey (NEHRS) (formerly approved as the National Ambulatory Medical Care Survey (NAMCS) National Electronic Health Records Survey (NEHRS)) (OMB No. 0920-1015, Expires 04/30/2017)—Revision—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 242k), as amended, authorizes that the Secretary of Health and Human Services (DHHS), acting through NCHS, shall collect statistics on “utilization of health care” in the United States. NEHRS was originally designed as a mail supplement to the National Ambulatory Medical Care Survey (NAMCS). Questions in NEHRS have been asked in NAMCS starting in 2001.

    The purpose of NEHRS is to measure progress toward goals for electronic health records (EHRs) adoption. NEHRS target universe consists of all non-Federal office-based physicians (excluding those in the specialties of anesthesiology, radiology, and pathology) who are engaged in direct patient care.

    NEHRS is the principal source of data on national and state-level EHR adoption in the United States. In 2008 and 2009, the sample size was 2,000 physicians annually. Starting in 2010, the annual sample size was increased five-fold, from 2,000 physicians to 10,302 physicians. The increased sample size allows for more reliable national estimates as well as state-level estimates on EHR adoption without having to be combined with NAMCS. For these reasons, in 2012 NEHRS became an independent survey, not as a supplement under NAMCS.

    NEHRS collects information on characteristics of physician practices, the capabilities of EHRs in those practices, and intent to apply for meaningful use incentive payments. These data, together with trend data, may be used to monitor the adoption of EHR as well as accessing factors associated with EHR adoption.

    Users of NEHRS data include, but are not limited to, Congressional offices, Federal agencies, state and local governments, schools of public health, colleges and universities, private industry, nonprofit foundations, professional associations, clinicians, researchers, administrators, and health planners.

    There is no cost to the respondents other than their time.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (hours)
  • Total burden
  • (hours)
  • Office-based physicians NEHRS 10,302 1 30/60 5,151 Office-based physicians Follow-up NEHRS 3,434 1 30/60 1,717 Total 6,868
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-22448 Filed 9-16-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-0976] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    Million Hearts® Hypertension Control Challenge (OMB No. 0920-0976, exp. 7/31/2016)—Reinstatement with Change—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    In September 2011, HHS launched the Million Hearts® initiative to prevent one million heart attacks and strokes by 2017. There is scientific evidence that provides general guidance on the types of system-based changes to clinical practice that can improve patient blood pressure control, but more information is needed to fully understand implementation practices so that they can be shared and promoted.

    In 2013, CDC launched the Million Hearts® Hypertension Control Challenge (OMB No. 0920-0976, exp. 7/31/2016). The Challenge is authorized by Public Law 111-358, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science Reauthorization Act of 2010 (COMPETES Act). The annual Challenge is designed to help CDC (1) identify clinical practices and health systems that have been successful in achieving high rates of hypertension control, and (2) develop models for dissemination. The Challenge is open to single practice providers, group practice providers, and healthcare systems.

    In 2013, 2014, and 2015, CDC collected information needed to assess candidates for recognition through the Million Hearts® Hypertension Control Challenge. A total of 59 public and private health care practices and systems were recognized as Million Hearts® Hypertension Control Champions for achieving exemplary levels of hypertension control in adults ages 18-85.

    CDC plans to reinstate the Million Hearts® Hypertension Control Challenge, with changes, for information collection beginning in 2017. Challenges were previously launched in late summer/early fall. The 2016 Challenge is scheduled to launch in February 2017, coinciding with American Heart Month. The nomination period will be open for approximately 60 days, with recognition of the 2016 Million Hearts® Hypertension Control Champions in the fall of 2017. A similar calendar year schedule is planned for 2018 (information collection and recognition for the 2017 Champions) and 2019 (information collection and recognition for the 2018 Champions).

    Information collection supporting the Challenge will be conducted in three steps. First, interested providers or practices will complete a web-based nomination form which provides the minimum amount of data needed to demonstrate evidence of clinical success in achieving hypertension control, including: (a) Two point-in-time measures of the clinical hypertension control rate for the patient population, (b) the size of the clinic population served, (c) a description of the patient population served and geographic location, and (d) a description of the sustainable systems and strategies adopted to achieve and maintain hypertension control rates. The estimated burden for completing the nomination form is 30 minutes. CDC scientists or contractors will review each nomination form and assign a preliminary score.

    In the second phase of assessment, nominees with the highest preliminary scores (finalists) will be asked to participate in a one-hour data verification process. The nominee will review the nomination form with a reviewer or abstractor, describe how information was obtained from the provider's (or practice's) electronic records, chart reviews, or other sources, and review the methodology used to calculate the reported hypertension control rate. CDC conducts data verification to ensure that all nominees meet eligibility criteria and calculate their reported hypertension control rate according to a standardized method.

    In the third phase of the assessment, each remaining finalist will participate in a two-hour, semi-structured interview and provide detailed information about the patient population served, the geographic region served, and the strategies employed by the practice or health system to achieve exemplary rates of hypertension control, including barriers and facilitators for those strategies.

    Based on experience with administration of the Challenge in previous years, CDC plans to eliminate the cash prize awarded to Champions in previous years, and to implement minor changes to the nomination form and the data verification form that will improve usability and data quality. There are no changes to the estimated burden per response. Finally, CDC anticipates an overall reduction in burden due to a reduction in the estimated number of nominees. During the period of this Reinstatement request, on an annual basis, CDC estimates that information will be collected from up to 500 nominees using the nomination form, at most 40 data verifications, and at most 40 semi-structured interviews.

    CDC will use the information collected through the Million Hearts® Hypertension Control Challenge to increase widespread attention to hypertension at the clinical practice level, improve understanding of successful and sustainable implementation strategies at the practice or health system level, bring visibility to organizations that invest in hypertension control, and motivate individual practices to strengthen their hypertension control efforts. Information collected through the Million Hearts® Hypertension Control Challenge will link success in clinical outcomes of hypertension control with information about procedures that can be used to achieve similar favorable outcomes so that the strategies can be replicated by other providers and health care systems.

    OMB approval is requested for three years. Participation is voluntary and there are no costs to the respondents other than their time. The total estimated annualized burden hours are 370.

    Estimated Annualized Burden Hours Type of responses Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hr)
  • Physicians (Single or Group Practices) Million Hearts® Hypertension Control Champion Nomination form 500 1 30/60 Finalists Data Verification Form 40 1 1 Semi-structured Interview 40 1 2
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-22446 Filed 9-16-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-160544; Docket No. CDC-2016-0088] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection plan entitled Evaluation of Effectiveness of NIOSH Publications: NIOSH Customer Satisfaction and Impact Survey.

    DATES:

    Written comments must be received on or before November 18, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2016-0088 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

    Please note:

    All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Proposed Project

    Evaluation of Effectiveness of NIOSH Publications (OMB Control No. 0920-0544, Expired 4/30/2010)—Reinstatement with Change—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    As mandated in the Occupational Safety and Health Act of 1970 (Pub. L. 91-596), the mission of the National Institute for Occupational Safety and Health (NIOSH) is to conduct research and investigations on work-related disease and injury and to disseminate information for preventing identified workplace hazards (Sections 20(a)(1) and (d), Attachment 1). NIOSH is proposing a two-year study to collect stakeholder feedback on the effectiveness of NIOSH products and their dissemination. This dual responsibility recognizes the need to translate research into workplace application if it is to impact worker safety and well-being.

    NIOSH, through its communication efforts, seeks to promote greater awareness of occupational hazards and their control, influence public policy and regulatory action, shape national research priorities, change organizational practices and individual behavior, and ultimately, improve American working life. NIOSH's primary communication vehicle is its series of numbered publications catalogued by the Institute as Policy Documents, Technical Documents, and Educational Documents.

    The aforementioned types of documents are available to the public through the use of mailing lists, NIOSH eNews, the NIOSH Web site, promotion at conferences, and by other means. In Fiscal Year 2015, combined digital downloads and hard copy distributions of NIOSH publications registered at over 790,000. Yet, these numbers tell little of whether the reports are reaching all of the appropriate audiences, or whether the information is perceived as credible and useful by the recipients. Therefore, a Customer Satisfaction Survey (CSS) was conducted in 2003 and a follow-up CSS in 2010 to assess customer satisfaction and perceived impact of NIOSH publications.

    The proposed survey seeks to update the data collected for the 2010 survey (OMB Control No. 0920-0544) and gather data on outreach initiatives NIOSH has undertaken in recent years. The findings reported in 2010 confirmed that NIOSH continues to be a credible source of occupational safety and health information, NIOSH publications were being used more frequently than in previous years, and respondents are relying more on the NIOSH Web site and other electronic resources. With regard to having read or referred to a NIOSH product or resource in the past, 82% of the total respondents said they had, and responses grouped by organization—AAOHN (80%), ACOEM (71%), AIHA (90%), and ASSE (85%)—also show an increase. However, the 2010 CSS also revealed that the percentage of respondents who looked to NIOSH for OSH information dropped from 84% in 2003 to 76% in 2009 (when the 2010 survey data were collected).

    Results from the 2010 CSS suggest that NIOSH needs to partner more with stakeholder associations to assess the needs of those in the OSH community who are not using NIOSH resources. Since then, NIOSH has established a partner database, which documents the private companies, professional associations, and labor unions listed as partners on various projects. Another recommendation is that NIOSH develop strategies to increase awareness of electronic resources and newsletters. NIOSH has since established additional notifications, such as the monthly Research Rounds (http://www.cdc.gov/niosh/research-rounds/) that highlights research conducted at NIOSH. There also is the NIOSH Science Blog (http://blogs.cdc.gov/niosh-science-blog/) with articles on NIOSH research, products, and timely topics of interest to workers, employers, and other stakeholders. The NIOSH Web site also has expanded its offerings of video and multimedia products.

    The third recommendation from the 2010 survey was that NIOSH develop a broader range of tools that have direct application and provide clearer guidance on policy. In addition to being offered as a downloadable PDF document, the Pocket Guide to Chemical Hazards, NIOSH's most popular product, is being offered as a mobile app as well as a PDF document, both of which can be downloaded from the NIOSH Web site (http://www.cdc.gov/niosh/npg/). As a larger strategy that addresses the aforementioned recommendations, NIOSH launched a 5-year Web Plan that considers the direction of the Institute's work and reviews the history of the NIOSH Web. The plan identifies five key Web challenges NIOSH will experience in 2015-2019: Adapting web content for mobile web delivery, preparing for growth of digital products and dissemination, sustainability of new digital products, developing a future strategy for new communication products and technology, and addressing projected staffing needs. Various goals have been identified as critical to maintaining NIOSH Web effectiveness in the next five years.

    The currently proposed Customer Satisfaction and Impact (CSI) Survey, is an effort by the agency to obtain current estimates of consumer use/benefit from NIOSH communication products as a whole, as well as to determine the adequacy of the agency's circulation/delivery practices in light of changing distribution approaches and technologies. The CSI will account for changes in NIOSH publications, digital product formats, and new dissemination channels emerging since survey data were last collected. The CSI will also solicit more audience-based information that reflects the new media environment in which many NIOSH publications are offered. Such expansions will yield findings that show how well customer service practices at NIOSH have followed the 2003 and 2010 recommendations, as well as provide insights into how users seek and use NIOSH information in the current digital environment.

    The survey will be directed to the community of occupational safety and health (OSH) professionals as well as business and trade association intermediaries as this audience represents the primary and traditional customer base for NIOSH information materials. Intermediaries use their connections to small businesses and other organizations to disseminate information to stakeholders who might not otherwise receive it. Intermediaries include occupational health service providers, labor organizations, chambers of commerce, and insurance companies.

    NIOSH estimates that it will take 315 total burden hours to complete information collections, compared to 204 burden hours estimated for the 2010 CSS. There are no costs to the respondents other than their time.

    Customer Satisfaction and Impact (CSI) Survey:

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hrs.)
  • Total burden
  • (in hrs.)
  • AIHA members NIOSH Customer Satisfaction Survey—full version 150 1 20/60 50 AIHA Members NIOSH Customer Satisfaction Survey—full version 150 1 5/60 13 AAOHN Members NIOSH Customer Satisfaction Survey—full version Work, 150 1 20/60 50 AAOHN Members NIOSH Customer Satisfaction Survey—short version 150 1 5/60 13 ACOEM members NIOSH Customer Satisfaction Survey—full version 150 1 20/60 50 ACOEM members NIOSH Customer Satisfaction Survey—short version 150 1 5/60 13 ASSE members NIOSH Customer Satisfaction Survey—full version 150 1 20/60 50 ASSE members NIOSH Customer Satisfaction Survey—short version 150 1 5/60 13 Other members* NIOSH Customer Satisfaction Survey—full version 150 1 20/60 50 Other members NIOSH Customer Satisfaction Survey—short version 150 1 5/60 13 Total 315
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-22447 Filed 9-16-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families RPG National Cross-Site Evaluation 30-Day Notice AGENCY:

    Children's Bureau, Administration for Children and Families, U.S. Department of Health and Human Services.

    ACTION:

    Proposed Information Collection Activity; Comment Request.

    Title: RPG National Cross-Site Evaluation and Evaluation Technical Assistance.

    OMB No.: 0970-0444.

    Description: The Children's Bureau within the Administration for Children and Families of the U.S. Department of Health and Human Services seeks a renewal of clearance to collect information for the Regional Partnership Grants to Increase the Well-being of and to Improve Permanency Outcomes for Children Affected by Substance Abuse Cross-Site Evaluation and Evaluation-Related Technical Assistance and Data Collection Support for Regional Partnership Grant Program Round Three Sites or “RPG” projects. Under RPG, the Children's Bureau has issued 21 grants to organizations such as child welfare or substance abuse treatment providers or family court systems to develop interagency collaborations and integration of programs, activities, and services designed to increase well-being, improve permanency, and enhance the safety of children who are in an out-of-home placement or are at risk of being placed in out-of-home care as a result of a parent's or caretaker's substance use dependence. The Child and Family Services Improvement and Innovation Act (Pub. L. 112-34) includes a targeted grants program (section 437(f) of the Social Security Act) that directs the Secretary of Health and Human Services to reserve a specified portion of the appropriation for these Regional Partnership Grants, to be used to improve the well-being of children affected by substance abuse. The overall objective of the Cross-Site Evaluation and Technical Assistance projects (the RPG Cross-Site Evaluation) is to plan, develop, and implement a rigorous national cross-site evaluation of the RPG Grant Program, provide legislatively-mandated performance measurement, furnish evaluation-related technical assistance to the grantees in order to improve the quality and rigor of their local evaluations, and support their participation in the cross-site evaluation. The project will evaluate the programs and activities conducted through the RPG Program. The evaluation is being undertaken by the Children's Bureau and its contractor Mathematica Policy Research. The evaluation is being implemented by Mathematica Policy Research and its subcontractors, WRMA, Inc., and Synergy Enterprises.

    The RPG Cross-Site Evaluation includes the following components:

    1. Implementation and Partnership Study. The RPG cross-site implementation and partnership study will contribute to building the knowledge base about effective implementation strategies by examining the process of implementation in the 21 RPG projects, with a focus on factors shown in the research literature to be associated with quality implementation of evidence-based programs. This component of the study describes the RPG projects' target populations, selected interventions and their fit with the target populations, inputs to implementation, and actual services provided (including dosage, duration, content, adherence to curricula, and participant responsiveness). It examines the key attributes of the regional partnerships that grantees develop (for example, partnerships among child welfare and substance abuse treatment providers, social services, and family courts). It describes the characteristics and roles of the partner organizations, the extent of coordination and collaboration, and their potential to sustain the partnerships after the grant ends. Key data collection activities of the implementation and partnership study are: (1) Conducting site visits during which researchers interview RPG program directors, managers, supervisors, and frontline staff who work directly with families; (2) administering a survey to frontline staff involved in providing direct services to children, adults, and families; (3) asking grantees to provide information about implementation and their partnerships as part of their federally required semi-annual progress reports; (4) obtaining service use data from grantees, enrollment date and demographics of enrollees, exit date and reason, and service participation, which are entered into a web-based system operated by Mathematica Policy Research and its subcontractors; and (5) administering a survey to representatives of the partner organizations.

    2. Outcomes Study. The goal of the outcomes study is to describe the changes that occur in children and families who participate in the RPG programs. This study will describe participant outcomes in five domains: (1) Child well-being, (2) family functioning/stability, (3) adult recovery from substance use disorder, (4) child permanency, and (5) child safety. Two main types of outcome data will be used—both of which are being collected by RPG grantees: (1) Administrative child welfare and adult substance abuse treatment records and (2) standardized instruments administered to the parents and/or caregivers. The Children's Bureau is requiring grantees to obtain and report specified administrative records, and to use a prescribed set of standardized instruments. Grantees will provide these data to the cross-site evaluation team twice a year by uploading them to a data system operated by Mathematica Policy Research and its subcontractors.

    3. Impact Study. The goal of the impact study is to assess the impact of the RPG interventions on child, adult, and family outcomes by comparing outcomes for people enrolled in RPG services to those in comparison groups, such as people who do not receive RPG services or receive only a subset of the services. The impact study will use demographic and outcome data on both program (treatment) and comparison groups from a subset of grantees with appropriate local evaluation designs such as randomized controlled trials or strong quasi-experimental designs; 5 of the 21 grantees have such designs. Site-specific impacts will be estimated for these seven grantees. Aggregated impact estimates will be created by pooling impact estimates across appropriate sites to obtain a more powerful summary of the effectiveness of RPG interventions.

    In addition to conducting local evaluations and participating in the RPG Cross-Site Evaluation, the RPG grantees are legislatively required to report performance indicators aligned with their proposed program strategies and activities. A key strategy of the RPG Cross-Site Evaluation is to minimize burden on the grantees by ensuring that the cross-site evaluation, which includes all grantees in a study that collects data to report on implementation, the partnerships, and participant characteristics and outcomes, fully meets the need for performance reporting. Thus, rather than collecting separate evaluation and performance indicator data, the grantees need only participate in the cross-site evaluation. In addition, using the standardized instruments that the Children's Bureau has specified will ensure that grantees have valid and reliable data on child and family outcomes for their local evaluations. The inclusion of an impact study conducted on a subset of grantees with rigorous designs will also provide the Children's Bureau, Congress, grantees, providers, and researchers with information about the effectiveness of RPG programs.

    A 60-Day Federal Register Notice was published for this study on June 24, 2016. This 30-Day Federal Register Notice covers the following data collection activities: (1) The site visits with grantees; (2) the web-based survey of frontline staff who provide direct services to children, adults, and families, and their supervisors; (3) the semi-annual progress reports; (4) enrollment and service data provided by grantees; (5) the web-based survey of grantee partners; and (6) outcome data provided by grantees.

    Respondents. Respondents include grantee staff or contractors (such as local evaluators) and partner staff. Specific types of respondents and the expected number per data collection effort are noted in the burden table below.

    Annual burden estimates. The following instruments are proposed for public comment under this 30-Day Federal Register Notice. Burden for all components is annualized over three years.

    RPG Cross-Site Evaluation Annualized Burden Estimates Data collection activity Total
  • number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • (in hours)
  • Estimated
  • Total
  • burden hours
  • Total
  • Annual
  • burden hours
  • Implementation and Partnership Study Program director individual interview 4 1 2 8 2.67 Program manager/supervisor group interview 36 1 2 72 24 Program manager/supervisor individual interviews 24 1 1 24 8 Frontline staff individual interviews 24 1 1 24 8 Semi-annual progress reports 21 6 16.5 2,079 693 Case enrollment data 63 90 0.25 1,417.5 472.5 Service log entries 126 2,340 0.05 14,742 4,914 Staff survey 80 1 0.42 33.6 11.2 Partner survey 80 1 0.33 26.4 8.8 Data Entry for Outcomes Study Administrative Data: Obtain access to administrative data 21 2 18 378 126 Report administrative data 21 6 144 18,144 6,048 Standardized instruments: Enter data into local database 21 6 112.5 14,175 4,725 Review records and submit 21 6 100 12,600 4,200 Additional Data Entry for Impact Study Data entry for comparison study sites (7 grantees) 5 1 .25 1,085 361.6 Estimated Total Burden Hours 21,602.77

    In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Children's Bureau within the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to Administration for Children and Families, Office of Planning, Research, and Evaluation, 330 C Street SW., Washington, DC 20416, Attn: ACF Reports Clearance Officer. Email address: [email protected] All requests should be identified by the title of the information collection.

    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 of Children and Families.

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2016-22458 Filed 9-16-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request; Child Care and Development Fund Financial Report (ACF-696) for States and Territories

    OMB No.: 0970-0163.

    Description: States and Territories use the Financial Report Form ACF-696 to report Child Care and Development Fund (CCDF) expenditures. Authority to collect and report this information is found in section 658G of the Child Care and Development Block Grant Act of 1990, as revised. In addition to the Program Reporting Requirements set forth in 45 CFR part 98, subpart H, the regulations at 45 CFR 98.65(g) and 98.67(c)(1) authorize the Secretary to require financial reports as necessary.

    The form provides specific data regarding claims and provides a mechanism for States to request Child Care grant awards and to certify the availability of State matching funds. Failure to collect this data would seriously compromise ACF's ability to monitor Child Care and Development Fund expenditures. This information is also used to estimate outlays and may be used to prepare ACF budget submissions to Congress.

    The previous information collection requirements related to the American Recovery and Reinvestment Act (ARRA) of 2009, (Pub. L.111-5) have been deleted from this reporting form.

    Respondents: States and territories.

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Total burden
  • hours
  • ACF-696 56 4 5 1120

    Estimated Total Annual Burden Hours: 1120.

    Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]

    OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected] Attn: Desk Officer for the Administration for Children and Families

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2016-22449 Filed 9-16-16; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2633] International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4-Methylethcathinone and Eleven Other Substances; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 12 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (the CSA).

    DATES:

    Submit either electronic or written comments by October 4, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-2633 for “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (U-47700); Butyrfentanyl (Butyrylfentanyl); 4-Methylethcathinone (4-MEC); 3-Methylmethcathinone (3-methyl-N-methylcathinone; 3-MMC); Ethylone (3,4-methylenedioxy-N-ethylcathinone; bk-MDEA; MDEC); Pentedrone (α-Methylaminovalerophenone); Ethylphenidate (EPH); Methiopropamine (MPA); MDMB-CHMICA; 5F-APINACA (5F-AKB48); JWH-073; XLR-11 (5-Fluoro UR-144, 5F-UR-144); Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    James R. Hunter, Center for Drug Evaluation and Research, Controlled Substance Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver Spring, MD 20993-0002, 301-796-3156, email: [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    The United States is a party to the 1971 Convention on Psychotropic Substances (Psychotropic Convention). Article 2 of the Psychotropic Convention provides that if a party to the convention or WHO has information about a substance, which in its opinion may require international control or change in such control, it shall so notify the Secretary-General of the United Nations (the U.N. Secretary-General) and provide the U.N. Secretary-General with information in support of its opinion.

    Section 201 of the CSA (21 U.S.C. 811) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) provides that when WHO notifies the United States under Article 2 of the Psychotropic Convention that it has information that may justify adding a drug or other substances to one of the schedules of the Psychotropic Convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State must transmit the notice to the Secretary of Health and Human Services (Secretary of HHS). The Secretary of HHS must then publish the notice in the Federal Register and provide opportunity for interested persons to submit comments that will be considered by HHS in its preparation of the scientific and medical evaluations of the drug or substance.

    II. WHO Notification

    The Secretary of HHS received the following notice from WHO (non-relevant text removed):

    Ref.: C.L.28.2015

    The World Health Organization (WHO) presents its compliments to Member States and Associate Members and has the pleasure of informing that the Thirty-eighth Expert Committee on Drug Dependence (ECDD) will meet in Geneva from 14 to 18 November 2016 to review a number of substances with potential for dependence, abuse and harm to health, and will make recommendations to the U.N. Secretary-General, on the need for and level of international control of these substances.

    At its 126th session in January 2010, the Executive Board approved the publication “Guidance on the WHO review of psychoactive substances for international control” (EB126/2010/REC1, Annex 6) which requires the Secretariat to request relevant information from Ministers of Health in Member States to prepare a report for submission to the ECDD. For this purpose, a questionnaire was designed to gather information on the legitimate use, harmful use, status of national control and potential impact of international control for each substance under evaluation. Member States are invited to collaborate, as in the past, in this process by providing pertinent information as requested in the questionnaire and concerning substances under review.

    It would be appreciated if a person from the Ministry of Health could be designated as the focal point responsible for coordinating and answering the questionnaire. The designated focal point, and only this person, should access and complete the questionnaires:

    1. U-47700;

    2. Butyrfentanyl (Butyrylfentanyl);

    3. 4-Methylethcathinone (4-MEC);

    4. 3-Methylmethcathinone (3-methyl-N-methylcathinone; 3-MMC);

    5. Ethylone (3,4-methylenedioxy-N-ethylcathinone; bk-MDEA; MDEC);

    6. Pentedrone (α-Methylaminovalerophenone);

    7. Ethylphenidate (EPH);

    8. Methiopropamine (MPA);

    9. MDMB-CHMICA;

    10. 5F-APINACA (5F-AKB48);

    11. JWH-073;

    12. XLR-11 (5-Fluoro UR-144, 5F-UR-144).

    For ease of reference a PDF version of the questionnaire in English, French and Spanish may be downloaded from the link http://www.who.int/medicines/access/controlled-substances/ecdd/en/. Please note that these versions are for reference only and all questionnaires must be answered through the online system. Further clarification regarding the questionnaire may be obtained from the Secretariat by emailing: [email protected]

    Replies to the questionnaire must reach the Secretariat by 20 September 2016 in order to facilitate analyses and preparation of the report before the planned meeting. Where there is a competent National Authority under the International Drug Control Treaties, it is kindly requested that the questionnaire be completed in collaboration with such body.

    The summary information from the questionnaire will be published online as part of the report on the Web site for the 38th ECDD linked to the Department of Essential Medicines and Health Products (EMP).

    The World Health Organization takes this opportunity to renew to Member States and Associate Members the assurance of its highest consideration.

    GENEVA, 8 August 2016

    HHS received an extension from WHO that replies to the questionnaire must reach the Secretariat by October 11, 2016. FDA has verified the Web site addresses contained in the WHO notice, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    III. Substances Under WHO Review

    U-47700 is a synthetic opioid drug developed in the 1970s. U-47700 is structurally related to the opioid AH-7921. U-47700 is selective for the µ-opioid receptor. U-47700 has never been studied on humans, but would be expected to produce effects similar to those of other potent opioid agonists, including strong analgesia, sedation, euphoria, constipation, itching, and respiratory depression which could be harmful or fatal. Overdoses and overdose fatalities have been directly attributed to U-47700 misuse. There have been reports of U-47700 being encountered in counterfeit pills. On September 7, 2016, the Drug Enforcement Administration issued a notice of intent to temporarily schedule U-47700 into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act.

    Butyrfentanyl (butyrylfentanyl) is a synthetic opioid and analog of fentanyl. Fentanyl is controlled in Schedule II of the CSA, and an active ingredient in drug products approved for medical use and marketed in the United States. Butyrylfentanyl has a pharmacological profile similar to that of fentanyl and other µ-opioid receptor agonists. Risks associated with abuse of butyrylfentanyl include development of substance use disorder, overdose, and death similar to that of other µ-opioid agonists. The U.S. Drug Enforcement Administration (DEA) is aware of at least 40 confirmed fatalities associated with butyrylfentanyl. It has no approved medical use in the United States. On May 12, 2016, butyrylfentanyl was temporarily placed into Schedule I of the CSA for 2 years upon finding that it posed an imminent hazard to the public safety. The Attorney General, though, may extend this temporary scheduling for up to 1 year.

    4-Methylethcathinone (4-MEC), 3-Methylmethcathinone (3-methyl-N-methylcathinone; 3-MMC): 3-methyl-methcathinone (3-MMC), pentedrone, and ethylone (3,4-methylenedioxy-N-ethylcathinone; bk-MDEA; MDEC) are synthetic cathinones that are structurally and pharmacologically similar to amphetamine, 3-4 methylenedioxymethamphetamine (MDMA), cathinone, and other related substances. These substances are central nervous system stimulants with psychoactive properties similar to Schedule I and II amphetamine type substances. Public health risks associated with the use of synthetic cathinones suggest that these substances are associated with cardiac, psychiatric, and neurological symptoms that may lead to emergency department admissions, violent behaviors causing harm to self or others, or death. 4-MEC, 3-MMC, pentedrone, and ethylone have no known medical use in the United States. On March 7, 2014, the DEA published a final order in the Federal Register amending 21 CFR 1308.11(h) to temporarily place 4-MEC and pentedrone into Schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). On March 4, 2016, the temporary Schedule I status of 4-MEC and pentedrone was extended for 1 year, or until permanent scheduling is completed. Permanent scheduling for 4-MEC and pentedrone was initiated on March 4, 2016, upon publication of the notice of proposed rulemaking. As a positional isomer of 4-methylmethcathinone, 3-MMC is considered a Schedule I substance under the CSA. In the United States, ethylone has been sold as the street drug “Molly” and encountered as a replacement for methylone. As a positional isomer of the controlled drug butylone, ethylone is considered a Schedule I controlled substance under the CSA.

    Ethylphenidate (EPH) is structurally related to methylphenidate. Methylphenidate is controlled in Schedule IV of the CSA, and an active ingredient in drug products approved for medical use and marketed in the United States. Ethylphenidate is not approved for medical use in the United States. Ethylphenidate is structurally related to methylphenidate are being marketed as novel psychoactive substances with psychoactive effects similar to methylphenidate, therefore posing similar health risks to the users. Ethylphenidate is a controlled substance in several European countries, and is not a controlled substance in the United States under the CSA.

    Methiopropamine (MPA) is a structural analogue of the Schedule II controlled substance methamphetamine. Pharmacologically, it functions as a norepinephrine-dopamine reuptake inhibitor and, secondarily, as a serotonin reuptake inhibitor. MPA is a thiophene based analog of methamphetamine. It has stimulant properties as an inhibitor of dopamine, norepinephrine transporters in the central nervous system. MPA was critically reviewed by the WHO at its 36th meeting of the Expert Committee on Drug Dependence in June 2014. It is not approved for medical use or controlled in the United States under the CSA, but is a controlled substance in the United Kingdom.

    MDMB-CHMICA is an indole-based synthetic cannabinoid that is a potent full agonist at CB1 receptors and mimics functionally (biologically) the effects of the structurally unrelated delta-9-tetrahydrocannabinol (THC), a Schedule I substance, and the main active ingredient of marijuana. Synthetic cannabinoids are marketed under the guise of “herbal incense,” and promoted by drug traffickers as legal alternatives to marijuana. MDMB-CHMICA use is associated with serious adverse events including death in several European countries. There are no commercial or approved medical uses for MDMB-CHMICA. MDMB-CHMICA is not controlled under the CSA, but may be treated as a “controlled substance analogue” under the CSA pursuant to 21 U.S.C 802(32)(A) and 813, and is a controlled substance in the State of Louisiana.

    5F-APINACA (5F-AKB48) is a synthetic cannabinoid belonging to a chemical structural class with an indazole core. In vitro studies show that it binds to the cannabinoid CB1 receptors and displays agonist properties in functional assays, suggesting that it would share in vivo effects with delta-9-THC and various synthetic cannabinoids. There are no commercial or medical uses for 5F-APINACA. Synthetic cannabinoids are marketed under the guise of “herbal incense,” and promoted by drug traffickers as legal alternatives to marijuana. SF-APINACA is not a controlled substance under the CSA, but may be treated as a “controlled substance analogue” under the CSA pursuant to 21 U.S.C. 802(32)(A) and 813.

    JWH-073 is an indole-based synthetic cannabinoid agonist without the classical cannabinoid chemical structure. Pharmacology studies have been conducted on this substance. Behavioral pharmacology studies show that JWH-073 has delta-9-THC-like activity in animals. Synthetic cannabinoids are marketed under the guise of “herbal incense,” and promoted by drug traffickers as legal alternatives to marijuana. On March 1, 2011, JWH-073 was temporarily controlled in Schedule I and on July 9, 2012, JWH-073 was permanently controlled as a Schedule I substance under the CSA.

    XLR-11 (5-Fluoro-UR-144, 5F-UR-144) is an indole-based synthetic cannabinoid and acts as an agonist at cannabinoid CB1 receptors. Animal studies indicate that it mimics functionally (biologically) the effects of the structurally unrelated delta-9-THC, a Schedule I substance, and the main active ingredient of marijuana and numerous other Schedule I synthetic cannabinoids. Synthetic cannabinoids are marketed under the guise of “herbal incense,” and promoted by drug traffickers as legal alternatives to marijuana. On May 16, 2013, XLR-11 was temporarily placed under Schedule I and on May 11, 2016, XLR11 was permanently controlled as a Schedule I substance under the CSA.

    IV. Opportunity To Submit Domestic Information

    As required by section 201(d)(2)(A) of the CSA, FDA, on behalf of the Department of Health and Human Services (HHS), invites interested persons to submit comments regarding the 12 named drugs. Any comments received will be considered by HHS when it prepares a scientific and medical evaluation of these drugs. HHS will forward a scientific and medical evaluation of these drugs to WHO, through the Secretary of State, for WHO's consideration in deciding whether to recommend international control/decontrol of any of these drugs. Such control could limit, among other things, the manufacture and distribution (import/export) of these drugs and could impose certain recordkeeping requirements on them.

    Although FDA is, through this notice, requesting comments from interested persons which will be considered by HHS when it prepares an evaluation of these drugs, HHS will not now make any recommendations to WHO regarding whether any of these drugs should be subjected to international controls. Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in early 2017. Any HHS position regarding international control of these drugs will be preceded by another Federal Register notice soliciting public comments, as required by section 201(d)(2)(B) of the CSA.

    V. 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: September 14, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-22472 Filed 9-16-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1112] Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public meeting and Webcast; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting (which will also be Webcast) entitled “Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The goal of this meeting is to provide information and receive comments on the current activities of ICH, as well as the upcoming ICH meetings in Osaka, Japan, in November 2016. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting in Osaka. The purpose of this public meeting is to solicit public input prior to the next ICH Assembly meeting and the Expert Working Group meetings in Osaka, Japan, scheduled for November 6 through November 11, 2015.

    DATES:

    The public meeting will be held on October 24, 2016, from 1 p.m. to 3 p.m., EST. Registration to attend the meeting and requests for oral presentations must be received by October 21, 2016; see the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting. Interested persons may submit either electronic or written comments to the public docket (see ADDRESSES) by October 19, 2016.

    ADDRESSES:

    The meeting will be held at Sir Frederick G. Banting Research Centre, 251 Sir Frederick Banting Driveway, Ottawa, ON K1Y 0M1, Canada. It will also be broadcast on the Web allowing participants to join in person or via the Web.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-1112 for “Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting.” 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:

    Amanda Roache, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Strategic Programs, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993, 301-796-4548, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    The ICH, formerly known as the International Conference on Harmonisation was established in 1990 as a joint regulatory/industry project to improve, through harmonization, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States without compromising the regulatory obligations of safety and effectiveness. In 2015 the ICH was reformed to make the ICH a true global initiative that expands beyond the previous ICH members. More involvement from regulators around the world is expected, as they will join their counterparts from Europe, Japan, the United States, Canada, and Switzerland as ICH regulatory members. The reforms build on a 25-year track record of successful delivery of harmonized guidelines for global pharmaceutical development, and their regulation. In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for medical product development among regulatory Agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. The ICH process has achieved significant harmonization of the technical requirements for the approval of pharmaceuticals for human use in the ICH regions over the past two decades. The current ICH process and structure can be found at the following Web site: http://www.ich.org. (FDA has verified the Web site addresses as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.)

    II. Webinar Attendance and Participation A. Registration

    If you wish to attend the meeting, please register at the following Web site: https://healthcanada-usfda_ich_consultation.eventbrite.ca. Registrations may be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, the number of participants from each organization may be limited based on space limitations. Registrants will receive confirmation once they have been accepted. If you need special accommodations because of a disability, please contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the Webinar.

    B. Requests for Oral Presentations

    Interested persons may present data, information, or views orally or in writing on issues pending at the public Webinar. Public oral presentations will be scheduled between approximately 2:30 p.m. and 3 p.m. Time allotted for oral presentations may be limited to 5 minutes. Those desiring to make oral presentations should notify Amanda Roache (see FOR FURTHER INFORMATION CONTACT) by October 19, 2016, and submit a brief statement of the general nature of the evidence or arguments they wish to present; the names and addresses, telephone number, FAX, and email of proposed participants; and an indication of the approximate time requested to make their presentation. The agenda for the public Webinar will be made available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm516166.htm.

    Dated: September 14, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-22471 Filed 9-16-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2683] Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a generic clearance to collect information to support social and behavioral research used by FDA about drug products.

    DATES:

    Submit either electronic or written comments on the collection of information by November 18, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-2683 for “Data To Support Social and Behavioral Research as Used by the Food and Drug Administration.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Data To Support Social and Behavioral Research as Used by the Food and Drug Administration—(OMB Control Number 0910—NEW)

    Understanding patients, consumers and health care professionals' perceptions and behaviors plays an important role in improving FDA's regulatory decisionmaking processes and communications impacting various stakeholders. The methods to be employed to achieve these goals include individual indepth interviews, general public focus group interviews, intercept interviews, self-administered surveys, gatekeeper surveys, and focus group interviews. The methods to be used serve the narrowly defined need for direct and informal opinion on a specific topic and as a qualitative and quantitative research tool, and have two major purposes:

    1. To obtain information that is useful for developing variables and measures for formulating the basic objectives of social and behavioral research and;

    2. To assess the potential effectiveness of FDA communications, behavioral interventions and other materials in reaching and successfully communicating and addressing behavioral change with their intended audiences.

    FDA will use these methods to test and refine its ideas and to help develop communication and behavioral strategies research, but will generally conduct further research before making important decisions such as adopting new policies and allocating or redirecting significant resources to support these policies.

    FDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Office of the Commissioner, and any other Centers or Offices will use this mechanism to test communications and social and behavioral methods about regulated drug products on a variety of subjects related to consumer, patient, or healthcare professional perceptions, beliefs, attitudes, behaviors and use of drug and biological products and related materials, including, but not limited to, social and behavioral research, decisionmaking processes, and communication and behavioral change strategies.

    Annually, FDA projects about 45 social and behavioral studies using the variety of test methods listed in this document. FDA is requesting this burden so as not to restrict the Agency's ability to gather information on public sentiment for its proposals in its regulatory and communications programs.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses
  • per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • (minutes)
  • Total hours
    Interviews/Surveys 20,000 1 20,000 15 5,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Dated: September 13, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-22437 Filed 9-16-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-2033] Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey entitled “Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types (2015-2025).”

    DATES:

    Submit either electronic or written comments on the collection of information by November 18, 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-2014-N-2033 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types (2015-2025)—OMB Control Number 0910-0799—Extension I. Background

    From 1998 to 2008, FDA's National Retail Food Team conducted a study to measure trends in the occurrence of foodborne illness risk factors, preparation practices, and employee behaviors most commonly reported to the Centers for Disease Control and Prevention as contributing factors to foodborne illness outbreaks at the retail level. Specifically, data was collected by FDA Specialists in retail and foodservice establishments at 5-year intervals (1998, 2003, and 2008) in order to observe and document trends in the occurrence of the following foodborne illness risk factors:

    • Food from Unsafe Sources,

    • Poor Personal Hygiene,

    • Inadequate Cooking,

    • Improper Holding/Time and Temperature, and

    • Contaminated Equipment/Cross-Contamination.

    FDA developed reports summarizing the findings for each of the three data collection periods (1998, 2003, and 2008) (Refs. 1 to 3). Data from all three data collection periods were analyzed to detect trends in improvement or regression over time and to determine whether progress had been made toward the goal of reducing the occurrence of foodborne illness risk factors in selected retail and foodservice facility types (Ref. 4).

    Using this 10-year survey as a foundation, in 2013-2014, FDA initiated a new study in full service and fast food restaurants. This study will span 10 years with additional data collections planned for 2017-2018 and 2021-2022.

    FDA is currently collecting data in select institutional foodservice, schools, and retail food store facility types in 2015-2016. This proposed study will also span 10 years with additional data collections planned for 2019-2020 and 2023-2024.

    The current data collection in selected institutional foodservice, schools, and retail food store facilities was initiated on October 1, 2016, with a target date for completion by December 31, 2016. FDA is requesting a 90 day extension to complete this data collection by March 31, 2017. The extension is being requested to ensure that the number of facilities included in the study provide a sufficient sample size to conduct statistically significant analysis.

    Table 1—Description of the Facility Types Included in the Survey Facility type Description Health Care Facilities Hospitals and long-term care facilities foodservice operations that prepare meals for highly susceptible populations as defined as follows: • Hospitals—A foodservice operation that provides for the nutritional needs of inpatients by preparing meals and transporting them to the patient's room and/or serving meals in a cafeteria setting (meals in the cafeteria may also be served to hospital staff and visitors). • Long-term care facilities—A foodservice operation that prepares meals for the residents in a group care living setting such as nursing homes and assisted living facilities. Note: For the purposes of this study, health care facilities that do not prepare or serve food to a highly susceptible population, such as mental health care facilities, are not included in this facility type category. Schools (K-12) Foodservice operations that have the primary function of preparing and serving meals for students in one or more grade levels from kindergarten through grade 12. A school foodservice may be part of a public or private institution. Retail Food Stores Supermarkets and grocery stores that have a deli department/operation as described as follows: • Deli department/operation—Areas in a retail food store where foods, such as luncheon meats and cheeses, are sliced for the customers and where sandwiches and salads are prepared on-site or received from a commissary in bulk containers, portioned, and displayed. Parts of deli operations may include: • Salad bars, pizza stations, and other food bars managed by the deli department manager. • Areas where other foods are cooked or prepared and offered for sale as ready-to-eat and are managed by the deli department manager. Data will also be collected in the following areas of a supermarket or grocery store, if present: • Meat and seafood department/operation—Areas in a retail food store where raw animal food products, such as beef, pork, poultry, or seafood, are cut, prepared, stored, or displayed for sale to the consumer. • Produce department/operation—Areas in a retail food store where produce is cut, prepared, stored, or displayed for sale to the consumer. A produce operation may include salad bars or juice stations that are managed by the produce manager.

    The purpose of the study is to:

    • Assist FDA with developing retail food safety initiatives and policies focused on the control of foodborne illness risk factors;

    • Identify retail food safety work plan priorities and allocate resources to enhance retail food safety nationwide;

    • Track changes in the occurrence of foodborne illness risk factors in retail and foodservice establishments over time; and

    • Inform recommendations to the retail and foodservice industry and State, local, tribal, and territorial regulatory professionals on reducing the occurrence of foodborne illness risk factors.

    The statutory basis for FDA conducting this study is derived from the Public Health Service Act (PHS Act) (42 U.S.C. 243, section 311(a)). Responsibility for carrying out the provisions of the PHS Act relative to food protection was transferred to the Commissioner of Food and Drugs in 1968 (21 CFR 5.10(a)(2) and (4)). Additionally, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the Economy Act (31 U.S.C. 1535) require FDA to provide assistance to other Federal, State, and local government bodies.

    The objectives of the study are to:

    • Identify the foodborne illness risk factors that are in most need of priority attention during each data collection period;

    • Track trends in the occurrence of foodborne illness risk factors over time;

    • Examine potential correlations between operational characteristics of food establishments and the control of foodborne illness risk factors;

    • Examine potential correlations between elements within regulatory retail food protection programs and the control of foodborne illness risk factors; and

    • Evaluate the impact of industry food safety management systems in controlling the occurrence of foodborne illness risk factors.

    The methodology to be used for this information collection is described as follows. To obtain a sufficient number of observations to conduct statistically significant analysis, FDA will conduct approximately 400 data collections in each facility type. This sample size has been calculated to provide for sufficient observations to be 95 percent confident that the compliance percentage is within 5 percent of the true compliance percentage.

    A geographical information system database containing a listing of businesses throughout the United States provides the establishment inventory for the data collections. FDA samples establishments from the inventory based on the descriptions in table 1. FDA does not intend to sample operations that handle only prepackaged food items or conduct low-risk food preparation activities. The “FDA Food Code” contains a grouping of establishments by risk, based on the type of food preparation that is normally conducted within the operation (Ref. 5). The intent is to sample establishments that fall under risk categories 2 through 4.

    FDA has approximately 25 Regional Retail Food Specialists (Specialists) who serve as the data collectors for the 10-year study. The Specialists are geographically dispersed throughout the United States and possess technical expertise in retail food safety and a solid understanding of the operations within each of the facility types to be surveyed. The Specialists are also standardized by FDA's Center for Food Safety and Applied Nutrition personnel in the application and interpretation of the FDA Food Code (Ref. 5).

    Sampling zones have been established that are equal to the 150-mile radius around a Specialist's home location. The sample is selected randomly from among all eligible establishments located within these sampling zones. The Specialists are generally located in major metropolitan areas (i.e., population centers) across the contiguous United States. Population centers usually contain a large concentration of the establishments FDA intends to sample. Sampling from the 150-mile radius sampling zones around the Specialists' home locations provides three advantages to the study:

    1. It provides a cross-section of urban and rural areas from which to sample the eligible establishments.

    2. It represents a mix of small, medium, and large regulatory entities having jurisdiction over the eligible establishments.

    3. It reduces overnight travel and therefore reduces travel costs incurred by the Agency to collect data.

    The sample for each data collection period is evenly distributed among Specialists. Given that participation in the study by industry is voluntary and the status of any given randomly selected establishment is subject to change, substitute establishments have been selected for each Specialist for cases where the institutional foodservice, school, or retail food facility is misclassified, closed, or otherwise unavailable, unable, or unwilling to participate.

    Prior to conducting the data collection, Specialists contact the State or local jurisdiction that has regulatory responsibility for conducting retail food inspections for the selected establishment. The Specialist verifies with the jurisdiction that the facility has been properly classified for the purposes of the study and is still in operation. The Specialist ascertains whether the selected facility is under legal notice from the State or local regulatory authority. If the selected facility is under legal notice, the Specialist will not conduct a data collection, and a substitute establishment will be used. An invitation is extended to the State or local regulatory authority to accompany the Specialist on the data collection visit.

    A standard form is used by the Specialists during each data collection. The form is divided into three sections: Section 1—”Establishment Information”; Section 2—”Regulatory Authority Information”; and Section 3—”Foodborne Illness Risk Factor and Food Safety Management System Assessment”. The information in Section 1—”Establishment Information” of the form is obtained during an interview with the establishment owner or person in charge by the Specialist and includes a standard set of questions.

    The information in Section 2—”Regulatory Authority Information” is obtained during an interview with the program director of the State or local jurisdiction that has regulatory responsibility for conducting inspections for the selected establishment. Section 3 includes three parts: Part A for tabulating the Specialists' observations of the food employees' behaviors and practices in limiting contamination, proliferation, and survival of food safety hazards; Part B for assessing the food safety management being implemented by the facility; and Part C for assessing the frequency and extent of food employee hand washing. The information in Part A is collected from the Specialists' direct observations of food employee behaviors and practices. Infrequent, nonstandard questions may be asked by the Specialists if clarification is needed on the food safety procedure or practice being observed. The information in Part B is collected by making direct observations and asking followup questions of facility management to obtain information on the extent to which the food establishment has developed and implemented food safety management systems. The information in Part C is collected by making direct observations of food employee hand washing. No questions are asked in the completion of Section 3, Part C of the form.

    FDA collects the following information associated with the establishment's identity: Establishment name, street address, city, state, zip code, county, industry segment, and facility type. The establishment identifying information is collected to ensure the data collections are not duplicative. Other information related to the nature of the operation, such as seating capacity and number of employees per shift, is also collected. Data will be consolidated and reported in a manner that does not reveal the identity of any establishment included in the study.

    FDA is working with the National Center for Food Protection and Defense to develop a Web-based platform in FoodSHIELD to collect, store, and analyze data for the Retail Risk Factor Study. Once developed, this platform will be accessible to State, local, territorial, and tribal regulatory jurisdictions to collect data relevant to their own risk factor studies. FDA is currently transitioning from the manual entry of data to the use of hand-held technology. Contingent upon the completion of the Web-based platform, FDA intends to pilot test the use of hand-held technology during its 2015-2016 risk factor study data collection in institutional foodservice, school, and retail food store facility types, with the goal to have it fully implemented by the next data collection in restaurant facility types that will occur in 2017-2018. When a data collector is assigned a specific establishment, he or she conducts the data collection and enters the information into the Web-based data platform. The interface will support the manual entering of data, as well as the ability to upload a fillable PDF.

    The burden for this collection of information is as follows. For each data collection, the respondents includes: (1) The person in charge of the selected facility type (whether it be a health care facility, school, or supermarket/grocery store); and (2) the program director (or designated individual) of the respective regulatory authority. To provide the sufficient number of observations needed to conduct a statistically significant analysis of the data, FDA has determined that 400 data collections will be required in each of the three facility types. Therefore, the total number of responses will be 2,400 (400 data collections × 3 facility types × 2 respondents per data collection).

    The burden associated with the completion of Sections 1 and 3 of the form is specific to the persons in charge of the selected facilities. It includes the time it will take the persons in charge to accompany the data collectors during the site visit and answer the data collectors' questions. The burden related to the completion of Section 2 of the form is specific to the program directors (or designated individuals) of the respective regulatory authorities. It includes the time it will take to answer the data collectors' questions and is the same regardless of the facility type.

    To calculate the estimate of the hours per response, FDA uses the average data collection duration for similar facility types during FDA's 2008 Risk Factor Study (Ref. 3) plus an extra 30 minutes (0.5 hours) for the information collection related to Section 3, Part B of the form. FDA estimates that it will take the persons in charge of health care facility types, schools, and retail food stores 150 minutes (2.5 hours), 120 minutes (2 hours), and 180 minutes (3 hours), respectively, to accompany the data collectors while they complete Sections 1 and 3 of the form. FDA estimates that it will take the program director (or designated individual) of the respective regulatory authority 30 minutes (0.5 hours) to answer the questions related to Section 2 of the form. The total burden estimate for a data collection, including both the program director's and the person in charge's responses, in health care facility types is 180 minutes (150+30)(3 hours), in schools is 150 minutes (120+30)(2.5 hours), and in retail food stores is 210 minutes (180+30)(3.5 hours).

    Based on the number of entry refusals from the 2013-2014 Risk Factor Study in the restaurant facility types, we estimate a refusal rate of 2 percent in the institutional foodservice and retail food store facility types. The estimate of the time per non-respondent is 5 minutes (0.08 hours) for the person in charge to listen to the purpose of the visit and provide a verbal refusal of entry.

    Table 2—Estimated Annual Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Number of
  • non-respondents
  • Number of
  • responses per
  • non-respondent
  • Total annual
  • non-responses
  • Average burden per response Total hours
    2015-2016 Data Collection (Health Care Facilities)—Completion of Sections 1 and 3 400 1 400 2.5 1,000 2015-2016 Data Collection (Schools)—Completion of Sections 1 and 3 400 1 400 2 800 2015-2016 Data Collection (Retail Food Stores)—Completion of Sections 1 and 3 400 1 400 3 1,200 2015-2016 Data Collection-Completion of Section 2—All Facility Types 1,200 1 1,200 0.5 600 2017-2018 Data Collection-Entry Refusals—All Facility Types 24 1 24 0.08 (5 minutes) 1.92 Total Hours 3,601.92 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    II. References

    The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    1. “Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors (2000).” Available at: http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/ucm123546.pdf. 2. “FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004).” Available at: http://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/UCM423850.pdf. 3. “FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2009).” Available at: http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224682.pdf. 4. FDA National Retail Food Team. “FDA Trend Analysis Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (1998-2008).” Available at: http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224152.pdf. 5. “FDA Food Code.” Available at: http://www.fda.gov/FoodCode. Dated: September 13, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-22438 Filed 9-16-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3326] Biosimilar User Fee Act; Public Meeting AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public meeting; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. BsUFA authorizes FDA to collect fees and use them for the process for the review of biosimilar biological product applications. The current legislative authority for BsUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting biosimilar biological product user fees in future fiscal years. Following an initial consultation with public stakeholders and discussions with the regulated industry, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider the public views and comments and revise the recommendations as necessary.

    DATES:

    The public meeting will be held on October 20, 2016, from 9 a.m. to 2 p.m. Please register for the meeting by October 19, 2016, at http://bsufapublicmeeting.eventbrite.com. Submit electronic or written comments to the public docket by October 19, 2016.

    ADDRESSES:

    The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503, Section A), Silver Spring, MD 20993-0002. Participants must enter through Building 1 and undergo security screening. For more information on parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2015-N-3326 for “Biosimilar User Fee Act; Public Meeting.” 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.

    FDA will post the agenda approximately 5 days before the meeting at: http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm.

    FOR FURTHER INFORMATION CONTACT:

    Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993, 301-796-4548, FAX: 301-847-8443, [email protected]

    SUPPLEMENTARY INFORMATION: I. Introduction

    FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of BsUFA, the legislation that authorizes FDA to collect user fees and use them for the process for the review of biosimilar biological product applications. The current authorization of the program (BsUFA I) expires in September 2017. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the process for the review of biosimilar biological product applications. Section 744I(e)(2) of the FD&C Act (21 U.S.C. 379j-53(e)(2)) requires that after FDA holds negotiations with regulated industry, we do the following: (1) Present recommendations to the relevant Congressional committees, (2) publish recommendations in the Federal Register, (3) provide a period of 30 days for the public to provide written comments on the recommendations, (4) hold a meeting at which the public may present its views on the recommendations, and (5) after consideration of public views and comments, revise the recommendations as necessary.

    This notice, the 30-day comment period, and the public meeting will satisfy some of these requirements.

    The purpose of the meeting is to hear the public's views on the proposed recommendations for the reauthorization of BsUFA II. The following information is provided to help potential meeting participants better understand the history and evolution of the BsUFA program and the proposed BsUFA II recommendations.

    II. What is BsUFA and what does it do?

    BsUFA is a law that authorizes FDA to collect fees from drug companies that submit marketing applications for certain biosimilar biological products. BsUFA was originally enacted in 2012 as the Biosimilar User Fee Act (Pub. L. 112-144) for a period of 5 years.

    BsUFA's intent is to provide additional revenues so that FDA can hire more staff, improve systems, and establish a better-managed biosimilar biological product review process to make important therapies available to patients sooner without compromising review quality or FDA's high standards for safety, efficacy, and quality. As part of FDA's agreement with industry during each reauthorization, the Agency agrees to certain performance goals. These goals apply to the process for the review of new biosimilar biological product applications, resubmissions of original applications, and new and resubmitted supplements to approved applications. Phased in over the 5 years of BsUFA I, the goals were to review and act on 90 percent of original biosimilar biological product application submissions within 10 months of receipt and resubmitted original biosimilar biological product applications within 6 months of receipt; to review and act on 90 percent of original supplements with clinical data within 10 months of receipt and resubmitted supplements with clinical data within 6 months of receipt; and review and act on 90 percent of manufacturing supplements within 6 months of receipt.

    III. Proposed BsUFA II Recommendations

    In preparing the proposed recommendations to Congress for BsUFA reauthorization, FDA conducted discussions with the regulated industry and consulted with stakeholders, as required by the law. We began the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input on the reauthorization and announcing a public meeting that was held on December 18, 2015. The meeting included presentations by FDA and a series of panels with representatives of different stakeholder groups, including patient advocates, consumer groups, regulated industry, health professionals, and academic researchers. The materials from the meeting, including a transcript and Webcast recording, can be found at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm.

    Following the December 2015 public meeting, FDA conducted negotiations with the regulated industry from March 2016 through May 2016. FDA posted minutes of these meetings on its Web site at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm.

    The proposed enhancements for BsUFA II address many of the top priorities identified by public stakeholders, the regulated industry, and FDA. While some of the proposed enhancements are new, many either build on successful enhancements or refine elements from the existing program. The enhancements are proposed in the following areas: Review performance, meeting management, guidance development, and administrative areas (hiring and financial management). The full text of the proposed BsUFA II commitment letter can be found here at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm. Each significant new or modified enhancement is described briefly in sections III.A through III.K.

    A. The Review Cycle

    FDA and the regulated industry jointly identified an opportunity to reduce multiple review cycles for biosimilar biological products by increasing transparency and communication during the review process of a 351(k) application. For BsUFA II, it is therefore proposed to establish a model for the review of biosimilar biological products similar to the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and original Biologics License Applications (the Program) that was established in the fifth authorization of the Prescription Drug User Fee Act (PDUFA).

    The Program was first established for PDUFA in 2012. An interim assessment of the Program suggested that it has created conditions that enhance the ability of applicants and FDA reviewers to work toward application approval in the first cycle (see http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327030.htm). Likewise, it is anticipated that the review model will promote efficiency and effectiveness of the first cycle review process and minimize the number of review cycles necessary for approval for 351(k) applications.

    The Program will allow for additional communication between FDA review teams and the applicants of biosimilar biological products in the form of pre-submission meetings, mid-cycle communications, and late-cycle meetings, while also adding 60 days to the review timeframe to accommodate this additional interaction.

    This enhancement is described in section I.B. of the proposed BsUFA II commitment letter.

    B. Review Goal Extension for Missing Manufacturing Facilities

    When manufacturing facilities are not adequately identified, this may result in the need for FDA to conduct inspections late in the review process. This can adversely impact FDA's ability to complete application review within the performance goal timeframes. Accordingly, FDA proposes to extend the goal date for an original application or a supplement when FDA identifies a need to inspect a facility that was not included in a comprehensive and readily located list of manufacturing facilities. This enhancement is described in section I.A.5.b of the proposed BsUFA II commitment letter.

    C. Special Protocol Assessment and Agreement

    Further clarity is needed regarding the types of clinical study protocols that may qualify for a Special Protocol Assessment and Agreement under BsUFA. Pharmacokinetic (PK) and Pharmacodynamic (PD) similarity studies should be added to the examples provided in the goals letter. It is proposed that the language in the goals is revised to include PK and PD similarity studies. This enhancement is described in section I.H.1.c of the proposed BsUFA II commitment letter.

    D. Prior Approval Manufacturing Supplements

    The review goal date for biosimilar prior approval manufacturing supplements is currently 6 months under BsUFA I, compared to 4 months for stand-alone biologics under PDUFA. Therefore, to increase consistency among user fee programs, it is proposed that prior approval manufacturing supplements are reviewed in 4 months, instead of 6 months, with a phased-in performance goal. The language for prior approval supplements is included in section I.A.3 of the proposed BsUFA II commitment letter.

    E. Meeting Management

    The enhancements in this section focus on FDA's ability to better manage meetings with sponsors of 351(k) applications. The details for these enhancements can be found in section I.I of the proposed BsUFA II commitment letter.

    1. Addition of a Written Response Meeting Format for Biosimilar Initial Advisory (BIA) and Biosimilar Program Development (BPD) Type 2 Meetings

    Currently, there is no mechanism to grant a meeting request and provide a written response in place of a face-to-face meeting, videoconference, or teleconference. From FY 2013 to FY2015, FDA provided written responses to sponsors for 16 out of 22 meetings that were denied or cancelled due to incomplete, premature, or unnecessary requests in order to support biosimilar development programs. Such responses are not on a user fee clock and are not tracked work. For BsUFA II, it is proposed that for BIA and BPD Type 2 meetings, the sponsor may request a written response to questions rather than a face-to-face meeting, videoconference, or teleconference. If a written response is deemed appropriate, FDA will notify the requester of the date it intends to send the written response. This date will be consistent with the timeframes specified for the specific meeting type.

    2. Increase the Scheduling Timeframe for BPD Type 2 Meetings

    The FDA has had challenges scheduling BPD type 2 meetings within the 75-day timeframe. Scheduling challenges occur due to an increasing number of Type 2 meetings to discuss novel and complex aspects of development that require extensive internal discussion. A review committee must address many of these aspects to ensure implementation of consistent scientific advice and policy concerning biosimilar development. Consequently, FDA is unable to answer and provide comprehensive responses to such questions at meetings within the 75-day timeframe. This results in unresolved issues and additional followup questions that ultimately leads to a delay in a sponsor's overall development program. To provide the necessary time for FDA discussions and to develop comprehensive responses, it is proposed that BPD Type 2 Meetings occur within 90 calendar days, instead of 75 days, from receipt of the meeting request and meeting package with a phased in performance goal. Additionally, it is proposed that the Agency will send preliminary responses to the sponsor's questions contained in the background package no later than five calendar days before the face-to-face videoconference or teleconference meeting date for BPD Type 2 and Type 3 meetings.

    3. Reduce the Scheduling Timeframe for Biosimilar Initial Advisory (BIA) Meetings

    On average, five BIA meetings were scheduled per fiscal year from 2013 to 2015. The content of a BIA meeting is limited to a general discussion on whether a proposed product could be developed as a biosimilar product and to provide high-level advice on the expected content of the development program. Targeted advice on the adequacy of any comparative data or extensive advice for any aspect of an ongoing biosimilar development program is not expected to be provided in a BIA meeting. The current 90-day scheduling timeframe may no longer be appropriate and should be shortened. Therefore, it is proposed for BIA meetings to occur within 75 calendar days, instead of 90 days, from receipt of the meeting request and meeting package.

    F. Guidance Development

    FDA has received feedback that additional clarity is needed on regulatory processes and the scientific criteria for biosimilar development and approval to provide certainty to industry and other stakeholders related to Agency expectations. Therefore, it is proposed that FDA revise its guidance entitled “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants” and update the draft guidance entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development” to include communications between IND sponsors and FDA during biosimilar biological product development. Additionally, it is proposed that FDA publish draft or final guidance on several issues related to biosimilar biological product development including considerations in demonstrating interchangeability with a reference product; statistical considerations for analytic similarity for biosimilar biological products; processes and further considerations related to post-approval manufacturing changes for biosimilar biological products; clinical pharmacology data to support a demonstration of biosimilarity to a reference product; nonproprietary naming of biological products; and labeling for biosimilar biological products. The proposed goals related to guidance development are described in sections I.I.6 and II of the proposed BsUFA II commitment letter.

    G. Improving FDA Hiring and Retention of Review Staff

    To speed and improve development of safe and effective biosimilar biological products for patients, FDA must hire and retain sufficient numbers and types of technical and scientific experts to efficiently conduct reviews of 351(k) applications. In order to strengthen this core function during BsUFA II, FDA proposes to implement a full time equivalent staff-based position management system capability and an online position classification system. In addition, FDA will complete implementation of corporate recruiting practices, augment hiring capacity with expert contractor support, establish a dedicated function for staffing of the human drug review program, establish clear goals for biosimilar review program hiring, and conduct comprehensive and continuous assessments of hiring and retention performance. These enhancements are described in section V of the proposed BsUFA II commitment letter.

    H. Enhancing Capacity for Biosimilar Guidance Development, Reviewer Training, and Timely Communication

    In order to accelerate patient access to safe and effective biosimilar biological products and ensure accuracy, consistency, and timeliness FDA needs a more focused and better resourced capacity to coordinate key legal, scientific, review, and outreach functions in FDA's development phase advice and premarket review. It is proposed that FDA strengthen its staff capacity to: (1) Develop new regulations and guidance to clarify scientific criteria for biosimilar development and approval, and to provide certainty to industry and other stakeholders on key regulatory issues including the scope of eligible biosimilar biological products; (2) develop or revise manuals of policy and procedures, standard operating procedures, and review templates to facilitate rapid update and application of new policies and guidance by review staff, and to develop and deliver timely, comprehensive training to all Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research review staff and special government employees involved in the review of 351(k) BLAs; (3) deliver timely information to the public to improve public understanding of biosimilarity and interchangeability; and (4) deliver information concerning the date of first licensure and the reference product exclusivity expiry date, to be included in the Purple Book.1 The language for enhanced capacity is included in section III of the proposed BsUFA II commitment letter.

    1 The “Purple Book” lists biological products, including any interchangeable biological products, licensed by FDA under the Public Health Service Act.

    I. Enhancing Management of User Fee Resources

    FDA is committed to enhancing management of BsUFA resources and ensuring BsUFA user fee resources are administered, allocated, and reported in an efficient and transparent manner. In BsUFA II, FDA proposes to establish a resource capacity planning function to improve its ability to analyze current resource needs and project future resource needs, to modernize its time reporting approach, to conduct an evaluation of BsUFA program resource management, to publish a 5-year BsUFA financial plan with annual updates, and to convene an annual public meeting, beginning in FY 2019, to discuss the financial plan and progress towards the financial management enhancements. FDA also proposes to reduce the carryover balance to no greater than 21 weeks of the FY 2022 target revenue by the end of FY 2022. These enhancements are described in section IV of the proposed BsUFA II commitment letter.

    J. Enhancements to Fee Structure and Related Mechanisms for Increased Predictability, Stability, and Efficiency

    The current BsUFA fee structure references PDUFA fees each fiscal year and calculates biosimilar biological product development program (BPD) fees based on the PDUFA application fee. FDA and industry agreed that the BsUFA II fee structure and the fee setting process could be updated to enhance the predictability and stability of fee amounts and revenues in a manner to improve FDA's ability to engage in long-term financial planning. To address these issues, FDA proposes to discontinue the reduction of the biosimilar biological product application fee by the cumulative BPD fees paid by sponsors, to discontinue the establishment and supplement fees, to rename the product fee as the BsUFA Program fee, to modify the Program fee billing date to minimize the need for multiple billing cycles, and to add a limitation that a sponsor shall not be assessed more than five BsUFA Program fees for a fiscal year for products identified in each distinct approved biosimilar biological product application held by that sponsor.

    K. Enhancements to User Fee Revenue Amounts and Adjustments

    FDA and industry agreed that the BsUFA II user fee revenue amounts and fee amounts should be independent of PDUFA and based on BsUFA program costs. FDA proposes to establish fees to generate a total of $45 million in user fee revenue for FY 2018. However, FDA also proposes that it can adjust this amount when setting the user fee amounts published in the FY 2018 Federal Register notice to reflect an updated assessment of the BsUFA workload, with the limitation that this adjustment cannot increase user fee revenue by more than $9 million (i.e. relative to the $45 million specified for FY 2018 user fee revenue). To enhance the predictability of user fee amounts, FDA proposes that the amount for each BsUFA fee cannot increase more than 25 percent from the respective FY2018 fee amount until the capacity planning adjustment is effective and that FDA can otherwise modify the amount of the user fee revenue generated from each fee type each fiscal year. FDA proposes to adjust the annual user fee revenue amount for inflation, to develop a robust methodology for adjusting fees based on the capacity needs of the program, and to introduce an annual operating reserve adjustment to provide for adequate carryover resources.

    IV. Purpose and Scope of the Meeting

    If you wish to attend this meeting, visit http://bsufapublicmeeting.eventbrite.com. Please register by October 19, 2016. If you are unable to attend the meeting in person, you can register to view a live Webcast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Webcast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations because of a disability, please contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting.

    The meeting will include a presentation by FDA and a series of invited panels representing different stakeholder groups identified in the statute (such as patient advocacy groups, consumer advocacy groups, health professionals, and regulated industry). We will also provide an opportunity for other organizations and individuals to make presentations at the meeting or to submit written comments to the docket before the meeting.

    FDA will also hold an open public comment period at the meeting to give the public an opportunity to present their comments. Registration for open public comment will occur at the registration desk on the day of the meeting and workshop on a first-come, first-served basis.

    Transcripts: As soon as a transcript is available, FDA will post it at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm.

    Dated: September 13, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-22442 Filed 9-16-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2673] Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act; Public Meeting; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public meeting; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing a public meeting entitled “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act.” This public meeting is intended to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share information with FDA about the efforts underway to implement the Drug Supply Chain Security Act's (DSCSA's) product identification requirements, including the use of product identifiers to enhance tracing at the product level.

    DATES:

    The public meeting will be held on October 14, 2016, from 9 a.m. to 4 p.m. To permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public meeting topics. The deadline for submitting comments related to this public meeting is November 14, 2016.

    ADDRESSES:

    The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503A), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-2673 for “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security 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.

    FOR FURTHER INFORMATION CONTACT:

    Daniel Bellingham, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4285, Silver Spring, MD 20993, 301-796-3130, FAX: 301-847-8722, email: [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    On November 27, 2013, the DSCSA (Title II, Pub. L. 113-54) was signed into law. The DSCSA outlines critical steps to build an electronic, interoperable system by 2023 to identify and trace certain prescription drugs as they are distributed within the United States. This system will enhance FDA's ability to protect U.S. consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful by improving the detection and removal of potentially dangerous drugs from the drug supply chain.

    Section 582(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360eee-1), which was added by the DSCSA, directs FDA to hold at least five public meetings to enhance the safety and security of the pharmaceutical distribution supply chain and provide opportunities for comment from stakeholders. In carrying out these public meetings, FDA is required to prioritize topics necessary to inform the guidances described in section 582(h)(3) and (h)(4) related to unit-level tracing and standards for the interoperable data exchanges, respectively, and to take all reasonable and practicable measures to ensure the protection of confidential commercial information and trade secrets. FDA is also required to address each of the eight topics enumerated in section 582(i)(2) in at least one of the five required public meetings.

    FDA will hold a public meeting on October 14, 2016, to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share information about current practices and industry efforts to implement the DSCSA's product identification requirements, including the use of product identifiers. The format of the meeting involves presentations from the public and followup questions from an FDA panel. FDA will not be inviting specific presenters; rather, with this notice, FDA is soliciting presentations from interested stakeholders.

    II. Topics for This Public Meeting

    The main topic FDA is interested in discussing at the public meeting is the supply chain's progress toward implementing the DSCSA's product identification requirements, including best practices in each sector of the pharmaceutical distribution supply chain to conduct product tracing, verification, and product identification. This may include the processes needed to utilize the product identifiers to enhance tracing of product at the package level, including allowing for verification, aggregation, and inference, as necessary. (The product identifier is a standardized graphic that includes, in both human- and machine-readable forms, the National Drug Code, serial number, lot number, and expiration date of the product.) Under section 582(b)(2) and (e)(2) of the FD&C Act, manufacturers and repackagers must affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce, by November 2017 and November 2018, respectively.

    Other topics of interest to FDA that may be presented at the public meeting include, but are not limited to:

    • An assessment of the steps taken by supply chain members to build capacity for a unit-level system for electronic product tracing, including the impact on (1) the ability of the health care system to maintain patient access to medicines; (2) the scalability of such requirements, including as it relates to product lines; and (3) the capability of different sectors and subsectors, including both large and small businesses, to affix and utilize the product identifier; and

    • information related to the secure, interoperable electronic data exchange among sectors within the pharmaceutical distribution supply chain.

    FDA will post the agenda of the meeting at http://www.fda.gov/Drugs/NewsEvents/ucm519587.htm.

    III. Registration

    Registration to attend is free and will be on a first-come, first-served basis. To register for the meeting either: (1) Email your registration information to [email protected], or (2) mail your registration information to the contact person (see FOR FURTHER INFORMATION CONTACT). Registration information should include:

    • “Registration for October 14, 2016, DSCSA meeting” in the subject line, and

    • Registrant name, company or organization, address, phone number, and email address in the body of your email or mailing.

    Registration requests should be received by October 6, 2016. Onsite registration on the day of the meeting, starting at 8 a.m., will be based on space availability. Seating will be limited; therefore, if registration meets the maximum capacity, FDA will post a notice closing meeting registration for the meeting on FDA's Web site at: http://www.fda.gov/Drugs/NewsEvents/ucm519587.htm.

    If you need special accommodations due to a disability, please contact Daniel Bellingham (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the public meeting.

    IV. Requests for Oral Presentations

    Any person interested in presenting at the public meeting should include a request to present in a single email with a registration request (see section III. Registration). The request should specify the topic(s) that will be addressed in the presentation. FDA will do its best to accommodate requests for oral presentations. Individuals and organizations with common interests are encouraged to consolidate or coordinate their presentations and can submit a single request to present.

    All requests to make oral presentations must be received by October 5, 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 public comment session, FDA may conduct a lottery to determine the speakers for the public comment session. The contact person will notify interested persons regarding their request to speak by October 7, 2016. Presenters must email their presentation materials, if any, to [email protected] no later than October 12, 2016. This meeting is not intended to be a venue for circulation of product-specific promotional material, but rather an opportunity to gather information related to stakeholder progress towards implementing the product identification requirements of the DSCSA.

    V. Webcasting of the Public Meeting

    Portions of this public meeting will be recorded and Webcast on the day of the meeting. Information for how to access the Webcast will be available at http://www.fda.gov/Drugs/NewsEvents/ucm519587.htm by October 14, 2016. The Webcast will be conducted in listening mode only.

    Dated: September 13, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-22441 Filed 9-16-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2610] A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and