Federal Register Vol. 81, No.73,

Federal Register Volume 81, Issue 73 (April 15, 2016)

Page Range22173-22509
FR Document

81_FR_73
Current View
Page and SubjectPDF
81 FR 22503 - Establishment of the Belmont-Paul Women's Equality National MonumentPDF
81 FR 22209 - Government in the Sunshine Act Meeting NoticePDF
81 FR 22239 - Sunshine Act Meeting NoticePDF
81 FR 22365 - Sunshine Act Meetings; Unified Carrier Registration Plan Board of DirectorsPDF
81 FR 22323 - Sunshine Act; Notice of Public MeetingPDF
81 FR 22314 - Importer of Controlled Substances Registration: Mylan Technologies, Inc.PDF
81 FR 22367 - Request for InformationPDF
81 FR 22261 - Agency Information Collection Activities; Proposed Renewal of an Existing Collection (EPA ICR No. 0152.11); Comment RequestPDF
81 FR 22263 - Change in Public Notice Procedures for EPA Region 5's Proposed Establishment of TMDLs and Proposed Impaired Waters Listings Under Section 303(d) of the Clean Water ActPDF
81 FR 22246 - Meeting of the President's Advisory Commission on Educational Excellence for African AmericansPDF
81 FR 22286 - National Institutes of Health (NIH) Office of Science Policy (OSP) Recombinant or Synthetic Nucleic Acid Research: Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)PDF
81 FR 22203 - Importation of Fresh Apple and Pear Fruit Into the Continental United States From Certain Countries in the European UnionPDF
81 FR 22264 - National Environmental Education Advisory CouncilPDF
81 FR 22262 - Performance Partnership GrantsPDF
81 FR 22204 - Negotiated Rulemaking Committee; Schedule of Committee MeetingsPDF
81 FR 22210 - Foreign-Trade Zone (FTZ) 186-Waterville, Maine; Notification of Proposed Production Activity; Flemish Master Weavers (Area Rugs); Sanford, MainePDF
81 FR 22176 - Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic AcidPDF
81 FR 22210 - Foreign-Trade Zone 172-Oneida County, New York; Application for Reorganization and Expansion Under Alternative Site FrameworkPDF
81 FR 22213 - U.S. Travel and Tourism Advisory BoardPDF
81 FR 22260 - Pesticide Program Dialogue Committee; Notice of Public MeetingPDF
81 FR 22211 - Silicomanganese From Ukraine: Notice of Rescission of Antidumping Duty Administrative ReviewPDF
81 FR 22263 - Environmental Impact Statements; Notice of AvailabilityPDF
81 FR 22361 - KCVN, LLC and Colorado Pacific Railroad, LLC-Feeder Line Application-Line of V and S Railway, LLC, Located in Crowley, Pueblo, Otero, and Kiowa Counties, ColoradoPDF
81 FR 22272 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
81 FR 22368 - Mutual Savings Association Advisory CommitteePDF
81 FR 22245 - Public Availability of Defense Nuclear Facilities Safety Board FY 2014 Service Contract Inventory Analysis/FY 2015 Service Contract InventoryPDF
81 FR 22192 - Special Local Regulation; Hebda Cup Rowing Regatta; Detroit River, Trenton Channel; Wyandotte, MIPDF
81 FR 22296 - Section 8 Housing Assistance Payments Program-Fiscal Year (FY) 2016 Inflation Factors for Public Housing Agency (PHA) Renewal FundingPDF
81 FR 22214 - Fisheries of the South Atlantic; South Atlantic Fishery Management Council and Mid-Atlantic Fishery Management Council; Public MeetingPDF
81 FR 22215 - Gulf of Mexico Fishery Management Council; Public HearingsPDF
81 FR 22297 - 30-Day Notice of Proposed Information Collection: Certified Housing Counselor RegistrationPDF
81 FR 22183 - Title Evidence for Trust Land AcquisitionsPDF
81 FR 22292 - Privacy Act of 1974; Notice of a Computer Matching Program Between the Department of Housing and Urban Development (HUD) and the Department of Veteran's Affairs (VA)PDF
81 FR 22293 - Implementation of the Privacy Act of 1974, as Amended; System of Records Notice Amendment, Distributive Shares and Refunds SubsystemPDF
81 FR 22184 - Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Paying BenefitsPDF
81 FR 22271 - World War One Centennial Commission; Notification of Upcoming Public Advisory MeetingPDF
81 FR 22361 - Culturally Significant Objects Imported for Exhibition Determinations: “Dadaglobe Reconstructed” ExhibitionPDF
81 FR 22361 - Culturally Significant Objects Imported for Exhibition Determinations: “Slavery and Freedom” ExhibitionPDF
81 FR 22364 - Federal Aviation AdministrationPDF
81 FR 22359 - Culturally Significant Objects Imported for Exhibition Determinations: “Emperors' Treasures: Chinese Art From the National Palace Museum, Taipei” ExhibitionPDF
81 FR 22363 - Deadline for Notification of Intent To Use the Airport Improvement Program (AIP) Primary, Cargo, and Nonprimary Entitlement Funds Available to Date for Fiscal Year 2016PDF
81 FR 22209 - Notice of Request for Applications for the Veterinary Medicine Loan Repayment ProgramPDF
81 FR 22321 - Information Collection: NRC Form 237, Request for Access AuthorizationPDF
81 FR 22318 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)PDF
81 FR 22319 - TUV SUD America Inc.: Grant of Expansion of RecognitionPDF
81 FR 22233 - Request for Comments on the Application of the Written Description Requirement to Specific Situations in Design ApplicationsPDF
81 FR 22248 - Environmental Management Site-Specific Advisory Board, Oak Ridge ReservationPDF
81 FR 22249 - Environmental Management Site-Specific Advisory Board, PortsmouthPDF
81 FR 22249 - Environmental Management Site-Specific Advisory BoardPDF
81 FR 22239 - Proposed Collection; Comment RequestPDF
81 FR 22252 - Notice of Petition for Waiver From Cleaver-Brooks From the Department of Energy Commercial Packaged Boiler Test ProcedurePDF
81 FR 22255 - Notice of Petition for Waiver From York-Shipley Global, Division of AESYS Technologies, LLC From the Department of Energy Commercial Packaged Boiler Test ProcedurePDF
81 FR 22322 - New Postal ProductPDF
81 FR 22364 - Office of Commercial Space Transportation; Notice of Availability of the Final Environmental Assessment (Final EA), Finding of No Significant Impact (FONSI)/Record of Decision (ROD) for the Kodiak Launch Complex Launch Pad 3, Kodiak Island, AlaskaPDF
81 FR 22318 - Notice of Availability of Funds and Funding Opportunity Announcement for: Pathways to Justice Careers for YouthPDF
81 FR 22317 - Notice of Availability of Funds and Funding Opportunity Announcement for Women in Apprenticeship and Nontraditional Occupations (WANTO) Technical Assistance (TA) GrantsPDF
81 FR 22232 - Fisheries of the South Atlantic, Gulf of Mexico, and Caribbean; Southeast Data, Assessment, and Review (SEDAR); Public MeetingPDF
81 FR 22233 - Gulf of Mexico Fishery Management Council; Public MeetingPDF
81 FR 22305 - Notice of Availability of the Proposed Resource Management Plan and Final Environmental Impact Statement for Western OregonPDF
81 FR 22239 - Procurement List; Proposed Additions and DeletionsPDF
81 FR 22249 - Notice of Petition for Waiver From Superior Boiler Works, Inc. From the Department of Energy Commercial Packaged Boiler Test ProcedurePDF
81 FR 22280 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPDF
81 FR 22244 - Notice of Availability of Invention for Licensing; Government-Owned InventionPDF
81 FR 22245 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Fiscal Operations Report for 2014-2015 and Application To Participate 2016-2017 (FISAP) and Reallocation FormPDF
81 FR 22247 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; EZ-Audit: Electronic Submission of Financial Statements and Compliance AuditsPDF
81 FR 22299 - Aquatic Nuisance Species Task Force MeetingPDF
81 FR 22304 - Idaho: Filing of Plats of SurveyPDF
81 FR 22210 - National Advisory CommitteePDF
81 FR 22216 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Installation of the Block Island Wind Farm Export and Inter-Array CablesPDF
81 FR 22317 - Mitsubishi Motors North America, Inc.; A Subsidiary of Mitsubishi Motors Corporation; Manufacturing Division; Including On-Site Leased Workers From ETG, HRU Technical Resources, Kelly Temporary Services, Randstad Technologies (Formerly Technisource), STL Commercial Staffing (Formerly Firstaff), and MPW Industrial Services; Normal, Illinois; Amended Certification Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
81 FR 22298 - Endangered and Threatened Wildlife and Plants; Receipt of Application for Incidental Take Permit; Availability of Proposed Low-Effect Habitat Conservation Plan and Associated Documents; Indian River County, FLPDF
81 FR 22302 - Endangered Species; Recovery Permit ApplicationsPDF
81 FR 22246 - Agency Information Collection Activities; Comment Request; International Computer and Information Literacy Study (ICILS 2018) Field Test and Recruitment for Main StudyPDF
81 FR 22363 - Meeting of the Regional Energy Resource CouncilPDF
81 FR 22208 - Central Idaho Resource Advisory CommitteePDF
81 FR 22185 - Hizballah Financial Sanctions RegulationsPDF
81 FR 22315 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Federal Firearms Licensee (FFL) Enrollment/National Instant Criminal Background Check System (NICS) E-Check Enrollment Form, Federal Firearms Licensee (FFL) Officer/Employee Acknowledgement of Responsibilities Under the NICS FormPDF
81 FR 22173 - Regulatory Capital Rules: Regulatory Capital, Final Revisions Applicable to Banking Organizations Subject to the Advanced Approaches Risk-Based Capital RulePDF
81 FR 22274 - Announcing the Award of a Single-Source Program Expansion Supplement Grant to the National Resources Center on Domestic Violence, Inc. (NRCDV) in Harrisburg, PAPDF
81 FR 22275 - Proposed Information Collection Activity; Comment RequestPDF
81 FR 22215 - New England Fishery Management Council; Public MeetingPDF
81 FR 22314 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection Reporting and Recordkeeping for Digital CertificatesPDF
81 FR 22316 - Agency Information Collection Activities; Proposed eCollection, eComments Requested;PDF
81 FR 22365 - Guidelines for the Safe Deployment and Operation of Automated Vehicle Safety TechnologiesPDF
81 FR 22240 - Privacy Act of 1974; System of RecordsPDF
81 FR 22322 - Product Change-Priority Mail Express and Priority Mail Negotiated Service AgreementPDF
81 FR 22322 - Product Change-First-Class Package Service Negotiated Service AgreementPDF
81 FR 22369 - Pricing for the 2016 Mercury Dime, Standing Liberty Quarter, and Walking Liberty Half-Dollar Centennial Gold CoinsPDF
81 FR 22370 - Notice of Open Public HearingPDF
81 FR 22309 - Notice of Temporary Concession Contract for the Operation of Lodging, Food and Beverage and Retail Services in Oregon Caves National Mounument and PreservePDF
81 FR 22308 - Notice of Availability Mining Plan of Operations for Claims Within Wrangell-St. Elias National Park and Preserve, AlaskaPDF
81 FR 22309 - Notice of Availability for Public Review of Mining Plan of Operations for Claims Within Wrangell-St. Elias National Park and Preserve, AlaskaPDF
81 FR 22307 - National Register of Historic Places; Notification of Pending Nominations and Related ActionsPDF
81 FR 22309 - National Register of Historic Places; Notification of Pending Nominations and Related ActionsPDF
81 FR 22308 - National Register of Historic Places; Notification of Pending Nominations and Related ActionsPDF
81 FR 22232 - Notice Requesting Nominations for the Advisory Committee on Commercial Remote Sensing (ACCRES)PDF
81 FR 22276 - Determination of Regulatory Review Period for Purposes of Patent Extension; CYRAMZAPDF
81 FR 22285 - Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and ChildrenPDF
81 FR 22194 - Drawbridge Operation Regulation; Delaware River, Delair, NJ to Philadelphia, PAPDF
81 FR 22283 - Xanodyne Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 8 New Drug Applications and 46 Abbreviated New Drug Applications for Propoxyphene Products; CorrectionPDF
81 FR 22259 - Northern Indiana Public Service Company; Notice of Technical Conference and Public Meeting To Discuss Proposed Operational Changes at the Norway-Oakdale ProjectPDF
81 FR 22260 - Columbia Gas Transmission, LLC; Notice of Schedule for Environmental Review of the SM-80 MAOP Restoration ProjectPDF
81 FR 22258 - Combined Notice of Filings #1PDF
81 FR 22277 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals ProcessesPDF
81 FR 22174 - Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Guidance for Industry; AvailabilityPDF
81 FR 22281 - Data Integrity and Compliance With Current Good Manufacturing Practice; Draft Guidance for Industry; AvailabilityPDF
81 FR 22283 - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; AvailabilityPDF
81 FR 22279 - Pharmaceutical Distribution Supply Chain Pilot Projects; Request for InformationPDF
81 FR 22312 - Certain Network Devices, Related Software and Components Thereof (I); Commission's Determination To Review In-Part a Final Initial Determination Finding a Violation of Section 337; Request for Written SubmissionsPDF
81 FR 22271 - Statement of Organization, Functions, and Delegations of AuthorityPDF
81 FR 22248 - Meeting NoticePDF
81 FR 22266 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
81 FR 22265 - Information Collections Being Reviewed by the Federal Communications CommissionPDF
81 FR 22268 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 22265 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 22303 - Draft 2016-2020 Environmental Justice Strategic PlanPDF
81 FR 22320 - Applied Sciences Advisory Committee; Meeting CancellationPDF
81 FR 22289 - Proposed Collection; 60-Day Comment Request; NLM PEOPLE LOCATOR® SystemPDF
81 FR 22290 - Proposed Collection; 60-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study-Wave 4 of Data Collection (NIDA)PDF
81 FR 22274 - Announcement of the Award of a Single-Source Expansion Supplement Grant to National Safe Place Network in Louisville, KYPDF
81 FR 22268 - Privacy Act of 1974; Systems of RecordsPDF
81 FR 22208 - Secretary's Advisory Committee on Animal Health; MeetingPDF
81 FR 22310 - Hot-Rolled Steel Flat Products From Australia, Brazil, Japan, Korea, Netherlands, Turkey, and the United Kingdom; Scheduling of the Final Phase of Countervailing Duty and Antidumping Duty InvestigationsPDF
81 FR 22273 - Announcement of the Award of a Single-Source Expansion Supplement Grant to the Washington State Department of Social and Health Services in Lacey, WAPDF
81 FR 22323 - Self-Regulatory Organizations; Bats EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Non-Substantive Correction to Rule 11.27PDF
81 FR 22335 - Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Non-Substantive Correction to Rule 11.27PDF
81 FR 22333 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Partial Amendment No. 1 to Proposed Rule Change Relating to Proposed Rule Change To Adopt FINRA Capital Acquisition Broker RulesPDF
81 FR 22328 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend BOX Rule 100 (Definitions) Relating to ProfessionalsPDF
81 FR 22347 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 2 and Designation of a Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change To Amend FINRA Rule 4210 (Margin Requirements) To Establish Margin Requirements for the TBA Market, as Modified by Amendment Nos. 1 and 2PDF
81 FR 22344 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Nasdaq Rule 7039PDF
81 FR 22324 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Qualified Contingent Cross Rebates and Certain Floor Options Transaction ChargesPDF
81 FR 22337 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To List and Trade Shares of AdvisorShares Cornerstone Small Cap ETF Under NYSE Arca Equities Rule 8.600PDF
81 FR 22334 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule To Amend the Fees SchedulePDF
81 FR 22359 - Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Upland Pipeline in Williams, Mountrail, and Burke Counties, North Dakota and Conduct a Public Scoping MeetingPDF
81 FR 22278 - Antimicrobial Drugs Advisory Committee; Notice of MeetingPDF
81 FR 22242 - Privacy Act of 1974; System of RecordsPDF
81 FR 22237 - Request for Public Comment on a Commercial Availability Request Under the U.S.-Morocco Free Trade AgreementPDF
81 FR 22238 - Request for Public Comment on a Commercial Availability Request Under the U.S.-Morocco Free Trade AgreementPDF
81 FR 22236 - Request for Public Comment on a Commercial Availability Request Under the U.S.-Morocco Free Trade AgreementPDF
81 FR 22304 - Notice of Temporary Closures of Public Land in Washoe County, NevadaPDF
81 FR 22197 - Government Accountability Office, Administrative Practice and Procedure, Bid Protest Regulations, Government ContractsPDF
81 FR 22194 - Adequacy Status of Motor Vehicle Emissions Budgets in Submitted PM2.5PDF
81 FR 22204 - Limited Approval, Limited Disapproval of California 9+Air Plan Revisions, Eastern Kern Air Pollution Control DistrictPDF
81 FR 22299 - Availability of the Draft Midwest Wind Energy Multi-Species Habitat Conservation Plan and Draft Environmental Impact StatementPDF
81 FR 22212 - Glycine From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review; 2014-2015PDF
81 FR 22371 - Federal Property Suitable as Facilities To Assist the HomelessPDF

Issue

81 73 Friday, April 15, 2016 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Statements of Organization, Functions, and Delegations of Authority, 22271-22272 2016-08679 Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

See

Forest Service

See

National Institute of Food and Agriculture

Animal Animal and Plant Health Inspection Service PROPOSED RULES Importation of Fresh Apple and Pear Fruit into the Continental United States from Certain Countries in the European Union, 22203-22204 2016-08806 NOTICES Meetings: Secretary's Advisory Committee on Animal Health, 22208 2016-08651 Broadcasting Broadcasting Board of Governors NOTICES Meetings; Sunshine Act, 22209-22210 2016-08901 Census Bureau Census Bureau NOTICES Meetings: National Advisory Committee, Public Virtual Meeting; Correction, 22210 2016-08730 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22272-22273 2016-08784 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Phase II Evaluation Activities for Implementing a Next Generation Evaluation Agenda for the Chafee Foster Care Independence Program, 22275-22276 2016-08715 Awards of Single-Source Expansion Supplement Grants: National Resources Center on Domestic Violence, Inc. (NRCDV) in Harrisburg, PA, 22274 2016-08716 National Safe Place Network, Louisville, KY, 22274-22275 2016-08654 Washington State Department of Social and Health Services, Lacey, WA, 22273 2016-08649 Coast Guard Coast Guard RULES Drawbridge Operations: Delaware River, Delair, NJ to Philadelphia, PA, 22194 2016-08690 Special Local Regulations: Hebda Cup Rowing Regatta; Detroit River, Trenton Channel; Wyandotte, MI, 22192-22194 2016-08781 Commerce Commerce Department See

Census Bureau

See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

Patent and Trademark Office

Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 22239 2016-08739 Committee Implementation Committee for the Implementation of Textile Agreements NOTICES Requests for Comments: Commercial Availability Request under the U.S.-Morocco Free Trade Agreement, 22236-22239 2016-08632 2016-08633 2016-08635 Comptroller Comptroller of the Currency NOTICES Meetings: Mutual Savings Association Advisory Committee, 22368-22369 2016-08783 Consumer Product Consumer Product Safety Commission NOTICES Meetings; Sunshine Act, 22239 2016-08883 Defense Department Defense Department See

Navy Department

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22239-22240 2016-08752 Privacy Act; Systems of Records, 22240-22244 2016-08636 2016-08707
Defense Nuclear Defense Nuclear Facilities Safety Board NOTICES FY 2014 Service Contract Inventory Analysis/FY 2015 Service Contract Inventory, 22245 2016-08782 Drug Drug Enforcement Administration NOTICES Importers of Controlled Substances; Registrations: Mylan Technologies, Inc., 22314 2016-08846 Education Department Education Department PROPOSED RULES Improving Basic Programs Operated by Local Educational Agencies; Negotiated Rulemaking Committee Meetings, 22204 2016-08795 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: EZ-Audit -- Electronic Submission of Financial Statements and Compliance Audits, 22247-22248 2016-08734 Fiscal Operations Report for 2014-2015 and Application to Participate 2016-2017 and Reallocation Form, 22245-22246 2016-08735 International Computer and Information Literacy Study Field Test and Recruitment for Main Study, 22246-22247 2016-08723 Meetings: President's Advisory Commission on Educational Excellence for African Americans, 22246 2016-08811 Election Election Assistance Commission NOTICES Meetings: Board of Advisors, 22248 2016-08677 Employment and Training Employment and Training Administration NOTICES Funding Availability: Pathways to Justice Careers for Youth, 22318 2016-08745 Women in Apprenticeship and Nontraditional Occupations Technical Assistance Grants, 22317-22318 2016-08744 Worker Adjustment Assistance; Amended Certifications: Mitsubishi Motors North America, Inc., Normal, IL, 22317 2016-08728 Energy Department Energy Department See

Energy Efficiency and Renewable Energy Office

See

Federal Energy Regulatory Commission

NOTICES Charter Renewals: Environmental Management Site-Specific Advisory Board, 22249 2016-08755 Meetings: Environmental Management Site-Specific Advisory Board, Oak Ridge Reservation, 22248-22249 2016-08759 Environmental Management Site-Specific Advisory Board, Portsmouth, 22249 2016-08757
Energy Efficiency Energy Efficiency and Renewable Energy Office NOTICES Petitions for Waivers: Cleaver-Brooks; Packaged Boiler Test Procedure, 22252-22255 2016-08750 Superior Boiler Works, Inc.; Commercial Packaged Boiler Test Procedure, 22249-22252 2016-08738 York-Shipley Global, Division of AESYS Technologies, LLC; Commercial Packaged Boiler Test Procedure, 22255-22258 2016-08749 Environmental Protection Environmental Protection Agency RULES Adequacy Status of Motor Vehicle Emissions Budgets: California; San Joaquin Valley; Submitted PM2.5 Moderate Area Plan, 22194-22196 2016-08510 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; Eastern Kern Air Pollution Control District, 22204-22207 2016-08508 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22261-22262 2016-08830 Change in Public Notice Procedures for EPA Region 5's Proposed Establishment of TMDLs and Proposed Impaired Waters Listings under Section 303(d) of the Clean Water Act, 22263-22264 2016-08828 Environmental Impact Statements; Availability, etc.; Weekly Receipts, 22263 2016-08786 Meetings: Pesticide Program Dialogue Committee, 22260-22261 2016-08788 Performance Partnership Grants, 22262-22263 2016-08798 Requests for Nominations: National Environmental Education Advisory Council, 22264-22265 2016-08799 Federal Aviation Federal Aviation Administration NOTICES Airport Improvement Program: Primary, Cargo, and Nonprimary Entitlement Funds Available to Date for Fiscal Year 2016, 22363-22364 2016-08766 Environmental Assessments; Availability, etc.: Kodiak Launch Complex Launch Pad 3, Kodiak Island, AK, 22364-22365 2016-08746 Requests to Release Airport Property, 22364 2016-08768 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22265-22268 2016-08672 2016-08673 2016-08674 2016-08675 Federal Deposit Federal Deposit Insurance Corporation RULES Regulatory Capital Rules: Regulatory Capital, Final Revisions Applicable to Banking Organizations Subject to the Advanced Approaches Risk-Based Capital Rule; Correction, 22173-22174 2016-08717 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 22258-22259 2016-08686 Environmental Assessments; Availability, etc.: Columbia Gas Transmission, LLC; SM-80 MAOP Restoration Project, 22260 2016-08687 Meetings: Northern Indiana Public Service Co.; Norway-Oakdale Project Proposed Operational Changes, 22259 2016-08688 Federal Housing Finance Agency Federal Housing Finance Agency NOTICES Privacy Act; Systems of Records, 22268-22271 2016-08652 Federal Motor Federal Motor Carrier Safety Administration NOTICES Meetings; Sunshine Act, 22365 2016-08865 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Species: Applications for Incidental Take Permit; Proposed Low-Effect Habitat Conservation Plan and Associated Documents; Indian River County, FL, 22298-22299 2016-08727 Endangered Species; Recovery Permit Applications, 22302-22303 2016-08725 Environmental Impact Statements; Availability, etc.: Draft Midwest Wind Energy Multi-Species Habitat Conservation Plan Availability, 22299-22302 2016-08449 Meetings: Aquatic Nuisance Species Task Force, 22299 2016-08733 Food and Drug Food and Drug Administration RULES Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid, 22176-22183 2016-08792 Guidance for Industry: Exempt Infant Formula Production -- Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports, 22174-22175 2016-08684 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Center for Devices and Radiological Health Appeals Processes, 22277-22278 2016-08685 Determination of Regulatory Review Periods: CYRAMZA, 22276-22277 2016-08692 Guidance for Industry: Data Integrity and Compliance With Current Good Manufacturing Practice, 22281-22283 2016-08683 Product-Specific Bioequivalence Recommendations, 22283-22285 2016-08682 Meetings: Antimicrobial Drugs Advisory Committee, 22278-22279 2016-08637 Circulatory System Devices Panel of the Medical Devices Advisory Committee, 22280-22281 2016-08737 New Drug Applications: Xanodyne Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 8 New Drug Applications and 46 Abbreviated New Drug Applications for Propoxyphene Products, 22283 2016-08689 Pharmaceutical Distribution Supply Chain Pilot Projects, 22279-22280 2016-08681 Foreign Assets Foreign Assets Control Office RULES Hizballah Financial Sanctions Regulations, 22185-22192 2016-08720 Foreign Trade Foreign-Trade Zones Board NOTICES Applications for Reorganization and Expansion under Alternative Site Framework: Foreign-Trade Zone 172, Oneida County, NY, 22210-22211 2016-08791 Proposed Production Activities: Flemish Master Weavers (Area Rugs), Foreign-Trade Zone 186, Waterville, ME, 22210 2016-08794 Forest Forest Service NOTICES Meetings: Central Idaho Resource Advisory Committee, 22208-22209 2016-08721 General Services General Services Administration NOTICES Meetings: World War One Centennial Commission, 22271 2016-08772 Government Accountability Government Accountability Office PROPOSED RULES Bid Protests: Government Contracts, 22197-22203 2016-08622 Health and Human Health and Human Services Department See

Agency for Healthcare Research and Quality

See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

Health Resources Health Resources and Services Administration NOTICES Requests for Nominations: Advisory Committee on Heritable Disorders in Newborns and Children, 22285-22286 2016-08691 Homeland Homeland Security Department See

Coast Guard

Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certified Housing Counselor Registration, 22297-22298 2016-08777 Federal Property Suitable as Facilities to Assist the Homeless, 22372-22501 2016-08117 Privacy Act; Systems of Records, 22292-22296 2016-08774 2016-08775 Section 8 Housing Assistance Payments Program: Fiscal Year 2016 Inflation Factors for Public Housing Agency Renewal Funding, 22296-22297 2016-08780 Indian Affairs Indian Affairs Bureau RULES Title Evidence for Trust Land Acquisitions, 22183-22184 2016-08776 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Land Management Bureau

See

National Park Service

NOTICES Draft 2016-2020 Environmental Justice Strategic Plan, 22303-22304 2016-08671
International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Glycine from the People's Republic of China, 22212-22213 2016-08229 Silicomanganese from Ukraine, 22211-22212 2016-08787 Applications for Memberships: U.S. Travel And Tourism Advisory Board, 22213-22214 2016-08789 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Hot-Rolled Steel Flat Products from Australia, Brazil, Japan, Korea, Netherlands, Turkey, and the United Kingdom, 22310-22312 2016-08650 Investigations; Determinations, Modifications and Rulings, etc.: Certain Network Devices, Related Software and Components Thereof (I), 22312-22314 2016-08680 Justice Department Justice Department See

Drug Enforcement Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Firearms Licensee Enrollment/National Instant Criminal Background Check System E-Check Enrollment Form, Federal Firearms Licensee Officer/Employee Acknowledgement of Responsibilities under the NICS Form, 22315-22316 2016-08719 Report of Mail Order Transactions, 22316-22317 2016-08711 Reporting and Recordkeeping for Digital Certificates, 22314-22315 2016-08712
Labor Department Labor Department See

Employment and Training Administration

See

Occupational Safety and Health Administration

Land Land Management Bureau NOTICES Environmental Impact Statements; Availability, etc.: Western Oregon, 22305-22307 2016-08740 Plats of Survey: Idaho, 22304 2016-08731 Temporary Closures of Public Lands: Washoe County, NV, 22304 2016-08625 NASA National Aeronautics and Space Administration NOTICES Meetings: Applied Sciences Advisory Committee, 22320-22321 2016-08669 National Highway National Highway Traffic Safety Administration NOTICES Meetings: Guidelines for the Safe Deployment and Operation of Automated Vehicle Safety Technologies, 22365-22367 2016-08708 Requests for Information, 22367-22368 2016-08831 National Institute Food National Institute of Food and Agriculture NOTICES Requests for Applications: Veterinary Medicine Loan Repayment Program, 22209 2016-08764 National Institute National Institutes of Health NOTICES Actions under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, 22286-22289 2016-08810 Agency Information Collection Activities; Proposals, Submissions, and Approvals: NLM PEOPLE LOCATOR System, 22289-22290 2016-08659 Population Assessment of Tobacco and Health Study Wave 4 of Data Collection, 22290-22291 2016-08658 National Oceanic National Oceanic and Atmospheric Administration NOTICES Meetings: Fisheries of the South Atlantic, Gulf of Mexico, and Caribbean; Southeast Data, Assessment, and Review, 22232-22233 2016-08743 Fisheries of the South Atlantic; South Atlantic Fishery Management Council and Mid-Atlantic Fishery Management Council, 22214-22215 2016-08779 Gulf of Mexico Fishery Management Council, 22233 2016-08742 New England Fishery Management Council, 22215 2016-08714 Public Hearings: Gulf of Mexico Fishery Management Council, 22215-22216 2016-08778 Requests for Nominations: Advisory Committee on Commercial Remote Sensing, 22232 2016-08693 Takes of Marine Mammals: Installation of the Block Island Wind Farm Export and Inter-Array Cables, 22216-22232 2016-08729 National Park National Park Service NOTICES Availabilities: Public Review of Mining Plan of Operations for Claims within Wrangell-St. Elias National Park and Preserve, Alaska, 22309 2016-08697 Mining Plan of Operations for Claims within Wrangell-St. Elias National Park and Preserve, AK, 22308-22309 2016-08698 National Register of Historic Places: Notification of Pending Nominations and Related Actions, 22307-22310 2016-08694 2016-08695 2016-08696 Temporary Concession Contract for the Operation of Lodging, Food and Beverage and Retail Services in Oregon Caves National Mounument and Preserve, 22309 2016-08700 Navy Navy Department NOTICES Availability of Invention for Licensing; Government-Owned Inventions, 22244-22245 2016-08736 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Request for Access Authorization, 22321-22322 2016-08763 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Expansion of Recognition: TUV SUD America Inc., 22319-22320 2016-08761 Meetings: Maritime Advisory Committee for Occupational Safety and Health, 22318-22319 2016-08762 Patent Patent and Trademark Office NOTICES Application of the Written Description Requirement to Specific Situations in Design Applications, 22233-22236 2016-08760 Pension Benefit Pension Benefit Guaranty Corporation RULES Benefits Payable in Terminated Single-Employer Plans: Interest Assumptions for Paying Benefits, 22184-22185 2016-08773 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 22322 2016-08748 Postal Service Postal Service NOTICES Product Changes: First-Class Package Service Negotiated Service Agreement, 22322 2016-08704 Priority Mail Express and Priority Mail Negotiated Service Agreement, 22322-22323 2016-08705 Presidential Documents Presidential Documents PROCLAMATIONS Belmont-Paul Women's Equality National Monument; Establishment (Proc. 9423), 22503-22509 2016-08970 Railroad Retirement Railroad Retirement Board NOTICES Meetings; Sunshine Act, 22323 2016-08850 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Bats EDGA Exchange, Inc., 22323-22324 2016-08648 Bats EDGX Exchange, Inc., 22335-22337 2016-08647 BOX Options Exchange, LLC, 22328-22333 2016-08645 Chicago Board Options Exchange, Inc., 22334-22335 2016-08640 Financial Industry Regulatory Authority, Inc., 22333-22334, 22347-22359 2016-08644 2016-08646 NASDAQ PHLX, LLC, 22324-22328 2016-08642 NYSE Arca, Inc., 22337-22344 2016-08641 The NASDAQ Stock Market, LLC, 22344-22347 2016-08643 State Department State Department NOTICES Culturally Significant Objects Imported for Exhibition: Dadaglobe Reconstructed, 22361 2016-08771 Emperors' Treasures -- Chinese Art from the National Palace Museum, Taipei, 22359 2016-08767 Slavery and Freedom, 22361 2016-08769 Environmental Impact Statements; Availability, etc.: Proposed Upland Pipeline in Williams, Mountrail, and Burke Counties, ND, 22359-22360 2016-08638 Surface Transportation Surface Transportation Board NOTICES Feeder Line Applications: KCVN, LLC and Colorado Pacific Railroad, LLC: Line of V and S Railway, LLC, Located in Crowley, Pueblo, Otero, and Kiowa Counties, CO, 22361-22363 2016-08785 Tennessee Tennessee Valley Authority NOTICES Meetings: Regional Energy Resource Council, 22363 2016-08722 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Foreign Assets Control Office

See

United States Mint

U.S. China U.S.-China Economic and Security Review Commission NOTICES Meetings: U.S.-China Economic and Security Review Commission, 22370 2016-08701 U.S. Mint United States Mint NOTICES Pricing for the 2016 Mercury Dime, Standing Liberty Quarter, and Walking Liberty Half-Dollar Centennial Gold Coins, 22369 2016-08702 Separate Parts In This Issue Part II Housing and Urban Development Department, 22372-22501 2016-08117 Part III Presidential Documents, 22503-22509 2016-08970 Reader Aids

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

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

81 73 Friday, April 15, 2016 Rules and Regulations FEDERAL DEPOSIT INSURANCE CORPORATION 12 CFR Part 324 RIN 3064-AE12 Regulatory Capital Rules: Regulatory Capital, Final Revisions Applicable to Banking Organizations Subject to the Advanced Approaches Risk-Based Capital Rule AGENCY:

Federal Deposit Insurance Corporation (FDIC).

ACTION:

Correcting amendment.

SUMMARY:

The FDIC is correcting a Final Rule that appeared in the Federal Register on July 15, 2015 (80 FR 41409), regarding Regulatory Capital Rules: Regulatory Capital, Final Revisions Applicable to Banking Organizations Subject to the Advanced Approaches Risk-Based Capital Rule (“prior Federal Register publication”). This publication corrects a technical error in the instructions to the regulatory text appearing at page 41426 of the prior Federal Register publication, where the inadvertent omission of certain language in the instructions to the FDIC's amendatory text in § 324.403 caused the unintended deletion of § 324.403(b)(2) through § 324.403(d) as published in the Code of Federal Regulations.

DATES:

The correction is effective April 15, 2016.

FOR FURTHER INFORMATION CONTACT:

Ryan Billingsley, Acting Associate Director, [email protected]; or Benedetto Bosco, Chief, Capital Policy Section, [email protected]; Capital Markets Branch, Division of Risk Management Supervision, (202) 898-6888; or Michael Phillips, Counsel, [email protected]; Rachel Ackmann, Counsel, [email protected]; Supervision Branch, Legal Division, Federal Deposit Insurance Corporation, 550 17th Street NW., Washington, DC 20429.

SUPPLEMENTARY INFORMATION:

This document sets out in full the text of section 324.403 as adopted by the FDIC Board of Directors, including the revisions published in the Federal Register of July 15, 2015 (80 FR 41426) and the text inadvertently deleted in the Code of Federal Regulations as 12 CFR 324.403.

List of Subjects in 12 CFR Part 324

Administrative practice and procedure, Banks, Banking, Capital adequacy, Reporting and recordkeeping requirements, Savings associations, State non-member banks.

12 CFR CHAPTER III Authority and Issuance

For the reasons stated in the preamble, the Federal Deposit Insurance Corporation amends part 324 of chapter III of Title 12, Code of Federal Regulations as follows:

PART 324—CAPITAL ADEQUACY 1. The authority citation for part 324 continues to read as follows: Authority:

12 U.S.C. 1815(a), 1815(b), 1816, 1818(a), 1818(b), 1818(c), 1818(t), 1819(Tenth), 1828(c), 1828(d), 1828(i), 1828(n), 1828(o), 1831o, 1835, 3907, 3909, 4808; 5371; 5412; Pub. L. 102-233, 105 Stat. 1761, 1789, 1790 (12 U.S.C. 1831n note); Pub. L. 102-242, 105 Stat. 2236, 2355, as amended by Pub. L. 103-325, 108 Stat. 2160, 2233 (12 U.S.C. 1828 note); Pub. L. 102-242, 105 Stat. 2236, 2386, as amended by Pub. L. 102-550, 106 Stat. 3672, 4089 (12 U.S.C. 1828 note); Pub. L. 111-203, 124 Stat. 1376, 1887 (15 U.S.C. 78o-7 note).

2. Section 324.403 is revised to read as follows:
§ 324.403 Capital measures and capital category definitions.

(a) Capital measures. For purposes of section 38 of the FDI Act and this subpart H, the relevant capital measures shall be:

(1) The total risk-based capital ratio;

(2) The Tier 1 risk-based capital ratio; and

(3) The common equity tier 1 ratio;

(4) The leverage ratio;

(5) The tangible equity to total assets ratio; and

(6) Beginning January 1, 2018, the supplementary leverage ratio calculated in accordance with § 324.11 for advanced approaches FDIC-supervised institutions that are subject to subpart E of this part.

(b) Capital categories. For purposes of section 38 of the FDI Act and this subpart, an FDIC-supervised institution shall be deemed to be:

(1) “Well capitalized” if it:

(i) Has a total risk-based capital ratio of 10.0 percent or greater; and

(ii) Has a Tier 1 risk-based capital ratio of 8.0 percent or greater; and

(iii) Has a common equity tier 1 capital ratio of 6.5 percent or greater; and

(iv) Has a leverage ratio of 5.0 percent or greater;

(v) Is not subject to any written agreement, order, capital directive, or prompt corrective action directive issued by the FDIC pursuant to section 8 of the FDI Act (12 U.S.C. 1818), the International Lending Supervision Act of 1983 (12 U.S.C. 3907), or the Home Owners' Loan Act (12 U.S.C. 1464(t)(6)(A)(ii)), or section 38 of the FDI Act (12 U.S.C. 1831o), or any regulation thereunder, to meet and maintain a specific capital level for any capital measure; and

(vi) Beginning on January 1, 2018 and thereafter, an FDIC-supervised institution that is a subsidiary of a covered BHC will be deemed to be well capitalized if the FDIC-supervised institution satisfies paragraphs (b)(1)(i) through (v) of this section and has a supplementary leverage ratio of 6.0 percent or greater. For purposes of this paragraph, a covered BHC means a U.S. top-tier bank holding company with more than $700 billion in total assets as reported on the company's most recent Consolidated Financial Statement for Bank Holding Companies (FR Y-9C) or more than $10 trillion in assets under custody as reported on the company's most recent Banking Organization Systemic Risk Report (FR Y-15).

(2) “Adequately capitalized” if it:

(i) Has a total risk-based capital ratio of 8.0 percent or greater; and

(ii) Has a Tier 1 risk-based capital ratio of 6.0 percent or greater; and

(iii) Has a common equity tier 1 capital ratio of 4.5 percent or greater; and

(iv) Has a leverage ratio of 4.0 percent or greater; and

(v) Does not meet the definition of a well capitalized bank.

(vi) Beginning January 1, 2018, an advanced approaches FDIC-supervised institution will be deemed to be “adequately capitalized” if it satisfies paragraphs (b)(2)(i) through (v) of this section and has a supplementary leverage ratio of 3.0 percent or greater, as calculated in accordance with § 324.11 of subpart B of this part.

(3) “Undercapitalized” if it:

(i) Has a total risk-based capital ratio that is less than 8.0 percent; or

(ii) Has a Tier 1 risk-based capital ratio that is less than 6.0 percent; or

(iii) Has a common equity tier 1 capital ratio that is less than 4.5 percent; or

(iv) Has a leverage ratio that is less than 4.0 percent.

(v) Beginning January 1, 2018, an advanced approaches FDIC-supervised institution will be deemed to be “undercapitalized” if it has a supplementary leverage ratio of less than 3.0 percent, as calculated in accordance with § 324.11.

(4) “Significantly undercapitalized” if it has:

(i) A total risk-based capital ratio that is less than 6.0 percent; or

(ii) A Tier 1 risk-based capital ratio that is less than 4.0 percent; or

(iii) A common equity tier 1 capital ratio that is less than 3.0 percent; or

(iv) A leverage ratio that is less than 3.0 percent.

(5) “Critically undercapitalized” if the insured depository institution has a ratio of tangible equity to total assets that is equal to or less than 2.0 percent.

(c) Capital categories for insured branches of foreign banks. For purposes of the provisions of section 38 of the FDI Act and this subpart H, an insured branch of a foreign bank shall be deemed to be:

(1) “Well capitalized” if the insured branch:

(i) Maintains the pledge of assets required under § 347.209 of this chapter; and

(ii) Maintains the eligible assets prescribed under § 347.210 of this chapter at 108 percent or more of the preceding quarter's average book value of the insured branch's third-party liabilities; and

(iii) Has not received written notification from:

(A) The OCC to increase its capital equivalency deposit pursuant to 12 CFR 28.15, or to comply with asset maintenance requirements pursuant to 12 CFR 28.20; or

(B) The FDIC to pledge additional assets pursuant to § 347.209 of this chapter or to maintain a higher ratio of eligible assets pursuant to § 347.210 of this chapter.

(2) “Adequately capitalized” if the insured branch:

(i) Maintains the pledge of assets required under § 347.209 of this chapter; and

(ii) Maintains the eligible assets prescribed under § 347.210 of this chapter at 106 percent or more of the preceding quarter's average book value of the insured branch's third-party liabilities; and

(iii) Does not meet the definition of a well capitalized insured branch.

(3) “Undercapitalized” if the insured branch:

(i) Fails to maintain the pledge of assets required under § 347.209 of this chapter; or

(ii) Fails to maintain the eligible assets prescribed under § 347.210 of this chapter at 106 percent or more of the preceding quarter's average book value of the insured branch's third-party liabilities.

(4) “Significantly undercapitalized” if it fails to maintain the eligible assets prescribed under § 347.210 of this chapter at 104 percent or more of the preceding quarter's average book value of the insured branch's third-party liabilities.

(5) “Critically undercapitalized” if it fails to maintain the eligible assets prescribed under § 347.210 of this chapter at 102 percent or more of the preceding quarter's average book value of the insured branch's third-party liabilities.

(d) Reclassifications based on supervisory criteria other than capital. The FDIC may reclassify a well capitalized FDIC-supervised institution as adequately capitalized and may require an adequately capitalized FDIC-supervised institution or an undercapitalized FDIC-supervised institution to comply with certain mandatory or discretionary supervisory actions as if the FDIC-supervised institution were in the next lower capital category (except that the FDIC may not reclassify a significantly undercapitalized FDIC-supervised institution as critically undercapitalized) (each of these actions are hereinafter referred to generally as “reclassifications”) in the following circumstances:

(1) Unsafe or unsound condition. The FDIC has determined, after notice and opportunity for hearing pursuant to § 308.202(a) of this chapter, that the FDIC-supervised institution is in unsafe or unsound condition; or

(2) Unsafe or unsound practice. The FDIC has determined, after notice and opportunity for hearing pursuant to § 308.202(a) of this chapter, that, in the most recent examination of the FDIC-supervised institution, the FDIC-supervised institution received and has not corrected a less-than-satisfactory rating for any of the categories of asset quality, management, earnings, or liquidity.

Dated at Washington, DC, this 12th day of April, 2016.

By order of the Board of Directors.

Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
[FR Doc. 2016-08717 Filed 4-14-16; 8:45 am] BILLING CODE 6714-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 106 [Docket No. FDA-2014-D-0044] Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Guidance for Industry; Availability AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of availability.

SUMMARY:

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled “Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.” The guidance describes our current thinking on the manufacturing of exempt infant formula in relation to the requirements for CGMPs, quality control procedures, conduct of audits, and records and reports that apply to non-exempt infant formulas.

DATES:

Submit either electronic or written comments on FDA guidances at any time.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2014-D-0044 for the “Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Submit written requests for single copies of the guidance to the Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:

Carrie L. Assar, Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1453.

SUPPLEMENTARY INFORMATION: I. Background

We are announcing the availability of a guidance for industry entitled “Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.” Section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350a(h)(1)) exempts an infant formula that is represented and labeled for use by an infant with an inborn error of metabolism, low birth weight, or who otherwise has an unusual medical or dietary problem from the requirements of sections 412(a), (b), and (c) of the FD&C Act. These formulas are customarily referred to as “exempt infant formulas.” The guidance is intended to describe the significance of the regulations in 21 CFR part 106 for the production of exempt infant formulas. A final rule amending part 106 was published in the Federal Register on June 10, 2014 (79 FR 33057).

In the Federal Register of February 10, 2014 (79 FR 7610), we made available a draft guidance entitled “Draft Guidance for Industry; Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports” and gave interested parties an opportunity to submit comments by May 12, 2014, for us to consider before beginning work on the final version of the guidance. We received one comment on the draft guidance, but the comment pertained to infant formula ingredients and not to the guidance itself. Consequently, we did not modify the guidance in response to the comment. However, we have modified the final guidance where appropriate to refer to the final rule that was published in the Federal Register on June 10, 2014. The guidance announced in this notice finalizes the draft guidance dated February 2014.

We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 106 have been approved under OMB control number 0910-0811.

III. Electronic Access

Persons with access to the Internet may obtain the guidance at http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.

Dated: April 8, 2016. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2016-08684 Filed 4-14-16; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 172 [Docket No. FDA-2012-F-0480] Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of folic acid in corn masa flour. We are taking this action in response to a food additive petition filed jointly by Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza.

DATES:

This rule is effective April 15, 2016. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 16, 2016. The Director of the Federal Register approves the incorporation by reference of certain publications listed in the rule as of April 15, 2016.

ADDRESSES:

You may submit objections and requests for a hearing as follows:

Electronic Submissions

Submit electronic objections in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection 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 objection, that information will be posted on http://www.regulations.gov.

• If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection 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 objections submitted to the Division of Dockets Management, FDA will post your objection, 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-2012-F-0480 for “Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid.” Received objections 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 an objection with confidential information that you do not wish to be made publicly available, submit your objections 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:

Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1071.

SUPPLEMENTARY INFORMATION:

I. Background

In a document published in the Federal Register on June 13, 2012 (77 FR 35317), we announced that Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza (the petitioners), c/o Alston & Bird, LLP, 950 F Street NW., Washington, DC 20004-1404, had jointly filed a food additive petition (FAP 2A4796). Subsequently, the March of Dimes Foundation informed us that Alston & Bird, LLP, was no longer representing the petitioners and that the March of Dimes Foundation would be the main contact for the petition. The address of the March of Dimes Foundation is 1401 K. St. NW., Suite 900A, Washington, DC 20005. The March of Dimes Foundation also informed us that Royal DSM N.V. no longer was affiliated with this petition. The petition proposed that we amend the food additive regulations in § 172.345 Folic acid (folacin) (21 CFR 172.345) to provide for the addition of folic acid to corn masa flour (CMF) at levels not to exceed 0.7 milligrams (mg) per pound (lb) (154 micrograms (μg) folic acid/100 grams (g) CMF). The petition requested this fortification to increase the folic acid intake for U.S. women of childbearing age who regularly consume products made from CMF as a staple in their diet, including, in particular, women of Latin American descent (for example, Mexican Americans), to help reduce the incidence of neural tube defects (NTDs), which are birth defects affecting the spine, brain, and spinal cord. This final rule is a complete response to the petition.

Folic acid is the synthetic form of folate, an important B vitamin essential to fetal development and other body functions. (Folate is the form of the vitamin found naturally in food.) It is well recognized that pregnant women with folate deficiency have a higher risk of giving birth to infants affected with NTDs, specifically spina bifida and anencephaly. To reduce the incidence of NTDs, the U.S. Public Health Service (PHS) and Centers for Disease Control and Prevention (CDC) recommend that all women of childbearing age consume 0.4 mg (400 μg) of folic acid daily, in addition to the consumption of naturally occurring folate from the diet. In response to this recommendation, FDA began a mandatory folic acid fortification program in 1998, requiring folic acid to be added to enriched cereal grains and cereal grain products that have a standard of identity under 21 CFR parts 136, 137, and 139 at levels ranging from 0.43 mg to 1.4 mg/lb of the finished product (61 FR 8781, March 5, 1996) (1996 final rule).

Fortification with folic acid was required for enriched cereal-grain products that already had standards of identity at the time the 1996 final rule went into effect on January 1, 1998. (Standards of identity are FDA regulations that define a given food product, its name, and ingredients that must be used, or may be used, in the manufacture of the food. They were created to maintain the integrity of food products and to ensure that foods meet buyers' expectations.) Many foods do not have standards of identity, including CMF. The amounts of folic acid required in enriched cereal-grain products (bread, rolls, and buns; wheat flours; corn meals; farina; rice; and macaroni and noodle products) were specifically chosen to increase daily folic acid consumption for women of childbearing age without consumers in the general population exceeding established safe levels. In addition to mandatory fortification of these foods, folic acid may voluntarily be added at specified levels in breakfast cereal, corn grits, meal replacement products, infant formula, foods for special dietary uses, and medical foods (§ 172.345).

To support the safety of the proposed uses of folic acid, the petitioners submitted dietary exposure estimates of folic acid from the proposed use in CMF, as well as all dietary sources from currently permitted uses of folic acid at levels reported in the U.S. Department of Agriculture's Food and Nutrient Database for Dietary Studies, which represents the most current database for nutrient composition in foods, including folic acid found in fortified foods. The petitioners included intake from dietary supplements reported in the National Health and Nutrition Examination Survey (NHANES) 2001-2008 datasets in their estimates. They reported exposure estimates at the median for several population groups stratified by gender, race/ethnicity, and age. The petitioners also reported estimates of the percentage of the different population groups whose intake estimates exceeded the Tolerable Upper Intake Levels (ULs) established by the Institute of Medicine (IOM) for folic acid. The IOM UL is the highest level of daily nutrient intake that is likely to pose no risk of adverse health effects to almost all individuals in the general population. Generally, the UL represents total intake from conventional food, water and dietary supplements.

Additionally, the petitioners included over 300 scientific literature reports on folic acid published through 2012. The majority of these references concern epidemiological studies that investigated associations between folate status or folic acid intake levels and health outcomes. The petitioners included some animal studies, most of which focused on the mechanisms of action of folic acid.

The petitioners also provided safety information from the 1998 IOM Dietary Reference Intake (DRI) report on folic acid (Ref. 1). In the 1998 report, the IOM established Recommended Dietary Allowances (RDA) for folate and ULs for folic acid. The petitioners also presented safety reviews and data evaluations on folic acid that were conducted by various national health agencies: United Kingdom (UK) Scientific Advisory Committee on Nutrition (Refs. 2 and 3); Food Standards Australia New Zealand (Refs. 4 and 5); Food Safety Authority Ireland (Refs. 6 and 7); and Health Council of the Netherlands (Refs. 8 and 9). These health agencies conducted thorough reviews of scientific papers, published through 2009, on the potential health outcomes of folic acid intake.

II. Evaluation of Safety

To establish with reasonable certainty that a food additive is not harmful under its intended conditions of use, we consider the projected human dietary exposure to the additive, toxicological data on the additive, and other relevant information (such as published literature) available to us. We compare an individual's estimated daily intake (EDI) of the additive from all food sources, including dietary supplements, to an acceptable intake level established by toxicological data. The EDI is determined by projections based on the amount of the additive proposed for use in particular foods and on data regarding the amount consumed from all food sources of the additive. We chose the 95th percentile of exposure as a conservative representation of habitual intake of folic acid by “high” consumers.

As part of our safety evaluation of folic acid fortification in CMF, we conducted an updated literature search for relevant scientific publications from 1998 through 2015. Results of our updated literature search confirmed that the petitioners adequately covered the available published relevant safety information on folic acid, and we found only a few additional relevant publications in our search.

A. Acceptable Daily Intake Level for Folic Acid

In the 1993 proposed rule (58 FR 53305, October 14, 1993) and the 1996 final rule for mandatory folic acid fortification in certain foods, we adopted a safe upper limit of 1 mg per day (d) of total folate intake for the general population. This decision was based on the recommendation of the PHS that all women of childbearing age consume 0.4 mg (400 μg) of folic acid daily to reduce the risk of NTDs. The PHS further reported that total folate and folic acid consumption should be maintained at levels under 1 mg/d because high folic acid intakes could mask the signs of pernicious anemia thereby complicating the diagnosis of vitamin B12 deficiency (Ref. 10).

In its 1998 safety assessment, the IOM concluded that, based on the weight of the limited but suggestive evidence, excessive folic acid intake may precipitate or exacerbate neuropathy in vitamin B12-deficient individuals and justifies the selection of this endpoint as the critical endpoint for the development of a UL (Ref. 1). In its dose-response analysis, the IOM evaluated case reports of patients with vitamin B12 deficiency who developed or demonstrated a progression of neurological complications and who had been treated with oral administrations of folic acid. The data from this analysis did not provide a no-observed-adverse-effect level. Instead, the IOM established a lowest-observed-adverse-effect level (LOAEL) at the 5 mg/d dose based on the number of reported cases of neurological deterioration at certain doses of folic acid.

An uncertainty factor of 5 was applied to the LOAEL, establishing a UL of 1 mg/d for adults 19 years and older. This UL was adjusted for children and adolescents on the basis of relative metabolic body weights and the resulting values were rounded down. For children 1 to 3 years of age, the IOM established a UL of 300 µg/p/d; for children 4 to 8 years of age, the IOM established a UL of 400 µg/p/d; for children 9 to 13 years of age, the IOM established a UL of 600 µg/p/d; for children 14 to 18 years of age; the IOM established a UL of 800 µg/p/d. The IOM determined that a UL for infants could not be established because of a lack of data on adverse effects in this age group and concerns about the infant's ability to handle excess amounts of folic acid (Ref. 1).

Folic acid intake of 1 mg/d is widely recognized by different international bodies as the safe or tolerable UL for adults. This UL has been used by different countries in the evaluation of their fortification policies, including Australia and New Zealand, the UK, Ireland, and the Netherlands. In a reevaluation in 2008, the European Food Safety Authority (EFSA) concluded that the evidence and dose-response information on other health endpoints were not sufficient to support establishing a different UL (Ref. 11). We reviewed available updated safety and epidemiological studies published after the publication of the 1998 IOM report and found no scientific concerns that would justify revision of the current IOM ULs (Ref. 12).

B. Estimated Daily Intake for Folic Acid

The petitioners provided dietary intake estimates for folic acid from the proposed use in CMF and from all current dietary sources, including dietary supplements. In calculating exposure to folic acid from foods, the petitioners used food consumption data from the NHANES 2001-2002 dataset, which is based on one 24-hour dietary recall survey, and from the NHANES 2003-2008 dataset, which is based on two 24-hour dietary recall surveys. We note that estimates of nutrient exposure based on a single day of consumption do not adequately account for within-person variation in intake and can lead to underestimation of population variance, thereby underestimating the exposure (Ref. 13).

In modeling folic acid exposure from fortified CMF, the petitioners identified 103 foods as containing CMF. The petitioners considered CMF as a non-whole grain and used a proxy of non-whole grains to estimate the amount of CMF in each identified food item based on the number of “ounce equivalents” of non-whole grains present in each food item. The petitioners' estimate indirectly determined the proportion of CMF present in a grain product; however, we typically use the weight (e.g., gram, milligram) percentage of CMF in each food item for dietary exposure assessments. Based on our review, we identified 118 foods currently available on the market that contain CMF as an ingredient. For these reasons, we conducted our own exposure estimate to folic acid for the overall U.S. population 1 year of age and older, excluding pregnant women, and various population subgroups stratified by age, gender, and race/ethnicity, and for various percentiles of intake.

Specifically, we calculated total dietary exposure estimates for folic acid that included exposure to folic acid from currently fortified foods, dietary supplements, and the proposed fortification in CMF. We used consumption data from the NHANES 2003-2008 database and a method for estimating usual dietary intakes of foods and nutrients developed by the National Cancer Institute (http://appliedresearch.cancer.gov/diet/usualintakes/method.html.). Naturally occurring food folate was not included in the total folic acid exposure estimates because the IOM ULs were established for synthetic folic acid only.

The NHANES survey has five race/ethnicity codes in its demographic data file. According to NHANES, this race/ethnicity variable was derived from responses to the survey questions on race and Hispanic origin. Respondents who self-identified as “Mexican American” were coded as such (Mexican American) regardless of their other race-ethnicity identities. For respondents who self-identified as “Hispanic” but not as “Mexican American” the race/ethnicity was categorized as “Other Hispanic.” Non-Hispanic respondents were categorized based on their self-reported races: Non-Hispanic White, non-Hispanic Black, and other non-Hispanic races including non-Hispanic multiracial (Ref. 14).

Using a statistical analysis software program (SAS®), we calculated exposure to folic acid from the proposed use in CMF by adding the daily exposure to folic acid from conventional foods to the average daily exposure of folic acid from dietary supplements. We used this software program to determine distributions of exposure (i.e., means, medians, percentiles) and the percentage of individuals with usual daily total folic acid whose exposure exceeded the UL (1,000 µg or other age-specific ULs). We estimated exposure for the same population subgroups for which the petitioners reported exposure in their submission in 8 age groups (1 to 3 years, 4 to 8 years, 9 to 13 years, 14 to 18 years, 19 to 30 years, 31 to 50 years, 51 to 70 years, and 71+ years), 2 gender groups (male and female), and 3 race/ethnicity subgroups (Non-Hispanic (NH) White, NH Black, and Mexican American).

We estimated exposure for two scenarios. The first estimate represented a background (current) cumulative exposure of folic acid that included currently permitted uses of folic acid in conventional foods and dietary supplement use. The second estimate represented a modeled cumulative exposure of folic acid that included currently permitted uses of folic acid in conventional food, dietary supplement use, and the proposed use in CMF and products made from CMF, such as tortillas and tortilla chips (modeled). For the second scenario, we assumed a fortification level of 140 µg folic acid/100 g CMF. This fortification level was chosen to account for the petitioners' estimates of loss of folic acid during processing and storage (Ref. 13). Exposure estimates at the 95th percentile represent “high” consumers of folic acid and provide a conservative estimate of exposure.

Table 1 summarizes our exposure estimates for the overall U.S. population for each of the scenarios at the median and 95th percentile of intake with the number of people represented in each age group in the NHANES survey indicated in the table:

Table 1—Estimated Cumulative Folic Acid Intake for the U.S. Population Age
  • (years)
  • NHANES
  • (n)
  • IOM UL
  • (µg/d)
  • Median intake
  • (µg/d)
  • Current Modeled 95th percentile intake
  • (µg/d)
  • Current Modeled
    All (1+ years) 22717 231 244 765 775 1-3 1911 300 156 160 493 504 4-8 2071 400 255 267 618 633 9-13 2608 600 240 257 622 628 14-18 3038 800 239 252 646 658 19-30 2608 1000 229 247 744 758 31-50 4118 1000 219 237 769 783 51-70 3861 1000 266 271 919 927 71+ 2302 1000 255 258 836 840

    The median intakes for all age groups are well below the respective ULs. For children (1 to 13 years of age), the current 95th percentile folic acid intake estimates exceed their respective age-corresponding IOM ULs. We estimate that the addition of folic acid in CMF at the proposed level would result in a small additional increase of up to 15 µg/d of folic acid intake for this population group. Our exposure estimates at the 95th percentile for the adult population 19 years of age and older and for children 14 to 18 years of age did not exceed the IOM UL for either exposure scenario.

    Results from our exposure assessment demonstrate that CMF fortification would result in a slight increase in total folic acid exposure among the U.S. population. Further, as shown in Table 2, the proposed CMF fortification would result in a greater proportional increase in the median usual total folic acid exposure among Mexican Americans than among the NH White and NH Black populations. The estimated current median usual total folic acid intake of Mexican Americans is lower than that of the NH White population. Intake estimates that include the proposed CMF fortification show a larger increase for the median usual total folic acid exposure of Mexican Americans compared to the other groups, but the median intake estimate for Mexican Americans remains lower than that of NH Whites.

    Table 2—Usual Total Folic Acid Intake Estimates for the U.S. Population by Race/Ethnicity Race/Ethnicity Exposure
  • (median/95th percentile)
  • Current
  • (µg/d)
  • Modeled
  • (µg/d)
  • All 231/765 244/775 Non-Hispanic White 253/820 261/834 Non-Hispanic Black 181/597 191/608 Mexican American 187/588 228/622

    In addition, for non-pregnant women of childbearing age (15 to 44 years), our exposure estimates show an increase in the median usual total folic acid intake of Mexican American women from 164 µg/d to 206 µg/d when intake from fortified CMF was included in the analysis. Our exposure estimates also show an increase in folic acid intake among NH White women (214 µg/d to 221 µg/d) and NH Black women (168 µg/d to 179 µg/d) from the petitioned use of folic acid in CMF (Ref. 13).

    Dietary Supplements

    Because the use of supplements containing folic acid is a contributing factor to total exposure, we calculated usual folic acid intake for supplement non-users (i.e., those who did not report consuming supplements containing folic acid in the NHANES Dietary Supplement Questionnaire) and supplement users (i.e., those who reported consuming supplements containing folic acid).

    As shown in Table 3, among dietary supplement users who consume CMF products, the 95th percentile total folic acid intake estimates for all age groups exceeded the respective age-corresponding ULs, except for the population 71 years of age and older.

    Table 3—Estimated Total Folic Acid Intake Among Corn Masa Consumers Who Are Dietary Supplement Users and Non-Users Dietary supplement usage Age
  • (years)
  • NHANES
  • (n)
  • IOM UL
  • (µg/d)
  • 95th percentile intake
  • (µg/d)
  • Current Modeled Amount of folic acid intake
  • exceeding the UL
  • (95th percentile minus UL)
  • (µg/d)
  • Current Modeled
    Users 1-3 362 300 552 575 252 275 4-8 626 400 774 811 374 411 9-13 444 600 699 724 99 124 14-18 361 800 998 1051 198 251 19-30 536 1000 1091 1135 91 135 31-50 1161 1000 1107 1130 107 130 51-70 1482 1000 1133 1148 133 148 71+ 947 1000 889 866 0 0 Non-users 1-3 655 300 259 287 0 0 4-8 830 400 357 388 0 0 9-13 1086 600 450 489 0 0 14-18 1239 800 457 510 0 0 19-30 862 1000 344 400 0 0 31-50 1122 1000 329 389 0 0 51-70 675 1000 312 354 0 0 71+ 258 1000 413 419 0 0

    For the 51 to 70 year age group, exposure at the 95th percentile was estimated to be 1133 µg/d, representing 113 µg/d more than the adult UL of 1 mg/d (1000 µg/d). CMF fortification would further increase the 95th percentile intake by 15 µg/d, resulting in an intake estimated to be 1148 µg/d, which is 148 µg/d more than the UL.

    In contrast, CMF consumers who are not dietary supplement users had considerably lower folic acid exposure estimates compared to the supplement users. The 95th percentile folic acid intakes for all dietary supplement non-user age groups did not exceed their respective age-corresponding IOM ULs. While the proposed folic acid CMF fortification will increase folic acid intakes in these individuals, their modeled 95th percentile folic acid intakes remain below their respective age-corresponding ULs.

    The population group of users of dietary supplements with the highest percentile exceeding the UL for folic acid was children 1 to 8 years of age. For this population, exposure estimates exceed the age-specific ULs whether consumption of fortified CMF was included in the estimate or not (Ref. 13). Children are more likely than adults to exceed their age-specific UL because of their higher consumption of food and drink on a body weight basis as compared to adults. Another reason is the lower UL values established for children. We note that the ULs for children were not based on adverse effects, but extrapolated from the adult UL.

    C. Safety of the Petitioned Uses of Folic Acid

    In our safety review, we considered several potential health effects of folic acid intake that the petitioners reported in their submission. Specifically, these health effects include:

    • Masking vitamin B12 deficiency;

    • Direct effects on vitamin B12 deficiency-related neurological complications and cognitive decline;

    • Cancer;

    • Effects of prenatal exposure on childhood health outcomes;

    • Hypersensitivity;

    • Reproductive effects; and

    • Folic acid-drug interaction.

    Of these health effects, our review found suggestive evidence for masking of vitamin B12 deficiency and exacerbation of vitamin B12 deficiency-related neurological complications and cognitive decline. The most at-risk population for both of these potential health effects is the population 50 years of age and older. For the other health effects, the overall evidence is unclear and could not be substantiated based on the available evidence (Ref. 12).

    1. Masking Effect of Folic Acid on Vitamin B12 Deficiency

    We reviewed data from clinical case reports from vitamin B12 deficient patients and found that masking cases were mostly associated with pharmacological doses of folic acid (greater than 5 mg/d). There was no information in the reports to identify the lowest level of folic acid associated with the masking effect. For populations with dietary exposure to folic acid, epidemiological studies have shown mixed results and study design limitations. In a recent study in which data from the NHANES 1991-1994 (pre-mandatory fortification in the United States) and 2001-2006 (post-mandatory fortification) surveys were compared, the prevalence of low vitamin B12 status in the absence of megaloblastic anemia or macrocytosis among adults 50 years of age and older did not increase after fortification (Ref. 15). The masking effect of folic acid has been reviewed by other regulatory authorities (Refs. 2 to 9). We agree with their conclusions that folic acid intake up to the UL of 1 mg/d is not likely to mask vitamin B12 deficiency. Additionally, current medical practice does not rely primarily on the hematological index to screen for vitamin B12 deficiency (Refs. 16 to 18). Currently, the recommended testing for vitamin B12 deficiency includes analyzing for serum levels of vitamin B12 and of the metabolites, methylmalonic acid and homocysteine. Based on our exposure estimates and the incremental increase in estimated exposure from the proposed use of folic acid in CMF, we conclude that the CMF fortification at the proposed level is not likely to increase the risk of masking vitamin B12 deficiency, and that the risk of the masking effect from current and proposed levels of dietary folic acid intake is low (Ref. 12).

    2. Direct Effects of Folic Acid on Vitamin B12 Deficiency-Related Neurological Complications and Cognitive Decline

    a. Accelerating or exacerbating neurological complications. In addition to the indirect masking effect of folic acid, there have been concerns that excess folic acid also may directly accelerate or exacerbate B12 deficiency-related neurological complications such as neuropathy. These endpoints were evaluated by IOM to determine the folic acid UL. In reviewing the historical clinical cases of neuropathy related to vitamin B12 deficiency, we noted that the rate of disease progression varied significantly among vitamin B12-deficient patients, regardless of folic acid treatment. Because of the limited number of recorded cases, the large variability among patients at clinical presentation, and no new evidence presented after the IOM evaluation, the evidence remains suggestive as IOM stated in 1998. A definitive conclusion cannot be determined in this review whether folic acid directly enhances or worsens B12 deficiency-related neuropathy.

    The potential neurological effects of high folic acid intake in children and women of childbearing age have not been thoroughly studied. However, because vitamin B12 deficiency is rare in these two populations in the United States (Ref. 19), the public health risk of this effect associated with increased exposure from folic acid fortification of CMF is likely to be insignificant.

    b. Cognitive decline among the population group ages 50 years and older. Acceleration of cognitive decline among individuals who are vitamin B12-deficient is a potential adverse health effect if undetected because of high folic acid intake. The most at-risk population for this adverse effect are consumers 50 years and older who have total folic acid intake higher than the UL. As described previously, people 50 years of age and older are unlikely to have total folic acid intake higher than the UL unless they use dietary supplements. According to an analysis in 2007, most multivitamins for seniors that contain folic acid also contain vitamin B12 (Ref. 20). Therefore, unless their vitamin B12 absorption is severely impaired due to certain diseases, individuals in this age group who have total folic acid higher than the UL are unlikely to have vitamin B12 deficiency, and thus are not at risk for this effect. Therefore, we conclude that cognitive health risks are not likely to be an issue for this sensitive population as a result of the petitioned use of folic acid in CMF (Ref. 12).

    3. Metabolic Fate of Folic Acid

    Folic acid is a water soluble vitamin that is quickly absorbed by the body. In humans, the bioavailability of folic acid is about 85 percent in fortified foods (Ref. 1). To be used as a methyl group donor, it must first be converted to dihydrofolate (DHF) and then tetrahydrofolate (THF) by the liver enzyme dihydrofolate reductase (DHFR). Evidence has shown that the activity of DHFR in humans is extremely low in comparison to that in rats; highly variable due to genetic polymorphism; and may become saturated when folic acid is consumed at levels higher than the 1 mg/d (Ref. 21). In addition, unlike DHF, folic acid is a poor substrate of DHFR, making the first step of metabolism rate-limiting (Ref. 22).

    Upon conversion, THF is distributed in all body tissues. Excretion is the main elimination route of folic acid. In response to normal intake from food, the majority of folate is effectively reabsorbed in the kidney proximal tubules and little or no folate is lost in the urine (Ref. 22). Following oral administration of single 0.1 mg to 0.2 mg doses of folic acid in healthy adults, only a trace amount appears in urine. However, after doses of about 2.5 mg to 5 mg folic acid, about 50 percent is excreted in urine as a result of exceeded renal capacity for reabsorption (Refs. 22 and 23). Therefore, a significant amount of folic acid can be excreted from urine when the renal capacity for reabsorption is saturated by high intake, eliminating excess folic acid (Refs. 22 and 24).

    4. Conclusions on the Potential Adverse Health Outcomes From High Intakes of Folic Acid

    There is some evidence linking two potential adverse health outcomes with high folic acid intake in adults: (1) Masking vitamin B12 deficiency and (2) accelerating or exacerbating neurological complications and cognitive decline among those who are vitamin B12 deficient.

    For both of these adverse health outcomes, the most at-risk population is individuals 50 years of age and older who have total folic acid intake higher than the UL. According to the results from our exposure assessment, these individuals primarily are dietary supplement users. The NHANES 1999-2002 data have established that, among the 60 years of age and older population in the United States, about 25 percent have low vitamin B12 status. Because about 10 to 30 percent of the population 50 years and older have decreased absorption of food-bound vitamin B12, the IOM DRI report recommends that individuals 50 years of age and older obtain most of their vitamin B12 RDA, (2.4 µg/d) from vitamin B12-fortified foods or supplements (Ref. 1). Since most multivitamins for seniors contain both folic acid and vitamin B12 (Ref. 20), their risk for vitamin B12 deficiency should be low, unless their vitamin B12 absorption is severely impaired due to certain diseases. In addition, because the currently recommended medical practice in the United States does not rely primarily on the hematological index to screen for vitamin B12 deficiency but rather serum B12 metabolites, the masking effect is less likely. Therefore, we conclude that these health risks (vitamin B12 masking and exacerbating neurological deterioration) are not likely to be an issue for this population as a result of the petitioned use of folic acid in CMF.

    For other potential health outcomes, such as promoting the progression of established neoplasms, childhood hypersensitivity and reproductive outcomes, the evidence is not clear but suggests further study. There may be other, as-yet unidentified potential adverse effects of high folic acid intake in children and further study is warranted. However, as previously discussed, allowing folic acid in CMF is only projected to result in a slight increase for children 1 to 13 years and 14 to 18 years of age at the 95th percentile of folic acid intake, such that there is only a marginal increase in exposure beyond the current intake levels for children.

    5. Safety and Risk Characterization for Folic Acid

    Based on the data reviewed in this safety and risk assessment on folic acid, there was no definitive association of adverse effects of folic acid at the noted levels of folic acid exposure. We do not consider that any of the intake estimates in excess of the UL in this evaluation would cause an adverse health impact on any of the population subgroups because of the following reasons:

    • The increase in exposure to folic acid for the studied populations from CMF fortification is small other than for Mexican Americans. For Mexican Americans, the increase in exposure is significantly larger but the resultant exposure levels are still below the levels for the general population.

    • The ULs were calculated using a five-fold uncertainty factor, which is approximately twice that used for other B vitamins, providing an additional margin of safety (Ref. 12).

    • The risk of masking vitamin B12 deficiency and related neurological complications from the estimated intake levels of folic acid is low because the most at-risk population to these health outcomes are individuals 50 years of age and older and most multivitamins for seniors that contain folic acid also contain vitamin B12. Additionally, current medical practice does not rely primarily on the hematological index to screen for vitamin B12 deficiency but rather serum testing for vitamin B12 and its metabolites, making the masking effect less likely.

    • The metabolic activation of folic acid by the enzyme DHFR is slow in humans and may be saturated at doses higher than 1 mg/d.

    • Unmetabolized folic acid (UMFA) has no known biological function as a methyl group donor in DNA synthesis and methylation. To become active, folic acid must be reduced to THF. Excess levels of folic acid are unable to completely convert to its active form resulting in circulating UMFA. Currently there is no consistent evidence of adverse health effects causatively associated with circulating UMFA.

    • Folic acid is a water-soluble vitamin. A significant amount of folic acid is excreted from urine when the renal capacity for reabsorption is saturated by high intake, eliminating excess folic acid.

    • FDA's modeled intake estimates for folic acid in CMF are conservative in that they assume all CMF will be fortified with folic acid at the maximum permitted level and that manufacturing and storage losses would result in folic acid levels of 140 µg/100 g in CMF as consumed.

    III. Incorporation by Reference

    FDA is incorporating by reference the Food Chemicals Codex (FCC), 9th ed. (updated through Third Supplement, effective December 1, 2015), pp. 495-496 (the most current edition), which was approved by the Office of the Federal Register. You may obtain a copy of the material from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852, 1-800-227-8772, http://www.usp.org/.

    The FCC is a compendium of internationally recognized standards for the purity and identity of food ingredients. Because the current regulation for the use of folic acid in food (§ 172.345) indicates that the additive must meet the specifications in the FCC, we are amending the regulation to provide for the most current edition.

    IV. Conclusion

    Based on all data relevant to folic acid that we reviewed, we conclude that the petitioned use of folic acid in CMF at a level not to exceed 0.7 mg folic acid per lb. CMF is safe. Consequently, we are amending the food additive regulations as set forth in this document. Additionally, the current regulation for the use of folic acid in food (§ 172.345) indicates that the additive must meet the specifications in the FCC, 7th Edition (FCC 7). The more current FCC is the 9th Edition (FCC 9). Because the specifications for folic acid in FCC 9 are identical to those in FCC 7, we are amending § 172.345 by adopting the specifications for folic acid in FCC 9 in place of FCC 7.

    V. Public Disclosure

    In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in § 171.1(h), we will delete from the documents any materials that are not available for public disclosure.

    VI. Analysis of Environmental Impacts

    We previously considered the environmental effects of this rule, as stated in the June 13, 2012, Federal Register notice of petition for FAP 2A4796 (77 FR 35317). We stated that we had determined, under 21 CFR 25.32(k), that this action “is of a type that does not individually or cumulatively have a significant effect on the human environment” such that neither an environmental assessment nor an environmental impact statement is required. We have not received any new information or comments that would affect our previous determination.

    VII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

    VIII. Objections

    If you will be adversely affected by one or more provisions of this regulation, you may file with the Division of Dockets Management (see ADDRESSES) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.

    Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    Our review of this petition was limited to section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348). This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (ll)(4) of the FD&C Act applies. In our review of this petition, FDA did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this additive. Accordingly, this final rule should not be construed to be a statement that a food containing this additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all food additive final rules and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

    X. References

    The following references marked with an asterisk (*) are on display at the Division of Dockets Management (see ADDRESSES), under Docket No. FDA-2012-F-0480, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday, they also are available electronically at http://www.regulations.gov. References without asterisks are not on display; they are available as published articles and books.

    1. IOM, 1998. “Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline.” Washington, DC: National Academy Press. Available at: http://www.ncbi.nlm.nih.gov/books/NBK114310/ (accessed April 1, 2016). *2. Scientific Advisory Committee on Nutrition (SACN), 2006. “Folate and Disease Prevention,” London. *3. SACN, 2009. “Folic Acid and Colorectal Cancer Risk: Review of Recommendation for Mandatory Folic Acid Fortification.” *4. Food Standards Australia New Zealand (FSANZ), 2007. “Folic Acid and Colorectal Cancer Risk: Review of Recommendation for Mandatory Folic Acid Fortification.” *5. FSANZ, 2009. “Mandatory Folic Acid Fortification and Health Outcomes.” *6. Food Safety Authority of Ireland (FSAI), 2006. “Report of the National Committee on Folic Acid Food Fortification.” *7. FSAI, 2008. “Report of the Implementation Group on Folic Acid Food Fortification to the Department of Health and Children.” *8. GR Health Council of the Netherlands (HCN), 2000. “Risks of Folic Acid Fortification.” The Hague, Health Council of the Netherlands 2000/21. *9. GR HCN, 2008. “Towards an Optimal Use of Folic Acid.” The Hague, Health Council of the Netherlands 2008/02E. 10. CDC, 1992. “Recommendations for the Use of Folic Acid to Reduce the Number of Cases of Spina Bifida and Other Neural Tube Defects.” Morbidity and Mortality Weekly Report 41. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00019479.htm (accessed April 1, 2016). *11. EFSA, 2009. Report prepared by the EFSA Scientific Cooperation Working Group on “Analysis of Risks and Benefits of Fortification of Food with Folic A.” *12. Memorandum from J. Zang, Toxicology Team, Division of Petition Review, to J. Kidwell, Division of Petition Review, March 23, 2016. *13. Memorandum from H. Lee, Chemistry Review Group, Division of Petition Review, to J. Kidwell, Regulatory Group I, Division of Petition Review, April 2, 2014. 14. National Health and Nutrition Examination Survey 2007-2008 Data Documentation, Codebook, and Frequencies, CDC, 2009. Available at: http://wwwn.cdc.gov/nchs/nhanes/search/nhanes07_08.aspx (accessed April 1, 2016). 15. Qi, Y.P., A.N. Do, H.C. Hamner, C.M. Pfeiffer, et al., 2014. “The Prevalence of Low Serum Vitamin B-12 Status in the Absence of Anemia or Macrocytosis Did Not Increase Among Older U.S. Adults after Mandatory Folic Acid Fortification.” The Journal of Nutrition 144, 170-176. 16. Oh, R. and D.L. Brown, 2003. “Vitamin B12 Deficiency.” American Family Physician 67, 979-986. 17. Stabler, S.P., 2013. “Clinical Practice. Vitamin B12 Deficiency.” New England Journal of Medicine 368(2): 149-160. 18. Hunt A., D. Harrington, and S. Robinson, 2014. “Vitamin B12 Deficiency.” British Medical Journal 349: g5226. 19. Wright J.D., K. Bialostosky, E.W. Gunter, M.D. Carroll, et al., 1998. “Blood Folate and Vitamin B12: United States, 1988-94.” Vital Health and Statistics 11:1-78. 20. Berry, R.J., H.K. Carter, and Q. Yang, 2007. “Cognitive Impairment in Older Americans in the Age of Folic Acid Fortification.” American Journal of Clinical Nutrition 86, 265-267; author reply 267-269. 21. Bailey, S.W. and J.E. Ayling, 2009. “The Extremely Slow and Variable Activity of Dihydrofolate Reductase in Human Liver and its Implications for High Folic Acid Intake.” Proceedings of the National Academy of Sciences of the United States of America 106 (36), 15424-15429. 22. Shane, B., “Folate Chemistry and Metabolism,” in Folate in Health and Disease, L. B. Bailey, Ed. Marcel Dekker, Boca Raton, FL, USA, 2nd edition, 2009. 23. McEvoy, G.K. (ed.). “American Hospital Formulary Service—Drug Information 2005.” Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements). 24. Tamura, T. and E.L. Stokstad, 1973. “The Availability of Food Folate in Man.” British Journal of Haematology 25(4): 512-532. List of Subjects in 21 CFR Part 172

    Food additives, Incorporation by reference, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 172 is amended as follows:

    PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 1. The authority citation for 21 CFR part 172 continues to read as follows: Authority:

    21 U.S.C. 321, 341, 342, 348, 371, 379e.

    2. Amend § 172.345 by revising the first sentence of paragraph (b) and adding paragraph (i) to read as follows:
    § 172.345 Folic acid (folacin).

    (b) Folic acid meets the specifications of the Food Chemicals Codex, 9th ed., updated through Third Supplement, effective December 1, 2015, pp. 495-496, which is incorporated by reference. * * *

    (i) Folic acid may be added to corn masa flour at a level not to exceed 0.7 milligrams of folic acid per pound of corn masa flour.

    Dated: April 12, 2016. Susan Bernard, Director, Office of Regulations, Policy and Social Sciences, Center for Food Safety and Applied Nutrition.
    [FR Doc. 2016-08792 Filed 4-14-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [167A2100DD/AAKC001030/A0A501010.999900 253G] 25 CFR Part 151 RIN 1076-AF28 Title Evidence for Trust Land Acquisitions AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Interim final rule; delay of effective date.

    SUMMARY:

    The Bureau of Indian Affairs (BIA) published an interim final rule on title evidence for trust land acquisitions and received comments during the public comment period. The BIA anticipates making technical revisions to the rule in response to those comments. This notice delays the effective date of the interim final rule for 30 days, during which time BIA plans to publish a final rule with technical revisions.

    DATES:

    The effective date of the interim final rule published March 1, 2016 (81 FR 10477) is delayed from April 15, 2016 to May 16, 2016.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    On March 1, 2016, BIA published an interim final rule with an effective date of April 15, 2016. 81 FR 10477. The interim final rule deletes the requirement for fee-to-trust applicants to furnish title evidence that meets the “Standards for the Preparation of Title Evidence in Land Acquisitions by the United States” issued by the U.S. Department of Justice (DOJ), and replaces the requirement with a more targeted requirement for title evidence, because adherence to the DOJ standards is not required for acquisitions of land in trust for individual Indians or Indian tribes. The BIA received 13 comments during the public comment period and anticipates making technical changes in response to those comments. The interim final rule stated that BIA may withdraw, initiate a proposed rulemaking, or revise the rule in response to comments. The BIA has determined that technical revisions to the rule may be appropriate and is therefore delaying the effective date of the rule for 30 days, during which time BIA will publish a final rule with technical revisions.

    Dated: April 12, 2016. Lawrence S. Roberts, Acting Assistant Secretary—Indian Affairs.
    [FR Doc. 2016-08776 Filed 4-14-16; 8:45 am] BILLING CODE 4337-15-P
    PENSION BENEFIT GUARANTY CORPORATION 29 CFR Part 4022 Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Paying Benefits AGENCY:

    Pension Benefit Guaranty Corporation.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule amends the Pension Benefit Guaranty Corporation's regulation on Benefits Payable in Terminated Single-Employer Plans to prescribe interest assumptions under the regulation for valuation dates in May 2016. The interest assumptions are used for paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC.

    DATES:

    Effective May 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Catherine B. Klion ([email protected]), Assistant General Counsel for Regulatory Affairs, Pension Benefit Guaranty Corporation, 1200 K Street NW., Washington, DC 20005, 202-326-4024. (TTY/TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4024.)

    SUPPLEMENTARY INFORMATION:

    PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribes actuarial assumptions—including interest assumptions—for paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulation are also published on PBGC's Web site (http://www.pbgc.gov).

    PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.

    The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for May 2016.1

    1 Appendix B to PBGC's regulation on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) prescribes interest assumptions for valuing benefits under terminating covered single-employer plans for purposes of allocation of assets under ERISA section 4044. Those assumptions are updated quarterly.

    The May 2016 interest assumptions under the benefit payments regulation will be 1.00 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for April 2016, these interest assumptions are unchanged.

    PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

    Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during May 2016, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

    PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

    Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

    List of Subjects in 29 CFR Part 4022

    Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements.

    In consideration of the foregoing, 29 CFR part 4022 is amended as follows:

    PART 4022—BENEFITS PAYABLE IN TERMINATED SINGLE-EMPLOYER PLANS 1. The authority citation for part 4022 continues to read as follows: Authority:

    29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344.

    2. In appendix B to part 4022, Rate Set 271, as set forth below, is added to the table. Appendix B to Part 4022—Lump Sum Interest Rates for PBGC Payments Rate set For plans with a valuation date On or after Before Immediate
  • annuity rate
  • (percent)
  • Deferred annuities
  • (percent)
  • i 1 i 2 i 3 n 1 n 2
    *         *         *         *         *         *         * 271 5-1-16 6-1-16 1.00 4.00 4.00 4.00 7 8
    3. In appendix C to part 4022, Rate Set 271, as set forth below, is added to the table. Appendix C to Part 4022—Lump Sum Interest Rates for Private-Sector Payments Rate set For plans with a valuation date On or after Before Immediate
  • annuity rate
  • (percent)
  • Deferred annuities
  • (percent)
  • i 1 i 2 i 3 n 1 n 2
    *         *         *         *         *         *         * 271 5-1-16 6-1-16 1.00 4.00 4.00 4.00 7 8
    Issued in Washington, DC, on this 11th day of April 2016. Judith Starr, General Counsel, Pension Benefit Guaranty Corporation.
    [FR Doc. 2016-08773 Filed 4-14-16; 8:45 am] BILLING CODE 7709-02-P
    DEPARTMENT OF THE TREASURY Office of Foreign Assets Control 31 CFR Part 566 Hizballah Financial Sanctions Regulations AGENCY:

    Office of Foreign Assets Control, Treasury.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of the Treasury's Office of Foreign Assets Control (OFAC) is adding new part 566 to 31 CFR chapter V to implement the Hizballah International Financing Prevention Act of 2015, which requires the President to prescribe certain regulations.

    DATES:

    Effective: April 15, 2016.

    FOR FURTHER INFORMATION CONTACT:

    The Department of the Treasury's Office of Foreign Assets Control: Assistant Director for Licensing, tel.: 202-622-2480, Assistant Director for Regulatory Affairs, tel.: 202-622-4855, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202-622-2410.

    SUPPLEMENTARY INFORMATION:

    Electronic and Facsimile Availability

    This document and additional information concerning OFAC are available from OFAC's Web site (www.treasury.gov/ofac). Certain general information pertaining to OFAC's sanctions programs also is available via facsimile through a 24-hour fax-on-demand service, tel.: 202-622-0077.

    Background

    On December 18, 2015, the President signed the Hizballah International Financing Prevention Act of 2015, Public Law 114-102 (HIFPA), into law. Section 102(a)(1) of HIFPA requires the President, within 120 days of the enactment of HIFPA, to prescribe regulations to prohibit or impose strict conditions on the opening or maintaining in the United States of a correspondent account or a payable-through account by a foreign financial institution that the President determines, on or after December 18, 2015, engages in one or more of the following activities: (1) Knowingly facilitating a significant transaction or transactions for Hizballah; (2) knowingly facilitating a significant transaction or transactions of a person identified on the List of Specially Designated Nationals and Blocked Persons (SDN List) maintained by OFAC, the property and interests in property of which are blocked pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) for acting on behalf of or at the direction of, or being owned or controlled by, Hizballah; (3) knowingly engaging in money laundering to carry out an activity described in (1) or (2); or (4) knowingly facilitating a significant transaction or transactions or providing significant financial services to carry out an activity described in (1), (2), or (3).

    Pursuant to Presidential Memorandum of March 18, 2016: Delegation of Functions Under Sections 102(a), 102(c), 204, and 302 of HIFPA, the President delegated certain functions and authorities, with respect to the determinations provided for therein, to the Secretary of the Treasury, in consultation with the Secretary of State. In furtherance of HIFPA's requirement and the Presidential delegation of functions and authorities noted above, OFAC is promulgating the Hizballah Financial Sanctions Regulations, 31 CFR part 566 (the “Regulations”).

    Subpart A of the Regulations clarifies the relation of this part to other laws and regulations. Subpart B of the Regulations implements section 102(a) of HIFPA. The names of foreign financial institutions that are determined by the Secretary of the Treasury, in consultation with the Secretary of State, to engage in the activities described in § 566.201(a) of the Regulations, and which are subject to prohibitions or strict conditions on the opening or maintaining of correspondent or payable-through accounts as set forth in § 566.201(b) of the Regulations, will be listed on the Hizballah Financial Sanctions Regulations List (HFSR List) on OFAC's Web site (www.treasury.gov/ofac) on the Counter Terrorism Sanctions page and published in the Federal Register.

    Subpart C of the Regulations defines key terms used throughout the Regulations, and subpart D contains interpretive sections regarding the Regulations. Section 566.404 of subpart D of the Regulations sets forth the types of factors that, as a general matter, the Secretary of the Treasury will consider in determining, for purposes of paragraph (a) of § 566.201, whether transactions or financial services are significant.

    Transactions otherwise prohibited under the Regulations but found to be consistent with U.S. policy may be authorized by the general licenses contained in subpart E of the Regulations or by a specific license issued pursuant to the procedures described in subpart E of 31 CFR part 501. Subpart E of the Regulations includes a general license in § 566.504 authorizing transactions related to winding down and closing a correspondent account or a payable-through account. Section 566.504 authorizes transactions related to closing a correspondent account or payable-through account for a foreign financial institution whose name is added to the HFSR List during the 10-day period beginning on the effective date of the prohibition in § 566.201. This general license includes a reporting requirement pursuant to which a U.S. financial institution that maintained a correspondent account or a payable-through account for a foreign financial institution whose name is added to the HFSR List must file a report with OFAC that provides full details on the closing of each such account within 30 days of the closure of the account. The report must include complete information on all transactions processed or executed in winding down and closing the account.

    Subpart F of the Regulations refers to subpart C of part 501 for recordkeeping and reporting requirements. Subpart G of the Regulations describes the civil and criminal penalties applicable to violations of the Regulations, as well as the procedures governing the potential imposition of a civil monetary penalty. Subpart G also refers to Appendix A of part 501 for a more complete description of these procedures.

    Subpart H of the Regulations refers to subpart E of part 501 for applicable provisions relating to administrative procedures and contains a delegation of authority by the Secretary of the Treasury. Subpart I of the Regulations sets forth a Paperwork Reduction Act notice.

    Public Participation

    Because the Regulations involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.

    Paperwork Reduction Act

    With respect to section 2 of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507, the collection of information in § 566.601 of the Regulations is made pursuant to OFAC's Reporting, Procedures and Penalties Regulations, 31 CFR part 501, and has been approved by OMB under control number 1505-0164. See 31 CFR 501.901. The collection of information in § 566.504(b) of the Regulations has been submitted to OMB under Information Collection Request (ICR) number 201603-1505-002 and is pending approval. Section 566.504(b) specifies that a U.S. financial institution that maintained a correspondent account or payable-through account for a foreign financial institution listed on the HFSR List must file a report with OFAC that provides full details on the closing of each such account within 30 days of the closure of the account. This collection of information assists in verifying that U.S. financial institutions are complying with prohibitions on maintaining correspondent accounts or payable-through accounts for foreign financial institutions listed on the HFSR List, and the information collected will be used to further OFAC's compliance and enforcement functions.

    With respect to all of the foregoing collections of information, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection of information displays a valid control number. The likely respondents and recordkeepers affected by the new collection of information in § 566.504(b) are U.S. financial institutions operating correspondent accounts or payable-through accounts for foreign financial institutions. Because this is a new collection of information, OFAC cannot predict the response rate for the § 566.504(b) reporting requirement at this time. For future submissions, OFAC will report retrospectively on the response rate during the previous reporting period.

    The estimated average reporting/recordkeeping burden is 2 hours per response.

    Comments are invited on: (a) Whether this collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques and other forms of information technology; and (e) the estimated capital or start-up costs of the operation, maintenance, and/or purchase of services to provide information.

    Comments concerning the above information and the accuracy of these burden estimates, and suggestions for reducing this burden, should be directed to OMB, Attention: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503, with a copy to Chief of Records, Attention: Request for Comments, Office of Foreign Assets Control, Department of the Treasury, 1500 Pennsylvania Avenue NW., Freedman's Bank Building, Washington, DC 20220. Any such comments should be submitted not later than June 14, 2016. All comments on the collection of information in § 566.504(b) will be a matter of public record.

    List of Subjects in 31 CFR Part 566

    Administrative practice and procedure, Banking, Banks, Brokers, Foreign trade, Hizballah, Investments, Loans, Money laundering, Securities, Services.

    For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control adds part 566 to 31 CFR chapter V to read as follows:

    PART 566—HIZBALLAH FINANCIAL SANCTIONS REGULATIONS Subpart A—Relation of This Part to Other Laws and Regulations Sec. 566.101 Relation of this part to other laws and regulations. Subpart B—Prohibitions 566.201 Prohibitions or strict conditions with respect to correspondent or payable-through accounts of certain foreign financial institutions identified by the Secretary of the Treasury. 566.202 Evasions; attempts; causing violations; conspiracies. Subpart C—General Definitions 566.300 Applicability of definitions. 566.301 Agent. 566.302 Correspondent account. 566.303 Covered financial institution. 566.304 Effective date. 566.305 Entity. 566.306 Financial institution. 566.307 Financial services. 566.308 Financial transaction. 566.309 Foreign financial institution. 566.310 HIFPA. 566.311 Hizballah. 566.312 Knowingly. 566.313 Licenses; general and specific. 566.314 Money laundering. 566.315 OFAC. 566.316 Payable-through account. 566.317 Person. 566.318 Transaction account. 566.319 United States. 566.320 U.S. financial institution. Subpart D—Interpretations 566.401 Reference to amended sections. 566.402 Effect of amendment. 566.403 Facilitation of certain efforts, activities, or transactions by foreign financial institutions. 566.404 Significant transaction or transactions; significant financial services. Subpart E—Licenses, Authorizations, and Statements of Licensing Policy 566.501 General and specific licensing procedures. 566.502 Effect of license or authorization. 566.503 Exclusion from licenses. 566.504 Transactions related to closing a correspondent or payable-through account. Subpart F—Reports 566.601 Records and reports. Subpart G—Penalties 566.701 Penalties. 566.702 Pre-Penalty Notice; settlement. 566.703 Penalty imposition. 566.704 Administrative collection; referral to United States Department of Justice. Subpart H—Procedures 566.801 Procedures. 566.802 Delegation by the Secretary of the Treasury. Subpart I—Paperwork Reduction Act 566.901 Paperwork Reduction Act notice. Authority:

    3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 note); Pub. L. 110-96, 121 Stat. 1011 (50 U.S.C. 1705 note); Pub. L. 114-102.

    Subpart A—Relation of This Part to Other Laws and Regulations
    § 566.101 Relation of this part to other laws and regulations.

    This part is separate from, and independent of, the other parts of this chapter, with the exception of part 501 of this chapter, the recordkeeping and reporting requirements and license application and other procedures of which apply to this part. Actions taken pursuant to part 501 of this chapter with respect to the prohibitions contained in this part are considered actions taken pursuant to this part. Differing foreign policy and national security circumstances may result in differing interpretations of similar language among the parts of this chapter. No license or authorization contained in or issued pursuant to those other parts authorizes any transaction prohibited by this part. No license or authorization contained in or issued pursuant to any other provision of law or regulation authorizes any transaction prohibited by this part. No license or authorization contained in or issued pursuant to this part relieves the involved parties from complying with any other applicable laws or regulations.

    Subpart B—Prohibitions
    § 566.201 Prohibitions or strict conditions with respect to correspondent or payable-through accounts of certain foreign financial institutions identified by the Secretary of the Treasury.

    Upon a determination by the Secretary of the Treasury that a foreign financial institution knowingly engages in one or more of the activities described in paragraphs (a)(1) through (a)(4) of this section, the Secretary of the Treasury may, as set forth in paragraph (b) of this section, impose one or more strict conditions on the opening or maintaining of a correspondent account or a payable-through account in the United States for that foreign financial institution, or, as set forth in paragraph (c) of this section, prohibit a U.S. financial institution from opening or maintaining a correspondent account or a payable-through account in the United States for that foreign financial institution.

    (a) A foreign financial institution engages in an activity described in this paragraph if, in any location or currency, the foreign financial institution, on or after December 18, 2015, knowingly:

    (1) Facilitates a significant transaction or transactions for Hizballah;

    (2) Facilitates a significant transaction or transactions of a person identified on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List), the property and interests in property of which are blocked pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) (IEEPA) for acting on behalf of or at the direction of, or being owned or controlled by, Hizballah;

    Note to paragraph (a)(2):

    The SDN List is accessible through the following page on OFAC's Web site: www.treasury.gov/sdn. Additional information pertaining to the SDN List can be found in appendix A to this chapter. Persons whose property and interests in property are blocked pursuant to IEEPA for acting on behalf of or at the direction of or being owned or controlled by Hizballah are identified by a special reference to Hizballah at the end of their entries on the SDN List, in addition to the reference to the regulatory part of this chapter pursuant to which their property and interests in property are blocked. For example, a person whose property and interests in property are blocked pursuant to the Global Terrorism Sanctions Regulations, 31 CFR part 594, and identified on the SDN List, will have the program tag “[SDGT]” and descriptive text [“Subject to secondary sanctions pursuant to the Hizballah Financial Sanctions Regulations”].

    (3) Engages in money laundering to carry out an activity described in paragraphs (a)(1) or (a)(2) of this section; or

    (4) Facilitates a significant transaction or transactions or provides significant financial services to carry out an activity described in paragraphs (a)(1), (a)(2), or (a)(3) of this section.

    (b) The Secretary of the Treasury may impose one or more strict conditions on the opening or maintaining by a U.S. financial institution of a correspondent account or a payable-through account in the United States for a foreign financial institution that the Secretary finds engages in one or more of the activities described in paragraph (a) of this section. Except as otherwise authorized pursuant to this part, a U.S. financial institution shall not open or maintain a correspondent account or payable-through account in the United States in a manner that is inconsistent with any strict condition imposed and in effect pursuant to this paragraph. Such conditions may include the following:

    (1) Prohibiting or restricting any provision of trade finance through the correspondent account or payable-through account of the foreign financial institution;

    (2) Restricting the transactions that may be processed through the correspondent account or payable-through account of the foreign financial institution to certain types of transactions, such as personal remittances;

    (3) Placing monetary limits on, or limiting the volume of, the transactions that may be processed through the correspondent account or payable-through account of the foreign financial institution;

    (4) Requiring pre-approval from the U.S. financial institution for all transactions processed through the correspondent account or payable-through account of the foreign financial institution; or

    (5) Prohibiting or restricting the processing of foreign exchange transactions through the correspondent account or payable-through account of the foreign financial institution.

    Note to paragraph (b):

    The name of the foreign financial institution, together with the actual strict condition(s) to be imposed, will be added to the HFSR List on the Office of Foreign Assets Control's Web site (www.treasury.gov/ofac) on the Counter Terrorism Sanctions page, and published in the Federal Register.

    (c) If the Secretary of the Treasury does not impose one or more strict conditions, pursuant to paragraph (b) of this section, on the opening or maintaining by a U.S. financial institution of a correspondent account or a payable-through account in the United States for a foreign financial institution that the Secretary determines engages in one or more of the activities described in paragraph (a) of this section, the Secretary may prohibit the opening or maintaining by a U.S. financial institution of a correspondent account or a payable-through account in the United States for that foreign financial institution. Except as otherwise authorized pursuant to this part, a U.S. financial institution shall not open or maintain a correspondent account or a payable-through account in the United States for a foreign financial institution for which the opening or maintaining of such an account is prohibited pursuant to this paragraph.

    Note to paragraph (c):

    The names of foreign financial institutions for which the opening or maintaining of a correspondent account or a payable-through account in the United States is prohibited will be listed on the HFSR List on OFAC's Web site (www.treasury.gov/ofac) on the Counter Terrorism Sanctions page, and published in the Federal Register.

    § 566.202 Evasions; attempts; causing violations; conspiracies.

    (a) Any transaction on or after the effective date that evades or avoids, has the purpose of evading or avoiding, causes a violation of, or attempts to violate any of the prohibitions set forth in this part is prohibited.

    (b) Any conspiracy formed to violate any of the prohibitions set forth in this part is prohibited.

    Subpart C—General Definitions
    § 566.300 Applicability of definitions.

    The definitions in this subpart apply throughout the entire part.

    § 566.301 Agent.

    The term agent includes an entity established by a person for purposes of conducting transactions on behalf of the person in order to conceal the identity of the person.

    § 566.302 Correspondent account.

    The term correspondent account means an account established to receive deposits from, make payments on behalf of, or handle other financial transactions related to a foreign financial institution.

    § 566.303 Covered financial institution.

    The term covered financial institution means a broker or dealer in securities registered, or required to be registered, with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.), except persons who register pursuant to section 15(b)(11) of the Securities Exchange Act of 1934; a futures commission merchant or an introducing broker registered, or required to be registered, with the Commodity Futures Trading Commission under the Commodity Exchange Act (7 U.S.C. 1 et seq.), except persons who register pursuant to section 4(f)(a)(2) of the Commodity Exchange Act; or a mutual fund.

    § 566.304 Effective date.

    The effective date refers to the effective date of a prohibition or strict condition imposed pursuant to § 566.201 on the opening or maintaining of a correspondent account or a payable-through account in the United States by a U.S. financial institution for a particular foreign financial institution and is the earlier of the date the U.S. financial institution receives actual or constructive notice of such prohibition or condition.

    § 566.305 Entity.

    The term entity means a partnership, association, trust, joint venture, corporation, group, subgroup, or other organization.

    § 566.306 Financial institution.

    The term financial institution means:

    (a) An insured bank (as defined in section 3(h) of the Federal Deposit Insurance Act (12 U.S.C. 1813(h));

    (b) A commercial bank or trust company;

    (c) A private banker;

    (d) An agency or branch of a foreign bank in the United States;

    (e) Any credit union;

    (f) A thrift institution;

    (g) A broker or dealer registered with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.);

    (h) A broker or dealer in securities or commodities;

    (i) An investment banker or investment company;

    (j) A currency exchange;

    (k) An issuer, redeemer, or cashier of travelers' checks, checks, money orders, or similar instruments;

    (l) An insurance company;

    (m) A dealer in precious metals, stones, or jewels;

    (n) A loan or finance company;

    (o) A licensed sender of money or any other person who engages as a business in the transmission of funds including any person who engages as a business in an informal money transfer system or any network of people who engage as a business in facilitating the transfer of money domestically or internationally outside of the conventional financial institutions system;

    (p) A business engaged in vehicle sales, including automobile, airplane, and boat sales;

    (q) Any business or agency which engages in any activity which the Secretary of the Treasury determines, by regulation, to be an activity which is similar to, related to, or a substitute for any activity in which any business described in this paragraph is authorized to engage; or

    (r) Any other business designated by the Secretary whose cash transactions have a high degree of usefulness in criminal, tax, or regulatory matters.

    § 566.307 Financial services.

    The term financial services includes loans, transfers, accounts, insurance, investments, securities, guarantees, foreign exchange, letters of credit, and commodity futures or options.

    § 566.308 Financial transaction.

    The term financial transaction means any transfer of value involving a financial institution.

    § 566.309 Foreign financial institution.

    (a) The term foreign financial institution means:

    (1) A foreign bank;

    (2) Any branch or office located outside the United States of a covered financial institution, as defined in § 566.304;

    (3) Any other person organized under foreign law (other than a branch or office of such person in the United States) that, if it were located in the United States, would be a covered financial institution, as defined in § 566.304; and

    (4) Any person organized under foreign law (other than a branch or office of such person in the United States) that is engaged in the business of, and is readily identifiable as, a dealer in foreign exchange or a money transmitter.

    (b) For purposes of paragraph (a)(4) of this section, a person is not “engaged in the business” of a dealer in foreign exchange or a money transmitter if such transactions are merely incidental to the person's business.

    § 566.310 HIFPA.

    The term HIFPA means the Hizballah International Financing Prevention Act of 2015, Public Law 114-102.

    § 566.311 Hizballah.

    The term Hizballah means:

    (a) The entity known as Hizballah and designated by the Secretary of State as a foreign terrorist organization pursuant to section 219 of the Immigration and Nationality Act (8 U.S.C. 1189); or

    (b) Any person:

    (1) The property and interests in property of which are blocked pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.); and

    (2) Who is identified on the Specially Designated Nationals and Blocked Persons List (SDN List) maintained by OFAC as an agent, instrumentality, or affiliate of Hizballah.

    Note to § 566.311:

    The SDN List is accessible through the following page on OFAC's Web site: www.treasury.gov/sdn. Additional information pertaining to the SDN List can be found in Appendix A to this chapter. Persons on the SDN List that fall within the definition of Hizballah set forth in this section are identified by a special reference to Hizballah at the end of their entries on the SDN List, in addition to the reference to the regulatory part of this chapter pursuant to which their property and interests in property are blocked. For example, a person whose property and interests in property are blocked pursuant to the Global Terrorism Sanctions Regulations, 31 CFR part 594, and identified on the SDN List will have the program tag “[SDGT]” and descriptive text [“Subject to secondary sanctions pursuant to the Hizballah Financial Sanctions Regulations”].

    § 566.312 Knowingly.

    The term knowingly, with respect to conduct, a circumstance, or a result, means that a person has actual knowledge, or should have known, of the conduct, the circumstance, or the result.

    § 566.313 Licenses; general and specific.

    (a) Except as otherwise provided in this part, the term license means any license or authorization contained in or issued pursuant to this part.

    (b) The term general license means any license or authorization the terms of which are set forth in subpart E of this part or made available on OFAC's Web site: www.treasury.gov/ofac.

    (c) The term specific license means any license or authorization issued pursuant to this part but not set forth in subpart E of this part or made available on OFAC's Web site: www.treasury.gov/ofac.

    Note to § 566.313:

    See § 501.801 of this chapter on licensing procedures.

    § 566.314 Money laundering.

    The term money laundering includes the movement of illicit cash or cash equivalent proceeds into, out of, or through a country, or into, out of, or through a financial institution.

    § 566.315 OFAC.

    The term OFAC means the Department of the Treasury's Office of Foreign Assets Control.

    § 566.316 Payable-through account.

    The term payable-through account means an account, including a transaction account as defined in § 566.317, opened at a depository institution by a foreign financial institution by means of which the foreign financial institution permits its customers to engage, either directly or through a subaccount, in banking activities usual in connection with the business of banking in the United States.

    § 566.317 Person.

    The term person means an individual or entity.

    § 566.318 Transaction account.

    The term transaction account means a deposit or account on which the depositor or account holder is permitted to make withdrawals by negotiable or transferable instrument, payment orders of withdrawal, telephone transfers, or other similar items for the purpose of making payments or transfers to third persons or others. Such term includes demand deposits, negotiable order of withdrawal accounts, savings deposits subject to automatic transfers, and share draft accounts.

    § 566.319 United States.

    The term United States means the United States, its territories and possessions, and all areas under the jurisdiction or authority thereof.

    § 566.320 U.S. financial institution.

    The term U.S. financial institution means a financial institution located in or organized under the laws of the United States or any jurisdiction within the United States.

    Subpart D—Interpretations
    § 566.401 Reference to amended sections.

    Except as otherwise provided in this part, reference to any provision in or appendix to this part or chapter or to any regulation, ruling, order, instruction, directive, or license issued pursuant to this part refers to the same as currently amended.

    § 566.402 Effect of amendment.

    Unless otherwise specifically provided, any amendment, modification, or revocation of any provision in or appendix to this part or chapter or of any regulations, ruling, order, instruction, or license issued by OFAC does not affect any act done or omitted, or any civil or criminal proceeding commenced or pending, prior to such amendment, modification, or revocation. All penalties, forfeitures, and liabilities under any such regulation, ruling, order, instruction, or license continue and may be enforced as if such amendment, modification, or revocation had not been made.

    § 566.403 Facilitation of certain efforts, activities, or transactions by foreign financial institutions.

    For purposes of § 566.201, the term facilitate used with respect to certain efforts, activities, or transactions refers to the provision of assistance by a foreign financial institution for those efforts, activities, or transactions, including the provision of currency, financial instruments, securities, or any other transmission of value; purchasing; selling; transporting; swapping; brokering; financing; approving; guaranteeing; the provision of other services of any kind; the provision of personnel; or the provision of software, technology, or goods of any kind.

    § 566.404 Significant transactions; significant financial services.

    In determining, for purposes of paragraph (a) of § 566.201, whether a transaction(s) or financial service(s) is significant, the Secretary of the Treasury may consider the totality of the facts and circumstances. As a general matter, the Secretary may consider some or all of the following factors:

    (a) Size, number, and frequency. The size, number, and frequency of transaction(s) or financial service(s) performed over a period of time, including whether the transaction(s) or financial service(s) is increasing or decreasing over time and the rate of increase or decrease.

    (b) Nature. The nature of the transaction(s) or financial service(s), including the type, complexity, and commercial purpose of the transaction(s) or financial service(s).

    (c) Level of awareness; pattern of conduct. (1) Whether the transaction(s) or financial service(s) is performed with the involvement or approval of management or only by clerical personnel; and

    (2) Whether the transaction(s) or financial service(s) is part of a pattern of conduct or the result of a business development strategy.

    (d) Nexus. The proximity between the foreign financial institution engaging in the transaction(s) or providing the financial service(s) and Hizballah or a blocked person described in paragraph (a)(2) of § 566.201. For example, a transaction or financial service in which a foreign financial institution provides brokerage or clearing services to, or maintains an account or makes payments for, Hizballah or such a blocked person generally would be of greater significance than a transaction or financial service a foreign financial institution conducts for or provides to Hizballah or such a blocked person indirectly or in a tertiary relationship.

    (e) Impact. The impact of the transaction(s) or financial service(s) on the objectives of the Hizballah International Financing Prevention Act of 2015, including:

    (1) The economic or other benefit conferred or attempted to be conferred on Hizballah or a blocked person described in paragraph (a)(2) of § 566.201; and

    (2) Whether and how the transaction(s) or financial service(s) contributes to support for international terrorism.

    (f) Deceptive practices. Whether the transaction(s) or financial service(s) involves an attempt to obscure or conceal the actual parties or true nature of the transaction(s) or financial service(s) to evade sanctions.

    (g) Other relevant factors. Such other factors that the Secretary deems relevant on a case-by-case basis in determining the significance of a transaction(s) or financial service(s).

    Subpart E—Licenses, Authorizations, and Statements of Licensing Policy
    § 566.501 General and specific licensing procedures.

    For provisions relating to licensing procedures, see part 501, subpart E of this chapter. Licensing actions taken pursuant to part 501 of this chapter with respect to the prohibitions contained in this part are considered actions taken pursuant to this part. General licenses and statements of licensing policy relating to this part also may be available through the Counter Terrorism Sanctions page on OFAC's Web site: www.treasury.gov/ofac.

    § 566.502 Effect of license or other authorization.

    (a) No license or other authorization contained in this part, or otherwise issued by OFAC, authorizes or validates any transaction or financial service effected prior to the issuance of such license or other authorization, unless specifically provided in such license or authorization.

    (b) No regulation, ruling, instruction, or license authorizes any transaction or financial service prohibited under this part unless the regulation, ruling, instruction, or license is issued by OFAC and specifically refers to this part. No regulation, ruling, instruction, or license referring to this part shall be deemed to authorize any transaction or financial services prohibited by any other part of this chapter unless the regulation, ruling, instruction, or license specifically refers to such part.

    (c) Any regulation, ruling, instruction, or license authorizing any transaction or financial service otherwise prohibited under this part has the effect of removing a prohibition contained in this part from the transaction, but only to the extent specifically stated by its terms. Unless the regulation, ruling, instruction, or license otherwise specifies, such an authorization does not create any right, duty, obligation, claim, or interest in, or with respect to, any property that would not otherwise exist under ordinary principles of law.

    (d) Nothing contained in this part shall be construed to supersede the requirements established under any other provision of law or to relieve a person from any requirement to obtain a license or other authorization from another department or agency of the U.S. Government in compliance with applicable laws and regulations subject to the jurisdiction of that department or agency.

    § 566.503 Exclusion from licenses.

    OFAC reserves the right to exclude any person, property, transaction, or class thereof from the operation of any license or from the privileges conferred by any license. OFAC also reserves the right to restrict the applicability of any license to particular persons, property, transactions, or classes thereof. Such actions are binding upon actual or constructive notice of the exclusions or restrictions.

    § 566.504 Transactions related to closing a correspondent or payable-through account.

    (a) During the 10-day period beginning on the effective date of the prohibition in § 566.201(c) on the opening or maintaining of a correspondent account or a payable-through account for a foreign financial institution listed in the HFSR List, U.S. financial institutions that maintain correspondent accounts or payable-through accounts for the foreign financial institution are authorized to:

    (1) Process only those transactions through the account, or permit the foreign financial institution to execute only those transactions through the account, that are for the purpose of, and necessary for, closing the account; and

    (2) Transfer the funds remaining in the correspondent account or the payable-through account to an account of the foreign financial institution located outside of the United States and close the correspondent account or the payable-through account.

    (b) A report must be filed with OFAC within 30 days of the closure of an account, providing full details on the closing of each correspondent account or payable-through account maintained by a U.S. financial institution for a foreign financial institution whose name is added to the HFSR List, maintained on OFAC's Web site (www.treasury.gov/ofac) on the Hizballah Sanctions page. Such report must include complete information on the closing of the account and on all transactions processed or executed through the account pursuant to this section, including the account outside of the United States to which funds remaining in the account were transferred. Reports should be addressed to the attention of the Sanctions, Compliance & Evaluation Division, Office of Foreign Assets Control, U.S. Department of the Treasury, 1500 Pennsylvania Avenue NW., Freedman's Bank Building, Washington, DC 20220.

    (c) Specific licenses may be issued on a case-by-case basis to authorize transactions outside the scope or time period authorized in paragraph (a) by a U.S. financial institution with respect to a correspondent account or a payable-through account maintained by the U.S. financial institution for a foreign financial institution whose name is added to the HFSR List. License applications should be filed in conformance with § 501.801 of the Reporting, Procedures and Penalties Regulations, 31 CFR part 501.

    (d) Nothing in this section authorizes the opening of a correspondent account or a payable-through account for a foreign financial institution whose name appears on the HFSR List.

    Note to § 566.504:

    This section does not authorize a U.S. financial institution to unblock property or interests in property, or to engage in any transaction or dealing in property or interests in property, blocked pursuant to any other part of this chapter, in the process of closing a correspondent account or a payable-through account for a foreign financial institution whose name has been added to the HFSR List, maintained on OFAC's Web site (www.treasury.gov/ofac) on the Counter Terrorism Sanctions page. See § 566.101.

    Subpart F—Reports
    § 566.601 Records and reports.

    For provisions relating to required records and reports, see part 501, subpart C, of this chapter. Recordkeeping and reporting requirements imposed by part 501 of this chapter with respect to the prohibitions contained in this part are considered requirements arising pursuant to this part.

    Subpart G—Penalties
    § 566.701 Penalties.

    (a) Civil penalties. As set forth in section 102(a)(3) of the Hizballah International Financing Prevention Act of 2015 (Pub. L. 114-102, 129 Stat. 2205 (50 U.S.C. 1701 note)), a civil penalty not to exceed the amount set forth in section 206(b) of the International Emergency Economic Powers Act (IEEPA) (50 U.S.C. 1705(b)) may be imposed on any person who violates, attempts to violate, conspires to violate, or causes a violation of any license, order, regulation, or prohibition set forth in or issued pursuant to this part.

    Note to paragraph (a):

    As of the date of publication in the Federal Register of the final rule adding this part to 31 CFR chapter V, April 15, 2016), IEEPA provides for a maximum civil penalty not to exceed the greater of $250,000 or an amount that is twice the amount of the transaction that is the basis of the violation with respect to which the penalty is imposed.

    (b) Criminal penalties. As set forth in section 102(a)(3) of HIFPA, a person who willfully commits, willfully attempts to commit, or willfully conspires to commit a violation of any license, order, regulation, or prohibition set forth in or issued pursuant to this part shall, upon conviction, be fined not more than $1,000,000, or if a natural person, be imprisoned for not more than 20 years, or both.

    (c) Adjustments to penalty amounts. (1) The civil penalties provided in IEEPA are subject to adjustment pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, as amended, 28 U.S.C. 2461 note).

    (2) The criminal penalties provided in IEEPA are subject to adjustment pursuant to 18 U.S.C. 3571.

    (d) Attention is also directed to 18 U.S.C. 1001, which provides that “whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully falsifies, conceals, or covers up by any trick, scheme, or device a material fact; or makes any materially false, fictitious, or fraudulent statement or representation; or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry” shall be fined under title 18, United States Code, imprisoned, or both.

    (e) Violations of this part may also be subject to other applicable laws.

    § 566.702 Pre-Penalty Notice; settlement.

    (a) When required. If OFAC has reason to believe that there has occurred a violation of any provision of this part or a violation of the provisions of any license, ruling, regulation, order, directive, or instruction issued by or pursuant to the direction or authorization of the Secretary of the Treasury pursuant to this part and determines that a civil monetary penalty or finding of violation is warranted, OFAC will issue a Pre-Penalty Notice informing the alleged violator of the agency's intent to impose a monetary penalty or finding of violation. A Pre-Penalty Notice shall be in writing. The Pre-Penalty Notice may be issued whether or not another agency has taken any action with respect to the matter. For a description of the contents of a Pre-Penalty Notice, see Appendix A to part 501 of this chapter.

    (b)(1) Right to respond. An alleged violator has the right to respond to a Pre-Penalty Notice by making a written presentation to OFAC. For a description of the information that should be included in such a response, see Appendix A to part 501 of this chapter.

    (2) Deadline for response. A response to a Pre-Penalty Notice must be made within 30 days as set forth below. The failure to submit a response within 30 days shall be deemed to be a waiver of the right to respond.

    (i) Computation of time for response. A response to a Pre-Penalty Notice must be postmarked or date-stamped by the U.S. Postal Service (or foreign postal service, if mailed abroad) or courier service provider (if transmitted to OFAC by courier) on or before the 30th day after the postmark date on the envelope in which the Pre-Penalty Notice was mailed. If the Pre-Penalty Notice was personally delivered by a non-U.S. Postal Service agent authorized by OFAC, a response must be postmarked or date-stamped on or before the 30th day after the date of delivery.

    (ii) Extensions of time for response. If a due date falls on a federal holiday or weekend, that due date is extended to include the following business day. Any other extensions of time will be granted, at the discretion of OFAC, only upon specific request to OFAC.

    (3) Form and method of response. A response to a Pre-Penalty Notice need not be in any particular form, but it must be typewritten and signed by the alleged violator or a representative thereof, must contain information sufficient to indicate that it is in response to the Pre-Penalty Notice, and must include the OFAC identification number listed on the Pre-Penalty Notice. A copy of the written response may be sent by facsimile, but the original also must be sent to OFAC's Enforcement Division by mail or courier and must be postmarked or date-stamped in accordance with paragraph (b)(2) of this section.

    (c) Settlement. Settlement discussions may be initiated by OFAC, the alleged violator, or the alleged violator's authorized representative. For a description of practices with respect to settlement, see Appendix A to part 501 of this chapter.

    (d) Guidelines. Guidelines for the imposition or settlement of civil penalties or finding of violations by OFAC are contained in Appendix A to part 501 of this chapter.

    (e) Representation. A representative may act on behalf of the alleged violator, but any oral communication with OFAC prior to a written submission regarding the specific allegations contained in the Pre-Penalty Notice must be preceded by a written letter of representation, unless the PrePenalty Notice was served upon the alleged violator in care of the representative.

    § 566.703 Penalty imposition.

    If, after considering any written response to the Pre-Penalty Notice and any relevant facts, OFAC determines that there was a violation by the alleged violator named in the Pre-Penalty Notice and that a civil monetary penalty or finding of violation is appropriate, OFAC may issue a Penalty Notice or finding of violation to the violator containing a determination of the violation and the imposition of the monetary penalty, if appropriate. For additional details concerning issuance of a Penalty Notice or finding of violation, see Appendix A to part 501 of this chapter. The issuance of the Penalty Notice or finding of violation shall constitute final agency action. The violator has the right to seek judicial review of that final agency action in federal district court.

    § 566.704 Administrative collection; referral to United States Department of Justice.

    In the event that the violator does not pay the penalty imposed pursuant to this part or make payment arrangements acceptable to OFAC, the matter may be referred for administrative collection measures by the Department of the Treasury or to the United States Department of Justice for appropriate action to recover the penalty in a civil suit in a federal district court.

    Subpart H—Procedures
    § 566.801 Procedures.

    For license application procedures and procedures relating to amendments, modifications, or revocations of licenses; administrative decisions; rulemaking; and requests for documents pursuant to the Freedom of Information and Privacy Acts (5 U.S.C. 552 and 552a), see part 501, subpart E, of this chapter.

    § 566.802 Delegation by the Secretary of the Treasury.

    Any action that the Secretary of the Treasury is authorized to take pursuant to the Hizballah International Financing Prevention Act of 2015 (Pub. L. 114-102, 129 Stat. 2205 (50 U.S.C. 1701 note)) may be taken by the Director of OFAC or by any other person to whom the Secretary of the Treasury has delegated authority to so act.

    Subpart I—Paperwork Reduction Act
    § 566.901 Paperwork Reduction Act notice.

    For approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) of information collections relating to recordkeeping and reporting requirements, licensing procedures (including those pursuant to statements of licensing policy), and other procedures, see § 501.901 of this chapter. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB.

    Dated: April 11, 2016. John E. Smith, Acting Director, Office of Foreign Assets Control. Approved:

    Dated: April 11, 2016.

    Adam J. Szubin, Acting Under Secretary, Office of Terrorism and Financial Intelligence, Department of the Treasury.
    [FR Doc. 2016-08720 Filed 4-14-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2016-0208] RIN 1625-AA08 Special Local Regulation; Hebda Cup Rowing Regatta; Detroit River, Trenton Channel; Wyandotte, MI AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

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

    DATES:

    This temporary final rule is effective from 7:30 a.m. until 3 p.m. on April 30, 2016. For the purposes of enforcement, actual notice will be used on April 30, 2016.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0208 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 final rule, call or email Petty Officer Todd Manow, Prevention Department, Sector Detroit, Coast Guard; telephone 313-568-9508, email [email protected]

    SUPPLEMENTARY INFORMATION:

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

    On April 30, 2016, the Wyandotte Boat Club is holding a rowing regatta in which at least 100 youth rowers will participate in a race in the Trenton Channel, a tributary of the Detroit River. Due to the projected amount of human-powered watercraft on the water, there is a need to require vessels in the affected waterways to maintain a minimum speed for safe navigation. The rowing regatta will occur between 7:30 a.m. and 3 p.m. on April 30, 2016. This event has taken place under the same sponsorship in the same location annually for the past 51 years.

    The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency, for good cause, finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The final details of this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be impracticable because it would inhibit the Coast Guard's ability to event participants, spectators, and other waterway users during this youth rowing regatta.

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

    III. Legal Authority and Need for Rule

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

    IV. Discussion of Rule

    This rule establishes a temporary special local regulation from 7:30 a.m. until 3 p.m. on April 30, 2016. In light of the aforementioned hazards, the COTP has determined that a special local regulation is necessary to protect spectators, vessels, and participants. The special local regulation will encompass the following waterway: All waters of the Detroit River, Trenton Channel between the following two lines going from bank-to-bank: The first line is drawn directly across the channel from position 42°11.0′ N., 083°09.4′ W. (NAD 83); the second line, to the north, is drawn directly across the channel from position 42°11.7′ N., 083°8.9′ W. (NAD 83).

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

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

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

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

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

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

    B. Impact on Small Entities

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

    This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in this portion of the Detroit River, Trenton Channel in the vicinity of Wyandotte, MI between 7:30 a.m. and 3 p.m. on April 30, 2016.

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

    C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them. If this rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

    Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against entities that question or complain about this rule or any policy or action of the Coast Guard.

    D. Collection of Information

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

    E. Federalism

    A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

    F. Protest Activities

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

    G. Unfunded Mandates Reform Act

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

    H. Taking of Private Property

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

    I. Civil Justice Reform

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

    J. Protection of Children

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

    K. Indian Tribal Governments

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

    L. Energy Effects

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

    M. Technical Standards

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

    N. Environment

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

    List of Subjects in 33 CFR Part 100

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

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

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

    33 U.S.C. 1233.

    2. Add § 100.35T09-0208 to read as follows:
    § 100.35T09-0208 Special Local Regulation; Hebda Cup Rowing Regatta; Detroit River, Trenton Channel; Wyandotte, MI.

    (a) Regulated area. A regulated area is established to encompass the following waterway: All waters of the Detroit River, Trenton Channel between the following two lines going from bank-to-bank: The first line is drawn directly across the channel from position 42°11.0′ N., 083°9.4′ W. (NAD 83); the second line, to the north, is drawn directly across the channel from position 42°11.7′ N., 083°8.9′ W. (NAD 83).

    (b) Effective period. This section is effective and will be enforced from 7:30 a.m. until 3 p.m. on April 30, 2016.

    (c) Regulations. (1) Vessels transiting through the regulated area are to maintain the minimum speeds for safe navigation.

    (2) Vessel operators desiring to operate in the regulated area must contact the Coast Guard Patrol Commander to obtain permission to do so. The Captain of the Port Detroit (COTP) or his on-scene representative may be contacted via VHF Channel 16 or at 313-568-9560. Vessel operators given permission to operate within the regulated area must comply with all directions given to them by the COTP or his on-scene representative.

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

    Dated: March 25, 2016. Scott B. Lemasters, Captain, U. S. Coast Guard, Captain of the Port Detroit.
    [FR Doc. 2016-08781 Filed 4-14-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0228] Drawbridge Operation Regulation; Delaware River, Delair, NJ to Philadelphia, PA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Delair Bridge across the Delaware River, mile 104.6, between Philadelphia PA and Delair, NJ. The deviation is necessary to perform bridge repairs. This deviation allows the bridge to remain in the closed-to-navigation position.

    DATES:

    This deviation is effective from 5 a.m. on April 30, 2016 to 5 a.m. on June 11, 2016.

    ADDRESSES:

    The docket for this deviation, [USCG-2016-0228] is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Mrs. Traci Whitfield, Bridge Administration Branch Fifth District, Coast Guard; telephone (757) 398-6629, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Conrail, owner of the Delair Bridge, has requested a temporary deviation from the current operating regulation to perform urgent repairs by replacing wire ropes connecting the counterweights and the lift span. The bridge is a vertical lift-span bridge and has a vertical clearance in the closed position of 49 feet above mean high water.

    The current operating schedule is set out in 33 CFR 117.716. Under this temporary deviation, the bridge will remain in the closed-to-navigation position from 5 a.m. April 30, 2016 to 5 a.m. May 7, 2016; from 5 a.m. May 14, 2016 to 5 a.m. May 21, 2016; and from 5 a.m. June 4, 2016 to 5 a.m. June 11, 2016. The lift span will not be able to open since one counterweight will be detached until the end of the repair work.

    Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels unable to pass through the bridge in the closed position. The rope replacement construction schedule was developed through the coordination with Coast Guard Sector Delaware Bay and the Mariners' Advisory Committee for the Bay and River Delaware (MAC). The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

    Dated: April 11, 2016. Hal R. Pitts, Bridge Program Manager, Fifth Coast Guard District.
    [FR Doc. 2016-08690 Filed 4-14-16; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 81 [EPA-R09-OAR-2014-0636; FRL-9944-93-Region 9] Adequacy Status of Motor Vehicle Emissions Budgets in Submitted PM2.5 Moderate Area Plan for San Joaquin Valley; California AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of adequacy.

    SUMMARY:

    The Environmental Protection Agency (EPA) is notifying the public that the Agency has found that the motor vehicle emissions budgets (MVEBs or “budgets”) for the years 2014 and 2017 in the San Joaquin Valley Moderate Area Plan, as revised in a December 29, 2014 submittal, for the 2006 24-hour fine particulate (PM2.5) national ambient air quality standards (NAAQS) are adequate for transportation conformity purposes. The Moderate Area Plan was submitted to the EPA on March 4, 2013 by the California Air Resources Board (CARB) as a revision to the California State Implementation Plan (SIP) and includes a demonstration of reasonable further progress for the 2006 PM2.5 NAAQS. CARB submitted a Supplement to the Moderate Area Plan on November 6, 2014 (“2014 Supplement”) and a revision to the budgets on December 29, 2014. We refer to these submittals collectively as the “2012 PM2.5 Plan” or “Plan.” Upon the effective date of this notice of adequacy, the San Joaquin Valley metropolitan planning organizations (MPO) and the U.S. Department of Transportation (DOT) must use these budgets for future transportation conformity determinations.

    DATES:

    This finding is effective May 2, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Wienke Tax, U.S. EPA, Region IX, Air Division AIR-2, 75 Hawthorne Street, San Francisco, CA 94105-3901; (415) 947-4192 or [email protected].

    SUPPLEMENTARY INFORMATION:

    Throughout this document, whenever “we,” “us,” or “our” is used, we mean the EPA.

    This action is simply an announcement of a finding that we have already made. EPA Region IX sent a letter to CARB on April 1, 2016 stating that the motor vehicle emissions budgets in the submitted 2012 PM2.5 Plan for the reasonable further progress (RFP) milestone years of 2014 and 2017 are adequate.

    In response to an October 7, 2014 request by CARB for parallel processing of the revised budgets in the 2012 PM2.5 Plan,1 we announced the availability of the revised budgets on the EPA's adequacy review Web page at http://www.epa.gov/otaq/stateresources/transconf/currsips.htm from October 23, 2014 to November 24, 2014. We received no comments on the budgets during this period.

    1 See letter dated October 7, 2014, from Richard Corey, Executive Officer, CARB, to Jared Blumenfeld, Regional Administrator, EPA Region 9.

    On January 13, 2015, we proposed to approve these budgets as part of our proposed action on the 2012 PM2.5 Plan and 2014 Supplement.2 We received two comments on the budgets.3 We respond to the first of these two comments below. The second comment concerns the transportation conformity interpollutant trading mechanism in the 2012 PM2.5 Plan that we proposed to approve for use in transportation conformity analyses. We will respond to this comment when we take final action on the interpollutant trading mechanism as part of our final action on the 2012 PM2.5 Plan and 2014 Supplement. The interpollutant trading mechanism cannot be used until it is approved as part of the SIP. Therefore, the appropriate venue for responding to the comment on the trading mechanism is the final rule on the 2012 PM2.5 Plan and 2014 Supplement.

    2 80 FR 1816 at 1841 (January 13, 2015).

    3 See letter dated February 27, 2015, from Paul Cort and Adenike Adeyeye, Earthjustice, to Wienke Tax, Air Planning Office, EPA Region 9.

    Transportation conformity is required by Clean Air Act section 176(c). The EPA's conformity rule requires that transportation plans, transportation improvement programs, and projects conform to a SIP and establishes the criteria and procedures for determining whether or not they do. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the NAAQS.

    The criteria by which we determine whether a SIP's MVEBs are adequate for conformity purposes are outlined in 40 CFR 93.118(e)(4) which was promulgated in our August 15, 1997 final rule (62 FR 43780 at 43781-43783). We have further described our process for determining the adequacy of submitted SIP MVEBs in our July 1, 2004 final rule (69 FR 40004 at 40038), and we used the information in these resources in making our adequacy determination. Please note that an adequacy review is separate from the EPA's completeness review and should not be used to prejudge the EPA's ultimate action on the SIP. Even if we find a budget adequate, the SIP could later be disapproved.

    Response to Comment

    Comment: Earthjustice asserts that the EPA must disapprove the RFP demonstration in the 2012 PM2.5 Plan and 2014 Supplement because it does not adequately address ammonia emission reductions and, therefore, does not provide “such annual incremental reductions in emissions of the relevant air pollutant as are required . . . for the purpose of ensuring attainment . . . by the applicable date.” Earthjustice argues that, because the RFP demonstration is not approvable, the EPA cannot find that the motor vehicle emissions budgets in the 2012 PM2.5 Plan and 2014 Supplement are consistent with applicable requirements for reasonable further progress, as required by 40 CFR 98.118(e)(4)(iv).

    Response: On January 13, 2015, the EPA proposed to approve several elements of the 2012 PM2.5 Plan and 2014 Supplement, which California submitted to address Clean Air Act requirements for the 2006 PM2.5 NAAQS in the San Joaquin Valley.4 As part of this action, the EPA proposed to approve the Plan's RFP demonstration for 2014 and 2017, based on a conclusion that the 2014 and 2017 emissions projections for direct PM2.5, nitrogen oxides (NOX), sulfur dioxide (SO2), and ammonia (NH3) reflect full implementation of the State's and District's Reasonably Available Control Measures/Reasonably Available Control Technology control strategy, which achieves substantial reductions in emissions of each of these pollutants over the period covered by the Plan. Id. at 1835-37. The EPA also proposed to approve the direct PM2.5 and NOX MVEBs for 2014 and 2017, based on a conclusion that these MVEBs are consistent with applicable requirements for reasonable further progress and the other adequacy requirements. Id. at 1838-41. Finally, in accordance with 40 CFR 93.102(b)(2)(v), the EPA proposed to find that on-road emissions of volatile organic compounds (VOC), SO2, and NH3 are not significant contributors to the PM2.5 nonattainment problem in the SJV area, and accordingly, that transportation conformity requirements do not apply for these pollutants in this area. Id. at 1840.

    4 See 80 FR 1816 (January 13, 2015).

    In PM2.5 nonattainment areas, the transportation conformity provisions of 40 CFR part 93, subpart A, apply with respect to emissions of VOC, SO2 and/or NH3 if the EPA Regional Administrator or the director of the state air agency has made a finding that on-road emissions of any of these precursors within the nonattainment area are a significant contributor to the PM2.5 nonattainment problem and has so notified the MPO and DOT, or if the applicable implementation plan (or implementation plan submission) establishes an approved (or adequate) budget for such emissions as part of the reasonable further progress, attainment or maintenance strategy. 40 CFR 93.102(b)(2)(v). With respect to VOC, SO2, and NH3, neither the EPA nor the State has made a finding that on-road emissions of any of these precursors are a significant contributor to the PM2.5 nonattainment problem in the SJV area, and neither the approved California SIP nor the submitted 2012 PM2.5 Plan and 2014 Supplement establish adequate MVEBs for such emissions as part of an RFP, attainment or maintenance strategy for the PM2.5 NAAQS. Accordingly, the transportation conformity provisions of 40 CFR part 93, subpart A, do not apply with respect to emissions of VOC, SO2 or NH3 for purposes of the 2006 PM2.5 NAAQS in the SJV.

    The provisions of 40 CFR part 93, subpart A, apply with respect to emissions of NOX because neither the EPA nor the State has made a finding that on-road emissions of NOX within the SJV nonattainment are not a significant contributor to the PM2.5 nonattainment problem, and because the 2012 PM2.5 Plan and 2014 Supplement establish adequate budgets for such emissions as part of the Plan's RFP strategy. 40 CFR 93.102(b)(2)(iv). The provisions of 40 CFR part 93, subpart A, also apply with respect to emissions of direct PM2.5 because PM2.5 is a criteria pollutant identified in 40 CFR 93.102(b)(1).

    In order to find an MVEB in a submitted control strategy implementation plan revision to be adequate for transportation conformity purposes, the EPA must find, among other things, that the motor vehicle emissions budget(s), when considered together with all other emission sources, is consistent with applicable requirements for reasonable further progress, attainment, or maintenance (whichever is relevant to the given plan). 40 CFR 93.118(e)(4)(iv). Because the provisions of 40 CFR part 93, subpart A, apply only with respect to emissions of NOX and direct PM2.5 for purposes of the 2006 PM2.5 NAAQS in the SJV area, we have evaluated the submitted NOX and direct PM2.5 MVEBs for consistency with our adequacy criteria in § 93.118(e)(4). The commenter's arguments about NH3 emissions are not germane to our evaluation of the MVEBs under these adequacy criteria.

    As explained in our January 13, 2015 proposed rule, the 2014 and 2017 MVEBs for NOX and direct PM2.5 in the 2012 PM2.5 Plan and 2014 Supplement are consistent with the RFP demonstration with respect to these pollutants in the submitted plan. We find, therefore, that these MVEBs meet the requirement in 40 CFR 93.118(e)(4) for consistency with applicable requirements for RFP in the submitted plan. We note that our adequacy review is a cursory review of the SIP and MVEBs to ensure that the minimum adequacy criteria are met before a submitted budget is used in a conformity determination. This adequacy finding should not be used to prejudge the EPA's final rulemaking action on the SIP.

    In summary, we are announcing our finding that the motor vehicle emissions budgets for the years 2014 and 2017 from the 2012 PM2.5 Plan are adequate for transportation conformity purposes. The finding is available at the EPA's conformity Web site: http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm. The adequate MVEBs are provided in the following table:

    Adequate MVEBs in the San Joaquin Valley for the 2006 24-Hour PM2.5 Standards [Winter daily average in tons] County 2014 PM2.5 NOX 2017 PM2.5 NOX Fresno 1.0 31.6 0.9 25.2 Kern (SJV) 1.2 43.2 1.0 34.4 Kings 0.2 8.8 0.2 7.2 Madera 0.3 8.7 0.2 7.0 Merced 0.5 17.2 0.4 13.7 San Joaquin 0.7 20.0 0.6 15.9 Stanislaus 0.5 15.1 0.5 12.0 Tulare 0.5 14.3 0.4 10.7 Total * 4.9 159.0 4.3 126.0 Source: Letter, Richard Corey, Executive Officer, CARB, to Jared Blumenfeld, Regional Administrator, EPA Region 9, dated December 29, 2014, and Staff Report, Appendix A, Table C-4. * Totals reflect disaggregated emissions and may not add exactly as shown here due to rounding. Letter, Richard Corey, Executive Officer, CARB, to Jared Blumenfeld, Regional Administrator, EPA Region 9, dated December 29, 2014, Staff Report with Attachment, revised Table C-4, “Transportation Conformity Budgets” to 2012 PM2.5 Plan. Authority:

    42 U.S.C. 7401 et seq.

    Dated: April 1, 2016. Jared Blumenfeld, Regional Administrator, Region IX.
    [FR Doc. 2016-08510 Filed 4-14-16; 8:45 am] BILLING CODE 6560-50-P
    81 73 Friday, April 15, 2016 Proposed Rules GOVERNMENT ACCOUNTABILITY OFFICE 4 CFR Part 21 Government Accountability Office, Administrative Practice and Procedure, Bid Protest Regulations, Government Contracts AGENCY:

    Government Accountability Office.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Government Accountability Office (GAO) is proposing to amend its Bid Protest Regulations, promulgated in accordance with the Competition in Contracting Act of 1984 (CICA), to implement the requirements in sec. 1501 of the Consolidated Appropriations Act for Fiscal Year 2014, which was enacted on January 14, 2014, and to make certain administrative changes. The proposed amendments implement the legislation's direction to establish and operate an electronic filing and document dissemination system for the filing of bid protests with GAO. At this time, GAO believes that these proposed revisions are the only regulatory changes necessary to implement the statutory requirement of sec. 1501. The proposed amendments also include administrative changes to reflect current practice and to streamline the bid protest process.

    DATES:

    Comments must be submitted on or before May 16, 2016.

    ADDRESSES:

    Comments may be submitted by email at [email protected], to the attention of Jonathan L. Kang, Senior Attorney, Government Accountability Office, 441 G Street NW., Washington, DC 20548. GAO intends to make all comments filed available to the public, including names and other identifying information. Information in a submission that the sender does not believe should be released should be clearly marked.

    FOR FURTHER INFORMATION CONTACT:

    Ralph O. White (Managing Associate General Counsel, [email protected]), Kenneth E. Patton (Managing Associate General Counsel, [email protected]) or Jonathan L. Kang (Senior Attorney, [email protected]).

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    GAO is not subject to the Administrative Procedures Act and accordingly is not required by law to seek comments before issuing a final rule. However, GAO has decided to invite written comments regarding the proposed revisions. Application of the Administrative Procedures Act to GAO is not to be inferred from this invitation for comments. GAO will consider all comments received on or before the closing date for comments. GAO may change the proposed revisions based on the comments received.

    Background

    GAO determined to undertake these revisions to GAO's Bid Protest Regulations as the result of a statutory requirement imposed by the Consolidated Appropriations Act for 2014, Public Law 113-76, 128 Stat. 5 (Jan. 14, 2014). Section 1501 of this act directs GAO to establish and operate an electronic filing and document dissemination system, “under which, in accordance with procedures prescribed by the Comptroller General—(A) a person filing a protest under this subchapter may file the protest through electronic means; and (B) all documents and information required with respect to the protest may be disseminated and made available to the parties to the protest through electronic means.” Public Law 113-76, div. I, title I, sec. 1501, 128 Stat. 5, 433-34 (Jan. 17, 2014). At the time of this proposed rule, GAO is developing the system, which will be called the Electronic Protest Docketing System (EPDS). EPDS will be the sole means for filing a bid protest at GAO (with the exception of protests containing classified information), and will enable parties to a bid protest and GAO to file and receive documents. Additional guidance for the use of EPDS will be provided by GAO, separate from the regulations in 4 CFR part 21.

    In addition to directing GAO to establish and operate an electronic filing and document dissemination system, sec. 1501 of the Consolidated Appropriations Act for 2014 authorizes GAO to “require each person who files a protest under this subchapter to pay a fee to support the establishment and operation of the electronic system under this subsection.” Public Law 113-76, div. I, title I, sec. 1501, 128 Stat. 5, 434 (Jan. 17, 2014). GAO anticipates requiring persons filing a protest to pay a fee to file a protest through EPDS, which, as discussed above, will be the sole means for filing a bid protest at GAO. Additional guidance regarding procedures for payment of the fee will be provided by GAO, separate from the regulations in 4 CFR part 21.

    GAO anticipates the bid protest filing fee will be $350. GAO derived the fee using actual costs GAO has incurred to develop the system, estimates of future costs for hosting and maintaining the system (adjusted for inflation), estimates of future annual bid protest filings as determined by considering historical filings of the past five fiscal years, and a recovery period for development costs of approximately six years. System establishment costs include payments made by GAO under an interagency agreement for development of the system, as well as GAO's internal costs incurred for system development. Costs to maintain the system include estimated payments for post-development hosting and support of the electronic protest filing system, as well as estimates of GAO's internal costs associated with maintaining the system after it has been deployed. All fees collected will be maintained in a separate account established by GAO. The fee will be reviewed every two years to ensure that it is properly calibrated to recover the costs of establishing and maintaining the system.

    The proposed revisions to GAO's Bid Protest Regulations to implement sec. 1501 of the Consolidated Appropriations Act for Fiscal Year 2014 and to make certain administrative changes to reflect current practice and to streamline the bid protest process are set forth below:

    Interested Party

    GAO proposes to revise paragraph (a)(2) of 4 CFR 21.0 to clarify that the Office of Management and Budget should be abbreviated as “OMB.”

    Federal Agency or Agency

    GAO proposes to revise paragraph (c) of 4 CFR 21.0 to change a reference to the Architect of the Capitol to be gender-neutral.

    Electronic Protest Docket System (EPDS)

    GAO proposes to redesignate paragraph (f) of 4 CFR 21.0 as paragraph (g), redesignate paragraph (g) as paragraph (h), and add a new paragraph (f). Revised paragraph (f) defines EPDS as GAO's web-based electronic docketing system. In the final rule, GAO will provide a Web site where additional guidance regarding the EPDS may be found.

    To clarify how a document is “filed” under GAO's Bid Protest Regulations, GAO proposes to revise redesignated paragraph (g) to specify that EPDS is the sole method for filing a document with GAO for a bid protest (with the exception of protests containing classified material, as explained in a sentence added to the revised paragraph (h) of 4 CFR 21.1). The proposed revisions throughout this proposed rule reflect that all filings are presumed to be made through EPDS (with the exception of protests containing classified material), which will enable the parties and GAO to file and receive documents.

    Filing a Protest

    GAO proposes to revise paragraph (b) of 4 CFR 21.1 to specify that EPDS will be the sole means for filing a bid protest at GAO.

    GAO proposes to revise paragraph (c)(1) of 4 CFR 21.1 to ensure a consistent reference to the term “email.”

    GAO proposes to revise the last sentence of paragraph (g) of 4 CFR 21.1 to reflect the requirement in redesignated paragraph (g) of 4 CFR 21.0 that documents must be filed through EPDS.

    GAO proposes to add a sentence to paragraph (h) of 4 CFR 21.1 to reflect that documents containing classified material may not be filed through EPDS.

    Time for Filing a Protest

    GAO proposes to add a sentence to paragraph (a)(1) of 4 CFR 21.2 to clarify the time for filing challenges to a solicitation where the basis for a protest becomes known when there is no solicitation closing date or when no further submissions in response to the solicitation are anticipated. Such protests must be filed within 10 days of when the alleged impropriety was known or should have been known.

    GAO proposes to revise paragraph (a)(2) of 4 CFR 21.2 to clarify that the 10-day “safe-harbor” provision in paragraph (a)(2) (i.e., the provision in paragraph (a)(2) establishing that protests challenging a procurement conducted on the basis of competitive proposals under which a debriefing is requested and, when requested, is required shall be filed not later than 10 days after the date on which the debriefing is held) does not apply to protests challenging alleged solicitation improprieties covered by paragraph (a)(1) of 4 CFR 21.2. This clarification resolves a potential uncertainty in 4 CFR 21.2(a)(2) that was addressed by GAO in a recent decision, Protect the Force, Inc.—Recon., B-411897.3, Sept. 30, 2015, 2015 CPD ¶ 306, wherein we denied the protester's request to reconsider our dismissal of its protest challenging the terms of a solicitation as untimely. The protest was filed within 10 days of a requested and required debriefing, but more than 10 days after the agency allegedly revised its solicitation. Because the solicitation did not establish a new closing date, we concluded that the challenge to the terms of the solicitation was required to be filed within 10 days of the revision to the solicitation. We concluded that the outcome in the prior dismissal was consistent with our decision in Armorworks Enters., LLC, B-400394, B-400394.2, Sept. 23, 2008, 2008 CPD ¶ 176 at 6, and the principles enunciated by the United States Court of Appeals for the Federal Circuit in Blue & Gold Fleet, L.P. v. United States, 492 F.3d 1308, 1313-14 (Fed. Cir. 2007). The revision here is to ensure that paragraph (a)(2) of 4 CFR 21.2 expressly reflects our decision in Protect the Force, Inc.—Recon.

    GAO proposes to revise paragraph (a)(3) of 4 CFR 21.2 to make a minor phrasing change for purposes of consistency to the requirement that protests to GAO following agency-level protests must be filed within 10 days of actual or constructive knowledge of initial adverse agency action.

    Communications Among Parties

    GAO proposes to revise the heading of 4 CFR 21.3.

    GAO proposes to revise paragraph (a) of 4 CFR 21.3 to make minor phrasing changes for purposes of consistency, and to reflect the requirement in redesignated paragraph (g) of 4 CFR 21.0 that documents must be filed through EPDS. Revised paragraph (a) also requires that parties to a protest must provide copies of all communications with the agency or other parties to the protest to the other participating parties either through EPDS or email. When the final rule is published GAO will provide a link to a GAO Web site in revised paragraph (a) that will provide information concerning when communications must be made through EPDS or email.

    Submission of Agency Report

    GAO proposes to revise paragraph (c) of 4 CFR 21.3 to reflect the requirement in redesignated paragraph (g) of 4 CFR 21.0 that documents must be filed through EPDS. Revised paragraph (c) also clarifies that if the fifth day for filing the agency's required response to a protester's request for documents falls on a weekend or federal holiday, the response shall be filed on the last business day that precedes the weekend or federal holiday.

    GAO proposes to revise paragraph (d) of 4 CFR 21.3 to reflect the requirement in redesignated paragraph (g) of 4 CFR 21.0 that documents must be filed through EPDS. Revised paragraph (d) also deletes the requirement for the agency report to include a copy of the protest, as this document will have already been provided to all parties.

    GAO proposes to revise paragraph (e) of 4 CFR 21.3 to provide that where a protester or intervenor does not have counsel admitted to a protective order, and documents are withheld from the protester or intervenor on that basis, the agency must provide appropriately-redacted documents that adequately inform the protester or intervenor of the basis for the agency's arguments in response to the protest. In the final rule, the revised paragraph (e) will provide a link to a GAO Web site that provides information concerning filing of documents when no protective order is issued, or where a protester or intervenor is not admitted to a protective order.

    Additional Documents

    GAO proposes to revise paragraph (f) of 4 CFR 21.3 to reflect the requirement in redesignated paragraph (g) of 4 CFR 21.0 that documents must be filed through EPDS. Paragraph (f) is also revised to make minor phrasing changes, consistent with the proposed revisions in paragraph (c) of 4 CFR 21.3.

    GAO proposes to revise paragraphs (g) and (h) of 4 CFR 21.3 to reflect the requirement in redesignated paragraph (g) of 4 CFR 21.0 that documents must be filed through EPDS.

    GAO proposes to revise paragraph (i) of 4 CFR 21.3 by replacing the previous section with new paragraphs (i)(1), (i)(2), and (i)(3), to clarify the time when comments on the agency report must be filed. New paragraph (i)(1) provides that comments on the agency report must be filed within 10 days after the agency files the report, unless GAO establishes a shorter period of time or grants an extension. New paragraph (i)(2) provides that a protest shall be dismissed if the protester does not file comments within the period of time established in revised paragraph (i)(1). New paragraph (i)(3) provides that a protest allegation or argument shall be dismissed where the agency report responds to the allegation or argument, but the protester's comments do not address the agency's response. New paragraph (i)(3) reflects a longstanding practice by GAO, described in numerous GAO bid protest decisions.

    Protective Orders

    GAO proposes to revise paragraph (a) of 4 CFR 21.4 to reflect that GAO generally does not issue a protective order where an intervenor retains counsel, but the protester does not. This revision reflects GAO's longstanding practice of generally permitting the protester's decision whether to retain counsel to dictate whether GAO will issue a protective order. This practice is consistent with GAO's statutory mandate to provide for an inexpensive protest forum. 31 U.S.C. 3554(a)(1). Notwithstanding this general practice, GAO may, if circumstances warrant, issue a protective order where the protester is not represented by counsel.

    GAO proposes to redesignate paragraph (b) of 4 CFR 21.4 as paragraph (c), redesignate paragraph (c) as paragraph (d), redesignate paragraph (d) as paragraph (e), and add a new paragraph (b). New paragraph (b) provides that when parties file documents that are covered by a protective order, the parties must provide copies of proposed redacted versions of the document to the other parties. Proposed redacted versions of documents should not be filed in EPDS; rather, the party responsible for preparing the proposed redacted version of the document should provide the document to the other parties by email or facsimile. New paragraph (b) provides that, where appropriate, the exhibits to the agency report or other documents may be proposed for redaction in their entirety. New paragraph (b) also provides that the party that files the protected document must file in EPDS within 5 days a final, agreed-to redacted version of the document. New paragraph (b) also directs the parties to seek GAO's resolution of any disputes concerning redacted documents.

    GAO proposes to revise redesignated paragraph (c) of 4 CFR 21.4, to reflect the requirements of revised paragraph (e) of 4 CFR 21.3.

    GAO proposes to revise redesignated paragraph (d) of 4 CFR 21.4, to reflect the requirement in redesignated paragraph (g) of 4 CFR 21.0 that documents must be filed through EPDS.

    Protest Issues Not for Consideration

    GAO proposes to revise paragraph (a) of 4 CFR 21.5 to reflect the recodification of statutory provisions in Title 41 of the United States Code.

    GAO proposes to revise paragraph (b) of 4 CFR 21.5 to make consistent references to the Small Business Administration (SBA). GAO proposes to revise paragraph (d) of 4 CFR 21.5 to reflect the recodification of statutory provisions in Title 41 of the United States Code.

    GAO proposes to revise paragraph (e) of 4 CFR 21.5 to revise the term “in GAO” to “with GAO.”

    GAO proposes to revise paragraph (f) of 4 CFR 21.5 to replace the word “which” with “that” in two locations.

    GAO proposes to revise paragraph (g) of 4 CFR 21.5 to reflect the recodification of statutory provisions in Title 40 of the United States Code.

    GAO proposes to revise paragraph (h) of 4 CFR 21.5 to reflect the requirement in redesignated paragraph (g) of 4 CFR 21.0 that documents must be filed through EPDS.

    GAO proposes to add paragraph (l) to 4 CFR 21.5 to reflect that, under the provisions of 10 U.S.C. 2304(e)(1) and 41 U.S.C. 4106(f)(1), GAO does not have jurisdiction to review protests of orders issued under task or delivery order contracts where the order is valued at less than $10 million, unless it is alleged that the order increases the scope, period, or maximum value of the contract under which the order was issued. At the time of this proposed rule, the provisions concerning procurements under Title 10 are permanent. The provisions concerning procurements under Title 41, however, are subject to a sunset clause, under which GAO's jurisdiction to hear protests over $10 million will no longer be in effect after September 30, 2016. 41 U.S.C. 4106(f)(1).

    GAO proposes to add paragraph (m) to 4 CFR 21.5 to clarify GAO's review of awards that are not procurement contracts. Proposed new paragraph (m) reflects GAO's longstanding view that GAO's statutory jurisdiction under CICA does not include the review of protests of awards, or solicitations for awards, or of agreements other than procurement contracts, with the exception of instances where an agency has agreed in writing to have nonstatutory protests decided by GAO, as described in 4 CFR 21.13. The new paragraph (m) proposes to clarify that GAO reviews protests that an agency is improperly using a nonprocurement instrument.

    Withholding of Award and Suspension of Contract Performance

    GAO proposes to revise 4 CFR 21.6 to require agencies to file a notification where it overrides a statutory requirement to withhold award or suspend contract performance and to require agencies to file any issued determination. 31 U.S.C. 3553(c)(2)(B), (d)(3)(C)(ii). GAO previously did not require this information, but believes it is necessary to implement our statutory requirement, pursuant to 31 U.S.C. 3554(b)(2), to consider the basis for an agency's override in determining the remedy to recommend in the event GAO sustains a protest, as provided in paragraph (c) of 4 CFR 21.8.

    Hearings

    GAO proposes to revise paragraph (a) of 4 CFR 21.7 to reflect the requirement in redesignated paragraph (g) of 4 CFR 21.0 that documents must be filed through EPDS.

    GAO proposes to revise paragraph (e) of 4 CFR 21.7 to reflect GAO's longstanding practice of not providing hearing transcripts, but permitting the parties to provide for transcription of a hearing as long as a copy of such transcript is provided to GAO at the parties' expense.

    Remedies

    GAO proposed to add new headings to paragraphs (e) and (f) which will distinguish the different remedial recommendations.

    Recommendation for Reimbursement of Costs

    GAO proposes to revise paragraph (e) of 4 CFR 21.8 to provide more specific guidance regarding recommendations for reimbursement of protest costs. Revised paragraph (e) requires the agency to file a response to the request within 15 days after the request is filed. The prior version of paragraph (e) provided that the agency “may” respond within 15 days. This change is intended to allow the agency to either agree to the request, which eliminates the need for GAO to issue a decision, or to provide a specific basis for the agency's objection to the request, upon which the protester must comment. Revised paragraph (e) also requires the protester to file comments on the agency's response within 10 days, and further provides that GAO will dismiss the request if the protester fails to file comments within 10 days. This change is intended to provide an adequate record for GAO to review in issuing its decision, and also reflects that GAO will not issue a decision where the protester effectively abandons its request by failing to comment on the agency's response.

    Recommendation on the Amount of Costs

    GAO proposes to add a heading to paragraph (f) of 4 CFR 21.8 to highlight specific guidance regarding recommendations on the amount of costs to be reimbursed.

    GAO proposes to revise paragraph (f)(2) by moving the discussion of disagreements between the agency and protester to revised paragraph (f)(3) for purposes of clarity.

    New paragraph (f)(3) reflects GAO's longstanding practice of not recommending that an agency reimburse a protester its costs for filing and pursuing a protest where the protester does not diligently pursue its claim for costs.

    GAO proposes to add a new paragraph (f)(4) to require the agency to file a response to the request within 15 days after the request is filed. The prior version of paragraph (f) did not require the agency to respond to a request. This change is intended to allow the agency to either agree to the request, which eliminates the need for GAO to issue a decision, or to provide a specific basis for the agency's objection to the request, upon which the protester must comment. Revised paragraph (f)(4) also requires the protester to file comments on the agency's response within 10 days, and further provides that GAO will dismiss the request if the protester fails to file comments within 10 days. This change is intended to provide an adequate record for GAO to review in issuing its decision, and also reflects that GAO will not issue a decision where the protester effectively abandons its request by failing to comment on the agency's response.

    GAO proposes to add a new paragraph (f)(5) to reflect that GAO will recommend the amount of costs the agency should pay, and that GAO may also recommend that the agency pay the protester the costs of pursuing a claim for costs before GAO.

    GAO proposes to redesignate former paragraph (f)(3) as paragraph (f)(6). Redesignated paragraph (f)(6) is revised to require the agency to file within 60 days a notification of the action the agency took in response to the recommendation.

    Time for Decision by GAO

    GAO proposes to revise paragraph (a) of 4 CFR 21.9 to reflect that a bid protest will be resolved within 100 days after it is filed, but that other decisions are not subject to the 100-day deadline. Revised paragraph (a) provides that GAO will attempt to resolve a request for recommendation for reimbursement of protest costs under 4 CFR 21.8(e), a request for recommendation on the amount of protest costs under 4 CFR 21.8(f), or a request for reconsideration under 4 CFR 21.14 within 100 days after the request is filed.

    Express Options, Flexible Alternative Procedures, Accelerated Schedules, Summary Decisions, and Status and Other Conferences

    GAO proposes to revise paragraphs (a), (c), (d)(1), (d)(2), and (d)(3) of 4 CFR 21.10 to reflect the requirement in redesignated paragraph (g) of 4 CFR 21.0 that documents must be filed through EPDS.

    Effect of Judicial Proceedings

    GAO proposes to revise paragraph (a) of 4 CFR 21.11 to reflect the requirement in redesignated paragraph (g) of 4 CFR 21.0 that documents must be filed through EPDS.

    Distribution of Decisions

    GAO proposes to revise paragraph (b) of 4 CFR 21.12 to reflect that GAO will distribute decisions on protests to the parties through EPDS.

    Nonstatutory Protests

    GAO proposes to revise paragraph (b) of 4 CFR 21.13 to reflect proposed revisions to sections 21.6 and 21.8 of this title.

    Request for Reconsideration

    GAO proposes to revise paragraph (b) of 4 CFR 21.14 to reflect the requirement in redesignated paragraph (g) of 4 CFR 21.0 that documents must be filed through EPDS.

    GAO proposes to revise paragraph (c) of 4 CFR 21.11 to clarify that the word “our” refers to GAO.

    List of Subjects in 4 CFR Part 21

    Administrative practice and procedure, Appeals, Bid protest regulations, Government contracts.

    For the reasons set out in the preamble, title 4, chapter i, subchapter B, part 21 of the Code of Federal Regulations is proposed to be revised to read as follows:

    PART 21—BID PROTEST REGULATIONS 1. The authority citation for Part 21 continues to read as follows: Authority:

    31 U.S.C. 3551-3556.

    2. In § 21.0: a. Amend paragraph (a)(2) introductory text by adding the abbreviation “(OMB)” between the words Budget and Circular; b. Amend paragraph (c) by removing the word “his” and adding in its place the words “the Architect's”; c. Redesignate paragraphs (f) and (g) as paragraphs (g) and (h), respectively, and add a new paragraph (f); d. Revise newly redesignated paragraph (g).

    The revision and addition read as follows:

    § 21.0 Definitions.

    (f) Electronic Protest Docket System (EPDS) is GAO's web-based electronic docketing system. GAO's Web site includes instructions and guidance on the use of EPDS.

    (g) A document is filed on a particular day when it is received in EPDS by 5:30 p.m., Eastern Time. Delivery of a protest or other document by means other than those set forth in the online EPDS instructions does not constitute a filing. Filing a document in EPDS constitutes notice to all parties of that filing.

    3. Amend § 21.1 by revising paragraphs (b) and (c)(1), the third sentence of paragraph (g), and by adding a new first sentence to paragraph (h) to read as follows:
    § 21.1 Filing a protest.

    (b) Protests must be filed through the EPDS.

    (c)* * *

    (1) Include the name, street address, email address, and telephone and facsimile numbers of the protester,

    (g) * * * This information must be identified wherever it appears, and within 1 day after the filing of its protest, the protester must file a final redacted copy of the protest which omits the information.

    (h) Protests and other documents containing classified information may not be filed through the EPDS. * * *

    4. Amend § 21.2 by adding a third sentence to paragraph (a)(1) and by revising the second sentence of paragraph (a)(2) and the first sentence of paragraph (a)(3) to read as follows:
    § 21.2 Time for filing.

    (a)(1) * * * If no closing time has been established, or if no further submissions are anticipated, any alleged solicitation improprieties must be protested within 10 days of when the alleged impropriety was known or should have been known.

    (2) * * * In such cases, with respect to any protest basis which is known or should have been known either before or as a result of the debriefing, and which does not involve an alleged solicitation impropriety covered by paragraph (a)(1) of this section, the initial protest shall not be filed before the debriefing date offered to the protester, but shall be filed not later than 10 days after the date on which the debriefing is held.

    (3) If a timely agency-level protest was previously filed, any subsequent protest to GAO must be filed within 10 days of actual or constructive knowledge of initial adverse agency action, provided the agency-level protest was filed in accordance with paragraphs (a)(1) and (2) of this section, unless the agency imposes a more stringent time for filing, in which case the agency's time for filing will control. * * *

    5. Amend § 21.3 by revising the section heading and paragraphs (a), (c), (d), and (e), the first sentence of paragraph (f), paragraph (g), the first sentence of paragraph (h), and paragraph (i) to read as follows:
    § 21.3 Notice of protest, communications among parties, submission of agency report, and time for filing of comments on report.

    (a) GAO shall notify the agency within 1 day after the filing of a protest, and, unless the protest is dismissed under this part, shall promptly provide a written confirmation to the agency and an acknowledgment to the protester. The agency shall immediately give notice of the protest to the awardee if award has been made or, if no award has been made, to all bidders or offerors who appear to have a substantial prospect of receiving an award. The agency shall provide copies of the protest submissions to those parties, except where disclosure of the information is prohibited by law, with instructions to communicate further directly with GAO. All parties shall provide copies of all protest communications to the agency and to other participating parties either through EPDS or by email. GAO's Web site includes guidance regarding when to file through EPDS versus communicating by email or other means.

    (c) The agency shall file a report on the protest within 30 days after receiving notice of the protest from GAO. The report provided to the parties need not contain documents which the agency has previously provided or otherwise made available to the parties in response to the protest. At least 5 days prior to the filing of the report, in cases in which the protester has filed a request for specific documents, the agency shall file a response to the request for documents. If the fifth day prior to the filing of the report falls on a weekend or Federal holiday, the response shall be filed on the last business day that precedes the weekend or holiday. The agency's response shall, at a minimum, identify whether the requested documents exist, which of the requested documents or portions thereof the agency intends to produce, which of the requested documents or portions thereof the agency intends to withhold, and the basis for not producing any of the requested documents or portions thereof. Any objection to the scope of the agency's proposed disclosure or nondisclosure of documents must be filed within 2 days of receipt of this response.

    (d) The report shall include the contracting officer's statement of the relevant facts, including a best estimate of the contract value, a memorandum of law, and a list and a copy of all relevant documents, or portions of documents, not previously produced, including, as appropriate: the bid or proposal submitted by the protester; the bid or proposal of the firm which is being considered for award, or whose bid or proposal is being protested; all evaluation documents; the solicitation, including the specifications; the abstract of bids or offers; and any other relevant documents. In appropriate cases, a party may file a request that another party produce relevant documents, or portions of documents, that are not in the agency's possession.

    (e) Where a protester or intervenor does not have counsel admitted to a protective order and documents are withheld from the protester or intervenor on that basis, the agency shall file redacted documents that adequately inform the protester and/or intervenor of the basis of the agency's arguments in response to the protest. GAO's Web site provides guidance regarding filing documents where no protective order is issued or where a protester or intervenor does not have counsel admitted to a protective order.

    (f) The agency may file a request for an extension of time for the submission of the response to be provided by the agency pursuant to § 21.3(c) or for the submission of the agency report. * * *

    (g) The protester may file a request for additional documents after receipt of the agency report when their existence or relevance first becomes evident. Except when authorized by GAO, any request for additional documents must be filed not later than 2 days after their existence or relevance is known or should have been known, whichever is earlier. The agency shall file the requested documents, or portions of documents, within 2 days or explain why it is not required to produce the documents.

    (h) Upon a request filed by a party, GAO will decide whether the agency must provide any withheld documents, or portions of documents, and whether this should be done under a protective order. * * *

    (i)(1) Comments on the agency report shall be filed within 10 days after the agency has filed the report, except where GAO has granted an extension of time, or where GAO has established a shorter period for filing of comments. Extensions will be granted on a case-by-case basis.

    (2) The protest shall be dismissed unless the protester files comments within the period of time established in § 21.3(i)(1).

    (3) GAO will dismiss any protest allegation or argument where the agency's report responds to the allegation or argument, but the protester's comments fail to address that response.

    6. In § 21.4: a. Amend paragraph (a) by removing the word “under” in the first sentence and adding in its place the word “to”; and adding a fifth sentence; b. Redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and (e), respectively, and add a new paragraph (b); c. Revise the first sentence of newly redesignated paragraph (c); and revise the first and third sentences of newly designated paragraph (d).

    The addition and revisions read as follows:

    § 21.4 Protective orders.

    (a) * * * GAO generally does not issue a protective order where an intervenor retains counsel, but the protester does not.

    (b) Any agency or party filing a document that the agency or party believes to contain protected material shall provide to the other parties (unless they are not admitted to the protective order) an initial proposed redacted version of the document within 1 day after the protected version is filed. Where appropriate, the exhibits to the agency report or other documents may be proposed for redaction in their entirety. Within 5 days after the proposed redacted version of a document is provided, the party that authored the document shall file a final redacted version of the document, which has been agreed to by all of the parties. Only the final agreed-to version of a redacted document must be filed. If the parties are unable to reach an agreement regarding redactions, the objecting party may submit the matter to GAO for resolution. Until GAO resolves the matter, the disputed information must be treated as protected.

    (c) If no protective order has been issued, or a protester or intervenor does not have counsel admitted to a protective order, the agency may withhold from the parties those portions of its report that would ordinarily be subject to a protective order, provided that the requirements of § 21.3(e) are met. * * *

    (d) After a protective order has been issued, counsel or consultants retained by counsel appearing on behalf of a party may apply for admission under the order by filing an application. * * * Objections to an applicant's admission shall be filed within 2 days after the application is filed, although GAO may consider objections filed after that time.

    7. In § 21.5: a. Amend paragraph (a) by removing “601-613” and adding in its place “7101-7109”; b. Revise paragraph (b)(1), the first sentence in paragraph (b)(2), and paragraph (b)(3); c. Amend paragraph (d) by removing “423” and adding in its place “2101-2107”; d. Amend paragraph (e) by removing the words “in GAO” and adding in their place the words “with GAO”; e. Amend paragraph (f) by removing the word “which” in two places and adding in its place the word “that”; f. Amend paragraph (g) by removing “472” and adding in its place “102”; g. Revise paragraph (h); and h. Add paragraphs (l) and (m).

    The revisions and additions read as follows:

    § 21.5 Protest issues not for consideration.

    (b) Small Business Administration (SBA) issues. (1) Small business size standards and North American Industry Classification System (NAICS) standards. Challenges of established size standards or the size status of particular firms, and challenges of the selected NAICS code may be reviewed solely by the SBA. 15 U.S.C. 637(b)(6).

    (2) Small Business Certificate of Competency Program. Referrals made to the SBA pursuant to sec. 8(b)(7) of the Small Business Act, or the issuance of, or refusal to issue, a certificate of competency under that section will generally not be reviewed by GAO. * * *

    (3) Procurements under sec. 8(a) of the Small Business Act. Under that section, since contracts are entered into with the SBA at the contracting officer's discretion and on such terms as are agreed upon by the procuring agency and the SBA, the decision to place or not to place a procurement under the 8(a) program is not subject to review absent a showing of possible bad faith on the part of government officials or that regulations may have been violated. 15 U.S.C. 637(a).

    (h) Subcontract protests. GAO will not consider a protest of the award or proposed award of a subcontract except where the agency awarding the prime contract has filed a request that subcontract protests be decided pursuant to § 21.13.

    (l) Protests of orders issued under task or delivery order contracts. As established in 10 U.S.C. 2304c(e)(1) and 41 U.S.C. 4106(f)(1), GAO does not have jurisdiction to review protests of orders issued under task or delivery order contracts where the order is valued at less than $10 million, unless it is alleged that the order increases the scope, period, or maximum value of the contract under which the order was issued.

    (m) Protests of awards, or solicitations for awards, of agreements other than procurement contracts. GAO generally does not review protests of awards, or solicitations for awards, of agreements other than procurement contracts, with the exception of awards or agreements as described in § 21.13; GAO does, however, review protests alleging that an agency is improperly using a non-procurement instrument.

    8. Revise § 21.6 to read as follows:
    § 21.6 Withholding of award and suspension of contract performance.

    When a protest is filed, the agency may be required to withhold award and to suspend contract performance. The requirements for the withholding of award and the suspension of contract performance are set forth in 31 U.S.C. 3553(c) and (d); GAO does not administer the requirements to stay award or suspend contract performance. An agency shall file a notification in instances where it overrides a requirement to withhold award or suspend contract performance, and it shall file a copy of any issued determination and finding.

    9. Amend § 21.7 by revising the first sentence of paragraph (a) and revising paragraph (e) to read as follows:
    § 21.7 Hearings.

    (a) Upon a request filed by a party or on its own initiative, GAO may conduct a hearing in connection with a protest. * * *

    (e) GAO does not provide for hearing transcripts. If the parties wish to have a hearing transcribed, they may do so at their own expense, so long as a copy of the transcript is provided to GAO at the parties' expense.

    10. Amend § 21.8 by revising paragraphs (e), adding a paragraph (f) subject heading, revising paragraphs (f)(2) and (3), and adding paragraphs (f)(4) through (6) to read as follows:
    § 21.8 Remedies.

    (e) Recommendation for reimbursement of costs. If the agency decides to take corrective action in response to a protest, GAO may recommend that the agency pay the protester the reasonable costs of filing and pursuing the protest, including attorneys' fees and consultant and expert witness fees. The protester shall file any request that GAO recommend that costs be paid not later than 15 days after the date on which the protester learned (or should have learned, if that is earlier) that GAO had closed the protest based on the agency's decision to take corrective action. The agency shall file a response within 15 days after the request is filed. The protester shall file comments on the agency response within 10 days of receipt of the response. GAO shall dismiss the request unless the protester files comments within the 10-day period, except where GAO has granted an extension or established a shorter period.

    (f) Recommendation on the amount of costs.

    (2) The agency shall issue a decision on the claim for costs as soon as practicable after the claim is filed.

    (3) If the protester and the agency cannot reach agreement regarding the amount of costs within a reasonable time, the protester may file a request that GAO recommend the amount of costs to be paid, but such request shall be filed within 10 days of when the agency advises the protester that the agency will not participate in further discussions regarding the amount of costs.

    (4) Within 15 days after receipt of the request that GAO recommend the amount of costs to be paid, the agency shall file a response. The protester shall file comments on the agency response within 10 days of receipt of the response. GAO shall dismiss the request unless the protester files comments within the 10-day period, except where GAO has granted an extension or established a shorter period.

    (5) In accordance with 31 U.S.C. 3554(c), GAO may recommend the amount of costs the agency should pay. In such cases, GAO may also recommend that the agency pay the protester the costs of pursuing the claim for costs before GAO.

    (6) Within 60 days after GAO recommends the amount of costs the agency should pay the protester, the agency shall file a notification of the action the agency took in response to the recommendation.

    11. Amend § 21.9 by revising paragraph (a) to read as follows:
    § 21.9 Time for decision by GAO.

    (a) GAO shall issue a decision on a protest within 100 days after it is filed. GAO will attempt to resolve a request for recommendation for reimbursement of protest costs under § 21.8(e), a request for recommendation on the amount of protest costs under § 21.8(f), or a request for reconsideration under § 21.14 within 100 days after the request is filed.

    12. Amend § 21.10 by revising paragraph (a), the first sentence of paragraph (c), and paragraphs (d)(1) and (2) and (e) as follows:
    § 21.10 Express options, flexible alternative procedures, accelerated schedules, summary decisions, and status and other conferences.

    (a) Upon a request filed by a party or on its own initiative, GAO may decide a protest using an express option.

    (c) Requests for the express option shall be filed not later than 5 days after the protest or supplemental/amended protest is filed. * * *

    (d) * * *

    (1) The agency shall file a complete report within 20 days after it receives notice from GAO that the express option will be used.

    (2) Comments on the agency report shall be filed within 5 days after receipt of the report.

    (e) GAO, on its own initiative or upon a request filed by the parties, may use flexible alternative procedures to promptly and fairly resolve a protest, including alternative dispute resolution, establishing an accelerated schedule, and/or issuing a summary decision.

    13. Amend § 21.11 by revising paragraph (a) to read as follows:
    § 21.11 Effect of judicial proceedings.

    (a) A protester must immediately advise GAO of any court proceeding which involves the subject matter of a pending protest and must file copies of all relevant court documents.

    14. Amend § 21.12 by revising paragraph (b) to read as follows:
    § 21.12 Distribution of decisions.

    (b) Decisions will be distributed to the parties through the EPDS.

    15. Amend § 21.13 by revising paragraph (b) to read as follows:
    § 21.13 Nonstatutory protests.

    (b) The provisions of this part shall apply to nonstatutory protests except for:

    (1) § 21.8(d) pertaining to recommendations for the payment of costs; and

    (2) § 21.6 pertaining to the withholding of award and the suspension of contract performance pursuant to 31 U.S.C. 3553(c) and (d).

    16. Amend § 21.14 by revising paragraph (b) and the second sentence of paragraph (c) to read as follows:
    § 21.14 Request for reconsideration.

    (b) A request for reconsideration of a bid protest decision shall be filed not later than 10 days after the basis for reconsideration is known or should have been known, whichever is earlier.

    (c) * * * To obtain reconsideration, the requesting party must show that GAO's prior decision contains errors of either fact or law, or must present information not previously considered that warrants reversal or modification of the decision; GAO will not consider a request for reconsideration based on repetition of arguments previously raised.

    Susan A. Poling, General Counsel, United States Government Accountability Office.
    [FR Doc. 2016-08622 Filed 4-14-16; 8:45 am] BILLING CODE 1610-02-P
    DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 319 [Docket No. APHIS-2015-0073] RIN 0579-AE18 Importation of Fresh Apple and Pear Fruit Into the Continental United States From Certain Countries in the European Union AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Proposed rule; reopening of comment period.

    SUMMARY:

    We are reopening the comment period for our proposed rule that would amend the regulations to allow the importation of fresh apple and pear fruit from certain countries in the European Union into the continental United States, provided that the fruit is produced in accordance with a systems approach, as an alternative to importation under the current preclearance program. This action will allow interested persons additional time to prepare and submit comments.

    DATES:

    The comment period for the proposed rule published on January 20, 2016 (81 FR 3033-3038) is reopened. We will consider all comments that we receive on or before May 5, 2016.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0073.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2015-0073, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

    Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0073 or in our reading room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

    FOR FURTHER INFORMATION CONTACT:

    Mr. David B. Lamb, Senior Regulatory Policy Specialist, PPQ, APHIS, USDA, 4700 River Road Unit 133, Riverdale, MD 20737-1236; (301) 851-2103; [email protected]

    SUPPLEMENTARY INFORMATION:

    On January 20, 2016, we published in the Federal Register (81 FR 3033-3038, Docket No. APHIS-2015-0073) a proposal to amend the regulations to allow the importation of fresh apple and pear fruit from certain countries in the European Union into the continental United States, provided that the fruit is produced in accordance with a systems approach, as an alternative to importation under the current preclearance program.

    Comments on the proposed rule were required to be received on or before March 21, 2016. We are reopening the comment period on Docket No. APHIS-2015-0073 for an additional 45 days until May 5, 2016. This action will allow interested persons additional time to prepare and submit comments. We will also consider all comments received between March 22, 2016, and the date of this notice.

    Authority:

    7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 11th day of April 2016. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2016-08806 Filed 4-14-16; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF EDUCATION 34 CFR Chapter II [Docket ID ED-2015-OESE-0130] Negotiated Rulemaking Committee; Schedule of Committee Meetings AGENCY:

    Office of Elementary and Secondary Education, Department of Education.

    ACTION:

    Intent to establish a negotiated rulemaking committee.

    SUMMARY:

    On February 4, 2016, we announced our intention to establish a negotiated rulemaking committee prior to publishing proposed regulations to implement part A of title I, Improving Basic Programs Operated by Local Educational Agencies, of the Elementary and Secondary Education Act of 1965 (ESEA), as amended by the Every Student Succeeds Act (ESSA). We also announced the schedule for three sessions of committee meetings and the location for each of those meetings. We now announce a change of location for the meeting on the first day of the third session.

    DATES:

    The dates, times, and locations of the committee meetings are set out in the Schedule for Negotiations section in the SUPPLEMENTARY INFORMATION section of this notice.

    FOR FURTHER INFORMATION CONTACT:

    James Butler, U.S. Department of Education, 400 Maryland Avenue SW., Room 3W246, Washington, DC 20202. Telephone (202) 260-9737 or by email: [email protected]

    For general information about the negotiated rulemaking process, see The Negotiated Rulemaking Process for the Every Student Succeeds Act—Frequently Asked Questions, available at http://www2.ed.gov/policy/elsec/leg/essa/essanegregnoticefaqs02022016.pdf.

    If you use a telecommunications device for the deaf or a text telephone, call the Federal Relay Service, toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION: Background

    On February 4, 2016, we published a notice in the Federal Register (81 FR 5969) announcing our intention to establish a negotiated rulemaking committee prior to publishing proposed regulations to implement part A of title I of the ESEA, as amended by the ESSA. We explained that the negotiated rulemaking committee would be convened to address proposed regulations that would: (1) Update existing assessment regulations to reflect changes to section 1111(b)(2) of the ESEA; and (2) relate to the requirement under section 1118(b) of the ESEA that title I, part A funds be used to supplement, and not supplant, non-Federal funds. In the February 4, 2016, notice, we set a schedule for three sessions of committee meetings, including an optional third session from April 18-April 19, 2016, if the committee determined that a third session would enable the committee to complete its work of developing regulations that reflect a final consensus of the committee. We also announced the date, time, and locations of the three sessions.

    We now announce that the April 18, 2016, meeting of the committee will be held at a different location than indicated in the February 4, 2016, notice.

    Schedule for Negotiations: The committee will meet for its third session on April 18-April 19, 2016. The committee meetings will run from 9 a.m. to 5 p.m. each day.

    The April 18, 2016, committee meeting will be held at the U.S. Department of Education, Potomac Center Plaza, 550 12th Street SW., Washington, DC 22202. The April 19, 2016, committee meeting will be held at the U.S. Department of Education, 400 Maryland Avenue SW., Washington, DC 20202.

    The meetings are open to the public.

    Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT.

    The negotiated rulemaking meeting sites are accessible to individuals with disabilities. If you need an auxiliary aid or service to participate in the meeting (e.g., interpreting service, assistive listening device, or materials in alternative format), notify the program contact person listed under FOR FURTHER INFORMATION CONTACT in advance of the scheduled meeting date. We will make every effort to meet any request we receive.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site. You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Dated: April 12, 2016. John B. King, Jr., Secretary of Education.
    [FR Doc. 2016-08795 Filed 4-14-16; 8:45 am] BILLING CODE 4000-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2016-0105 FRL-9944-94-Region 9] Limited Approval, Limited Disapproval of California 9+Air Plan Revisions, Eastern Kern Air Pollution Control District AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing a limited approval and limited disapproval of revisions to the Eastern Kern Air Pollution Control District (EKAPCD) portion of the California State Implementation Plan (SIP). These revisions concern volatile organic compounds (VOCs) emitted from motor vehicle and mobile equipment refinishing operations. We are proposing action on a local rule that regulates these emission sources under the Clean Air Act (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.

    DATES:

    Any comments must arrive by May 16, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0105 at http://www.regulations.gov, or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

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

    Table of Contents I. The State's Submittal A. What rule did the State submit? B. Are there other versions of this rule? C. What is the purpose of the submitted rule revision? II. The EPA's Evaluation and Action A. How is the EPA evaluating the rule? B. Does the rule meet the evaluation criteria? C. What are the rule deficiencies? D. EPA Recommendations To Further Improve the Rule E. Proposed Action and Public Comment III. Incorporation by Reference IV. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Paperwork Reduction Act (PRA) C. Regulatory Flexibility Act (RFA) D. Unfunded Mandates Reform Act (UMRA) E. Executive Order 13132: Federalism F. Executive Order 13175: Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act (NTTAA) J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Population I. The State's Submittal A. What rule did the State submit?

    Table 1 lists the rule addressed by this proposal with the dates that it was adopted by the local air agency and submitted by the California Air Resources Board (CARB).

    Table 1—Submitted Rule Local agency Rule # Rule title Amended Submitted EKAPCD 410.4A Motor Vehicle and Mobile Equipment Refinishing Operations 03/13/14 07/25/14

    On September 11, 2014, the submittal for EKAPCD Rule 410.4A was found to meet the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.

    B. Are there other versions of this rule?

    We approved an earlier version of Rule 410.4A into the SIP on November 13, 1998 (63 FR 63410). The EKAPCD adopted revisions to the SIP-approved version on March 13, 2014 and CARB submitted them to us on July 25, 2014.

    C. What is the purpose of the submitted rule revision?

    VOCs help produce ground-level ozone, smog and particulate matter (PM), which harm human health and the environment. Section 110(a) of the CAA requires States to submit regulations that control VOC emissions. The purpose of this rule is to limit VOC emissions from coatings and solvents used in production, repair, refinish, or maintenance operations where motor vehicles, mobile equipment, or associated parts and components are coated.

    The EPA's technical support document (TSD) has more information about this rule.

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

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

    Generally, SIP rules must require Reasonably Available Control Technology (RACT) for each category of sources covered by a Control Techniques Guidelines (CTG) document as well as each major source of VOCs in ozone nonattainment areas classified as moderate or above (see CAA section 182(b)(2)). The EKAPCD regulates an ozone nonattainment area classified as Marginal Nonattainment for the 8-hour Ozone National Ambient Air Quality Standard (40 CFR 81.305). In addition, EKAPCD is classified as Moderate for the 1997 8-hour ozone NAAQS (40 CFR 81.305). There is no EPA CTG for Motor Vehicle and Mobile Equipment Refinishing Operations and, according to CARB's facility search engine, there are no facilities that emit VOC in the EKAPCD for this category for the most recent database year of 2013. Therefore, Rule 410.4A is not required to implement reasonably available control technology (RACT) pursuant to CAA section 182(b)(2).

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

    1. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992). 2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the “Bluebook,” revised January 11, 1990). 3. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the “Little Bluebook”). 4. Code of Federal Regulations (CFR) Title 40, Subpart B, Table 1, “Volatile Organic Compound Emission Standards for Automobile Refinish Coatings” (40 CFR part 59, subpart B, table 1). B. Does the rule meet the evaluation criteria?

    Rule 410.4A improves the SIP by establishing more stringent emission limits, and by clarifying labeling, test methods and recordkeeping provisions. The rule is largely consistent with CAA requirements and relevant guidance regarding enforceability, stringency and SIP revisions. Rule provisions that do not meet the evaluation criteria are summarized below and discussed further in the TSD.

    C. What are the rule deficiencies?

    These provisions do not satisfy the requirements of section 110 and part D of title I of the Act and prevent full approval of the SIP revision.

    • Paragraph VI(A), “VOC Content Limits,” provides VOC limits for cavity wax, deadener, gasket/gasket sealing material, lubricating wax/compounds and trunk interior coatings. However, in conflict with long-standing guidance on enforceability such as discussed in the Bluebook, these terms are not defined in the rule.1

    1See “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” (a.k.a., Bluebook) EPA OAQPS, May 25, 1988. P2-7.

    D. EPA Recommendations To Further Improve the Rule

    The TSD describes additional rule revisions that we recommend for the next time the local agency modifies the rule.

    E. Proposed Action and Public Comment

    As authorized in sections 110(k)(3) and 301(a) of the Act, the EPA is proposing a limited approval of the submitted rule. If finalized, this action would incorporate the submitted rule into the SIP, including those provisions identified as deficient. This approval is limited because EPA is simultaneously proposing a limited disapproval of the rule under section 110(k)(3).

    Neither sanctions nor a Federal Implementation Plan (FIP) would be imposed should the EPA finalize this limited disapproval. Sanctions would not be imposed under CAA 179(b) because the submittal of Rule 410.4A is discretionary (i.e., not required to be included in the SIP), and the EPA would not promulgate a FIP in this instance under CAA 110(c)(1) because the disapproval does not reveal a deficiency in the SIP for the area that a FIP must correct. Specifically, there is no EPA CTG for Motor Vehicle and Mobile Equipment Refinishing Operations and, according to CARB's Facility Search Engine, there are no facilities that emit VOC in the EKAPCD for this category for the most recent database year of 2013. Accordingly, the failure of the EKAPCD to adopt revisions to Rule 410.4A would not adversely affect the SIP's compliance with the CAA's requirements, such as the requirements for section 182 ozone RACT, reasonable further progress, and attainment demonstrations.

    Note that the submitted rule has been adopted by the EKAPCD, and the EPA's final limited disapproval would not prevent the local agency from enforcing it. The limited disapproval also would not prevent any portion of the rule from being incorporated by reference into the federally enforceable SIP.

    We will accept comments from the public on the proposed limited approval and limited disapproval for the next 30 days.

    III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference EKAPCD Rule 410.4A as described in Table 1 of this notice. The EPA has made, and will continue to make, these documents available electronically through www.regulations.gov and in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

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

    This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

    B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under the PRA because this action does not impose additional requirements beyond those imposed by state law.

    C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities beyond those imposed by state law.

    D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action does not impose additional requirements beyond those imposed by state law. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, will result from this action.

    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: Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in Executive Order 13175, because the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, and will not impose substantial direct costs on tribal governments or preempt tribal law. 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 does not impose additional requirements beyond those imposed by state law.

    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 (NTTAA)

    Section 12(d) of the NTTAA directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. The EPA believes that this action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with the CAA.

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

    The EPA lacks the discretionary authority to address environmental justice in this rulemaking.

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: April 4, 2016. Jared Blumenfeld, Regional Administrator, Region IX.
    [FR Doc. 2016-08508 Filed 4-14-16; 8:45 am] BILLING CODE 6560-50-P
    81 73 Friday, April 15, 2016 Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2016-0029] Secretary's Advisory Committee on Animal Health; Meeting AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    This is a notice to inform the public of the next meetings of the Secretary's Advisory Committee on Animal Health. The meetings are being organized by the Animal and Plant Health Inspection Service to discuss matters of animal health.

    DATES:

    The meetings will be held May 2, 2016, and June 16, 2016, from 11 a.m. to 1:30 p.m. eastern standard time.

    ADDRESSES:

    The meetings will be conducted as multisite teleconferences. Opportunities for public attendance are described in the Supplementary Information section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Mrs. R.J. Cabrera, Designated Federal Officer, VS, APHIS, 4700 River Road, Unit 34, Riverdale, MD 20737; (301) 851-3478; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Secretary's Advisory Committee on Animal Health (the Committee) advises the Secretary of Agriculture on matters of animal health, including means to prevent, conduct surveillance on, monitor, control, or eradicate animal diseases of national importance. In doing so, the Committee will consider public health, conservation of natural resources, and the stability of livestock economies.

    Tentative topics for discussion during the May 2, 2016, meeting include:

    • One Health

    ○ U.S. Department of Agriculture Antimicrobial Resistance Action Plan; and

    ○ Zoonotic Diseases.

    Tentative topics for discussion during the June 16, 2016, meeting include:

    • Emerging Disease Response; and

    • Comprehensive Integrated Animal Health Surveillance.

    A final agenda will be posted on the Committee Web site 2 weeks prior to each scheduled meeting.

    Those wishing to listen in on the meetings should complete a brief registration form by clicking on the “SACAH Meeting Sign-up” button on the Committee's Web site (http://www.aphis.usda.gov/animalhealth/sacah). Members of the public may join the teleconference in “listen-only” mode by dialing 1-800-619-4086 and then entering the public passcode, 4414646# for the May 2 meeting, and 9786716# for the June 16 meeting.

    Questions and written statements for the Committee's consideration may be submitted up to 5 working days before each scheduled meeting. They may be sent to [email protected] or mailed to the person listed in this notice under FOR FURTHER INFORMATION CONTACT. Statements filed with the Committee must include the name of the individual listed under FOR FURTHER INFORMATION CONTACT, the docket number listed in this notice, and specify the meeting to which they pertain.

    This notice of meeting is given pursuant to section 10 of the Federal Advisory Committee Act (5 U.S.C. App. 2).

    Done in Washington, DC, this 11th day of April 2016. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2016-08651 Filed 4-14-16; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Forest Service Central Idaho Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Central Idaho Resource Advisory Committee (RAC) will meet in Challis, Idaho. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. Additional RAC information, including the meeting agenda and the meeting summary/minutes can be found at the following Web site: http://www.fs.usda.gov/main/scnf/workingtogether/advisorycommittees.

    DATES:

    The meeting will be held May 10, 2016.

    All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Challis-Yankee Fork and Middle Fork Ranger District Office, 311 N. US Highway 93; Challis, ID 83226.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at Public Lands Center, 1206 S. Challis Street, Salmon, Idaho 83467. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Amy Baumer, Public Affairs Officer by phone at 208-756-5145 or via email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is:

    1. To review and vote on project proposals for 2016.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by May 1, 2016 to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Amy Baumer, Public Affairs Officer; 1206 S. Challis St., Salmon, Idaho 83467; or by email to Salmon, Idaho, or via facsimile to 208-756-5289.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: April 5, 2016. Charles A. Mark, Forest Supervisor.
    [FR Doc. 2016-08721 Filed 4-14-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE National Institute of Food and Agriculture Notice of Request for Applications for the Veterinary Medicine Loan Repayment Program AGENCY:

    National Institute of Food and Agriculture, USDA.

    ACTION:

    Notice.

    SUMMARY:

    The National Institute of Food and Agriculture (NIFA) is announcing the release of the Veterinary Medicine Loan Repayment Program (VMLRP) request for applications. General information regarding the VMLRP can be obtained at: www.nifa.usda.gov/vmlrp.

    The Request for Applications (RFA) can be obtained at: http://nifa.usda.gov/vmlrp-request-applications-rfa.

    DATES:

    Applications are due May 20, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Danielle Tack, Program Coordinator, Institute of Food Production and Sustainability, National Institute of Food and Agriculture, U.S. Department of Agriculture, Washington, DC 20024; telephone: (202) 401-6802; fax: (202) 720-6486; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background and Purpose

    In January 2003, the National Veterinary Medical Service Act (NVMSA) was passed into law adding section 1415A to the National Agricultural Research, Extension, and Teaching Policy Act of 1997 (NARETPA). This law established a new Veterinary Medicine Loan Repayment Program (7 U.S.C. 3151a) authorizing the Secretary of Agriculture to carry out a program of entering into agreements with veterinarians under which they agree to provide veterinary services in veterinarian shortage situations.

    Section 7105 of FCEA amended section 1415A to revise the determination of veterinarian shortage situations to consider (1) geographical areas that the Secretary determines have a shortage of veterinarians; and (2) areas of veterinary practice that the Secretary determines have a shortage of veterinarians, such as food animal medicine, public health, epidemiology, and food safety. This section also added that priority should be given to agreements with veterinarians for the practice of food animal medicine in veterinarian shortage situations.

    NARETPA section 1415A requires the Secretary, when determining the amount of repayment for a year of service by a veterinarian to consider the ability of USDA to maximize the number of agreements from the amounts appropriated and to provide an incentive to serve in veterinary service shortage areas with the greatest need. This section also provides that loan repayments may consist of payments of the principal and interest on government and commercial loans received by the individual for the attendance of the individual at an accredited college of veterinary medicine resulting in a degree of Doctor of Veterinary Medicine or the equivalent. This program is not authorized to provide repayments for any government or commercial loans incurred during the pursuit of another degree, such as an associate or bachelor degree. Loans eligible for repayment include educational loans made for one or more of the following: Loans for tuition expenses; other reasonable educational expenses, including fees, books, and laboratory expenses, incurred by the individual; and reasonable living expenses as determined by the Secretary. In addition, the Secretary is directed to make such additional payments to participants as the Secretary determines appropriate for the purpose of providing reimbursements to participants for individual tax liability resulting from participation in this program. Finally, this section requires USDA to promulgate regulations within 270 days of the enactment of FCEA (i.e., June 18, 2008). The Secretary delegated the authority to carry out this program to NIFA. The final rule was published in the Federal Register on April 19, 2010 [75 FR 20239-20248] allowing eligible veterinarians to competitively apply for and receive a VMLRP award.

    From FY 2010 through FY 2015, NIFA received 996 applications from which 340 VMLRP awards were offered. Additional information by funding year can be found at http://nifa.usda.gov/vmlrp-reports-and-statistics. On December 18, 2015, the President signed into law the Consolidated Appropriations Act, 2016 (Pub. L. 114-113), which appropriated $5,000,000 for the VMLRP. Funding for future years will be based on annual appropriations and balances, if any, remaining from prior years.

    The eligibility criteria for applicants and the application forms and associated instructions needed to apply for a VMLRP award can be viewed and downloaded from the VMLRP Web site at: http://nifa.usda.gov/vmlrp-applicants.

    Done in Washington, DC, this 6th day of April, 2016. Sonny Ramaswamy, Director, National Institute of Food and Agriculture.
    [FR Doc. 2016-08764 Filed 4-14-16; 8:45 am] BILLING CODE 3410-22-P
    BROADCASTING BOARD OF GOVERNORS Government in the Sunshine Act Meeting Notice DATE AND TIME:

    Wednesday, April 20, 2016, 10:30 a.m.-12:30 p.m. EDT.

    PLACE:

    Cohen Building, Room 3321, 330 Independence Ave. SW., Washington, DC 20237.

    SUBJECT:

    Notice of Meeting of the Broadcasting Board of Governors.

    SUMMARY:

    The Broadcasting Board of Governors (Board) will be meeting at the time and location listed above. The Board will vote on a consent agenda consisting of the minutes of its February 26, 2016 meeting, a resolution honoring the 70th anniversary of Voice of America's (VOA) VOA's Thai Service, a resolution honoring the 25th anniversary of VOA's Tibetan Service, and a resolution changing the June Board meeting date. The Board will receive a report from the Chief Executive Officer (CEO) and Director of BBG. The Board will also hear from representatives of the BBG's networks regarding their efforts to expand in digital and social media.

    This meeting will be available for public observation via streamed webcast, both live and on-demand, on the agency's public Web site at www.bbg.gov. Information regarding this meeting, including any updates or adjustments to its starting time, can also be found on the agency's public Web site.

    The public may also attend this meeting in person at the address listed above as seating capacity permits. Members of the public seeking to attend the meeting in person must register at http://bbgboardmeetingapril2016.eventbrite.com by 12:00 p.m. (EDT) on April 19. For more information, please contact BBG Public Affairs at (202) 203-4400 or by email at [email protected]

    CONTACT PERSON FOR MORE INFORMATION:

    Persons interested in obtaining more information should contact Oanh Tran at (202) 203-4545.

    Oanh Tran, Director of Board Operations.
    [FR Doc. 2016-08901 Filed 4-13-16; 4:15 pm] BILLING CODE 8610-01-P
    DEPARTMENT OF COMMERCE Bureau of the Census National Advisory Committee AGENCY:

    Bureau of the Census, Department of Commerce.

    ACTION:

    Notice of Public Virtual Meeting; correction.

    SUMMARY:

    The Bureau of the Census (Census Bureau) is issuing this notice to correct the Census Bureau Web site address that identifies how to access the teleconference meeting via WebEx. The Census Bureau originally published in the Federal Register on Friday, April 8, 2016 (81 FR 20617), a Notice of Public Virtual Meeting for the National Advisory Committee. This notice corrects the Census Bureau WebEx teleconference URL link. The next to last sentence in the ADDRESSES section now reads: “The meeting will be available via WebEx, please use the following URL link: https://census.webex.com/mw0401lsp13/mywebex/default.do?service=1&siteurl=census&nomenu=true&main_url=%2Fmc0901lsp13%2Fe.do%3Fsiteurl%3Dcensus%26AT%3DMI%26EventID%3D424606577%26UID%3D2991726397%26Host%3DQUhTSwAAAAIyQSQiyawT_DJbOTsUe68M-jWVHAe0Ru7RWgg7cubgEHSWvbjgXWgLvItWgQm2Cxyfl2o-icLRBmNBhEFs_QRx0%26FrameSet%3D2%26MTID%3Dm7d3200255f93f2afdcb115cd1b80bc0c.

    The last sentence in the ADDRESSES section is unchanged and continues to read as: “The meeting number is 744882915.” There were no other changes to the notice.

    FOR FURTHER INFORMATION CONTACT:

    Tara Dunlop, Advisory Committee Branch Chief, Customer Liaison and Marketing Services Office, [email protected], Department of Commerce, U.S. Census Bureau, Room 8H177, 4600 Silver Hill Road, Washington, DC 20233, telephone 301-763-5222. For TTY callers, please use the Federal Relay Service 1-800-877-8339.

    Dated: April 12, 2016. John H. Thompson, Director, Bureau of the Census.
    [FR Doc. 2016-08730 Filed 4-14-16; 8:45 am] BILLING CODE 3510-07-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-18-2016] Foreign-Trade Zone (FTZ) 186—Waterville, Maine; Notification of Proposed Production Activity; Flemish Master Weavers (Area Rugs); Sanford, Maine

    The City of Waterville, Maine, grantee of FTZ 186, submitted a notification of proposed production activity to the FTZ Board on behalf of Flemish Master Weavers (FMW), located in Sanford, Maine. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on March 31, 2016.

    The FMW facility is located at 96 Gatehouse Road, Sanford, Maine. A separate application for subzone designation at the FMW facility has been submitted and will be processed under Section 400.25 of the FTZ Board's regulations. The facility is used for the production of area rugs using polypropylene and polyester yarns. Pursuant to 15 CFR 400.14(b) of the regulations, FTZ activity would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

    Production under FTZ procedures could exempt FMW from customs duty payments on foreign status materials used in export production. On its domestic sales, FMW would be able to choose the duty rate during customs entry procedures that applies to area rugs (free) for the polypropylene and polyester yarns (duty rates: 8.0% and 8.8%, respectively) sourced from abroad. Customs duties also could possibly be deferred or reduced on foreign status production equipment.

    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 May 25, 2016.

    A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via www.trade.gov/ftz.

    For further information, contact Pierre Duy at [email protected] or (202) 482-1378.

    Dated: April 11, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-08794 Filed 4-14-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-19-2016] Foreign-Trade Zone 172—Oneida County, New York; Application for Reorganization and Expansion Under Alternative Site Framework

    An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the County of Oneida, grantee of FTZ 172, requesting authority to reorganize and expand the zone under the alternative site framework (ASF) adopted by the FTZ Board (15 CFR 400.2(c)). The ASF is an option for grantees for the establishment or reorganization of zones and can permit significantly greater flexibility in the designation of new subzones or “usage-driven” FTZ sites for operators/users located within a grantee's “service area” in the context of the FTZ Board's standard 2,000-acre activation limit for a zone. The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on April 12, 2016.

    FTZ 172 was approved by the FTZ Board on January 8, 1991 (Board Order 502, 56 FR 1791; January 17, 1991). The current zone includes the following sites: Site 1 (534 acres)—Oneida County Airport Industrial Park, Oneida County Airport, Oriskany; Site 2 (412 acres)—West Rome Industrial Park, 1 Success Dr, Rome; Site 2a (100 acres)—Griffiss Business & Technology Park Hanger Road, Rome; Site 3 (100 acres)—Boonville Industrial Park, Industrial Road, Boonville; Site 4 (82 acres)—Utica Business Park, Business Park Drive, Utica; and, Site 5 (52 acres)—East Arterial Industrial Park, Dwyer Avenue, Utica. The zone also includes Subzone 172A (Oneida Ltd.) with three sites in Sherrill and Oneida, New York.

    The grantee's proposed service area under the ASF would be Oneida County, New York, as described in the application. If approved, the grantee would be able to serve sites throughout the service area based on companies' needs for FTZ designation. The application indicates that the proposed service area is within and adjacent to the Syracuse, New York Customs and Border Protection port of entry.

    The applicant is requesting authority to renumber existing Site 2a as Site 6 and to include the renumbered Site 6 as a “magnet” site, as well as to remove Sites 1, 2, 3, 4, 5 and Subzone 172A. The ASF allows for the possible exemption of one magnet site from the “sunset” time limits that generally apply to sites under the ASF, and the applicant proposes that Site 6 be so exempted. The applicant is also requesting approval of the following magnet site: Proposed Site 7 (316.5 acres)—Marcy Nanocenter at SUNYIT, 5737 Marcy-SUNYIT Parkway, Marcy, Oneida County.

    In accordance with the FTZ Board's regulations, Elizabeth Whiteman of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and 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 June 14, 2016. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to June 29, 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 Elizabeth Whiteman at [email protected] or (202) 482-0473.

    Dated: April 12, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-08791 Filed 4-14-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-823-805] Silicomanganese From Ukraine: Notice of Rescission of Antidumping Duty Administrative Review AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    FOR FURTHER INFORMATION CONTACT:

    Dmitry Vladimirov or Minoo Hatten, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0665, and (202) 482-1690, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On August 3, 2015, the Department of Commerce (the Department) published in the Federal Register a notice of “Opportunity to Request Administrative Review” of the antidumping duty order on silicomanganese from Ukraine for the period of review (POR), August 1, 2014, through July 31, 2015.1 On September 3, 2015, we received an untimely-filed request 2 for an administrative review from two Ukrainian producers and/or exporters of silicomanganese, JSC Zaporizhya Ferroalloy Plant (ZFP) and JSC Nikopol Ferroalloy Plant (NFP), requesting an administrative review of exports of subject merchandise for the period of September 1, 2014, through August 31, 2015. On September 21, 2015, we received comments from a domestic interested party, Eramet Marietta, Inc. (Eramet), objecting to initiation and placing on the record certain import statistics stating that there were no entries of subject merchandise from Ukraine during the period of review.

    1See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 80 FR 45952 (August 3, 2015) (August 2015 Opportunity Notice).

    2 The Ukrainian producers' September 3, 2015, request for an administrative review was untimely under 19 CFR 351.213(b) and 19 CFR 351.302(d) because we did not receive it during the anniversary month of August 2015, as required by the regulations and specified in the August 2015 Opportunity Notice.

    On October 6, 2015, the Department initiated the administrative review of the antidumping duty order on silicomanganese from Ukraine with respect to ZFP and NFP for the POR, August 1, 2014, through July 31, 2015,3 notwithstanding the untimely nature of the Ukrainian producers' request for review.

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 80 FR 60356 (October 6, 2015).

    In accordance with our practice, we requested information from U.S. Customs and Border Protection (CBP) concerning imports of subject merchandise from these companies during the POR. We received the requested CBP information, which showed that neither ZFP nor NFP had suspended entries of subject merchandise during the POR. On October 6, 2015, we documented this finding and invited comments from interested parties regarding this CBP query result.4

    4See Memorandum to the File, “Silicomanganese from Ukraine—U.S. Customs and Border Protection (CBP) Data” dated October 6, 2015.

    On October 19, 2015, we received comments from domestic interested parties, Eramet and Felman Production, LLC (collectively, U.S. producers). On October 20, 2015, we received comments from ZFP and NFP (Ukrainian producers). ZFP's and NFP's October 20, 2015, submission contained documentation establishing that both companies made both a sale and an entry of subject merchandise in August 2015.

    Because there is no evidence that there were entries of subject merchandise into the United States from Ukraine during the POR, on November 17, 2015, the Department placed a memorandum on the record notifying interested parties of its intent to rescind the 2014-2015 administrative review of silicomanganese from Ukraine, and invited comments.5 In its November 17, 2015, memorandum, the Department rejected the Ukrainian producers' arguments that the Department provided defective or inadequate notice concerning the correct anniversary month of the antidumping duty order on silicomanganese from Ukraine, and found no basis to alter the POR to capture the Ukrainian producers' entries of subject merchandise made after the POR.6

    5See Memorandum to James Maeder, Senior Director for AD/CVD Operations, Office I, “2014-2015 Antidumping Duty Administrative Review of Silicomanganese from Ukraine; Intent to Rescind Administrative Review” dated November 17, 2015.

    6Id.

    On November 24, 2015, we received comments from ZFP and NFP. On November 30, 2015, we received rebuttal comments from U.S. producers.

    Rescission of Review

    It is the Department's practice to rescind an administrative review pursuant to 19 CFR 351.213(d)(3) when there are no suspended entries of subject merchandise during the POR from the country in question.7 At the end of an administrative review, all suspended entries during the POR for the parties under review are liquidated at the assessment rate computed in the final results of review.8 Therefore, since the purpose of an administrative review is to assess antidumping duties, there must be a suspended AD/CVD entry to be liquidated at the newly calculated assessment rate. As discussed in the Decision Memorandum accompanying this notice,9 we find that, because there were no entries of subject merchandise during the POR from Ukraine, we are rescinding the 2014-2015 administrative review of the antidumping duty order on silicomanganese from Ukraine, pursuant to 19 CFR 351.213(d)(3).

    7See, e.g., Certain Frozen Warmwater Shrimp From Brazil: Notice of Rescission of Antidumping Duty Administrative Review, 77 FR 32498 (June 1, 2012).

    8See 19 CFR 351.212(b)(l).

    9See Memorandum to James Maeder, Senior Director for AD/CVD Operations, Office I, “2014-2015 Antidumping Duty Administrative Review of Silicomanganese from Ukraine; Rescission of Administrative Review” dated concurrently with this notice (Decision Memorandum).

    Analysis of Comments Received

    All issues raised by parties in this administrative review are addressed in the accompanying Decision Memorandum, which is adopted by this notice. The 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 to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/index.html. The signed and electronic versions of the Decision Memorandum are identical in content.

    This notice is published in accordance with section 751 of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).

    Dated: April 7, 2016. Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2016-08787 Filed 4-14-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-836] Glycine From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review; 2014-2015 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on glycine from the People's Republic of China (PRC). The period of review (POR) is March 1, 2014, through February 28, 2015. This review covers five companies, Baoding Mantong Fine Chemistry Co., Ltd. (Baoding Mantong), Nutracare International (Nutracare), Ravi Industries (Ravi), Kumar Industries (Kumar), and Rudraa International (Rudraa). The Department preliminarily finds that these five companies did not have reviewable entries during the POR. We invite interested parties to comment on these preliminary results.

    DATES:

    Effective Date: April 15, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Dena Crossland or Brian Davis, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3362 or (202) 482-7924, respectively.

    Scope of the Order

    The product covered by the antidumping duty order is glycine, which is a free-flowing crystalline material, like salt or sugar.1 The subject merchandise is currently classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) subheading 2922.49.4020. The HTSUS subheading is provided for convenience and customs purposes only; the written product description of the scope of the order is dispositive.2

    1See “Decision Memorandum for the Preliminary Results of Antidumping Duty Administrative Review: Glycine from the People's Republic of China; 2014-2015” from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance, dated concurrently with this notice (Preliminary Decision Memorandum), for a complete description of the scope of the order.

    2See Glycine from the People's Republic of China: Antidumping Duty Order, 60 FR 16116 (March 29, 1995).

    Methodology

    The Department is conducting this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act). For a full description of the methodology underlying our conclusions, see Preliminary Decision Memorandum. This 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 Issues and Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and the electronic versions of the memorandum are identical in content.

    Background

    On April 30, 2015, in accordance with section 751(a) of the Act, the Department published in the Federal Register a notice of initiation of this antidumping duty administrative review.3 For a detailed background discussion, see Preliminary Decision Memorandum.

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 80 FR 24233 (April 30, 2015).

    Preliminary Results of Review

    The Department preliminarily determines that Baoding Mantong, Kumar, Nutracare, Ravi, and Rudraa did not have reviewable transactions of subject merchandise during the POR.

    Disclosure and Public Comment

    Interested parties are invited to comment on the preliminary results and may submit case briefs and/or written comments, filed electronically using ACCESS, within 30 days of the date of publication of this notice, pursuant to 19 CFR 351.309(c)(1)(ii). Rebuttal briefs, limited to issues raised in the case briefs, will be due five days after the due date for case briefs, pursuant to 19 CFR 351.309(d). Parties that submit case or rebuttal briefs in this proceeding are requested to submit with each argument a statement of the issue, a summary of the argument not to exceed five pages, and a table of statutes, regulations, and cases cited, in accordance with 19 CFR 351.309(c)(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, U.S. Department of Commerce, filed electronically using ACCESS. Electronically filed case briefs/written comments and hearing requests must be received successfully in their entirety by the Department's electronic records system, ACCESS, by 5:00 p.m. Eastern Time, within 30 days after the date of publication of this notice.4 Hearing requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those issues raised in the respective case briefs. If a request for a hearing is made, parties will be notified of the time and date of the hearing which will be held at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230. The Department intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act.

    4See 19 CFR 351.310(c).

    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. The Department intends to issue assessment instructions to CBP 15 days after the publication date of the final results of this review. Additionally, pursuant to a refinement to its assessment practice in NME cases, if the Department continues to determine that an exporter under review had no shipments of the subject merchandise, any suspended entries that entered under the exporter's case number (i.e., at that exporter's rate) will be liquidated at the PRC-wide rate. For a full discussion of this practice, see Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 23, 2011).

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For Baoding Mantong, Nutracare International, Ravi Industries, Kumar Industries, and Rudraa International, which all claimed no shipments, the cash deposit rate will remain unchanged from rates assigned to these companies in the most recently completed reviews of these companies; (2) for previously investigated or reviewed PRC and non-PRC exporters who are not under review in this segment of the proceeding but who have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recent period; (3) for all PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the PRC-wide rate of 453.79 percent; and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter(s) that supplied the non-PRC 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 certification regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries of this 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.

    This administrative review and notice are in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).

    Dated: April 4, 2016. Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-08229 Filed 4-14-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board AGENCY:

    International Trade Administration, U.S. Department of Commerce.

    ACTION:

    Notice of an opportunity to apply for membership on the U.S. Travel and Tourism Advisory Board.

    SUMMARY:

    The Department of Commerce is currently seeking applications for membership on the U.S. Travel and Tourism Advisory Board (Board). The purpose of the Board is to advise the Secretary of Commerce on matters relating to the travel and tourism industry.

    DATES:

    Applications for immediate consideration for membership must be received by the Office of Advisory Committees and Industry Outreach by 5:00 p.m. Eastern Daylight Time (EDT) on Friday, May 6, 2016. Applications will continue to be accepted on a rolling basis to fill vacancies when they arise during over the next two years.

    ADDRESSES:

    Please submit application information by email to [email protected], attention to Li Zhou, Office of Advisory Committees and Industry Outreach.

    FOR FURTHER INFORMATION CONTACT:

    Li Zhou, Deputy Director, Office of Advisory Committees and Industry Outreach, U.S. Department of Commerce, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230, telephone: 202-482-4501, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The U.S. Travel and Tourism Advisory Board (Board) is established pursuant to Department of Commerce authority under 15 U.S.C. 1512 and under the Federal Advisory Committee Act, as amended, 5 U.S.C. App. (FACA), and advises the Secretary of Commerce (Secretary) on matters relating to the U.S. travel and tourism industry. The Board provides a means of ensuring regular contact between the U.S. Government and the travel and tourism industry. The Board advises the Secretary on government policies and programs that affect United States travel and tourism, and the Board serves as a forum for discussing and proposing solutions to industry-related problems. The Board acts as a liaison among the stakeholders represented by the membership and provides a forum for those stakeholders on current and emerging issues in the travel and tourism sector. The Board recommends ways to ensure that the United States remains the preeminent destination for international visitation and tourism throughout the world.

    The Office of Advisory Committees and Industry Outreach is accepting applications for Board members. The Board shall consist of no more than 32 members appointed by the Secretary. Members shall represent companies and organizations in the travel and tourism sector from a broad range of products and services, company sizes, and geographic locations and shall be drawn from large, medium, and small travel and tourism companies, private-sector organizations involved in the export of travel and tourism-related products and services, and other tourism-related entities.

    Each Board member shall serve as the representative of a U.S. company in the travel and tourism industry, a private sector U.S. organization involved in the export of travel and tourism-related products and services, or a tourism-related U.S. entity. For eligibility purposes, a “U.S. company” is a for-profit firm that is incorporated in the United States (or an unincorporated U.S. firm with its principal place of business in the United States) that is controlled by U.S. citizens or by other U.S. companies. A company is not a U.S. company if 50 percent plus one share of its stock (if a corporation, or a similar ownership interest of an unincorporated entity) is known to be controlled, directly or indirectly, by non-U.S. citizens or non-U.S. companies. For eligibility purposes, a “U.S. organization” is an organization, including trade associations and nongovernmental organizations (NGOs), established under the laws of the United States, that is controlled by U.S. citizens, by another U.S. organization (or organizations), or by a U.S. company (or companies), as determined based on its board of directors (or comparable governing body), membership, and funding sources, as applicable. For eligibility purposes, a U.S. entity is a tourism-related entity that can demonstrate U.S. ownership or control, including but not limited to state and local tourism marketing entities, state government tourism offices, state and/or local government-supported tourism marketing entities, and multi-state tourism marketing entities.

    Members of the Board will be selected, in accordance with applicable Department of Commerce guidelines, based on their ability to carry out the objectives of the Board as set forth in the charter. Members of the Board shall be selected in a manner that ensures that the Board is balanced in terms of points of view, industry subsector, range of products and services, demographics, geography, and company size.

    Additional factors which will be considered in the selection of Board members include candidates' proven experience in the strategic development and management of travel and tourism-related or other service-related organizations; or the candidate's proven experience in promoting, developing, and implementing advertising and marketing programs for travel-related or tourism-related industries.

    Priority may be given to a Chief Executive Officer, Executive Director, or President (or comparable level of responsibility) of a U.S. company, U.S. organization, or U.S. entity in the travel and tourism sector.

    Members shall serve a term of two years from the date of appointment, at the discretion of the Secretary of Commerce. Although the Board's current charter terminates in September 2017, it is anticipated that it will be rechartered.

    Members shall serve in a representative capacity, representing the views and interests of their particular industry subsector. Board members are not special government employees, and will receive no compensation for their participation in Board activities. Members participating in Board meetings and events will be responsible for their travel, living and other personal expenses. Meetings will be held regularly and, to the extent practical, not less than twice annually, usually in Washington, DC.

    For immediate consideration for membership, please provide the following information by the Friday, May 6, 2016 deadline to the address listed in the ADDRESSES section:

    1. Name and title of the individual requesting consideration.

    2. A sponsor letter from the applicant on his or her company/organization/entity letterhead or, if the applicant is to represent a company/organization/entity other than his or her employer, a letter from the company/organization/entity to be represented, containing a brief statement of why the applicant should be considered for membership on the Board. This sponsor letter should also address the applicant's travel and tourism-related experience.

    3. The applicant's personal resume.

    4. An affirmative statement that the applicant is not required to register as a foreign agent under the Foreign Agents Registration Act of 1938, as amended.

    5. If the applicant is to represent a company, information regarding the control of the company, including the stock holdings as appropriate, signifying compliance with the criteria set forth above.

    6. If the applicant is to represent an organization, information regarding the control of the organization, including the governing structure, members, and revenue sources as appropriate, signifying compliance with the criteria set forth above.

    7. If the applicant is to represent a tourism-related entity, the functions and responsibilities of the entity, and information regarding the entity's U.S. ownership or control, signifying compliance with the criteria set forth above.

    8. The company's, organization's, or entity's size, product or service line and major markets in which the company, organization, or entity operates.

    9. Brief statement describing how the applicant will contribute to the work of the Board based on his or her unique experience and perspective (not to exceed 100 words).

    Dated: April 12, 2016. Tricia Van Orden, Office of Advisory Committees & Industry Outreach.
    [FR Doc. 2016-08789 Filed 4-14-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Fisheries of the South Atlantic; South Atlantic Fishery Management Council and Mid-Atlantic Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The South Atlantic Fishery Management Council, in conjunction with the Mid-Atlantic Fishery Management Council, will hold a Question and Answer (Q&A) public meeting to address cobia management issues in Kill Devil Hills, NC.

    DATES:

    The Cobia Q&A public meeting will be held beginning at 6 p.m. on May 9, 2016.

    ADDRESSES:

    Meeting address: The meeting will be held at the Hilton Garden Inn Outer Banks/Kitty Hawk, 5353 N. Virginia Dare Trail, Kitty Hawk, NC 27949; phone: (252) 261-1290; fax: (252) 255-0153. The meeting will be broadcast via webinar as it occurs. Registration is required and information will be posted on the South Atlantic Council's Web site at www.safmc.net as it becomes available.

    Council addresses: South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N. Charleston, SC 29405; Mid-Atlantic Fishery Management Council, 800 North State Street, Suite 201, Dover, DE 19901.

    FOR FURTHER INFORMATION CONTACT:

    Kim Iverson, Public Information Officer, SAFMC; phone: (843) 571-4366 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The recreational fishery for Atlantic migratory group cobia is scheduled to close on June 20, 2016. The closure applies to those fishing for cobia recreationally in federal waters from Georgia to New York from a private vessel, charter vessel, or headboat. The closure is the result of accountability measures required by federal regulations to protect the cobia resource and prevent overfishing. The 2015 recreational catch was 1,540,775 pounds, 123% over the recreational Annual Catch Limit (ACL) of 690,000 pounds.

    The scheduled recreational closure has caused concerns from fishermen, particularly those from North Carolina and Virginia where the closure will have negative economic and social impacts due to the seasonality of the fishery. As a result, the two Councils will host a Cobia Q&A public meeting to provide information and help address questions and concerns. Council staff will give a presentation that includes an overview of the Council federal management process, historical management of cobia, and information about current cobia management and the pending recreational closure. The presentation will also include an overview of future management actions for cobia currently under consideration by the South Atlantic Council. Council staff and area Council members will be available to answer questions following the presentation.

    Written comments should be directed to Gregg Waugh, Executive Director, South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N. Charleston, SC 29405. Email comments to [email protected] with the Subject Line “Cobia Comments”. FAX comments to (843) 769-4520. Comments must be received in the Council office by 5 p.m. on May 20, 2016.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see ADDRESSES) 5 days prior to the meeting.

    Note:

    The times and sequence specified in this agenda are subject to change.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: April 12, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-08779 Filed 4-14-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE570 New England Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The New England Fishery Management Council (Council) is scheduling a public meeting of its Scallop Plan Development Team and Advisory Panel on Wednesday, May 4, 2016, to consider actions affecting New England Fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

    DATES:

    This meeting will be held on Wednesday, May 4, 2016, at 9 a.m., to view the agenda, see SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    The meeting will be held at the Hilton Garden Inn Boston Logan Airport, 100 Boardman Street, Boston, MA 02128; telephone: (617) 571-5478; fax: (617) 561-0798.

    Council address: New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950.

    FOR FURTHER INFORMATION CONTACT:

    Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.

    SUPPLEMENTARY INFORMATION: Agenda

    Recipients of recent Scallop Research Set-Aside (RSA) awards will provide a status update and summary of preliminary findings to the Scallop Plan Development Team (PDT) and Advisory Panel (AP). Presentations will include RSA projects that have not yet been used directly in the scallop management process. This meeting is not a formal review of the methods or results of these projects. Instead, this meeting is only an overview to better inform the PDT and AP of current research status and help identify future research priority recommendations. The PDT and AP will review current RSA research priorities and discuss potential recommended changes for the 2017/2018 Scallop RSA funding announcement. Other business discussed as necessary.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at 978-465-0492, at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: April 12, 2016. Tracey L. Thompson, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-08714 Filed 4-14-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Gulf of Mexico Fishery Management Council; Public Hearings AGENCY:

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

    ACTION:

    Notice; public hearings and webinar.

    SUMMARY:

    The Gulf of Mexico Fishery Management Council (Council) will hold two public hearings and one webinar to solicit public comments on Reef Fish Amendment 43—Hogfish stock definition, status determination criteria, annual catch limits, and size limit.

    DATES:

    The public hearings will be held May 9-11, 2016. The hearings will begin at 6 p.m. and will conclude no later than 9 p.m. For specific dates and locations, see SUPPLEMENTARY INFORMATION. Written public comments must be received on or before 5 p.m. EST on Friday, May 6, 2016.

    ADDRESSES:

    The public documents can be obtained by contacting the Gulf of Mexico Fishery Management Council, 2203 N. Lois Avenue, Suite 1100, Tampa, FL 33607; (813) 348-1630 or on their Web site at www.gulfcouncil.org.

    Meeting addresses: The public hearings will be held in Naples and St. Petersburg, FL; and one webinar. For specific locations, see SUPPLEMENTARY INFORMATION.

    Public comments: Comments may be submitted online through the Council's public portal by visiting www.gulfcouncil.org and clicking on “CONTACT US”.

    FOR FURTHER INFORMATION CONTACT:

    Douglas Gregory, Executive Director, Gulf of Mexico Fishery Management Council; telephone: (813) 348-1630.

    SUPPLEMENTARY INFORMATION:

    The agenda for the two public hearings and one webinar are as follows: Council staff will brief the public on Reef Fish Amendment 43. The staff will then open the meeting for questions and public comments.

    Locations, Schedules, and Agendas

    Monday, May 9, 2016; Holiday Inn Express & Suites, 1785—5th Avenue South, Naples, FL 34102; telephone: (239) 261-3500.

    Tuesday, May 10, 2016; Holiday Inn Express, 2171—54th Avenue North, St. Petersburg, FL 33714; telephone: (727) 520-7800.

    Wednesday, May 11, 2016, Webinar—6 p.m. EST at: https://attendee.gotowebinar.com/register/3081763240819912449.

    After registering, you will receive a confirmation email containing information about joining the webinar.

    Special Accommodations

    These hearings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira (see ADDRESSES), at least 5 working days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: April 12, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-08778 Filed 4-14-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE498 Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Installation of the Block Island Wind Farm Export and Inter-Array Cables AGENCY:

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

    ACTION:

    Notice; proposed incidental harassment authorization; request for comments.

    SUMMARY:

    NMFS has received an application from Deepwater Wind Block Island, LLC (DWBI) for an Incidental Harassment Authorization (IHA) to take marine mammals, by harassment, incidental to the installation of the Block Island Wind Farm (BIWF) Export and Inter-Array Cables. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an IHA to DWBI to incidentally take, by Level B harassment only, small numbers of marine mammals during the specified activity.

    DATES:

    Comments and information must be received no later than May 16, 2016.

    ADDRESSES:

    Comments on DWBI's IHA application (the application) should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910. The mailbox address for providing email comments is [email protected] Comments sent via email, including all attachments, must not exceed a 25-megabyte file size. NMFS is not responsible for comments sent to addresses other than those provided here.

    Instructions: All comments received are a part of the public record and will generally be posted to http://www.nmfs.noaa.gov/pr/permits/incidental/ without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.

    FOR FURTHER INFORMATION CONTACT:

    John Fiorentino, Office of Protected Resources, NMFS, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    Availability

    An electronic copy of the application and supporting documents, as well as a list of the references cited in this document, may be obtained by visiting the Internet at: www.nmfs.noaa.gov/pr/permits/incidental/. In case of problems accessing these documents, please call the contact listed above.

    Background

    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

    An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].

    Summary of Request

    On March 11, 2016, NMFS received an application from DWBI for the taking of marine mammals incidental to the installation of the BIWF export and inter-array cables. This work was originally authorized by NMFS as part of a September 2014 (modified in June 2015) IHA issued to DWBI for construction of the BIWF (offshore installation of wind turbine generator [WTG] jacket foundations and export/inter-array cable installation [79 FR 53409]); however, only the construction activities associated with the WTG jacket foundation installation were performed during that one-year authorization which expired in October 2015. DWBI has, therefore, reapplied for a new IHA to complete the remaining export and inter-array cable installation activities. The proposed export and inter-array cable installation activities remain the same as those described in the Federal Register notice for the original 2014 BIWF IHA. NMFS determined that the application was adequate and complete on March 14, 2016.

    DWBI has begun construction of the BIWF, a 30 megawatt offshore wind farm. Construction activities began in July of 2015 with the installation of the five WTG foundations. The submarine cable (export and inter-array cables) installation is scheduled to occur sometime between May and October, 2016. Use of dynamically positioned (DP) vessel thrusters during cable installation may result in the take of marine mammals. Take, by Level B Harassment only, of individuals of nine species is anticipated to result from the specified activity.

    Description of the Specified Activity Overview

    The BIWF will consist of five, 6 megawatt WTGs, a submarine cable interconnecting the WTGs, and a transmission cable. The WTG jacket foundations were installed in 2015. Erection of the five WTGs, installation of the inter-array and export cable, and construction of the onshore components of the BIWF is planned for 2016. The generation of underwater noise during use of vessel thrusters while the cable laying vessel is keeping position by its DP system during installation activities may result in the incidental take of marine mammals.

    Dates and Duration

    BIWF cable installation activities are scheduled to occur sometime between May and October, 2016. NMFS is proposing to issue an authorization effective May 2016 through April 2017, based on the anticipated work window for the in-water cable installation activities construction that could result in the incidental take of marine mammals. While project activities may occur for over a 6-month period, use of the DP vessel thruster during cable installation activities is expected to occur for approximately 28 days. Cable installation (and subsequent use of the DP vessel thruster) would be conducted 24 hours per day.

    Specified Geographic Region

    The offshore components of the BIWF will be located in state territorial waters. The WTGs will be located on average of about 4.8 kilometers (km) southeast of Block Island, and about 25.7 km south of the Rhode Island mainland. The WTGs will be arranged in a radial configuration spaced about 0.8 km apart. The inter-array cable will connect the five WTGs for a total length of 3.2 km from the northernmost WTG to the southernmost WTG (Figure 1-1 of DWBI's application). Water depths along the inter-array cable range up to 23.3 meters (m). The export cable will originate at the northernmost WTG and travel 10 km to a manhole located in the town of New Shoreham (Block Island) in Washington County, Rhode Island. Water depths along the export cable submarine route range up to 36.9 m. Construction staging and laydown for offshore construction is planned to occur at the Port of Providence, Providence, Rhode Island.

    The inter-array cable and submarine portions of the export cable will be installed by a jet plow supported by a DP vessel.

    Detailed Description of Activities

    DWBI would use a jet plow, supported by a DP cable installation barge, to install the export cable and inter-array cable below the seabed. The jet plow would be positioned over the trench and pulled from shore by the cable installation vessel. The jet plow would be pulled along the seafloor behind the cable-laying barge with assistance of a non-DP material barge. High-pressure water from vessel- mounted pumps would be injected into the sediments through nozzles situated along the plow, causing the sediments to temporarily fluidize and create a liquefied trench. DWBI anticipates a temporary trench width of up to 1.5 m. As the plow is pulled along the route behind the barge, the cable would be laid into the temporary, liquefied trench through the back of the plow. The trench would be backfilled by the water current and the natural settlement of the suspended material. Umbilical cords would connect the submerged jet plow to control equipment on the vessel to allow the operators to monitor and control the installation process and make adjustments to the speed and alignment as the installation proceeds across the water.

    The Export Cable and Inter-Array Cable would be buried to a target depth of 1.8 m beneath the seafloor. The actual burial depth depends on substrate encountered along the route and could vary from 1.2 to 2.4 m. If less than 1.2 m burial is achieved, DWBI may elect to install additional protection, such as concrete matting or rock piles. At each of the WTGs, the Inter-Array cable would be pulled into the jacket foundation through J-tubes installed on the sides of the jacket foundations. At the J-tubes, additional cable armoring such as sand bags and/or rocks would be used to protect the inter-array cable.

    A DP vessel would be used during cable installation in order to maintain precise coordinates. DP systems maintain their precise coordinates in waters through the use of automatic controls. These control systems use variable levels of power to counter forces from current and wind. During cable-lay activities, DWBI expects that a reduced 50 percent power level will be used by DP vessels. DWBI modeled scenarios using a source level of 180 dB re 1 micro Pascal (μPa) for the DP vessel thruster, assuming water depths of 7, 10, 20, and 40 m, and thruster power of 50 percent. Detailed information on the acoustic modeling for this source is provided in Appendix A of DWBI's application. Installation of the export cable and inter-array cable is expected to take approximately 28 days. Cable installation will occur 24 hours per day, seven days a week.

    Description of Marine Mammals in the Area of the Specified Activity

    There are 38 species of marine mammals protected under the MMPA that potentially occur within the marine waters around Rhode Island Sound (see Table 3-1 of DWBI's application). The majority of these species are pelagic and/or northern species, or are so rarely sighted that their presence in the project area is unlikely. Six marine mammal species are listed under the Endangered Species Act (ESA) and are known to be present, at least seasonally, in the waters of Southern New England: Blue whale, fin whale, humpback whale, right whale, sei whale, and sperm whale. These species are highly migratory and do not spend extended periods of time in a localized area; the waters of Southern New England are primarily used as a stopover point for these species during seasonal movements north or south between important feeding and breeding grounds. While fin, humpback, and right whales have the potential to occur within the project area, the sperm, blue, and sei whales are more pelagic and/or northern species, and their presence within the shallow waters of the project area is unlikely. Because the potential for sperm, blue, and sei whales to occur within the project area during the marine construction period is unlikely, these species will not be described further in this analysis.

    The following species are both common in the waters of Rhode Island Sound and have the highest likelihood of occurring, at least seasonally, in the project area: North Atlantic right whale (Eubalaena glacialis), humpback whale (Megaptera novaeangliae), fin whale (Balaenoptera physalus), minke whale (Balaenoptera acutorostrata), harbor porpoise (Phocoena phocoena), Atlantic white-sided dolphin (Lagenorhynchus acutus), short-beaked common dolphin (Delphinus delphis), harbor seal (Phoca vitulina), and gray seal (Halichorus grypus) (Right Whale Consortium, 2014) (Table 1).

    Further information on the biology, ecology, abundance, and distribution of those species likely to occur in the project area can be found in section 4 of the application (which NMFS has reviewed and concluded as adequate), and the NMFS Marine Mammal Stock Assessment Reports (see Waring et al., 2015), which are available online at: http://www.nmfs.noaa.gov/pr/sars/. Marine mammal species descriptions are also available online at: http://www.nmfs.noaa.gov/pr/species/mammals/.

    Table 2—Marine Mammals Likely To Occur in the Project Area Common name Scientific name NMFS status Stock
  • abundance
  • Stock
    Toothed Whales (Odontoceti) Atlantic white-sided dolphin Lagenorhynchus acutus N/A 48,819 W. North Atlantic. Short-beaked common dolphin Delphinus delphis N/A 120,743 W. North Atlantic. Harbor porpoise Phocoena phocoena N/A 79,833 Gulf of Maine/Bay of Fundy. Baleen Whales (Mysticeti) Minke whale Balaenoptera acutorostrata N/A 20,741 Canadian East Coast. Fin whale Balaenoptera physalus Endangered 1,618 W. North Atlantic. Humpback whale Megaptera novaeangliae Endangered 823 Gulf of Maine. North Atlantic right whale Eubalaena glacialis Endangered 465 W. North Atlantic. Earless Seals (Phocidae) Gray seals Halichoerus grypus N/A 348,900 North Atlantic. Harbor seals Phoca vitulina N/A 75,834 W. North Atlantic. Sources: Waring et al., 2015; Waring et al., 2013; Waring et al., 2011; Warring et al., 2010; RI SAMP, 2011; Kenney and Vigness-Raposa, 2009; NMFS, 2012.
    Potential Effects of the Specified Activity on Marine Mammals

    This section includes a summary and discussion of the ways that the types of stressors associated with the specified activity have been observed to impact marine mammals. This discussion may also include reactions that we consider to rise to the level of a take and those that we do not consider to rise to the level of a take (for example, with acoustics, we may include a discussion of studies that showed animals not reacting at all to sound or exhibiting barely measurable avoidance). This section is intended as a background of potential effects and does not consider either the specific manner in which this activity will be carried out or the mitigation that will be implemented, and how either of those will shape the anticipated impacts from this specific activity. The “Estimated Take by Incidental Harassment” section later in this document will include a quantitative analysis of the number of individuals that are expected to be taken by this activity. The “Negligible Impact Analysis” section will include the analysis of how this specific activity will impact marine mammals and will consider the content of this “Potential Effects of the Specified Activity on Marine Mammals” section, the “Estimated Take by Incidental Harassment” section, the “Proposed Mitigation” section, and the “Anticipated Effects on Marine Mammal Habitat” section to draw conclusions regarding the likely impacts of this activity on the reproductive success or survivorship of individuals, and from that on the affected marine mammal populations or stocks.

    Background on Sound

    Sound is a physical phenomenon consisting of minute vibrations that travel through a medium, such as air or water, and is generally characterized by several variables. Frequency describes the sound's pitch and is measured in hertz (Hz) or kilohertz (kHz), while sound level describes the sound's intensity and is measured in decibels (dB). Sound level increases or decreases exponentially with each dB of change. The logarithmic nature of the scale means that each 10-dB increase is a 10-fold increase in acoustic power (and a 20-dB increase is then a 100-fold increase in power). A 10-fold increase in acoustic power does not mean that the sound is perceived as being 10 times louder, however. Sound levels are compared to a reference sound pressure (micro-Pascal) to identify the medium. For air and water, these reference pressures are “re: 20 μPa” and “re: 1 μPa,” respectively. Root mean square (RMS) is the quadratic mean sound pressure over the duration of an impulse. RMS is calculated by squaring all of the sound amplitudes, averaging the squares, and then taking the square root of the average (Urick, 1975). RMS accounts for both positive and negative values; squaring the pressures makes all values positive so that they may be accounted for in the summation of pressure levels. This measurement is often used in the context of discussing behavioral effects, in part because behavioral effects, which often result from auditory cues, may be better expressed through averaged units rather than by peak pressures.

    Acoustic Impacts

    Use of the DP vessel thrusters during the BIWF project may temporarily impact marine mammals in the area due to elevated in-water sound levels. Marine mammals are continually exposed to many sources of sound. Naturally occurring sounds such as lightning, rain, sub-sea earthquakes, and biological sounds (e.g., snapping shrimp, whale songs) are widespread throughout the world's oceans. Marine mammals produce sounds in various contexts and use sound for various biological functions including, but not limited to: (1) Social interactions; (2) foraging; (3) orientation; and (4) predator detection. Interference with producing or receiving these sounds may result in adverse impacts. Audible distance, or received levels of sound depend on the nature of the sound source, ambient noise conditions, and the sensitivity of the receptor to the sound (Richardson et al., 1995). Type and significance of marine mammal reactions to sound are likely dependent on a variety of factors including, but not limited to, (1) the behavioral state of the animal (e.g., feeding, traveling, etc.); (2) frequency of the sound; (3) distance between the animal and the source; and (4) the level of the sound relative to ambient conditions (Southall et al., 2007).

    When considering the influence of various kinds of sound on the marine environment, it is necessary to understand that different kinds of marine life are sensitive to different frequencies of sound. Current data indicate that not all marine mammal species have equal hearing capabilities (Richardson et al., 1995; Southall et al., 1997; Wartzok and Ketten, 1999; Au and Hastings, 2008).

    Southall et al. (2007) designated “functional hearing groups” for marine mammals based on available behavioral data; audiograms derived from auditory evoked potentials; anatomical modeling; and other data. Southall et al. (2007) also estimated the lower and upper frequencies of functional hearing for each group. However, animals are less sensitive to sounds at the outer edges of their functional hearing range and are more sensitive to a range of frequencies within the middle of their functional hearing range. Note that direct measurements of hearing sensitivity do not exist for all species of marine mammals, including low-frequency cetaceans. The functional hearing groups and the associated frequencies developed by Southall et al. (2007) were revised by Finneran and Jenkins (2012) and have been further modified by NOAA. Table 2 provides a summary of sound production and general hearing capabilities for marine mammal species (note that values in this table are not meant to reflect absolute possible maximum ranges, rather they represent the best known ranges of each functional hearing group). For purposes of the analysis in this document, marine mammals are arranged into the following functional hearing groups based on their generalized hearing sensitivities: High-frequency cetaceans, mid-frequency cetaceans, low-frequency cetaceans (mysticetes), phocids (true seals), and otariids (sea lion and fur seals). A detailed discussion of the functional hearing groups can be found in Southall et al. (2007) and Finneran and Jenkins (2012).

    Table 3—Marine Mammal Functional Hearing Groups Functional hearing group Functional hearing range* Low-frequency (LF) cetaceans (baleen whales) 7 Hz to 25 kHz. Mid-frequency (MF) cetaceans (dolphins, toothed whales, beaked whales, bottlenose whales) 150 Hz to 160 kHz. High-frequency (HF) cetaceans (true porpoises, Kogia, river dolphins, cephalorhynchid, Lagenorhynchus cruciger and L. australis) 200 Hz to 180 kHz. Phocid pinnipeds (underwater) (true seals) 75 Hz to 100 kHz. Otariid pinnipeds (underwater) (sea lions and fur seals) 100 Hz to 48 kHz. Adapted and derived from Southall et al. (2007). * Represents frequency band of hearing for entire group as a composite (i.e., all species within the group), where individual species' hearing ranges are typically not as broad. Functional hearing is defined as the range of frequencies a group hears without incorporating non-acoustic mechanisms (Wartzok and Ketten, 1999). This is ~60 to ~70 dB above best hearing sensitivity (Southall et al., 2007) for all functional hearing groups except LF cetaceans, where no direct measurements on hearing are available. For LF cetaceans, the lower range is based on recommendations from Southall et al., 2007 and the upper range is based on information on inner ear anatomy and vocalizations.

    When sound travels (propagates) from its source, its loudness decreases as the distance traveled by the sound increases. Thus, the loudness of a sound at its source is higher than the loudness of that same sound a kilometer away. Acousticians often refer to the loudness of a sound at its source (typically referenced to one meter from the source) as the source level and the loudness of sound elsewhere as the received level (i.e., typically the receiver). For example, a humpback whale 3 km from a device that has a source level of 230 dB may only be exposed to sound that is 160 dB loud, depending on how the sound travels through water (e.g., spherical spreading [6 dB reduction with doubling of distance] was used in this example). As a result, it is important to understand the difference between source levels and received levels when discussing the loudness of sound in the ocean or its impacts on the marine environment.

    As sound travels from a source, its propagation in water is influenced by various physical characteristics, including water temperature, depth, salinity, and surface and bottom properties that cause refraction, reflection, absorption, and scattering of sound waves. Oceans are not homogeneous and the contribution of each of these individual factors is extremely complex and interrelated. The physical characteristics that determine the sound's speed through the water will change with depth, season, geographic location, and with time of day (as a result, in actual active sonar operations, crews will measure oceanic conditions, such as sea water temperature and depth, to calibrate models that determine the path the sonar signal will take as it travels through the ocean and how strong the sound signal will be at a given range along a particular transmission path). As sound travels through the ocean, the intensity associated with the wavefront diminishes, or attenuates. This decrease in intensity is referred to as propagation loss, also commonly called transmission loss.

    As mentioned previously in this document, nine marine mammal species (seven cetaceans and two pinnipeds) are most likely to occur in the project area. Of the seven cetacean species likely to occur in the project area, four are classified as low-frequency cetaceans (i.e., minke whale, fin whale, humpback whale, and North Atlantic right whale), two are classified as mid-frequency cetaceans (i.e., Atlantic white-sided dolphin and short-beaked common dolphin), and one is classified as a high-frequency cetacean (i.e., harbor porpoise) (Southall et al., 2007). A species' functional hearing group is a consideration when we analyze the effects of exposure to sound on marine mammals.

    Hearing Impairment

    Marine mammals may experience temporary or permanent hearing impairment when exposed to loud sounds. Hearing impairment is classified by temporary threshold shift (TTS) and permanent threshold shift (PTS). There are no empirical data for onset of PTS in any marine mammal; therefore, PTS-onset must be estimated from TTS-onset measurements and from the rate of TTS growth with increasing exposure levels above the level eliciting TTS-onset. PTS is presumed to be likely if the hearing threshold is reduced by ≥40 dB (that is, 40 dB of TTS). PTS is considered auditory injury (Southall et al., 2007) and occurs in a specific frequency range and amount. Irreparable damage to the inner or outer cochlear hair cells may cause PTS; however, other mechanisms are also involved, such as exceeding the elastic limits of certain tissues and membranes in the middle and inner ears and resultant changes in the chemical composition of the inner ear fluids (Southall et al., 2007). Given the higher level of sound and longer durations of exposure necessary to cause PTS as compared with TTS, it is considerably less likely that PTS would occur during DP vessel thruster use associated with the cable laying activities.

    Temporary Threshold Shift (TTS)

    TTS is the mildest form of hearing impairment that can occur during exposure to a loud sound (Kryter, 1985). While experiencing TTS, the hearing threshold rises and a sound must be stronger in order to be heard. At least in terrestrial mammals, TTS can last from minutes or hours to (in cases of strong TTS) days, can be limited to a particular frequency range, and can occur to varying degrees (i.e., a loss of a certain number of dBs of sensitivity). For sound exposures at or somewhat above the TTS threshold, hearing sensitivity in both terrestrial and marine mammals recovers rapidly after exposure to the noise ends.

    Marine mammal hearing plays a critical role in communication with conspecifics and in interpretation of environmental cues for purposes such as predator avoidance and prey capture. Depending on the degree (elevation of threshold in dB), duration (i.e., recovery time), and frequency range of TTS and the context in which it is experienced, TTS can have effects on marine mammals ranging from discountable to serious. For example, a marine mammal may be able to readily compensate for a brief, relatively small amount of TTS in a non-critical frequency range that takes place during a time when the animals is traveling through the open ocean, where ambient noise is lower and there are not as many competing sounds present. Alternatively, a larger amount and longer duration of TTS sustained during a time when communication is critical for successful mother/calf interactions could have more serious impacts if it were in the same frequency band as the necessary vocalizations and of a severity that it impeded communication. The fact that animals exposed to levels and durations of sound that would be expected to result in this physiological response would also be expected to have behavioral responses of a comparatively more severe or sustained nature is also notable and potentially of more importance than the simple existence of a TTS.

    Currently, TTS data only exist for four species of cetaceans (bottlenose dolphin, beluga whale [Delphinapterus leucas], harbor porpoise, and Yangtze finless porpoise [Neophocoena asiaeorientalis]) and three species of pinnipeds (northern elephant seal, harbor seal, and California sea lion) exposed to a limited number of sound sources (i.e., mostly tones and octave-band noise) in laboratory settings (e.g., Finneran et al., 2002 and 2010; Nachtigall et al., 2004; Kastak et al., 2005; Lucke et al., 2009; Mooney et al., 2009; Popov et al., 2011; Finneran and Schlundt, 2010). In general, harbor seals (Kastak et al., 2005; Kastelein et al., 2012a) and harbor porpoises (Lucke et al., 2009; Kastelein et al., 2012b) have a lower TTS onset than other measured pinniped or cetacean species. However, even for these animals, which are better able to hear higher frequencies and may be more sensitive to higher frequencies, exposures on the order of approximately 170 dB rms or higher for brief transient signals are likely required for even temporary (recoverable) changes in hearing sensitivity that would likely not be categorized as physiologically damaging (NEFSC, 2014). Additionally, the existing marine mammal TTS data come from a limited number of individuals within these species. There are no data available on noise-induced hearing loss for mysticetes. For summaries of data on TTS in marine mammals or for further discussion of TTS onset thresholds, please see Southall et al. (2007), Finneran and Jenkins (2012), and Finneran (2015).

    Scientific literature highlights the inherent complexity of predicting TTS onset in marine mammals, as well as the importance of considering exposure duration when assessing potential impacts (Mooney et al., 2009a, 2009b; Kastak et al., 2007). Generally, with sound exposures of equal energy, quieter sounds (lower SPL) of longer duration were found to induce TTS onset more than louder sounds (higher SPL) of shorter duration. For intermittent sounds, less threshold shift will occur than from a continuous exposure with the same energy (some recovery will occur between intermittent exposures) (Kryter et al., 1966; Ward, 1997). For sound exposures at or somewhat above the TTS-onset threshold, hearing sensitivity recovers rapidly after exposure to the sound ends. Southall et al. (2007) considers a 6 dB TTS (that is, baseline thresholds are elevated by 6 dB) to be a sufficient definition of TTS-onset. NMFS considers TTS as Level B harassment that is mediated by physiological effects on the auditory system; however, NMFS does not consider TTS-onset to be the lowest level at which Level B harassment may occur.

    Although the duration of the DP thruster sound source has the potential to induce TTS onset, animals in the project during the inter-array and export cable installation activities are not expected to incur more than mild TTS hearing impairment due to low source levels and the fact that most marine mammals would more likely avoid a loud sound source rather than swim in such close proximity as to result in TTS. Any disturbance to marine mammals is likely to be in the form of temporary avoidance or alteration of opportunistic foraging behavior near the survey location.

    Masking

    Masking is the obscuring of sounds of interest to an animal by other sounds, typically at similar frequencies. Chronic exposure to excessive, though not high-intensity, noise has the potential to cause masking at particular frequencies for marine mammals that utilize sound for vital biological functions (Clark et al. 2009). Marine mammals are highly dependent on sound, and their ability to recognize sound signals amid other sound is important in communication and detection of both predators and prey. Background ambient sound may interfere with or mask the ability of an animal to detect a sound signal even when that signal is above its absolute hearing threshold. Even in the absence of anthropogenic sound, the marine environment is often loud. Natural ambient sound includes contributions from wind, waves, precipitation, other animals, and (at frequencies above 30 kHz) thermal sound resulting from molecular agitation (Richardson et al., 1995).

    Background sound may also include anthropogenic sound, and masking of natural sounds can result when human activities produce high levels of background sound. Conversely, if the background level of underwater sound is high (e.g., on a day with strong wind and high waves), an anthropogenic sound source would not be detectable as far away as would be possible under quieter conditions and would itself be masked. Ambient sound is highly variable on continental shelves (Thompson, 1965; Myrberg, 1978; Chapman et al., 1998; Desharnais et al., 1999). This results in a high degree of variability in the range at which marine mammals can detect anthropogenic sounds.

    Although masking is a phenomenon which may occur naturally, the introduction of loud anthropogenic sounds into the marine environment at frequencies important to marine mammals increases the severity and frequency of occurrence of masking. For example, if a baleen whale is exposed to continuous low-frequency sound from an industrial source, this would reduce the size of the area around that whale within which it can hear the calls of another whale. The components of background noise that are similar in frequency to the signal in question primarily determine the degree of masking of that signal. In general, little is known about the degree to which marine mammals rely upon detection of sounds from conspecifics, predators, prey, or other natural sources. In the absence of specific information about the importance of detecting these natural sounds, it is not possible to predict the impact of masking on marine mammals (Richardson et al., 1995). In general, masking effects are expected to be less severe when sounds are transient than when they are continuous. Masking is typically of greater concern for those marine mammals that utilize low-frequency communications, such as baleen whales, because of how far low-frequency sounds propagate. Therefore, since noise generated from vessels dynamic positioning activity is mostly concentrated at low frequency ranges, it may have less effect on high frequency echolocation sounds by odontocetes (toothed whales).

    As the DP vessel is continually moving along the cable route over a 24-hour period, the area within the 120 dB isopleth is constantly moving and shifting within a 24-hour period.

    Therefore, no single area in Rhode Island Sound will have noise levels above 120 dB for more than a few hours. While continuous sound from the DP thruster when in use is predicted to extend up to 4.75 km to the 120 dB threshold, the low source levels, coupled with the likelihood of animals to avoid the sound source, would result in very little opportunity for this activity to mask the communication of local marine mammals for more than a brief period of time.

    Non-Auditory Physical Effects (Stress)

    Classic stress responses begin when an animal's central nervous system perceives a potential threat to its homeostasis. That perception triggers stress responses regardless of whether a stimulus actually threatens the animal; the mere perception of a threat is sufficient to trigger a stress response (Moberg, 2000; Sapolsky et al., 2005; Seyle, 1950). Once an animal's central nervous system perceives a threat, it mounts a biological response or defense that consists of a combination of the four general biological defense responses: Behavioral responses, autonomic nervous system responses, neuroendocrine responses, or immune responses.

    In the case of many stressors, an animal's first and sometimes most economical (in terms of biotic costs) response is behavioral avoidance of the potential stressor or avoidance of continued exposure to a stressor. An animal's second line of defense to stressors involves the sympathetic part of the autonomic nervous system and the classical “fight or flight” response which includes the cardiovascular system, the gastrointestinal system, the exocrine glands, and the adrenal medulla to produce changes in heart rate, blood pressure, and gastrointestinal activity that humans commonly associate with “stress.” These responses have a relatively short duration and may or may not have significant long-term effect on an animal's welfare.

    An animal's third line of defense to stressors involves its neuroendocrine systems; the system that has received the most study has been the hypothalamus-pituitary-adrenal system (also known as the HPA axis in mammals or the hypothalamus-pituitary-interrenal axis in fish and some reptiles). Unlike stress responses associated with the autonomic nervous system, virtually all neuro-endocrine functions that are affected by stress—including immune competence, reproduction, metabolism, and behavior—are regulated by pituitary hormones. Stress-induced changes in the secretion of pituitary hormones have been implicated in failed reproduction (Moberg, 1987; Rivier, 1995), altered metabolism (Elasser et al., 2000), reduced immune competence (Blecha, 2000), and behavioral disturbance. Increases in the circulation of glucocorticosteroids (cortisol, corticosterone, and aldosterone in marine mammals; see Romano et al., 2004) have been equated with stress for many years.

    The primary distinction between stress (which is adaptive and does not normally place an animal at risk) and distress is the biotic cost of the response. During a stress response, an animal uses glycogen stores that can be quickly replenished once the stress is alleviated. In such circumstances, the cost of the stress response would not pose a risk to the animal's welfare. However, when an animal does not have sufficient energy reserves to satisfy the energetic costs of a stress response, energy resources must be diverted from other biotic function, which impairs those functions that experience the diversion. For example, when mounting a stress response diverts energy away from growth in young animals, those animals may experience stunted growth. When mounting a stress response diverts energy from a fetus, an animal's reproductive success and its fitness will suffer. In these cases, the animals will have entered a pre-pathological or pathological state which is called “distress” (Seyle, 1950) or “allostatic loading” (McEwen and Wingfield, 2003). This pathological state will last until the animal replenishes its biotic reserves sufficient to restore normal function. Note that these examples involved a long-term (days or weeks) stress response exposure to stimuli.

    Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses have also been documented fairly well through controlled experiments; because this physiology exists in every vertebrate that has been studied, it is not surprising that stress responses and their costs have been documented in both laboratory and free-living animals (for examples see, Holberton et al., 1996; Hood et al., 1998; Jessop et al., 2003; Krausman et al., 2004; Lankford et al., 2005; Reneerkens et al., 2002; Thompson and Hamer, 2000). Information has also been collected on the physiological responses of marine mammals to exposure to anthropogenic sounds (Fair and Becker, 2000; Romano et al., 2002; Wright et al., 2008). For example, Rolland et al. (2012) found that noise reduction from reduced ship traffic in the Bay of Fundy was associated with decreased stress in North Atlantic right whales. In a conceptual model developed by the Population Consequences of Acoustic Disturbance (PCAD) working group, serum hormones were identified as possible indicators of behavioral effects that are translated into altered rates of reproduction and mortality.

    Studies of other marine animals and terrestrial animals would also lead us to expect some marine mammals to experience physiological stress responses and, perhaps, physiological responses that would be classified as “distress” upon exposure to high frequency, mid-frequency, or low-frequency sounds. For example, Jansen (1998) reported on the relationship between acoustic exposures and physiological responses that are indicative of stress responses in humans (for example, elevated respiration and increased heart rates). Jones (1998) reported on reductions in human performance when faced with acute, repetitive exposures to acoustic disturbance. Trimper et al. (1998) reported on the physiological stress responses of osprey to low-level aircraft noise while Krausman et al. (2004) reported on the auditory and physiology stress responses of endangered Sonoran pronghorn to military overflights. Smith et al. (2004a, 2004b), for example, identified noise-induced physiological transient stress responses in hearing-specialist fish (i.e., goldfish) that accompanied short- and long-term hearing losses. Welch and Welch (1970) reported physiological and behavioral stress responses that accompanied damage to the inner ears of fish and several mammals.

    Hearing is one of the primary senses marine mammals use to gather information about their environment and to communicate with conspecifics. Although empirical information on the relationship between sensory impairment (TTS, PTS, and acoustic masking) on marine mammals remains limited, it seems reasonable to assume that reducing an animal's ability to gather information about its environment and to communicate with other members of its species would be stressful for animals that use hearing as their primary sensory mechanism. Therefore, we assume that acoustic exposures sufficient to trigger onset PTS or TTS would be accompanied by physiological stress responses because terrestrial animals exhibit those responses under similar conditions (NRC, 2003). More importantly, marine mammals might experience stress responses at received levels lower than those necessary to trigger onset TTS. Based on empirical studies of the time required to recover from stress responses (Moberg, 2000), we also assume that stress responses are likely to persist beyond the time interval required for animals to recover from TTS and might result in pathological and pre-pathological states that would be as significant as behavioral responses to TTS.

    In general, there are few data on the potential for strong, anthropogenic underwater sounds to cause non-auditory physical effects in marine mammals. Such effects, if they occur at all, would presumably be limited to short distances and to activities that extend over a prolonged period. The available data do not allow identification of a specific exposure level above which non-auditory effects can be expected (Southall et al., 2007). There is no definitive evidence that any of these effects occur even for marine mammals in close proximity to an anthropogenic sound source. In addition, marine mammals that show behavioral avoidance of vessels and related sound sources, are unlikely to incur non-auditory impairment or other physical effects. NMFS does not expect that the generally short-term and transitory cable installation activities would create conditions of long-term, continuous noise leading to long-term physiological stress responses in marine mammals.

    Behavioral Disturbance

    Behavioral responses to sound are highly variable and context-specific. An animal's perception of and response to (in both nature and magnitude) an acoustic event can be influenced by prior experience, perceived proximity, bearing of the sound, familiarity of the sound, etc. (Southall et al., 2007). If a marine mammal does react briefly to an underwater sound by changing its behavior or moving a small distance, the impacts of the change are unlikely to be significant to the individual, let alone the stock or population. However, if a sound source displaces marine mammals from an important feeding or breeding area for a prolonged period, impacts on individuals and populations could be significant (e.g., Lusseau and Bejder, 2007; Weilgart, 2007).

    Southall et al. (2007) reports the results of the efforts of a panel of experts in acoustic research from behavioral, physiological, and physical disciplines that convened and reviewed the available literature on marine mammal hearing and physiological and behavioral responses to human-made sound with the goal of proposing exposure criteria for certain effects. This peer-reviewed compilation of literature is very valuable, though Southall et al. (2007) note that not all data are equal, some have poor statistical power, insufficient controls, and/or limited information on received levels, background noise, and other potentially important contextual variables—such data were reviewed and sometimes used for qualitative illustration but were not included in the quantitative analysis for the criteria recommendations. All of the studies considered, however, contain an estimate of the received sound level when the animal exhibited the indicated response.

    In the Southall et al. (2007) publication, for the purposes of analyzing responses of marine mammals to anthropogenic sound and developing criteria, the authors differentiate between pulse sounds (single and multiple) and non-pulse sounds.

    The studies that address responses of low-frequency cetaceans to non-pulse sounds sounds (such as the sound emitted from a DP vessel thruster) include data gathered in the field and related to several types of sound sources, including: Vessel noise, drilling and machinery playback, low-frequency M-sequences (sine wave with multiple phase reversals) playback, tactical low-frequency active sonar playback, drill ships, and non-pulse playbacks. These studies generally indicate no (or very limited) responses to received levels in the 90 to 120 dB re: 1µPa range and an increasing likelihood of avoidance and other behavioral effects in the 120 to 160 dB range. As mentioned earlier, though, contextual variables play a very important role in the reported responses and the severity of effects do not increase linearly with received levels. Also, few of the laboratory or field datasets had common conditions, behavioral contexts, or sound sources, so it is not surprising that responses differ.

    The studies that address responses of mid-frequency cetaceans to non-pulse sounds include data gathered both in the field and the laboratory and related to several different sound sources, including: Pingers, drilling playbacks, ship and ice-breaking noise, vessel noise, Acoustic harassment devices (AHDs), Acoustic Deterrent Devices (ADDs), mid-frequency active sonar, and non-pulse bands and tones. Southall et al. (2007) were unable to come to a clear conclusion regarding the results of these studies. In some cases animals in the field showed significant responses to received levels between 90 and 120 dB, while in other cases these responses were not seen in the 120 to 150 dB range. The disparity in results was likely due to contextual variation and the differences between the results in the field and laboratory data (animals typically responded at lower levels in the field).

    The studies that address responses of high-frequency cetaceans to non-pulse sounds include data gathered both in the field and the laboratory and related to several different sound sources, including: Pingers, AHDs, and various laboratory non-pulse sounds. All of these data were collected from harbor porpoises. Southall et al. (2007) concluded that the existing data indicate that harbor porpoises are likely sensitive to a wide range of anthropogenic sounds at low received levels (around 90 to 120 dB), at least for initial exposures. All recorded exposures above 140 dB induced profound and sustained avoidance behavior in wild harbor porpoises (Southall et al., 2007). Rapid habituation was noted in some but not all studies.

    The studies that address the responses of pinnipeds in water to non-pulse sounds include data gathered both in the field and the laboratory and related to several different sound sources, including: AHDs, various non-pulse sounds used in underwater data communication, underwater drilling, and construction noise. Few studies exist with enough information to include them in the analysis. The limited data suggest that exposures to non-pulse sounds between 90 and 140 dB generally do not result in strong behavioral responses of pinnipeds in water, but no data exist at higher received levels (Southall et al., 2007).

    The low source level and relatively short duration of the DP vessel thrusters during cable installation activities would likely result in only brief startling reactions or short-term and temporary avoidance of the area, rather than permanent abandonment, by marine mammals.

    Tolerance

    Numerous studies have shown that underwater sounds from industrial activities are often readily detectable by marine mammals in the water at distances of many kilometers. However, other studies have shown that marine mammals at distances more than a few kilometers away often show no apparent response to industrial activities of various types (Miller et al., 2005). This is often true even in cases when the sounds must be readily audible to the animals based on measured received levels and the hearing sensitivity of that mammal group. Although various baleen whales, toothed whales, and (less frequently) pinnipeds have been shown to react behaviorally to underwater sound from sources such as airgun pulses or vessels under some conditions, at other times, mammals of all three types have shown no overt reactions (e.g., Malme et al., 1986; Richardson et al., 1995; Madsen and Mohl, 2000; Croll et al., 2001; Jacobs and Terhune, 2002; Madsen et al., 2002; Miller et al., 2005). In general, pinnipeds seem to be more tolerant of exposure to some types of underwater sound than are baleen whales. Richardson et al. (1995) found that vessel sound does not seem to strongly affect pinnipeds that are already in the water. Richardson et al. (1995) went on to explain that seals on haul-outs sometimes respond strongly to the presence of vessels and at other times appear to show considerable tolerance of vessels, and Brueggeman et al. (1992) observed ringed seals (Pusa hispida) hauled out on ice pans displaying short-term escape reactions when a ship approached within 0.16-0.31 mi (0.25-0.5 km).

    Vessel Strike

    Ship strikes of marine mammals can cause major wounds, which may lead to the death of the animal. An animal at the surface could be struck directly by a vessel, a surfacing animal could hit the bottom of a vessel, or a vessel's propeller could injure an animal just below the surface. The severity of injuries typically depends on the size and speed of the vessel (Knowlton and Kraus, 2001; Laist et al., 2001; Vanderlaan and Taggart, 2007).

    The most vulnerable marine mammals are those that spend extended periods of time at the surface in order to restore oxygen levels within their tissues after deep dives (e.g., the sperm whale). In addition, some baleen whales, such as the North Atlantic right whale, seem generally unresponsive to vessel sound, making them more susceptible to vessel collisions (Nowacek et al., 2004). These species are primarily large, slow moving whales. Smaller marine mammals (e.g., bottlenose dolphin) move quickly through the water column and are often seen riding the bow wave of large ships. Marine mammal responses to vessels may include avoidance and changes in dive pattern (NRC, 2003).

    An examination of all known ship strikes from all shipping sources (civilian and military) indicates vessel speed is a principal factor in whether a vessel strike results in death (Knowlton and Kraus, 2001; Laist et al., 2001; Jensen and Silber, 2003; Vanderlaan and Taggart, 2007). In assessing records with known vessel speeds, Laist et al. (2001) found a direct relationship between the occurrence of a whale strike and the speed of the vessel involved in the collision. The authors concluded that most deaths occurred when a vessel was traveling in excess of 24.1 km/h (14.9 mph; 13 kts).

    Given the slow vessel speeds and predictable course necessary for jet-plowing and related cable installation activities for the BIWF project, ship strike is unlikely to occur. Marine mammals would be able to easily avoid vessels and are likely already habituated to the presence of numerous vessels in the area. Right whales have been observed in or near Rhode Island during all four seasons; however, they are most common in the spring when they are migrating and in the fall during their southbound migration (Kenney and Vigness-Raposa, 2009). Portions of the BIWF project area are located within the NMFS-designated Mid-Atlantic seasonal management area (SMA) (see 50 CFR 224.105); thus, to minimize the potential for vessel collision with right whales and other marine mammal species all DWBI vessels associated with the BIWF construction will operate at speeds of 10 knots or less from the November 1 to April 30 time period, regardless of whether they are inside or outside of the designated SMA. In addition, all DWBI vessels associated with the BIWF construction will adhere to NMFS guidelines for marine mammal ship striking avoidance (available online at: http://www.nmfs.noaa.gov/pr/pdfs/education/viewing_northeast.pdf), including maintaining a distance of at least 1,500 feet from right whales and having dedicated protected species observers who will communicate with the captain to ensure that all measures to avoid whales are taken. NMFS believes that the size of right whales, their slow movements, and the amount of time they spend at the surface will make them extremely likely to be spotted by protected species observers during construction activities within the BIWF project area.

    Anticipated Effects on Marine Mammal Habitat

    There are no feeding areas, rookeries, or mating grounds known to be biologically important to marine mammals within the proposed project area. There is also no designated critical habitat for any ESA-listed marine mammals. Harbor seals haul out on Block Island and points along Narragansett Bay, the most important haul-out being on the edge of New Harbor, about 2.4 km from the proposed BIWF landfall on Block Island. The only consistent haul-out locations for gray seals within the vicinity of Rhode Island are around Monomoy National Wildlife Refuge and Nantucket Sound in Massachusetts (more than 80 nautical miles from the proposed project area). As discussed above, NMFS' regulations at 50 CFR 224 designated the nearshore waters of the Mid-Atlantic Bight as the Mid-Atlantic U.S. SMA for right whales in 2008. Mandatory vessel speed restrictions are in place in that SMA from November 1 through April 30 to reduce the threat of collisions between ships and right whales around their migratory route and calving grounds.

    The BIWF involves activities that would disturb the seafloor and potentially affect benthic and finfish communities. Installation of the inter-array cable and export cable would result in the temporary disturbance of no more than 3.7 and 11.6 acres of seafloor, respectively. These installation activities would also result in temporary and localized increases in turbidity around the proposed project area. DWBI may also be required to install additional protective armoring in areas where the burial depth achieved is less than 1.2 m. DWBI expects that additional protection would be required at a maximum of 1 percent of the entire submarine cable, resulting in a conversion of up to 0.4 acres of soft substrate to hard substrate along the cable route. During the installation of additional protective armoring at the cable crossings and as necessary along the cable route, anchors and anchor chains would temporarily impact about 1.8 acres of bottom substrate during each anchoring event.

    Jet-plowing and impacts from construction vessel anchor placement and/or sweep would cause either the displacement or loss of benthic and finfish resources in the immediate areas of disturbance. This may result in a temporary loss of forage items and a temporary reduction in the amount of benthic habitat available for foraging marine mammals in the immediate proposed project area. However, the amount of habitat affected represents a very small percentage of the available foraging habitat in the proposed project area. It is likely that marine mammals may temporarily shift their foraging efforts to other areas within or around the project area. While this would affect the movements of individual marine mammals, it is likely to be temporary and is not likely to affect marine mammal nourishment or result in any injury or mortality. Increased underwater sound levels may temporarily result in marine mammals avoiding or abandoning the area.

    Because of the temporary nature of the disturbance, the availability of similar habitat and resources in the surrounding area, and the lack of important or unique marine mammal habitat, the impacts to marine mammals and the food sources that they utilize are not expected to cause significant or long-term consequences for individual marine mammals or their populations.

    Mitigation

    In order to issue an incidental take authorization under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (where relevant).

    Proposed Mitigation Measures

    With NMFS' input during the application process, DWBI is proposing the following mitigation measures during cable installation operations using DP vessel thruster use. These mitigation measures were also reviewed and approved by NMFS for the BIWF IHA issued in 2014 and amended in June 2015, and are consistent with the terms and conditions of the amended Incidental Take Statement for the Biological Opinion on the Construction and Operation of the Block Island Wind Farm:

    Exclusion and Monitoring Zones: Exclusion zones (defined by NMFS as the Level A harassment zone of influence [ZOI] out to the 180/190 dB isopleth) and monitoring zones (defined by NMFS as the Level B harassment ZOI out to the 120 dB isopleth for continuous noise) are typically established to minimize impacts to marine mammals. However, noise analysis has indicated that DP vessel thruster use will not produce sound levels at 180/190 dB at any appreciable distance (see DWBI's Underwater Acoustic Modeling Report in Appendix A of the application). This is consistent with acoustic modeling results for other Atlantic wind farm projects using DP vessel thrusters (Tetra Tech, 2014; DONG Energy, 2016), as well as subsea cable-laying activities using DP vessel thruster use (Quintillion, 2015 and 2016). Therefore, injury to marine mammals is not expected and no Level A harassment exclusion zone is proposed.

    Consultation with NMFS has indicated that the monitoring zones established out to the 120 dB isopleth for continuous noise will result in zones too large to effectively monitor (up to 4.75 km). Therefore, based on precedent set by the U.S. Department of the Navy and recent European legislation regarding compliance thresholds for wind farm construction noise (DoN, 2012; OSPAR, 2008), and consistent with the previous IHA's issued to DWBI and Deepwater Wind Block Island Transmission, L.L.C. (DWBITS), DWBI will establish a monitoring zone equivalent, at a minimum, to the size of the predicted 160 dB isopleth for DP vessel thruster use (5-m radius from the DP vessel) based on DWBI's underwater acoustic modeling. All marine mammal sightings which are visually feasible beyond the 160 dB isopleth will be recorded and potential takes will be noted.

    DP Thruster Power Reduction—During cable installation a constant tension must be maintained to ensure the integrity of the cable. Any significant stoppage in vessel maneuverability during jet plow activities has the potential to result in significant damage to the cable. Therefore, during cable lay if marine mammals enter or approach the established 160 dB isopleth monitoring zone, DWBI proposes to reduce DP thruster to the maximum extent possible, except under circumstances when reducing DP thruster use would compromise safety (both human health and environmental) and/or the integrity of the Project. Reducing thruster energy will effectively reduce the potential for exposure of marine mammals to sound energy. After decreasing thruster energy, protected species observers (PSOs) will continue to monitor marine mammal behavior and determine if the animal(s) is moving towards or away from the established monitoring zone. If the animal(s) continues to move towards the sound source then DP thruster use would remain at the reduced level. Normal thruster use will resume when PSOs report that marine mammals have moved away from and remained clear of the monitoring zone for a minimum of 30 minutes since last the sighting.

    Vessel Speed Restrictions—To minimize the potential for vessel collision with North Atlantic right whales and other marine mammals, all DWBI project vessels shall operate at speeds of 10 knots or less from November 1 through April 30.

    Ship Strike Avoidance—DWBI shall adhere to NMFS guidelines for marine mammal ship strike avoidance (http://www.nmfs.noaa.gov/pr/pdfs/education/viewing_northeast.pdf).

    Mitigation Conclusions

    NMFS has carefully evaluated DWBI's mitigation measures in the context of ensuring that we prescribe the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another:

    • The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals;

    • The proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and

    • The practicability of the measure for applicant implementation.

    Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed here:

    • Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).

    • A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to received levels of activities that we expect to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    • A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels of activities that we expect to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    • A reduction in the intensity of exposures (either total number or number at biologically important time or location) to received levels of activities that we expect to result in the take of marine mammals (this goal may contribute to a, above, or to reducing the severity of harassment takes only).

    • Avoidance or minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.

    • For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

    Based on our evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammals species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Monitoring and Reporting

    In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth, “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for ITAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area.

    Monitoring measures prescribed by NMFS should accomplish one or more of the following general goals:

    1. An increase in our understanding of the likely occurrence of marine mammal species in the vicinity of the action, i.e., presence, abundance, distribution, and/or density of species.

    2. An increase in our understanding of the nature, scope, or context of the likely exposure of marine mammal species to any of the potential stressor(s) associated with the action (e.g. sound or visual stimuli), through better understanding of one or more of the following: The action itself and its environment (e.g. sound source characterization, propagation, and ambient noise levels); the affected species (e.g. life history or dive pattern); the likely co-occurrence of marine mammal species with the action (in whole or part) associated with specific adverse effects; and/or the likely biological or behavioral context of exposure to the stressor for the marine mammal (e.g. age class of exposed animals or known pupping, calving or feeding areas).

    3. An increase in our understanding of how individual marine mammals respond (behaviorally or physiologically) to the specific stressors associated with the action (in specific contexts, where possible, e.g., at what distance or received level).

    4. An increase in our understanding of how anticipated individual responses, to individual stressors or anticipated combinations of stressors, may impact either: The long-term fitness and survival of an individual; or the population, species, or stock (e.g. through effects on annual rates of recruitment or survival).

    5. An increase in our understanding of how the activity affects marine mammal habitat, such as through effects on prey sources or acoustic habitat (e.g., through characterization of longer-term contributions of multiple sound sources to rising ambient noise levels and assessment of the potential chronic effects on marine mammals).

    6. An increase in understanding of the impacts of the activity on marine mammals in combination with the impacts of other anthropogenic activities or natural factors occurring in the region.

    7. An increase in our understanding of the effectiveness of mitigation and monitoring measures.

    8. An increase in the probability of detecting marine mammals (through improved technology or methodology), both specifically within the safety zone (thus allowing for more effective implementation of the mitigation) and in general, to better achieve the above goals.

    Proposed Monitoring Measures

    DWBI submitted a marine mammal monitoring and reporting plan as part of the IHA application. The plan may be modified or supplemented based on comments or new information received from the public during the public comment period.

    Visual Monitoring—Visual observation of the 160-dB monitoring zone established for DP vessel operation during cable installation will be performed by qualified and NMFS approved protected species observers (PSOs), the resumes of whom will be provided to NMFS for review and approval prior to the start of construction activities. Observer qualifications will include direct field experience on a marine mammal observation vessel and/or aerial surveys in the Atlantic Ocean/Gulf of Mexico. A minimum of two PSOs will be stationed aboard the cable lay vessel. Each PSO will monitor 360 degrees of the field of vision. PSOs stationed on the DP vessel will begin observation of the monitoring zone as the vessel initially leaves the dock. Observations of the monitoring zone will continue throughout the cable installation and will end after the DP vessel has returned to dock.

    Observers would estimate distances to marine mammals visually, using laser range finders, or by using reticle binoculars during daylight hours. During night operations, night vision binoculars will be used. If vantage points higher than 25 ft (7.6 m) are available, distances can be measured using inclinometers. Position data will be recorded using hand-held or vessel global positioning system (GPS) units for each sighting, vessel position change, and any environmental change.

    Each PSO stationed on the cable lay vessel will scan the surrounding area for visual indication of marine mammal presence that may enter the monitoring zone. Observations will take place from the highest available vantage point on the cable lay vessel. General 360-degree scanning will occur during the monitoring periods, and target scanning by the PSO will occur when alerted of a marine mammal presence.

    Data on all observations will be recorded based on standard PSO collection requirements. This will include dates and locations of construction operations; time of observation; location and weather; distance from sound source, DP vessel thruster status (i.e., energy level); details of marine mammal sightings (e.g., species, age classification [if known], numbers); details of any observed “taking” (behavioral disturbances or injury/mortality); and reaction of the animal(s) to relevant sound source (if any) and observed behavior, including bearing and direction of travel. All marine mammal sightings which are visually feasible beyond the 160 dB isopleth, will also be recorded and potential takes will be noted.

    In addition, prior to initiation of construction work, all crew members on barges, tugs and support vessels, will undergo environmental training, a component of which will focus on the procedures for sighting and protection of marine mammals. A briefing will also be conducted between the construction supervisors and crews, the PSOs, and DWBI. The purpose of the briefing will be to establish responsibilities of each party, define the chains of command, discuss communication procedures, provide an overview of monitoring purposes, and review operational procedures. The DWBI Construction Compliance Manager (or other authorized individual) will have the authority to stop or delay construction activities, if deemed necessary. New personnel will be briefed as they join the work in progress.

    Acoustic Field Verification—DWBI would perform field verification to confirm the 160-dB isopleth monitoring zone. Field verification during cable installation using DP thrusters will be performed using acoustic measurements from two reference locations at two water depths (a depth at mid-water and a depth at approximately 1 m above the seafloor). As necessary, the monitoring zone will be modified to ensure adequate protection to marine mammals.

    Proposed Reporting Measures

    Observers would record dates and locations of construction operations; times of observations; location and weather; details of marine mammal sightings (e.g., species, age, numbers, behavior); and details of any observed take.

    DWBI proposes to provide the following notifications and reports during construction activities:

    • Notification to NMFS and the U.S. Army Corps of Engineers (USACE) within 24-hours of beginning construction activities and again within 24-hours of completion;

    • The USACE and NMFS should be notified within 24 hours whenever a monitoring zone is re-established by DWBI. After any re-establishment of the monitoring zone, DWBI will provide a report to the USACE and NMFS detailing the field-verification measurements within 7 days. This includes information, such as: a detailed account of the levels, durations, and spectral characteristics of DP thruster use, and the peak, RMS, and energy levels of the sound pulses and their durations as a function of distance, water depth, and tidal cycle. The USACE and NMFS will be notified within 24 hours if field verification measurements suggest a larger DP thruster power reduction zone.

    • Within 120 days after completion of the construction activities, a final technical report will be provided to USACE, and NMFS that fully documents the methods and monitoring protocols, summarizes the data recorded during monitoring, estimates the number of marine mammals that may have been taken during construction activities, and provides an interpretation of the results and effectiveness of all monitoring tasks

    Notification of Injured or Dead Marine Mammals—In the unanticipated event that the specified activities clearly causes the take of a marine mammal in a manner prohibited by the IHA, such as a serious injury, or mortality (e.g., ship-strike, gear interaction, and/or entanglement), DWBI would immediately cease the specified activities and report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources and the NOAA Greater Atlantic Regional Fisheries Office (GARFO) Stranding Coordinator. The report would include the following information:

    ○ Time, date, and location (latitude/longitude) of the incident;

    ○ Name and type of vessel involved;

    ○ Vessel's speed during and leading up to the incident;

    ○ Description of the incident;

    ○ Status of all sound source use in the 24 hours preceding the incident;

    ○ Water depth;

    ○ Environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

    ○ Description of all marine mammal observations in the 24 hours preceding the incident;

    ○ Species identification or description of the animal(s) involved;

    ○ Fate of the animal(s); and

    ○ Photographs or video footage of the animal(s) (if equipment is available).

    Activities would not resume until NMFS is able to review the circumstances of the event. NMFS would work with DWBI to minimize reoccurrence of such an event in the future. DWBI would not resume activities until notified by NMFS.

    In the event that DWBI discovers an injured or dead marine mammal and determines that the cause of the injury or death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition), DWBI would immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources and the GARFO Stranding Coordinator. The report would include the same information identified in the paragraph above. Activities would be able to continue while NMFS reviews the circumstances of the incident. NMFS would work with the Applicant to determine if modifications in the activities are appropriate.

    In the event that DWBI discovers an injured or dead marine mammal and determines that the injury or death is not associated with or related to the activities authorized in the IHA (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), DWBI would report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, and the NMFS Greater Atlantic Regional Fisheries Office Regional Stranding Coordinator, within 24 hours of the discovery. DWBI would provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS. DWBI can continue its operations under such a case.

    Estimated Take by Incidental Harassment

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].

    Underwater sound associated with the use of DP vessel thrusters during inter-array and export cable installation is the only project activity that has the potential to harass marine mammals, as defined by the MMPA. Harassment could take the form of temporary threshold shift, avoidance, or other changes in marine mammal behavior. NMFS anticipates that impacts to marine mammals would be in the form of Level B behavioral harassment and no take by injury, serious injury, or mortality is proposed. NMFS does not anticipate take resulting from the movement of vessels (i., vessel strike) associated with construction because there will be a limited number of vessels moving at slow speeds over a relatively shallow, nearshore area, and PSOs on the vessels will be monitoring for marine mammals and will be able to alert the vessels to avoid any marine mammals in the area.

    NMFS' current acoustic exposure criteria for estimating take are shown in Table 3 below. DWBI's modeled distances to these acoustic exposure criteria are shown in Table 4. Details on the model characteristics and results are provided in the Underwater Acoustic Modeling Report found in Appendix A of the application. As discussed in the application and in Appendix A, acoustic modeling took into consideration sound sources using the loudest potential operational parameters, bathymetry, geoacoustic properties of the project area, time of year, and marine mammal hearing ranges. Results from the acoustic modeling showed that estimated maximum critical distance to the 120 dB re 1 μPa (rms) MMPA threshold was approximately 4,750 m for 10-m water depth, 4,275 m for 20-m water depth, and 3,575 m for 40-m water depth. More information on results including figures displaying critical distance information can be found in Appendix A. DWBI and NMFS believe that these estimates represent the worst-case scenario and that the actual distances to the Level B harassment threshold may be shorter. DP vessel thruster use will not produce sound levels at 180/190 dB at any appreciable distance; therefore, no injurious (Level A harassment) takes have been requested or are being proposed for authorization. To verify the distance to the MMPA thresholds calculated by underwater acoustic modeling, DWBI has committed to conducting real-time underwater acoustic measurements of the DP vessel thrusters. Field verification of actual sound propagation will enable adjustment of the MMPA threshold level distances to fit actual construction conditions, if necessary.

    Table 3—NMFS' Current Acoustic Exposure Criteria Non-Explosive Sound Criterion Criterion definition Threshold Level A Harassment (Injury) Permanent Threshold Shift (PTS) (Any level above that which is known to cause TTS) 180 dB re 1 µPa-m (cetaceans)/190 dB re 1 µPa-m (pinnipeds) root mean square (rms). Level B Harassment Behavioral Disruption (for impulse noises) 160 dB re 1 µPa-m (rms). Level B Harassment Behavioral Disruption (for continuous, noise) 120 dB re 1 µoPa-m (rms). Table 4—Maximum Distances to MMPA Thresholds From DP Vessel Thrusters During Submarine Cable Installation Source Marine mammal level A
  • harassment
  • 80/190 dBRMS re 1 µPa
  • (m)
  • Marine
  • mammal level B harassment
  • 120 dBRMS re 1 µPa
  • (m)
  • DP Vessel Thrusters—at 10 m N/A 4,750 DP Vessel Thrusters—at 20 m N/A 4,275 DP Vessel Thrusters—at 40 m N/A 3,575

    DWBI estimated species densities within the proposed project area in order to estimate the number of marine mammal exposures to sound levels above 120 dB (continuous noise). The data used as the basis for estimating species density for the project area are sightings per unit effort (SPUE) taken from Kenney and Vigness-Raposa (2009). SPUE (or, the relative abundance of species) is derived by using a measure of survey effort and number of individual cetaceans sighted. SPUE allows for comparison between discrete units of time (i.e. seasons) and space within a project area (Shoop and Kenney, 1992). SPUE calculated by Kenney and Vigness-Raposa (2009) was derived from a number of sources including: (1) North Atlantic Right Whale Consortium database; (2) CeTAP (CeTAP, 1982); (3) sightings data from the Coastal Research and Education Society of Long Island, Inc. and Okeanos Ocean Research Foundation; (4) the Northeast Regional Stranding network (marine mammals); and (5) the NOAA Northeast Fisheries Science Center's Fisheries Sampling Branch (Woods Hole, MA).

    The Northeast Navy Operations Area (OPAREA) Density Estimates (DoN, 2007) were also used in support for estimating take for seals, which represents the only available comprehensive data for seal abundance. However, abundance estimates for the Southern New England area includes breeding populations on Cape Cod, and therefore using this dataset alone will result in a substantial over-estimate of take in the Project Area. However, based on reports conducted by Kenney and Vigness-Raposa (2009), Schroeder (2000), and Ronald and Gots (2003), harbor seal abundance off the Southern New England coast in the vicinity of the survey is likely to be approximately 20 percent of the total abundance. In addition, because the seasonality of, and habitat use by, gray seals roughly overlaps with harbor seals, the same abundance assumption of 20 percent of the southern New England population of gray seals can be applied when estimating abundance. Per this data, take due to Level B harassment for harbor seals and gray seals have been calculated based on 20 percent of the Northeast Navy OPAREA abundance estimates and resulting adjusted density values.

    The methodology for calculating takes is the same as that described in the Federal Register notice for the original 2014 (modified in 2015) BIWF IHA. Estimated takes were calculated by multiplying the maximum species density (per 100 km2) by the zone of influence (ZOI), multiplied by a correction factor of 1.5 to account for marine mammals underwater, multiplied by the number of days of the specified activity.

    A detailed description of the model used to calculate zones of influence is provided in the Underwater Acoustic Modeling Report found in Appendix A of the application. Acoustic modeling was completed with the U.S. Naval Research Laboratory's Range-dependent Acoustic Model (RAM) which is widely used by sound engineers and marine biologists due to its adaptability to describe highly complex acoustic scenarios. This modeling analysis method considers range and depth along with a geo-referenced dataset to automatically retrieve the time of year information, bathymetry, and geoacoustic properties (e.g. hard rock, sand, mud) along propagation transects radiating from the sound source. Transects are run along compass points (45°, 90°, 135°, 180°, 225°, 270°, 315°, and 360°) to determine received sound levels at a given location. These values are then summed across frequencies to provide broadband received levels at the MMPA Level A and Level B harassment thresholds as described in Table 3. The representative area ensonified to the MMPA Level B threshold for DP vessel thruster use during cable installation was used to estimate take. The distances to the MMPA thresholds were used to conservatively estimate how many marine mammals would receive a specified amount of sound energy in a given time period and to support the development of monitoring and/or mitigation measures.

    DWBI used a ZOI of 9.7 mi2 (25.1 km2) and a maximum installation period of 28 days to estimate take from use of the DP vessel thruster during cable installation. The ZOI represents the average ensonified area across the three representative water depths (10 m, 20 m, and 40 m) along a 13.2-km cable route. DWBI expects cable installation to occur between May and October. To be conservative, take calculations were based on the highest seasonal species density when cable installation may occur (see Table 5). The resulting take estimates (rounded to the nearest whole number) based upon these conservative assumptions for North Atlantic right, humpback, fin, and minke whales, as well as, short-beaked common and Atlantic white-sided dolphins, harbor porpoise, and harbor and gray seals are presented in Table 5. These numbers represent less than 1.5 percent of the stock for these species, respectively (Table 5). These percentages are the upper boundary of the animal population that could be affected.

    Table 5—DWBI's Estimated Take for DP Thruster Use During the BIWF Project Species Maximum
  • seasonal
  • density
  • (number/100 km2)
  • Estimated
  • take
  • (number)
  • Percentage of
  • stock
  • potentially
  • affected
  • North Atlantic Right Whale 0.07 1 0.22 Humpback Whale 0.11 2 0.24 Fin Whale 2.15 23 1.42 Minke Whale 0.44 5 0.02 Short-beaked Common Dolphin 8.21 28 0.07 Atlantic White-sided Dolphin 7.46 13 0.16 Harbor Porpoise 0.74 8 0.01 Harbor Seal 1.95 21 0.03 Gray Seal 2.83 30 0.01

    DWBI's requested take numbers are provided in Table 5 and this is also the number of takes NMFS is proposing to authorize. DWBI's take calculations do not take into account whether a single animal is harassed multiple times or whether each exposure is a different animal. Therefore, the numbers in Table 5 are the maximum number of animals that may be harassed during the cable installation activities (i.e., DWBI assumes that each exposure event is a different animal). These estimates do not account for prescribed mitigation measures that DWBI would implement during the specified activities and the fact that powerdown procedures shall be implemented if an animal enters the Level B harassment zone (160 dB), further reducing the potential for any takes to occur during these activities.

    DWBI did not request, and NMFS is not proposing, take from vessel strike. We do not anticipate marine mammals to be impacted by vessel movement because a limited number of vessels would be involved in construction activities and they would mostly move at slow speeds during DP vessel thruster use during cable installation activities. However, DWBI shall implement measures (e.g., vessel speed restrictions and separation distances; see Proposed Mitigation Measures) to further minimize potential impacts to marine mammals from vessel strikes during vessel operations and transit in the project area.

    Analysis and Determinations Negligible Impact

    Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of takes, alone, is not enough information on which to base an impact determination, as the severity of harassment may vary greatly depending on the context and duration of the behavioral response, many of which would not be expected to have deleterious impacts on the fitness of any individuals. In determining whether the expected takes will have a negligible impact, in addition to considering estimates of the number of marine mammals that might be “taken,” NMFS must consider other factors, such as the likely nature of any responses (their intensity, duration, etc.), the context of any responses (critical reproductive time or location, migration, etc.), as well as the number and nature of estimated Level A harassment takes, the number of estimated mortalities, and the status of the species.

    To avoid repetition, the discussion of our analyses applies to all the species listed in Table 5, given that the anticipated effects of this activity on these different marine mammal stocks are expected to be similar. There is no information about the nature or severity of the impacts, or the size, status, or structure of any of these species or stocks that would lead to a different analysis for this activity.

    As discussed in the Potential Effects section, permanent threshold shift, masking, non-auditory physical effects, and vessel strike are not expected to occur. There is some potential for limited TTS; however, animals in the area would likely incur no more than brief hearing impairment (i.e., TTS) due to low source levels and the fact that most marine mammals would more likely avoid a loud sound source rather than swim in such close proximity as to result in TTS. Moreover, as the DP vessel is continually moving along the cable route over a 24-hour period, the area within the 120 dB isopleth is constantly moving (i.e., transient sound field) and shifting within a 24-hour period. Therefore, no single area in Rhode Island Sound will have noise levels above 120 dB for more than a few hours; once an area has been surveyed, it is not likely that it will be surveyed again, therefore reducing the likelihood of repeated impacts within the project area.

    Potential impacts to marine mammal habitat were discussed previously in this document (see the Anticipated Effects on Habitat section). Marine mammal habitat may be impacted by elevated sound levels and some sediment disturbance, but these impacts would be temporary. Feeding behavior is not likely to be significantly impacted. Prey species are mobile, and are broadly distributed throughout the project area; therefore, marine mammals that may be temporarily displaced during survey activities are expected to be able to resume foraging once they have moved away from areas with disturbing levels of underwater noise. Because of the temporary nature of the disturbance, the availability of similar habitat and resources in the surrounding area, and the lack of important or unique marine mammal habitat, the impacts to marine mammals and the food sources that they utilize are not expected to cause significant or long-term consequences for individual marine mammals or their populations. There are no feeding areas known to be biologically important to marine mammals within the proposed project area.

    There are no rookeries or mating grounds known to be biologically important to marine mammals within the proposed project area. ESA-listed species for which takes are proposed are North Atlantic right, humpback, and fin whales. Recent estimates of abundance indicate a stable or growing humpback whale population, while examination of the minimum number alive population index calculated from the individual sightings database for the years 1990-2010 suggests a positive and slowly accelerating trend in North Atlantic right whale population size (Waring et al., 2015). There are currently insufficient data to determine population trends for fin whale) (Waring et al., 2015). There is no designated critical habitat for any ESA-listed marine mammals within the project area, and none of the stocks for non-listed species proposed to be taken are considered “depleted” or “strategic” by NMFS under the MMPA.

    The proposed mitigation measures are expected to reduce the potential for exposure of marine mammals by reducing the DP thruster power if a marine mammal is observed within the 160 dB isopleth monitoring zone. Additional vessel strike avoidance requirements will further mitigate potential impacts to marine mammals during vessel transit in the Study Area. DWBI vessels associated with the BIWF construction will adhere to NMFS guidelines for marine mammal ship striking avoidance (available online at: http://www.nmfs.noaa.gov/pr/pdfs/education/viewing_northeast.pdf), including maintaining a distance of at least 1,500 feet from right whales and having dedicated protected species observers who will communicate with the captain to ensure that all measures to avoid whales are taken. NMFS believes that the size of right whales, their slow movements, and the amount of time they spend at the surface will make them extremely likely to be spotted by protected species observers during construction activities within the project area.

    DWBI did not request, and NMFS is not proposing, take of marine mammals by injury, serious injury, or mortality. NMFS expects that all takes would be in the form of short-term Level B behavioral harassment in the form of brief startling reaction and/or temporary vacating of the area, or decreased foraging (if such activity were occurring)—reactions that are considered to be of low severity and with no lasting biological consequences (e.g., Southall et al., 2007). This is largely due to the short time scale of the proposed activities and the nature of the DP vessel noise (i.e., low source level, constantly moving resulting in a transient sound field), as well as the required mitigation.

    Based on best available science, NMFS preliminarily concludes that exposures to marine mammal species and stocks due to DWBI's DP vessel thruster use during cable installation activities would result in only short-term (temporary and short in duration) and relatively infrequent effects to individuals exposed, and not of the type or severity that would be expected to be additive for the very small portion of the stocks and species likely to be exposed. Given the intensity of the activities, and the fact that shipping contributes to the ambient sound levels in the surrounding waters, NMFS does not anticipate the proposed take estimates to impact annual rates of recruitment or survival. Animals may temporarily avoid the immediate area, but are not expected to permanently abandon the area. Major shifts in habitat use, distribution, or foraging success, are not expected.

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS preliminarily finds that the total marine mammal take from DWBI's DP vessel thruster use during cable installation activities will have a negligible impact on the affected marine mammal species or stocks.

    Small Numbers

    The requested takes proposed to be authorized for the cable installation activities utilizing DP vessel thrusters represent 0.22 percent of the Western North Atlantic (WNA) stock of North Atlantic right whale, 0.24 percent of the Gulf of Maine stock of humpback whale, 1.42 percent of the WNA stock of fin whale, 0.02 percent of the Canadian East Coast stock of minke whale, 0.07 percent of the WNA stock of short-beaked common dolphin, 0.16 percent of the WNA stock of Atlantic white-sided dolphin, 0.01 percent of the Gulf of Maine/Bay of Fundy stock of harbor porpoise, 0.03 percent of the WNA stock of harbor seal, and 0.01 percent of the North Atlantic stock of gray seal. These take estimates represent the percentage of each species or stock that could be taken by Level B behavioral harassment and represent extremely small numbers (less than 1.5 percent) relative to the affected species or stock sizes. Further, the proposed take numbers are the maximum numbers of animals that are expected to be harassed during the project; it is possible that some of these exposures may occur to the same individual. Therefore, NMFS preliminarily finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.

    Impact on Availability of Affected Species for Taking for Subsistence Uses

    There are no relevant subsistence uses of marine mammals implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

    Endangered Species Act

    There are three marine mammal species that are listed as endangered under the ESA: Fin whale, humpback whale, and North Atlantic right whale. Under section 7 of the ESA, the U.S. Army Corps of Engineers (the federal permitting agency for the actual construction) consulted with NMFS on the proposed BIWF project. NMFS also consulted internally on the issuance of an IHA under section 101(a)(5)(D) of the MMPA for this activity. NMFS' Greater Atlantic Regional Fisheries Office (GARFO) issued a Biological Opinion on January 30, 2014 which was amended on June 5, 2015, concluding that the Block Island Wind Farm project may adversely affect but is not likely to jeopardize the continued existence of fin whale, humpback whale, or North Atlantic right whale.

    National Environmental Policy Act

    NMFS conducted the required analysis under NEPA and prepared an EA for its issuance of the original BIWF IHA, issuing a Finding of No Significant Impact (FONSI) for the action on August 21, 2014 (reaffirmed on June 9, 2015). The potential environmental impacts of the proposed IHA are within the scope of the environmental impacts analyzed in the NMFS' EA, which was used to support NMFS' FONSI. NMFS has determined that there are no substantial changes to the action and that there are no new direct, indirect, or cumulative effects to the human environment resulting from the IHA modifications. Therefore, NMFS has determined that a new or supplemental EA or Environmental Impact Statement are unnecessary, and reaffirms the existing FONSI for this action.

    Proposed Authorization

    As a result of these preliminary determinations, NMFS proposes to issue an Incidental Harassment Authorization (IHA) to DWBI for cable installation activities that use DP vessel thrusters from May 2016 through April 2017, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. The proposed IHA language is provided next.

    This section contains a draft of the IHA itself. The wording contained in this section is proposed for inclusion in the IHA (if issued).

    Deepwater Wind Block Island, LLC, 56 Exchange Terrace, Suite 101, Providence, RI, 02903-1772, is hereby authorized under section 101(a)(5)(D) of the Marine Mammal Protection Act (16 U.S.C. 1371(a)(5)(D)) and 50 CFR 216.107, to harass marine mammals incidental to dynamic positioning vessel thruster use associated with inter-array and export cable installation activities off the southeast coast of Block Island, Rhode Island.

    1. This Authorization is valid from May 1, 2016 through April 30, 2017.

    2. This Authorization is valid only for DP vessel thruster use associated with cable installation activities, as described in the IHA application.

    3. The holder of this authorization (Holder) is hereby authorized to take, by Level B harassment only, 13 Atlantic white-sided dolphins (Lagenorhynchus acutus), 28 short-beaked common dolphins (Delphinus delphis), 8 harbor porpoises (Phocoena phocoena), 2 minke whales (Balaenoptera acutorostrata), 23 fin whales (Balaenoptera physalus), 2 humpback whales (Megaptera novaeangliae), 1 North Atlantic right whales (Eubalaena glacialis), 30 gray seals (Halichoerus grypus), and 21 harbor seals (Phoca vitulina) incidental to the Block Island Wind Farm inter-array and export cable installation activities using dynamic positioning (DP) vessel thrusters.

    4. The taking of any marine mammal in a manner prohibited under this IHA must be reported immediately to NMFS' Greater Atlantic Regional Fisheries Office (GARFO), 55 Great Republic Drive, Gloucester, MA 01930-2276; phone 978-281-9300, and NMFS' Office of Protected Resources, 1315 East-West Highway, Silver Spring, MD 20910; phone 301-427-8401.

    5. The Holder or designees must notify NMFS' GARFO and Office of Protected Resources (Headquarters) at least 24 hours prior to the seasonal commencement of the specified activity (see contact information in 4 above).

    6. The holder of this Authorization must notify the Chief of the Permits and Conservation Division, Office of Protected Resources, or her designee at least 24 hours prior to the start of survey activities (unless constrained by the date of issuance of this Authorization in which case notification shall be made as soon as possible) at 301-427-8401 or to [email protected]

    7. Mitigation Requirements

    The Holder is required to abide by the following mitigation conditions listed in 7(a)-(c). Failure to comply with these conditions may result in the modification, suspension, or revocation of this IHA.

    (a) DP Thruster Power Reduction—During cable installation, if marine mammals enter or approach the established 160 dB isopleth monitoring zone, DWBI shall reduce DP thruster to the maximum extent possible, except under circumstances when reducing DP thruster use would compromise safety (both human health and environmental) and/or the integrity of the Project. After decreasing thruster energy, protected species observers (PSOs) will continue to monitor marine mammal behavior and determine if the animal(s) is moving towards or away from the established monitoring zone. If the animal(s) continues to move towards the sound source then DP thruster use would remain at the reduced level. Normal thruster use will resume when PSOs report that marine mammals have moved away from and remained clear of the monitoring zone for a minimum of 30 minutes since last the sighting.

    (b) Vessel Speed Restrictions: All project vessels shall operate at speeds of 10 knots or less from November 1 through April 30.

    (c) Ship Strike Avoidance: The Holder shall adhere to NMFS guidelines for marine mammal ship strike avoidance (http://www.nmfs.noaa.gov/pr/pdfs/education/viewing_northeast.pdf).

    8. Monitoring Requirements

    The Holder is required to abide by the following monitoring conditions listed in 8(a)-(b). Failure to comply with these conditions may result in the modification, suspension, or revocation of this IHA.

    (a) Visual Monitoring—Visual observation of the 160-dB monitoring zone will be performed by qualified and NMFS approved protected species observers (PSOs). Observer qualifications will include direct field experience on a marine mammal observation vessel and/or aerial surveys in the Atlantic Ocean/Gulf of Mexico. A minimum of two PSOs will be stationed aboard the DP vessel. Each PSO will monitor 360 degrees of the field of vision. PSOs stationed on the DP vessel will begin observation of the monitoring zone as the vessel initially leaves the dock. Observations of the monitoring zone will continue throughout the cable installation and will end after the DP vessel has returned to dock. Observers would estimate distances to marine mammals visually, using laser range finders, or by using reticle binoculars during daylight hours. During night operations, night vision binoculars will be used. Position data will be recorded using hand-held or vessel global positioning system (GPS) units for each sighting, vessel position change, and any environmental change. Each PSO stationed on the cable lay vessel will scan the surrounding area for visual indication of marine mammal presence that may enter the monitoring zone. Observations will take place from the highest available vantage point on the cable lay vessel. General 360-degree scanning will occur during the monitoring periods, and target scanning by the PSO will occur when alerted of a marine mammal presence. Information recorded during each observation shall be used to estimate numbers of animals potentially taken and shall include the following:

    • Dates and locations of construction operations;

    • Number of observations;

    • Time and frequency of observations;

    • Location (i.e., distance from sound source);

    • DP vessel thruster status (i.e., energy level)

    • Weather conditions;

    • Details of mammal sightings (species, age classification [if known], numbers)

    • Reaction of the animal(s) to relevant sound source (if any) and observed behavior, including bearing and direction of travel; and

    • Details of any observed “taking” (behavioral disturbances or injury/mortality;

    All marine mammal sightings which are visually feasible beyond the 160 dB isopleth, shall also be recorded and potential takes shall be noted.

    (b) Acoustic Field Verification—DWBI would perform field verification to confirm the 160-dB isopleth monitoring zone. Field verification during cable installation using DP thrusters will be performed using acoustic measurements from two reference locations at two water depths (a depth at mid-water and a depth at approximately 1 m above the seafloor). As necessary, the monitoring zone will be modified to ensure adequate protection to marine mammals.

    9. Reporting Requirements

    (a) The Holder shall provide the following notifications during construction activities:

    • Notification to NMFS and the U.S. Army Corps of Engineers (USACE) within 24-hours of beginning construction activities and again within 24-hours of completion

    • The USACE and NMFS shall be notified within 24 hours whenever a monitoring zone is re-established by DWBI. After any re-establishment of the monitoring zone, DWBI will provide a report to the USACE and NMFS detailing the field-verification measurements within 7 days. This shall include the following information: a detailed account of the levels, durations, and spectral characteristics of DP thruster use, and the peak, RMS, and energy levels of the sound pulses and their durations as a function of distance, water depth, and tidal cycle. The USACE and NMFS will be notified within 24 hours if field verification measurements suggest a larger DP thruster power reduction zone. Implementation of a smaller zone shall be contingent on NMFS' review and shall not be used until NMFS approves the change.

    Notification of Injured or Dead Marine Mammals—In the unanticipated event that the specified activities clearly causes the take of a marine mammal in a manner prohibited by the IHA, such as a serious injury, or mortality (e.g., ship-strike, gear interaction, and/or entanglement), DWBI would immediately cease the specified activities and report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources and the NOAA Greater Atlantic Regional Fisheries Office (GARFO) Stranding Coordinator. The report would include the following information:

    ○ Time, date, and location (latitude/longitude) of the incident;

    ○ Name and type of vessel involved;

    ○ Vessel's speed during and leading up to the incident;

    ○ Description of the incident;

    ○ Status of all sound source use in the 24 hours preceding the incident;

    ○ Water depth;

    ○ Environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

    ○ Description of all marine mammal observations in the 24 hours preceding the incident;

    ○ Species identification or description of the animal(s) involved;

    ○ Fate of the animal(s); and

    ○ Photographs or video footage of the animal(s) (if equipment is available).

    Activities would not resume until NMFS is able to review the circumstances of the event. NMFS would work with DWBI to minimize reoccurrence of such an event in the future. DWBI would not resume activities until notified by NMFS.

    In the event that DWBI discovers an injured or dead marine mammal and determines that the cause of the injury or death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition), DWBI would immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources and the GARFO Stranding Coordinator. The report would include the same information identified in the paragraph above. Activities would be able to continue while NMFS reviews the circumstances of the incident. NMFS would work with the Applicant to determine if modifications in the activities are appropriate.

    In the event that DWBI discovers an injured or dead marine mammal and determines that the injury or death is not associated with or related to the activities authorized in the IHA (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), DWBI would report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, and the NMFS Greater Atlantic Regional Fisheries Office Regional Stranding Coordinator, within 24 hours of the discovery. DWBI would provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS. DWBI can continue its operations under such a case.

    (b) The Holder shall provide a final technical report to USACE and NMFS, within 120 days after completion of the construction activities, that fully documents the methods and monitoring protocols, summarizes the data recorded during monitoring, estimates the number of marine mammals that may have been taken during construction activities, and provides an interpretation of the results and effectiveness of all monitoring tasks. The report shall contain the following information:

    • A summary of the activity and monitoring plan (i.e., dates, times, locations);

    • A summary of mitigation implementation;

    • Monitoring results and a summary that addresses the goals of the monitoring plan, including the following:

    ○ Environmental conditions when observations were made:

    ○ Water conditions (i.e., Beaufort sea-state, tidal state)

    ○ Weather conditions (i.e., percent cloud cover, visibility, percent glare)

    ○ Date and time survey initiated and terminated

    ○ Date, time, number, species, age, and any other relevant data regarding marine mammals observed

    ○ Description of the observed behaviors (in both the presence and absence of activities):

    If possible, the correlation to underwater sound level occurring at the time of any observable behavior

    • Estimated exposure/take numbers during activities; and

    • An assessment of the implementation and effectiveness of prescribed mitigation and monitoring measures.

    10. This Authorization may be modified, suspended, or withdrawn if the Holder fails to abide by the conditions prescribed herein or if the authorized taking is having more than a negligible impact on the species or stock of affected marine mammals, or if there is an unmitigable adverse impact on the availability of such species or stocks for subsistence uses.

    11. A copy of this Authorization and the Incidental Take Statement must be in the possession of each vessel operator taking marine mammals under the authority of this Incidental Harassment Authorization.

    12. The Holder is required to comply with the Terms and Conditions of the Incidental Take Statement corresponding to NMFS' Biological Opinion.

    Request for Public Comments

    NMFS requests comment on our analysis, the draft authorization, and any other aspect of the Notice of Proposed IHA for DWBI's proposed dynamic positioning vessel thruster use associated with inter-array and export cable installation activities off the southeast coast of Block Island, Rhode Island. Please include with your comments any supporting data or literature citations to help inform our final decision on DWBI's request for an MMPA authorization.

    Dated: April 11, 2016. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-08729 Filed 4-14-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Notice Requesting Nominations for the Advisory Committee on Commercial Remote Sensing (ACCRES) ACTION:

    Notice requesting nominations for the Advisory Committee on Commercial Remote Sensing (ACCRES).

    SUMMARY:

    The Department of Commerce is seeking highly qualified individuals who are knowledgeable about the commercial space-based remote sensing industry and uses of space-based remote sensing data to serve on the Advisory Committee on Commercial Remote Sensing (ACCRES). The Committee is comprised of leaders in the commercial space-based remote sensing industry, space-based remote sensing data users, government, and academia. The SUPPLEMENTARY INFORMATION section of this notice provides committee and membership criteria.

    SUPPLEMENTARY INFORMATION:

    ACCRES was established by the Secretary of Commerce on May 21, 2002, to advise the Secretary, through the Under Secretary of Commerce for Oceans and Atmosphere, on matters relating to the U.S. commercial remote sensing industry and NOAA's activities to carry out responsibilities of the Department of Commerce as set forth in Title 51 U.S.C. 60101, et seq, the National and Commercial Space Programs Act of 2010.

    Committee members serve in a representative capacity for a term of two years and may serve additional terms, if reappointed. No more than 20 individuals at a time may serve on the Committee. ACCRES will have a fairly balanced membership consisting of approximately 9 to 20 members. Nominations are encouraged from all interested U.S. persons and organizations representing interests affected by the National and Commercial Space Programs Act of 2010 and the U.S. commercial space based remote sensing policy. Nominees must possess demonstrable expertise in a field related to the spaced based commercial remote sensing industry or exploitation of space based commercial remotely sensed data and be able to attend committee meetings that are held usually two times per year. Membership is voluntary, and service is without pay. Each nomination that is submitted should include the proposed committee member's name and organizational affiliation, a brief description of the nominee's qualifications and interest in serving on the Committee, a curriculum vitae or resume of the nominee, and no more than three supporting letters describing the nominee's qualifications and interest in serving on the Committee. Self-nominations are acceptable. The following contact information should accompany each submission: the nominee's name, address, phone number, fax number, and email address.

    Nominations should be sent to Tahara Dawkins, Director, Commercial Remote Sensing Regulatory Affairs Office, 1335 East-West Highway, Room 8260, Silver Spring, Maryland 20910. Nominations must be postmarked no later than 30 days from the publication date of this notice. The full text of the Committee Charter and its current membership can be viewed at the Agency's Web page at: http://www.nesdis.noaa.gov/CRSRA/accresHome.html.

    FOR FURTHER INFORMATION CONTACT:

    Samira Patel, Commercial Remote Sensing Regulatory Affairs Office, NOAA Satellite and Information Services, 1335 East-West Highway, Room 8247, Silver Spring, Maryland 20910; telephone (301) 713-7077, email [email protected].

    Stephen M. Volz, Assistant Administrator for Satellite and Information Services.
    [FR Doc. 2016-08693 Filed 4-14-16; 8:45 am] BILLING CODE 3510-HR-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE546 Fisheries of the South Atlantic, Gulf of Mexico, and Caribbean; Southeast Data, Assessment, and Review (SEDAR); Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The SEDAR Steering Committee will meet via webinar to discuss the SEDAR assessment schedule and progress on SEDAR projects. See SUPPLEMENTARY INFORMATION.

    DATES:

    The SEDAR Steering Committee will meet from 1 p.m. to 3 p.m. on Monday, May 9, 2016.

    ADDRESSES:

    Meeting address: The Steering Committee meeting will be held via webinar. The webinar is open to members of the public. Those interested in participating should contact John Carmichael at SEDAR (see FOR FURTHER INFORMATION CONTACT below) at least 24 hours in advance to request webinar access information.

    SEDAR address: South Atlantic Fishery Management Council (SAFMC), 4055 Faber Place Drive, Suite 201, N. Charleston, SC 29405; www.sedarweb.org.

    FOR FURTHER INFORMATION CONTACT:

    John Carmichael, Deputy Director for Science and Statistics, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The items of discussion are as follows:

    SEDAR Steering Committee Agenda, Monday, May 9 2016, 1 p.m.-3 p.m.

    1. Review and consideration of ongoing SEDAR projects including data best practices, identification of priority stocks to address MRIP data revisions, SSC and Council feedback on the research track process, and the NMFS stock assessment prioritization.

    2. Review and consideration of the SEDAR assessment schedule, including updates on 2016 assessment projects, 2017 workshop schedules and data deadlines, and future assessment priorities.

    Although non-emergency issues not contained on this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

    Special Accommodations

    This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SAFMC office (see ADDRESSES) at least 10 business days prior to the meeting.

    Note:

    The times and sequence specified in this agenda are subject to change.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: April 12, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-08743 Filed 4-14-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Gulf of Mexico Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The Gulf of Mexico Fishery Management Council will hold a meeting of its Ad Hoc Reef Fish Headboat Advisory Panel (AP).

    DATES:

    The meeting will convene Tuesday, May 3, 2016, from 9 a.m. to 5 p.m. and Wednesday, May 4, 2016, from 9 a.m. to 12 p.m.

    ADDRESSES:

    The meeting will take place at the Gulf of Mexico Fishery Management Council's office, 2203 N. Lois Avenue, Suite 1100, Tampa, FL 33607; telephone: (813) 348-1630.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Assane Diagne, Economist, Gulf of Mexico Fishery Management Council; [email protected]; telephone: (813) 348-1630.

    SUPPLEMENTARY INFORMATION:

    The items of discussion on the agenda are as follows:

    1. Adoption of Agenda 2. Summary of April Council Meeting 3. Management Goals and Objectives for the Headboat Component 4. Review of Management Alternatives 5. Recommendations to the Council 6. Other Business —Meeting Adjourns—

    The Agenda is subject to change, and the latest version along with other meeting materials will be posted on the Council's file server. To access the file server, the URL is https://public.gulfcouncil.org:5001/webman/index.cgi, or go to the Council's Web site and click on the File Server link in the lower left of the Council Web site: http://www.gulfcouncil.org. The username and password are both “gulfguest”. Click on the “Library Folder”, then scroll down to “Ad Hoc Reef Fish Headboat AP”.

    The meeting will be webcast over the internet. A link to the webcast will be available on the Council's Web site, http://www.gulfcouncil.org.

    Although other non-emergency issues not on the agenda may come before the Advisory Panel for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Advisory Panel will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see ADDRESSES), at least 5 working days prior to the meeting.

    Dated: April 12, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-08742 Filed 4-14-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE United States Patent and Trademark Office [Docket No.: PTO-P-2016-0001] Request for Comments on the Application of the Written Description Requirement to Specific Situations in Design Applications AGENCY:

    United States Patent and Trademark Office, Commerce.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The United States Patent and Trademark Office (“USPTO” or “Office”) is evaluating how the written description requirement applies to certain design applications. In particular, the USPTO has developed a proposed approach for design examiners to apply general principles governing compliance with the written description requirement to specific situations in design applications. The USPTO is seeking public comment on the proposed approach as well as examples that the public believes would be helpful to illustrate the proposed approach or any suggested approach for applying the written description requirement in design applications.

    DATES:

    Written comments must be received on or before June 14, 2016.

    ADDRESSES:

    Comments should be sent by electronic mail message over the Internet (email) addressed to: [email protected] Comments may also be submitted by mail addressed to: Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450, marked to the attention of Nicole D. Haines.

    Although comments may be submitted by postal mail, the USPTO prefers to receive comments by email in order to facilitate posting on the USPTO's Internet Web site. Plain text is preferred, but comments may also be submitted in ADOBE® portable document format or MICROSOFT WORD® format. Comments not submitted electronically should be submitted on paper, and will be digitally scanned into ADOBE® portable document format.

    The comments will be available for public inspection, upon request, at the Office of the Commissioner for Patents, currently located at Madison Building East, Tenth Floor, 600 Dulany Street, Alexandria, Virginia. Comments also will be available for viewing via the USPTO's Internet Web site (http://www.uspto.gov). Because comments will be made available for public inspection, information that the submitter does not desire to be made public, such as an address or phone number, should not be included in the comments.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information may be directed to Nicole D. Haines, Senior Legal Advisor, Office of the Deputy Commissioner for Patent Examination Policy, by telephone to (571) 272-7717, or to Erin M. Harriman, Legal Advisor, Office of the Deputy Commissioner for Patent Examination Policy, by telephone to (571) 272-7747. Alternatively, mail may be addressed to: United States Patent and Trademark Office, Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450, marked to the attention of Nicole D. Haines.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The USPTO held a roundtable on March 5, 2014 (“Roundtable”), to solicit public opinion regarding the written description requirement of 35 U.S.C. 112(a), or pre-America Invents Act (“AIA”) 35 U.S.C. 112, para. 1 (“35 U.S.C. 112(a)”) as applied to design applications in certain limited situations. Specifically, the USPTO sought comments on the application of the written description requirement to an amended claim or a claim in a continuing design application (“later-claimed design”) that includes only a subset of originally disclosed elements (the later-claimed design does not introduce any new elements that were not originally disclosed). See Request for Comments and Notice of Roundtable Event on the Written Description Requirement for Design Applications, 79 FR 7171 (Feb. 6, 2014) (“the Notice”). As discussed in the Notice, it has been the experience of the USPTO that in the vast majority of cases there is no question that a later-claimed design, composed of only a subset of originally disclosed elements, satisfies the written description requirement. In certain limited situations, however, the subset of originally disclosed elements, although visible in the original disclosure, composes a later-claimed design that an ordinary designer might not have recognized in the original disclosure. In those certain limited situations, a question arises as to whether the later-claimed design satisfies the written description requirement.

    In the Notice, the USPTO requested input on its proposed factors-based approach, in which design examiners would consider certain enumerated factors when evaluating a claim for compliance with the written description requirement. The Roundtable featured public presentations and discussion of the topics identified in the Notice. The USPTO also received written comments on the topics identified in the Notice and discussed at the Roundtable. Details of the Roundtable, as well as the public presentations, the USPTO's examples presented for discussion, the webcast recording, and the written comments received are available at http://www.uspto.gov/patent/contact-patents/roundtable-written-description-requirement-design-applications.

    The USPTO considered all of the comments, both those expressed at the Roundtable and those received in writing. Responsive to these comments, the USPTO has decided not to pursue the factors-based approach set forth in the Notice. Also, in view of the comments, it became clear that there exists a need to supplement the current provisions in the Manual of Patent Examining Procedure (“MPEP”) relating to 35 U.S.C. 112 for design applications. A majority of the comments urged that the USPTO focus on precedent from the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) pertaining to written description issues in the context of design patents and applications. Specific emphasis was placed on Racing Strollers Inc. v. TRI Industries Inc., 878 F.2d 1418 (Fed. Cir. 1989) (en banc) and In re Daniels, 144 F.3d 1452 (Fed. Cir. 1998). Most comments suggested that these cases establish “a simple visual test” for determining compliance with the written description requirement; that is, the written description requirement is satisfied because the elements of the later-claimed design are visible in the original disclosure. Several comments also addressed In re Owens, 710 F.3d 1362 (Fed. Cir. 2013). In developing the proposed approach set forth in section III of this notice, the USPTO considered these Federal Circuit design cases, along with other seminal Federal Circuit cases concerning the written description requirement.

    II. General Principles Governing Compliance With the Written Description Requirement for Design Applications

    35 U.S.C. 112(a) provides that “[t]he specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same . . . .” The Federal Circuit has explained that “requiring a written description of the invention plays a vital role in curtailing claims . . . that have not been invented, and thus cannot be described.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (en banc). Further, “the purpose of the written description requirement is to `ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' ” Id., 598 F.3d at 1353-54 (citations omitted).

    In evaluating written description, “the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id., 598 F.3d at 1351 (citations omitted). See also Daniels, 144 F.3d at 1456. With respect to showing possession, the Federal Circuit has emphasized that “the hallmark of written description is disclosure” and “[t]hus, `possession as shown in the disclosure' is a more complete formulation.” Ariad, 598 F.3d at 1351. Accordingly, “the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art” and “[b]ased on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Id.

    The test for sufficiency of written description is the same for design and utility patents. Daniels, 144 F.3d at 1456. For designs, “[i]t is the drawings of the design patent that provide the description of the invention.” Id. (stating, “Although linguists distinguish between a drawing and a writing, the drawings of the design patent are viewed in terms of the `written description' requirement of Section 112.”).

    In Racing Strollers, the Federal Circuit stated, “[a]s a practical matter, meeting the [written description] requirement of § 112 is, in the case of an ornamental design, simply a question of whether the earlier application contains illustrations, whatever form they may take, depicting the ornamental design illustrated in the later application and claimed therein . . . .” Racing Strollers, 878 F.2d at 1420. Subsequent cases explain that the written description analysis must be conducted from the perspective of an ordinary designer. For example, in finding that the inventor in Daniels had possession of a later-claimed design to a leecher without leaf ornamentation where an earlier design application depicted the leecher with leaf ornamentation, the Federal Circuit stated, “The leecher as an article of manufacture is clearly visible in the earlier design application, demonstrating to the artisan viewing that application that [the inventor] had possession at that time of the later claimed design of that article . . . .” Daniels, 144 F.3d at 1456-57 (citations omitted) (emphasis added).

    This principle is articulated again in Owens, where the Federal Circuit found that a parent application disclosing a design for a bottle with an undivided pentagonal center-front panel did not provide written description support for a continuation claiming only the trapezoidal top portion of the center-front panel. Owens, 710 F.3d at 1368. Specifically, the Federal Circuit stated that “the question for written description purposes is whether a skilled artisan would recognize upon reading the parent's disclosure that the trapezoidal top portion of the front panel might be claimed separately from the remainder of that area.” Owens, 710 F.3d at 1368 (citing Ariad, 598 F.3d at 1351) (emphasis added). These design cases are consistent with the written description case law requiring that the application relied upon must reasonably convey to a person of skill in the art that the inventor had possession of the claimed subject matter. See Ariad, 598 F.3d at 1351 (stating, “the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art” and “[b]ased on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.”).

    III. Applying the General Principles to Specific Situations in Design Applications Where Issues of Compliance With the Written Description Requirement May Arise

    A question as to whether the original or earlier disclosure of a design provides an adequate written description may arise when an amended claim is presented, or where a claim to entitlement of an earlier priority date or effective filing date (e.g., under 35 U.S.C. 120) has been made. A continuation application must comply with the written description requirement to be entitled to a parent application's effective filing date. See Owens, 710 F.3d at 1366 (citing Daniels, 144 F.3d at 1456). Similarly, an amended claim must find written description support in the original disclosure. In determining whether a claim complies with the written description requirement, an examiner would bear in mind that “the written description question does not turn upon what has been disclaimed, but instead upon whether the original disclosure `clearly allow[s] persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.' ” Owens, 710 F.3d at 1368 (quoting Ariad, 598 F.3d at 1351) (alternations in original) (emphasis added).

    Issues of compliance with the written description requirement may arise where a later-claimed design is composed of only a subset of originally disclosed elements (the later-claimed design does not introduce any new elements that were not originally disclosed). In the vast majority of such situations, the fact that the subset of originally disclosed elements composing the later-claimed design is visible (claimed or unclaimed) in the original/earlier application is sufficient to demonstrate to the ordinary designer viewing the original/earlier application that the inventor had possession of the later-claimed design at the time of filing the original/earlier application. See Racing Strollers, 878 F.2d at 1420 (stating “[a]s a practical matter, meeting the [written description] requirement of § 112 is, in the case of an ornamental design, simply a question of whether the earlier application contains illustrations, whatever form they may take, depicting the ornamental design illustrated in the later application and claimed therein . . . .”); see also Daniels, 144 F.3d at 1456 (stating “when an issue of priority arises under § 120 in the context of design patent prosecution, one looks to the drawings of the earlier application for disclosure of the subject matter claimed in the later application” and finding that “[t]he leecher as an article of manufacture is clearly visible in the earlier design application, demonstrating to the artisan viewing that application that [the inventor] had possession at that time of the later claimed design of that article [alone without the leaf ornamentation claimed in the earlier design application]”). In these situations, no further analysis by the examiner would be necessary with respect to the written description requirement.

    However, as mentioned earlier, limited situations may exist where a later-claimed design, composed of only a subset of originally disclosed elements (claimed or unclaimed), raises a question as to whether the later-claimed design is supported by the original/earlier disclosure, even though the elements composing the later-claimed design are visible in the original/earlier disclosure. An example of such limited situations is the situation in which there is an original disclosure composed of a grid of one hundred blocks (or a grid of several million pixels) and a later-claimed design composed of only a subset of interior blocks (or pixels) that form patterns (e.g., a smiling face or a frowning face). In this situation, there is a question as to whether the later-claimed design is supported by the original disclosure, even though the interior blocks (or pixels) composing the patterns are visible in the original disclosure. See also, “AIPLA Comments to USPTO on Written Description,” March 14, 2014, at page 3, available at http://www.uspto.gov/patents/law/comments/dr_a-aipla_20140314.pdf, for a similar concept. In such limited situations, the examiner would determine whether an ordinary designer would recognize upon reviewing the complete original/earlier application that the inventor had possession of the later-claimed design in the original/earlier disclosure. See Daniels, 144 F.3d at 1456 (stating, “In general, precedent establishes that although the applicant `does not have to describe exactly the subject matter claimed, . . . the description must clearly allow persons of ordinary skill in the art to recognize that [the applicant] invented what is claimed.' ”) (citations omitted). See also Owens, 710 F.3d at 1368 (quoting Ariad, 598 F.3d at 1351).

    When making this determination, the examiner would consider what the original/earlier application, in its totality (e.g., including the title, any descriptive statements, and the drawings), would have reasonably conveyed to an ordinary designer at the time of the invention, and how an ordinary designer in the art would have designed the article that is the subject of the design claim. Such considerations can include the nature and intended use of the article embodying the claimed design as identified by the title or description (see, e.g., MPEP § 1503.01 I (9th ed. 2015)). If, based on these considerations, the examiner determines that an ordinary designer would not recognize upon reviewing the complete original/earlier application the later-claimed design in the original/earlier disclosure, the examiner would reject the claim for lack of written description (or in the case of a priority or benefit claim, the application would not be entitled to the earlier date).

    Since the Office has the initial burden of establishing a prima facie case of lack of written description, should an examiner determine that a rejection is appropriate, the examiner must set forth express findings of fact which support the lack of written description determination (see MPEP § 2163 for examination guidelines pertaining to the written description requirement). Upon reply by applicant, before rejecting the claim again under 35 U.S.C. 112(a) for lack of written description, the examiner would need to review the basis for the rejection in view of the record as a whole, including amendments, arguments, and any evidence submitted by applicant, such as affidavits or declarations.

    If the record as a whole demonstrates that the written description requirement is satisfied, the rejection would not be repeated in the next Office action. If, on the other hand, the record does not demonstrate that the written description is adequate to support the claim, the examiner again would reject the claim under 35 U.S.C. 112(a), fully respond to applicant's rebuttal arguments, and properly treat any further showings submitted by applicant in the reply. When rejecting the claim again for lack of written description, the examiner would need to thoroughly analyze and discuss any affidavits or declarations filed by applicant that are relevant to the 35 U.S.C. 112(a) written description requirement. See In re Alton, 76 F.3d 1168, 1176 (Fed. Cir. 1996).

    IV. Request for Public Comments

    The USPTO is requesting written public comments on the USPTO's proposed approach for applying the written description requirement in design applications as discussed in this notice. Because the USPTO is considering providing examples after reviewing public comments on the proposed approach, the USPTO also is requesting specific examples that the public believes would be helpful to illustrate the proposed approach or any suggested approach for applying the written description requirement in design applications. In particular, the USPTO is seeking examples from the public that demonstrate adequate written description as well as examples that demonstrate a lack of written description. Additionally, examples of situations in which the presence or lack of written description is not readily apparent, i.e., examples that are close to the line between adequate written description and insufficient written description, would be most helpful. Once the USPTO has considered the comments and examples received, the USPTO will determine how best to proceed in view of the public feedback on the proposed approach for applying the written description requirement in design applications.

    Dated: April 8, 2016. Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.
    [FR Doc. 2016-08760 Filed 4-14-16; 8:45 am] BILLING CODE 3510-16-P
    COMMITTEE FOR THE IMPLEMENTATION OF TEXTILE AGREEMENTS Request for Public Comment on a Commercial Availability Request Under the U.S.-Morocco Free Trade Agreement AGENCY:

    Committee for the Implementation of Textile Agreements (CITA).

    ACTION:

    Request for public comments concerning a request for modification of the U.S.-Morocco Free Trade Agreement (USMFTA) rules of origin for dresses, skirts, blouses and tops made from certain woven fabric.

    SUMMARY:

    The Government of the United States received a request from the Government of Morocco, dated March 1, 2016, on behalf of ARYANS to initiate consultations under Article 4.3.3 of the USMFTA. The Government of Morocco is requesting that the United States and Morocco (“the Parties”) consider revising the rules of origin for dresses, skirts, blouses and tops to address availability of supply of certain woven fabric in the territories of the Parties. The President of the United States may proclaim a modification to the USMFTA rules of origin for textile and apparel products after the United States reaches an agreement with the Government of Morocco on a modification under Article 4.3.6 of the USMFTA to address issues of availability of supply of fibers, yarns, or fabrics in the territories of the Parties. CITA hereby solicits public comments on this request, in particular with regard to whether certain woven fabric can be supplied by the U.S. domestic industry in commercial quantities in a timely manner.

    DATES:

    Comments must be submitted by May 16, 2016 to the Chairman, Committee for the Implementation of Textile Agreements, Room 30003, United States Department of Commerce, Washington, DC 20230.

    FOR FURTHER INFORMATION CONTACT:

    Maria D'Andrea, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-1550.

    SUPPLEMENTARY INFORMATION: Authority:

    Section 203 (j)(2)(B)(i) of the United States—Morocco Free Trade Agreement Implementation Act (19 U.S.C. 3805 note) (USMFTA Implementation Act); Executive Order 11651 of March 3, 1972, as amended.

    Background: Article 4.3.3 of the USMFTA provides that, on the request of either Party, the Parties shall consult to consider whether the rules of origin applicable to a particular textile or apparel good should be revised to address issues of availability of supply of fibers, yarns, or fabrics in the territories of the Parties. In the consultations, pursuant to Article 4.3.4 of the USMFTA, each Party shall consider data presented by the other Party that demonstrate substantial production in its territory of a particular fiber, yarn, or fabric. The Parties shall consider that there is substantial production if a Party demonstrates that its domestic producers are capable of supplying commercial quantities of the fiber, yarn, or fabric in a timely manner. The USMFTA Implementation Act provides the President with the authority to proclaim as part of the HTSUS, modifications to the USMFTA rules of origin set out in Annex 4-A of the USMFTA as are necessary to implement an agreement with Morocco under Article 4.3.6 of the USMFTA, subject to the consultation and layover requirements of Section 104 of the USMFTA Implementation Act. See Section 203(j)(2)(B)(i) of the USMFTA Implementation Act. Executive Order 11651 established CITA to supervise the implementation of textile trade agreements and authorizes the Chairman of CITA to take actions or recommend that appropriate officials or agencies of the United States take actions necessary to implement textile trade agreements. 37 FR 4699 (March 4, 1972).

    The Government of the United States received a request from the Government of Morocco, dated March 1, 2016, on behalf of ARYANS, requesting that the United States consider whether the USMFTA rule of origin for dresses, skirts, blouses and tops classified in HTSUS chapter 62, should be modified to allow the use of 87%-93% cotton/5%-9% polyester/2%-4% elastane woven fabric classified in subheading 5209.42 of the HTSUS that is not originating under the USMFTA.

    CITA is soliciting public comments regarding this request, particularly with respect to whether 87%-93% cotton/5%-9% polyester/2%-4% elastane woven fabric described above can be supplied by the U.S. domestic industry in commercial quantities in a timely manner. Comments must be received no later than May 16, 2016.

    Interested persons are invited to submit such comments or information electronically to [email protected], and/or in hard copy to: Chairman, Committee for the Implementation of Textile Agreements, Room 30003, U.S. Department of Commerce, 14th and Constitution Avenue NW., Washington, DC 20230.

    If comments include business confidential information, commenters must submit a business confidential version in hard copy to the Chairman of CITA, and also provide a public version, either in hard copy or electronically. CITA will protect any information that is marked business confidential from disclosure to the full extent permitted by law. All public versions of the comments will be posted on OTEXA's Web site for Commercial Availability proceedings under the Morocco FTA: http://otexa.trade.gov/Morocco_CA.htm.

    Joshua Teitelbaum, Chairman, Committee for the Implementation of Textile Agreements.
    [FR Doc. 2016-08632 Filed 4-14-16; 8:45 am] BILLING CODE 3510-DR-P
    COMMITTEE FOR THE IMPLEMENTATION OF TEXTILE AGREEMENTS Request for Public Comment on a Commercial Availability Request Under the U.S.-Morocco Free Trade Agreement AGENCY:

    Committee for the Implementation of Textile Agreements (CITA).

    ACTION:

    Request for public comments concerning a request for modification of the U.S.-Morocco Free Trade Agreement (USMFTA) rules of origin for certain women's pants made from certain woven fabrics.

    SUMMARY:

    The Government of the United States received a request from the Government of Morocco, dated March 9, 2016, on behalf of MODALINE HOLDING to initiate consultations under Article 4.3.3 of the USMFTA. The Government of Morocco is requesting that the United States and Morocco (“the Parties”) consider revising the rules of origin for women's pants to address availability of supply of certain woven fabrics in the territories of the Parties. The President of the United States may proclaim a modification to the USMFTA rules of origin for textile and apparel products after the United States reaches an agreement with the Government of Morocco on a modification under Article 4.3.6 of the USMFTA to address issues of availability of supply of fibers, yarns, or fabrics in the territories of the Parties. CITA hereby solicits public comments on this request, in particular with regard to whether certain woven fabrics can be supplied by the U.S. domestic industry in commercial quantities in a timely manner.

    DATES:

    Comments must be submitted by May 16, 2016 to the Chairman, Committee for the Implementation of Textile Agreements, Room 30003, United States Department of Commerce, Washington, DC 20230.

    FOR FURTHER INFORMATION CONTACT:

    Maria D'Andrea, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-1550.

    SUPPLEMENTARY INFORMATION:

    Authority:

    Section 203 (j)(2)(B)(i) of the United States—Morocco Free Trade Agreement

    Implementation Act (19 U.S.C. 3805 note) (USMFTA Implementation Act); Executive Order 11651 of March 3, 1972, as amended.

    Background: Article 4.3.3 of the USMFTA provides that, on the request of either Party, the Parties shall consult to consider whether the rules of origin applicable to a particular textile or apparel good should be revised to address issues of availability of supply of fibers, yarns, or fabrics in the territories of the Parties. In the consultations, pursuant to Article 4.3.4 of the USMFTA, each Party shall consider data presented by the other Party that demonstrate substantial production in its territory of a particular fiber, yarn, or fabric. The Parties shall consider that there is substantial production if a Party demonstrates that its domestic producers are capable of supplying commercial quantities of the fiber, yarn, or fabric in a timely manner. The USMFTA Implementation Act provides the President with the authority to proclaim as part of the HTSUS, modifications to the USMFTA rules of origin set out in Annex 4-A of the USMFTA as are necessary to implement an agreement with Morocco under Article 4.3.6 of the USMFTA, subject to the consultation and layover requirements of Section 104 of the USMFTA Implementation Act. See Section 203(j)(2)(B)(i) of the USMFTA Implementation Act. Executive Order 11651 established CITA to supervise the implementation of textile trade agreements and authorizes the Chairman of CITA to take actions or recommend that appropriate officials or agencies of the United States take actions necessary to implement textile trade agreements. 37 FR 4699 (March 4, 1972).

    The Government of the United States received a request from the Government of Morocco, dated March 9, 2016, on behalf of MODALINE HOLDING, requesting that the United States consider whether the USMFTA rule of origin for women's pants classified in HTSUS heading 6204 should be modified to allow the use of certain woven fabrics that are not originating under the USMFTA. The fabrics subject to this request are:

    Fabric 1: 45%-52% polyester, 45%-52% rayon, 1%-7% spandex woven synthetic bi-stretch fabric, classified in subheading 5515.11 of the HTSUS;

    Fabric 2: 60%-68% polyester, 29%-37% rayon, 1%-7% spandex woven poly-viscose fabric, classified in subheading 5515.11 of the HTSUS;

    Fabric 3: 31%-37% viscose, 17%-23% polyester, 17%-23% cotton, 13%-19% wool, 5%-11% nylon, 1%-6% spandex woven herringbone fabric, classified in subheading 5408.33 of the HTSUS;

    Fabric 4: 94%-99% virgin wool, 1%-6% spandex, twill stretch flannel reactive dyed fabric, classified in subheading 5112.11 of the HTSUS; and

    Fabric 5: 89%-95% polyester, 5%-11% spandex printed and solid woven polyester crepe fabric (with filament yarn size of 120D + 40D*120D + 40D and a construction of 175*104), classified in subheading 5407.61 of the HTSUS.

    CITA is soliciting public comments regarding this request, particularly with respect to whether the fabrics described above can be supplied by the U.S. domestic industry in commercial quantities in a timely manner. Comments must be received no later than May 16, 2016. Interested persons are invited to submit such comments or information electronically to [email protected], and/or in hard copy to: Chairman, Committee for the Implementation of Textile Agreements, Room 30003, U.S. Department of Commerce, 14th and Constitution Avenue NW., Washington, DC 20230.

    If comments include business confidential information, commenters must submit a business confidential version in hard copy to the Chairman of CITA, and also provide a public version, either in hard copy or electronically. CITA will protect any information that is marked business confidential from disclosure to the full extent permitted by law. All public versions of the comments will be posted on OTEXA's Web site for Commercial Availability proceedings under the Morocco FTA: http://otexa.trade.gov/Morocco_CA.htm.

    Joshua Teitelbaum, Chairman, Committee for the Implementation of Textile Agreements.
    [FR Doc. 2016-08635 Filed 4-14-16; 8:45 am] BILLING CODE 3510-DR-P
    COMMITTEE FOR THE IMPLEMENTATION OF TEXTILE AGREEMENTS Request for Public Comment on a Commercial Availability Request Under the U.S.-Morocco Free Trade Agreement AGENCY:

    Committee for the Implementation of Textile Agreements (CITA).

    ACTION:

    Request for public comments concerning a request for modification of the U.S.-Morocco Free Trade Agreement (USMFTA) rules of origin for pants, skirts, jackets, shirts, and casual dresses made from certain woven fabrics.

    SUMMARY:

    The Government of the United States received a request from the Government of Morocco, submitted on March 9, 2016, and updated on April 1, 2016, on behalf of CROSSING to initiate consultations under Article 4.3.3 of the USMFTA. The Government of Morocco is requesting that the United States and Morocco (“the Parties”) consider revising the rules of origin for pants, skirts, jackets, shirts and casual dresses to address availability of supply of certain woven fabrics in the territories of the Parties. The President of the United States may proclaim a modification to the USMFTA rules of origin for textile and apparel products after the United States reaches an agreement with the Government of Morocco on a modification under Article 4.3.6 of the USMFTA to address issues of availability of supply of fibers, yarns, or fabrics in the territories of the Parties. CITA hereby solicits public comments on this request, in particular with regard to whether certain woven fabrics can be supplied by the U.S. domestic industry in commercial quantities in a timely manner.

    DATES:

    Comments must be submitted by May 16, 2016 to the Chairman, Committee for the Implementation of Textile Agreements, Room 30003, United States Department of Commerce, Washington, DC 20230.

    FOR FURTHER INFORMATION CONTACT:

    Maria D'Andrea, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-1550.

    SUPPLEMENTARY INFORMATION: Authority:

    Section 203 (j)(2)(B)(i) of the United States-Morocco Free Trade Agreement Implementation Act (19 U.S.C. 3805 note) (USMFTA Implementation Act); Executive Order 11651 of March 3, 1972, as amended.

    Background: Article 4.3.3 of the USMFTA provides that, on the request of either Party, the Parties shall consult to consider whether the rules of origin applicable to a particular textile or apparel good should be revised to address issues of availability of supply of fibers, yarns, or fabrics in the territories of the Parties. In the consultations, pursuant to Article 4.3.4 of the USMFTA, each Party shall consider data presented by the other Party that demonstrate substantial production in its territory of a particular fiber, yarn, or fabric. The Parties shall consider that there is substantial production if a Party demonstrates that its domestic producers are capable of supplying commercial quantities of the fiber, yarn, or fabric in a timely manner.

    The USMFTA Implementation Act provides the President with the authority to proclaim as part of the HTSUS, modifications to the USMFTA rules of origin set out in Annex 4-A of the USMFTA as are necessary to implement an agreement with Morocco under Article 4.3.6 of the USMFTA, subject to the consultation and layover requirements of Section 104 of the USMFTA Implementation Act. See Section 203(j)(2)(B)(i) of the USMFTA Implementation Act. Executive Order 11651 established CITA to supervise the implementation of textile trade agreements and authorizes the Chairman of CITA to take actions or recommend that appropriate officials or agencies of the United States take actions necessary to implement textile trade agreements. 37 FR 4699 (March 4, 1972).

    The Government of the United States received a request from the Government of Morocco, submitted on March 9, 2016, and updated on April 1, 2016, on behalf of CROSSING, requesting that the United States consider whether the USMFTA rule of origin for pants, skirts, jackets, shirts, and casual dresses classified in HTSUS subheading 6204.52 and 6206.40 should be modified to allow the use of certain woven fabrics that are not originating under the USMFTA. The fabrics subject to this request are:

    Fabric 1: 100% lyocell classified in subheading 5516.11 and 5516.12 of the HTSUS;

    Fabric 2: Lyocell/cotton classified in subheading 5516.41, 5516.42, and 5516.43 of the HTSUS;

    Fabric 3: Cotton/polyester classified in subheading 5210.49 and 5211.42 of the HTSUS;

    Fabric 4: Cotton/polyester/elastane classified in subheading 5210.49 and 5211.4210 of the HTSUS;

    Fabric 5: Corduroy with cotton classified in subheading 5801.22 of the HTSUS; and

    Fabric 6: Corduroy polyester classified in subheading 5801.32 of the HTSUS.

    CITA is soliciting public comments regarding this request, particularly with respect to whether the fabrics described above can be supplied by the U.S. domestic industry in commercial quantities in a timely manner. Comments must be received no later than May 16, 2016. Interested persons are invited to submit such comments or information electronically to [email protected], and/or in hard copy to: Chairman, Committee for the Implementation of Textile Agreements, Room 30003, U.S. Department of Commerce, 14th and Constitution Avenue NW., Washington, DC 20230.

    If comments include business confidential information, commenters must submit a business confidential version in hard copy to the Chairman of CITA, and also provide a public version, either in hard copy or electronically. CITA will protect any information that is marked business confidential from disclosure to the full extent permitted by law. All public versions of the comments will be posted on OTEXA's Web site for Commercial Availability proceedings under the Morocco FTA: http://otexa.trade.gov/Morocco_CA.htm.

    Joshua Teitelbaum, Chairman, Committee for the Implementation of Textile Agreements.
    [FR Doc. 2016-08633 Filed 4-14-16; 8:45 am] BILLING CODE 3510-DR-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Proposed Additions and Deletions AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Proposed additions to and deletions from the Procurement List.

    SUMMARY:

    The Committee is proposing to add services to the Procurement List that will be provided by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products previously furnished by such agencies.

    DATES:

    Comments must be received on or before: 5/15/2016.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202-4149.

    FOR FURTHER INFORMATION OR TO SUBMIT COMMENTS CONTACT:

    Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

    Addition

    If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to provide the services listed below from the nonprofit agencies employing persons who are blind or have other severe disabilities.

    The following services are proposed for addition to the Procurement List for provision by the nonprofit agencies listed:

    Services Service Type: Custodial Service Mandatory For: U.S. Department of Defense Education Activity Domestic Dependent Elementary and Secondary Schools (DDESS), Fort Bragg Community Schools, Fort Bragg, NC. Mandatory Source(s) of Supply: Brevard Achievement Center, Rockledge, FL. Contracting Activity: DDESS Area Center, Procurement Division, Peachtree City, GA. Service Type: Operations and Maintenance Service. Mandatory for: US Army Corps of Engineers, Savannah, Defense Forensic Science Center, Fort Gillem, GA. Mandatory Source(s) of Supply: Pride Industries, Inc., Roseville, CA. Contracting Activity: US Army Corps of Engineers Savannah District, Savannah, GA. Deletions

    The following products are proposed for deletion from the Procurement List:

    Products NSN(s)—Product Name(s): MR 938—Set, Cleaning, Microfiber, Leaf Print, 5 Piece, MR 951—Set, Cleaning, Microfiber, Cherry Print, 5 Piece. Mandatory Source(s) of Supply: New York City Industries for the Blind, Inc., Brooklyn, NY. (Deleted) Contracting Activity: Defense Commissary Agency. NSN(s)—Product Name(s): MR 417—Latex Gloves, Long Cuff, Medium, 2 Pair, MR 418—Latex Gloves, Long Cuff, Large, 2 Pair. Mandatory Source(s) of Supply: Alphapointe, Kansas City, MO. Contracting Activity: Defense Commissary Agency. Barry S. Lineback, Director, Business Operations.
    [FR Doc. 2016-08739 Filed 4-14-16; 8:45 am] BILLING CODE 6353-01-P
    CONSUMER PRODUCT SAFETY COMMISSION Sunshine Act Meeting Notice Time and Date:

    Wednesday, April 20, 2016; 9:30 a.m.-12 p.m.

    Place:

    Hearing Room 420, Bethesda Towers, 4330 East West Highway, Bethesda, Maryland.

    Status:

    Closed to the Public.

    Matter to be Considered:

    Compliance Briefing—The Commission staff will brief the Commission on the status of compliance matters.

    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: April 12, 2016. Todd A Stevenson, Secretary.
    [FR Doc. 2016-08883 Filed 4-13-16; 4:15 pm] BILLING CODE 6355-01-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2016-OS-0043] Proposed Collection; Comment Request AGENCY:

    Defense Finance and Accounting Service (DFAS), DoD.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the DFAS announces a proposed public information collection and seeks public comment on the provisions thereof. 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 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 through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by June 14, 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: ODCMO, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Attn: 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 Defense Finance and Accounting Services, P.O. Box 998002, ATTN: DFAS-HGA/CL, Scott Lafferty, Deputy Assistant General Counsel for Garnishment Operations, Cleveland, OH 44199-8002; via email at [email protected] or at (216) 522-5118.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Application for Former Spouse Payments From Retired Pay, DD Form 2293; OMB Number 0730-0008.

    Needs and Uses: The information collection requirement is necessary to provide DFAS with the basic data needed to process court orders for division of military retired pay as property or order alimony and child support payment from that retired pay per Title 10 U.S.C. 1408, “Payment of retired or retainer pay in compliance with court orders.” The former spouse may apply to the DFAS for direct payment of these monies by using DD Form 2293.

    Affected Public: Individuals and households.

    Annual Burden Hours: 6741.

    Number of Respondents: 26,963.

    Responses per Respondent: 1.

    Annual Responses: 26,963.

    Average Burden per Response: 15 minutes.

    Frequency: On occasion.

    The respondents of this information collection are spouses or former spouses of military members. The applicant submits a DD Form 2293 to the DFAS. The information from the DD Form 2293 is used by DFAS in processing the applicant's request as authorized under 10 U.S.C. 1408. The DD Form 2293 was devised to standardize applications for payment under the Act. Information on the form is also used to determine the applicant's current status and contains statutory required certifications the applicant/former spouse must make when applying for payments.

    Dated: April 12, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-08752 Filed 4-14-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2016-HA-0042] Privacy Act of 1974; System of Records AGENCY:

    Defense Health Agency, DoD.

    ACTION:

    Notice to alter a System of Records.

    SUMMARY:

    Consistent with the Defense Health Agency's creation on October 1, 2013, the existing system of records, DHA 20 DoD, entitled “Department of Defense Suicide Event Report (DoDSER) System,” is being realigned to the Defense Health Agency's compilation of Privacy Act System of Records Notices (SORNs). The realignment of this system requires a change in its system identifier to reflect the numbering system used by the Defense Health Agency.

    The Defense Health Agency also proposes to alter this system of records. This system establishes, collects, and maintains integrated DoD enterprise and survey data to be used for direct reporting of Reportable Events involving individuals on active duty or serving in the Reserves, supporting ongoing population-based health surveillance activities and public health within DoD, and for analysis. Surveillance activities include the systematic collection, analysis, interpretation, and reporting of outcome-specific data for use in planning and development of best practices, education, public health within DoD, and training on protocols for identifying, responding to, and managing individuals at increased risk of suicide; and implementation, evaluation, and prevention of suicide behaviors and Reportable Events within the DoD.

    DATES:

    Comments will be accepted on or before May 16, 2016. This proposed action will be effective the date following the end of the comment period unless comments are received which result in a contrary determination.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    * Mail: ODCMO, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Attn: Mailbox 24, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name and docket number for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Linda S. Thomas, Chief, Defense Health Agency Privacy and Civil Liberties Office, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101, or by phone at (703) 275-6363.

    SUPPLEMENTARY INFORMATION:

    The Defense Health Agency notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT or at the Defense Privacy and Civil Liberties Division Web site at http://dpcld.defense.gov/. The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on April 1, 2016, to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

    Dated: April 12, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. DHA 20 DoD System Name:

    Department of Defense Suicide Event Report (DoDSER) System (May 6, 2010, 75 FR 24928)

    Changes: System identifier:

    Delete entry and replace with “EDHA 20 DoD.”

    Categories of individuals covered by the system:

    Delete entry and replace with “Individuals who are Active Duty, Reserve, and National Guard Component personnel serving in the Air Force, Army, Navy, and/or Marines, with reportable suicide or self-directed violence (to include self-harm behaviors, suicide attempts, and suicidal ideation) while on active duty or serving as a member of the Reserves (Reportable Event).”

    Categories of records in the system:

    Delete entry and replace with “Demographic records: Name, Social Security Number (SSN) and/or DoD Identification (DoD ID) number, date of birth, gender, race/ethnic group, marital status, rank/pay grade, religious preference, military service, military status, job title, service duty specialty code, duty environment/status, Unit Identification Code, permanent duty station, the major command of the permanent duty station, temporary duty station (if applicable), home address, home phone number, and deployment history.

    Reportable Event records:

    Reportable Event type or description; individual's residence at time of event; circumstances of event; potential precipitating factors and psychological stressors at the time of the event; post-intervention activities, and, if applicable, medical facility, unit or military treatment facility where Reportable Event occurred.

    Other records:

    Individual's use of military and community helping services, past military experience, medical treatment, psychological, and legal records; social history; medical history; event details, including prior suicidal behaviors; behavioral, developmental, and economic, education/training history; form completer information (name, rank/grade, and contact information); and data sources used to compile records.”

    Authority for maintenance of the system:

    Delete entry and replace with “10 U.S.C. 136, Under Secretary of Defense for Personnel and Readiness; 10 U.S.C. 3013, Secretary of the Army; 10 U.S.C. 5013, Secretary of the Navy; 10 U.S.C. 8013, Secretary of the Air Force; 10 U.S.C. Chapter 55, Medical and Dental Care; DoD Directive (DoDD) 5124.02, Under Secretary of Defense for Personnel and Readiness (USD(P&R)); DoDD 5136.01, Assistant Secretary of Defense for Health Affairs (ASD(HA)); DoDD 6490.02E, Comprehensive Health Surveillance; DoDD 6490.14, Defense Suicide Prevention Program; Army Regulation 600-63, Army Health Promotion; OPNAV Instruction 1720.4A, Suicide Prevention Program; Air Force Instruction 90-505, Suicide Prevention Program; and E.O. 9397 (SSN), as amended.”

    Purpose(s):

    Delete entry and replace with “To establish, collect, and maintain integrated DoD enterprise and survey data to be used for direct reporting of Reportable Events involving individuals on Active Duty or serving in the Reserves, supporting ongoing population-based health surveillance activities and public health within DoD, and for analysis. Surveillance activities include the systematic collection, analysis, interpretation, and reporting of outcome-specific data for use in planning and development of best practices, education, public health within DoD, and training on protocols for identifying, responding to, and managing individuals at increased risk of suicide; and implementation, evaluation, and prevention of suicide behaviors and Reportable Events within the DoD.

    Records in this system may be made available to the Military Services to provide Service level integrated enterprise and analysis data for Service level direct reporting requirements; to provide the Services with data for planning, implementation, evaluation, and prevention of suicide behaviors; to support Service-level population-based health surveillance activities; to facilitate Service-level behavioral health and medical care and treatment programs; and, to the extent the information provided does not include personally identifiable information, to provide or permit compilation of command level reports and/or trend reporting at a military installation level.

    Records in this system may be made available to DoD components that are designated as public health authorities within DoD to support DoD suicide prevention and resilience programs, provide DoD-wide comprehensive strategic approaches for suicide prevention, postvention, and surveillance; assist the Military Services to reduce the impact of suicidal self-directed violence on the readiness of the Military Services; fuse, analyze, and assess DoD-wide surveillance and research activities related to suicidal self-direct violence and other high risk activities to identify risk factors and key outcomes to inform suicide prevention policies and programs; and otherwise fulfill such DoD public health authority's responsibilities.”

    Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

    Delete entry and replace with “In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, the records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

    Statistical summary data with no personally identifiable information may be provided to public health authorities and to federal, state, and local governments not a part of DoD for health surveillance and research.

    Records in this system of records that are part of an individual's Service Treatment Record (STR) as defined in DoD Instruction 6040.45, November 16, 2015 (USD(P&R)), and in any successor DoD issuances, and may be provided to the Veterans Administration (VA) in connection with the individual's separation from Service. Such STR-related records in this system may be provided directly to the VA or collected with STR-related records not part of this system and made available to VA.

    Except as stipulated in NOTE 1 and NOTE 2 below, the DoD Blanket Routine Uses set forth at the beginning of the Defense Privacy and Civil Liberties Division compilation of systems of records notices may apply to this system. The complete list of DoD Blanket Routine Uses can be found online at: http://dpcld.defense.gov/Privacy/SORNsIndex/BlanketRoutineUses.aspx.

    NOTE 1: This system of records may contain individually identifiable health information. The DoD Health Information Privacy Regulation (DoD 6025.18-R) or any successor DoD issuances implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and 45 CFR parts 160 and 164, Health and Human Services, General Administrative Requirements and Security & Privacy, respectively, applies to most such health information. DoD 6025.18-R or a successor issuance may place additional procedural requirements on uses and disclosures of such information beyond those found in the Privacy Act of 1974, as amended, or mentioned in this system of records notice.

    NOTE 2: Records of identity, diagnosis, prognosis or treatment information of any patient maintained in connection with the performance of any program or activity relating to substance abuse education, prevention, training, treatment, rehabilitation, or research which is conducted, regulated, or directly or indirectly assisted by any department or agency of the United States, will be treated as confidential and disclosed only for the purposes and under the circumstances expressly authorized in 42 U.S.C. 290d-2.”

    Retrievability:

    Delete entry and replace with “By individual's name and SSN or DoD ID number.”

    Safeguards:

    Delete entry and replace with “Physical access to the system is restricted by the use of locks, access controls, and is accessible only to authorized personnel. Each system end user device is protected within a locked storage container, room, or building outside of normal business hours. All visitors or other persons without authorized access to server and/or network facilities are escorted by appropriately screened/cleared personnel at all times. The system is restricted by two-factor authentication including Common Access Card (CAC) and personal identification number. All personnel with authorized access to the system must have appropriate and applicable Information Assurance, Privacy Act, and HIPAA training. All access to records is tracked by electronic audit logs. Audit logs are always on and are archived for historical review and tracking.”

    Retention and disposal:

    Delete entry and replace with “DoDSER System Master File: Cutoff annually upon separation or retirement of service member. Transfer to inactive storage when 25 years old. Destroy when 75 years old. DoDSER System Annual Reports: Cutoff annually after report is published. Transfer to NARA 3 years after cutoff.”

    System manager(s) and address:

    Delete entry and replace with “Director, National Center for Telehealth & Technology (T2) Defense Centers of Excellence, 9933 West Hayes Street, Madigan Army Medical Center, Joint Base Lewis-McChord, Tacoma, WA 98431-1100.”

    Notification procedures:

    Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this system of records should address written inquiries to the Chief, Freedom of Information Act (FOIA) Service Center, Defense Health Agency Privacy and Civil Liberties Office, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.

    Written requests should contain the individual's full name, home address, home phone number, and SSN/DoD ID number, the identifier of this system of records notice, and signature.

    In addition, the requester must provide a notarized statement or an unsworn declaration made in accordance with 28 U.S.C. 1746, in the following format:

    If executed outside the United States:

    `I declare (or certify, verify, or state) under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on (date). (Signature)'.

    If executed within the United States, its territories, possessions, or commonwealths:

    `I declare (or certify, verify, or state) under penalty of perjury that the foregoing is true and correct. Executed on (date). (Signature)'.”

    Record access procedures:

    Delete entry and replace with “Individuals seeking access to records about themselves contained in this system of records should address written inquiries to the Chief, FOIA Service Center, Defense Health Agency Privacy and Civil Liberties Office, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.

    Written requests should contain the individual's full name, home address, home phone number, and SSN/DoD ID number, the identifier of this system of records notice, and signature.

    In addition, the requester must provide a notarized statement or an unsworn declaration made in accordance with 28 U.S.C. 1746, in the following format:

    If executed outside the United States:

    `I declare (or certify, verify, or state) under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on (date). (Signature).'

    If executed within the United States, its territories, possessions, or commonwealths:

    `I declare (or certify, verify, or state) under penalty of perjury that the foregoing is true and correct. Executed on (date). (Signature)'.”

    Contesting record procedures:

    Delete entry and replace with “The Office of the Secretary of Defense (OSD) rules for accessing records, for contesting contents and appealing initial agency determinations are published in OSD Administrative Instruction 81, 32 CFR part 311, or may be obtained from the system manager.”

    Record Source Categories

    Delete entry and replace with “Medical and behavioral health records; military personnel records; investigative agency records, pre and post deployment screening records, family advocacy records; court martial records; records related to manner of death such as casualty reports, toxicology/lab reports, and pathology/autopsy reports; and suicide notes. Record sources also include interviews with an individual's coworkers/supervisors, responsible investigative agencies, involved professionals such as physicians, behavioral health counselors, chaplains, military police, family service personnel, family members, and, in the case of non-fatal self-directed violence, the individual involved in that Reportable Event.

    Records included in this system of records also may be obtained from the Defense Eligibility and Enrollment Reporting System, Armed Forces Health Longitudinal Technology Application, Composite Health Care System, information systems maintained by a Service, and DoD enterprise data systems.”

    [FR Doc. 2016-08707 Filed 4-14-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID DOD-2016-OS-0041] Privacy Act of 1974; System of Records AGENCY:

    Office of the Secretary of Defense, DoD.

    ACTION:

    Notice to alter a system of records.

    SUMMARY:

    The Office of the Secretary of Defense proposes to alter a system of records, DMDC 04, entitled “Emergency Evacuation Tracking and Repatriation.” Repatriation centers will use this information to track and account for individuals evacuated from emergency situations due to military operations, political situations, natural disasters, or other potentially dangerous circumstances. Repatriation centers assist evacuees in securing requested relocation services, and recording and recovering relocation costs.

    DATES:

    Comments will be accepted on or before May 16, 2016. This proposed action will be effective the day following the end of the comment period unless comments are received which result in a contrary determination.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    * Mail: ODCMO, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Attn: Mailbox 24, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name and docket number for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Cindy Allard, Chief, OSD/JS Privacy Office, Freedom of Information Directorate, Washington Headquarters Service, 1155 Defense Pentagon, Washington, DC 20301-1155, or by phone at (571) 372-0461.

    SUPPLEMENTARY INFORMATION:

    The Office of the Secretary of Defense notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT or at http://dpcld.defense.gov/. The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on April 1, 2016, to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

    Dated: April 11, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. DMDC 04 System name:

    Emergency Evacuation Tracking and Repatriation (April 14, 2009, 74 FR 17173).

    Changes: System name:

    Delete entry and replace with “Non-combatant Tracking System (NTS) & Evacuation Tracking and Accountability System (ETAS).”

    System location:

    Delete entry and replace with “Defense Manpower Data Center, DoD Center Monterey Bay, 400 Gigling Road, Seaside, CA 93955-6771.”

    Categories of individuals covered by the system:

    Delete entry and replace with “Noncombatant evacuees include service members and their dependents, DoD and other federal civilian employees and their dependents, U.S. Government contractors, U.S. citizens residing abroad or on business or personal travel.”

    Categories of records in the system:

    Delete entry and replace with “Social Security Number (SSN), Passport Number, U.S. Driver License Number, DoD Teslin Bar Code, or Common Access Card (CAC) Bar Code, Evacuee ID (assigned bracelet), name, date of birth, place of birth, gender, weight, country of citizenship, marital status, sponsor information, country evacuated from, location code (e.g., airport, ship port) (same information is reported for each family member). Also collected are classification number and agency code (an agency code identifying DoD or other U.S. Federal Agency sponsorship), final destination, point of contact name and contact information, emergency contact name and contact information, evacuee minor category (i.e., pregnant woman, unaccompanied child, aged and infirm), pet name, pet type, transportation information and identification of any services requested (e.g., oxygen, wheelchair).”

    Authority for maintenance of the system:

    Delete entry and replace with “E.O. 12656, Assignment of Emergency Preparedness Responsibilities, as amended; DoD Directive 3025.14, Evacuation of U.S. Citizens and Designated Aliens from Threatened Areas Abroad; and E.O. 9397 (SSN), as amended.”

    Purpose(s):

    Delete entry and replace with “Repatriation centers will use this information to track and account for individuals evacuated from emergency situations due to military operations, political situations, natural disasters, or other potentially dangerous circumstances. Repatriation centers assist evacuees in securing requested relocation services, and recording and recovering relocation costs.”

    Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

    Delete entry and replace with “In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, the records contained herein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

    To individuals who have been evacuated but who have been separated from their family and/or spouse. Information will be released to the individual indicating where the family member was evacuated from and final destination.

    To Department of State to plan and monitor evacuation effectiveness and need for services and to verify the number of people by category who have been evacuated.

    To the American Red Cross so that upon receipt of information from a repatriation center that a DoD family has arrived safely in the U.S., the Red Cross may notify the service member (sponsor) still in the foreign country that his/her family has safely arrived in the United States.

    To the Department of Health and Human Services to facilitate the delivery of personal and financial assistance and to recoup the costs of financial services. To identify individuals who might arrive with an illness which would require quarantine.

    To the Internal Revenue Service to recoup unpaid loans made on an emergency basis as a result of emergency evacuation.

    To State and local health departments to further implement the quarantine of an ill individual.

    Law Enforcement Routine Use: If a system of records maintained by a DoD Component to carry out its functions indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or by regulation, rule, or order issued pursuant thereto, the relevant records in the system of records may be referred, as a routine use, to the agency concerned, whether federal, state, local, or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute, rule, regulation, or order issued pursuant thereto.

    Congressional Inquiries Disclosure Routine Use: Disclosure from a system of records maintained by a DoD Component may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.

    Disclosure to the for Litigation Routine Use: A record from a system of records maintained by a DoD Component may be disclosed as a routine use to any component of the Department of Justice for the purpose of representing the Department of Defense, or any officer, employee or member of the Department in pending or potential litigation to which the record is pertinent.

    Disclosure of Information to the National Archives and Records Administration Routine Use: A record from a system of records maintained by a DoD Component may be disclosed as a routine use to the National Archives and Records Administration for the purpose of records management inspections conducted under authority of 44 U.S.C. 2904 and 2906.

    Data Breach Remediation Purposes Routine Use: A record from a system of records maintained by a Component may be disclosed to appropriate agencies, entities, and persons when (1) The Component suspects or has confirmed that the security or confidentiality of the information in the system of records has been compromised; (2) the Component has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Component or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Components efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.

    The DoD Blanket Routine Uses set forth at the beginning of the Office of the Secretary of Defense (OSD) compilation of systems of records notices may apply to this system. The complete list of DoD blanket routine uses can be found online at: http://dpcld.defense.gov/Privacy/SORNsIndex/BlanketRoutineUses.aspx.”

    Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Storage:

    Delete entry and replace with “Electronic storage media.”

    Retrievability:

    Delete entry and replace with “Retrieved by ID Number and type, name, and evacuee ID.”

    Safeguards:

    Delete entry and replace with “Computerized records are maintained in a controlled area accessible only to authorized personnel. At Defense Manpower Data Center (DMDC), entry to these areas is restricted by the use of locks, guards, and administrative procedures such as periodic security audits and regular Monitoring of Users' Security Practices. Access to personal information is limited to those who require the records in the performance of their official duties. Access to personal information is further restricted by the use of passwords which are changed periodically, the Common Access Card (CAC), intrusion detection system (IDS), encryption, and firewalls.”

    Retention and disposal:

    Delete entry and replace with “Permanent: Cut off (take a snapshot) at end of fiscal year and transfer to the National Archives and Record Administration in accordance with 36 CFR 1228.270 and 36 CFR 1234.”

    System manager(s) and address:

    Delete entry and replace with “Director, Defense Manpower Data Center, 4800 Mark Center Drive, Alexandria, VA 22350-6000.”

    Notification procedure:

    Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the Director, Defense Manpower Data Center, 4800 Mark Center Drive, Alexandria, VA 22350-6000.

    Signed, written requests should contain the full name, person ID or evacuee ID, date of birth, and current address and telephone number of the individual.”

    Record access procedures:

    Delete entry and replace with “Individuals seeking access to information about themselves contained in this system should address written inquiries to the Office of the Secretary of Defense/Joint Staff Freedom of Information Act Requester Service Center, 1155 Defense Pentagon, Washington, DC 20301-1155.

    Signed, written requests should contain the full name, person ID or evacuee ID, date of birth, and current address and telephone number of the individual.”

    Record source categories:

    Delete entry and replace with “Individuals via DD form 2585, “Repatriation Processing Center Processing Sheet”, and the repatriation processing centers staff.”

    [FR Doc. 2016-08636 Filed 4-14-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Navy Notice of Availability of Invention for Licensing; Government-Owned Invention AGENCY:

    Department of the Navy, DoD.

    ACTION:

    Notice.

    SUMMARY:

    The inventions listed below are assigned to the United States Government as represented by the Secretary of the Navy and are available for licensing by the Department of the Navy. U.S. Patent No. 7,724,500: Nanoscale Manganese Oxide on Ultraporous Carbon Nanoarchitecture, Navy Case No. 098,802.//U.S. Patent No. 9,093,721: Dual-Function Air Cathode Nanoarchitectures for Metal-Air Batteries with Pulse-Power Capability, Navy Case No. 100,774.//U.S. Patent Application No. 13/784,942: Macroporous Carbon Nanofoam Composites, Navy Case No. 099,270.//U.S. Patent Application No. 13/832,576: Zinc Electrodes for Batteries, Navy Case No. 102,137 and any continuations, divisionals or re-issues thereof.

    ADDRESSES:

    Requests for copies of the inventions cited should be directed to the Naval Research Laboratory, Code 1004, 4555 Overlook Avenue SW., Washington, DC 20375-5320 and must include the Navy Case number.

    FOR FURTHER INFORMATION CONTACT:

    Rita Manak, Head, Technology Transfer Office, NRL Code 1004, 4555 Overlook Avenue SW., Washington, DC 20375-5320, telephone 202-767-3083. Due to U.S. Postal delays, please fax 202-404-7920, email: [email protected] or use courier delivery to expedite response.

    Authority:

    35 U.S.C. 207, 37 CFR part 404.

    Dated: April 11, 2016. N.A. Hagerty-Ford, Federal Register Liaison Officer, Commander, Judge Advocate General's Corps, U.S. Navy.
    [FR Doc. 2016-08736 Filed 4-14-16; 8:45 am] BILLING CODE 3810-FF-P
    DEFENSE NUCLEAR FACILITIES SAFETY BOARD Public Availability of Defense Nuclear Facilities Safety Board FY 2014 Service Contract Inventory Analysis/FY 2015 Service Contract Inventory AGENCY:

    Defense Nuclear Facilities Safety Board.

    ACTION:

    Notice of Public Availability of FY 2014 Service Contract Inventory Analysis/FY 2015 Service Contract Inventories.

    SUMMARY:

    In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), DNFSB is publishing this notice to advise the public of the availability of (1) its analysis of the FY 2014 Service Contract inventories and (2) the FY 2015 Service Contract inventories. This inventory provides information on service contract actions over $25,000 that were made in FY 2015. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on December 19, 2011 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at http://www.whitehouse.gov/sites/default/files/omb/procurement/memo/service-contract-inventory-guidance.pdf. DNFSB has posted its FY 2014 analysis and FY 2015 inventory and a summary of the inventory on the DNFSB homepage at the following link: http://www.dnfsb.gov/open.

    FOR FURTHER INFORMATION CONTACT:

    Questions regarding the service contract inventory should be directed to Sherrill King at 202-694-7070 or [email protected]

    Dated: April 12, 2016. Mark T. Welch, General Manager.
    [FR Doc. 2016-08782 Filed 4-14-16; 8:45 am] BILLING CODE 3670-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0016] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Fiscal Operations Report for 2014-2015 and Application To Participate 2016-2017 (FISAP) and Reallocation Form 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 May 16, 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-0016. 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-103, 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: Fiscal Operations Report for 2014-2015 and Application to Participate 2016-2017 (FISAP) and Reallocation Form.

    OMB Control Number: 1845-0030.

    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: 4,223.

    Total Estimated Number of Annual Burden Hours: 86,022.

    Abstract: The data submitted electronically in the Fiscal Operations Report and Application to Participate (FISAP) through FISAP on the Web is used by the Department of Education to determine the institution's funding need for the award year and monitor program effectiveness and accountability of fund expenditures.

    The Reallocation form is part of FISAP on the Web. The Higher Education Amendments (HEA) requires that if an institution anticipates not using all of its allocated funds for the Perkins, Federal Work Study (FWS), and Federal Supplemental Education Opportunity Grant (FSEOG) programs by the end of an award year, it must specify the anticipated remaining unused amount to the Secretary. In addition to renewing the expiration date, references to dates and award years dates have been updated on the forms and in the instructions for both documents. The FISAP form has been revised: (1) To use technology to gather existing data electronically from other sources requiring less data entry concerning Additional Institutions in Part I; (2) per discussions with OMB staff on 11/26/12 with concurrence on 11/30/12 to allow applicable aggregate level data entry concerning graduate and professional students for schools with non-traditional academic calendars; and (3) per OMB staff request and discussions on 8/21/12 with concurrence on 8/24/12, to expand the income grid in the Part VI summary to collect a more concise breakdown of student data at the aggregate level.

    Dated: April 12, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-08735 Filed 4-14-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION Meeting of the President's Advisory Commission on Educational Excellence for African Americans AGENCY:

    President's Advisory Commission on Educational Excellence for African Americans, U.S. Department of Education.

    ACTION:

    Announcement of an open meeting.

    SUMMARY:

    This notice sets forth the schedule and agenda of the meeting of the President's Advisory Commission on Educational Excellence for African Americans (PACEEAA). The notice also describes the functions of the PACEEAA. Notice of the meeting is required by § 10(a)(2) of the Federal Advisory Committee Act and intended to notify the public of its opportunity to attend. In order to accommodate the availability of the Chair and ensure a quorum, this meeting notice is being published less than 15 days prior to the scheduled meeting date.

    DATES:

    The President's Advisory Commission on Educational Excellence for African Americans meeting will be held on April 18, 2016 from 8:00 a.m.- 4:00 p.m. EST at the Liaison Capitol Hill, 415 New Jersey Avenue NW., Washington, DC 20001.

    FOR FURTHER INFORMATION CONTACT:

    Lauren Mims. [email protected] (202) 453-7207.

    SUPPLEMENTARY INFORMATION:

    Statutory Authority and Function: The President's Advisory Commission on Educational Excellence for African Americans is established under Executive Order 13621, dated July 26, 2012 and extended by Executive Order 13708 dated September 15, 2015. The Commission is governed by the provisions of the Federal Advisory Committee Act (FACA) (Pub. L. 92-463; as amended, 5 U.S.C.A., Appendix 2) which sets forth standards for the formation and use of advisory committees. The purpose of the Commission is to advise the President and the Secretary of Education on matters pertaining to the educational attainment of the African American community, including: (a) The development, implementation, and coordination of educational programs and initiatives at the Department and other agencies to improve educational opportunities and outcomes for African Americans of all ages; (2) efforts to increase the participation of the African American community and institutions that serve the African American community in the Department's programs and in education programs at other agencies; (3) efforts to engage the philanthropic, business, nonprofit, and education communities in a national dialogue on the mission and objectives of this order; and (4) the establishment of partnerships with public, private, philanthropic, and nonprofit stakeholders to meet the mission and policy objectives of its Executive Order.

    Meeting Agenda

    9:00 a.m.-11:00 a.m. EST  Policy Updates

    12:00 p.m.-12:30 p.m. EST  Policy Updates from Undersecretary Ted Mitchell

    12:30 p.m.-1:30 p.m. EST  Commission Member Deliberation & Discussion

    1:00 p.m.-3:00 p.m. EST  Work through the end of the term

    • Media, Messaging and Ethics • Commission Lead Engagements: ○ Transition—Commissioner Spencer Overton ○ AfAmEdSummits —Commissioner Sharon Lettman-Hicks; Commissioner Tykiah Wright; Commissioner Michael Nettles ○ Student Agency—Commissioner Tiffany Loftin ○ AfAmWomenLead—Commissioners Wright and Loftin

    4:00 p.m. EST Adjournment

    Access to Records of the Meeting: The Department will post the official report of the meeting on the PACEEAA's Web site 90 days after the meeting. Pursuant to the FACA, the public may also inspect the materials at 400 Maryland Avenue SW., Washington, DC, by emailing [email protected] or by calling (202) 453-5721 to schedule an appointment.

    Reasonable Accommodations: The meeting site is accessible to individuals with disabilities. If you will need an auxiliary aid or service to participate in the meeting (e.g., interpreting service, assistive listening device, or materials in an alternate format), notify Lauren Mims listed in this notice at least two weeks before the scheduled meeting date. Although we will attempt to meet a request received after that date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Authority:

    PACEEAA-Executive Order 13621, dated July 26, 2012 and extended by Executive Order 13708 dated September 15, 2015.

    Ted Mitchell, Under Secretary, U.S. Department of Education.
    [FR Doc. 2016-08811 Filed 4-14-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0043] Agency Information Collection Activities; Comment Request; International Computer and Information Literacy Study (ICILS 2018) Field Test and Recruitment for Main Study 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 new information collection.

    DATES:

    Interested persons are invited to submit comments on or before June 14, 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-0043. 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-103, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Kashka Kubzdela 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: International Computer and Information Literacy Study (ICILS 2018) Field Test and Recruitment for Main Study.

    OMB Control Number: 1850-New

    Type of Review: A new information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 1,983.

    Total Estimated Number of Annual Burden Hours: 1,984.

    Abstract: The International Computer and Information Literacy Study (ICILS) is a computer-based international assessment of eighth-grade students' computer and information literacy (CIL) skills that will provide a comparison of U.S. student performance and technology access and use with those of the international peers. ICILS collects data on eighth-grade students' abilities to collect, manage, evaluate, and share digital information; their understanding of issues related to the safe and responsible use of electronic information; on student access to, use of, and engagement with ICT at school and at home; school environments for teaching and learning CIL; and teacher practices and experiences with ICT. The data collected through ICILS will also provide information about the nature and extent of the possible “digital divide” and has the potential to inform understanding of the relationship between technology skills and experience and student performance in other core subject areas. ICILS is conducted by the International Association for the Evaluation of Educational Achievement (IEA), an international collective of research organizations and government agencies that create the assessment framework, assessment, and background questionnaires. In the U.S., the National Center for Education Statistics (NCES) conducts this study. In preparation for the ICILS 2018 main study, NCES will conduct a field test from March through May 2017 to evaluate new assessment items and background questions, to ensure practices that promote low exclusion rates, and to ensure that classroom and student sampling procedures proposed for the main study are successful. The U.S. ICILS main study will be conducted in the spring of 2018. Field recruitment will begin in October 2016 and main study recruitment in May of 2017. This request is for the 2017 field test and the 2018 main study recruitment activities and the 2017 field test data collection.

    Dated: April 12, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management.
    [FR Doc. 2016-08723 Filed 4-14-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0010] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; EZ-Audit: Electronic Submission of Financial Statements and Compliance Audits 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 May 16, 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-0010. 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-103, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Ti Baker, 202-377-3156.

    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: EZ-Audit: Electronic Submission of Financial Statements and Compliance Audits.

    OMB Control Number: 1845-0072.

    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: 6,100.

    Total Estimated Number of Annual Burden Hours: 2,491.

    Abstract: eZ-Audit is a web-based process designed to facilitate the submission of compliance and financial statement audits, expedite the review of those audits by the Department, and provide more timely and useful information to public, non-profit and proprietary institutions regarding the Department's review. eZ-Audit establishes a uniform process under which all institutions submit directly to the Department any audit required under the Title IV, HEA program regulations. eZ-Audit continues to have minimal number of financial template line items and general information questions. No additional burden hours have been added.

    Dated: April 12, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-08734 Filed 4-14-16; 8:45 am] BILLING CODE 4000-01-P
    ELECTION ASSISTANCE COMMISSION Meeting Notice AGENCY:

    U.S. Election Assistance Commission.

    ACTION:

    Notice of Public Meeting for EAC Board of Advisors.

    Date and Time: Wednesday, May 4, 2016, 9:00 a.m.-4:30 p.m. and Thursday, May 5, 2016, 8:15 a.m.-12:20 p.m.

    Place: The Crowne Plaza Chicago Metro Hotel, 733 W. Madison, Chicago IL 60661, Phone: (312) 829-5000.

    Purpose: In accordance with the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C. Appendix 2), the U.S. Election Assistance Commission (EAC) Board of Advisors will meet to address its responsibilities under the Help America Vote Act of 2002 (HAVA), to present its views on issues in the administration of Federal elections, formulate recommendations to the EAC, and receive updates on EAC activities.

    Agenda: The Board of Advisors will receive an overview of EAC Agency Operations, and will receive updates on EAC Grants and Audits, EAC Testing and Certification and Voluntary Voting System Guidelines (VVSG) 1.1, EAC Election Administration and Voting Survey (EAVS), EAC Election Worker Recruitment, Training and Retention Project, EAC and the National Voter Registration Act (NVRA), and EAC's New Web site Rollout. The Board will receive briefings from the U.S. Department of Justice (DOJ), the Federal Voting Assistance Program (FVAP), and the Counsel of State Governments (CSG).

    The Board of Advisors will conduct breakout sessions of the Executive/By-law subcommittee. The Board will discuss and vote on proposed Bylaws amendments, and will fill vacancies for officers. The Board will consider other administrative matters.

    Supplementary: Members of the public may submit relevant written statements to the Board of Advisors with respect to the meeting no later than 5:00 p.m. EDT on Wednesday, April 27, 2016. Statements may be sent via email at [email protected], via standard mail addressed to the U.S. Election Assistance Commission, 1335 East West Highway, Suite 4300, Silver Spring, MD 20910, or by fax at 301-734-3108.

    This meeting will be open to the public.

    Person To Contact for Information: Bryan Whitener, Telephone: (301) 563-3961.

    Bryan Whitener, Director of Communications and Clearinghouse, U.S. Election Assistance Commission.
    [FR Doc. 2016-08677 Filed 4-14-16; 8:45 am] BILLING CODE 6820-KF-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Oak Ridge Reservation AGENCY:

    Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Oak Ridge Reservation. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Wednesday, May 11, 2016, 6:00 p.m.

    ADDRESSES:

    Department of Energy Information Center, Office of Science and Technical Information, 1 Science.gov Way, Oak Ridge, Tennessee 37830.

    FOR FURTHER INFORMATION CONTACT:

    Melyssa P. Noe, Federal Coordinator, Department of Energy Oak Ridge Operations Office, P.O. Box 2001, EM-90, Oak Ridge, TN 37831. Phone (865) 241-3315; Fax (865) 576-0956 or email: [email protected] or check the Web site at http://energy.gov/orem/services/community-engagement/oak-ridge-site-specific-advisory-board.

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

    Tentative Agenda • Welcome and Announcements • Comments from the Deputy Designated Federal Officer (DDFO) • Comments from the DOE, Tennessee Department of Environment and Conservation, and Environmental Protection Agency Liaisons • Public Comment Period • Presentation: EM Disposal Facility • Additions/Approval of Agenda • Motions/Approval of March 9, 2016 Meeting Minutes • Status of Recommendations with DOE • Committee Reports • Alternate DDFO Report • Adjourn

    Public Participation: The EM SSAB, Oak Ridge, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Melyssa P. Noe at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to the agenda item should contact Melyssa P. Noe at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

    Minutes: Minutes will be available by writing or calling Melyssa P. Noe at the address and phone number listed above. Minutes will also be available at the following Web site: http://energy.gov/orem/services/community-engagement/oak-ridge-site-specific-advisory-board.

    Issued at Washington, DC, on April 11, 2016. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2016-08759 Filed 4-14-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board AGENCY:

    Office of Environmental Management, Department of Energy.

    ACTION:

    Notice of renewal.

    SUMMARY:

    Pursuant to Section 14(a)(2)(A) of the Federal Advisory Committee Act (Pub. L. 92-463), and in accordance with Title 41 of the Code of Federal Regulations, section 102-3.65(a), and following consultation with the Committee Management Secretariat, General Services Administration, notice is hereby given that the Environmental Management Site-Specific Advisory Board (EM SSAB or Board) will be renewed for a two-year period beginning April 11, 2016.

    The Board provides the Assistant Secretary for Environmental Management (EM) with information, advice, and recommendations concerning issues affecting the EM program at various sites. These site-specific issues include clean-up standards and environmental restoration; waste management and disposition; stabilization and disposition of non-stockpile nuclear materials; excess facilities; future land use and long-term stewardship; risk assessment and management; and clean-up science and technology activities.

    Additionally, the renewal of the Board has been determined to be essential to conduct DOE's business and to be in the public interest in connection with the performance of duties imposed on the DOE by law and agreement. The Board will operate in accordance with the provisions of the Federal Advisory Committee Act, and rules and regulations issued in implementation of that Act.

    FOR FURTHER INFORMATION CONTACT:

    Mr. David Borak, Designated Federal Officer, at (202) 586-9928 or [email protected]

    Issued in Washington, DC, on April 11, 2016. LaTanya R. Butler, Acting Committee Management Officer.
    [FR Doc. 2016-08755 Filed 4-14-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY:

    Department of Energy (DOE)

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Thursday, May 5, 2016 6:00 p.m.

    ADDRESSES:

    Ohio State University, Endeavor Center, 1862 Shyville Road, Piketon, Ohio 45661.

    FOR FURTHER INFORMATION CONTACT:

    Greg Simonton, Alternate Deputy Designated Federal Officer, Department of Energy Portsmouth/Paducah Project Office, Post Office Box 700, Piketon, Ohio 45661, (740) 897-3737, [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and related activities.

    Tentative Agenda • Call to Order, Introductions, Review of Agenda • Approval of March Minutes • Deputy Designated Federal Officer's Comments • Federal Coordinator's Comments • Liaison's Comments • EM SSAB Chairs Meeting Recap • Presentation • Administrative Issues • Subcommittee Updates • Public Comments • Final Comments from the Board • Adjourn

    Public Participation: The meeting is open to the public. The EM SSAB, Portsmouth, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Greg Simonton at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Greg Simonton at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

    Minutes: Minutes will be available by writing or calling Greg Simonton at the address and phone number listed above. Minutes will also be available at the following Web site: http://www.ports-ssab.energy.gov/.

    Issued at Washington, DC, on April 11, 2016. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2016-08757 Filed 4-14-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy [Case No. BLR-004] Notice of Petition for Waiver From Superior Boiler Works, Inc. From the Department of Energy Commercial Packaged Boiler Test Procedure AGENCY:

    Office of Energy Efficiency and Renewable Energy, Department of Energy.

    ACTION:

    Notice of petition for waiver and request for public comments.

    SUMMARY:

    This notice announces receipt of a petition for waiver from Superior Boiler Works, Inc. (Superior) seeking an exemption from specified portions of the U.S. Department of Energy (DOE) test procedure applicable to commercial packaged boilers. Superior contends that some of their commercial packaged boilers cannot be accurately tested using the currently applicable DOE test procedure and, as a result, seeks to use an alternate test procedure to test these basic models. DOE solicits comments, data, and information concerning Superior's petition and the suggested alternate test procedure.

    DATES:

    DOE will accept comments, data, and information with respect to the Superior petition until May 16, 2016.

    ADDRESSES:

    You may submit comments, identified by case number “BLR-004,” by any of the following methods:

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

    Email: [email protected]. Include the case number [Case No. BLR-004] in the subject line of the message.

    Mail: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Program, Mailstop EE-2B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-2945. Please submit one signed original paper copy.

    Hand Delivery/Courier: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Program, 950 L'Enfant Plaza SW., Suite 600, Washington, DC 20024. Please submit one signed original paper copy.

    Docket: For access to the docket to review the background documents relevant to this matter, you may visit http://www.regulations.gov. Available documents include the following items: (1) This notice; (2) public comments received; and (3) the petition for waiver.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Bryan Berringer, U.S. Department of Energy, Building Technologies Program, Mail Stop EE-2B, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-0371. Email: [email protected].

    Mr. Peter Cochran, U.S. Department of Energy, Office of the General Counsel, Mail Stop GC-33, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585-0103. Telephone: (202) 586-9496. Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    In a petition received July 21, 2015, Superior requested that the U.S. Department of Energy (“DOE”) grant a waiver to certain models of larger commercial package boilers that cannot be tested under the existing DOE test procedure. The models of commercial packaged boilers at issue are models with higher input capacities that typically require higher steam pressure and alternative instrumentation due to the large quantities of fluids being measured.

    I. Background and Authority

    Title III, Part C of the Energy Policy and Conservation Act of 1975 (EPCA), as amended (42 U.S.C. 6311 et seq.), established the Energy Conservation Program for certain industrial equipment, which includes commercial packaged boilers.1 Part C specifically includes definitions (42 U.S.C. 6311), energy conservation standards (42 U.S.C 6313), test procedures (42 U.S.C. 6314), labeling provisions (42 U.S.C. 6315), and the authority to require information and reports from manufacturers (42 U.S.C. 6316). Part C authorizes the Secretary of Energy (the Secretary) to prescribe test procedures that are reasonably designed to produce results that measure energy efficiency, energy use, and estimated annual operating costs, and that are not unduly burdensome to conduct. (42 U.S.C. 6314(a)(2)) With respect to commercial packaged boilers, Part C requires DOE to use industry test procedures developed or recognized by the Air-Conditioning, Heating, and Refrigeration Institute (AHRI) or the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE), as referenced in ASHRAE/IES 2 Standard 90.1, “Energy Standard for Buildings Except Low-Rise Residential Buildings.” (42 U.S.C. 6314(a)(4)(A)) Further, if such an industry test procedure is amended, DOE is required to amend its test procedure to be consistent with the amended industry test procedure, unless it determines, by rule published in the Federal Register and supported by clear and convincing evidence, that the amended test procedure would be unduly burdensome to conduct or would not produce test results that reflect the energy efficiency, energy use, and estimated operating costs of that equipment during a representative average use cycle. (42 U.S.C. 6314(a)(4)(B)). The test procedure for commercial packaged boilers is contained in 10 CFR part 431, subpart E.

    1 For editorial reasons, upon codification in the U.S. Code, Part C was re-designated Part A-1.

    2 Illuminating Engineering Society.

    DOE's regulations permit a person to seek a waiver from the test procedure requirements for covered commercial equipment if at least one of the following conditions is met: (1) The petitioner's basic model contains one or more design characteristics that prevent testing according to the prescribed test procedures; or (2) the prescribed test procedures may evaluate the basic model in a manner so unrepresentative of its true energy consumption as to provide materially inaccurate comparative data. 10 CFR 431.401(a)(1). Petitioners must include in their petition any alternate test procedures known to the petitioner to evaluate the basic model in a manner representative of its energy consumption. 10 CFR 431.401(b)(1)(iii).

    DOE may grant a waiver subject to conditions, including adherence to alternate test procedures. 10 CFR 431.401(f)(2). As soon as practicable after the granting of any waiver, DOE will publish in the Federal Register a notice of proposed rulemaking to amend its regulations so as to eliminate any need for the continuation of such waiver. As soon thereafter as practicable, DOE will publish in the Federal Register a final rule. 10 CFR 431.401(l).

    II. Petition for Waiver of Test Procedure

    On July 21, 2015, Superior submitted a petition for waiver from the DOE test procedure for certain basic models of its commercial packaged boilers. The DOE test procedure for commercial packaged boilers is set forth at 10 CFR 431.86 and incorporates by reference Hydronics Institute (HI) BTS-2000, “Method to Determine Efficiency of Commercial Space Heating Boilers” (BTS-2000).

    According to Superior, there are several issues that make BTS-2000 incompatible with larger commercial packaged boilers, including those identified in its petition for waiver. Superior stated that the requirements to use test conditions specified in BTS-2000 and the instrumentation requirements are outdated. Specifically, Superior indicated the following regarding the test conditions:

    • The 0 to 2 psig test pressure for steam boilers may be adequate for residential and small commercial (cast iron) boilers sized [commercial packaged] boilers, however such steam pressures are not compatible with large [commercial packaged] boilers as it will cause water carryover in large quantities, and an inability to meet design water flow rates and firing rates;

    • Typically test steam pressures in the range of 10 to 12 psig are required; and

    • Test temperatures defined for hot water [commercial packaged] boilers cause thermal shock problems in large [commercial packaged] boilers.

    Superior also indicated the following regarding the instrumentation chart in Table 1 of section 6.0, “Instruments,” of BTS-2000:

    • Steam pressure cannot be measured by mercury manometer as the use of mercury in instruments and controls is banned; the correct instrument is a Bourdon Tube Gauge for pressures of 0 to 30 psig;

    • Large boilers typically fire into a positive pressure combustion chamber, thus gas pressure, firebox pressure and vent/flue pressure instruments all need to reflect this;

    • The use of scales to measure water/condensate/moisture flow rates is incompatible with the volume of these fluids being used or generated by large [commercial packaged] boilers;

    • Water flow meters should be used and in the case of moisture content, current practice is to use a throttling calorimeter;

    • The measurement of carbon dioxide as a means of calculating excess air or oxygen is considered obsolete in the large [commercial packaged] boiler industry; direct measurement of excess oxygen is the preferred method as modern oxygen meters can easily be calibrated against the oxygen in the ambient air;

    • Carbon Monoxide levels are no longer measured as a percentage; the current preferred unit is parts per million (ppm).

    To address these concerns, Superior proposes to use the newly published American National Standards Institute (ANSI)/Air-Conditioning, Heating, and Refrigeration Institute (AHRI) 1500-2015, “Standard for Performance Rating of Commercial Space Heating Boilers” (ANSI/AHRI Standard 1500-2015) in place of BTS-2000. AHRI developed ANSI/AHRI Standard 1500-2015 as a replacement for BTS-2000 in order to make the test procedure suitable for use with larger commercial packaged boilers, as well as improve and clarify the test method. Superior claims that use of this ANSI/AHRI Standard 1500-2015 is necessary as it is compatible with the size of commercial packaged boilers they manufacture.

    Additionally, for the large commercial packaged boilers capable of supplying either steam or hot water identified in this petition, Superior requests that, when determining the combustion efficiency in hot water mode based on testing in steam mode only, the combustion efficiency rating be determined based on an adjusted combustion efficiency. Superior requests that an adjustment be made to the measured stack temperature to be used in calculating combustion efficiency based on the relative difference between the flue gas temperature and the bulk fluid temperature when operating in steam mode as opposed to hot water using the following relationship:

    Tstack, hw = (Tstack, steam − Tsat) + Tbulk, hw where Tstack, hw is the stack temperature to be used to determine the combustion efficiency in hot water mode, Tstack, steam is the measured stack temperature when testing on steam, Tsat is the saturation temperature of steam at the test pressure, and Tbulk is the temperature of the outlet water when testing in hot water mode and is equal to 180 °F. According to Superior, using this adjusted stack temperature to calculate combustion efficiency is a more accurate representation of the actual efficiency when operating as a hot water commercial packaged boiler than simply using combustion efficiency value for steam mode.

    The following basic models are included in Superior's petition: Arrowhead, Triad, Apache, Seminole, Super Seminole, Mohican, Aztec, Mohawk, Osage, SX-6, and SX-8.

    DOE notes that it has published a notice of proposed rulemaking (March 2016 CPB TP NOPR) to amend its test procedure for commercial packaged boilers prescribed in 10 CFR part 431 subpart E. 81 FR 14641 (Mar. 17, 2016). The proposed amended test procedure addresses, among other changes, the issues raised in this waiver request by incorporating by reference ANSI/AHRI Standard 1500-2015 as a replacement for BTS-2000 in the DOE test procedure for commercial packaged boilers. In addition to adopting ANSI/AHRI Standard 1500-2015 as a replacement for BTS-2000, DOE further proposes several modifications to its test procedure that are not captured in ANSI/AHRI Standard 1500-2015 in order to improve repeatability, add clarification, and accommodate testing of some equipment that has experienced difficulty in testing to the existing DOE test procedure. Among these changes, DOE proposes to adopt the stack temperature adjustment described by Superior when using the tested combustion efficiency of large steam commercial packaged boilers to represent the combustion efficiency of large commercial packaged boilers in hot water mode.

    III. Summary and Request for Comments

    Through this notice, DOE is publishing Superior's petition for waiver pursuant to 10 CFR 431.401(b)(1)(iv). The petition contains no confidential information. The petition includes a suggested alternate test procedure applicable to measurement of energy efficiency of certain models of commercial packaged boilers manufactured by Superior.

    DOE solicits comments from interested parties on all aspects of the petition, including the suggested alternate test procedure. Pursuant to 10 CFR 431.401(d), any person submitting written comments to DOE must also send a copy of such comments to the petitioner. The contact information for the petitioner is: Mokhtar Matallah, Vice President, Engineering, Superior Boiler Works, Inc., 3524 E. 4th St., Hutchinson, KS 67504. All submissions received must include the agency name and case number for this proceeding. Submit electronic comments in WordPerfect, Microsoft Word, Portable Document Format (PDF), or text (American Standard Code for Information Interchange (ASCII)) file format and avoid the use of special characters or any form of encryption. Wherever possible, include the electronic signature of the author. DOE does not accept telefacsimiles (faxes).

    According to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit two copies: one copy of the document including all the information believed to be confidential, and one copy of the document with the information believed to be confidential deleted. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

    Issued in Washington, DC, on April 7, 2016. Kathleen B. Hogan, Deputy Assistant Secretary for Energy Efficiency, Energy Efficiency and Renewable Energy. Superior Boiler Works, Inc. 3524 E. 4th St. Hutchinson, KS 67504 (620) 662-6693 July 21, 2015 U.S. Department of Energy Attention: Ms. Ashley Armstrong Subject: Revised Commercial Packaged Boilers Waiver Request Dear Ms. Armstrong,

    We previously submitted a waiver request on June 30, 2015 but wish to submit this revised waiver request in place of it. In accordance with the provisions of the Code of Federal Regulations Part 431, paragraph 431.401, Superior Boiler Works, Inc. is hereby petitioning for a waiver from the following specific test procedures specified for Commercial Packaged Boilers:

    1. Paragraph 431.86 Uniform test method for the measurement of energy efficiency of commercial packaged boilers. This section requirements that boilers be tested using the provisions of HI BTS-2000. We propose to use the newly published AHRI Standard 1500, 2015 Standard for Performance Rating of Commercial Space Heating Boilers. There are several issues that make BTS 2000 incompatible with larger boilers that were previously identified and discussed. AHRI has worked diligently over the last year or so to revise BTS-2000 in order to address those issues and make BTS 2000 suitable for larger boilers. AHRI Standard 1500 is the result of that work. Use of this new standard is desirable as it is compatible with the various size boilers we manufacture.

    2. Paragraph 431.86(c)(1)(iv) The requirement to use test conditions specified in BTS-2000 specifically the requirements for the test pressure for steam boilers, the required water temperatures for hot water boilers and instrumentation requirements seem to refer back to the middle of the last century rather than the present day, for example:

    • The 0 to 2 psig test pressure for steam boilers may be perfectly adequate for residential and small commercial (cast iron) boilers sized boilers, however is not compatible with large boilers as it will cause water carryover in large quantities, and an inability to meet design water flow rates and firing rates. Typically test pressures in range 10 to 12 psig are required.

    • Test temperatures defined for hot water boilers are guaranteed to cause thermal shock problems in large boilers.

    • The instrumentation chart, Table 1, has several problem areas, as follows:

    ○ Steam pressure cannot be measured by mercury manometer as the use of mercury in instruments and controls is banned. The correct instrument is a Bourdon Tube Gauge 0 to 30 psig

    ○ Large boilers typically fire into a positive pressure combustion chamber, thus gas pressure, firebox pressure and vent/flue pressure instruments all need to reflect this.

    ○ The use of scales to measure water/condensate/moisture flow rates is incompatible with the sheer volume of these fluids being used or generated by large boilers. Water flow meters should be used and in the case of moisture content, current practice is to use a throttling calorimeter.

    ○ The measurement of carbon dioxide as a means of calculating excess air or oxygen is considered obsolete in the large boiler industry. Direct measurement of excess oxygen is the preferred method as modern oxygen meters can easily be calibrated against the oxygen in the ambient air.

    ○ Carbon Monoxide levels are no longer measured as a percentage. The current preferred unit is ppm.

    AHRI 1500 has taken into account these changes.

    3. Paragraph 431.86(c)(2)(iii)(B) Rating. This paragraph specifies that for boilers capable of supplying either steam or hot water, that are tested on steam only, the hot water efficiency shall be based on the testing in the steam mode. We propose to use an adjusted steam efficiency for hot water when testing on steam only. The adjustment is made to the measured stack temperature to be used in calculating efficiency based on the relative difference between the flue gas temperature and the bulk fluid temperature when operating on steam vs. hot water using the following relationship:

    Tstackhw = (Tstacksteam − Tsat) + Tbulkhw, where Tstackhw = stack temperature to be used to determine the efficiency on hot water. Tstacksteam = measured stack temperature when testing on steam. Tbulkhw = 180 °F

    The dominant heat transfer variable for both steam and hot water boilers is the gas side coefficient and there is very little difference in the overall heat transfer coefficient between steam and hot water boilers. It is possible therefore to determine what a hot water boiler stack temperature will be based on a steam test based on the difference in the bulk fluid temperature in the boiler. We believe that using this adjusted stack temperature to calculate efficiency is a more accurate representation of the actual efficiency when operating as a hot water boiler than simply using the steam efficiency value.

    The basic models that this request is applicable to are scotch marine, firetube boilers used for commercial packaged space heating, Section IV ASME applications. The specific models offered by Superior Boiler Works in this category for section IV ASME applications includes the following:

    1. Arrowhead

    2. Triad

    3. Apache

    4. Seminole

    5. Super Seminole

    6. Mohican

    7. Aztec

    8. Mohawk

    9. Osage

    10. SX-6

    11. SX-8

    Other know manufacturers of similar products are listed below. These manufacturers will be notified by Superior Boiler Works, Inc. of this waiver, if and when the deviation is granted, in accordance with paragraph 431.401(c).

    AESYS Technologies, LLC Bryan Steam Burnham Commercial Cleaver-Brooks Easco Fulton Boiler Works Hurst Boiler Johnston Boiler Company Lattner Boiler Company Miura Precision Boilers, LLC Unilux Vapor Power International, LLC Victory Energy Operations, LLC Williams & Davis Boilers

    We appreciate your consideration of this request. If you have any additional questions please don't hesitate to contact me.

    Sincerely, Mokhtar Matallah Vice President, Engineering Cc: Mr. Doug Wright, President & CEO, Superior Boiler Works, Inc.
    [FR Doc. 2016-08738 Filed 4-14-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy [Case No. BLR-007] Notice of Petition for Waiver From Cleaver-Brooks From the Department of Energy Commercial Packaged Boiler Test Procedure AGENCY:

    Office of Energy Efficiency and Renewable Energy, Department of Energy.

    ACTION:

    Notice of petition for waiver and request for public comments.

    SUMMARY:

    This notice announces receipt of a petition for waiver from Cleaver-Brooks seeking an exemption from specified portions of the U.S. Department of Energy (DOE) test procedure applicable to commercial packaged boilers. Cleaver-Brooks contends that some of their commercial packaged boilers cannot be accurately tested using the currently applicable DOE test procedure and, as a result, seeks to use an alternate test procedure to test these basic models. DOE solicits comments, data, and information concerning Cleaver-Brooks' petition and the suggested alternate test procedure.

    DATES:

    DOE will accept comments, data, and information with respect to the Cleaver-Brooks petition until May 16, 2016.

    ADDRESSES:

    You may submit comments, identified by case number “BLR-007,” by any of the following methods:

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

    Email: [email protected]. Include the case number [Case No. BLR-007] in the subject line of the message.

    Mail: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Program, Mailstop EE-2B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-2945. Please submit one signed original paper copy.

    Hand Delivery/Courier: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Program, 950 L'Enfant Plaza SW., Suite 600, Washington, DC 20024. Please submit one signed original paper copy.

    Docket: For access to the docket to review the background documents relevant to this matter, you may visit http://www.regulations.gov. Available documents include the following items: (1) This notice; (2) public comments received; and (3) the petition for waiver.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Bryan Berringer, U.S. Department of Energy, Building Technologies Program, Mail Stop EE-2B, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-0371. Email: [email protected]

    Mr. Peter Cochran, U.S. Department of Energy, Office of the General Counsel, Mail Stop GC-33, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585-0103. Telephone: (202) 586-9496. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    In a petition received July 24, 2015, Cleaver-Brooks requested that the U.S. Department of Energy (“DOE”) grant a waiver to certain models of larger commercial package boilers that cannot be tested under the existing DOE test procedure. The models of commercial packaged boilers at issue are models with higher input capacities that typically require higher steam pressure and alternative instrumentation due to the large quantities of fluids being measured.

    I. Background and Authority

    Title III, Part C of the Energy Policy and Conservation Act of 1975 (EPCA), as amended (42 U.S.C. 6311 et seq.), established the Energy Conservation Program for certain industrial equipment, which includes commercial packaged boilers.1 Part C specifically includes definitions (42 U.S.C. 6311), energy conservation standards (42 U.S.C 6313), test procedures (42 U.S.C. 6314), labeling provisions (42 U.S.C. 6315), and the authority to require information and reports from manufacturers (42 U.S.C. 6316). Part C authorizes the Secretary of Energy (the Secretary) to prescribe test procedures that are reasonably designed to produce results that measure energy efficiency, energy use, and estimated annual operating costs, and that are not unduly burdensome to conduct. (42 U.S.C. 6314(a)(2)) With respect to commercial packaged boilers, Part C requires DOE to use industry test procedures developed or recognized by the Air-Conditioning, Heating, and Refrigeration Institute (AHRI) or the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE), as referenced in ASHRAE/IES 2 Standard 90.1, “Energy Standard for Buildings Except Low-Rise Residential Buildings.” (42 U.S.C. 6314(a)(4)(A)) Further, if such an industry test procedure is amended, DOE is required to amend its test procedure to be consistent with the amended industry test procedure, unless it determines, by rule published in the Federal Register and supported by clear and convincing evidence, that the amended test procedure would be unduly burdensome to conduct or would not produce test results that reflect the energy efficiency, energy use, and estimated operating costs of that equipment during a representative average use cycle. (42 U.S.C. 6314(a)(4)(B)). The test procedure for commercial packaged boilers is contained in 10 CFR part 431, subpart E.

    1 For editorial reasons, upon codification in the U.S. Code, Part C was re-designated Part A-1.

    2 Illuminating Engineering Society.

    DOE's regulations for covered products and equipment permit a person to seek a waiver from the test procedure requirements for covered commercial equipment if at least one of the following conditions is met: (1) The petitioner's basic model contains one or more design characteristics that prevent testing according to the prescribed test procedures; or (2) the prescribed test procedures may evaluate the basic model in a manner so unrepresentative of its true energy consumption as to provide materially inaccurate comparative data. 10 CFR 431.401(a)(1). Petitioners must include in their petition any alternate test procedures known to the petitioner to evaluate the basic model in a manner representative of its energy consumption. 10 CFR 431.401(b)(1)(iii).

    DOE may grant a waiver subject to conditions, including adherence to alternate test procedures. 10 CFR 431.401(f)(2). As soon as practicable after the granting of any waiver, DOE will publish in the Federal Register a notice of proposed rulemaking to amend its regulations so as to eliminate any need for the continuation of such waiver. As soon thereafter as practicable, DOE will publish in the Federal Register a final rule. 10 CFR 431.401(l).

    II. Petition for Waiver of Test Procedure

    On July 24, 2015, Cleaver-Brooks submitted a petition for waiver from the DOE test procedure for certain basic models of its commercial packaged boilers. The DOE test procedure for commercial packaged boilers is set forth at 10 CFR 431.86 and incorporates by reference Hydronics Institute (HI) BTS-2000, “Method to Determine Efficiency of Commercial Space Heating Boilers” (BTS-2000).

    According to Cleaver-Brooks, there are several issues that make BTS-2000 incompatible with larger commercial packaged boilers, including those identified in its petition for waiver. Cleaver-Brooks stated that the requirements to use test conditions specified in BTS-2000 and the instrumentation requirements are outdated. Specifically, Cleaver-Brooks indicated the following regarding the test conditions:

    • The 0 to 2 psig test pressure for steam boilers may be adequate for residential and small commercial (cast iron) boilers sized [commercial packaged] boilers, however such steam pressures are not compatible with large [commercial packaged] boilers as it will cause water carryover in large quantities, and an inability to meet design water flow rates and firing rates;

    • Typically test steam pressures in the range of 10 to 12 psig are required; and

    • Test temperatures defined for hot water [commercial packaged] boilers cause thermal shock problems in large [commercial packaged] boilers.

    Cleaver-Brooks also indicated the following regarding the instrumentation chart in Table 1 of section 6.0, “Instruments,” of BTS-2000:

    • Steam pressure cannot be measured by mercury manometer as the use of mercury in instruments and controls is banned; the correct instrument is a Bourdon Tube Gauge for pressures of 0 to 30 psig;

    • Large boilers typically fire into a positive pressure combustion chamber, thus gas pressure, firebox pressure and vent/flue pressure instruments all need to reflect this;

    • The use of scales to measure water/condensate/moisture flow rates is incompatible with the volume of these fluids being used or generated by large [commercial packaged] boilers;

    • Water flow meters should be used and in the case of moisture content, current practice is to use a throttling calorimeter;

    • The measurement of carbon dioxide as a means of calculating excess air or oxygen is considered obsolete in the large [commercial packaged] boiler industry; direct measurement of excess oxygen is the preferred method as modern oxygen meters can easily be calibrated against the oxygen in the ambient air;

    • Carbon Monoxide levels are no longer measured as a percentage; the current preferred unit is parts per million (ppm).

    To address these concerns, Cleaver-Brooks proposes to use the newly published American National Standards Institute (ANSI)/Air-Conditioning, Heating, and Refrigeration Institute (AHRI) 1500-2015, “Standard for Performance Rating of Commercial Space Heating Boilers” (ANSI/AHRI Standard 1500-2015) in place of BTS-2000. AHRI developed ANSI/AHRI Standard 1500-2015 as a replacement for BTS-2000 in order to make the test procedure suitable for use with larger commercial packaged boilers, as well as improve and clarify the test method. Cleaver-Brooks claims that use of this ANSI/AHRI Standard 1500-2015 is necessary as it is compatible with the size of commercial packaged boilers they manufacture.

    Additionally, for the large commercial packaged boilers capable of supplying either steam or hot water identified in this petition, Cleaver-Brooks requests that, when determining the combustion efficiency in hot water mode based on testing in steam mode only, the combustion efficiency rating be determined based on an adjusted combustion efficiency. Cleaver-Brooks requests that an adjustment be made to the measured stack temperature to be used in calculating combustion efficiency based on the relative difference between the flue gas temperature and the bulk fluid temperature when operating in steam mode as opposed to hot water using the following relationship:

    Tstack, hw = (Tstack, steam − Tsat) + Tbulk, hw where Tstack, hw is the stack temperature to be used to determine the combustion efficiency in hot water mode, Tstack, steam is the measured stack temperature when testing on steam, Tsat is the saturation temperature of steam at the test pressure, and Tbulk, hw is the temperature of the outlet water when testing in hot water mode and is equal to 180 °F. According to Cleaver-Brooks, using this adjusted stack temperature to calculate combustion efficiency is a more accurate representation of the actual efficiency when operating as a hot water commercial packaged boiler than simply using combustion efficiency value for steam mode.

    The following basic models are included in Cleaver-Brooks' petition: CBEX-E, CBEX-P, 4WI/4WG, CBLE, CBR, CBL, CB, CFC, CFLC, CFW, CFH, FLX and M5.

    DOE notes that it has published a notice of proposed rulemaking (March 2016 CPB TP NOPR) to amend its test procedure for commercial packaged boilers prescribed in 10 CFR part 431 subpart E. 81 FR 14641 (Mar. 17, 2016). The proposed amended test procedure addresses, among other changes, the issues raised in this waiver request by incorporating by reference ANSI/AHRI Standard 1500-2015 as a replacement for BTS-2000 in the DOE test procedure for commercial packaged boilers. In addition to adopting ANSI/AHRI Standard 1500-2015 as a replacement for BTS-2000, DOE further proposes several modifications to its test procedure that are not captured in ANSI/AHRI Standard 1500-2015 in order to improve repeatability, add clarification, and accommodate testing of some equipment that has experienced difficulty in testing to the existing DOE test procedure. Among these changes, DOE proposes to adopt the stack temperature adjustment described by Cleaver-Brooks when using the tested combustion efficiency of large steam commercial packaged boilers to represent the combustion efficiency of large commercial packaged boilers in hot water mode.

    III. Summary and Request for Comments

    Through this notice, DOE is publishing Cleaver-Brooks' petition for waiver pursuant to 10 CFR 431.401(b)(1)(iv). The petition contains no confidential information. The petition includes a suggested alternate test procedure applicable to measurement of energy efficiency of certain models of commercial packaged boilers manufactured by Cleaver-Brooks.

    DOE solicits comments from interested parties on all aspects of the petition, including the suggested alternate test procedure. Pursuant to 10 CFR 431.401(d), any person submitting written comments to DOE must also send a copy of such comments to the petitioner. The contact information for the petitioner is: Peter A. Molvie, P.E., Manager, Codes & Standards, Cleaver-Brooks Product Development, 3232 W. Lancaster Ave., Milwaukee, WI 53209. All submissions received must include the agency name and case number for this proceeding. Submit electronic comments in WordPerfect, Microsoft Word, Portable Document Format (PDF), or text (American Standard Code for Information Interchange (ASCII)) file format and avoid the use of special characters or any form of encryption. Wherever possible, include the electronic signature of the author. DOE does not accept telefacsimiles (faxes).

    According to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit two copies: One copy of the document including all the information believed to be confidential, and one copy of the document with the information believed to be confidential deleted. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

    Issued in Washington, DC, on April 7, 2016. Kathleen B. Hogan, Deputy Assistant Secretary for Energy Efficiency, Energy Efficiency and Renewable Energy. From: Peter Molvie Sent: Friday, July 24, 2015 2:44 p.m. To: AS_Waiver_Request Subject: RE: Test Procedure Waiver

    In accordance with the provisions of the Code of Federal Regulations Part 431, paragraph 431.401, Cleaver-Brooks is hereby petitioning for a waiver from the following test procedures specified for Commercial Packaged Boilers:

    1. Paragraph 431.86 Uniform test method for the measurement of energy efficiency of commercial packaged boilers. This section requires the boilers be tested using the provisions of HI BTS-2000. We propose to use the newly published AHRI 1500, 2015 Standard for Performance Rating of Commercial Space Heating Boilers. There are several issues that make BTS 2000 incompatible with the larger boilers that were identified in previous waiver requests. AHRI has worked diligently over the past year to revise BTS-2000 in order to address those issues and make BTS-2000 suitable for use with larger boilers. AHRI Standard 1500 is the result of that work. Use of this new standard is required as it is compatible with the size boilers we manufacture.

    2. Paragraph 431.86(c)(1)(iv) The requirement to use test conditions specified in BTS-2000 specifically the requirements for the test pressure for steam boilers, the required water temperatures for hot water boilers and instrumentation requirements seem to refer back to the middle of the last century rather than the present day, for example:

    • The 0 to 2 psig test pressure for steam boilers may be perfectly adequate for residential and small commercial (cast iron) boilers sized boilers, however is not compatible with large boilers as it will cause water carryover in large quantities, and an inability to meet design water flow rates and firing rates. Typically test pressures in range 10 to 12 psig are required.

    • Test temperatures defined for hot water boilers are guaranteed to cause thermal shock problems in large boilers.

    • The instrumentation chart, Table 1, has several problem areas, as follows:

    ○ Steam pressure cannot be measured by mercury manometer as the use of mercury in instruments and controls is banned. The correct instrument is a Bourdon Tube Gauge 0 to 30 psig

    ○ Large boilers typically fire into a positive pressure combustion chamber, thus gas pressure, firebox pressure and vent/flue pressure instruments all need to reflect this.

    ○ The use of scales to measure water/condensate/moisture flow rates is incompatible with the sheer volume of these fluids being used or generated by large boilers. Water flow meters should be used and in the case of moisture content, current practice is to use a throttling calorimeter.

    ○ The measurement of carbon dioxide as a means of calculating excess air or oxygen is considered obsolete in the large boiler industry. Direct measurement of excess oxygen is the preferred method as modern oxygen meters can easily be calibrated against the oxygen in the ambient air.

    ○ Carbon Monoxide levels are no longer measured as a percentage. The current preferred unit is ppm.

    AHRI 1500 has taken into account these changes.

    3. Paragraph 431.86(c)(2)(iii)(B) Rating. This paragraph specifies that for boilers capable of supplying either steam or hot water, that they are tested on steam only, the hot water efficiency shall be based on the testing in the steam mode. We propose to use an adjusted steam efficiency for hot water when testing on steam only. The adjustment is made to the measured stack temperature to be used in calculating efficiency based on the relative difference between the flue gas temperature and the bulk fluid temperature when operating on steam v hot water using the following relationship:

    Tstackhw = (Tstacksteam−Tsat) + Tbulkhw Where: Tstackhw = Stack temperature to be used to determine the efficiency on hot water Tstacksteam = Measured stack temperature when testing on steam Tsat = Saturation temperature of steam at the test pressure Tbulkhw = 180 °F

    The dominant heat transfer variable for both steam and hot water boilers is the gas side coefficient and there is very little difference in the overall heat transfer coefficient between steam and hot water boilers. It is possible therefore to determine what a hot water boiler stack temperature will be, based on a steam test and the bulk fluid temperature difference within the boiler. We believe that using this adjusted stack temperature to calculate efficiency is a more accurate representation of the actual efficiency when operating as a hot water boiler than simply using the steam efficiency value.

    The basic models that this request is applicable to are as follows: CBEX-E, CBEX-P, 4WI/4WG, CBLE, CBR, CBL, CB, CFC, CFLC, CFW, CFH, FLX and M5.

    Other known Manufacturers of similar products are listed below. These manufacturers will be notified by Cleaver-Brooks of this waiver, if and when the deviation is granted, in accordance with paragraph 431.401(c).

    AESYS Technologies, LLC Bryan Steam Burnham Commercial Easco Fulton Boiler Works Hurst Johnston Boiler Company Lattner Boiler Company Miura Precision Boilers LLC Superior Boiler Works Unilux Vapor Power International LLC Victory Energy Operations LLC Williams & Davis Peter A. Molvie, P.E. Manager, Codes & Standards Cleaver-Brooks Product Development 3232 W. Lancaster Ave. Milwaukee, WI 53209 414-438-5465
    [FR Doc. 2016-08750 Filed 4-14-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy [Case No. BLR-005] Notice of Petition for Waiver From York-Shipley Global, Division of AESYS Technologies, LLC From the Department of Energy Commercial Packaged Boiler Test Procedure AGENCY:

    Office of Energy Efficiency and Renewable Energy, Department of Energy.

    ACTION:

    Notice of petition for waiver and request for public comments.

    SUMMARY:

    This notice announces receipt of a petition for waiver from York-Shipley Global, Division of AESYS Technologies, LLC (York-Shipley) seeking an exemption from specified portions of the U.S. Department of Energy (DOE) test procedure applicable to commercial packaged boilers. York-Shipley contends that some of their commercial packaged boilers cannot be accurately tested using the currently applicable DOE test procedure and, as a result, seeks to use an alternate test procedure to test these basic models. DOE solicits comments, data, and information concerning York-Shipley's petition and the suggested alternate test procedure.

    DATES:

    DOE will accept comments, data, and information with respect to the York-Shipley petition until May 16, 2016.

    ADDRESSES:

    You may submit comments, identified by case number “BLR-005,” by any of the following methods:

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

    Email: [email protected]. Include the case number [Case No. BLR-005] in the subject line of the message.

    Mail: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Program, Mailstop EE-2B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-2945. Please submit one signed original paper copy.

    Hand Delivery/Courier: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Program, 950 L'Enfant Plaza SW., Suite 600, Washington, DC 20024. Please submit one signed original paper copy.

    Docket: For access to the docket to review the background documents relevant to this matter, you may visit http://www.regulations.gov. Available documents include the following items: (1) This notice; (2) public comments received; and (3) the petition for waiver.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Bryan Berringer, U.S. Department of Energy, Building Technologies Program, Mail Stop EE-5B, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-0371. Email: [email protected]

    Mr. Peter Cochran, U.S. Department of Energy, Office of the General Counsel, Mail Stop GC-33, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585-0103. Telephone: (202) 586-9496. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    In a petition received July 21, 2015, York-Shipley requested that the U.S. Department of Energy (“DOE”) grant a waiver to certain models of larger commercial package boilers that cannot be tested under the existing DOE test procedure. The models of commercial packaged boilers at issue are models with higher input capacities that typically require higher steam pressure and alternative instrumentation due to the large quantities of fluids being measured.

    I. Background and Authority

    Title III, Part C of the Energy Policy and Conservation Act of 1975 (EPCA), as amended (42 U.S.C. 6311 et seq.), established the Energy Conservation Program for certain industrial equipment, which includes commercial packaged boilers.1 Part C specifically includes definitions (42 U.S.C. 6311), energy conservation standards (42 U.S.C 6313), test procedures (42 U.S.C. 6314), labeling provisions (42 U.S.C. 6315), and the authority to require information and reports from manufacturers (42 U.S.C. 6316). Part C authorizes the Secretary of Energy (the Secretary) to prescribe test procedures that are reasonably designed to produce results that measure energy efficiency, energy use, and estimated annual operating costs, and that are not unduly burdensome to conduct. (42 U.S.C. 6314(a)(2)) With respect to commercial packaged boilers, Part C requires DOE to use industry test procedures developed or recognized by the Air-Conditioning, Heating, and Refrigeration Institute (AHRI) or the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE), as referenced in ASHRAE/IES 2 Standard 90.1, “Energy Standard for Buildings Except Low-Rise Residential Buildings.” (42 U.S.C. 6314(a)(4)(A)) Further, if such an industry test procedure is amended, DOE is required to amend its test procedure to be consistent with the amended industry test procedure, unless it determines, by rule published in the Federal Register and supported by clear and convincing evidence, that the amended test procedure would be unduly burdensome to conduct or would not produce test results that reflect the energy efficiency, energy use, and estimated operating costs of that equipment during a representative average use cycle. (42 U.S.C. 6314(a)(4)(B)). The test procedure for commercial packaged boilers is contained in 10 CFR part 431, subpart E.

    1 For editorial reasons, upon codification in the U.S. Code, Part C was re-designated Part A-1.

    2 Illuminating Engineering Society.

    DOE's regulations permit a person to seek a waiver from the test procedure requirements for covered commercial equipment if at least one of the following conditions is met: (1) The petitioner's basic model contains one or more design characteristics that prevent testing according to the prescribed test procedures; or (2) the prescribed test procedures may evaluate the basic model in a manner so unrepresentative of its true energy consumption as to provide materially inaccurate comparative data. 10 CFR 431.401(a)(1). Petitioners must include in their petition any alternate test procedures known to the petitioner to evaluate the basic model in a manner representative of its energy consumption. 10 CFR 431.401(b)(1)(iii).

    DOE may grant a waiver subject to conditions, including adherence to alternate test procedures. 10 CFR 431.401(f)(2). As soon as practicable after the granting of any waiver, DOE will publish in the Federal Register a notice of proposed rulemaking to amend its regulations so as to eliminate any need for the continuation of such waiver. As soon thereafter as practicable, DOE will publish in the Federal Register a final rule. 10 CFR 431.401(l).

    II. Petition for Waiver of Test Procedure

    On July 21, 2015, York-Shipley submitted a petition for waiver from the DOE test procedure for certain basic models of its commercial packaged boilers. The DOE test procedure for commercial packaged boilers is set forth at 10 CFR 431.86 and incorporates by reference Hydronics Institute (HI) BTS-2000, “Method to Determine Efficiency of Commercial Space Heating Boilers” (BTS-2000).

    According to York-Shipley, there are several issues that make BTS-2000 incompatible with larger commercial packaged boilers, including those identified in its petition for waiver. York-Shipley stated that the requirements to use test conditions specified in BTS-2000 and the instrumentation requirements are outdated. Specifically, York-Shipley indicated the following regarding the test conditions:

    • The 0 to 2 psig test pressure for steam boilers may be adequate for residential and small commercial (cast iron) boilers sized [commercial packaged] boilers, however such steam pressures are not compatible with large [commercial packaged] boilers as it will cause water carryover in large quantities, and an inability to meet design water flow rates and firing rates;

    • Typically test steam pressures in the range of 10 to 12 psig are required; and

    • Test temperatures defined for hot water [commercial packaged] boilers cause thermal shock problems in large [commercial packaged] boilers.

    York-Shipley also indicated the following regarding the instrumentation chart in Table 1 of section 6.0, “Instruments,” of BTS-2000:

    • Steam pressure cannot be measured by mercury manometer as the use of mercury in instruments and controls is banned; the correct instrument is a Bourdon Tube Gauge for pressures of 0 to 30 psig;

    • Large boilers typically fire into a positive pressure combustion chamber, thus gas pressure, firebox pressure and vent/flue pressure instruments all need to reflect this;

    • The use of scales to measure water/condensate/moisture flow rates is incompatible with the volume of these fluids being used or generated by large [commercial packaged] boilers;

    • Water flow meters should be used and in the case of moisture content, current practice is to use a throttling calorimeter;

    • The measurement of carbon dioxide as a means of calculating excess air or oxygen is considered obsolete in the large [commercial packaged] boiler industry; direct measurement of excess oxygen is the preferred method as modern oxygen meters can easily be calibrated against the oxygen in the ambient air;

    • Carbon Monoxide levels are no longer measured as a percentage; the current preferred unit is parts per million (ppm).

    To address these concerns, York-Shipley proposes to use the newly published American National Standards Institute (ANSI)/Air-Conditioning, Heating, and Refrigeration Institute (AHRI) 1500-2015, “Standard for Performance Rating of Commercial Space Heating Boilers” (ANSI/AHRI Standard 1500-2015) in place of BTS-2000. AHRI developed ANSI/AHRI Standard 1500-2015 as a replacement for BTS-2000 in order to make the test procedure suitable for use with larger commercial packaged boilers, as well as improve and clarify the test method. York-Shipley claims that use of this ANSI/AHRI Standard 1500-2015 is necessary as it is compatible with the size of commercial packaged boilers they manufacture.

    Additionally, for the large commercial packaged boilers capable of supplying either steam or hot water identified in this petition, York-Shipley requests that, when determining the combustion efficiency in hot water mode based on testing in steam mode only, the combustion efficiency rating be determined based on an adjusted combustion efficiency. York-Shipley requests that an adjustment be made to the measured stack temperature to be used in calculating combustion efficiency based on the relative difference between the flue gas temperature and the bulk fluid temperature when operating in steam mode as opposed to hot water using the following relationship:

    Tstack, hw = (Tstack, steam − Tsat) + Tbulk, hw where Tstack, hw is the stack temperature to be used to determine the combustion efficiency in hot water mode, Tstack, steam is the measured stack temperature when testing on steam, Tsat is the saturation temperature of steam at the test pressure, and Tbulk, hw is the temperature of the outlet water when testing in hot water mode and is equal to 180 °F. According to York-Shipley, using this adjusted stack temperature to calculate combustion efficiency is a more accurate representation of the actual efficiency when operating as a hot water commercial packaged boiler than simply using combustion efficiency value for steam mode.

    The following basic models are included in York-Shipley's petition:

    • York-Shipley Global—Series 400C and 500C —Centerline Furnace—Dryback Configuration—ASME SCIV • York-Shipley Global—Series 400L and 500L —Low-Offset Furnace—Waterback Configuration—ASME SCIV.

    DOE notes that it has published a notice of proposed rulemaking (March 2016 CPB TP NOPR) to amend its test procedure for commercial packaged boilers prescribed in 10 CFR part 431 subpart E. 81 FR 14641 (Mar. 17, 2016). The proposed amended test procedure addresses, among other changes, the issues raised in this waiver request by incorporating by reference ANSI/AHRI Standard 1500-2015 as a replacement for BTS-2000 in the DOE test procedure for commercial packaged boilers. In addition to adopting ANSI/AHRI Standard 1500-2015 as a replacement for BTS-2000, DOE further proposes several modifications to its test procedure that are not captured in ANSI/AHRI Standard 1500-2015 in order to improve repeatability, add clarification, and accommodate testing of some equipment that has experienced difficulty in testing to the existing DOE test procedure. Among these changes, DOE proposes to adopt the stack temperature adjustment described by York-Shipley when using the tested combustion efficiency of large steam commercial packaged boilers to represent the combustion efficiency of large commercial packaged boilers in hot water mode.

    III. Summary and Request for Comments

    Through this notice, DOE is publishing York-Shipley's petition for waiver pursuant to 10 CFR 431.401(b)(1)(iv). The petition contains no confidential information. The petition includes a suggested alternate test procedure applicable to measurement of energy efficiency of certain models of commercial packaged boilers manufactured by York-Shipley.

    DOE solicits comments from interested parties on all aspects of the petition, including the suggested alternate test procedure. Pursuant to 10 CFR 431.401(d), any person submitting written comments to DOE must also send a copy of such comments to the petitioner. The contact information for the petitioner is: Kevin J. Hoey, President & CEO, York-Shipley Global, Division of AESYS Technologies, LLC, 693 North Hills Road, York, PA 17402-2211. All submissions received must include the agency name and case number for this proceeding. Submit electronic comments in WordPerfect, Microsoft Word, Portable Document Format (PDF), or text (American Standard Code for Information Interchange (ASCII)) file format and avoid the use of special characters or any form of encryption. Wherever possible, include the electronic signature of the author. DOE does not accept telefacsimiles (faxes).

    According to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit two copies: One copy of the document including all the information believed to be confidential, and one copy of the document with the information believed to be confidential deleted. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

    Issued in Washington, DC, on April 7, 2016. Kathleen B. Hogan, Deputy Assistant Secretary for Energy Efficiency, Energy Efficiency and Renewable Energy. York-Shipley Global Division of AESYS Technologies, LLC 693 North Hills Road York, PA 17402-2211 July 21, 2015 U.S. DEPARTMENT OF ENERGY ATTN: Ms. Ashley Armstrong RE: US-DOE—Waiver Request Efficiency Rating of Commercial Packaged Space Heating Boilers Dear Ms. Armstrong,

    In accordance with the provisions of the Code of Federal Regulations Part 431, paragraph 431.401, York-Shipley Global—Division of AESYS Technologies, LLC is hereby petitioning for a waiver from the following test procedures specified for Commercial Packaged Space Heating Boilers:

    A. Paragraph 431.86 Uniform test method for the measurement of energy efficiency of commercial packaged boilers. This section requires the boilers be tested using the provisions of HI BTS-2000. We propose to use the newly published ANSI/AHRI 1500-2015, 2015 Standard for Performance Rating of Commercial Space Heating Boilers. There are several issues that make BTS 2000 incompatible with the larger boilers that were identified in previous waiver requests. AHRI has worked diligently over the past year to revise BTS-2000 in order to address those issues and make BTS-2000 suitable for use with larger boilers. ANSI/AHRI Standard 1500-2015 is the result of that work. Use of this new standard is required as it is compatible with the size boilers we manufacture.

    B. Paragraph 431.86(c)(1)(iv) The requirement to use test conditions specified in BTS-2000 specifically the requirements for the test pressure for steam boilers, the required water temperatures for hot water boilers and instrumentation requirements seem to refer back to the middle of the last century rather than the present day, for example:

    1. The 0 to 2 psig test pressure for steam boilers may be perfectly adequate for residential and small commercial (cast iron) boilers sized boilers, however is not compatible with large boilers as it will cause water carryover in large quantities, and an inability to meet design water flow rates and firing rates. Typically test pressures in range 10 to 12 psig are required.

    2. Test temperatures defined for hot water boilers are guaranteed to cause thermal shock problems in large boilers.

    3. The instrumentation chart, Table 1, has several problem areas, as follows:

    a. Steam pressure cannot be measured by mercury manometer as the use of mercury in instruments and controls is banned. The correct instrument is a Bourdon Tube Gauge 0 to 30 psig

    b. Large boilers typically fire into a positive pressure combustion chamber, thus gas pressure, firebox pressure and vent/flue pressure instruments all need to reflect this.

    c. The use of scales to measure water/condensate/moisture flow rates is incompatible with the sheer volume of these fluids being used or generated by large boilers. Water flow meters should be used and in the case of moisture content, current practice is to use a throttling calorimeter.

    d. The measurement of carbon dioxide as a means of calculating excess air or oxygen is considered obsolete in the large boiler industry. Direct measurement of excess oxygen is the preferred method as modern oxygen meters can easily be calibrated against the oxygen in the ambient air.

    e. Carbon Monoxide levels are no longer measured as a percentage. The current preferred unit is ppm.

    ANSI/AHRI 1500-2015 has taken into account these changes.

    C. Paragraph 431.86(c)(2)(iii)(B) Rating. This paragraph specifies that for boilers capable of supplying either steam or hot water, that they are tested on steam only, the hot water efficiency shall be based on the testing in the steam mode. We propose to use an adjusted steam efficiency for hot water when testing on steam only. The adjustment is made to the measured stack temperature to be used in calculating efficiency based on the relative difference between the flue gas temperature and the bulk fluid temperature, when operating on steam versus hot water, using the following relationship:

    Tstackhw = (Tstacksteam−Tsat) + Tbulkhw Where: Tstackhw = Stack temperature to be used to determine the efficiency on hot water Tstacksteam = Measured stack temperature when testing on steam Tsat = Saturation temperature of steam at the test pressure Tbulkhw = 180 °F

    The dominant heat transfer variable for both steam and hot water boilers is the gas side coefficient and there is very little difference in the overall heat transfer coefficient between steam and hot water boilers. It is possible therefore to determine what a hot water boiler stack temperature will be, based on a steam test and the bulk fluid temperature difference within the boiler. We believe that using this adjusted stack temperature to calculate efficiency is a more accurate representation of the actual efficiency when operating as a hot water boiler than simply using the steam efficiency value.

    The basic York-Shipley Global—Division of AESYS Technologies, LLC model series for which this request is applicable to, are as follows:

    • York-Shipley Global—Series 400C and 500C — Centerline Furnace—Dryback Configuration—ASME SCIV • York-Shipley Global—Series 400L and 500L — Low-Offset Furnace—Waterback Configuration—ASME SCIV

    Other known Manufacturers of similar products are listed below. These manufacturers will be notified by York-Shipley Global—Division of AESYS Technologies, LLC of this waiver, if and when the deviation is granted, in accordance with paragraph 431.401(c).

    Bryan Steam Burnham Commercial Cleaver Brooks Easco Fulton Boiler Works Hurst Johnston Boiler Company Lattner Boiler Company Miura Precision Boilers LLC Superior Boiler Works Unilux Vapor Power International LLC Victory Energy Operations LLC Williams & Davis

    We kindly request your consideration for this waiver. If there are any further comments or concerns, please feel free to call.

    Sincerely,

    York-Shipley Global Division of AESYS Technologies, LLC Kevin J. Hoey President & CEO
    cc. File (15-0721 AESYS US-DOE Waiver Request R2) S. Lynch—ABMA
    [FR Doc. 2016-08749 Filed 4-14-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC16-88-000.

    Applicants: The Empire District Electric Company, Liberty Utilities (Central) Co.

    Description: Supplement to March 16, 2016 Application for Authorization for Disposition of Jurisdictional Facilities of The Empire District Electric Company, et al.

    Filed Date: 4/8/16.

    Accession Number: 20160408-5339.

    Comments Due: 5 p.m. ET 4/22/16.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-2265-010; ER14-1818-010; ER12-261-018; ER12-1239-007; ER12-1238-007; ER11-4308-019; ER11-4307-019; ER11-2805-018; ER11-2508-018; ER11-2108-010; ER11-2107-010; ER11-2062-019; ER10-2888-019; ER10-2385-008; ER10-2382-008; ER10-2369-007; ER10-2368-007; ER10-2361-003; ER10-2357-008; ER10-2340-012; ER10-2338-012.

    Applicants: NRG Power Marketing LLC, Boston Energy Trading and Marketing LLC, Broken Bow Wind, LLC, CP Power Sales Nineteen, L.L.C., CP Power Sales Twenty, L.L.C., Crofton Bluffs Wind, LLC, Elkhorn Ridge Wind, LLC, Energy Plus Holdings LLC, GenOn Energy Management, LLC, Green Mountain Energy Company, Independence Energy Group LLC, Laredo Ridge Wind, LLC, North Community Turbines LLC, North Wind Turbines LLC, Norwalk Power LLC, Reliant Energy Northeast LLC, RRI Energy Services, LLC, San Juan Mesa Wind Project, LLC, Sleeping Bear, LLC, Taloga Wind, LLC, Wildorado Wind, LLC.

    Description: Supplement to December 31, 2015 Updated Market Power Analysis for the Southwest Power Pool Region of NRG SPP MBR Sellers.

    Filed Date: 4/11/16.

    Accession Number: 20160411-5135.

    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: ER10-3079-010.

    Applicants: Tyr Energy LLC.

    Description: Supplement to December 28, 2015 Updated Market Power Analysis of Tyr Energy, LLC.

    Filed Date: 4/8/16.

    Accession Number: 20160408-5312.

    Comments Due: 5 p.m. ET 4/29/16.

    Docket Numbers: ER12-2600-001.

    Applicants: American Illuminating Company, LLC.

    Description: Notice of Material Change in Status of American Illuminating Company, LLC.

    Filed Date: 4/11/16.

    Accession Number: 20160411-5134.

    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: ER13-77-009.

    Applicants: Tucson Electric Power Company.

    Description: Compliance filing: Attachment K Compliance Filing to be effective 6/3/2015.

    Filed Date: 4/11/16.

    Accession Number: 20160411-5000.

    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: ER16-206-003.

    Applicants: Midcontinent Independent System Operator, Inc., ITC Midwest LLC.

    Description: Compliance filing: 2016-04-11_SA 2862 ITC Midwest-WPL FSA (G870) Compliance Filing to be effective 11/1/2015.

    Filed Date: 4/11/16.

    Accession Number: 20160411-5110.

    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: ER16-1375-000.

    Applicants: PJM Interconnection, L.L.C., Trans-Allegheny Interstate Line Company, American Transmission Systems, Incorporated, Monongahela Power Company, West Penn Power Company, The Potomac Edison Company, Pennsylvania Electric Company.

    Description: § 205(d) Rate Filing: American Transmission Systems, Inc., et al. Filing of Revised Service Agreeme to be effective 5/20/2016.

    Filed Date: 4/8/16.

    Accession Number: 20160408-5305.

    Comments Due: 5 p.m. ET 4/29/16.

    Docket Numbers: ER16-1376-000.

    Applicants: Taloga Wind, LLC.

    Description: § 205(d) Rate Filing: Market-Based Rate Tariff Revisions to be effective 4/12/2016.

    Filed Date: 4/11/16.

    Accession Number: 20160411-5199.

    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: ER16-1377-000.

    Applicants: Midcontinent Independent System Operator, Inc., Otter Tail Power Company.

    Description: § 205(d) Rate Filing: 2016-04-11_SA 2915 Otter Tail Power-Minnkota Power FCA (Warsaw Substation) to be effective 4/12/2016.

    Filed Date: 4/11/16.

    Accession Number: 20160411-5228.

    Comments Due: 5 p.m. ET 5/2/16.

    Docket Numbers: ER16-1378-000.

    Applicants: Rocky Mountain Reserve Group.

    Description: Compliance filing: Re-baseline to be effective 4/15/2016.

    Filed Date: 4/11/16.

    Accession Number: 20160411-5233.

    Comments Due: 5 p.m. ET 5/2/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: April 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-08686 Filed 4-14-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12514-074] Northern Indiana Public Service Company; Notice of Technical Conference and Public Meeting To Discuss Proposed Operational Changes at the Norway-Oakdale Project

    a. Date and Time of Meetings: A technical conference will be held with Northern Indiana Public Service Company (NIPSCO), U.S. Fish and Wildlife Service, other resource agencies, and non-governmental organizations on Tuesday May 10, 2016, from 9:00 a.m. to 12:00 p.m. (EDT). A public meeting will be held Tuesday May 10, 2016, from 6:00 p.m. to 9:00 p.m. (EDT). Although the technical conference is primarily designed for resource agencies and non-governmental organizations, anyone may attend one or both of these meetings.

    b. Location for both meetings: Sportsman Inn, 12340 N Upper Lakeshore Dr., Monticello, Indiana 47960. (574) 583-5133.

    c. FERC Contact: Mark Pawlowski at (202) 502-6052 or email at [email protected]

    d. Purpose of Technical Conference: Commission staff will meet with NIPSCO, the resource agencies, and non-governmental organizations to discuss NIPSCO's proposed operational changes to protect threatened and endangered mussels in the Tippecanoe River downstream of Oakdale dam. We will discuss the several hydraulic analyses that have been performed, effects on lake levels in project reservoirs, alternatives to NIPSCO's proposal, and Commission staff's analysis in the Draft Environmental Assessment (DEA) issued October 10, 2015.

    Purpose of Public Meeting: Commission staff is providing the public and other stakeholders another opportunity to provide comments on Commission staff's DEA and any alternatives to NIPSCO's proposal. Staff will be available to answer any questions on the DEA.

    e. At the technical meeting resource agencies, and non-governmental organizations will participate in a technical discussion regarding NIPSCO's proposed operational changes to protect threatened and endangered mussels and alternatives to NIPSCO proposal. A summary of the technical meeting will be prepared for the Commission's public record for the project. The public meeting will be recorded by a court reporter and all statements (verbal and written) will become part of the Commission's public record for the project.

    f. All local, state, and federal agencies, Indian tribes, and other interested parties are invited to attend. Please call Mark Pawlowski at (202) 502-6052 or send an email to [email protected] by May 6, 2016, to register to attend the morning meeting. No registration is required to attend the evening meeting.

    Dated: April 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-08688 Filed 4-14-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP15-549-000] Columbia Gas Transmission, LLC; Notice of Schedule for Environmental Review of the SM-80 MAOP Restoration Project

    On September 2, 2015, Columbia Gas Transmission, LLC (Columbia) filed an application in Docket No. CP15-549-000 requesting a Certificate of Public Convenience and Necessity pursuant to Sections 7(c) and 7(b) of the Natural Gas Act to abandon, construct, and operate certain natural gas pipeline facilities in Wayne County, West Virginia. The proposed project is known as the SM-80 MAOP Restoration Project (Project) and would restore the maximum allowable operating pressure of part of the SM-80 system.

    On September 15, 2015, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the Project. Among other things, that notice alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's Environmental Assessment (EA) for the Project. This instant notice identifies the FERC staff's planned schedule for the completion of the EA for the Project.

    Schedule for Environmental Review Issuance of EA—5/18/16 90-Day Federal Authorization Decision Deadline—8/16/16

    If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.

    Project Description

    Columbia proposes to abandon in place about 3.3 miles of 30-inch-diameter pipeline and associated aboveground appurtenances located on its existing SM-80 natural gas transmission system located in Wayne County, West Virginia. This section would be abandoned due to its age and condition. Columbia would also construct about 3.9 miles of 30-inch-diameter pipeline to replace the abandoned pipeline. The new pipeline would be co-located with the existing SM-80 Loop 1 and other existing easements for 3.8 of the 3.9 miles.

    1 A pipeline loop is a segment of pipe constructed parallel to an existing pipeline to increase capacity.

    Background

    On October 15, 2015, the Commission issued a Notice of Intent to Prepare an Environmental Assessment for the Proposed SM-80 MAOP Restoration Project and Request for Comments on Environmental Issues (NOI). The NOI was sent to affected landowners; federal, state, and local government agencies; elected officials; environmental and public interest groups; Native American tribes; other interested parties; and local libraries and newspapers. In response to the NOI, the Commission received comments from two landowners. The primary issues raised by the commentors are the potential for soil and water contamination, impacts on wildlife, air, and noise, and cumulative impacts.

    Additional Information

    In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC Web site (www.ferc.gov). Using the “eLibrary” link, select “General Search” from the eLibrary menu, enter the selected date range and “Docket Number” excluding the last three digits (i.e., CP15-549), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at [email protected] The eLibrary link on the FERC Web site also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.

    Dated: April 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-08687 Filed 4-14-16; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2016-0198; FRL-9944-61] Pesticide Program Dialogue Committee; Notice of Public Meeting AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act (FACA), EPA's Office of Pesticide Programs is announcing a public meeting of the Pesticide Program Dialogue Committee (PPDC) on May 18-19, 2016. This meeting provides advice and recommendations to the EPA Administrator on issues associated with pesticide regulatory development and reform initiatives, evolving public policy and program implementation issues, and science issues associated with evaluating and reducing risks from use of pesticides.

    DATES:

    The meeting will be held on Wednesday, May 18, 2016, from 9 a.m. to 5:00 p.m., and Thursday, May 19, 2016, from 9 a.m. to 12:00 p.m.

    Agenda: A draft agenda will be posted on or before May 4, 2016.

    Accommodations requests: To request accommodation of a disability, please contact the person listed under FOR FURTHER INFORMATION CONTACT, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

    ADDRESSES:

    The PPDC Meeting will be held at 1 Potomac Yard South, 2777 S. Crystal Drive, Arlington, VA, in the lobby-level Conference Center.

    EPA's Potomac Yard South Bldg. is approximately 1 mile from the Crystal City Metro Station.

    FOR FURTHER INFORMATION CONTACT:

    Dea Zimmerman, Office of Pesticide Programs (LC-8J), Environmental Protection Agency, 77 W. Jackson Boulevard, Chicago, IL 60604; telephone number: (312) 353-6344; email address: [email protected].

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

    You may be potentially affected by this action if you work in an agricultural setting, or if you are concerned about implementation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the Federal Food, Drug, and Cosmetic Act (FFDCA); and the amendments to both of these major pesticide laws by the Food Quality Protection Act (FQPA) of 1996; the Pesticide Registration Improvement Act (PRIA), and the Endangered Species Act (ESA). Potentially affected entities may include, but are not limited to: Agricultural workers and farmers; pesticide industry and trade associations; environmental, consumer, and farm worker groups; pesticide users and growers; animal rights groups; pest consultants; State, local, and tribal governments; academia; public health organizations; and the public. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

    B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0198 is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    II. Background

    The PPDC is a federal advisory committee chartered under the Federal Advisory Committee Act (FACA), Public Law 92-463. EPA established the PPDC in September 1995 to provide advice and recommendations to the EPA Administrator on issues associated with pesticide regulatory development and reform initiatives, evolving public policy and program implementation issues, and science issues associated with evaluating and reducing risks from use of pesticides. The following sectors are represented on the current PPDC: Environmental/public interest and animal rights groups; farm worker organizations; pesticide industry and trade associations; pesticide user, grower, and commodity groups; Federal and State/local/tribal governments; the general public; academia; and public health organizations.

    III. How can I request to participate in this meeting?

    PPDC meetings are free, open to the public, and no advance registration is required. Public comments may be made during the public comment session of each meeting or in writing to the person listed under FOR FURTHER INFORMATION CONTACT.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: April 7, 2016. Jack Housenger, Director, Office of Pesticide Programs.
    [FR Doc. 2016-08788 Filed 4-14-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2016-0122; FRL-9944-62] Agency Information Collection Activities; Proposed Renewal of an Existing Collection (EPA ICR No. 0152.11); Comment Request AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). The ICR, entitled “Notice of Arrival of Pesticides and Devices under section 17(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)” and identified by EPA ICR No. 0152.11 and OMB Control No. 2070-0020, represents the renewal of an existing ICR that is scheduled to expire on November 30, 2016. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection that is summarized in this document. The ICR and accompanying material are available in the docket for public review and comment.

    DATES:

    Comments must be received on or before June 14, 2016.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2016-0122, 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:

    Ryne Yarger, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 605-1193; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), EPA specifically solicits comments and information to enable it to:

    1. 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.

    2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

    3. Enhance the quality, utility, and clarity of the information to be collected.

    4. 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. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

    II. What information collection activity or ICR does this action apply to?

    Title: Notice of Arrival of Pesticides and Devices under section 17(c) of FIFRA.

    ICR number: EPA ICR No. 0152.11.

    OMB control number: OMB Control No. 2070-0020.

    ICR status: This ICR is currently scheduled to expire on November 30, 2016. 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 regulations in title 40 of the Code of Federal Regulations (CFR), after appearing in the Federal Register when approved, are listed in 40 CFR part 9, 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. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

    Abstract: The U.S. Customs and Border Protection (Customs) regulations at 19 CFR 12.112 require that an importer desiring to import a pesticide or device into the United States shall, prior to the shipment's arrival in the United States, submit a Notice of Arrival (NOA) of Pesticides and Devices (EPA Form 3540-1) to EPA. Once EPA receives the NOA, EPA will determine the disposition of the shipment upon its arrival in the United States. Upon completing its review, the EPA response is sent to the importer of record or licensed customs broker, who must present the NOA to Customs upon arrival of the shipment at the port of entry. This is necessary to ensure that EPA is notified of the arrival of pesticides and pesticidal devices as required under FIFRA section 17(c), and that EPA has the ability to examine such shipments to determine compliance with FIFRA. Customs compares entry documents for the shipment with the NOA and notifies the EPA regional office of any discrepancies.

    Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 0.43 hours per response. Burden is defined in 5 CFR 1320.3(b).

    The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized here:

    Respondents/affected entities: Entities potentially affected by this ICR are pesticide importers, which includes many types of business entities ranging from Commercial and Institutional Building Construction (NAICS 236220) to Pesticide and Other Agricultural Chemical Manufacturing (NAICS 325300) and even Public Administration: Executive Offices (NAICS 921110). Other business and institutions that import pesticides include Agriculture, Forestry, Fishing and Hunting (Sector 11), Wholesale Trade, (Sector 42). The majority of responses come from businesses that fall under NAICS code 325300.

    Estimated total number of potential respondents: 38,000.

    Frequency of response: On occasion.

    Estimated total average number of responses for each respondent: 1.

    Estimated total annual burden hours: 16,340 hours.

    Estimated total annual costs: $1,006,034. This is the estimated burden cost; there is no cost for capital investment or maintenance and operational costs.

    III. Are there changes in the estimates from the last approval?

    There is an increase of 3,870 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This increase reflects EPA's updating of burden estimates for this collection based upon historical information on the number of NOAs received by EPA. Based upon revised estimates, the number of NOAs received has increased from 35,000 to 38,000. The average burden hours per response will remain unchanged from the previous ICR renewal of 0.43 hours per response. This change is an adjustment.

    IV. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Authority:

    44 U.S.C. 3501 et seq.

    Dated: April 8, 2016. James Jones, Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
    [FR Doc. 2016-08830 Filed 4-14-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9945-02-OA] Performance Partnership Grants AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    This action adds the new multi-purpose categorical grant program for states and tribes, which was established by and funded through the Consolidated Appropriations Act, 2016, to the list of the Environmental Protection Agency's (EPA) environmental grant programs eligible for inclusion in Performance Partnership Grants (PPGs).

    FOR FURTHER INFORMATION CONTACT:

    Reynold Meni, Office of Congressional and Intergovernmental Relations, Office of the Administrator (Mail Code 1301), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-3669; fax number: (202) 501-1540; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Omnibus Consolidated Rescissions and Appropriations Act of 1996 (Pub. L. 104-134) and the Department of Veterans Affairs and Housing and Urban Development, and Independent Agencies Appropriations Act of 1998 (Pub. L. 105-65) authorize EPA to combine categorical grant funds appropriated in EPA's State and Tribal Assistance Grant (STAG) account and award the funds as PPGs. Public Law 104-134 states, in relevant part, that: “the Administrator is authorized to make grants annually from funds appropriated under this heading, subject to such terms and conditions as the Administrator shall establish, to any State or federally recognized Indian tribe for multimedia or single media pollution prevention, control and abatement and related environmental activities at the request of the Governor or other appropriate State official or the tribe.”

    Public Law 105-65 amended the PPG authority by authorizing “interstate agencies, tribal consortia, and air pollution control agencies” to receive PPGs. Pursuant to the authority granted in Public Law 104-134 and Public Law 105-65, EPA promulgated PPG regulations in January of 2001 as part of the Agency's revision of 40 CFR part 35, the rules governing categorical environmental program grants. The regulation at 40 CFR 35.133(b) states that: “The Administrator may, in guidance or regulation, describe subsequent additions, deletions, or changes to the list of environmental programs eligible for inclusion in Performance Partnership Grants.”

    EPA is authorized under the Consolidated Appropriations Act, 2016 (Pub. L. 114-113), Title II of Division G to award $21 million in multi-purpose grants to states and tribes for implementation of environmental programs and projects that complement existing environmental program grants, including interagency agreements. The conference report's language clarifies that these funds will allow states and tribes to have the necessary flexibility to direct resources for the implementation of high priority activities, including the processing of permits, which complement programs under established environmental statutes.

    The multi-purpose categorical grant program is funded under EPA's STAG appropriations account and, therefore, is eligible for inclusion in PPGs. This notice is made pursuant to 40 CFR 35.133(b), to inform entities eligible to receive PPGs that the program listed above may be included in a PPG subject to any limitations herein defined. Hereafter, multi-purpose grants are eligible for inclusion in PPGs and may be included in a PPG at the request of the appropriate official of an eligible entity, subject to EPA's regulations at 2 CFR part 200 and 2 CFR part 1500 and 40 CFR 35.001-35.138 and 35.500-35.538. The authority to issue this Federal Register notice has been delegated to the Deputy Associate Administrator for Intergovernmental Relations.

    Dated: April 11, 2016. Mark W. Rupp, Deputy Associate Administrator for Intergovernmental Relations.
    [FR Doc. 2016-08798 Filed 4-14-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-9026-5] Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General Information (202) 564-7146 or http://www2.epa.gov/nepa.

    Weekly receipt of Environmental Impact Statements (EISs) Filed 04/04/2016 Through 04/08/2016 Pursuant to 40 CFR 1506.9. Notice

    Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

    EIS No. 20160076, Final, BLM, WY, Continental Divide Creston Natural Gas Development Project, Review Period Ends: 05/16/2016, Contact: Jennifer Fleuret 307-775-6329. EIS No. 20160077, Draft, BLM, UT, Enefit Utility Corridor Project, Comment Period Ends: 06/07/2016, Contact: Stephanie Howard 435-781-4469. EIS No. 20160078, Draft, USFWS, MN, Midwest Wind Energy Multi-Species Habitat Conservation Plan, Comment Period Ends: 07/14/2016, Contact: Rick Amidon 612-713-5164. EIS No. 20160079, Final, BLM, OR, Western Oregon Resource Management Plan, Review Period Ends: 05/16/2016, Contact: Mark Brown 503-808-6233. Dated: April 12, 2016. Dawn Roberts, Management Analyst, NEPA Compliance Division, Office of Federal Activities.
    [FR Doc. 2016-08786 Filed 4-14-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-R05-OW-2016; FRL-9945-18-Region 5] Change in Public Notice Procedures for EPA Region 5's Proposed Establishment of TMDLs and Proposed Impaired Waters Listings Under Section 303(d) of the Clean Water Act AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of change in public notice procedures.

    SUMMARY:

    The Environmental Protection Agency (EPA) Region 5 is announcing a change to its procedures for issuing public notices seeking comment when the Region proposes to list impaired waters after disapproving or partially disapproving a state's list of impaired waters (303(d) list) under Clean Water Act (CWA) Section 303(d), or the Region proposes to establish a total maximum daily load (TMDL) under CWA Section 303(d). For any future proposed action to include waters on a state's 303(d) list or establish a TMDL, EPA Region 5 will provide public notice on the 303(d)/TMDL Program Web page (http://www.epa.gov/tmdl/impaired-waters-and-tmdls-region-5) rather than by publication in the Federal Register.

    DATES:

    This change in procedures will be effective on April 15, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Vilma Rivera-Carrero at (312) 886-7795 or by email at [email protected]; or Donna Keclik at (312) 886-6766 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    This notice announces a change in procedures by which EPA Region 5 issues public notices seeking comment under 40 CFR 130.7(d)(2) for its proposed listing of impaired waters where the Region disapproves a state's 303(d) list, or proposes to establish TMDLs.

    Under Section 303(d)(1)(A) of the CWA, each state is required to identify and prioritize the waters within its boundaries for which technology-based effluent limitations and other required controls are not stringent enough to achieve the applicable water quality standards. See also 40 CFR 130.7(b)(1). Each state must submit biennially a 303(d) list to the EPA Regional Administrator for review and approval. See 40 CFR 130.7(d)(1). Within 30 days of a state's submission, EPA must approve or disapprove the state's list. If EPA disapproves the state's 303(d) list, it must identify the impaired waters that should be listed within 30 days from the date of disapproval. EPA regulations provide that the Regional Administrator must promptly issue a public notice seeking comment on EPA's listing decision. After considering public comment and making appropriate revisions, the Region is required to transmit the list to the state. See 40 CFR 130.7(d)(2).

    Under Section 303(d)(1)(C) of the CWA, each state is required to establish TMDLs for 303(d) listed waters. See also 40 CFR 130.7(c)(1). After a state develops a TMDL, the state must submit the TMDL to EPA for review and approval. See 40 CFR 130.7(d)(1). Within 30 days of a state's submission, EPA must approve or disapprove the state's TMDL. If EPA disapproves the state's TMDL, it must establish the TMDL within 30 days from the date of disapproval. EPA may also establish TMDLs in certain circumstances where the State has not previously submitted a TMDL for review. EPA regulations provide that the Regional Administrator must promptly issue a public notice seeking comment on EPA's TMDL. After considering public comment and making appropriate revisions, the Region is required to transmit the TMDL to the state. See 40 CFR 130.7(d)(2).

    In the past, EPA Region 5 has issued public notices through publication in the Federal Register. In light of EPA's quest for improvements in efficiency, EPA Region 5 intends to notify the public of listing and TMDL actions under 40 CFR 130.7(d)(2) by placing notices directly on the Regional Internet Page rather than by publication in the Federal Register. The Region believes that placing the notices on the 303(d)/TMDL Program Web page (http://www.epa.gov/tmdl/impaired-waters-and-tmdls-region-5) provides a more effective, and efficient of providing notice. The Region also plans to issue notifications to the affected states so that these states can include links to the notices on their state Web sites. The letters and accompanying documents transmitting final lists and/or federal TMDLs to the state will also be accessible from the 303(d)/TMDL Program Web page.

    To the extent that this announcement may be considered a rule, EPA considers it to be a procedural rule, which is exempt from notice and comment rulemaking requirements under 5 U.S.C. 553(b)(3)(A).

    Authority:

    33 U.S.C. 1313(d); 40 CFR 130.7.

    Dated: March 25, 2016. Tinka G. Hyde, Director, Water Division, EPA Region 5.
    [FR Doc. 2016-08828 Filed 4-14-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9945-16-OA] National Environmental Education Advisory Council AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The U.S. Environmental Protection Agency (EPA or Agency) office of Public Engagement and Environmental Education is soliciting applications for environmental education professionals for consideration to serve on the National Environmental Education Advisory Council (NEEAC). There are up to eleven vacancies on the Advisory Council that must be filled. Additional avenues and resources may be utilized in the solicitation of applications. In an effort to obtain nominations of diverse candidates, EPA encourages nominations of women and men of all racial and ethnic groups.

    DATES:

    Applications date is extended thru April 29, 2016.

    ADDRESSES:

    Submit non-electronic application materials to Javier Araujo, Designated Federal Officer, National Environmental Education Advisory Council, U.S. Environmental Protection Agency, Office of Public Engagement and Environmental Education (MC 1704A), 1200 Pennsylvania Ave. NW., Room 1426 (WJCN), Washington, DC 20460, Phone: (202) 564-2642, Fax (202) 564-2753, email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For information regarding this Request for Nominations, please contact Mr. Javier Araujo, Designated Federal Officer, [email protected], 202-564-2642, U.S. EPA, Office of Environmental Education, William Jefferson Clinton North Room 1426, 1200 Pennsylvania Avenue NW., Washington, DC 20460.

    General Information concerning NEEAC can be found on the EPA Web site at: http://www2.epa.gov/education/national-environmental-education-advisory-council.

    SUPPLEMENTARY INFORMATION:

    The National Environmental Education Act requires that the council be comprised of (11) members appointed by the Administrator of the EPA. Members represent a balance of perspectives, professional qualifications, and experience. The Act specifies that members must represent the following sectors: Primary and secondary education (one of whom shall be a classroom teacher), two members; colleges and universities, two members; business and industry, two members; non-profit organizations, two members; state departments of education and natural resources, two members, and one member to represent senior Americans. Members are chosen to represent various geographic regions of the country, and the Council strives for a diverse representation. The professional backgrounds of Council members should include education, science, policy, or other appropriate disciplines. Each member of the Council shall hold office for a one (1) to three (3) year period. Members are expected to participate in up to two (2) meetings per year and monthly or more conference calls per year. Members of the council shall receive compensation and allowances, including travel expenses at a rate fixed by the Administrator.

    Expertise Sought: The NEEAC staff office seeks candidates with demonstrated experience and or knowledge in any of the following environmental education issue areas: (a) Integrating environmental education into state and local education reform and improvement; (b) state, local and tribal level capacity building for environmental education; (c) cross-sector partnerships to foster environmental education; (d) leveraging resources for environmental education; (e) design and implementation of environmental education research; (f) evaluation methodology; professional development for teachers and other education professionals; and targeting under-represented audiences, including low-income, multi-cultural, senior citizens and other adults.

    The NEEAC is best served by a structurally and geographically diverse group of individuals. Each individual will demonstrate the ability to make a time commitment. In addition, the individual will demonstrate both strong leadership and analytical skills. Also, strong writing skills, communication skills and the ability to evaluate programs in an unbiased manner are essential. Team players, which can meet deadlines and review items on short notice are ideal candidates.

    How to apply: Any interested and qualified individuals may be considered for appointment on the National Environmental Education Advisory Council. In order to apply, the following four items should be submitted in electronic format to the Designated Federal Officer, Javier Araujo, [email protected] and contain the following: (1) Contact information including name, address, phone and fax numbers and an email address; (2) a curriculum vitae or resume; (3) the specific area of expertise in environmental education and the sector or slot the applicant is applying for; (4) recent service on other national advisory committees or national professional organizations; a one page commentary on the applicant's philosophy regarding the need for, development, implementation and or management of environmental education nationally.

    Persons having questions about the application procedure or who are unable to submit applications by electronic means, should contact Javier Araujo (DFO), at the contact information provided above in this notice. Non-electronic submissions must contain the same information as the electronic. The NEEAC staff Office will acknowledge receipt of the application. The NEEAC staff office will develop a short list of candidates for more detailed consideration. The short list candidates will be required to fill out the Confidential Disclosure Form for Special Government Employees serving Federal Advisory Committees at the U.S. Environmental Protection Agency. (EPA form 3110-48). This confidential form allows government officials to determine whether there is a statutory conflict between that person's public responsibilities (which include membership on a Federal Advisory Committee) and private interests and activities and the appearance of a lack of impartiality as defined by Federal regulation. The form may be viewed and downloaded from the following URL address. Please note this form is not an application form. http://intranet.epa.gov/ogc/ethics/EPA3110-48ver3.pdf.

    Dated: April 11, 2016. Sarah Sowell, Deputy Director, Office of Environmental Education. Javier Araujo, Designated Federal Officer.
    [FR Doc. 2016-08799 Filed 4-14-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1190] 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 June 14, 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: 3060-1190.

    Title: Section 87.287(b), Aeronautical Advisory Stations (Unicoms)—“Squitters.”

    Form No.: N/A.

    Respondents: Business or other for-profit entities, not for profit institutions and state, local or tribal government.

    Number of Respondents and Responses: 200 respondents; 200 responses.

    Estimated Time per Response: 1 hour.

    Frequency of Response: On-occasion reporting requirement and third party disclosure requirement.

    Total Annual Burden: 85 hours.

    Annual Cost Burden: $28,750.

    Obligation to Respond: Require to obtain or retain benefits. The statutory authority for this collection is contained in 47 U.S.C. 151, 154(i), 154(j), 155, 157, 225, 303(r), and 309 of the Communications Act of 1934, as amended.

    Privacy Act 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 87.287(b) requires that before submitting an application for an aircraft data link land test station, an applicant must obtain written permission from the licensee of the aeronautical enroute stations serving the areas in which the aircraft data link land test station will operate on a co-channel basis. The Commission may request an applicant to provide documentation as to this fact.

    The written permissions will aid the Commission in ensuring that licensees are complying with its policies and rules, while allowing the owners of antenna structures and other aviation obstacles to use Audio Visual Warning Systems (AVWS) stations, thereby helping aircraft avoid potential collisions and enhancing aviation safety, without causing harmful interference to other communications.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2016-08672 Filed 4-14-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0179 and 3060-0500] Information Collections Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before June 14, 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: 3060-0179.

    Title: Section 73.1590, Equipment Performance Measurements.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities; not-for-profit institutions.

    Number of Respondents and Responses: 13,049 respondents and 13,049 responses.

    Estimated Time per Response: 0.5-18 hours.

    Frequency of Response: Recordkeeping requirement.

    Total Annual Burden: 12,335 hours.

    Total Annual Cost: None.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in Section 154(i) of the Communications Act of 1934, as amended.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Impact Assessment: No impact(s).

    Needs and Uses: 47 CFR 73.1590(d) requires licensees of AM, FM and TV stations to make audio and video equipment performance measurements for each main transmitter. These measurements and a description of the equipment and procedures used in making the measurements must be kept on file at the transmitter or remote control point for two years. In addition, this information must be made available to the FCC upon request.

    OMB Control Number: 3060-0500.

    Title: Section 76.1713, Resolution of Complaints.

    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: 10,750 respondents and 21,500 responses.

    Estimated Hours per Response: 1-17 hours.

    Frequency of Response: Recordkeeping and third party disclosure requirements; annual reporting requirement.

    Total Annual Burden: 193,500 hours.

    Total Annual Cost: None.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in Sections 4(i), 303 and 308 of the Communications Act of 1934, as amended.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Impact Assessment: No impact(s).

    Needs and Uses: 47 CFR 76.1713 states cable system operators shall establish a process for resolving complaints from subscribers about the quality of the television signal delivered. Commission and franchising authorities, upon request. These records shall be maintained for at least a one-year period. Prior to being referred to the Commission, complaints from subscribers about the quality of the television signal delivered must be referred to the local franchising authority and the cable system operator.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2016-08674 Filed 4-14-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1203] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The Federal Communications Commission (FCC), as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act (PRA) of 1995. Comments are requested concerning (a) 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; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) 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 (e) ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before June 14, 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 the Federal Communications Commission via email to [email protected] and [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: 3060-1203.

    Title: Section 79.107—User Interfaces Provided by Digital Apparatus; Section 79.108—Video Programming Guides and Menus Provided by Navigation Devices; Section 79.110—Complaint Procedures for User Interfaces, Menus and Guides, and Activating Accessibility Features on Digital Apparatus and Navigation Devices.

    Form Number: N/A.

    Type of Review: Revision of a currently approved collection.

    Respondents: Business or other for-profit entities; individuals or households; not-for-profit institutions; and state, local, or tribal Governments.

    Number of Respondents and Responses: 4,245 respondents; 517,052 responses.

    Estimated Time per Response: 0.0167 hours to 10 hours.

    Frequency of Response: On occasion reporting requirement; Third party disclosure requirement; Recordkeeping requirement.

    Obligation to Respond: Voluntary. The statutory authority for this information collection is contained in the Twenty-First Century Communications and Video Accessibility Act of 2010, Public Law 111-260, 124 Stat. 2751, and Sections 4(i), 4(j), 303(r), 303(u), 303(aa), 303(bb), and 716(g) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 303(r), 303(u), 303(aa), 303(bb), and 617(g).

    Total Annual Burden: 24,153 hours.

    Total Annual Cost: $70,500.

    Nature and Extent of Confidentiality: Confidentiality is an issue to the extent that individuals and households provide personally identifiable information, which is covered under the FCC's updated system of records notice (SORN), FCC/CGB-1, “Informal Complaints and Inquiries,” which became effective on January 25, 2010. The Commission believes that it provides sufficient safeguards to protect the privacy of individuals who file complaints under 47 CFR 79.110.

    Privacy Impact Assessment: The Privacy Impact Assessment (PIA) for Informal Complaints and Inquiries was completed on June 28, 2007. It may be reviewed at http://www.fcc.gov/omd/privacyact/Privacy-Impact-Assessment.html. The Commission is in the process of updating the PIA to incorporate various revisions to it as a result of revisions to the SORN.

    Needs and Uses: On November 20, 2015, in document FCC 15-156, the Commission released a Second Report and Order, Order on Reconsideration, and Further Notice of Proposed Rulemaking, MB Docket No. 12-108, FCC 15-156, adopting additional rules implementing Sections 204 and 205 of the Twenty-First Century Communications and Video Accessibility Act of 2010 (CVAA) related to accessible user interfaces and video programming guides and menus. These rules are codified at 47 CFR 79.107 and 79.108. First, the Second Report and Order implements Section 204's requirement that both the “appropriate built-in apparatus functions” and the “on-screen text menus or other visual indicators built in to the digital apparatus” to access such functions be “usable by individuals who are blind or visually impaired” by relying on the existing definition of “usable” in Section 6.3(l) of the Commission's rules. The 6.3(l) definition of “usable” requires that “individuals with disabilities have access to the full functionality and documentation for the product, including instructions, product information (including accessible feature information), documentation, bills and technical support which is provided to individuals without disabilities.” In addition, the Second Report and Order adopts information, documentation, and training requirements comparable to those in Section 6.11 of the Commission's rules for entities covered by both Section 204 and Section 205 of the CVAA. The Second Report and Order also adopts consumer notification requirements for equipment manufacturers of digital apparatus and navigation devices that will require manufacturers to publicize the availability of accessible devices on manufacturer Web sites that must be accessible to those with disabilities. The Second Report and Order requires MVPDs, as well as manufacturers, to ensure that the contact office or person listed on their Web site is able to answer both general and specific questions about the availability of accessible equipment, including, if necessary, providing information to consumers or directing consumers to a place where they can locate information about how to activate and use accessibility features.

    The following rule sections and other requirements contain new and revised information collection requirements for which the Commission is seeking approval from the Office of Management and Budget (OMB):

    (1) Usability requirements for manufacturers of digital apparatus.

    The Second Report and Order adopts usability requirements for digital apparatus covered by 47 CFR 79.107. A digital apparatus manufacturer must make functions that are used for the reception, play back, or display of video programming, as well as on-screen text menus or other visual indicators used to access these functions, usable to individuals who are blind or visually impaired. Pursuant to 47 CFR 79.107(a)(5), the term “usable” means that individuals with disabilities have access to information and documentation on the full functionalities of digital apparatus, including instructions, product information (including accessible feature information), documentation, bills, and technical support which are provided to individuals without disabilities.

    (2) Information, documentation, and training requirements for manufacturers of digital apparatus.

    Pursuant to 47 CFR 79.107(d), manufacturers of digital apparatus must ensure access to information and documentation provided to customers, including user guides, bills, installation guides for end-user installable devices, and product support communications, regarding both the product in general and the accessibility features of the product. Manufacturers of digital apparatus must include the contact method for obtaining this information and documentation in general product information. Manufacturers should take such other steps as necessary including providing a description of the accessibility and compatibility features of the product and end-user product documentation upon request in alternate formats or alternate modes at no additional charge; and ensuring usable customer support and technical support in the call centers and service centers which support their products at no additional charge. In developing training programs, manufacturers of digital apparatus must consider the following topics: (i) Accessibility requirements of individuals with disabilities; (ii) means of communicating with individuals with disabilities; (iii) commonly used adaptive technology used with the manufacturer's products; (iv) designing for accessibility; and (v) solutions for accessibility and compatibility.

    (3) Information, documentation, and training requirements for covered MVPDs and manufacturers of navigation devices.

    Pursuant to 47 CFR 79.108(f), covered MVPDs and manufacturers of navigation devices must ensure access to information and documentation provided to customers, including user guides, bills, installation guides for end-user installable devices, and product support communications, regarding both the product in general and the accessibility features of the product. MVPDs and manufacturers of navigation devices must include the contact method for obtaining this information and documentation in general product information. MVPDs and manufacturers should take such other steps as necessary including providing a description of the accessibility and compatibility features of the product and end-user product documentation upon request in alternate formats or alternate modes at no additional charge; and ensuring usable customer support and technical support in the call centers and service centers which support their products at no additional charge. In developing training programs, MVPDs and manufacturers of navigation devices must consider the following topics: (i) Accessibility requirements of individuals with disabilities; (ii) means of communicating with individuals with disabilities; (iii) commonly used adaptive technology used with the manufacturer's products; (iv) designing for accessibility; and (v) solutions for accessibility and compatibility. If a consumer with a disability requests an accessible navigation device, this also constitutes a request for a description of the accessibility features of the device and end-user product documentation in accessible formats.

    (4) Notifications by covered manufacturers regarding the availability of accessible digital apparatus. Pursuant to 47 CFR 79.107(e), manufacturers of digital apparatus must provide notice on their official Web sites about the availability of accessible devices. Manufacturers must prominently display information about accessible devices and solutions on their Web sites in a way that makes such information available to all consumers and in a format that is accessible to people with disabilities. The notice for digital apparatus must publicize the availability of accessible devices and the specific person, office or entity who can answer consumer questions about which products contain the required accessibility features. The contact office or person listed on the Web site must be able to answer both general and specific questions about the availability of accessible equipment, including, if necessary, providing information to consumers or directing consumers to a place where they can locate information about how to activate and use accessibility features.

    (5) Notifications by covered manufacturers regarding the availability of accessible navigation devices.

    Pursuant to 47 CFR 79.108(d)(2), manufacturers of navigation devices must provide notice on their official Web sites about the availability of accessible devices. Manufacturers must prominently display information about accessible devices and solutions on their Web sites in a way that makes such information available to all consumers and in a format that is accessible to people with disabilities. The notice for navigation devices must publicize the availability of accessible devices and separate solutions and explain the means for making requests for accessible equipment and the specific person, office, or entity to whom such requests are to be made. The contact office or person listed on the Web site must be able to answer both general and specific questions about the availability of accessible equipment, including, if necessary, providing information to consumers or directing consumers to a place where they can locate information about how to activate and use accessibility features.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2016-08675 Filed 4-14-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1181] 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 June 14, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email to [email protected] and to [email protected].

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-1181.

    Title: Study Area Boundary Data Reporting in Esri Shapefile Format, DA 12-1777 and DA 13-282.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities and state, local or tribal government.

    Number of Respondents: 747 respondents; 757 responses.

    Estimated Time per Response: 26 hours for submitting updates; less than 1 hour for recertification.

    Frequency of Response: On occasion and biennially reporting requirements.

    Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. 254(b) of the Communications Act of 1934, as amended.

    Total Annual Burden: 171 hours.

    Total Annual Cost: $3,977.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: No questions of a confidential nature are asked.

    Needs and Uses: The Commission uses the study area boundary data collected for this information collection to implement certain universal service reforms. The Universal Service Fund supports the deployment of voice and broadband-capable infrastructure in rural, high cost areas. High-cost support is granted to a carrier based on the characteristics of its “study area,” the geographic area served by an incumbent local exchange carrier within a state. Therefore, complete and accurate study area boundary data are essential for calculating a carrier's costs and expenses, which in turn determine the amount of support that carrier can receive to serve high-cost areas. Initial study area boundaries were submitted in 2013. These maps were submitted via a secure Internet-browser web interface developed and maintained by the Commission. If a study area boundary changes, filers are required to submit, via this interface, revised boundary data incorporating such changes by March 15 of the year following the change. In addition, all filers are required to recertify their study area boundaries every two years.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2016-08673 Filed 4-14-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL HOUSING FINANCE AGENCY [No. 2016-N-04] Privacy Act of 1974; Systems of Records AGENCY:

    Federal Housing Finance Agency.

    ACTION:

    Notice of revision to an existing Privacy Act system of records.

    SUMMARY:

    In accordance with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a (Privacy Act), the Federal Housing Finance Agency (FHFA) gives notice of a revision to an existing Privacy Act system of records.

    The existing system is Emergency Notification System (FHFA-14) and is being revised in its entirety. The system is being revised to add additional information that is being collected; to change the location of the system; and to update the routine uses of the system. The revised system will contain information that FHFA will use to maintain emergency contact information for current FHFA employees and contractor personnel. The system will provide for high-speed message delivery that reaches agency and contractor personnel in response to threat alerts issued by the Department of Homeland Security, weather related emergencies, or other critical situations that disrupt the operations of and accessibility to an FHFA worksite. The system also provides for personnel accountability during an emergency through personnel sign-in and rapid alert and notification.

    DATES:

    To be assured of consideration, comments should be received on or before May 16, 2016. This revised system of records will become effective on May 25, 2016 without further notice unless comments necessitate otherwise. FHFA will publish a new notice if the effective date is delayed to review comments or if changes are made based on comments received.

    ADDRESSES:

    Submit comments to FHFA only once, identified by “2016-N-04,” using any one of the following methods:

    Agency Web site: www.fhfa.gov/open-for-comment-or-input.

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. If you submit your comment to the Federal eRulemaking Portal, you may also send it by email to FHFA at [email protected] to ensure timely receipt by the agency. Please include “Comments/No. 2016-N-04” in the subject line of the message.

    Hand Delivered/Courier: The hand delivery address is: Alfred M. Pollard, General Counsel, Attention: Comments/No. 2016-N-04, Federal Housing Finance Agency, Eight Floor, 400 7th Street SW., Washington, DC 20219. The package should be delivered to the Seventh Street entrance Guard Desk, First Floor, on business days between 9 a.m. and 5 p.m.

    U.S. Mail, United Parcel Service, Federal Express, or Other Mail Service: The mailing address for comments is: Alfred M. Pollard, General Counsel, Attention: Comments/No. 2016-N-04, Federal Housing Finance Agency, Eighth Floor, 400 7th Street SW., Washington, DC 20219. Please note that all mail sent to FHFA via the U.S. Postal Service is routed through a national irradiation facility, a process that may delay delivery by approximate two weeks.

    See SUPPLEMENTARY INFORMATION for additional information on submission and posting of comments.

    FOR FURTHER INFORMATION CONTACT:

    Andrew Wheeler, Supervisory Security Specialist, Office of the Chief Operating Officer at (202) 649-3764; or David A. Lee, Senior Agency Official for Privacy, [email protected], (202) 649-3803 (not toll free numbers), Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219. The telephone number for the Telecommunications Device for the Hearing Impaired is (800) 877-8339.

    SUPPLEMENTARY INFORMATION:

    I. Comments

    Instructions: FHFA seeks public comments on the revised system of records and will take all comments into consideration before issuing the final notice. See 5 U.S.C. 552a(e)(4) and (11). In addition to referencing “Comments/No. 2016-N-04,” please reference the title and number of the system of records your comment addresses: “Emergency Notification System (FHFA-14).”

    Posting and Public Availability of Comments: All comments received will be posted without change on the FHFA Web site at http://www.fhfa.gov, and will include any personal information provided, such as your name, address (home and email), telephone number and any other information you provide. In addition, copies of all comments received will be available for examination by the public on business days between the hours of 10 a.m. and 3 p.m., at the Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219. To make an appointment to inspect comments, please call the Office of General Counsel at (202) 649-3804.

    II. Introduction

    This notice informs the public of FHFA's proposal to revise in its entirety an existing system of records. This notice satisfies the Privacy Act requirement that an agency publish a system of records notice in the Federal Register when there is an addition to the agency's system of records. It has been recognized by Congress that application of all requirements of the Privacy Act to certain categories of records may have an undesirable and often unacceptable effect upon agencies in the conduct of necessary public business. Consequently, Congress established general exemptions and specific exemptions that could be used to exempt records from provisions of the Privacy Act. Congress also required that exempting records from provisions of the Privacy Act would require the head of an agency to publish a determination to exempt a record from the Privacy Act as a rule in accordance with the Administrative Procedures Act. The Director of FHFA has determined that records and information in this revised system of records are not exempt from requirements of the Privacy Act.

    As required by the Privacy Act, 5 U.S.C. 552a(r), and pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (61 FR 6428, 6435 (February 20, 1996)), FHFA has submitted a report describing the revised system of records covered by this notice, to the Committee on Oversight and Government Reform of the House of Representatives, the Committee on Homeland Security and Governmental Affairs of the Senate, and the Office of Management and Budget.

    The revised system of records described above is set forth in its entirety below.

    FHFA-14 SYSTEM NAME:

    Emergency Notification System.

    SECURITY CLASSIFICATION:

    Sensitive but unclassified.

    SYSTEM LOCATION:

    Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219; Everbridge, Inc., Burbank, CA and Denver, CO; and any alternate work site utilized by Federal Housing Finance Agency (FHFA) employees or by individuals assisting such employees.

    CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:

    Current and former FHFA employees and contractor personnel, and emergency contacts for these individuals.

    CATEGORIES OF RECORDS IN THE SYSTEM:

    Name and contact information such as addresses (home, mailing and/or business), telephone numbers (personal and/or business), electronic mail addresses (personal and/or business), photographs, and geospatial and/or geolocation data.

    AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

    5 U.S.C. 552a; 12 U.S.C. 4515; and Executive Orders 12656, 12148, and 10995.

    PURPOSE(S):

    The purpose of this system of records is to maintain emergency contact information for current FHFA employees and contractor personnel. The system provides for high-speed message delivery that reaches all agency and contractor personnel in response to threat alerts issued by the Department of Homeland Security, weather related emergencies, or other critical situations that disrupt the operations of and accessibility to an FHFA worksite. The system also provides for personnel accountability during an emergency, through personnel sign-in and rapid alert and notification.

    ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSE OF SUCH USES:

    In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, these records or information contained therein may specifically be disclosed outside FHFA as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

    (1) When (a) it is suspected or confirmed that the security or confidentiality of information in the system of records has been compromised; (b) FHFA has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by FHFA or another agency or entity) that rely upon the compromised information; and (c) the disclosure is made to such agencies, entities, and persons who are reasonably necessary to assist in connection with FHFA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.

    (2) Records in this system may be disclosed to any individual during the course of any inquiry or investigation conducted by FHFA, or in connection with civil or administrative litigation, if FHFA has reason to believe that the individual to whom the record is disclosed may have further information about the matters related therein, and those matters appeared to be relevant at the time to the subject matter of the inquiry.

    (3) A record or information in the system may be disclosed to any individual with whom FHFA contracts to reproduce, by typing, photocopy or other means, any record within this system for use by FHFA and its employees in connection with their official duties or to any individual who is utilized by FHFA to perform clerical or stenographic functions relating to the official business of FHFA.

    (4) To appropriate federal, state, and local authorities responsible for investigating or prosecuting a violation of, or for enforcing or implementing a statute, rule, regulation, or order issued, when the information indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule, or order issued pursuant thereto.

    (5) To a court, magistrate, or other administrative body in the course of presenting evidence, including disclosures to counsel or witnesses in the course of civil discovery, litigation, or settlement negotiations or in connection with criminal proceedings, when FHFA is a party to the proceeding or has a significant interest in the proceeding, to the extent that the information is determined to be relevant and necessary.

    (6) To a Congressional office from the record of an individual in response to an inquiry from the Congressional office made at the request of that individual.

    (7) To contractor personnel, interns, and others performing or working on a contract, service, grant, cooperative agreement, or project for FHFA.

    (8) To any Federal government authority for the purpose of coordinating with or reviewing FHFA's continuity of operations plans or emergency contingency plans.

    (9) To any Federal, State or Local government authority for the purpose of coordinating a response to threat alerts issued by the Department of Homeland Security, weather related emergencies, or other critical situations that disrupt the operations of and accessibility to an FHFA worksite.

    (10) To the National Archives and Records Administration, Office of Government Information Services (OGIS), to the extent necessary to fulfill its responsibilities in 5 U.S.C. 552(b), to review administrative agency policies, procedures and compliance with the Freedom of Information Act (FOIA), and to facilitate OGIS' offering of mediation services to resolve disputes between persons making FOIA requests and administrative agencies.

    DISCLOSURE TO CONSUMER REPORTING AGENCIES:

    None.

    POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE:

    Records are maintained in electronic format, paper form, and magnetic disk or tape. Electronic records are stored in computerized databases. Paper and magnetic disk, or tape records are stored in locked file rooms, locked file cabinets and/or safes.

    RETRIEVABILITY:

    Records may be retrieved by any of the following: Name, email address, telephone number, or an assigned file number for the purpose of responding to the requestor. Information may additionally be retrieved by other personal identifiers.

    SAFEGUARDS:

    Records are safeguarded in a secured environment. Buildings where records are stored have security cameras and 24-hour security guard service. Computerized records are safeguarded through use of access codes and other information technology security measures. Paper records are safeguarded by locked file rooms, locked file cabinets, and/or safes. Access to the records is restricted to those who require the records in the performance of official duties related to the purposes for which the system is maintained.

    RETENTION AND DISPOSAL:

    Records are periodically purged and disposed of for individuals who are no longer employees or contractors of FHFA. Otherwise, records are retained and disposed of in accordance with the appropriate National Archives and Records Administration General Records Schedules and FHFA Retention Schedules.

    SYSTEM MANAGER(S) AND ADDRESS:

    Office of the Chief Operating Officer, Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219.

    NOTIFICATION PROCEDURES:

    Direct inquiries as to whether this system contains a record pertaining to an individual to the Privacy Act Officer. Inquiries may be mailed to the Privacy Act Officer, Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219, or can be submitted electronically at http://www.fhfa.gov/AboutUs/FOIAPrivacv/Pages/Privacv.aspx in accordance with the procedures set forth in 12 CFR part 1204.

    RECORD ACCESS PROCEDURES:

    Direct requests for access to a record to the Privacy Act Officer. Requests may be mailed to the Privacy Act Officer, Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219, or can be submitted electronically at http://www.fhfa.gov/AboutUs/FOIAPrivacv/Pages/Privacv.aspx in accordance with the procedures set forth in 12 CFR part 1204.

    CONTESTING RECORD PROCEDURES:

    Direct requests to contest or appeal an adverse decision for a record to the Privacy Act Appeals Officer. Requests may be mailed to the Privacy Act Appeals Officer, Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219, or can be submitted electronically at http://www.fhfa.gov/AboutUs/FOIAPrivacv/Pages/Privacv.aspx in accordance with the procedures set forth in 12 CFR part 1204.

    RECORD SOURCE CATEGORIES:

    Information is provided by FHFA employees and FHFA contractor personnel.

    EXEMPTIONS CLAIMED FOR THE SYSTEM:

    None.

    Dated: April 6, 2016. Melvin L. Watt, Director, Federal Housing Finance Agency.
    [FR Doc. 2016-08652 Filed 4-14-16; 8:45 am] BILLING CODE 8070-01-P
    GENERAL SERVICES ADMINISTRATION [Notice-WWICC-2016-03; Docket No. 2016-0006; Sequence 3] World War One Centennial Commission; Notification of Upcoming Public Advisory Meeting AGENCY:

    World War One Centennial Commission, GSA.

    ACTION:

    Meeting Notice.

    SUMMARY:

    Notice of this meeting is being provided according to the requirements of the Federal Advisory Committee Act, 5 U.S.C. App. 10(a)(2). This notice provides the schedule and agenda for the May 4, 2016 meeting of the World War One Centennial Commission (the Commission). The meeting is open to the public.

    DATES:

    Effective: April 15, 2016.

    Meeting Date and Location: The meeting will be held on Wednesday, May 4, 2016 starting at 9:00 a.m., Central Daylight Time (CDT), and ending no later than 11:30 a.m., CDT. The meeting will be held at the National World War I Museum and Memorial, 100 W 26th Street, Kansas City, MO 64108. This location is handicapped accessible. The meeting will be open to the public and will also be available telephonically. Persons attending in person are requested to refrain from using perfume, cologne, and other fragrances (see http://www.accessboard.gov/about/policies/fragrance.htm for more information).

    Persons wishing to listen to the proceedings may dial 712-432-1001 and enter access code 474845614. Note this is not a toll-free number. Written Comments may be submitted to the Commission and will be made part of the permanent record of the Commission. Comments must be received by 5:00 p.m., Eastern Daylight Time (EDT), April 29, 2016, and may be provided by email to: [email protected] Contact Daniel S. Dayton at [email protected] to register to comment during the meeting's 30-minute public comment period.

    Registered speakers/organizations will be allowed 5 minutes and will need to provide written copies of their presentations. Requests to comment, together with presentations for the meeting, must be received by 5:00 p.m., EDT, on Friday, April 29, 2016. Please contact Mr. Dayton at the email address above to obtain meeting materials.

    FOR FURTHER INFORMATION CONTACT:

    Daniel S. Dayton, Designated Federal Officer, World War 1 Centennial Commission, 701 Pennsylvania Avenue NW., 123, Washington, DC 20004-2608 at 202-380-0725 (note: this is not a toll-free number).

    SUPPLEMENTARY INFORMATION:

    Background

    The World War One Centennial Commission was established by Public Law 112-272 (as amended), as a commission to ensure a suitable observance of the centennial of World War I, to provide for the designation of memorials to the service of members of the United States Armed Forces in World War I, and for other purposes.

    Under this authority, the Committee will plan, develop, and execute programs, projects, and activities to commemorate the centennial of World War I, encourage private organizations and State and local governments to organize and participate in activities commemorating the centennial of World War I, facilitate and coordinate activities throughout the United States relating to the centennial of World War I, serve as a clearinghouse for the collection and dissemination of information about events and plans for the centennial of World War I, and develop recommendations for Congress and the President for commemorating the centennial of World War I. The Commission does not have an appropriation and operated solely on donated funds.

    Agenda: Wednesday May 4, 2016 Old Business

    Approval of minutes of previous meetings.

    • Public Comment Period.

    New Business

    • Commission Operating Status—Exec. Director Dayton.

    • Fund Raising—Roger Fisk.

    • Program Operations—Rebekah Wilson.

    • Communications—Chris Isleib.

    • World War 1 Memorial at Pershing Park Status Report—Commissioner Fountain.

    • Education Report—Commissioner O'Connell.

    • Requests for Support and International Report—Commissioner Seefried.

    • Chairman's Report—Chairman Rob Dalessandro.

    • Set next meeting—August 17, 2016 in Washington, DC.

    Other business as may properly come before the Commission Adjourns.

    Dated: April 11, 2016. Daniel S. Dayton, Designated Federal Official, World War I Centennial Commission.
    [FR Doc. 2016-08772 Filed 4-14-16; 8:45 am] BILLING CODE 6820-95-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Statement of Organization, Functions, and Delegations of Authority

    Part E, Chapter E (Agency for Healthcare Research and Quality), of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (68 FR 44084, July 25, 2003, most recently amended at 79 FR 42326, on July 21, 2014) is amended to reflect recent organizational changes. The specific amendments are as follows:

    I. Under Section E-10, Organization, delete F. Office of Communications and Knowledge Transfer and replace with the following:

    F. Office of Communications.

    II. Under Section E-20, Functions, delete Office of Communications and Knowledge Transfer in its entirety and replace with the following:

    Office of Communications. Manages the Agency's communication activities, including print and electronic publishing, dissemination, and communications support, and media relations activities. Responsible for communicating information to internal and external stakeholders. Develops, implements, and manages programs to reach stakeholders about the results of AHRQ-funded research and evidence, tools and training materials, and data and measures. Helps stakeholders understand how AHRQ research, tools, and data can help improve quality and safety of care.

    Shall be organized into the following three divisions:

    • Division of Outreach and Stakeholder Engagement: ○ Assesses findings from AHRQ-funded research, products, and tools for dissemination and use by stakeholders; ○ Develops, coordinates, and implements dissemination plans using a wide variety of strategies and tactics; ○ Provides strategic guidance to Agency program staff and various Agency contractors on opportunities for dissemination; ○ Develops and coordinates outreach to prospective dissemination partners, and produces case studies on use of AHRQ findings and tools. • Division of Print and Electronic Publishing: ○ Disseminates AHRQ research, tools, and data to stakeholders via both electronic and print publications. Manages the full publishing process from concept to Web site posting, including planning, advising and managing publishing projects for the Agency; ○ Writes and edits articles; packages products and tools for presentations and dissemination. • Division of Media Relations: ○ Creates and implements strategy for traditional and social media relations activities as part of overall efforts to communicate with AHRQ stakeholders and partners about Agency-funded work;

    All delegations and redelegations of authority to officers and employees of the Agency for Healthcare Research and Quality that were in effect immediately prior to the effective date of this reorganization shall continue in effect pending further redelegation provided they are consistent with this reorganization.

    These changes are effective upon date of signature.

    Sharon B. Arnold, Acting Director.
    [FR Doc. 2016-08679 Filed 4-14-16; 8:45 am] BILLING CODE 4160-90-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-276 and CMS-1957] Agency Information Collection Activities: Submission for OMB Review; Comment Request ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments on the collection(s) of information must be received by the OMB desk officer by May 16, 2016.

    ADDRESSES:

    When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 OR Email: [email protected].

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    Reports Clearance Office at (410) 786-1326.

    SUPPLEMENTARY INFORMATION:

    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. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

    1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Prepaid Health Plan Cost Report; Use: Health Maintenance Organizations and Competitive Medical Plans (HMO/CMPs) contracting with the Secretary under Section 1876 of the Social Security Act are required to submit a budget and enrollment forecast, semi-annual interim report, 4th Quarter interim report, and a final certified cost report in accordance with 42 CFR 417.572-417.576. Health Care Prepayment Plans (HCPPs) contracting with the Secretary under Section 1833 of the Social Security Act are required to submit a budget and enrollment forecast, semi-annual interim report, and final cost report in accordance with 42 CFR 417.808 and 42 CFR 417.810. Form Number: CMS-276 (OMB control number 0938-0165); Frequency: Quarterly; Affected Public: Private Sector (Business or other for-profits); Number of Respondents: 91; Total Annual Responses: 74; Total Annual Hours: 3728. (For policy questions regarding this collection contact Bilal Farrakh at 410-786-4456.)

    2. Type of Information Collection Request: Reinstatement of a previously approved collection; Title of Information Collection: Social Security Office (SSO) Report of State Buy-in Problem; Use: Under Section 1843 of the Social Security Act, States may enter into an agreement with the Department of Health and Human Services to enroll eligible individuals in Medicare and pay their premiums. The purpose of the State Buy-in' program is to assure that Medicaid is the payer of last resort by permitting a State to provide Medicare protection to certain groups of needy individuals, as part of the State's total assistance plan. State Buy-in also has the effect of transferring some medical costs for this population from the Medicaid program, which is partially State funded to the Medicare program, which is funded by the federal government and individual premiums. Generally, the States Buy-in for individuals who meet the eligibility requirements for Medicare and are cash recipients or deemed cash recipients or categorically needy under Medicaid. In some cases, States may also include individuals who are not cash assistance recipients under the Medical Assistance Only group. The day-to-day operations of the State Buy-in program is accomplished through an automated data exchange process. The automated data exchange process is used to exchange Medicare and Buy-in entitlement information between the Social Security District Offices, Medicaid State Agencies and the Centers for Medicare & Medicaid Services. When problems arise however that cannot be resolved though the normal data exchange process, clerical actions are required. The CMS-1957, “SSO Report of State Buy-In Problem” is used to report Buy-in problems cases. The CMS-1957 is the only standardized form available for communications between the aforementioned agencies for the resolution of beneficiary complaints and inquiries regarding State Buy-in eligibility. Form Number: CMS-1957 (OMB control number: 0938-0035); Frequency: Reporting—Annually; Affected Public: Individuals and Households; Number of Respondents: 3,936; Total Annual Responses: 3,936; Total Annual Hours: 1,311. (For policy questions regarding this collection contact Keith Robinson at 410-786-1148.)

    Dated: April 12, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2016-08784 Filed 4-14-16; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [CFDA Number: 93.564] Announcement of the Award of a Single-Source Expansion Supplement Grant to the Washington State Department of Social and Health Services in Lacey, WA AGENCY:

    Office of Child Support Enforcement, ACF, HHS.

    ACTION:

    Notice of the award of a single-source expansion supplement grant to the Washington State Department of Social and Health Services in Lacey, WA, to support the development of additional dissemination tools such as reports and web-based trainings on the lessons learned and early findings from the Evaluation of Behavioral Interventions for Child Support Services of the Behavioral Interventions for Child Support Services (BICS) Demonstration.

    SUMMARY:

    The Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), Division of Program Innovation, announces the award of a single-source program expansion supplement grant in the amount of $34,568 to the Washington State Department of Social and Health Services in Lacey, WA, to support the development of additional dissemination tools such as reports and web-based trainings on the lessons learned and early findings from the Evaluation of the Behavioral Interventions for Child Support Services of the Behavioral Interventions for Child Support Services (BICS) Demonstration.

    In FY 2014, OCSE competitively awarded a cooperative agreement to the Washington State Department of Social and Health Services to conduct a 5-year evaluation of OCSE's national demonstration called Behavioral Interventions for Child Support Services (BICS) under Funding Opportunity Announcement (FOA) number HHS-2014-ACF-OCSE-FD-0822. Under this FOA, a total of $1.7 million of 1115 funds are made available over the five year project period to conduct this evaluation. The Washington State Department of Social and Health Services was the only grantee that received funding under this FOA.

    DATES:

    The period of support for this supplement is September 30, 2015 through September 29, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Lauren Antelo, Senior Program Specialist, Office of Child Support Enforcement, 330 C Street SW., Washington, DC 20201. Telephone: 202-401-5099; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    In FY 2014, OCSE competitively awarded a cooperative agreement to the Washington State Department of Social and Health Services to conduct a 5-year evaluation of OCSE's national demonstration called Behavioral Interventions for Child Support Services (BICS).

    This supplement will allow the Washington State Department of Social and Health Services to develop additional dissemination tools such as reports and web-based trainings on the lessons learned and early findings from the evaluation of Behavioral Interventions for Child Support Services Demonstration.

    The cost of the BICS evaluation is larger than originally budgeted because the process mapping and project design phase has been significantly slower than anticipated for the grantees. This has led to the need for increased technical assistance to the BICS grantees by the evaluation grantee. Additionally, as a result of the mapping and design phase, OCSE anticipates an increased number of interesting findings that will be of benefit to the greater child support field.

    The supplement funds will allow Washington State Department of Social and Health Services to provide increased technical assistance to the BICS demonstration sites, and support the development additional dissemination tools such as reports and web-based trainings on the lessons learned and early findings from the Evaluation of BICS.

    Specifically, the Washington State Department of Social and Health Services will explore the development of innovative, user-friendly tools such as podcasts and infographics that will provide research findings and learning to the child support community in a way that is easily accessible to interested program administrators and policy officials. These tools will also continue to build the evidence-base in what works in the delivery of child support services.

    Statutory Authority: Section 1115 of the Social Security Act authorizes funds for experimental, pilot, or demonstration projects that are likely to assist in promoting the objectives of Part D of Title IV.

    Christopher Beach, Senior Grants Policy Specialist, Office of Administration.
    [FR Doc. 2016-08649 Filed 4-14-16; 8:45 am] BILLING CODE 4184-42-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [CFDA Numbers: 93.592, 93.136, 16.582] Announcing the Award of a Single-Source Program Expansion Supplement Grant to the National Resources Center on Domestic Violence, Inc. (NRCDV) in Harrisburg, PA AGENCY:

    Family and Youth Services Bureau, ACYF, ACF, HHS.

    ACTION:

    Notice of the award of a single-source program expansion supplement grant of $686,000 under the Family Violence Prevention and Services Act (FVPSA) Technical Assistance (TA) Project to the National Resources Center on Domestic Violence, Inc. (NRCDV) to support training and technical assistance activities. This is a collaboration between the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), Administration for Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), FVPSA; HHS/Centers for Disease Control and Prevention (CDC), National Center for Injury Prevention and Control (NCIPC), Division of Violence Prevention (DVP); and the Department of Justice (DOJ), Office of Victims of Crime (OVC).

    SUMMARY:

    ACF/ACYF/FYSB/DFVPS, in collaboration with CDC/NIPC/DVP announce the award of $686,000 to NRCDV in Harrisburg, Pennsylvania. The grantee is a technical assistance (TA) provider that assists FVPSA service providers to build the capacity of domestic violence programs, continuums of care, homeless service providers, and housing service providers.

    DATES:

    The period of support for the single-source program expansion supplement is September 30, 2015 through September 29, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Shawndell Dawson, Senior Program Specialist, Family Violence Prevention and Services Program, 330 C Street SW., Washington, DC 20201. Telephone: 202-205-1476; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supplemental award funds will support the grantee in providing training and technical assistance (T/TA) to domestic violence service providers, continuums of care, homeless service providers, and housing service providers. In addition to the $250,000 from ACF/ACYF/FYSB/DFVPS, the supplemental award consists of $186,000 contributed by CDC/NIPC/DVP and $250,000 contributed by DOJ/OVC.

    In accordance with an inter-agency agreement, the CDC/NIPC/DVP has provided national-level support and coordination for Intimate Partner Violence (IPV) prevention TA. In accordance with this inter-agency agreement, ACF/DFVPS has supplemented the T/TA cooperative agreement that funds the NRCDV through September 30, 2016. ACF and CDC staffs will meet regularly and facilitate ongoing communication to coordinate the delivery of national training and technical assistance.

    This award will expand the scope of the NRCDV's TA assistance activities to include activities concerned with the prevention of IPV by: (1) Coordinating engagement with national-level partners, including foundations, for the purpose of enhancing communication related to IPV prevention; (2) engaging in planning to facilitate dialogue that will include the sharing of tools and lessons learned among state domestic violence coalitions engaged in IPV primary prevention efforts; (3) continuing to identify and disseminate information on lessons learned and key findings from state domestic violence coalitions that have implemented IPV primary prevention activities through www.PreventIPV.org, and other means; (4) maintaining a virtual workspace to assist in the sharing of resources among state and territorial domestic violence coalitions that are engaged in IPV primary prevention activities; and (5) facilitating regular, ongoing communication between the IPV Prevention Council, ACF/DFVPS and CDC/DVP.

    In addition to the prevention activities, the grantee will coordinate national domestic violence, housing, and homelessness technical assistance by: (1) Providing comprehensive trauma-informed and culturally relevant TA for continuums of care, homeless service providers, housing service providers, domestic violence programs, and culturally specific community based organizations; (2) creating a virtual learning network for domestic violence programs and housing service providers; (3) documenting the housing needs, challenges, and best practice models of culturally specific and historically marginalized communities, including African American, Latina, Asian/Pacific Islander, and LGBTQ communities; (4) coordinating national webinars to raise awareness about best practices, research, and new resources; (5) developing factsheets, white papers, and/or a conceptual framework for meeting the housing needs of domestic violence survivors and their children.

    In accordance with an inter-agency agreement, the DOJ/OVC has provided obligation authority for $250,000 to ACF/DFVPS to provide national-level support and coordination for domestic violence and housing TA. In accordance with this inter-agency agreement, ACF/DFVPS has supplemented the T/TA cooperative agreement that funds the NRCDV through September 30, 2016. DOJ/OVC and ACF/DFVPS staffs will meet regularly and facilitate ongoing communication to coordinate the delivery of national T/TA.

    The solicited application underwent objective review by a federal panel that use criteria related to the project's approach, the organization's capacity, and the development of costs in the proposed budget.

    Statutory Authority:

    Section 310 of the Family Violence Prevention and Services Act, as amended by Section 201 of the CAPTA Reauthorization Act of 2010, Public Law 111-320. The statutory authority for the additional funds from the Centers for Disease Control and Prevention is 42 U.S.C. 247b(k)(2) and 42 U.S.C. 280b-1 of the Public Health Service Act. The statutory authority for the additional funds from the Department of Justice (DOJ), Office for Victims of Crime (OVC), is 42 U.S.C. 10603(c)(1)(A), 42 U.S.C. 10603(c)(4), and 28 U.S.C. 530C. 42 U.S.C. 10603(c)(1)(A) authorizes the OVC Director to make grants for demonstration projects, program evaluation, compliance efforts, T/TA services.

    Christopher Beach, Senior Grants Policy Specialist, Division of Grants Policy, Office of Administration.
    [FR Doc. 2016-08716 Filed 4-14-16; 8:45 am] BILLING CODE 4184-32-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [CFDA NUMBER: 93.550] Announcement of the Award of a Single-Source Expansion Supplement Grant to National Safe Place Network in Louisville, KY AGENCY:

    Family and Youth Services Bureau, ACYF, ACF, HHS.

    ACTION:

    Notice of the award of a single-source expansion supplement grant to support the Runaway and Homeless Youth Training and Technical Assistance Center (RHYTTAC) operated by the National Safe Place Network to expand the original scope of approved activities.

    SUMMARY:

    The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Adolescent Development and Support (DADS), announces the award of a single-source expansion supplement grant of $852,000 to the National Safe Place Network located in Louisville, KY, to support costs associated with the expansion of the scope of approved activities under its award for the Runaway and Homeless Youth Training and Technical Assistance Center (RHYTTAC).

    DATES:

    The period of support under this supplement is September 30, 2015, through September 29, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Christopher Holloway, Program Manager, Runaway and Homeless Youth Program, Division of Adolescent Development and Support, Family and Youth Services Bureau, 330 C Street SW., Washington, DC 20201. Telephone: 202-205-9560; Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    The expansion supplement award will allow the National Safe Place Network to:

    • Provide Runaway and Homeless Youth (RHY) grantees with resources necessary to better understand and respond to human trafficking through the creation of a Community Awareness Toolkit and Youth Prevention Action Kit, which will enhance their sustainability to provide human trafficking related services;

    • Provide a clear and responsive framework by which all grantees of Domestic Victims of Human Trafficking (DVHT) funding can access relevant training and responsive technical assistance;

    • Partner with a national leader in services to human trafficking victims/survivors to provide all RHY grantees with enhanced access to human trafficking information on assessments, referrals, applicable state laws and trafficking, including sex and labor categories;

    • Provide stipends to grantees to assist them in meeting federal requirements to submit data under RHY-Homeless Management Information System (RHY-HMIS).

    Using evidence-based practices derived from the best available research, professional expertise, and input from youth and families, RHYTTAC serves as a national resource for training and technical assistance directed to assisting RHY organizations in their engagement in continuous quality improvement of their services in building organizational capacity to effectively serve runaway and homeless youth. RHYTTAC's focus is to help the nation's network of RHY service providers boost “protective factors” for their clients.

    Statutory Authority:

    Runaway and Homeless Youth Act, 42 U.S.C. 5701 through 5752, as most recently amended by the Reconnecting Homeless Youth Act of 2008, Public Law 110-378 on October 8, 2008.

    Christopher Beach, Senior Grants Policy Specialist, Division of Grants Policy, Office of Administration.
    [FR Doc. 2016-08654 Filed 4-14-16; 8:45 am] BILLING CODE 4184-33-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request

    Title: Phase II Evaluation Activities for Implementing a Next Generation Evaluation Agenda for the Chafee Foster Care Independence Program.

    OMB No.: New Collection.

    Description: The Administration for Children and Families (ACF), Office of Planning Research and Evaluation (OPRE) is proposing an information collection activity as part of the Phase II Evaluation Activities for Implementing a Next Generation Evaluation Agenda for the Chafee Foster Care Independence Program. The proposed information collection consists of site visits by staff from the Urban Institute and Chapin Hall at the University of Chicago to conduct formative evaluations of programs serving transition-age foster youth. The evaluations will include preliminary visits to discuss the evaluation process with program administrators. Then, the research team will conduct site visits to each program to speak with program leaders, partners and key stakeholders, front-line staff, and participants. These formative evaluations will determine programs' readiness for more rigorous evaluation in the future. The activities and products from this project will help ACF to fulfill their ongoing legislative mandate for program evaluation specified in the Foster Care Independence Act of 1999.

    Respondents: Program leaders, partners and stakeholders, and front-line staff as well as young adults being served by the programs.

    Annual Burden Estimates Instrument Total
  • number of
  • respondents
  • Annual
  • number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours per response
  • Annual
  • burden hours
  • Discussion Guide for program leaders 48 24 4 1 96 Discussion Guide for program partners and stakeholders 80 40 2 1 80 Discussion Guide for program front-line staff 128 64 1 1 64 Focus Group Guide for program participants 200 100 1 2 200 Compilation and Submission of Administrative Data Files 24 12 2 12 288

    Estimated Total Annual Burden Hours: 728.

    In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C St SW., Washington, DC 20201, Attn: OPRE Reports Clearance Officer. Email address: [email protected] All requests should be identified by the title of the information collection.

    The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

    Robert Sargis, ACF Certifying Officer.
    [FR Doc. 2016-08715 Filed 4-14-16; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-2353] Determination of Regulatory Review Period for Purposes of Patent Extension; CYRAMZA AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) has determined the regulatory review period for CYRAMZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

    DATES:

    Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by June 14, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by October 12, 2016. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2014-E-2353 for Determination of Regulatory Review Period for Purposes of Patent Extension; CYRAMZA.

    Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION: I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human biologic product CYRAMZA (ramucirumab). CYRAMZA is indicated for treatment of gastric cancer. Subsequent to this approval, the U.S. Patent and Trademark Office (USPTO) received a patent term restoration application for CYRAMZA (U.S. Patent No. 7,498,414) from Eli Lilly and Co., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 19, 2015, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of CYRAMZA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for CYRAMZA is 3,521 days. Of this time, 3,279 days occurred during the testing phase of the regulatory review period, while 242 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: September 1, 2004. FDA has verified the applicant's claim that the date the investigational new drug application (IND) became effective was on September 1, 2004.

    2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): August 23, 2013. FDA has verified the applicant's claim that the biologics license application (BLA) for CYRAMZA (BLA 125477) was initially submitted on August 23, 2013.

    3. The date the application was approved: April 21, 2014. FDA has verified the applicant's claim that BLA 125477 was approved on April 21, 2014.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,059 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: April 11, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08692 Filed 4-14-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by May 16, 2016.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-0738. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected].

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Center for Devices and Radiological Health Appeals Processes— OMB Control Number 0910-0738—Extension

    The guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes” describes the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH) employees. FDA is seeking approval for the new reporting burden associated with requests for additional review of decisions and actions by CDRH employees as described in the guidance.

    Individuals outside of FDA who disagree with a decision or action taken by CDRH and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including: Requests for supervisory review of an action; petitions; and hearings. Of these, by far the most commonly used is a request for supervisory review under § 10.75 (21 CFR 10.75) (a “10.75 appeal”). Section 517A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360g-1), added by section 603 of the Food and Drug Safety and Innovation Act of 2012, includes new requirements pertaining to the process and timelines for 10.75 appeals of “significant decisions” regarding 510(k) premarket notifications, applications for premarket approvals (PMAs), and applications for investigational device exemptions (IDEs).

    A request for review under § 10.75 should be based on the information that was already present in the administrative file at the time of the decision that is being reviewed as provided in § 10.75(d). New section 517A of the FD&C Act refers to significant decisions regarding the information in the administrative file for premarket notifications (section 510(k)); PMAs (section 515); and IDEs (section 520(g)) submissions is collected under existing regulations which specify the information manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of medical devices. The information collections associated with these regulations are currently approved by the Office of Management and Budget as follows: The collections of information in 21 CFR part 807, subpart E (premarket notification) have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814 (premarket approval) have been approved under OMB control number 0910-0231; and the collections of information in 21 CFR part 812 (investigational device exemption) have been approved under OMB control number 0910-0078.

    While CDRH already possesses in the administrative file the information that would form the basis of a decision on a matter under appeal, the submission of particular information regarding the request itself and the data and information relied on by the requestor in the appeal would facilitate timely resolution of the decision under review. The guidance describes the collection of information not expressly specified under existing regulations such as: The submission of the request for review, minor clarifications as part of the request, and supporting information.

    In the Federal Register of October 21, 2015 (80 FR 63804), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

    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
  • Total hours
    CDRH Appeals Processes Guidance Document 50 1 50 8 400 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Dated: April 8, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08685 Filed 4-14-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Antimicrobial Drugs Advisory Committee; Notice of Meeting AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

    Name of Committee: Antimicrobial Drugs Advisory Committee.

    General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

    Date and Time: The meeting will be held on June 9, 2016, from 8:30 a.m. to 5 p.m.

    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    Contact Person: Lauren D. Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    Agenda: The committee will discuss biologics license application (BLA) 761046, bezlotoxumab (MK-6072) injection, submitted by Merck Sharpe & Dohme Corp., for the proposed indication of prevention of Clostridium difficile infection recurrence.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 25, 2016. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 17, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 18, 2016.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Lauren D. Tesh at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: April 11, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs.
    [FR Doc. 2016-08637 Filed 4-14-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1114] Pharmaceutical Distribution Supply Chain Pilot Projects; Request for Information AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; request for information.

    SUMMARY:

    The Food and Drug Administration (FDA) is soliciting information regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from public comments will assist with the design and development of the pilot project(s) that FDA establishes under the DSCSA.

    DATES:

    Submit written or electronic comments and information by May 16, 2016.

    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-1114 for “Pharmaceutical Distribution Supply Chain Pilot Projects; Request for Information.” 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, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    On November 27, 2013, the DSCSA (Title II of Pub. L. 113-54) was signed into law. The DSCSA outlines critical steps to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed within the United States. Section 202 of the DSCSA added new sections 581 and 582 to the Food Drug and Cosmetic Act (21 U.S.C. 360eee and 360eee-1). Under section 582(j), FDA is required to establish one or more pilot projects, in coordination with authorized manufacturers, repackagers, wholesale distributors, and dispensers, to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. The projects established by FDA will take into consideration any pilot projects that were conducted prior to enactment of the DSCSA.

    II. Purpose of the Request for Information

    The request for information is intended to provide interested persons an opportunity to submit comments relating to FDA's implementation of the DSCSA. We are particularly interested in comments regarding past or present pilot projects related to enhancing the safety and security of the pharmaceutical distribution supply chain. Stakeholders that may be interested in responding to this request for information include: Manufacturers, repackagers, wholesale distributors, dispensers, State and Federal authorities, solution providers, standards organizations, and other interested persons. FDA is particularly interested in learning about the practices, processes, and systems that supply chain stakeholders have used or considered using in such pilot projects. This includes, but is not limited to, information about the following:

    • Utilizing the product identifier for tracing of a product, which may include verification of the product identifier of a product, including the use of aggregation and inference;

    • Technical capabilities each sector of the supply chain to comply with systems and processes needed to utilize the product identifier to enhance the tracing of a product; or

    • System attributes that are necessary to implement the requirements established under the DSCSA.

    Interested persons are requested to provide any other relevant information that may assist with FDA's development of a pilot project under the DSCSA.

    Dated: April 11, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08681 Filed 4-14-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1126] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice, establishment of a public docket; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

    DATES:

    The meeting will be held on June 2 and 3, 2016, from 8 a.m. to 6 p.m.

    ADDRESSES:

    Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone number is 301-977-8900. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-1126 for “Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, 301-796-5290, [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: On June 2 and 3, 2016, the committee will discuss recent reports and epidemiologic investigations of nontuberculous mycobacteria (NTM) infections associated with the use of heater-cooler devices during cardiac surgical procedures. FDA is convening this committee to seek expert scientific and clinical opinion related to contamination of heater-cooler devices, associated patient infections, and mitigation strategies based on available scientific information. The committee will make recommendations on: (1) The effectiveness of cleaning and disinfection methods for heater-cooler devices; (2) the amount and type of premarket data and information needed to demonstrate validation of cleaning and disinfection of heater-cooler devices in support of labeling claims and technical instructions; (3) appropriate risk mitigations to be implemented by manufacturers of heater-cooler devices and/or hospital facilities to ensure patient safety during surgical procedures where these devices are used; and (4) appropriate guidelines and/or criteria based on a risk stratification schema for notifying patients who may have already been exposed to NTM during prior cardiac surgeries. Recommendations on these issues will assist FDA in minimizing patient exposure to infections that may result from contaminated heater-cooler devices.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 19, 2016. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on June 2, 2016, and between approximately 9 a.m. and 10 a.m. on June 3, 2016. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 11, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 12, 2016.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA is establishing a docket for public comment on this document. The docket number is FDA-2016-N-1126. The docket will close on June 16, 2016. Comments received on or before May 19, 2016, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency.

    For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact AnnMarie Williams, at [email protected], or 301-796-5966, at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: April 12, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs.
    [FR Doc. 2016-08737 Filed 4-14-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1113] Data Integrity and Compliance With Current Good Manufacturing Practice; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Data Integrity and Compliance With CGMP.” The purpose of the draft guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. The draft guidance is in response to an increase in CGMP violations involving data integrity observed in recent CGMP inspections. When finalized, the draft guidance is intended to provide the Agency's current thinking on the creation and handling of data in accordance with CGMP requirements.

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 14, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-D-1113 for “Data Integrity and Compliance With CGMP.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg, 4th Floor, Silver Spring, MD 20993-0002; the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Karen Takahashi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 4244, Silver Spring, MD 20993-0002, 301-796-3191; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 240-402-7911; or Jonathan Bray, Center for Veterinary Medicine (HFV-232), Food and Drug Administration, 7519 Standish Pl., Rm.130, Rockville, MD 20855, 240-402-5623.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Data Integrity and Compliance With CGMP.” Increased CGMP violations involving data integrity observed in recent CGMP inspections have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. The purpose of this draft guidance is to clarify the role of data integrity in CGMP for drugs, as required in 21 CFR parts 210, 211, and 212.

    The draft guidance addresses specific questions about how data integrity relates to compliance with CGMP for drugs, as well as more general data integrity concepts, in question and answer format. Parts of this draft guidance have been previously published on the FDA Web site in Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance—Records and Reports (Q&A Level 2 guidance). When finalized, this draft guidance will replace the Q&A Level 2 guidance on data integrity in CGMP.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on data integrity and compliance with CGMP. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 210 and 211 (CGMPs), 212 (PET CGMPs), and 21 CFR part 11 (electronic records and signatures) have been approved under OMB control numbers 0910-0139, 0910-0667, and 0910-0303, respectively.

    III. Electronic Access

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

    Dated: April 11, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08683 Filed 4-14-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0198] Xanodyne Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 8 New Drug Applications and 46 Abbreviated New Drug Applications for Propoxyphene Products; Correction AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; correction.

    SUMMARY:

    The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 10, 2014 (79 FR 13308). The document withdrew approval of 8 new drug applications (NDAs) and 46 abbreviated new drug applications (ANDAs) for prescription pain medications containing propoxyphene from multiple applicants. The document failed to withdraw approval of NDA 017507, held by Xanodyne Pharmaceuticals, Inc. (Xanodyne). Xanodyne wrote to FDA asking the Agency to withdraw approval of NDA 017507 and waiving its opportunity for a hearing. FDA confirms the withdrawal of approval of NDA 017507.

    FOR FURTHER INFORMATION CONTACT:

    David Joy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, 301-796-3601.

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of Monday, March 10, 2014, FR Doc. 2014-05063, on page 13308, the following correction is made:

    On page 13308, in table 1, the following entry is added in numerical order by Application No.:

    Application No. Drug Applicant or holder NDA 017507 Darvocet-N 100 (propoxyphene napsylate and acetaminophen) Suspension, 100 milligrams (mg)/650 mg/15 milliliters Xanodyne Pharmaceuticals, Inc., One Riverfront Pl., Newport, KY 41071. Dated: April 11, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08689 Filed 4-14-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 14, 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-2007-D-0369 for Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. Under that process, draft recommendations are posted on FDA's Web site and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final recommendations or publishes revised draft recommendations for comment. Recommendations were last announced in the Federal Register on January 28, 2016 (81 FR 4913). This notice announces draft product-specific recommendations, either new or revised, that are posted on FDA's Web site.

    II. Drug Products for Which New Draft Product-Specific BE Recommendations Are Available

    FDA is announcing the availability of a new draft guidance for industry on product-specific BE recommendations for drug products containing the following active ingredients:

    Table 1—New Draft Product-Specific BE Recommendations for Drug Products Albendazole Amlodipine besylate; perindopril arginine Betamethasone dipropionate Chlorpheniramine polistirex; codeine polistirex Clobetasol propionate (multiple reference listed drugs) Cobicistat; darunavir ethanolate Daclatasvir dihydrochloride Deferasirox Doxycycline hyclate Eluxadoline Empagliflozin; linagliptin Erythromycin ethylsuccinate Ferric Carboxymaltose Fluticasone furoate Fluticasone furoate; Vilanterol trifenatate Gefitinib Glatiramer Acetate Halobetasol propionate (multiple reference listed drugs) Indacaterol Maleate Isavuconazonium sulfate Ivabradine hydrochloride Ivacaftor Ivacaftor; lumacaftor Lenvatinib mesylate Mometasone furoate (multiple reference listed drugs) Oxaprozin Oxybutynin chloride Palbociclib Sacubitril; valsartan Sonidegib phosphate Tazarotene Triamcinolone acetonide (multiple reference listed drugs) III. Drug Products for Which Revised Draft Product-Specific BE Recommendations Are Available

    FDA is announcing the availability of a revised draft guidance for industry on product-specific BE recommendations for drug products containing the following active ingredients:

    Table 2—Revised Draft Product-Specific BE Recommendations for Drug Products Ciprofloxacin; Dexamethasone Cyclosporine (multiple reference listed drugs) Testosterone Ticagrelor Valganciclovir hydrochloride

    For a complete history of previously published Federal Register notices related to product-specific BE recommendations, go to http://www.regulations.gov and enter Docket No. FDA-2007-D-0369.

    These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    IV. Electronic Access

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

    Dated: April 7, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08682 Filed 4-14-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children AGENCY:

    Health Resources and Services Administration, HHS.

    ACTION:

    Request for nominations.

    SUMMARY:

    The Health Resources and Services Administration (HRSA) is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of Health and Human Services. HRSA is seeking nominations of qualified candidates to fill three positions on the Committee.

    Authority:

    Section 1111 of the Public Health Service (PHS) Act, Title XI, § 1111(g)(1) (42 U.S.C. 300b-10(g)(1)), as amended by the Newborn Screening Saves Lives Reauthorization Act of 2014. The Committee is governed by the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. App.), and 41 CFR part 102-3 and 41 CFR part 102-3, which set forth standards for the formation and use of advisory committees.

    DATES:

    Written nominations for membership on the Committee must be received on or before May 16, 2016.

    ADDRESSES:

    Nomination packages must be submitted electronically as email attachments to Alaina Harris, Genetic Services Branch, Maternal and Child Health Bureau, Health Resources and Services Administration, [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Alaina Harris, Genetic Services Branch, Maternal and Child Health Bureau, HRSA, at [email protected] or (301) 443-0721. A copy of the Committee Charter and list of the current membership can be obtained by accessing the Advisory Committee Web site at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.

    SUPPLEMENTARY INFORMATION:

    The Committee is chartered under section 1111 of the Public Health Service (PHS) Act, 42 U.S.C. 300b-10, as amended by the Newborn Screening Saves Lives Reauthorization Act of 2015 (Act). The Committee was established in 2003 to advise the Secretary of the U.S. Department of Health and Human Services regarding newborn screening tests, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having or at risk for heritable disorders. In addition, the Committee provides advice and recommendations to the Secretary concerning the grants and projects authorized under section 1109 of the PHS Act and technical information to develop policies and priorities for grants, including those that will enhance the ability of the state and local health agencies to provide for newborn and child screening, counseling and health care services for newborns, and children having or at risk for heritable disorders.

    The Committee is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. App. 2), and 41 CFR part 102-3, which set forth standards for the formation and use of advisory committees. The Committee reviews and reports regularly on newborn and childhood screening practices for heritable disorders, recommends improvements in the national newborn and childhood heritable screening programs, and recommends conditions for inclusion in the Recommended Uniform Screening Panel (RUSP). The Committee's recommendations regarding additional conditions/inherited disorders for screening that have been adopted by the Secretary are included in the RUSP and constitute part of the comprehensive guidelines supported by the Health Resources and Services Administration. Pursuant to section 2713 of the Public Health Service Act, codified at 42 U.S.C. 300gg-13, non-grandfathered health plans and group and individual health insurance issuers are required to cover screenings included in the HRSA-supported comprehensive guidelines without charging a co-payment, co-insurance, or deductible for plan years (i.e., in the individual market, policy years) beginning on or after the date that is 1 year from the Secretary's adoption of the condition for screening.

    Nominations: HRSA is requesting nominations to fill three (3) positions for voting members to serve on the Committee. Nominations of potential candidates for consideration are being sought for individuals who are medical, technical, or scientific professionals with special expertise in the field of heritable disorders or in providing screening, counseling, testing, or specialty services for newborns and children at risk for heritable disorders; who have expertise in ethics (i.e., bioethics) and infectious diseases and who have worked and published material in the area of newborn screening; members of the public having special expertise about or concern with heritable disorders; or representatives from such federal agencies, public health constituencies, and medical professional societies as determined to be necessary by the Secretary to fulfill the duties of the Advisory Committee established under subsection (b) of section 1111 of the Public Health Service (PHS) Act, 42 U.S.C. 300b-10, as amended by the Newborn Screening Saves Lives Reauthorization Act of 2015 (Act). Interested applicants may self-nominate or be nominated by another individual and/or organization.

    Individuals selected for appointment to the Committee will be invited to serve for up to 4 years. Members who are not federal officers or permanent federal employees are appointed as special government employees and receive a stipend and reimbursement for per diem and any travel expenses incurred for attending Committee meetings and/or conducting other business on behalf of the Committee, as authorized by section 5 U.S.C. 5703 for persons employed intermittently in government service. Members who are officers or employees of the United States Government shall not receive additional compensation for service on the Committee, but receive per diem and travel expenses incurred for attending Committee meetings and/or conducting other business on behalf of the Committee. Nominees will be invited to serve during calendar year 2017.

    The following information must be included in the package of materials submitted for each individual being nominated for consideration: (1) A statement that clearly states the name and affiliation of the nominee, the basis for the nomination (i.e., specific attributes such as expertise in bioethics, evidence review, public health, laboratory, maternal and child health, or clinical expertise in heritable disorders, which qualify the nominee for service in this capacity), and that the nominee is willing to serve as a member of the Committee; (2) the nominee's name, address, and daytime telephone number and the home/or work address, telephone number, and email address; and (3) a current copy of the nominee's curriculum vitae. Nomination packages may be summited directly by the individual being nominated or by the person/organization recommending the candidate.

    The Department of Health and Human Services will make every effort to ensure that the membership of the Committee is fairly balanced in terms of points of view represented. Every effort is made to ensure that individuals from a broad representation of geographic areas, gender, ethnic and minority groups, as well as individuals with disabilities are given consideration for membership. Appointments shall be made without discrimination on the basis of age, ethnicity, gender, sexual orientation, and cultural, religious, or socioeconomic status.

    Individuals who are selected to be considered for appointment will be required to provide detailed information regarding their financial holdings, consultancies, and research grants or contracts. Disclosure of this information is necessary in order to determine if the selected candidate is involved in any activity that may pose a potential conflict with the official duties to be performed as a member of the Committee.

    Jackie Painter, Director, Division of the Executive Secretariat.
    [FR Doc. 2016-08691 Filed 4-14-16; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health (NIH) Office of Science Policy (OSP) Recombinant or Synthetic Nucleic Acid Research: Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) SUMMARY:

    The NIH OSP is amending portions of the NIH Guidelines in order to provide investigators with biosafety guidance regarding the standards for containment of non-human primates (NHPs) in biosafety level (BL) 4 laboratories and to make such guidance consistent with the expectations articulated in the Centers for Disease Control and Prevention (CDC)/NIH Biosafety in Microbiological and Biomedical Laboratories 5th edition (BMBL). Specifically, the NIH Guidelines will allow for housing of NHPs in open caging in a dedicated animal holding room provided there are two physical barriers between that animal holding room and non-containment space within the laboratory, the animal holding room has negative air pressure with respect to any adjacent non-containment corridors, and there are specific decontamination protocols in place before the door to the animal holding room is opened to allow for the periodic transfer of new animals into the room. These amendments do not change the current containment requirements in the NIH Guidelines but rather offer an alternative for achieving primary containment without compromising safety.

    In addition, the recertification requirement for biosafety cabinets in BL4 laboratories is updated in recognition of the technological standards for modern biosafety cabinets. The NIH OSP also is updating the validation requirements for equipment responsible for centralized heat decontamination of liquid effluents in laboratories working with large animals.

    These amendments to the NIH Guidelines will be implemented immediately upon publication in the Federal Register. These changes were developed after extensive consultation with biosafety experts, directors of and principal investigators in BL4 facilities working with NHPs, and CDC's Division of Select Agent and Toxins (DSAT) leadership at a public workshop and discussion at a public Recombinant DNA Advisory Committee (RAC) meeting. Publication in the Federal Register will inform the scientific and biosafety communities.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions, or require additional information about these changes, please contact the NIH OSP by email at [email protected], or telephone at 301-496-9838.

    SUPPLEMENTARY INFORMATION:

    The first three editions of the BMBL and the NIH Guidelines were consistent in their approach to requiring primary containment for animal work in BL4 containment laboratories. However, in the early 1990s, the BMBL was amended and the fourth edition stated that animals housed in BL4 suit laboratories (i.e., laboratories in which Class III cabinets are not used but instead personnel wear positive pressure protective suits) should be housed in a primary containment system (such as open cages covered with filtered bonnets and opened in laminar flow hoods or other equivalent containment systems). This language remains in the current BMBL (5th edition). With the change in the BMBL, primary containment caging was arguably preferred but no longer required under BL4 containment. In contrast, the NIH Guidelines have always required primary containment caging for all animals in BL4 laboratories.

    Non-human primates are social animals and require environmental enrichment. Researchers in several U.S. BL4 laboratories engaged in NHP research approached the NIH OSP with concerns that primary containment caging in BL4 laboratories hindered the creation of an environment that allowed animals to benefit from adequate social interaction. Also based on risk assessments and experiences comparing several primary containment caging systems, the researchers concluded that primary containment caging may actually create new hazards for laboratory workers. These findings included interference with observation of the animals from outside the room leading to more frequent entries into the BL4 animal room to monitor the animals, and exacerbation of cramped working conditions created by the additional barriers required by some containment systems, which increases the difficulty of working in inflated pressure suits as well as the potential for damage to the pressure suit. In addition, investigators stated that current BL4 laboratory designs incorporate sophisticated engineering systems, which provide biosafety protection in a dedicated animal room equivalent to the primary containment caging required under the NIH Guidelines. On March 28, 2014, the NIH OSP, together with the CDC Division of Select Agents (DSAT), held a meeting with investigators and biosafety personnel from nine BL4 laboratories in the U.S. and five international laboratories (agenda and roster available at http://osp.od.nih.gov/office-biotechnology-activities/event/2014-03-28-120000-2014-03-28-211500/primary-containment-non-human-primates-biosafety-level-4-laboratories-challenges-and-best-practices). That meeting was followed by a discussion at the June 11, 2014, meeting of the NIH RAC regarding housing of NHPs in BL4 laboratories (a webcast of that discussion is available at http://videocast.nih.gov/summary.asp?Live=14300&bhcp=1.)

    As a result of these discussions and after consultation with CDC DSAT, the NIH OSP is amending the NIH Guidelines to allow the housing of NHP in open cages in a dedicated animal room provided certain conditions as articulated below are met.

    In addition, OSP is updating the requirement for testing and certification of Class I and II biosafety cabinets at BL4 from every six months to annually, recognizing the technological advances in biosafety cabinet design and engineering that have occurred over the period since this performance measure was originally implemented.

    Finally, Appendix Q of the NIH Guidelines currently requires that the centralized heat treatment catch tank system in BL4 large animal laboratories be validated every 30 days. To carry out this testing effectively, the system should be near capacity (i.e. “under load”). Some laboratories do not use their catch tank systems on a regular basis; therefore, a mandatory 30 day validation would require them to demonstrate that the equipment is functioning when it is not in use or is not at capacity. This will not serve the intended purpose of demonstrating that the equipment is functioning as intended. Therefore, validation intervals will need to be set based on the utilization of the system provided it is done at least once a year.

    To implement these changes, the following sections of the NIH Guidelines are to be amended:

    Appendix G-II-D-2-l. currently states:

    Appendix G-II-D-2-l. Laboratory animals involved in experiments requiring BL4 level physical containment shall be housed either in cages contained in Class III cabinets or in partial containment caging systems, such as Horsfall units (see Appendix G-III-K, Footnotes and References of Appendix G), open cages placed in ventilated enclosures, or solid-wall and -bottom cages placed on holding racks equipped with ultraviolet irradiation lamps and reflectors that are located in a specially designed area in which all personnel are required to wear one-piece positive pressure suits.

    Appendix G-II-D-2-1 is amended as follows with the addition of a new Appendix G-II-D-2-1-(2) that will address housing of NHPs:

    Appendix G-II-D-2-l. Containment for Animal Research

    Appendix G-II-D-2-l-(1). Laboratory animals involved in experiments requiring BL4 level physical containment shall be housed either in cages contained in Class III cabinets or in partial containment caging systems, such as Horsfall units (see Appendix G-III-K, Footnotes and References of Appendix G), open cages placed in ventilated enclosures, or solid-wall and -bottom cages placed on holding racks equipped with ultraviolet irradiation lamps and reflectors that are located in a specially designed area in which all personnel are required to wear one-piece positive pressure suits.

    Appendix G-II-D-2-l-(2). Non-human primates (NHP) may be housed (1) under the containment conditions described in Appendix G-II-D-2-l-(1) above, or (2) in open cages within a dedicated animal holding room that serves as the primary barrier and in which all personnel are required to wear one-piece positive pressure suits. A room serving as a primary barrier must be air-tight and capable of being decontaminated using fumigation. If NHPs are to be contained in a dedicated animal holding room serving as the primary barrier, the following conditions shall be met:

    (i) Access to the animal holding room from service corridors outside of the BL4 containment space shall require passage through two sets of doors, and the inner most door must be an air pressure resistant (APR) door;

    (ii) For any animal holding room considered to be a primary barrier, APR door(s) providing direct ingress from the exterior service corridor shall be fitted with appropriate and redundant lock-out mechanisms to prevent access when the animal holding room is contaminated and in use. There should be more than one mechanism to ensure that this primary barrier door cannot be opened when the animal room is contaminated and the APR door shall not serve as an emergency exit from the BL4 laboratory. The APR door shall be appropriately tested to demonstrate that in the closed, locked-out mode, the door provides an air-tight barrier proven by pressure decay testing or other equivalent method;

    (iii) Any door(s) allowing access into a corridor from which there is direct ingress to an animal holding room must be fitted with either (1) an APR door or (2) a non-APR door, providing directional airflow is maintained from the laboratory corridor space into the animal room. For the purpose of fumigation, animal rooms equipped with non-APR doors opening into the adjacent interior corridors shall be considered one space (i.e., areas between air-tight doors shall be fumigated together).

    (iv) Any door(s) used for access to the service corridor (the secondary barrier) shall be self-closing and of solid construction, designed not to corrode, split or warp;

    (v) Access to the service corridor inside the secondary barrier shall be restricted and strictly controlled when animal rooms are in use. Whenever possible, the secondary barrier door(s) should be fitted with safety interlock switches designed to prevent it from opening when an animal holding room door (the primary barrier) is opened following room decontamination; if interlock devices cannot be used, specific administrative procedures shall be implemented to control access to the service corridor;

    (vi) The service corridor shall maintain a negative pressure (inward directional airflow) relative to adjoining traffic corridors;

    (vii) Prior to fumigation of the animal holding room, cages should be removed for autoclaving or chemical decontamination.

    (viii) Caging should be chosen to reduce the amount of animal detritus that can be thrown out of the cage and onto the floor of the animal holding room;

    (ix) The flow of personnel, material and equipment should be directed in order to minimize the spread of contamination from the animal holding room into adjacent areas of the laboratory.

    (x) Following animal room decontamination, safeguards involving the use of personal protective equipment and appropriate administrative controls shall be implemented for the safe retrieval of biological indicators in order to prevent the spread of infectious agents in the event of a decontamination failure.

    With regard to the frequency of class II biosafety cabinet recertification and testing, the NIH Guidelines require recertification/testing of biosafety cabinets at six-month intervals. However, modern biosafety cabinet design specifications incorporate continuous electronic and physical monitoring systems that track multiple operational parameters such as pressure differential, air flow velocity and plenum pressure with added capabilities for remote control and monitoring. Continuous performance monitoring and redundant safety features obviate the need for frequent testing of modern biosafety cabinets under normal conditions of use. Also the testing of biosafety cabinets in biomedical high containment (BL4) laboratories entails a complete shutdown of the laboratory for decontamination with appropriate sterilants to allow technicians to access the equipment safely. This procedure increases risks to laboratory staff working with the sterilants (often in the form of toxic gasses) and requires a halt to all research activities for an extended period of time depending on the number of cabinets to be tested or recertified. The NIH is in agreement with the recommendation of the BMBL that class II biosafety cabinets be tested and certified at least annually, with the understanding that retesting may have to be performed as needed at the discretion of the Institutional Biosafety Committee (IBC), if for example, equipment is moved or subject to unusual conditions of use.

    Appendix G-II-D-4-p currently states:

    Appendix G-II-D-4-p. The treated exhaust air from Class I and II biological safety cabinets may be discharged into the laboratory room environment or the outside through the facility air exhaust system. If exhaust air from Class I or II biological safety cabinets is discharged into the laboratory the cabinets are tested and certified at six-month intervals. The exhaust air from Class III biological safety cabinets is discharged, without recirculation through two sets of high efficiency particulate air/HEPA filters in series, via the facility exhaust air system. If the treated exhaust air from any of these cabinets is discharged to the outside through the facility exhaust air system, it is connected to this system in a manner (e.g., thimble unit connection (see Appendix G-III-L, Footnotes and References of Appendix G)) that avoids any interference with the air balance of the cabinets or the facility exhaust air system.

    Appendix G-II-D-4-p is amended as follows:

    Appendix G-II-D-4-p. The treated exhaust air from Class I and II biological safety cabinets may be discharged into the laboratory room environment or the outside through the facility air exhaust system. If exhaust air from Class I or II biological safety cabinets is discharged into the laboratory the cabinets are tested and certified at minimum on a yearly basis. More frequent testing and certification, based on the amount of use or other safety factors, shall be left to the discretion of the IBC. The exhaust air from Class III biological safety cabinets is discharged, without recirculation through two sets of high efficiency particulate air/HEPA filters in series, via the facility exhaust air system. If the treated exhaust air from any of these cabinets is discharged to the outside through the facility exhaust air system, it is connected to this system in a manner (e.g., thimble unit connection (see Appendix G-III-L, Footnotes and References of Appendix G)) that avoids any interference with the air balance of the cabinets or the facility exhaust air system.

    With regard to the periodic biologic validation of the centralized heat treatment process for all BL3 and BL4 facilities, the NIH Guidelines requires that this process be performed every 30 days while the BMBL recommends at least an annual biological validation. Similar to biosafety cabinets, modern catch tank systems for heat treatment of all laboratory effluents have also become more sophisticated and now incorporate redundant monitoring systems to track temperature and pressure parameters during each heat treatment cycle. In addition it should be noted that proper validation of the heat treatment catch tank system requires that testing be performed when the system is at or near capacity (i.e. “under load”)—more frequent validation of a heat treatment system that is below capacity may not serve the intended purpose of demonstrating that the equipment is functioning as intended. An additional margin of safety is achieved by monitoring sterilization cycle parameters on a routine basis. We are, therefore, in agreement with the recommendation of the BMBL that validation be performed as frequently as necessary at the discretion of the IBC and at least once annually to ensure that the centralized effluent heat treatment system is performing as intended under the established process parameters. This amendment shall apply to heat treatment systems used in both large animal BL3 and BL4 facilities.

    For large animal BL3 laboratories, the requirement for decontamination and inactivation (BL3-N) found at Appendix Q-II-C-1-b-(5) currently states:

    Appendix Q-II-C-1-b-(5). Liquid effluent from containment equipment, sinks, biological safety cabinets, animal rooms, primary barriers, floor drains, and sterilizers shall be decontaminated by heat treatment before being released into the sanitary system. The procedure used for heat decontamination of liquid wastes shall be monitored with a recording thermometer. The effectiveness of the heat decontamination process system shall be revalidated every 30 days with an indicator organism.

    Appendix Q-II-C-1-b-(5) is amended as follows:

    Appendix Q-II-C-1-b-(5). Liquid effluent from containment equipment, sinks, biological safety cabinets, animal rooms, primary barriers, floor drains, and sterilizers shall be decontaminated by heat treatment before being released into the sanitary system. The procedure used for heat decontamination of liquid wastes shall be monitored with a recording thermometer. The effectiveness of the heat decontamination process system shall be revalidated at minimum on a yearly basis with an indicator organism. More frequent validation, based on the amount of use or other safety factors, shall be left to the discretion of the IBC.

    For large animal BL3 laboratories, the requirement for animal facilities (BL3-N) found at Appendix Q-II-C-2-h currently states:

    Appendix Q-II-C-2-h. Liquid effluent from containment equipment, sinks, biological safety cabinets, animal rooms, primary barriers, floor drains, and sterilizers shall be decontaminated by heat treatment before being released into the sanitary system. The procedure used for heat decontamination of liquid wastes shall be monitored with a recording thermometer. The effectiveness of the heat decontamination process system shall be revalidated every 30 days with an indicator organism.

    Appendix Q-II-C-2-h is amended as follows:

    Appendix Q-II-C-2-h. Liquid effluent from containment equipment, sinks, biological safety cabinets, animal rooms, primary barriers, floor drains, and sterilizers shall be decontaminated by heat treatment before being released into the sanitary system. The procedure used for heat decontamination of liquid wastes shall be monitored with a recording thermometer. The effectiveness of the heat decontamination process system shall be revalidated at minimum on a yearly basis with an indicator organism. More frequent validation, based on the amount of use or other safety factors, shall be left to the discretion of the IBC.

    For large animal BL4 laboratories, the requirement for decontamination and inactivation (BL4-N) found at Appendix Q-II-D-1-b-(9) currently states:

    Appendix Q-II-D-1-b-(9). Liquid effluent from containment equipment, sinks, biological safety cabinets, animal rooms, primary barriers, floor drains, and sterilizers shall be decontaminated by heat treatment before being released into the sanitary system. Liquid wastes from shower rooms and toilets shall be decontaminated with chemical disinfectants or heat by methods demonstrated to be effective. The procedure used for heat decontamination of liquid wastes shall be monitored with a recording thermometer. The effectiveness of the heat decontamination process system shall be revalidated every 30 days with an indicator organism. Liquid wastes from the shower shall be chemically decontaminated using an Environmental Protection Agency-approved germicide. The efficacy of the chemical treatment process shall be validated with an indicator organism. Chemical disinfectants shall be neutralized or diluted before release into general effluent waste systems.

    Appendix Q-II-D-1-b-(9) is amended as follows:

    Appendix Q-II-D-1-b-(9). Liquid effluent from containment equipment, sinks, biological safety cabinets, animal rooms, primary barriers, floor drains, and sterilizers shall be decontaminated by heat treatment before being released into the sanitary system. If required by design, regulation, local ordinance or policy, liquid wastes from shower rooms and toilets shall be decontaminated with chemical disinfectants or heat by methods demonstrated to be effective. The procedure used for heat decontamination of liquid wastes shall be monitored with a recording thermometer. The effectiveness of the heat decontamination process system shall be revalidated at minimum on a yearly basis with an indicator organism. More frequent validation, based on the amount of use or other safety factors, shall be left to the discretion of the IBC. If required by design, regulation, local ordinance or policy, liquid wastes from the shower shall be chemically decontaminated using an Environmental Protection Agency-approved germicide. The efficacy of the chemical treatment process shall be validated with an indicator organism. Chemical disinfectants shall be neutralized or diluted before release into general effluent waste systems.

    For large animal BL4 laboratories, the requirement for animal facilities (BL4-N) found at Appendix Q-II-D-2-i currently states:

    Appendix Q-II-D-2-i. Liquid effluent from containment equipment, sinks, biological safety cabinets, animal rooms, primary barriers, floor drains, and sterilizers shall be decontaminated by heat treatment before being released into the sanitary system. Liquid wastes from shower rooms and toilets shall be decontaminated with chemical disinfectants or heat by methods demonstrated to be effective. The procedure used for heat decontamination of liquid wastes shall be monitored with a recording thermometer. The effectiveness of the heat decontamination process system shall be revalidated every 30 days with an indicator organism. Liquid wastes from the shower shall be chemically decontaminated using an Environmental Protection Agency-approved germicide. The efficacy of the chemical treatment process shall be validated with an indicator organism. Chemical disinfectants shall be neutralized or diluted before release into general effluent waste systems.

    Appendix Q-II-D-2-i is amended as follows:

    Appendix Q-II-D-2-i. Liquid effluent from containment equipment, sinks, biological safety cabinets, animal rooms, primary barriers, floor drains, and sterilizers shall be decontaminated by heat treatment before being released into the sanitary system. If required by design, regulation, local ordinance or policy, liquid wastes from shower rooms and toilets shall be decontaminated with chemical disinfectants or heat by methods demonstrated to be effective. The procedure used for heat decontamination of liquid wastes shall be monitored with a recording thermometer. The effectiveness of the heat decontamination process system shall be revalidated at minimum on a yearly basis with an indicator organism. More frequent validation, based on the amount of use or other safety factors, shall be left to the discretion of the IBC. If required by design, regulation, local ordinance or policy, liquid wastes from the shower shall be chemically decontaminated using an Environmental Protection Agency-approved germicide. The efficacy of the chemical treatment process shall be validated with an indicator organism. Chemical disinfectants shall be neutralized or diluted before release into general effluent waste systems.

    Dated: April 9, 2016. Lawrence A. Tabak, Deputy Director, National Institutes of Health.
    [FR Doc. 2016-08810 Filed 4-14-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; NLM PEOPLE LOCATOR® System

    Summary: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

    Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: David Sharlip, NLM Project Clearance Liaison, Office of Administrative and Management Analysis Services, OAMAS, NLM, NIH, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number (301) 496-5441, or Email your request, including your address to: [email protected] Formal requests for additional plans and instruments must be requested in writing.

    Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

    Proposed Collection: NLM People Locator System 0925-0612, Expiration Date: 07/31/2016, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH).

    Need and Use of Information Collection: This collection of data is intended to assist in the reunification of family members and friends who are separated during a disaster. Experience in operational drills and during real-world disasters such as the January 2010 earthquakes in Haiti demonstrates that family members and loved ones are often separated during disasters and have significant difficulty determining each other's safety, condition, and location. Reunification can not only improve their emotional well-being during the recovery period, but also improve the chances that injured victims will be cared for once they are released from urgent medical care. Family and friends are also a valuable source of medical information that may be important to the care of injured victims (e.g., by providing family or personal medical history, information about allergies). The National Library of Medicine (NLM) aims to assist Federal, State and Local agencies in disaster relief efforts and to serve its mission of supporting national efforts to the response to disasters via the PEOPLE LOCATOR® system and related mobile app (ReUniteTM) developed as part of the intramural Lost Person Finder (LPF) R&D project. The information collection would support efforts to reunite family and friends who are separated during a disaster. Information about missing (“lost”) people would be collected from family members or loved ones who are searching for them. Information about recovered (“found”) people could be provided by medical personnel, volunteers and other relief workers assisting in the disaster recovery effort. Information collected about missing and recovered persons would vary including any one of the following and possibly all: A photograph, name (if available for a found person), age group (child, adult) and/or range, gender, status (alive and well, injured, deceased, unknown), and location. The information collection would be voluntary. It would be activated only during times of declared emergencies, training and demonstration support activities, and would operate in declared emergencies until relief efforts have ceased in response to a particular disaster. This data collection is authorized pursuant to sections 301, 307, 465 and 478A of the Public Health Service Act [42 U.S.C. 241, 242l, 286 and 286d]. NLM has in its mission the development and coordination of communication technology to improve the delivery of health services.

    OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 7,500.

    Estimated Annualized Burden Hours Types of respondent Number of
  • respondents
  • Number of
  • responses per respondent
  • Average time per response
  • (in hours)
  • Total annual burden
  • hours
  • Emergency Care First-Responders, Physicians, Other Health Care Providers 500 100 3/60 2,500 Family members seeking a missing person 50,000 2 3/60 5,000 Total 50,500 150,000 7,500
    Dated: April 7, 2016. David Sharlip, Project Clearance Liaison, NLM, NIH.
    [FR Doc. 2016-08659 Filed 4-14-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study—Wave 4 of Data Collection (NIDA)

    Summary: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

    Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing or request more information on the proposed project, contact: Kevin P. Conway, Ph.D., Deputy Director, Division of Epidemiology, Services, and Prevention Research, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 5185; or call non-toll-free number (301) 443-8755; or Email your request, including your address to: [email protected]. Formal requests for additional plans and instruments must be requested in writing.

    Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

    Proposed Collection: Population Assessment of Tobacco and Health (PATH) Study—Wave 4 of Data Collection (NIDA)—0925-0664, expiration date 8/31/2018—REVISION—NIDA, NIH, in partnership with the Food and Drug Administration (FDA).

    Need and Use of Information Collection: This is a revision request (OMB number 0925-0664, expiration date 8/31/2018) for the Population Assessment of Tobacco and Health (PATH) Study to conduct the fourth wave of data collection. The PATH Study is a large national longitudinal cohort study on tobacco use behavior and health among the U.S. household population of adults age 18 and older and youth ages 12 to 17. On an annual basis, the PATH Study conducts interviews with and collects biospecimens from adults and youth to help inform the development, implementation, and evaluation of tobacco-product regulations by FDA in meeting its mission under the Family Smoking Prevention and Tobacco Control Act (TCA) to regulate tobacco products, including tobacco-product advertising, labeling, marketing, constituents, ingredients, and additives. The longitudinal design of the PATH Study provides it with the capacity to measure and report within-person changes and between-person differences in tobacco product use behaviors and health effects within the cohort over time. These data will help to inform regulatory decisions and actions by FDA and FDA's evaluations of associations between its regulations and tobacco use behaviors and health indicators in the population.

    OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 105,079.

    Estimated Annualized Burden Hours Form name Type of respondent Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total annual burden hours
    1. Household Screener Households 86,559 1 14/60 20,197 2. Shadow Youth Only Screener Households 56,659 1 5/60 4,722 3. Extended Interview * Adults—Adult respondents—previous wave 23,414 1 1 23,414 4. Consent for Extended Interview Adults—New adults and Wave 1 youth respondents who age up to adult cohort—Wave 4 13,984 1 4/60 932 5. Individual Screener Adults—New adults 9,152 1 6/60 915 6. Extended Interview * Adults—New adults and Wave 1 youth respondents who age up to adult cohort—Wave 4 10,737 1 68/60 12,169 7. Consent for Biological Samples Adults—New adults and Wave 1 youth respondents who age up to adult cohort—Wave 4 10,737 1 5/60 895 8. Biospecimen Collection: Urine Adults 18,301 1 10/60 3,050 9. Biospecimen Collection: Blood Adults—New adults and Wave 1 youth respondents who age up to adult cohort—Wave 4 4,832 1 18/60 1,450 10. Tobacco Use Form Adults 23,133 1 5/60 1,928 11. Follow-up/Tracking Participant Information Form Adults 34,151 2 8/60 9,107 12. Verification Interview Adults 33,889 1 2/60 1,130 13. Validation Interview Adults 301 1 4/60 20 14. Extended Interview ** Youth—Youth respondents—previous wave 8,627 1 35/60 5,032 15. Assent for Extended Interview Youth—New youth and shadow youth who age up to youth cohort—Wave 4 7,657 1 3/60 383 16. Extended Interview ** Youth—New youth and shadow youth who age up to youth cohort—Wave 4 6,432 1 45/60 4,824 17. Assent for urine collection Youth 15,059 1 5/60 1,255 18. Biospecimen Collection: Urine Youth 10,239 1 10/60 1,707 19. Tobacco Use Form Youth 10,239 1 5/60 853 20. Parent Interview Adults—Parents of youth respondents—previous wave 8,800 1 16/60 2,347 21. Parent Permission and Consent for Parent Interview Adults—Parents of new youth and parents of Shadow youth who age up to youth cohort—Wave 4 7,657 1 5/60 638 22. Parent Interview Adults—Parents of new youth and parents of shadow youth who age up to youth cohort—Wave 4 6,561 1 19/60 2,078 23. Parent permission for urine collection Adults—Parents of youth respondents—previous wave 15,360 1 3/60 768 24. Follow-up/Tracking Participant Information Form for Youth (completed by parents) Adults—Parents of youth respondents 15,059 2 8/60 4,016 25. Follow-up/Tracking Participant Information Form for sample shadow youth (completed by parents) Adults—Parents of shadow youth 4,684 2 8/60 1,249 Total 49,210 496,116 105,079
    Dated: April 5, 2016. Genevieve deAlmeida-Morris, Project Clearance Liaison, National Institute on Drug Abuse, NIH.
    [FR Doc. 2016-08658 Filed 4-14-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR- 5921-N-05] Privacy Act of 1974; Notice of a Computer Matching Program Between the Department of Housing and Urban Development (HUD) and the Department of Veteran's Affairs (VA) AGENCY:

    Office of Administration, HUD.

    ACTION:

    Notice of a computer matching program between HUD and VA.

    SUMMARY:

    In accordance with the Privacy Act of 1974 (5 U.S.C. 552a), as amended by the Computer Matching and Privacy Protection Act of 1988 (Pub. L. 100-503), and the Office of Management and Budget (OMB) Guidelines on the Conduct of Matching Programs (54 FR 25818) (June 19, 1989); and OMB Bulletin 89-22, “Instructions on Reporting Computer Matching Programs to the Office of Management and Budget (OMB), Congress and the Public,” HUD is issuing a public notice of its intent to conduct a recurring computer matching program with VA for the purpose of incorporating VA debtor files into the Credit Alert Verification Reporting System (CAIVRS), which is a HUD computer information system.

    DATES:

    Effective Date: The effective date of the matching program shall begin May 16, 2016, or at least 40 days from the date that copies of the Computer Matching Agreement, signed by both HUD and VA Data Integrity Boards (DIBs), are sent to OMB and Congress, whichever is later, provided that no comments that would result in a contrary determination are received.

    Comments Due Date: May 16, 2016.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this notice to the Rules Docket Clerk, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street SW., Room 10110, Washington, DC 20410. Communications should refer to the above docket number and title. A copy of each communication submitted will be available for public inspection and copying between 8:00 a.m. and 5:00 p.m. weekdays at the above address.

    FOR FURTHER INFORMATION CONTACT:

    Contact the “Recipient Agency” Acting Departmental Privacy Officer, Department of Housing and Urban Development, 451 Seventh Street SW., Room 10139, Washington, DC 20410, telephone number (202) 402-6147 or the “Source Agency” Department of Veteran's Affairs, U.S. Department of Veterans Affairs, Debt Management Center, Jorgeana Williams, 156E, 1 Federal Drive, Ft. Snelling, MN 55111, telephone number (612) 970-5703. [These are not a toll-free numbers.] A telecommunication device for hearing- and speech-impaired individuals (TTY) is available at (800) 877-8339 (Federal Information Relay Service).

    SUPPLEMENTARY INFORMATION:

    HUD's CAIVRS database includes delinquent debt information from the Departments of Veteran's Affairs (VA), Education, Justice (DOJ), the Small Business Administration (SBA), and the U.S. Department of Agriculture (USDA). This data match will allow the prescreening of applicants for federal direct loans or federally guaranteed loans, for the purpose of determining the applicant's credit worthiness, by ascertaining whether the applicant is delinquent or in default on a loan owed directly to, or federally guaranteed by, the Federal government. Lending Federal agencies and authorized private lending institution will be able to use the CAIVRS debtor file to verify that the loan applicant is not in default, or delinquent on a Federal direct or federally guaranteed loan, prior to granting the applicant a loan. The CAIVRS database contains Personally Identifiable Information (PII) contributed by participating Federal agencies, including Social Security Numbers (SSNs) and other records of borrowers delinquent or in default on debts owed to, or guaranteed by HUD and other Federal agencies. Authorized users may not deny, terminate, or make a final decision concerning any loan assistance to an applicant or take other adverse action against such applicant based on the information produced by data matches conducted under CAIVRS, until such authorized users have independently verified such adverse information.

    Reporting of Matching Program

    In accordance with Public Law 100-503, the Computer Matching and Privacy Protection Act of 1988 as amended, and OMB Bulletin 89-22, “Instructions on Reporting Computer Matching Programs to the Office of Management and Budget (OMB), Congress and the Public,” copies of this notice and report are being provided to the U.S. House Committee on Oversight Government Reform, the U.S. Senate Homeland Security and Governmental Affairs Committee, and OMB.

    Authority

    HUD has authority to collect and review mortgage data pursuant to the National Housing Act, as amended, 12 U.S.C. 1701 et seq., and related laws. This computer matching will be conducted pursuant to Public Law 100-503, “The Computer Matching and Privacy Protection Act of 1988,” as amended, and OMB Circulars A-129 (Managing Federal Credit Programs). One of the purposes of all Executive departments and agencies is to implement efficient management practices for Federal Credit Programs. OMB Circular A-129 was issued under the authority of the Budget and Accounting Act of 1921, as amended; the Budget and Accounting Act of 1950, as amended; the Debt Collection Act of 1982, as amended by the Debt Collection Improvement Act of 1996; Section 2653 of Public Law 98-369; the Federal Credit Reform Act of 1990, as amended; the Federal Debt Collection Procedures Act of 1990, the Chief Financial Officers Act of 1990, as amended; Executive Order 8248; the Cash Management Improvement Act Amendments of 1992; and pre-existing common law authority to charge interest on debts and to offset payments to collect debts administratively.

    Objectives To Be Met by the Matching Program

    The objective of this matching program is to give program agencies access to a system that allows them to prescreen applicants for loans made, or loans guaranteed, by the Federal Government to ascertain if the applicant is delinquent in paying a debt owed to or guaranteed by the Federal Government. As part of this process, HUD will be provided access to VA's debtor data for prescreening purposes.

    The use of CAIVRS will allow HUD to better monitor its credit programs and to reduce the credit extended to individuals with outstanding delinquencies on debts owed to HUD and other Federal agencies. VA expects to achieve savings through risk reduction and debt recovery. By the very nature of debt prevention, expected savings must be the subject of some assumptions, including the anticipated behavior of the matching subjects.VA also participates in CAIVRS as a cooperative effort in a governmentwide credit plan that may benefit other agencies as much, if not more, than VA.

    Under this computer matching program, HUD/CAIVRS receives limited information on borrowers who have defaulted on loans administered by participating Federal agencies each month. The information includes: Borrower ID Number—The Social Security Number (SSN), Employer Identification Number (EIN) or Taxpayer Identification Number (TIN) of the borrower on a delinquent or defaulted federal direct loan or federally-guaranteed loan. Federal agency personnel and authorized lenders must enter a user authorization code followed by either a SSN or EIN to access CAIVRS. Only the following information is returned or displayed:

    • Yes/No as to whether the holder of that SSN/EIN is in default on a Federal loan; and

    • If Yes, then CAIVRS provides to the lender:

    ○ Loan case number;

    ○ Record type (claim, default, foreclosure, or judgment);

    ○ Agency administering the loan program;

    ○ Phone number at the applicable Federal agency (to call to clear up the default); and

    ○ Confirmation Code associated with the query.

    Federal law mandates the suspension of the processing of applications for Federal credit benefits (such as government-insured loans) if the applicants are delinquent on Federal or Federally-guaranteed debt. Processing may continue only after the borrower satisfactorily resolves the debt (e.g., pays in full or renegotiates a new payment plan). To remove a CAIVRS sanction, the borrower must contact the Federal agency that reported their SSN or EIN to HUD/CAIVRS using the information provided.

    Records To Be Matched

    HUD will use records from the Single Family Default Monitoring System (SFDMS/F42D) (72 FR 65350, November 20, 2007, and Single Family Insurance System—Claims Subsystem, CLAIMS, A43C (79 FR 10825, February 26, 2014), as combined in CAIVRS to provide an up-to-date dataset to be used in records matching. SFDMS maintains data on mortgages that are 90 or more days delinquent. The Mortgagee or Servicer must submit a Monthly Delinquent Loan Report (HUD-92068-A) to HUD on a monthly basis until the mortgage status has been completed by all Mortgagees, or is otherwise terminated or deleted. Mortgagees and Servicers provide default data to HUD via Electronic Data Interchange (EDI) or using the Internet via FHA Connection, through which the data is sorted, pre-screened, key entered, edited, and otherwise processed. Reports are generated for HUD Headquarters and Field Offices to review.

    CLAIMS provides automated receipt, tracking and processing of form HUD-27011, Single Family Application for Insurance Benefits. CLAIMS provides online update and inquiry capability to Single Family Insurance and Claims databases, and to cumulative history files. Claims payments are made by Electronic Funds Transfer (EFT) via an HDS platform (IBM mainframe/Treasury interface) on a daily basis.

    For the actual data match, VA will use records from the system of records entitled “Accounts Receivable Records 88VA244.”

    Notice Procedures

    HUD and VA have separate procedures for notifying individuals that their records will be matched to determine whether they are delinquent or in default on a Federal debt. HUD will notify individuals at the time of application for a HUD/FHA mortgage, and VA will notify individuals at the time of application for a VA loan services. VA may disclose information from that application to other Federal agencies under published “routine use,” without the applicants' consent, as permitted by law.

    HUD and VA published a notice concerning routine use disclosures in the Federal Register to inform individuals that a computer match may be performed to determine a loan applicant's credit status with the Federal Government. The Privacy Act also requires that a copy of each Computer Matching Agreement entered into with a recipient agency shall be available upon request to the public.

    Categories of Records/Individuals Involved

    Data elements disclosed in computer matching governed by this Agreement are Personally Identifiable Information (PII) from the specified VA system of record. The data elements supplied by VA to CAIVRS are the following:

    • Borrower ID Number—The Social Security Number (SSN), Employer Identification.

    • Number (EIN) or Taxpayer Identification Number (TIN) of the borrower on a delinquent or defaulted Federal direct loan or Federally guaranteed loan.

    • Case Number—A reference number issued by the reporting agency for the delinquent or defaulted Federal direct loan or Federally guaranteed loan.

    • Agency Code—A code assigned to the reporting agency.

    • Type Code—A code that indicates the type of record—claim, default, foreclosure, or judgment.

    • Borrower ID Type—A code that indicates whether the Borrower ID Number is a SSN, EIN, or TIN.

    Period of the Match

    Matching will begin at least 40 days from the date that copies of the Computer Matching Agreement, signed by HUD and VA DIBs, are sent to both Houses of Congress and OMB; or at least 30 days from the date this notice is published in the Federal Register, whichever is later, provided that no comments that would result in a contrary determination are received. The matching program will be in effect and continue for 18 months with an option to renew for 12 additional months unless one of the Parties to the Agreement advises the other in writing to terminate or modify the Agreement.

    Dated: April 6, 2016. Patricia A. Hoban-Moore, Chief Administrative Officer, Office of Administration.
    [FR Doc. 2016-08775 Filed 4-14-16; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5921-N-04] Implementation of the Privacy Act of 1974, as Amended; System of Records Notice Amendment, Distributive Shares and Refunds Subsystem AGENCY:

    Office of Housing, HUD.

    ACTION:

    System of records notice amendment.

    SUMMARY:

    HUD is proposing to amend information published in the Federal Register about one of its system of records, Distributive Shares and Refunds Subsystem (DSRS). The revision implemented under this republication reflects administrative changes to the system of records location, authority, purpose, and records retention statements to refine previously published information, and incorporates a new coding structure to easily differentiate this system of records notice (SORN) from other program specific SORNs. This update improves previously published details in a clear and cohesive format. A more detailed description of the present systems status is republished under this notice. This notice deletes and supersedes prior notice published in the Federal Register at 72 FR 40890 on July 25, 2007. The scope and functional purpose in place for this system remain unchanged.

    DATES:

    This action shall become effective immediately upon publication of this notice April 15, 2016.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this notice to the Rules Docket Clerk, Office of the General Counsel, Department of Housing and Urban Development, 451 Seventh Street SW., Room 10276, Washington, DC 20410-0500. Communication should refer to the above docket number and title. Faxed comments are not accepted. A copy of each communication submitted will be available for public inspection and copying between 8 a.m. and 5 p.m. weekdays at the above address.

    FOR FURTHER INFORMATION CONTACT:

    Frieda B. Edwards, Acting Chief Privacy Officer, 451 Seventh Street SW., Room 10139, Washington, DC 20410, telephone number 202-402-6828 (this is not a toll-free number). Individuals who are hearing- and speech-impaired may access this number via TTY by calling the Federal Relay Service telephone number at 800-877-8339 (this is a toll-free number).

    SUPPLEMENTARY INFORMATION:

    Publication of this notice allows the Department to satisfy its reporting requirement and keep an up-to-date accounting of its SORN publications. The amended SORN proposal will incorporate Federal privacy requirements and the Department's policy requirements. The Privacy Act provides individuals with certain safeguards against an invasion of their personal privacy by requiring Federal agencies to protect records contained in an agency system of records from unauthorized disclosure, by ensuring that the information collected is current and collected only for its intended use, and by providing adequate safeguards to prevent misuse of such information. In addition, this notice demonstrates the Department's focus on following industry best practices to protect the personal privacy of the individuals covered by this SORN. This SORN states the name and location of the record system, the authority for and manner of its operations, the categories of individuals that it covers, the type of records that it contains, the sources of the information for those records, the routine uses made of the records and the type of exemption in place for the records. This notice includes the business address of Department officials who will inform interested persons of the procedures whereby they may gain access to and/or request amendments to records pertaining to them.

    This publication does not meet the threshold requirements established by the Office of Management and Budget (OMB) for filing a report to OMB, the Senate Committee on Homeland Security and Governmental Affairs, and the House Committee on Oversight and Government Reform as instructed by Paragraph 4c of Appendix l to OMB Circular No. A-130, “Federal Agencies Responsibilities for Maintaining Records About Individuals,” November 28, 2000. Accordingly, this notice is being revised to provide non-substantive changes that clarify text published under the prior notice location, purpose, and retention and disposal of records sections.

    Authority:

    5 U.S.C. 552a; 88 Stat. 1896; 42 U.S.C. 3535(d).

    Dated: April 8, 2016. Patricia A. Hoban-Moore, Senior Agency Official for Privacy. HSNG.SF/FB.01

    System of Records No.: HSNG.SF/FB.01 System Name:

    Distributive Shares and Refunds Subsystem (DSRS)-A80D.

    System Location:

    Department of Housing and Urban Development, 470 L'Enfant Plaza East, Room 3119, Washington, DC 20026; HUD Information Technology Systems Production Data Center in South Charleston, West Virginia, and Lanham, Maryland; and at the location of the service providers under contract with HUD.

    Categories of Individuals Covered by the System:

    Homeowners (Mortgagors) who had Federal Housing Administration (FHA) mortgage insured loans and may be eligible for an upfront mortgage insurance premium (UFMIP) or distributive shares refund.

    Categories of Records in the System:

    Homeowners (Mortgagors) information is made up of the following elements: Borrower and/or co-borrower names, Social Security number (SSN), mailing address, property address, FHA case number, loan endorsement and termination dates, homeowners distributive shares refunds amount due, correspondence actions, including the number of times it was mailed to the homeowner, type of correspondence sent, and status of issued refund check.

    Authority for Maintenance of the System:

    The National Housing Act and Section 7(d) of the Department of Housing and Urban Development Act, section 203; Public Law 89-174; 24 CFR 5.210, 24 CFR 200.1101; 24 CFR 203.35; Debt Collection Act of 1982, Public Law 97-365; Housing and Community Development Act of 1987, 42 U.S.C § 3543, titled “Preventing fraud and abuse in Department of Housing and Urban Development programs” and enacted as part of the Housing and Community Development Act of 1987, which permits the collection of SSN.

    Purpose(s):

    The DSRS was designed in response to a Congressional mandate, wherein HUD established a new method for collecting and processing FHA UFMIP refunds or distributive share payments. The DSRS maintains records on individuals that are entitled to either two types of payments: (1) An UFMIP refund, or (2) a distributive share payment. The system is operated by the Department's Office of Single Family Insurance Operations to service unclaimed terminated loan transactions, should a homeowner terminate their mortgage insurance prior to loan maturity, entitling the homeowner to a premium refund. The DSRS records, controls, and tracks appropriations data for all terminations, disbursements, transfers, transactions, and produces daily, weekly, monthly, quarterly, and annual reports on these transactions. The system gives the Department's operating areas access to their own cash data, provides management access to all the cash data in prescribed formats, produces appropriation reports in accordance with the Federal Credit Reform Act of 1990, 2 U.S.C. 661 et.1 seq., produces and transmits monthly cash reconciliation to the Department's accountants, and processes returned checks, check tracer actions, and related correspondence for distribution to homeowners.

    DSRS interfaces with the following systems to facilitate payment and refund transactions:

    (1) Single Family Insurance System (SFIS)—to calculate the unearned portion of the UFMIP for eligible cases, to send refund data to the DSRS for distribution of payments to the homeowner for the unearned portions of the UFMIP or distributive shares.

    (2) Single Family Premium Collection Subsystems (SFPCS) Upfront, and the Single Family Premium Collection Subsystems for Periodic (SFPCS-P)—to receive refund data from DSRS to generate the UFMIP refund or distributive share payments.

    a. Equally important, the Department utilizes the DSRS to generate correspondence actions to attempt to notify each unpaid mortgagor of their FHA insurance refund for a period of 2 years. This process occurs once the Department receives notification of a mortgage insurance termination. After this 2-year hold, the Department makes available to the general public a cumulative listing of any unpaid refund that remains unpaid. The information includes the homeowner's name, last known address, FHA case number, termination data, and refund amount. This information is also made available to the public by HUD's refund database, “Does HUD Owe You a Refund?”

    Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of Such Uses.

    In addition to those disclosures generally permitted under 5 U.S.C. Section 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside HUD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

    (1) To authorized requesters or third party tracers who request access to UFMIP and distributive shares homeowner refund information, when such information is unavailable on HUD's FOIA reading room or refunds database Web sites. This information is releasable under FOIA. Third party release of this material may require authorized consent of the homeowner to whom the records belong, and must adhere to all HUD procedures prior to release.

    (2) To the U.S. Department of the Treasury for collection and disbursement of check transactions.

    (3) To the recorders' offices for recording legal documents and responses to offsets (i.e., child support) or other legal responses required during the servicing of the insured loan to allow HUD to release mortgage liens, and respond to bankruptcies or deaths of mortgagors to protect the interest of the Secretary of HUD.

    (4) To the Office of Inspector General to investigate possible fraud revealed in servicing homeowners refunds to allow HUD to protect the interest of the Secretary.

    (5) To contractors, grantees, experts, consultants and their agents, or others performing or working under a contract, service, grant, or cooperative agreement with HUD, when necessary to accomplish an agency function related to a system of records. Disclosure requirements are limited to only those data elements considered relevant to accomplishing an agency function. Individuals provided information under this routine use conditions are subject to Privacy Act requirements and disclosure limitations imposed on the Department.

    (6) To appropriate agencies, entities, and persons when:

    (a) HUD suspects or has confirmed that the security or confidentiality of information in a system of records has been compromised;

    (b) HUD 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 systems or programs (whether maintained by HUD or another agency or entity) that rely upon the compromised information; and

    (c) The disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with HUD's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm for purposes of facilitating responses and remediation efforts in the event of a data breach.

    (7) To appropriate agencies, entities, and persons to the extent that such disclosures are compatible with the purpose for which records in this system were collected, as set forth by Appendix I 1—HUD's Library of Routine Uses published in the Federal Register.

    1http://portal.hud.gov/hudportal/documents/huddoc?id=append1.pdf.

    Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System: Storage:

    Electronic records are maintained on the mainframe and on CD and DVD. Paper records are maintained in locked file cabinets and destroyed immediately after electronic imaging and payment verification has occurred. This is usually done within 30 days of receipt.

    Retrievability:

    Records are retrieved by FHA case number and by an individual's name. Paper records are not retrieved from the system.

    Safeguards:

    CDs and DVDs are maintained in secured office space and secure file rooms to which access is limited to those personnel who service the records. Access to electronic records is granted by user ID and password and to users who have a need to access such records. Paper records are maintained in locked file cabinets and destroyed immediately after electronic imaging and payment verification has occurred.

    Retention and Disposal:

    DSRS records are maintained in accordance with HUD's Deposition General Records Schedule 1.1, Financial Management and Reporting Records, Item 010. Paper records do not require storage by the Federal Records Center. Paper records consist of the HUD form, HUD-27050-B (Application for Premium Refund or Distributive Share Payment), which is transferred to electronic media, and then destroyed immediately after electronic imaging and payment verification has occurred. Paper records are destroyed by shredding. Paper records are maintained for a period not to exceed 30 days. CD and DVD images of records are maintained for 40 years after which they are destroyed as instructed by guidelines outlined in HUD's IT Security Handbook (2400.25), pursuant to NIST Special Publication 800-88 “Guidelines for Media Sanitization.”

    System Manager(s) and Address:

    Department of Housing and Urban Development, Office of Single Family Insurance Operations Division, Chief, Disbursements and Customer Service Branch, 470 L'Enfant Plaza East, Room 3119, Washington, DC 20026.

    Notification and Record Access Procedures:

    For Information, assistance, or inquiries about the existence of records contact Frieda B. Edwards, Acting Chief Privacy Officer, 451 Seventh Street SW., Room 10139, Washington, DC 20410, telephone number 202-402-6828. When seeking records about yourself from this system of records or any other HUD system of records, your request must conform with the Privacy Act regulations set forth in 24 CFR part 16. You must first verify your identity by providing your full name, current address, and date and place of birth. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. In addition, your request should:

    (1) Explain why you believe HUD would have information on you.

    (2) Identify which HUD office you believe has the records about you.

    (3) Specify when you believe the records would have been created.

    (4) Provide any other information that will help the Freedom of Information Act (FOIA) staff determine which HUD office may have responsive records.

    If you are is seeking records pertaining to another living individual, you must obtain a statement from that individual certifying their agreement for you to access their records. Without the above information, the HUD FOIA Office may not be able to conduct an effective search, and your request may be denied due to lack of specificity or lack of compliance with applicable regulations.

    Contesting Records Procedures:

    The Department's rules for contesting contents of records and appealing initial denials appear in 24 CFR part 16, Procedures for Inquiries. Additional assistance may be obtained by contacting Frieda B. Edwards, Acting Chief Privacy Officer, 451 Seventh Street, SW., Room 10139, Washington, DC 20410, or the HUD Departmental Privacy Appeals Officers, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 10110 Washington DC 20410.

    Record Source Categories:

    The records maintained by the system are provided directly by the homeowners, by completion of the Uniform Residential Loan Application (form HUD-92900-A). Information is also collected by the mortgagees (lenders), who collect the personal information from the homeowner and enters the information into the HUD Single Family Computerized Home Underwriting Management System (CHUMS). After the case is endorsed, CHUMS sends case data to SFIS, which is maintained in SFIS until the case is terminated (non-claim, claim, or other type of cancellation). Once the case is non-claim terminated, termination data is sent to the DSRS.

    Exemptions From Certain Provisions of the Act:

    None.

    [FR Doc. 2016-08774 Filed 4-14-16; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5939-N-01] Section 8 Housing Assistance Payments Program—Fiscal Year (FY) 2016 Inflation Factors for Public Housing Agency (PHA) Renewal Funding AGENCY:

    Office of the Assistant Secretary for Policy Development and Research, HUD.

    ACTION:

    Notice.

    SUMMARY:

    The Consolidated Appropriations Act, 2016 requires that HUD apply “an inflation factor as established by the Secretary, by notice published in the Federal Register” to adjust FY 2016 renewal funding for the Tenant-based Rental Assistance Program or Housing Choice Voucher (HCV) Program of each PHA. HUD began using Renewal Funding Inflation Factors in FY 2012. These Renewal Funding Inflation Factors incorporate economic indices to measure the expected change in per unit costs (PUC) for the HCV program. The methodology for FY 2016 is modified from what was used in FY 2015.

    DATES:

    Effective date: April 15, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Miguel A. Fontanez, Director, Housing Voucher Financial Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, telephone number 202-402-4212; or Peter B. Kahn, Director, Economic and Market Analysis Division, Office of Policy Development and Research, telephone number 202-402-2409, for technical information regarding the development of the schedules for specific areas or the methods used for calculating the inflation factors, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410. Hearing- or speech-impaired persons may contact the Federal Relay Service at 800-877-8339 (TTY). (Other than the “800” TTY number, the above-listed telephone numbers are not toll free.)

    SUPPLEMENTARY INFORMATION: I. Background

    Tables showing Renewal Funding Inflation Factors will be available electronically from the HUD data information page at: http://www.huduser.gov/portal/datasets/rfif/FY2016/FY2016_RFIF_FMR_AREA_REPORT.pdf.

    Division L, Title II, Consolidated Appropriations Act, 2016 requires that the HUD Secretary, for the calendar year 2016 funding cycle, provide renewal funding for each public housing agency (PHA) based on validated voucher management system (VMS) leasing and cost data for the prior calendar year and by applying an inflation factor as established by the Secretary, by notice published in the Federal Register. This notice provides the FY 2016 inflation factors and describes the methodology for calculating them.

    II. Methodology

    The Department has focused on measuring the change in average per unit cost (PUC) as captured in HUD's administrative data in VMS. In order to predict the likely path of PUC over time, HUD has implemented a model that uses three economic indices that capture key components of the economic climate and assist in explaining the changes in PUC. These economic components are the seasonally-adjusted unemployment rate (lagged twelve months), the Consumer Price Index from the Bureau of Labor Statistics, and the “wages and salaries” component of personal income from the National Income and Product Accounts from the Bureau of Economic Analysis. This model subsequently forecasts the expected annual change in average PUC from Calendar Year (CY) 2015 to CY 2016 for the voucher program on a national basis by incorporating comparable economic variables from the Administration's economic assumptions. For reference, these economic assumptions are described in the FY 2016 Budget. The inflation factor for an individual geographic area is based on the annualized change in the area's Fair Market Rent (FMR) between FY 2014 and FY 2016. These changes in FMR are then scaled such that the voucher-weighted average of all individual area inflation factors is equal to the expected annual change in national PUC from 2015 to 2016, and also such that no area has a factor less than one. HUD subsequently applies these calculated individual area inflation factors to eligible renewal funding for each PHA based on VMS leasing and cost data for the prior calendar year. The CY 2016 PHA HCV allocation uses 0.8 percent as the annual change in PUC. This figure was calculated by using VMS data through December of 2015 and actual performance of economic indices through December of 2015.

    III. The Use of Inflation Factors

    The inflation factors have been developed to account for relative differences in the changes of local rents so that HCV funds can be allocated among PHAs. In response to comments provided to HUD as requested in the 2015 Renewal Funding Inflation Factor notice, HUD has used the annualized change in FMRs measured between FY 2014 and FY 2016 in the apportionment of the national inflation rate to account for both the current change in rents but also the changes in rents experienced last year when the predicted inflation rate was negative. HUD anticipates that in 2017, the national inflation rate will be based on a new model of Per Unit Cost HUD is developing in response to comments that is based on independent forecasts of gross rents and tenant incomes without relying on historical values of Per Unit Cost, and will apportion this change based on the change in individual areas FMRs between FY 2016 and FY 2017.

    IV. Geographic Areas and Area Definitions

    Inflation factors based on renewal funding and area FMR changes are produced for all FMR areas. The tables showing the Renewal Funding Inflation Factors available electronically from the HUD data information page list the inflation factors for each FMR area and are created on a state by state basis. The inflation factors use the same OMB metropolitan area definitions, as revised by HUD, that are used in the FY 2016 FMRs. To make certain that they are referencing the correct inflation factors, PHAs should refer to the Area Definitions Table on the following Web page: http://www.huduser.org/portal/datasets/rfif/FY2016/FY2016_RFIF_FMR_AREA_REPORT.pdf. The Area Definitions Table lists areas in alphabetical order by state, and the counties associated with each area. In the six New England states, the listings are for counties or parts of counties as defined by towns or cities.

    V. Environmental Impact

    This notice involves a statutorily required establishment of a rate or cost determination which does not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 24 CFR 50.19(c)(6), this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).

    Dated: April 8, 2016. Katherine M. O'Regan, Assistant Secretary for Policy, Development and Research.
    [FR Doc. 2016-08780 Filed 4-14-16; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5909-N-29] 30-Day Notice of Proposed Information Collection: Certified Housing Counselor Registration AGENCY:

    Office of the Chief Information Officer, HUD.

    ACTION:

    Notice.

    SUMMARY:

    HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.

    DATES:

    Comments Due Date: May 16, 2016.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email: [email protected].

    FOR FURTHER INFORMATION CONTACT:

    Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at [email protected] or telephone 202-402-3400. This is not a toll-free number. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.

    Copies of available documents submitted to OMB may be obtained from Ms. Pollard.

    SUPPLEMENTARY INFORMATION:

    This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.

    The Federal Register notice that solicited public comment on the information collection for a period of 60 days was published on October 9, 2015 at 80 FR 61224.

    A. Overview of Information Collection

    Title of Information Collection: Certified Housing Counselor Registration.

    OMB Approval Number: 2502—New.

    Type of Request: New collection.

    Form Number: None.

    Description of the need for the information and proposed use: Pursuant to Section 1445 of the Dodd-Frank Act, all individuals providing homeownership or rental housing counseling related to HUD programs must be HUD-certified housing counselors. To become certified, a housing counselor must pass a written examination. HUD established a Housing Counselor Certification Exam and training program, as mandated by Subtitle D of title XIV of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Pub. L. 111-203, 124 Stat. 1376 (July 21, 2010)) (Dodd-Frank Act), and created a Web site for individuals to register for the examination and training. To track individuals using the training, successful passage of the examination, and eligibility for certification, the Web site has a registration requirement. Registration through HUD's certification contractor's Web site for the on-line training will require name, city, state, telephone number, email address, occupation, if employer is a HUD-participating housing counseling agency, and a HUD's Housing Counseling System number. Registration for the practice and certification examinations through this system will require, in addition to the information for general registration, a full mailing address, social security number, language(s) spoken by the counselor when providing counseling servicing, and optional demographic data (race, ethnicity, gender). Collection of social security numbers is required for linking the individual's information to HUD's FHA Connection system, so HUD can verify applicants are employed by participating agencies. HUD estimates the collection of this information to average five minutes for each individual that registers for the on-line training, practice examination, and certification examination. Public reporting burden for this collection of information is estimated to average 1,700 hours per year.

    Respondents: Individuals.

    Estimated Number of Respondents: 10,700.

    Estimated Number of Annual Responses: 3,567.

    Frequency of Response: Once.

    Average Hours per Response: 15 minutes (.25).

    Total Estimated Burdens: 892 hours.

    B. Solicitation of Public Comment

    This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

    (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    (2) The accuracy of the agency's estimate of the burden of the proposed collection of information;

    (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and

    (4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    HUD encourages interested parties to submit comment in response to these questions.

    Authority:

    Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.

    Dated: April 12, 2016. Colette Pollard, Department Reports Management Officer, Office of the Chief Information Officer.
    [FR Doc. 2016-08777 Filed 4-14-16; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R4-ES-2016-N063; FXES1112040000-167-FF04EF2000] Endangered and Threatened Wildlife and Plants; Receipt of Application for Incidental Take Permit; Availability of Proposed Low-Effect Habitat Conservation Plan and Associated Documents; Indian River County, FL AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of availability; request for comment/information.

    SUMMARY:

    We, the Fish and Wildlife Service (Service), announce the availability of an incidental take permit (ITP) application and a Habitat Conservation Plan (HCP). Remington Stewart, LLP (applicant), requests an ITP under the Endangered Species Act of 1973, as amended (Act). The applicant's HCP describes the minimization and mitigation measures proposed to address the effects of the project on the Florida scrub-jay. We invite written comments on the ITP application and HCP.

    DATES:

    Written comments on the ITP application and HCP should be sent to the South Florida Ecological Services Office (see ADDRESSES) and should be received on or before May 16, 2016.

    ADDRESSES:

    See the SUPPLEMENTARY INFORMATION section for information on how to submit your comments on the ITP application and HCP. You may obtain a copy of the ITP application and HCP by writing the South Florida Ecological Services Office, Attn: Permit number TE90853B-0, U.S. Fish and Wildlife Service, 1339 20th Street, Vero Beach, FL 32960-3559. In addition, we will make the ITP application and HCP available for public inspection by appointment during normal business hours at the above address.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Ted Martin, Wildlife Biologist, South Florida Ecological Services Office, Vero Beach, FL (see ADDRESSES); telephone: 772-562-3909, extension 232.

    SUPPLEMENTARY INFORMATION:

    We announce the availability of an ITP application and HCP. Remington Stewart, LLP (applicant), requests an ITP under the Act. The applicant proposes to construct two commercial buildings with associated infrastructure (project) at the southwest corner of US-1 and Jackson Street in Sebastian, Florida, and more specifically at: Latitude 27°49′38.44″ N. and longitude −80°28′40.12″ W.

    Site preparation and construction will result in the permanent alteration of 2.21 acres of suitable Florida scrub-jay (Aphelocoma coerulescens) (scrub-jay) foraging and caching habitat that is within an occupied scrub-jay territory. The applicant's HCP describes the minimization and mitigation measures proposed to address the effects of the project on the scrub jay.

    Applicant's Proposed Project

    We received an application from the applicant for an ITP, along with a proposed HCP. The applicant requests a 10-year permit under section 10(a)(1)(B) of the Act (16 U.S.C. 1531 et seq.). The applicant proposes to construct two commercial buildings with associated infrastructure (project).

    Site preparation and construction will result in the permanent alteration of 2.21 acres of suitable Florida scrub-jay (Aphelocoma coerulescens) (scrub-jay) foraging and caching habitat that is within an occupied scrub-jay territory.

    The applicant proposes the contribution of $126,676.56 to The Nature Conservancy (TNC) to satisfy mitigation requirements. A receipt from TNC will be provided to the Service.

    Our Preliminary Determination

    The Service has made a preliminary determination that the applicant's project, including the mitigation measures, will individually and cumulatively have a minor or negligible effect on the species covered in the HCP. Therefore, our proposed issuance of the requested incidental take permit qualifies as a categorical exclusion under the National Environmental Policy Act, as provided by Department of the Interior implementing regulations in part 46 of title 43 of the Code of Federal Regulations (43 CFR 46.205, 46.210, and 46.215). We base our determination that issuance of the ITP qualifies as a low-effect action on the following three criteria: (1) Implementation of the project would result in minor or negligible effects on federally listed, proposed, and candidate species and their habitats; (2) Implementation of the project would result in minor or negligible effects on other environmental values or resources; and (3) Impacts of the project, considered together with the impacts of other past, present, and reasonably foreseeable similarly situated projects, would not result, over time, in cumulative effects to environmental values or resources that would be considered significant. The applicants' proposed project qualifies as a “low-effect” project, as more fully explained in our environmental action statement and associated Low Effect Screening Form. This preliminary determination may be revised based on our review of public comments that we receive in response to this notice.

    Public Comment

    If you wish to comment on the ITP application and HCP, you may submit comments by any one of the following methods:

    Email: [email protected] Use “Attn: Permit number TE90853B-0” as your message subject line.

    Fax: Ted Martin, (772) 562-4288, Attn: Permit number TE90853B-0.

    U.S. mail: Ted Martin, Wildlife Biologist, South Florida Ecological Services Field Office, Attn: Permit number TE90853B-0, U.S. Fish and Wildlife Service, 1339 20th Street, Vero Beach, FL 32960-3559.

    In-person drop-off: You may drop off information during regular business hours at the above office address.

    Before including your address, phone number, email address, or other personal identifying information in your comments, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Next Steps

    The Service will evaluate the HCP and comments submitted thereon to determine whether the application meet the requirements of section 10(a) of the Act. The Service will also evaluate whether issuance of the section 10(a)(1)(B) ITP complies with section 7 of the Act by conducting an intra-Service section 7 consultation. The results of this consultation, in combination with the above findings, will be used in the final analysis to determine whether or not to issue the ITP. If it is determined that the requirements of the Act are met, the ITP will be issued.

    Authority

    We provide this notice under Section 10 of the Endangered Species Act (16 U.S.C. 1531 et seq.) and NEPA regulations (40 CFR 1506.6).

    Dated: April 7, 2016. Roxanna Hinzman, Field Supervisor, South Florida Ecological Services Office.
    [FR Doc. 2016-08727 Filed 4-14-16; 8:45 am] BILLING CODE 4310-55-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-HQ-FAC-2016-N054; FXFR13360900000-FF09F14000-167] Aquatic Nuisance Species Task Force Meeting AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of meeting.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service, announce a public meeting of the Aquatic Nuisance Species (ANS) Task Force. The ANS Task Force's purpose is to develop and implement a program for U.S. waters to prevent introduction and dispersal of aquatic invasive species (AIS); to monitor, control, and study such species; and to disseminate related information.

    DATES:

    The ANS Task Force will meet from 8 a.m. to 5:30 p.m. on Wednesday, May 4, 2016; 8 a.m. to 5 p.m. on Thursday, May 5, 2016; and 8 a.m. to 12:30 p.m. on Friday, May 6, 2016. For more information, contact the ANS Task Force Executive Secretary (see FOR FURTHER INFORMATION CONTACT).

    ADDRESSES:

    The ANS Task Force meeting will take place at the Park Place Hotel, 300 East State Street, Traverse City, Michigan 49684 (telephone: 231-946-5000).

    FOR FURTHER INFORMATION CONTACT:

    Susan Pasko, Executive Secretary, ANS Task Force, by telephone at 703-358-2466, or by email at [email protected] If you use a telecommunications device for the deaf (TDD), please call the Federal Information Relay Service (FIRS) at 800-877-8339.

    SUPPLEMENTARY INFORMATION:

    In accordance with the requirements of the Federal Advisory Committee Act, 5 U.S.C. App., we announce that the ANS Task Force will hold a meeting.

    Background

    The ANS Task Force was established by the Nonindigenous Aquatic Nuisance Prevention and Control Act of 1990 (Act) (Pub. L. 106-580, as amended), and is composed of 13 Federal and 14 ex-officio members, and co-chaired by the U.S. Fish and Wildlife Service and the National Oceanic and Atmospheric Administration. The ANS Task Force provides advice on AIS infesting waters of the United States and other nations, among other duties as specified in the Act.

    Meeting Agenda • Great Lakes Restoration Initiative Project Updates • Nonindigenous Aquatic Species and Great Lakes Aquatic Non-indigenous Species Information System Database Update • Presentation on Idaho's Aquatic Invasive Species Prevention Program • Update on the Boat Manufacturer Technical Information Report • Session on Interbasin Transfer of AIS • Session on Asian Carp Risk Assessments • Presentation on Genome Editing Applications for AIS • Update on the Government Accountability Office Report for AIS • Approval of the Revised New York State ANS Management Plan • Updates on Efforts to Address AIS Transport at Federally Managed Water Bodies • Update on the National Early Detection Rapid Response Framework and Emergency Response Funding Plan • Update on Policy and Planning from the National Invasive Species Council

    There will be a field trip Wednesday, May 4, 2016, from 1 p.m. to 5:30 p.m. to Sleeping Bear Dunes National Lakeshore near Empire, Michigan. The field trip will include additional presentations on and viewing of AIS control projects within Sleeping Bear Dunes. To register for the field trip, contact the ANS Task Force Executive Secretary (see FOR FURTHER INFORMATION CONTACT).

    The final agenda and other related meeting information will be posted on the ANS Task Force Web site at http://anstaskforce.gov.

    Meeting Minutes

    Summary minutes of the meeting will be maintained by the Executive Secretary (see FOR FURTHER INFORMATION CONTACT). The minutes will be available for public inspection within 60 days after the meeting and will be posted on the ANS Task Force Web site at http://anstaskforce.gov.

    Dated: April 8, 2016. David W. Hoskins, Co-Chair, Aquatic Nuisance Species Task Force, Assistant Director for Fish and Aquatic Conservation.
    [FR Doc. 2016-08733 Filed 4-14-16; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R3-ES-2015-0033; FF03E00000-FXES11120300000-167] Availability of the Draft Midwest Wind Energy Multi-Species Habitat Conservation Plan and Draft Environmental Impact Statement AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of availability; request for comments.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), under the Endangered Species Act of 1973, as amended (ESA), announce the availability of the Midwest Wind Energy Multi-Species Habitat Conservation Plan (MSHCP). Planning partners include the State conservation agencies from the States of Michigan, Indiana, Wisconsin, Minnesota, Iowa, Illinois, and Missouri, the American Wind Energy Association (AWEA), who is representing a consortium of wind energy companies called WEBAT (Wind Energy Bat Action Team), and The Conservation Fund. The Plan Area encompasses all lands within the States of Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, and Wisconsin. The covered species include six federally listed bat and bird species, one bat species that may be listed in the future, and the bald eagle. The activities covered under the MSHCP (“covered activities”) include the construction, operation, maintenance, decommissioning and repowering of wind energy facilities, as well as monitoring activities. Up to 18,004 megawatts (MW) of existing facilities and 33,000 MW of new wind development are proposed to be covered under the MSHCP. In accordance with the National Environmental Policy Act of 1969 (NEPA), as amended, and the Council on Environmental Quality (CEQ) regulations, the Service is also announcing the availability of the MSHCP draft environmental impact statement (DEIS).

    DATES:

    To ensure consideration, please submit your comments on or before July 14, 2016. The Service will host two online webinars during the public comment period. The webinar dates have not been determined at this time. Information on how to participate in the webinars will be provided on the In