Federal Register Vol. 81, No.104,

Federal Register Volume 81, Issue 104 (May 31, 2016)

Page Range34241-34857
FR Document

81_FR_104
Current View
Page and SubjectPDF
81 FR 34379 - Annual Board of Directors Meeting; Sunshine Act MeetingPDF
81 FR 34337 - Sunshine Act MeetingsPDF
81 FR 34429 - Environmental Impact Statement for the Link Union Station Project, Los Angeles, CAPDF
81 FR 34334 - Intent To Disclose Confidential Business Information Contained in Vehicle Sales Data for Model Years 2009-2014 to the U.S. Energy Information Administration for Use in Modeling and Projecting Energy Demand in the Light-Duty Vehicle SectorPDF
81 FR 34357 - Findings of Research MisconductPDF
81 FR 34363 - Notice of Issuance of Final Determination Concerning Certain Network Cables and TransceiversPDF
81 FR 34435 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; OCC Supplier Registration FormPDF
81 FR 34428 - Notice of Funding Opportunity for the Advanced Transportation and Congestion Management Technologies Deployment ProgramPDF
81 FR 34268 - Delay of Discharge Requirements for U.S. Coast Guard Activities in Greater Farallones and Cordell Bank National Marine SanctuariesPDF
81 FR 34313 - Evaluations of National Estuarine Research Reserves and Coastal Management ProgramsPDF
81 FR 34309 - Information Collection; Land ExchangesPDF
81 FR 34310 - Multilayered Wood Flooring From the People's Republic of China: Preliminary Rescission of 2014-2015 Antidumping Duty New Shipper ReviewsPDF
81 FR 34371 - Bulk Manufacturer of Controlled Substances Application: Rhodes TechnologiesPDF
81 FR 34372 - Importer of Controlled Substances Application: Wildlife Laboratories, Inc.PDF
81 FR 34382 - Virginia Electric and Power Company; Surry Power Station, Unit Nos. 1 and 2PDF
81 FR 34379 - Entergy Operations, Inc.; Waterford Steam Electric Station, Unit 3PDF
81 FR 34326 - Applications for New Awards; American History and Civics Academies ProgramPDF
81 FR 34379 - Advisory Committee on Reactor Safeguards 635th MeetingPDF
81 FR 34317 - Applications for New Awards; Teacher Incentive FundPDF
81 FR 34368 - 30-Day Notice of Proposed Information Collection: Office of Hospital Facilities Transactional Forms for FHA Programs 242, 241, 223(f), 223(a)(7)PDF
81 FR 34437 - Submission for OMB Review; Comment RequestPDF
81 FR 34283 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; 2016 Accountability Measure-Based Closures for Commercial and Recreational Species in the U.S. Caribbean Off Puerto RicoPDF
81 FR 34378 - National Council on the Arts 188th MeetingPDF
81 FR 34360 - Submission for OMB review; 30-day Comment Request;PDF
81 FR 34282 - Fluazinam; Pesticide Tolerances; Technical CorrectionPDF
81 FR 34278 - Safety Zone; Chesapeake Bay, Cape Charles, VAPDF
81 FR 34427 - 30-Day Notice of Proposed Information Collection: Office of Language Services Contractor Application FormPDF
81 FR 34370 - Notice of Availability: Well Stimulation Treatments on the Pacific Outer Continental ShelfPDF
81 FR 34316 - Proposed Collection; Comment RequestPDF
81 FR 34313 - Pacific Fishery Management Council; Public MeetingPDF
81 FR 34311 - Pacific Fishery Management Council; Public MeetingPDF
81 FR 34317 - Uniform Formulary Beneficiary Advisory Panel; Notice of Federal Advisory Committee MeetingPDF
81 FR 34280 - Safety Zones; Upper Mississippi River Between Mile 179.2 and 180.5, St. Louis, MO and Between Mile 839.5 and 840, St. Paul, MNPDF
81 FR 34371 - Certain Electronic Devices, Including Wireless Communication Devices, Computers, Tablet Computers, Digital Media Players, and Cameras; Commission Determination to Affirm an Initial Determination Granting a Joint Motion to Terminate the Investigation on the Basis of Settlement; Termination of InvestigationPDF
81 FR 34336 - Disability Advisory Committee; Announcement of Next MeetingPDF
81 FR 34333 - Exelon Generation Company, LLC; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and ProtestsPDF
81 FR 34352 - Determination of Regulatory Review Period for Purposes of Patent Extension; OLYSIOPDF
81 FR 34314 - Agency Information Collection Activities: Notice of Intent To Renew Collection 3038-0017, Market SurveysPDF
81 FR 34342 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 34341 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 34332 - Ware River Power, Inc.; Notice of Application Accepted for Filing, Soliciting Comments, Motions to Intervene, and ProtestsPDF
81 FR 34332 - Cottonwood Wind Project, LLC v. Nebraska Public Power District, Inc; Notice of ComplaintPDF
81 FR 34334 - Rover Pipeline LLC; Notice of Amendment to ApplicationPDF
81 FR 34337 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
81 FR 34372 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Trade Adjustment Assistance Program Reserve Funding RequestPDF
81 FR 34375 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Workforce Investment Act Management Information and Reporting SystemPDF
81 FR 34376 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Reporting and Performance Standards System for Migrant and Seasonal Farmworker ProgramsPDF
81 FR 34377 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Process Safety Management Standard of Highly Hazardous ChemicalsPDF
81 FR 34374 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Standard Job Corps Contractor Information GatheringPDF
81 FR 34373 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Employee Retirement Income Security Act of 1974 Investment Manager Electronic RegistrationPDF
81 FR 34343 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
81 FR 34378 - Notice of Intent To Grant Exclusive LicensePDF
81 FR 34312 - Proposed Information Collection; Comment Request; Southeast Region Dealer and Interview Family of FormsPDF
81 FR 34301 - Comment Sought on Implementation of Transmitter Identification Requirements for Video Uplink TransmissionsPDF
81 FR 34426 - Agency Information Collection Activities: Proposed Request and Comment RequestPDF
81 FR 34241 - List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Certificate of Compliance No. 1014, Amendment No. 10; CorrectionsPDF
81 FR 34431 - Fiscal Year 2015 and 2016 Passenger Ferry Grant Program Project SelectionsPDF
81 FR 34276 - Drawbridge Operation Regulation; Housatonic River, Stratford, CTPDF
81 FR 34275 - Special Local Regulation; Annual Dragon Boat Races, Portland, OregonPDF
81 FR 34349 - Collaboration in Regulatory Systems Strengthening and Standardization Activities To Increase Access to Safe and Effective Biological ProductsPDF
81 FR 34354 - Facilitating Antibacterial Drug Development for Patients With Unmet Need and Developing Antibacterial Drugs That Target a Single Species Media; Public WorkshopPDF
81 FR 34269 - Medical Devices; Ophthalmic Devices; Classification of the Diurnal Pattern Recorder SystemPDF
81 FR 34335 - Information Collection Approved by the Office of Management and Budget (OMB)PDF
81 FR 34315 - Notice of Availability of Draft Environmental Impact Statement for the Continental United States Interceptor SitePDF
81 FR 34369 - Renewal of Agency Information Collection for Appointed Counsel in Involuntary Indian Child Custody Proceedings in State CourtsPDF
81 FR 34368 - Homeland Security Science and Technology Advisory CommitteePDF
81 FR 34367 - Sector Outreach and Programs Division Online Meeting Registration ToolPDF
81 FR 34434 - International Standards on the Transport of Dangerous GoodsPDF
81 FR 34387 - Submission for OMB Review; Comment RequestPDF
81 FR 34403 - Submission for OMB Review; Comment RequestPDF
81 FR 34393 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing of Proposed Rule Change Removing From Its Rules Certain Internal Procedures Regarding the Use of Fine IncomePDF
81 FR 34404 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto, Amending Section 4.01(a) of the NYSE Arca's Bylaws and NYSE Arca Rule 3.3 to Establish a Committee for Review as a Sub-Committee of the ROC and Making Conforming Changes to NYSE Arca RulesPDF
81 FR 34401 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Rule 6.43 Regarding Definition of Floor BrokerPDF
81 FR 34407 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change, as Modified by Amendment No. 1 Thereto, Relating to the Listing and Trading of the Shares of the First Trust CEF Income Opportunity ETF and the First Trust Municipal CEF Income Opportunity ETF of First Trust Exchange-Traded Fund VIIIPDF
81 FR 34414 - Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Options Pricing at Chapter XV, Section 2PDF
81 FR 34388 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change Regarding Use of Rule 144A Securities by the Fidelity Corporate Bond ETF, Fidelity Investment Grade Bond ETF, Fidelity Limited Term Bond ETF, and Fidelity Total Bond ETFPDF
81 FR 34419 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change, as Modified by Amendment No. 1 Thereto, Relating to the Listing and Trading of the Shares of the Amplify Dow Theory Forecasts Buy List ETF of Amplify ETF TrustPDF
81 FR 34398 - Self-Regulatory Organizations; Bats EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Change to the Market Data Section of its Fee SchedulePDF
81 FR 34384 - Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Change to the Market Data Section of Its Fee SchedulePDF
81 FR 34336 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 34275 - Drawbridge Operation Regulation; St. Croix River, Stillwater, MNPDF
81 FR 34360 - National Cancer Institute; Notice of Closed MeetingsPDF
81 FR 34436 - Proposed Collection; Comment Request for Information Collection ToolsPDF
81 FR 34437 - Proposed Collection; Comment Request for Information Collection toolsPDF
81 FR 34354 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingPDF
81 FR 34353 - Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; RenewalPDF
81 FR 34355 - Sequencing Quality Control II; Public WorkshopPDF
81 FR 34347 - Determination That LEVOTHROID (Levothyroxine Sodium) Tablets, 0.025 Milligram, 0.05 Milligram, 0.075 Milligram, 0.088 Milligram, 0.112 Milligram, 0.125 Milligram, 0.137 Milligram, 0.15 Milligram, 0.175 Milligram, 0.1 Milligram, 0.2 Milligram, and 0.3 Milligram, Were Not Withdrawn From Sale for Reasons of Safety or EffectivenessPDF
81 FR 34348 - Clinical Trial Design Considerations for Malaria Drug Development; Notice of Public Workshop; CorrectionPDF
81 FR 34277 - Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, South Branch of the Elizabeth River, Portsmouth-Chesapeake, VAPDF
81 FR 34277 - Drawbridge Operation Regulation; Chester River, Chestertown, MDPDF
81 FR 34345 - Agency Information Collection Activities; Proposed Collection; Comment Request; E6(R2) Good Clinical Practice; International Council for HarmonisationPDF
81 FR 34362 - National Institute of Dental & Craniofacial Research; Notice of Closed MeetingPDF
81 FR 34359 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingsPDF
81 FR 34363 - National Library of Medicine; Notice of Closed MeetingPDF
81 FR 34361 - National Institute on Drug Abuse; Notice of Closed MeetingPDF
81 FR 34363 - National Institute on Drug Abuse; Notice of Closed MeetingsPDF
81 FR 34362 - National Heart, Lung, and Blood Institute; Amended Notice of MeetingPDF
81 FR 34363 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
81 FR 34359 - Notice of Establishment of the NIH Clinical Center Research Hospital BoardPDF
81 FR 34361 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 34356 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingPDF
81 FR 34344 - Advisory Committee; Psychopharmacologic Drugs Advisory Committee, RenewalPDF
81 FR 34343 - Advisory Committee; Allergenic Products Advisory Committee, RenewalPDF
81 FR 34428 - Air Traffic Procedures Advisory CommitteePDF
81 FR 34855 - Agency Information Collection Activities: Proposed Collection, Comment Request: Final Rule, Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants-Cross-Border Application of the Margin RequirementsPDF
81 FR 34817 - Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants-Cross-Border Application of the Margin RequirementsPDF
81 FR 34290 - Native American Housing Assistance and Self-Determination Act; Revisions to the Indian Housing Block Grant Program FormulaPDF
81 FR 34287 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 34271 - Categorical ExclusionsPDF
81 FR 34623 - Distribution of Continued Dumping and Subsidy Offset to Affected Domestic ProducersPDF
81 FR 34426 - Small Business Innovation Research Program and Small Business Technology Transfer Program Policy DirectivePDF
81 FR 34265 - Airworthiness Directives; Turbomeca S.A. Turboshaft EnginesPDF
81 FR 34285 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 34267 - Establishment of Class E Airspace; Lisbon, NDPDF
81 FR 34243 - Small Business Government Contracting and National Defense Authorization Act of 2013 AmendmentsPDF
81 FR 34539 - Elementary and Secondary Education Act of 1965, As Amended by the Every Student Succeeds Act-Accountability and State PlansPDF
81 FR 34302 - General Services Administration Acquisition Regulation (GSAR); Unenforceable Commercial Supplier Agreement TermsPDF
81 FR 34777 - Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018PDF
81 FR 34439 - Energy Conservation Program: Energy Conservation Standards for Commercial Water Heating EquipmentPDF
81 FR 34358 - National Committee on Vital and Health Statistics: MeetingPDF
81 FR 34274 - Leasing of Sulfur or Oil and Gas in the Outer Continental Shelf; Correction MMAA104000PDF
81 FR 34434 - Hazardous Materials: Notice of Applications for Special PermitsPDF

Issue

81 104 Tuesday, May 31, 2016 Contents Agriculture Agriculture Department See

Forest Service

Safety Enviromental Enforcement Bureau of Safety and Environmental Enforcement NOTICES Environmental Assessments; Availability, etc.: Well Stimulation Treatments on the Pacific Outer Continental Shelf, 34370 2016-12718 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 34337-34343 2016-12701 2016-12705 2016-12706 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 34343 2016-12694 Coast Guard Coast Guard RULES Drawbridge Operations: Atlantic Intracoastal Waterway, South Branch of the Elizabeth River, Portsmouth-Chesapeake, VA, 34277-34278 2016-12653 Chester River, Chestertown, MD, 34277 2016-12652 Housatonic River, Stratford, CT, 34276 2016-12687 St. Croix River, Stillwater, MN, 34275-34276 2016-12663 Safety Zones: Chesapeake Bay, Cape Charles, VA, 34278-34280 2016-12720 Upper Mississippi River Between Mile 179.2 and 180.5, St. Louis, MO and Between Mile 839.5 and 840, St. Paul, MN, 34280-34282 2016-12712 Special Local Regulations: Annual Dragon Boat Races, Portland, OR, 34275 2016-12686 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Commodity Futures Commodity Futures Trading Commission RULES Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants; Cross-Border Application of the Margin Requirements, 34818-34854 2016-12612 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants; Cross-Border Application of the Margin Requirements, 34855-34857 2016-12613 Market Surveys, 34314-34315 2016-12707 Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: OCC Supplier Registration Form, 34435-34436 2016-12786 Defense Department Defense Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 34316 2016-12717 Environmental Impact Statements; Availability, etc.: Continental United States Interceptor Site, 34315-34316 2016-12681 Meetings: Uniform Formulary Beneficiary Advisory Panel, 34317 2016-12713 Drug Drug Enforcement Administration NOTICES Bulk Manufacturer of Controlled Substances; Applications: Rhodes Technologies, 34371-34372 2016-12752 Importer of Controlled Substances; Applications: Wildlife Laboratories, Inc., 34372 2016-12751 Education Department Education Department PROPOSED RULES Elementary and Secondary Education Act of 1965, As Amended By the Every Student Succeeds Act: Accountability and State Plans, 34540-34621 2016-12451 NOTICES Applications for New Awards: American History and Civics Academies Program, 34326-34331 2016-12738 Teacher Incentive Fund, 34317-34325 2016-12733 Energy Department Energy Department See

Federal Energy Regulatory Commission

PROPOSED RULES Energy Conservation Program: Standards for Commercial Water Heating Equipment, 34440-34537 2016-12178
Environmental Protection Environmental Protection Agency RULES Pesticide Tolerances: Fluazinam; Technical Corrections, 34282-34283 2016-12721 PROPOSED RULES Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018, 34778-34816 2016-12369 NOTICES Disclosure of Confidential Business Information: Vehicle Sales Data for Model Years 2009-2014 to the U.S. Energy Information Administration for Use in Modeling and Projecting Energy Demand in the Light-Duty Vehicle Sector, 34334-34335 2016-12802 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Turbomeca S.A. Turboshaft Engines, 34265-34267 2016-12549 Establishment of Class E Airspace: Lisbon, ND, 34267-34268 2016-12508 PROPOSED RULES Airworthiness Directives: Airbus Airplanes, 34285-34290 2016-12522 2016-12593 NOTICES Meetings: Air Traffic Procedures Advisory Committee, 34428 2016-12634 Federal Communications Federal Communications Commission PROPOSED RULES Implementation of Transmitter Identification Requirements for Video Uplink Transmissions; Request for Comments, 34301-34302 2016-12691 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 34335-34336 2016-12664 2016-12682 Meetings: Disability Advisory Committee, 34336-34337 2016-12710 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 34337 2016-12820 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Exelon Generation Co., LLC, 34333-34334 2016-12709 Ware River Power, Inc., 34332-34333 2016-12704 Applications; Amendments: Rover Pipeline LLC, 34334 2016-12702 Complaints: Cottonwood Wind Project, LLC v. Nebraska Public Power District, Inc., 34332 2016-12703 Federal Highway Federal Highway Administration RULES Categorical Exclusions, 34271-34274 2016-12577 NOTICES Funding Opportunities: Advanced Transportation and Congestion Management Technologies Deployment Program, 34428-34429 2016-12785 Federal Railroad Federal Railroad Administration NOTICES Environmental Impact Statements; Availability, etc.: Link Union Station Project, Los Angeles, CA, 34429-34431 2016-12813 Federal Transit Federal Transit Administration RULES Categorical Exclusions, 34271-34274 2016-12577 NOTICES Fiscal Year 2015 and 2016 Passenger Ferry Grant Program Project Selections; Correction, 34431-34434 2016-12688 Food and Drug Food and Drug Administration RULES Medical Devices: Ophthalmic Devices; Classification of the Diurnal Pattern Recorder System, 34269-34271 2016-12683 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Good Clinical Practice; International Council for Harmonisation, 34345-34347 2016-12651 Charter Renewals: Allergenic Products Advisory Committee, 34343-34344 2016-12636 Psychopharmacologic Drugs Advisory Committee, 34344-34345 2016-12637 Science Advisory Board to the National Center for Toxicological Research, 34353-34354 2016-12657 Determinations that Products were Not Withdrawn from Sale for Reasons of Safety or Effectiveness: Levothroid Tablets, 0.025 Milligram, etc., 34347-34348 2016-12655 Funding Availabilities: Collaboration in Regulatory Systems Strengthening and Standardization Activities to Increase Access to Safe and Effective Biological Products, 34349-34351 2016-12685 Meetings: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee, 34354-34357 2016-12641 2016-12658 Clinical Trial Design Considerations for Malaria Drug Development; Public Workshop; Corrections, 34348-34349 2016-12654 Facilitating Antibacterial Drug Development for Patients With Unmet Need and Developing Antibacterial Drugs That Target a Single Species Media; Public Workshop, 34354 2016-12684 Sequencing Quality Control II; Public Workshop, 34355-34356 2016-12656 Patent Extensions: OLYSIO, 34352-34353 2016-12708 Forest Forest Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Land Exchanges, 34309 2016-12771 General Services General Services Administration PROPOSED RULES Administration Acquisition Regulations: Unenforceable Commercial Supplier Agreement Terms, 34302-34308 2016-12448 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

National Institutes of Health

NOTICES Findings of Research Misconduct, 34357-34358 2016-12800 Meetings: National Committee on Vital and Health Statistics, 34358-34359 2016-12160
Homeland Homeland Security Department See

Coast Guard

See

U.S. Customs and Border Protection

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Sector Outreach and Programs Division Online Meeting Registration Tool, 34367 2016-12678 Meetings: Homeland Security Science and Technology Advisory Committee, 34368 2016-12679
Housing Housing and Urban Development Department PROPOSED RULES Native American Housing Assistance and Self-Determination Act: Revisions to the Indian Housing Block Grant Program Formula, 34290-34301 2016-12596 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Office of Hospital Facilities Transactional Forms for FHA Programs, 34368-34369 2016-12731 Indian Affairs Indian Affairs Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Appointed Counsel in Involuntary Indian Child Custody Proceedings in State Courts, 34369-34370 2016-12680 Interior Interior Department See

Bureau of Safety and Environmental Enforcement

See

Indian Affairs Bureau

See

Ocean Energy Management Bureau

Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 34436-34437 2016-12659 2016-12660 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Multilayered Wood Flooring from the People's Republic of China, 34310-34311 2016-12753 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Electronic Devices, Including Wireless Communication Devices, Computers, Tablet Computers, Digital Media Players, and Cameras, 34371 2016-12711 Justice Department Justice Department See

Drug Enforcement Administration

Labor Department Labor Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Employee Retirement Income Security Act of 1974 Investment Manager Electronic Registration, 34373-34374 2016-12695 Process Safety Management Standard of Highly Hazardous Chemicals, 34377-34378 2016-12697 Reporting and Performance Standards System for Migrant and Seasonal Farmworker Programs, 34376-34377 2016-12698 Standard Job Corps Contractor Information Gathering, 34374-34375 2016-12696 Trade Adjustment Assistance Program Reserve Funding Request, 34372-34373 2016-12700 Workforce Investment Act Management Information and Reporting System, 34375-34376 2016-12699 NASA National Aeronautics and Space Administration NOTICES Exclusive Licenses, 34378 2016-12693 National Endowment for the Arts National Endowment for the Arts NOTICES Meetings: National Council on the Arts, 34378-34379 2016-12727 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Arts

National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research, 34360-34361 2016-12726 Board Establishments: NIH Clinical Center Research Hospital Board, 34359 2016-12643 Meetings: Center for Scientific Review, 34361-34362 2016-12642 National Cancer Institute, 34360 2016-12662 National Heart, Lung, and Blood Institute, 34362-34363 2016-12644 2016-12645 National Institute of Allergy and Infectious Diseases, 34359-34360 2016-12649 National Institute of Dental and Craniofacial Research, 34362 2016-12650 National Institute on Drug Abuse, 34361, 34363 2016-12646 2016-12647 National Library of Medicine, 34363 2016-12648 National Oceanic National Oceanic and Atmospheric Administration RULES Delay of Discharge Requirements for U.S. Coast Guard Activities: Greater Farallones and Cordell Bank National Marine Sanctuaries, 34268-34269 2016-12784 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Commercial and Recreational Species in the U.S. Caribbean off Puerto Rico; Accountability Measure-based Closures, 34283-34284 2016-12728 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Southeast Region Dealer and Interview Family of Forms, 34312-34313 2016-12692 Evaluations of National Estuarine Research Reserves and Coastal Management Programs, 34313 2016-12783 Meetings: Pacific Fishery Management Council, 34311-34314 2016-12714 2016-12715 Neighborhood Neighborhood Reinvestment Corporation NOTICES Meetings; Sunshine Act, 34379 2016-12889 Nuclear Regulatory Nuclear Regulatory Commission RULES List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Certificate of Compliance No. 1014, Amendment No. 10; Corrections, 34241-34242 2016-12689 NOTICES Environmental Assessments; Availability, etc.: Virginia Electric and Power Co.; Surry Power Station, Unit Nos. 1 and 2, 34382-34383 2016-12742 License Renewal Applications: Entergy Operations, Inc.; Waterford Steam Electric Station, Unit 3, 34379-34382 2016-12739 Meetings: Advisory Committee on Reactor Safeguards; Cancellation, 34379 2016-12737 Ocean Energy Management Ocean Energy Management Bureau RULES Leasing of Sulfur or Oil and Gas in the Outer Continental Shelf; Correction, 34274-34275 2016-12095 NOTICES Environmental Assessments; Availability, etc.: Well Stimulation Treatments on the Pacific Outer Continental Shelf, 34370 2016-12718 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Hazardous Materials: Applications for Special Permits, 34434-34435 2016-11985 Meetings: International Standards on the Transport of Dangerous Goods, 34434 2016-12677 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 34387-34388, 34403-34404 2016-12674 2016-12675 2016-12676 Self-Regulatory Organizations; Proposed Rule Changes: Bats EDGA Exchange, Inc., 34398-34401 2016-12666 Bats EDGX Exchange, Inc., 34384-34387 2016-12665 NASDAQ BX, Inc., 34414-34419 2016-12669 New York Stock Exchange LLC, 34393-34398 2016-12673 NYSE Arca, Inc, 34388-34393 2016-12668 NYSE Arca, Inc., 34401-34407 2016-12671 2016-12672 The NASDAQ Stock Market LLC, 34407-34414, 34419-34426 2016-12667 2016-12670 Small Business Small Business Administration RULES Small Business Government Contracting and National Defense Authorization Act of 2013 Amendments, 34243-34265 2016-12494 NOTICES Small Business Innovation Research Program and Small Business Technology Transfer Program Policy Directive, 34426 2016-12566 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 34426-34427 2016-12690 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Office of Language Services Contractor Application Form, 34427-34428 2016-12719 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Railroad Administration

See

Federal Transit Administration

See

Pipeline and Hazardous Materials Safety Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Internal Revenue Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 34437-34438 2016-12729
Customs U.S. Customs and Border Protection NOTICES Countries of Origin; Final Determinations: Certain Network Cables and Transceivers, 34363-34367 2016-12798 Distribution of Continued Dumping and Subsidy Offset to Affected Domestic Producers, 34624-34776 2016-12575 Separate Parts In This Issue Part II Energy Department, 34440-34537 2016-12178 Part III Education Department, 34540-34621 2016-12451 Part IV Homeland Security Department, U.S. Customs and Border Protection, 34624-34776 2016-12575 Part V Environmental Protection Agency, 34778-34816 2016-12369 Part VI Commodity Futures Trading Commission, 34818-34857 2016-12612 2016-12613 Reader Aids

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

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81 104 Tuesday, May 31, 2016 Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2015-0270] RIN 3150-AJ71 List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Cask System; Certificate of Compliance No. 1014, Amendment No. 10; Corrections AGENCY:

Nuclear Regulatory Commission.

ACTION:

Direct final rule; confirmation of effective date and correcting amendments.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) is confirming the effective date of May 31, 2016, for the direct final rule that was published in the Federal Register on March 14, 2016. The direct final rule amended the NRC's spent fuel storage regulations by revising the Holtec International (Holtec) HI-STORM 100 Cask System listing within the “List of approved spent fuel storage casks” to include Amendment No. 10 to Certificate of Compliance (CoC) No. 1014. In addition, the NRC is correcting the direct final rule because it inadvertently omitted Revision 1 to Amendment Nos. 8 and 9 to CoC No. 1014.

DATES:

Effective date: The effective date of May 31, 2016, for the direct final rule published March 14, 2016 (81 FR 13265), is confirmed. The correcting amendments are effective on May 31, 2016.

ADDRESSES:

Please refer to Docket ID NRC-2015-0270 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0270. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]

NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT:

Robert MacDougall, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-5175; email: [email protected]

SUPPLEMENTARY INFORMATION:

I. Discussion

On March 14, 2016 (81 FR 13265), the NRC published a direct final rule amending its regulations in § 72.214 of title 10 of the Code of Federal Regulations by revising the Holtec HI-STORM 100 Cask System listing within the “List of approved spent fuel storage casks” to include Amendment No. 10 to CoC No. 1014. Amendment No. 10 adds new fuel classes to the contents approved for the loading of 16 x 16-pin fuel assemblies into a HI-STORM 100 Cask System; allows a minor increase in manganese in an alloy material for the system's overpack and transfer cask; clarifies the minimum water displacement required of a dummy fuel rod (i.e., a rod not filled with uranium pellets); and clarifies the design pressures needed for normal operation of forced helium drying systems. Additionally, Amendment No. 10 revises Condition No. 9 of CoC No. 1014 to provide clearer direction on the measurement of air velocity and modeling of heat distribution through the storage system.

The March 14, 2016, direct final rule inadvertently omitted Revision 1 to Amendment No. 8 (effective May 2, 2012, as corrected on November 16, 2012) to CoC No. 1014. In a final rule published in the Federal Register on August 18, 2015 (80 FR 49887), the NRC amended its spent fuel storage regulations by revising the Holtec HI-STORM 100 Cask System listing within the “List of approved spent fuel storage casks” to add Revision 1 to Amendment No. 8 (effective May 2, 2012, as corrected on November 16, 2012) to the CoC No. 1014. In addition, the March 14, 2016, direct final rule inadvertently omitted Revision 1 to Amendment No. 9. In a final rule published in the Federal Register on January 6, 2016 (81 FR 371), the NRC amended its spent fuel storage regulations by revising the Holtec HI-STORM 100 Cask System listing within the “List of approved spent fuel storage casks” to add Revision 1 to Amendment No. 9 to the CoC No. 1014. This document restores Revision 1 to Amendment Nos. 8 and 9 to CoC No. 1014.

II. Rulemaking Procedure

Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive the normal notice and comment requirements if it finds, for good cause, that they are impracticable, unnecessary, or contrary to the public interest. As authorized by 5 U.S.C. 553(b)(B), the NRC finds good cause to waive notice and opportunity for comment on the amendments because they will have no substantive impact and the amendments are of a minor and administrative nature. Specifically, these amendments are to restore Revision 1 to Amendment Nos. 8 and 9 to CoC No. 1014. These amendments do not require action by any person or entity regulated by the NRC. Also, the amendments do not change the substantive responsibilities of any person or entity regulated by the NRC. For these reasons, the NRC finds, pursuant to 5 U.S.C. 553(d)(3), that good cause exists to make the amendments effective upon publication of this document.

III. Public Comments on the Companion Proposed Rule

In the direct final rule, the NRC stated that if no significant adverse comments were received, the direct final rule would become effective on May 31, 2016. The NRC received four comment submissions with 22 individual comments on the companion proposed rule (81 FR 13295). Electronic copies of these comments can be obtained from the Federal Rulemaking Web site, http://www.regulations.gov, by searching for Docket ID NRC-2015-0270. The comments are also available in ADAMS under Accession Nos. ML16105A423, ML16105A424, ML16105A425, and ML16105A426. For the reasons discussed in more detail in Section IV, “Public Comment Analysis,” of this document, none of the comments received are considered significant adverse comments as defined in NUREG/BR-0053, Revision 6, “United States Nuclear Regulatory Commission Regulations Handbook” (ADAMS Accession No. ML052720461).

IV. Public Comment Analysis

The NRC received four comment submissions with 22 individual comments on the companion proposed rule. As explained in the March 14, 2016, direct final rule, the NRC would withdraw the direct final rule only if it received a “significant adverse comment.” This is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or Technical Specifications.

The NRC determined that none of the comments submitted on this direct final rule met any of these criteria. The comments either were already addressed by the NRC staff's safety evaluation report (SER) (ADAMS Accession No. ML15331A309), or were beyond the scope of this rulemaking. The NRC has not made any changes to the direct final rule as a result of the public comments. However, the NRC will take the opportunity to respond to the comments in a separate Federal Register notice that will be published in June 2016. You will be able to access the separate Federal Register notice on the Federal rulemaking Web site at http://www.regulations.gov under Docket ID NRC-2015-0270. The Federal rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2015-0270); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

The NRC staff has concluded that the comments received on the companion proposed rule for the Holtec HI-STORM 100 Cask System, CoC No. 1014, Amendment No. 10, are not significant adverse comments as defined in NUREG/BR-0053, Revision 6. Therefore, the direct final rule will become effective as scheduled.

List of Subjects for 10 CFR Part 72

Administrative practice and procedure, Criminal penalties, Hazardous waste, Indians, Intergovernmental relations, Manpower training programs, Nuclear energy, Nuclear materials, Occupational safety and health, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR part 72:

PART 72—LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE 1. The authority citation for part 72 continues to read as follows: Authority:

Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183,184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act of 1969 (42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a), 132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 note.

2. In § 72.214, Certificate of Compliance No. 1014 is revised to read as follows:
§ 72.214 List of approved spent fuel storage casks.

Certificate Number: 1014.

Initial Certificate Effective Date: May 31, 2000.

Amendment Number 1 Effective Date: July 15, 2002.

Amendment Number 2 Effective Date: June 7, 2005.

Amendment Number 3 Effective Date: May 29, 2007.

Amendment Number 4 Effective Date: January 8, 2008.

Amendment Number 5 Effective Date: July 14, 2008.

Amendment Number 6 Effective Date: August 17, 2009.

Amendment Number 7 Effective Date: December 28, 2009.

Amendment Number 8 Effective Date: May 2, 2012, as corrected on November 16, 2012 (ADAMS Accession No. ML12213A170); superseded by Amendment Number 8, Revision 1 Effective Date: February 16, 2016.

Amendment Number 8, Revision 1 Effective Date: February 16, 2016.

Amendment Number 9 Effective Date: March 11, 2014, superseded by Amendment Number 9, Revision 1, on March 21, 2016.

Amendment Number 9, Revision 1, Effective Date: March 21, 2016.

Amendment Number 10 Effective Date: May 31, 2016.

Safety Analysis Report (SAR) Submitted by: Holtec International.

SAR Title: Final Safety Analysis Report for the HI-STORM 100 Cask System.

Docket Number: 72-1014.

Certificate Expiration Date: May 31, 2020.

Model Number: HI-STORM 100.

Dated at Rockville, Maryland, this 25th day of May, 2016.

For the Nuclear Regulatory Commission.

Cindy Bladey, Chief, Rules, Announcements, and Directives Branch, Division of Administrative Services, Office of Administration.
[FR Doc. 2016-12689 Filed 5-27-16; 8:45 am] BILLING CODE 7590-01-P
SMALL BUSINESS ADMINISTRATION 13 CFR Parts 121, 124, 125, 126 and 127 RIN 3245-AG58 Small Business Government Contracting and National Defense Authorization Act of 2013 Amendments AGENCY:

U.S. Small Business Administration.

ACTION:

Final rule.

SUMMARY:

This rule amends the U.S. Small Business Administration's (SBA or Agency) regulations to implement provisions of the National Defense Authorization Act of 2013, which pertain to performance requirements applicable to small business and socioeconomic program set-aside contracts and small business subcontracting. This rule also amends SBA's regulations concerning the nonmanufacturer rule and affiliation rules. Further, this rule allows a joint venture to qualify as small for any government procurement as long as each partner to the joint venture qualifies individually as small under the size standard corresponding to the NAICS code assigned in the solicitation.

DATES:

This rule is effective on June 30, 2016.

FOR FURTHER INFORMATION CONTACT:

Michael McLaughlin, Office of Policy, Planning and Liaison, 409 Third Street SW., Washington, DC 20416; (202) 205-5353; [email protected]

SUPPLEMENTARY INFORMATION:

Introduction

SBA published a proposed rule regarding these changes in the Federal Register on December 29, 2014 (79 FR 77955), inviting the public to submit comments on or before February 27, 2015. This comment period was extended through April 6, 2015, by notice in the Federal Register published on March 9, 2015 (80 FR 12353). SBA also conducted tribal consultations in Washington, DC (February 26, 2015), Catoosa, OK (April 20, 2015), and Anchorage, AK (April 22, 2015), in which SBA accepted comments on the proposed rule. Transcripts of these consultations are in the rule docket (SBA-2014-0006, viewable on Regulations.gov using the docket number). SBA received a total of 216 comments on the proposed rule. Twenty-eight comments were supportive of the rule generally without referencing specific sections of the rule. Seventeen of those generally supportive comments advocated for fast implementation of the rule. Several of these commenters suggested that SBA issue this rule as an interim final rule. Once SBA has published a proposed rule, the next step in the process is to analyze public comments and publish a final rule. Publishing an “interim final rule” after publishing a proposed rule would not expedite the process to finalize the provisions contained in the proposed rule. As such, SBA has not followed that recommendation and is publishing this rule as a final rule. Sixteen comments requested an extension of time for the submission of comments. An extension of the comment period was provided through April 6, 2015, and SBA believed that a further extension was not needed. Seven comments did not support the rulemaking generally and did not reference specific sections that were opposed. Some of these comments were related to regulations not subject to changes in the proposed rule and were considered outside the scope of this rulemaking. SBA's discussion below summarizes the proposed rule, the comments related to each section of the proposed rule and SBA's responses.

Summary of Proposed Rule, Comments, and SBA's Responses Procurement Center Representative Responsibilities

Section 1621 of the National Defense Authorization Act of 2013 (NDAA), Public Law 112-239, 126 Stat. 1632 (Jan. 2013), revised the Small Business Act regarding the responsibilities of Procurement Center Representatives (PCRs). Section 1621 clarifies that PCRs have the ability to review barriers to small business participation in Federal contracting and to review any bundled or consolidated solicitation or contract in accordance with the Small Business Act. SBA proposed to amend 13 CFR 125.2(b)(1)(i)(A), based on the changes in Section 1621(c)(6)(H) of the NDAA. SBA also proposed to add language to § 125.2(b)(1)(i)(A) and to § 125.2(b)(1)(ii), which clarifies that PCRs advocate for the maximum practicable utilization of small business concerns in Federal contracting, including advocating against the unjustified consolidation or bundling of contract requirements.

Pursuant to Section 1621(c)(6)(G) of the NDAA, SBA proposed new § 125.2(b)(1)(iv), which states that PCRs will consult with the agency's Office of Small and Disadvantaged Business Utilization (OSDBU) and Office of Small Business Program (OSBP) Director regarding an agency's decision to convert an activity performed by a small business concern to an activity performed by a Federal employee. SBA also proposed new § 125.2(b)(1)(v) pursuant to the language enacted by Section 1621(c)(6)(F) of the NDAA, which allows PCRs to receive unsolicited proposals from small business concerns and to provide those proposals to the appropriate agency's personnel for review and disposition.

SBA proposed to amend § 125.2(b)(1) and (2), which pertain to Breakout PCRs (BPCRs). Sections 1621(e) and (f) of the NDAA effectively eliminate the statutory authority for the separate BPCR role. As a result, SBA proposed to reassign the responsibilities currently held by BPCRs to PCRs. SBA proposed to add § 125.2(b)(1)(i)(F), which states that PCRs also advocate full and open competition in Federal contracting and recommend the breakout for competition of items and requirements which previously have not been competed. SBA also proposed to eliminate § 125.2(b)(2) that provided guidance on the role and responsibilities of BPCRs, and redesignate current § 125.2(b)(3) as the new § 125.2(b)(2) and remove any reference to BPCRs from that paragraph.

SBA received 13 comments regarding its proposed changes to § 125.2. Ten of these comments were supportive of the changes to this section. One commenter suggested that SBA clarify the proposed language in § 125.2(b)(1)(i)(A), which states “This review includes acquisitions that are Multiple Award Contracts where the agency has not set-aside all or part of the acquisition or reserved the acquisition for small businesses.” This commenter suggested that SBA delete the words “or part” to make it clear that PCRs can review any Multiple Award Contract that is not 100% set-aside for small business competition. SBA is not adopting this recommendation because the proposed language states that PCRs can review Multiple Award Contracts that are not entirely set aside for small businesses, meaning partially set-aside. Furthermore, if SBA eliminated “or part” it would indicate that PCRs cannot review Multiple Award Contracts that are entirely set aside for small businesses, which is within the PCRs responsibilities.

Another commenter suggested that SBA should meet with contracting officers to assist with setting aside contracts for small businesses. It is the role of the PCR to review procurements that are not set aside for small businesses. PCRs are often located at the procuring activity and routinely interface with contracting officers regarding whether to set aside acquisitions for small business competition. It is already part of their responsibilities to meet with contracting officers and discuss acquisition planning. As such, it is not necessary to adopt this suggested change.

Another commenter suggested that the term “acquisition” as used in § 125.2 should be changed to “acquisition, including bridge, interim, and follow-on contracts.” The term “acquisition” is defined broadly in section 2.101 of the Federal Acquisition Regulation (FAR) to include “award of contracts.” The commenter is referencing specific types of contracts that are included in the FAR definition of “acquisition.” SBA believes that this clarification is not necessary and does not adopt it in this final rule.

Another commenter suggested that PCRs should unbundle sole source contracts that are made to incumbent vendors in order to allow the agency time to competitively re-procure the goods or services. The proposed rule directly addresses this concern by providing PCRs with the ability to advocate against consolidation or bundling of contract requirements and reviewing any justification provided for such bundling or consolidation. The same commenter also suggested that a prime contract not be awarded on a sole source basis unless the prime contractor agrees to retain its subcontractors under the previous award and incorporates the small business plan associated with the previous award. SBA does not have the authority to mandate which subcontractors a prime contractor chooses to include in a subcontracting plan or to mandate that a prime contractor incorporate a particular subcontracting plan into its offer, and therefore SBA is not adopting this suggestion.

One commenter requested clarification of the language proposed in § 125.2(b)(1)(i)(F) stating, “PCRs also advocate competitive procedures and recommend the breakout for competition when appropriate.” The commenter raised concerns that this language will discourage contracting officers from utilizing the sole source authority provided for the 8(a) Business Development (BD) program, the Women-Owned Small Business (WOSB) program and the HUBZone program. The commenter suggests that SBA clarify what a PCR would consider as “appropriate” in the decision to recommend competition, and if such a decision is made, that contracting officers and PCRs document this decision in the contract file along with an explanation for why competition is considered more appropriate than a small business program sole source award. The language referenced by the commenter is a BPCR responsibility that SBA is transferring to PCRs due to the statute's elimination of the BPCR role. In addition, PCRs provide contracting officers with guidance on the availability of sole source and competitive options, but the contracting officer has the discretion to choose an acquisition program or method, in accordance with SBA's guidance on parity.

Another commenter noted that PCRs will have to coordinate with agency officials to implement the NDAA's requirement, set forth at § 125.2(b)(1)(iv), that PCRs consult with agency OSDBUs regarding an agency's decision to convert an activity performed by a small business concern to an activity performed by a Federal employee. The statute provides that the PCR will consult with the OSDBU. SBA understands that the PCR and OSDBU will consult with other agency officials, as necessary. However, SBA does not believe that additional clarification is necessary and therefore SBA adopts the proposed language in this final rule.

Section 1623 of the NDAA requires that each Federal department or agency provide opportunities for the participation of small business concerns during acquisition planning processes and in acquisition plans. This section also requires that each Federal department or agency invite the participation of the appropriate OSDBU Director in acquisition planning processes and provides that Director with access to acquisition plans. SBA incorporates the exact statutory text from Section 1623 of the NDAA into 13 CFR 125.2(c)(1) by adding new paragraphs (vi) and (vii).

Limitations on Subcontracting

Section 1651 of the NDAA, as codified at 15 U.S.C. 657s, requires that the limitations on subcontracting for full or partial small business set-aside contracts, HUBZone contracts, 8(a) BD contracts, Service-Disabled Veteran-Owned (SDVO) Small Business Concern (SBC) contracts, and WOSB and Economically Disadvantaged Women Owned Small Business (EDWOSB) contracts, be evaluated based on the percentage of the overall award amount that a prime contractor spends on its subcontractors. Significantly, the NDAA excludes from the limitations on subcontracting calculation the percentage of the award amount that the prime contractor spends on similarly situated entity subcontractors. Specifically, the NDAA deems work done by similarly situated entities not to be subcontracted work for purposes of complying with the limitations on subcontracting requirement. Thus, work done by a similarly situated entity is counted in determining whether the applicable limitation on subcontracting is met. When a contract is awarded pursuant to a small business set-aside or socioeconomic program set-aside or sole source authority, a similarly situated entity subcontractor is a small business concern subcontractor that is a participant of the same SBA program that qualified the prime contractor as an eligible offeror and awardee of the contract.

Currently, SBA's regulations contain different terms for compliance with the performance of work requirements based on the type of small business program set-aside at issue. The method for calculating compliance not only varies by program set-aside type, but also based on whether the acquisition is for services, supplies, general construction, or specialty trade construction. Section 1651 of the NDAA creates a shift from the concept of a required percentage of work to be performed by a prime contractor to the concept of limiting a percentage of the award amount to be spent on subcontractors. The goal is the same: To ensure that a certain amount of work is performed by a small business concern (SBC) that qualified for a small business program set-aside or sole source procurement due to its socioeconomic program status. The Government's policy of promoting contracting opportunities for small businesses, HUBZone SBCs, SDVO SBCs, WOSBs/EDWOSBs, and 8(a) SBCs is seriously undermined when firms pass on work in excess of applicable limitations to firms that are other than small or that are not otherwise eligible for specific types of small business contracts. SBA has revised all references to “performance of work” requirements found in parts 121, 124, 125, 126, and 127 to “limitations on subcontracting.”

SBA proposed to totally revise § 125.6 to take into account the new definition and calculation for the limitations on subcontracting as described in Section 1651 of the NDAA. Additionally, SBA reorganized and simplified this section for easier use. Proposed § 125.6(a) explains how to apply the limitations on subcontracting requirements to small business set-aside contracts. Instead of providing different methods of determining compliance based on the type of small business set-aside program at issue and the type of good or service sought, Section 1651(a) of the NDAA provides one method for determining compliance that is shared by almost all applicable small business set-aside programs, but varies based on whether the contract is for services, supplies or products, general construction, specialty trade construction, or a combination of both services and supplies.

The approach described in Sections 1651(a) and (d) of the NDAA is to create a limit on the percentage of the award amount received by the prime contractor that may be spent on other-than-small subcontractors. Specifically, the NDAA provides that a small business awarded a small business set-aside, 8(a), SDVO small business, HUBZone, or WOSB/EDWOSB award “may not expend on subcontractors” more than a specified amount. However, as noted below, work done by “similarly situated entities” does not count as subcontracted work for purposes of determining compliance with the limitation on subcontracting requirements. Proposed § 125.6(a)(1) and (a)(2) addressed the limitations on subcontracting applicable to small business set-aside contracts requiring services or supplies. The limitation on subcontracting for both services and supplies is statutorily set at 50% of the award amount received by the prime contractor. See 15 U.S.C. 657s(a).

Proposed § 125.6(a)(3) addressed how the limitation on subcontracting requirement would be applied to a procurement that combines both services and supplies. This provision intended to clarify that the contracting officer's (CO) selection of the applicable NAICS code will determine which limitation of subcontracting requirement applies. Proposed § 125.6(a)(4) and (5) addressed the limitations on subcontracting for general and specialty trade construction contracts. SBA proposed to keep the same percentages that currently apply: 15% for general construction and 25% for specialty trade construction.

SBA received 115 comments regarding proposed § 125.6(a). The overwhelming majority of these comments requested that SBA allow contractors to exclude the “cost of materials”, as that term is currently defined in § 125.1(i), from the limitations on subcontracting calculation for all contracts. SBA notes that the cost of materials has never been, and was not proposed to be, a term that applies to service contracts. Historically and as proposed, the term cost of materials is applicable to supply, construction, or specialty trade construction set-aside contracts. “Cost of materials” is currently excluded from the performance of work requirements and SBA did not intend to remove this exclusion in proposed paragraph 125.6(a). The exclusion of “cost of materials” from the limitations on subcontracting for supply, construction, and specialty trade construction procurements is included in this final rule. Several commenters suggested that SBA extend this exclusion to procurements assigned a service NAICS code, but, SBA does not believe that this change is needed. As discussed below, because the limitations on subcontracting for a services contract apply only to the services portion of the contract, any “cost of materials” would not be part of the services to be provided through the contract and, thus, would be excluded from the limitations on subcontracting analysis on that basis.

For a mixed contract (i.e., one in which both supplies and services are being procured), commenters believed that the limitation on subcontracting should apply only to that portion of the requirement identified as the primary purpose of the contract. In other words, where, for example, a contracting officer has assigned a services NAICS code to a requirement that has both a services and supply component, the commenters believed that the limitation on subcontracting should apply only to the services portion of the work to be performed. In our view, Section 46(a)(3) of the Small Business Act, 15 U.S.C. 657s(a)(3), which was established by Section 1651 of the NDAA, provides the necessary guidance for mixed contracts. The CO must first determine which category, services or supplies, has the greatest percentage of the contract value, and then assign the appropriate NAICS code. The corresponding limitations on subcontracting will apply to the contract, depending on whether the CO has selected a supply NAICS code or a services NAICS code. Thus, the statutory authority authorizes that the limitations on subcontracting apply only to that portion of the requirement identified as the primary purpose of the contract. SBA has clarified that intent in this final rule, and has moved the requirements pertaining to mixed contracts to § 125.6(b). Therefore, where a procurement combines supplies and services, the limitations on subcontracting apply only to subcontracts that correspond to the principal purpose of the prime contract. For a contract principally for services, but which also requires supplies, this means that the prime contractor or its similarly situated subcontractors cannot subcontract more than 50 percent of the services to other than small concerns. However, the prime contractor can subcontract all of the supply components to any size business.

Several commenters also recommended that SBA change the current definition of “cost of materials” to include any service or product that cannot be procured from a small business. Other commenters recommended that very specific types of services be included in the definition of “cost of materials” such as transportation when procured in the performance of an environmental remediation procurement. SBA did not propose to change the definition of “cost of materials” and does not believe that a change is necessary or required to implement NDAA 2013.

One commenter requested clarity on whether contractors can exclude from the limitations on subcontracting the non-service costs associated with a procurement for services. As noted above, SBA believes that only the services portion of a requirement identified as a services requirement are considered in determining compliance with the limitation on subcontracting requirements. This means that any costs associated with supply items are excluded from that analysis. However, all costs associated with providing the services, including any overhead or indirect costs associated with those services, must be included in determining compliance. This final rule clarifies this application. SBA has also added another example to § 125.6(a)(3) that involves both supplies and services to clarify how the limitations on subcontracting apply in these circumstances.

As noted above, the NDAA prohibits subcontracting beyond a certain specified amount for any small business set-aside, 8(a), SDVO small business, HUBZone, or WOSB/EDWOSB contract. Section 1651(b) of the NDAA creates an exclusion from the limitations on subcontracting for “similarly situated entities.” In effect, the NDAA deems any work done by a similarly situated entity not to constitute “subcontracting” for purposes of determining compliance with the applicable limitation on subcontracting. A similarly situated entity is a small business subcontractor that is a participant of the same small business program that the prime contractor is a certified participant and which qualifies the prime contractor to receive the award. Subcontracts between a small business prime contractor and a similarly situated entity subcontractor are excluded from the limitations on subcontracting calculation because it does not further the goals of SBA's government contracting and business development programs to penalize small business prime contract recipients that benefit the same small business program participants through subcontract awards.

The proposed rule identified SBA's concern with determining compliance with the limitations on subcontracting by looking solely to the first tier of the contracting process (agreements between the prime contractor and its direct subcontractors). If all that was looked at was the first tier subcontract, that first tier subcontractor could in turn pass all of its performance on to a large or otherwise not similarly situated entity through a second subcontract. SBA believes that the intent of the changes in the NDAA were to ensure that the benefits of set-aside contracts flow to the intended beneficiaries. SBA does not believe that an intended consequence of the change was to make it easier to divert these benefits to ineligible entities by merely moving contracts down one or two tiers in the contracting process. As such, the proposed rule retained a requirement that firms benefiting from contracts, and their similarly situated subcontractors perform a required amount of work on the contract themselves. SBA believes that requiring firms to perform significant portions of the work, as well as to retain a significant portion of the contract award, will continue to help ensure that the benefits from these contracts flow to the intended parties.

SBA requested comments on this issue, including whether there may be unintended consequences, as well as comments about SBA's proposed solution. SBA also requested comments on whether prime contractors should be required to report to the contracting officer concerning meeting the performance of work requirements, and comments concerning the frequency and method of reporting.

SBA received three comments regarding SBA's proposal to apply the limitations on subcontracting collectively to all similarly situated entities that are performing work on the contract and that are counted toward the prime contractor's percentage of performance. Two commenters supported SBA's proposed approach and one commenter opposed this approach, and suggested that SBA apply the limitations on subcontracting only to the prime contractor and the first tier subcontractor. Applying the limitations on subcontracting to only the prime contractor and first tier subcontractor creates the possibility that the first tier subcontractor may subcontract 100% of the work it received from the prime to an entity that is not similarly situated as the prime contractor. SBA remains concerned that this would create a loophole for entities that are not small business concerns and would not have qualified to receive the prime contract to benefit, as subcontractors, from government contracts that are set aside for performance by small business concerns. To address these concerns, SBA will apply the limitations on subcontracting collectively to the prime and any similarly situated first tier subcontractor, and any work performed by a similarly situated first tier subcontractor will count toward compliance with the applicable limitation on subcontracting. Any work that a similarly situated first tier subcontractor subcontracts, to any entity, will count as subcontracted to a non-similarly situated entity for purposes of determining whether the prime/sub team performed the required amount of work. In other words, work that is not performed by the employees of the prime contractor or employees of first tier similarly situated subcontractors will count as subcontracts performed by non-similarly situated concerns.

Proposed § 125.6(b)(1) required prime contractors to enter a written agreement with each similarly situated entity that identifies the similarly situated entity and the percentage of work to be performed by that entity. The proposed rule provided that the written agreement must be signed by the similarly situated entity and provided to the contracting officer with the prime contractor's offer. Proposed § 125.6(b)(2) stated that it is immaterial whether the specific subcontractors identified in the written agreement satisfy the percentage of work identified, as long as all similarly situated entities collectively, along with the prime contractor, satisfy the performance of work requirements. Proposed § 125.6(b)(3) stated that a prime contractor may be debarred for a violation of the spirit and intent of this paragraph.

SBA received forty-seven comments related to its proposed § 125.6(b), which described how subcontracts to similarly situated entities will be excluded from the prime contractor's limitations on subcontracting. Eight of these comments generally supported § 125.6(b) as proposed. Four of these comments were considered outside the scope of this rulemaking as they advocated for an interim final rule to apply the exclusion of subcontracts to similarly situated entities from the limitations on subcontracting. One comment generally opposed proposed § 125.6(b), but did not have any suggested alternatives.

Twenty-three of the forty-seven comments received were related to proposed § 125.6(b)(1), which discussed the details that must be included in the required written agreements between the prime contractor and its similarly situated entity subcontractors. Six of these commenters supported the concept of a required written agreement but disagreed with specific aspects of the agreement such as identifying the proposed similarly situated entity subcontractors and identifying the percentage of work to be performed by those subcontractors. Seventeen of the commenters opposed the requirement for any written agreement between a prime contractor and a similarly situated entity subcontractor because it would be impossible to know their identity and possible percentage of performance in advance of the award and because it would be unnecessarily burdensome on small business prime contractors to draft and enter these agreements. SBA also received comments concerning how to address the substitution of one subcontractor for another, or a decision by the prime contractor after award to either perform the work itself or subcontract work to a similarly situated entity.

In response to these comments, SBA has decided not to require a written agreement in order for a prime contractor to rely on the work to be performed by similarly situated entities. For many years SBA's rules have allowed similarly situated entities to be counted towards the limitations on subcontracting requirements under SDVO or HUBZone set-asides or sole source awards, without also requiring a separate written agreement. There is no evidence that this long-standing policy has been difficult to understand or administer, and the rule change that limits subcontracting without regard to cost incurred for personnel should make it easier to track and identify subcontracts, especially in light of other existing requirements to report on subcontracts, such as FAR 52.204-10 (48 CFR 52.204-10). (Reporting Executive Compensation and First-Tier Subcontract Awards). In addition, SBA is concerned that requiring a written agreement would cause an administrative burden on small business concerns, which would in turn cause them to utilize this tool less often, for fear of violating the written agreement or because they would need to constantly amend the agreement based on modifications with respect to team members or to percentages of work performed by individual team members. Further, requiring a written agreement prior to offer would limit a firm's ability to decide to utilize a similarly situated entity after award and during contract performance. Many of the commenters pointed out that it may be difficult to determine whether a subcontractor will or will not be used on certain contracts, especially indefinite delivery indefinite quantity task or delivery order contracts. Small business concerns should have the discretion to run their business and perform contracts as they see fit, and the discretion to subcontract or not subcontract at any point during contract performance, provided they comply with the overall performance requirements. Further, SBA and agencies do not have the resources to review agreements or amendments to those agreements.

SBA received several comments in response to its request for comments on whether prime contractors should be required to report to the contracting officer on their compliance with the limitations on subcontracting. Eight commenters supported mandatory compliance reporting, and five of those commenters recommended that the reporting be made at the end of the contract term. Three of the supportive commenters recommended compliance reporting on a quarterly or annual basis. Three commenters opposed mandatory compliance reporting because it would be too burdensome on small business concerns. One commenter suggested that SBA use its auditing and investigating authority to determine compliance rather than requiring contractors to report their compliance. Another commenter suggested that the only necessary compliance reporting should be made in the offer.

In addition to the requirement for a written agreement, SBA also proposed to require compliance reporting from small business concerns that rely on similarly situated entities to meet their performance obligations under a set aside contract. Notably, SBA did not propose to require compliance reporting from all small business concerns (i.e., firms that do not rely on similarly situated small business concerns to meet their performance obligations). Upon further review, SBA believes that this proposal would create a disincentive to utilize this new statutory authority. Compliance reporting was not required by the statute, and in fact, reliance on similarly situated entities to help meet their performance requirements actually makes it easier these firms to comply with their obligations. Moreover, requiring a prime contractor to report on compliance with the limitations on subcontracting when it uses one or more similarly situated entities could hamper flexibility for firms during contract performance. For example, a firm may initially intend to comply on its own, but may find during contract performance that it must rely on one or more similarly situated subcontractors to meet its performance obligations. In addition, a firm may intend to use one or more similarly situated entities to help it meet its performance obligations, but then may decide during contract performance that it will perform all of the required work with its own employees. These practical realities have led us to remove the compliance reporting requirement with respect to similarly situated entities. SBA may, in the future, propose a rule that requires compliance reporting from all small business concerns, not just those that rely on similarly situated entities. However, such a change would require notice and a request for public comment that is not part of this rulemaking.

For many years, SBA's regulations have allowed similarly situated entities to count towards fulfilling the limitations on subcontracting requirements under a HUBZone or SDVO set-aside or sole source contract, without a requirement to report to the CO. As discussed above, prime contractors are already required to report on subcontracting pursuant to FAR clause 52.204-10 (48 CFR 52.204-10). Thus, because SBA is not requiring written agreements in this final rule, at this time SBA has decided not to require compliance reports from firms that are utilizing similarly situated subcontractors. SBA believes that to the extent compliance reporting should be required, it should be required from all small businesses, not just those that team with similarly situated subcontractors. Thus, SBA intends to issue a proposed rule to request public comment on the issue of whether all small businesses (and not only those that are using similarly situated entities to perform a contract) should be required to report on compliance with the limitations on subcontracting on set-aside contracts. SBA understands the recommendations made by the Government Accountability Office to strengthen the monitoring and oversight of the required performance percentages for all small businesses that receive set-aside awards, including 8(a) contractors, and believes that a separate rulemaking should address that issue more appropriately.

SBA's proposed § 125.6(b) explained that work subcontracted to similarly situated entities may be excluded from a prime contractor's calculation of its limitation on subcontracting. SBA proposed to include three examples to § 125.6(b) to demonstrate how a small business concern or Federal agency should apply the exclusion for similarly situated entities and determine compliance with the limitations on subcontracting. The final rule has redesignated proposed § 125.6(b) as § 125.6(c). As mentioned above, in response to comments, SBA is adding three more examples to redesignated § 125.6(c) to clarify how the limitations on subcontracting apply when the procurement involves a mix of services and supplies.

SBA received six comments in response to proposed § 125.6(b)(3). All six commenters opposed SBA's ability to consider a party's failure to comply with the spirit and intent of the subcontract with a similarly situated entity as a basis for debarment. These commenters argued that the proposed regulation is too vague because it is unclear how SBA would demonstrate a violation of the spirit and intent, and that the penalty of debarment is too severe. SBA clarifies that a contractor's violation of the spirit and intent of a subcontract with a similarly situated entity is something SBA may consider as a basis for debarment, but is not required to consider for debarment. SBA does not take debarment and suspension lightly and understands fully the implications of such an action. As such, SBA would not initiate any debarment or suspension action unless SBA believed that the government's interests needed to be protected. This would happen where, for example, a small business prime contractor had no intent to actually use similarly situated entities. In such a case, the firm's certification would be a misrepresentation to the government, and the government could no longer rely on any representations made by the firm. SBA would not consider a debarment or suspension action where a firm made a good faith representation that it, along with one or more similarly situated entities, would meet the performance of work requirements and through unforeseen circumstances it failed to do so. Additionally, should SBA choose to consider this as a basis for debarment, the entity at issue would have an opportunity to respond to any allegation with its own arguments and evidence. SBA believes this provision is necessary to deter potential fraud, waste, and abuse of the prime contractor's ability to exclude similarly situated entity work from its limitations on subcontracting. SBA has moved the discussion of debarment to redesignated § 125.6(h).

SBA proposed to relocate the definitions that are relevant to the limitations on subcontracting that are currently found in § 125.6(e) to § 125.1 with the other definitions that are applicable to part 125. Section 1651(e) of the NDAA provides the definitions of “similarly situated entity” and “covered small business concern.” Proposed § 125.1(x) interprets the statutorily prescribed definition for similarly situated entity.

SBA received 34 comments about its proposed definition of similarly situated entity. Fifteen of these comments opposed SBA's proposition that a small business concern qualifies as a similarly situated entity if it qualifies as small for the NAICS code assigned to the prime contractor's procurement, in addition to the other requirements included in the definition of “similarly situated entity.” Three commenters requested further clarification of the definition. Two commenters supported the definition as proposed. The remaining comments were questions regarding the application of the proposed definition to procurements for specific types of services or were comments that were considered outside the scope of this rulemaking, as they suggested changes that were not proposed and are not authorized by the statute. For example, one commenter recommended that when a solicitation requires the use of a specific subcontractor, that entity should qualify as a similarly situated entity, regardless of the subcontractor's size or small business program participation. SBA believes that this would conflict with the statutory intent that only entities that would be eligible as prime contractors may qualify as similarly situated entity subcontractors. Another commenter recommended that all individuals classified by the Internal Revenue Service as independent contractors should be included in the definition of similarly situated entity. Again, this would conflict with the statutory intent that only contractors who would qualify for the prime contract are eligible to count toward the prime contractor's performance of work as similarly situated entity provisions. However, SBA has clarified in § 125.6(e)(3) that performance by an independent contractor is considered a subcontract, and may qualify as a similarly situated entity if the contractor meets the relevant criteria.

The majority of the questions related to the application of the definition to procurements for architecture and engineering services. Often the prime contract is assigned the NAICS code representing architecture services and has a size standard that is less than the size standard for engineering services. In these cases, the engineering services are often subcontracted and commenters were concerned about how the engineering firm could qualify as a similarly situated entity if it were required to comply with the size standard assigned to the prime contract. SBA received other comments which described complex procurements involving multiple services. Firms that are small for certain types of services would not qualify as small for the NAICS assigned to the contract. In response to the comments received, SBA is not adopting its proposed definition of “similarly situated entity” and instead will allow an entity to qualify as a similarly situated entity if it is small for the NAICS code that the prime contractor assigns to the subcontract. SBA believes that this alteration to the definition will address the concerns raised about specific types of service procurements. Requiring the subcontractors to be small for the size standard assigned to the prime contract would unduly restrict the ability of prime contractors to find and use similarly situated entities to satisfy the limitations on subcontracting. SBA believes the approach adopted in this final rule will increase the ability of small business prime contractors to utilize similarly situated entity subcontractors. In addition, this approach is consistent with SBA's rules which require a prime contractor to assign the NAICS code to a subcontract which describes the principal purpose of the subcontract. 13 CFR 125.3(c)(1)(v).

In § 125.6(c), SBA proposed to require a certification requirement in connection with the limitations on subcontracting requirement. However, existing regulations require firms to agree to comply with the limitations on subcontracting in connection with a set-aside contract, including firms that are utilizing similarly situated entities, and it is SBA's intent to continue that practice. Consequently, SBA's rules do not specifically require certification from the prime contractor when utilizing similarly situated entities. In order to be awarded a set-aside contract as a small business, the prime contractor must agree to comply with the limitations on subcontracting in connection with the offer, whether that entails using similarly situated entities or not.

Proposed § 125.6(f) and (h) contained language that is included in the current rule and did not contain any proposed changes to that language aside from adding new headings to these paragraphs and reorganizing this language. These provisions have been redesignated as § 125.6(d) and (e) in this final rule. Proposed § 125.6(f) discussed HUBZone procurements of commodities. SBA did not receive any comments within the scope of this rulemaking that relate to proposed § 125.6(f) and SBA is adopting the language of proposed § 125.6(f) in § 125.6(d). Proposed § 125.6(g) discussed how to request a change in the applicable limitation on subcontracting for a particular industry. SBA received two comments related to proposed § 125.6(g). One comment supported the language and the other comment was a question regarding the transition period for industries where the limitations on subcontracting percentages do not align with industry practices. It is unclear what the commenter is requesting as this paragraph does not reference a transition period. This final rule adopts the language of proposed § 125.6(g).

Proposed § 125.6(h) discussed the period of time used to determine compliance with the limitations on subcontracting. While SBA did not propose a change to the time period used to determine compliance, SBA received 15 comments related to this paragraph. Twelve of the comments contained suggestions for how to modify the proposed language to be less burdensome on small business prime contractors and allow prime contractors to have the maximum flexibility to choose and manage subcontractors. The majority of these commenters suggested that SBA use the entire contract term, the base and all option periods, to determine whether the prime contractor has complied with the limitations on subcontracting. Other commenters suggested that periodic checks of compliance would suffice in addition to checking compliance during contract close-out. The remaining commenters believed that the current requirement was too onerous on prime contractors to check compliance for each task order issued under an IDIQ contract.

In response to these comments, SBA again emphasizes that redesignated paragraph (e) is not a change in policy. It recites the policy set forth in a prior SBA rulemaking on multiple award contracting, as set forth at § 125.2(e)(2)(iv), but clarifies that this policy applies to single award task and delivery order contracts, not just multiple award contracts. SBA believes that this provides contracting officers with the maximum flexibility to determine the time period that will be used for determining compliance with the limitations on subcontracting for performance of a task or delivery order contract. SBA does not believe it is appropriate for compliance to be determined at the end of the contract term, including all option periods, because it would eliminate the ability to monitor compliance during performance and request a proposed corrective action from the contractor in order to satisfy the limitations on subcontracting during the performance period. When compliance is monitored per base period and each option period, or per order in some cases, it helps ensure that the intended benefits are flowing to the intended recipients. If the policy were to wait until performance was concluded, the remedies would be much more limited.

Proposed § 125.6(i) addressed how the limitations on subcontracting apply to members of a Small Business Teaming Arrangement (SBTA) that are exempt from affiliation according to § 121.103(b)(9). Proposed § 125.6(i) stated that the limitations on subcontracting apply to the combined effort of the SBTA members, not to the individual members of the SBTA separately. However, SBTAs only apply to bundled contracts, and a bundled contract is a contract that is not suitable for award to a small business concern. The Small Business Act allows small businesses to team together on a bundled contract and requires the agency to consider the capabilities of subcontractors on the team, and exempt those team members from affiliation. 15 U.S.C. 644(e)(4). If a contract contains a reserve, it is suitable for award to a small business, and thus the contract is not bundled and the SBTA would not apply. Thus, SBA is removing language concerning reserves from § 121.109(b)(9) and language concerning SBTAs from § 125.6, because the limitations on subcontracting do not apply. SBTAs with respect to bundled and consolidation contracts are discussed in depth at § 125.2(b)(iii)(G).

SBA proposed to add new § 125.6(j), which exempted small business set-aside contracts valued between $3,500 and $150,000 from the limitations on subcontracting requirements. Section 46 of the Small Business Act mandates that the statutory performance of work requirements (limitations on subcontracting) apply to small business set-aside contracts with values above $150,000, and contracts of any amount awarded to socioeconomically disadvantaged contracting programs, such as 8(a), WOSB/EDWOSB, HUBZone, and SDVO set-aside contracts. 15 U.S.C. 657s. Although the limitations on subcontracting apply to all of these contracts, Section 46 does not specifically cite Section 15(j) of the Small Business Act, which is the statutory authority for non-socioeconomically disadvantaged small business set-asides between $3,500 and $150,000. Further, Section 15(j) of the Small Business Act does not mention any limitation on subcontracting requirements in connection with the performance of set-aside contracts under Section 15(j). Thus, the FAR provides that “[t]he contracting officer shall insert the clause at 52.219-14, Limitations on Subcontracting, in solicitations and contracts for supplies, services, and construction, if any portion of the requirement is to be set aside or reserved for small business and the contract amount is expected to exceed $150,000.” FAR 19.508(e) (48 CFR 19.508(e)). SBA proposed not to expand the application of the limitations on subcontracting to apply to small business set-asides below $150,000, but rather to adopt what the FAR has done. The limitation on subcontracting requirements would continue to apply to all 8(a), HUBZone, SDVO, and WOSB/EDWOSB set-aside contract awards regardless of value, including but not limited to contracts with values between $3,500 and $150,000. SBA requested comments regarding whether the limitations on subcontracting should apply to small business set-aside contracts valued between $3,500 and $150,000. In addition, SBA requested comments on whether, for policy reasons and for purposes of consistency, the performance of work/subcontracting limitation requirements should apply to a small business set-aside contract with a value between $3,500 and $150,000.

SBA received thirteen comments regarding proposed § 125.6(j). Ten of these comments supported SBA's proposed approach to exclude procurements with a value between $3,500 and $150,000 from the limitations on subcontracting. One commenter opposed this approach and stated that eliminating the application of the nonmanufacturer rule (NMR) to procurements of this value would open itself up to direct competition with non-U.S., other than small manufacturers. Another commenter suggested that SBA should exclude all small business program set-aside procurements valued between $3,500 and $150,000 from the limitations on subcontracting rather than just small business set-aside procurements. The remaining comment received was outside the scope of this rule-making.

In response to these comments, SBA notes that the limitations on subcontracting rule and the NMR as set forth in the Small Business Act do not exclude set-asides under other authorities from those requirements based on the value of the contract. 15 U.S.C. 657s. The only set-aside authority that is not cited in the limitations on subcontracting provision is Section 15(j) of the Small Business Act, which is the statutory authority for small business set-asides valued between $3,500 and $150,000. SBA is adopting the proposed language of § 125.6(j), in redesignated § 125.6(f), as the majority of comments supported this approach and it is supported by the Small Business Act and consistent with the existing FAR.

Section 1652 of the NDAA, codified at 15 U.S.C. 645 (Section 16 of the Small Business Act), prescribes penalties for concerns that violate the limitations on subcontracting requirements. SBA proposed to add new § 125.6(k) to incorporate these penalties into the regulations. Proposed § 125.6(k) stated that concerns that violate the limitations on subcontracting are subject to the penalties listed in 15 U.S.C. 645(d) except that the fine associated with these penalties will be the greater of either $500,000 or the dollar amount spent in excess of the permitted levels for subcontracting.

SBA received twenty-nine comments related to proposed § 125.6(k). Twenty-eight of these comments requested that SBA alter this paragraph to lower the penalties and allow a good faith exception for a violation of the limitations on subcontracting. Most of these commenters were concerned that by violating the limitations on subcontracting by even $1, possibly due to a miscalculation or a change in the Service Contract Act wage rates, a prime contractor could be exposed to a minimum fine of $500,000. Many commenters requested that SBA change the language from imposing a minimum fine of $500,000 to imposing a fine that is the lesser of $500,000 or the amount spent in excess of the permitted levels. Several commenters requested that the fine be imposed on the subcontractor that is not qualified to receive the funds, as it is likely that the prime contractor relied in good faith on a misrepresentation of the subcontractor's small business or small business program participation status. Other commenters requested that SBA allow a contractor that has violated the limitations on subcontracting to submit a mitigation plan and provide the contracting officer with discretion to apply the penalty when appropriate and in an amount proportional to the severity of the violation. One commenter supported the penalty language as proposed.

In response to these comments, SBA notes that the language of proposed § 125.6(k) mirrors the language of Section 1652 of the NDAA. The penalty provision is statutory and the use of the $500,000 fine as the minimum amount to be applied is also statutory. SBA believes that the penalty provision will deter contractors from agreeing to comply with the limitations on subcontracting without a practical plan for compliance because it provides a strong enforcement mechanism. It is critical that firms that obtain set-aside and preferential contracts comply with applicable subcontracting limitations. The government's policy of promoting contracting opportunities for small and socioeconomically disadvantaged businesses is seriously undermined when firms pass on work in excess of applicable limitations to firms that are other than small or that are not disadvantaged. SBA is adopting the proposed language into redesignated § 125.6(h).

This rule also proposed to revise § 121.103(h)(4). Paragraph (h) discusses the circumstances under which SBA will find affiliation among joint venturers for size purposes. Paragraph (h)(4) addresses the ostensible subcontractor rule, which is the concept that a subcontractor who performs the majority of the primary and vital requirements of a contract or whom the prime contractor is unusually reliant upon may be considered a joint venturer with the prime contractor and thus affiliated with the prime contractor for size determination purposes. SBA proposed to revise this paragraph to exclude subcontractors that are similarly situated subcontractors, as that term is defined in 13 CFR 125.1, from affiliation under the ostensible subcontractor rule. Such a position clearly flows from the NDAA's treatment of similarly situated subcontractors.

SBA received eleven comments in response to proposed § 121.103(h)(4). All eleven comments supported the exclusion of similarly situated entity subcontractors from the application of the ostensible subcontractor rule, as discussed in § 121.103(h)(4). As such, SBA is adopting the language in § 121.103(h)(4) as proposed.

SBA proposed to amend § 124.510(a), (b), and (c) to reflect the limitations on subcontracting rules with respect to the 8(a) Business Development (BD) program. Part 124 addresses the 8(a) BD program and the limitations on subcontracting that apply to procurements set aside for competition among 8(a) BD participants. SBA proposed to delete paragraphs (a) and (b) and add new paragraph (a). Currently, paragraphs (a) and (b) discuss how 8(a) BD participants can comply with the performance of work requirements even though these specifications are also discussed in § 125.6. To eliminate confusion and repetition, SBA proposed to remove current paragraph (b) and add a new paragraph (a), which will direct 8(a) BD participants to comply with the limitations on subcontracting set forth in § 125.6. The proposed rule would redesignate current paragraph (c) as paragraph (b) and include references to the limitations on subcontracting as opposed to the performance of work requirements in newly redesignated paragraph (b). The NDAA uses the term “limitations on subcontracting” to describe the concept that is currently referred to as “performance of work requirements.” This change provides consistency throughout the rules.

SBA received seventeen comments in response to the proposed language in § 124.510. Ten of these commenters opposed the proposed language and specifically disagreed with providing contracting officers the discretion to apply the limitations on subcontracting to 8(a) contracts per order. Commenters also opposed SBA's proposed § 124.510(b)(2), which allows the SBA District Director the ability to waive the applicable limitations on subcontracting in certain circumstances. Three of the comments received were suggestions to modify the language of proposed § 124.510(b) to clarify that subcontracts awarded to similarly situated entities for an 8(a) procurement are not counted toward that 8(a) prime contractor's limitations on subcontracting but are counted toward their non-8(a) revenue for purposes of meeting their business activity targets. Two commenters supported the language of § 124.510(b) as proposed.

For purposes of counting 8(a) revenue, the dollar amount of a prime contract award is credited towards the revenue of the prime contractor. Thus, to the extent an 8(a) prime decides to utilize a subcontractor for purposes of meeting the limitations on subcontracting provisions, any amount subcontracted is not deducted from the prime's 8(a) revenue. SBA notes that the language in § 124.510(b) is not new, and as such, no changes to this language were proposed. Nonetheless, several commenters expressed their opposition to a District Director's ability to waive compliance with the limitations on subcontracting in certain circumstances and disagreed with the time period used to determine compliance with the limitations on subcontracting for 8(a) procurements. In response to these comments, SBA is eliminating this provision. SBA has not received any comments or input indicating this provision has benefited specific 8(a) concerns. In addition, this exemption is not based on any statutory authority. Thus, in accordance with the intent of the section to make the performance requirements uniform across all programs, SBA is eliminating paragraphs (c)(4) and (c)(5) of § 124.510.

SBA proposed to revise § 125.15(a)(3) and (b)(3), which address the requirements for an SDVO SBC to submit an offer on a contract. SBA proposed to revise paragraph (a)(3) to state that a concern that represents itself as an SDVO SBC must also represent that it will comply with the limitations on subcontracting, as set forth in § 125.6, as part of its initial offer, including price. SBA proposed to revise paragraph (b)(3) to state that joint ventures that represent themselves as an SDVO SBC joint venture must comply with the applicable limitations on subcontracting, as set forth in § 125.6. SBA received no comments related to these paragraphs and as such is adopting the language as proposed.

HUBZone Program

SBA also proposed to revise § 126.200(b)(6). This paragraph addresses the requirements that a concern must meet in order to receive SBA's certification as a qualified HUBZone SBC. Paragraphs (b)(6) and (d) are repetitive as both address the requirement that HUBZone SBCs must comply with the relevant performance of work requirements. SBA proposed to delete paragraph (d) and revise paragraph (b)(6). Specifically, proposed paragraph (b)(6) would state that the concern must represent in its application for the HUBZone program that it will comply with the applicable limitations on subcontracting requirements with respect to any procurement that it receives as a qualified HUBZone SBC. SBA received one comment related to proposed § 126.200(b)(6), which was a request to clarify whether a HUBZone similarly situated entity subcontractor must meet the 35% residency requirement for HUBZone program participation. In response, SBA clarifies that a HUBZone similarly situated entity subcontractor must be able to qualify for the prime HUBZone procurement in order to be considered a similarly situated entity. This means that it must also be HUBZone certified and be considered small for the NAICS code assigned to its subcontract. SBA is adopting the language in § 126.200(b)(6) as proposed.

SBA proposed to revise § 126.700 in its entirety, including revision of paragraph (a) and removal of paragraphs (b) and (c). This section currently addresses the performance of work requirements for HUBZone contracts. SBA proposed to retitle the section to include the terminology “limitations on subcontracting”; remove references to the “performance of work” requirements; and replace the deleted text with a reference to 13 CFR 125.6 for guidance on the applicable limitations on subcontracting for HUBZone contracts. SBA believes that it would be confusing to have each section of SBA's set-aside program regulations repeat the relevant limitations on subcontracting, and therefore SBA proposed to list all of the limitations on subcontracting requirements at § 125.6 and provide references to that section in each of the various small business government contracting and business development program sections. SBA did not receive comments related to this paragraph and is adopting the language as proposed.

SBA proposed to revise § 127.504(b), which addresses the requirements a concern must satisfy to submit an offer for an EDWOSB or WOSB requirement. Paragraph (b) states that the concern must meet the performance of work requirements in § 125.6. SBA proposed to revise this paragraph to replace the reference to “performance of work requirement” with “limitations on subcontracting.” SBA did not receive comments related to this paragraph and is adopting the language as proposed.

SBA proposed to revise § 127.506(d), which addresses the requirements that a joint venture must satisfy in order to submit an offer for an EDWOSB or WOSB requirement. SBA proposed to revise this paragraph by replacing the reference to “performance of work requirement” with “limitations on subcontracting.” SBA did not receive comments related to this paragraph and is adopting the language as proposed.

Subcontracting Plans

Section 1653 of the NDAA, as codified at 15 U.S.C. 637(d) (Section 8(d) of the Small Business Act), addresses amendments to the requirements for subcontracting plans. Section 1653(a)(2) of the NDAA states that the head of the contracting agency shall ensure that the agency collects, reports, and reviews data on the extent to which the agency's contractors meet the goals and objectives set out in their subcontracting plans. SBA proposed to add a new § 125.3(f)(8) to incorporate these provisions. SBA received three comments on this addition. Two were positive, and the one negative comment felt that the statutory language may be too burdensome for contracting officers and prime contractors. This final rule adopts the proposed language.

Section 1653(a)(3) of the NDAA modifies the Small Business Act to state that a contractor that fails to provide a written corrective action plan after receiving a marginal or unsatisfactory rating for its subcontracting plan performance or that fails to make a good faith effort to comply with its subcontracting plan will not only be in material breach of the contract, but such failure shall also be considered in any past performance evaluation of the contractor. SBA proposed to revise § 125.3(f)(5) to incorporate this language. SBA also proposed adding a new sentence to the end of § 125.3(f)(5), which would prescribe the process for a Commercial Market Representative (CMR) to report firms that are found to have acted fraudulently or in bad faith to the SBA's Area Director for the Office of Government Contracting Area Office where the firm is headquartered. SBA received eight comments on this proposed change. One of the comments wanted SBA to ensure that there was a definitive statement that contracting officers shall take into consideration ratings on performance of past subcontracting plans when evaluating past performance. SBA agrees with this position, but believes that it is already clear in the regulatory text. The provisions of the NDAA make clear that contracting officers shall take into consideration previous performance of its subcontracting plans. The remaining comments were generally supportive of the changes. Two negative comments were related to requirements of the Act itself which can be modified or changed only by another Act passed of Congress. Thus, SBA is not making any changes to the proposed rule.

Section 1653(a)(4) of the NDAA modifies the Small Business Act to state that contracting agencies also perform evaluations of a prime contractor's subcontracting plan performance, and that SBA's evaluations of subcontracting plan performance are completed as a supplement to the contracting agency's review. SBA proposed to revise § 125.3(f)(1) to incorporate this language. SBA did not receive any comments on this change and will be keeping the proposed language.

Section 1653(a)(5) of the NDAA requires that if an SBC is identified as a potential subcontractor in a proposal, offer, bid or subcontracting plan in connection with a covered Federal contract, the prime contractor shall notify the SBC prior to such identification. Section 1653(a)(5) also requires that the Administrator establish a reporting mechanism that allows potential subcontractors to report fraudulent activity or bad faith behavior by a prime contractor with respect to a subcontracting plan. SBA proposed to incorporate these requirements in new § 125.3(c)(8) and (9). SBA received eight comments on these changes. Several comments asked for clarification on how the notification requirements can be met. SBA believes that rule is very clear. There are two requirements: First that the notification is in writing; and second that it be given to the party in question. Ensuring that it is in writing and has been received is the responsibility of the contractor. SBA is not making any changes with regard to this requirement. Several commenters requested that additional requirements be added that would also require notification to SBA or another government party that the contract has provided the written notification that is required. SBA does not believe that this additional step is required by the statute, or that the additional burden on contractors is necessary to ensure compliance with the other provision.

Affiliation

SBA proposed to make changes to its regulations in § 121.103(f), which defines affiliation based on an identity of interest. Paragraph 121.103(f) discusses the circumstances where an identity of interest between two or more persons leads to affiliation among those persons and their interests are aggregated. SBA proposed to add additional guidance on how to analyze affiliation due to an identity of interest. SBA believed that the additional clarifications will better enable concerned parties to understand and determine when they are affiliated.

SBA proposed to divide paragraph (f) into two paragraphs. Paragraph (f)(1) will include further clarification regarding the type of relationships between individuals that will create a presumption of affiliation due to an identity of interest. Specifically, SBA proposed to insert language clarifying that a presumption of affiliation exists for firms that conduct business with each other and are owned and controlled by persons who are married couples, parties to a civil union, parents and children, and siblings. SBA proposed that the presumption would be a rebuttable presumption. The proposed rule is based on size appeal decisions that have been issued interpreting this regulation.

SBA received several comments with respect to identity of interest based on family relationships. Four commenters thought that the list of family relationships was not exhaustive enough and should include all relationships, such as grandparents and cousins. These commenters believed that all familial relationships should create the presumption, and that other information such as estrangement or distance could be used in rebuttal. Two commenters agreed that the clarity SBA was providing was helpful and agreed with the changes. Two commenters did not believe that affiliation should ever be found based on familial relationships.

As noted in SBA's proposed rule, the enumerated family relationships are relationships in which SBA's Office of Hearings and Appeals (OHA) has consistently found affiliation in the past. See Size Appeal of Knight Networking & Web Design, Inc., SBA No. SIZ-5561 (2014); Size Appeal of RGB Group, Inc., SBA No. SIZ-5351 (2012); and Size Appeal of Jenn-Kans, Inc., SBA No. SIZ-5114 (2010). The rule is intended to take this knowledge and precedent and provide it in the rule itself in order to make compliance and understanding easier for small businesses. SBA believes the proposed rule accurately encompassed the precedential history of SBA size decisions and that it will be beneficial in providing some clarity to small businesses. Thus, SBA is adopting the language in (f)(1) in the final rule.

In paragraph (f)(2), SBA proposed adopting a presumption of affiliation based on economic dependence. Specifically, if a firm derives 70% or more of its revenue from another firm over the previous fiscal year, SBA will presume that the one firm is economically dependent on the other and, therefore, that the two firms are affiliated. Currently there is no fixed percentage that SBA applies when evaluating this criteria. However, OHA size appeal decisions have provided the 70% figure as a guide. SBA believes that providing clarity on this issue will be beneficial for firms, and will enable them to more easily identify their affiliates. Further, this presumption is rebuttable, such as when a firm is new or a start-up and has only received a few contracts or subcontracts. Often new firms will not have as many partners and clients, and therefore will normally be generating more of their revenue from a much smaller number of other companies. Over time these firms should diversify and become less dependent on one entity.

SBA received 26 comments on this section. Several commenters pointed out that SBA should use a three-year time frame rather than a one year time frame because SBA already uses a three-year time frame when averaging annual receipts for size purposes. SBA agrees, and has adopted a three-year measuring period in the final rule. Several commenters were also concerned that this new rule and its interpretation could adversely impact “start-ups” that have low revenues to begin with and fewer contracts. SBA does not want this new rule to negatively impact start-ups or any other company that operates in a unique industry. That is precisely why this is not a bright line rule, but a rebuttable presumption. This rebuttable presumption is based on OHA cases, and OHA has in fact rebutted the presumption in appropriate circumstances. For instance, OHA has held that the mechanical application of the economic dependence rule is erroneous when a startup has only been able to secure one or two contracts. Size Appeal of Argus & Black, Inc., SBA No. SIZ-5204 (2011). In addition, OHA has held that where the receipts from an alleged affiliate are not enough to sustain a firm's business operations, and the firm is able to look to other financial support from its Alaska Native Corporation (ANC) affiliates to remain viable, the fact that the firm received more than 70% of its receipts from its alleged affiliate is not sufficient to establish affiliation. Size Appeal of Olgoonik Solutions LLC, SBA No SIZ-5669 (2015). In response to the comments and in an effort to provide greater clarity, this final rule specifies that the presumption of affiliation based on economic dependence may be rebutted by a showing that despite the contractual relations with another concern, the concern at issue is not solely dependent on that other concern. In addition, SBA has provided examples in the regulatory text for clarification. Several comments asked for a specific list of acceptable rebuttals, and one commenter requested that Tribally-owned firms be granted an explicit exception. SBA does not believe that providing a list of acceptable rebuttals may have the unintended consequence of limiting the types of rebuttals that are acceptable. Instead SBA believes that firms should be permitted to make any arguments and provide any evidence that they believe demonstrates that no affiliation should be found. In addition, SBA has clarified that SBA will not find affiliation between two concerns owned by an Indian Tribe, ANC, Native Hawaiian Organization (NHO) or Community Development Corporation (CDC) based solely on the contractual relations of the two concerns. The Small Business Act and SBA's rules clearly recognize that ANC, NHO, CDC, and Tribally-owned concerns will provide assistance to sister entities, and it does not make sense to find affiliation based on economic dependence among such concerns.

Joint Ventures

SBA proposed to amend § 121.103(h) to broaden the exclusion from affiliation for small business size status to allow two or more small businesses to joint venture for any procurement without being affiliated with regard to the performance of that procurement requirement. Currently, in addition to the exclusion from affiliation given to an 8(a) protégé firm that joint ventures with its SBA-approved mentor for any small business procurement, there is also an exclusion from affiliation between two or more small businesses that seek to perform a small business procurement as a joint venture where the procurement is bundled or large (i.e., greater than half the size standard for a procurement assigned a NAICS code with a receipts-based size standard and greater than $10 million for a procurement assigned a NAICS code with an employee-based size standard). SBA proposed to remove the restriction on the type of contract for which small businesses may joint venture without being affiliated for size determination purposes. SBA proposed this change for several reasons. First, the proposed change would encourage more small business joint venturing, in furtherance of the government-wide goals for small business participation in federal contracting. Second, the proposed change is consistent with the results from the Small Business Teaming Pilot Program indicating there is a need for more small business opportunities and firms have greater success on small contracts than on large contracts. Third, this proposed change would better align with the new provisions of the NDAA governing the limitations on subcontracting, which allow a small business prime contractor to subcontract to as many similarly situated subcontractors as desired. If a small business prime contractor can subcontract significant portions of that contract to one or more other small businesses and, in doing so, meet the performance of work requirements for small business (without being affiliated with the small business subcontractor(s)), it is SBA's view that similar treatment should be afforded joint ventures—so that a joint venture of two or more small businesses could perform a procurement requirement as a small business when each is individually small.

SBA received 43 comments on this section. The comments were overwhelmingly supportive of the change. As such, this final rule adopts the proposed language requiring only that each member of a joint venture individually qualify as small. Several commenters also suggested that SBA provide additional guidance regarding joint ventures that perform contracts as similarly situated entities. This final rule clarifies that a joint venture of two or more business concerns may submit an offer as a small business for a Federal procurement, subcontract or sale so long as each concern is small under the size standard corresponding to the NAICS code assigned to the contract.

Calculation of Annual Receipts

SBA proposed to amend § 121.104, which explains how SBA calculates annual receipts when determining the size of a business concern. SBA proposed to clarify that receipts include all income, and the only exclusions from income are the ones specifically listed in paragraph (a). It was always SBA's intent to include all income, except for the listed exclusions; however, SBA has found that some business concerns misinterpreted the current definition of receipts to exclude passive income. SBA's proposed change clarifies the intent to include all income, including passive income, in the calculation of receipts.

SBA received 15 comments on this section. The majority of the comments were supportive. Several commenters believed that SBA should not count certain expenses to subcontractors as revenue. The comments were asking SBA to consider new exemptions. The proposed change was not intended to fundamentally change the meaning of SBA's regulation, but merely ensure that small businesses are aware that all income is considered including passive income. Thus, SBA is adopting the proposed language in this final rule.

Recertification

SBA proposed to amend § 121.404(g)(2)(ii) by adding new paragraph (D) to clarify when recertification of size is required following the merger or acquisition of a firm that submitted an offer as a small business concern. Paragraph (D) clarifies that if the merger or acquisition occurs after offer but prior to award, the offeror must recertify its size to the contracting officer prior to award.

SBA received twenty-one comments on this proposed change. Nine commenters supported SBA's proposal. One commenter asked that SBA go further and specifically allow contracting officers to refuse novation of contacts if an acquisition or merger occurs within 90 days of an award. Seven commenters strongly opposed SBA's proposed changes. Two commenters argued that there should be a 30 day period prior to award requirement. SBA does not know how this could be implemented given that offerors do not know when an award announcement will be made. One commenter suggested SBA should only require recertification if the merger or sale involves a large business. One commenter was confused about whether this rule would negate the requirement to certify at the time at offer.

SBA is adopting the proposed language in this final rule. For several years SBA's rules have required recertification in connection with a contract when there is an acquisition or merger involving the prime contractor. SBA never intended for the recertification requirement to not apply based on when the acquisition or merger occurred. If recertification is required for an existing contract, it should be required for a pending contract. An agency's receipt of small business credit should not depend on whether an acquisition or merger occurs the day before award of contract.

Small Business Innovation Research and Small Business Technology Transfer Programs

SBA proposed to amend § 121.702(a)(2), which addresses an ownership and control element of the eligibility requirements for the Small Business Innovation and Research (SBIR) Program, to clarify that a single venture capital operating company (VCOC), hedge fund, or private equity firm may own more than 50% of an SBIR awardee if that single VCOC, hedge fund, or private equity firm qualifies as a small business concern which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States.

Section 121.702(a) establishes the SBIR program eligibility requirements related to ownership and control. Awardees that satisfy any of the permissible ownership and control structures discussed in § 121.702(a) must also satisfy all of the size and affiliation requirements stated in § 121.702(c). Section 121.702(a)(1)(ii) allows an SBIR awardee to be majority-owned by multiple VCOCs, hedge funds, or private equity firms. Section 121.702(a)(2) prohibits ownership by a single VCOC, hedge fund, or private equity firm that owns a majority of the concern. This paragraph has been misread because it does not account for the scenario where an awardee is majority-owned by a single VCOC, hedge fund, or private equity firm that is itself another small business concern and therefore qualifies as an allowable ownership structure under § 121.702(a)(1)(i). To clarify this point, SBA is amending § 121.702(a)(2) to explain that it is permissible for an SBIR awardee to be majority owned by a single VCOC, hedge fund, or private equity firm if that firm meets the definition of a small business concern under this section and is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States. SBA did not receive any comments related to this proposed change and is adopting the change as proposed.

Size Protests

SBA proposed to amend § 121.1001(a), which specifies who may initiate a size status protest. Small businesses and contracting officers have found the current language to be unclear because it contains a double negative, stating that any offeror that has not been eliminated for reasons not related to size may file a size protest. The intent is to provide standing to any offeror that is in line or consideration for award, but to not provide standing for an offeror that has been found to be non-responsive, technically unacceptable or outside of the competitive range.

In addition, the proposed rule added a new § 121.1001(b)(11) that would authorize the SBA's Director, Office of Government Contracting, to initiate a formal size determination in connection with eligibility for the SDVO SBC and the WOSB/EDWOSB programs. This change is needed to correct an oversight that did not authorize such requests for size determinations when those programs were added to SBA's regulations.

SBA received 16 comments on this change. All commenters were supportive; however one commenter believed that the protests should be allowed for firms outside the competitive range. SBA disagrees. A firm outside of the competitive range is not eligible for award and does not have standing. However, SBA and the contracting officer may file a size protest at any time, so any firm, including those that do not have standing, may bring information pertaining to the size of the apparent successful offeror to the attention of SBA and/or the contracting officer for their consideration.

North American Industry Classification System Code Appeals

SBA sought comments on the appropriate timeline for filing a NAICS code appeal. SBA's regulations currently state that, “[a]n appeal from a contracting officer's NAICS code or size standard designation must be served and filed within 10 calendar days after the issuance of the solicitation or amendment affecting the NAICS code or size standard.” 13 CFR 121.1103(b)(1). SBA received 23 comments on this issue. Most of the comments were supportive of SBA's current timing. Several commenters recommended other changes that SBA could make. Based on the comments, SBA is not altering the timeliness rules for NAICS code appeals.

Nonmanufacturer Rule

SBA proposed to clarify that the limitations on subcontracting and the nonmanufacturer rule (NMR) do not apply to small business set-aside contracts valued between $3,000 and $150,000. The statutory nonmanufacturer rule, which is contained in Section 8(a)(17) of the Small Business Act, 15 U.S.C. 637(a)(17), is an exception to the limitations on subcontracting (LOS). It provides that a concern may not be denied the opportunity to compete for a supply contract under Sections 8(a) and 15(a) of the Small Business Act simply because it is not the actual manufacturer or processor of the product. Section 8(a)(17) of the Small Business Act does not, however, also reference Section 15(j) of the Small Business Act, the authority requiring small business set-aside contracts valued between $3,500 and $150,000. Thus, there is no specific statutory requirement that the nonmanufacturer rule apply to the mandated small business set-asides between $3,500 and $150,000. SBA believes that not applying the nonmanufacturer rule to small business set-asides valued between $3,500 and $150,000 will spur small business competition by making it more likely that a contracting officer will set aside an acquisition for small business concerns because the agency will not have to request a waiver from SBA where there are no small business manufacturers available. In order to request a waiver, an agency must provide SBA with the solicitation and market research on whether manufacturers exist and wait several weeks for SBA to verify the data and grant the waiver. Without a waiver, an offeror on a small business set-aside supply contract must either manufacture at least 50% of the product on its own or supply the product of a small business made in the United States. Many waiver requests below $150,000 are for name brand items (e.g., computers) that are clearly not made by small businesses in the United States. Whether an agency can procure name brand items is not within the jurisdiction of SBA. The contracting officer must make that determination, which can be protested by interested parties.

SBA received 28 comments on this issue, of which 19 were supportive. The non-supportive comments believed that this change would drastically hurt small business manufacturers because most of their contracts fell within the exemption range. One commenter maintained that the proposed rule would hurt resellers by increasing competition among resellers. Given the support for the change and the consistency between the FAR and SBA's regulations that this creates, SBA is adopting the proposed language in the final rule.

Several commenters asked for additional clarity on several discrete issues. Specifically, commenters sought guidance on how the NMR applies to multiple item procurements generally, and especially to procurements with multiple NAICS codes, and how the NMR and LOS apply when a multiple-item procurement contains items manufactured by multiple large and small businesses.

Further, commenters requested guidance on the treatment of rentals with regard to the NMR and LOS. In order to provide more clarity SBA is proposing new language in § 121.406(b)(4) and (e). SBA has also provided several additional examples to demonstrate how the rules should be applied. The final rule clarifies that rental services are not supplies. SBA bases this clarification on the NAICS code and NAICS manual, as well as the FAR and other government contracting statutes which indicate that renting an item is not the same thing as buying an item. SBA is also adding additional language to clarify how to apply the NMR, LOS, and size standards, to address comments concerning how to apply the various rules when the government acquires more than one item in a single procurement. SBA believes this language will more clearly state how the various regulations interact in that situation.

The intent is for the NMR, LOS, and size standards to operate in conjunction with each other in a manner consistent with all of SBA's regulations. Therefore SBA believes that the proper way to calculate LOS requirements with regard to a contract that contains waived item(s)/small business item(s) is that the value of the waived item(s) are subtracted from the total and the prime contractor is responsible for meeting the requirements on the remainder. SBA has added several examples to § 125.6(a) to help explain how this should be calculated in practice.

SBA proposed to amend § 121.1203 to require that contracting officers notify potential offerors of any waivers, whether class waivers or contract specific waivers, that will be applied to the procurement. SBA proposed that this notification of the application of a waiver be contained in the solicitation itself. Without notification that a waiver is being applied by the contracting officer, potential offerors cannot reasonably anticipate what if any requirements they must meet in order to perform the procurement in accordance with SBA's regulations. SBA believed that providing notice of waivers in the solicitation will provide all potential offerors with the information needed to decide if they should submit an offer.

SBA also proposed to amend § 121.1203, regarding waivers to the nonmanufacturer rule. SBA proposed to amend § 121.1203(a) to specifically authorize SBA to grant a waiver to the nonmanufacturer rule for an individual contract award after a solicitation has been issued, provided the contracting officer agrees to provide all potential offerors additional time to respond. SBA believes that a waiver may be appropriate even after a solicitation has been issued, but wants to ensure that all potential offerors would be fully apprised of any waiver granted after the solicitation is issued and have a reasonable amount of time (depending upon the complexities of the procurement) to adjust their offers accordingly.

SBA proposed in § 121.1203(b) to allow some waivers to be granted after the contract has been awarded. SBA believed that granting post-award waivers, when additional items that are eligible for a waiver are sought through in-scope modifications, is reasonable and will increase the use of the waiver process and allow firms to compete for contracts in a manner consistent with SBA regulations. SBA envisioned these types of post-award waivers to be given in situations similar to the example contained in the proposed regulation—where a need for an item occurs after contract award, where requiring the item would be an in-scope modification, and where the item is one for which a waiver would have been granted if sought prior to contract award.

SBA received 32 comments on the changes being made to NMR waivers. Many commenters supported the proposed language regarding notification by the contracting officer. Commenters universally agreed that being informed of the application of a waiver as early as possible would be beneficial to small business contractors. Several comments requested additional guidance or a firmer statement about the application of waivers granted on base contract to orders issued against that contract. Contract specific waivers are granted for individual items and the waiver is good for the entirety of that contract with regard to the item that was waived. Therefore, the waiver would by necessity also include all orders for supplies under that contract that would require the item(s) that had been waived.,

SBA proposed to add a new § 121.1203(d), dealing with waivers to the nonmanufacturer rule for the purchase of software. SBA proposed to address whether the nonmanufacturer rule should apply to certain software that can readily be treated as an item and not a service. SBA proposed to treat this type of software as a product or item of supply rather than a service. SBA believed that this change will bring SBA's regulations in line with how most buyers already perceive these types of software. Readily available software that is generally available to both the public and private sector unmodified is almost universally perceived to be a supply item, even though SBA's regulations currently would treat the production of any type of software as a service. SBA proposed to allow for certain types of software to be eligible for waivers of the nonmanufacturer rule. SBA proposed to grant waivers on software that meet criteria that establishes that the Government is buying something that is more like a product or supply item than a service. Clearly, when the Government seeks to award a contract to a business concern to create, design, customize or modify custom software, that should be classified as a service requirement and the activity will remain classified in a service NAICS code to which the nonmanufacturer rule does not apply. For a service procurement set aside for small business, the prime (together with one or more similarly situated subcontractors) would have to perform the required percentage of work. On the other hand, when the government buys certain types of unmodified software that is generally available to both the public and the government from a business concern, SBA believes that the contracting officer should classify the requirement as a commodity or supply. If the procurement is a supply contract set aside for small business, the prime contractor, together with any similarly situated subcontractors, would have to perform at least 50% of the cost of manufacturing the software, unless SBA granted a waiver of the nonmanufacturer rule.

Commenters generally supported SBA's proposed language. One commenter stated that given this new approach by SBA, that some software products should be granted class waivers. Once this rule is effective, the public will be able to request a class waiver for a software item under SBA's existing regulations for class waivers. 13 CFR 121.1204. Many commenters requested drastic changes to SBA's current waiver procedures. Specifically, the commenters requested that a waiver requested by CO be assumed granted if SBA does not respond in specified period of time. Two commenters requested language that would allow bidders to assume pending waiver requests are granted when they submit offers. SBA cannot adopt these recommendations. The Small Business Act is clear that only SBA may grant a waiver of the NMR. These comments reinforce SBA's belief that the current situation has caused too much confusion for small contractors, and SBA is adopting the proposed language in this final rule, which requires the contracting officer to request a contract specific waiver prior to issuing the solicitation, and provide notification of the application of the waiver in the solicitation itself.

One commenter complained that the application of the software waiver is not also being applied to cloud based solutions. It is SBA's current position that cloud based solutions are services that are being provided to the government and not supplies that the government is purchasing, and therefore the NMR is not applicable. In our view, cloud based solutions are similar to rentals, which, as discussed above, SBA treats as services. Several commenters asked SBA to address the issue of NMR waiver requests when the issue is contractor requesting a brand name item. The decision to request a brand name item is in the discretion of the contracting officer. However, the Small Business Act does not exclude brand name item acquisitions from the statutory NMR waiver requirements.

In the proposed rule, SBA proposed to amend § 121.201 by adding a footnote to NAICS code 511210, Software Publishers, explaining that this is the proper NAICS code to use when the government is purchasing software that is eligible for a waiver of the NMR. The 2012 NAICs manual provides the following definition of this industry:

This industry comprises establishments primarily engaged in computer software publishing or publishing and reproduction. Establishments in this industry carry out operations necessary for producing and distributing computer software, such as designing, providing documentation, assisting in installation, and providing support services to software purchasers. These establishments may design, develop, and publish, or publish only.

SBA believes that this accurately reflects the type of companies that would be producing and supplying the government with the type of software eligible for a waiver. Further, SBA proposed that the procurement of this type of software would be treated by SBA as a supply requirement, and therefore the NMR would apply, as long as the acquisition meets all of the requirements of the rule. SBA reiterates that the custom design or modification of software for the government will generally continue to be treated as a service. Therefore, if the software being acquired requires any custom modifications in order to meet the needs of the government, it is not eligible for a waiver of the NMR because the contractor is performing a service, not providing a supply.

SBA proposed to amend § 121.406(b)(5) to make a technical correction. Section 121.406(b) addresses how a nonmanufacturer may qualify as a small business concern for a requirement to provide a manufactured product or other supply item. Currently, paragraph (b)(5) states that the SBA's Administrator or designee may waive the requirement set forth in paragraph (b)(1)(iii) of this section, that requires nonmanufacturers to supply the end item of a small business manufacturer, processor or producer made in the United States. The citation to paragraph (b)(1)(iii) is incorrect and as such, SBA proposed to amend this paragraph to include the correct citation, paragraph (b)(1)(iv). SBA also proposed to make this correction in the size standard proposed rule for industries with employee based size standards that are not part of manufacturing, wholesale trade or retail trade. 79 FR 53646 (Sept. 10, 2014). The size standard rule was finalized on January 26, 2016 (81 FR 4436), and SBA has removed the proposed amendment from this final rule.

In addition, in the proposed rule SBA proposed to amend § 121.406(b)(7) to clarify that SBA's waiver of the NMR has no effect on requirements external to the Small Business Act which involve domestic sources of supply, such as the Buy American Act and the Trade Agreements Act.

In order to clarify whether the NMR applies, or whether a general or specific waiver is attached to a procurement, SBA proposed to add a new § 121.1206 to require contracting officers to receive specific waivers prior to posting a solicitation, and also to provide notification to all potential offerors of any waivers that will be applied (whether class or specific) to a given solicitation. As noted above, commenters were generally in favor of this provision, and SBA is adopting the proposed language in the final rule.

Adverse Impact and Construction Requirements

SBA proposed to amend § 124.504 to clarify when a procurement for construction services is considered a new requirement. This section generally addresses when SBA must conduct an adverse impact analysis for the award of an 8(a) contract. SBA is not required to perform an adverse impact analysis for new requirements. Currently, paragraph (c)(1)(ii)(B) states that “Construction contracts, by their very nature (e.g., the building of a specific structure), are deemed new requirements.” SBA proposed to clarify the definition of “new requirement” for construction contracts by specifying that generally, the building of a specific structure is considered a new requirement. However, recurring indefinite delivery or indefinite quantity (IDIQ) procurements for construction services are not considered new. SBA has found that agencies have misinterpreted the current language of § 124.504(c)(1)(ii)(B) to consider recurring IDIQ construction services procurements as new. SBA intended to clarify that such recurring requirements are not considered new. A determination of whether a construction contract is recurring or new will have to be made on a case by case basis, and there is a process in place that allows SBA to file an appeal with the procuring agency when there is a disagreement.

SBA received 11 comments on this proposed change, and most were supportive. The non-supportive comments seemed to have misunderstood how the rule will be implemented. There is no presumption that IDIQ task or delivery order contracts are not new. The rule is neutral and the determination will be made on a case-by-case basis, subject to SBA's statutory authority to appeal. Thus, SBA is adopting the proposed language in the final rule.

Certificate of Competency

SBA proposed to amend § 125.5(f), which addresses SBA's review of an application for the Certificate of Competency (COC) program. SBA proposed to insert new § 125.5(f)(3) to address how SBA should review an application for a COC based on a finding of non-responsibility due to financial capacity where the applicant is the apparent successful offeror for an IDIQ task order or contract. SBA frequently receives inquiries regarding the application of the COC process for financial capacity to the potential award of an IDIQ contract. SBA intended to clarify this process by proposing changes to § 125.5(f). The proposed changes provided that the SBA's Area Director will consider the firm's maximum financial capacity and if such COC is issued, it will be for a specific amount that serves as the limit of the firm's financial capacity for that contract. The contracting officer cannot deny the firm the award of an order or contract on the basis of financial incapacity if the firm has not reached the financial maximum identified by the Area Director.

SBA received two comments on this issue. One was supportive, and one thought it added too much of a burden to small businesses. SBA believes this rule will address certain issues that arise for IDIQ contracts. This rule provides clarity to the process and ensures that small business participation is maximized. Further, the COC process is statutory and provides SBA with the ability to review non-responsibility determinations concerning small businesses. Thus, SBA is adopting the proposed language in the final rule.

SBA is also revising 13 CFR 121.408(a), which provides the size procedures for the COC program. The revision is a technical correction. This paragraph currently references 13 CFR 121.1009 to explain how SBA would initiate a formal size determination; however, § 121.1009 relates to the process SBA uses to make a formal size determination. The correct regulatory reference is to 13 CFR 121.1001(b)(3)(ii), which explains how SBA initiates a formal size determination for the COC program.

SBA is also revising 13 CFR 121.409, to remove the second sentence. This section addresses the size standard that applies in an unrestricted or full and open procurement. The second sentence states that in an unrestricted procurement, the small business concern must supply a domestically furnished product. That may or may not be true, depending on whether or how the Buy American Act or the Trade Agreements Act apply to the procurement. The Small Business Act does not impose such a requirement on full and open or unrestricted procurements.

Compliance With Executive Orders 12866, 13563, 13175, 12988, 13132, the Paperwork Reduction Act (44 U.S.C. Ch. 35), and the Regulatory Flexibility Act (5 U.S.C. 601-612) Executive Order 12866

The Office of Management and Budget (OMB) has determined that this final rule is a “significant” regulatory action for purposes of Executive Order 12866. Accordingly, the next section contains SBA's Regulatory Impact Analysis. However, this is not a major rule under the Congressional Review Act, 5 U.S.C. 801, et seq.

Regulatory Impact Analysis 1. Is there a need for the regulatory action?

The final rule implements Sections 1621, 1623, 1651, 1652, 1653 and 1654 of the National Defense Authorization Act of 2013, Public Law 112-239, 126 Stat. 1632, January 2, 2013; 15 U.S.C. 637(d), 644(l), 645, 657s. In addition, it makes several other changes needed to clarify ambiguities in or remedy perceived problems with the current regulations. These changes should make SBA's regulations easier to use and understand.

2. What are the potential benefits and costs of this regulatory action?

These final regulations should benefit small business concerns by allowing small business concerns to use similarly situated subcontractors in the performance of a set-aside contract, thereby expanding the capacity of the small business prime contractor and potentially enabling the firm to compete for and obtain larger contracts. It also strengthens the small business subcontracting provisions, which may result in more subcontract awards to small business concerns. The final rule also seeks to address or clarify issues that are ambiguous or subject to dispute, thereby providing clarity to contracting officers as well as small business concerns. SBA does not believe that this rule will impose new costs on small business concerns.

3. What are the alternatives to this final rule?

Many provisions in this final rule are required to implement statutory provisions, thus there are no alternatives for these regulations. SBA did consider various options in the proposed rule, including a requirement that small business concerns that want to team with similarly situated entities enter into a written agreement, certify that they will comply and report on compliance. However, in response to the public comments discussed in the Supplementary Information, SBA is not requiring a written agreement or compliance reporting in this rule. Contracting officers in their discretion may require compliance reporting. Further, firms agree to comply with the limitations on subcontracting when they submit an offer. Thus, an additional certification is unnecessary. SBA also considered whether it should not waive the NMR for the purchase of software. However, this would inhibit the ability of agencies to set aside contracts for commodity software for small business concerns.

Executive Order 13563

This executive order directs agencies to, among other things: (a) afford the public a meaningful opportunity to comment through the Internet on proposed regulations, with a comment period that should generally consist of not less than 60 days; (b) provide for an “open exchange” of information among government officials, experts, stakeholders, and the public; and (c) seek the views of those who are likely to be affected by the rulemaking, even before issuing a notice of proposed rulemaking. As far as practicable or relevant, SBA considered these requirements in developing this rule, as discussed below.

1. Did the agency use the best available techniques to quantify anticipated present and future costs when responding to Executive Order 12866 (e.g., identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes)?

To the extent possible, the agency utilized the most recent data available in the Federal Procurement Data System—Next Generation, System for Award Management and Electronic Subcontracting Reporting System.

2. Public participation: Did the agency: (a) Afford the public a meaningful opportunity to comment through the Internet on any proposed regulation, with a comment period that should generally consist of not less than 60 days; (b) provide for an “open exchange” of information among government officials, experts, stakeholders, and the public; (c) provide timely online access to the rulemaking docket on Regulations.gov; and (d) seek the views of those who are likely to be affected by rulemaking, even before issuing a notice of proposed rulemaking?

The proposed rule had a 60-day comment period and was posted on www.regulations.gov to allow the public to comment meaningfully on its provisions. In addition, the agency extended the comment period in response to public requests to do so. SBA then submitted the final rule to the Office of Management and Budget for interagency review. Further, as discussed in the Supplementary Information, SBA conducted tribal consultations where these rules were discussed.

3. Flexibility: Did the agency identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public?

Yes, the final rule implements statutory provisions and will provide clarification to rules that were requested by agencies and stakeholders. On many occasions, SBA made changes to language or provided additional examples, in response to public comment. The final rule will make it easier for small businesses to contract with the Federal government.

Executive Order 12988

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

Executive Order 13132

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

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

For the purposes of the Paperwork Reduction Act, SBA has determined that this rule would not impose new government-wide reporting requirements on small business concerns.

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

According to the Regulatory Flexibility Act (RFA), 5 U.S.C. 601, when an agency issues a rulemaking, it must prepare a regulatory flexibility analysis to address the impact of the rule on small entities. However, section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. The RFA defines “small entity” to include “small businesses,” “small organizations,” and “small governmental jurisdictions.” This final rule concerns various aspects of SBA's contracting programs, as such the rule relates to small business concerns but would not affect “small organizations” or “small governmental jurisdictions” because those programs generally apply only to “business concerns” as defined by SBA's regulations, in other words, to small businesses organized for profit. “Small organizations” or “small governmental jurisdictions” are non-profits or governmental entities and do not generally qualify as “business concerns” within the meaning of SBA's regulations.

There are approximately 300,000 concerns listed as small business concerns in the System for Award Management (SAM) in at least one industry category that could potentially be impacted by the implementation of the NDAA 2013 contracting provisions. However, we cannot say with any certainty how many will be impacted because we do not know how many of these concerns will team together to submit offers, nor do we know how many will be awarded contracts as teams. The number of firms participating in teaming will be lower than the number of firms registered in SAM. However, as discussed elsewhere in this rule, including section 2 of the Regulatory Impact Analysis, the final rule does not impose significant new compliance or other costs on small business concerns. Under current law, firms must adhere to certain performance requirements when performing set-aside contracts. SBA expects that costs now incurred by small business concerns as a result of ambiguous or indefinite regulations will be eliminated or reduced. Clarifying the confusion and uncertainty concerning the applicability of SBA's contracting regulations would also reduce the time burden on the small business contracting community and therefore make it easier for them to contract with the Federal Government. In sum, the final rule would not have a disparate impact on small businesses and would increase their opportunities to participate in Federal Government contracting without imposing any additional costs. For the reasons discussed, SBA certifies that this final rule would not have a significant economic impact on a substantial number of small business concerns.

List of Subjects 13 CFR Part 121

Administrative practice and procedure, Government procurement, Government property, Grant programs—business, Individuals with disabilities, Loan programs—business, Small businesses.

13 CFR Part 124

Administrative practice and procedure, Government procurement, Hawaiian Natives, Indians—business and finance, Minority businesses, Reporting and recordkeeping requirements, Technical assistance.

13 CFR Part 125

Government contracts, Government procurement, Reporting and recordkeeping requirements, Small businesses, Technical assistance, Veterans.

13 CFR Part 126

Administrative practice and procedure, Government procurement, Penalties, Reporting and Recordkeeping requirements, Small businesses.

13 CFR Part 127

Government contracts, Reporting and recordkeeping requirements, Small businesses.

Accordingly, for the reasons stated in the preamble, SBA amends 13 CFR parts 121, 124, 125, 126, and 127 as follows:

PART 121—SMALL BUSINESS SIZE REGULATIONS 1. The authority citation for 13 CFR part 121 continues to read as follows: Authority:

15 U.S.C. 632, 634(b)(6), 662, and 694a(9).

2. Amend § 121.103 by a. Revising paragraph (b)(9); b. Adding paragraphs (f)(1) and (2); c. Adding a new final sentence to paragraph (h) introductory text; and d. Revising paragraphs (h)(3)(i) and (h)(4) to read as follows:
§ 121.103 How does SBA determine affiliation?

(b) * * *

(9) In the case of a solicitation for a bundled contract, a small business contractor may enter into a Small Business Teaming Arrangement with one or more small business subcontractors and submit an offer as a small business without regard to affiliation, so long as each team member is small for the size standard assigned to the contract or subcontract. The agency shall evaluate the offer in the same manner as other offers with due consideration of the capabilities of the subcontractors.

(f) * * *

(1) Firms owned or controlled by married couples, parties to a civil union, parents, children, and siblings are presumed to be affiliated with each other if they conduct business with each other, such as subcontracts or joint ventures or share or provide loans, resources, equipment, locations or employees with one another. This presumption may be overcome by showing a clear line of fracture between the concerns. Other types of familial relationships are not grounds for affiliation on family relationships.

(2) SBA may presume an identity of interest based upon economic dependence if the concern in question derived 70% or more of its receipts from another concern over the previous three fiscal years.

(i) This presumption may be rebutted by a showing that despite the contractual relations with another concern, the concern at issue is not solely dependent on that other concern, such as where the concern has been in business for a short amount of time and has only been able to secure a limited number of contracts.

(ii) A business concern owned and controlled by an Indian Tribe, ANC, NHO, CDC, or by a wholly-owned entity of an Indian Tribe, ANC, NHO, or CDC, is not considered to be affiliated with another concern owned by that entity based solely on the contractual relations between the two concerns.

Example 1 to paragraph (f).

Firm A has been in business for 9 months and has two contracts. Contract 1 is with Firm B and is valued at $900,000 and Contract 2 is with Firm C and is valued at $200,000. Thus, Firm B accounts for over 70% of Firm A's receipts. Absent other connections between A and B, the presumption of affiliation between A and B is rebutted because A is a new firm.

Example 2 to paragraph (f).

Firm A has been in business for five years. It has over 200 contracts. Of that 200, 195 are with Firm B, and the value of those contracts is greater than 70% of the revenue over the previous three years. In this case, SBA would most likely find the two firms affiliated unless the firm could provide some other compelling rebuttal to the very strong presumption that it should be considered affiliated with Firm B.

(h) * * * For purposes of this section, contract refers to prime contracts, and any subcontract in which the joint venture is treated as a similarly situated entity as the term is defined in part 125 of this chapter.

* * *

(3) Exception to affiliation for certain joint ventures. (i) A joint venture of two or more business concerns may submit an offer as a small business for a Federal procurement, subcontract or sale so long as each concern is small under the size standard corresponding to the NAICS code assigned to the contract.

(4) A contractor and its ostensible subcontractor are treated as joint venturers, and therefore affiliates, for size determination purposes. An ostensible subcontractor is a subcontractor that is not a similarly situated entity, as that term is defined in § 125.1 of this chapter, and performs primary and vital requirements of a contract, or of an order, or is a subcontractor upon which the prime contractor is unusually reliant. All aspects of the relationship between the prime and subcontractor are considered, including, but not limited to, the terms of the proposal (such as contract management, technical responsibilities, and the percentage of subcontracted work), agreements between the prime and subcontractor (such as bonding assistance or the teaming agreement), and whether the subcontractor is the incumbent contractor and is ineligible to submit a proposal because it exceeds the applicable size standard for that solicitation.

3. Amend § 121.104 by revising the introductory text in paragraph (a) to read as follows:
§ 121.104 How does SBA calculate annual receipts?

(a) Receipts means all revenue in whatever form received or accrued from whatever source, including from the sales of products or services, interest, dividends, rents, royalties, fees, or commissions, reduced by returns and allowances. Generally, receipts are considered “total income” (or in the case of a sole proprietorship “gross income”) plus “cost of goods sold” as these terms are defined and reported on Internal Revenue Service (IRS) tax return forms (such as Form 1120 for corporations; Form 1120S and Schedule K for S corporations; Form 1120, Form 1065 or Form 1040 for LLCs; Form 1065 and Schedule K for partnerships; Form 1040, Schedule F for farms; Form 1040, Schedule C for other sole proprietorships). Receipts do not include net capital gains or losses; taxes collected for and remitted to a taxing authority if included in gross or total income, such as sales or other taxes collected from customers and excluding taxes levied on the concern or its employees; proceeds from transactions between a concern and its domestic or foreign affiliates; and amounts collected for another by a travel agent, real estate agent, advertising agent, conference management service provider, freight forwarder or customs broker. For size determination purposes, the only exclusions from receipts are those specifically provided for in this paragraph. All other items, such as subcontractor costs, reimbursements for purchases a contractor makes at a customer's request, investment income, and employee-based costs such as payroll taxes, may not be excluded from receipts.

4. Amend § 121.201 by adding footnote 20 to read as follows:
§ 121.201 What size standards has SBA identified by North American Industry Classification System codes?

Footnotes

20. NAICS code 511210—For purposes of Government procurement, the purchase of software subject to potential waiver of the nonmanufacturer rule pursuant to § 121.1203(d) should be classified under this NAICS code.

§ 121.402 [Amended]
5. Amend § 121.402(d) by removing the term “paragraph (d)” and adding in its place “paragraph (e)”. 6. Amend § 121.404 as follows: a. Revise paragraph (f); b. Revise first sentence of paragraph (g)(2)(i); and c. Add paragraph (g)(2)(ii)(D) to read as follows:
§ 121.404 When is the size status of a business concern determined?

(f) For purposes of architect-engineering, design/build or two-step sealed bidding procurements, a concern must qualify as small as of the date that it certifies that it is small as part of its initial bid or proposal (which may or may not include price).

(g) * * *

(2)(i) In the case of a merger, sale, or acquisition, where contract novation is not required, the contractor must, within 30 days of the transaction becoming final, recertify its small business size status to the procuring agency, or inform the procuring agency that it is other than small. * * *

(ii) * * *

(D) If the merger, sale or acquisition occurs after offer but prior to award, the offeror must recertify its size to the contracting officer prior to award.

7. Amend § 121.406 as follows: a. Revise the section heading; b. Revise paragraph (a) introductory text; c. Add a sentence to the end of paragraph (b)(4); d. Revise paragraphs (b)(7) and (d); and e. Redesignate paragraph (e) as paragraph (f) and add new paragraph (e) to read as follows:
§ 121.406 How does a small business concern qualify to provide manufactured products or other supply items under a small business set-aside, service-disabled veteran-owned small business, HUBZone, WOSB or EDWOSB, or 8(a) contract?

(a) General. In order to qualify as a small business concern for a small business set-aside, service-disabled veteran-owned small business set-aside or source contract, HUBZone set-aside or sole source contract, WOSB or EDWOSB set-aside or sole source contract, 8(a) set-aside or sole source contract, partial set-aside, or set aside of an order against a multiple award contract to provided manufactured products or other supply items, an offeror must either:

(b) * * *

(4) * * * The rental of an item(s) is a service and should be treated as such in the application of the nonmanufacturer rule and the limitation on subcontracting.

(7) SBA's waiver of the nonmanufacturer rule means that the firm can supply the product of any size business without regard to the place of manufacture. However, SBA's waiver of the nonmanufacturer rule has no effect on requirements external to the Small Business Act which involve domestic sources of supply, such as the Buy American Act or the Trade Agreements Act.

(d) The performance requirements (limitations on subcontracting) and the nonmanufacturer rule do not apply to small business set-aside acquisitions with an estimated value between $3,500 and $150,000.

(e) Multiple item acquisitions. (1) If at least 50% of the estimated contract value is composed of items that are manufactured by small business concerns, then a waiver of the nonmanufacturer rule is not required. There is no requirement that each and every item acquired in a multiple-item procurement be manufactured by a small business.

(2) If more than 50% of the estimated contract value is composed of items manufactured by other than small concerns, then a waiver is required. SBA may grant a contract specific waiver for one or more items in order to ensure that at least 50% of the value of the products to be supplied by the nonmanufacturer comes from domestic small business manufacturers or are subject to a waiver.

(3) If a small business is both a manufacturer of item(s) and a nonmanufacturer of other item(s), the manufacturer size standard should be applied.

8. Amend § 121.408 by revising paragraph (a) to read as follows:
§ 121.408 What are the size procedures for SBA's Certificate of Competency Program?

(a) A firm which applies for a COC must file an “Application for Small Business Size Determination” (SBA Form 355). If the initial review of SBA Form 355 indicates the applicant, including its affiliates, is small for purposes of the COC program, SBA will process the application for COC. If the review indicates the applicant, including its affiliates is other than small SBA will initiate a formal size determination as set forth in § 121.1001(b)(3)(ii). In such a case, SBA will not further process the COC application until a formal size determination is made.

§ 121.409 [Amended]
9. Amend § 121.409 by removing the second sentence.
10. Amend § 121.702 by revising paragraph (a)(2) to read as follows:
§ 121.702 What size and eligibility standards are applicable to the SBIR and STTR programs?

(a) * * *

(2) No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern unless that single venture capital operating company, hedge fund, or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States.

11. Amend § 121.1001 as follows: a. Revise paragraphs (a)(1)(i) and (a)(2)(i); and b. Redesignate paragraph (b)(11) as paragraph (b)(12) and add a new paragraph (b)(11).
§ 121.1001 Who may initiate a size protest or request a formal size determination?

(a) * * * (1) * * *

(i) Any offeror that the contracting officer has not eliminated from consideration for any procurement-related reason, such as non-responsiveness, technical unacceptability or outside of the competitive range;

(2) * * *

(i) Any offeror that the contracting officer has not eliminated from consideration for any procurement related reason, such as non-responsiveness, technical unacceptability or outside of the competitive range;

(b) * * *

(11) In connection with eligibility for the SDVO SBC and the WOSB/EDWSOB programs, the Director, Office of Government Contracting, may initiate a formal size determination.

12. Revise § 121.1203 to read as follows:
§ 121.1203 When will a waiver of the Nonmanufacturer Rule be granted for an individual contract?

(a) Where appropriate, SBA will generally grant waivers for an individual contract or order prior to the issuance of a solicitation, or, where a solicitation has been issued, when the contracting officer provides all potential offerors additional time to respond.

(b) SBA may grant a waiver after contract award, where the contracting officer has determined that the modification is within the scope of the contract and the agency followed the regulations prior to issuance of the solicitation and properly and timely requested a waiver for any other items under the contract, where required.

Example to paragraph (b):

The Government seeks to buy spare parts to fix Item A. After conducting market research, the government determines that Items B, C, and D that are being procured may be eligible for waivers and requests and receives waivers from SBA for those items prior to issuing the solicitation. After the contract is awarded, the Government determines that it will need additional spare parts to fix Item A. The Government determines that adding the additional parts as a modification to the original contract is within scope. The contracting officer believes that one of the additional parts is also eligible for a waiver from SBA, and requests the waiver at the time of the modification. If all other criteria are met, SBA would grant the waiver, even though the contract has already been awarded.

(c) An individual waiver for an item in a solicitation will be approved when the SBA Director, Office of Government Contracting, reviews and accepts a contracting officer's determination that no small business manufacturer or processor can reasonably be expected to offer a product meeting the specifications of a solicitation, including the period of performance.

(d) Waivers for the purchase of software. (1) SBA may grant an individual waiver for the procurement of software provided that the software being sought is an item that is of a type customarily used by the general public or by non-governmental entities for purposes other than governmental purposes, and the item:

(i) Has been sold, leased, or licensed to the general public, or has been offered for sale, lease, or license to the general public;

(ii) Is sold in substantial quantities in the commercial marketplace; and

(iii) Is offered to the Government, without modification, in the same form in which it is sold in the commercial marketplace.

(2) If the value of services provided related to the purchase of a supply item that meets the requirements of paragraph (d)(1) of this section exceeds the value of the item itself, the procurement should be identified as a service procurement, even if the services are provided as part of the same license, lease, or sale terms. If a contracting officer cannot make a determination of the value of services being provided, SBA will assume that the value of the services is greater than the value of items or supplies, and will not grant a waiver.

(3) Subscription services, remote hosting of software, data, or other applications on servers or networks of a party other than the U.S. Government are considered by SBA to be services and not the procurement of a supply item. Therefore SBA will not grant waivers of the nonmanufacturer rule for these types of services.

13. Amend § 121.1204 by revising paragraphs (b)(1)(ii) and (iii) to read as follows:
§ 121.1204 What are the procedures for requesting and granting waivers?

(b) * * * (1) * * *

(ii) The proposed solicitation number, NAICS code, dollar amount of the procurement, and a brief statement of the procurement history;

(iii) A determination by the contracting officer that no small business manufacturer or processor reasonably can be expected to offer a product or products meeting the specifications (including period of performance) required by a particular solicitation. Include a narrative describing market research and supporting documentation; and

14. Add § 121.1206 to read as follows:
§ 121.1206 How will potential offerors be notified of applicable waivers?

(a) Contracting officers must provide written notification to potential offerors of any waivers being applied to a specific acquisition, whether it is a class waiver or a contract specific waiver. This notification must be provided at the time a solicitation is issued. If the notification is provided after a solicitation is issued, the contracting officer must provide potential offerors a reasonable amount of additional time to respond to the solicitation.

(b) If a contracting officer does not provide notice, and additional reasonable time for responses when required, then the waiver cannot be applied to the solicitation. This applies to both class waivers and individual waivers.

PART 124—8(a) BUSINESS DEVELOPMENT/SMALL DISADVANTAGED BUSINESS STATUS DETERMINATIONS 15. The authority citation for 13 CFR part 124 is revised to read as follows: Authority:

15 U.S.C. 634(b)(6), 636(j), 637(a), 637(d), 644 and Pub. L. 99-661, Pub. L. 100-656, sec.1207, Pub. L. 101-37, Pub. L. 101-574, section 8021, Pub. L. 108-87, and 42 U.S.C. 9815.

16. Amend § 124.504 by revising paragraph (c)(1)(ii)(B) to read as follows:
§ 124.504 What circumstances limit SBA's ability to accept a procurement for award as an 8(a) contract?

(c) * * *

(1) * * *

(ii) * * *

(B) Procurements for construction services (e.g., the building of a specific structure) are generally deemed to be new requirements. However, recurring indefinite delivery or indefinite quantity task or delivery order construction services are not considered new (e.g., a recurring procurement requiring all construction work at base X).

17. Revise § 124.510 to read as follows:
§ 124.510 What limitations on subcontracting apply to an 8(a) contract?

(a) To assist the business development of Participants in the 8(a) BD program, there are limitations on the percentage of an 8(a) contract award amount that may be spent on subcontractors. The prime contractor recipient of an 8(a) contract must comply with the limitations on subcontracting at § 125.6 of this chapter.

(b) Indefinite delivery and indefinite quantity contracts. In order to ensure that the required limitations on subcontracting requirements on an indefinite delivery or indefinite quantity 8(a) award are met by the Participant, the Participant cannot subcontract more than the required percentage to subcontractors that are not similarly situated entities for each performance period of the contract (i.e., during the base term and then during each option period thereafter). However, the contracting officer, in his or her discretion, may require the Participant to meet the applicable limitation on subcontracting or comply with the nonmanufacturer rule for each order.

(1) This includes Multiple Award Contracts that were set-aside or partially set-aside for 8(a) BD Participants.

(2) For orders that are set aside for eligible 8(a) Participants under full and open contracts or reserves, the Participant must meet the applicable limitation on subcontracting requirement and comply with the nonmanufacturer rule, if applicable, for each order.

18. Amend § 124.513 by revising paragraph (b) to read as follows:
§ 124.513 Under what circumstances can a joint venture be awarded an 8(a) contract?

(b) Size of concerns to an 8(a) joint venture. (1) A joint venture of at least one 8(a) Participant and one or more other business concerns may submit an offer as a small business for a competitive 8(a) procurement, or be awarded a sole source 8(a) procurement, so long as each concern is small under the size standard corresponding to the NAICS code assigned to the procurement.

(2) Notwithstanding the provisions of paragraph (b)(1) of this section, a joint venture between a protégé firm and its approved mentor (see § 124.520) will be deemed small provided the protégé qualifies as small for the size standard corresponding to the NAICS code assigned to the contract and has not reached the dollar limits set forth in § 124.519.

PART 125—GOVERNMENT CONTRACTING PROGRAMS 19. The authority citation for 13 CFR part 125 is revised to read as follows: Authority:

15 U.S.C. 632(p), (q); 634(b)(6), 637, 644, 657(f), 657q; and 657s.

20. Amend § 125.1 by: a. Removing paragraphs (f), (g), (h), (m), and (u); b. Removing all alphabetical paragraph designations and placing the definitions in alphabetical order; c. Adding in alphabetical order a definition for Similarly situated entity to read as follows:
§ 125.1 What definitions are important to SBA's Government Contracting Programs?

Similarly situated entity is a subcontractor that has the same small business program status as the prime contractor. This means that: For a HUBZone requirement, a subcontractor that is a qualified HUBZone small business concern; for a small business set-aside, partial set-aside, or reserve a subcontractor that is a small business concern; for a SDVO small business requirement, a subcontractor that is a self-certified SDVO SBC; for an 8(a) requirement, a subcontractor that is an 8(a) certified Program Participant; for a WOSB or EDWOSB contract, a subcontractor that has complied with the requirements of part 127. In addition to sharing the same small business program status as the prime contractor, a similarly situated entity must also be small for the NAICS code that the prime contractor assigned to the subcontract the subcontractor will perform.

21. Amend § 125.2 as follows: a. Revise paragraph (b)(1)(i)(A); b. Add paragraph (b)(1)(i)(F); c. Revise the introductory text to paragraph (b)(1)(ii); d. Revise paragraph (b)(1)(iii)(C); e. Add paragraphs (b)(1)(iv) and (v); f. Remove paragraph (b)(2) and redesignate paragraph (b)(3) as paragraph (b)(2); g. Revise redesignated paragraph (b)(2); h. Amend paragraph (c)(1)(iv) by removing the term “and” at the end of the last sentence; i. Amend paragraph (c)(1)(v) by removing the “.” at the end of the last sentence and adding in its place “;”. j. Add paragraph (c)(1)(vi); and k. Add paragraph (c)(1)(vii) to read as follows.
§ 125.2 What are SBA's and the procuring agency's responsibilities when providing contracting assistance to small businesses?

(b) * * *

(1) * * *

(i) * * *

(A) SBA has PCRs who are generally located at Federal agencies and buying activities which have major contracting programs. At the SBA's discretion, PCRs will review all acquisitions that are not totally set aside for small businesses to determine whether a set-aside or sole source award to a small business under one of SBA's programs is appropriate and to identify alternative strategies to maximize the participation of small businesses in the procurement. PCRs also advocate for the maximum practicable utilization of small business concerns in Federal contracting, including by advocating against the consolidation or bundling of contract requirements, as defined in § 125.1, and reviewing any justification provided by the agency for consolidation or bundling. This review includes acquisitions that are Multiple Award Contracts where the agency has not set-aside all or part of the acquisition or reserved the acquisition for small businesses. It also includes acquisitions where the agency has not set-aside orders placed against Multiple Award Contracts for small business concerns.

(F) PCRs also advocate competitive procedures and recommend the breakout for competition of items and requirements which previously have not been competed when appropriate. They may appeal the failure by the buying activity to act favorably on a recommendation in accord with the appeal procedures in paragraph (b)(2) of this section. PCRs also review restrictions and obstacles to competition and make recommendations for improvement.

(ii) PCR recommendations. The PCR must recommend to the procuring activity alternative procurement methods that would increase small business prime contract participation if a PCR believes that a proposed procurement includes in its statement of work goods or services currently being performed by a small business and is in a quantity or estimated dollar value the magnitude of which renders small business prime contract participation unlikely; will render small business prime contract participation unlikely (e.g., ensure geographical preferences are justified); or is for construction and seeks to package or consolidate discrete construction projects. If a PCR does not believe a bundled or consolidated requirement is necessary or justified the PCR shall advocate against the consolidation or bundling of such requirement and recommend to the procuring activity alternative procurement methods which would increase small business prime contract participation. Such alternatives may include:

(iii) * * *

(C) Recommending that the small business subcontracting goals be based on total contract dollars in addition to goals based on a percentage of total subcontracted dollars;

(iv) PCRs will consult with the agency OSDBU regarding agency decisions to convert an activity performed by a small business concern to an activity performed by a Federal employee.

(v) PCRs may receive unsolicited proposals from small business concerns and will transmit those proposals to the agency personnel responsible for reviewing such proposals. The agency personnel shall provide the PCR with information regarding the disposition of such proposal.

(2) Appeals of PCR recommendations. In cases where there is disagreement between a PCR and the contracting officer over the suitability of a particular acquisition for a small business set-aside, partial set-aside or reserve, whether or not the acquisition is a bundled, substantially bundled or consolidated requirement, the PCR may initiate an appeal to the head of the contracting activity. If the head of the contracting activity agrees with the contracting officer, SBA may appeal the matter to the Secretary of the Department or head of the agency. The time limits for such appeals are set forth in FAR subpart 19.5 (48 CFR 19.5).

(c) * * * (1) * * *

(i) * * *

(vi) Provide opportunities for the participation of small business concerns during acquisition planning processes and in acquisition plans; and

(vii) Invite the participation of the appropriate Director of Small and Disadvantaged Business Utilization in acquisition planning processes and provide that Director with access to acquisition plans.

22. Amend § 125.3 as follows: a. Add paragraphs (c)(8) and (9); b. Revise the first sentence of paragraph (f)(1); c. Revise paragraph (f)(5); and d. Add paragraph (f)(8) to read as follows:
§ 125.3 What types of subcontracting assistance are available to small businesses?

(c) * * *

(8) A prime contractor that identifies a small business by name as a subcontractor in a proposal, offer, bid or subcontracting plan must notify those subcontractors in writing prior to identifying the concern in the proposal, bid, offer or subcontracting plan.

(9) Anyone who has a reasonable basis to believe that a prime contractor or a subcontractor may have made a false statement to an employee or representative of the Federal Government, or to an employee or representative of the prime contractor, with respect to subcontracting plans must report the matter to the SBA Office of Inspector General. All other concerns as to whether a prime contractor or subcontractor has complied with SBA regulations or otherwise acted in bad faith may be reported to the Government Contracting Area Office where the firm is headquartered.

(f) * * * (1) A prime contractor's performance under its subcontracting plan is evaluated by means of on-site compliance reviews and follow-up reviews, as a supplement to evaluations performed by the contracting agency, either on a contract-by-contract basis or, in the case of contractors having multiple contracts, on an aggregate basis. * * *

(5) Any contractor that fails to comply with paragraph (f)(4) of this section, or any contractor that fails to demonstrate a good-faith effort, as set forth in paragraph (d) of this section:

(i) May be considered for liquidated damages under the procedures in 48 CFR 19.705-7 and the clause at 52.219-16; and

(ii) Shall be in material breach of such contract or subcontract, and such failure to demonstrate good faith must be considered in any past performance evaluation of the contractor. This action shall be considered by the contracting officer upon receipt of a written recommendation to that effect from the CMR. The CMR's recommendation must include a copy of the compliance report and any other relevant correspondence or supporting documentation. Furthermore, if the CMR has a reasonable basis to believe that a contractor has made a false statement to an employee or representative of the Federal Government, or to an employee or representative of the prime contractor, the CMR must report the matter to the SBA Office of Inspector General. All other concerns as to whether a prime contractor or subcontractor has complied with SBA regulations or otherwise acted in bad faith may be reported to the Area Government Contracting Office where the firm is headquartered.

(8) The head of the contracting agency shall ensure that:

(i) The agency collects and reports data on the extent to which contractors of the agency meet the goals and objectives set forth in subcontracting plans; and

(ii) The agency periodically reviews data collected and reported pursuant to paragraph (f)(8)(i) of this section for the purpose of ensuring that such contractors comply in good faith with the requirements of this section.

23. Amend § 125.5 as follows: a. Revise paragraph (b)(1)(ii); b. Remove paragraphs (b)(1)(iii), (iv) and (v); and c. Add paragraph (f)(3) to read as follows:
§ 125.5 What is the Certificate of Competency Program?

(b) * * * (1) * * *

(ii) To be eligible for a COC, an offeror must qualify as a small business under the applicable size standard in accordance with part 121 of this chapter, and must have agreed to comply with the applicable limitations on subcontracting and the nonmanufacturer rule, where applicable.

(f) * * *

(3) Where a contracting officer finds a concern to be non-responsible for reasons of financial capacity on an indefinite delivery or indefinite quantity task or delivery order contract, the Area Director will consider the firm's maximum financial capacity. If the Area Director issues a COC, it will be for a specific amount that is the limit of the firm's financial capacity for that contract. The contracting officer may subsequently determine to exceed the amount, but cannot deny the firm award of an order or contract on financial grounds if the firm has not reached the financial maximum the Area Director identified in the COC letter.

24. Revise § 125.6 to read as follows:
§ 125.6 What are the prime contractor's limitations on subcontracting?

(a) General. In order to be awarded a full or partial small business set-aside contract with a value greater than $150,000, an 8(a) contract, an SDVO SBC contract, a HUBZone contract, a WOSB or EDWOSB contract pursuant to part 127 of this chapter, with a value greater than $150,000, a small business concern must agree that:

(1) In the case of a contract for services (except construction), it will not pay more than 50% of the amount paid by the government to it to firms that are not similarly situated. Any work that a similarly situated subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded.

(2)(i) In the case of a contract for supplies or products (other than from a nonmanufacturer of such supplies), it will not pay more than 50% of the amount paid by the government to it to firms that are not similarly situated. Any work that a similarly situated subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(ii) In the case of a contract for supplies from a nonmanufacturer, it will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in § 121.406(b)(5) of this chapter is granted.

(A) For a multiple item procurement where a waiver as described in § 121.406(b)(5) of this chapter has not been granted for one or more items, more than 50% of the value of the products to be supplied by the nonmanufacturer must be the products of one or more domestic small business manufacturers or processors.

(B) For a multiple item procurement where a waiver as described in § 121.406(b)(5) of this chapter is granted for one or more items, compliance with the limitation on subcontracting requirement will not consider the value of items subject to a waiver. As such, more than 50% of the value of the products to be supplied by the nonmanufacturer that are not subject to a waiver must be the products of one or more domestic small business manufacturers or processors.

(C) For a multiple item procurement, the same small business concern may act as both a manufacturer and a nonmanufacturer.

Example 1 to paragraph (a)(2).

A contract calls for the supply of one item valued at $1,000,000. The market research shows that there are no small business manufacturers that produce this item, and the contracting officer seeks and is granted a contract specific waiver for this item. In this case, a small business nonmanufacturer may supply an item manufactured by a large business.

Example 2 to paragraph (a)(2).

A contract is for $1,000,000 and calls for the acquisition of 10 items. Market research shows that nine of the items can be sourced from small business manufacturers and one item is subject to an SBA class waiver. The projected value of the item that is waived is $10,000. Therefore, at least 50% of the value of the items not subject to a waiver, or 50% of $990,000, must be supplied by one or more domestic small business manufacturers, and the prime small business nonmanufacturer may act as a manufacturer for one or more items.

Example 3 to paragraph (a)(2).

A contract is for $1,000,000 and calls for the acquisition of 10 items. Market research shows that only four of these items are manufactured by small businesses. The value of the items manufactured by small business is estimated to be $400,000. The contracting officer seeks and is granted waivers on the other six items. Therefore, the value of the items granted waivers is excluded from the calculation and at least 50% of $400,000 would have to be spent by the prime contractor on items it manufactures itself, or on items manufactured by one or more other small business concerns.

Example 4 to paragraph (a)(2).

A contract is for $1,000,000 and calls for the acquisition of 10 items. Market research shows that eight of the items can be sourced from small business manufacturers, and the estimated value of these items is $800,000. At least 50% of the value of the contract (i.e., at least $500,000) will be spent on items manufactured by one or more small business concerns. As such, the contracting officer is not required to request contract specific waivers for the other two items valued at $200,000. In this case, the prime contractor can meet the requirement by sourcing some of the items from small businesses manufacturers and some from large businesses without a waiver and still satisfy the requirement.

(3) In the case of a contract for general construction, it will not pay more than 85% of the amount paid by the government to it to firms that are not similarly situated. Any work that a similarly situated subcontractor further subcontracts will count towards the 85% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(4) In the case of a contract for special trade contractors, no more than 75% of the amount paid by the government to the prime may be paid to firms that are not similarly situated. Any work that a similarly situated subcontractor further subcontracts will count towards the 75% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(b) Mixed contracts. Where a contract combines services and supplies, the contracting officer shall select the appropriate NAICS code as prescribed in § 121.402(b) of this chapter. The contracting officer's selection of the applicable NAICS code is determinative as to which limitation on subcontracting and performance requirement applies. In no case shall the requirements of paragraph (a)(1) and (a)(2) of this section both apply to the same contract. The relevant limitation on subcontracting in paragraph (a)(1) or (a)(2) of this section shall apply only to that portion of the contract award amount.

Example 1 to paragraph (b).

A procuring agency is acquiring both services and supplies through a small business set-aside. The total value of the requirement is $3,000,000, with the supply portion comprising $2,500,000, and the services portion comprising $500,000. The contracting officer appropriately assigns a manufacturing NAICS code to the requirement. The cost of material is $500,000. Thus, because the services portion of the contract and the cost of materials are excluded from consideration, the relevant amount for purposes of calculating the performance of work requirement is $2,000,000 and the prime and/or similarly situated entities must perform at least $1,000,000 and the prime contractor may not subcontract more than $1,000,000 to non-similarly situated entities.

Example 2 to paragraph (b).

A procuring agency is acquiring both services and supplies through a small business set-aside. The total value of the requirement is $3,000,000, with the services portion comprising $2,500,000, and the supply portion comprising $500,000. The contracting officer appropriately assigns a services NAICS code to the requirement. Thus, because the supply portion of the contract is excluded from consideration, the relevant amount for purposes of calculating the performance of work requirement is $2,500,000 and the prime and/or similarly situated entities must perform at least $1,250,000 and the prime contractor may not subcontract more than $1,250,000 to non-similarly situated entities.

(c) Subcontracts to similarly situated entities. A small business concern prime contractor that receives a contract listed in paragraph (a) of this section and spends contract amounts on a subcontractor that is a similarly situated entity shall not consider those subcontracted amounts as subcontracted for purposes of determining whether the small business concern prime contractor has violated paragraph (a) of this section, to the extent the subcontractor performs the work with its own employees. Any work that the similarly situated subcontractor does not perform with its own employees shall be considered subcontracted SBA will also exclude a subcontract to a similarly situated entity from consideration under the ostensible subcontractor rule (§ 121.103(h)(4)).

Example 1 to paragraph (c):

An SDVO SBC sole source contract is awarded in the total amount of $500,000 for hammers. The prime contractor is a manufacturer and subcontracts 51% of the total amount received, less the cost of materials ($100,000) or $204,000, to an SDVO SBC subcontractor that manufactures the hammers in the U.S. The prime contractor does not violate the limitation on subcontracting requirement because the amount subcontracted to a similarly situated entity (less the cost of materials) is excluded from the limitation on subcontracting calculation.

Example 2 to paragraph (c):

A competitive 8(a) BD contract is awarded in the total amount of $10,000,000 for janitorial services. The prime contractor subcontracts $8,000,000 of the janitorial services to another 8(a) BD certified firm. The prime contractor does not violate the limitation on subcontracting for services because the amount subcontracted to a similarly situated entity is excluded from the limitation on subcontracting.

Example 3 to paragraph (c):

A WOSB set-aside contract is awarded in the total amount of $1,000,000 for landscaping services. The prime contractor subcontracts $500,001 to an SDVO SBC subcontractor that is not also a WOSB under the WOSB program. The prime contractor is in violation of the limitation on subcontracting requirement because it has subcontracted more than 50% of the contract amount to an SDVO SBC subcontractor, which is not considered similarly situated to a WOSB prime contractor.

(d) HUBZone procurement for commodities. In the case of a HUBZone contract for the procurement of agricultural commodities, a HUBZone SBC may not purchase the commodity from a subcontractor if the subcontractor will supply the commodity in substantially the final form in which it is to be supplied to the Government.

(e) Determining compliance with applicable limitation on subcontracting. The period of time used to determine compliance for a total or partial set-aside contract will be the base term and then each subsequent option period. For an order set aside under a full and open contract or a full and open contract with reserve, the agency will use the period of performance for each order to determine compliance unless the order is competed among small and other-than-small businesses (in which case the subcontracting limitations will not apply).

(1) The contracting officer, in his or her discretion, may require the concern to comply with the applicable limitations on subcontracting and the nonmanufacturer rule for each order awarded under a total or partial set-aside contract.

(2) Compliance will be considered an element of responsibility and not a component of size eligibility.

(3) Work performed by an independent contractor shall be considered a subcontract, and may count toward meeting the applicable limitation on subcontracting where the independent contractor qualifies as a similarly situated entity.

(f) Inapplicability of limitations on subcontracting. The limitations on subcontracting do not apply to:

(1) Small business set-aside contracts with a value greater than $3,500 but not $150,000, or

(2) Subcontracts (except where a prime is relying on a similarly situated entity to meet the applicable limitations on subcontracting).

(g) Request to change applicable limitation on subcontracting. SBA may use different percentages if the Administrator determines that such action is necessary to reflect conventional industry practices among small business concerns that are below the numerical size standard for businesses in that industry group. Representatives of a national trade or industry group or any interested SBC may request a change in subcontracting percentage requirements for the categories defined by six digit industry codes in the North American Industry Classification System (NAICS) pursuant to the following procedures:

(1) Format of request. Requests from representatives of a trade or industry group and interested SBCs should be in writing and sent or delivered to the Director, Office of Government Contracting, U.S. Small Business Administration, 409 3rd Street SW., Washington, DC 20416. The requester must demonstrate to SBA that a change in percentage is necessary to reflect conventional industry practices among small business concerns that are below the numerical size standard for businesses in that industry category, and must support its request with information including, but not limited to:

(i) Information relative to the economic conditions and structure of the entire national industry;

(ii) Market data, technical changes in the industry and industry trends;

(iii) Specific reasons and justifications for the change in the subcontracting percentage;

(iv) The effect such a change would have on the Federal procurement process; and

(v) Information demonstrating how the proposed change would promote the purposes of the small business, 8(a), SDVO, HUBZone, WOSB, or EDWOSB programs.

(2) Notice to public. Upon an adequate preliminary showing to SBA, SBA will publish in the Federal Register a notice of its receipt of a request that it considers a change in the subcontracting percentage requirements for a particular industry. The notice will identify the group making the request, and give the public an opportunity to submit information and arguments in both support and opposition.

(3) Comments. SBA will provide a period of not less than 30 days for public comment in response to the Federal Register notice.

(4) Decision. SBA will render its decision after the close of the comment period. If SBA decides against a change, SBA will publish notice of its decision in the Federal Register. Concurrent with the notice, SBA will advise the requester of its decision in writing. If SBA decides in favor of a change, SBA will propose an appropriate change to this part.

(h) Penalties. Whoever violates the requirements set forth in paragraph (a) of this section shall be subject to the penalties prescribed in 15 U.S.C. 645(d), except that the fine shall be treated as the greater of $500,000 or the dollar amount spent, in excess of permitted levels, by the entity on subcontractors. A party's failure to comply with the spirit and intent of a subcontract with a similarly situated entity may be considered a basis for debarment on the grounds, including but not limited to, that the parties have violated the terms of a Government contract or subcontract pursuant to FAR 9.406-2(b)(1)(i) (48 CFR 9.406-2(b)(1)(i)).

25. Amend § 125.15 by revising paragraphs (a)(3), (b)(1), and (b)(3) to read as follows:
§ 125.15 What requirements must an SDVO SBC meet to submit an offer on a contract?

(a) * * *

(3) It will comply with the limitations on subcontracting requirements set forth in § 125.6;

(b) * * *

(1) Size of concerns to an SDVO SBC joint venture. A joint venture of at least one SDVO SBC and one or more other business concerns may submit an offer as a small business for a competitive SDVO SBC procurement, or be awarded a sole source SDVO contract, so long as each concern is small under the size standard corresponding to the NAICS code assigned to the procurement.

(3) Limitations on subcontracting. For any SDVO contract, the joint venture must comply with the applicable limitations on subcontracting required by § 125.6.

§ 125.20 [Amended]
26. Amend § 125.20 as follows: a. In paragraph (b)(1), remove “$5,500,000” and add in its place “$6,000,000”; and b. In paragraph (b)(2), remove “$3,000,000” and add in its place “$3,500,000”.
§ 125.26 [Amended]
27. Amend § 125.26 by removing the phrase “Associate Administrator for Government Contracting” and adding in its place the phrase “Director, Office of Government Contracting” in paragraph (b).
PART 126—HUBZONE PROGRAM 28. The authority citation for 13 CFR part 126 continues to read as follows: Authority:

15 U.S.C. 632(a), 632(j), 632(p), 644, and 657a.

29. Amend § 126.200 by revising paragraph (b)(6) and removing paragraph (d) to read as follows:
§ 126.200 What requirements must a concern meet to receive SBA certification as a qualified HUBZone SBC?

(b) * * *

(6) Subcontracting. The concern must represent, as provided in the application, that it will comply with the applicable limitations on subcontracting requirements in connection with any procurement that it receives as a qualified HUBZone SBC, as set forth in § 126.5 and § 126.700.

30. Amend § 126.601 by revising paragraph (f) to read as follows:
§ 126.601 What additional requirements must a HUBZone SBC meet to bid on a contract?

(f) A qualified HUBZone SBC may submit an offer on a HUBZone contract for supplies as a nonmanufacturer if it meets the requirements of the nonmanufacturer rule set forth at § 121.406 of this chapter.

31. Revise § 126.700 to read as follows:
§ 126.700 What are the limitations on subcontracting requirements for HUBZone contracts?

A prime contractor receiving an award as a qualified HUBZone SBC must meet the limitations on subcontracting requirements set forth in § 125.6 of this chapter.

PART 127—WOMEN-OWNED SMALL BUSINESS FEDERAL CONTRACT PROGRAM 32. The authority citation for 13 CFR part 127 continues to read as follows: Authority:

15 U.S.C. 632, 634(b)(6), 637(m), and 644.

33. Amend § 127.504 by revising paragraph (b) to read as follows:
§ 127.504 What additional requirements must a concern satisfy to submit an offer on an EDWOSB or WOSB requirement?

(b) The concern must also meet the applicable limitations on subcontracting requirements as set forth in § 125.6 of this chapter.

34. Amend § 127.506 by revising paragraphs (a) and (d) to read as follows:
§ 127.506 May a joint venture submit an offer on an EDWOSB or WOSB requirement?

(a) Size of concerns. A joint venture of at least one WOSB or EDWOSB and one or more other business concerns may submit an offer as a small business for a competitive WOSB or EDWOSB procurement so long as each concern is small under the size standard corresponding to the NAICS code assigned to the procurement;

(d) The joint venture must comply with the limitations on subcontracting, as required by § 125.6 of this chapter;

Maria Contreras-Sweet, Administrator.
[FR Doc. 2016-12494 Filed 5-27-16; 8:45 am] BILLING CODE 8025-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-2859; Directorate Identifier 2016-NE-04-AD; Amendment 39-18536; AD 2016-11-09] RIN 2120-AA64 Airworthiness Directives; Turbomeca S.A. Turboshaft Engines AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for Turbomeca S.A. Arriel 1D and 1D1 turboshaft engines with a pre-modification (mod) TU357 gas generator module (M03), installed. This AD requires removing the pre-modification (mod) TU357 gas generator module (M03) and replacing with a part eligible for installation. This AD was prompted by reports of divergent rubbing between the piston shaft small diameter labyrinth and the rear bearing support. We are issuing this AD to prevent failure of the labyrinth seal and engine, in-flight shutdown, and loss of control of the helicopter.

DATES:

This AD becomes effective July 5, 2016.

ADDRESSES:

For service information identified in this final rule, contact Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; fax: 33 (0)5 59 74 45 15. You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-2859; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the mandatory continuing airworthiness information (MCAI), the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Philip Haberlen, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7770; fax: 781-238-7199; email: [email protected]

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to the specified products. The NPRM was published in the Federal Register on March 1, 2016 (81 FR 10544). The NPRM proposed to correct an unsafe condition for the specified products.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2016-0009, dated January 13, 2016 (referred to hereinafter as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

Some cases of divergent rubbing between the piston shaft small diameter labyrinth and the rear bearing support have been reported.

This condition, if not corrected, could lead to an uncommanded engine in-flight shutdown.

You may obtain further information by examining the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-2859.

Comments

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (81 FR 10544, March 1, 2016).

Conclusion

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

Related Service Information

Turbomeca S.A. has issued Mandatory Service Bulletin (MSB) No. 292 72 1357, Version B, dated November 12, 2015. The MSB describes procedures for installing a post-modification (mod) TU357 gas generator module (M03). This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

We estimate that this proposed AD affects 426 engines installed on helicopters of U.S. registry. We also estimate that it would take about 40 hours per engine to comply with this proposed AD. The average labor rate is $85 per hour. Required parts cost about $16,500 per engine. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $8,477,400.

Authority for This Rulemaking

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

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

Regulatory Findings

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

For the reasons discussed above, I certify this AD:

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

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

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2016-11-09 Turbomeca S.A.: Amendment 39-18536; Docket No. FAA-2016-2859; Directorate Identifier 2016-NE-04-AD. (a) Effective Date

This AD becomes effective July 5, 2016.

(b) Affected ADs

None.

(c) Applicability

This AD applies to all Arriel 1D and 1D1 turboshaft engines with a pre-modification (mod) TU357 gas generator module (M03), installed.

(d) Reason

This AD was prompted by reports of divergent rubbing between the piston shaft small diameter labyrinth and the rear bearing support. We are issuing this AD to prevent failure of the labyrinth seal and engine, in-flight shutdown, and loss of control of the helicopter.

(e) Actions and Compliance

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

(1) Within 4 months or 240 engine operating hours after the effective date of this AD, whichever occurs later, remove the pre-modification (mod) TU357 gas generator module (M03) from service and replace with a part eligible for installation.

(2) Reserved.

(f) Alternative Methods of Compliance (AMOCs)

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

(g) Related Information

(1) For more information about this AD, contact Philip Haberlen, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7770; fax: 781-238-7199; email: [email protected]

(2) Refer to MCAI European Aviation Safety Agency AD 2016-0009, dated January 13, 2016, for more information. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2016-2859.

(3) Turbomeca S.A. Mandatory Service Bulletin (MSB) No. 292 72 1357, Version B, dated November 12, 2015, which is not incorporated by reference in this AD, can be obtained from Turbomeca S.A., using the contact information in paragraph (g)(4) of this AD.

(4) Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; fax: 33 (0)5 59 74 45 15.

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

(h) Material Incorporated by Reference

None.

Issued in Burlington, Massachusetts, on May 23, 2016. Colleen M. D'Alessandro, Manager, Engine & Propeller Directorate, Aircraft Certification Service.
[FR Doc. 2016-12549 Filed 5-27-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2015-5800; Airspace Docket No. 15-AGL-21] Establishment of Class E Airspace; Lisbon, ND AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action establishes Class E airspace in Lisbon, ND. Controlled airspace is necessary to accommodate new Area Navigation (RNAV) Standard Instrument Approach Procedures at Lisbon Municipal Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at the airport.

DATES:

Effective 0901 UTC, September 15, 2016. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES:

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

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

FOR FURTHER INFORMATION CONTACT:

Raul Garza, Jr., Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone: (817) 222-5874.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Lisbon Municipal Airport, Lisbon, ND.

History

On February 17, 2016, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to establish Class E Airspace in the Lisbon, ND area. (81 FR 8026) Docket No. FAA-2015-5800. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

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

The Rule

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Lisbon Municipal Airport, Lisbon, ND, to accommodate new RNAV standard instrument approach procedures. Controlled airspace is needed for the safety and management of IFR operations at the airport.

Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

Regulatory Notices and Analyses

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

Environmental Review

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

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, effective September 15, 2015, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AGL ND E5 Lisbon, ND [New] Lisbon Municipal Airport, ND (Lat. 46°26′49″ N., long. 097°43′42″ W.)

That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Lisbon Municipal Airport.

Issued in Fort Worth, TX, on May 9, 2016. Robert W. Beck Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2016-12508 Filed 5-27-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 15 CFR Part 922 [Docket Number [160413330-6330-01]] RIN 0648-BF99 Delay of Discharge Requirements for U.S. Coast Guard Activities in Greater Farallones and Cordell Bank National Marine Sanctuaries AGENCY:

Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).

ACTION:

Final rule; delay of effectiveness for discharge requirements with regard to U.S. Coast Guard activities.

SUMMARY:

The National Oceanic and Atmospheric Administration (NOAA) expanded the boundaries of Gulf of the Farallones National Marine Sanctuary (now renamed Greater Farallones National Marine Sanctuary or GFNMS) and Cordell Bank National Marine Sanctuary (CBNMS) to an area north and west of their previous boundaries with a final rule published on March 12, 2015. The final rule entered into effect on June 9, 2015. At that time, NOAA postponed the effectiveness of the discharge requirements in both sanctuaries' regulations in the areas added to GFNMS and CBNMS boundaries in 2015 with regard to U.S. Coast Guard activities for 6 months. This notice extends the postponement of the discharge requirements for these activities for another 6 months to provide adequate time for completion of an environmental assessment, and subsequent rulemaking, as appropriate.

DATES:

The effectiveness for the discharge requirements in both CBNMS and GFNMS expansion areas with regard to U.S. Coast Guard activities is December 9, 2016.

ADDRESSES:

Copies of the FEIS, final management plans, and the final rule published on March 12, 2015, can be viewed or downloaded at http://farallones.noaa.gov/manage/expansion_cbgf.html.

FOR FURTHER INFORMATION CONTACT:

Maria Brown, Greater Farallones National Marine Sanctuary Superintendent, at [email protected] or 415-561-6622.

SUPPLEMENTARY INFORMATION:

I. Background

On March 12, 2015, NOAA expanded the boundaries of Gulf of the Farallones National Marine Sanctuary (now renamed Greater Farallones National Marine Sanctuary or GFNMS) and Cordell Bank National Marine Sanctuary (CBNMS) to an area north and west of their previous boundaries with a final rule (80 FR 13078). The final rule entered into effect on June 9, 2015 (80 FR 34047). To ensure that the March 12, 2015, rule does not undermine USCG's ability to perform its duties, at that time, NOAA postponed the effectiveness of the discharge requirements in both sanctuaries' regulations with regard to U.S. Coast Guard (USCG) activities for 6 months. An additional six month postponement of the effectiveness of the discharge requirements was published in the Federal Register on December 1, 2015 (80 FR 74985), to provide adequate time for completion of an environmental assessment and to determine NOAA's next steps. Without further NOAA action, the discharge regulations would become effective with regard to USCG activities June 9, 2016. However, NOAA needs more time to assess USCG activities, conduct public scoping, and develop alternatives for an environmental assessment developed pursuant to the requirements of the National Environmental Policy Act. Therefore, this notice postpones the effectiveness of the discharge requirements in the expansion areas of both sanctuaries with regard to USCG activities for another 6 months, until December 9, 2016. During this time, NOAA will consider how to address USCG's concerns and will consider, among other things, whether to exempt certain USCG activities in sanctuary regulations. The public, other federal agencies, and interested stakeholders will be given an opportunity to comment on various alternatives that are being considered. This will include the opportunity to review any proposed rule and related environmental analysis. In the course of the rule making to expand GFNMS and CBNMS, NOAA learned from USCG that the discharge regulations had the potential to impair the operations of USCG vessels and air craft conducting law enforcement and on-water training exercises in GFNMS and CBNMS. The USCG supports national marine sanctuary management by providing routine surveillance and dedicated law enforcement of the National Marine Sanctuaries Act and sanctuary regulations.

II. Classification A. National Environmental Policy Act

NOAA previously conducted an environmental analysis under the National Environmental Policy Act (NEPA) as part of the rulemaking process leading to the expansion of CBNMS and GFNMS, which addressed regulations regarding the discharge of any matter or material in the sanctuaries. The environmental impacts of the decision to postpone effectiveness reflect a continuation of the environmental baseline and the no action alternative presented in that analysis. Should NOAA decide to amend the regulations governing discharges for USGS activities in CBNMS and GFNMS, any additional environmental analysis required under NEPA would be prepared and released for public comment.

B. Executive Order 12866: Regulatory Impact

This action has been determined to be not significant for purposes of the meaning of Executive Order 12866.

C. Administrative Procedure Act

The Assistant Administrator of National Ocean Service (NOS) finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive the notice and comment requirements of the Administrative Procedure Act (APA) because this action is administrative in nature. This action postpones the effectiveness of the discharge requirements in the regulations for CBNMS and GFNMS in the areas added to the sanctuaries' boundaries in 2015 (subject to notice and comment review) with regard to U.S. Coast Guard activities for 6 months to provide adequate time for public scoping, completion of an environmental assessment, and subsequent rulemaking, as appropriate. Should NOAA decide to amend the regulations governing discharges in CBNMS and GFNMS, it would publish a proposed rule followed by an appropriate public comment period as required by the APA. The substance of the underlying regulations remains unchanged. Therefore, providing notice and opportunity for public comment under the Administrative Procedure Act would serve no useful purpose. The delay in effectiveness provided by this action will also enable NOAA to fully implement its statutory responsibilities under the NMSA to protect resources of a national marine sanctuary. For the reasons above, the Assistant Administrator also finds good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness and make this action effective immediately upon publication.

Authority:

16 U.S.C. 1431 et seq.

Dated: May 24, 2016. Christopher C. Cartwright, Acting, Deputy Assistant Administrator for Ocean Services and Coastal Management.
[FR Doc. 2016-12784 Filed 5-27-16; 8:45 am] BILLING CODE 3510-NK-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 [Docket No. FDA-2016-N-1268] Medical Devices; Ophthalmic Devices; Classification of the Diurnal Pattern Recorder System AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final order.

SUMMARY:

The Food and Drug Administration (FDA) is classifying the diurnal pattern recorder system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the diurnal pattern recorder system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

DATES:

This order is effective May 31, 2016. The classification was applicable on March 4, 2016.

FOR FURTHER INFORMATION CONTACT:

Alexander Beylin, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2404, Silver Spring, MD 20993-0002, 301-796-6463.

SUPPLEMENTARY INFORMATION:

I. Background

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

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

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

On April 28, 2014, Sensimed AG submitted a request for classification of the SENSIMED Triggerfish® device under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1).

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

Therefore, on March 4, 2016, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 886.1925.

Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a diurnal pattern recorder system will need to comply with the special controls named in this final order.

The device is assigned the generic name diurnal pattern recorder system, and it is identified as a nonimplantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.

FDA has identified the following risks to health associated with this type of device and the measures required to mitigate these risks in Table 1:

Table 1—Diurnal Pattern Recorder System Risks and Mitigation Measures Identified risk Mitigation measure Ocular Adverse Events: Clinical testing. • Hyperemia Biocompatibility evaluation. • Punctate keratitis Labeling. • Discomfort • Dry eye—dry sensation in the eye where the sensor is placed • Foreign body sensation—gritty feeling • Itching, burning • Swelling of eyelids • Pink eye • Excessive watering, unusual secretions or redness of the eye • Eye pain or irritation • Eye injury Infection Sterilization validation. Labeling. Adverse Tissue Reaction Biocompatibility evaluation. Labeling. Software Malfunction Software verification, validation, and hazard analysis. Hardware Malfunction Nonclinical testing. Use Error (e.g., improper fit, device manipulation) Clinical testing. Labeling. Electromagnetic Interference with Other Devices Electromagnetic compatibility (EMC) and electromagnetic interference (EMI) testing. Labeling. Electrical Malfunction (e.g., shock, battery-related issues) Electrical safety testing. Labeling. Measurement Noise or Artifact Leading to Incorrect Graphical Representation of Variation Labeling.

FDA believes that the special controls, in addition to the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness.

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

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the diurnal pattern recorder system they intend to market.

II. Analysis of Environmental Impact

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485.

IV. Reference

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

1. DEN140017: De novo request per 513(f)(2) from Sensimed AG, dated April 28, 2014.

List of Subjects in 21 CFR Part 886

Medical devices, Ophthalmic goods and services.

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

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

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

2. Add § 886.1925 to subpart B to read as follows:
§ 886.1925 Diurnal pattern recorder system.

(a) Identification. A diurnal pattern recorder system is a nonimplantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance data must demonstrate that the device and all of its components perform as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:

(i) Ability of the device to detect diurnal changes.

(ii) Tolerability of the system at the corneoscleral interface in the intended use population.

(2) Nonclinical testing must validate measurements in an appropriate nonclinical testing model to ensure ability to detect changes in intraocular pressure.

(3) Patient-contacting components must be demonstrated to be biocompatible.

(4) Any component that is intended to contact the eye must be demonstrated to be sterile throughout its intended shelf life.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Performance testing must demonstrate the electromagnetic compatibility and electromagnetic interference of the device.

(7) Performance testing must demonstrate electrical safety of the device.

(8) Labeling must include the following:

(i) Warning against activities and environments that may put the user at greater risk.

(ii) Specific instructions for the safe use of the device, which includes:

(A) Description of all device components and instructions for assembling the device;

(B) Explanations of all available programs and instructions for their use;

(C) Instructions and explanation of all user-interface components;

(D) Instructions on all safety features of the device; and

(E) Instructions for properly maintaining the device.

(iii) A summary of nonclinical testing information to describe EMC safety considerations.

(iv) A summary of safety information obtained from clinical testing.

(v) Patient labeling to convey information regarding appropriate use of device.

Dated: May 24, 2016. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2016-12683 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF TRANSPORTATION Federal Highway Administration 23 CFR Part 771 Federal Transit Administration 49 CFR Part 622 [Docket No. FHWA-2016-0008] RIN 2125-AF69; 2132-AB29 Categorical Exclusions AGENCY:

Federal Highway Administration (FHWA), Federal Transit Administration (FTA), DOT.

ACTION:

Final rule.

SUMMARY:

This final rule amends FHWA and FTA categorical exclusions (CE) for projects receiving limited Federal assistance to reflect a requirement in the Fixing America's Surface Transportation (FAST) Act to index for inflation the monetary thresholds for these CEs. This final rule also implements a provision in the FAST Act that directs FHWA to amend its rules on programmatic agreements for CEs. The amendments contained in this rule reflect statutory language in the FAST Act.

DATES:

Effective on June 30, 2016.

FOR FURTHER INFORMATION CONTACT:

For the Federal Highway Administration: Owen Lindauer, Ph.D., Office of Project Delivery and Environmental Review, HEPE, (202) 366-2655, [email protected], or Jennifer Mayo, Office of the Chief Counsel, (202) 366-1523, [email protected] For FTA: Megan Blum, Office of Planning and Environment, (202) 366-0463, [email protected], or Nancy-Ellen Zusman, Office of Chief Counsel, (312) 353-2577, [email protected] The FHWA and FTA are both located at 1200 New Jersey Ave. SE., Washington, DC 20590-0001. Office hours are from 8:00 a.m. to 4:30 p.m. E.T., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access and Filing

This document may be viewed online through the Federal eRulemaking portal at http://www.regulations.gov. Retrieval help and guidelines are available on the Web site. It is available 24 hours each day, 365 days a year. An electronic copy of this document may also be downloaded from the Office of the Federal Register home page at: http://www.ofr.gov and the Government Printing Office Web page at: http://www.thefederalregister.org.

Background

On December 4, 2015, President Obama signed into law the FAST Act, Public Law 114-94, 129 Stat. 1312, which contains new requirements that FHWA and FTA (hereafter referred to as “the Agencies”) must meet in complying with the National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq.). Section 1314(a) of the FAST Act amends section 1317 of the Moving Ahead for Progress in the 21st Century Act (MAP-21), Public Law 112-141, 126 Stat. 405, by inserting “(as adjusted annually by the Secretary to reflect any increases in the Consumer Price Index prepared by the Department of Labor)” after “$5,000,000” in paragraph (1)(A) and after “$30,000,000” in paragraph (1)(B) of the CE for projects receiving limited Federal financial assistance. The Agencies relied on the authority in MAP-21, section 1317 to establish limited Federal financial assistance CEs for FHWA at 23 CFR 771.117(c)(23) and for FTA at 23 CFR 771.118(c)(13). Those CEs were published in a final rule in the Federal Register on January 13, 2014 (79 FR 2107). With this final rule, the Agencies are amending the limited Federal financial assistance CEs to incorporate the adjustment for inflation requirement created by the FAST Act.

The Agencies included a reference to their respective Web sites (www.fhwa.dot.gov and www.fta.dot.gov) in the CE language in order to provide a source for locating the consumer price index (CPI), as adjusted annually. Per the FAST Act, section 1314(b), the first adjustment made pursuant to section 1314(a) must reflect the increase in the CPI since July 1, 2012. The Agencies divided the November 2015 CPI figure (237.336)—the latest data from the Department of Labor—by the July 2012 CPI figure (229.104), and multiplied the product (1.0359) by $5,000,000. The resulting value is $5,179,656.40, which is the $5 million limit found in sections 771.117(c)(23)(i) and 771.118(c)(13)(i) after adjusting for inflation, and should be considered when applying the limited Federal financial assistance CE to projects during the 2016 calendar year. Similarly, to determine the inflation figure for subparagraph (ii) under sections 771.117(c)(23) and 771.118(c)(13), the Agencies multiplied 1.0359 by $30,000,000 with the following result: $31,077,938.44. These figures ($5,179,656.40 and $31,077,938.44) are posted on the Agencies' Web sites and will be updated annually in January of subsequent years. Posting these figures also complies with section 1314(b)(1) which requires providing the first adjustment “not later than 60 days after the date of enactment of [the FAST] Act.”

Section 1315(b) requires FHWA to revise its CE regulation on programmatic agreements. Specifically, FHWA must revise 23 CFR 771.117(g) to allow a State Department of Transportation (State DOT) to make a CE determination on behalf of FHWA. The revision must clarify that the authority under such agreements may include the responsibility to make CE determinations for actions described in 23 CFR 771.117(c)-(d) that meet the criteria for a CE under 40 CFR 1508.4 (the President's Council on Environmental Quality's Regulations for Implementing the Procedural Provisions of NEPA) and are identified in the programmatic agreement.

This rulemaking adopts the language used in FAST Act section 1315(b) with two minor changes to retain the style used throughout the regulation: FHWA uses the abbreviation “CE” instead of “categorical exclusion” and “40 CFR 1508.4” instead of the statutory language of “section 1508.4 of title 40, Code of Federal Regulations.” The rule set forth below incorporates the new phrase “and that meet the criteria for a CE under 40 CFR 1508.4, and are identified in the programmatic agreement” into the otherwise existing regulatory language in 23 CFR 771.117(g). The FHWA reprints below the paragraph 771.117(g) to show how the statutory language is incorporated into the paragraph as a whole.

The Agencies have determined that a final rule is appropriate in this instance because the language in the FAST Act is clear and does not require interpretive text. Therefore the amendments to 23 CFR 771.117(c)(23), 23 CFR 771.118(c)(13), and 23 CFR 771.117(g) follow the statutory language without substantive modification.

Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive the normal notice and comment procedure if it finds, for good cause, that it would be impracticable, unnecessary, or contrary to the public interest. The Agencies find good cause as notice and comment for this rule would be unnecessary due to the nature of the revisions (i.e., the rule simply incorporates the statutory language found in sections 1315(b) and 1314 of FAST without interpretation). The statutory language does not require regulatory interpretation to carry out its intent. The regulatory amendments in this final rule incorporate the statutory language, and comments cannot alter the regulation given the explicit mandate. Accordingly, the Agencies find good cause under 5 U.S.C. 553(b)(3)(B) to waive notice and opportunity for comment.

Rulemaking Analyses and Notices Executive Order 12866 (Regulatory Planning and Review), Executive Order 13563 (Improving Regulation and Regulatory Review), and DOT Regulatory Policies and Procedures

The Agencies have determined this action is not a significant regulatory action within the meaning of Executive Order 12866, and within the meaning of the U.S. Department of Transportation's regulatory policies and procedures. Since this rulemaking implements a congressional mandate to allow States to make a CE determination on behalf of FHWA in specific instances and to adjust existing monetary-based CEs for inflation, the Agencies anticipate that the economic impact of this rulemaking would be minimal. This final rule will not adversely affect, in a material way, any sector of the economy. Additionally, this action complies with the principles of Executive Order 13563. In addition, these changes will not interfere with any action taken or planned by another agency and would not materially alter the budgetary impact of any entitlements, grants, user fees, or loan programs. Consequently, a full regulatory evaluation is not required.

Regulatory Flexibility Act

Since the Agencies find good cause under 5 U.S.C. 553(b)(3)(B) to waive notice and opportunity for comment for this rule, the provisions of the Regulatory Flexibility Act (Pub. L. 96-354, 5 U.S.C. 601-612) do not apply. However, the Agencies evaluated the effects of this action on small entities and determined the action would not have a significant economic impact on a substantial number of small entities. This final rule will not make any substantive changes to the Agencies' regulations or in the way that the Agencies' regulations affect small entities; it merely incorporates statutory text. For this reason, the Agencies certify that this action will not have a significant economic impact on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

This final rule does not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 109 Stat. 48, March 22, 1995) as it will not result in the expenditure by State, local, tribal governments, in the aggregate, or by the private sector, of $155 million or more in any one year (2 U.S.C. 1532).

Executive Order 13132 (Federalism Assessment)

Executive Order 13132 requires agencies to assure meaningful and timely input by State and local officials in the development of regulatory policies that may have a substantial, direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. This action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 dated August 4, 1999, and the Agencies determined this action will not have a substantial direct effect or sufficient federalism implications on the States. The Agencies also determined this action will not preempt any State law or regulation or affect the States' ability to discharge traditional State governmental functions.

Executive Order 12372 (Intergovernmental Review)

The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.

Paperwork Reduction Act

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et seq.), Federal agencies must obtain approval from the Office of Management and Budget for each collection of information they conduct, sponsor, or require through regulations. The Agencies analyzed this final rule under the PRA and determined this rule does not contain collection of information requirements for the purposes of the PRA.

National Environmental Policy Act

Agencies are required to adopt implementing procedures for NEPA that establish specific criteria for, and identification of, three classes of actions: Those that normally require preparation of an Environmental Impact Statement; those that normally require preparation of an Environmental Assessment; and those that are categorically excluded from further NEPA review (40 CFR 1507.3(b)). The CEQ regulations do not direct agencies to prepare a NEPA analysis or document before establishing Agency procedures (such as this regulation) that supplement the CEQ regulations for implementing NEPA. The changes proposed in this rule are part of those agency procedures, and therefore establishing the proposed changes does not require preparation of a NEPA analysis or document. Agency NEPA procedures are generally procedural guidance to assist agencies in the fulfillment of agency responsibilities under NEPA, but are not the agency's final determination of what level of NEPA analysis is required for a particular proposed action. The requirements for establishing agency NEPA procedures are set forth at 40 CFR 1505.1 and 1507.3.

Executive Order 12898 (Environmental Justice)

Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, and DOT Order 5610.2(a), 77 FR 27534 (May 10, 2012) (available online at www.fhwa.dot.gov/environment/environmental_justice/ej_at_dot/order_56102a/index.cfm), require DOT agencies to achieve environmental justice (EJ) as part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects, including interrelated social and economic effects, of their programs, policies, and activities on minority populations and low-income populations in the United States. The DOT Order requires DOT agencies to address compliance with the Executive Order and the DOT Order in all rulemaking activities. In addition, the Agencies have issued additional documents relating to administration of the Executive Order and the DOT Order. On June 14, 2012, FHWA issued an update to its EJ order, FHWA Order 6640.23A, FHWA Actions to Address Environmental Justice in Minority Populations and Low Income Populations (available online at www.fhwa.dot.gov/legsregs/directives/orders/664023a.cfm). The FTA also issued an update to its EJ policy, FTA Policy Guidance for Federal Transit Recipients, 77 FR 42077 (July 17, 2012) (available online at http://www.fta.dot.gov/legislation_law/12349_14740.html).

The Agencies have evaluated this final rule under the Executive Order, the DOT Order, the FHWA Order, and FTA Policy Guidance. They determined that the amendment would not cause disproportionately high and adverse human health and environmental effects on minority or low income populations.

At the time the Agencies apply the NEPA implementing procedures in 23 CFR part 771, they would have an independent obligation to conduct an evaluation of the proposed action under the applicable EJ orders and guidance to determine whether the proposed action has the potential for EJ effects. The rule would not affect the scope or outcome of that EJ evaluation. In any instance where there are potential EJ effects resulting from a proposed Agency action covered under any of the NEPA classes of action in 23 CFR part 771, public outreach under the applicable EJ orders and guidance would provide affected populations with the opportunity to raise any concerns about those potential EJ effects. See DOT Order 5610.2(a), FHWA Order 6640.23A, and FTA Policy Guidance for Transit Recipients (available at links above). Indeed, outreach to ensure the effective involvement of minority and low income populations where there is potential for EJ effects is a core aspect of the EJ orders and guidance. For these reasons, the Agencies have determined that no further EJ analysis is needed and no mitigation is required in connection with the proposed revisions to the Agencies' NEPA regulations (23 CFR parts 771).

Executive Order 12630 (Taking of Private Property)

The Agencies have analyzed this final rule under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. The Agencies found this final rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630.

Executive Order 12988 (Civil Justice Reform)

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

Executive Order 13045 (Protection of Children)

The Agencies analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. The Agencies certify that this action would not cause an environmental risk to health or safety that might disproportionately affect children.

Executive Order 13175 (Tribal Consultation)

The Agencies have analyzed this action under Executive Order 13175, dated November 6, 2000, and determined the action will not have substantial direct effects on one or more Indian tribes; will not impose substantial direct compliance costs on Indian tribal governments; and will not preempt tribal laws. This final rule addresses obligations of Federal funds to States for Federal-aid highway projects and Federal funds to transit agencies for Federal public transportation projects and will not impose any direct compliance requirements on Indian tribal governments. Therefore, a tribal summary impact statement is not required.

Executive Order 13211 (Energy Effects)

The Agencies have analyzed this action under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The Agencies determined this rule is not a significant energy action under that order since it is not a significant regulatory action under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required.

Regulation Identification Number

A regulation identification number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document can be used to cross-reference this action with the Unified Agenda.

List of Subjects 23 CFR Part 771

Categorical exclusions, Environmental review process, Environmental protection, Grant programs—transportation, Highways and roads, Programmatic approaches, Reporting and recordkeeping requirements.

49 CFR Part 622

Categorical exclusions, Environmental review process, Environmental protection, Grant programs—transportation, Public transportation, Transit.

Issued on: May 20, 2016. Gregory G. Nadeau, Federal Highway Administrator. Carolyn Flowers, Acting Administrator, Federal Transit Administration.

In consideration of the foregoing, the Agencies amend title 23, Code of Federal Regulations part 771, and title 49, Code of Federal Regulations part 662, as follows:

TITLE 23—Highways PART 771—ENVIRONMENTAL IMPACT AND RELATED PROCEDURES 1. Revise the authority citation for part 771 to read as follows: Authority:

42 U.S.C. 4321 et seq.; 23 U.S.C. 106, 109, 128, 138, 139, 315, 325, 326, and 327; 49 U.S.C. 303; 40 CFR parts 1500-1508; 49 CFR 1.81, 1.85, and 1.91; Pub. L. 109-59, 119 Stat. 1144, Sections 6002 and 6010; Pub. L. 112-141, 126 Stat. 405, Sections 1315, 1316, 1317, 1318, and 1319; Pub. L. 114-94, 129 Stat. 1312, Sections 1314 and 1315.

2. Revise § 771.117(c)(23) and (g) introductory text to read as follows:
§ 771.117 FHWA categorical exclusions.

(c) * * *

(23) Federally-funded projects:

(i) That receive less than $5,000,000 (as adjusted annually by the Secretary to reflect any increases in the Consumer Price Index prepared by the Department of Labor, see www.fhwa.dot.gov or www.fta.dot.gov) of Federal funds; or

(ii) With a total estimated cost of not more than $30,000,000 (as adjusted annually by the Secretary to reflect any increases in the Consumer Price Index prepared by the Department of Labor, see www.fhwa.dot.gov or www.fta.dot.gov) and Federal funds comprising less than 15 percent of the total estimated project cost.

(g) FHWA may enter into programmatic agreements with a State to allow a State DOT to make a NEPA CE certification or determination and approval on FHWA's behalf, for CEs specifically listed in paragraphs (c) and (d) of this section and that meet the criteria for a CE under 40 CFR 1508.4, and are identified in the programmatic agreement. Such agreements must be subject to the following conditions:

3. Revise § 771.118(c)(13) to read as follows:
§ 771.118 FTA categorical exclusions.

(c) * * *

(13) Federally-funded projects:

(i) That receive less than $5,000,000 (as adjusted annually by the Secretary to reflect any increases in the Consumer Price Index prepared by the Department of Labor, see www.fhwa.dot.gov or www.fta.dot.gov) of Federal funds; or

(ii) With a total estimated cost of not more than $30,000,000 (as adjusted annually by the Secretary to reflect any increases in the Consumer Price Index prepared by the Department of Labor, see www.fhwa.dot.gov or www.fta.dot.gov) and Federal funds comprising less than 15 percent of the total estimated project cost.

TITLE 49—Transportation PART 622—ENVIRONMENTAL IMPACT AND RELATED PROCEDURES 4. Revise the authority citation for part 622 to read as follows: Authority:

42 U.S.C. 4321 et seq.; 49 U.S.C. 303 and 5323(q); 23 U.S.C. 139 and 326; Pub. L. 109-59, 119 Stat. 1144, Sections 6002 and 6010; 40 CFR parts 1500-1508; 49 CFR 1.81; Pub. L. 112-141, 126 Stat. 405, Sections 1315, 1316, 1317, 1318, and 1319; and Pub. L. 114-94, 129 Stat. 1312, Section 1314.

[FR Doc. 2016-12577 Filed 5-27-16; 8:45 am] BILLING CODE 4910-22-P
DEPARTMENT OF THE INTERIOR Bureau of Ocean Energy Management 30 CFR Part 556 [Docket ID: BOEM-2016-0031] RIN 1010-AD06 Leasing of Sulfur or Oil and Gas in the Outer Continental Shelf; Correction MMAA104000 AGENCY:

Bureau of Ocean Energy Management (BOEM), Interior.

ACTION:

Final rule; correction.

SUMMARY:

On March 30, 2016, the Bureau of Ocean Energy Management (BOEM) published in the Federal Register a final rule that updates and streamlines the Outer Continental Shelf (OCS) oil and gas and sulfur leasing regulations, which will become effective on May 31, 2016 (81 FR 18111) (“Leasing Rule”). One of the regulations contained in the final rule was incorrectly stated. This document corrects that error

DATES:

This correction is effective on May 31, 2016.

FOR FURTHER INFORMATION CONTACT:

Robert Sebastian, Office of Policy, Regulation and Analysis at (504) 736-2761 or email at [email protected].

SUPPLEMENTARY INFORMATION: Need for Correction

BOEM has the authority, under certain conditions, to disqualify a party from acquiring a lease or an interest in a lease on the Outer Continental Shelf (OCS). The title, as well as the verbiage, of § 556.403 in the final Leasing Rule, states that BOEM may disqualify entities from “holding,” a lease or lease interest on the OCS. This could be interpreted to imply that BOEM would not allow a disqualified party to retain a pre-existing OCS lease interest. That interpretation is incorrect. Disqualified entities may not acquire new leases or lease interests, but they may continue to hold existing leases or lease interests. BOEM is correcting the wording of § 556.403 to avoid the implication that the use of the word “hold” might authorize BOEM, under the conditions stated in § 556.403, to require forfeiture of leases already acquired. The final rule was issued under Docket ID: MMS-2007-OMM-0069, which has expired and is no longer accessible. Therefore, BOEM is utilizing a new Docket ID for this correction (BOEM-2016-0031).

Procedural Requirements

Section V, Legal and Regulatory Analyses, of the final rule issued on March 30, 2016 (81 FR 18145), summarizes BOEM's analyses of that rule pursuant to applicable statutes and executive orders. This amendment does not change the conclusions described in that section because the amendment conforms the regulatory text to BOEM's intent in the final rule, as then analyzed. Therefore, no additional analysis is necessary.

The Administrative Procedure Act, 5 U.S.C. 553(b), provides that, when an agency for good cause finds that “notice and public procedure . . . are impracticable, unnecessary, or contrary to the public interest,” the agency may issue a rule without providing notice and an opportunity for prior public comment. To the extent this rule has substantive effects, it is to relieve regulated parties from sanctions. It does not require any party to change its conduct, and it does not change the rights of any party affected by the final rule. Therefore, BOEM believes that the public would not be interested in commenting on this correction, and thus notice and comment are unnecessary. Moreover, if BOEM were to first publish a proposed rule, allow the public sufficient time to submit comments, analyze the comments, and then publish a final rule, it would not be possible to correct this error and make it effective on the same day as the earlier final rule, May 31, 2016. Accordingly, notice and comment is impracticable. For these reasons, BOEM finds that soliciting public comment is unnecessary and impracticable and that there is good cause to promulgate this rule without first providing for public comment.

Similarly, BOEM finds that there is good cause to waive the usual 30-day delay in the effective date for this correction. This correction will not require any party to adjust its conduct and will not change the effect of the already published final rule. For these reasons, BOEM believes that the public does not need 30 days advance notice of this correction and that a delay in effectiveness is unnecessary. If this correction is not made effective on the same date, it would not become effective until after the erroneous language in the already published rule becomes effective, May 31, 2016. This could cause confusion to anyone potentially affected by § 556.403, making a 30-day delay in effectiveness impracticable. Therefore, pursuant to 5 U.S.C. 553(d), BOEM has determined that a 30-day delay in the effective date is unnecessary and impractical, and there is good cause to waive the delayed effective date for this final rule.

Dated: May 16, 2016. Amanda C. Leiter, Acting Assistant Secretary—Land and Minerals Management.

For the reasons stated in the preamble, BOEM amends 30 CFR part 556 (as amended by the final rule published on March 30, 2016, at 81 FR 18111) as follows:

PART 556—LEASING OF SULFUR OR OIL AND GAS AND BONDING REQUIREMENTS IN THE OUTER CONTINENTAL SHELF 1. The authority citation for part 556 continues to read as follows: Authority:

30 U.S.C. 1701 note, 30 U.S.C. 1711, 31 U.S.C. 9701, 42 U.S.C. 6213, 43 U.S.C. 1331 note, 43 U.S.C. 1334, 43 U.S.C. 1801-1802.

2. Revise § 556.403 to read as follows:
§ 556.403 Under what circumstances may I be disqualified from acquiring a lease or an interest in a lease on the OCS?

You may be disqualified from acquiring a lease or an interest in a lease on the OCS if:

(a) You or your principals are excluded or disqualified from participating in a transaction covered by Federal non-procurement debarment and suspension (2 CFR parts 180 and 1400), unless the Department explicitly approves an exception for a transaction pursuant to the regulations in those parts;

(b) The Secretary finds, after notice and hearing, that you or your principals (including in the meaning of “you,” for purposes of this subparagraph, a bidder or prospective bidder) fail to meet due diligence requirements or to exercise due diligence under section 8(d) of OCSLA (43 U.S.C. 1337(d)) on any OCS lease; or

(c) BOEM disqualifies you from acquiring a lease or an interest in a lease on the OCS based on your unacceptable operating performance. BOEM will give you adequate notice and opportunity for a hearing before imposing a disqualification, unless BSEE has already provided such notice and opportunity for a hearing.

[FR Doc. 2016-12095 Filed 5-27-16; 8:45 am] BILLING CODE 4310-MR-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2016-0356] Special Local Regulation; Annual Dragon Boat Races, Portland, Oregon AGENCY:

Coast Guard, DHS.

ACTION:

Notice of enforcement of regulation.

SUMMARY:

The Coast Guard will enforce the special local regulation requirements for the Portland Annual Dragon Boat Races from 7 a.m. until 6 p.m. on June 11, 2016 and 7 a.m. until 6 p.m. on June 12, 2016. This action is necessary to ensure the safety of maritime traffic, including the public vessels present, on the Willamette River during the Portland Annual Dragon Boat Races. During the enforcement period, no person or vessel may transit this regulated area without permission from the Sector Columbia River Captain of the Port or a designated representative.

DATES:

The regulations in 33 CFR 100.1302 will be enforced from 7 a.m. until 6 p.m., on June 11, 2016 and June 12, 2016.

FOR FURTHER INFORMATION CONTACT:

If you have questions about this notice of enforcement, call or email Ken Lawrenson, Waterways Management Division, Marine Safety Unit Portland, U.S. Coast Guard; telephone 503-240-9319, email [email protected]

SUPPLEMENTARY INFORMATION:

The Coast Guard will enforce special local regulations in 33 CFR 100.1302 from 7 a.m. until 6 p.m. on June 11, 2016 and 7 a.m. until 6 p.m. on June 12, 2016, for the Portland Annual Dragon Boat races in the Willamette River. This action is being taken to provide for the safety of life on navigable waterways during the regatta. Our regulation for the Annual Dragon Boat Races, Portland, Oregon, § 100.1302, specifies the location of the regulated area for this regatta course as all waters of the Willamette River shore to shore, bordered on the north by the Hawthorne Bridge, and on the south by the Marquam Bridge. As specified in § 100.1302, during the enforcement period, no vessel may transit this regulated area without approval from the Captain of the Port Sector Columbia River (COTP) or a COTP designated representative.

This notice of enforcement is issued under authority of 33 CFR 100.1302 and 5 U.S.C. 552 (a). In addition to this notice of enforcement in the Federal Register, the Coast Guard plans to provide notification of this enforcement period via the Local Notice to Mariners and marine information broadcasts.

Dated: May 20, 2016. D.J. Travers, Captain, U.S. Coast Guard, Captain of the Port, Sector Columbia River.
[FR Doc. 2016-12686 Filed 5-27-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0426] Drawbridge Operation Regulation; St. Croix River, Stillwater, MN AGENCY:

Coast Guard, DHS.

ACTION:

Notice of deviation from drawbridge regulations.

SUMMARY:

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Stillwater Highway Bridge across the St. Croix River, mile 23.4, at Stillwater, Minnesota. The deviation is necessary due to increased vehicular traffic after a local Independence Day fireworks display. This deviation allows the bridge to remain in the closed-to-navigation position to clear increased vehicular traffic congestion.

DATES:

This deviation is effective from 10 p.m. to 11:30 p.m., July 4, 2016.

ADDRESSES:

The docket for this deviation, (USCG-2016-0426) 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 Eric A. Washburn, Bridge Administrator, Western Rivers, Coast Guard; telephone 314-269-2378, email [email protected]

SUPPLEMENTARY INFORMATION:

The Minnesota Department of Transportation requested a temporary deviation for the Stillwater Highway Bridge, across the St. Croix River, mile 23.4, at Stillwater, Minnesota. This deviation allows the bridge to remain in the closed-to-navigation position from 10 p.m. to 11:30 p.m. on July 4, 2016.

The Stillwater Highway Bridge currently operates in accordance with 33 CFR 117.667(b), which states specific seasonal and commuter hour operating requirements.

The Stillwater Highway Bridge provides a vertical clearance of 10.9 feet above normal pool in the closed-to-navigation position. Navigation on the waterway consists primarily of commercial sightseeing/dinner cruise boats and recreational watercraft. This temporary deviation has been coordinated with waterway users. No objections were received.

The bridge will not be able to open for emergencies and there are no alternate routes for vessels transiting this section of the St. Croix River. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so the 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: May 24, 2016. Eric A. Washburn, Bridge Administrator, Western Rivers.
[FR Doc. 2016-12663 Filed 5-27-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0403] Drawbridge Operation Regulation; Housatonic River, Stratford, CT 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 Metro-North Devon Bridge across the Housatonic River, mile 3.9, at Stratford, Connecticut. This deviation is necessary to allow the bridge owner to perform timber ties and headblocks replacement at the bridge.

DATES:

This deviation is effective from 8 a.m. on May 31, 2016 to 8 a.m. on July 18, 2016.

ADDRESSES:

The docket for this deviation [USCG-2016-0403], 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 Judy Leung-Yee, Project Officer, First Coast Guard District, telephone (212) 514-4330, email [email protected]

SUPPLEMENTARY INFORMATION:

The Metro-North Devon Bridge, mile 3.9, across the Housatonic River, has a vertical clearance in the closed position of 19 feet at mean high water and 25 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.207(b).

The waterway is transited by seasonal recreational vessels.

The bridge owner, Connecticut Department of Transportation, requested a temporary deviation from the normal operating schedule to perform timber ties and headblocks replacement at the bridge.

Under this temporary deviation, the Metro-North Devon Bridge will operate according to the schedule below:

a. From 8 a.m. on May 31, 2016 through 4 a.m. on June 3, 2016, the bridge will not open to marine traffic.

b. From 4 a.m. on June 3, 2016 through 8 a.m. on June 6, 2016, the bridge will open fully on signal upon 24 hr advance notice.

c. From 8 a.m. on June 6, 2016 through 4 a.m. on June 10, 2016, the bridge will not open to marine traffic.

d. From 4 a.m. on June 10, 2016 through 8 a.m. on June 13, 2016, the bridge will open fully on signal upon 24 hr advance notice.

e. From 8 a.m. on June 13, 2016 through 4 a.m. on June 17, 2016, the bridge will not open to marine traffic.

f. From 4 a.m. on June 17, 2016 through 8 a.m. on June 20, 2016, the bridge will open fully on signal upon 24 hr advance notice.

g. From 8 a.m. on June 20, 2016 through 4 a.m. on June 24, 2016, the bridge will not open to marine traffic.

h. From 4 a.m. on June 24, 2016 through 8 a.m. on June 27, 2016, the bridge will open fully on signal upon 24 hr advance notice.

i. From 8 a.m. on June 27, 2016 through 4 a.m. on July 1, 2016, the bridge will not open to marine traffic.

j. From 4 a.m. on July 1, 2016 through 8 a.m. on July 5, 2016, bridge will open in accordance with 33 CFR 117.207(b).

k. From 8 a.m. on July 5, 2016 through 4 a.m. on July 8, 2016, the bridge will not open to marine traffic.

l. From 4 a.m. on July 8, 2016 through 8 a.m. on July 11, 2016, the bridge will open fully on signal upon 24 hr advance notice.

m. From 8 a.m. on July 11, 2016 through 4 a.m. on July 15, 2016, the bridge will not open to marine traffic.

n. From 4 a.m. on July 15, 2016 through 8 a.m. on July 18, 2016, the bridge will open fully on signal upon 24 hr advance notice.

Vessels able to pass under 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 to pass.

The Coast Guard will inform the users of the waterways through our Local Notice and Broadcast to Mariners of the change in operating schedule for the bridge so that vessel operations 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: May 25, 2016. C.J. Bisignano, Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2016-12687 Filed 5-27-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0112] Drawbridge Operation Regulation; Chester River, Chestertown, MD AGENCY:

Coast Guard, DHS.

ACTION:

Notice of temporary deviation from drawbridge regulation; modification.

SUMMARY:

The Coast Guard has modified a temporary deviation from the operating schedule that governs the S213 (MD213) Bridge across the Chester River, mile 26.8, at Chestertown, MD. This modified deviation is necessary to perform bridge maintenance and repairs. This modified deviation allows the bridge to remain in the closed-to-navigation position.

DATES:

This modified deviation is effective without actual notice from May 31, 2016 through 6 p.m. on July 31 2016. For the purposes of enforcement, actual notice will be used from May 24, 2016 at 2 p.m., until May 31, 2016.

ADDRESSES:

The docket for this deviation, [USCG-2016-0112] 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 modified temporary deviation, call or email Mr. Hal R. Pitts, Bridge Administration Branch Fifth District, Coast Guard, telephone 757-398-6222, email [email protected]

SUPPLEMENTARY INFORMATION:

On February 25, 2016, the Coast Guard published a temporary deviation entitled “Drawbridge Operation Regulation; Chester River, Chestertown, MD” in the Federal Register (81 FR 9338). Under that temporary deviation, the bridge would remain in the closed-to-navigation position from 6 a.m. on February 22, 2016 to 6 p.m. on June 1, 2016. The Maryland Department of Transportation State Highway Administration, that owns and operates the S213 (MD213) Bridge, has requested an extension of time for the temporary deviation from the current operating regulations to complete a bridge stringer replacement project, due to delays related to inclement weather. The bridge is a bascule draw bridge and has a vertical clearance in the closed position of 12 feet above mean high water.

The current operating schedule is open on signal if at least six hours notice is given as set out in 33 CFR 117.551. Under this modified temporary deviation, the bridge will remain in the closed-to-navigation position from 6 a.m. on February 22, 2016 to 6 p.m. on July 31, 2016.

The Chester River is used by a variety of vessels including small U.S. government and public vessels, small commercial vessels, and recreational vessels. The Coast Guard has carefully considered the nature and volume of vessel traffic on the waterway in publishing this temporary deviation.

During the closure times there will be limited opportunity for vessels able to safely pass through the bridge in the closed position to do so. Vessels able to safely pass through the bridge in the closed position may do so, after receiving confirmation from the bridge tender that it is safe to transit through the bridge. The bridge will be able to open for emergencies if at least six hours notice is given and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transit 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: May 24, 2016. Hal R. Pitts, Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2016-12652 Filed 5-27-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0434] Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, South Branch of the Elizabeth River, Portsmouth-Chesapeake, VA 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 Norfolk and Western railroad bridge (Norfolk Southern V6.8 Bridge) across the South Branch of the Elizabeth River, mile 3.6, at Portsmouth-Chesapeake, VA. The deviation is necessary to perform bridge maintenance and repairs. This deviation allows the bridge to remain in the closed-to-navigation position.

DATES:

This deviation is effective from 7 a.m. on June 6, 2016, to 5 p.m. on June 23, 2016.

ADDRESSES:

The docket for this deviation, [USCG-2016-0434] 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 Hal R. Pitts, Bridge Administration Branch Fifth District, Coast Guard, telephone 757-398-6222, email [email protected]

SUPPLEMENTARY INFORMATION:

The Norfolk Southern Corporation, that owns and operates the Norfolk and Western railroad bridge (Norfolk Southern V6.8 Bridge), has requested a temporary deviation from the current operating regulations to install a new tie deck across the vertical lift span and under the mitre joints on the fixed approach spans. The bridge is a vertical lift draw bridge and has a vertical clearance in the closed position of 10 feet above mean high water.

The current operating schedule is set out in 33 CFR 117.997(b). Under this temporary deviation, the bridge will remain in the closed-to-navigation position from 7 a.m. to 11:30 a.m. and from 12:30 p.m. to 5 p.m. from June 6, 2016 through June 9, 2016, June 13, 2016 through June 16, 2016, and June 20, 2016 through June 23, 2016. At all other times the bridge will operate per 33 CFR 117.997(b).

The South Branch of the Elizabeth River is used by a variety of vessels including deep draft ocean-going vessels, U.S. government vessels, small commercial vessels, recreational vessels and tug and barge traffic. The Coast Guard has carefully coordinated the restrictions with waterway users.

There will be limited opportunity for vessels to transit through the bridge in the closed position during this temporary deviation. Vessels able to pass through the bridge in the closed position may do so after receiving confirmation from the bridge tender that it is safe to transit through the bridge. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the 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 transit 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: May 24, 2016. Hal R. Pitts, Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2016-12653 Filed 5-27-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2016-0319] RIN 1625-AA00 Safety Zone; Chesapeake Bay, Cape Charles, VA AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing a safety zone on the navigable waters of the Chesapeake Bay in Cape Charles, Virginia. This safety zone will restrict vessel movement in the specified area during a fireworks display. This action is necessary to provide for the safety of life and property on the surrounding navigable waters during the fireworks display.

DATES:

This rule is effective and enforced from 8 p.m. through 8:30 p.m. on July 2, 2016.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0319 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email LCDR Barbara Wilk, Waterways Management Division Chief, Sector Hampton Roads, U.S. Coast Guard; telephone 757-668-5580, email [email protected].

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule is impracticable, because information about the fireworks on July 2, 2016 was not received by the Coast Guard with sufficient time to allow for an opportunity to comment on the proposed rule. Publishing an NPRM would also be contrary to the public interest as immediate action is needed to ensure the safety of the fireworks participants, patrol vessels, and other vessels transiting the fireworks display area. The Coast Guard will provide advance notifications to users of the affected waterway via marine information broadcasts and local notice to mariners. For the same reasons, we find good cause, under 5 U.S.C. 553(d)(3), for making this rule effective less than 30 days after publication in the Federal Register.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Hampton Roads (COTP) has determine that potential hazards associated with the fireworks display starting on July 2, 2016 will be a safety concern for anyone within a 420-foot radius of the fireworks barge. This rule is needed to protect the participants, patrol vessels, and other vessels transiting the navigable waters of the Chesapeake Bay, in the vicinity of the Sunset Beach Resort in Cape Charles, VA from hazards associated with a fireworks display. The potential hazards to mariners within the safety zone include accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris.

IV. Discussion of the Rule

The Captain of the Port of Hampton Roads is establishing a safety zone on the Chesapeake Bay, in the vicinity of the Sunset Beach Resort, in Cape Charles, VA. The safety zone will encompass all navigable waters within a 420 foot radius of the fireworks display barge location. This safety zone still allows for navigation on the waterway. This safety zone will be effective and enforced from 8 p.m. through 8:30 p.m. on July 2, 2016. Access to the safety zone will be restricted during the effective period. Except for participants and vessels authorized by the Captain of the Port or his Representative, no person or vessel may enter or remain in the regulated area.

The Captain of the Port will give notice of the enforcement of the safety zone by all appropriate means to provide the widest dissemination of notice to the affected segments of the public. This includes publication in the Local Notice to Mariners and Marine Information Broadcasts.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

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

Although this safety zone restricts vessel traffic through the regulated area, the effect of this rule will not be significant because: (i) This rule will only be enforced for the limited size and duration of the event; and (ii) the Coast Guard will make extensive notification to the maritime community via marine information broadcasts so mariners may adjust their plans accordingly.

B. Impact on Small Entities

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

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

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

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

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

E. Unfunded Mandates Reform Act

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

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting less than 2 hours that will prohibit entry within 420 feet of the fireworks display. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority:

33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Department of Homeland Security Delegation No. 0170.1.

2. Add § 165.T05-0319 to read as follows:
§ 165.T05-0319 Safety Zone, Chesapeake Bay; Cape Charles, VA.

(a) Definitions. For the purposes of this section, Captain of the Port means the Commander, Sector Hampton Roads. Representative means any Coast Guard commissioned, warrant or petty officer who has been authorized to act on the behalf of the Captain of the Port. Participants mean individuals and vessels involved in explosives training.

(b) Locations. The following area is a safety zone:

(1) All waters in the vicinity of the of the Sunset Beach Resort, on the Chesapeake Bay, within a 420 foot radius of the fireworks display barge in approximate position 37°08′12″ N., 075°58′34″ W. (NAD 1983).

(c) Regulations. (1) All persons are required to comply with the general regulations governing safety zones in § 165.23 of this part.

(2) With the exception of participants, entry into or remaining in this safety zone is prohibited unless authorized by the Captain of the Port, Hampton Roads or his designated representatives.

(3) All vessels underway within this safety zone at the time it is implemented are to depart the zone immediately.

(4) The Captain of the Port, Hampton Roads or his representative can be contacted at telephone number (757) 668-5555.

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

(6) This section applies to all persons or vessels wishing to transit through the safety zone except participants and vessels that are engaged in the following operations:

(i) Enforcing laws;

(ii) Servicing aids to navigation, and

(iii) Emergency response vessels.

(7) The U.S. Coast Guard may be assisted in the patrol and enforcement of the safety zone by Federal, State, and local agencies.

(d) Enforcement Period. This section will be enforced from 8 p.m. through 8:30 p.m. on July 2, 2016.

Dated: May 17, 2016. Christopher S. Keane, Captain, U.S. Coast Guard, Captain of the Port Hampton Roads.
[FR Doc. 2016-12720 Filed 5-27-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2016-0354] RIN 1625-AA00 Safety Zones; Upper Mississippi River Between Mile 179.2 and 180.5, St. Louis, MO and Between Mile 839.5 and 840, St. Paul, MN AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing four temporary safety zones for two areas of the Upper Mississippi River (UMR); three safety zones between UMR mile 179.2 and 180.5, and one between UMR mile 839.5 to 840. These temporary safety zones are necessary to protect persons and property from potential damage and safety hazards during fireworks displays on or over the navigable waterway. During the period of enforcement, entry into these safety zones is prohibited unless specifically authorized by the Captain of the Port (COTP) Upper Mississippi River or other designated representative.

DATES:

This rule is effective from 7:45 p.m. on June 2, 2016 until 10:30 p.m. on July 4, 2016.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0354 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email LCDR Sean Peterson, Chief of Prevention, Sector Upper Mississippi River, U.S. Coast Guard; telephone 314-269-2332, email [email protected]

SUPPLEMENTARY INFORMATION:

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

The Coast Guard is issuing this temporary 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 finds good cause 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 these rules because fireworks displays on or over the navigable waterway poses safety concerns for waterway users. In this case, the Coast Guard was not notified of the fireworks displays until April 26, 2016 and May 16, 2016. After full review of the details for the planned and locally advertised displays, the Coast Guard determined action is needed to protect people and property from the safety hazards associated with the fireworks displays on the UMR near St. Louis, MO and St. Paul, MN. It is impracticable to publish an NPRM because we must establish these safety zones by June 2 and 11, and July 3 and 4, 2016.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making the rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of the rule is contrary to the public interest as it would delay the effectiveness of the temporary safety zones needed to respond to potential related safety hazards until after the planned fireworks displays. This rule does provide approximately 7 to 30 days notice for the four safety zones related to the four planned fireworks displays on the UMR near St. Louis, MO and St. Paul, MN.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP has determined that potential hazards associated with fireworks displays taking place on or over these sections of navigable waterway will be a safety concern for anyone within the areas that are designated as the safety zones. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zones during the fireworks displays.

IV. Discussion of the Rule

This rule establishes four safety zones as follows:

(1) From 7:45 p.m. until 9 p.m. on June 2, 2016, for the Ribbon Cutting Celebration for the Completion of the Riverfront Component for the Great Rivers Greenway barge based fireworks display, all waters of the UMR from mile 179.2 to 180;

(2) from 9 p.m. until 11 p.m. on June 11, 2016, for the St. Louis Brewers Guild barge based fireworks display, all waters of the UMR from mile 179.2 to 180.5;

(3) from 8:30 p.m. until 11 p.m. on July 3, 2016, for the Lumiere Place July 3, 2016 barge based fireworks display, all waters of the UMR from mile 180 to 180.5; and

(4) from 10 p.m. until 10:30 p.m. on July 4, 2016, for the City of St. Paul July 4th Celebration, all waters of the UMR from mile 839.5 to 840.

Exact times of the closures and any changes to the planned scheduled will be communicated to mariners using Broadcast Notices to Mariners and Local Notices to Mariners. The safety zones are intended to protect personnel, vessels, and the marine environment in these navigable waters during the fireworks displays. No vessel or person will be permitted to enter the safety zones without obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

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

This temporary final rule establishes four safety zones, each of which will be enforced for a limited time period. During the enforcement periods, vessels are prohibited from entering into or remaining within the safety zones unless specifically authorized by the COTP or other designated representative. Based on the locations, limited safety zone sizes, and short duration of the enforcement periods, these rules do not pose a significant regulatory impact. Additionally, notice of the safety zones or any changes in the planned schedules will be made via Broadcast Notices to Mariners and Local Notices to Mariners. Deviation from these rules may be requested from the COTP or other designated representative and will be considered on a case-by-case basis.

B. Impact on Small Entities

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

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding these rules. If the rules would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

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

E. Unfunded Mandates Reform Act

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

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that the actions are one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves safety zones, each lasting less than three hours that will limit access to specific areas on the UMR. These safety zones are categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority:

33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

2. Add § 165.T08-0354 to read as follows:
§ 165.T08-0354 Safety zones; Upper Mississippi River between mile 179.2 and 180.5; St. Louis, MO and between mile 839.5 and 840, St. Paul, MN.

(a) Safety zones. The following areas are safety zones:

(1) Great Rivers Greenway fireworks display, St. Louis, MO:

(i) Location. All waters of the Upper Mississippi River from mile 179.2 to 180.

(ii) Enforcement period. This safety zone will be enforced from 7:45 p.m. until 9 p.m. on June 2, 2016;

(2) St. Louis Brewers Guild fireworks display, St. Louis, MO:

(i) Location. All waters of the Upper Mississippi River from mile 179.2 to 180.5.

(ii) Enforcement period. This safety zone will be enforced from 9 p.m. until 11 p.m. on June 11, 2016;

(3) Lumiere Place fireworks display, St. Louis, MO:

(i) Location. All waters of the Upper Mississippi River from mile 180 to 180.5.

(ii) Enforcement period. This safety zone will be enforced from 8:30 p.m. until 11 p.m. on July 3, 2016; and

(4) City of St. Paul July 4th Celebration, St. Paul MN.

(i) Location. All waters of the Upper Mississippi River from mile 839.5 to 840.

(ii) Enforcement period. This safety zone will be enforced from 10 p.m. until 10:30 p.m. on July 4, 2016.

(b) Definitions. As used in this section, designated representative means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the Captain of the Port (COTP) Upper Mississippi River in the enforcement of the safety zone.

(c) Regulations. (1) Under the general safety zone regulations in subpart C of this part, you may not enter the safety zones described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative.

(2) To seek permission to enter, contact the COTP or designated representative via VHF-FM Channel 16, or through Coast Guard Sector Upper Mississippi River at (314) 269-2332.

(3) All persons and vessels shall comply with the instruction of the COTP and designated on-scene personnel.

(d) Information Broadcasts. The COTP or a designated representative will inform the public through Broadcast Notices to Mariners, Local Notices to Mariners, and/or Safety Marine Information Broadcasts as appropriate of the enforcement period for each safety zone as well as any changes in the planned and published dates and times of enforcement.

Dated: May 19, 2016. M.L. Malloy, Captain, U.S. Coast Guard, Captain of the Port Upper Mississippi River.
[FR Doc. 2016-12712 Filed 5-27-16; 8:45 am] BILLING CODE 9110-04-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0197; FRL-9945-05] Fluazinam; Pesticide Tolerances; Technical Correction AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule; technical correction.

SUMMARY:

EPA issued a final rule in the Federal Register of April 8, 2016, concerning the addition of certain commodities to 40 CFR 180.574. Vegetable cucurbit, group 9 was inadvertently omitted. This document corrects that omission.

DATES:

This final rule correction is effective May 31, 2016.

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0197, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave., NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

The Agency included in the April 8, 2016 final rule a list of those who may be potentially affected by this action.

II. What does this technical correction do?

EPA issued a final rule in the Federal Register of April 8, 2016 (81 FR 20545) (FRL-9942-99) that was adding commodities including Vegetable cucurbit, group 9 to 40 CFR 180.574(a)(1). EPA inadvertently omitted the language in the codified text, which would have added Vegetable cucurbit, group 9.

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

Section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)(3)(B)) provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making this technical correction final without prior proposal and opportunity for comment, because this is correcting a typographical error. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

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

No. For a detailed discussion concerning the statutory and executive order review, refer to Unit VI. of the April 8, 2016 final rule.

V. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

Dated: May 24, 2016. Susan Lewis, Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR part 180 is corrected as follows:

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

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

2. In the table in § 180.574(a)(1), alphabetically add the entry “Vegetable cucurbit, group 9” to read as follows:
§  180.574 Fluazinam; tolerances for residues.

(a) * * *

(1) * * *

Commodity Parts
  • per million
  • *    *    *    *    * Vegetable, cucurbit, group 9 0.07 *    *    *    *    *
    [FR Doc. 2016-12721 Filed 5-27-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 100120037-1626-02 and 101217620-1788-03] RIN 0648-XE491 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; 2016 Accountability Measure-Based Closures for Commercial and Recreational Species in the U.S. Caribbean Off Puerto Rico AGENCY:

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

    ACTION:

    Temporary rule; closures.

    SUMMARY:

    NMFS implements accountability measures (AMs) for species and species groups in the exclusive economic zone (EEZ) of the U.S. Caribbean off Puerto Rico for the 2016 fishing year through this temporary rule. NMFS has determined that annual catch limits (ACLs) in the EEZ off Puerto Rico were exceeded for spiny lobster; the commercial sectors for triggerfish and filefish, wrasses, Snapper Unit 2, and parrotfishes; and the recreational sector for jacks, based on average landings during the 2012-2014 fishing years. This temporary rule reduces the lengths of the 2016 fishing seasons for these species and species groups by the amounts necessary to ensure that landings do not exceed the applicable ACLs in 2016. NMFS closes the applicable sectors for these species and species groups beginning on the dates specified below (in the DATES section) and continuing until the end of the fishing year, December 31, 2016. These AMs are necessary to protect the Caribbean reef fish and spiny lobster resources in the EEZ off Puerto Rico.

    DATES:

    This rule is effective June 30, 2016, until 12:01 a.m., local time, January 1, 2017. The AMs apply in the EEZ off Puerto Rico for the following species and species groups, and fishing sectors, at the times and dates specified below, until 12:01 a.m., local time, January 1, 2017.

    • Triggerfish and filefish, combined (commercial) effective at 12:01 a.m., local time, October 16, 2016;

    • Jacks (recreational) effective at 12:01 a.m., local time, November 4, 2016;

    • Wrasses (commercial) effective at 12:01 a.m., local time, November 16, 2016;

    • Snapper Unit 2 (commercial) effective at 12:01 a.m., local time, November 26, 2016;

    • Spiny lobster (commercial and recreational) effective at 12:01 a.m., local time, December 10, 2016;

    • Parrotfishes (commercial) effective at 12:01 a.m., local time, December 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    William S. Arnold, NMFS Southeast Regional Office, telephone: 727-824-5305, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The reef fish fishery of the Caribbean, which includes triggerfish and filefish, wrasses, snappers in Snapper Unit 2, parrotfishes, and jacks, is managed under the Fishery Management Plan for the Reef Fish Fishery of Puerto Rico and the U.S. Virgin Islands (Reef Fish FMP). Caribbean spiny lobster is managed under the FMP for the Spiny Lobster Fishery of Puerto Rico and the U.S. Virgin Islands (Spiny Lobster FMP). The FMPs were prepared by the Caribbean Fishery Management Council (Council) and are implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

    The 2010 Caribbean ACL Amendment (Amendment 2 to the FMP for the Queen Conch Resources of Puerto Rico and the U.S. Virgin Islands (Queen Conch FMP) and Amendment 5 to the Reef Fish FMP) and 2011 Caribbean ACL Amendment (Amendment 3 to the Queen Conch FMP, Amendment 6 to the Reef Fish FMP, Amendment 5 to the Spiny Lobster FMP, and Amendment 3 to FMP for Corals and Reef Associated Plants and Invertebrates of Puerto Rico and the U.S. Virgin Islands) revised the Reef Fish and Spiny lobster FMPs (76 FR 82404, December 30 2011, and 76 FR 82414, December 30, 2011). Among other actions, the 2010 and 2011 Caribbean ACL Amendments and the associated final rules established ACLs and AMs for Caribbean spiny lobster and reef fish, including the species and species groups identified in this temporary rule. The 2010 and 2011 Caribbean ACL Amendments and final rules also allocated ACLs among three Caribbean island management areas, i.e., the Puerto Rico, St. Croix, and St. Thomas/St. John management areas of the EEZ, as specified in Appendix E to part 622. The ACLs for species and species groups in the Puerto Rico management area, except for spiny lobster, were further allocated between the commercial and recreational sectors, and AMs apply to each of these sectors separately.

    On May 11, 2016, NMFS published the final rule implementing the Comprehensive AM Application Amendment to the U.S. Caribbean FMPs: Application of Accountability Measures and additional regulatory clarifications (81 FR 29166). Among other things, the final rule clarified that the spiny lobster ACL for the Puerto Rico management area is applied as a single ACL for both the commercial and recreational sectors, consistent with the Council's intent in the 2011 Caribbean ACL Amendment. Additionally, the final rule clarified the fishing restrictions that occur in the Caribbean EEZ when an ACL is exceeded and an AM is implemented.

    The ACLs for the applicable species and species groups, and fishing sectors in the EEZ off Puerto Rico covered by this temporary rule are as follows and are given in round weight:

    • The commercial ACL for triggerfish and filefish, combined, is 58,475 lb (26,524 kg), as specified in § 622.12(a)(1)(i)(Q).

    • The commercial ACL for wrasses is 54,147 lb (24,561 kg), as specified in § 622.12(a)(1)(i)(L).

    • The commercial ACL for Snapper Unit 2 is 145,916 lb (66,186 kg), as specified in § 622.12(a)(1)(i)(D).

    • The ACL for spiny lobster is 327,920 lb (148,742 kg), as specified in § 622.12(a)(1)(iii).

    • The commercial ACL for parrotfishes is 52,737 lb (23,915 kg), as specified in § 622.12(a)(1)(i)(B).

    • The recreational ACL for jacks is 51,001 lb (23,134 kg), as specified in § 622.12(a)(1)(ii)(M).

    In accordance with regulations at 50 CFR 622.12(a), if landings from a Caribbean island management area are estimated to have exceeded the applicable ACL, the Assistant Administrator for NOAA Fisheries (AA), will file a notification with the Office of the Federal Register to reduce the length of the fishing season for the applicable species or species group the following fishing year by the amount necessary to ensure landings do not exceed the applicable ACL. NMFS evaluates landings relative to the applicable ACL based on a moving 3-year average of landings, as described in the FMPs.

    Based on the most recent landings data, from the 2012-2014 fishing years, NMFS has determined that the ACLs for spiny lobster; the commercial sectors for triggerfish and filefish, wrasses, Snapper Unit 2, spiny lobster, and parrotfishes; and the recreational sector of jacks have been exceeded. In addition, NMFS has determined that the ACLs for these species and species groups were exceeded because of increased catches and not as a result of enhanced data collection and monitoring efforts.

    This temporary rule implements AMs for the identified commercial and recreational sectors for the species and species groups listed in this temporary rule, to reduce the 2016 fishing season lengths to ensure that landings do not exceed the applicable ACLs in the 2016 fishing year. The 2016 fishing seasons for the applicable sectors for these species and species groups in the Puerto Rico management area of the EEZ are closed at the times and dates listed below. These closures remain in effect until the 2017 fishing seasons begin at 12:01 a.m., local time, January 1, 2017.

    • The commercial sector for triggerfish and filefish, combined, is closed effective at 12:01 a.m., local time, October 16, 2016. Triggerfish and filefish, combined, include ocean (Canthidermis sufflamen), queen (Balistes vetula), and sargassum triggerfish (Xanthichthys ringens), scrawled (Aluterus scriptus) and whitespotted filefish (Cantherhines macrocerus), and black durgon (Melichthys niger);

    • The recreational sector for jacks is closed effective at 12:01 a.m., local time, November 4, 2016. Jacks include horse-eye (Caranx latus), black (Caranx lugubris), almaco (Seriola rivoliana), bar (Caranx ruber), and yellow jack (Caranx bartholomaei), greater amberjack (Seriola dumerili), and blue runner (Caranx crysos);

    • The commercial sector for wrasses is closed effective at 12:01 a.m., local time, November 16, 2016. Wrasses include hogfish (Lachnolaimus maximus), puddingwife (Halichoeres radiatus) and Spanish hogfish (Bodianus rufus);

    • The commercial sector for Snapper Unit 2 is closed effective at 12:01 a.m., local time, November 26, 2016. Snapper Unit 2 include queen (Etelis oculatus) and cardinal snapper (Pristipomoides macrophthalmus);

    • The commercial and recreational sectors for spiny lobster (Panulirus argus) are closed effective at 12:01 a.m., local time, December 10, 2016; and

    • The commercial sector for parrotfishes is closed effective at 12:01 a.m., local time, December 19, 2016. Parrotfishes include queen (Scarus vetula), princess (Scarus taeniopterus), striped (Scarus iseri), redband (Sparisoma aurofrenatum), redfin (Sparisoma rubripinne), redtail (Sparisoma chrysopterum), and stoplight parrotfish (Sparisoma viride).

    During the Puerto Rico commercial sector closures announced in this temporary rule, the commercial sectors for the indicated species or species groups are closed. All harvest or possession of the indicated species or species group in or from the Puerto Rico management area is limited to the recreational bag and possession limits specified in § 622.437, and the sale or purchase of the indicated species or species group in or from the Puerto Rico management area is prohibited. During the Puerto Rico recreational sector closure for jacks announced in this temporary rule, the jacks recreational sector is closed, and the recreational bag and possession limits for jacks in or from the Puerto Rico management area are zero.

    During the spiny lobster closure in the Puerto Rico management area, both the commercial and recreational sectors fo spiny lobster are closed. The harvest, possession, purchase, or sale of spiny lobster in or from the Puerto Rico management area is prohibited. The bag and possession limits for spiny lobster in or from the Puerto Rico management area are zero.

    Classification

    The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of the species and species groups included in this temporary rule, in the EEZ off Puerto Rico, and is consistent with the Magnuson-Stevens Act and other applicable laws.

    This action is taken under 50 CFR 622.12(a)(1) and is exempt from review under Executive Order 12866.

    These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

    This action responds to the best scientific information available. The AA finds good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such prior notice and opportunity for public comment is unnecessary and contrary to the public interest. Such procedures are unnecessary because the rules implementing the ACLs and AMs for these species and species groups have been subject to notice and comment, and all that remains is to notify the public that the ACLs were exceeded and that the AMs are being implemented for the 2016 fishing year. Prior notice and opportunity for public comment on this action would be contrary to the public interest, because many of those affected by the length of the commercial and recreational fishing seasons, including commercial operations, and charter vessel and headboat operations that book trips for clients in advance, need advance notice to adjust their business plans to account for the reduced commercial and recreational fishing seasons.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: May 25, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-12728 Filed 5-27-16; 8:45 am] BILLING CODE 3510-22-P
    81 104 Tuesday, May 31, 2016 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6894; Directorate Identifier 2015-NM-120-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A300 F4-600R series airplanes. This proposed AD was prompted by a report of two adjacent frame forks that were found cracked on the aft lower deck cargo door (LDCD) of two Model A300-600F4 airplanes during scheduled maintenance. This proposed AD would require repetitive high frequency eddy current (HFEC) inspections of the aft LDCD frame forks; a one-time check of the LDCD clearances; and a one-time detailed visual inspection of hooks, eccentric bushes, and x-stops; and corrective actions if necessary. We are proposing this AD to detect and correct cracked or ruptured aft LDCD frames, which could allow loads to be transferred to the remaining structural elements. This condition could lead to the rupture of one or more vertical aft LDCD frames, which could result in reduced structural integrity of the aft LDCD.

    DATES:

    We must receive comments on this proposed AD by July 15, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

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

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6894; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-6894; Directorate Identifier 2015-NM-120-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

    Discussion

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0152, dated July 24, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A300 F4-605R and A300 F4-622R. The MCAI states:

    During scheduled maintenance at frames (FR) 61 and FR61A on the aft lower deck cargo door (LDCD) of two A300-600F4 aeroplanes, two adjacent frame forks were found cracked.

    Subsequent analysis determined that, in case of cracked or ruptured aft cargo door frame(s), loads will be transferred to the remaining structural elements. However, these secondary load paths will be able to sustain the loads for a limited number of flight cycles only.

    This condition, if not detected and corrected, could lead to the rupture of one or more vertical aft cargo door frame(s), resulting in reduced structural integrity of the aft cargo door.

    To address this unsafe condition, Airbus issued Alert Operators Transmission (AOT) A52W011-15 to provide inspection instructions.

    For the reason described above, this [EASA] AD requires repetitive inspections [for cracking] of the aft LDCD frame forks and, depending on findings, the accomplishment of corrective action(s).

    This [EASA] AD is considered interim action and further [EASA] AD action may follow.

    Required actions include a one-time check of the LDCD clearances; and a one-time detailed visual inspection of hooks, eccentric bushes, x-stops; and corrective actions if necessary. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6894.

    Related Service Information Under 1 CFR Part 51

    Airbus has issued Alert Operators Transmission (AOT) A52W011-15, Revision 00, dated July 23, 2015. The service information describes procedures for repetitive HFEC inspections for cracking of the aft LDCD frame forks; a one-time check of the LDCD clearances; and a one-time detailed visual inspection of hooks, eccentric bushes, and x-stops; and corrective actions if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

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

    Costs of Compliance

    We estimate that this proposed AD affects 58 airplanes of U.S. registry. We also estimate that it would take about 4 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $0 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $19,720, or $340 per product.

    In addition, we estimate that any necessary follow-on actions would take about 15 work-hours and require parts costing $10,000, for a cost of $11,275 per product. We have no way of determining the number of aircraft that might need these actions.

    Also, we estimate that the reporting requirement would take about 1 work-hour, for a cost of $85 per product.

    Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this proposed AD is 2120-0056. The paperwork cost associated with this proposed AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this proposed AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Airbus: Docket No. FAA-2016-6894; Directorate Identifier 2015-NM-120-AD. (a) Comments Due Date

    We must receive comments by July 15, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Airbus Model A300 F4-605R and A300 F4-622R airplanes, certificated in any category, on which Airbus Modification 12046 has been embodied in production. Modification 12046 has been embodied in production on manufacturer serial numbers (MSNs) 0805 and above, except MSNs 0836, 0837, and 0838.

    (d) Subject

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

    (e) Reason

    This AD was prompted by a report of two adjacent frame forks that were found cracked on the aft lower deck cargo door (LDCD) of two Model A300-600F4 airplanes during scheduled maintenance. We are issuing this AD to detect and correct cracked or ruptured aft LDCD frames, which could allow loads to be transferred to the remaining structural elements. This condition could lead to the rupture of one or more vertical aft LDCD frames, which could result in reduced structural integrity of the aft LDCD.

    (f) Compliance

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

    (g) Inspection Requirements

    At the applicable time specified in paragraph (h) of this AD, do the actions specified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD, in accordance with Airbus Alert Operators Transmission (AOT) A52W011-15, Revision 00, dated July 23, 2015.

    (1) Do a one-time check of the aft LDCD clearances “U” and “V” between the latching hooks and the eccentric bush at FR60 through FR64A. If any value outside tolerance is found, adjust the latching hook before further flight.

    (2) Do a one-time detailed inspection to detect signs of wear of the hooks, eccentric bushes, and x-stops. If any wear is found, do all applicable corrective actions before further flight.

    (3) Do a high frequency eddy current (HFEC) inspection to detect cracking at all frame fork stations of the aft LDCD. If any crack is found, replace the cracked frame fork before further flight. Repeat the HFEC inspection thereafter at intervals not to exceed 600 flight cycles.

    (h) Compliance Times

    At the later of the times specified in paragraphs (h)(1) and (h)(2) of this AD, do the actions required by paragraph (g) of this AD.

    (1) Before the accumulation of 4,500 total flight cycles.

    (2) At the applicable time specified by paragraph (h)(2)(i) or (h)(2)(ii) of this AD.

    (i) For airplanes that have accumulated 8,000 or more total flight cycles as of the effective date this AD: Within 100 flight cycles after the effective date of this AD.

    (ii) For airplanes that have accumulated fewer than 8,000 total flight cycles as of the effective date of this AD: Within 400 flight cycles after the effective date of this AD.

    (i) Reporting

    At the applicable time specified in paragraph (i)(1) or (i)(2) of this AD, report the findings (both positive and negative) of the clearance check and detailed inspection required by paragraphs (g)(1) and (g)(2) of this AD, and each HFEC inspection required by paragraph (g)(3) of this AD. Send the report to Airbus in accordance with paragraph 7 of Airbus AOT A52W011-15, Revision 00, dated July 23, 2015. The report must include the applicable information specified in Appendix 2 of Airbus AOT A52W011-15, Revision 00, dated July 23, 2015.

    (1) If the inspection was done on or after the effective date of this AD: Submit the report within 60 days after the inspection.

    (2) If the inspection was done before the effective date of this AD: Submit the report within 60 days after the effective date of this AD.

    (j) Post-Repair Provisions

    (1) Accomplishment of corrective actions required by this AD does not terminate the repetitive HFEC inspections required by paragraph (g)(3) of this AD.

    (2) If all frame forks are replaced at the same time on the aft LDCD of an airplane, the next HFEC inspection required by paragraph (g)(3) of this AD can be deferred up to 4,500 flight cycles after the frame fork replacement.

    (k) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

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

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

    (l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) European Airworthiness Directive 2015-0152, dated July 24, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6894.

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

    Issued in Renton, Washington, on May 18, 2016. Dionne Palermo, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-12522 Filed 5-27-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6896; Directorate Identifier 2016-NM-016-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for all Airbus Model A318-111, and -112 airplanes, Model A319-111, -112, -113, -114, and -115 airplanes, Model A320-211, -212 and -214 airplanes, and Model A321-111, -112, -211, -212, and -213 airplanes. This proposed AD was prompted by a report of a production quality deficiency on the inner retainer installed on link assemblies of the engine mount, which could result in failure of the retainer. This proposed AD would require an inspection for, and replacement of, all non-conforming aft engine mount retainers. We are proposing this AD to detect and correct non-conforming retainers of the aft engine mount. This condition could result in the loss of the locking feature of the nuts of the inner and outer pins; loss of the pins will result in the aft mount engine link no longer being secured to the aft engine mount, possibly resulting in damage to the airplane and injury to persons on the ground.

    DATES:

    We must receive comments on this proposed AD by July 15, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

    Hand Delivery: Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

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

    For Goodrich service information identified in this NPRM, contact Goodrich Corporation, Aerostructures, 850 Lagoon Drive, Chula Vista, CA 91910-2098; telephone: 619-691-2719; email: [email protected]; Internet: http://www.goodrich.com/TechPubs.

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

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6896; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-6896; Directorate Identifier 2016-NM-016-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

    Discussion

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2016-0010R1, dated February 16, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A318-111, and -112 airplanes, Model A319-111, -112, -113, -114, and -115 airplanes, Model A320-211, -212, and -214 airplanes, and Model A321-111, -112, -211, -212, and -213 airplanes. The MCAI states:

    During in-service inspections, several aft engine mount inner retainers, fitted on aeroplanes equipped with CFM56-5A/5B engines, have been found broken. The results of the initial investigations highlighted that two different types of surface finish had been applied (respectively bright and dull material finishes), and that dull finish affects the strength of the retainer with regard to fatigue properties of the part. The pins which attach the engine link to the aft mount are secured by two nuts, which do not have a self-locking feature; this function is provided by the retainer brackets. In case of failure of the retainer bracket, the locking feature of the nuts of the inner and outer pins is lost; as a result, these nuts could subsequently become loose.

    In case of full loss of the nuts, there is the potential to also lose the pins, in which case the aft mount link will no longer be secured to the aft engine mount. The same locking feature is used for the three link assemblies of the aft mount.

    This condition, if not detected and corrected, could lead to in-flight loss of an aft mount link, possibly resulting in damage to the aeroplane and/or injury to persons on the ground.

    To address this potential unsafe condition, EASA issued AD 2013-0050 [http://ad.easa.europa.eu/blob/easa_ad_2013_0050_superseded.pdf/AD_2013-0050_1] [which corresponds to FAA AD 2014-14-06, Amendment 39-17901 (79 FR 42655, July 23, 2014)] to require a detailed inspection (DET) of the aft engine mount inner retainers and the replacement of all retainers with dull finish with retainers having a bright finish. Since that [EASA] AD was issued, inspection results showed that the main cause of crack initiation remains the vibration dynamic effect that affects both retainers, either with “dull” or “bright” surface finishes. The non-conforming “dull” surface's pitting is an aggravating factor. Consequently, EASA issued AD 2015-0021 [http://ad.easa.europa.eu/blob/EASA_AD_2015_0021_superseded.pdf/AD_2015-0021_1] [which corresponds to FAA NPRM Docket No. FAA-2015-3632; Directorate Identifier 2015-NM-023-AD (80 FR 55798, September 7, 2015)], retaining the requirements of EASA AD 2013-0050, which was superseded, and requiring repetitive DET of all aft engine mount inner retainers and, depending on findings, their replacement.

    Since that [EASA] AD was issued, a production quality deficiency was identified by Airbus and UTAS (formerly Goodrich Aerostructures, the engine mount retainer manufacturer) on the delivery of the inner retainer, Part Number (P/N) 238-0252-505, installed in the three Link assemblies of the engine mount fitted on CFM56-5A/5B engines. Airbus issued AOT A71N011-15 and SB A320-71-1070 providing a list of affected parts and applicable corrective actions.

    Consequently, EASA issued [a new] AD * * *, retaining the requirements of EASA AD 2015-0021, which was superseded, and in addition requiring the identification and replacement of all non-conforming aft engine mount inner retainers.

    Since that [new EASA] AD was issued, AOT A71N011-15 was revised, removing errors and reducing the list of affected parts.

    For the reason described above, this [EASA] AD is revised, adding reference to the revised AOT, and removing [EASA] AD appendixes, which content is included in the referenced Airbus documentation.

    This [EASA] AD is still considered to be an interim action, pending development and availability of a final solution.

    This proposed AD would require an inspection for, and replacement of, all non-conforming aft engine mount retainers. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6896.

    Related Service Information Under 1 CFR Part 51

    We reviewed the following service information. This service information describes procedures for replacement of all non-conforming aft engine mount retainers.

    • Airbus Service Bulletin A320-71-1070, dated November 23, 2015. This service information also describes procedures for an inspection for non-conforming aft engine mount retainers.

    • Airbus Alert Operators Transmission (AOT) A71N011-15, Revision 01, dated February 1, 2016.

    • Goodrich Service Bulletin RA32071-165, dated October 9, 2015.

    This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

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

    Costs of Compliance

    We estimate that this proposed AD affects 959 airplanes of U.S. registry.

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

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Inspection 4 work-hours × $85 per hour = $340 $0 $340 Up to $326,060.

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

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Replacement Up to 36 work-hours × $85 per hour = $3,060 $10,000 Up to $13,060.
    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Airbus: Docket No. FAA-2016-6896; Directorate Identifier 2016-NM-016-AD. (a) Comments Due Date

    We must receive comments by July 15, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to the Airbus airplanes identified in paragraphs (c)(1) through (c)(4) of this AD, certificated in any category, all manufacturer serial numbers.

    (1) Airbus Model A318-111 and -112 airplanes.

    (2) Airbus Model A319-111, -112, -113, -114, and -115 airplanes.

    (3) Airbus Model A320-211, -212, and -214 airplanes.

    (4) Airbus Model A321-111, -112, -211, -212, and -213 airplanes.

    (d) Subject

    Air Transport Association (ATA) of America Code 71, Powerplant.

    (e) Reason

    This AD was prompted by a report of a production quality deficiency on the inner retainer installed on link assemblies of the engine mount, which could result in failure of the retainer. We are issuing this AD to detect and correct non-conforming retainers of the aft engine mount. This condition could result in loss of the locking feature of the nuts of the inner and outer pins; loss of the pins will result in the aft mount engine link no longer being secured to the aft engine mount, possibly resulting in damage to the airplane and injury to persons on the ground.

    (f) Compliance

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

    (g) Inspection and Replacement

    Within 2 months after the effective date of this AD, do an inspection to determine the part number of each engine mount inner retainer; and within 2 months after the effective date of this AD, replace each part that meets any of the criteria specified in paragraph (g)(1), (g)(2), or (g)(3) of this AD. Do the inspection in accordance with the service information specified in paragraph (h)(1) of this AD. Do the replacement in accordance with the service information specified in paragraph (h)(1), (h)(2), or (h)(3) of this AD. A review of airplane maintenance records is acceptable in lieu of the inspection required by this paragraph, if the part number of the engine mount inner retainer can be conclusively determined from that review.

    (1) An aft engine mount having a serial number listed in table 1 of Airbus Alert Operators Transmission (AOT) A71N011-15, Rev 01, dated February 1, 2016.

    (2) An engine mount inner retainer installed on an airplane between the first flight of the airplane or March 1, 2015 (whichever occurs later), and the effective date of this AD, and that can be identified by a purchase order (PO) listed in table 2 of Airbus AOT A71N011-15, Rev 01, dated February 1, 2016.

    (3) An engine mount inner retainer installed on an airplane between the first flight of the airplane or March 1, 2015 (whichever occurs later), and the effective date of this AD, and that cannot be identified by a PO.

    (h) Service Information for Actions Required by Paragraph (g) of This AD

    Accomplish the replacement required by paragraph (g) of this AD in accordance with the service information specified in paragraph (h)(1), (h)(2), or (h)(3) of this AD.

    (1) The Accomplishment Instructions of Airbus Service Bulletin A320-71-1070, dated November 23, 2015.

    (2) Paragraph 4.2.2, “Requirements,” of Airbus AOT A71N011-15, Revision 01, dated February 1, 2016.

    (3) The Accomplishment Instructions of Goodrich Service Bulletin RA32071-165, dated October 9, 2015.

    (i) Credit for Previous Actions

    This paragraph provides credit for the applicable actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Airbus AOT A71N011-15, Revision 01, dated February 1, 2016, which is not incorporated by reference in this AD.

    (j) Parts Installation Prohibition

    As of the effective date of this AD, no person may install any part that meets any of the criteria specified in paragraph (j)(1), (j)(2), (j)(3) of this AD on any airplane.

    (1) An aft engine mount having a serial number listed in table 1 of Airbus AOT A71N011-15, Rev 01, dated February 1, 2016.

    (2) An engine mount inner retainer delivered through a PO listed in table 2 of Airbus AOT A71N011-15, Rev 01, dated February 1, 2016.

    (3) An engine mount inner retainer delivered through an unidentified PO.

    (k) Special Flight Permits

    Special flight permits, as described in Section 21.197 and Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199), are not allowed.

    (l) Other FAA AD Provisions

    The following provisions also apply to this AD:

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

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

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

    (m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2016-0010R1, dated February 16, 2016, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6896.

    (2) For Airbus service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 44 51; email: [email protected]; Internet: http://www.airbus.com. For Goodrich service information identified in this AD, contact Goodrich Corporation, Aerostructures, 850 Lagoon Drive, Chula Vista, CA 91910-2098; telephone: 619-691-2719; email: [email protected]; Internet: http://www.goodrich.com/TechPubs. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on May 20, 2016. Victor Wicklund, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-12593 Filed 5-27-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 1000 [Docket No. FR-5650-P-12] RIN 2577-AC90 Native American Housing Assistance and Self-Determination Act; Revisions to the Indian Housing Block Grant Program Formula AGENCY:

    Office of the Assistant Secretary for Public and Indian Housing, HUD.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule would revise the Indian Housing Block Grant (IHBG) Program allocation formula authorized by section 302 of the Native American Housing Assistance and Self-Determination Act of 1996, as amended (NAHASDA). Through the IHBG Program, HUD provides federal housing assistance for Indian tribes in a manner that recognizes the right of Indian self-determination and tribal self-government. HUD negotiated the proposed rule with active tribal participation and using the procedures of the Negotiated Rulemaking Act of 1990. The proposed regulatory changes reflect the consensus decisions reached by HUD and the tribal representatives on ways to improve and clarify the current regulations governing the IHBG Program formula.

    DATES:

    Comment Due Date: August 1, 2016.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposed rule to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500. Communications must refer to the above docket number and title. There are two methods for submitting public comments. All submissions must refer to the above docket number and title.

    1. Submission of Comments by Mail. Comments may be submitted by mail to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500.

    2. Electronic Submission of Comments. Interested persons may submit comments electronically through the Federal eRulemaking Portal at www.regulations.gov. HUD strongly encourages commenters to submit comments electronically. Electronic submission of comments allows the commenter maximum time to prepare and submit a comment, ensures timely receipt by HUD, and enables HUD to make them immediately available to the public. Comments submitted electronically through the www.regulations.gov Web site can be viewed by other commenters and interested members of the public. Commenters should follow the instructions provided on that site to submit comments electronically.

    Note:

    To receive consideration as public comments, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the rule.

    No Facsimile Comments. Facsimile (fax) comments are not acceptable.

    Public Inspection of Public Comments. HUD will make all properly submitted comments and communications available for public inspection and copying between 8 a.m. and 5 p.m. weekdays at the above address. Due to security measures at the HUD Headquarters building, you must schedule an appointment in advance to review the public comments by calling the Regulations Division at 202-708-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the toll-free Federal Relay Service at 800-877-8339. Copies of all comments submitted are available for inspection and downloading at www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Randall R. Akers, Acting Deputy Assistant Secretary for Native American Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 4126, Washington, DC 20410-5000, telephone, (202) 402-7598 (this is not a toll-free number). Hearing or speech-impaired individuals may access this number via TTY by calling the toll-free Federal Relay Service at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION: I. Background

    The Native American Housing Assistance and Self-Determination Act of 1996 (25 U.S.C. 4101 et seq.) (NAHASDA) changed the way that housing assistance is provided to Native Americans. NAHASDA eliminated several separate assistance programs and replaced them with a single block grant program, known as the Indian Housing Block Grant (IHBG) Program. NAHASDA and its implementing regulations, codified at 24 CFR part 1000, recognize tribal self-determination and self-governance while establishing reasonable standards of accountability. Reflective of this, section 106 of NAHASDA provides that HUD shall develop implementing regulations with active tribal participation and using the procedures of the Negotiated Rulemaking Act of 1990 (5 U.S.C. 561-570).

    NAHASDA has been amended and reauthorized several times since being signed into law in 1996. Following the enactment of the Native American Housing Assistance and Self-Determination Reauthorization Act of 2008 (Pub. L. 110-411, approved October 14, 2008) (NAHASDA Reauthorization Act) HUD established a negotiated rulemaking committee on January 5, 2010 (75 FR 423), that focused on implementing the NAHASDA Reauthorization Act and prior amendments to NAHASDA. The negotiated rulemaking committee addressed all IHBG program regulations, except those provisions which govern the NAHASDA allocation formula codified in subpart D of 24 CFR part 1000. As a result of that negotiated rulemaking, HUD published a final rule on December 3, 2012 (77 FR 71513), that revised HUD regulations governing the IHBG Program and the Title VI Loan Guarantee program (under Title VI of NAHASDA, 25 U.S.C. 4191, et seq.) A separate negotiated rulemaking was subsequently begun to review the allocation formula regulations.

    II. The IHBG Formula Negotiated Rulemaking Committee

    On July 3, 2012 (77 FR 39452) and September 18, 2012 (77 FR 57544), HUD published notices in the Federal Register announcing HUD's intent to establish a negotiated rulemaking committee for the purposes of reviewing the regulations at 24 CFR part 1000, subpart D, and negotiating recommendations for a possible proposed rule modifying the IHBG formula. On June 12, 2013 (78 FR 35178), HUD published for public comment the names and affiliations of the committee's proposed members. On July 30, 2013 (78 FR 45903), after considering public comment on the proposed membership, HUD published a Federal Register notice announcing the final list of members of the IHBG Formula Negotiated Rulemaking Committee (Committee) and announcing the date of the first meeting of the Committee. The Committee membership consists of 24 designated representatives of tribal governments (or authorized designees of those tribal governments). The Committee membership reflected a balanced representation of Indian tribes, both geographically and based on size. In addition to the tribal members, there were two HUD representatives on the Committee. Committee meetings took place on August 27-28, 2013, September 17-19, 2013, April 23-24, 2014, June 11-13, 2014, July 29-31, 2014, August, 26-28, 2014, August 11-13, 2015, and January 26-27, 2016. The Committee agreed to operate based on consensus rulemaking and its approved charter and protocols. All of the Committee meetings were announced in the Federal Register and were open to the public.1

    1 See, 78 FR 45903 (July 30, 2013); 78 FR 54416 (September 4, 2013); 79 FR 14204 (March 13, 2014); 79 FR 28700 (May 23, 2014); 80 FR 30004 (May 26, 2015); 80 FR 33157 (June 11, 2015); 81 FR 881 (January 8, 2016).

    The Committee divided itself into multiple workgroups to analyze specified provisions of the IHBG formula and to draft any new or revised regulatory language it believed was necessary. A workgroup was responsible for analyzing the regulations for the Need component. Another workgroup reviewed the provisions governing the Formula Current Assisted Stock (FCAS) component. The workgroups were not authorized to reach any final or binding decisions but rather, reported to the full Committee. The draft regulatory language developed by the workgroups was then brought before the full Committee for review, amendment, and approval.

    At the August 2014 meeting, an additional study group, the Data Study Group, was established to assess alternative data sources to the 2000 United States Decennial Census, which currently serves as the data source for the factors that are used to calculate the Need component of the allocation formula, including American Indian and Alaskan Native (AIAN) households with housing cost burdens, inadequate housing, low- and moderate-income AIAN households, and AIAN population. The Data Study Group was comprised of one Committee member from each of the six HUD-designated ONAP regions, plus one HUD representative. The Data Study Group members identified three technical experts and HUD provided a technical expert to assist with the work. Meetings of the Data Study Group were open to all Committee members and to the public. The Data Study Group met both telephonically and in-person and operated on a consensus basis.

    In a Federal Register notice published on September 25, 2014 at 79 FR 57489, the Committee solicited suggestions from the public for potential data sources that would achieve an optimal balance of the following factors: recognition of tribal sovereignty; data relevant to eligible AIAN housing needs; and collected using a methodology that is objective, equitable, transparent, consistent, capable of being applied to all existing formula areas, statistically reliable, and replicable both over time and diverse geographies. The data would need to be collected and submitted by proficient persons or organizations with appropriate capacity and training and to be collected on a recurring basis at reasonable intervals or be capable of reliable statistical aging. Finally, the data source could not impose an undue administrative or financial burden upon tribes, needed to be cost-effective, and be capable of being fully evaluated by the Data Study Group within a one-year timeframe.

    After receiving responses to the September 25, 2014 Federal Register notice, the Data Study Group identified 49 different data sources that were reviewed by the technical experts against a pre-determined set of screening criteria. Of the 49 nominated data sources, the Data Study Group agreed unanimously that 30 did not meet these criteria. The technical experts then prepared detailed characterizations of the remaining 19 data sources. Based on the characterization process and the discussion that followed, the Data Study Group rejected 10 more data sources that did not meet the pre-determined criteria. The Data Study Group moved nine remaining data sources forward for comprehensive evaluation. These included the following four sets of core data and five sets of support data:

    Core Data • Most Recent Decennial Census data collected by the U.S. Census Bureau • American Community Survey collected by the U.S. Census Bureau • National Tribal Survey to be Administered by a Federal Agency • National Tribal Survey to be Administered by tribes Support Data • Tribal Enrollment Data • Indian Health Service Population Projections • U.S. Census Bureau Population Estimates • Data Reported by IHBG Grant Recipients on Formula Response Form • Total Development Costs (TDC)

    The Data Study Group carefully considered the evaluation results of technical experts, had multiple discussions among its membership, including requests for clarification from the technical experts, and on July 31, 2015, issued its final report containing a recommendation for a data source or sources to be used in calculating the AIAN persons variable of the Need component of the IHBG funding formula, which it presented to the full Committee. Specifically, the Data Study Group recommended that the AIAN population be the greater of the most recently available American Community Survey (ACS), Decennial Census, or Challenge data, and that data no longer be aged. This proposal did not reach consensus at the full Committee level. The Data Study Group's full report can be found as a supporting document to this proposed rule at www.Regulations.gov.

    III. This Proposed Rule

    The Committee undertook a comprehensive review of the IHBG Formula. The Committee also reviewed any statutory changes that still needed to be addressed in the regulations. The Committee identified certain areas of the IHBG formula that required clarification, were outdated, or could be improved. With the exception of changes to § 1000.330(b)(ii), this proposed rule reflects the consensus decisions reached by the Committee during the negotiated rulemaking process on the best way to address these issues. The following section of this preamble provides a summary of the consensus recommended changes to the IHBG formula by this proposed rule.

    A. Revision of Definition of Formula Area (§ 1000.302)

    To conform § 1000.302 to the decision of the United States Court of Appeals for the Tenth Circuit in United Keetoowah Band of Cherokee Indians of Oklahoma v. United States Department of Housing and Urban Development, 2 HUD is revising the definition of formula area at 24 CFR 1000.302 by striking the reference to “court jurisdiction” in paragraph (2)(i) of the definition.

    2 567 F.3d 1235 (10th Cir. 2009).

    B. Continued Funding of Section 8 Units (§ 1000.306)

    The proposed rule would make a technical amendment to § 1000.306 to eliminate paragraph (c), an outdated section that addressed how Section 8 units would be treated under the formula. Currently, § 1000.306(c) provides that, during the five-year review of the FCAS component of the formula, the count of units associated with expired contracts for tenant-based Section 8 rental assistance would be reduced by the same percentage as the current assisted rental stock has diminished since September 30, 1999. After HUD issued this regulation, section 502(a) of NAHASDA was amended by the Omnibus Indian Advancement Act (Pub. L. 106-568, approved December 27, 2000) (25 U.S.C. 4181(a)) to provide that housing subject to a contract for tenant-based Section 8 rental assistance prior to September 30, 1997, under the authority of the United States Housing Act of 1937 (42 U.S.C. 1437 et seq.) is to be considered a dwelling unit for purposes of section 302(b)(1) of NAHASDA. As a result, the proposed rule removes paragraph (c) from § 1000.306.

    C. Components of IHBG Formula (§ 1000.310)

    The proposed rule would revise § 1000.310 to reflect that the IHBG formula would consist of four components: FCAS (§ 1000.316), Need (§ 1000.324), 1996 Minimum (§ 1000.340), and Undisbursed IHBG funds factor (§ 1000.342). FCAS, Need, and 1996 Minimum are existing components of the formula. The proposed addition of the Undisbursed IHBG funds factor is discussed below.

    D. Conversions of Units From Low-Rent FCAS to Mutual Help or From Mutual Help to Low-Rent FCAS (§ 1000.316)

    This proposed rule would clarify the type and eligibility of low-income dwelling units developed under the United States Housing Act of 1937 that are converted from Low-Rent to Mutual Help or, from Mutual Help to Low-Rent. The Committee proposed a new paragraph (c) to codify HUD's existing practice and establish the following. Units that were converted before NAHASDA's effective date of October 1, 1997, would count in the formula as the type of unit to which they were converted, and their FCAS eligibility would be evaluated on the basis of the type of unit to which they were converted. The amount of per unit FCAS funding for units that were converted after October 1, 1997, would be determined according to the unit's type specified in the original Annual Contributions Contract (ACC), i.e. the ACC in effect on September 30, 1997, while their FCAS eligibility would be evaluated on the basis of the type to which they were converted. Furthermore, the rule would require recipients to report conversions on their Formula Response Form. The Committee emphasized that the decision to convert a unit was a local decision for the tribe or TDHE (tribally designated housing entity) to make at its discretion.

    E. Mutual Help Unit Conveyance (§ 1000.318(a))

    This proposed rule would clarify in § 1000.318 the FCAS eligibility of Mutual Help and Turnkey III units developed under the United States Housing Act of 1937 that are not conveyed within 25 years from the Date of Full Availability (DOFA plus 25 years). The proposed rule would provide specific milestones for demonstrating FCAS eligibility. Specifically, the proposed rule would provide that a unit may continue to be considered FCAS when conveyance of the unit is prevented by a legal impediment, if the tribe, TDHE, or Indian Housing Authority (IHA) has taken all other steps necessary to effectuate the conveyance and has made and documented reasonable efforts to remove the impediment. Mutual Help and Turnkey III units that are eligible for conveyance under the terms of their Mutual Help and Occupancy Agreement (MHOA) but not conveyed would continue to be considered FCAS if the delay in conveyance is caused by reasons beyond the control of the tribe, TDHE, or IHA. Section 302(b)(1)(D) of NAHASDA (25 U.S.C. 4152(b)(1)(D)) provides that the term “reasons beyond the control of a recipient” means, after the recipient makes “reasonable efforts” to resolve all issues necessary for conveyance, the conveyance is still delayed because there remain delays in obtaining or, the absence of title status reports, incorrect or inadequate legal descriptions or other legal documentation necessary for conveyance, clouds on title due to probate or intestacy or other court proceedings, or any other legal impediment. Thus, under this proposed rule, to demonstrate reasonable efforts, the tribe, TDHE or IHA would be required, no later than four months after the unit becomes eligible for conveyance, to create a written plan of action that describes the impediment and the actions it will take to resolve the impediment within 24 months after the date the unit became eligible for conveyance. If the legal impediment remains after that 24-month period, the unit would no longer be considered FCAS unless the tribe, TDHE, or IHA provides evidence from a third party, such as a Federal, State, or tribal court, or State or Federal agency, documenting that the impediment continues to prevent conveyance. Proposed § 1000.318(a)(3) would address Mutual Help and Turnkey III units that, as of the effective date of this regulation, have not been conveyed because timely conveyance was demonstrably beyond the tribe's control. These units would be considered to have become eligible to convey on the effective date of this regulation, triggering the time periods for creating a written plan of action to resolve the impediment and conveying the units or providing the third party evidence of continued impediment within the 24-month period. Section 1000.318(a)(3)(iv) would apply to units that have not been conveyed due to legal impediments, and would not apply to units that are eligible for conveyance before the effective date of this regulation but have not been conveyed for other reasons.

    F. Demolition and Rebuilding of FCAS Units

    At the August 2014 meeting, the Committee approved revising § 1000.318 to add a new paragraph (d) to establish the eligibility criteria for FCAS units that are demolished and rebuilt. Under section 302(b)(1)(C) of NAHASDA, if a unit is demolished and the recipient rebuilds the unit within 1-year of demolition of the unit, the unit may continue to be considered an FCAS unit under the formula. To implement this requirement, the Committee approved a regulatory provision that would permit the unit to continue to be considered FCAS if the recipient certifies in writing, within one-year from the date that the unit becomes damaged or deteriorated, that it has taken tangible action to demolish and rebuild the unit. In addition, the provision would require that reconstruction of the unit be completed within four years of the point at which demolition or replacement became necessary. At the end of the four year period, the unit would no longer be considered FCAS unless the recipient notified HUD that the reconstruction of the unit has been completed. If a recipient fails to rebuild a unit within the four-year time frame, the unit would nonetheless have been considered eligible as FCAS during those four years. This provision was intended to incentivize the reconstruction of properties in a condition of such significant disrepair that they must be demolished and rebuilt in order to preserve critical housing stock and ensure that housing remains available to assist low-income Indian families in the future.

    Upon further review, HUD has determined that this provision may exceed the scope of section 302(b)(1)(C) of NAHASDA. The provision would have potentially allowed FCAS units that are rebuilt in a time period that exceeds 1-year from the time of demolition to remain FCAS units under the formula. While this proposed rule does not propose specific regulatory language addressing demolished FCAS units, HUD is seeking public comment on how to address this issue by regulation, while also remaining within the scope of section 302(b)(1)(C) of NAHASDA.

    In this regard, HUD notes that during this negotiated rulemaking, the FCAS workgroup considered defining the term “demolition” in order to help clarify the point in time in which the 1-year period begins to run. For instance, the workgroup discussed whether to define demolition in cases involving natural disasters or fires as occurring at the time of the event. The workgroup also considered whether demolition should be defined as occurring only when a recipient voluntarily demolishes units in order to clear a site for a new replacement unit. HUD is specifically soliciting public comment, therefore, on these and alternative proposals that address section 302(b)(1)(C). Once HUD receives all public comments on this proposed rule, it is HUD's intent to afford the Committee, based on the public comment received, another opportunity at the final negotiated rulemaking session to consider specific regulatory language addressing this issue to be included in a final rule.

    G. Overlapping Formula Areas (§ 1000.326)

    This proposed rule would revise § 1000.326(a) to provide in cases where a State recognized tribe's formula area overlaps with the formula area of a Federally recognized Indian tribe, that the Federally recognized Indian tribe would receive the allocation for the formula area up to its population cap. The revision also provides that the State recognized tribe would receive the balance of the allocation, if any exists, up to its own population cap.

    Section 1000.326 would also be revised to require that HUD follow the notice and comment procedures in the definition of “Formula Area” (§ 1000.302 (2)(ii)) upon receiving a request for expansion or redefinition of a tribe's formula area, if approving the request would create an overlap of formula areas with one or more other tribes. This proposed change is intended to ensure that tribes potentially affected by the request be notified and have the opportunity to comment on the request.

    H. Minimum Total Grant Allocation of Carryover Funds (§ 1000.329)

    Section 1000.329 is proposed as a new provision of the Need component of the IHBG formula. Section 1000.329 would provide for a minimum block grant allocation in the event that amounts available for allocation include carryover funds. This section would provide that allocations be adjusted to ensure all tribes a minimum block grant allocation of 0.011547 percent of that year's IHBG appropriation. HUD and the Committee estimated, based on current year appropriations, that approximately $3 million would be required to ensure that tribes receive a minimum allocation of approximately 0.011547 percent of the annual IHBG appropriation (close to $75,000, given historical appropriated amounts). Therefore, HUD would set aside an amount equal to the lesser of $3 million of available carryover funds or the entire amount of available carryover funds to increase allocations pursuant to this section. If set-aside carryover funds are insufficient to fund all eligible tribes at 0.011547 percent of that year's appropriations, the minimum total grant would be reduced to an amount which can be fully funded with the available set-aside carryover funds. Set-aside carryover funds that are not required to fund this additional allocation would be carried over to the subsequent year's formula. A tribe would be eligible for a minimum allocation under § 1000.329 if there are eligible households at or below 80 percent of median income in the tribe's formula area. For purposes of this proposed rule, “carryover funds” are defined as any grant funds voluntarily returned to the formula or not accepted by tribes in a fiscal year. The definition of carryover funds would not include any amounts that are returned to the IHBG formula voluntarily or involuntarily pursuant to § 1000.536, as a result of a HUD action under § 1000.532. The Committee considered and rejected including such amounts in the definition of carryover funds under this section.

    I. Volatility Control of Changes in Need Component of Formula Caused by Introduction of New Data Source (§ 1000.331)

    Section 1000.331 would be added to minimize and phase-in funding changes to allocations under the Need component of the formula resulting from the introduction of a new data source under § 1000.330, beginning in fiscal year 2018 (the first year that a new data source could be introduced). Under § 1000.331, if as a direct result of the introduction of a new data source, an Indian tribe's allocation under the Need component of the formula results in an allocation that is less than 90 percent of the amount it received under the Need component in the immediate previous fiscal year, the Indian tribe's Need allocation would be adjusted upward to an amount equal to 90 percent of the previous year's Need allocation. As proposed, this volatility control provision would not impact other adjustments under 24 CFR part 1000, including minimum funding, census challenges, formula area changes, or an increase in the total amount of funds available under the Need component. Section 1000.331 also proposes that in the event that HUD's IHBG appropriation is reduced and results in a decrease in the total amount of funds available under the Need component, an Indian tribe's adjusted allocation under § 1000.331(a) would be reduced by an amount proportionate to the reduced amount available for distribution under the Need component of the formula. Adjustments to the tribe's Need allocation under §§ 1000.331(b) or (c) would be made after adjustment of the tribe's allocation under § 1000.331(a).

    J. Data Challenges and Appeals of HUD Formula Determinations (§ 1000.336)

    This rule proposes to revise § 1000.336 to provide that an Indian tribe, TDHE, and HUD may challenge data used to determine the proposed undisbursed funds factor, § 1000.342. Specifically, this section would add the undisbursed funds factor to the list of IHBG formula data and HUD formula determinations that Indian tribes and TDHEs may appeal under the formula appeal procedures in § 1000.336. As the undisbursed funds factor is part of the formula for determining allocations, its application is not an enforcement action (under 24 CFR part 1000, subpart F).

    In addition, § 1000.336(d) would be revised to clarify the format and provide the timeframes by which the tribe or TDHE must submit its appeal of the undisbursed funds factor. As proposed, this section would provide that the appeal must be in writing and submitted to HUD no later than 30 days after the tribe's or TDHE's receipt of HUD's application of the undisbursed funds factor.

    This proposed rule also revises §§ 1000.336(e) and (f) for clarity. These revisions do not substantively amend these provisions.

    K. Undisbursed IHBG Funds Factor (§ 1000.342)

    The Committee proposed adding § 1000.342 to encourage tribes to timely expend their annual grants. Section 1000.342 would add an undisbursed funds factor to the IHBG formula. As proposed, the undisbursed funds factor would apply to Indian tribes whose initial allocation calculation is $5 million or more. A tribe's initial allocation calculation would include its FCAS, Need, the 1996 Minimum, and repayments or additions for past over- or under-funding for each Indian tribe (under 24 CFR part 1000, subpart D). Repayments or additions would not include repayments resulting from enforcement actions (24 CFR part 1000, subpart F).

    Section § 1000.342(a) proposes that an Indian tribe would be subject to the undisbursed funds factor if it has undisbursed IHBG funds in an amount that is greater than the sum of its prior 3 years initial allocation calculations. Under proposed § 1000.342(c), for purposes of this section, “undisbursed IHBG funds” means the amount of IHBG funds allocated to an Indian tribe in HUD's line of credit control system (or successor system) on October 1 of the fiscal year for which the allocation is made. To determine the amount of undisbursed IHBG funds of a tribe under an umbrella TDHE (a recipient that has been designated to receive grant amounts by more than one Indian tribe), § 1000.342(c) proposes that the TDHE's total balance in HUD's line of credit control system on October 1 of the fiscal year for which the allocation is made would be multiplied by a percentage based on the tribe's proportional share of the initial allocation calculation of all tribes under the umbrella. Under proposed § 1000.342(b), if subject to the undisbursed funds factor in a given fiscal year, the Indian tribe's grant allocation would be the greater of the initial allocation calculation minus the amount of undisbursed IHBG funds that exceed the sum of the prior 3 years' initial allocation calculations, or its 1996 Minimum. Section 1000.342(d) also proposes that amounts subtracted from an initial allocation calculation under this section would be redistributed under the Need component of the formula to Indian tribes not subject to this section.

    IV. Eighth Meeting of Negotiated Rulemaking Committee—Data Sources for the Need Variables (§ 1000.330)

    The eighth meeting of the Committee, which took place on January 26-27, 2016, was convened at the request of the Committee following HUD's issuance of a proposal on November 19, 2015, to resolve the data source issue. Specifically, HUD proposed the use of the ACS 5-year Estimates as the source of the data for the variables in paragraphs (a) through (f) of § 1000.324 and the most recent Decennial Census as the source for the total AIAN persons variable in § 1000.324(g). In each case, HUD proposed adjusting the data sources in order to address undercounts reported by the U.S. Census Bureau and the unique concerns resulting from conducting the ACS sample in Indian Country.

    In an effort to address the concerns of the Committee regarding this proposal, HUD scheduled the eighth meeting to discuss the use of these data sources, vote on adjustments to data sources and approve the final preamble language. HUD's proposal is discussed in more detail later in this preamble.

    Section 1000.330 describes the data source used for the Need variables in § 1000.324. Currently, § 1000.330 provides that the data sources for the Need variables “shall be data available that is collected in a uniform manner that can be confirmed and verified for all AIAN households and persons living in an identified area.” Current § 1000.330 also states that “[i]nitially, the data used are the U.S. Decennial Census data.” HUD originally codified § 1000.330 in 1998 3 and revised the section in 2007.4 Currently, HUD uses the 2000 Decennial Census as the data source for the Needs variables.

    3 63 FR 12334, March 12, 1998.

    4 72 FR 20018, April 20, 2007.

    Beginning in 2010, the U.S. Census Bureau discontinued use of the “long form” that, along with the short-form census questionnaire, went to a sample of households. The “long form” contained additional questions and provided more detailed socioeconomic information about the population. As part of this change, the more detailed socioeconomic information once collected by the long-form questionnaire is now collected by the ACS. The ACS potentially provides more current data regarding communities and is sent to a sample of the population on a rotating basis throughout the decade.

    One impact of the discontinuation of the use of the “long form” is that data for six of the seven variables in § 1000.324 are no longer collected by the Decennial Census. During the course of this negotiated rulemaking the Committee extensively discussed revising § 1000.330 to use more current data sources, including the ACS, that might be used to determine Need under the formula. Because of the complexity of the issue, the Committee agreed by consensus to a procedure to identify and evaluate alternate data sources. Specifically, at the sixth negotiated rulemaking meeting in August 2014, the Committee agreed to provide itself with an additional year to study the issue by delaying implementation of any new data source until fiscal year 2018. At the same time, the Committee agreed to form the Data Study Group that would seek to identify and evaluate potential data sources that could replace the 2000 Decennial Census. The Committee provided that the Data Study Group would report its findings and recommendations by the seventh negotiated rulemaking scheduled for August 2015. The Committee also agreed that absent a consensus decision by the Committee regarding a new data source, HUD would make a final decision on a new data source that would be introduced starting in fiscal year 2018. The data source would be data collected in a uniform manner that can be confirmed and verified for all AIAN household and persons living in an identified area. Initially, the data used would be the most recent data available from the U.S. Census Bureau.

    As discussed in this preamble, the Data Study Group conducted an extensive review of several potential data sources and reported the results of its work and its recommendations at the seventh negotiated rulemaking session. The Committee did not accept the recommendations of the Data Study Group and did not come to a consensus on a new data source. This inability to reach consensus was based in part on a concern expressed by several Committee members that the 2010 Decennial Census undercounted AIAN persons in some tribal areas and that the ACS suffered from similar inaccuracies.

    Throughout the negotiated rulemaking process, HUD's Committee representatives made it known that while HUD was open to the results of the Data Study Group and worked toward reaching consensus on the data source, HUD considered the ACS as providing an up-to-date, reliable, comprehensive and accurate data source available for the variables in § 1000.324. In this regard, HUD made clear that the ACS were data “collected in a uniform manner that can be confirmed and verified for all AIAN households and persons living in an identified area.” HUD also made it known that the 2010 Decennial Census also met these standards for the count of AIAN persons variable in § 1000.324(g). Accordingly, and consistent with the Committee's consensus decision to establish the Need study group, this rule proposes to use the ACS 5-Year Estimates as the source of the data for the variables in paragraphs (a) through (f) of § 1000.324, and the most recent Decennial Census as the source for the total AIAN person variable in § 1000.324(g). HUD believes that the use of these sources more accurately reflect Indian Country given the substantial changes that have taken place since 2000.

    Notwithstanding, HUD recognized that the Data Study Group found evidence to support the concerns of a number of tribes that the 2010 Decennial Census has a significant undercount in some tribal areas and that the ACS suffers from a similar inaccuracy. HUD has further researched these concerns and identified three adjustments that mitigate these problems. These adjustments were the focus of eighth meeting of the Committee, which took place on January 26-27, 2016.

    Undercount on reservations. After each Decennial Census, the U.S. Census Bureau conducts a follow-up survey to determine the extent that the Decennial Census under- or over-counted particular subgroups within the U.S. population. To address any undercount in the formula, HUD proposed in § 1000.330(b)(i) to increase the count of AIAN persons (single race; and single and multi-race) for all geographies identified in the most recent Decennial Census as having a statistically significant undercount confirmed by the U.S. Census Bureau. The U.S. Census Bureau determined in its post-Census 2010 enumeration that there was a statistically significant 4.88 percent undercount of AIAN persons living in Reservations and Trust Lands, including restricted fee land acquired under the Treaty of Guadalupe Hidalgo, but not in other tribal areas.5 As proposed, this adjusted total would serve as the basis to determine the total AIAN person factor at § 1000.324(g) until the next Decennial Census is released. If a statistically significant undercount occurs in the next Decennial Census, the AIAN person count for § 1000.324(g) would be adjusted based on the amount of that undercount.

    5 See, https://www.census.gov/coverage_measurement/pdfs/g04.pdf. The U.S. Census Bureau also found a not statistically significant overcount of 3.86 percent for tribal areas off reservation (this including Oklahoma Tribal Statistical Area, Tribal Designated Statistical Area and the Alaska Native Village Statistical Area). HUD is not proposing that these tribal areas be adjusted down for the overcount because the overcount was not statistically significant.

    The eighth meeting of the Committee, considered this adjustment, and after consideration, voted on the adjustment. The Committee proposed to modify the language to clarify that the count would be adjusted for a statistically significant undercount specifically for the AIAN population count. After this language was changed, the Committee reached consensus on this adjustment. In addition, the Committee considered a proposal to consider Indian Lands in Remote Alaska the same as Reservation and Trust Lands when it is determined that there has been a statistically significant undercount in Reservation and Trust Lands, unless the U.S. Census has included Remote Alaska in its coverage. This provision was proposed in order to address the fact that the U.S. Census Bureau's Census Coverage Measurement (CCM) Study did not include Indian Lands in Remote Alaska. The term “Remote Alaska” means Type of Enumeration Area as delineated by the U.S. Census Bureau for the 2010 Decennial Census. With the addition of this provision to § 1000.330(b)(i), the Committee reached consensus on this item.

    Control total weights within the ACS. A critical component of any sample survey is to accurately weight completed surveys to reflect the full population the sample is drawn from. HUD recognizes that the weighting methodology used by the U.S. Census Bureau for ACS differs from what it used for the long-form data from the 2000 Census. For the 2000 Census long-form, the U.S. Census set the control totals at small geographies—places, tribal areas, Census Tracts, etc. As a result, a sample set of data for subgroup populations—such as a count of Native Americans in a tribal area—were generally very close to the count of those same variables from the short-form of the Decennial Census.

    The U.S. Census Bureau adopted a different approach for the ACS, setting population control total weights at the county and place levels that have population estimates. That is, they are set at a higher level geography, mostly county and incorporated places, and not tribal areas. The ACS has adopted this approach because it establishes weights for all variables according to annual population estimates that are only available at these higher level geographies.

    This change in methodology for setting control total weights can create a problem for the IHBG formula data for tribes. Without a small geography control total for the weights, the ACS can produce a population count for a subgroup in a small geography that is much different than the Decennial Census count for the same population.

    To address this issue, HUD proposed in § 1000.330(b)(ii) to adjust the ACS data for the variables described in paragraphs (a) through (f) of § 1000.324 by the ratio of the adjusted total of AIAN persons based on the aged 2010 Decennial Census to the most recently available ACS count of AIAN persons as adjusted by § 1000.330(b)(i). HUD believes that this adjustment would make the ACS data methodology for small area geographic areas better align with the methodology used in the 2000 Decennial Census and provide a more accurate count of AIAN persons for smaller tribes. Some tribal members of the Committee did not agree.

    During the eighth meeting of the Committee, the Committee considered this adjustment, and after consideration, voted on the adjustment. The Committee did not reach consensus on the vote for this adjustment. The majority of tribal Committee members did not support this adjustment. While some members supported this adjustment, the majority of tribal Committee members expressed concern with this proposal. Some members opposed the use of ACS as the data source for the formula and therefore voted against the adjustment. Other members supported the use of ACS data but believed that reweighting the data as proposed by HUD was not appropriate for other reasons. Specifically, some tribal Committee members believed that the undercount of one variable, AIAN persons, could not be properly assumed to translate to other variables. Notwithstanding, this rule proposes to adjust the ACS data for the variables described in paragraph (a) through (f) of § 1000.324 by the ratio of the adjusted total of AIAN persons based on the aged 2010 Decennial Census to the most recently available ACS count of AIAN persons as adjusted by § 1000.330(b)(i).

    Aging of the Data. In addition to the adjustments to the 2010 Decennial Census and ACS data described in this preamble, HUD proposed revising the method of aging the data. Specifically, based on the work of the Data Study Group, HUD in § 1000.330(b)(i) proposed, beginning in fiscal year 2018, to age the data using the U.S. Census Bureau county level Population Estimates for Native Americans. In proposing this change, HUD notes that the Data Study Group determined that the Indian Health Service (IHS) projections based on birth and death rate, which is currently used to age the data, do not take into account migration and may result in both under and over estimates of population growth over time. While not perfect, the U.S. Census Bureau county level Population Estimates take into account migration and provide a more accurate count of AIAN persons. These Population Estimates do not come from the ACS. As a result, § 1000.330(b)(i) would state that the data source used to determine the AIAN person variable in § 1000.324(g) would be updated annually using the U.S. Census Bureau county level Population Estimates for Native Americans.

    During the eighth meeting of the Committee, the Committee considered this adjustment, and after consideration, voted on the adjustment. The Committee reached consensus on this adjustment.

    Transition Period in Fiscal Years 2016 and 2017. As agreed by the Committee by consensus, this proposed rule would delay implementation of these changes until fiscal year 2018. In this regard, § 1000.330(a) of this rule proposes to maintain the status quo during this period by providing that the data used to determine the Need variables would be the 2000 U.S. Decennial Census and any HUD-accepted Census challenges until fiscal year 2018. This section would also provide that this data would continue to be aged using IHS birth and death records. HUD believes that delaying the use of new data sources will help ensure that tribes do not encounter instability or lack of predictability for their grants when the rule takes effect. For this reason, HUD agreed to this delay.

    Challenge Data. This proposed rule continues to maintain the right of Indian tribes to challenge the data described in this section pursuant to § 1000.336. Specifically, this proposed rule would redesignate currently codified § 1000.330(d) as § 1000.330(c) making minor, technical edits to ensure accuracy of the cross-reference.

    V. Tribal Comments

    After HUD's issuance of a proposal on November 19, 2015, and prior to the eighth meeting of Committee, HUD invited the tribal members of the Committee to submit comments on its proposal and on the preamble section describing its proposal. The comment period lasted from November 23, 2015, to December 23, 2015. HUD received comments from six Committee members during this time frame.

    Several Committee members expressed support for the use of aged 2010 Decennial Census data for the AIAN population count. Those same commenters supported the use of ACS data for the remaining six Need variables.

    Other commenters expressed dissatisfaction with the compensation of any undercounts and the use of a weighting adjustment for any undercounts. All of these tribal Committee members opined that HUD improperly made these unanticipated adjustments without consulting the Committee or allowing the Committee sufficient time to review. Some commenters noted that such adjustments are unnecessary since the Study Group found that improvements to the ACS data will be fully implemented upon the release of the 2012-2016 ACS data set. One commenter stated that if the Decennial Census and ACS were used as data sources, a generalized adjustment based on a 4.88 percent undercount would be insufficient in some areas and disproportionately beneficial in others. Another commenter pointed out that the use of the ACS as proposed in the rule will unfairly and significantly harm villages in rural Alaska. According to the commenter, these populations are substantially undercounted, but HUD is not applying a weighting adjustment to rural Alaska because the exact amount of the undercount is unknown.

    One commenter expressed support for developing and using a federally- or tribally-administered national tribal survey to collect information concerning enrollment in a recognized tribe, in lieu of the Decennial Census or the ACS.

    VI. Other Nonconsensus Items and Issues for Consideration A. Current Assisted Stock Cost Adjustment Factor

    In response to a discussion of the Allowable Expense Level adjustment factor in § 1000.320 during the 2005 IHBG Negotiated Rulemaking Session, HUD commissioned a study to assess the cost of operating 1937 Act housing programs across Indian Country and Alaska. The Indian Housing Operating Cost Study 6 examined the potential for using, among other sources, data from the U.S. Department of Agriculture's 515 program to determine how to weight the operating costs for different tribes. The USDA 515 data is derived from Section 515 units, which are affordable rental housing units in rural areas for very low-, low-, and moderate-income families; the elderly; and persons with disabilities. Because the data set includes operating expense data for projects in some rural counties that serve low- and very low-income households, it could be used to estimate costs in some tribes' formula area counties.

    6 This study investigated the costs of operating 1937 Act housing programs in Indian Country and Alaska and determined the efficacy of the Allowable Expense Level factor in ascertaining these costs. For more information, the study can be found at: http://ihbgrulemaking.firstpic.org/images/Library/ihoc_report_final%20423.pdf.

    During the seventh Negotiated Rulemaking Session, the FCAS Working Group considered whether USDA 515 data could be used as an additional cost adjustment factor under § 1000.320. The Committee requested the USDA 515 data and requested that HUD calculate block grant allocations to all tribes under two scenarios: (1) Using a local area cost adjustment factor that is the greater of Fair Market Rents (FMR), Allowable Expense Level (AEL), and USDA 515 factors for each tribe, and (2) using a factor that is the greater of the FMR and USDA 515 factors. Ultimately, the Committee considered a proposal to revise § 1000.320 to use a local area cost adjustment factor that is the greater of FMR, AEL, and USDA 515 factors for each tribe. After discussion of the proposal, the Committee was unable to reach consensus on how to modify the Current Assisted Stock local cost adjustment in § 1000.320. Several Committee members raised concerns that the USDA 515 rural housing rental program did not provide cost data for some locations and others felt that insufficient data was available to determine how the addition of this factor would affect tribes nationwide.

    B. Revise the Definition of AIAN

    Although the Data Study Group did not reach consensus on the issue, it recommended that the Committee discuss whether or not to exclude South, Central, and Canadian AIAN persons from the data provided by the Decennial Census and the ACS for purposes of the IHBG formula. The study group made this recommendation after some study group members expressed concern that the IHBG is intended to serve only AIAN persons with a tribal affiliation in the United States. Because individuals having their origins in the indigenous peoples of Central America, South America, and Canada may or may not fall within the category of persons eligible to be served through the IHBG program, the study group referred the matter to the full Committee for consideration. The Committee discussed this issue as recommended, considered language drafted by the Drafting Committee, however the full Committee did not take the language up for a formal vote due to the withdrawal of the language.

    VII. Question for Commenters

    HUD understands that other organizations, including State and local governments or nonprofits, may use certain factors or data from the IHBG formula to inform their own work with Indian tribes. HUD requests public comment on what factors or data are used by these organizations and how the changes proposed to the IHBG formula would impact the work done by such organizations.

    VIII. Tribal Recommendation

    Non-HUD members of the Committee recommend HUD establish a joint task force that includes tribal and HUD representatives to develop a methodology to collect operating cost data from IHBG recipients in a consistent and accurate manner that could be used to adjust for local operating costs in the adjustment to the operating subsidy under the current assisted stock portion of the formula (i.e. replace the current factors under section 1000.320(a)). Non-HUD members recommend that resources other than IHBG funds be made available to fund technical experts and task force members and other costs that may be identified.

    The Committee notes that for a variety of reasons, the Committee did not accommodate the examination of the Needs variables.

    IX. Findings and Certifications Regulatory Review—Executive Orders 12866 and 13563

    Under Executive Order 12866 (Regulatory Planning and Review), a determination must be made whether a regulatory action is significant and, therefore, subject to review by the Office of Management and Budget (OMB) in accordance with the requirements of the order. Executive Order 13563 (Improving Regulations and Regulatory Review) directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.” Executive Order 13563 also directs that, where relevant, feasible, and consistent with regulatory objectives, and to the extent permitted by law, agencies are to identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public. This proposed rule was determined to be a “significant regulatory action” as defined in section 3(f) of Executive Order 12866. The docket file is available for public inspection in the Regulations Division, Office of General Counsel, 451 7th Street, SW., Room 10276, Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, an advance appointment to review the public comments must be scheduled by calling the Regulations Division at 202 402-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service, toll free, at 1-800-877-8339.

    Paperwork Reduction Act

    The information collection requirements contained in this rule have been submitted to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). In accordance with the Paperwork Reduction Act, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection displays a currently valid OMB control number.

    The burden of the information collections in this proposed rule is estimated as follows:

    Reporting and Recordkeeping Burden: I Section reference Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Estimated
  • average time for
  • requirement
  • (in hours)
  • Estimated
  • annual burden
  • (in hours)
  • § 1000.316 226 1 0.2 45.2 § 1000.318 212 1 0.5 106 § 1000.336 10 1 4 40 Total Burden 191.2
    In accordance with 5 CFR 1320.8(d)(1), HUD is soliciting comments from members of the public and affected agencies concerning this collection of information 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 estimate of the burden of the proposed collection of information;

    (3) Enhance the quality, utility, and clarity of the information to be collected; and

    (4) 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.

    Interested persons are invited to submit comments regarding the information collection requirements in this rule. Comments must refer to the proposal by name and docket number (FR-5650) and must be sent to:

    HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503, Fax: (202) 395-6947, and Reports Liaison Officer, Office of Public and Indian Housing, Department of Housing and Urban Development, Room 451, 7th Street SW., Washington, DC 20410 Interested persons may submit comments regarding the information collection requirements electronically through the Federal eRulemaking Portal at http://www.regulations.gov. HUD strongly encourages commenters to submit comments electronically. Electronic submission of comments allows the commenter maximum time to prepare and submit a comment, ensures timely receipt by HUD, and enables HUD to make them immediately available to the public. Comments submitted electronically through the http://www.regulations.gov Web site can be viewed by other commenters and interested members of the public. Commenters should follow the instructions provided on that site to submit comments electronically. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) generally requires an agency to conduct a regulatory flexibility analysis for any rule that is subject to notice and comment rulemaking requirements, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The requirements of this rule apply to Indian tribal governments and their tribal housing authorities. Tribal governments and their tribal housing authorities are not covered by the definition of “small entities” under the RFA. Accordingly, the undersigned certifies that this rule will not have a significant impact on a substantial number of small entities.

    Notwithstanding HUD's view that this rule will not have a significant effect on a substantial number of small entities, HUD specifically invites comments regarding any less burdensome alternatives to this rule that will meet HUD's objectives as described in this preamble.

    Executive Order 13132, Federalism

    Executive Order 13132 (entitled “Federalism”) prohibits, to the extent practicable and permitted by law, an agency from promulgating a regulation that has federalism implications and either imposes substantial direct compliance costs on state and local governments and is not required by statute, or preempts state law, unless the relevant requirements of section 6 of the Executive Order are met. This rule does not have federalism implications and does not impose substantial direct compliance costs on state and local governments or preempt state law within the meaning of the Executive Order.

    Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments, and on the private sector. This rule will not impose any federal mandate on any state, local, or tribal government, or on the private sector, within the meaning of UMRA.

    Environmental Review

    A Finding of No Significant Impact (FONSI) with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The Finding of No Significant Impact is available for public inspection between the hours of 8 a.m. and 5 p.m. weekdays in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the FONSI by calling the Regulations Division at 202-708-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service, toll free, at 1-800-877-8339.

    Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance Number (CFDA) for Indian Housing Block Grants is 14.867, and the CFDA for Title VI Federal Guarantees for Financing Tribal Housing Activities is 14.869.

    List of Subjects in 24 CFR Part 1000

    Aged, Community development block grants, Grant programs—housing and community development, Grant programs—Indians, Indians, Individuals with disabilities, Public housing, Reporting and recordkeeping requirements.

    Accordingly, for the reasons described in the preamble, HUD proposes to amend 24 CFR part 1000 as follows:

    PART 1000—NATIVE AMERICAN HOUSING ACTIVITIES 1. The authority citation for 24 CFR part 1000 continues to read as follows: Authority:

    25 U.S.C. 4101 et seq.; 42 U.S.C. 3535(d).

    2. In § 1000.302, revise paragraph (2)(i) of the definition of “Formula area” to read as follows:
    § 1000.302 What are the definitions applicable for the IHBG formula?

    Formula area. * * *

    (2) * * *

    (i) For a geographic area not identified in paragraph (1) of this definition, and for expansion or re-definition of a geographic area from the prior year, including those identified in paragraph (1) of this definition, the Indian tribe must submit, on a form agreed to by HUD, information about the geographic area it wishes to include in its Formula Area, including proof that the Indian tribe, where applicable, has agreed to provide housing services pursuant to a Memorandum of Agreement (MOA) with the tribal and public governing entity or entities of the area, or has attempted to establish such an MOA, and is providing substantial housing services and will continue to expend or obligate funds for substantial housing services, as reflected in its Indian Housing Plan and Annual Performance Report for this purpose.

    3. Revise § 1000.306 to read as follows:
    § 1000.306 How can the IHBG formula be modified?

    (a) The IHBG formula can be modified upon development of a set of measurable and verifiable data directly related to Indian and Alaska Native housing need. Any data set developed shall be compiled with the consultation and involvement of Indian tribes and examined and/or implemented not later than 5 years from the date of issuance of these regulations and periodically thereafter.

    (b) The IHBG formula shall be reviewed not later than May 21, 2012, to determine if a subsidy is needed to operate and maintain NAHASDA units or if any other changes are needed in respect to funding under the Formula Current Assisted Stock component of the formula.

    4. Revise § 1000.310 to read as follows:
    § 1000.310 What are the components of the IHBG formula?

    The IHBG formula consists of four components:

    (a) Formula Current Assisted Stock (FCAS) (§ 1000.316);

    (b) Need (§ 1000.324);

    (c) 1996 Minimum (§ 1000.340); and

    (d) Undisbursed IHBG funds factor (§ 1000.342).

    5. In § 1000.316 add paragraph (c) to read as follows:
    § 1000.316 How is the Formula Current Assisted Stock (FCAS) Component developed?

    (c) Conversion. Conversion of FCAS units from homeownership (Mutual Help or Turnkey III) to low-rent or from low-rent to a home ownership program.

    (1) If units were converted before October 1, 1997, as evidenced by an amended ACC, then those units will be counted for formula funding and eligibility purposes as the type of unit to which they were converted.

    (2) If units were converted on or after October 1, 1997, the following applies:

    (i) Funding type. Units that converted after October 1, 1997 will be funded as the type of unit specified on the original ACC in effect on September 30, 1997.

    (ii) Continued FCAS eligibility. Whether or not it is the first conversion, a unit converted after October 1, 1997, will be considered as the type converted to when determining continuing FCAS eligibility. A unit that is converted to low-rent will be treated as a low-rent unit for purposes of determining continuing FCAS eligibility. A unit that is converted to homeownership will be treated as a homeownership unit for purposes of determining continuing FCAS eligibility.

    (3) The Indian tribe, TDHE, or IHA shall report conversions on the Formula Response Form.

    6. Revise § 1000.318 by adding paragraph (a)(3) to read as follows:
    § 1000.318 When do units under Formula Current Assisted Stock cease to be counted or expire from the inventory use for the formula?

    (a) * * *

    (3) A Mutual Help or Turnkey III unit not conveyed after the unit becomes eligible for conveyance by the terms of the MHOA may continue to be considered Formula Current Assisted Stock only if a legal impediment prevented conveyance; the legal impediment continues to exist; the tribe, TDHE, or IHA has taken all other steps necessary for conveyance and all that remains for conveyance is a resolution of the legal impediment; and the tribe, TDHE, or IHA made the following reasonable efforts to overcome the impediments:

    (i) No later than four months after the unit becomes eligible for conveyance, the tribe, TDHE, or IHA creates a written plan of action, which includes a description of specific legal impediments as well as specific, ongoing, and appropriate actions for each applicable unit that have been taken and will be taken to resolve the legal impediments within a 24-month period; and

    (ii) The tribe, TDHE, or IHA has carried out or is carrying out the written plan of action; and

    (iii) The tribe, TDHE, or IHA has documented undertaking the plan of action.

    (iv) No Mutual Help or Turnkey III unit will be considered FCAS 24 months after the date the unit became eligible for conveyance, unless the tribe, TDHE, or IHA provides evidence from a third party, such as a court or state or federal government agency, documenting that a legal impediment continues to prevent conveyance. FCAS units that have not been conveyed due to legal impediments on [effective date of this regulation] shall be treated as having become eligible for conveyance on [effective date of this regulation].

    7. In § 1000.326 revise paragraph (a)(3), redesignate paragraph (c) as paragraph (d) and add a new paragraph (c), to read as follows:
    § 1000.326 What if a formula area is served by more than one Indian tribe?

    (a) * * *

    (3) In cases where a State recognized tribe's formula area overlaps with the formula area of a Federally recognized Indian tribe, the Federally recognized Indian tribe receives the allocation for the formula area up to its population cap, and the State recognized tribe receives the balance of the overlapping area (if any) up to its population cap.

    (c) Upon receiving a request for expansion or redefinition of a tribe's formula area, if approving the request would create an overlap, HUD shall follow the notice and comment procedures set forth in paragraph (2)(ii) of the definition of “Formula area” in § 1000.302.

    8. Add § 1000.329 to read as follows:
    § 1000.329 What is the minimum total grant allocated to a tribe if there is carryover funds available?

    (a) If in any given year there are carryover funds, then HUD will hold the lesser amount of $3 million or available carryover funds for additional allocations to tribes with grant allocations of less than 0.011547 percent of that year's appropriations. All tribes eligible under this section shall receive a grant allocation equal to 0.011547 percent of that year's appropriations.

    (b)(1) If the set-aside carryover funds are insufficient to fund all eligible tribes at 0.011547 percent of that year's appropriations, the minimum total grant shall be reduced to an amount which can be fully funded with the available set-aside carryover funds.

    (2) If less than $3 million is necessary to fully fund tribes under paragraph (a) of this section, any remaining carryover amounts of the set aside shall be carried forward to the next year's formula.

    (c) Certify in its Indian Housing Plan the presence of any eligible households at or below 80 percent of median income;

    (d) For purposes of this section, carryover funds means grant funds voluntarily returned to the formula or not accepted by tribes in a fiscal year.

    9. Revise § 1000.330 to read as follows:
    § 1000.330 What are the data sources for the need variables?

    (a) The sources of data for the Need variables shall be data that are available and collected in a uniform manner that can be confirmed and verified for all AIAN households and persons living in an identified area. Until fiscal year 2018, the data used are 2000 U.S. Decennial Census data and any HUD-accepted Census challenges. The 2000 U.S. Decennial Census data shall be adjusted annually using IHS projections based upon birth and death rate data provided by the National Center for Health Statistics.

    (b)(i) Beginning fiscal year 2018, the data source used to determine the AIAN persons variable described in § 1000.324(g) shall be the most recent U.S. Decennial Census data adjusted for any statistically significant undercount for AIAN population confirmed by the U.S. Census Bureau and updated annually using the U.S. Census Bureau county level Population Estimates for Native Americans. For purposes of this paragraph, Indian Lands in Remote Alaska shall be treated as Reservation and Trust Lands, unless the U.S. Census Bureau includes Remote Alaska in their Census Coverage Measurement or comparable study. The data under this paragraph shall be updated annually using the U.S. Census Bureau county level Population Estimates for Native Americans.

    (ii) Beginning fiscal year 2018, the data source used to determine the variables described in paragraphs (a) through (f) of § 1000.324 shall initially be the American Community Survey (ACS) 5-year Estimates adjusted by the ratio of the count of AIAN persons as provided by paragraph (b)(i) of this section to the ACS count of AIAN persons.

    (c) Indian tribes may challenge the data described in this section pursuant to § 1000.336.

    10. Add § 1000.331 to read as follows:
    § 1000.331 How will the impacts from adoption of a new data source be minimized as the new data source is implemented?

    (a) To minimize the impact of funding changes based on the introduction of a new data source under § 1000.330, in fiscal year 2018 and each year thereafter, if, solely as a direct result of the introduction of a new data source, an Indian tribe's allocation under the Need component of the formula is less than 90 percent of the amount it received under the Need component in the immediate previous fiscal year, the Indian tribe's Need allocation shall be adjusted up to an amount equal to 90 percent of the previous year's Need allocation.

    (b) Nothing in this section shall impact other adjustments under this part, including minimum funding, census challenges, formula area changes, or an increase in the total amount of funds available under the Need component.

    (c) In the event of a decrease in the total amount of funds available under the Need component, an Indian tribe's adjusted allocation under paragraph (a) of this section shall be reduced by an amount proportionate to the reduced amount available for distribution under the Need component of the formula.

    (d) Adjustments under paragraph (b) or (c) of this section shall be made to a tribe's Need allocation after adjusting that allocation under paragraph (a) of this section.

    11. Revise § 1000.336 as follows: a. In paragraph (a)(6) remove “and”; b. In paragraph (a)(7) remove the period and add in its place “and;” c. Add paragraph (a)(8); d. Revise paragraphs (d), (e), and (f).
    § 1000.336 How may an Indian tribe, TDHE, or HUD challenge data or appeal HUD formula determinations?

    (a) * * *

    (8) The undisbursed funds factor.

    (d) An Indian tribe or TDHE that seeks to appeal data or a HUD formula determination, and has data in its possession that are acceptable to HUD, shall submit the challenge or appeal in writing with data and proper documentation to HUD. An Indian tribe or TDHE may appeal the undisbursed funds factor no later than 30 days after the receipt of the formula determination. Data used to challenge data contained in the U.S. Census must meet the requirements described in § 1000.330(a). Further, in order for a census challenge to be considered for the upcoming fiscal year allocation, documentation must be submitted by March 30th.

    (e) HUD shall respond to all challenges or appeals no later than 45 days after receipt and either approve or deny the appeal in writing, setting forth the reasons for its decision.

    (1) If HUD challenges the validity of the submitted data HUD and the Indian tribe or TDHE shall attempt in good faith to resolve any discrepancies so that such data may be included in the formula allocation.

    (2) If HUD denies a challenge or appeal, the Indian tribe or TDHE may request reconsideration of HUD's denial within 30 calendar days of receipt of HUD's denial. The request shall be in writing and set forth justification for reconsideration.

    (3) HUD shall in writing affirm or deny the Indian tribe's or TDHE's request for reconsideration, setting forth HUD's reasons for the decision, within 20 calendar days of receiving the request. HUD's denial of a request for reconsideration shall constitute final agency action.

    (4) If HUD approves the Indian tribe or TDHE's appeal, HUD will adjust to the Indian tribe's or TDHE's subsequent fiscal year allocation to include only the disputed fiscal year(s).

    (f) In the event HUD questions whether the data contained in the formula accurately represents the Indian tribe's need, HUD shall request the Indian tribe to submit supporting documentation to justify the data and, if applicable, to provide a commitment to serve the population indicated in the geographic area.

    12. Add § 1000.342 to subpart D to read as follows:
    § 1000.342 Are undisbursed IHBG funds a factor in the grant formula?

    Yes, beginning fiscal year 2018. After calculating the initial allocation calculation for the current fiscal year by calculating FCAS, Need, the 1996 Minimum, and repayments or additions for past over- or under-funding for each Indian tribe, the undisbursed funds factor shall be applied as follows:

    (a) The undisbursed funds factor applies if an Indian tribe's initial allocation calculation is $5 million or more and the Indian tribe has undisbursed IHBG funds in an amount that is greater than the sum of the prior 3 years' initial allocation calculations.

    (b) If subject to paragraph (a) of this section, the Indian tribe's grant allocation shall be the greater of the initial allocation calculation minus the amount of undisbursed IHBG funds that exceed the sum of the prior 3 years' initial allocation calculations, or its 1996 Minimum.

    (c) For purposes of this section, “undisbursed IHBG funds” means the amount of IHBG funds allocated to an Indian tribe in HUD's line of credit control system (or successor system) on October 1 of the fiscal year for which the allocation is made. For Indian tribes under an umbrella TDHE (a recipient that has been designated to receive grant amounts by more than one Indian tribe), if the Indian tribe's initial allocation calculation is $5 million or more, its undisbursed IHBG funds is the amount calculated by multiplying the umbrella TDHE's total balance in HUD's line of credit control system (or successor system) on October 1 of the fiscal year for which the allocation is made by a percentage based on the Indian tribe's proportional share of the initial allocation calculation of all tribes under the umbrella.

    (d) Amounts subtracted from an initial allocation calculation under this section shall be redistributed under the Need component among all Indian tribes not subject to paragraph (a) of this section (while also retaining the 1996 Minimum).

    Dated: May 4, 2016. Lourdes Castro Ramirez, Principal Deputy Assistant Secretary for Public and Indian Housing.
    [FR Doc. 2016-12596 Filed 5-27-16; 8:45 am] BILLING CODE 4210-67-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 25 [IB Docket No. 12-267; DA 16-367] Comment Sought on Implementation of Transmitter Identification Requirements for Video Uplink Transmissions AGENCY:

    Federal Communications Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Federal Communications Commission (Commission) seeks comment on the appropriate schedule for implementing carrier identification requirements for digital video uplink transmissions, which were adopted by the Commission in August 2013.

    DATES:

    Submit comments on or before June 30, 2016, and replies on or before July 15, 2016.

    ADDRESSES:

    You may submit comments, identifying IB Docket No. 12-267, by any of the following means:

    Federal Communications Commission's Web site: http://apps.fcc.gov/ecfs. Follow the instructions for submitting comments.

    People with Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email: [email protected] or phone: 202-418-0530 or TTY: 202- 418-0432.

    For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Clay DeCell, 202-418-0803.

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's document, DA 16-367, released April 6, 2016. The full text of this document is available at https://apps.fcc.gov/edocs_public/attachmatch/DA-16-367A1.pdf. It is also available for inspection and copying during business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. To request materials in accessible formats for people with disabilities, send an email to [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

    Synopsis

    By this Public Notice, we seek comment on the appropriate schedule for implementing carrier identification requirements for digital video uplink transmissions, as adopted by the Commission in August 2013.

    Background. Since 1991, the Commission has required satellite uplink transmissions carrying “broadband” video information to include a signal identifying the source of the transmission. This signal, produced by an Automatic Transmitter Identification System (ATIS), allows satellite operators that may be receiving interference from the video transmission to more quickly identify and address the source of interference.

    In August 2013, the Commission updated the ATIS requirement in 47 CFR 25.281 to better accommodate digitally modulated video transmissions. Comprehensive Review of Licensing and Operating Rules for Satellite Services, Report and Order, FCC 13-111, 28 FCC Rcd 12403, 12466-70, paras. 208-220 (2013). Specifically, for digital video uplinks from temporary-fixed earth stations, the Commission replaced the requirement to transmit a 7.1 megahertz subcarrier signal with a requirement to include a spread-spectrum ATIS message conforming to a modern industry standard.

    The record in the 2013 proceeding indicated that the new ATIS requirement for digital video could be accommodated by replacing the equipment with new facilities incorporating an embedded modulator or upgrading existing earth station equipment with an external modulator. Based on this record, the Commission adopted a two-year grace period for operators to bring their equipment into compliance with the new ATIS rule in 47 CFR 25.281(b). The Commission concluded that two years was a sufficient implementation period, and declined a proposed five-year phase-in schedule, because it was not requiring the ATIS to be embedded and therefore not requiring existing facilities to be replaced.

    Recent information from affected earth station operators, and independent staff market surveillance, indicate that suitable external modulators have not become widely available. Many earth station operators would therefore be unable to retro-fit their current transmitting equipment in order to comply with 47 CFR 25.281(b), and instead would need to replace the equipment at considerably greater expense than anticipated when the rule was adopted.

    Temporary Waiver Order. On March 4, 2016, we issued a waiver of 47 CFR 25.281(b) for a period of one year, beginning on September 3, 2016, the date for compliance with the new requirement. Temporary Waiver of Section 25.281(b) Transmitter Identification Requirements for Video Uplink Transmissions, Order, DA 16-222 (IB 2016). The waiver was adopted to allow additional time for comment and development of an updated record on the appropriate implementation schedule for the new ATIS requirement.

    Comment Sought. We now seek comment on the appropriate timeframe for implementation of the carrier identification requirement for digital video transmissions. In particular, we invite comment on the costs to both earth station operators and space station operators of further delaying the effective date of the requirement. We specifically request that commenters provide supporting materials such as technical documentation and price quotations for equipment compliant with the carrier identification requirement. We note that the World Broadcasting Unions have resolved that the ATIS (Carrier ID) requirement be implemented by no later than January 1, 2018.

    Interested parties may file comments and reply comments in IB Docket No. 12-267 on or before the dates indicated in the DATES section of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

    Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS: http://apps.fcc.gov/ecfs/.

    Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.

    Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

    • All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.

    • Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.

    • U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington DC 20554.

    People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

    Documents in IB Docket No. 12-267 are available for public inspection and copying during business hours at the FCC Reference Information Center, Portals II, 445 12th St. SW., Room CY A257, Washington, DC 20554.

    Ex parte status. This matter will be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Persons making ex parte presentations must comply with 47 CFR 1.1206(b).

    Paperwork Reduction Act

    This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

    Federal Communications Commission.

    Stephen Duall, Chief, Policy Branch, International Bureau.
    [FR Doc. 2016-12691 Filed 5-27-16; 8:45 am] BILLING CODE 6712-01-P
    GENERAL SERVICES ADMINISTRATION 48 CFR Parts 502, 512, 513, 532, and 552 [GSAR Case 2015-G512; Docket No. 2016-0010; Sequence No. 1] RIN 3090-AJ67 General Services Administration Acquisition Regulation (GSAR); Unenforceable Commercial Supplier Agreement Terms AGENCY:

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

    ACTION:

    Proposed rule.

    SUMMARY:

    The General Services Administration (GSA) is proposing to amend the General Services Administration Acquisition Regulation (GSAR) to address common Commercial Supplier Agreement terms that are inconsistent with or create ambiguity with Federal Law.

    DATES:

    Interested parties should submit written comments to the Regulatory Secretariat Division at one of the addresses shown below on or before August 1, 2016 to be considered in the formation of the final rule.

    ADDRESSES:

    Submit comments in response to GSAR Case 2015-G512 by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching for “GSAR Case 2015-G512”. Select the link “Comment Now” that corresponds with GSAR Case 2015-G215. Follow the instructions provided on the screen. Please include your name, company name (if any), and “GSAR Case 2015-G512” on all attached document(s).

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., 2nd Floor, ATTN: Ms. Flowers, Washington, DC 20405.

    Instructions: Please submit comments only and cite GSAR Case 2015-G512, in all correspondence related to this case. All comments received will generally be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    For clarification about content, contact Ms. Janet Fry, General Services Acquisition Policy Division, by phone at 703-605-3167 or by email at [email protected] For information pertaining to status or publication schedules, contact the Regulatory Secretariat Division at 202-501-4755. Please cite GSAR Case 2015-G512.

    SUPPLEMENTARY INFORMATION:

    I. Background A. Incompatibility of Commercial Supplier Agreements

    GSA defines Commercial Supplier Agreements as terms and conditions that are customarily offered to the public by vendors of supplies or services that meet the definition of “commercial item” and are intended to create a binding legal obligation on the end user. Commercial Supplier Agreements are particularly common in information technology acquisitions, including acquisitions of commercial computer software and commercial technical data, but they may apply to any supply or service.

    Customarily, commercial supplies and services are offered to the public under standard agreements that may take a variety of forms, including license agreements, terms of service (TOS), terms of sale or purchase, and similar agreements. These customary, standard Commercial Supplier Agreements typically contain terms and conditions that make sense when the purchaser is a private party but are inappropriate when the purchaser is the Federal Government.

    The existence of Federally-incompatible terms in standard Commercial Supplier Agreements has long been recognized in FAR 27.405-3(b), which is limited to the acquisition of commercial computer software. This clause advises contracting officers to exercise caution when accepting a contractor's terms and conditions. The use of Commercial Supplier Agreements is not limited to information technology acquisitions; Commercial Supplier Agreements have become ubiquitous in a broad variety of contexts, from travel to telecommunications to financial services to building maintenance systems, including purchases below the simplified acquisition threshold.

    Discrepancies between Commercial Supplier Agreements and Federal law or the Government's needs create recurrent points of inconsistency. Below are several examples of incompatible clauses that are commonly found in Commercial Supplier Agreements:

    • Jurisdiction or venue clauses may require that disputes be resolved in a particular state or Federal court. Such clauses conflict with the sovereign immunity of the U.S. Government and cannot apply to litigation where the U.S. Government is a defendant because those disputes must be heard either in U.S. District Court (28 U.S.C. 1346) or the U.S. Court of Federal Claims (28 U.S.C. 1491).

    • Automatic renewal clauses may automatically renew or extend contracts unless affirmative action is taken by the Government. Such clauses that require the obligation of funds prior to appropriation violate the restrictions of the Anti-Deficiency Act (31 U.S.C. 1341(a)(1)(B)).

    • Termination clauses may allow the contractor to unilaterally terminate a contract if the Government is alleged to have breached the contract. Government contracts are subject to the Contract Disputes Act of 1978 (41 U.S.C. 601-613). The Contract Disputes Act requires a certain process for resolving disputes, including terminations, and that the “Contractor shall proceed diligently with performance of this contract, pending final resolution” under the terms of the FAR Disputes clause at 52.233-1.

    Additionally, the current order of precedence contained in the Commercial Items clause at FAR 52.212-4 is not clear on prevailing terms, and potentially allows Commercial Supplier Agreements to supersede the terms of Federal contracts, especially in those areas where Federal law is implicated indirectly. As a result, industry and Government representatives must spend significant time and resources negotiating and tailoring Commercial Supplier Agreements to comply with Federal law and to ensure both parties have agreement on the contract terms.

    B. Value of Addressing Incompatible Commercial Supplier Agreements

    GSA has identified common illegal, improper or inappropriate Commercial Supplier Agreement terms that constitute the majority of the negotiated Commercial Supplier Agreement terms. The outcome of the negotiations regarding these identified terms is generally predetermined by rule of law, but GSA and contractors must spend significant time and resources to negotiate out these terms. By explicitly addressing common unenforceable terms within the Commercial Items clause at FAR 52.212-4 and clarifying prevailing terms in the order of precedence, it eliminates the need for negotiation on these identified terms, and makes clear to both parities the precedence of terms.

    This approach will decrease the time needed for legal review prior to contract formation and will significantly reduce costs to both the Government and contractors. GSA believes that such an approach will benefit contractors, including small business concerns by (1) decreasing proposal costs associated with negotiating the identified unenforceable Commercial Supplier Agreement terms; (2) facilitating faster procurement and contract lead times, therefore decreasing the time it takes for contractors to make a return on their investment; (3) reducing administrative costs for companies that maintain alternate Federally compliant Commercial Supplier Agreements; and (4) for small business concerns it levels the playing field with larger competitors since negotiations will only be required if the Commercial Supplier Agreements contains objectionable clauses outside of those already identified in proposed clause. Additionally, this approach ensures consistent application and understanding of these unenforceable terms.

    C. GSA Class Deviation

    On July 31, 2015, GSA issued a class deviation to immediately address the order of precedence and Commercial Supplier Agreement terms that are incompatible with Federal law. The class deviation protects GSA and contractors by uniformly addressing common unacceptable terms, immediately reducing risk, reducing administrative cost and further streamlining the acquisition process for commercial-item supplies and services. Additionally the class deviation clarifies the precedence of terms to ensure both parties have a mutual understanding of the contract terms. For example, bilateral modifications to the commercial supplier agreements are only required for material changes to ensure the contracting officer is aware of and agrees to the changes.

    A supplement to the class deviation was issued on September 30, 2015, to (1) reiterate that the change in the order of precedence protects GSA in the occasion where unilateral license updates could change government rights, and (2) clarify that Commercial Supplier Agreement terms can be negotiated except for the improper terms addressed in paragraph (w) of the GSAR clause 552.212-4. GSA refined the language in the class deviation while developing this proposed rule to further clarify (1) unauthorized obligations and other fees; (2) unilateral termination provisions; and (3) terms incorporated by reference. These issues are discussed in greater detail in Section II of this rule.

    II. Discussion and Analysis

    GSA is proposing to amend the General Services Administration Acquisition Regulation (GSAR) to implement standard terms and conditions for the most common conflicting Commercial Supplier Agreement terms to minimize the need for the negotiation of the terms of Commercial Supplier Agreements on an individual basis. The proposed rule will add provisions to contracts making certain conflicting or inconsistent terms in a Commercial Supplier Agreement unenforceable, so long as an express exception is not authorized elsewhere by Federal statute. GSA is also proposing to amend the GSAR to modify the order of precedence contained in the Commercial Items clause (52.212-4) to make clear that all of the terms of the GSAR clause control in the event of a conflict with a Commercial Supplier Agreement unless both parties agree to specific terms during the course of negotiating the contract.

    Both of the above changes will be accomplished by revising guidance and clauses contained throughout the GSAR. The specific changes contained in the proposed rule are as follows:

    • A definition for Commercial Supplier Agreements is added at GSAR 502.101.

    • GSAR 512.216 is created and clarifies that paragraph (u) of the Commercial Items clause at 552.212-4 prevents violation of the Anti-Deficiency Act.

    • GSAR 512.301 is updated to prescribe the use of the deviated Commercial Items clause at 552.212-4 in lieu of FAR 52.212-4.

    • GSAR 513.202 is created and will automatically apply the clause at 552.232-39 into all purchases below the micro-purchase threshold.

    • GSAR 513.302-5 is created and requires the inclusion of GSAR 552.232-39 and 552.232-78 in all acquisitions for supplies or services that are offered under a Commercial Supplier Agreement.

    • GSAR 532.705 is created and clarifies the definition of supplier license agreements as used in the Unenforceability of Unauthorized Obligations clause at FAR 32.705.

    • GSAR 532.706-3 is created and directs contracting officers to utilize the clause at GSAR 552.232-39 in lieu of FAR 52.232-39 and prescribes the use of the clause Commercial Supplier Agreements—Unenforceable Clauses at 552.232-78.

    • The Commercial Items clause at GSAR 552.212-4 is modified to include instructions to contracting officers on how to incorporate the change in language from FAR 52.212-4.

    • The order of precedence contained in paragraph (s) of the Commercial Items clause at GSAR 552.212-4 is amended to ensure that all of the terms of GSAR 552.212-4 shall control over the terms of a Commercial Supplier Agreement by moving “Addenda to this solicitation or contract, including any license agreements for computer software” down two spaces in the order of precedence, behind “Solicitation provisions as awarded if there is a solicitation” and “Other paragraphs of this clause.”

    • Paragraph (u) of the Commercial Items clause at GSAR 552.212-4 is amended to (1) reflect the new Commercial Supplier Agreement definition contained in GSAR 502.101, (2) to expand coverage to “language or provision” in addition to “clause” in order to ensure that all Commercial Supplier Agreement terms are covered, regardless of terminology utilized, and (3) to include future fees, penalties, interest and legal costs as unauthorized obligations in addition to indemnification.

    • Paragraph (w) of the Commercial Items clause at GSAR 552.212-4 is created to address the following commonplace unenforceable elements found in Commercial Supplier Agreements:

    ○ Definition of contracting parties: Contract agreements are between the commercial supplier or licensor and the U.S. Government. Government employees or persons acting on behalf of the Government will not be bound in their personal capacity by the Commercial Supplier Agreement.

    ○ Laws and disputes: Clauses that conflict with the sovereign immunity of the U.S. Government cannot apply to litigation where the U.S. Government is a defendant because those disputes must be heard either in U.S. District Court or the U.S. Court of Federal Claims. Commercial Supplier Agreement terms that require the resolution of a dispute in a forum or time period other than that expressly authorized by Federal law are deleted. Statutes of limitation on potential claims shall be governed by U.S. Government law.

    ○ Continued Performance: Commercial suppliers may not unilaterally terminate or suspend a contract based upon a suspected breach of contract by the Government. Accepting terms that can be unilaterally terminated or revoked places the Government at risk of not receiving goods or services for money it has obligated on a contract or task order, if the price paid by the Government is non-refundable. This position is in violation of 31 U.S.C. 3324, which provides that payment under a contract may not exceed the value of a service or product already delivered. A license that is prematurely terminated outside of the regular dispute resolution procedures results in the Government not receiving the value of that license because the license is no longer delivered. The removal of the contractor's right to unilateral termination does not impair the contractor's ability to pursue remedies. It preserves all the legal remedies the contractor otherwise has under Federal law, including Contract Disputes Act claims. Remedies through the Contract Disputes Act or other applicable Federal statutes align with the continuing performance requirement set forth in subparagraph (d) Disputes.

    ○ Arbitration; equitable or injunctive relief: A binding arbitration may not be enforced unless explicitly authorized by agency guidance or statute. Equitable remedies or injunctive relief such as attorney fees, cost or interest may only be awarded against the U.S. Government when expressly authorized by statute (e.g., Prompt Payment Act).

    ○ Additional Terms: Incorporation of terms by reference is allowed provided the full text of terms is provided with the offer. Unilateral modifications to the Commercial Supplier Agreement after the time of award may be allowed to the extent that the modified terms do not materially change the Government's rights or obligations, increase the Government's prices, decrease the level of service provided, or limit any Government right addressed elsewhere in the contract. A bilateral contract modification is required in order for any of the above described changes to be enforceable against the Government.

    ○ Automatic renewals: Due to Anti-Deficiency Act restrictions, automatic contract renewal clauses are impermissible. Any such Commercial Supplier Agreement clauses are unenforceable.

    ○ Indemnity (contractor assumes control of proceedings): Any clause requiring that the commercial supplier or licensor control any litigation arising from the Government's use of the contractor's supplies or services is deleted. Such representation when the Government is a party is reserved by statute for the U.S. Department of Justice.

    ○ Audits (automatic liability for payment): Discrepancies found during an audit must comply with the invoicing procedures from the underlying contract. Disputed charges must be resolved through the Disputes clause. Any audits requested by the commercial supplier or licensor will be performed at supplier or licensor's expense.

    ○ Taxes or surcharges: Any taxes or surcharges that will be passed along to the Government will be governed by the terms of the underlying contract. The cognizant contracting officer must make a determination of applicability of taxes whenever such a request is made.

    ○ Assignment of Commercial Supplier Agreement or Government contract by supplier: The contract, Commercial Supplier Agreement, party rights and party obligations may not be assigned or delegated without express Government approval. Payment to a third party financial institution may still be reassigned.

    ○ Confidentiality of Commercial Supplier Agreement terms and conditions: The content of the Commercial Supplier Agreement and the Federal Supply Schedule list price (if applicable) may not be deemed confidential. The Government may retain other marked confidential information as required by law, regulation or agency guidance, but will appropriately guard such confidential information.

    • GSAR 552.232-78 is created and addresses the same common unenforceable Commercial Supplier Agreement terms addressed in GSAR 552.212-4(w) described above.

    • GSAR 552.232-39 is created to amended the language of FAR 52.232-39 to reflect the definition of Commercial Supplier Agreements contained at GSAR 502.101, to expand coverage to “language or provision” in addition to “clause” in order to ensure that all Commercial Supplier Agreement terms are covered, regardless of terminology utilized, and to include future fees, penalties, interest and legal costs as unauthorized obligations in addition to indemnification.

    This proposed rule will reduce risk by uniformly addressing common unacceptable Commercial Supplier Agreement terms, facilitate efficiency and effectiveness in the contracting process by reducing the administrative burden for the Government and industry, and promote competition by reducing barriers to industry, particularly for small businesses.

    III. Executive Orders 12866 and 13563

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

    IV. Regulatory Flexibility Act

    The change may have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act 5 U.S.C. 601, et seq. The analysis is summarized as follows:

    This effort is expected to reduce the overall burden on small entities by reducing the amount of time and resources required to negotiate Commercial Supplier Agreements. GSA believes that such an approach will disproportionately benefit small business concerns since they are less likely to retain in-house counsel and the GSAR revision will reduce or eliminate the costs associated with the negotiation of the identified unenforceable elements. Furthermore, this approach will allow small businesses that do not have Commercial Supplier Agreements tailored to Federal Government procurements to potentially utilize their otherwise compliant, standard Commercial Supplier Agreements when conducting business with the Government.

    The Regulatory Secretariat Division will be submitting a copy of the Initial Regulatory Flexibility Analysis (IRFA) to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the Regulatory Secretariat Division. GSA invites comments from small business concerns and other interested parties on the expected impact of this proposed rule on small entities.

    GSA will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (GSAR Case 2015-G512) in correspondence.

    V. Paperwork Reduction Act

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

    List of Subjects in 48 CFR Parts 502, 512, 513, 532, and 552

    Government procurement.

    Dated: May 20, 2016. Jeffrey A. Koses, Senior Procurement Executive, Office of Acquisition Policy, Office of Government-wide Policy, General Services Administration.

    Therefore, GSA proposes to amend 48 CFR parts 502, 512, 513, 532, and 552 as set forth below:

    1. Add part 502 to read as follows: PART 502—DEFINITIONS OF WORDS AND TERMS Subpart 502.1—Definitions 502.101 Definitions. Authority:

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

    Subpart 502.1—Definitions
    502.101 Definitions.

    Commercial supplier agreements means terms and conditions customarily offered to the public by vendors of supplies or services that meet the definition of “commercial item” set forth in FAR 2.101 and intended to create a binding legal obligation on the end user. Commercial supplier agreements are particularly common in information technology acquisitions, including acquisitions of commercial computer software and commercial technical data, but they may apply to any supply or service. The term applies—

    (1) Regardless of the format or style of the document. For example, a commercial supplier agreement may be styled as standard terms of sale or lease, Terms of Service (TOS), End User License Agreement (EULA), or another similar legal instrument or agreement, and may be presented as part of a proposal or quotation responding to a solicitation for a contract or order;

    (2) Regardless of the media or delivery mechanism used. For example, a commercial supplier agreement may be presented as one or more paper documents or may appear on a computer or other electronic device screen during a purchase, software installation, other product delivery, registration for a service, or another transaction.

    PART 512—ACQUISITION OF COMMERCIAL ITEMS 2. The authority citation for part 512 is revised to read as follows: Authority:

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

    3. Add subpart 512.2, consisting of 512.216, to read as follows: Subpart 512.2—Special Requirements for the Acquisition of Commercial Items
    512.216 Unenforceability of unauthorized obligations.

    GSA has a deviation to FAR 12.216 for this section to read as follows:

    For commercial contracts, supplier license agreements are referred to as commercial supplier agreements (defined in 502.101). Paragraph (u) of clause 552.212-4 prevents violations of the Anti-Deficiency Act (31 U.S.C. 1341) for supplies or services acquired subject to a commercial supplier agreement.

    4. Amend section 512.301 by adding paragraph (e) to read as follows:
    512.301 Solicitation provisions and contract clauses for the acquisition of commercial items.

    (e) GSA has a deviation to revise certain paragraphs of FAR clause 52.212-4. Use clause 552.212-4 Contract Terms and Conditions—Commercial Items (FAR DEVIATION), for acquisitions of commercial items in lieu of FAR 52.212-4. The contracting officer may tailor this clause in accordance with FAR 12.302 and GSAM 512.302.

    5. Add part 513 to read as follows: PART 513—SIMPLIFIED ACQUISITION PROCEDURES Subpart 513.2—Actions At or Below the Micro-Purchase Threshold 513.202 Unenforceability of unauthorized obligations in micro-purchases. Subpart 513.3—Simplified Acquisition Methods
    513.302-5 Clauses. Authority:

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

    Subpart 513.2—Actions At or Below the Micro-Purchase Threshold
    513.202 Unenforceability of unauthorized obligations in micro-purchases.

    Clause 552.232-39, Unenforceability of Unauthorized Obligations (FAR DEVIATION), will automatically apply to any micro-purchase in lieu of FAR 52.232-39 for supplies and services acquired subject to a commercial supplier agreement (as defined in 502.101).

    Subpart 513.3—Simplified Acquisition Methods
    513.302-5 Clauses.

    Where the supplies or services are offered under a commercial supplier agreement (as defined in 502.101), the purchase order or modification shall incorporate clause 552.232-39, Unenforceability of Unauthorized Obligations (FAR DEVIATION), in lieu of FAR 52.232-39, and clause 552.232-78, Commercial Supplier Agreements-Unenforceable Clauses.

    PART 532—CONTRACT FINANCING 6. The authority citation for 48 CFR part 532 continues to read as follows: Authority:

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

    7. Add subpart 532.7, consisting of 532.705 and 532.706-3, to read as follows: Subpart 532.7—Contract Funding
    532.705 Unenforceability of unauthorized obligations.

    Supplier license agreements defined in FAR 32.705 are equivalent to commercial supplier agreements defined in 502.101.

    532.706-3 Clause for unenforceability of unauthorized obligations.

    (a) The contracting officer shall utilize the clause at 552.232-39, Unenforceability of Unauthorized Obligations (FAR DEVIATION) in all solicitations and contracts in lieu of FAR 52.232-39.

    (b) The contracting officer shall utilize the clause at 552.232-78, Commercial Supplier Agreements—Unenforceable Clauses, in all solicitations and contracts (including orders) when not using FAR part 12.

    PART 552—SOLICITATION PROVISIONS AND CONTRACT CLAUSES 8. The authority citation for 48 CFR part 552 continues to read as follows: Authority:

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

    9. Revise section 552.212-4 to read as follows.
    552.212-4 Contract Terms and Conditions—Commercial Items (FAR DEVIATION).

    As prescribed in 512.301(e), replace paragraphs (g)(2), (s), and (u) of FAR clause 52.212-4. Also, add paragraph (w) to FAR clause 52.212-4.

    Contract Terms and Conditions—Commercial Items (FAR DEVIATION) (Date)

    (g)(2) The due date for making invoice payments by the designated payment office is the later of the following two events:

    (i) The 10th day after the designated billing office receives a proper invoice from the Contractor. If the designated billing office fails to annotate the invoice with the date of receipt at the time of receipt, the invoice payment due date shall be the 10th day after the date of the Contractor's invoice; provided the Contractor submitted a proper invoice and no disagreement exists over quantity, quality, or Contractor compliance with contract requirements.

    (ii) The 10th day after Government acceptance of supplies delivered or services performed by the Contractor.

    (s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

    (1) The schedule of supplies/services.

    (2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, Unauthorized Obligations, and Commercial Supplier Agreements-Unenforceable Clauses paragraphs of this clause.

    (3) The clause at 52.212-5.

    (4) Solicitation provisions if this is a solicitation.

    (5) Other paragraphs of this clause.

    (6) Addenda to this solicitation or contract, including any license agreements for computer software.

    (7) The Standard Form 1449.

    (8) Other documents, exhibits, and attachments.

    (9) The specification.

    (u) Unauthorized Obligations. (1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any commercial supplier agreement (as defined in 502.101) that includes any language, provision, or clause requiring the Government to pay any future fees, penalties, interest, legal costs or to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

    (i) Any such language, provision, or clause is unenforceable against the Government.

    (ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the commercial supplier agreement. If the commercial supplier agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

    (iii) Any such language, provision, or clause is deemed to be stricken from the commercial supplier agreement.

    (2) Paragraph (u)(1) of this clause does not apply to indemnification or any other payment by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

    (w) Commercial supplier agreements—unenforceable clauses. When any supply or service acquired under this contract is subject to a commercial supplier agreement (as defined in 502.101), the following language shall be deemed incorporated into the commercial supplier agreement. As used herein, “this agreement” means the commercial supplier agreement:

    (1) Notwithstanding any other provision of this agreement, when the end user is an agency or instrumentality of the U.S. Government, the following shall apply:

    (i) Applicability. This agreement is a part of a contract between the commercial supplier and the U.S. Government for the acquisition of the supply or service that necessitates a license (including all contracts, task orders, and delivery orders under FAR Part 12).

    (ii) End user. This agreement shall bind the ordering activity as end user but shall not operate to bind a Government employee or person acting on behalf of the Government in his or her personal capacity.

    (iii) Law and disputes. This agreement is governed by Federal law.

    (A) Any language purporting to subject the U.S. Government to the laws of a U.S. state, U.S. territory, district, or municipality, or a foreign nation, except where Federal law expressly provides for the application of such laws, is hereby deleted.

    (B) Any language requiring dispute resolution in a specific forum or venue that is different from that prescribed by applicable Federal law is hereby deleted.

    (C) Any language prescribing a different time period for bringing an action than that prescribed by applicable Federal law in relation to a dispute is hereby deleted.

    (iv) Continued performance. The supplier or licensor shall not unilaterally revoke, terminate or suspend any rights granted to the Government except as allowed by this contract. If the supplier or licensor believes the ordering activity to be in breach of the agreement, it shall pursue its rights under the Contract Disputes Act or other applicable Federal statute while continuing performance as set forth in paragraph (d) (Disputes).

    (v) Arbitration; equitable or injunctive relief. In the event of a claim or dispute arising under or relating to this agreement, a binding arbitration shall not be used unless specifically authorized by agency guidance, and equitable or injunctive relief, including the award of attorney fees, costs or interest, may be awarded against the U.S. Government only when explicitly provided by statute (e.g., Prompt Payment Act or Equal Access to Justice Act).

    (vi) Additional terms. (A) This commercial supplier agreement may incorporate additional terms by reference, provided that the full text of the terms are provided with the offer.

    (B) After award, the contractor may unilaterally revise terms provided:

    (1) Terms do not materially change government rights or obligations;

    (2) Terms do not increase government prices;

    (3) Terms do not decrease overall level of service; and

    (4) Terms do not limit any other Government right addressed elsewhere in this contract.

    (C) The order of precedence clause of this contract is not enforceable against the government, notwithstanding any software license terms unilaterally revised subsequent to award that is inconsistent with any material term or provision of this contract.

    (vii) No automatic renewals. If any license or service tied to periodic payment is provided under this agreement (e.g., annual software maintenance or annual lease term), such license or service shall not renew automatically upon expiration of its current term without prior express Government approval.

    (viii) Indemnification. Any clause of this agreement requiring the commercial supplier or licensor to defend or indemnify the end user is hereby amended to provide that the U.S. Department of Justice has the sole right to represent the United States in any such action, in accordance with 28 U.S.C. 516.

    (ix) Audits. Any clause of this agreement permitting the commercial supplier or licensor to audit the end user's compliance with this agreement is hereby amended as follows:

    (A) Discrepancies found in an audit may result in a charge by the commercial supplier or licensor to the ordering activity. Any resulting invoice must comply with the proper invoicing requirements specified in the underlying Government contract or order.

    (B) This charge, if disputed by the ordering activity, will be resolved through the Disputes clause at 522.212-4(d); no payment obligation shall arise on the part of the ordering activity until the conclusion of the dispute process.

    (C) Any audit requested by the contractor will be performed at the contractor's expense, without reimbursement by the Government.

    (x) Taxes or surcharges. Any taxes or surcharges which the commercial supplier or licensor seeks to pass along to the Government as end user will be governed by the terms of the underlying Government contract or order and, in any event, must be submitted to the Contracting Officer for a determination of applicability prior to invoicing unless specifically agreed to otherwise in the Government contract.

    (xi) Non-assignment. This agreement may not be assigned, nor may any rights or obligations thereunder be delegated, without the Government's prior approval, except as expressly permitted under subparagraph (b) of this clause at 552.212-4.

    (xii) Confidential information. If this agreement includes a confidentiality clause, such clause is hereby amended to state that neither the agreement nor the Federal Supply Schedule price list shall be deemed “confidential information.” Issues regarding release of “unit pricing” will be resolved consistent with the Freedom of Information Act. Notwithstanding anything in this agreement to the contrary, the Government may retain any confidential information as required by law, regulation or its internal document retention procedures for legal, regulatory or compliance purposes; provided, however, that all such retained confidential information will continue to be subject to the confidentiality obligations of this agreement.

    (2) If any language, provision, or clause of this agreement conflicts or is inconsistent with the preceding paragraph (w)(1), the language, provisions, or clause of paragraph (w)(1) shall prevail to the extent of such inconsistency.

    (End of clause)
    10. Add section 552.232-39 to read as follows:
    552.232-39 Unenforceability of Unauthorized Obligations (FAR DEVIATION).

    As prescribed in 513.302-5 and 532.706-3, insert the following clause:

    Unenforceability of Unauthorized Obligations (FAR DEVIATION) (Date)

    (a) Except as stated in paragraph (b) of this clause, when any supply or service acquired under this contract is subject to any commercial supplier agreement (as defined in 502.101) that includes any language, provision, or clause requiring the Government to pay any future fees, penalties, interest, legal costs or to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

    (1) Any such language, provision, or clause is unenforceable against the Government.

    (2) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such language, provision, or clause by virtue of it appearing in the commercial supplier agreement. If the commercial supplier agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

    (3) Any such language, provision, or clause is deemed to be stricken from the commercial supplier agreement.

    (b) Paragraph (a) of this clause does not apply to indemnification or any other payment by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

    (End of clause)
    11. Add section 552.232-78 to read as follows:
    552.232-78 Commercial Supplier Agreements—Unenforceable Clauses.

    As prescribed in 513.302-5 and 532.706-3 insert the following clause:

    Commercial Supplier Agreements—Unenforceable Clauses (Date)

    (a) When any supply or service acquired under this contract is subject to a commercial supplier agreement, the following language shall be deemed incorporated into the commercial supplier agreement. As used herein, “this agreement” means the commercial supplier agreement:

    (1) Notwithstanding any other provision of this agreement, when the end user is an agency or instrumentality of the U.S. Government, the following shall apply:

    (i) Applicability. This agreement is part of a contract between the commercial supplier and the U.S. Government for the acquisition of the supply or service that necessitates a license (including all contracts, task orders, and delivery orders under FAR Parts 13, 14 or 15).

    (ii) End user. This agreement shall bind the ordering activity as end user but shall not operate to bind a Government employee or person acting on behalf of the Government in his or her personal capacity.

    (iii) Law and disputes. This agreement is governed by Federal law.

    (A) Any language purporting to subject the U.S. Government to the laws of a U.S. state, U.S. territory, district, or municipality, or foreign nation, except where Federal law expressly provides for the application of such laws, is hereby deleted.

    (B) Any language requiring dispute resolution in a specific forum or venue that is different from that prescribed by applicable Federal law is hereby deleted.

    (C) Any language prescribing a different time period for bringing an action than that prescribed by applicable Federal law in relation to a dispute is hereby deleted.

    (iv) Continued performance. The supplier or licensor shall not unilaterally revoke, terminate or suspend any rights granted to the Government except as allowed by this contract. If the supplier or licensor believes the ordering activity to be in breach of the agreement, it shall pursue its rights under the Contract Disputes Act or other applicable Federal statute while continuing performance as set forth in subparagraph (d) (Disputes).

    (v) Arbitration; equitable or injunctive relief. In the event of a claim or dispute arising under or relating to this agreement, a binding arbitration shall not be used unless specifically authorized by agency guidance, and equitable or injunctive relief, including the award of attorney fees, costs or interest, may be awarded against the U.S. Government only when explicitly provided by statute (e.g., Prompt Payment Act or Equal Access to Justice Act).

    (vi) Additional terms. (A) This commercial supplier agreement may incorporate additional terms by reference, provided that the full text of the terms are provided with the offer.

    (B) After award the contractor may unilaterally revise terms provided:

    (1) Terms do not materially change government rights or obligations; and

    (2) Terms do not increase government prices; and

    (3) Terms do not decrease overall level of service; and

    (4) Terms do not limit any other Government right addressed elsewhere in this contract.

    (C) The order of precedence clause of this contract notwithstanding, any software license terms unilaterally revised subsequent to award that is inconsistent with any material term or provision of this contract is not enforceable against the government.

    (vii) No automatic renewals. If any license or service tied to periodic payment is provided under this agreement (e.g., annual software maintenance or annual lease term), such license or service shall not renew automatically upon expiration of its current term without prior express Government approval.

    (viii) Indemnification. Any clause of this agreement requiring the commercial supplier or licensor to defend or indemnify the end user is hereby amended to provide that the U.S. Department of Justice has the sole right to represent the United States in any such action, in accordance with 28 U.S.C. 516.

    (ix) Audits. Any clause of this agreement permitting the commercial supplier or licensor to audit the end user's compliance with this agreement is hereby amended as follows:

    (A) Discrepancies found in an audit may result in a charge by the commercial supplier or licensor to the ordering activity. Any resulting invoice must comply with the proper invoicing requirements specified in the underlying Government contract or order.

    (B) This charge, if disputed by the ordering activity, will be resolved through the Disputes clause at 52.233-1; no payment obligation shall arise on the part of the ordering activity until the conclusion of the dispute process.

    (C) Any audit requested by the contractor will be performed at the contractor's expense, without reimbursement by the Government.

    (x) Taxes or surcharges. Any taxes or surcharges which the commercial supplier or licensor seeks to pass along to the Government as end user will be governed by the terms of the underlying Government contract or order and, in any event, must be submitted to the Contracting Officer for a determination of applicability prior to invoicing unless specifically agreed to otherwise in the Government contract.

    (xi) Non-assignment. This agreement may not be assigned, nor may any rights or obligations thereunder be delegated, without the Government's prior approval, except as expressly permitted under the clause at 52.232-23, Assignment of Claims.

    (xii) Confidential information. If this agreement includes a confidentiality clause, such clause is hereby amended to state that neither the agreement nor the Federal Supply Schedule price list shall be deemed “confidential information.” Issues regarding release of “unit pricing” will be resolved consistent with the Freedom of Information Act. Notwithstanding anything in this agreement to the contrary, the Government may retain any confidential information as required by law, regulation or its internal document retention procedures for legal, regulatory or compliance purposes; provided, however, that all such retained confidential information will continue to be subject to the confidentiality obligations of this agreement.

    (2) If any language, provision or clause of this agreement conflicts or is inconsistent with the preceding subparagraph (a)(1), the language, provisions, or clause of subparagraph (a)(1) shall prevail to the extent of such inconsistency.

    (End of clause)
    [FR Doc. 2016-12448 Filed 5-27-16; 8:45 am] BILLING CODE 6820-61-P
    81 104 Tuesday, May 31, 2016 Notices DEPARTMENT OF AGRICULTURE Forest Service Information Collection; Land Exchanges AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension with no revision of a currently approved information collection, OMB 0596-0105, Land Exchanges.

    DATES:

    Comments must be received in writing on or before August 1, 2016 to be assured of consideration. Comments received after that date will be considered to the extent practicable.

    ADDRESSES:

    Comments concerning this notice should be addressed to Nancy Parachini, National Land Adjustment Program Manager, Lands, Forest Service, 201 14th Street SW., Suite 1SE, Mail Stop 1124, Washington, DC 20024.

    Comments also may be submitted via facsimile to 703-605-5117 or by email to: [email protected]

    The public may inspect comments received at Office of the Land Adjustment Program Manager—Lands Staff, Yates Building, 201 14th Street, SW., Washington, DC during normal business hours. Visitors are encouraged to call ahead to 202-205-3563 or 800-832-1355 to facilitate entry to the building.

    FOR FURTHER INFORMATION CONTACT:

    Nancy Parachini, Lands Adjustment Program Manager, 202-205-1238.

    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:

    Title: Land Exchanges.

    OMB Number: 0596-0105.

    Expiration Date of Approval: July 31, 2016.

    Type of Request: Extension with revision of a currently approved information collection.

    Abstract: Land exchanges are discretionary, voluntary real estate transactions between the Secretary of Agriculture (acting by and through the Forest Service) and a non-Federal exchange party (or parties). Land exchanges can be initiated by a non-Federal party (or parties), an agent of a landowner, a broker, a third party, or a non-Federal public agency.

    Each land exchange requires preparation of an Agreement to Initiate as required by Title 36 Code of Federal Regulations (CFR), part 254, subpart A—section 254.4—Agreement to Initiate. The Agreement to Initiate document specifies the preliminary and non-binding intentions of the non-Federal land exchange party and the Forest Service in pursuing a land exchange. The Agreement to Initiate can contain such information as the description of properties being considered in the land exchange, an implementation schedule of action items, identification of the party responsible for each action item, as well as target dates for completion of each action item.

    As the exchange proposal develops, the Forest Service and the non-Federal land exchange party may enter into a binding Exchange Agreement, pursuant to Title 36 CFR part 254, subpart A, section 254.14—Exchange Agreement. The Exchange Agreement documents the conditions that must be met to complete the exchange. The Exchange Agreement can contain information such as identification of parties, description of lands and interests to be exchanged, identification of all reserved and outstanding interest, and all other terms and conditions necessary to complete the exchange.

    The Forest Service collects the information from the non-Federal party (or parties) necessary to complete the Agreement to Initiate and the Exchange Agreement. The information is collected by Forest Service personnel from parties involved in the exchange via telephone, email or in person. Data from this information collection is unique to each land exchange and is not available from other sources. No standardized forms are associated with this information collection.

    Estimate of Annual Burden

    Agreement to Initiate: 3 hours.

    Exchange Agreement: 1 hour.

    Type of Respondents: Non-Federal party (or parties) that can include landowners, agents of landowners, brokers, a third party or a non-Federal public agency.

    Estimated Annual Number of Respondents: 25.

    Estimated Annual Number of Responses per Respondent: 1.826.

    Estimated Total Annual Burden on Respondents: 88.

    Comment Is Invited

    Comment is invited on: (1) whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the Agency, including whether the information will have practical or scientific utility; (2) the accuracy of the Agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission request toward Office of Management and Budget approval.

    Dated: May 24, 2016. Brian Ferebee, Associate Deputy Chief National Forest System.
    [FR Doc. 2016-12771 Filed 5-27-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-970] Multilayered Wood Flooring From the People's Republic of China: Preliminary Rescission of 2014-2015 Antidumping Duty New Shipper Reviews AGENCY:

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

    SUMMARY:

    The Department of Commerce (“the Department”) is conducting two new shipper reviews (“NSRs”) of the antidumping duty order on multilayered wood flooring from the People's Republic of China (“PRC”). The NSRs cover two exporters and producers of subject merchandise, Dongtai Zhangshi Wood Industry Co., Ltd. (“Zhangshi”) and Huzhou Muyun Wood Co., Ltd. (“Muyun”). The period of review (“POR”) is December 1, 2014 through May 31, 2015. The Department preliminarily determines that both Zhangshi's sale and Muyun's sale to the United States were not bona fide; therefore, we intend to rescind these NSRs. Interested parties are invited to comment on the preliminary results of this review.

    DATES:

    Effective date: May 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Robert Galantucci or Aleksandras Nakutis, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2923 or (202) 482-3147, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On July 29, 2015, the Department published a notice of initiation of two NSRs of the antidumping duty order on multilayered wood flooring from the PRC.1 The Department subsequently issued an antidumping duty questionnaire, and supplemental questionnaires, to both Zhangshi and Muyun and received timely responses thereto.2 Also, interested parties submitted comments on surrogate country and surrogate value selection. The Department extended the deadline for issuing the preliminary results of this review until May 20, 2016.3

    1See Multilayered Wood Flooring From the People's Republic of China: Initiation of Antidumping Duty New Shipper Review; 2014-2015, 80 FR 45192 (July 29, 2015).

    2 The Department issued a brief supplemental questionnaire to each respondent on May 12, 2016. The deadline for the parties to respond was May 18, 2016. The Department received the responses on May 18, 2016, however due to the timing of the responses, the Department has not considered the responses for the preliminary results, but may consider this information for the final results.

    3See the memoranda to Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, from Maisha Cryor, International Trade Analyst, Office IV, Antidumping and Countervailing Duty Operations, entitled, “Multilayered Wood Flooring from the People's Republic of China: Extension of Deadline for Preliminary Results of Antidumping Duty New Shipper Review” dated January 13, 2016 and the memorandum from Ron Lorentzen, Acting Assistant Secretary, for Enforcement and Compliance, entitled, “Tolling of Administrative Deadlines as a Result of the Government Closure during Snowstorm `Jonas' ” dated January 27, 2016.

    Scope of the Order

    Multilayered wood flooring is composed of an assembly of two or more layers or plies of wood veneer(s) in combination with a core. The several layers, along with the core, are glued or otherwise bonded together to form a final assembled product. For a full description of the scope, see the Preliminary Decision Memorandum.4 The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”). ACCESS is available to registered users at http://access.trade.gov and in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/index.html. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    4See Memorandum from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, “Decision Memorandum for the Preliminary Rescission of the 2014-2015 Antidumping Duty Reviews of Multilayered Wood Flooring from the People's Republic of China,” dated concurrently with, and hereby adopted by, this notice (“Preliminary Decision Memorandum”).

    Methodology

    The Department is conducting this review in accordance with section 751(a)(2)(B) of the Tariff Act of 1930, as amended (“the Act”) and 19 CFR 351.214.5 For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum dated concurrently with this notice.

    5 On February 24, 2016, the President of the United States signed into law the Trade Facilitation and Trade Enforcement Act of 2015, Public Law 114-125 (Feb. 24, 2016), which made amendments to section 751(a)(2)(B) of the Act. These amendments apply to this determination.

    Preliminary Rescission of the Antidumping New Shipper Reviews of Muyun and Zhangshi

    As discussed in the Bona Fide Sales Analysis Memoranda,6 the Department preliminarily finds that both of the single sales made by Zhangshi and Muyun to the United States during the POR are not bona fide sales. The Department reached this conclusion based on the totality of circumstances surrounding each reported sale. Namely, with respect to Zhangshi's single sale, the sales price, the timing of the payment, the implementation of the terms of sale and the inconsistent responses from the importer call into question whether the sale is indicative of normal business practices. With respect to Muyun's single sale, we find that the sales price, the lack of record evidence demonstrating that Muyun's customer resold the merchandise for a profit, the timing of the sale and the negotiation period call into question whether the sale is indicative of normal business practices. Because the non-bona fide sales were the only reported sales of subject merchandise during the POR, and thus there are no reviewable transactions on this record, we are preliminarily rescinding the NSRs.7 Because much of the factual information used in our analysis of Zhangshi's sale and Muyun's sale involves business proprietary information, a full discussion of the basis for our preliminary determination is set forth in the Memoranda to Abdelali Elouaradia, Director, AD/CVD Operations, Office IV, “Antidumping Duty New Shipper Review of Multilayered Wood Flooring from the People's Republic of China: Bona Fide Sale Analysis for Dongtai Zhangshi Wood Industry Co., Ltd.,” and “Antidumping Duty New Shipper Review of Multilayered Wood Flooring from the People's Republic of China: Bona Fide Sale Analysis for Huzhou Muyun Wood Co., Ltd.,” dated May 20, 2015, which are on the record of this proceeding.

    6See Memorandum from Robert Galantucci, International Trade Analyst, Office IV AD/CVD Operations, to Abdelali Elouaradia, Director, Office IV, AD/CVD Operations entitled “Antidumping Duty New Shipper Review of Multilayered Wood Flooring from the People's Republic of China: Bona Fide Sale Analysis for Dongtai Zhangshi Wood Industry Co., Ltd.”; see also Memorandum from Aleksandras Nakutis, International Trade Analyst, Office IV AD/CVD Operations, to Abdelali Elouaradia, Director, Office IV, AD/CVD Operations entitled “Antidumping Duty New Shipper Review of Multilayered Wood Flooring from the People's Republic of China: Bona Fide Sale Analysis for Huzhou Muyun Wood Co., Ltd.” dated concurrently with and hereby adopted by this notice (collectively, “Bona Fide Sales Analysis Memoranda”).

    7See 19 CFR 351.213(d)(3).

    Public Comment

    Interested parties may submit case briefs no later than 30 days after the date of publication of the preliminary results of review.8 Rebuttals to case briefs may be filed no later than five days after the briefs are filed. All rebuttal comments must be limited to comments raised in the case briefs.9

    8See 19 CFR 351.309(c).

    9See 19 CFR 351.309(d).

    Interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement & Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice.10 Requests should contain the party's name, address, and telephone number, the number of participants, and a list of the issues to be discussed. Oral argument presentations will be limited to issues raised in the briefs. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230, at a date and time to be determined.11 Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    10See 19 CFR 351.310(c).

    11See 19 CFR 351.310(d).

    All submissions, with limited exceptions, must be filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety by the Department's electronic records system, ACCESS, by 5 p.m. Eastern Time (“ET”) on the due date. Documents excepted from the electronic submission requirements must be filed manually (i.e., in paper form) with the APO/Dockets Unit in Room 18022, and stamped with the date and time of receipt by 5 p.m. ET on the due date.12

    12See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011).

    The Department intends to issue the final results of these NSRs, which will include the results of its analysis of issues raised in any briefs received, no later than 90 days after the date these preliminary results of review are issued pursuant to section 751(a)(2)(B)(iv) of the Act.

    Assessment Rates

    If the Department proceeds to a final rescission of Zhangshi and Muyun's NSRs, the assessment rate to which Zhangshi and Muyun's shipments will be subject will not be affected by this review. However, the Department initiated an administrative review of the antidumping duty order on multilayered wood flooring from the PRC covering numerous exporters, including Zhangshi and Muyun, for the period December 1, 2014 through November 30, 2015 which encompasses the POR of these NSRs.13 Thus, if the Department proceeds to a final rescission, we will instruct U.S. Customs and Border Protection (“CBP”) to continue to suspend entries during the period December 1, 2014 through November 30, 2015 of subject merchandise exported by Zhangshi and Muyun until CBP receives instructions relating to the administrative review of this order covering the period December 1, 2014 through November 30, 2015.

    13See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 81 FR 6832 (February 9, 2016).

    If the Department does not proceed to a final rescission of this new shipper review, pursuant to 19 CFR 351.212(b)(1), we will calculate importer-specific (or customer) assessment rates based on the final results of this review. However, pursuant to the Department's refinement to its assessment practice in non-market economy cases, for entries that were not reported in the U.S. sales database submitted by Zhangshi or Muyun, the Department will instruct CBP to liquidate such entries at the PRC-wide rate.14

    14 For a full discussion of this practice, see Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011).

    Cash Deposit Requirements

    Effective upon publication of the final rescission or the final results of these NSRs, pursuant to section 751(a)(2)(B)(iii) of the Act and 19 CFR 351.214(e), the Department will instruct CBP to discontinue the option of posting a bond or security in lieu of a cash deposit for entries of subject merchandise by Zhangshi and Muyun. If the Department proceeds to a final rescission of these NSRs, the cash deposit rate will continue to be the PRC-wide rate for Zhangshi and Muyun because the Department will not have determined an individual margin of dumping for either company. If the Department issues final results for these NSRs, the Department will instruct CBP to collect cash deposits, effective upon the publication of the final results, at the rates established therein.

    Notification to Importers

    This notice also serves as a reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    We are issuing and publishing these results in accordance with sections 751(a)(2)(B) and 777(i)(1) of the Act.

    Dated: May 20, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I—List of Topics Discussed in the Preliminary Decision Memorandum 1. Summary 2. Background 3. Scope of the Order 4. Discussion of the Methodology 5. Conclusion
    [FR Doc. 2016-12753 Filed 5-27-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE653 Pacific Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The Pacific Fishery Management Council's (Pacific Council) Salmon Technical Team (STT) and Salmon Advisory Subpanel (SAS) will hold a webinar, which is open to the public, to discuss and make recommendations on issues on the Council's June 2016 agenda.

    DATES:

    The webinar will be held on Friday, June 17, 2016, from 1:30 p.m. until business for the day is complete.

    ADDRESSES:

    To attend the webinar, visit: http://www.gotomeeting.com/online/webinar/join-webinar. Enter the Webinar ID, which is 142-415-203, and your name and email address (required). After logging in to the webinar, please: dial this TOLL number +1 (631) 992-3221 (not a toll-free number), enter the Attendee phone audio access code 774-887-965, and then enter your audio phone pin (shown after joining the webinar). Participants are encouraged to use their telephone, as this is the best practice to avoid technical issues and excessive feedback. (See http://www.pcouncil.org/wp-content/uploads/PFMC_Audio_Diagram_GoToMeeting.pdf.) System Requirements for PC-based attendees: Required: Windows® 7, Vista, or XP; for Mac®-based attendees: Required: Mac OS® X 10.5 or newer; and for mobile attendees: iPhone®, iPad®, AndroidTM phone or Android tablet (See the GoToMeeting Webinar Apps). You may send an email to [email protected] or contact him at (503) 820-2280, extension 425 for technical assistance. A public listening station will also be provided at the Pacific Council office.

    Council address: Pacific Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Mike Burner, Pacific Council; telephone: (503) 820-2414.

    SUPPLEMENTARY INFORMATION:

    The STT and SAS will discuss and make recommendations on items on the Council's June 2016 meeting agenda. Major topics include, but are not limited to: Sacramento River Winter Chinook Harvest Control Rule Update, Scoping of Pacific Halibut Catch Share Plan Allocation Changes, and Western Region Climate Change Action Plan. The STT and SAS may also address one or more of the Council's scheduled Administrative Matters. Public comments during the webinar will be received from attendees at the discretion of the STT and SAS Chairs.

    Although nonemergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document 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

    The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2425 at least 5 days prior to the meeting date.

    Dated: May 25, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-12714 Filed 5-27-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Southeast Region Dealer and Interview Family of Forms AGENCY:

    National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

    DATES:

    Written comments must be submitted on or before August 1, 2016.

    ADDRESSES:

    Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at [email protected]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Dr. David Gloeckner, (305) 361-4257 or [email protected]

    SUPPLEMENTARY INFORMATION: I. Abstract

    This request is for revision of a current information collection.

    Fishery quotas are established for many species in the fishery management plans developed by the Gulf of Mexico Reef Fish Fishery Management Council, the South Atlantic Fishery Management Council, and The Caribbean Fishery Management Council. The Southeast Fisheries Science Center has been delegated the responsibility to monitor these quotas. To do so in a timely manner, seafood dealers that handle these species are required to report the purchases (landings) of these species. The frequency of these reporting requirements varies depending on the magnitude of the quota (e.g., lower quota usually require more frequent reporting) and the intensity of fishing effort. The most common reporting frequency is twice a month; however, some fishery quotas, (e.g., the mackerel gill net) necessitate weekly or by the trip reporting.

    In addition, information collection included in this family of forms includes interview with fishermen to gather information on the fishing effort, location and type of gear used on individual trips. This data collection is conducted for a subsample of the fishing trips and vessel/trips in selected commercial fisheries in the Southeast region and commercial fisheries of the U.S. Caribbean. Fishing trips and individuals are selected at random to provide a viable statistical sample. These data are used for scientific analyses that support critical conservation and management decisions made by national and international fishery management organizations.

    A revision to this collection is requested because the Caribbean Fishery Management Council has asked that commercial trip interviews be conducted for the fisheries of the Caribbean. In order to support this request, the SEFSC has developed a sampling procedure which will require additional commercial trip interview with fishers in the Caribbean. This data collection is authorized under 50 CFR part 622.5.

    II. Method of Collection

    Dealer reports may be emailed, faxed or mailed. Information from fisherman is obtained by face-to-face interviews.

    III. Data

    OMB Number: 0648-0013.

    Form Number: None.

    Type of Review: Regular submission (revision of a current information collection).

    Affected Public: Business and other for-profit organizations.

    Estimated Number of Respondents: 7,580.

    Estimated Time per Response:

    Dealer reporting for monitoring Federal fishery annual catch limits (ACLs): Coastal fisheries dealers reporting, 10 minutes; mackerel dealer reporting (non-gillnet), 10 minutes; mackerel dealer reporting (gillnet), 10 minutes; mackerel vessel reporting (gillnet), 10 minutes; wreckfish dealer reporting, 10 minutes.

    Bioprofile data from Trip Interview programs (TIP): Shrimp Interviews,10 minutes; Fin Fish interviews, 10 minutes.

    Estimated Total Annual Burden Hours: 3,404.

    Estimated Total Annual Cost to Public: $0 in recordkeeping/reporting costs.

    IV. Request for Comments

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

    Dated: May 25, 2016. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2016-12692 Filed 5-27-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Evaluations of National Estuarine Research Reserves and Coastal Management Programs AGENCY:

    Office for Coastal Management (OCM), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).

    ACTION:

    Notice.

    SUMMARY:

    The National Oceanic and Atmospheric Administration (NOAA), Office for Coastal Management will hold a public meeting to solicit comments on the performance evaluation of the Tijuana River National Estuarine Research Reserve. Notice is also hereby given of the availability of the final evaluation findings for the Florida Coastal Management Program.

    DATES:

    Tijuana River National Estuarine Research Reserve Evaluation: The public meeting will be held on Tuesday, July 19, 2016, and written comments must be received on or before Friday, July 29, 2016.

    For specific dates, times, and locations of the public meetings, see SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    You may use any of the following methods to submit comments regarding the reserve NOAA intends to evaluate:

    Public Meeting and Oral Comments: Public meetings will be held in Imperial City, California. For specific locations, see SUPPLEMENTARY INFORMATION.

    Written Comments: Please direct written comments to Ralph Cantral, Evaluator, Policy, Planning and Communications, Office for Coastal Management, NOS/NOAA, 1305 East-West Highway, 11th Floor, N/OCM1, Silver Spring, Maryland 20910, or email comments to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Ralph Cantral, Evaluator, Policy, Planning and Communications, Office for Coastal Management, NOS/NOAA, 1305 East-West Highway, 11th Floor, N/OCM1, Silver Spring, Maryland 20910, or [email protected] Copies of the final evaluation findings and related material (including past performance reports and notices prepared by NOAA's Office for Coastal Management) may be obtained upon written request by contacting Ralph Cantral. Copies of the final evaluation findings may also be downloaded or viewed on the Internet at http://coast.noaa.gov/czm/evaluations/evaluation_findings/index.html.

    SUPPLEMENTARY INFORMATION:

    Sections 312 and 315 of the Coastal Zone Management Act (CZMA) require NOAA to conduct periodic evaluations of federally approved national estuarine research reserves. The process includes a public meeting, consideration of written public comments and consultations with interested Federal, state, and local agencies and members of the public. During the evaluation, NOAA will consider the extent to which the state has met the national objectives, adhered to the final management plan approved by the Secretary of Commerce, and adhered to the terms of financial assistance under the CZMA. When the evaluation is completed, NOAA's Office for Coastal Management will place a notice in the Federal Register announcing the availability of the Final Evaluation Findings.

    Specific information on the periodic evaluation of reserves that are the subject of this notice are detailed below:

    Tijuana River National Estuarine Research Reserve Evaluation

    You may participate or submit oral comments at the public meeting scheduled as follows:

    Date: July 19, 2016.

    Time: 6 p.m., local time.

    Location: 301 Caspian Way, Imperial Beach, California 91932.

    Written comments must be received on or before July 29, 2016.

    Availability of Final Evaluation Findings of Other State and Territorial Coastal Programs

    The NOAA Office for Coastal Management has completed review of the Coastal Zone Management Program evaluations for the state of Florida. The state was found to be implementing and enforcing their federally approved coastal management program, addressing the national coastal management objectives identified in CZMA Section 303(2)(A)-(K), and adhering to the programmatic terms of their financial assistance awards. Copies of the final evaluation findings may be downloaded at http://coast.noaa.gov/czm/evaluations/evaluation_findings/index.html or by submitting a written request to the person identified under FOR FURTHER INFORMATION CONTACT.

    Dated: May 23, 2016. John King, Deputy Director, Office for Coastal Management, National Ocean Service, National Oceanic and Atmospheric Administration. Federal Domestic Assistance Catalog 11.419 Coastal Zone Management Program Administration
    [FR Doc. 2016-12783 Filed 5-27-16; 8:45 am] BILLING CODE 3510-08-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE654 Pacific Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The Pacific Fishery Management Council's (Pacific Council) Ad hoc Sacramento River Winter Chinook Workgroup (SRWCW) will hold a webinar, which is open to the public, to discuss progress on development of potential harvest control rule options.

    DATES:

    The webinar will be held on Wednesday, June 15, from 1:30 p.m. until business for the day is complete.

    ADDRESSES:

    To attend the webinar, visit: http://www.gotomeeting.com/online/webinar/join-webinar. Enter the Webinar ID, which is 131-571-715, and your name and email address (required). After logging in to the webinar, please: Dial this TOLL number +1 (562) 247-8422 (not a toll-free number), enter the Attendee phone audio access code 684-586-345, and then enter your audio phone pin (shown after joining the webinar). Participants are encouraged to use their telephone, as this is the best practice to avoid technical issues and excessive feedback. (See http://www.pcouncil.org/wp-content/uploads/PFMC_Audio_Diagram_GoToMeeting.pdf). System Requirements for PC-based attendees: Required: Windows® 7, Vista, or XP; for Mac®-based attendees: Required: Mac OS® X 10.5 or newer; and for mobile attendees: iPhone®, iPad®, AndroidTM phone or Android tablet (See the GoToMeeting Webinar Apps). You may send an email to [email protected] or contact him at (503) 820-2280, extension 425 for technical assistance. A public listening station will also be provided at the Pacific Council office.

    Council address: Pacific Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Mike Burner, Pacific Council; telephone: (503) 820-2414.

    SUPPLEMENTARY INFORMATION:

    The SRWCW will discuss progress on the development of new indicators and predictors of Sacramento River winter Chinook ocean abundance, review methods for evaluating the relative risks and benefits of alternative harvest control rules, prepare a report for the Council's June 2016 meeting, and discuss future meeting plans.

    Although nonemergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document 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

    The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2280, extension 425 at least 5 days prior to the meeting date.

    Dated: May 25, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-12715 Filed 5-27-16; 8:45 am] BILLING CODE 3510-22-P
    COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities: Notice of Intent To Renew Collection 3038-0017, Market Surveys AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Commodity Futures Trading Commission (“CFTC” or “Commission”) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (“PRA”), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment. This notice solicits comments on market investigations.

    DATES:

    Comments must be submitted on or before August 1, 2016.

    ADDRESSES:

    You may submit comments, identified by “Market Surveys,” Collection Number 3038-0017, by any of the following methods:

    • The Agency's Web site, at http://comments.cftc.gov/. Follow the instructions for submitting comments through the Web site.

    Mail: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581.

    Hand Delivery/Courier: Same as Mail above.

    Please submit your comments using only one method.

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

    Please submit your comments using only one method.

    All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http://www.cftc.gov.

    FOR FURTHER INFORMATION CONTACT:

    Gary J Martinaitis, Associate Deputy Director, Division of Market Oversight, Commodity Futures Trading Commission, (202) 418-5209; email: [email protected], and refer to OMB Control No. 3038-0017.

    SUPPLEMENTARY INFORMATION:

    Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, the CFTC is publishing notice of the proposed collection of information listed below.

    Title: Market Surveys (OMB Control No. 3038-0017). This is a request for extension of a currently approved information collection.

    Abstract: Under Commission Rule 21.02, upon call by the Commission, information must be furnished related to futures or options positions held or introduced by futures commission merchants, members of contract markets, introducing brokers, foreign brokers, and for options positions, by each reporting market. This rule is designed to assist the Commission in prevention of market manipulation and is promulgated pursuant to the Commission's rulemaking authority contained in section 8a of the Commodity Exchange Act, 7 U.S.C. 12a (2010).

    With respect to the collection of information, the CFTC invites comments on:

    • Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;

    • The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Ways to enhance the quality, usefulness, and clarity of the information to be collected; and

    • Ways to minimize the burden of 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.

    You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations.1

    1 17 CFR 145.9.

    The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from http://www.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the Information Collection Request will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act.

    Burden Statement: The respondent burden for this collection is estimated to be as follows.

    Estimated Annual Reporting Burden 17 CFR section Annual number of respondents Frequency of response Total annual responses Hours per
  • response
  • Total hours
    21.02 400 Annually 400 1.75 700

    Respondents/Affected Entities: futures commission merchants, members of contract markets, introducing brokers, foreign brokers, contract markets.

    Estimated number of respondents: 400.

    Estimated total annual burden on respondents: 700 hours.

    Frequency of collection: Annually.

    Authority:

    44 U.S.C. 3501 et seq.

    Dated: May 25, 2016. Robert N. Sidman, Deputy Secretary of the Commission.
    [FR Doc. 2016-12707 Filed 5-27-16; 8:45 am] BILLING CODE 6351-01-P
    DEPARTMENT OF DEFENSE Office of the Secretary Notice of Availability of Draft Environmental Impact Statement for the Continental United States Interceptor Site AGENCY:

    Missile Defense Agency, Department of Defense.

    ACTION:

    Notice of availability and notice of activity in Wetlands as required by Executive Order 11990 (Protection of Wetlands).

    SUMMARY:

    The Missile Defense Agency (MDA) announces the availability of the Draft Environmental Impact Statement (EIS) for the potential deployment of a Continental United States (CONUS) Interceptor Site (CIS). A CIS Draft EIS was prepared in accordance with the National Environmental Policy Act (NEPA) of 1969 and the Council on Environmental Quality Regulations for Implementing the Procedural Provisions of NEPA and assesses the impacts of the potential deployment of a CIS.

    As required by the fiscal year 2013 National Defense Authorization Act, the MDA has conducted extensive surveys and assessments for development of a Draft EIS in order to evaluate candidate sites for the potential future deployment of additional ground-based interceptors for homeland defense against threats from nations such as North Korea and Iran.

    All potential sites analyzed in this Draft EIS contain wetlands that would be affected. All practicable measures were taken to arrange a CIS footprint to minimize and avoid impacts to wetlands while still maintaining operational effectiveness. However there are no practicable deployment alternatives that would completely avoid impacts to wetlands. If a deployment decision were made MDA would coordinate with the U.S. Army Corps of Engineers and applicable state department of environmental protection to determine appropriate mitigations for wetland impacts. As required by Executive Order (EO) 11990 (Protection of Wetlands), MDA would prepare a Finding of No Practicable Alternative (FONPA) for the selected site. The FONPA would explain why there is no practicable alternative to impacting wetlands at the identified site. MDA is providing a public review, in accordance with EO 11990, of its findings in the Draft EIS concerning wetlands impacts and potential mitigation measures.

    DATES:

    The public comment period will be from June 3 to July 18, 2016.

    ADDRESSES:

    Comments on the Draft EIS should be received by July 18, 2016 by one of the following methods:

    Mail: U.S. Postal Service to: Black & Veatch Special Projects Corp. Attn: MDA CIS EIS, 6800 W 115th Street, Suite 2200, Overland Park, KS-66211-2420.

    Email: [email protected]

    Public comments on the Draft EIS are requested pursuant to the NEPA. All written comments received during the comment period will become part of the public record. Providing private address information with your comment is voluntary and such personal information will be kept confidential unless release is required by law. All comments received by the public, including at public meetings, will be addressed in the Final EIS. A NOA will be published notifying the public of the final EIS.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Christopher Johnson, MDA Public Affairs, at 571-231-8212, or by email: [email protected] For more information, including a downloadable copy of the Draft EIS, visit the MDA Web site at http://www.mda.mil.

    SUPPLEMENTARY INFORMATION:

    Proposed Action and Alternative: The Department of Defense (DoD) does not have a proposed action and has not made a decision to deploy or construct an additional interceptor site. Current sites in Alaska and California provide the necessary protection of the homeland from a ballistic missile attack by countries such as North Korea and Iran. If the DoD were to make a decision in the future to construct a new site, the prior completion of the required site studies and EIS could shorten the timeline necessary to build such a site.

    If deployed, a CIS would be an extension of the existing Ground-based Midcourse Defense (GMD) element of the Ballistic Missile Defense System. To the extent practicable, the CIS would be built as a contiguous Missile Defense Complex, similar to that found at Fort Greely, Alaska, and would consist of a deployment of up to a total of 60 Ground-Based Interceptors (GBIs) in up to three GBI fields. The GBIs would not be fired from their deployment site except in the Nation's defense and no test firing would be conducted at a CIS. The overall system architecture and baseline requirements for a notional CIS include, but are not limited to, the GBI fields, Command Launch Equipment, In-Flight Interceptor Communication System Data Terminals, GMD Communication Network, supporting facilities, such as lodging and dining, recreation, warehouse and bulk storage, vehicle storage and maintenance, fire station, hazardous materials/waste storage, and roads and parking where necessary.

    Candidate site locations under consideration include: Fort Custer Training Center in Michigan; Camp Ravenna Joint Military Training Center in Ohio; and Fort Drum in New York. Earlier this year, MDA designated the Center for Security Forces Detachment Kittery Survival, Evasion, Resistance and Escape Facility (SERE East) in Redington Township, Maine as an Alternative Considered, but Not Carried Forward. The Draft EIS also analyzed a No Action Alternative or no CIS deployment. The DoD has not made a decision to deploy or construct a CIS and does not have a preferred alternative.

    For each of the candidate site locations, the following resource areas were assessed: air quality, air space, biological, cultural, environmental justice, geology and soils, hazardous materials and hazardous waste management, health and safety, land use, noise, socioeconomics, transportation, utilities, water, wetlands, and visual and aesthetics.

    Information: The MDA will host open house public meetings at each of the candidate site locations to review the Draft EIS. Similar to the scoping meetings held in August 2014, the open house event will allow attendees to talk with experts at a series of information stations. Attendees can learn about findings in the Draft EIS and may provide verbal and written comments.

    The open house events and dates are as follows: (1) June 21, 2016 from 5:00 p.m. to 8:00 p.m.; Lakeview Middle School, 300 S. 28th St., Battle Creek, Michigan; (2) June 23, 2016 from 5:00 p.m. to 8:00 p.m.; Richland Community Center, 9400 E. Cd Ave., Richland, Michigan; (3) June 28, 2016 from 5:00 p.m. to 8:00 p.m.; Carthage Senior High School, 36500 New York 26, Carthage, New York; (4) June 30, 2016 from 5:00 p.m. to 8:00 p.m.; Ravenna High School, 6589 N. Chestnut Street, Ravenna, Ohio.

    Dated: May 24, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-12681 Filed 5-27-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2016-OS-0065] Proposed Collection; Comment Request AGENCY:

    Department of Defense Education Activity, DoD.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the Department of Defense Education Activity announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed information collection; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) 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 August 1, 2016.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at http://www.regulations.gov for submitting comments. Please submit comments on any given form identified by docket number, form number, and title.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Aniko Maher, MED, BSN, RN, NCSN, Instructional System Specialist, Nursing, Department of Defense Education Activity, 4800 Mark Center Drive, Alexandria Virginia, 22350-1400, [email protected], or call at (571) 372-6001.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: School Health Services Guide, DoDEA Forms, H-1-1, H-1-2, H-2-1, H-2-2, H-2-2a, H-3-2, H-3-6, H-3-7, H-3-9, H-4-8, H-4-9, H-4-9-1, H-6-3, H-6-5, H-8-2, H-8-3, H-8-4, H-9-3, H-9-6, H-10-3, H-10-6, H12-3, H-13-1; 0704-XXXX.

    Needs and Uses: The information collection requirement is necessary to obtain and record student health information, required immunizations, existing medical conditions, limitations, treatments that may require nursing care and intervention at school, for school age children attending DoDEA schools.

    Affected Public: Individuals or households, not-for-profit institutions.

    Annual Burden Hours: 29,200.

    Number of Respondents: 292,000.

    Responses per Respondent: 1.

    Annual Responses: 292,000.

    Average Burden per Response: 6 minutes.

    Frequency: On occasion.

    Respondents are sponsors/parents/guardians for military dependent school aged children attending DoDEA schools, and medical professionals who provide medical care for those children. Forms collect health history, immunization history, medical care plans, and physical clearance on students for safe health care management during school hours and activities. If the form is not collected, unsafe conditions may develop impacting the welfare of individual students, the school community and the community at large. The 23 forms are batched based on the purpose of the forms being collection of health status and medical related information to be processed by the school nurse or other authorized personnel in DoDEA schools.

    Dated: May 25, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-12717 Filed 5-27-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Uniform Formulary Beneficiary Advisory Panel; Notice of Federal Advisory Committee Meeting AGENCY:

    Assistant Secretary of Defense (Health Affairs), DoD.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Department of Defense is publishing this notice to announce a Federal Advisory Committee meeting of the Uniform Formulary Beneficiary Advisory Panel (hereafter referred to as the Panel).

    DATES:

    Wednesday, June 22, 2016, from 9 a.m. to 12 p.m.

    ADDRESSES:

    Naval Heritage Center Theater, 701 Pennsylvania Avenue NW., Washington, DC 20004.

    FOR FURTHER INFORMATION CONTACT:

    CAPT Edward Norton, Designated Federal Officer (DFO), Uniform Formulary Beneficiary Advisory Panel, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101. Telephone: (703) 681-2890. Fax: (703) 681-1940. Email Address: [email protected]

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (Title 5, United States Code (U.S.C.), Appendix, as amended) and the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended).

    Purpose of Meeting: The Panel will review and comment on recommendations made to the Director of Defense Health Agency, by the Pharmacy and Therapeutics Committee, regarding the Uniform Formulary.

    Meeting Agenda 1. Sign-In 2. Welcome and Opening Remarks 3. Public Citizen Comments 4. Scheduled Therapeutic Class Reviews (Comments will follow each agenda item) a. Oral Contraceptives—Emergency Contraceptives b. Anticonvulsants Agents c. Antipsychotic Agents—Atypical 5. Designated Newly Approved Drugs in Already-Reviewed Classes 6. Designated Newly FDA Approved Drugs 7. Pertinent Utilization Management Issues 8. Panel Discussions and Vote

    Meeting Accessibility: Pursuant to 5 U.S.C. 552b, as amended, and 41 Code of Federal Regulations (CFR) 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is limited and will be provided only to the first 220 people signing-in. All persons must sign-in legibly.

    Administrative Work Meeting: Prior to the public meeting, the Panel will conduct an Administrative Work Meeting from 8:30 a.m. to 9:00 a.m. to discuss administrative matters of the Panel. The Administrative Work Meeting will be held at the Naval Heritage Center, 701 Pennsylvania Avenue NW., Washington, DC 20004. Pursuant to 41 CFR 102-3.160, the Administrative Work Meeting will be closed to the public.

    Written Statements: Pursuant to 41 CFR 102-3.140, the public or interested organizations may submit written statements to the membership of the Panel at any time or in response to the stated agenda of a planned meeting. Written statements should be submitted to the Panel's DFO. The DFO's contact information can be obtained from the General Services Administration's Federal Advisory Committee Act Database at http://facadatabase.gov/.

    Written statements that do not pertain to the scheduled meeting of the Panel may be submitted at any time. However, if individual comments pertain to a specific topic being discussed at a planned meeting, then these statements must be submitted no later than 5 business days prior to the meeting in question. The DFO will review all submitted written statements and provide copies to all the committee members.

    Public Comments: In addition to written statements, the Panel will set aside 1 hour for individuals or interested groups to address the Panel. To ensure consideration of their comments, individuals and interested groups should submit written statements as outlined in this notice; but if they still want to address the Panel, then they will be afforded the opportunity to register to address the Panel. The Panel's DFO will have a “Sign-Up Roster” available at the Panel meeting for registration on a first-come, first-serve basis. Those wishing to address the Panel will be given no more than 5 minutes to present their comments, and at the end of the 1-hour time period, no further public comments will be accepted. Anyone who signs-up to address the Panel, but is unable to do so due to the time limitation, may submit their comments in writing; however, they must understand that their written comments may not be reviewed prior to the Panel's deliberation.

    To ensure timeliness of comments for the official record, the Panel encourages that individuals and interested groups consider submitting written statements instead of addressing the Panel.

    Dated: May 25, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-12713 Filed 5-27-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION Applications for New Awards; Teacher Incentive Fund AGENCY:

    Office of Innovation and Improvement, Department of Education.

    ACTION:

    Notice.

    Overview Information Teacher Incentive Fund (TIF).

    Notice inviting applications for new awards for fiscal year (FY) 2016.

    Catalog of Federal Domestic Assistance (CFDA) Number: 84.374A. DATES:

    Applications Available: May 31, 2016.

    Deadline for Notice of Intent To Apply: June 30, 2016.

    Dates of Pre-Application Workshops: For information about pre-application workshops, visit the TIF Web site at: http://innovation.ed.gov/what-we-do/teacher-quality/teacher-incentive-fund/.

    Deadline for Transmittal of Applications: July 15, 2016.

    Deadline for Intergovernmental Review: September 28, 2016.

    Full Text of Announcement I. Funding Opportunity Description

    Purpose of Program: The purpose of the TIF program is to support, develop, and implement sustainable Performance-based Compensation Systems for teachers, principals, and other personnel in High-Need Schools,1 within the context of a local educational agency's (LEA's) overall Human Capital Management System, in order to increase Educator effectiveness and student achievement in those schools.

    1 Throughout this notice, all defined terms are denoted with initial capitals.

    Background: The TIF program is based on the premise, supported by 20 years of research, that effective teachers are the most critical in-school factor in improving student outcomes. Recent research suggests that principals and principal quality are also key, but often overlooked, in-school factors for improving student outcomes. Given the importance of ensuring that Educators are as effective as possible—especially for high-need students—the TIF program uses performance-based compensation and related supports for Educators to catalyze improvements in a district's human capital management and in student outcomes.

    The Department designed each of the previous three TIF competitions in FYs 2006, 2010, and 2012 to build on earlier efforts as the Department, States, districts, and schools learned more about how to support Educators in their efforts to help students learn. Through the most recent TIF competition (in FY 2012), the Department funded projects that encompassed broader human capital management systems that supported sustainable performance-based compensation. This is in contrast to earlier TIF competitions, which focused almost exclusively on the provision of annual one-time bonuses. The FY 2012 competition also focused on projects under which grantees deployed a variety of human capital management strategies throughout an Educator's career trajectory (e.g., from pre-service through retention) to help support and sustain the grantees' performance-based compensation systems.

    For example, several grantees in the FY 2012 cohort changed their district-wide compensation systems to: (1) Allow Educators who demonstrate effectiveness to earn significantly higher pay or to significantly accelerate the timeline for increased compensation, particularly for those Educators in High-Need Schools and subjects; (2) provide incentives and supports to increase the number of effective Educators who are recruited and retained in High-Need Schools; (3) develop and implement career ladders to give Educators opportunities for leadership and advancement inside and outside the classroom; and (4) implement a salary system where increases are based in part on effectiveness. This expanded strategy of incentivizing effective Educators through performance-based compensation aligns with the purpose and goals of the TIF program.

    There is no single set of best practices that districts should use to demonstrate their readiness to implement innovative human capital management strategies, including performance-based compensation. We know, however, that when TIF grantees have a set of human capital policies and practices in place at the outset of the grant period that support and align with their performance-based compensation strategies, these grantees face fewer challenges in implementing transformation efforts than those without such a foundation in place. The experience of these grantees demonstrates that building the systems and tools designed to evaluate, support, and manage Educators in ways that support and sustain their performance-based compensation requires districts to make significant infrastructure and capacity commitments, including: a district-wide, Educator evaluation and support system that includes multiple measures, including gains in student achievement, and meaningfully differentiates performance levels of Educators; data systems that collect and report on the elements of an Educator evaluation and support system in clear and coherent ways; a range of mechanisms to identify specific areas for Educator development and support, and for providing that support; and practices that enable administrators, school leaders, and Educators to communicate and influence the implementation of these systems. Efforts to create these kinds of systems and tools are more likely to drive enduring, sustainable improvements in Educator practice and student learning if they are aligned with the current district work to improve student outcomes and produce valid, reliable, and trusted information. A robust Educator evaluation system—one that uses, among other things, gains in student academic achievement and multiple annual observations—is not only statutorily required for TIF grantees, but is also critical to the readiness of a district to take on this work.

    Additionally, TIF grantees are more successful when they collaborate with key stakeholders in designing, implementing, and continuously improving their projects. A district's Performance-based Compensation System, developed with the input of teachers and school leaders in the schools to be served by the grant, prepares districts to immediately take on this work by regularly seeking the feedback of Educators on initiatives and programs that impact schools. Districts that have systems in place for seeking this feedback demonstrate an understanding of the critical role Educator voice plays in successful human capital transformation. Common effective practices include initial design teams that bring together teachers and principals; task forces to tackle specific issues, such as selecting a rubric for use in evaluations; and focus groups that provide feedback on proposed career ladder systems or new compensation models. This ongoing engagement is critical to obtaining Educator buy-in to, and the success of, high-quality evaluation and support systems that are critical to a viable, meaningful Performance-based Compensation System.

    District-level human capital strategies have shifted significantly since the FY 2012 competition. In recent years, many State educational agencies (SEAs) and LEAs have developed high-quality educator evaluation and support systems as part of comprehensive reform strategies implemented consistent with competitive federal awards and flexibility offered by the Department under the Elementary and Secondary Education Act of 1965, as amended (ESEA). States and Districts have used these systems as part of their efforts to improve districts' hiring practices, provide Educators with meaningful feedback and targeted professional development, and use Educator performance information to inform key school- and district-level decisions, such as teacher placement or leadership opportunities. Consequently, an increasing number of districts are prepared to make more informed human capital decisions that both support Educators and improve student outcomes. While section 4(c) of the Every Student Succeeds Act (ESSA) (Pub. L. 114-95, December 10, 2015) ends waivers under ESEA flexibility as of August 1, 2016, section 2101(c)(4)(B)(ii) of the ESEA, as amended by ESSA, provides States and districts with explicit authority to “support the design and implementation of teacher, principal, or other school leader evaluation and support systems.” This will allow States and districts to continue to improve the systems they have established.

    While SEAs and LEAs have made substantial progress, additional work is needed to ensure that these Educator evaluation and support systems are robust, relevant, reliably producing trusted information, and seamlessly integrated into school- and district-level human capital processes. In some cases, this may mean expanding or improving existing approaches within a current educator evaluation and support system, by, for example, providing more mentoring and coaching opportunities for Educators. In other cases, districts may be well-positioned to take on new challenges or opportunities that affect Educator effectiveness, such as partnering with institutions of higher education to strengthen pre-service programming.

    Finally, SEAs are now engaged in renewed efforts to ensure that high-need students have equitable access to the most effective Educators. Research indicates that students' race and family income often predict their access to excellent educators. Low-income students and high-need schools tend to have teachers who are less experienced, have fewer credentials and do not demonstrate a track record of success.2 For example, while we know there are many excellent first-year teachers, based on 2011-12 data from the Department's Civil Rights Data Collection, African American and American Indian students are four times as likely as white students to be enrolled in a school with more than twenty percent of first-year teachers, and Latino students are three times as likely.3 The Department helped spur States' efforts to increase equitable access to excellent Educators through its Excellent Educators for All Initiative, launched in July 2014, under which the Department required each SEA to submit a plan describing the steps it will take to ensure that “poor and minority children are not taught at higher rates than other children by inexperienced, unqualified, or out-of-field teachers,” as required by section 1111(b)(8)(C) of the ESEA, as amended by the No Child Left Behind Act of 2001. To date, all fifty states, the District of Columbia and Puerto Rico have approved plans to advance educator equity consistent with the requirements in the law. SEAs must continue to engage in educator equity efforts under section 1111(g)(1)(B) of the ESEA, as amended by the ESSA.

    2 See, e.g., Isenberg, Eric, et al. “Access to Effective Teaching for Disadvantaged Students. NCEE 2014-4001.” Institute of Education Sciences (2013): http://ies.ed.gov/ncee/pubs/20144001/pdf/20144001.pdf.

    Sass, Tim, Jane Hannaway, Zeyu Xu, David Figlio, and Li Feng. “Value Added of Teachers in High-Poverty Schools and Lower-Poverty Schools.” Journal of Urban Economics, vol. 72, 2012, pp.104-122: http://www.sciencedirect.com/science/article/pii/S0094119012000216.

    Tennessee Department of Education. “Tennessee's Most Effective Teachers: Are They Assigned to the Schools That Need Them Most?” Nashville, TN: Tennessee Department of Education, 2007: http://www.gtlcenter.org/webcasts/addressingInequities/Tennessee_McCargar.pdf.

    3 U.S. Department of Education Office for Civil Rights, Civil Rights Data Collection: Data Snapshot (Teacher Equity) (March 21, 2014 (revised July 3, 2014)): http://ocrdata.ed.gov/Downloads/CRDC-Teacher-Equity-Snapshot.pdf.

    Most SEAs started to implement approved plans in the 2015-16 school year; these plans can be found at www2.ed.gov/programs/titleiparta/resources.html. Based on Department review of these plans, and consistent with requirements that will take effect when ESSA is implemented, the Department believes TIF can support SEAs and LEAs in implementing strategies aimed at improving equitable access to effective Educators.

    Priorities: This notice contains one absolute priority, two competitive preference priorities, and one invitational priority. The absolute priority aligns with the language of the 2016 Appropriations Act that authorizes funding for this competition, the notice of final priorities, requirements, definitions, and selection criteria for this program (TIF NFP), published in the Federal Register on June 14, 2012 (77 FR 35757), and basic provisions of ESSA's Teacher and School Leader Incentive Fund Grants Program (ESSA sections 2211 and 2212), which we adopt under the authority for an orderly transition to this Act contained in section 4(b) of the ESSA. The competitive preference priorities are from the Secretary's final supplemental priorities and definitions for discretionary grant programs (Supplemental Priorities) published in the Federal Register on December 10, 2014 (79 FR 73425) and basic provisions of ESSA's Teacher and Leader Incentive Fund Grants Program (ESSA sections 2211 and 2212), which we adopt under the authority for an orderly transition to this Act contained in section 4(b) of the ESSA.

    Absolute Priority: For FY 2016, this priority is an absolute priority. Under 34 CFR 75.105(c)(3) we consider only applications that meet this priority.

    The priority is:

    An LEA-Wide Human Capital Management System (HCMS) With Educator Evaluation and Support Systems at the Center

    To meet this priority, the applicant must include, in its application, a description of its LEA-wide HCMS, as it exists currently and with any modifications proposed for implementation during the project period of the grant. The application must describe—

    (1) How the HCMS is or will be aligned with the LEA's vision of instructional improvement;

    (2) How the LEA uses or will use the information generated by the Evaluation and Support System it describes in its application to inform key human capital decisions, such as decisions on recruitment, hiring, placement, retention, dismissal, compensation, professional development, tenure, and promotion;

    (3) The human capital strategies the LEA uses or will use to ensure that High-Need Schools are able to attract and retain effective Educators; and

    (4) Whether or not modifications are needed to an existing HCMS to ensure that it includes the features described in response to paragraphs (1), (2), and (3) of this priority, and a timeline for implementing the described features, provided that the use of evaluation information to inform the design and delivery of professional development and the award of performance-based compensation under the applicant's proposed Performance-based Compensation Systems in High-Need Schools begins no later than the third year of the grant's project period in the High-Need Schools listed in response to paragraph (a) of Requirement 2—Documentation of High-Need Schools.

    Note:

    TIF funds can be used to support the costs of the systems and strategies described under this priority.

    Competitive Preference Priorities: For FY 2016, these priorities are competitive preference priorities. Under 34 CFR 75.105(c)(2) we award an additional two points to an application that meets Competitive Preference Priority 1, and we award up to an additional five points to an application, depending on how well the application meets Competitive Preference Priority 2.

    The priorities are:

    Competitive Preference Priority 1—Supporting High-Need Students (0 or 2 points). Projects that are designed to improve academic outcomes for students served by Rural Local Educational Agencies.

    Competitive Priority 2—Improving Teacher Effectiveness and Promoting Equitable Access to Effective Educators (up to 5 points). Projects that are designed to promote equitable access to effective teachers for students from low-income families and minority students across and within schools and districts.

    For the purposes of this priority, teacher effectiveness must be measured using an Evaluation and Support System.

    Within this competitive preference priority, we are particularly interested in applications that address the following invitational priority. Whether an LEA's TIF application addresses the competitive preference priority based on strategies they are already implementing or strategies they propose to implement, this invitational priority encourages LEAs to align their own strategies with the State Equity Plan.

    Invitational Priority: Under 34 CFR 75.105(c)(1) we do not give an application that meets this invitational priority a competitive or absolute preference over other applications.

    This priority is:

    Invitational Priority—Promoting Equitable Access Through State Plans To Ensure Equitable Access to Excellent Educators: Applications that include a description of how the applicant's project promotes equitable access to effective Educators for students from low-income families and for minority students across and within districts, consistent with approved State Plans to Ensure Equitable Access to Excellent Educators.

    Requirements: The following requirements are from the TIF 2012 NFP and the 2016 Appropriations Act.

    Requirement 1—Implementation of Performance-based Compensation Systems: Each applicant must describe a plan to develop and implement Performance-based Compensation Systems for teachers, principals, and other personnel in High-Need Schools in LEAs, including charter schools that are LEAs.

    Applications must: address how applicants will implement Performance-based Compensation Systems as defined in this notice. Applicants also must demonstrate that such Performance-based Compensation Systems are developed with the input of teachers and school leaders in the schools and LEAs to be served by the grant.

    Requirement 2—Documentation of High-Need Schools: Each applicant must demonstrate, in its application, that the schools participating in the implementation of the TIF-funded Performance-based Compensation Systems are High-Need Schools (as defined in this notice), including High-Poverty Schools, Priority Schools, or Persistently Lowest-Achieving Schools. Each applicant must provide, in its application—

    (a) A list of High-Need Schools in which the proposed TIF-supported Performance-based Compensation Systems would be implemented; and

    (b) For each High-Poverty School listed, the most current data on the percentage of students who are eligible for free or reduced-price lunch subsidies under the Richard B. Russell National School Lunch Act or are considered students from low-income families based on another poverty measure that the LEA uses (see section 1113(a)(5) of the ESEA (20 U.S.C. 6313(a)(5))). Data provided to demonstrate eligibility as a High-Poverty School must be school-level data; the Department will not accept LEA- or State-level data for purposes of documenting whether a school is a High-Poverty School; and

    (c) For any Priority Schools listed, documentation verifying that the State has received approval of a request for ESEA flexibility, and that the schools have been identified by the State as priority schools.

    Definitions: The following definitions are from the TIF NFP, the Supplemental Priorities, the ESEA, as amended by the ESSA, and 34 CFR 77.1. The source of each definition is noted in parentheses following the text of the definition.

    Educators means teachers and principals. (TIF NFP)

    Evaluation and Support System means a system that is fair, rigorous, valid, reliable, and objective and reflects clear and fair measures of teacher, principal, or other school leader performance, based in part on demonstrated improvement in student academic achievement; and provides teachers, principals, or other school leaders with ongoing, differentiated, targeted, and personalized support and feedback for improvement, including professional development opportunities designed to increase effectiveness. (ESSA § 2212(c)(4) and (e)(2))

    High-need school means:

    (a) A high-poverty school, or

    (b) A persistently lowest-achieving school, or

    (c) In the case of States that have received the Department's approval of a request for ESEA flexibility, a priority school. (TIF NFP)

    High-poverty school means a school with 50 percent or more of its enrollment from low-income families, based on eligibility for free or reduced-price lunch subsidies under the Richard B. Russell National School Lunch Act, or other poverty measures that LEAs use (see section 1113(a)(5) of the ESEA (20 U.S.C. 6313(a)(5)). For middle and high schools, eligibility may be calculated on the basis of comparable data from feeder schools. Eligibility as a high-poverty school under this definition is determined on the basis of the most currently available data. (TIF NFP)

    Human capital management system (HCMS) means a system by which an LEA makes and implements human capital decisions, such as decisions on recruitment, hiring, placement, retention, dismissal, compensation, professional development, tenure, and promotion. (TIF NFP)

    Logic model (also referred to as a theory of action) means a well-specified conceptual framework that identifies key components of the proposed process, product, strategy, or practice (i.e., the active “ingredients” that are hypothesized to be critical to achieving the relevant outcomes) and describes the relationships among the key components and outcomes, theoretically and operationally. (34 CFR 77.1)

    Performance-based Compensation System means a system of compensation for teachers, principals, and other school leaders—

    (A) That differentiates levels of compensation based in part on measurable increases in student academic achievement; and

    (B) Which may include—

    (i) Differentiated levels of compensation, which may include bonus pay, on the basis of the employment responsibilities and success of effective teachers, principals, and other school leaders in hard-to-staff schools or high-need subject areas; and

    (ii) Recognition of the skills and knowledge of teachers, principals, and other school leaders as demonstrated through—

    (I) Successful fulfillment of additional responsibilities or job functions, such as teacher leadership roles; and

    (II) Evidence of professional achievement and mastery of content knowledge and superior teaching and leadership skills. (ESSA § 2211(b)(4))

    Persistently lowest-achieving school means, as determined by the State:

    (i) Any Title I school in improvement, corrective action, or restructuring that—

    (a) Is among the lowest-achieving five percent of Title I schools in improvement, corrective action, or restructuring or the lowest-achieving five Title I schools in improvement, corrective action, or restructuring in the State, whichever number of schools is greater; or

    (b) Is a high school that has had a graduation rate as defined in 34 CFR 200.19(b) that is less than 60 percent over a number of years; and

    (ii) Any secondary school that is eligible for, but does not receive, Title I funds that—

    (a) Is among the lowest-achieving five percent of secondary schools or the lowest-achieving five secondary schools in the State that are eligible for, but do not receive, Title I funds, whichever number of schools is greater; or

    (b) Is a high school that has had a graduation rate as defined in 34 CFR 200.19(b) that is less than 60 percent over a number of years.

    To identify the persistently lowest achieving schools, a State must take into account both:

    (i) The academic achievement of the “all students” group in a school in terms of proficiency on the State's assessments under section 1111(b)(3) of the ESEA in reading/language arts and mathematics combined; and

    (ii) The school's lack of progress on those assessments over a number of years in the “all students” group. (TIF NFP)

    NOTE: For purposes of this definition, the Department considers schools that are identified as Tier I or Tier II schools under the School Improvement Grants program (see 75 FR 61363) as lowest performing schools.

    Priority school means a school that has been identified by the State as a priority school pursuant to the State's approved request for ESEA flexibility. (TIF NFP)

    Relevant outcome means the student outcome(s) (or the ultimate outcome if not related to students) the proposed process, product, strategy, or practice is designed to improve; consistent with the specific goals of a program. (34 CFR 77.1)

    Rural local educational agency means an LEA that is eligible under the Small Rural School Achievement program or the Rural and Low-Income School program authorized under Title VI, Part B of the ESEA. Eligible applicants may determine whether a particular LEA is eligible for these programs by referring to information on the Department's Web site at www2.ed.gov/nclb/freedom/local/reap.html. (Supplemental Priorities)

    Strong theory means a rationale for the proposed process, product, strategy, or practice that includes a logic model. (34 CFR 77.1)

    Program Authority:

    Public Law 114-113, 2016 Appropriations Act; the ESEA, as amended by the ESSA.

    Applicable Regulations: (a) The Education Department General Administrative Regulations in 34 CFR parts 75, 77, 79, 81, 82, 84, 86, 97, 98, and 99. (b) The Office of Management and Budget Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted and amended as regulations of the Department in 2 CFR part 3474. (d) The TIF NFP. (e) The Supplemental Priorities.

    Note:

    The regulations in 34 CFR part 86 apply to institutions of higher education only.

    II. Award Information

    Type of Award: Discretionary grants.

    Estimated Available Funds: $50,000,000-$70,000,000.

    Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2017 from the list of unfunded applications from this competition.

    Estimated Range of Awards: $500,000-$12,000,000 for the first year of the project period.

    Note:

    The Department estimates a wide range of awards given the potentially large differences in the scope of funded projects, including the size and number of participating LEAs.

    Estimated Average Size of Awards: $10,000,000 for the first year of the project period. Funding for the second through fifth years of the project period is subject to the availability of funds and the approval of continuation awards (see 34 CFR 75.253).

    Estimated Number of Awards: 5-10.

    Note:

    The Department is not bound by any estimates in this notice.

    Project Period: Up to 60 months.

    III. Eligibility Information

    1. Eligible Applicants:

    (a) LEAs, including charter schools that are LEAs.

    (b) States that apply with one or more LEAs.

    (c) Nonprofit organizations that apply in partnership with one or more LEAs or an LEA and State.

    2. Cost Sharing or Matching: This program does not require cost sharing or matching.

    IV. Application and Submission Information 1. Address to Request Application Package

    Vicki Robinson, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W103, Washington, DC 20202-6200. Telephone: (202) 205-5471 or by email: [email protected]

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

    Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the program contact person listed in this section.

    2. Content and Form of Application Submission

    Requirements concerning the content of an application, together with the forms you must submit, are in the application package for this program.

    Notice of Intent to Apply: We will be able to develop a more efficient process for reviewing grant applications if we can anticipate the number of applicants that intend to apply for funding under this competition. Therefore, we strongly encourage each potential applicant to notify us of the applicant's intent to submit an application for funding by sending a short email message. This short email should provide (1) the applicant organization's name and address; and (2) all priorities the applicant intends to address. Please send this email notification to [email protected] with “Intent to Apply” in the email subject line. Applicants that do not provide this email notification may still apply for funding and are not required to, or prohibited from, addressing priorities they do not mention in their notice of intent to apply.

    Page Limit: The application narrative is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. Please limit the application narrative to no more than 40 pages, using the following standards:

    • A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.

    • Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs.

    • Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).

    • Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.

    The suggested page limit does not apply to the cover sheet; the budget section, including the narrative budget justification; the assurances and certifications; or the one-page abstract, the resumes, the bibliography, or the letters of support. However, the suggested page limit does apply to all of the application narrative.

    b. Submission of Proprietary Information: Given the types of projects that may be proposed in applications for the TIF program, an application may include business information that the applicant considers proprietary. The Department's regulations define “business information” in 34 CFR 5.11.

    Because we plan to make successful applications available to the public, you may wish to request confidentiality of business information.

    Consistent with Executive Order 12600, please designate in your application any information that you believe is exempt from disclosure under Exemption 4. In the appropriate Appendix section of your application, under “Other Attachments Form,” please list the page number or numbers on which we can find this information. For additional information please see 34 CFR 5.11(c).

    3. Submission Dates and Times

    Applications Available: May 31, 2016.

    Deadline for Notice of Intent to Apply: June 30, 2016.

    Deadline for Transmittal of Applications: July 15, 2016.

    Pre-application workshops will be held for this competition in the spring of 2016. The workshops are intended to provide technical assistance to all interested grant applicants. Detailed information regarding the pre-application workshops times, and online registration form, can be found on the Teacher Incentive Fund's Web site at http://innovation.ed.gov/what-we-do/teacher-quality/teacher-incentive-fund/.

    Applications for grants under this program must be submitted electronically using the Grants.gov Apply site (Grants.gov). For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to Other Submission Requirements in section IV of this notice.

    We do not consider an application that does not comply with the deadline requirements.

    Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice. If the Department provides an accommodation or auxiliary aid to an individual with a disability in connection with the application process, the individual's application remains subject to all other requirements and limitations in this notice.

    Deadline for Intergovernmental Review: September 28, 2016.

    4. Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this program.

    5. Funding Restrictions: We reference regulations outlining funding restrictions in the Applicable Regulations section of this notice.

    6. Data Universal Numbering System Number, Taxpayer Identification Number, and System for Award Management: To do business with the Department of Education, you must—

    a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);

    b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry), the Government's primary registrant database;

    c. Provide your DUNS number and TIN on your application; and

    d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.

    You can obtain a DUNS number from Dun and Bradstreet at the following Web site: http://fedgov.dnb.com/webform. A DUNS number can be created within one to two business days.

    If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.

    The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.

    Note:

    Once your SAM registration is active, it may be 24 to 48 hours before you can access the information in, and submit an application through, Grants.gov.

    If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.

    Information about SAM is available at www.SAM.gov. To further assist you with obtaining and registering your DUNS number and TIN in SAM or updating your existing SAM account, we have prepared a SAM.gov Tip Sheet, which you can find at: www2.ed.gov/fund/grant/apply/sam-faqs.html.

    In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page: www.grants.gov/web/grants/register.html.

    7. Other Submission Requirements

    Applications for grants under this program must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.

    a. Electronic Submission of Applications

    Applications for grants under the Teacher Incentive Fund, CFDA number 84.374A, must be submitted electronically using the Governmentwide Grants.gov Apply site at www.Grants.gov. Through this site, you will be able to download a copy of the application package, complete it offline, and then upload and submit your application. You may not email an electronic copy of a grant application to us.

    We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement and submit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section under Exception to Electronic Submission Requirement.

    You may access the electronic grant application for the Teacher Incentive Fund competition at www.Grants.gov. You must search for the downloadable application package for this program by the CFDA number. Do not include the CFDA number's alpha suffix in your search (e.g., search for 84.374, not 84.374A).

    Please note the following:

    • When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.

    • Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.

    • The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.

    • You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this program to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at www.G5.gov. In addition, for specific guidance and procedures for submitting an application through Grants.gov, please refer to the Grants.gov Web site at: www.grants.gov/web/grants/applicants/apply-for-grants.html.

    • You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.

    • You must submit all documents electronically, including all information you typically provide on the following forms: the Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.

    • You must upload any narrative sections and all other attachments to your application as files in a read-only, non-modifiable Portable Document format (PDF). Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF or submit a password-protected file, we will not review that material. Please note that this could result in your application not being considered for funding because the material in question—for example, the project narrative—is critical to a meaningful review of your proposal. For that reason it is important to allow yourself adequate time to upload all material as PDF files. The Department will not convert material from other formats to PDF.

    • Your electronic application must comply with any page-limit requirements described in this notice.

    • After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. This notification indicates receipt by Grants.gov only, not receipt by the Department. Grants.gov will also notify you automatically by email if your application met all the Grants.gov validation requirements or if there were any errors (such as submission of your application by someone other than a registered Authorized Organization Representative, or inclusion of an attachment with a file name that contains special characters). You will be given an opportunity to correct any errors and resubmit, but you must still meet the deadline for submission of applications.

    Once your application is successfully validated by Grants.gov, the Department will retrieve your application from Grants.gov and send you an email with a unique PR/Award number for your application.

    These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by Grants.gov, it must also meet the Department's application requirements as specified in this notice and in the application instructions. Disqualifying errors could include, for instance, failure to upload attachments in a read-only, non-modifiable PDF; failure to submit a required part of the application; or failure to meet applicant eligibility requirements. It is your responsibility to ensure that your submitted application has met all of the Department's requirements.

    • We may request that you provide us original signatures on forms at a later date.

    Application Deadline Date Extension in Case of Technical Issues with the Grants.gov System: If you are experiencing problems submitting your application through Grants.gov, please contact the Grants.gov Support Desk, toll free, at 1-800-518-4726. You must obtain a Grants.gov Support Desk Case Number and must keep a record of it.

    If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.

    If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice and provide an explanation of the technical problem you experienced with Grants.gov, along with the Grants.gov Support Desk Case Number. We will accept your application if we can confirm that a technical problem occurred with the Grants.gov system and that the problem affected your ability to submit your application by 4:30:00 p.m., Washington, DC time, on the application deadline date. We will contact you after we determine whether your application will be accepted.

    Note:

    The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.

    Exception to Electronic Submission Requirement: You qualify for an exception to the electronic submission requirement, and may submit your application in paper format, if you are unable to submit an application through the Grants.gov system because—

    • You do not have access to the Internet; or

    • You do not have the capacity to upload large documents to the Grants.gov system;

    and

    • No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.

    If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.

    Address and mail your statement to: Vicki Robinson, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W103, Washington, DC 20202-6200.

    Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.

    b. Submission of Paper Applications by Mail

    If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.374A), LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.

    You must show proof of mailing consisting of one of the following:

    (1) A legibly dated U.S. Postal Service postmark.

    (2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.

    (3) A dated shipping label, invoice, or receipt from a commercial carrier.

    (4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.

    If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:

    (1) A private metered postmark.

    (2) A mail receipt that is not dated by the U.S. Postal Service.

    Note:

    The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.

    We will not consider applications postmarked after the application deadline date.

    c. Submission of Paper Applications by Hand Delivery

    If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.374A), 550 12th Street SW., Room 7039, Potomac Center Plaza, Washington, DC 20202-4260.

    The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.

    Note for Mail or Hand Delivery of Paper Applications:

    If you mail or hand deliver your application to the Department—

    (1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and

    (2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.

    V. Application Review Information

    1. Selection Criteria: The selection criteria for this program are from 34 CFR 75.210, the TIF NFP, and the 2016 Appropriations Act.

    The maximum score for all the selection criteria is 100 points. The maximum score for each criterion is indicated in parentheses. The selection criteria for this competition are as follows:

    (a) Significance (20 points) (34 CFR 75.210)

    The Secretary considers the significance of the proposed project. In determining the significance of the proposed project, the Secretary considers the extent to which the proposed project is likely to build local capacity to provide, improve, or expand services that address the needs of the target population.

    (b) Quality of the Project Design (45 Points) (34 CFR 75.210)

    The Secretary considers the quality of the design of the proposed project. In determining the quality of the design of the proposed project, the Secretary considers the following factors:

    (1) The extent to which the proposed project is part of a comprehensive effort to improve teaching and learning and support rigorous academic standards for students.

    (2) The extent to which the services to be provided by the proposed project involve the collaboration of appropriate partners for maximizing the effectiveness of project services.

    (3) The extent to which the proposed project is supported by a strong theory.

    (4) The extent to which the proposed project will integrate with or build on similar or related efforts to improve relevant outcomes (as defined in 34 CFR 77.1(c)), using existing funding streams from other programs or policies supported by community, State, and Federal resources.

    (c) Professional Development Systems to Support the Needs of Teachers and Principals Identified Through the Evaluation Process (15 Points) (TIF NFP)

    The Secretary considers the extent to which each participating LEA has a high-quality plan for professional development to help all Educators located in High-Need Schools, listed in response to Requirement 2(a), to improve their effectiveness. In determining the quality of each plan for professional development, the Secretary considers the extent to which the plan describes how the participating LEA will use the disaggregated information generated by the proposed educator Evaluation and Support System to identify the professional development needs of individual Educators and schools.

    (d) Quality of the Management Plan (15 Points) (34 CFR 75.210)

    The Secretary considers the quality of the management plan for the proposed project. In determining the quality of the management plan for the proposed project, the Secretary considers the adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks.

    (e) Adequacy of Resources (5 Points) (2016 Appropriations Act; 34 CFR 75.210)

    The Secretary considers the adequacy of resources for the proposed project. In determining the adequacy of resources for the proposed project, the Secretary considers the following factors:

    (1) The extent to which the applicant demonstrates that Performance-based Compensation Systems are developed with the input of teachers and school leaders in the schools and local educational agencies to be served by the grant.

    (2) The extent to which the applicant demonstrates a plan to sustain financially the activities conducted and systems developed under the grant once the grant period has expired.

    2. Review and Selection Process: We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

    In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

    3. Risk Assessment and Special Conditions: Consistent with 2 CFR 200.205, before awarding grants under this program the Department conducts a review of the risks posed by applicants. Under 2 CFR 3474.10, the Secretary may impose special conditions and, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

    VI. Award Administration Information

    1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN); or we may send you an email containing a link to access an electronic version of your GAN. We may notify you informally, also.

    If your application is not evaluated or not selected for funding, we notify you.

    2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice.

    We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

    3. Reporting: (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

    (b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to www.ed.gov/fund/grant/apply/appforms/appforms.html.

    (c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.

    4. Performance Measures: Pursuant to the Government Performance and Results Act of 1993, the Department has established the following performance measures that it will use to evaluate the overall effectiveness of the grantee's project, as well as the TIF program as a whole:

    (a) The percentage of educators in all schools who earned performance-based compensation.

    (b) The percentage of educators in all High-Need Schools who earned performance-based compensation.

    (c) The gap between the retention rate of educators receiving performance-based compensation and the average retention rate in each high-need school.

    (d) The number of school districts participating in a TIF grant that use educator evaluation systems to inform the following human capital decisions: Recruitment; hiring; placement; retention; dismissal; professional development; tenure; promotion; or all of the above.

    (e) The percentage of performance-based compensation paid to educators with State, local, or other non-TIF Federal resources.

    (f) The percentage of teachers and principals who receive the highest effectiveness rating.

    (g) The percentage of teachers and principals in high-needs schools who receive the highest effectiveness rating.

    5. Continuation Awards: In making a continuation award under 34 CFR 75.253, the Secretary considers, among other things: Whether a grantee has made substantial progress in achieving the goals and objectives of the project; whether the grantee has expended funds in a manner that is consistent with its approved application and budget; and, if the Secretary has established performance measurement requirements, the performance targets in the grantee's approved application.

    In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

    VII. Agency Contact FOR FURTHER INFORMATION CONTACT:

    Vicki Robinson, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W103, Washington, DC 20202-6200. Telephone: (202) 205-5471 or by email: [email protected]

    If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.

    VIII. Other Information

    Accessible Format: Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under For Further Information Contact in section VII of this notice.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or PDF. To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Dated: May 25, 2016. Nadya Chinoy Dabby, Assistant Deputy Secretary for Office of Innovation and Improvement.
    [FR Doc. 2016-12733 Filed 5-27-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION Applications for New Awards; American History and Civics Academies Program AGENCY:

    Office of Innovation and Improvement, Department of Education.

    ACTION:

    Notice.

    Overview Information

    American History and Civics Academies Program.

    Notice inviting applications for new awards for fiscal year (FY) 2016.

    Catalog of Federal Domestic Assistance (CFDA) Number: 84.422A. DATES:

    Applications Available: May 31, 2016.

    Deadline for Notice of Intent to Apply: June 30, 2016.

    Deadline for Transmittal of Applications: July 15, 2016.

    Date of Pre-Application Webinar: June 9, 2016.

    Deadline for Intergovernmental Review: September 13, 2016.

    Full Text of Announcement I. Funding Opportunity Description

    Purpose of Program: The American History and Civics Academies Program (Academies Program) supports the establishment of: (1) Presidential Academies for the Teaching of American History and Civics that offer workshops for both veteran and new teachers to strengthen their knowledge of American history and civics (Presidential Academies); and (2) Congressional Academies for Students of American History and Civics that provide high school students with opportunities to develop a broader and deeper understanding of these subjects (Congressional Academies).

    Background

    On December 10, 2015, the President signed into law the Every Student Succeeds Act (ESSA), Public Law 114-95, which reauthorized the Elementary and Secondary Education Act of 1965 (ESEA), as amended by the No Child Left Behind Act of 2001 (NCLB). Among other things, the ESSA amends part B of title II of the ESEA to include a reauthorized Academies program, which was previously authorized under the American History and Civics Education Act of 2004. Under section 5(c) of the ESSA, however, the amendments made by the ESSA to the ESEA with respect to competitive grant programs (including the Academies program) take effect beginning with FY 2017 appropriations. Accordingly, the Department will use the FY 2016 funds available for this competition to make Academies grants in accordance with the requirements of the American History and Civics Education Act of 2004, and not those of the ESEA, as amended by the ESSA. In addition, we intend to use FY 2016 funds to support the entire project period of awards made under this competition and expect that, consistent with section 5(c) of the ESSA, any funding provided by Congress in FY 2017 and future years for the Academies program would be for the new program as authorized by the ESEA, as amended by the ESSA.

    Students who have an understanding of and engagement with American history and civics are more likely to be civically engaged and active participants in their community.1 Moreover, students' understanding of American history and civics will likely be enhanced if their learning experiences are interesting, engaging, and relevant to students' perspectives and communities. It is therefore important to ensure that teachers have a thorough understanding of American history and civics and are well-equipped to implement effective teaching strategies that help their students master the necessary content knowledge and skills. Students who are engaged in learning in these content areas will be better equipped to be active members of their community and the world at large, and to participate fully in all forms of civic engagement.2

    1 American Academy of Arts and Sciences, The Heart of the Matter: The Humanities and Social Sciences for a Vibrant, Competitive, and Secure Nation (2013) via www.humanitiescommission.org/_pdf/hss_report.pdf.

    2 Campaign for the Civic Mission of Schools, “Guardian of Democracy: The Civic Mission of Schools,” (2011), via http://civicmission.s3.amazonaws.com/118/f0/5/171/1/Guardian-of-Democracy-report.pdf.

    Recent studies indicate a critical need to improve teaching and learning in American history and civics. For example, only 18 percent of eighth-graders performed at or above the proficient level on the National Assessment of Educational Progress (NAEP) assessment in U.S. history, and only 23 percent performed at or above the proficient level on the NAEP assessment in civics.3

    3 U.S. Department of Education, Institute of Education Sciences, National Center for Education Statistics, National Assessment of Educational Progress (NAEP), The Nation's Report Card: 2014 U.S. History, Geography, and Civics at Grade 8 (NCES 2015112) via www.nationsreportcard.gov/hgc_2014/

    The Academies Program supports projects to raise student achievement in American history and civics by improving teachers' and students' knowledge, understanding, and engagement with these subjects through intensive workshops with scholars, master teachers, and curriculum experts. Project activities should reflect the best available research and practice in teaching and learning. Presidential Academies will strive to enable teachers to develop further expertise in the content areas of American history and civics, teaching strategies, use of technologies, and other essential elements of teaching to rigorous college- and career-ready standards. Congressional Academies are intended to broaden and deepen students' interest in and understanding of American history and civics through the use of content-rich, engaging learning resources and strategies.

    Offering a wide array of perspectives in teaching and learning American history and civics is essential to acknowledging students' rich and diverse perspectives and experiences, and to stimulating their long-term interest in these subjects. Accordingly, projects funded under this grant program might consider incorporating diverse historical perspectives and relying on an array of resources (e.g., historical documents, oral histories, and artifacts) that convey the full range of American experiences.

    Through a competitive preference priority, we encourage applicants to consider projects that will focus on serving high-need students and students from underserved populations to help ensure that these students have access to high-quality, interactive instruction that will help them become college- and career-ready and be better prepared to participate fully in civic activities. In addition, applicants may want to consider projects that are designed to recruit teachers and students from the same schools and school districts in order to promote a seamless delivery of training and instruction into a target district and maximize project benefits.

    Grantees will be expected to measure the impact of their projects on teacher development and student learning. Early findings from grantee evaluations are expected to help guide the grantee's subsequent teacher professional development and student learning efforts over the three-year project period.

    Priorities: This notice contains two absolute priorities and one competitive preference priority. Both absolute priorities are from the American Civics and History Education Act of 2004, Public Law 108-474. The competitive priority is from the Secretary's final supplemental priorities and definitions for discretionary grant programs, published in the Federal Register on December 10, 2014 at 79 FR 73425 (Supplemental Priorities).

    Absolute Priorities: For FY 2016 and any subsequent year in which we make awards from the list of unfunded applications from this competition, these priorities are absolute priorities. Under 34 CFR 75.105(c)(3), we consider only applications that meet both of the following priorities:

    Absolute Priority 1—Presidential Academies for the Teaching of American History and Civics

    Under this priority, an applicant must propose to establish a Presidential Academy for Teaching of American History and Civics that may offer workshops for both veteran and new teachers of American history and civics.

    Absolute Priority 2—Congressional Academies for Students of American History and Civics

    Under this priority, an applicant must propose to establish a Congressional Academy for Students of American History and Civics.

    Competitive Preference Priority: For FY 2016 and any subsequent year in which we make awards from the list of unfunded applications from this competition, this priority is a competitive preference priority. Under 34 CFR 75.105(c)(2)(ii) we award up to an additional 10 points to an application depending on how well the application meets this priority. If an applicant wishes to be considered for these competitive preference points, it must clearly identify where in the project narrative section of its application it addresses this priority.

    This priority is:

    Competitive Preference Priority—Supporting High-Need Students (Up to 10 Points)

    Projects that are designed to improve academic outcomes for high-need students (as defined in this notice).

    Definitions

    The following definitions are from the Supplemental Priorities and apply to this competition:

    High-minority school means a school as that term is defined by a local educational agency (LEA), which must define the term in a manner consistent with its State's Teacher Equity Plan, as required by section 1111(b)(8)(C) of the Elementary and Secondary Education Act of 1965, as amended (ESEA). The applicant must provide the definition(s) of “high-minority schools” used in its application.

    High-need students means students who are at risk of educational failure or otherwise in need of special assistance and support, such as students who are living in poverty, who attend high-minority schools, who are far below grade level, who have left school before receiving a regular high school diploma, who are at risk of not graduating with a diploma on time, who are homeless, who are in foster care, who have been incarcerated, who have disabilities, or who are English learners.

    Regular high school diploma means the standard high school diploma that is awarded to students in the State and that is fully aligned with the State's academic content standards or a higher diploma and does not include a General Education Development (GED) credential, certificate of attendance, or any alternative award.

    Authority:

    American History and Civics Education Act of 2004, Pub. Law 108-474.

    Applicable Regulations: (a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 75, 77, 79, 82, 84, 86, 97, 98, and 99. (b) The Office of Management and Budget (OMB) Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted and amended as regulations of the Department in 2 CFR part 3474.

    Note:

    The regulations in 34 CFR part 86 apply to institutions of higher education only.

    II. Award Information

    Type of Award: Discretionary grants.

    Estimated Available Funds: $1,785,000.

    Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2017 from the list of unfunded applicants from this competition.

    Estimated Average Size of Awards: $600,000 per year.

    Estimated Number of Awards: 1.

    Note:

    The Department is not bound by any estimates in this notice.

    Project Period: 36 months. The Department intends to fund the entire project period of a grant with FY 2016 funds.

    III. Eligibility Information

    1. Eligible Applicants: Eligible applicants include:

    • Local educational agencies;

    • Institutions of higher education; and

    • Other public and private agencies, organizations, and institutions, including cultural institutions and museums.

    To be eligible to receive an award, an applicant must include in its application evidence of its expertise in historical methodology or the teaching of history.

    Note:

    If more than one eligible entity wishes to form a consortium and jointly submit a single application, they must follow the procedures for group applications described in 34 CFR 75.127 through 34 CFR 75.129.

    2. Cost Sharing or Matching: This program does not require cost sharing or matching.

    IV. Application and Submission Information

    1. Address to Request Application Package: Christine Miller, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W205, Washington, DC 20202-5970. Telephone: (202) 453-6740 or by email: [email protected]

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

    Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the program contact person listed in this section.

    2. Content and Form of Application Submission: Requirements concerning the content of an application, together with the forms you must submit, are in the application package for this program.

    Notice of Intent to Apply: June 30, 2016.

    The Department will be able to develop a more efficient process for reviewing grant applications if it has a better understanding of the number of entities that intend to apply for funding under this competition. Therefore, the Secretary strongly encourages each potential applicant to notify the Department by sending a short email message indicating the applicant's intent to submit an application for funding. The email need not include information regarding the content of the proposed application, only the applicant's intent to submit it. The Department requests that this email notification be sent to the Academies Program inbox at: [email protected] Applicants that fail to provide this email notification may still apply for funding.

    Page Limit: The application narrative (Part III of the application) is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. We recommend that you limit the application narrative to no more than 50 pages, using the following standards:

    • A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.

    • Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions. However, you may single space all text in charts, tables, figures, and graphs.

    • Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).

    Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman or Arial Narrow) will not be accepted.

    The recommended page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the one-page abstract, the resumes, the bibliography, or the letters of support. However, the recommended page limit does apply to all of the application narrative.

    b. Submission of Proprietary Information: Given the types of projects that may be proposed in applications for the Academies Program, your application may include business information that you consider proprietary. In 34 CFR 5.11 we define “business information” and describe the process we use in determining whether any of that information is proprietary and, thus, protected from disclosure under Exemption 4 of the Freedom of Information Act (5 U.S.C 552, as amended).

    Because we plan to post the project narrative section of funded Academies Program applications on our Web site, you may wish to request confidentiality of business information.

    Consistent with Executive Order 12600, please designate in your application any information that you believe is exempt from disclosure under Exemption 4. In the appropriate Appendix section of your application, under “Other Attachments Form,” please list the page number or numbers on which we can find this information. For additional information please see 34 CFR 5.11(c).

    3. Submission Dates and Times:

    Applications Available: May 31, 2016.

    Deadline for Notice of Intent to Apply: June 30, 2016.

    Date of Pre-Application Webinar: June 9, 2016.

    Deadline for Transmittal of Applications: July 15, 2016.

    Applications for grants under this program must be submitted electronically using the Grants.gov Apply site (Grants.gov). For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to Other Submission Requirements in section IV of this notice.

    We do not consider an application that does not comply with the deadline requirements.

    Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice. If the Department provides an accommodation or auxiliary aid to an individual with a disability in connection with the application process, the individual's application remains subject to all other requirements and limitations in this notice.

    Deadline for Intergovernmental Review: September 13, 2016.

    4. Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this program.

    5. Funding Restrictions: We specify unallowable costs in 2 CFR 200, subpart E. We reference regulations outlining funding restrictions in the Applicable Regulations section of this notice.

    6. Data Universal Numbering System Number, Taxpayer Identification Number, and System for Award Management: To do business with the Department of Education, you must—

    a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);

    b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry), the Government's primary registrant database;

    c. Provide your DUNS number and TIN on your application; and

    d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.

    You can obtain a DUNS number from Dun and Bradstreet at the following Web site: http://fedgov.dnb.com/webform. A DUNS number can be created within one to two business days.

    If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.

    The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.

    Note:

    Once your SAM registration is active, it may be 24 to 48 hours before you can access the information in, and submit an application through, Grants.gov.

    If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.

    Information about SAM is available at www.SAM.gov. To further assist you with obtaining and registering your DUNS number and TIN in SAM or updating your existing SAM account, we have prepared a SAM.gov Tip Sheet, which you can find at: http://www2.ed.gov/fund/grant/apply/sam-faqs.html.

    In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page: www.grants.gov/web/grants/register.html.

    7. Other Submission Requirements:

    Applications for grants under this program must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.

    a. Electronic Submission of Applications

    Applications for grants under the Academies Program, CFDA 84.422, must be submitted electronically using the Government wide Grants.gov Apply site at www.Grants.gov. Through this site, you will be able to download a copy of the application package, complete it offline, and then upload and submit your application. You may not email an electronic copy of a grant application to us.

    We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement and submit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section under Exception to Electronic Submission Requirement.

    You may access the electronic grant application for the Academies Program at www.Grants.gov. You must search for the downloadable application package for this program by the CFDA number. Do not include the CFDA number's alpha suffix in your search (e.g., search for 84.422, not 84.422A).

    Please note the following:

    • When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.

    • Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.

    • The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.

    • You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this program to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at www.G5.gov. In addition, for specific guidance and procedures for submitting an application through Grants.gov, please refer to the Grants.gov Web site at: www.grants.gov/web/grants/applicants/apply-for-grants.html.

    • You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.

    • You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.

    • You must upload any narrative sections and all other attachments to your application as files in a read-only, non-modifiable Portable Document Format (PDF). Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF (e.g., Word, Excel, WordPerfect, etc.) or submit a password-protected file, we will not review that material. Please note that this could result in your application not being considered for funding because the material in question—for example, the project narrative—is critical to a meaningful review of your proposal. For that reason, it is important to allow yourself adequate time to upload all material as PDF files. The Department will not convert material from other formats to PDF.

    • Your electronic application must comply with any page-limit requirements described in this notice.

    • After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. This notification indicates receipt by Grants.gov only, not receipt by the Department. Grants.gov will also notify you automatically by email if your application met all the Grants.gov validation requirements or if there were any errors (such as submission of your application by someone other than a registered Authorized Organization Representative, or inclusion of an attachment with a file name that contains special characters). You will be given an opportunity to correct any errors and resubmit, but you must still meet the deadline for submission of applications.

    Once your application is successfully validated by Grants.gov, the Department will retrieve your application from Grants.gov and send you an email with a unique PR/Award number for your application.

    These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by Grants.gov, it must also meet the Department's application requirements as specified in this notice and in the application instructions. Disqualifying errors could include, for instance, failure to upload attachments in a read-only, non-modifiable PDF; failure to submit a required part of the application; or failure to meet applicant eligibility requirements. It is your responsibility to ensure that your submitted application has met all of the Department's requirements.

    • We may request that you provide us original signatures on forms at a later date.

    Application Deadline Date Extension in Case of Technical Issues with the Grants.gov System: If you are experiencing problems submitting your application through Grants.gov, please contact the Grants.gov Support Desk, toll free, at 1-800-518-4726. You must obtain a Grants.gov Support Desk Case Number and must keep a record of it.

    If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.

    If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice and provide an explanation of the technical problem you experienced with Grants.gov, along with the Grants.gov Support Desk Case Number. We will accept your application if we can confirm that a technical problem occurred with the Grants.gov system and that the problem affected your ability to submit your application by 4:30:00 p.m., Washington, DC time, on the application deadline date. We will contact you after we determine whether your application will be accepted.

    Note:

    The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.

    Exception to Electronic Submission Requirement: You qualify for an exception to the electronic submission requirement, and may submit your application in paper format, if you are unable to submit an application through the Grants.gov system because--

    • You do not have access to the Internet; or

    • You do not have the capacity to upload large documents to the Grants.gov system; and

    • No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.

    If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.

    Address and mail or fax your statement to: Christine Miller, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W205, Washington, DC 20202-5960. FAX: (202) 205-5630.

    Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.

    b. Submission of Paper Applications by Mail

    If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.422A), LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.

    You must show proof of mailing consisting of one of the following:

    (1) A legibly dated U.S. Postal Service postmark.

    (2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.

    (3) A dated shipping label, invoice, or receipt from a commercial carrier.

    (4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.

    If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:

    (1) A private metered postmark.

    (2) A mail receipt that is not dated by the U.S. Postal Service.

    Note:

    The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.

    We will not consider applications postmarked after the application deadline date.

    c. Submission of Paper Applications by Hand Delivery

    If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.422A), 550 12th Street SW., Room 7039, Potomac Center Plaza Washington, DC 20202-4260.

    The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.

    Note for Mail or Hand Delivery of Paper Applications:

    If you mail or hand deliver your application to the Department—

    (1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and

    (2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.

    V. Application Review Information

    1. Selection Criteria: The selection criteria for this program are from 34 CFR 75.210. An applicant may earn up to a total of 100 points based on the selection criteria. The maximum score for addressing each criterion is indicated in parentheses. Each criterion also includes the factors that the reviewers will consider in determining how well an application addresses the criterion.

    Selection Criteria

    A. Quality of the Project Design (up to 35 points). In determining the quality of the design of the proposed project, the Secretary considers the following factors—

    (i) The extent to which the proposed project represents an exceptional approach to the priority or priorities established for the competition.

    (ii) The extent to which the services to be provided by the proposed project involve the collaboration of appropriate partners for maximizing the effectiveness of project services.

    (iii) The extent to which the design of the proposed project reflects up-to-date knowledge from research and effective practice.

    B. Significance (20 points). In determining the significance of the proposed project, the Secretary considers the following factors:

    (i) The extent to which the proposed project is likely to build local capacity to provide, improve, or expand services that address the needs of the target population.

    (ii) The importance or magnitude of the results or outcomes likely to be attained by the proposed project, especially improvements in teaching and student achievement.

    C. Quality of the Management Plan (30 points). In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:

    (i) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks.

    (ii) The adequacy of mechanisms for ensuring high-quality products and services from the proposed project.

    D. Quality of the Project Evaluation (15 points). In determining the quality of project evaluation, the Secretary considers the following factors:

    (i) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible.

    (ii) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes.

    2. Review and Selection Process: We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

    In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

    3. Risk Assessment and Special Conditions: Consistent with 2 CFR 200.205, before awarding grants under this competition the Department conducts a review of the risks posed by applicants. Under 2 CFR 3474.10, the Secretary may impose special conditions and, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

    VI. Award Administration Information

    1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN); or we may send you an email containing a link to access an electronic version of your GAN. We may notify you informally, also.

    If your application is not evaluated or not selected for funding, we notify you.

    2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice.

    We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

    3. Reporting: (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

    (b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to www.ed.gov/fund/grant/apply/appforms/appforms.html.

    (c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.

    4. Performance Measures

    The Department has established the following Government Performance and Results Act of 1993 (GPRA) performance objective for the Academies Program:

    Participants will demonstrate through pre- and post-assessments an increased understanding of American history and civics that can be directly linked to their participation in the Presidential Academy or Congressional Academy.

    We will track performance on this objective through the following indicators:

    Presidential Academies: The average percentage gain on an assessment after participation in the Presidential Academy.

    Congressional Academies: The average percentage gain on an assessment after participation in the Congressional Academy.

    We advise an applicant for a grant under this program to give careful consideration to these indicators in conceptualizing the approach and evaluation of its proposed project. Each grantee will be required to provide, in its annual and final performance reports, data about its performance with respect to the performance objective and these indicators.

    VII. Agency Contact FOR FURTHER INFORMATION CONTACT:

    Christine Miller, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W205, Washington, DC 20202-5960, telephone (202) 453-6740. Or by email: [email protected]

    If you use a TDD or a TTY, call the FRS, toll-free, at 1-800-877-8339.

    VIII. Other Information

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

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or PDF. To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Dated: May 25, 2016. Nadya Chinoy Dabby, Assistant Deputy Secretary for Innovation and Improvement.
    [FR Doc. 2016-12738 Filed 5-27-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL16-70-000] Cottonwood Wind Project, LLC v. Nebraska Public Power District, Inc; Notice of Complaint

    Take notice that on May 20, 2016, pursuant to sections 206 and 306 of the Federal Power Act, 16 U.S.C. 824e and 825e (2012), and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 (2015), Cottonwood Wind Project, LLC (Cottonwood or Complainant) filed a formal complaint against Nebraska Public Power District (Respondent) alleging that Respondent made unauthorized expenditures for network upgrade construction under the Cottonwood Generator Interconnection Agreement, as more fully explained in its complaint.

    Complainant certifies that copies of the complaint were served on the contacts for Respondent listed on the Commission's list of Corporate Officials.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainant.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern Time on June 20, 2016.

    Dated: May 24, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-12703 Filed 5-27-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 3127-023] Ware River Power, Inc.; Notice of Application Accepted for Filing, Soliciting Comments, Motions to Intervene, and Protests

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:

    a. Type of Application: Application to amend 5 MW exemption from licensing.

    b. Project No.: 3127-023.

    c. Date Filed: January 27, 2016.

    d. Applicant: Ware River Power, Inc.

    e. Name of Project: Ware River Project.

    f. Location: The project is located on the Ware River in Hampshire County, Massachusetts.

    g. Filed Pursuant to: Public Utility Regulatory Policies Act of 1978, 16 U.S.C. 2705, 2708.

    h. Applicant Contact: Mr. Lucus Wright, Ware River Power, Inc., 48 Allen Drive, P.O. Box 512, Barre, MA 01005 (508) 355-4575.

    i. FERC Contact: Mr. Mark Pawlowski, (202) 502-6052, or [email protected].

    j. Deadline for filing comments, motions to intervene, protests, and recommendations is 15 days from the date of issuance of this notice by the Commission. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, or recommendations using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. Please include the project number (P-3127-023) on any comments, motions to intervene, protests, or recommendations filed.

    k. Description of Request: The Ware River Project consists of an Upper and Lower development. The applicant proposes to replace the lower development's single 250-kilowatt (kW) turbine with a 280-kW turbine and install a new 110-kW minimum flow turbine. The lower development's installed capacity would increase by 140 kW and the hydraulic capacity would increase by 94 cubic feet per second. In addition, the applicant proposes replace the lower development's existing 30-foot-wide by 10-foot-deep trashrack structure with a new 50-foot-wide by 10-foot deep trashrack structure. The new trashrack would maintain the current 1.5-inch spacing between the trashrack bars. To facilitate the trashrack replacement the applicant proposes to draw down the 10-acre lower development's impoundment from June 2016 through September 2016.

    l. Locations of the Application: A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street, NE., Room 2A, Washington, DC 20426, or by calling (202) 502-8371. This filing may also be viewed on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits in the docket number field to access the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, call 1-866-208- 3676 or email [email protected], for TTY, call (202) 502-8659. A copy is also available for inspection and reproduction at the address in item (h) above.

    m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.

    n. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

    o. Filing and Service of Responsive Documents: Any filing must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading, the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). All comments, motions to intervene, or protests should relate to project works which are the subject of the license amendment. Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. If an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: May 24, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-12704 Filed 5-27-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2355-021] Exelon Generation Company, LLC; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:

    a. Application Type: Recreation Plan Amendment.

    b. Project No: 2355-021.

    c. Date Filed: May 20, 2016.

    d. Applicant: Exelon Generation Company, LLC.

    e. Name of Project: Muddy Run Pumped Storage Project.

    f. Location: The project is located on the Susquehanna River at river mile 22 and its tributary Muddy Run, in Lancaster and York counties, Pennsylvania.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.

    h. Applicant Contact: Ms. Kimberly Long, FERC License Compliance Manager, Exelon Power, 300 Exelon Way, Kennett Square, PA 19348, (610) 765-5572.

    i. FERC Contact: Mr. Kevin Anderson, (202) 502-6465, [email protected]

    j. Deadline for filing comments, motions to intervene, and protests: June 23, 2016.

    The Commission strongly encourages electronic filing. Please file comments, motions to intervene, and protests using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-2355-021.

    The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.

    k. Description of Request: The licensee filed a revised recreation management plan pursuant to Article 407 of the license order issued December 22, 2015. The proposed revised plan includes: (1) Tables documenting all project recreation facilities and amenities; (2) a schedule for implementing recreation site improvements; and (3) a provision for monitoring and reporting on recreation use and demand and updating the plan, as needed, throughout the license term. Aside from these revisions and other minor edits, other aspects of the current recreation management plan would remain the same.

    l. Locations of the Application: A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street NE., Room 2A, Washington, DC 20426, or by calling (202) 502-8371. This filing may also be viewed on the Commission's Web site at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, call 1-866-208-3676 or email [email protected], for TTY, call (202) 502-8659. A copy is also available for inspection and reproduction at the address in item (h) above. Agencies may obtain copies of the application directly from the applicant.

    m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.

    n. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214, respectively. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

    o. Filing and Service of Documents: Any filing must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person commenting, protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis. Any filing made by an intervenor must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 385.2010.

    Dated: May 23, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-12709 Filed 5-27-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. CP15-93-001; CP15-93-000] Rover Pipeline LLC; Notice of Amendment to Application

    Take notice that on May 19, 2016, Rover Pipeline LLC (Rover), 1300 Main Street, Houston, Texas 77002, filed an amendment to its application in Docket No. CP15-93-000, pursuant to section 7(c) of the Natural Gas Act (NGA) and Part 157 of the Commission's regulations for a certificate of public convenience and necessity to construct and operate the Rover Pipeline Project. Specifically, Rover filed an amendment to its proposed pro forma tariff and updated Exhibits K, L, N, O, and P, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing may be viewed on the web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at [email protected] or call toll-free, (886) 208-3676 or TYY, (202) 502-8659.

    Any questions concerning these applications may be directed to Stephen Veatch, Senior Director of Certificates, Rover Pipeline LLC, 1300 Main Street, Houston, Texas 77002, by telephone at (713) 989-2024, by facsimile at (713) 989-1205, or by email at [email protected]

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental impact statement (EIS) and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) for this proposal. The filing of the FEIS in the Commission's public record for this proceeding or the issuance of a Notice of Schedule will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 5 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 7 copies of the protest or intervention to the Federal Energy regulatory Commission, 888 First Street NE., Washington, DC 20426.

    Comment Date: June 14, 2016.

    Dated: May 24, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-12702 Filed 5-27-16; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9947-14-OAR] Intent To Disclose Confidential Business Information Contained in Vehicle Sales Data for Model Years 2009-2014 to the U.S. Energy Information Administration for Use in Modeling and Projecting Energy Demand in the Light-Duty Vehicle Sector AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    On May 12, 2016, the Environmental Protection Agency received a written request from the U.S. Energy Information Administration (EIA) for historical model year sales data for years 2009 through 2014 by manufacturer and nameplate. This requested data may contain confidential business information (CBI). Pursuant to 40 CFR 2.209(c), the EPA may disclose business information to other Federal agencies that otherwise is not available to the public if certain requirements are met. The EPA intends to share certain information, detailed below, with EIA ten (10) days after publication of this notice. The information requested has been used to model and project energy demand in the light-duty vehicle sector and is critical to EIA's efforts to project energy demand, fuel efficiency, fuel consumption, and greenhouse gas emissions for the transportation sector. EIA has agreed to keep the data confidential and not disclose it further.

    DATES:

    The sales data will be disclosed to EIA on or after June 10, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Sara Zaremski, Office of Transportation and Air Quality, Compliance Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: 734-214-4362; fax number: 734-214- 4053; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

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

    Entities potentially affected by this action are those involved with the production and sale of motor vehicles. Regulated categories include:

    Category NAICS 1 codes SIC 2 codes Examples of potentially regulated entities Industry 336111, 336112 3711 Light-duty vehicle and light-duty truck manufacturers. 1 North American Industry Classification System (NAICS) 2 Standard Industrial Classification (SIC) system code.

    This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by the disclosure.

    II. EIA's Request for Model Year Sales Data for Years 2009-2014

    In their May 12, 2016 request letter to EPA, EIA requested that EPA provide to EIA historical model year sales data for years 2009 through 2014 by manufacturer and nameplate. As noted above, EIA uses this information to model and project energy demand in the light-duty vehicle sector. Additionally, EIA noted that these data are critical to EIA's continued efforts to project energy demand, fuel efficiency, fuel consumption, and greenhouse gas emissions for the transportation sector. Previously, EIA had been unable to obtain official model year sales data for 2009 through 2014 due to the fact that it contained CBI. The specific data they requested includes all the data fields currently available in the Excel files provided on the fueleconomy.gov Web site (see the Download Fuel Economy Data page at http://www.fueleconomy.gov/feg/download.shtml). Additionally, EIA requested the following data fields: model year sales, tank size, track width, wheelbase, curb weight, horsepower, interior volume, fleet (DP, IP, LT), and test weight.

    EIA indicated that they are aware that this information is subject to claims of confidential business information. EIA's letter states “We will take the necessary steps to ensure the data are secure and kept confidential. EIA routinely works with sensitive data and has strong data handling safeguards in place.”

    Pursuant to 40 CFR 2.209(c), EPA may disclose business information to another Federal agency if: (1) EPA receives a written request for disclosure of the information from a duly authorized officer or employee of the other agency; (2) the request sets forth the official purpose for which the information is needed; (3) when the information has been claimed as confidential or has been determined to be confidential, the responsible EPA office provides notice to each affected business of the type of information to be disclosed and to whom it is to be disclosed, and such notice may be given by notice published in the Federal Register at least 10 days prior to disclosure; (4) EPA notifies the other agency of any unresolved business confidentiality claim covering the information and of any determination under this subpart that the information is entitled to confidential treatment, and that further disclosure of the information may be a violation of the Trade Secrets Act, 18 U.S.C. 1905; and (5) the other agency agrees in writing that in accordance with the law, it will not disclose further any information designated as confidential.

    In the case at hand, all of the required elements of 40 CFR 2.209(c) have been met upon publication of this notice.

    III. Impact on Vehicle Manufacturers

    Given that EIA is aware that the shared information is CBI or has been claimed as CBI, and intends to take the necessary steps to ensure that the data provided is kept secure and confidential, there is no impact on vehicle manufacturers to the release of this data.

    Dated: May 24, 2016. Byron J. Bunker, Director, Compliance Division, Office of Transportation and Air Quality, Office of Air and Radiation.
    [FR Doc. 2016-12802 Filed 5-27-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1218] Information Collection Approved by the Office of Management and Budget (OMB) AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Federal Communications Commission (FCC) has received Office of Management and Budget (OMB) approval for a new information collection pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). An agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number, and no person is required to respond to a collection of information unless it displays a currently valid control number. Comments about the accuracy of the burden estimates and any suggestions for reducing the burden should be directed to the person listed in the FOR FURTHER INFORMATION CONTACT section below.

    FOR FURTHER INFORMATION CONTACT:

    Cathy Williams, Office of the Managing Director, at (202) 418-2918, or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The total annual reporting burdens and costs for the respondents are as follows:

    OMB Control Number: 3060-1218.

    OMB Approval Date: May 23, 2016.

    OMB Expiration Date: May 31, 2019.

    Title: Carriage of Digital Television Broadcast Signals: Amendment to Part 76 of the Commission's Rules

    Respondents: Business or other for profit entities.

    Number of Respondents/Responses: 11 respondents; 11 responses.

    Estimated Hours per Response: 0.25 hours (15 minutes).

    Frequency of Response: Third party disclosure requirement and recordkeeping requirement.

    Total Annual Burden: 3 hours.

    Total Annual Cost: None.

    Obligation To Respond: Required in order to monitor regulatory compliance. The statutory authority for this information collection is contained in sections 4, 303, 614, and 615 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 Act Assessment: No impact(s).

    Needs and Uses: The information collection imposes a notification requirement on certain small cable systems that become ineligible for exemption from the requirement to carry high definition broadcast signals in HD (adopted in FCC 15-65). In particular, the information collection requires that, beginning December 12, 2016, at the time a small cable system utilizing the HD carriage exemption offers any programming in HD, the system must give notice that it is offering HD programming to all broadcast stations in its market that are carried on its system. Cable operators also must keep records of such notification. This information collection requirement allows affected broadcast stations to monitor compliance with the requirement that cable operators transmit high definition broadcast signals in HD.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2016-12682 Filed 5-27-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1000] 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 August 1, 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 to [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: 3060-1000.

    Title: Section 87.147, Authorization of Equipment.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents: 25 respondents; 25 responses.

    Estimated Time per Response: 1 hour.

    Frequency of Response: One time and occasion reporting requirements and third party disclosure requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154, 303 and 307(e) of the Communications Act of 1934, as amended.

    Total Annual Burden: 25 hours.

    Total Annual Cost: N/A.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Needs and Uses: Section 87.147 is needed to require applicants for aviation equipment certification to submit a Federal Aviation Administration (FAA) determination of the equipment's compatibility with the National Airspace System (NAS). This will ensure that radio equipment operating in certain frequencies is compatible with the NAS, which shares system components with the military. The notification must describe the equipment, along with a report of measurements, give the manufacturer's identification, antenna characteristics, rated output power, emission type and characteristics, the frequency or frequencies of operation, and essential receiver characteristics if protection is required.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2016-12664 Filed 5-27-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [DA 16-572] Disability Advisory Committee; Announcement of Next Meeting AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice.

    SUMMARY:

    This document announces the date of the next meeting of the Commission's Disability Advisory Committee (Committee or DAC). The meeting is open to the public. During this meeting, members of the Committee will receive and discuss summaries of activities and recommendations from its subcommittees.

    DATES:

    The Committee's next meeting will take place on Thursday, June 16, 2016, from 9:00 a.m. to 3:30 p.m. (EST).

    ADDRESSES:

    Federal Communications Commission, 445 12th Street SW., Washington, DC 20554, in the Commission Meeting Room.

    FOR FURTHER INFORMATION CONTACT:

    Elaine Gardner, Consumer and Governmental Affairs Bureau: 202-418-0581 (voice); email: [email protected]; or Suzy Rosen Singleton, Alternate DAC Designated Federal Officer, Consumer and Governmental Affairs Bureau: 202-510-9446 (VP/voice), at the same email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Committee was established in December 2014 to make recommendations to the Commission on a wide array of disability matters within the jurisdiction of the Commission, and to facilitate the participation of people with disabilities in proceedings before the Commission. The Committee is organized under, and operated in accordance with, the provisions of the Federal Advisory Committee Act (FACA). The Committee held its first meeting on March 17, 2015.

    At its June 16, 2016 meeting, the Committee is expected to receive and consider a report on the activities of its Communications Subcommittee; a report and recommendation from its Emergency Communications Subcommittee regarding proposed DAC comments on the Commission's Notice of Proposed Rulemaking on Wireless Emergency Alerts; a report on the activities of its Relay & Equipment Distribution Subcommittee; a report and recommendation from its Technology Transitions Subcommittee regarding the benefits of HD Voice and ways to address the transition to HD Voice; and a report and possible recommendation from its Video Programming Subcommittee regarding appropriate capitalization of offline captioning of video programming. The Committee will also (1) hear presentations from Commission staff on recent activities; (2) hear reports from various FCC bureaus, including: A report from the FCC Wireline Competition Bureau on the modernization of the Lifeline program; a report from FCC Media Bureau on the commercial availability of set top boxes and the expansion of video description; and an update on the ACE Direct project; and (3) discuss new issues for its consideration.

    A limited amount of time may be available on the agenda for comments and inquiries from the public. The public may comment or ask questions of presenters via the email address [email protected]

    The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. If making a request for an accommodation, please include a description of the accommodation you will need and tell us how to contact you if we need more information. Make your request as early as possible by sending an email to [email protected] or calling the Consumer and Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY). Last minute requests will be accepted, but may be impossible to fill. The meeting will be webcast with open captioning, at: www.fcc.gov/live.

    To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

    Federal Communications Commission. Karen Peltz Strauss, Deputy Chief, Consumer and Governmental Affairs Bureau.
    [FR Doc. 2016-12710 Filed 5-27-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meetings AGENCY:

    Federal Election Commission

    DATE & TIME:

    Thursday, May 26, 2016 At 10:00 a.m.

    PLACE:

    999 E Street NW., Washington, DC (Ninth Floor)

    STATUS:

    This meeting will be open to the public.

    Federal Register Notice of Previous Anouncement—81 FR 32753

    CHANGE IN THE MEETING:

    The May 26, 2016 meeting was cancelled.

    PERSON TO CONTACT FOR INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Shelley E. Garr, Deputy Secretary of the Commission.
    [FR Doc. 2016-12820 Filed 5-26-16; 11:15 am] BILLING CODE 6715-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-0666; Docket No. CDC-2016-0046] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the National Healthcare Safety Network (NHSN). NHSN is a system designed to accumulate, exchange, and integrate relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and promote healthcare safety.

    DATES:

    Written comments must be received on or before August 1, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2016-0046 by any of the following methods:

    Federal eRulemaking Portal: Regulation.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

    Please note:

    All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Proposed Project

    National Healthcare Safety Network (NHSN)—Revision—National Center for Emerging and Zoonotic Infection Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    The National Healthcare Safety Network (NHSN) is a system designed to accumulate, exchange, and integrate relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and promote healthcare safety. Specifically, the data is used to determine the magnitude of various healthcare-associated adverse events and trends in the rates of these events among patients and healthcare workers with similar risks. The data will be used to detect changes in the epidemiology of adverse events resulting from new and current medical therapies and changing risks. The NHSN currently consists of five components: Patient Safety, Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility (LTCF), and Dialysis. The Outpatient Procedure Component is on track to be released in NHSN in 2017/2018. The development of this component has been previously delayed to obtain additional user feedback and support from outside partners.

    Changes were made to six facility surveys and two new facility surveys were added. Based on user feedback and internal reviews of the annual facility surveys it was determined that questions and response options be amended, removed, or added to fit the evolving uses of the annual facility surveys. The surveys are being increasingly used to help intelligently interpret the other data elements reported into NHSN. Currently the surveys are used to appropriately risk adjust the numerator and denominator data entered into NHSN while also guiding decisions on future division priorities for prevention.

    Further, three new forms were added to expand NHSN surveillance to pediatric ventilator-associated events, adult sepsis, and custom HAI event surveillance. An additional 14 forms were added to the Hemovigilance Component to streamline data collection/entry for adverse reaction events.

    Additionally, minor revisions have been made to 22 forms within the package to clarify and/or update surveillance definitions. The previously approved NHSN package included 52 individual collection forms; the current revision request adds nineteen forms and removes one form for a total of 70 forms. The reporting burden will increase by 489,174 hours, for a total of 5,110,716 hours.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per Respondent
  • Avg. burden per response (in hrs.) Total burden (in hrs.)
    Registered Nurse (Infection Preventionist) 57.100 NHSN Registration Form 2,000 1 5/60 167 Registered Nurse (Infection Preventionist) 57.101 Facility Contact Information 2,000 1 10/60 333 Registered Nurse (Infection Preventionist) 57.103 Patient Safety Component—Annual Hospital Survey 5,000 1 55/60 4,583 Registered Nurse (Infection Preventionist) 57.105 Group Contact Information 1,000 1 5/60 83 Registered Nurse (Infection Preventionist) 57.106 Patient Safety Monthly Reporting Plan 6,000 12 15/60 18,000 Registered Nurse (Infection Preventionist) 57.108 Primary Bloodstream Infection (BSI) 6,000 44 30/60 132,000 Registered Nurse (Infection Preventionist) 57.111 Pneumonia (PNEU) 6,000 72 30/60 216,000 Registered Nurse (Infection Preventionist) 57.112 Ventilator-Associated Event 6,000 144 25/60 360,000 Registered Nurse (Infection Preventionist) 57.113 Pediatric Ventilator-Associated Event (PedVAE) 2,000 120 25/60 100,000 Registered Nurse (Infection Preventionist) 57.114 Urinary Tract Infection (UTI) 6,000 40 20/60 80,000 Registered Nurse (Infection Preventionist) 57.115 Custom Event 2,000 91 35/60 106,167 Staff RN 57.116 Denominators for Neonatal Intensive Care Unit (NICU) 6,000 9 3 162,000 Staff RN 57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC) 6,000 9 5 270,000 Staff RN 57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA) 6,000 60 5 1,800,000 Registered Nurse (Infection Preventionist) 57.120 Surgical Site Infection (SSI) 6,000 36 35/60 126,000 Staff RN 57.121 Denominator for Procedure 6,000 540 10/60 540,000 Laboratory Technician 57.123 Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables 6,000 12 5/60 6,000 Pharmacist 57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables 6,000 12 5/60 6,000 Registered Nurse (Infection Preventionist) 57.125 Central Line Insertion Practices Adherence Monitoring 1,000 100 25/60 41,667 Registered Nurse (Infection Preventionist) 57.126 MDRO or CDI Infection Form 6,000 72 30/60 216,000 Registered Nurse (Infection Preventionist) 57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring 6,000 24 15/60 36,000 Registered Nurse (Infection Preventionist) 57.128 Laboratory-identified MDRO or CDI Event 6,000 240 20/60 480,000 Registered Nurse (Infection Preventionist) 57.129 Adult Sepsis 50 250 25/60 5,208 Registered Nurse (Infection Preventionist) 57.137 Long-Term Care Facility Component—Annual Facility Survey 350 1 1.08 378 Registered Nurse (Infection Preventionist) 57.138 Laboratory-identified MDRO or CDI Event for LTCF 350 12 15/60 1,050 Registered Nurse (Infection Preventionist) 57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF 350 12 10/60 700 Registered Nurse (Infection Preventionist) 57.140 Urinary Tract Infection (UTI) for LTCF 350 14 30/60 2,450 Registered Nurse (Infection Preventionist) 57.141 Monthly Reporting Plan for LTCF 350 12 5/60 350 Registered Nurse (Infection Preventionist) 57.142 Denominators for LTCF Locations 350 12 3.35 14,070 Registered Nurse (Infection Preventionist) 57.143 Prevention Process Measures Monthly Monitoring for LTCF 300 12 5/60 300 Registered Nurse (Infection Preventionist) 57.150 LTAC Annual Survey 400 1 55/60 367 Registered Nurse (Infection Preventionist) 57.151 Rehab Annual Survey 1,000 1 55/60 917 Occupational Health RN/Specialist 57.200 Healthcare Personnel Safety Component Annual Facility Survey 50 1 8 400 Occupational Health RN/Specialist 57.203 Healthcare Personnel Safety Monthly Reporting Plan 17,000 1 5/60 1,417 Occupational Health RN/Specialist 57.204 Healthcare Worker Demographic Data 50 200 20/60 3,333 Occupational Health RN/Specialist 57.205 Exposure to Blood/Body Fluids 50 50 1 2,500 Occupational Health RN/Specialist 57.206 Healthcare Worker Prophylaxis/Treatment 50 30 15/60 375 Laboratory Technician 57.207 Follow-Up Laboratory Testing 50 50 15/60 625 Occupational Health RN/Specialist 57.210 Healthcare Worker Prophylaxis/Treatment-Influenza 50 50 10/60 417 Medical/Clinical Laboratory Technologist 57.300 Hemovigilance Module Annual Survey 500 1 2 1,000 Medical/Clinical Laboratory Technologist 57.301 Hemovigilance Module Monthly Reporting Plan 500 12 1/60 100 Medical/Clinical Laboratory Technologist 57.303 Hemovigilance Module Monthly Reporting Denominators 500 12 1.17 7,020 Medical/Clinical Laboratory Technologist 57.305 Hemovigilance Incident 500 10 10/60 833 Medical/Clinical Laboratory Technologist 57.306 Hemovigilance Module Annual Survey—Non-acute care facility 200 1 35/60 117 Medical/Clinical Laboratory Technologist 57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion Reaction 500 4 25/60 833 Medical/Clinical Laboratory Technologist 57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction 500 4 25/60 833 Medical/Clinical Laboratory Technologist 57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction 500 2 25/60 417 Medical/Clinical Laboratory Technologist 57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion Reaction 500 4 25/60 833 Medical/Clinical Laboratory Technologist 57.312 Hemovigilance Adverse Reaction—Hypotensive Transfusion Reaction 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.313 Hemovigilance Adverse Reaction—Infection 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.314 Hemovigilance Adverse Reaction—Post Transfusion Purpura 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.315 Hemovigilance Adverse Reaction—Transfusion Associated Dyspnea 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.316 Hemovigilance Adverse Reaction—Transfusion Associated Graft vs. Host Disease 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.317 Hemovigilance Adverse Reaction—Transfusion Related Acute Lung Injury 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.318 Hemovigilance Adverse Reaction—Transfusion Associated Circulatory Overload 500 2 25/60 417 Medical/Clinical Laboratory Technologist 57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction 500 1 25/60 208 Medical/Clinical Laboratory Technologist 57.400 Patient Safety Component—Annual Facility Survey for Ambulatory Surgery Center (ASC) 5,000 1 5/60 417 Staff RN 57.401 Outpatient Procedure Component—Monthly Reporting Plan 5,000 12 15/60 15,000 Staff RN 57.402 Outpatient Procedure Component Event 5,000 25 40/60 83,333 Staff RN 57.403 Outpatient Procedure Component—Monthly Denominators and Summary 5,000 12 40/60 40,000 Staff RN 57.500 Outpatient Dialysis Center Practices Survey 6,500 1 2.0 13,000 Registered Nurse (Infection Preventionist) 57.501 Dialysis Monthly Reporting Plan 6,500 12 5/60 6,500 Staff RN 57.502 Dialysis Event 6,500 60 25/60 162,500 Staff RN 57.503 Denominator for Outpatient Dialysis 6,500 12 10/60 13,000 Staff RN 57.504 Prevention Process Measures Monthly Monitoring for Dialysis 1,500 12 1.25 22,500 Staff RN 57.505 Dialysis Patient Influenza Vaccination 325 75 10/60 4,063 Staff RN 57.506 Dialysis Patient Influenza Vaccination Denominator 325 5 10/60 271 Staff RN 57.507 Home Dialysis Center Practices Survey 600 1 25/60 250 Total 5,110,716
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-12701 Filed 5-27-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-16TM] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    Prevalence Survey of Healthcare-Associated Infections and Antimicrobial Use in U.S. Nursing Homes—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Preventing healthcare-associated infections (HAI) and encouraging appropriate use of antimicrobials are priorities of both the U.S. Department of Health and Human Services and the Centers for Disease Control and Prevention. The burden and epidemiology of HAIs and antimicrobial use in U.S. nursing homes is currently unknown. Understanding the scope and magnitude of all types of HAIs in patient populations across the spectrum of U.S. healthcare facilities is essential to the development of effective prevention and control strategies and policies.

    HAI prevalence and antimicrobial use estimates can be obtained through prevalence surveys in which data are collected in healthcare facilities during a short, specified time period. Essential steps in reducing the occurrence of HAIs and the prevalence of resistant pathogens include estimating the burden, types, and causative organisms of HAIs; assessing the nature and extent of antimicrobial use in U.S. healthcare facilities; and assessing the nature and extent of antimicrobial use.

    Prevalence surveys, in which data are collected in healthcare facilities during a short, specified time period represent an efficient and cost-effective alternative to prospective studies of HAI and antimicrobial use incidence. Given the absence of existing HAI and antimicrobial use data collection mechanisms for nursing homes, prevalence surveys represent a robust method for obtaining the surveillance data required to identify HAIs and antibiotic use practices that should be targeted for more intensive surveillance and to guide and evaluate prevention efforts.

    The methods for the data collection are based on those used in CDC hospital prevalence surveys and informed by a CDC pilot survey conducted in nine U.S. nursing homes. The survey will be performed by the CDC through the Emerging Infections Program (EIP), a collaboration with CDC and 10 state health departments with experience in HAI surveillance and data collection. Respondents are nursing homes certified by the Centers for Medicare & Medicare Services in EIP states. Nursing homes will be randomly selected for participation. The EIP will recruit 20 nursing homes in each of the 10 EIP sites. Nursing home participation is voluntary.

    OMB approval is requested for three years. Participation is voluntary and there are no costs to respondents other than their time. The total estimated annual burden hours are 5,217.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses
  • per
  • respondent
  • Avgerage
  • burden per
  • response
  • (in hrs.)
  • Director of Nursing, Registered Nurse, Infection Control and Prevention Officer Healthcare Facility Assessment 200 1 45/60 Registered Nurse Residents by Location Form 200 38 20/60 Licensed Practical or Licensed Vocational Nurses 200 38 20/60
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-12705 Filed 5-27-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-0984] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    DELTA FOCUS Program Evaluation (OMB No. 0920-0984)—Reinstatement with Change—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Intimate Partner Violence (IPV) is a serious, preventable public health problem that affects millions of Americans and results in serious consequences for victims, families, and communities. IPV occurs between two people in a close relationship. The term “intimate partner” describes physical, sexual, or psychological harm by a current or former partner or spouse. IPV can impact health in many ways, including long-term health problems, emotional impacts, and links to negative health behaviors. IPV exists along a continuum from a single episode of violence to ongoing battering; many victims do not report IPV to police, friends, or family. In 2002, authorized by the Family Violence Prevention Services Act (FVPSA), CDC developed the Domestic Violence Prevention Enhancements and Leadership Through Alliances (DELTA) Program, with a focus on the primary prevention of IPV.

    The purpose of the DELTA FOCUS program is to promote the prevention of IPV through the implementation and evaluation of strategies that create a foundation for the development of practice-based evidence. By emphasizing primary prevention, this program will support comprehensive and coordinated approaches to IPV prevention. On March 2, 2013, CDC awarded 10 cooperative agreements to state domestic violence coalitions (SDVCs).

    Each SDVC is required to identify and fund one to two well-organized, broad-based, active local organizations (referred to as coordinated community responses or CCRs) that are already engaging in, or are at capacity to engage in, IPV primary prevention strategies affecting the structural determinants of health at the societal and/or community levels of the SEM. SDVCs must facilitate and support local-level implementation and hire empowerment evaluators (EEs) to support the evaluation of IPV prevention strategies by the CCRs. SDVCs must also implement and with their empowerment evaluators, evaluate state-level IPV prevention strategies.

    The CDC seeks OMB approval for three years to collect program evaluation data. Information will be collected from awardees funded under FOA-CE13-1302, the DELTA FOCUS (Domestic Violence Prevention Enhancement and Leadership Through Alliances, Focusing on Outcomes for Communities United with States) cooperative agreement program. The information will be used to guide program improvements by CDC in the national DELTA FOCUS program implementation and program improvements by SDVCs in implementation of the program within their state. Not collecting this data could result in inappropriate implementation, resulting in ineffective use of tax payer resources. Thus, this data collection is an essential program evaluation activity and the results will not be generalizable to the universe of study. The estimated annual burden hours are 59. There is no cost to respondents other than their time.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • DELTA FOCUS Awardees (SDVC executive directors, SDVC project coordinators, SDVC empowerment evaluators, and SDVC-funded CCR project coordinators) DELTA FOCUS Survey 59 1 1
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-12706 Filed 5-27-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-855(A, B, I)] 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 a 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 June 30, 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: Extension of a currently approved collection; Title of Information Collection: Medicare Enrollment Application; Use: The primary function of the CMS-855 Medicare enrollment application is to gather information from a provider or supplier that tells us who it is, whether it meets certain qualifications to be a health care provider or supplier, where it practices or renders its services, the identity of the owners of the enrolling entity, and other information necessary to establish correct claims payments. No comments were received during the 60-day comment period (April 1, 2016 (81 FR 18855)). Form Number: CMS-855(A, B, I) (OMB control number: 0938-0685); Frequency: Annually; Affected Public: Private Sector; Business or other for-profit and not-for-profit institutions; Number of Respondents: 1,735,800; Total Annual Responses: 86,480; Total Annual Hours: 290,193. (For policy questions regarding this collection contact Kimberly McPhillips at 410-786-5374.)

    Dated: May 25, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2016-12694 Filed 5-27-16; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Advisory Committee; Allergenic Products Advisory Committee, Renewal AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; renewal of advisory committee.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the renewal of the Allergenic Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Allergenic Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until July 9, 2018.

    DATES:

    Authority for the Allergenic Products Advisory Committee will expire on July 9, 2016, unless the Commissioner formally determines that renewal is in the public interest.

    FOR FURTHER INFORMATION CONTACT:

    Janie Kim, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6129, Silver Spring, MD 20993-0002; 301-796-9016, [email protected]

    SUPPLEMENTARY INFORMATION:

    Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Allergenic Products Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility.

    The Committee reviews and evaluates available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease, and makes appropriate recommendations to the Commissioner of its findings regarding the affirmation or revocation of biological product licenses, on the safety, effectiveness, and labeling of the products, on clinical and laboratory studies of such products, on amendments or revisions to regulations governing the manufacture, testing, and licensing of allergenic biological products, and on the quality and relevance of FDA's research programs which provide the scientific support for regulating these agents.

    The Committee shall consist of a core of nine voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of allergy, immunology, pediatrics, internal medicine, biochemistry, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests.

    Further information regarding the most recent charter and other information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/AllergenicProductsAdvisoryCommittee/ucm129360.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

    This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: May 24, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs.
    [FR Doc. 2016-12636 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Advisory Committee; Psychopharmacologic Drugs Advisory Committee, Renewal AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; renewal of advisory committee.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the renewal of the Psychopharmacologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Psychopharmacologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the June 4, 2018.

    DATES:

    Authority for the Psychopharmacologic Drugs Advisory Committee will expire on June 4, 2016, unless the Commissioner formally determines that renewal is in the public interest.

    FOR FURTHER INFORMATION CONTACT:

    Kalyani Bhatt, 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, [email protected]

    SUPPLEMENTARY INFORMATION:

    Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Psychopharmacologic Drugs Advisory Committee. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Psychopharmacologic Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility. The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the practice of psychiatry and related fields and make appropriate recommendations to the Commissioner of Food and Drugs.

    The Committee shall consist of a core of nine voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of psychopharmacology, psychiatry, epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests.

    Further information regarding the most recent charter and other information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/ucm107528.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

    This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: May 24, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs.
    [FR Doc. 2016-12637 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-3327] Agency Information Collection Activities; Proposed Collection; Comment Request; E6(R2) Good Clinical Practice; International Council for Harmonisation AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA, we, or the Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collections of information marked as “ADDENDUM” in the draft guidance entitled “E6(R2) Good Clinical Practice” (E6(R2) draft guidance). The E6(R2) draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The E6(R2) draft guidance amends the guidance entitled “E6 Good Clinical Practice: Consolidated Guidance” (E6(R1) consolidated guidance), issued in April 1996, to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and data integrity. Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated. The E6(R2) draft guidance was intended to improve clinical trial quality and efficiency while maintaining human subject protection. This notice solicits comments on the collection of information in the draft guidance concerning the development of a system to manage quality, as well as information to include in a clinical study report about the quality management approach.

    DATES:

    Submit either electronic or written comments on the collection of information by August 1, 2016 on the “ADDENDUM” sections of the E6(R2) draft guidance.

    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 Submission” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2015-D-3327 for “Agency Information Collection Activities; Proposed Collection; Comment Request; E6(R2) Good Clinical Practice; International Council for Harmonisation.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    E6(R2) Good Clinical Practice Draft Guidance; International Council for Harmonisation OMB Control Number 0910-NEW I. Background

    In the Federal Register of September 29, 2015 (80 FR 58492), we announced the availability of and requested public comments on the E6(R2) draft guidance. The draft guidance is the product of the ICH E6 Expert Working Group of the ICH. The E6(R2) draft guidance provides additions to the E6(R1) consolidated guidance that are identified as “ADDENDUM” and marked with vertical lines on both sides of the text. The additions are intended to encourage implementation of the described approaches and processes to improve the quality and efficiency of clinical trials while maintaining the protection of human subjects. The E6(R2)draft guidance includes information collection provisions that are subject to review by OMB under the PRA. This Federal Register notice begins the process of requesting public comment and obtaining OMB approval for those information collections that are new and are not already covered by previously approved collections of information.

    II. Burden Estimates for the E6(R2) Draft Guidance

    The E6(R2) draft guidance recommends that sponsors develop and maintain a system to manage quality when designing, conducting, recording, evaluating, reporting, and archiving clinical trials. The draft guidance also recommends that the sponsor describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits in the clinical study report. We are requesting OMB approval for the following collections of information identified in the “ADDENDUM” sections of the E6(R2) draft guidance and are inviting public comments on these sections.

    In table 1 of this document, we estimate that approximately 1,457 sponsors of clinical trials of human drugs will develop approximately 1,457 quality management systems per year (as described in section 5.0 of the E6(R2) draft guidance). We further estimate that it will take sponsors approximately 60 hours to develop and implement each quality management system, totaling 87,420 hours annually. These estimates are based on the number of annual investigational new drug applications (IND) and new drug applications (NDA) submitted to the Center for Drug Evaluation and Research in previously approved collections of information. The estimated number of sponsors that will develop a quality management system as described in the guidance, as well as the estimated number of hours it will take, is based on FDA interactions with sponsors about activities that support drug development plans.

    In table 2 of this document, we estimate that approximately 1,457 sponsors of clinical trials of human drugs will describe the quality management approach implemented in a clinical trial and summarize important deviations from the predefined quality tolerance limits in a clinical study report (as described in section 5.0.7 of the E6(R2) draft guidance). We further estimate that sponsors will submit approximately 4.6 responses per respondent and that it will take sponsors 3 hours to complete this reporting task, totaling 20,107 reporting hours annually. These estimates are based on past experiences with IND, NDA, and previously approved collections of information.

    In table 3 of this document, we estimate that approximately 218 sponsors of clinical trials of biological products will develop approximately 218 quality management systems per year (as described in section 5.0.7 of the E6(R2) draft guidance). We further estimate that it will take sponsors approximately 60 hours to develop and implement each quality management system, totaling 13,080 hours annually. These estimates are based on past experiences with INDs, biologics license applications (BLA), and previously approved collections of information.

    In table 4 of this document, we estimate that 218 sponsors of biological products will describe the quality management approach implemented in a clinical trial and summarize important deviations from the predefined quality tolerance limits in a clinical study report (as described in section 5.0.7 of the E6(R2) draft guidance). We further estimate that sponsors will submit approximately 3.69 responses per respondent and that it will take sponsors 3 hours to complete this reporting task, totaling 2,413 reporting hours annually. As described previously, these estimates are also based on past experiences with IND, BLA, and previously approved collections of information.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Recordkeeping Burden for Human Drugs 1 E6(R2) Good Clinical Practice; International Council for Harmonisation; Draft Guidance for Industry Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Section 5.0—Quality Management (including sections 5.0.1 to 5.0.7) 1,457 1 1,457 60 87,420 Developing a Quality Management System 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2—Estimated Annual Reporting Burden for Human Drugs 1 E6(R2) Good Clinical Practice; International Council for Harmonisation; Draft Guidance for Industry Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Section 5.0.7—Risk Reporting 1,457 4.6 6,702 3 20,107 Describing the Quality Management Approach Implemented in a Clinical Trial and Summarizing Important Deviations From the Predefined Quality Tolerance Limits in a Clinical Study Report 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Table 3—Estimated Annual Recordkeeping Burden for Biologics 1 E6(R2) Good Clinical Practice; International Council for Harmonisation; Draft Guidance for Industry Number of recordkeepers Number of records per recordkeeper Total records Average burden per record Total hours Section 5.0—Quality Management (including 5.0.1 to 5.0.7) 218 1 218 60 13,080 Developing a Quality Management System 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Table 4—Estimated Annual Reporting Burden for Biologics 1 E6(R2) Good Clinical Practice; International Council for Harmonisation; Draft Guidance for Industry Number of responses Number of responses per respondent Total annual responses Average burden per response Total hours Section 5.0.7—Risk Reporting 218 3.69 804 3 2,413 Describing the Quality Management Approach Implemented in a Clinical Trial and Summarizing Important Deviations From the Predefined Quality Tolerance Limits in a Clinical Study Report 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    The collections of information included in the sections marked as “ADDENDUM” in the E6(R2) draft guidance also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA. The collections of information found in 21 CFR part 11 have been approved under OMB control number 0910-0303; the collections of information found in 21 CFR part 312 have been approved under OMB control number 0910-0014; and collections of information found in 21 CFR part 314 have been approved under OMB control number 0910-0001. The collections of information found in 21 CFR part 601 have been approved under OMB control number 0910-0338.

    Dated: May 24, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-12651 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-P-0403] Determination That LEVOTHROID (Levothyroxine Sodium) Tablets, 0.025 Milligram, 0.05 Milligram, 0.075 Milligram, 0.088 Milligram, 0.112 Milligram, 0.125 Milligram, 0.137 Milligram, 0.15 Milligram, 0.175 Milligram, 0.1 Milligram, 0.2 Milligram, and 0.3 Milligram, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) has determined that LEVOTHROID (levothyroxine sodium) tablets, 0.025 milligram (mg), 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, if all other legal and regulatory requirements are met.

    FOR FURTHER INFORMATION CONTACT:

    Reena Raman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6284, Silver Spring, MD 20993-0002, 301-796-7577.

    SUPPLEMENTARY INFORMATION:

    In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

    The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

    A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

    LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, are the subject of NDA 021116, held by Lloyd Inc., and initially approved on October 24, 2002. LEVOTHROID is used for the following indications:

    • Hypothyroidism—As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: Primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.

    • Pituitary Thyrotropine-Stimulating Hormone Suppression—In the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter, and as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

    LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg are currently listed in the “Discontinued Drug Product List” section of the Orange Book.

    Lachman Consultant Services, Inc., submitted a citizen petition dated February 4, 2015 (Docket No. FDA-2015-P-0403), under 21 CFR 10.30, requesting that the Agency determine whether LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, were withdrawn from sale for reasons of safety or effectiveness.

    After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that this drug product was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.

    Accordingly, the Agency will continue to list LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to this drug product may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

    Dated: May 24, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-12655 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Clinical Trial Design Considerations for Malaria Drug Development; Notice of Public Workshop; 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 Tuesday, May 10, 2016 (81 FR 28876). The document announced a public workshop entitled “Clinical Trial Design Considerations for Malaria Drug Development.” The document was published with the incorrect title and incorrect Internet address in the Transcripts section. This document corrects those errors.

    FOR FURTHER INFORMATION CONTACT:

    Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-0002, 301-796-1300.

    SUPPLEMENTARY INFORMATION:

    In FR Doc. 2016-10913, appearing on page 28876 in the Federal Register of Tuesday, May 10, 2016, the following corrections are made:

    1. On page 28876, in the first column, the title is corrected to read “Clinical Trial Design Considerations for Malaria Drug Development.”

    2. On page 28876, in the second column, the Transcripts section is corrected to read “Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD. A transcript will also be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, Rm. 6-30, Rockville, MD 20857. Transcripts will also be available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm490084.htm approximately 45 days after the workshop.

    If you need special accommodations because of a disability, please contact Jessica Barnes or Lori Benner (see Contact Person) at least 7 days in advance.”

    Dated: May 24, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-12654 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1269] Collaboration in Regulatory Systems Strengthening and Standardization Activities To Increase Access to Safe and Effective Biological Products AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for award of a cooperative agreement to the World Health Organization (WHO) in support of collaboration in regulatory systems strengthening, development of norms and standards, and innovative research to advance global access to safe and effective biological products that meet international standards. The goal of FDA's Center for Biologics Evaluation and Research (FDA/CBER) is to enhance technical collaboration and cooperation between the FDA, WHO, and its member states to facilitate strengthening regulatory capacity and support product development and standardization activities to increase access to safe and effective biologicals globally.

    DATES:

    The application due date is July 5, 2016.

    ADDRESSES:

    Submit electronic applications to http://www.grants.gov. For more information, see section III of the SUPPLEMENTARY INFORMATION section of this notice.

    FOR FURTHER INFORMATION CONTACT:

    Gopa Raychaudhuri, CBER Liaison to WHO, Office of the Director, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7250, Silver Spring, MD 20993, 240-402-8000, [email protected]; or Leslie Haynes, Foreign Regulatory Capacity Building Coordinator, International Affairs, Office of the Director, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7222, Silver Spring, MD 20993, 240-402-8074, [email protected]; or Bryce Jones, Grants Management Specialist, Division of Acquisition and Grants, Office of Acquisitions and Grants Services, Food and Drug Administration, 5630 Fishers Lane, Rm. 2026, Rockville, MD 20857, 240-402-2111, [email protected]

    For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at http://www.grants.gov. Search by Funding Opportunity Number: RFA-FD-16-044.

    SUPPLEMENTARY INFORMATION:

    I. Funding Opportunity Description RFA-FD-16-044 93.103 A. Background

    WHO is the directing and coordinating authority on international health within the United Nations' (UN) system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. WHO assists countries in building capacity to increase and sustain access to medical products to prevent, detect, and treat communicable diseases, including reducing vaccine-preventable diseases. WHO also coordinates efforts to respond to public health emergencies by monitoring the health situation, undertaking risk assessments, identifying priorities, and providing technical guidance and other forms of support to countries and regions.

    Providing adequate regulatory oversight throughout the product life cycle (pre- and post-licensure) is essential for assuring the safety, purity, and potency of vaccines and other biologicals. However, this is a major challenge for many National Regulatory Authorities (NRAs) confronted by a steadily increasing number of novel products, complex quality concerns, new regulatory issues arising from rapid technical and technological advances, and emerging infectious diseases (e.g., pandemic influenza, Middle East Respiratory Syndrome, Ebola, Zika). WHO has an important role in strengthening regulatory systems and other supportive activities to increase access to high quality, safe, and effective biological products especially in low-and-middle-income countries. It is the only organization with the mandate, access to technical expertise, and broad reach to meet the research objectives.

    FDA/CBER has been a leader and active participant in the global community to improve human health in the world's populations over many years. Its international engagements have been informed by the knowledge that protection of global public health against infectious disease threats translates into protection of public health in the United States. FDA, through CBER, has longstanding collaborations with WHO in the area of biologicals (vaccines, blood and blood products, relevant in vitro diagnostics, and cell and tissue therapies).

    FDA/CBER has been a Pan American Health Organization/WHO Collaborating Center for Biological Standardization since 1998 with the current commitment running until 2020 and expectation of future extensions. As a WHO Collaborating Center for Biological Standardization, CBER has provided scientific and technical support to WHO for development of international standards, strengthening regulatory systems, advancing product safety and vigilance, vaccine prequalification, and research activities to advance development and improve standardization of vaccines and other biologicals. These areas of collaboration reflect FDA/CBER's longstanding commitment to increasing global access of high quality, safe and effective biological products that meet international standards.

    1. Development of Norms and Standards

    WHO plays a key role in establishing the WHO International Biological Reference Preparations and in developing WHO guidelines and recommendations on the production and control of vaccines and other biological products and technologies. The WHO Expert Committee on Biological Standardization (ECBS) is commissioned by WHO to advise the Organization on international standards setting activities. These norms and standards are based on wide scientific consultation and on international consensus and are intended to ensure the consistent quality and safety of biological products and related in vitro diagnostic tests worldwide.

    Blood products are inherently variable due to the nature of the source materials as well as the methods used to test them. The objective is to ensure that only blood products of acceptable quality, safety, and efficacy are used in the patient population. Similarly, ensuring the quality, safety, and effectiveness of vaccines is one of WHO's highest priorities. The WHO works in close collaboration with the international scientific and professional communities, regional and national regulatory authorities, manufacturers, and expert laboratories worldwide to ensure that global standards are developed and made readily available to assess the quality, safety, and effectiveness of biological products, and to support monitoring safety throughout the product life cycle.

    2. Regulatory Systems Strengthening

    NRAs play a vital role in the national health care system. Providing regulatory oversight throughout the product life cycle (pre- and post-licensure) is a major challenge for many NRAs confronted by a steadily increasing number of novel products, complex quality concerns, new regulatory issues arising from rapid technical and technological advances, and emerging infectious diseases (e.g., pandemic influenza, MERS, Ebola, Zika). WHO has an important role in strengthening regulatory systems to increase access to high quality, safe, and effective biological products especially in low-and-middle-income countries. In this era of globalization, establishment of robust regulatory systems in other regions of the world also benefits the U.S. population as it facilitates FDA's ability to better monitor and ensure the safety of the supply chain for medical and other products entering the United States from other countries.

    3. WHO Prequalification Program

    The WHO prequalification program was established in response to the need to supply quality health products, including vaccines and in vitro diagnostic tests for the prevention, diagnosis, and treatment of priority diseases in low-and-middle-income countries. Through the prequalification program, WHO assures the quality, safety, and effectiveness/performance of these products, and suitability for use in the target settings.

    As part of the vaccine prequalification program, WHO provides advice to the United Nations Children's Fund (UNICEF) and other UN agencies on the acceptability, in principle, of vaccines considered for purchase by such agencies for vaccination programs they administer. An important part of the vaccine prequalification program is WHO's reliance upon a stringent NRA to provide regulatory oversight of the vaccine throughout the product's life cycle. In 2009, FDA entered into a confidentiality arrangement with WHO to enable FDA/CBER to serve as a NRA of record in the vaccine prequalification program and currently serves in this capacity for nine U.S. licensed, WHO prequalified vaccines.

    4. Product Safety and Vigilance

    The safety of medical products depends on a variety of factors that range from good manufacturing practices to strong national systems able to monitor the products in domestic markets. However, with increasing globalization of trade, overall effective surveillance of medical products depends on international regulatory cooperation and information sharing. WHO promotes the global safety of medical products by coordinating global networks for information sharing, such as data bases and monitoring and alert systems, and by supporting countries to develop national capacities for the post-marketing surveillance of biological products.

    WHO and partners have developed a strategic framework (“Global Vaccine Safety Blueprint”) to promote the establishment of effective vaccine pharmacovigilance systems globally. The Blueprint proposes a strategic plan for strengthening vaccine safety activities worldwide, focusing on building national capacity for vaccine safety in the world's poorest countries through the coordinated efforts of major stakeholders.

    WHO advisory bodies also play a significant role in reviewing and assessing product safety data and making recommendations to WHO regarding use of vaccines and other biological products. For example, the Global Advisory Committee on Vaccine Safety (GACVS) provides independent, authoritative, scientific advice to WHO on vaccine safety issues of global or regional concern, and the Blood Regulators' Network (BRN) serves as an advisory body to WHO on matters related to safety and availability of blood and blood products.

    5. Regulatory Science to Promote Development and Increased Access to Safe and Effective Biological Products

    Regulatory science aims to contribute to the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated biological products. Examples include tools to standardize assays used for regulatory purposes (e.g., development of correlates of immunity; correlates of safety; improved methods for product characterization; new or alternative potency assays etc.). Results generated through methods and tools developed through regulatory science efforts such as adaptive clinical trial designs, benefit/risk assessment, novel pharmacovigilance methodologies, and other tools inform regulatory decisionmaking processes. Knowledge gained through regulatory science can play a significant role in regulatory decisionmaking, policy development, and preparedness to address threats from existing or emerging infectious diseases.

    FDA, with other HHS technical agencies and offices, WHO, and other regulatory counterparts, are strategizing on approaches to increase access of the global population to safe and effective biological products for the prevention, diagnosis, and treatment of priority diseases, especially for use in low-and-middle-income countries. This project represents a collaborative effort between FDA and WHO (and complements and builds upon the U.S. Government's existing commitments with WHO) to support scientific collaboration and enhance regulatory capabilities of NRAs and networks to advance global access to safe and effective vaccines and other biologicals that meet international standards. This project will further support science-based and data-driven public health strategies and approaches, and lead to improved technical cooperation between FDA, WHO, and its member states.

    B. Research Objectives

    The project has the following goals:

    1. Contribute to the Knowledge Base of the Current State of Regulatory Oversight of Vaccines and Other Biological Products

    • Support NRA assessments and analyses and synthesis of the data, and development of an institutional development plan to enhance regulatory performance in low-and-middle-income countries. Assessment of regulatory systems could include but is not limited to, analyses and synthesis of existing data from assessments of vaccine regulatory capabilities of different NRAs, and new applications of assessment frameworks to specific areas, such as pharmacovigilance (e.g., monitoring safety and effectiveness of new vaccines following introduction in a specific country or regional setting). NRA assessments also support WHO's vaccine prequalification program;

    • Analysis of regulatory systems performance can include assessment of challenges, risks, and emerging trends, with the aim of further strengthening the development of data/information systems as sources of inputs for evidence-based regulatory decisions and actions; and

    • Expected outputs could include analyses, reports, and data-driven strategy papers, among others.

    2. Providing Technical Support to Regulatory Systems Strengthening Efforts

    • Enable the strengthening of regulatory systems at the national and regional levels in such critical domains as good manufacturing, clinical, and laboratory practices; monitoring and evaluation of product quality; lot release; inspection and surveillance of products throughout the supply chain; pharmacovigilance systems building and analyses; risk assessment, analysis, and management etc.;

    • Support the diffusion and application of knowledge, data, and information through active participation in regional and global committees and networks, such as the African Vaccine Regulatory Forum, ECBS, GACVS, BRN etc.; and

    • Expected outputs could include analyses, reports, and data-driven strategy papers, among others.

    3. Development of Global Norms and Standards

    • Enable the timely and effective sharing of scientific findings and data through international collaboration to develop WHO International Biological Reference Preparations and WHO guidelines and recommendations on the production and control of vaccines and other biological products and technologies;

    • Assist Member States in the implementation of internationally-recognized standards and guidelines, e.g. WHO guidelines and standards and those emerging from standards development venues such as the International Council for Harmonisation of the Technical Requirements for Pharmaceuticals for Human Use;

    • Utilize WHO's convening power to engage with relevant stakeholders in support of data-driven and science-based public health strategies and approaches to enhancing global regulatory capacity and cooperation; and

    • Expected outputs could include guideline documents, physical standards (e.g., reference reagents, reference panels etc.), reports, and data-driven strategy papers, among others.

    4. Support Regulatory Science and Other Activities To Promote Development and increased Access to Safe and Effective Biological Products

    • Enable development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated biological products;

    • Support programs, including but not limited to WHO prequalification, that increase access to safe and effective biological products; and

    • Expected outputs could include analyses, reports, and data-driven strategy papers, among others.

    C. Eligibility Information

    The following organization is eligible to apply: WHO.

    II. Award Information/Funds Available A. Award Amount

    FDA/CBER anticipates providing in FY2016 up to $2 million (total costs including indirect costs) for one award (subject to availability of funds) in support of this project. Future year amounts will depend on annual appropriations, availability of funding, and awardee performance. CBER anticipates providing four additional years of support up to the following amounts:

    FY 2017: $2 million FY 2018: $2 million FY 2019: $2 million FY 2020: $2 million B. Length of Support

    The support will be 1 year with the possibility of an additional 4 years of noncompetitive support. Continuation beyond the first year will be based on satisfactory performance during the preceding year, receipt of a noncompeting continuation application, and available Federal Fiscal Year appropriations.

    III. Electronic Application, Registration, and Submission Information

    Only electronic applications will be accepted. To submit an electronic application in response to this FOA, applicants should first review the full announcement located at http://www.grants.gov. Search by Funding Opportunity Number: RFA-FD-16-044. (FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register) For all electronically submitted applications, the following steps are required.

    • Step 1: Obtain a Dun and Bradstreet (DUNS) Number.

    • Step 2: Register with System for Award Management (SAM)(formerly CCR).

    • Step 3: Obtain Username & Password.

    • Step 4: Authorized Organization Representative (AOR) Authorization.

    • Step 5: Track AOR Status.

    • Step 6: Register with Electronic Research Administration (eRA) Commons.

    Steps 1 through 5, in detail, can be found at http://www.grants.gov/web/grants/applicants/organization-registration.html. Step 6, in detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps, submit electronic applications to: http://www.grants.gov.

    Dated: May 24, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-12685 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2015-E-3441 and FDA-2015-E-3439] Determination of Regulatory Review Period for Purposes of Patent Extension; OLYSIO AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) has determined the regulatory review period for OLYSIO 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 drug product.

    DATES:

    Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by August 1, 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 November 28, 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-2015-E-3441 or FDA-2015-E-3439 for “Determination of Regulatory Review Period for Purposes of Patent Extension; OLYSIO.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human drug product OLYSIO (simeprevir). OLYSIO is indicated for treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen. Subsequent to this approval, the USPTO received patent term restoration applications for OLYSIO (U.S. Patent Nos. 7,671,032 and 8,349,869) from Medivir AB and Janssen R&D Ireland, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of OLYSIO 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 OLYSIO is 2,006 days. Of this time, 1,766 days occurred during the testing phase of the regulatory review period, while 240 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: May 28, 2008. FDA has verified the Medivir AB and Janssen R&D Ireland claim that May 28, 2008, is the date the investigational new drug application (IND) became effective.

    2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: March 28, 2013. FDA has verified the applicant's claim that the new drug application (NDA) for OLYSIO (NDA 205123) was initially submitted on March 28, 2013.

    3. The date the application was approved: November 22, 2013. FDA has verified the applicant's claim that NDA 205123 was approved on November 22, 2013.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension and amendments, the applicants seek 801 or 280 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: May 24, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-12708 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Renewal AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; renewal of advisory committee.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the renewal of the Science Advisory Board to the National Center for Toxicological Research (NCTR) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Science Advisory Board to the National Center for Toxicological Research for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 2, 2018.

    DATES:

    Authority for the Science Advisory Board to the National Center for Toxicological Research will expire on June 2, 2016, unless the Commissioner formally determines that renewal is in the public interest.

    FOR FURTHER INFORMATION CONTACT:

    Donna L. Mendrick, National Center for Toxicological Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301-796-8892, [email protected]

    SUPPLEMENTARY INFORMATION:

    Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Science Advisory Board to the National Center for Toxicological Research. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Science Advisory Board to the National Center for Toxicological Research advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Board advises the Director, NCTR, in establishing, implementing, and evaluation the research programs that assist the Commissioner of Food and Drugs in fulfilling his regulatory responsibilities. The Board provides an extra-agency review in ensuring that the research programs at NCTR are scientifically sound and pertinent.

    The Committee shall consist of a core of nine voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of toxicological research. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons.

    Further information regarding the most recent charter and other information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ToxicologicalResearch/ucm148166.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

    This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: May 24, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs.
    [FR Doc. 2016-12657 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Facilitating Antibacterial Drug Development for Patients With Unmet Need and Developing Antibacterial Drugs That Target a Single Species Media; Public Workshop AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing a public workshop regarding antibacterial drug development for patients with unmet need and developing antibacterial drugs that target a single species. FDA is interested in discussing the scientific challenges pertaining to such development programs, including enrollment challenges, clinical trial designs, and trial population. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. government Agencies, public health organizations, academic experts, and industry on various aspects of drug development for new antibacterial drugs for patients with unmet need and new antibacterial drugs that target a single species. The input from this public workshop will also help in developing topics for future discussion.

    DATES:

    The public workshop will be held on July 18, 2016, from 8:30 a.m. to 5 p.m. and July 19, 2016, from 8:30 a.m. to 4 p.m. See the SUPPLEMENTARY INFORMATION section for registration information.

    ADDRESSES:

    The public workshop will be held at FDA's White Oak campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    FOR FURTHER INFORMATION CONTACT:

    Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221 Silver Spring, MD 20993-0002, 301-796-1300.

    SUPPLEMENTARY INFORMATION:

    FDA is announcing a public workshop regarding antibacterial drug development for patients with unmet need and developing antibacterial drugs that target a single species. Discussions will focus on potential development pathways, aspects of clinical trials including patient population, trial designs, and endpoints, and the role of clinical trial networks in antibacterial drug development.

    Registration: Registration is free for the public workshop. Interested parties are encouraged to register early. Seating will be available on a first-come, first-served basis. To register electronically, email registration information (including name, title, firm name, address, telephone, and fax number) to [email protected] Persons without access to the Internet can call 301-796-1300 to register.

    If you need special accommodations due to a disability, please contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance.

    Agenda: The workshop draft Agenda will be made available at: http://wwwfda.gov/Drugs/NewsEvents/ucm497650.htm at least 2 days prior to the meeting. The Agency encourages individuals, industry, health care professionals, researchers, public health organizations and other interested persons to attend this public workshop.

    Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov. Transcripts will also be available on the Internet at: http://wwwfda.gov/Drugs/NewsEvents/ucm497650.htm approximately 45 days after the workshop.

    Dated: May 24, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-12684 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Clinical Chemistry and Clinical Toxicology 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.

    DATES:

    The meeting will be held on August 10, 2016, from 8 a.m. to 6 p.m.

    ADDRESSES:

    Gaithersburg Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD 20879. The hotel's telephone number is 301-948-8900. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    FOR FURTHER INFORMATION CONTACT:

    Patricio G. Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1611, Silver Spring, MD 20993-0002, [email protected], 301-796-6875, 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 August 10, 2016, the committee will discuss, make recommendations, and vote on information regarding a de novo request for the SEEKER Newborn Screening System (SEEKER System), by Baebies, Inc. The SEEKER System consists of the SEEKER Analyzer, the SEEKER 4-Plex Assay Kit, the SEEKER Cartridges, the Spot Logic software, and quality control materials; it uses digital microfluidic technology to measure multiple lysosomal enzymatic activities quantitatively from newborn dried blood spot specimens. The proposed Indication for Use for the SEEKER System device, as stated in the de novo request, is as follows:

    The SEEKER System is intended for quantitative measurement of the activity of multiple lysosomal enzymes from newborn dried blood spot specimens. Reduced activity of these enzymes may be indicative of a lysosomal storage disorder. The enzymes measured using the SEEKER 4-Plex Assay Kit and their associated lysosomal storage disorder are listed in the following table.

    Enzyme (abbreviation) Disorder α-L-iduronidase (IDUA) Mucopolysaccharidosis Type I (MPS I) disease. α-D-glucosidase (GAA) Pompe disease. β-glucocerebrosidase (GBA) Gaucher disease. α-D-galactosidase A (GLA) Fabry disease.

    Reduced activity for any of the four enzymes must be confirmed by other confirmatory diagnostic methods.

    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 August 3, 2016. On August 10, 2016, oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before July 26, 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 July 27, 2016.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact 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: May 24, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs.
    [FR Doc. 2016-12658 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Sequencing Quality Control II; Public Workshop AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing a public workshop entitled “Sequencing Quality Control II.” The purpose of the public workshop is to define the scope of project and study designs, and solicit participation of DNA sequencing community and stakeholders for data generation, management, analysis, and interpretation.

    DATES:

    The public workshop will be held on September 13 and 14, 2016, from 8 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information.

    ADDRESSES:

    The public workshop will be held at Wilson Hall, Bldg. 1, National Institutes of Health (NIH), 31 Center Dr., Bethesda, MD 20892. Entrance for the public workshop participants (non-NIH employees) is through the NIH Gateway Center where routine security check procedures will be performed. For parking and security information, please refer to https://www.nih.gov/about-nih/visitor-information/campus-access-security.

    FOR FURTHER INFORMATION CONTACT:

    Weida Tong, National Center for Toxicological Research (NCTR), Food and Drug Administration, 3900 NCTR Rd., Jefferson, AR 72079, 870-543-7142, FAX: 870-543-7854, [email protected]

    SUPPLEMENTARY INFORMATION:

    FDA's Critical Path Initiative (http://www.fda.gov/oc/initiatives/criticalpath/) identifies pharmacogenomics as a key opportunity in advancing medical product development and personalized medicine. FDA has issued the “Guidance for Industry: Pharmacogenomic Data Submissions” (http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm079849.pdf) to facilitate scientific progress in the field of pharmacogenomic data integration in drug development and medical diagnostics. Microarrays represent a core technology in pharmacogenomics and toxicogenomics; however, next-generation sequencing technologies promise to provide some unique advantages in DNA and RNA analyses and are expected to be adopted by the pharmaceutical and medical industries for advancing personalized nutrition and medicine.

    Starting in 2005, FDA initiated an open project, MicroArray Quality Control (MAQC), which has gone through three phases. MAQC-I focused on the technical aspects of microarray-based gene expression measurements, the MAQC-II focused on validation of microarray-based predictive models, and MAQC-III, which is also called the Sequencing Quality Control (SEQC), focused on assessing the performance of whole transcriptome sequencing (RNA-seq).

    The Sequencing Quality Control Phase 2 (SEQC-II) is a natural extension of the SEQC project with emphasis on DNA-Seq for various applications. The SEQC-II project, with broad participation from scientists and reviewers within FDA and collaborators across the public, academic, and private sectors, is expected to help prepare FDA for the next wave of submission of genomic data generated from the next-generation sequencing technologies.

    Registration: Mail, fax, or email your registration information (including name, title, firm name, address, telephone, and fax numbers) to the contact person by August 31, 2016. FDA will email a confirmation to those who have registered. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. No registration on the day of the public workshop will be provided.

    If you need special accommodations due to a disability, please contact Weida Tong (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance.

    Dated: May 24, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-12656 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Clinical Chemistry and Clinical Toxicology 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.

    DATES:

    The meeting will be held on July 21 and July 22, 2016, from 8 a.m. to 6 p.m.

    ADDRESSES:

    Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's 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.

    FOR FURTHER INFORMATION CONTACT:

    Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1116, 10903 New Hampshire Ave., Silver Spring, MD 20993; [email protected]; 301-796-6875, 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 July 21, 2016, the committee will discuss, make recommendations, and vote on information regarding a premarket approval application (PMA) panel-track supplement for a proposed change in intended use of Dexcom, Inc.'s, Dexcom G5® Mobile Continuous Glucose Monitoring System (CGM) device so that, in addition to tracking and trending interstitial fluid glucose concentrations, patients can use the device as a replacement for their blood glucose meters and make treatment decisions based on the interstitial fluid glucose concentration reported by the CGM.

    On July 22, 2016, the committee will discuss and make recommendations on information regarding a premarket notification (510(k)) submission for the Alere AfinionTM HbA1c Dx point-of-care test system, sponsored by Alere Technologies AS. The proposed intended use, as stated by the sponsor:

    Alere Afinion HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human whole blood. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus. For use in clinical laboratories and point of care laboratory settings.

    Current clinical guidelines contraindicate the use of point-of-care hemoglobin A1c (HbA1c) tests to diagnose diabetes. FDA is seeking feedback from the clinical community to determine significant, scientific and practical, reservations or support for using this point-of-care HbA1c test as an aid in the diagnosis of diabetes and pre-diabetes.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before July 15, 2016. Oral presentations from the public will be scheduled on July 21 and 22, 2016, between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before July 7, 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 July 8, 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 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: May 24, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs.
    [FR Doc. 2016-12641 Filed 5-27-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct AGENCY:

    Office of the Secretary, HHS.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case:

    Ricky Malhotra, Ph.D., University of Michigan and University of Chicago: Based on the Respondent's admission to committing research misconduct at the University of Michigan (UM) and subsequently at the University of Chicago (UC), the reports of separate investigations conducted by UM and UC, and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Ricky Malhotra, former Research Assistant Professor, Department of Internal Medicine, UM, from 2005-2006, and Research Assistant Professor, Department of Surgery, UC, from 2007-2011, engaged in research misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grants K08 HL081472 and R01 HL107949.

    ORI found that falsified and/or fabricated data were included in the following three (3) NIH grant applications, one (1) NIH grant progress report, one (1) publication, seven (7) presentations, and one (1) image file:

    • R03 AG029508-01 • R21 AG030361-01 • R01 HL102405-01 • K08 HL081472-05 Progress Report J Biol Chem. 285(18):13748-60, 2010 Apr 30 (hereafter referred to as “JBC 2010”) • Presentation: Autophagy Pathway.ppt, MKK4 expression after UV.ppt, Oct PPt.ppt, RicDec.ppt, Ricky Presentation 06.ppt, Ricky STC.ppt, and RM.ppt • Image file: Final LC 3.jpg

    ORI found that Respondent reused and falsely relabeled Western blot gel images, falsified the related densitometry measurements based on the falsified Western blots, and falsified and/or fabricated data for experiments that were not performed. Respondent continued this falsification at UC, after the UM research misconduct investigation was completed. Specifically:

    • While at UM, Respondent falsified and/or fabricated images in R03 AG029508-01 and three (3) presentations, where:

    R03 AG029508-01, Figure 2, represented Western blots for phosphorylated p53 (Ser15) and β-actin expression in normal and Snell dwarf mice fibroblasts (mN/SF) treated with the DNA alkylating agent methyl methanesulfonate (MMS), when the same images were duplicated to represent different proteins and treatments in the presentations Autophagy Pathway.ppt and RM.ppt.

    R03 AG029508-01, Figure 3, represented Western blots for p16Ink4a and β-actin expression in mN/SF, when the same images were duplicated to represent different proteins and treatments in the presentations Autophagy Pathways.ppt, RicDec.ppt, and RM.ppt.

    • While at UM, Respondent fabricated data in R21 AG030361-01 and supporting data for the grant application in the research record, where:

    R21 AG030361-01, Figure 2, represented a Western blot for phosphorylated c-Jun-N-terminal kinase (JNK) expression in mN/SF exposed to cadmium, when the experiment was not performed.

    The research record contained ninety (90) Western blot images and ninety (90) densitometry measurement files for 45 experiments that examined phosphorylated JNK or Mitogen-activated protein kinase 4 (MMK4) expression in mN/SF exposed to UV light, H2O2, cadmium, or anisomycin, when the experiments were not performed.

    The research record contained densitometric analyses for an additional twenty-eight (28) experiments that examined phosphorylated JNK or MMK4 expression in mN/SF exposed to UV light, H2O2, cadmium, or anisomycin, when the quantifications were based on experiments that were not performed.

    • While at UM, Respondent falsified and/or fabricated Western blots for phosphorylated and total Rac1/cdc42 expression in mN/SF, total JNK expression in mN/SF treated with anisomycin, phosphorylated JNK expression in Snell dwarf mice fibroblasts treated with cadmium, β-actin expression in mN/SF, β-actin expression in Snell dwarf mice fibroblasts treated with or without MMS, β-actin expression in normal mice fibroblasts treated with cadmium, and β-actin expression in mN/SF treated with H2O2 in the presentations Autophagy Pathway.ppt, Oct PPt.ppt, RicDec.ppt, Ricky Presentation 06.ppt, Ricky STC.ppt, and RM.ppt, and the image file Final LC 3.jpg, when the images were duplicated and falsely relabeled Western blots of unrelated experiments.

    • While at UM, Respondent falsified twenty-four (24) Western blots for phosphorylated JNK or MMK4 expression in mN/SF exposed to UV light, H2O2, cadmium, or anisomycin in the seven (7) presentations and twenty-six (26) data files in the research record, when the images were duplicated and falsely relabeled Western blots of unrelated experiments.

    • While at UC, Respondent falsified and/or fabricated Western blots by using images from unrelated experiments and the related densitometric analyses that were based on falsified Western blots in the following:

    R01 HL102405-01 for:

    —Figure 1A for phosphorylated Rhodopsin (Rho) expression in neonatal rat ventricular cardiac myocytes (NRVCM) subjected to stimulation with Angiotension II (Ang II) —Figure 1A for G protein-coupled receptor kinase-2 (GRK2) expression in NRVCM subjected to cyclical mechanical stretch —Figure 1B for densitometric analysis of GRK2 activity —Figure 2A for phosphorylated Rho and GRK2 expression in NRVCM subjected to mechanical stretch —Figure 2B for densitometric analysis of GRK2 activity —Figure 3A for phosphorylated Rho expression in NRVCM after mechanical stretch and treatment with protein kinase C (PKC) inhibitor chelerythrine (lanes 5 and 6) —Figure 3B for densitometric analyses of GRK2 activity after PKC inhibition via chelerythrine treatment

    K08 HL081472-05 Progress Report for:

    —Figure 1A for phosphorylated Rho and GRK2 expression in NRVCM subjected to mechanical stretch —Figure 1B for densitometric analyses of GRK2 activity after PKC inhibition via chelerythrine treatment

    JBC 2010 for:

    —Figure 1B for phosphorylated Rho expression in NTVCM subjected to stimulation with Ang II —Figure 1B for GRK2 expression in NRVCM subjected to cyclical mechanical stretch panel —Figure 1C for densitometric analysis of GRK2 activity —Figure 2A for phosphorylated Rho expression in NRVCM after mechanical stretch and treatment with the Ang II type 1 (AT1) receptor antagonist Irbesartan (lanes 5 and 6) —Figure 2B for densitometric analyses of GRK2 activity after PKC inhibition via Irbesartan treatment —Figure 4C for phosphorylated Rho and GRK2 expression in NRVCM subjected to mechanical stretch —Figure 4D for densitometric analysis of GRK2 activity after RNAi treatment

    Dr. Malhotra has entered into a Voluntary Settlement Agreement with ORI, in which he voluntarily agreed to the administrative actions set forth below:

    (1) Respondent agreed that he had no intention in applying for or engaging in U.S. Public Health Service (PHS)-supported research or otherwise working with PHS. However, if within five (5) years of the effective date of the Agreement (May 6, 2016), Respondent receives or applies for PHS support, Respondent agreed to have his research supervised for a period of ten (10) years beginning on the date of his employment in a position in which he receives or applies for PHS support and to notify his employer/institution(s) of the terms of this supervision.

    (2) Respondent certified that he is not currently engaged in or receiving PHS support. Respondent agreed that prior to the submission of an application for PHS support for a research project on which the Respondent's participation is proposed and prior to the Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent's duties is submitted to ORI for approval. The supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution as outlined below. Respondent agreed that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI. Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan.

    (3) The requirements for Respondent's supervision plan are as follows:

    i. A committee of senior faculty members and officials at the institution who are familiar with Respondent's field of research, but not including Respondent's supervisor or collaborators, will provide oversight and guidance for ten (10) years. The committee will review primary data for Respondent's PHS-supported research on a quarterly basis setting forth the committee meeting dates, Respondent's compliance with appropriate research standards, and confirming the integrity of Respondent's research.

    ii. The committee will conduct an advance review of any PHS grant application (including supplements, resubmissions, etc.), manuscripts reporting PHS-funded research submitted for publication, and abstracts. The review will include a discussion with Respondent of the primary data represented in those documents and will include a certification that the data presented in the proposed application/publication is supported by the research record.

    (4) If within five (5) years from the effective date of the Agreement, Respondent receives or applies for PHS support, Respondent agreed that for a period of ten (10) years beginning on the date of his employment that any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a report and certification to ORI at six (6) month intervals that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract.

    (5) If no supervisory plan is provided to ORI, Respondent agreed to provide certification to ORI on a quarterly basis for a period of five (5) years, beginning on May 6, 2016, that he has not engaged in, applied for, or had his name included on any application, proposal, or other request for PHS funds made available through grants, subgrants, cooperative agreements, contracts, subcontracts, supplements, awards, fellowships, projects, programs, small business technology transfer (STTR) and small business innovation research (SBIR) programs, conferences, meetings, centers, resources, studies, and trials, without prior notification to ORI.

    (6) Respondent agreed to exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of five (5) years, beginning on May 6, 2016.

    (7) As a condition of the Agreement, Respondent agreed to the retraction of JBC 2010.

    FOR FURTHER INFORMATION CONTACT:

    Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.

    Kathryn M. Partin, Director, Office of Research Integrity.
    [FR Doc. 2016-12800 Filed 5-27-16; 8:45 am] BILLING CODE 4150-31-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting AGENCY:

    National Committee on Vital and Health Statistics (NCVHS), HHS

    ACTION:

    Notice of full committee and subcommittee meetings.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting.

    DATES:

    Tuesday, June 14, 2016: 9 a.m.-5:40 p.m.—Full Committee Meeting.

    Wednesday, June 15, 2016: 8 a.m.-2:25 p.m.—Full Committee Meeting.

    Thursday, June 16, 2016: 8:30 a.m.-5 p.m.—Privacy Subcommittee Meeting on “Minimum Necessary and the Health Insurance Portability and Accountability Act (HIPAA)”.

    Friday, June 17, 2016: 8:15 a.m.-4 p.m.—NCVHS Meeting on Claims-based Databases for Policy Development and Evaluation.

    ADDRESSES:

    The public meetings on June 14-16, 2016 will be held at the U.S. Department of Health and Human Services, Hubert H. Humphrey Building, Room 705-A, 200 Independence Avenue SW., Washington, DC 20024. The public meeting on June 17, 2016 will be held at the Wilbur J. Cohen Building, 330 Independence Avenue SW, Snow Room, #5051, Washington, DC 20201. Phone: (202) 690-7100.

    FOR FURTHER INFORMATION CONTACT:

    Substantive program information may be obtained from Rebecca Hines, Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Hyattsville, Maryland 20782, telephone (301) 458-4715. Summaries of meetings and a roster of committee members are available on the NCVHS home page of the HHS Web site: http://www.ncvhs.hhs.gov/, where further information including an agenda and information for remote audio access to the meetings will be posted.

    Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (301) 458-4EEO (4336) as soon as possible.

    SUPPLEMENTARY INFORMATION:

    Status: Open.

    Purpose: At the June 14-15, 2016 meeting the Committee will hear presentations and hold discussions on several health data policy topics. The Committee will receive updates from the Department, including from the Office of the National Coordinator and the Centers for Medicare and Medicaid Services. The Committee will discuss and take action on two recommendation letters stemming from the February 16, 2016 Standards Subcommittee hearing on the proposed Phase IV Operating Rules and proposed Attachment Standard. Findings from the June 2015 Review Committee Hearing on Adopted Transaction Standards, Operating Rules, Code Sets and Identifiers also will be discussed. The Committee will review the current public health data landscape with briefings from the National Center for Health Statistics, U.S. Census Bureau and CDC's Center for Surveillance, Epidemiology, and Laboratory Services. CMS will provide a briefing on MACRA and the Merit-Based Incentive Payment System (MIPS). The Committee will further review its strategic plan for 2016 and all Subcommittees will report on work plans and next steps. The Subcommittee on Privacy, Confidentiality, and Security will brief the full Committee on proceedings from the meeting on De-identification and the Health Insurance Portability and Accountability Act (HIPAA) scheduled for May 24-25, 2016, and discuss preliminary findings.

    After the plenary session adjourns, the Work Group on HHS Data Access and Use will continue strategic discussions on building a framework for guiding principles for data access and use.

    Privacy-specific topics will be addressed during the same week at the following meeting: The NCVHS Privacy, Confidentiality and Security Subcommittee will hold a one day meeting on June 16, 2016 to review the state of implementation of current policies and practices of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Minimum Necessary provisions. The Subcommittee plans to identify and discuss issues and challenges that the industry is facing when addressing this requirement for potential recommendations to the HHS Secretary for policy and practice guidance addressing compliance with the “minimum necessary” standard.

    On June 17th the full Committee will hold a meeting to explore the current state of the art associated with the collection and use of Multipayor claims data bases. These data bases include private data bases (sometimes known as Multi-claims Data Bases) and State claims data bases referred to as All-Payer Claims Databases (APCDs). The purpose of this meeting is to highlight the current state of development, challenges, issues, and opportunities faced by these initiatives, engage stakeholders on key issues, and identify priority areas and opportunities for recommendations to the Secretary of HHS and to the industry.

    Dated: May 16, 2016.

    James Scanlon, Deputy Assistant Secretary for Planning and Evaluation, Office of the Assistant Secretary for Planning and Evaluation.
    [FR Doc. 2016-12160 Filed 5-27-16; 8:45 am] BILLING CODE 4151-05-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Establishment of the NIH Clinical Center Research Hospital Board

    Pursuant to the Federal Advisory Committee Act, as amended (5 U.S.C. App.), the Director, National Institutes of Health (NIH) announces the establishment of the NIH Clinical Center Research Hospital Board (Board) as authorized by 42 U.S.C. 282(b)(16), Section 402(b)(16) of the Public Health Service Act, as amended.

    It has been determined that the NH Clinical Center Research Hospital Board is in the public interest in connection with the performance of duties imposed on the National Institutes of Health by law, and that these duties can best be performed through the advice and counsel of the Board.

    Inquiries may be directed to Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, Maryland 20892 (Mail code 4875), Telephone (301) 496-2123, or [email protected] .

    Dated: May 24, 2016. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-12643 Filed 5-27-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Peer Review Meeting.

    Date: June 21-22, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: Hilton Washington/Rockville, Jefferson Room, 1750 Rockville Pike, Rockville, MD 20852.

    Contact Person: Nancy Vazquez-Maldonado, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3F52B National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9834, Bethesda, MD 20892-9834, (240) 669-5044, [email protected].

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    Name of Committee: Allergy, Immunology, and Transplantation Research Committee.

    Date: June 22-23, 2016,

    Time: 10:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 4H100 and 3C100, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: James T. Snyder, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities/Room 3G31B, National Institutes of Health, NIAID, 5601 Fishers Lane MSC 9834, Bethesda, MD 20892-9834, (240) 669-5060, [email protected].

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Peer Review Meeting.

    Date: June 27-29, 2016.

    Time: June 27, 2016, 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: Hilton Washington/Rockville, Jefferson Room, 1750 Rockville Pike, Rockville, MD 20852.

    Time: June 28, 2016, 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: Hilton Washington/Rockville, Jefferson Room, 1750 Rockville Pike, Rockville, MD 20852.

    Time: June 29, 2016, 8:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: Hilton Washington/Rockville, Jefferson Room, 1750 Rockville Pike, Rockville, MD 20852.

    Contact Person: Nancy Vazquez-Maldonado, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3F52B National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9834, Bethesda, MD 20892-9834, (240) 669-5044, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS).
    Dated: May 24, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-12649 Filed 5-27-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Cancer Institute Special Emphasis Panel Development of a Biosensor-Based Core Needle Tumor Biopsy Device.

    Date: June 2, 2016.

    Time: 11:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: National Cancer Institute Shady Grove 9609 Medical Center Drive, Room 2W030, Rockville, MD 20850 (Telephone Conference Call).

    Contact Person: Kenneth L. Bielat, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W244, Rockville, MD 20892-9750, 240-276-6373, [email protected]

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS).
    Dated: May 24, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-12662 Filed 5-27-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB review; 30-day Comment Request;

    Request for Human Embryonic Stem Cell Line To Be Approved for Use in NIH Funded Research (OD)

    SUMMARY:

    In compliance with the requirement of Section 3507(a) (1) (D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection instrument listed below. This proposed information collection was previously published in the Federal Register on March 25, 2016, page 16190 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

    Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer.

    Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

    FOR FURTHER INFORMATION CONTACT:

    To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Dr. Ellen Gadbois, Office of Science Policy, Office of the Director, NIH, Building 1, Room 218, MSC 0166, 9000 Rockville Pike, Bethesda, MD 20892, or call non-toll-free number (301) 496-9838 or Email your request, including your address to: [email protected] Formal requests for additional plans and instruments must be requested in writing.

    Proposed Collection: Request for Human Embryonic Stem Cell Line to be approved for Use in NIH Funded Research. OMB No. 0925-0601- Expiration Date 5/31/2016—Extension- Office of Extramural Research (OER), National Institutes of Health (NIH).

    Need and Use of Information Collection: The form is used by applicants to request that human embryonic stem cell lines be approved for use in NIH funded research. Applicants may submit applications at any time.

    OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,550.

    Estimated Annualized Burden Hours Type of
  • respondent
  • Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average time
  • per response
  • ( in hours)
  • Total annual
  • burden hour
  • NIH grantees and others with hESC lines 50 3 17 2,550 Total 50 150 2,550
    Dated: May 24, 2016. Lawrence A. Tabak, Deputy Director, National Institutes of Health.
    [FR Doc. 2016-12726 Filed 5-27-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended

    (5 U.S.C. App), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Synthesis and Distribution of Opioid and Related Peptides (7795).

    Date: June 28, 2016.

    Time: 10:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Lyle Furr, Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892-9550, (301) 435-1439, lf33c.nih.gov.

    Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Non-Clinical ADME Studies (8931).

    Date: July 13, 2016.

    Time: 10:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Lyle Furr, Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892-9550, (301) 435-1439, lf33c.nih.gov.

    (Catalogue of Federal Domestic Assistance Program No.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS).
    Dated: May 24, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-12647 Filed 5-27-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: CVRS New Investigator.

    Date: June 22, 2016.

    Time: 10:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Margaret Chandler, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4126, MSC 7814, Bethesda, MD 20892, (301435-1743, [email protected]

    Name of Committee: Interdisciplinary Molecular Sciences and Training Integrated Review Group; Enabling Bioanalytical and Imaging Technologies Study Section.

    Date: June 23-24, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Kabuki, 1625 Post Street, San Francisco, CA 94115.

    Contact Person: Kenneth Ryan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3218, MSC 7717, Bethesda, MD 20892, 301-435-0229, [email protected]

    Name of Committee: Oncology 2—Translational Clinical Integrated Review Group;Cancer Immunopathology and Immunotherapy Study Section.

    Date: June 23-24, 2016.

    Time: 8:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Embassy Row Hotel, 2015 Massachusetts Avenue NW., Washington, DC 20036.

    Contact Person: Denise R. Shaw, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6158, MSC 7804, Bethesda, MD 20892, 301-435-0198, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Review of Neuroscience AREA Grant Applications.

    Date: June 23-24, 2016.

    Time: 8:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: DoubleTree by Hilton, 1515 Rhode Island Avenue NW., Washington, DC 20005.

    Contact Person: Richard D. Crosland, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4190, MSC 7850, Bethesda, MD 20892, 301-435-1220, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Biomedical Sensing, Measurement and Instrumentation.

    Date: June 24, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

    Contact Person: Inna Gorshkova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301-435-1784, [email protected]

    Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Biophysics of Neural Systems Study Section.

    Date: June 27-28, 2016.

    Time: 8:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Mayflower Park Hotel, 405 Olive Way, Seattle, WA 98101.

    Contact Person: Geoffrey G Schofield, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040-A, MSC 7850, Bethesda, MD 20892, 301-435-1235, [email protected]

    Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Cognition and Perception Study Section.

    Date: June 27-28, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Ritz Carlton Hotel, 1150 22nd Street NW., Washington, DC 20037.

    Contact Person: Mark D Lindner, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3182, MSC 7770, Bethesda, MD 20892, 301-915-6298, [email protected]

    Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Bacterial Pathogenesis Study Section.

    Date: June 27, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Alexandria Old Town/Duke Street, 1456 Duke Street, Alexandria, VA 22314.

    Contact Person: Marci Scidmore, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3192, MSC 7808, Bethesda, MD 20892, 301-435-1149, [email protected]

    Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Drug Discovery for the Nervous System Study Section.

    Date: June 27-28, 2016.

    Time: 8:00 a.m. to 10:00 a.m.

    Agenda: To review and evaluate grant applications.

    Place: Doubletree Hotel Washington, 1515 Rhode Island Avenue NW., Washington, DC 20005.

    Contact Person: Mary Custer, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4148, MSC 7850, Bethesda, MD 20892, (301) 435-1164, [email protected]

    Name of Committee: Oncology 2—Translational Clinical Integrated Review Group; Developmental Therapeutics Study Section.

    Date: June 27-28, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Westgate Hotel, 1055 Second Avenue, San Diego, CA 92101.

    Contact Person: Sharon K. Gubanich, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6214, MSC 7804, Bethesda, MD 20892, (301) 408-9512, [email protected]

    Name of Committee: Genes, Genomes, and Genetics Integrated Review Group; Therapeutic Approaches to Genetic Diseases Study Section.

    Date: June 27-28, 2016.

    Time: 8:30 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Ritz-Carlton Hotel at Pentagon City, 1250 South Hayes Street, Arlington, VA 22202.

    Contact Person: Richard Panniers, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2212, MSC 7890, Bethesda, MD 20892, (301) 435-1741, [email protected]

    Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated Review Group; Macromolecular Structure and Function A Study Section.

    Date: June 27-28, 2016.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Ritz-Carlton Hotel, 1700 Tysons Boulevard, McLean, VA 22102.

    Contact Person: Nitsa Rosenzweig, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4152, MSC 7760, Bethesda, MD 20892, (301) 404-7419, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: May 24, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-12642 Filed 5-27-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the Heart, Lung, and Blood Program Project Review Committee, June 17, 2016, 08:00 a.m. to June 17, 2016, 01:00 p.m., Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD, 20814 which was published in the Federal Register on May 24, 2016, 81FR32763-32764.

    The meeting notice is amended to change the location of the meeting from The Hyatt Regency Bethesda to The Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD, 20817. The meeting is closed to the public.

    Dated: May 24, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-12645 Filed 5-27-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Dental and Craniofacial Research Special Emphasis Panel; DSR Member Conflict SEP.

    Date: June 28, 2016.

    Time: 1:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892.

    Contact Person: Latarsha J. Carithers, Ph.D., Program Director, Division of Extramural Activities, NIDCR, 6701 Democracy Boulevard, Suite 672, Bethesda, MD 20892, 301-594-4859, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS).
    Dated: May 24, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-12650 Filed 5-27-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Library of Medicine; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Library of Medicine Special Emphasis Panel; R01/R13/R21/K01/K99/F31 Conflicts.

    Date: July 21, 2016.

    Time: 12:00 p.m. to 4:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Library of Medicine, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20817, (Telephone Conference Call).

    Contact Person: Zoe E. Huang, MD, Scientific Review Officer, Extramural Programs, National Library of Medicine, NIH, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20892-7968, 301-594-4937, [email protected].

    (Catalogue of Federal Domestic Assistance Program No. 93.879, Medical Library Assistance, National Institutes of Health, HHS)
    Dated: May 24, 2016. Michelle Trout, Program Analyst, Office of the Federal Advisory Committee Policy.
    [FR Doc. 2016-12648 Filed 5-27-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Heart, Lung, and Blood Initial Review Group; NHLBI Mentored Patient-Oriented Research Review Committee.

    Date: June 23-24, 2016.

    Time: 8:30 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Crowne Plaza Washington National Airport, (Between 15th Street and Crystal Drive), 1480 Crystal Drive, Arlington, VA 22202.

    Contact Person: Stephanie Johnson Webb, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7196, Bethesda, MD 20892, 301-435-0291, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: May 24, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-12644 Filed 5-27-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Services Planning Research in the Appalachian Region to Address Adverse Health Consequences Associated with Increased Opioid Injection Drug Use (R03).

    Date: June 24, 2016.

    Time: 11:00 a.m. to 2:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call).

    Contact Person: Hiromi Ono, Ph.D., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, National Institutes of Health, DHHS, 6001 Executive Boulevard, Room 4238, MSC 9550, Bethesda, MD 20892, 301-402-6020, [email protected]

    Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIH Pathway to Independence Award (K99/R00).

    Date: June 30, 2016.

    Time: 10:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call).

    Contact Person: Susan O. McGuire, Ph.D., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, National Institutes of Health, DHHS, 6001 Executive Blvd., Room 4245, Rockville, MD 20852, 301-435-1426, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS)
    Dated: May 24, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-12646 Filed 5-27-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Notice of Issuance of Final Determination Concerning Certain Network Cables and Transceivers AGENCY:

    U.S. Customs and Border Protection, Department of Homeland Security.

    ACTION:

    Notice of final determination.

    SUMMARY:

    This document provides notice that U.S. Customs and Border Protection (“CBP”) has issued a final determination concerning the country of origin of certain network cables and transceivers. Based upon the facts presented, CBP has concluded that the country of origin of the network cables and transceivers is China for purposes of U.S. Government procurement.

    DATES:

    The final determination was issued on May 19, 2016. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within June 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Grace A. Kim, Valuation and Special Programs Branch, Regulations and Rulings, Office of International Trade (202) 325-7941.

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given that on May 19, 2016, pursuant to subpart B of Part 177, U.S. Customs and Border Protection Regulations (19 CFR part 177, subpart B), CBP issued a final determination concerning the country of origin of certain network cables and transceivers, which may be offered to the U.S. Government under an undesignated government procurement contract. This final determination, HQ H273091, was issued under procedures set forth at 19 CFR part 177, subpart B, which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511-18). In the final determination, CBP concluded that the processing in the U.S. does not result in a substantial transformation. Therefore, the country of origin of the certain network cables and transceivers is China for purposes of U.S. Government procurement.

    Section 177.29, CBP Regulations (19 CFR 177.29), provides that a notice of final determination shall be published in the Federal Register within 60 days of the date the final determination is issued. Section 177.30, CBP Regulations (19 CFR 177.30), provides that any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of a final determination within 30 days of publication of such determination in the Federal Register.

    Dated: May 19, 2016. Myles B. Harmon, Acting Executive Director, Regulations and Rulings, Office of International Trade. HQ H258960 OT:RR:CTF:VS H258960 GaK CATEGORY: Origin Mr. Stuart P. Seidel Baker & McKenzie, LLP 815 Connecticut Ave. NW Washington, DC 20006-4078 RE: U.S. Government Procurement; Country of Origin Marking; Network Transceivers and High Speed Cabling Devices; Substantial Transformation Dear Mr. Seidel:

    This is in response to your letter dated October 24, 2014, requesting a final determination on behalf of AddOn Computer Peripherals LLC (“AddOn”) pursuant to Subpart B of Part 177 of the U.S. Customs & Border Protection (“CBP”) Regulations (19 CFR part 177). Under these regulations, which implement Title III of the Trade Agreements Act of 1979 (“TAA”), as amended (19 U.S.C. 2511 et seq.), CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or for products offered for sale to the U.S. Government. This final determination concerns the country of origin of AddOn's network transceivers and high speed cabling devices. As a U.S. importer, AddOn is a party-at-interest within the meaning of 19 CFR 177.22(d)(1) and is entitled to request this final determination. You also request a country of origin marking determination.

    In your letter, you requested confidential treatment for certain information contained in the file. Pursuant to 19 CFR 177.2(b)(7), the identified information has been bracketed and will be redacted in the public version of this final determination.

    FACTS:

    The products at issue are network transceivers and high speed cabling devices. You state that network transceivers are used for transmitting and receiving information between two network devices. The medium of transmission is usually copper or fiber optic cables and you claim that AddOn's network transceivers can work with one or the other. There are different models of transceivers based on the technology employed for a particular network device, transmission medium, speed and/or distance. Depending on the original equipment manufacturer (“OEM”), technology, and applications, the sales price for the transceivers range from [*******] to [*******]. You claim that the difference in cost and the sales price is attributable to the software program and subsequent testing and quality assurance process. The transceiver also “hot plugs,” which means that it can be plugged into a network device while the transceiver is working, and connect that device to a network.

    You state that most transceivers are built to a Multi-Source Agreement (“MSA”) standard to provide common formats and functions to ensure that transceivers can operate with systems and each other. The MSA standard is said to incorporate a programmable memory, called an EEPROM. The EEPROM can also be used to tell the transceiver to enable functionality that goes beyond the MSA standard, which can be unique to the network device manufacturer. You claim that sometimes the EEPROM is programmed to allow the transceiver to perform a proprietary handshake and be identified as capable of certain advanced features. You further claim that if the transceiver fails the proprietary handshake, it may be rendered inoperable. You state that AddOn's transceivers conform to the MSA standard and to the OEM's higher level of compatibility.

    You provided two scenarios in transceiver production. In both scenarios, the hardware components are manufactured in China or other Asian country. In Scenario 1, AddOn purchases the “blank” transceivers from an unrelated supplier in China or other Asian country. You state that “blank” transceivers are just hardware without any programming. AddOn downloads its proprietary software, which was developed in the U.S. and you claim that this makes the transceivers functional. This scenario applies to over 95% of the imported transceivers. In Scenario 2, AddOn purchases transceivers that have already been programmed with a generic program, which is removed and AddOn's proprietary software is installed to provide interoperability between different OEMs' systems. AddOn's transceivers are then tested for compatibility in its Certification Test Lab. In both scenarios, the programming and testing are conducted in the U.S.

    The second product is a high speed cabling device, which comprises two transceivers and a transmission medium (copper or fiber optic cable) in one integrated part. All programming and testing are said to be the same as the transceivers, except that AddOn programs and tests two transceivers instead of one for each product.

    AddOn's proprietary operational firmware/software was developed and programmed in the U.S. You state that the amount of time invested in development was approximately [*******] hours and the software developers have a Bachelors of Science or better or equivalent work experience. You also state that the dollar value increases significantly after programming, which ranges from [*******] depending on the part type, application and customer.

    ISSUE:

    What is the country of origin of the network transceivers and high speed cabling devices for purposes of U.S. government procurement and marking?

    LAW AND ANALYSIS:

    Government Procurement

    Pursuant to Subpart B of Part 177, 19 CFR 177.21 et seq., which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511 et seq.), CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government.

    Under the rule of origin set forth under 19 U.S.C. 2518(4)(B):

    An article is a product of a country or instrumentality only if (i) it is wholly the growth, product, or manufacture of that country or instrumentality, or (ii) in the case of an article which consists in whole or in part of materials from another country or instrumentality, it has been substantially transformed into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was so transformed.

    See also 19 CFR 177.22(a).

    In rendering advisory rulings and final determinations for purposes of U.S. government procurement, CBP applies the provisions of subpart B of part 177 consistent with the Federal Acquisition Regulations. See 19 CFR 177.21. In this regard, CBP recognizes that the Federal Acquisition Regulations restrict the U.S. Government's purchase of products to U.S.-made or designated country end products for acquisitions subject to the TAA. See 48 CFR 25.403(c)(1). The Federal Acquisition Regulations define “U.S.-made end product” as:

    . . .an article that is mined, produced, or manufactured in the United States or that is substantially transformed in the United States into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed.

    48 CFR 25.003.

    In Data General v. United States, 4 Ct. Int'l Trade 182 (1982), the court determined that for purposes of determining eligibility under item 807.00, Tariff Schedules of the United States (predecessor to subheading 9802.00.80, Harmonized Tariff Schedule of the United States), the programming of a foreign PROM (Programmable Read-Only Memory chip) in the United States substantially transformed the PROM into a U.S. article. In programming the imported PROMs, the U.S. engineers systematically caused various distinct electronic interconnections to be formed within each integrated circuit. The programming bestowed upon each circuit its electronic function, that is, its “memory” which could be retrieved. A distinct physical change was effected in the PROM by the opening or closing of the fuses, depending on the method of programming. This physical alteration, not visible to the naked eye, could be discerned by electronic testing of the PROM. The court noted that the programs were designed by a U.S. project engineer with many years of experience in “designing and building hardware.” In addition, the court noted that while replicating the program pattern from a “master” PROM may be a quick one-step process, the development of the pattern and the production of the “master” PROM required much time and expertise. The court noted that it was undisputed that programming altered the character of a PROM. The essence of the article, its interconnections or stored memory, was established by programming. The court concluded that altering the non-functioning circuitry comprising a PROM through technological expertise in order to produce a functioning read only memory device, possessing a desired distinctive circuit pattern, was no less a “substantial transformation” than the manual interconnection of transistors, resistors and diodes upon a circuit board creating a similar pattern.

    In Texas Instruments v. United States, 681 F.2d 778, 782 (CCPA 1982), the court observed that the substantial transformation issue is a “mixed question of technology and customs law.”

    In C.S.D. 84-85, 18 Cust. B. & Dec. 1044, CBP stated:

    We are of the opinion that the rationale of the court in the Data General case may be applied in the present case to support the principle that the essence of an integrated circuit memory storage device is established by programming; . . . [W]e are of the opinion that the programming (or reprogramming) of an EPROM results in a new and different article of commerce which would be considered to be a product of the country where the programming or reprogramming takes place.

    Accordingly, the programming of a device that confers its identity as well as defines its use generally constitutes substantial transformation. See also Headquarters Ruling Letter (“HQ”) 558868, dated February 23, 1995 (programming of SecureID Card substantially transformed the card because it gave the card its character and use as part of a security system and the programming was a permanent change that could not be undone); HQ 735027, dated September 7, 1993 (programming blank media (EEPROM) with instructions that allowed it to perform certain functions that prevented piracy of software constituted substantial transformation); and, HQ 733085, dated July 13, 1990; but see HQ 732870, dated March 19, 1990 (formatting a blank diskette did not constitute substantial transformation because it did not add value, did not involve complex or highly technical operations and did not create a new or different product); and, HQ 734518, dated June 28, 1993, (motherboards were not substantially transformed by the implanting of the central processing unit on the board because, whereas in Data General use was being assigned to the PROM, the use of the motherboard had already been determined when the importer imported it).

    In this case, the hardware components of the transceivers in both scenarios are wholly manufactured in a foreign country and imported into the U.S. In Scenario 1, the transceivers are “blanks”, and in Scenario 2, the transceivers are preprogrammed with a generic program. In both scenarios, AddOn will download its proprietary software onto the transceivers which will transform them into a proprietary network device capable of performing its intended functions. You argue that in both scenarios, the imported hardware is substantially transformed by the development, configuration, and download operations of the U.S. origin software. In Scenario 1, you argue that the completely non-functional hardware is transformed into a transceiver and in Scenario 2, you argue that the hardware with generic software is substantially transformed into a fully functional network device that is capable of performing their intended functions. You also state that the expenses for the work performed in the U.S. far outweigh the work performed abroad. In support of your argument, you cite to HQ 562964, dated March 29, 2004; HQ H034843, dated May 5, 2009; and HQ H175415, dated October 4, 2011.

    In HQ 562964, CBP considered certain network tape drive units and its components, including “bare bones” (basic) tape drives, imported into Country X where the components were assembled into a Small Computer System Interface (“SCSI”) tape drive rack unit. The assembly process involved approximately eight major components, simple operations, and required approximately twenty minutes. In Scenario 1, the “bare bones” tape drives were preprogrammed with the OEM's firmware prior to importation, which allowed the tape drives to be recognized and controlled by the OEM's network. CBP found that the assembly operations did not alter the function of the tape drive, and that its character and use as a network storage device was defined prior to importation into Country X, and therefore the tape drive rack unit was not substantially transformed. In Scenario 2, the “bare bones” tape drives were imported with a universal firmware that was installed only for testing and diagnostic purposes and the OEM proprietary firmware was burned onto the tape drives in Country X. CBP found that the OEM firmware allowed the tape drives to be recognized and controlled by the OEM's network and defined the character and use of the tape drive as a network storage device and concluded that the tape drive rack unit had been substantially transformed.

    In HQ H034843, CBP held that USB flash drives were products of Israel because, though the assembly process began in China and the software and firmware were developed in Israel, the installation and customization of the firmware and software that took place in Israel made the USB flash drives functional, permitted them to execute their security features, and increased their value. In HQ H175415, CBP held that Ethernet switches were products of the U.S. because, though the hardware components were fully assembled into Ethernet switches in China, they were programmed with U.S.-origin operating software enabling them to interact and route within the network, and to monitor, secure, and access control of the network.

    However, in HQ H241177, dated December 3, 2013, Ethernet switches were assembled to completion in Malaysia and then shipped to Singapore, where U.S.-origin software was downloaded onto the switches. CBP further found that software downloading did not amount to programming, which involved writing, testing and implementing code necessary to make the computer function a certain way. See also HQ H240199, dated March 10, 2015 (the notebook computer was not substantially transformed when the computer was assembled in Country A, imported into Country F, and Country D-origin BIOS was downloaded). CBP concluded in HQ H241177, that the software downloading performed in Singapore did not amount to programming and that the country of origin was Malaysia, where the last substantial transformation occurred.

    In Scenario 1, the imported transceivers are completely non-functional and AddOn's proprietary software is downloaded in the U.S., making the transceivers functional and compatible with the OEM technology. The proprietary software was developed in the U.S. at significant cost to AddOn over many years. Without the proprietary software, the transceivers could not function as a network device in any capacity. In accordance with HQ H175415, we find that the non-functional transceivers are substantially transformed as a result of downloading performed in the U.S., with proprietary software developed in the U.S. Therefore, the country of origin of the transceivers in Scenario 1 is the U.S.

    In Scenario 2, the imported transceivers are preprogrammed with a generic program prior to importation, which is replaced with the proprietary software in the U.S. While the transceivers have generic network functionality, it is stated that they will not be recognized by or work on proprietary networks. As HQ 732870 and HQ 734518 point out, when programming does not actually create a new or different product, it may not constitute a substantial transformation. Given these considerations, it would appear that programming an imported, already functional, transceiver just to customize its network compatibility, would not actually change the identity of the imported transceiver. See HQ H241177 supra. Also, in HQ 562964, CBP found that the “bare bones” tape drives were substantially transformed when the universal firmware was replaced with the proprietary firmware because the universal firmware was only for testing and diagnostic purposes. In this case, while the preprogrammed transceivers cannot function as intended by AddOn's market and its customers, the transceivers are capable of generic network functionality at the time of importation. Downloading the AddOn proprietary software does not actually change the identity of the imported transceiver and its name, character, and use remain the same. Therefore, in Scenario 2, we find that the imported transceivers with a generic program will not be substantially transformed in the U.S. Therefore, we find that the country where the last substantial transformation occurs is China or other Asian country where the hardware components are manufactured. The country of origin of the transceivers in Scenario 2 is China or other Asian country.

    Marking

    Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or container) will permit, in such manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article.

    Part 134, CBP Regulations (19 CFR part 134), implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.1(b), CBP Regulations (19 CFR 134.1(b)), defines the country of origin of an article as the country of manufacture, production, or growth of any article of foreign origin entering the U.S. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the country of origin for country of origin marking purposes.

    Thus, the issue in determining the country of origin of the transceivers is whether the transceivers of Chinese (or other Asian country) origin are substantially transformed as a result of the operations performed in the U.S. As indicated above, in Scenario 1, we have found that the Chinese (or other Asian country) origin transceivers are substantially transformed in the U.S., but not in Scenario 2. Therefore, pursuant to 19 U.S.C. 1304, the country of origin for marking purposes of the transceivers is the U.S. in Scenario 1, and China or other Asian country in Scenario 2.

    HOLDING:

    Based on the facts of this case, the country of origin of transceivers and high speed cabling devices is the U.S. in Scenario 1, and China or other Asian country in Scenario 2 for purposes of U.S. Government procurement and country of origin marking.

    Notice of this final determination will be given in the Federal Register, as required by 19 CFR 177.29. Any party-at-interest other than the party which requested this final determination may request, pursuant to 19 CFR 177.31, that CBP reexamine the matter anew and issue a new final determination. Pursuant to 19 CFR 177.30, any party-at-interest may, within 30 days of publication of the Federal Register Notice referenced above, seek judicial review of this final determination before the Court of International Trade.

    Sincerely, Myles B. Harmon Acting Executive Director Regulations and Rulings Office of International Trade
    [FR Doc. 2016-12798 Filed 5-27-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2013-0067] Sector Outreach and Programs Division Online Meeting Registration Tool AGENCY:

    National Protection and Programs Directorate, DHS.

    ACTION:

    60-day notice and request for comments; Renewal Information Collection Request: 1670-0019.

    SUMMARY:

    The Department of Homeland Security (DHS), National Protection and Programs Directorate (NPPD), Office of Infrastructure Protection (IP), Sector Outreach and Programs Division (SOPD), will submit the following Information Collection Request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35).

    DATES:

    Comments are encouraged and will be accepted until August 1, 2016. This process is conducted in accordance with 5 CFR 1320.1.

    ADDRESSES:

    Written comments and questions about this Information Collection Request should be forwarded to DHS/NPPD/IP/SOPD, 245 Murray Lane SW., Mail Stop 0608, Arlington, VA 20598-0640. Emailed requests should go to Michael Bowen, [email protected] Written comments should reach the contact person listed no later than August 1, 2016. Comments must be identified by “DHS-2013-0067” and may be submitted by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov.

    Email: Include the docket number in the subject line of the message.

    Instructions: All submissions received must include the words “Department of Homeland Security” and the docket number for this action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided.

    SUPPLEMENTARY INFORMATION:

    On behalf of DHS, NPPD/IP manages the Department's program to protect the Nation's 16 critical infrastructure sectors by implementing the National Infrastructure Protection Plan (NIPP) 2013, Partnering for Critical Infrastructure Security and Resilience. Under Presidential Policy Directive 21 on Critical Infrastructure Security and Resilience (February 2013), each sector is assigned a Sector-Specific Agency (SSA) to oversee Federal interaction with the array of sector security partners, both public and private. SSAs are responsible for leading unified public-private sector efforts to develop, coordinate, and implement a comprehensive physical, human, and cybersecurity strategy for its assigned sector. The Sector Outreach and Programs Division executes the SSA responsibilities for the six critical infrastructure sectors assigned to IP: Chemical; Commercial Facilities; Critical Manufacturing; Dams; Emergency Services; and Nuclear Reactors, Materials, and Waste.

    The mission of SOPD is to enhance the resiliency of the Nation by leading the unified public-private sector effort to ensure its assigned critical infrastructure is prepared, secure, and safe from terrorist attacks, natural disasters, and other incidents. To achieve this mission, SOPD leverages the resources and knowledge of its critical infrastructure sectors to develop and apply security initiatives that result in significant benefits to the Nation.

    Each SOPD branch builds sustainable partnerships with its public and private sector stakeholders to enable more effective sector coordination, information sharing, and program development and implementation. These partnerships are sustained through the Sector Partnership Model, described in the NIPP 2013, pages 10-12.

    Information sharing is a key component of the NIPP Partnership Model, and DHS-sponsored conferences are one mechanism for information sharing. To facilitate conference planning and organization, SOPD established an event registration tool for use by all of its branches. The information collection is voluntary and is used by the SSAs within the SOPD. The six SSAs within SOPD use this information to register public and private sector stakeholders for meetings hosted by the SSA. The Sector Outreach and Programs Division will use the information collected to reserve space at a meeting for the registrant, contact the registrant with a reminder about the event, develop meeting materials for attendees, determine key topics of interest, and efficiently generate attendee and speaker nametags. Additionally, it will allow SOPD to have a better understanding of the organizations participating in the critical infrastructure protection partnership events. By understanding who is participating, the SSA can identify portions of a sector that are underrepresented, and the SSA could then target that underrepresented sector element through outreach and awareness initiatives.

    OMB is particularly interested in comments that:

    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 estimate 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; and

    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 submissions of responses.

    Analysis

    Agency: Department of Homeland Security, National Protection and Programs Directorate, Office of Infrastructure Protection, Sector Outreach and Programs Division.

    Title: Sector Outreach and Programs Division Online Meeting Registration Tool.

    OMB Number: 1670-0019.

    Frequency: Annually.

    Affected Public: Federal, State, local, tribal, and territorial government personnel; private sector members.

    Number of Respondents: 3,000 respondents (estimate).

    Estimated Time per Respondent: 3 minutes.

    Total Burden Hours: 150 annual burden hours.

    Total Burden Cost (capital/startup): $0.

    Total Recordkeeping Burden: $0.

    Total Burden Cost (operating/maintaining): $34,416.

    Dated: May 24, 2016. David Epperson, Chief Information Officer, National Protection and Programs Directorate, Department of Homeland Security.
    [FR Doc. 2016-12678 Filed 5-27-16; 8:45 am] BILLING CODE 9110-9P-P
    DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2016-0028] Homeland Security Science and Technology Advisory Committee AGENCY:

    Science and Technology Directorate, DHS.

    ACTION:

    Committee management; notice of federal advisory committee meeting.

    SUMMARY:

    The Homeland Security Science and Technology Advisory Committee (HSSTAC) will meet on June 21-22, 2016 in Washington, DC. The meeting will be an open session with both in-person and webinar participation.

    DATES:

    The HSSTAC will meet in-person Tuesday, June 21, 2016, from 9:00 a.m.-4:25 p.m. and Wednesday, June 22, 2016, from 9:00 a.m.-3:00 p.m.

    Due to security requirements, screening pre-registration is required for this event. Please see the “REGISTRATION” section below.

    The meeting may close early if the committee has completed its business.

    ADDRESSES:

    Schafer Government Services, Homeland Security, 1125 15th St. NW., Suite 500, Washington, DC 20005.

    FOR FURTHER INFORMATION CONTACT:

    Bishop Garrison, HSSTAC Executive Director, S&T IAO STOP 0205, Department of Homeland Security, 245 Murray Lane, Washington, DC 20528-0205, 202-254-5617(Office), 202-254-6176 (Fax) [email protected] (Email).

    SUPPLEMENTARY INFORMATION: I. Background

    Notice of this meeting is given under the Federal Advisory Committee Act (FACA), 5 U.S.C. appendix (Pub. L. 92-463). The committee addresses areas of interest and importance to the Under Secretary for Science and Technology (S&T), such as new developments in systems engineering, cyber-security, knowledge management and how best to leverage related technologies funded by other Federal agencies and by the private sector. It also advises the Under Secretary on policies, management processes, and organizational constructs as needed.

    II. Registration

    To pre-register for the virtual meeting (webinar) please send an email to: [email protected] The email should include the name(s), title, organization/affiliation, email address, and telephone number of those interested in attending. For information on services for individuals with disabilities or to request special assistance at the meeting, please contact Bishop Garrison as soon as possible.

    If you plan to attend the meeting in-person you must RSVP by June 17, 2016. To register, email [email protected] with the following subject line: RSVP to HSSTAC Meeting. The email should include the name(s), title, organization/affiliation, email address, and telephone number of those interested in attending.

    III. Public Comment

    At the end of each open session, there will be a period for oral statements. Please note that the oral statement period may end before the time indicated, following the last call for oral statements. To register as a speaker, contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

    To facilitate public participation, we invite public comment on the issues to be considered by the committee as listed in the “Agenda” below. Written comments must be received by June 6, 2016. Please include the docket number (DHS-2016-0028) and submit via one of the following methods:

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

    • Email: [email protected] Include the docket number in the subject line of the message.

    • Fax: 202-254-6176.

    • Mail: Bishop Garrison, HSSTAC Executive Director, S&T IAO STOP 0205, Department of Homeland Security, 245 Murray Lane, Washington, DC 20528-0205.

    Instructions: All submissions received must include the words “Department of Homeland Security” and the docket number. Comments received will be posted without alteration at http://www.regulations.gov.

    Docket: For access to the docket to read the background documents or comments received by the HSSTAC, go to http://www.regulations.gov and enter the docket number into the search function: DHS-2016-0028.

    Agenda: Day 1: The morning session will cover the HSSTAC deliverables, specifically a white paper discussion on Interdisciplinary Centers of Excellence and an outbrief on the Social Media Working Group Subcommittee, which focuses on social media technologies for first responders. Comments and questions from the public will follow the first session. The second morning session will be a discussion led by Dr. Reginald Brothers on “How to reinvigorate traditional partners while building the innovation ecosystem.” Committee members will be asked to provide feedback on the right balance for an innovation ecosystem. The afternoon session will consist of discussions on innovation and private sector outreach. Topics will include: The innovation ecosystem, the future of innovation at the National Bio and Agro-Defense Facility (NBAF), innovation and public private sector outreach, defining instruments of innovation and the innovation ecosystem, best practices for public private partnerships on engagement with an innovation hub and return on investment (ROI). There will also be a briefing on the status of the Silicon Valley Office, followed by a discussion on where DHS S&T should focus in building the innovation ecosystem. Members will be asked to provide input on how DHS S&T can create a national model for innovation rather than regional models. Dr. Brothers will adjourn the meeting with a few closing remarks. Day 2: The morning session will begin with a briefing on the Quadrennial Homeland Security Review (QHSR). The afternoon session will include a continuation of the discussion where the members will be asked to provide feedback on the QHSR process. There will be a period for public comment followed by final comments on QHSR.

    Dated: May, 24, 2016. Bishop Garrison, Executive Director, Homeland Security Science and Technology Advisory Committee.
    [FR Doc. 2016-12679 Filed 5-27-16; 8:45 am] BILLING CODE 9110-9F-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5909-N-38] 30-Day Notice of Proposed Information Collection: Office of Hospital Facilities Transactional Forms for FHA Programs 242, 241, 223(f), 223(a)(7) 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