Federal Register Vol. 82, No.48,

Federal Register Volume 82, Issue 48 (March 14, 2017)

Page Range13549-13740
FR Document

82_FR_48
Current View
Page and SubjectPDF
82 FR 13659 - Sunshine Act MeetingsPDF
82 FR 13702 - Sunshine Act MeetingPDF
82 FR 13676 - Sunshine Act Meeting NoticePDF
82 FR 13599 - Filing Dates for the Montana Special Congressional ElectionPDF
82 FR 13600 - Filing Dates for the South Carolina Special Elections in the 5th Congressional DistrictPDF
82 FR 13717 - Proposed Agency Information Collection Activity; Comment RequestPDF
82 FR 13720 - Approved Agency Information Collection ActivitiesPDF
82 FR 13722 - Proposed Renewal of Agency Information Collection ActivitiesPDF
82 FR 13736 - Agency Requests for Renewal of a Previously Approved Information Collection(s): War Risk Insurance, Applications and Related InformationPDF
82 FR 13730 - Request for Comments of a Previously Approved Information CollectionPDF
82 FR 13737 - Request for Comments of a Previously Approved Information CollectionPDF
82 FR 13711 - Proposed Agency Information Collection Activities; Comment RequestPDF
82 FR 13722 - Proposed Agency Information Collection Activities; Comment RequestPDF
82 FR 13714 - Proposed Renewal of Agency Information Collection Activities; Comment RequestPDF
82 FR 13593 - Credit Union Advisory Council MeetingPDF
82 FR 13579 - Environmental Technologies Trade Advisory Committee (ETTAC) Public MeetingPDF
82 FR 13730 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel SLO GIN; Invitation for Public CommentsPDF
82 FR 13731 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel SWEPTAWAY; Invitation for Public CommentsPDF
82 FR 13728 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel SAILOR'S DELIGHT; Invitation for Public CommentsPDF
82 FR 13737 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel CAROUSEL; Invitation for Public CommentsPDF
82 FR 13735 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel CLUELESS; Invitation for Public CommentsPDF
82 FR 13727 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel ESCAPE; Invitation for Public CommentsPDF
82 FR 13732 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel FAST MOVING DIME; Invitation for Public CommentsPDF
82 FR 13728 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel FINN WAY; Invitation for Public CommentsPDF
82 FR 13732 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel GREYHOUND; Invitation for Public CommentsPDF
82 FR 13739 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel LATITUDE ADJUSTMENT; Invitation for Public CommentsPDF
82 FR 13733 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel LOTUS; Invitation for Public CommentsPDF
82 FR 13651 - Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Application for Replacement/Initial Nonimmigrant Arrival-Departure DocumentPDF
82 FR 13736 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MEET VIRGINIA; Invitation for Public CommentsPDF
82 FR 13734 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MOTIVATION; Invitation for Public CommentsPDF
82 FR 13735 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel NAUTI MERMAID; Invitation for Public CommentsPDF
82 FR 13598 - Next Meeting of the North American Numbering CouncilPDF
82 FR 13738 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel NOMADE; Invitation for Public CommentsPDF
82 FR 13731 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel PACIFIC RAIDER; Invitation for Public CommentsPDF
82 FR 13727 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel P-SQUARED; Invitation for Public CommentsPDF
82 FR 13738 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel SAPPHIRE; Invitation for Public CommentsPDF
82 FR 13733 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel BORNEO PRINCESS; Invitation for Public CommentsPDF
82 FR 13729 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel BLACKBIRD VII; Invitation for Public CommentsPDF
82 FR 13650 - Agency Information Collection Activities; Revision of a Currently Approved Collection: Affidavit of Support Under Section 213A of the Act, Form I-864; Contract Between Sponsor and Household Member, Form I-864A; EZ Affidavit of Support Under Section 213 of the Act, I-864EZ; Intending Immigrant's Affidavit of Support Exemption, I-864WPDF
82 FR 13652 - Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Request for Certification of Military or Naval ServicePDF
82 FR 13710 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Representatives of the AdministratorPDF
82 FR 13708 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Dealer's Aircraft Registration Certificate ApplicationPDF
82 FR 13709 - Notice of Intent To Rule on Change in Use of Aeronautical Property at Tallahassee International AirportPDF
82 FR 13710 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Certification of Aircraft and Airmen for the Operation of Light-Sport AircraftPDF
82 FR 13709 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Certification and Operation FAR 125PDF
82 FR 13709 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Domestic and International Flight PlansPDF
82 FR 13724 - Agency Information Collection Activity Under OMB ReviewPDF
82 FR 13726 - Notice of Request for the Extension of a Currently Approved Information CollectionPDF
82 FR 13725 - Notice of Request for Revisions of an Information CollectionPDF
82 FR 13723 - Notice of Request for Revisions of an Information CollectionPDF
82 FR 13638 - National Institute of Environmental Health Sciences; Notice of Closed MeetingsPDF
82 FR 13640 - National Institute of Neurological Disorders and Stroke; Notice of MeetingPDF
82 FR 13638 - Center for Scientific Review; Notice of Closed MeetingsPDF
82 FR 13707 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Safety, Awareness, Feedback, and Evaluation (SAFE) ProgramPDF
82 FR 13708 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Extended Operations (ETOPS) of Multi-Engine AirplanesPDF
82 FR 13706 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Service Difficulty Reporting SystemPDF
82 FR 13707 - Notice of Intent To Rule on Request To Release Airport Property at the Scholes International Airport, Galveston, TexasPDF
82 FR 13706 - Notice of Opportunity for Public Comment on a Surplus Property Release at the Valdosta Regional Airport, Valdosta, GeorgiaPDF
82 FR 13581 - Pacific Island Pelagic Fisheries; Deep-Set Tuna Longline FisheriesPDF
82 FR 13653 - Silicon Metal From Australia, Brazil, Kazakhstan, and Norway; Institution of Antidumping and Countervailing Duty Investigations and Scheduling of Preliminary Phase InvestigationsPDF
82 FR 13654 - Certain Electrical Connectors, Components Thereof, and Products Containing the Same; Institution of InvestigationPDF
82 FR 13740 - Open Meeting of the Advisory Committee on Risk-Sharing MechanismsPDF
82 FR 13677 - Report on Changes to Low-Level Waste Burial ChargesPDF
82 FR 13662 - Advisory Committee On Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on NuScale; Notice of MeetingPDF
82 FR 13636 - 60-Day Notice Template for Request for Generic Clearance for the Collection of Routine Customer Feedback on HHS CommunicationsPDF
82 FR 13643 - Prince William Sound Regional Citizens' Advisory Council (PWSRCAC) RecertificationPDF
82 FR 13642 - Certificate of Alternative Compliance for Gunderson Marine LLC HULL 115PDF
82 FR 13643 - Certificate of Alternative Compliance for Conrad Industries HULL C-1148PDF
82 FR 13643 - Certificate of Alternative Compliance for JT Marine Shipyard Hull #005PDF
82 FR 13608 - Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPDF
82 FR 13632 - Enhancing Patient Engagement Efforts Across the Food and Drug Administration; Establishment of a Public Docket; Request for CommentsPDF
82 FR 13634 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Workshop; Request for CommentsPDF
82 FR 13739 - Intelligent Transportation Systems Program Advisory Committee; Notice of MeetingPDF
82 FR 13572 - Safety Zone; United Illuminating Company Housatonic River Crossing Project; Housatonic River; Milford and Stratford, CTPDF
82 FR 13648 - Enforcement Actions SummaryPDF
82 FR 13575 - Surface Transportation Vulnerability Assessments and Security Plans (VASP); Reopening of Comment PeriodPDF
82 FR 13635 - National Advisory Council on the National Health Service CorpsPDF
82 FR 13579 - Foreign-Trade Zone (FTZ) 38-Spartanburg County, South Carolina, Authorization of Production Activity, ZF Transmissions Gray Court, LLC, (Automatic Transmission and Powertrain Subassemblies and Parts, Transmission Shafts and Cranks), Gray Court, South CarolinaPDF
82 FR 13578 - Foreign-Trade Zone 43-Battle Creek, Michigan, Application for Subzone Expansion, Mead Johnson & Company, LLC, Zeeland, MichiganPDF
82 FR 13578 - Foreign-Trade Zone (FTZ) 7-Mayaguez, Puerto Rico; Notification of Proposed Production Activity; Bristol-Myers Squibb Holdings Pharma, Ltd.; (Pharmaceuticals); Manati, Puerto RicoPDF
82 FR 13576 - Submission for OMB Review; Comment RequestPDF
82 FR 13597 - Information Collection Approved by the Office of Management and BudgetPDF
82 FR 13595 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
82 FR 13596 - Information Collections Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
82 FR 13580 - Caribbean Fishery Management Council; Public MeetingPDF
82 FR 13602 - Agency Information Collection Activities; Proposed Collection; Comment Request; ExtensionPDF
82 FR 13706 - Proposal To Extend Cultural Property Agreement Between the United States and MaliPDF
82 FR 13705 - Proposal To Extend Cultural Property Agreement Between the United States and GuatemalaPDF
82 FR 13705 - Proposal To Extend Cultural Property Agreement Between the United States and BelizePDF
82 FR 13562 - Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Adjustment of Georges Bank and Southern New England/Mid-Atlantic Yellowtail Flounder Annual Catch LimitsPDF
82 FR 13658 - Proposed Extension of Information Collection; Periodic Medical Surveillance Examinations for Coal MinersPDF
82 FR 13570 - Airworthiness Directives; International Aero Engines AG Turbofan EnginesPDF
82 FR 13594 - U.S. Air Force Scientific Advisory Board Notice of MeetingPDF
82 FR 13660 - Final Notice of Research Terms and Conditions (RTC) To Address and Implement the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards Issued by the U.S. Office of Management and Budget (OMB)PDF
82 FR 13644 - Notice of Issuance of Final Determination Concerning Certain Data Storage ProductsPDF
82 FR 13656 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; Application for Tax-Exempt Transfer of Firearm and Registration to Special Occupational Taxpayer, ATF Form 3 (5320.3)PDF
82 FR 13655 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension Without Change of a Currently Approved Collection; Relief of Disabilities and Application for Restoration of Explosives Privileges (ATF Form 5400.29)PDF
82 FR 13655 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; Prevent All Cigarette Trafficking (PACT) Act Registration Form, ATF F 5070.1PDF
82 FR 13657 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension Without Change of a Currently Approved Collection; Application for National Firearms Examiner Academy, ATF F 6330.1PDF
82 FR 13658 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection; Application for Restoration of Firearms Privileges, ATF F 3210.1PDF
82 FR 13576 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service DeliveryPDF
82 FR 13581 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to a Breakwater Replacement Project in Eastport, MainePDF
82 FR 13607 - Proposed Data Collection Submitted for Public Comment and Recommendations: Survey of Engineered Nanomaterial Occupational Safety and Health Practices; Extension of Public Comment PeriodPDF
82 FR 13551 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical UsePDF
82 FR 13549 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary DisplayPDF
82 FR 13553 - Medical Devices; Neurological Devices, Classification of the Vibratory Counter-Stimulation DevicePDF
82 FR 13609 - Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for CommentsPDF
82 FR 13607 - Notice of Proposed Subaward Under a Council-Selected Restoration Component AwardPDF
82 FR 13661 - Agency Information Collection Activities: Comment RequestPDF
82 FR 13677 - Submission for Review: Self-Certification of Full-Time School Attendance for the School Year, RI 25-14 and Information and Instructions for Completing the Self-Certification of Full-Time School Attendance for the School Year, RI 25-14APDF
82 FR 13564 - Fisheries of the Northeastern United States; Northeast Skate Complex; Adjustment to the Skate Wing and Skate Bait Inseason Possession LimitsPDF
82 FR 13579 - Request for Public Comments on Strategic Plan for the National Windstorm Impact Reduction ProgramPDF
82 FR 13605 - Agency Information Collection Activities; Submission for OMB Review; Comment RequestPDF
82 FR 13678 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Complex Order Price ProtectionsPDF
82 FR 13702 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to the Listing and Trading of Shares of the USCF Canadian Crude Oil Index Fund Under NYSE Arca Equities Rule 8.200PDF
82 FR 13698 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend FINRA Rule 6191 To Modify the Date of Appendix B Web Site Data Publication Pursuant to the Regulation NMS Plan To Implement a Tick Size Pilot ProgramPDF
82 FR 13700 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Rule 67 To Modify the Date of Appendix B Web Site Data Publication Pursuant to the Regulation NMS Plan To Implement a Tick Size Pilot ProgramPDF
82 FR 13688 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Rule 7.46 To Modify the Date of Appendix B Web site Data Publication Pursuant to the Regulation NMS Plan To Implement a Tick Size Pilot ProgramPDF
82 FR 13702 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending NYSE Arca Options Fee SchedulePDF
82 FR 13685 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Rule 67 To Modify the Date of Appendix B Web Site Data Publication Pursuant to the Regulation NMS Plan To Implement a Tick Size Pilot ProgramPDF
82 FR 13690 - Self-Regulatory Organizations; the Options Clearing Corporation; Notice of Filing of Proposed Rule Change Concerning Enhancements to OCC's Stock Loan ProgramsPDF
82 FR 13704 - Small Business Size Standards: Waiver of the Nonmanufacturer RulePDF
82 FR 13604 - Block Division, Inc.; Analysis of Proposed Consent Order To Aid Public CommentPDF
82 FR 13639 - National Institute on Aging; Notice of Closed MeetingsPDF
82 FR 13637 - National Cancer Institute; Notice of MeetingPDF
82 FR 13639 - Center for Scientific Review; Notice of Closed MeetingsPDF
82 FR 13640 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed MeetingsPDF
82 FR 13641 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
82 FR 13641 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingsPDF
82 FR 13577 - Agenda and Notice of Public Meeting of the South Dakota Advisory CommitteePDF
82 FR 13578 - Reorganization of Foreign-Trade Zone 283 (Expansion of Service Area) Under Alternative Site Framework; West Tennessee AreaPDF
82 FR 13662 - Biweekly Notice: Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards ConsiderationsPDF
82 FR 13565 - Airworthiness Directives; Airbus HelicoptersPDF
82 FR 13567 - Airworthiness Directives; Various Model 234 and Model CH-47D HelicoptersPDF
82 FR 13572 - Transparency of Airline Ancillary Service FeesPDF
82 FR 13554 - Revision of Regulations Governing Freedom of Information Act RequestsPDF

Issue

82 48 Tuesday, March 14, 2017 Contents Agriculture Agriculture Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13576-13577 2017-04971 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 13576 2017-04946 AIRFORCE Air Force Department NOTICES Meetings: Air Force Scientific Advisory Board, 13594-13595 2017-04956 Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for National Firearms Examiner Academy, 13657 2017-04948 Application for Restoration of Firearms Privileges, 13658 2017-04947 Application for Tax-Exempt Transfer of Firearm and Registration to Special Occupational Taxpayer, 13656-13657 2017-04951 Prevent All Cigarette Trafficking Act Registration Form, 13655 2017-04949 Relief of Disabilities and Application for Restoration of Explosives Privileges, 13655-13656 2017-04950 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Meetings: Credit Union Advisory Council, 13593-13594 2017-05045 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Survey of Engineered Nanomaterial Occupational Safety and Health Practices, 13607-13608 2017-04942 Civil Rights Civil Rights Commission NOTICES Meetings: South Dakota Advisory Committee, 13577-13578 2017-04912 Coast Guard Coast Guard PROPOSED RULES Safety Zones: United Illuminating Company Housatonic River Crossing Project, Housatonic River, Milford and Stratford, CT, 13572-13575 2017-04978 NOTICES Certificates of Alternative Compliance: Conrad Industries HULL C-1148, 13643 2017-04985 Gunderson Marine LLC HULL 115, 13642-13643 2017-04986 JT Marine Shipyard Hull #005, 13643 2017-04984 Recertification of Prince William Sound Regional Citizens' Advisory Council, 13643-13644 2017-04987 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Institute of Standards and Technology

See

National Oceanic and Atmospheric Administration

Court Court Services and Offender Supervision Agency for the District of Columbia RULES Freedom of Information Act Requests, 13554-13562 2017-01602 Defense Department Defense Department See

Air Force Department

Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives: Airbus Helicopters, 13565-13567 2017-04736 International Aero Engines AG Turbofan Engines, 13570-13572 2017-04957 Various Model 234 and Model CH-47D Helicopters, 13567-13569 2017-04735 NOTICES Aeronautical Properties; Disposals: Tallahassee International Airport, 13709-13710 2017-05015 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certification and Operation FAR 125, 13709 2017-05012 Certification of Aircraft and Airmen for the Operation of Light-Sport Aircraft, 13710-13711 2017-05014 Dealer' Aircraft Registration Certificate Application, 13708 2017-05016 Domestic and International Flight Plans, 13709 2017-05011 Extended Operations of Multi-Engine Airplanes, 13708 2017-05002 Representatives of the Administrator, 13710 2017-05017 Safety, Awareness, Feedback, and Evaluation Program, 13707 2017-05003 Service Difficulty Reporting System, 13706 2017-05001 Airport Property Releases: Scholes International Airport, Galveston, TX, 13707-13708 2017-04999 Surplus Property Releases: Valdosta Regional Airport, Valdosta, GA, 13706-13707 2017-04998 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13595-13598 2017-04966 2017-04967 2017-04968 2017-04969 Meetings: North American Numbering Council, 13598-13599 2017-05027 Federal Election Federal Election Commission NOTICES Filing Dates: Montana Special Congressional Election, 13599-13600 2017-05057 South Carolina Special Elections in the 5th Congressional District, 13600-13602 2017-05055 Federal Railroad Federal Railroad Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13711-13723 2017-05046 2017-05047 2017-05048 2017-05052 2017-05053 2017-05054 Federal Trade Federal Trade Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13602-13607 2017-04929 2017-04964 Proposed Consent Agreements: Block Division, Inc.; Analysis of Proposed Consent Order to Aid Public Comment, 13604-13605 2017-04919 Federal Transit Federal Transit Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13723-13727 2017-05007 2017-05008 2017-05009 2017-05010 Food and Drug Food and Drug Administration RULES Medical Devices: Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display, 13549-13550 2017-04940 Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use, 13551-13553 2017-04941 Neurological Devices, Classification of the Vibratory Counter-Stimulation Device, 13553-13554 2017-04939 NOTICES Enhancing Patient Engagement Efforts Across the Food and Drug Administration, 13632-13634 2017-04982 Medical Devices: Exemptions From Premarket Notification; Class II Devices, 13609-13632 2017-04938 Meetings: Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Establishment of a Public Docket, 13608-13609 2017-04983 Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Workshop, 13634-13635 2017-04981 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: Bristol-Myers Squibb Holdings Pharma, Ltd, Foreign-Trade Zone 7, Mayaguez, PR, 13578 2017-04972 ZF Transmissions Gray Court, LLC, Foreign-Trade Zone 38, Spartanburg County, SC, 13579 2017-04974 Reorganizations under Alternative Site Framework: Foreign-Trade Zone 283, West Tennessee Area, 13578 2017-04911 Subzone Expansions; Applications: Mead Johnson & Company, LLC, Foreign-Trade Zone 43, Battle Creek, MI, 13578-13579 2017-04973 Gulf Coast Ecosystem Restoration Council Gulf Coast Ecosystem Restoration Council NOTICES Proposed Subaward under a Council-Selected Restoration Component Award, 13607 2017-04937 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for the Collection of Routine Customer Feedback on HHS Communications, 13636-13637 2017-04989
Health Resources Health Resources and Services Administration NOTICES Meetings: National Advisory Council on the National Health Service Corps, 13635-13636 2017-04975 Homeland Homeland Security Department See

Coast Guard

See

Transportation Security Administration

See

U.S. Citizenship and Immigration Services

See

U.S. Customs and Border Protection

International Trade Adm International Trade Administration NOTICES Meetings: Environmental Technologies Trade Advisory Committee, 13579 2017-05044 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Silicon Metal from Australia, Brazil, Kazakhstan, and Norway, 13653-13654 2017-04994 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Electrical Connectors, Components Thereof, and Products Containing the Same, 13654-13655 2017-04993 Justice Department Justice Department See

Alcohol, Tobacco, Firearms, and Explosives Bureau

Labor Department Labor Department See

Mine Safety and Health Administration

Maritime Maritime Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13730, 13737-13738 2017-05049 2017-05050 Agency Information Collection Activities; Proposals, Submissions, and Approvals: War Risk Insurance, Applications and Related Information, 13736-13737 2017-05051 Requests for Administrative Waivers of the Coastwise Trade Laws: Vessel BORNEO PRINCESS, 13733-13734 2017-05022 Vessel BLACKBIRD VII, 13729 2017-05021 Vessel CAROUSEL, 13737 2017-05039 Vessel CLUELESS, 13735-13736 2017-05038 Vessel ESCAPE, 13727-13728 2017-05037 Vessel FAST MOVING, 13732-13733 2017-05036 Vessel FINN WAY, 13728-13729 2017-05035 Vessel GREYHOUND, 13732 2017-05034 Vessel LATITUDE ADJUSTMENT, 13739 2017-05033 Vessel LOTUS, 13733 2017-05032 Vessel MEET, 13736 2017-05030 Vessel MOTIVATION, 13734 2017-05029 Vessel NAUTI, 13735 2017-05028 Vessel NOMADE, 13738 2017-05026 Vessel PACIFIC RAIDER, 13731-13732 2017-05025 Vessel P-SQUARED, 13727 2017-05024 Vessel SAILOR'S, 13728 2017-05040 Vessel SAPPHIRE, 13738-13739 2017-05023 Vessel SLO GIN, 13730 2017-05042 Vessel SWEPTAWAY, 13731 2017-05041 Mine Mine Safety and Health Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Periodic Medical Surveillance Examinations For Coal Miners, 13658-13659 2017-04958 Mississippi Mississippi River Commission NOTICES Meetings; Sunshine Act, 13659-13660 2017-05110 National Institute National Institute of Standards and Technology NOTICES Request for Comments: National Windstorm Impact Reduction Program, 13579-13580 2017-04933 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 13638-13639 2017-04916 2017-05004 National Cancer Institute, 13637-13638 2017-04917 National Institute of Allergy and Infectious Diseases, 13641 2017-04913 National Institute of Diabetes and Digestive and Kidney Diseases, 13640-13641 2017-04915 National Institute of Environmental Health Sciences, 13638-13639 2017-05006 National Institute of Neurological Disorders and Stroke, 13640 2017-05005 National Institute on Aging, 13639-13640 2017-04918 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Northeastern United States: Northeast Multispecies Fishery; Adjustment of Georges Bank and Southern New England/Mid-Atlantic Yellowtail Flounder Annual Catch Limits, 13562-13563 2017-04959 Northeast Skate Complex; Adjustment to the Skate Wing and Skate Bait Inseason Possession Limits, 13564 2017-04934 NOTICES Environmental Impact Statements; Availability, etc.: Pacific Island Pelagic Fisheries; Deep-set Tuna Longline Fisheries, 13581 2017-04996 Meetings: Caribbean Fishery Management Council, 13580-13581 2017-04965 Takes of Marine Mammals: Breakwater Replacement Project in Eastport, ME, 13581-13593 2017-04943 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13661-13662 2017-04936 Research Terms and Conditions to address and implement the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards issued by the Office of Management and Budget, 13660-13661 2017-04955 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Facility Operating and Combined Licenses: Applications and Amendments Involving No Significant Hazards Considerations; Biweekly Notice, 13662-13676 2017-04757 Guidance: Report on Changes to Low-Level Waste Burial Charges, 13677 2017-04991 Meetings: Advisory Committee On Reactor Safeguards Subcommittee on NuScale, 13662 2017-04990 Meetings; Sunshine Act, 13676-13677 2017-05077 Personnel Personnel Management Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Self-Certification of Full-Time School Attendance For The School Year; Information and Instructions for Completing the Self-Certification of Full-Time School Attendance For The School Year, 13677-13678 2017-04935 Securities Securities and Exchange Commission NOTICES Meetings; Sunshine Act, 13702 2017-05084 Self-Regulatory Organizations; Proposed Rule Changes: Chicago Board Options Exchange, Inc., 13678-13685 2017-04928 Financial Industry Regulatory Authority, Inc., 13698-13699 2017-04926 New York Stock Exchange LLC, 13685-13687 2017-04922 NYSE Arca, Inc., 13688-13690, 13702-13704 2017-04923 2017-04924 2017-04927 NYSE MKT LLC, 13700-13702 2017-04925 Options Clearing Corp., 13690-13697 2017-04921 Small Business Small Business Administration NOTICES Small Business Size Standards: Rubber Gloves; Waiver of the Nonmanufacturer Rule, 13704-13705 2017-04920 State Department State Department NOTICES Memorandums of Understanding: Proposal to Extend Cultural Property Agreement between the United States and Guatemala, 13705 2017-04961 Proposal to Extend Cultural Property Agreement between the United States and Belize, 13705 2017-04960 Proposal to Extend Cultural Property Agreement between the United States and Mali, 13706 2017-04962 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13641-13642 2017-04914 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Railroad Administration

See

Federal Transit Administration

See

Maritime Administration

PROPOSED RULES Transparency of Airline Ancillary Service Fees, 13572 2017-04674 NOTICES Meetings: Intelligent Transportation Systems Program Advisory Committee, 13739-13740 2017-04980
Security Transportation Security Administration PROPOSED RULES Surface Transportation Vulnerability Assessments and Security Plans, 13575 2017-04976 NOTICES Enforcement Actions Summary, 13648-13650 2017-04977 Treasury Treasury Department NOTICES Meetings: Advisory Committee on Risk-Sharing Mechanisms, 13740 2017-04992 U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 13650-13651 2017-05020 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Replacement/Initial Nonimmigrant Arrival-Departure Document, 13651-13652 2017-05031 Certification of Military or Naval Service, 13652-13653 2017-05019 Customs U.S. Customs and Border Protection NOTICES Country of Origin Determinations: Certain Data Storage Products, 13644-13648 2017-04953 Reader Aids

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82 48 Tuesday, March 14, 2017 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2017-N-1141] Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final order.

SUMMARY:

The Food and Drug Administration (FDA) is classifying the continuous glucose monitor secondary display 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 continuous glucose monitor secondary display'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 March 14, 2017. The classification was applicable on January 23, 2015.

FOR FURTHER INFORMATION CONTACT:

Ryan Lubert, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002, 240-402-6357, [email protected]

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, also known as De Novo classification, 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). 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 shall classify the device by written order within 120 days. This classification will be the initial classification of the device.

On December 15, 2014, Dexcom Inc., submitted a request for classification of the Dexcom Share Direct Secondary Displays under section 513(f)(2) of the FD&C Act.

In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. FDA classifies devices into class 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 January 23, 2015, 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 862.1350.

Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a continuous glucose monitor secondary display will need to comply with the special controls named in this final administrative order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or PMA in order to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome pathway of 510(k), when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers.

The device is assigned the generic name continuous glucose monitor secondary display, and it is identified as a device intended to be used for passive real-time monitoring of continuous glucose monitoring data. The primary display device, which is not a part of the continuous glucose monitor secondary display, directly receives the glucose data (for example, it communicates directly with transmitter) from the continuous glucose meter, which is not a part of the continuous glucose monitor secondary display, and is the primary means of viewing the continuous glucose monitor data and alerting the patient to a low or high glucose value. A continuous glucose monitor secondary display can be used by caregivers of people with diabetes to monitor a person's continuous glucose monitoring data. A device is not a continuous glucose monitor secondary display if the data from the primary display device is modified (for example, predicting future glucose values) or the patient can use the secondary display in lieu of a primary display device (for example, the primary display device is blinded or the primary display does not have to be near the person wearing the sensor and transmitter).

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

Table 1—Continuous Glucose Monitor Secondary Display Risks and Mitigation Measures Identified risks Mitigation measures Incorrect glucose value reported on the secondary display or glucose value missed due to cybersecurity breach 21 CFR 862.1350(b)(1). Treatment recommendations are made based on data presented by secondary display device 21 CFR 862.1350(b)(2). Individual with diabetes becomes overly reliant on “followers” for monitoring their glucose levels 21 CFR 862.1350(b)(3).

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

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), 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 continuous glucose monitor secondary display they intend to market.

II. Analysis of Environmental Impact

We have 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.

List of Subjects in 21 CFR Part 862

Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 862 is amended as follows:

PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 1. The authority citation for part 862 is revised to read as follows: Authority:

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

2. Add § 862.1350 to subpart B to read as follows:
§ 862.1350 Continuous glucose monitor secondary display.

(a) Identification. A continuous glucose monitor secondary display is identified as a device intended to be used for passive real-time monitoring of continuous glucose monitoring data. It must not be capable of serving as a stand-alone primary display device. The primary display device, which is not a part of the continuous glucose monitor secondary display, directly receives the glucose data (for example, it communicates directly with transmitter) from the continuous glucose meter, which is not a part of the continuous glucose monitor secondary display, and is the primary means of viewing the continuous glucose monitor data and alerting the patient to a low or high glucose value. A continuous glucose monitor secondary display can be used by caregivers of people with diabetes to monitor a person's continuous glucose monitoring data. A device is not a continuous glucose monitor secondary display if the data from the primary display device is modified (for example, predicting future glucose values) or the patient can use the secondary display in lieu of a primary display device (for example, the primary display device is blinded or the primary display does not have to be near the person wearing the sensor and transmitter).

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

(1) Devices being marketed must include appropriate measures to protect against unauthorized access to data and unauthorized modification of data.

(2) The labeling must prominently and conspicuously display a warning that states “Dosing decisions should not be made based on this device. The user should follow instructions on the continuous glucose monitoring system.”

(3) The labeling for the device must include a statement that reads “This device is not intended to replace self-monitoring practices as advised by a physician.”

Dated: March 8, 2017. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2017-04940 Filed 3-13-17; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2017-N-1142] Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final order.

SUMMARY:

The Food and Drug Administration (FDA) is classifying the high throughput genomic sequence analyzer for clinical use 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 classification of the high throughput genomic sequence analyzer for clinical use device. 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 March 14, 2017. The classification was applicable on November 19, 2013.

FOR FURTHER INFORMATION CONTACT:

Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD, 20993-0002, 301-796-5866, [email protected]

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, also known as De Novo classification, 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 shall classify the device by written order within 120 days. This classification will be the initial classification of the device. In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on September 13, 2013, classifying the Illumina MiSeqDx Platform into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II.

On September 23, 2013, FDA received from Illumina, Inc., a request for classification of the Illumina MiSeqDx Platform submitted under section 513(f)(2) of the FD&C Act. In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. FDA classifies devices into class 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 November 19, 2013, 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 862.2265.

Following the effective date of this final classification order, any firm intending to market a high throughput genomic sequence analyzer for clinical use will need to comply with the special controls named in this final order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or PMA in order to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome pathway of 510(k), when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers.

The device is assigned the generic name high throughput genomic sequence analyzer for clinical use, and it is identified as an analytical instrument system intended to generate, measure and sort signals in order to analyze nucleic acid sequences in a clinical sample. The device may include a signal reader unit; reagent handling, dedicated instrument control, and other hardware components; raw data storage mechanisms; data acquisition software; and software to process detected signals.

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

Table 1—High Throughput Genomic Sequence Analyzer for Clinical Use Risks and Mitigation Measures Identified risks to health Required mitigations Inaccurate test results due to unavailability of necessary components of the instrument system Special Control (1) (21 CFR 862.2265(b)(1)). Inaccurate results due to unknown performance of the instrument system Special Control (2) (21 CFR 862.2265(b)(2)).

FDA believes that the special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness. The special controls for a high throughput genomic sequence analyzer for clinical use include a detailed outline of analytical performance information that must be generated for the instrument system (i.e., platform and all associated software). This includes analytical validation using well characterized samples (i.e., well characterized or reference materials) to demonstrate the system's capabilities and to identify limitations.

The validation testing, as required by the special controls, only establishes the instrument's general capabilities and does not establish the instrument's capabilities or suitability with respect to any specific claims. Instruments indicated for a specific diagnostic test, including those that make claims for a specific test, (e.g., hematology panel; oncology panel) require additional independent validation and are not high throughput genomic sequence analyzers for clinical use under 21 CFR 862.2265.

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), 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 believes premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, is planning to exempt the device from the premarket notification requirements under section 510(m) of the FD&C Act. Once finalized, persons who intend to market this device type need not submit a 510(k) premarket notification containing information on the high throughput genomic sequence analyzer for clinical use prior to marketing the device.

II. Analysis of Environmental Impact

We have 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.

List of Subjects in 21 CFR Part 862

Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 862 is amended as follows:

PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 1. The authority citation for part 862 is revised to read as follows: Authority:

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

2. Add § 862.2265 to subpart C to read as follows:
§ 862.2265 High throughput genomic sequence analyzer for clinical use.

(a) Identification. A high throughput genomic sequence analyzer for clinical use is an analytical instrument system intended to generate, measure and sort signals in order to analyze nucleic acid sequences in a clinical sample. The device may include a signal reader unit; reagent handling, dedicated instrument control, and other hardware components; raw data storage mechanisms; data acquisition software; and software to process detected signals.

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

(1) The labeling for the instrument system must reference legally marketed pre-analytical and analytical reagents to be used with the instrument system and include or reference legally marketed analytical software that includes sequence alignment and variant calling functions, to be used with the instrument system.

(2) The labeling for the instrument system must include a description of the following information:

(i) The specimen type(s) validated as an appropriate source of nucleic acid for this instrument.

(ii) The type(s) of nucleic acids (e.g., germline DNA, tumor DNA) validated with this instrument.

(iii) The type(s) of sequence variations (e.g. single nucleotide variants, insertions, deletions) validated with this instrument.

(iv) The type(s) of sequencing (e.g., targeted sequencing) validated with this instrument.

(v) The appropriate read depth for the sensitivity claimed and validation information supporting those claims.

(vi) The nucleic acid extraction method(s) validated for use with the instrument system.

(vii) Limitations must specify the types of sequence variations that the instrument cannot detect with the claimed accuracy and precision (e.g., insertions or deletions larger than a certain size, translocations).

(viii) Performance characteristics of the instrument system must include:

(A) Reproducibility data generated using multiple instruments and multiple operators, and at multiple sites. Samples tested must include all claimed specimen types, nucleic acid types, sequence variation types, and types of sequencing. Variants queried shall be located in varying sequence context (e.g., different chromosomes, GC-rich regions). Device results shall be compared to reference sequence data with high confidence.

(B) Accuracy data for all claimed specimen types and nucleic acid types generated by testing a panel of well characterized samples to query all claimed sequence variation types, types of sequencing, and sequences located in varying sequence context (e.g., different chromosomes, GC-rich regions). The well-characterized sample panel shall include samples from at least two sources that have highly confident sequence based on well-validated sequencing methods. At least one reference source shall have sequence generated independently of the manufacturer with respect to technology and analysis. Percent agreement and percent disagreement with the reference sequences must be described for all regions queried by the instrument.

(C) If applicable, data describing endogenous or exogenous substances that may interfere with the instrument system.

(D) If applicable, data demonstrating the ability of the system to consistently generate an accurate result for a given sample across different indexing primer combinations.

(ix) The upper and lower limit of input nucleic acid that will achieve the claimed accuracy and reproducibility. Data supporting such claims must also be summarized.

Dated: March 8, 2017. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2017-04941 Filed 3-13-17; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2017-N-1123] Medical Devices; Neurological Devices, Classification of the Vibratory Counter-Stimulation Device AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final order.

SUMMARY:

The Food and Drug Administration (FDA) is classifying the vibratory counter-stimulation device 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 vibratory counter-stimulation device'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 March 14, 2017. The classification was applicable on December 18, 2013.

FOR FURTHER INFORMATION CONTACT:

Michael Hoffmann, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2640, Silver Spring, MD 20993-0002, 301-796-6476, [email protected]

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, also known as De Novo classification, 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). 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 shall classify the device by written order within 120 days. This classification will be the initial classification of the device. In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on June 14, 2011, classifying the Symphony Device into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II.

On July 13, 2011, Sensory Medical, Inc. submitted a request for classification of the Symphony Device under section 513(f)(2) of the FD&C Act.

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 December 18, 2013, 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 882.5895.

Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a vibratory counter-stimulation device will need to comply with the special controls named in this final order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or PMA in order to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome pathway of 510(k), when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers.

The device is assigned the generic name vibratory counter-stimulation device, and it is identified as a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome.

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

Table 1—Vibratory Counter-Stimulation Device Risks and Mitigation Measures Identified risks Mitigation measure Pain, discomfort, worsening of Restless Legs Syndrome symptoms Non-clinical testing, Software testing, Labeling. Electrical shock Electrical safety testing, Labeling. Burns Electrical and thermal safety testing, Labeling. Adverse skin reactions Biocompatibility assessment, Labeling. Interference with other medical devices Electromagnetic compatibility testing, Labeling.

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

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

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), 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 the device is not exempt from the premarket notification requirements of the FD&C Act. Persons who intend to market this type of device must submit a premarket notification (510(k)), prior to marketing the device, which contains information on the vibratory counter-stimulation device 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 part 801, regarding labeling have been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 882

Medical devices, Neurological devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:

PART 882—NEUROLOGICAL DEVICES 1. The authority citation for part 882 continues to read as follows: Authority:

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

2. Add § 882.5895 to subpart F to read as follows:
§ 882.5895 Vibratory counter-stimulation device.

(a) Identification. A vibratory counter-stimulation device is a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome.

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

(1) Appropriate analysis/testing must demonstrate electromagnetic compatibility (EMC), electrical safety, and thermal safety.

(2) If the device contains software or firmware, appropriate verification, validation, and hazard analysis must be performed.

(3) The elements of the device that contact the patient must be assessed to be biocompatible.

(4) Non-clinical testing data (including vibration frequency, amplitude, and acceleration) must demonstrate that the device performs as intended under anticipated conditions of use.

(5) Labeling must include:

(i) Specific information pertinent to use of the device by the intended patient population and the treatment regimen;

(ii) Warning to only use the device on normal, intact, clean, healthy skin;

(iii) Warning to not use the device if the user has leg skin disorders, such as eczema, psoriasis, cellulitis, non-healing wounds;

(iv) Warning to discontinue use if Restless Leg Syndrome symptoms worsen; and

(v) Instructions for end users to contact the device manufacturer and MedWatch in case they experience any adverse events when using this device.

Dated: March 8, 2017. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2017-04939 Filed 3-13-17; 8:45 am] BILLING CODE 4164-01-P
COURT SERVICES AND OFFENDER SUPERVISION AGENCY FOR THE DISTRICT OF COLUMBIA 28 CFR Part 802 RIN 3225-AA12 Revision of Regulations Governing Freedom of Information Act Requests AGENCY:

Court Services and Offender Supervision Agency for the District of Columbia.

ACTION:

Interim final rule.

SUMMARY:

This interim final rule updates and clarifies the procedures for submitting Freedom of Information Act (FOIA) requests as required under the FOIA Improvement Act of 2016 (the 2016 Act) which was signed into law by the President on June 30, 2016. This rule makes the procedural changes necessitated by the 2016 Act, including requirements that agencies provide a minimum of 90 days for requesters to file an administrative appeal and that agencies provide dispute resolution services during the FOIA process. The 2016 Act also adds two new elements to agency Annual FOIA Reports. The rule codifies the “foreseeable harm” standard implemented by the 2016 Act. The principal changes that were required to the Court Services and Offender Supervision Agency for the District of Columbia's (“CSOSA”) current regulations are discussed below.

Congress mandated that agencies make changes to their regulations within 180 days of the law taking effect. Because the changes are mandated by Congress and are non-controversial, CSOSA is publishing this rule as an interim final rule.

DATES:

This interim final rule is effective March 14, 2017.

FOR FURTHER INFORMATION CONTACT:

Sheila Stokes, General Counsel, Court Services and Offender Supervision Agency for the District of Columbia, 633 Indiana Ave. NW., Room 1380, Washington, DC 20004; telephone: 202-220-5797; email: [email protected]

SUPPLEMENTARY INFORMATION:

The 2016 Act (Pub. L. 114-185) required agencies to update their regulations on FOIA compliance. The 2016 Act addresses procedural issues to help improve the FOIA process across all Federal agencies. It requires agencies to establish a minimum of 90 days for requesters to file administrative appeals, to establish additional dispute resolution services, and to codify the Department of Justice's “foreseeable harm” standard, which only allows agencies to withhold information if the agency reasonably foresees that disclosure would harm an interest protected by a FOIA exemption or the disclosure is prohibited by law.

CSOSA was established within the Executive Branch of the Federal Government by the National Capital Revitalization and Self-Government Improvement Act of 1997, Public Law 105-33, 111 Stat. 251, 712 (D.C. Code 24-1232, 24-1233). On August 4, 2000, CSOSA was certified by the Attorney General as an independent Federal agency.

CSOSA is amending its regulations on the process for requesting information under the Freedom of Information Act to comply with the 2016 Act. This includes the process for requests to the District of Columbia Pretrial Services Agency (“PSA”), an independent entity within CSOSA. CSOSA provides supervisory and treatment services to individuals on probation, parole, and supervised release for District of Columbia Code violations. CSOSA also provides supervisory and treatment services to offenders from other jurisdictions in accordance with the Interstate Parole and Probation Compact. PSA supervises, monitors, and provides treatment services to defendants in the U.S. District Court and the United States Court of Appeals for the District of Columbia Circuit and to individuals on pretrial release for District of Columbia Code violations.

I. Background

CSOSA is revising its FOIA regulations to comply with the 2016 Act. The following is a description of the changes.

CSOSA has updated its regulations at § 802.1 to provide additional information about the FOIA process at CSOSA.

CSOSA has updated its regulations at § 802.2 to include a designation of its Chief FOIA Officer and statement that the Chief FOIA Officer will be responsible for naming the FOIA Public Liaison.

CSOSA has updated its regulations by adding a new § 802.3 and renumbering the remaining sections. The new § 802.3 reinforces CSOSA's commitment to transparency and explains what information and records are available for public inspection. It also speaks to the preservation of records during a request, appeal, or lawsuit under FOIA and CSOSA's disposition and destruction schedule as allowed by the National Archives and Records Administration.

In the renumbered new § 802.4 CSOSA, which discusses the guidelines for disclosure, added information on the applicable exemptions and/or exclusions to disclosure.

In the renumbered new § 802.5 CSOSA added an additional definition.

In the renumbered new § 802.6 CSOSA inserted information about the new FOIA Public Liaison, its role, and the ability to seek dispute resolution from the Office of Government Information Services. In addition, CSOSA added directions for requesting information, the timelines for the release of information, and waiver of fee requests. CSOSA added information about requests for modifications, denials, and exceptional circumstances for agency non-compliance with deadlines set by law. CSOSA also added information about withholding information due to foreseeable harm, a standard that was codified by the 2016 Act. Finally, CSOSA added information about how requesters can file administrative appeals of agency decisions.

The old § 802.7 was deleted. In the new § 802.7 CSOSA inserted information of what occurs if the documents requested were created more than 25 years prior to the request for information and how CSOSA staff should handle requests for non-Federal agency records that are part of CSOSA records.

In § 802.8 CSOSA added information about expedited processing and how to determine if there is a compelling need for expediting processing.

The new fee provisions of the 2016 Act were incorporated into § 802.10, which include the inability of an agency to assign any search fees if it has failed to follow the deadlines set by the law. Unusual circumstances where more than 5,000 pages are required to comply with the request, fees may be charged by an agency if timely notice is supplied to the requestor. Any court actions may excuse any timeliness issues if a court sets its own time frames.

II. Procedural Issues and Regulatory Review

Administrative Procedure Act (APA): This action is taken under the requirements of the FOIA Improvement Act of 2016, Public Law 114-185, to publish regulations complying with the law by December 30, 2016 in the Federal Register. Because this rule pertains to explicit changes mandated by Congress, CSOSA is issuing the rule as final without general notice of proposed rulemaking and without any delay in its effectiveness. Any interested person, however, who wishes to submit comments on the rule may do so by writing or emailing the agency at the addresses given above in the FOR FURTHER INFORMATION CONTACT caption.

Executive Order 12866 and 13563 (Regulatory Planning and Review): CSOSA does not anticipate that this interim final rule will have significant economic impact, raise novel issues, and/or have any other significant impacts because it simply incorporates the provisions of the FOIA Improvement Act of 2016 into the current CSOSA FOIA regulations. Thus this interim final rule is not a significant regulatory action under 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under 6(a)(3) of the Order.

Regulatory Flexibility Act (RFA): The Regulatory Flexibility Act does not apply. This interim final rule will not directly regulate small entities. CSOSA, therefore, does not need to perform a regulatory flexibility analysis of small entity impacts.

Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA): CSOSA has determined that this interim final rule does not impose a significant impact on a substantial number of small entities under the RFA; therefore, CSOSA is not required to produce any Compliance Guides for Small Entities as mandated by the SBREFA.

Congressional Review Act: CSOSA has determined that this interim final rule is not a major rule under the Congressional Review Act, as it is unlikely to result in an annual effect on the economy of $100 million or more; is unlikely to result in a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies or geographic regions; and is unlikely to have a significant adverse effect on competition, employment, investment, productivity, or innovation, or on the ability of U.S.-based enterprises to compete in domestic and export markets.

Unfunded Mandates Reform Act (UMRA): This revision does not impose any federal mandates on state, local, or tribal governments, or on the private sector within the meaning of the UMRA.

National Environmental Policy Act (NEPA): This interim final rule will have no physical impact upon the environment and, therefore, will not require any further review under NEPA.

Paperwork Reduction Act (PRA): The Paperwork Reduction Act does not apply because the rule does not impose information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

Executive Order 13132 (Federalism): This final revision does not have new federalism implications under Executive Order 13132.

Executive Order 12988 (Civil Justice Reform): This interim final rule meets applicable standards of 3(a) and 3(b)(2) of Executive Order 12988 and CSOSA has determined that the interim final rule will not unduly burden the Federal court system.

Plain Language: E.O. 12866 and E.O. 13563 require regulations to be written in a manner that is easy to understand. CSOSA has concluded that it has drafted this interim final rule in plain language.

Assessment of Federal Regulations and Policies on Families: Section 654 of the Treasury and General Government Appropriations Act, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 (Pub. L. 105-277, 112 Stat. 2681) requires the assessment of the impact of this rule on family well-being. CSOSA has assessed this interim final rule and determined that the rule will not have a negative effect on families.

Executive Order 13175 (Indian Tribal Governments): CSOSA reviewed this interim final rule under the terms of E.O. 13175 and has determined that the rule will not have tribal implications.

Executive Order 12630 (Government Actions and Interference With Constitutionally Protected Property Rights): CSOSA has determined that this interim final rule is not subject to E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights, because it does not involve implementation of a policy with takings implications.

Executive Order 13211 (Energy Supply): This CSOSA interim final rule was drafted and reviewed in accordance with E.O. 13211, Energy Supply. CSOSA has determined that this interim final rule will not have a significant adverse effect on the supply, distribution, or use of energy and is not subject to E.O. 13211.

List of Subjects in 28 CFR Part 802

Administrative practice and procedure, Freedom of information, Government employees, Privacy, Probation and parole.

Authority and Issuance

For the reasons stated in the preamble, the Court Services and Offender Supervision Agency for the District of Columbia amends 28 CFR part 802 as set forth below:

PART 802—DISCLOSURE OF RECORDS 1. Revise the authority citation for part 802 to read as follows: Authority:

5 U.S.C. 301, 552, 552a; Pub. L. 105-33, 111 Stat. 251, 712 (DC Code 24-1232, 24-1233); Pub. L. 114-185, 130 Stat. 538 (Jun. 30, 2016).

2. Revise § 802.1 to read as follows:
§ 802.1 Introduction.

(a) This part contains regulations of the Court Services and Offender Supervision Agency for the District of Columbia (“CSOSA” or “Agency”) and the District of Columbia Pretrial Services Agency (“PSA” or “Agency”), which implement the Freedom of Information Act (FOIA), 5 U.S.C. 552, and the Privacy Act (PA), 5 U.S.C. 552a. The Agency provides for the disclosure and production of records in response to FOIA/PA requests, a demand from a court, or other non-congressional authority in connection with a proceeding to which the Agency is not a party. Due to CSOSA's nature as a federal agency with a local mission connected to the District of Columbia, exemption protections, including exclusions, are allowed under the FOIA and other safeguard requirements may be applied under the PA.

(b) It is the policy of CSOSA that all employees of CSOSA and PSA (collectively the “Agency”) are to submit all FOIA/PA requests to the Office of General Counsel (“OGC”). The OGC shall make release determinations under either the FOIA/PA pursuant to the procedures set forth in sections §§ 802.6, 802.7, 802.8, 802.14, 802.15, and 802.16.

3. Revise subpart B to read as follows: Subpart B—Freedom of Information Act Sec. 802.2 Purpose and scope. 802.3 Information and records for public inspection. 802.4 Guidelines for disclosure. 802.5 Definitions. 802.6 Freedom of Information Act requests. 802.7 Documents from other agencies. 802.8 Expedited processing. 802.9 Business information. 802.10 Fee schedule.
§ 802.2 Purpose and scope.

(a) The purpose of this subpart is to establish procedures for the release of records in the custody, possession or control of the Agency pursuant to the provisions of the FOIA as amended by the FOIA Improvement Act of 2016 (Pub. L. 114-185).

(b) The Director of CSOSA has designated the General Counsel to be the Chief FOIA Officer as defined in 5 U.S.C. 552(j).

(c) The Chief FOIA Officer shall designate at least one FOIA Public Liaison as defined in 5 U.S.C 552(j)(2)(H) and 552(l) for assisting in reducing delays, increasing transparency, understanding the status of requests, and assisting in the resolution of disputes.

§ 802.3 Information and records for public inspection.

(a) Public inspection. In accordance with this section, CSOSA makes the following information and materials available for public inspection pursuant to 5 U.S.C. 552:

(1) The Agency's publications in the Federal Register for the guidance of the public.

(2) Final opinions, including concurring and dissenting opinions, as well as orders, made in the adjudication of cases.

(3) The Agency's policy statements that have been adopted by the Agency and are not published in the Federal Register.

(4) Administrative staff manuals and instructions to staff that affect a member of the public.

(5) Copies of all records, regardless of format, that have become or are likely to become the subject of subsequent requests for substantially the same records or have been requested three or more times; and these available records exclude first party requests.

(6) Reports available for public inspection shall be available:

(i) In a timely manner;

(ii) With raw statistical data in electronic format;

(iii) In a general index;

(iv) Without charge, license, or registration requirement;

(v) In an aggregated, searchable format;

(vi) In a format that may be downloaded in bulk; and

(vii) Which include, but are not limited to the:

(A) Chief FOIA Officer Report;

(B) Annual FOIA Report; and

(C) Quarterly FOIA Report.

(7) An index of all major information systems of the agency.

(8) A description of major information and record locator systems maintained by the agency.

(9) A handbook for obtaining various types of categories of public information from the Agency pursuant to chapter 35 of Title 44 of the United States Code, and under this section.

(b) Preservation of records. (1) All agency correspondence as well as copies of all requested records shall be preserved until disposition or destruction is authorized pursuant to Title 44 of the United States Code or the General Records Schedule 4.2 of the National Archives and Records Administration (NARA).

(2) The agency will not dispose of or destroy records while they are the subject of a pending request, appeal, or lawsuit under the FOIA.

§ 802.4 Guidelines for disclosure.

(a) The authority to release, partially release, or deny access to records and information under the FOIA is limited to the Chief FOIA Officer, FOIA Public Liaison, and his or her designee.

(b) An Agency record will be released in response to a written request, unless a valid legal exemption and/or exclusion to disclosure is asserted.

(1) Any applicable exemption and/or exclusion to disclosure, which is provided under the FOIA in 5 U.S.C. 552, may be asserted. The applicable exemptions and/or exclusions to disclosure are as follows:

(i) Exclusions. (A) Where the subject of a criminal investigation or proceeding is unaware of the existence of records concerning a pending investigation and disclosure of such records would interfere with the investigation.

(B) Where there are informant records maintained by a criminal law enforcement agency and the individual's status as an informant is not known.

(C) Where there are classified FBI records pertaining to foreign intelligence, counterintelligence or international terrorism records.

(ii) Exemptions. (A) Information that is classified to protect national security.

(B) Information related solely to the internal personnel rules and practices of an agency.

(C) Information that is prohibited from disclosure by another federal law.

(D) Trade secrets or commercial or financial information that is confidential or privileged.

(E) Privileged communications within or between agencies, including:

(1) Deliberative process privilege;

(2) Attorney-work product privilege; and

(3) Attorney-client privilege.

(F) Information that, if disclosed, would invade another individual's personal privacy.

(G) Information compiled for law enforcement purposes that:

(1) Could reasonably be expected to interfere with enforcement proceedings.

(2) Would deprive a person of a right to a fair trial or an impartial adjudication.

(3) Could reasonably be expected to constitute an unwarranted invasion of personal privacy.

(4) Could reasonably be expected to disclose the identity of a confidential source.

(5) Would disclose techniques and procedures for law enforcement investigations or prosecutions.

(6) Could reasonably be expected to endanger the life or physical safety of any individual.

(H) Information that concerns the supervision of financial institutions.

(I) Geological information on wells.

(2) A record must exist and be in the possession and control of the Agency at the time of the request to be considered subject to this part and the FOIA. There is no obligation to create, compile, or obtain a record to satisfy a FOIA request.

§ 802.5 Definitions.

As used in this subpart, the following terms have the following meanings:

(a) Agency has the meaning given in 5 U.S.C. 551(1) and 5 U.S.C. 552(f).

(b) Appeal means a request for a review of the agency's determination with regard to a fee waiver, category of requester, expedited processing, or denial in whole or in part of a request for access to a record or records.

(c) Business information means trade secrets or other commercial or financial information.

(d) Business submitter means any entity which provides business information to the Agency and which has a proprietary interest in the information.

(e) Computer software means tools by which records are created, stored, and retrieved. Normally, computer software, including source code, object code, and listings of source and object codes, regardless of medium, are not agency records. Proprietary (or copyrighted) software is not an agency record.

(f) Confidential commercial information means records provided to the government by a submitter that arguably contain material exempt from release under Exemption 4 of the Freedom of Information Act, 5 U.S.C. 552(b)(4), because disclosure could reasonably be expected to cause substantial competitive harm.

(g) Duplication refers to the process of making a copy of a record in order to respond to a FOIA request. Such copies can take the form of paper copy, microform, audio-visual materials, or machine-readable documentation (e.g., magnetic tape or disk), among others.

(h) Electronic records mean those records and information which are created, stored, and retrievable by electronic means. This ordinarily does not include computer software, which is a tool by which to create, store, or retrieve electronic records.

(i) Record is defined pursuant to 44 U.S.C. 3301.

(j) Request means any request for records made pursuant to 5 U.S.C. 552(a)(3).

(k) Requester means any person who makes a request for access to records.

(l) Review for fee purposes, refers to the process of examining records located in response to a commercial use request to determine whether any portion of any record located is permitted to be withheld. It also includes processing any records for disclosure; e.g., doing all that is necessary to excise them and otherwise prepare them for release.

(m) Search includes all time spent looking for material that is responsive to a request, including page-by-page or line-by-line identification of material within records. Searches may be done manually or by automated means.

§ 802.6 Freedom of Information Act requests.

(a) Submission and processing procedures.(1) Requests for any record (including policy) ordinarily will be processed pursuant to the Freedom of Information Act, 5 U.S.C. 552. Your request must be made in writing and addressed to the FOIA Public Liaison Officer, Office of the General Counsel FOIA Office, Court Services and Offender Supervision Agency for the District of Columbia, 633 Indiana Avenue NW., 12th Floor, Washington, DC 20004. The requester should clearly mark on the face of the letter and the envelope “Freedom of Information Act Request.”

(2) Your request will be considered received as of the date it is received by CSOSA's FOIA Office.

(3) Generally, all FOIA requests will be processed in the approximate order of receipt, unless the requester shows exceptional circumstances exist to justify an expedited response (see § 802.8).

(4) You must describe the records that you seek in enough detail to enable Agency personnel to locate them with a reasonable amount of effort. Whenever possible, your request should include specific information about each record sought, such as the date, title or name, author, recipient and subject matter of the record. As a general rule, the more specific you are about the records or type of records that you want, the more likely the Agency will be able to locate the records in response to your request. If a determination is made that your request does not reasonably describe records, the Agency will tell you either what additional information is needed or why your request is otherwise insufficient. You will be given the opportunity to discuss your request so that you may modify it to meet the requirements of this section.

(5)(i) Requests by offender/defendant for offender's records. (A) An offender/defendant making a FOIA/PA request must provide his or her full name, current address, and date of birth. In addition, the requester must provide with the request his or her signature, which must be either notarized or sworn under penalty of perjury pursuant to 28 U.S.C. 1746, and dated within three (3) months of the date of the request.

(B) To assist in properly identifying requested records, the OGC and/or FOIA Office may request that the offender/defendant provide his/her DCDC or PDID number.

(ii) Requests for offender records on behalf of an offender/defendant. (A) A request for records made by an authorized representative of an offender/defendant will only be released with the subject's written authorization with appropriate releases. This authorization and releases must be dated within thirty (30) days of the date of the request letter and must be signed by the offender/defendant.

(B) To assist in properly identifying requested records, the OGC and/or FOIA Office may request that the offender/defendant provided his/her DCDC or PDID number.

(6) You must state in your request a firm agreement to pay the fees for search, duplication, and review as may ultimately be determined. The agreement may state the upper limit (but not less than $10.00) that the requester is willing to pay for processing the request. A request that fees be waived or reduced may accompany the agreement to pay fees and will be considered to the extent that such request is made in accordance with § 802.4(b) and provides supporting information to be measured against the fee waiver standard set forth in § 802.9(g). The requester shall be notified in writing of the decision to grant or deny the fee waiver. If a requester has an outstanding balance of search, review, or duplication fees due for FOIA request processing, the requirements of this paragraph (a)(6) are not met until the requester has remitted the outstanding balance due.

(b) Release determination—(1) Notification. You will be notified of the decision on the request within twenty (20) days after its receipt (excluding Saturdays, Sundays, and legal public holidays).

(i) The twenty (20) day period shall be tolled if:

(A) The Agency needs clarification and/or more information from the requester; or

(B) Clarification is needed with the requester regarding fee assessment.

(C) The agency's receipt of the requester's response to the agency's request for information or clarification ends the tolling period.

(ii) The twenty (20) day period shall be extended for ten (10) additional working days with written notice to the requester for unusual circumstances.

(A) Unusual circumstances means, but only to the extent reasonably necessary to the proper processing of particular requests—

(1) The need to search for and collect the requested records from field facilities or other establishments that are separate from the office processing the request;

(2) The need to search for, collect, and appropriately examine a voluminous amount of separate and distinct records which are demanded in a single request; or

(3) The need for consultation, which shall be conducted with all practicable speed, with another agency having a substantial interest in the determination of the request or among two or more components of the agency having substantial subject-matter interest therein.

(B) The written notice to the requester for unusual circumstances shall:

(1) Notify the person making the request if the request cannot be processed within the time limit specified;

(2) Provide the person an opportunity to limit the scope of the request so that it may be processed within that time limit or an opportunity to arrange with the agency an alternative time frame for processing the request or a modified request;

(3) Make available the Agency's FOIA Public Liaison Officer, who shall assist in the resolution of any disputes between the requester the Agency; and

(4) Notify the requester of the right of the requester to seek dispute resolution services from the Office of Government Information Services.

(iii) When the Agency fails to comply with the applicable time limit provisions of paragraph (b) of this section, if the Agency can show exceptional circumstances exist and that the Agency is exercising due diligence in responding to the request, the Agency may be allowed additional time to complete its review of the records.

(A) For purposes of this paragraph (b)(1)(iii), the term “exceptional circumstances” does not include a delay that results from a predictable agency workload of requests under this section, unless the agency demonstrates reasonable progress in reducing its backlog of pending requests.

(B) Refusal by a person to reasonably modify the scope of a request or arrange an alternative time frame for processing a request (or a modified request) after being given an opportunity to do so by the Agency to whom the person made the request shall be considered as a factor in determining whether exceptional circumstances exist for purposes of this paragraph (b)(1)(iii).

(2) Denial in whole or in part. If it is determined that the request for records should be denied in whole or in part, the requester shall be notified by mail with a letter stating the basis for partial or whole denial. The letter of notification shall:

(i) Be signed by the Chief FOIA Officer or his or her designee;

(ii) State the exemptions relied on to not release the information;

(A) Advise the requester of the reason of adverse determination and the right to administrative appeal in accordance with paragraph (c) of this section;

(B) Advise the right of such person to seek assistance from the FOIA Public Liaison Officer of the agency; and

(C) Advise the right of such person to seek assistance from the Office of Government Information Services;

(iii) If technically feasible, indicate the amount of information deleted at the place in the record where such deletion is made (unless providing such indication would harm an interest protected by the exemption relied upon to deny such material);

(iv) If a document contains information exempt from disclosure, any reasonably segregable portion of the record will be provided to you after deletion of the exempt portions;

(v) An agency shall—

(A) Withhold information under this section only if—

(1) The agency reasonably foresees that disclosure would harm an interest protected by an exemption described in paragraph (b) of this section; or

(2) Disclosure is prohibited by law; and

(B) Partially withhold information under this section only if—

(1) Partial disclosure of information is possible whenever the agency determines that a full disclosure of a requested record is not possible; and

(2) Take reasonable steps necessary to segregate and release nonexempt information; and

(vi) Nothing in this paragraph (b)(2) requires disclosure of information that is otherwise prohibited from disclosure by law, or otherwise exempted from disclosure by statute.

(3) No records found. If it is determined, after a thorough search for records by the responsible official or his delegate, that no records have been found to exist, the Chief FOIA Officer or his/her designee will so notify the requester in writing. The letter of notification will advise the requester of his or her right to administratively appeal within ninety (90) of the determination that no records exist (i.e., to challenge the adequacy of the search for responsive records) in accordance with paragraph (c) of this section. The response shall specify the official or office to which the appeal shall be submitted for review.

(c) Administrative appeal. (1) A requester may appeal an initial determination when:

(i) Access to records has been denied in whole or in part;

(ii) There has been an adverse determination of the requester's category as provided in § 802.10(d);

(iii) Inadequacy of the FOIA search;

(iv) A request for fee waiver or reduction has been denied; or

(v) It has been determined that no responsive records exist.

(2) Appeals must be made within ninety (90) days of the receipt of the letter with an adverse determination. Both the envelope and the letter of appeal should be sent to the Office of the General Counsel, Court Services and Offender Supervision Agency for the District of Columbia, 633 Indiana Avenue NW., 13th Floor, Washington, DC 20004 and must be clearly marked “Freedom of Information Act (FOIA) Appeal.”

(3) The General Counsel will make an appeal determination within twenty (20) days (excluding Saturdays, Sundays, and holidays) from the date of receipt of the appeal. However, for a good reason, this time limit may be extended up to an additional ten (10) days. If, after review, the General Counsel determines that additional information should be released, it will accompany the appeal response. If, after review, the General Counsel determines to uphold the initial review, we will inform you.

§ 802.7 Documents from other agencies.

(a) Documents from or relating to Federal agencies. (1) When a request for records includes a document that originated from another Federal agency, the document will be referred to the originating Federal agency for release determination, unless the information requested is for records created 25 years or more before the date on which the records were requested, in which case CSOSA will release them without referral and/or consultation with the other federal agency. The requester will be informed of the referral. This is not a denial of a FOIA request; thus, no appeal rights accrue to the requester.

(2) When a FOIA request is received for a record created by the Agency that includes information by another Federal agency, the record will be sent to the other Federal agency that has equities in the record. The consultation will request that the other Federal agency review and provide recommendations on disclosure. The Agency will not release any such record without prior consultation with the other Federal agency that has equities in the record.

(b) Documents from non-Federal agencies. When a request for records includes a document from a non-Federal agency, CSOSA staff must make a release determination.

(1) A release determination on the records from non-Federal agencies shall be analyzed on a case-by-case to determine if CSOSA or the non-Federal agency is best able to decide a record's sensitivity, and in turn its exemption status, in which case:

(i) The requester will be re-routed to submit a separate FOIA request to the non-Federal agency; or

(ii) CSOSA will consult with the non-Federal agency only if the non-Federal agency will provide a consultation within five (5) business days.

(2) [Reserved]

§ 802.8 Expedited processing.

(a) Requests and appeals will be taken out of order and given expedited treatment whenever CSOSA's FOIA Office determines that they involve:

(1) Circumstances in which the person requesting the records demonstrates a compelling need.

(i) For purposes of this paragraph (a)(1), the term “compelling need” means—

(A) Failure to obtain requested records on an expedited basis could reasonably be expected to pose an imminent threat to the life or physical safety of an individual; or

(B) A person is primarily engaged in disseminating information and the urgency to inform the public concerning actual or alleged Federal Government activity is a matter of widespread and exceptional media interest in which there exist possible questions about the government's integrity.

(1) With respect to a request made by a person primarily engaged in disseminating information that affect public confidence, the requester must adequately explain the matter or activity and why it is necessary to provide the records being sought on an expedited basis.

(i) A person “primarily engaged in disseminating information” does not include individuals who are engaged only incidentally in the dissemination of information.

(ii) The standard of “widespread and exceptional media interest” requires that the records requested pertain to a matter of current exigency to the American public and that delaying a response to a request for records would compromise a significant recognized interest to and throughout the general public. The requester must adequately explain the matter or activity and why it is necessary to provide the records being sought on an expedited basis.

(2) [Reserved]

(ii) [Reserved]

(2) [Reserved]

(b) If a requester seeks expedited processing, the requester must submit a statement, certified to be true and correct to the best of your knowledge and belief. The statement must be in the form prescribed by 28 U.S.C. 1746, “I declare under penalty of perjury that the foregoing is true and correct to the best of my knowledge and belief. Executed on [date].”

(c) The determination as to whether to grant or deny the request for expedited processing will be made, and the requester notified, within ten (10) days after the date of the request. Because a decision to take a FOIA request out of order delays other requests, simple fairness demands that such a decision be made by the FOIA Public Liaison Officer only upon careful scrutiny of truly exceptional circumstances. The decision will be made solely based on the information contained in the initial letter requesting expedited processing.

(d) Appeals of initial determinations to deny expedited processing must be made promptly. Both the envelope and the letter of appeal should be sent to the Office of the General Counsel, Court Services and Offender Supervision Agency for the District of Columbia, 633 Indiana Avenue NW., 12th Floor, Washington, DC 20004 and must be clearly marked “Expedited Processing Appeal.”

(e) The OGC or his or designee will make an appeal determination regarding expedited processing as soon as practicable.

§ 802.9 Business information.

(a) In general. Business information provided to the Agency by a business submitter will be disclosed pursuant to the FOIA, unless exemptions and/or exclusions apply. Any claim of confidentiality must be supported by a statement by an authorized representative of the company providing specific justification that the information in question is in fact confidential commercial or financial information and has not been disclosed to the public.

(b) Notice to business submitters. The Agency will provide a business submitter with prompt written notice of receipt of a request or appeal encompassing its business information whenever required in accordance with paragraph (c) of this section, and except as is provided in paragraph (g) of this section. Such written notice shall either describe the exact nature of the business information requested or provide copies of the records or portions of records containing the business information.

(c) When notice is required. (1) Notice of a request for business information falling within paragraph (c)(2)(i) or (ii) of this section will be required for a period of not more than ten years after the date of submission unless the business submitter had requested, and provided acceptable justification for, a specific notice period of greater duration.

(2) The Agency shall provide a business submitter with notice of receipt of a request or appeal whenever:

(i) The business submitter has in good faith designated the information as commercially or financially sensitive information; or

(ii) The Agency has reason to believe that disclosure of the information could reasonably be expected to cause substantial competitive harm.

(d) Opportunity to object to disclosure. (1) Through the notice described in paragraph (b) of this section, the Agency shall afford a business submitter ten (10) days from the date of the notice (exclusive of Saturdays, Sundays, and legal public holidays) to provide a detailed statement of any objection to disclosure. Such statement shall specify why the business submitter believes the information is considered to be a trade secret or commercial or financial information that is privileged or confidential. Information provided by a business submitter pursuant to this paragraph might itself be subject to disclosure under the FOIA.

(2) When notice is given to a submitter under this section, the requester shall be advised that such notice has been given to the submitter. The requester shall be further advised that a delay in responding to the request may be considered a denial of access to records and that the requester may proceed with an administrative appeal or seek judicial review, if appropriate. However, the requester will be invited to agree to a voluntary extension of time so that staff may review the business submitter's objection to disclose.

(e) Notice of intent to disclose. The Agency will consider carefully a business submitter's objections and specific grounds for nondisclosure prior to determining whether to disclose business information. Whenever a decision to disclose business information over the objection of a business submitter is made, the Agency shall forward to the business submitter a written notice which shall include:

(1) A statement of the reasons for which the business submitter's disclosure objections were not sustained;

(2) A description of the business information to be disclosed; and

(3) A specified disclosure date which is not less than five (5) days (exclusive of Saturdays, Sundays, and legal public holidays) after the notice of the final decision to release the requested information has been mailed to the submitter.

(f) Notice of FOIA lawsuit. Whenever a requester brings suit seeking to compel disclosure of business information covered by paragraph (c) of this section, the Agency shall promptly notify the business submitter.

(g) Exception to notice requirement. The notice requirements of this section shall not apply if:

(1) The Agency determines that the information shall not be disclosed;

(2) The information lawfully has been published or otherwise made available to the public; or

(3) Disclosure of the information is required by law (other than 5 U.S.C. 552).

§ 802.10 Fee schedule.

(a) Fees. The fees described in this section conform to the Office of Management and Budget Uniform Freedom of Information Act Fee Schedule and Guidelines. They reflect direct costs for search, review (in the case of commercial requesters), and duplication of documents, collection of which is permitted by the FOIA. However, for each of these categories, the fees may be limited, waived, or reduced for the reasons given below or for other reasons.

(b) Types of cost. The term direct costs means those expenditures the agency actually makes in searching for, review (in the case of commercial requesters), and duplicating documents to respond to a FOIA request.

(c) Types of fees. Fees shall be charged in accordance with the schedule contained in paragraph (i) of this section for services rendered in responding to requests for records, unless any one of the following applies:

(1) Services were performed without charge; or

(2) The fees were waived or reduced in accordance with paragraph (f) of this section.

(d) Categories of fees. Specific levels of fees are prescribed for each of the following categories of requesters:

(1) Commercial use requesters. These requesters are assessed charges, which recover the full direct costs of searching for, reviewing, and duplicating the records sought. Commercial use requesters are not entitled to two hours of free search time or 100 free pages of duplication of documents. Moreover, when a request is received for disclosure that is primarily in the commercial interest of the requester, the Agency is not required to consider a request for a waiver or reduction of fees based upon the assertion that disclosure would be in the public interest. The Agency may recover the cost of searching for and reviewing records even if there is ultimately no disclosure of records, or no records are located.

(2) Educational and non-commercial scientific institution requesters. Records shall be provided to requesters in these categories for the cost of duplication alone, excluding charges for the first 100 pages. To be eligible, requesters must show that the request is made under the auspices of a qualifying institution and that the records are not sought for a commercial use, but are sought in furtherance of scholarly (if the request is from an educational institution) or scientific (if the request is from a non-commercial scientific institution) research. These categories do not include requesters who want records for use in meeting individual academic research or study requirements.

(3) Requesters who are representatives of the news media. Records shall be provided to requesters in this category for the cost of duplication alone, excluding charges for the first 100 pages.

(4) All other requesters. Requesters who do not fit any of the categories described in paragraphs (d)(1) through (3) of this section shall be charged fees that will recover the full direct cost of searching for and duplicating records that are responsive to the request, except that the first 100 pages of duplication and the first two hours of search time shall be furnished without charge. The Agency may recover the cost of searching for records even if there is ultimately no disclosure of records, or no records are located. Requests from persons for records about themselves filed in a systems of records shall continue to be treated under the fee provisions of the Privacy Act of 1974 which permit fees only for duplication.

(e) Fee waiver determination. Where the initial request includes a request for reduction or waiver of fees, the responsible official shall determine whether to grant the request for reduction or waiver before processing the request and notify the requester of this decision. If the decision does not waive all fees, the responsible official shall advise the requester of the fact that fees shall be assessed and, if applicable, payment must be made in advance pursuant to paragraph (g) of this section.

(f) Waiver or reduction of fees. (1) Fees may be waived or reduced on a case-by-case basis in accordance with this paragraph (f)(1) by the official who determines the availability of the records, provided such waiver or reduction has been requested in writing. Fees shall be waived or reduced by this official when it is determined, based upon the submission of the requester, that a waiver or reduction of the fees is in the public interest because furnishing the information is likely to contribute significantly to public understanding of the operations or activities of the government and is not primarily in the commercial interest of the requester. Fee waiver/reduction requests shall be evaluated against the current fee waiver policy guidance issued by the Department of Justice.

(2) Appeals from denials of requests for waiver or reduction of fees shall be decided in accordance with the criteria set forth in this section by the official authorized to decide appeals from denials of access to records. Appeals shall be addressed in writing to the Office of the General Counsel, Court Services and Offender Supervision Agency for the District of Columbia, Office of the General Counsel, 633 Indiana Avenue NW., 13th Floor, Washington, DC 20004 within thirty (30) days of the denial of the initial request for waiver or reduction and shall be decided within twenty (20) days (excluding Saturdays, Sundays and holidays).

(3) Appeals from an adverse determination of the requester's category as described in paragraphs (d)(1) through (3) of this section shall be decided by the official authorized to decide appeals from denials of access to records and shall be based upon a review of the requester's submission and the Agency's own records. Appeals shall be addressed in writing to the office or officer specified in paragraph (d)(2) of this section within thirty (30) days of the receipt of the Agency's determination of the requester's category and shall be decided within twenty (20) days (excluding Saturdays, Sundays, and holidays).

(g) Advance notice of fees. (1) When the fees for processing the request are estimated to exceed the limit set by the requester, and that amount is less than $250.00, the requester shall be notified of the estimated costs. The requester must provide an agreement to pay the estimated costs; however, the requester will also be given an opportunity to reformulate the request in an attempt to reduce fees.

(2) If the requester has failed to state a limit and the costs are estimated to exceed $250.00, the requester shall be notified of the estimated costs and must pre-pay such amount prior to the processing of the request, or provide satisfactory assurance of full payment if the requester has a history of prompt payment of FOIA fees. The requester will also be given an opportunity to reformulate the request in an attempt to reduce fees.

(h) Form of payment. (1) Payment may be made by check or money order payable to the Treasury of the United States.

(2) The Agency reserves the right to request prepayment after a request is processed and before documents are released in the following circumstances.

(i) When costs are estimated or determined to exceed $250.00, the Agency shall either obtain satisfactory assurance of full payment of the estimated cost where the requester has a history of prompt payment of FOIA fees or require the requester to make an advance payment of the entire estimated or determined fee before continuing to process the request.

(ii) If a requester has previously failed to pay a fee within thirty (30) days of the date of the billing, the requester shall be required to pay the full amount owed plus any applicable interest, and to make an advance payment of the full amount of the estimated fee before the Agency begins to process a new request or the pending request. Whenever interest is charged, the Agency shall begin assessing interest on the 31st day following the day on which billing was sent. Interest shall be at the rate prescribed in 31 U.S.C. 3717.

(i) Amounts to be charged for specific services. The fees for services performed by an employee of the Agency shall be imposed and collected as set forth in this paragraph (i).

(1) Duplicating records. All requesters, except commercial requesters, shall receive the first 100 pages duplicated without charge; the first two hours of search time free; or charge which total $10.00 or less. Fees for the copies are to be calculated as follows:

(i) The duplication cost is calculated by multiplying the number of pages in excess of 100 by $0.25.

(ii) Photographs, films, and other materials—actual cost of duplication.

(iii) Other types of duplication services not mentioned above—actual cost.

(iv) Material provided to a private contractor for copying shall be charged to the requester at the actual cost charged by the private contractor.

(2) Search services. The cost of search time is calculated by multiplying the number of quarter hours in excess of two hours by the following rates for the staff conducting the search:

(i) $7.00 per quarter hour for clerical staff;

(ii) $10.00 per quarter hour for professional staff; and

(iii) $14.00 per quarter hour for managerial personnel.

(3) Only fees in excess of $10.00 will be assessed. This means that the total cost must be greater than $10.00, either for the cost of the search (for time in excess of two hours), for the cost of duplication (for pages in excess of 100), or for both costs combined.

(j) Searches for electronic records. The Agency shall charge for actual direct cost of the search, including computer search time, runs, and the operator's salary. The fee for computer output shall be actual direct costs. For requesters in the “all other” category, when the cost of the search (including the operator time and the cost of operating the computer to process a request) equals the equivalent dollar amount of two hours of the salary of the person performing the search (i.e., the operator), the charge for the computer search will begin.

(k) Aggregating requests. When the Agency reasonably believes that a requester or group of requesters is attempting to break a request down into a series of requests for the purpose of evading the assessment of fees, the Agency shall aggregate any such requests and charge accordingly.

(l) The agency shall not assess any search fees (or in the case of an educational or noncommercial scientific institution, or a representative of the news media—duplication fees) under this paragraph (l) if the agency has failed to comply with any time limit under 5 U.S.C. 552(a)(6) and § 802.6(b)(1).

(1) If an agency has determined that unusual circumstances apply (as the term is defined in 5 U.S.C. 552(a)(6)(B)) and the agency provided a timely written notice to the requester in accordance with 5 U.S.C. 552(a)(6)(B), a failure described in 5 U.S.C. 552(a)(6)(B) is excused for an additional 10 days. If the agency fails to comply with the extended time limit, the agency may not assess any search fees (or in the case of a requester as described under this paragraph (l)(1), duplication fees).

(2) If an agency has determined that unusual circumstances apply and more than 5,000 pages are necessary to respond to the request, an agency may charge search fees (or in the case of a requester described under paragraph (l)(1) of this section, duplication fees) if the agency has provided a timely written notice to the requester in accordance with 5 U.S.C. 552(a)(6)(B) and the agency has discussed with the requester via written mail, electronic mail, or telephone (or made not less than 3 good-faith attempts to do so) how the requester could effectively limit the scope of the request in accordance with 5 U.S.C. 552(a)(6)(B)(ii).

(3) If a court has determined that exceptional circumstances exist (as that term is defined in 5 U.S.C. 552(a)(6)(C)), a failure described in 5 U.S.C. 552(a)(6)(B) shall be excused for the length of time provided by the court order.

Dated: January 18, 2017. Nancy M. Ware, Director.
[FR Doc. 2017-01602 Filed 3-13-17; 8:45 am] BILLING CODE 3129-04-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 170207156-7225-01] RIN 0648-XF219 Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Adjustment of Georges Bank and Southern New England/Mid-Atlantic Yellowtail Flounder Annual Catch Limits AGENCY:

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

ACTION:

Temporary rule; adjustment of annual catch limits.

SUMMARY:

This action transfers unused quota of Georges Bank and Southern New England/Mid-Atlantic yellowtail flounder from the Atlantic scallop fishery to the Northeast multispecies fishery for the remainder of the 2016 fishing year, which ends on April 30, 2017. This quota transfer is justified when the scallop fishery is not expected to catch its entire allocations of yellowtail flounder. The quota transfer is intended to provide additional fishing opportunities for groundfish vessels to help achieve the optimum yield for these stocks while ensuring sufficient amounts of yellowtail flounder are available for the scallop fishery.

DATES:

Effective March 13, 2017, through April 30, 2017.

FOR FURTHER INFORMATION CONTACT:

Emily Keiley, Fishery Management Specialist, (978) 281-9116.

SUPPLEMENTARY INFORMATION:

NMFS is required to estimate the total amount of yellowtail flounder catch from the scallop fishery on or around January 15 each year. If the scallop fishery is expected to catch less than 90 percent of its Georges Bank (GB) or Southern New England/Mid-Atlantic (SNE/MA) yellowtail flounder sub-ACL, the Regional Administrator (RA) has the authority to reduce the scallop fishery sub-annual catch limit (sub-ACL) for these stocks to the amount projected to be caught, and increase the groundfish fishery sub-ACL for these stocks up to the amount reduced from the scallop fishery. This adjustment is intended to help achieve optimum yield for these stocks, while not threatening an overage of the ACLs for the stocks by the groundfish and scallop fisheries.

Based on the most current available data, we project that the scallop fishery will have unused quota in the 2016 fishing year. The scallop fishery is projected to catch approximately 2 mt of GB yellowtail flounder, or 5 percent of its 2016 fishing year sub-ACL, and approximately 17 mt of SNE/MA yellowtail flounder, or 53 percent of its 2016 fishing year sub-ACL. Because the scallop fishery is not expected to catch its entire allocation of GB and SNE/MA yellowtail flounder, this rule reduces the scallop sub-ACL for both stocks to the upper limit projected to be caught, and increases the groundfish sub-ACLs for these stocks by the same amount, effective March 13, 2017, through April 30, 2017. This transfer is based on the upper limit of expected yellowtail flounder catch by the scallop fishery, which is expected to minimize any risk of an ACL overage by the scallop fishery while still providing additional fishing opportunities for groundfish vessels.

Table 1 summarizes the revisions to the 2016 fishing year sub-ACLs, and Table 2 shows the revised allocations for the groundfish fishery as allocated between the sectors and common pool based on final sector membership for fishing year 2016.

Table 1—Georges Bank and Southern New England/Mid-Atlantic Yellowtail Flounder Sub-ACLs Stock Fishery Initial
  • sub-ACL
  • (mt)
  • Revised
  • sub-ACL
  • (mt)
  • Change
  • (mt)
  • Percent
  • change
  • GB Yellowtail Flounder Groundfish 211 250.8 +39.8 +19 Scallop 42 2.2 −39.8 −95 SNE/MA Yellowtail Flounder Groundfish 189 204.2 +15.2 +8 Scallop 32 16.8 −15.2 −48
    Table 2—Allocations for Sectors and the Common Pool [In pounds] Sector name GB yellowtail flounder Revised Original SNE/MA yellowtail flounder Revised Original Fixed Gear Sector/FGS 78 66 1,664 1,540 Maine Coast Community Sector 20 17 3,460 3,203 Maine Permit Bank 76 64 143 132 Northeast Coastal Communities Sector 4,620 3,887 3,238 2,997 North East Fishery Sector (NEFS) 1 NEFS 2 10,312 8,675 7,779 7,200 NEFS 3 248 209 300 277 NEFS 4 11,951 10,055 10,569 9,783 NEFS 5 7,443 6,262 104,801 97,000 NEFS 6 14,943 12,571 23,697 21,933 NEFS 7 18,865 15,872 11,114 10,287 NEFS 8 58,817 49,483 23,468 21,722 NEFS 9 139,287 117,183 39,219 36,300 NEFS 10 6 5 2,388 2,210 NEFS 11 8 7 79 73 NEFS 12 2 2 47 44 NEFS 13 190,714 160,449 94,545 87,507 New Hampshire Permit Bank 0 0 0 0 Sustainable Harvest Sector 1 6,702 5,639 2,691 2,491 Sustainable Harvest Sector 2 12,216 10,278 10,095 9,344 Sustainable Harvest Sector 3 68,558 57,678 33,573 31,074 Common Pool 8,053 6,775 77,312 71,558 Sector Total 544,866 458,400 372,871 345,116 Groundfish Total 552,919 465,175 450,184 416,674 Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that the management measures implemented in this final rule are necessary for the conservation and management of the Northeast multispecies fishery and consistent with the Magnuson-Stevens Act, and other applicable law.

    This action is authorized by 50 CFR part 648 and is exempt from review under Executive Order 12866.

    The Assistant Administrator for Fisheries finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment for these adjustments because notice and comment would be impracticable and contrary to the public interest. NMFS is required to project GB and SNE/MA yellowtail flounder catch in the scallop fishery on or around January 15 of each year so that projected unused quota can be transferred to the groundfish fishery. The data did not become available until February 8, 2017. There is insufficient time to allow for prior public notice and comment for the transfer of quota for these yellowtail flounder if the transfer is to be of benefit to the groundfish fishery. The Northeast multispecies fishing year ends on April 30, 2017. If NMFS allowed for the time necessary to provide for prior notice and comment, it would be unlikely that the transfer would occur in time to allow groundfish vessels to harvest the additional quota of these stocks before the end of the fishing year. As a result, groundfish fishermen would not receive additional allocation that is intended to offset their current negative economic circumstances due to the severe decreases in ACLs of several important groundfish stocks. Giving effect to this rule as soon as possible will help relieve fishermen from more restrictive ACLs for the yellowtail stocks and help achieve optimum yield in the fishery. For these same reasons, the NMFS Assistant Administrator also finds good cause pursuant to 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness for this action. Further, there is no need to allow the industry additional time to adjust to this rule because it does not require any compliance or other action on the part of individual scallop or groundfish fishermen.

    Because notice and opportunity for comment are not required pursuant to 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are inapplicable. Therefore, a regulatory flexibility analysis is not required and one has not been prepared.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: March 9, 2017. Alan D. Risenhoover, Acting Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
    [FR Doc. 2017-04959 Filed 3-13-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 160301164-6694-02] RIN 0648-XF260 Fisheries of the Northeastern United States; Northeast Skate Complex; Adjustment to the Skate Wing and Skate Bait Inseason Possession Limits AGENCY:

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

    ACTION:

    Temporary rule; inseason adjustments.

    SUMMARY:

    We are adjusting the commercial per-trip possession limits for the skate wing and skate bait fisheries for the remainder of the 2016 fishing year, through April 30, 2017, based on revised projection. These possession limit adjustments are necessary to allow fishermen the opportunity to fully harvest the remaining skate wing and skate bait annual commercial quotas. This announcement informs the public that the skate wing and skate bait possession limits have been increased.

    DATES:

    Effective March 15, 2017, through April 30, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Reid Lichwell, Fishery Management Specialist, 978-281-9112.

    SUPPLEMENTARY INFORMATION:

    Background

    The skate wing and skate bait fisheries are managed primarily through the Northeast Skate Complex Fishery Management Plan. On January 30, 2017, we reduced the commercial skate wing possession limit from 4,100 lb (1,860 kg) of skate wings [9,307 lb (4,222 kg) whole weight] to the incidental possession limit of 500 lb (227 kg) of skate wings [1,135 lb (515 kg) whole weight] per trip and reduced the skate bait possession limit from 25,000 lb (11,340 kg) to 1,135 lb (515 kg) (whole weight) per trip, equivalent to the skate wing limit, for the remainder of the fishing year. The NMFS Greater Atlantic Regional Administrator is authorized to reduce the skate wing possession limit and required to reduce the skate bait possession limit when landings reached 85 and 90 percent, respectively, of their annual total allowable landings (TAL). There is an exception, however, if the reduction is expected to prevent the attainment of the TAL. The regulations describing the process to adjust inseason commercial possession limits of skate wings and skate bait are described at 50 CFR 648.322(b) and (d).

    Based on landings data reported through February 21, 2017, our revised projections indicate that under the current possession limits, the skate wing and skate bait fisheries will only harvest 90 percent and 95 percent, respectively, of the annual TAL before the end of the fishing year. Because the annual TAL would not be fully utilized under the current possession limits, we are authorized to adjust the possession limits in accordance with the regulations to allow the attainment of the TAL. Revised projections indicate that if the possession limit for skate wings was increased from 500 lb (227 kg) back to the seasonal 4,100 lb (1,860 kg) of skate wings per trip [which would also, by regulation, increase the skate bait limit to 9,307 lb (4,222 lb), whole weight, per trip], these fisheries could operate at these higher possession limits for approximately 45 days before the end of the fishing year without exceeded the annual quota. Increasing the possession limits on March 15, 2017, until the end of the fishing year (April 30, 2017) would allow the annual TAL to be fully utilized while limiting the possibility of exceeding it.

    Inseason Action

    This action increases the commercial skate wing possession limit from 500 lb (227 kg) of skate wings [1,135 lb (515 kg) whole weight] to 4,100 lb (1,860 kg) of skate wings [9,307 lb (4,222 kg) whole weight] per trip. We also are increasing the skate bait possession limit from 1,135 lb (515 kg) to 9,307 lb (4,222 kg) (whole weight) per trip; the whole weight equivalent of the skate wing possession limit. The annual TAL for both the skate wing and skate bait fisheries is divided into seasonal quota periods in which landings are applied to each quota to evaluate the need for possession limit adjustments. We are currently in skate wing season 2 (September 1, 2016, through April 30, 2017) and skate bait season 3 (November 1, 2016, through April 30, 2017). These are the final skate seasons of the 2016 fishing year, providing us with cumulative annual landings data which allow us to project when the annual TAL would be harvested. We anticipate that implementing these inseason adjustments will allow an opportunity for both fisheries to harvest the annual TAL while reducing the possibility of exceeding it. Beginning March 15, 2017, no person may possess on board or land more than 9,307 lb (4,222 kg) of whole weight skate per trip for the remainder of the 2016 fishing year.

    On May 1, 2017, the commercial skate wing possession limit will revert to the skate wing season 1 (May 1, 2017, to August 31, 2017) possession limit of 2,600 lb (1,179 kg) of skate wing [5,902 lb (2,677 kg) whole weight] per trip, and the commercial skate bait possession limit will increase to 25,000 lb (11,340 kg) per trip until a possession limit adjustment is warranted.

    Classification

    This action is taken under 50 CFR part 648 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: March 7, 2017. Karen H. Abrams, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-04934 Filed 3-9-17; 4:15 pm] BILLING CODE 3510-22-P
    82 48 Tuesday, March 14, 2017 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-9143; Directorate Identifier 2013-SW-037-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Helicopters AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for Airbus Helicopters Model EC225LP helicopters. This proposed AD would require modifying the emergency lubrication system (EMLUB). This proposed AD is prompted by two incidents of emergency ditching after there was a warning of a loss of oil pressure and a false EMLUB failure. The proposed actions are intended to address an unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by May 15, 2017.

    ADDRESSES:

    You may send comments by any of the following methods:

    Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your comments electronically.

    Fax: 202-493-2251.

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

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

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9143; or in person at the Docket Operations Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the European Aviation Safety Agency (EASA) AD, the economic 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 service information identified in this proposed AD, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at http://www.airbushelicopters.com/techpub.

    You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, Texas 76177.

    FOR FURTHER INFORMATION CONTACT:

    Rao Edupuganti, Aviation Safety Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy., Fort Worth, Texas 76177; telephone (817) 222-5110; email [email protected]

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.

    We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.

    Discussion

    EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD No. 2013-0156, dated July 18, 2013, to correct an unsafe condition for Airbus Helicopters (formerly Eurocopter) Model EC225LP helicopters. EASA advises of two incidents of emergency ditching in the North Sea after a warning indication of MGB loss of oil pressure and subsequent additional red alarm on the EMLUB. In both cases, the EMLUB provided a false failure indication. EASA states in its AD that the EMLUB system was designed to guarantee 30 minutes of continued safe flight in the event of total loss of the dual oil lubrication system of the MGB.

    According to EASA, an investigation revealed that a design nonconformity on the electrical outputs of some EMLUB air and glycol pressure-switches, resulting in a connection inconsistency between the pressure switches' electrical pins and the helicopter wiring, caused the false EMLUB warnings. EASA states that a false red EMLUB warning during an MGB emergency lubrication system operation could cause the flight crew to perform an immediate landing or ditching. As a result, EASA required several modifications that restore safe operation of the EMLUB system for the full Model EC225LP flight envelope. Modifications, include installing a new glycol pump and new air and glycol pressure switches, wiring harness modifications, and installing an improved EMLUB electronic board. The EASA AD also specifies a new amendment to the Rotorcraft Flight Manual (RFM) emergency procedures and prohibits installing some EMLUB parts.

    FAA's Determination

    These helicopters have been approved by the aviation authority of France and are approved for operation in the United States. Pursuant to our bilateral agreement with France, EASA, its technical representative, has notified us of the unsafe condition described in its AD. We are proposing this AD because we evaluated all known relevant information and determined that an unsafe condition is likely to exist or develop on other products of the same type design.

    Related Service Information Under 1 CFR Part 51

    We reviewed Eurocopter (now Airbus Helicopters) Alert Service Bulletin (ASB) No. EC225-05A033, Revision 0, dated July 14, 2013, for Model EC225LP helicopters. This ASB specifies replacing the air and glycol pressure switches, modifying the helicopter wiring, replacing the glycol pump, replacing the MGB lubrication card, modifying the RFM emergency procedures in the event of EMLUB activation, and canceling the RFM limitations of Emergency ASB (EASB) No. 04A010, Revision 1, dated July 14, 2013.

    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.

    Other Related Service Information

    We reviewed the following Eurocopter (now Airbus Helicopters) EASBs, each dated July 14, 2013:

    • EASB, Revision 1, with two different numbers: No. 04A010 for Model EC225LP helicopters and No. 04A009 for military Model EC725AP helicopters, which are not FAA type certificated. This EASB specifies modifying the RFM emergency procedures in the event of activation of the EMLUB system and applies only to those helicopters that have not been altered by certain modifications.

    • EASB No. 05A032, Revision 2, for both Model EC225LP and military Model EC725AP helicopters. This EASB specifies checking that the EMLUB electrical system (harness, control, alarm, and indicator panel) operates correctly and applies only to those helicopters that have not been altered by certain modifications (the same as those for EASB No. 04A010 and No. 04A009).

    Proposed AD Requirements

    This proposed AD would require, within 500 hours time-in-service:

    • Replacing the EMLUB glycol pump.

    • Replacing the air and glycol pressure switches with switches from the same manufacturer.

    • Modifying and re-identifying the helicopter wiring harness.

    • Replacing the MGB lubrication card.

    • Testing the function of the EMLUB system and the electrical system.

    • Revising the Emergency Procedures section of the RFM.

    The proposed AD would also prohibit installing on any helicopter an EMLUB glycol pump part number (P/N) 332A32-5051-00, air pressure-switch P/N MA193-00 or P/N MC7014-0-00, glycol pressure-switch P/N MA194-01 or P/N MC7015-0-00, or an electronic board P/N 704A46580106 or P/N 704A46580127.

    Costs of Compliance

    We estimate that this proposed AD would affect 4 helicopters of U.S. Registry.

    We estimate that operators may incur the following costs to comply with this AD:

    The estimated labor cost is $85 per work hour. We estimate a total of 34 work hours to replace the air and glycol pressure switches, modify the helicopter wiring, replace the glycol pump, and replace the MGB lubrication card. The required parts would cost $121,695 per helicopter. Based on these estimates, the total cost would be $124,585 per helicopter and $498,340 for the U.S. fleet.

    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, 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 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.

    We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

    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 Helicopters (Formerly Eurocopter France): Docket No. FAA-2016-9143; Directorate Identifier 2013-SW-037-AD. (a) Applicability

    This AD applies to Model EC225LP helicopters, certificated in any category.

    (b) Unsafe Condition

    This AD defines the unsafe condition as a false emergency lubrication system (EMLUB) warning. This condition when associated with a loss of the main gearbox (MGB) oil pressure could result in an unnecessary emergency landing or ditching.

    (c) Comments Due Date

    We must receive comments by May 15, 2017.

    (d) Compliance

    You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.

    (e) Required Actions

    (1) Within 500 hours time-in-service:

    (i) Replace EMLUB glycol pump part number (P/N) 332A32-5051-00 with EMLUB glycol pump P/N 332A32-5043-00.

    (ii) Replace EMLUB air pressure switch P/N MA193-00 or MC7014-0-00 with P/N MC7014-1-00, and replace EMLUB glycol pressure switch P/N MA194-01 or MC7015-0-00 with P/N MC7015-1-00. P/N MC7014-1-00 and P/N MC7015-1-00 must be from the same manufacturer.

    (iii) Modify and re-identify the helicopter wiring harness. Refer to Figure 3 of Eurocopter Alert Service Bulletin No. EC225-05A033, Revision 0, dated July 14, 2013 (ASB EC225-05A033).

    (iv) Replace MGB lubrication card P/N 704A46580127 with P/N 704A46580146, and MGB lubrication card P/N 704A46580106 with P/N 704A46580146 or -147.

    (v) Accomplish a functional test of the EMLUB system and the electrical system.

    (vi) Revise the Emergency Procedures section of the Rotorcraft Flight Manual (RFM) by removing any pages from Section 3 of the RFM that pertain to the emergency procedures in the event of EMLUB activation and by inserting the pages from paragraph 4.C. Appendix 3, of ASB EC225-05A033 into Section 3 of the RFM.

    (2) Do not install on any helicopter EMLUB glycol pump P/N 332A32-5051-00, air pressure-switch P/N MA193-00 or P/N MC7014-0-00, glycol pressure-switch P/N MA194-01 or P/N MC7015-0-00, or electronic board P/N 704A46580106 or P/N 704A46580127.

    (f) Special Flight Permit

    Special flight permits are prohibited.

    (g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to Rao Edupuganti, Aviation Safety Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy., Fort Worth, Texas 76177; telephone (817) 222-5110; email [email protected]ov.

    (2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office before operating any aircraft complying with this AD through an AMOC.

    (h) Additional Information

    (1) Emergency Alert Service Bulletin (ASB) No.05A032, Revision 2, dated July 14, 2013, and Emergency ASB with two numbers (No. 04A010 and No. 04A009), Revision 1, dated July 14, 2013, which are not incorporated by reference, contain additional information about the subject of this AD. For service information identified in this AD, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at http://www.airbushelicopters.com/techpub. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, Texas 76177.

    (2) The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD 2013-0156, dated July 18, 2013. You may view the EASA AD on the Internet at http://www.regulations.gov in Docket No. FAA-2016-9143.

    (i) Subject

    Joint Aircraft Service Component (JASC) Code: 6320, Main Rotor Gearbox.

    Issued in Fort Worth, Texas, on March 1, 2017. Scott A. Horn, Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
    [FR Doc. 2017-04736 Filed 3-13-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-4007; Directorate Identifier 2015-SW-064-AD] RIN 2120-AA64 Airworthiness Directives; Various Model 234 and Model CH-47D Helicopters AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for various Model 234 and Model CH-47D helicopters. This proposed AD would require inspections of the pitch housing and revising the pitch housing retirement life. This proposed AD is prompted by reports of cracking in the pitch housing lugs. The proposed actions are intended to detect and prevent an unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by May 15, 2017.

    ADDRESSES:

    You may send comments by any of the following methods:

    Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your comments electronically.

    Fax: 202-493-2251.

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

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

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-4007; or in person at the Docket Operations Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the economic evaluation, the Special Airworthiness Information Bulletin (SAIB), 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 service information identified in this proposed AD, contact Boeing Helicopters, The Boeing Company, 1 S. Stewart Avenue, Ridley Park, PA 19078, telephone 610-591-2121, and Columbia Helicopters, Inc. (Columbia), 14452 Arndt Road NE., Aurora OR 97002, telephone (503) 678-1222, fax (503) 678-5841, or at http://www.colheli.com. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

    FOR FURTHER INFORMATION CONTACT:

    Kathleen Arrigotti, Aerospace Engineer, Seattle Aircraft Certification Office, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington 98057; telephone (425) 917-6426; email [email protected]

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.

    We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.

    Discussion

    We propose to adopt an AD for helicopters with a pitch housing part number (P/N) 145R2075-11, 145R2075-12, 145R2075-13, 145R2075-14, 145R2075-15, 145R2075-16, 234R2075-1, or 234R2075-2 installed. These pitch housings are installed on Model 234 and Model CH-47D helicopters. The type certificate (TC) holder for Model 234 helicopters is Columbia (type certificate previously held by Boeing Defense & Space Group), and the type certificate holders for Model CH-47D helicopters currently include Columbia, Billings Flying Service, Inc., and Tandem Rotor, LLC. We are not limiting this proposed AD to the type certificate holders listed above because we expect additional type certificate holders of helicopters that are subject to this same unsafe condition.

    This proposed AD is prompted by reports of cracking in the pitch housing lugs. In November 2007, Boeing reported the failure of an aft rotor pitch housing lower lug on a Model CH-47 helicopter operated by the Japanese Ground Self Defense Force. On March 26, 2009, a Model 234 helicopter also experienced a failure because of a crack on an aft rotor pitch housing lower lug. In both cases, the cracking was located on the lead side of the lower vertical pin lug and had initiated in the bore. The crack grew outward by fatigue, initiated by fretting damage.

    Those incidents prompted the FAA to issue SAIB SW-11-03, dated October 22, 2010. The SAIB recommends that all owners and operators of Columbia Model 234 helicopters perform repetitive ultrasonic inspections of the lugs. At that time, there were no civil Model CH-47D helicopters in service.

    On March 20, 2015, we received a report of lateral vibration on a Model 234 helicopter that prompted an immediate landing. A subsequent investigation found that a crack in an aft pitch housing upper lug resulted in the lateral vibrations. The pitch housing had accumulated 11,733 hours time-in-service (TIS). The crack was determined to be caused by fatigue and attributed to underestimated load conditions in the original life limit calculations. This cracking differed from the cracking described in the SAIB because the cracking initiated at the outer surface of the pitch housing lug and grew inward toward the bore.

    To correct this unsafe condition, we propose to require repetitive eddy current and ultrasonic inspections of the pitch housing. Based on the proximity of the most recent inward-growing crack to the outward cracks described in the SAIB, we propose to require ultrasonic inspections of the pitch housing, as recommended in the SAIB. Boeing, the original manufacturer of both model helicopters, developed service information for the SAIB ultrasonic inspections, which we would require in this proposed AD. Due to the rapid growth rate, an effective eddy current inspection must detect an inward-growing crack of no more than 0.10 inch. This proposed AD would require, for Columbia helicopters, the eddy current inspection method specified in Columbia's service information. Because the other TC holders have not developed service instructions, we propose to require the eddy current inspection procedures for all other helicopters be submitted to the Seattle or Denver Aircraft Certification Offices for approval.

    We are also proposing to require removing the pitch housing from service when it accumulates a total of 8,200 hours TIS. Forward pitch housings on Model CH-47D helicopters have no life limit and the aft pitch housing already has a life limit of 8,200 hours TIS. For Model 234 helicopters, the forward pitch housing has a life limit of 12,547 hours TIS and the aft pitch housing has a life limit of 19,077 hours TIS. This proposed AD would establish or reduce these life limits to 8,200 hours TIS for both forward and aft pitch housings, regardless of the model helicopter.

    The actions specified by this proposed AD are intended to detect and prevent a crack in a pitch housing lug. This condition could result in loss of a rotor blade and consequent loss of helicopter control.

    FAA's Determination

    We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Service Bulletin 145R2075-62-0001, Revision 1, dated September 27, 2011, which specifies updated life limits for the forward and aft pitch housings and revised overhaul and ultrasonic inspection procedures for various military Model CH-47 and 234 helicopters.

    We also reviewed Columbia Helicopters, Inc., Alert Service Bulletin No. 234-62-A0012, Revision 2, dated March 1, 2016, for Model 234 helicopters; and Alert Service Bulletin No. 47D-62-A0002, Revision 0, dated March 1, 2016, for Model CH-47D helicopters. This service information specifies procedures for performing repetitive eddy current inspections, visual inspections, and ultrasonic inspections and for reducing the life limit of the pitch housing assemblies.

    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.

    Proposed AD Requirements

    This proposed AD would require:

    Before further flight, removing from service any pitch housing P/N 145R2075-11, 145R2075-12, 145R2075-13, 145R2075-14, 145R2075-15, 145R2075-16, 234R2075-1, and 234R2075-2 that has accumulated 8,200 hours total time-in-service (TIS).

    Before the pitch housing accumulates 200 hours TIS after the effective date of this proposed AD and thereafter at intervals not to exceed 200 hours TIS, ultrasonic inspecting the pitch housing for a crack and replacing any cracked pitch housing. Within 400 hours TIS or before the pitch housing accumulates 4,000 hours total TIS, whichever occurs later, and thereafter at intervals not to exceed 500 hours TIS, eddy current inspecting the pitch housing for a crack and replacing any cracked pitch housing.

    For Columbia helicopters, this eddy current inspection would be performed in accordance with the Columbia service information. For all other helicopters, this proposed AD would require that the method for the eddy current inspection be approved by the Manager, Seattle Aircraft Certification Office (ACO) or Manager, Denver ACO.

    Differences Between This Proposed AD and the Service Information

    The service information provides different life limits for the forward and aft pitch housings, while this proposed AD would require a life limit of 8,200 hours TIS for all pitch housings. The service information requires either an ultrasonic inspection or a dye penetrant inspection as part of the overhaul procedures. The service information specifies different compliance times for the inspections than what would be required by this proposed AD.

    Costs of Compliance

    We estimate that this proposed AD would affect 15 helicopters of U.S. Registry and that labor costs would average $85 per work-hour. Based on these estimates, we expect the following costs:

    • An eddy current inspection would require 4 work-hours for a total cost of $340 per helicopter and $5,100 for the U.S. fleet, per inspection cycle.

    • An ultrasonic inspection would require 4 work-hours for a total cost of $340 per helicopter and $5,100 for the U.S. fleet, per inspection cycle.

    • Replacing a pitch housing would require 8 work-hours and parts would cost $13,000, for a total cost of $13,680 per helicopter.

    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, I certify that this proposed AD:

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

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

    3. Will not affect intrastate aviation in Alaska 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.

    We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

    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): Various Model 234 and Model CH-47D Helicopters: Docket No. FAA-2015-4007; Directorate Identifier 2015-SW-64-AD. (a) Applicability

    This AD applies to Model 234 and Model CH-47D helicopters, regardless of type certificate holder, with a pitch housing assembly (pitch housing) part number (P/N) 145R2075-11, 145R2075-12, 145R2075-13, 145R2075-14, 145R2075-15, 145R2075-16, 234R2075-1, or 234R2075-2 installed, certificated in any category.

    (b) Unsafe Condition

    This AD defines the unsafe condition as a crack in a pitch housing lug. This condition could result in loss of a rotor blade and consequent loss of helicopter control.

    (c) Comments Due Date

    We must receive comments by May 15, 2017.

    (d) Compliance

    You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.

    (e) Required Actions

    (1) Before further flight, remove from service any pitch housing P/N 145R2075-11, 145R2075-12, 145R2075-13, 145R2075-14, 145R2075-15, 145R2075-16, 234R2075-1, and 234R2075-2 that has accumulated 8,200 hours total time-in-service (TIS).

    (2) Before the pitch housing accumulates 200 hours TIS after the effective date of this AD and thereafter at intervals not to exceed 200 hours TIS, ultrasonic inspect the pitch housing for a crack in accordance with Attachment 1, paragraphs F and H through K, of Boeing Service Bulletin 145R2075-62-0001, Revision 1, dated September 27, 2011. If there is a crack, replace the pitch housing before further flight.

    (3) Within 400 hours TIS or before the pitch housing has accumulated 4,000 hours total TIS, whichever occurs later, and thereafter at intervals not to exceed 500 hours TIS:

    (i) For Columbia Helicopters, Inc., Model 234 and CH-47D helicopters, eddy current inspect the pitch housing for a crack by following paragraphs 3.C.(1) and 3.C.(2) of Columbia Helicopters, Inc., Alert Service Bulletin No. 234-62-A0012, Revision 2, dated March 1, 2016, or Alert Service Bulletin No. 47D-62-A0002, Revision 0, dated March 1, 2016, as applicable to your model helicopter. If there is a crack, replace the pitch housing before further flight.

    (ii) For all other helicopters, eddy current inspect the pitch housing for a crack. If there is a crack, replace the pitch housing before further flight. The eddy current inspection must be accomplished using a method approved by the Manager, Seattle Aircraft Certification Office (ACO) or Manager, Denver ACO. For a repair method to be approved as required by this AD, the Manager's approval letter must specifically refer to this AD.

    (f) Alternative Methods of Compliance (AMOCs)

    (1) For operators of helicopters with type certificates issued by the Denver Aircraft Certification Office, the manager of the Denver Aircraft Certification Office, FAA, may approve AMOCs for this AD. Send your proposal to: Greg Johnson, Senior Aerospace Engineer, Denver Aircraft Certification Office, 26805 East 68th Avenue, Denver, CO 80249; phone: 303-342-1083; fax: 303-342-1088; email: [email protected]

    (2) All other AMOC requests should be sent to the Manager, Seattle Aircraft Certification Office, FAA. Send your proposal to: Kathleen Arrigotti, Aerospace Engineer, Seattle Aircraft Certification Office, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington 98057; telephone (425) 917-6426; email [email protected]

    (3) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office before operating any aircraft complying with this AD through an AMOC.

    (g) Additional Information

    Special Airworthiness Information Bulletin SW-11-03, dated October 22, 2010 (SAIB), which is not incorporated by reference, contains additional information about the subject of this AD. You may view the SAIB on the internet at http://www.regulations.gov in the AD Docket.

    (h) Subject

    Joint Aircraft Service Component (JASC) Code: 6220, Main Rotor Head.

    Issued in Fort Worth, Texas, on March 1, 2017. Scott A. Horn, Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
    [FR Doc. 2017-04735 Filed 3-13-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-0021; Directorate Identifier 2017-NE-01-AD] RIN 2120-AA64 Airworthiness Directives; International Aero Engines AG Turbofan Engines AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain International Aero Engines AG (IAE) V2522-A5, V2524-A5, V2527-A5, V2527E-A5, V2527M-A5, V2530-A5, V2533-A5, V2525-D5, V2528-D5, and V2531-E5 turbofan engines. This proposed AD was prompted following a self-disclosure by IAE regarding manufacturing quality escapes. This proposed AD would require replacing the affected and suspect parts within the time limits specified in the compliance section. We are proposing this AD to correct the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by April 28, 2017.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact International Aero Engines AG, 400 Main Street, East Hartford, CT 06118; phone: 860-565-0140; email: [email protected]; Internet: http://fleetcare.pw.utc.com. 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-2017-0021; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Brian Kierstead, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7772; fax: 781-238-7199; email: [email protected]

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this NPRM. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-0021; Directorate Identifier 2017-NE-01-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

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

    Discussion

    IAE self-disclosed several quality escapes that had occurred during manufacture of high-pressure turbine (HPT) stage 2 air seals, HPT 1st stage air seals, and/or HPT stage 2 ring plates, at the Pratt and Whitney Chengdu facility. The quality escapes are associated with P&W's manufacturing source approval requirement, which includes reporting of tool breaks on life-limited parts. A number of documented and undocumented occurences of tool breaks were experienced during machining, which could affect the low-cycle fatigue capability of the suspect parts. In addition, several manufactured life-limited parts without logbooks are also suspected of experiencing occurences of a tool break. This proposed AD would require replacing the affected parts within the time limits specified in the compliance section. This condition, if not corrected, could result in failure of high-energy, rotating hardware, uncontained part release, damage to the engine, and damage to the airplane.

    Related Service Information Under 1 CFR Part 51

    We reviewed International Aero Engines, IAE Non-Modification Service Bulletin (NMSB) V2500-ENG-72-0676, dated October 14, 2016; IAE NMSB V2500-ENG-72-0677, Revision 1, dated January 11, 2017; IAE NMSB V2500-ENG-72-0682, dated December 2, 2016; IAE NMSB V2500-ENG-72-0681, Revision 2, dated January 9, 2017; and IAE NMSB V2500-ENG-72-0678, Revision 1, dated January 5, 2017. Each of the NMSBs describes procedures for replacing a different affected part. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination

    We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs.

    Proposed AD Requirements

    This proposed AD would require replacing the affected parts within the time limits specified in the compliance section.

    Costs of Compliance

    We estimate that this proposed AD affects 70 engines installed on 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
  • Removal of HPT stage 2 air seal (cycle limited) $0 $154,119.00 $154,119.00 $308,238.00 Removal of HPT 1st stage air seal (cycle limited) 0 87,503.00 87,503.00 175,006.00 Removal of HPT stage 2 ring plate (cycle limited) 0 56,207.00 56,207.00 112,414.00 Removal of HPT stage 2 ring plate (piece-part) 0 31,403.00 31,403.00 2,041,195.00

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

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    (3) Will not affect intrastate aviation in Alaska, and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [ [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): International Aero Engines AG: Docket No. FAA-2017-0021; Directorate Identifier 2017-NE-01-AD. (a) Comments Due Date

    We must receive comments by April 28, 2017.

    (b) Affected ADs

    None.

    (c) Applicability

    (1) This AD applies to International Aero Engines (IAE) V2522-A5, V2524-A5, V2527-A5, V2527E-A5, V2527M-A5, V2530-A5, V2533-A5, V2525-D5, V2528-D5, and V2531-E5 turbofan engines with one or more of the following installed:

    (i) High-pressure turbine (HPT) stage 2 air seal, part number (P/N) 2A4157, with a serial number (S/N) listed in Table 1 of IAE Non-Modification Service Bulletin (NMSB) V2500-ENG-72-0676, dated October 14, 2016.

    (ii) HPT 1st stage air seal, P/N 2A3423, with an S/N listed in Table 1 of IAE NMSB V2500-ENG-72-0677 Revision 1, dated January 11, 2017; or IAE NMSB V2500-ENG-72-0678, Revision 1, dated January 5, 2017.

    (iii) HPT stage 2 ring plate, P/N 2A3437, with an S/N listed in Table 1 of IAE NMSB V2500-ENG-72-0682, dated December 2, 2016; or IAE NMSB V2500-ENG-72-0681, Revision 2, dated January 9, 2017.

    (2) Reserved.

    (d) Subject

    Joint Aircraft System Component (JASC) Code 7250, Turbine Engine.

    (e) Unsafe Condition

    This AD was prompted by several reports by IAE of quality escapes during manufacture of HPT stage 2 air seals, HPT 1st stage air seals, and/or HPT stage 2 ring plates, at the Pratt and Whitney Chengdu facility. We are issuing this AD to prevent failure of high-energy, rotating hardware, uncontained part release, damage to the engine, and damage to the airplane.

    (f) Compliance

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

    (g) Required Actions

    (1) Remove the following hardware from service before reaching the specified part cycles since new listed in the service instructions in paragraphs (g)(1)(i) through (iii) of this AD, or within 50 cycles in service after the effective date of this AD, whichever occurs later, and replace with a part eligible for installation:

    (i) HPT stage 2 air seal, P/N 2A4157, identified in Table 1 of IAE NMSB V2500-ENG-72-0676, dated October 14, 2016.

    (ii) HPT 1st stage air seal, P/N 2A3423, identified in Table 1 of IAE NMSB V2500-ENG-72-0677, Revision 1, dated January 11, 2017.

    (iii) HPT stage 2 ring plate, P/N 2A3437, identified in Table 1 of IAE NMSB V2500-ENG-72-0682, dated December 2, 2016.

    (2) After the effective date of this AD, remove the following hardware from service when the HPT module is disassembled and access to the part is available and replace with a part eligible for installation;

    (i) HPT 1st stage air seal, P/N 2A3423, identified in Accomplishment Instructions, Table 1, of IAE NMSB V2500-ENG-72-0678, Revision 1, dated January 5, 2017.

    (ii) HPT stage 2 ring plate, P/N 2A3437, identified in Accomplishment Instructions, Table 1, of IAE NMSB V2500-ENG-72-0681, Revision 2, dated January 9, 2017.

    (h) 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]

    (i) Related Information

    (1) For more information about this AD, contact Brian Kierstead, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7772; fax: 781-238-7199; email: [email protected]

    (2) For service information identified in this AD, contact International Aero Engines AG, 400 Main Street, East Hartford, CT 06118; phone: 860-565-0140; email: [email protected]; Internet: http://fleetcare.pw.utc.com.

    (3) 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.

    Issued in Burlington, Massachusetts, on March 2, 2017. Thomas A. Boudreau, Acting Manager, Engine & Propeller Directorate, Aircraft Certification Service.
    [FR Doc. 2017-04957 Filed 3-13-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Office of the Secretary 14 CFR Part 399 [Docket No. DOT-OST-2017-0007] RIN 2105-AE56 Transparency of Airline Ancillary Service Fees AGENCY:

    Office of the Secretary (OST), U.S. Department of Transportation (DOT).

    ACTION:

    Suspension of comment period.

    SUMMARY:

    The DOT is suspending the public comment period for the supplemental notice of proposed rulemaking (SNPRM) on Transparency of Airline Ancillary Service Fees. The DOT published the SNPRM on January 19, 2017, and the comment period was scheduled to close on March 20, 2017. The suspension of the comment period will allow the President's appointees the opportunity to review and consider this action.

    DATES:

    The comment period for the SNPRM published January 19, 2017 (82 FR 7536) is indefinitely suspended effective March 14, 2017.

    ADDRESSES:

    Docket: For access to the docket to read background documents and comments received, go to http://www.regulations.gov or to the street address listed above. Follow the online instructions for accessing the docket.

    FOR FURTHER INFORMATION CONTACT:

    Kimberly Graber or Blane A. Workie, Office of the Assistant General Counsel for Aviation Enforcement and Proceedings, U.S. Department of Transportation, 1200 New Jersey Ave. SE., Washington, DC 20590, 202-366-9342 (phone), [email protected] or [email protected] (email).

    Issued this 2nd day of March 2017, in Washington, DC. Judith S. Kaleta, Deputy General Counsel.
    [FR Doc. 2017-04674 Filed 3-13-17; 8:45 am] BILLING CODE 4910-9X-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2016-0825] RIN 1625-AA00 Safety Zone; United Illuminating Company Housatonic River Crossing Project; Housatonic River; Milford and Stratford, CT AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to establish a temporary safety zone for certain waters of the Housatonic River. This action is necessary to provide for the safety of life on these navigable waters near Milford and Stratford, CT, during the United Illuminating Company Housatonic River Crossing Project from April 26, 2017 to May 4, 2017, and from July 29, 2017 to August 3, 2017. This proposed rulemaking would prohibit entry of vessels or people into the safety zone unless authorized by the Captain of the Port Long Island Sound or a designated representative. The safety zone will only be enforced during cable pulling operations or other instances which may create a hazard to navigation. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before April 13, 2017.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2016-0825 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this proposed rulemaking, call or email Petty Officer Katherine Linnick, Prevention Department, Coast Guard Sector Long Island Sound, telephone (203) 468-4565, 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 § Section U.S.C. United States Code NAD 83 North American Datum 1983 II. Background, Purpose, and Legal Basis

    This rulemaking proposes to establish a safety zone for certain waters of the Housatonic River near Milford and Stratford, CT. Corresponding regulatory history is discussed below.

    On August 25, 2016, United Illuminating Company notified the Coast Guard that it would conduct a project involving the installation of new transmission conductors over the Housatonic River near Stratford and Milford, CT. On December 13, 2016, the Coast Guard published a temporary final rule entitled, “Safety Zone; United Illuminating Company Housatonic River Crossing Project; Housatonic River, Milford and Stratford, CT” in the Federal Register (81 FR 89862).

    The project is scheduled to be completed in two phases, the first being the stringing of optical fiber ground wires on the North circuit from April 26, 2017 to May 4, 2017. The second phase will include the stringing of optical fiber ground wires on the South circuit from July 29, 2017 to August 3, 2017. The proposed work area is between the eastern and western shores of the Housatonic River from the southern boundary of the Metro-North Rail Bridge. It extends approximately 525 feet upstream for the northern boundary. Potential hazards from this project include entanglement of vessels with the messenger line and falling equipment from the electrical towers. The Captain of the Port Long Island Sound (COTP) has determined that the potential hazards associated with the cable crossing project could be a safety concern for anyone within the proposed work area.

    The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters within the work zone before, during, and after each messenger pulling operation. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to define regulatory safety zones.

    III. Discussion of Proposed Rule

    The COTP proposes to establish a safety zone from 8:00 a.m. on April 26, 2017 through 6:00 p.m. on May 4, 2017, and from 8:00 a.m. on July 29, 2017 through 6:00 p.m. on August 3, 2017. The safety zone will cover all navigable waters of the Housatonic River near Milford and Stratford, CT contained within the following area: Beginning at a point on land in position at 41°12′17″ N., 073°06′40″ W. near the Governor John Davis Lodge Turnpike (I-95) Bridge; then northeast across the Housatonic River to a point on land in position at 41°12′20″ N., 073°06′29″ W. near the Governor John Davis Lodge Turnpike (I-95) Bridge; then northwest along the shoreline to a point on land in position at 41°12′25″ N., 073°06′31″ W.; then southwest across the Housatonic River to a point on land in position at 41°12′22″ N., 073°06′43″ W.; then southeast along the shoreline back to point of origin (NAD 83). All positions are approximate. The duration of the zone is intended to ensure the safety of vessels and these navigable waters within the work zone before, during, and after each messenger pulling operation or during any instance that necessitates a temporary closure of the Housatonic River at the work site. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The safety zone will only be enforced during when project work causes a potential hazard to navigation. The Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 eight hours in advance of any scheduled enforcement period. The regulatory text we are proposing appears at the end of this document.

    IV. Regulatory Analyses

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

    A. Regulatory Planning and Review

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

    This regulatory action determination is based on the size, location, and duration of the safety zone. Vessel traffic would be able to safely transit around this safety zone, which would affect a small designated area of the Housatonic River for less than one hour at a time. It also may be enforced temporarily during the cable crossing project if necessitated by an emergency. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

    B. Impact on Small Entities

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

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

    If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a safety zone enforced for less than one hour at a time that would prohibit entry within the work zone during each messenger pulling operation. It also may be enforced temporarily during the cable-crossing project if necessitated by an emergency, such as equipment falling from the towers into the Housatonic River. Normally such actions are categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. A preliminary environmental analysis checklist is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    G. Protest Activities

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

    V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

    We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

    Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

    List of Subjects in 33 CFR Part 165

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

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

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

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

    2. Add § 165.T01-0825 to read as follows:
    § 165.T01-0825 Safety Zone; United Illuminating Company Housatonic River Crossing Project; Housatonic River; Milford and Stratford, CT.

    (a) Location: The following area is included with this safety zone:

    (1) All navigable waters of the Housatonic River near Milford and Stratford, CT contained within the following area; beginning at a point on land in position at 41°12′17″ N., 073°06′40″ W. near the Governor John Davis Lodge Turnpike (I-95) Bridge; then northeast across the Housatonic River to a point on land in position at 41°12′20″ N., 073°06′29″ W. near the Governor John Davis Lodge Turnpike (I-95) Bridge; then northwest along the shoreline to a point on land in position at 41°12′25″ N., 073°06′31″ W.; then southwest across the Housatonic River to a point on land in position at 41°12′22″ N., 073°06′43″ W.; then southeast along the shoreline back to point of origin (NAD 83).

    (2) All positions are approximate.

    (b) Effective and Enforcement Period: This rule will be effective from 8:00 a.m. on April 26, 2017 to 6:00 p.m. on May 4, 2017, and from 8:00 a.m. on July 29, 2017 to 6:00 p.m. on August 3, 2017. Vessel traffic would be able to safely transit around this safety zone, which would affect a small designated area of the Housatonic River for less than one hour at a time. It also may be enforced temporarily during the cable crossing cable-crossing project if necessitated by an emergency. The Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 eight hours in advance to any scheduled period of enforcement or as soon as practicable in response to an emergency.

    (c) Definitions. The following definitions apply to this section: A “designated representative” is any Coast Guard commissioned, warrant or petty officer of the U.S. Coast Guard who has been designated by the COTP, Sector Long Island Sound, to act on his or her behalf. The designated representative may be on an official patrol vessel or may be on shore and will communicate with vessels via VHF-FM radio or loudhailer. “Official patrol vessels” may consist of any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement vessels assigned or approved by the COTP Sector Long Island Sound. In addition, members of the Coast Guard Auxiliary may be present to inform vessel operators of this regulation. A “work vessel” is any vessel provided by United Illuminating Company for the Housatonic River Crossing Project and may be hailed via VHF channel 13 or 16.

    (d) Regulations. (1) The general regulations contained in 33 CFR 165.23 apply.

    (2) In accordance with the general regulations in 33 CFR 165.23, entry into or movement within this zone is prohibited unless authorized by the Captain of the Port, Long Island Sound.

    (3) Operators of vessels desiring to enter or operate within the safety zone should contact the COTP Sector Long Island Sound at 203-468-4401 (Sector LIS command center), or the designated representative via VHF channel 16 to obtain permission to do so. Request to enter or operate in the safety zone must be made 24 hours in advanced of the planned undertaking.

    (4) Mariners are requested to proceed with caution after passing arrangements have been made. Mariners are requested to cooperate with the United Illuminating Company work vessels for the safety of all concerned. The United Illuminating Company work vessels will be monitoring VHF channels 13 and 16. Mariners are requested to proceed with extreme caution and operate at their slowest safe speed as to not cause a wake.

    (5) Any vessel given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP Sector Long Island Sound, or the designated on-scene representative.

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

    Dated: February 24, 2017. A.E. Tucci, Captain, U.S. Coast Guard, Captain of the Port Sector Long Island Sound.
    [FR Doc. 2017-04978 Filed 3-13-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration 49 CFR Chapter XII [Docket No. TSA-2016-0002] RIN 1652-AA56 Surface Transportation Vulnerability Assessments and Security Plans (VASP); Reopening of Comment Period AGENCY:

    Transportation Security Administration, DHS.

    ACTION:

    Advance notice of proposed rulemaking; reopening of comment period.

    SUMMARY:

    The Transportation Security Administration is reopening the comment period for the advance notice of proposed rulemaking, published in the Federal Register on December 16, 2016, requesting public comments on several topics relevant to the development of surface transportation vulnerability assessment and security plan regulations mandated by the Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act). TSA is reopening the comment period for an additional 60 days due to several requests by commenters in the rulemaking docket.

    DATES:

    The comment period for the proposed rule published in the Federal Register on December 16, 2016 (81 FR 91401) is reopened. Comments must be received by May 15, 2017.

    ADDRESSES:

    You may submit comments, identified by the TSA docket number to this rulemaking, to the Federal Docket Management System (FDMS), a government-wide, electronic docket management system, using any one of the following methods:

    Electronically: You may submit comments through the Federal eRulemaking portal at http://www.regulations.gov. Follow the online instructions for submitting comments.

    Mail, In Person, or Fax: Address, hand-deliver, or fax your written comments to the Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001; fax (202) 493-2251. The Department of Transportation (DOT), which maintains and processes TSA's official regulatory dockets, will scan the submission and post it to FDMS.

    FOR FURTHER INFORMATION CONTACT:

    Harry Schultz (TSA Office of Security Policy and Industry Engagement) or Traci Klemm (TSA Office of the Chief Counsel) at telephone (571) 227-3531 or email to [email protected]

    SUPPLEMENTARY INFORMATION:

    On December 16, 2016, TSA published an advance notice of proposed rulemaking (ANPRM) in the Federal Register (81 FR 91401), requesting public comments on several topics relevant to the development of surface transportation vulnerability assessment and security plan regulations mandated by the Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act). Based on its regular interaction with stakeholders, TSA assumes many higher-risk railroads (freight and passenger), public transportation agencies, and over-the-road buses (OTRBs) have implemented security programs with security measures similar to those identified by the 9/11 Act's regulatory requirements. In general, TSA is requesting information on three types of issues: (1) Existing practices, standards, tools, or other resources used or available for conducting vulnerability assessments and developing security plans; (2) information on existing security measures, including whether implemented voluntarily or in response to other regulatory requirements, and the potential impact of additional requirements on operations; and (3) information on the scope/cost of current security systems and other measures used to provide security and mitigate vulnerabilities. This information is necessary for TSA to establish the current baseline, estimate cost of implementing the statutory mandate, and develop appropriate performance standards.

    The comment period closed on February 14, 2017. TSA received multiple requests to extend the comment period. TSA believes reopening the comment period is necessary to meet the intended purpose of the ANPRM—to obtain information and perspectives from potentially regulated entities. Please see the ANPRM for additional background.

    Dated: March 6, 2017. Huban A. Gowadia, Acting Administrator.
    [FR Doc. 2017-04976 Filed 3-13-17; 8:45 am] BILLING CODE 9110-05-P
    82 48 Tuesday, March 14, 2017 Notices DEPARTMENT OF AGRICULTURE Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY:

    National Institute of Food and Agriculture, USDA.

    ACTION:

    30-Day notice of submission of information collection approval from the Office of Management and Budget and request for comments.

    SUMMARY:

    As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, The National Institute of Food and Agriculture has submitted a Generic Information Collection Request (Generic ICR): “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery ” to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).

    DATES:

    Comments must be submitted April 13, 2017.

    ADDRESSES:

    Written comments may be submitted by any of the following methods: Email: [email protected]; Fax 202-720-0857; Mail: Office of Information Technology (OIT), NIFA, USDA, STOP 2216, 1400 Independence Avenue SW., Washington, DC 20250-2216.

    FOR FURTHER INFORMATION CONTACT:

    To request additional information, please contact Robert Martin, Records Officer, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.

    Abstract: The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.

    Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.

    The Agency received no comments in response to the 60-day notice published in the Federal Register of October 4th, 2016, Vol. 81 FR 192.

    Below we provide the National Institute of Food and Agriculture projected average estimates for the next three years:

    Current Actions: New collection of information.

    Type of Review: New Collection.

    Affected Public: Individuals and Households, Businesses and Organizations, State, Local or Tribal Government.

    Average Expected Annual Number of Activities: 20.

    Respondents: 10,500.

    Annual Responses: 1.

    Frequency of Response: Once per request.

    Average Minutes per Response: .5

    Burden Hours: 17,505.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2017-04946 Filed 3-13-17; 8:45 am] BILLING CODE 3410-09-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request March 9, 2017.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by April 13, 2017 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Food and Nutrition Service

    Title: Supplemental Nutrition Assistance Program (SNAP), State Law Enforcement Bureau (SLEB) Fraud Investigations.

    OMB Control Number: 0584-NEW.

    Summary of Collection: FNS works with State partners to establish State Law Enforcement Bureau (SLEB) agreements to improve program administration and ensure program integrity. Through SLEB agreements, FNS authorizes State agencies to conduct investigations into possible SNAP retailer/electronic benefits transfer (EBT) fraud, and to obtain Electronic Benefits Transfer (EBT) benefits for such law enforcement and investigative activities. These agreements provide State agencies with additional resources to conduct investigations, including, but not limited to, the authorized use of SNAP benefits to carry out covert investigations of retailers, as well as other retailer-related law enforcement techniques. FNS created a form FNS-878, titled SLEB SNAP Fraud Investigation Cost Reconciliation, that records costs associated with SLEB investigations.

    Need and Use of the Information: FNS will use this information for accounting purposes, and to document findings that will help the agency to adequately allocate resources and ensure program integrity.

    Description of Respondents: State, Local or Tribal Government.

    Number of Respondents: 53.

    Frequency of Responses: Reporting: Bi-annually.

    Total Burden Hours: 212.

    Food and Nutrition Service

    Title: The Loving Support Award of Excellence.

    OMB Control Number: 0584-0591.

    Summary of Collection: The Healthy, Hunger-Free Kid Act of 2010 (HHFKA) (Pub. L. 111-296, Sec 231) requires the U.S. Department of Agriculture (USDA) to implement a program to recognize exemplary breastfeeding support practices at Women, Infants, and Children (WIC) local agencies and clinics. The HHFKA requires the USDA to annually compile and publish breastfeeding performance measurements. The breastfeeding performance measurements will be used in the process to determine awardees for the top two level awards.

    Need and Use of the Information: The award application period is open one time, annually, and has been designed to allow local WIC agencies at different stages of progress in breastfeeding support practices to apply for an award. The information collection will meet the HHFKA requirement to implement a program to recognize exemplary breastfeeding support practices at WIC local agencies and clinics and the performance reporting requirements.

    Description of Respondents: State, Local or Tribal Government.

    Number of Respondents: 453.

    Frequency of Responses: Reporting: Annually.

    Total Burden Hours: 1,161.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2017-04971 Filed 3-13-17; 8:45 am] BILLING CODE 3410-30-P
    COMMISSION ON CIVIL RIGHTS Agenda and Notice of Public Meeting of the South Dakota Advisory Committee AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a briefing meeting of the South Dakota Advisory Committee to the Commission will convene at 1:00 p.m. (CDT) on Friday, March 24, 2017, in the Community Room on the 1st Floor of the Aberdeen Public Safety Building, 114 2nd Avenue SE., Aberdeen, SD 57401. The purpose of the briefing meeting is to hear testimony on the subtle effects of racism in South Dakota. The briefing topics will include the value of the use of body-worn cameras in law enforcement, and minority policing that impacts Native Americans and immigrant communities. The South Dakota Advisory Committee will hear from law enforcement, tribal officials, advocacy groups, community organizations, representatives of local, state, and Federal agencies, and the public.

    DATES:

    Friday, March 24, 2017, starting at 1:00 p.m. CST until 6:00 p.m. CST.

    ADDRESSES:

    Aberdeen Public Safety Building, Community Room, 1st Floor, 114 2nd Avenue SE., Aberdeen, SD 57401.

    FOR FURTHER INFORMATION CONTACT:

    Malee Craft at [email protected], or 303-866-1040.

    Time will be set aside at the end of the briefing so that members of the public may address the Committee after the formal presentations have been completed. Persons interested in the issue are also invited to submit written comments; the comments must be received in the regional office by Monday, April 24, 2017. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1050, or emailed to Evelyn Bohor at [email protected] Persons who desire additional information may contact the Rocky Mountain Regional Office at (303) 866-1040.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://database.faca.gov/committee/meetings.aspx?cid=274 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Rocky Mountain Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site, www.usccr.gov, or to contact the Rocky Mountain Regional Office at the above phone number, email or street address. If persons who plan to attend the meeting require accommodations, please contact Evelyn Bohor at [email protected] at the Rocky Mountain Regional Office at least ten (10) working days before the scheduled date of the meeting.

    Agenda Welcome and Introductions Richard Braunstein, Chair, South Dakota Advisory Committee Malee V. Craft, Regional Director, RMRO-USCCR, Denver, CO Briefing, South Dakota Advisory Committee Government and Tribal Officials, Advocates, Experts, Law Enforcement Dated: March 8, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-04912 Filed 3-13-17; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [Order No. 2030] Reorganization of Foreign-Trade Zone 283 (Expansion of Service Area) Under Alternative Site Framework; West Tennessee Area

    Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:

    Whereas, the Board adopted the alternative site framework (ASF) (15 CFR Sec. 400.2(c)) as an option for the establishment or reorganization of zones;

    Whereas, the Northwest Tennessee Regional Port Authority, grantee of Foreign-Trade Zone 283, submitted an application to the Board (FTZ Docket B-53-2016, docketed August 11, 2016) for authority to expand the service area of the zone to include the Counties of Fayette, Hardeman and McNairy as described in the application, adjacent to the Memphis Customs and Border Protection port of entry;

    Whereas, notice inviting public comment was given in the Federal Register (81 FR 54555, August 16, 2016) and the application has been processed pursuant to the FTZ Act and the Board's regulations; and,

    Whereas, the Board adopts the findings and recommendations of the examiner's report, and finds that the requirements of the FTZ Act and the Board's regulations are satisfied;

    Now, therefore, the Board hereby orders:

    The application to reorganize FTZ 283 to expand the service area under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, and to the Board's standard 2,000-acre activation limit for the zone.

    Dated: March 1, 2017. Ronald K. Lorentzen, Acting Assistant Secretary of Commerce for Enforcement and Compliance, Alternate Chairman, Foreign-Trade Zones Board.
    [FR Doc. 2017-04911 Filed 3-13-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-16-2017] Foreign-Trade Zone (FTZ) 7—Mayaguez, Puerto Rico; Notification of Proposed Production Activity; Bristol-Myers Squibb Holdings Pharma, Ltd.; (Pharmaceuticals); Manati, Puerto Rico

    Bristol-Myers Squibb Holdings Pharma, Ltd. (BMS) submitted a notification of proposed production activity to the FTZ Board for its facility in Manati, Puerto Rico within Subzone 7J. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on March 6, 2017.

    BMS already has authority to produce certain pharmaceutical products within Subzone 7J. The current request would add finished products and foreign status materials/components to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status materials/components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

    Production under FTZ procedures could exempt BMS from customs duty payments on the foreign-status materials/components used in export production. On its domestic sales, BMS would be able to choose the duty rates during customs entry procedures that apply to: Antisera; blood fractions; peptides and proteins; Orencia® (and other abatacept-containing products); Opdivo® (and other nivolumab-containing products); Yervoy® (and other ipilimumab-containing products); EmplicitiTM (and other elotuzumab-containing products); Nulojix® (and other belatacept-containing products); antineoplastic medicaments; and, immunosuppressive medicaments (duty-free) for the foreign-status materials/components noted below and in the existing scope of authority. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.

    The materials/components sourced from abroad include: Antisera; blood fractions; peptides and proteins; abatacept; belatacept; elotuzumab; ipilimumab; nivolumab; ferments; whole human blood; antiallergenic preparations; antineoplastic medicaments; and, immunosuppressive medicaments (duty-free).

    Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is April 24, 2017.

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

    For further information, contact Christopher Wedderburn at [email protected] or (202) 482-1963.

    Dated: March 8, 2017. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2017-04972 Filed 3-13-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-35-2017] Foreign-Trade Zone 43—Battle Creek, Michigan, Application for Subzone Expansion, Mead Johnson & Company, LLC, Zeeland, Michigan

    An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the City of Battle Creek, grantee of FTZ 43, requesting an expansion of Subzone 43B on behalf of Mead Johnson & Company, LLC dba Mead Johnson Nutrition (Mead Johnson), located in Zeeland, Michigan. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR 400). It was formally docketed on March 9, 2017.

    Subzone 43B currently consists of the following sites: Site 1 (29.63 acres), 725 East Main Street, Zeeland; and, Site 4 (2.3 acres), 8250 Logistics Drive, Zeeland. The applicant is now requesting authority to remove Site 4 and to add a new site: Proposed Site 5 (22.8 acres), 750 East Riley Street, Zeeland. No additional production authority is being requested at this time. The expanded subzone would be subject to the existing activation limit of FTZ 43.

    In accordance with the FTZ Board's regulations, Elizabeth Whiteman of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.

    Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is April 24, 2017. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to May 8, 2017.

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

    For further information, contact Elizabeth Whiteman at [email protected] or (202) 482-0473.

    Dated: March 9, 2017. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2017-04973 Filed 3-13-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-79-2016] Foreign-Trade Zone (FTZ) 38—Spartanburg County, South Carolina, Authorization of Production Activity, ZF Transmissions Gray Court, LLC, (Automatic Transmission and Powertrain Subassemblies and Parts, Transmission Shafts and Cranks), Gray Court, South Carolina

    On November 10, 2016, ZF Transmissions Gray Court, LLC submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board for its facility within FTZ 38—Sites 20 and 25 (now designated as Subzone 38K), in Gray Court, South Carolina.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (81 FR 83798, November 22, 2016). The FTZ Board has determined that no further review of the activity is warranted at this time. The production activity described in the notification is authorized, subject to the FTZ Act and the FTZ Board's regulations, including Section 400.14.

    Dated: March 9, 2017. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2017-04974 Filed 3-13-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration Environmental Technologies Trade Advisory Committee (ETTAC) Public Meeting AGENCY:

    International Trade Administration, DOC.

    ACTION:

    Notice of Federal Advisory Committee meeting.

    SUMMARY:

    This notice sets forth the schedule and proposed agenda of a meeting of the Environmental Technologies Trade Advisory Committee (ETTAC).

    DATES:

    The meeting is scheduled for Tuesday, April 4, 2017 from 8:30 a.m.-3:30 p.m. Eastern Standard Time (EST).

    ADDRESSES:

    The meeting will be held at the U.S. Department of Commerce, Herbert Clark Hoover Building, 1401 Constitution Avenue NW., Washington, DC 20230.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Amy Kreps, Office of Energy & Environmental Industries (OEEI), International Trade Administration, Room 28018, 1401 Constitution Avenue NW., Washington, DC 20230 (Phone: 202-482-3835; Fax: 202-482-5665; email: [email protected].) This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to OEEI at (202) 482-5225 no less than one week prior to the meeting.

    SUPPLEMENTARY INFORMATION:

    The meeting will take place on April 4 from 8:30 a.m. to 3:30 p.m. Eastern Standard Time (EST). The general meeting is open to the public and time will be permitted for public comment from 3:00-3:30 p.m. EST. Those interested in attending must provide notification by Friday, March 24, 2017 at 5:00 p.m. EST, via the contact information provided above. Written comments concerning ETTAC affairs are welcome any time before or after the meeting. Minutes will be available within 30 days of this meeting.

    Topic to be considered: The agenda for the April 4, 2017 meeting includes briefings from the U.S. interagency on topics about which the committee has expressed interest, including the Top Markets Report methodology, the trade classification system, and ITA's trade promotion programs. The committee also will discuss its priorities and objectives and deliberate on subcommittee topics.

    Background: The ETTAC is mandated by Section 2313(c) of the Export Enhancement Act of 1988, as amended, 15 U.S.C. 4728(c), to advise the Environmental Trade Working Group of the Trade Promotion Coordinating Committee, through the Secretary of Commerce, on the development and administration of programs to expand U.S. exports of environmental technologies, goods, services, and products. The ETTAC was originally chartered in May of 1994. It was most recently re-chartered until August 2018.

    Dated: March 9, 2017. Edward A. O'Malley, Director, Office of Energy and Environmental Industries.
    [FR Doc. 2017-05044 Filed 3-13-17; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE National Institute of Standards and Technology Request for Public Comments on Strategic Plan for the National Windstorm Impact Reduction Program AGENCY:

    National Institute of Standards and Technology, Commerce.

    ACTION:

    Notice; request for public comments.

    SUMMARY:

    The National Institute of Standards and Technology (NIST) requests comments on the Draft Strategic Plan for the National Windstorm Impact Reduction Program (NWIRP or Program). The Draft NWIRP Strategic Plan is posted on the NIST Web site at: https://www.nist.gov/el/mssd/nwirp.

    DATES:

    NIST requests comments on the Draft NWIRP Strategic Plan. Comments must be received by May 15, 2017.

    ADDRESSES:

    Written comments may be submitted to NIST in three ways. Comments may be submitted by email to [email protected], by fax to 301-869-6275, or by mail to: National Windstorm Impact Reduction Program, Attention: Dr. Marc Levitan, National Institute of Standards and Technology, 100 Bureau Drive, Stop 8611, Gaithersburg, MD 20899-8615. All comments will be made publicly available without redaction at https://www.nist.gov/el/mssd/nwirp. Accordingly, personal, proprietary or confidential information should not be included.

    FOR FURTHER INFORMATION CONTACT:

    Questions regarding the Draft NWIRP Strategic Plan should be directed to Dr. Marc Levitan, by email at [email protected], or by phone at 301-975-5340. Questions about the request for public comments should be directed to Steve Potts, by email at [email protected], or by phone at 301-975-5412. Please direct media inquiries to NIST's Office of Public Affairs at 301-975-2762.

    SUPPLEMENTARY INFORMATION:

    The NWIRP was established by Public Law 108-360 Title II and reauthorized in Public Law 114-52 (the National Windstorm Impact Reduction Act Reauthorization of 2015) on September 30, 2015. Congress established NWIRP “to achieve major measurable reductions in the losses of life and property from windstorms through a coordinated Federal effort, in cooperation with other levels of government, academia, and the private sector, aimed at improving the understanding of windstorms and their impacts and developing and encouraging the implementation of cost-effective mitigation measures to reduce those impacts.” 42 U.S.C. 15703(a).

    NIST has been designated as the Lead Agency for NWIRP. Other designated Program agencies are the Federal Emergency Management Agency (FEMA), the National Oceanic and Atmospheric Administration (NOAA), and the National Science Foundation (NSF). 42 U.S.C. 15703(b).

    As the lead agency, NIST has the primary responsibility for planning and coordinating the Program. This responsibility includes:

    • Ensuring that the Program includes the necessary components to promote the implementation of windstorm risk reduction measures;

    • Supporting the development of performance-based engineering tools, and working with appropriate groups to promote the commercial application of such tools;

    • Requesting the assistance of Federal agencies other than the Program agencies, as necessary;

    • Coordinating all Federal post-windstorm investigations to the extent practicable; and

    • When warranted by research or investigative findings, issuing recommendations to assist in informing the development of model codes, and providing information to Congress on the use of such recommendations.

    Statutory responsibilities for each of the Program agencies include:

    NSF—support research in (1) engineering and the atmospheric sciences to improve the understanding of the behavior of windstorms and their impact on buildings, structures, and lifelines; and (2) economic and social factors influencing windstorm risk reduction measures.

    NOAA—support atmospheric sciences research to improve the understanding of the behavior of windstorms and their impact on buildings, structures, and lifelines.

    NIST—carry out research and development to improve model building codes, voluntary standards, and best practices for the design, construction, and retrofit of buildings, structures, and lifelines.

    FEMA—(1) support the development of risk assessment tools and effective mitigation techniques; windstorm-related data collection and analysis; public outreach and information dissemination; and promotion of the adoption of windstorm preparedness and mitigation measures, including for households, businesses, and communities; and (2) work closely with national standards and model building code organizations, in conjunction with NIST, to promote the implementation of research results and better building practices within the building design and construction industry, including architects, engineers, contractors, builders, and inspectors.

    The Draft NWIRP Strategic Plan describes the goals, objectives, and strategic priorities needed to accomplish the Program purpose. They were developed following review and assessment of prior national research needs and planning documents, NWIRP Program agency input, and in consideration of stakeholder input. Stakeholder input was obtained through the NWIRP Strategic Planning Stakeholder's Workshop, held at the National Science Foundation on June 17, 2016. This Workshop was attended by over 80 participants from the public and private sectors who engaged in a series of 11 breakout sessions and provided ideas to help shape the Draft NWIRP Strategic Plan.

    Request for Public Comments: Persons interested in commenting on the Draft NWIRP Strategic Plan can submit their written comments to NIST in three ways. Comments may be submitted by email to [email protected], by fax to (301) 869-6275, or by mail to: National Windstorm Impact Reduction Program, Attention: Dr. Marc Levitan, National Institute of Standards and Technology, 100 Bureau Drive, Stop 8611, Gaithersburg, MD 20899-8615.

    When submitting comments, inclusion of name, affiliation, and contact information (phone number and/or email address in case of questions about the comment) are optional. All comments received in response to this notice will become part of the public record and will be posted on the NIST Web site at https://www.nist.gov/el/mssd/nwirp. Comments containing references, studies, research, and other empirical data that are not widely published should include copies of the referenced materials. All comments will be made publicly available; therefore, personal, proprietary or confidential information should not be included. All comments must be received by NIST by May 15, 2017 in accordance with the DATES and ADDRESSES sections of the notice above. Comments received after this time will not be considered.

    Kevin Kimball, Chief of Staff.
    [FR Doc. 2017-04933 Filed 3-13-17; 8:45 am] BILLING CODE 3510-13-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF277 Caribbean Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The Caribbean Fishery Management Council's (Council) Scientific and Statistical Committee (SSC) will hold a 5-day meeting in San Juan, Puerto Rico.

    DATES:

    The meetings will be held on April 3-7, 2017. The meeting will begin at 1 p.m. on Monday, April 3, 2017. On Tuesday, April 4 through Friday, April 7, 2017, the meetings will begin at 9 a.m. and adjourn at 5 p.m.

    ADDRESSES:

    The meetings will be held at the Council's Office, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico.

    FOR FURTHER INFORMATION CONTACT:

    Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918-1903, telephone: (787) 766-5926.

    SUPPLEMENTARY INFORMATION:

    The Council's SSC will hold a 5-day meeting to discuss the items contained in the following agenda:

    —Call to Order —Adoption of Agenda —Report from the DAPs Meetings (March 7-8, 2017) —Action 3: Management Reference Points for Stocks/Stock for each Puerto Rico, St. Thomas/St. John and St. Croix Fishery Management Plan (FMP): Process for setting Reference Points, MSY proxies, OFL, ABC for species/species complexes/groupings How indicator species will be employed? Time Series: Select a time series of landings data to establish management reference points for a stock/stock complex, as applicable. Determination of likely stock/complex status Define process for determination of scalars used in ABC Control Rule Define process for determination of buffers used in ABC Control Rule Determine References Points (e.g., OFL, ABC) for species/species groupings for each Island —Use of multi-year sequences for comparison to OFL (NS1) —Other Business —Next Meeting Special Accommodations

    These meetings are physically accessible to people with disabilities. For more information or request for sign language interpretation and other auxiliary aids, please contact Mr. Miguel A. Rolón, Executive Director, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico, 00918-1903; telephone (787) 766-5926, at least 5 days prior to the meeting date.

    Dated: March 9, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-04965 Filed 3-13-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF177 Pacific Island Pelagic Fisheries; Deep-Set Tuna Longline Fisheries AGENCY:

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

    ACTION:

    Notice of intent to prepare a Programmatic Environmental Impact Statement; rescheduled public meetings; request for comments.

    SUMMARY:

    NMFS, in coordination with the Western Pacific Fishery Management Council (Council), intends to prepare a Programmatic Environmental Impact Statement (PEIS) to analyze the environmental impacts of the continued authorization and management of U.S. Pacific Island deep-set tuna longline fisheries under the Fishery Ecosystem Plan for Pelagic Fisheries of the Western Pacific (FEP) and other applicable laws. The analysis would include certain longline fisheries based in Hawaii, the U.S. west coast, American Samoa, Guam, and the Commonwealth of the Northern Mariana Islands (CNMI). The PEIS is intended to support management of U.S. pelagic longline fisheries.

    DATES:

    See SUPPLEMENTARY INFORMATION section for meeting dates. NMFS must receive comments by April 14, 2017.

    ADDRESSES:

    You may submit comments on this action, identified by NOAA-NMFS-2017-0010, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to http://www.regulations.gov/docket?D=NOAA-NMFS-2017-0010, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Send written comments to Michael D. Tosatto, Regional Administrator, NMFS Pacific Islands Region (PIR), 1845 Wasp Blvd., Bldg. 176, Honolulu, HI 96818.

    Scoping Meeting: Submit written comments at a scoping meeting.

    Instructions: You must submit comments by the above methods to ensure that NMFS receives, documents, and considers your comments. NMFS may not consider comments sent by any other method, to any other address or individual, or received after the end of the comment period. NMFS will consider all comments received as part of the public record and will generally post comments for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address) submitted voluntarily by the sender will be publicly accessible. Do not submit confidential business information, or otherwise sensitive or protected information. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    Copies of the FEP, amendments, and previous EISs are available at http://www.regulations.gov/docket?D=NOAA-NMFS-2017-0010.

    FOR FURTHER INFORMATION CONTACT:

    Ariel Jacobs, NMFS, Pacific Islands Regional Office, (808) 725-5182.

    SUPPLEMENTARY INFORMATION:

    NMFS previously published a Notice of Intent (NOI) to prepare a PEIS to analyze the environmental impacts of the continued authorization and management of U.S. Pacific Island deep-set tuna longline fisheries under the FEP and other applicable laws (81 FR 10467, February 13, 2017). You may find details regarding development of the PEIS in that NOI; we do not repeat them here.

    The NOI announced public scoping meetings in Hawaii, American Samoa, Guam, and the CNMI. Due to circumstances beyond our control, we are rescheduling the meetings in American Samoa. NMFS will hold public meetings at the dates and locations below. All meetings will be from 6 p.m. to 9 p.m.

    1. Fagatogo Tuesday, March 28, 2017

    Fale Tele of the American Samoa Senate (Fono), Senate building, Fagatogo, Pago Pago, AS 96799.

    2. Laulii Wednesday, March 29, 2017

    Fale Tele of HTC Vaimaona, Laulii, Pago Pago, AS 96799.

    3. Tafuna Thursday, March 30, 2017

    NOAA GMD/PIFSC Compound Tafuna, 8043 Tasi St., Tafuna, AS 96799.

    Special Accommodations

    NMFS will make every attempt to make these meetings accessible to people with disabilities. Direct any requests for sign language interpretation, physical assistance, or other auxiliary aids to Ariel Jacobs at (808) 725-5182 at least five days prior to the meeting date.

    Dated: March 9, 2017. Karen H. Abrams, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-04996 Filed 3-13-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN0648-XE954 Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to a Breakwater Replacement Project in Eastport, Maine AGENCY:

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

    ACTION:

    Notice; issuance of an incidental harassment authorization.

    SUMMARY:

    In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to the Maine Department of Transportation (ME DOT) to incidentally harass, by Level B harassment only, marine mammals during in-water pile driving construction activities from the Eastport Breakwater Replacement Project (EBRP) in Eastport, ME.

    DATES:

    This Authorization is effective from January 24, 2017 through January 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Stephanie Egger, Office of Protected Resources, NMFS, at (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    Availability

    An electronic copy of ME DOT's application and supporting documents, as well as a list of the references cited in this document, may be obtained online at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm. In case of problems accessing these documents, please call the contact listed above.

    National Environmental Policy Act

    NMFS prepared an Environmental Assessment (EA) in accordance with the National Environmental Policy Act (NEPA) and considered comments submitted in response to the Proposed IHA as part of that process.

    Background

    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce to allow, upon request by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

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

    Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the U.S. can apply for an authorization to incidentally take small numbers of marine mammals by harassment. Section 101(a)(5)(D) establishes a 45-day time limit for NMFS review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of marine mammals. Within 45 days of the close of the comment period, NMFS must either issue or deny the authorization. Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as “any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).”

    Summary of Request

    On August 31, 2016, we received an application from ME DOT for authorization to take marine mammals incidental to construction activities associated with the replacement and expansion of the pier and breakwater in Eastport, ME. The project includes the removal of the original filled sheet pile structure (built in 1962), the replacement of the approach pier, expansion of the existing pier head, and the construction of a new wave attenuator. The ME DOT submitted a revised version of the application on October 21, 2016, and a final application on December 2, 2016, which we deemed adequate and complete.

    Harbor seal (Phoca vitulina), gray seal (Halichoerus grypus), harbor porpoise (Phocoena phocoena), Atlantic white-sided dolphin (Lagenorhynchus acutus) and minke whale (Balaenoptera acutorostrata) are expected to be present during the project activities. Pile driving activities are expected to produce in-water noise disturbance that has the potential to result in the behavioral harassment of marine mammals.

    Description of the Specified Activities

    Project activities will occur in Cobscook Bay (Washington County) in Eastport, ME. The breakwater lies near the mouth of the St. Croix River at the end of a long peninsula adjacent to Quoddy Head. Cobscook Bay has extremely strong tidal currents and notably high tides, creating an extensive intertidal habitat for marine and coastal species. Water depths at the project location are between 8 and 55 feet (ft) (2.4—17 meter (m)). The Bay is considered a relatively intact marine system, as the area has not experienced much industrialization.

    The overall pier replacement structure consists of an open pier supported by 151 piles, including steel pipe piles, reinforced concrete pile caps, and a precast pre-stressed plank deck with structural overlay. The approach pier will be 40 ft by 300 ft and the main pier section that will be parallel to the shoreline will be 50 ft by 400 ft.

    The replacement pier consists of two different sections. The approach pier will be replaced in kind by placing fill inside of a sheet pile enclosure, supported by driven piles. The sheet piles can be installed by use of a vibratory hammer only. The main pier, fender system, and wave fence system will be pile supported with piles ranging from 16 inch (in) to 36 in diameter pipe piles. These piles will be driven with a vibratory hammer to a point and must be seated with an impact hammer to ensure stability. In addition, approximately 50 old piles are expected to be removed through vibratory extraction (included in the estimated number of project workdays). The number of piles and types of piles needed to complete this project are described in Table 1.

    Table 1—Pile Types and Amounts Required To Complete The Project Pile size and type Number of piles
  • remaining to be
  • installed
  • 16″ steel pipe pile (vibratory hammer) 37 20″ steel pipe pile (impact and vibratory hammer) 25 36″ steel pipe pile (impact and vibratory hammer) 2 Steel sheet pile (vibratory hammer) 80 pairs

    ME DOT was issued an IHA for their previous work on this project in 2014 (79 FR 59247; October 4, 2014) with a revised date for project activities in 2015 (80 FR 46565; July 20, 2015). This prosed IHA is a continuation of the work to complete the project that began in 2015.

    A detailed description of the EBRP project is provided in the Federal Register notice for the proposed IHA (81 FR 89066; December 12, 2016). Since that time, no changes have been made to the planned activities. Therefore, a detailed description is not provided here. Please refer to that Federal Register notice for the description of the specific activity.

    Comments and Responses

    A notice of NMFS' proposal to issue an IHA to ME DOT was published in the Federal Register on December 12, 2016 (81 FR 89066). That notice described, in detail, ME DOT's activity, the marine mammal species that may be affected by the activity, and the anticipated effects on marine mammals. During the 30-day public comment period, NMFS received comments from the Marine Mammal Commission (MMC). The comments are posted online at http://www.nmfs.noaa.gov/pr/permits/incidental/construction.html. The following are the substantive comments and NMFS' responses:

    Comment 1: The MMC requested NMFS require the applicant to use a sound attenuation device (e.g., pile cushions or confined bubble curtain) during impact driving of steel piles.

    Response: NMFS added the a mitigation measure requiring the use of a sound attenuation device that specifically states: When using an impact pile hammer to install piles, sound absorption cushions and/or a bubble curtain shall be used to reduce underwater sound levels and avoid the potential for marine mammal injury.

    Comment 2: The MMC requested that for species for which authorization has not been granted or species for which authorization has been granted, but the authorized number of takes has already been met, NMFS require the applicant to use delay and shut-down procedures when individuals approach or are observed within the Level B harassment zone.

    Response: NMFS added this language to the Final IHA (see Pile Driving Shut Down and Delay Procedures in the Mitigation section).

    Comment 3: The MMC requested NMFS require the applicant use 15- and 30-min clearance times for small cetaceans and pinnipeds and large cetaceans, respectively.

    Response: In the Proposed IHA, a 30-min clearance time was proposed for all marine mammals. We have since modified the Final IHA to use the 15- and 30-min clearance times for small cetaceans and pinnipeds and large cetaceans, respectively.

    Comment 4: The MMC requested NMFS increase the Level B harassment takes from a total of 8 to 72 Atlantic white-sided dolphins based on group size and frequency of occurrence.

    Response: NMFS has made the recommended change from 8 dolphins to 72 based on 1 group (9 dolphins) that may enter the bay each month (also described in the Estimated Take of Incidental Harassment section).

    Comment 5: The MMC commented on a lack of information regarding the extent of Level A and B Harassment zones for installation of 16-, 20- and 36-in piles using a vibratory hammer. The MMC recommended using 161 and 167 decibel (dB) source levels (SL) to calculate harassment zones.

    Response: The applicant used a higher SL of 170 dB for vibratory pile driving (accounting for both sheet piles and piles) and used the new acoustic guidance, Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (July 2016), spreadsheet (NMFS 2016) (confirmed by NMFS) to determine the permanent threshold shift (PTS) isopleths for cetaceans and pinnipeds. The applicant then conservatively applied this one larger shutdown zone (Level A zone) to all cetaceans groups, using an area slightly larger than the PTS isopleth for high-frequency cetaceans, which provides greater protection for low- and mid-frequency cetaceans. The shutdown zone (Level A zone) for pinnipeds is slightly larger than the PTS isopleth calculated by the new acoustic guidance spreadsheet. Therefore, the Level A zones calculated under the 170 dB source level are more conservative and consider all pile sizes and sheet piles. For Level B Harassment zones for vibratory driving of piles, NMFS used the source levels of 161 dB and 167 dB, and used practical spreading to calculate zones of 500 m and 1,260 m for 16-20 in and 36 in piles, respectively (this is described in the Estimated Take of Incidental Harassment section).

    Comment 6: The MMC questioned why there were two Level B Harassment zones (400 m and 665 m) for installation of sheet piles using a vibratory hammer.

    Response: ME DOT will install two different types of sheet piles; therefore, two Level B Harassment zones were appropriately calculated for monitoring. The Level B Harassment zones were calculated at 400 m and 665 m based on the sheet pile type. Data from several sheet piles of each pile type were used to determine the Level B zones of influence (ZOI). The applicant indicated that the two types of sheet piles are not usually driven simultaneously. However, if they are, the larger Level B Harassment zone (665m) will be applied during vibratory pile driving of sheet piles.

    Comment 7: The MMC asked for clarification on whether sheet pile removal is part of the project and if so, by which method piles will be removed (e.g., vibratory extraction or cutting).

    Response: NMFS clarified with the applicant that an estimated 50 piles will be removed using vibratory extraction. The number of workdays includes pile removal; therefore, no revised take estimate is needed. This information was added to the Final IHA.

    Comment 8: The MMC commented that NMFS underestimated the number of Level B harassment takes for gray/harbor seals. The MMC recommends that NMFS use the maximum number of gray/harbor seals that were observed in the Level B Harassment zone on a given day during the previous authorization to inform the number of Level B harassments takes to be authorized.

    Response: In the proposed IHA, NMFS projected 120 pinnipeds per month from January through August would be taken by Level B harassment. This was calculated using an average group size of 6 animals per day for a 20-day work period/month. When comparing this to ME DOT's data collected from their previous authorization, the maximum number of seals that were observed in one month was 190 (July 2015), however; only 11 of those 190 seals were taken as Level B harassment over a 20-day period. The average of all seals observed in July 2015 was 10 seals per day. Therefore, NMFS has revised the take estimate to an average of 10 seals per day, increasing the total number of seals that may be taken by Level B harassment from 120 seals per month to 200 seals per month (also described in the Estimated Take of Incidental Harassment section). In a previous discussion with the applicant, ME DOT commented that in July 2015, 50 seals were observed in one monitoring day. However, the protected species observers for ME DOT believe it was a maximum of six pinnipeds seen multiple times that day.

    Comment 9: The MMC recommended the inclusion of Level B harassment takes for minke whales.

    Response: NMFS recognizes 28 minke whales were observed during ME DOT's previous authorization during a 4-month period (July through October); however, none of them were observed in the Level B Harassment zone, or thought to be taken by Level B harassment. The maximum number of minkes that were observed was in December 2015, where 11 animals occurred over an 18-day work period (but again, not within the harassment zone). However, at the recommendation of the MMC to authorize take of minke whales, NMFS will authorize 16 minke whales by Level B harassment, assuming an average group size of two whales that may enter the Level B Harassment zone once each month over an eight month period.

    Comment 10: The MMC suggested that ME DOT's application included some inaccuracies and that NMFS should have worked with the applicant more to ensure that its application was accurate and complete before sharing it with the public and publishing the Notice of a Proposed IHA.

    Response: NMFS works with applicants to ensure that applications are accurate, as well as adequate and complete, before we develop and publish a Notice of Proposed IHA, and we work internally to ensure that correct and comprehensive information is included in our proposed IHAs. In this case, in addition to working to attain this necessary quality of documentation, we worked hard to adhere to the aggressive timeline proposed by the applicant in order to support their important and time-sensitive work on this project. We will continue to ensure that the information we rely on for our decisions is based on the best available information and strive to conduct our regulatory processes in a timely manner that supports applicants' needs.

    Description of Marine Mammals in the Area of the Specified Activity

    The marine mammal species under NMFS jurisdiction authorized for incidental Level B take as a result of project activities, are the harbor seal, gray seal, harbor porpoise, Atlantic white-sided dolphin and minke whale (Table 2).

    Table 2—Marine Mammal Information for the Project Area Species Stock ESA/MMPA status;
  • strategic
  • (Y/N) 1
  • Stock abundance (CV, Nmin, most
  • recent abundance
  • survey) 2
  • PBR 3 Annua
  • M/SI 4
  • Relative occurrence/season of
  • occurrence
  • Harbor seal Western North Atlantic -; N 75,834 (0.15; 66,884; 2012) 2,006 420 Harbor seals are year-round inhabitants of the coastal waters of Maine and eastern Canada. Gray seal Western North Atlantic -; N unknown 505,000 (best estimate 2014 Canadian population DFO 2014) unknown 5,004 Gray seals currently pup at two established colonies in Maine: Green and Seal Islands. Harbor porpoise Gulf of Maine/Bay of Fundy -; N 79,883 (0.32; 61,415; 2011) 706 564 During winter (January to March), intermediate
  • densities of harbor porpoises can be found in
  • waters off New York to New Brunswick, Canada.
  • In spring (April-June), harbor porpoises are widely
  • dispersed from ME to NJ, with lower densities farther north and south.
  • Atlantic white-sided dolphin Western North Atlantic -; N 48,819 (0.61; 30,403; 2011) 304 102 During January to May, low numbers of white-sided dolphins are found from Georges Bank (separates the Gulf of Maine from the Atlantic Ocean to Jeffreys Ledge (in the Western Gulf of Maine off of New Hampshire). Minke whale Canadian East Coast -; N 20,741 (0.30; 16,199; 2007) 162 7.9 During the spring and fall, minkes are relatively widespread and common and when the whales are most abundant in New England waters. During the winter, minkes appears to be largely absent. 1 Endangered Species Act (ESA) status: Endangered (E), Threatened (T)/MMPA status: Depleted (D). A dash (-) indicates that the species is not listed under the ESA or designated as depleted under the MMPA. Under the MMPA, a strategic stock is one for which the level of direct human-caused mortality exceeds PBR (see footnote 3) or which is determined to be declining and likely to be listed under the ESA within the foreseeable future. Any species or stock listed under the ESA is automatically designated under the MMPA as depleted and as a strategic stock. 2 CV is coefficient of variation; Nmin is the minimum estimate of stock abundance. In some cases, CV is not applicable. For certain stocks of pinnipeds, abundance estimates are based upon observations of animals (often pups) ashore multiplied by some correction factor derived from knowledge of the species (or similar species) life history to arrive at a best abundance estimate; therefore, there is no associated CV. In these cases, the minimum abundance may represent actual counts of all animals ashore. The most recent abundance survey that is reflected in the abundance estimate is presented; there may be more recent surveys that have not yet been incorporated into the estimate. 3 Potential biological removal, defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population size (OSP). 4 These values, found in NMFS' SARs, represent annual levels of human-caused mortality plus serious injury from all sources combined (e.g., commercial fisheries, subsistence hunting, ship strike). Annual M/SI often cannot be determined precisely and is in some cases presented as a minimum value.

    A detailed description of the species likely to be affected by the EBRP, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the Federal Register notice for the proposed IHA (81 FR 89066; December 12, 2016) (with the exception of the minke whale that has been added to this Final IHA). Since that time, we are not aware of any changes in the status of these species and stocks that were previously described in the proposed IHA; therefore, detailed descriptions are not provided here. Please refer to that Federal Register notice for these descriptions. Please also refer to NMFS' Web site (www.nmfs.noaa.gov/pr/species/mammals/) for generalized species accounts.

    Minke whale

    The minke whale is common and widely distributed within the U.S. Atlantic Exclusive Economic Zone (EEZ) (CETAP 1982 as cited in Waring et al., 2015). During the spring to fall, minkes are relatively widespread and common occurrence, and when the whales are most abundant in New England waters. However, during winter months, minkes appear to be largely absent (e.g., Risch et al., 2013 as cited as Waring et al., 2015). Like most other baleen whales, minke whales generally occupy the continental shelf proper(< 100 m deep), rather than the continental shelf-edge region (Waring et al., 2015). In the North Atlantic, there are four recognized populations—Canadian East Coast, west Greenland, central North Atlantic, and northeastern North Atlantic (Donovan 1991 as cited in Waring et al., 2015). Minke whales off the eastern coast of the United States are considered to be part of the Canadian East Coast stock, which inhabits the area from the western half of the Davis Strait (45° W.) to the Gulf of Mexico (Waring et al., 2015). The most current abundance estimate for minke whales is 20,741. A current population trend analysis has not been conducted for this stock (Waring et al., 2015).

    Effects of the Specified Activity on Marine Mammals and Their Habitat

    In-water construction activities associated with the EBRP such as impact and vibratory pile driving components of the specified activity have the potential to result in impacts to marine mammals and their habitat in the project area. The Federal Register notice for the proposed IHA (81 FR 89066; December 12, 2016) included a detailed discussion of the behavioral and acoustic effects on marine mammals. Therefore, that information is not repeated here. Please refer to the referenced Federal Register notice for that information. No take by injury, serious injury, or death is anticipated as a result of the construction activities.

    Mitigation

    In order to issue an IHA for the under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, “and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking” for certain subsistence uses. NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks, their habitat (50 CFR 216.104(a)(11)).

    ME DOT worked with NMFS and developed the following mitigation measures to minimize the potential impacts to marine mammals in the project vicinity. The primary purposes of these mitigation measures are to minimize sound levels from the activities, and to monitor marine mammals within designated ZOI corresponding to NMFS' current Level A and B harassment thresholds. Here we provide a description of the mitigation measures required as part of the Authorization.

    Noise Attenuation Devices

    When using an impact hammer to “proof” piles, ME DOT shall use sound absorption cushions and/or a bubble curtain to reduce hydroacoustic sound levels and avoid the potential for marine mammal injury. Based on previous studies, sound attenuation devices are expected to reduce sound levels by at least 5 dB.

    Zones of Influence

    Direct measured data from the pile driving events of the EBRP IHA were used to calculate the ZOIs for Level B Harassment for pile driving activities. These values were used to develop mitigation measures for pile driving activities at EBRP. The ZOIs effectively represent the mitigation zone that will be established around each pile to prevent Level A harassment to marine mammals, while providing estimates of the areas within which Level B harassment might occur. In addition to the specific measures described later in this section, the EBRP will conduct briefings between construction supervisors and crews, marine mammal monitoring team, and EBRP staff prior to the start of all pile driving activity, and if/when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.

    Monitoring and Shutdown for Pile Driving

    The following measures will apply to the EBRP's mitigation through shutdown and disturbance zones:

    Shutdown Zone—For all pile driving activities, EBRP will establish exclusion zones (shutdown zones). Shutdown zones are intended to contain the area in which SPLs equal or exceed acoustic injury criteria, with the purpose being to define an area within which shutdown of activity will occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area), thus preventing injury marine mammals (PTS) of marine mammals (as described previously under Potential Effects of the Specified Activity on Marine Mammals, serious injury or death are unlikely outcomes even in the absence of mitigation measures).

    Using the user spreadsheet for the NMFS new acoustic guidance, injury zones were determined for low-, mid- and high-frequency cetaceans and pinnipeds (phocids) as the hearing groups analyzed for this project (see Table 3). The purpose of a shutdown zone is to define an area within which shutdown of activity will occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area). As a precautionary measure, intended to reduce the unlikely possibility of injury from direct physical interaction with construction operations, ME DOT will implement a minimum shutdown zone of 10 m radius around each pile for all construction methods for all marine mammals. The shutdown zones calculated for injury were rounded to the nearest 10 m to be more conservative or species were grouped (e.g., low-, mid- and high-frequency cetaceans combined into one group) for more streamlined monitoring in the field. For both impact and vibratory pile driving, the shutdown zones were increased for low- and mid-frequency cetaceans to that which was calculated for high-frequency cetaceans in order to group all cetaceans together for monitoring. The shutdown zones for vibratory pile driving were calculated considering all piles (sheet piles and piles) and are more conservative for piles as their source levels are lower than the one entered into the spreadsheet for sheet piles.

    Table 3—Injury Zones and Shutdown Zones for Hearing Groups for Each Construction Method Hearing group Low-frequency cetaceans
  • (m)
  • Mid-frequency cetaceans
  • (m)
  • High-
  • frequency cetaceans
  • (m)
  • Phocid pinnipeds
  • (m)
  • Vibratory Pile Driving1 PTS Isopleth to threshold 79.5 7.0 117.5 48.3 Shutdown Zone 120 50 Impact Pile Driving2 PTS Isopleth to threshold 130.7 4.6 155.6 69.9 Shutdown Zone 160 70 1 For vibratory driving, SL is 170 dB, TL is15logR, weighting function is 2.5, duration is 5 hours, and distance from the source is 10 m. This covers all vibratory hammering. 2 For impact driving, SL (Single Strike/shot SEL) is 171 dB, TL is 15log R, weighting function is 2, strikes per pile is 250, number off piles per day is 3, and distance from the source is 10 m.

    Disturbance Zone—Disturbance zones are the areas in which SPLs equal or exceed 160 and 120 dB rms (for impulse and continuous sound, respectively). Disturbance zones provide utility for monitoring conducted for mitigation purposes (i.e., shutdown zone monitoring) by establishing monitoring protocols for areas adjacent to the shutdown zones. Monitoring of disturbance zones enables observers to be aware of and communicate the presence of marine mammals in the project area but outside the shutdown zone and thus prepare for potential shutdowns of activity. However, the primary purpose of disturbance zone monitoring is for documenting incidents of Level B harassment; disturbance zone monitoring is discussed in greater detail later (see Monitoring and Reporting). Any marine mammal documented within the Level B harassment zone will constitute a Level B take (harassment), and will be recorded and reported as such. Nominal radial distances for disturbance zones are shown in Table 4. Given the size of the disturbance zone for both impact and vibratory pile driving, it is impossible to guarantee that all animals will be observed or to make comprehensive observations of fine-scale behavioral reactions to sound, and only a portion of the zone (e.g., what may be reasonably observed by visual observers) would be observed.

    Table 4—Calculated Threshold Distances (m) for Level B Harassment of Marine Mammals Source Threshold distances (m) 160 dB (m) 120 dB Vibratory pile driving n/a 400 m for PZC-18 Sheet Piles.
  • 665 m for PZC-26 Sheet Piles.
  • 500 m for 16-20 in piles.
  • 1,260 m for 36 in piles.
  • Impact pile driving 550 n/a. Note: If both types of sheet piles were installed simultaneously, the larger Level B zone of 665 m will be used.

    In order to document observed incidents of harassment, monitors will record all marine mammal observations, regardless of location. The observer's location, as well as the location of the pile being driven or removed, is known from a GPS unit. The location of the animal is estimated as a distance from the observer, which is then compared to the location from the pile. It may then be estimated whether the animal was exposed to sound levels constituting incidental harassment on the basis of predicted distances to relevant thresholds in post-processing of observational and acoustic data, and a precise accounting of observed incidences of harassment created. This information may then be used to extrapolate observed takes to reach an approximate understanding of actual total takes.

    Two Qualified Protected Species Observers (PSO) (NMFS approved biologists, monitoring responsibilities fully described in the Monitoring section) will be stationed on the pier. One PSO will be responsible for monitoring the shutdown zones, while the second observer will conduct behavioral monitoring outwards to a distance of 1 nautical mile (nmi).

    Pile Driving Shut Down and Delay Procedures

    If a PSO sees a marine mammal within or approaching the shutdown zones prior to start of pile driving, the observer will notify the on-site project lead (or other authorized individual) who will then be required to delay pile driving until the marine mammal has moved out of the shutdown zone from the sound source or if the animal has not been resighted within 15 min for small cetaceans and pinnipeds and 30 min for large cetaceans. If a marine mammal is sighted within or on a path toward a shutdown zone during pile driving, pile driving will cease until that animal has moved out of the shutdown zone and is on a path away from the shutdown zone or 15 min (pinnipeds and small cetaceans)/30 min (large cetaceans) has lapsed since the last sighting. Shutdown and delay procedures will also be required if a species for which authorization has not been granted or if a species for which authorization has been granted but the authorized number of takes has been met, approaches or is observed within the Level B harassment zone.

    Soft-Start Procedures

    A “soft-start” technique will be used at the beginning of each pile installation to allow any marine mammal that may be in the immediate area to leave before the pile hammer reaches full energy. For vibratory pile driving, the soft-start procedure requires contractors to initiate noise from the vibratory hammer for 15 seconds at 40-60 percent reduced energy followed by a 1-min waiting period. The procedure will be repeated two additional times before full energy may be achieved. For impact pile driving, contractors will be required to provide an initial set of 3 strikes from the impact hammer at 40 percent energy, followed by a 1-min waiting period, then two subsequent 3 strike sets. Soft-start procedures will be conducted any time hammering ceases for more than 30 min.

    Time Restrictions

    Work will occur only during daylight hours, when visual monitoring of marine mammals can be conducted.

    Mitigation Conclusions

    To ensure that the “least practicable adverse impact” will be achieved, NMFS has carefully evaluated mitigation measures in consideration of the following factors in relation to one another: The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, their habitat, and their availability for subsistence uses (latter where relevant); the proven or likely efficacy of the measures; and the practicability of the measures for applicant implementation (including, consideration of personnel safety, practicality of implementation).

    Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:

    1. Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).

    2. A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to received levels of pile driving, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    3. A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels of pile driving, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    4. A reduction in the intensity of exposures (either total number or number at biologically important time or location) to received levels of pile driving, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing the severity of harassment takes only).

    5. Avoidance or minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.

    6. For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

    Monitoring and Reporting

    In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking”. The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for incidental take authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the project action area.

    Any monitoring requirement we prescribe should improve our understanding of one or more of the following:

    • Occurrence of marine mammal species in the action area (e.g., presence, abundance, distribution, density).

    • Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (e.g., source characterization, propagation, ambient noise); (2) Affected species (e.g., life history, dive patterns); (3) Co-occurrence of marine mammal species with the action; or (4) Biological or behavioral context of exposure (e.g., age, calving or feeding areas).

    • Individual responses to acute stressors, or impacts of chronic exposures (behavioral or physiological).

    • How anticipated responses to stressors impact either: (1) Long-term fitness and survival of an individual; or (2) population, species, or stock.

    • Effects on marine mammal habitat and resultant impacts to marine mammals.

    • Mitigation and monitoring effectiveness.

    Visual Marine Mammal Observations

    PSOs shall be used to detect, document, and minimize impacts to marine mammals. Monitoring will be conducted before, during, and after construction activities. In addition, PSOs shall record all incidents of marine mammal occurrence, regardless of distance from activity, and document any behavioral reactions in concert with distance from construction activities. Important qualifications for PSOs for visual monitoring include:

    • Visual acuity in both eyes (correction is permissible) sufficient for discernment of marine mammals on land or in the water with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target;

    • Advanced education in biological science or related field (undergraduate degree or higher required);

    • Experience and ability to conduct field observations and collect data according to assigned protocols (this may include academic experience);

    • Experience or training in the field identification of marine mammals, including the identification of behaviors;

    • Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;

    • Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when construction activities were conducted; dates and times when construction activities were suspended, if necessary; and marine mammal behavior; and

    • Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.

    PSOs shall also conduct mandatory biological resources awareness training for construction personnel. The awareness training shall be provided to brief construction personnel on marine mammals and the need to avoid and minimize impacts to marine mammals. If new construction personnel are added to the project, the contractor shall ensure that the personnel receive the mandatory training before starting work. PSOs will have authority to stop construction if marine mammals appear distressed (evasive maneuvers, rapid breathing, inability to flush) or in danger of injury.

    The ME DOT has developed a monitoring plan based on discussions between ME DOT and NMFS. The ME DOT will collect sighting data and behavioral responses to construction activities for marine mammal species observed in the region of activity during the period of activity. All PSOs will be trained in marine mammal identification and behaviors and are required to have no other construction-related tasks while conducting monitoring.

    Data Collection

    We require that PSOs use approved data forms. Among other pieces of information, the ME DOT will record detailed information about any implementation of shutdowns, including the distance of animals to the pile and description of specific actions that ensued and resulting behavior of the animal, if any. In addition, the ME DOT will attempt to distinguish between the number of individual animals taken and the number of incidents of take. We require that, at a minimum, the following information be collected on the sighting forms:

    • Date and time that monitored activity begins or ends;

    • Construction activities occurring during each observation period;

    • Weather parameters (e.g., percent cover, visibility);

    • Water conditions (e.g., sea state, tide state);

    • Species, numbers, and, if possible, sex and age class of marine mammals;

    • Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;

    • Distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;

    • Locations of all marine mammal observations; and

    • Other human activity in the area.

    Reporting

    ME DOT is required to submit a draft monitoring report to NMFS within 90 days of completion of in-water construction activities. The report will include data from marine mammal sightings as described in the Data Collection section above (i.e., date, time, location, species, group size, and behavior), any observed reactions to construction, distance to operating pile hammer, and construction activities occurring at time of sighting and environmental data for the period (i.e., wind speed and direction, sea state, tidal state cloud cover, and visibility).

    In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by the IHA (if issued), such as an injury (Level A harassment), serious injury, or mortality, ME DOT will immediately cease the specified activities and immediately report the incident to the Permits and Conservation Division, Office of Protected Resources, NMFS and the Greater Atlantic Regional Fisheries Office Stranding Coordinator. The report must include the following information:

    • Time, date, and location (latitude/longitude) of the incident;

    • Name and type of vessel involved;

    • Vessel's speed during and leading up to the incident;

    • Description of the incident;

    • Status of all sound source use in the 24 hrs preceding the incident;

    • Water depth;

    • Environmental conditions (e.g., wind speed and direction, sea state, cloud cover, and visibility);

    • Description of all marine mammal observations in the 24 hrs preceding the incident;

    • Species identification or description of the animal(s) involved;

    • Fate of the animal(s); and

    • Photographs or video footage of the animal(s) (if equipment is available).

    Activities will not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with ME DOT to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. ME DOT may not resume their activities until notified by NMFS via letter, email, or telephone.

    In the event that ME DOT discovers an injured or dead marine mammal, and the lead PSO determines that the cause of the injury or death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition as described in the next paragraph), ME DOT will immediately report the incident to the NMFS' Permits and Conservation Division, Office of Protected Resources at (301) 427-840 and NMFS' GARFO Stranding Coordinator at (978) 282-8478. The report must include the same information identified in the paragraph above. Activities may continue while NMFS reviews the circumstances of the incident. NMFS will work with ME DOT to determine whether modifications in the activities are appropriate.

    In the event that ME DOT discovers an injured or dead marine mammal, and the lead PSO determines that the injury or death is not associated with or related to the activities authorized in the IHA (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), ME DOT will report the incident to the NMFS' Permits and Conservation Division, Office of Protected Resources at (301) 427-840 and the NMFS' GARFO Stranding Coordinator at (978) 282-8478 within 24 hrs of the discovery. ME DOT will provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS and the Marine Mammal Stranding Network. Activities may continue while NMFS reviews the circumstances of the incident.

    Estimated Take of Incidental Harassment

    Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: “. . . any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).”

    All anticipated takes will be by Level B harassment resulting from pile driving activities involving temporary changes in behavior. The mitigation and monitoring measures are expected to minimize the possibility of injurious or lethal takes such that potential for take by Level A harassment, serious injury, or mortality is considered discountable.

    Given the many uncertainties in predicting the quantity and types of impacts of sound on marine mammals, it is common practice to estimate take based on how many animals are likely to be present within a particular distance of a given activity, or exposed to a particular level of sound. In practice, depending on the amount of information available to characterize daily and seasonal movement and distribution of affected marine mammals, it can be difficult to distinguish between the number of individuals harassed and the instances of harassment and, when duration of the activity is considered, it can result in a take estimate that overestimates the number of individuals harassed. In particular, for stationary activities, it is more likely that some smaller number of individuals may accrue a number of incidences of harassment per individual than for each incidence to accrue to a new individual, especially if those individuals display some degree of residency or site fidelity and the impetus to use the site (e.g., because of foraging opportunities) is stronger than the deterrence presented by the harassing activity.

    Elevated in-water sound levels from pile driving activities in the project area may temporarily impact marine mammal behavior. Elevated in-air sound levels are not a concern because the nearest significant pinniped haul-out is more than six nmi away. Marine mammals are continually exposed to many sources of sound. For example, lightning, rain, sub-sea earthquakes, and animals are natural sound sources throughout the marine environment. Marine mammals produce sounds in various contexts and use sound for various biological functions including, but not limited to: (1) Social interactions; (2) Foraging; (3) Orientation; and (4) Predator detection. Interference with producing or receiving these sounds may result in adverse impacts. Audible distance or received levels will depend on the sound source, ambient noise, and the sensitivity of the receptor (Richardson et al., 1995). Marine mammal reactions to sound may depend on sound frequency, ambient sound, what the animal is doing, and the animal's distance from the sound source (Southall et al., 2007).

    Behavioral disturbances that could result from anthropogenic sound associated with these activities are expected to affect only a small number of individual marine mammals, although those effects could be recurring over the life of the project if the same individuals remain in the project vicinity.

    The ME DOT has requested authorization for the incidental taking of small numbers of harbor seals, gray seals, harbor porpoise, Atlantic white-sided dolphins, and minke whales incidental to the pile driving associated with the EBRP described previously in this document. In order to estimate the potential incidents of take that may occur incidental to the specified activity, we must first estimate the extent of the sound field that may be produced by the activity and then consider in combination with information about marine mammal density or abundance in the project area and the number of days the activity will be conducted. We first provide information on applicable sound thresholds for determining effects to marine mammals before describing the information used in estimating the sound fields, the available marine mammal density or abundance information, and the method of estimating potential incidents of take.

    As discussed above, in-water pile driving activities generate loud noises that could potentially harass marine mammals in the vicinity of ME DOT's EBRP. No impacts from visual disturbance are anticipated because there are no known pinniped haul-outs within the project area. The only potential disturbance anticipated to occur will be during driving operations, which may cause individual marine mammals to temporarily avoid the area.

    Sound Thresholds

    We use generic sound exposure thresholds to determine when an activity that produces sound might result in impacts to a marine mammal such that a take by Level B harassment might occur. To date, no studies have been conducted that explicitly examine impacts to marine mammals from pile driving sounds or from which empirical sound thresholds have been established. These thresholds (Table 5) are used to estimate when harassment may occur (i.e., when an animal is exposed to levels equal to or exceeding the relevant criterion) in specific contexts; however, useful contextual information that may inform our assessment of effects is typically lacking and we consider these thresholds as step functions. NMFS new technical guidance establishes new thresholds for predicting auditory injury, which equates to Level A harassment under the MMPA. The ME DOT project used this new technical guidance when determining the injury (Level A) zones (see Table 3).

    Table 5—Current Acoustic Exposure Criteria for Level B Harassment Criterion Definition Threshold Level B harassment (underwater) 1 Behavioral disruption 160 dB (impulsive source)/120 dB (continuous source). Level B harassment (airborne) 2 Behavioral disruption 90 dB (harbor seals)/100 dB (other pinnipeds) (unweighted). Note: All thresholds are based off of root mean square (rms) levels. 1 All decibels referenced to 1 micro Pascal (re: 1uPa). 2 All decibels referenced to 20 micro Pascals (re: 20uPa). Distance to Sound Thresholds

    Pile driving generates underwater noise that can potentially result in disturbance to marine mammals in the project area. Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:

    TL = B * log10(R1/R2), Where: R1 = the distance of the modeled SPL from the driven pile, and R2 = the distance from the driven pile of the initial measurement.

    This formula neglects loss due to scattering and absorption, which is assumed to be zero here. The degree to which underwater sound propagates away from a sound source is dependent on a variety of factors, most notably the water bathymetry and presence or absence of reflective or absorptive conditions including in-water structures and sediments. Spherical spreading occurs in a perfectly unobstructed (free-field) environment not limited by depth or water surface, resulting in a 6 dB reduction in sound level for each doubling of distance from the source (20*log[range]). Cylindrical spreading occurs in an environment in which sound propagation is bounded by the water surface and sea bottom, resulting in a reduction of 3 dB in sound level for each doubling of distance from the source (10*log[range]). A practical spreading value of fifteen is often used under conditions, where water increases with depth as the receiver moves away from the shoreline, resulting in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions.

    For Level B ZOIs for vibratory driving of piles, NMFS used source levels of 161 dB and 167 dB, and used practical spreading to calculate zones of 500 m and 1,260 m for 16-20 in and 36-in piles, respectively.

    In this case of sheet piles, we have measured field data available from the previous EBRP IHA at the same location and from the same type sheet piles showing at a particular point where the received level is below 120 dB, to determine the disturbance distance for the Level B ZOI. Data from several sheet piles of each pile type were used to determine the Level B ZOIs. For sheet pile type PZC-18, 400 m is the measured distance where the Level B ZOI is below 120 dB. For sheet pile type PZC-26, the farthest measurement did not go below 120 dB so the statistical analysis of 90 percent confidence interval was used, which pointed to 665 m for the Level B ZOI. For impact pile driving, we used the third farthest point from the measured field data, which was 550 m from the source, and measured under 160 dB.

    The sound field in the project area is the existing ambient noise plus additional construction noise from the project. The primary components of the project expected to affect marine mammals is the sound generated by impact and vibratory pile driving. The intensity of pile driving sounds is greatly influenced by factors such as the type of piles, hammers, and the physical environment in which the activity takes place. In order to determine the distance to the thresholds and the received levels to marine mammals that are likely to result from pile driving at EBRP, we evaluated the acoustic monitoring data (Table 6) from the previous EBRP IHA with similar properties to the current project activity.

    Table 6—Eastport Breakwater Noise Monitoring Data for Un-Attenuated Pile Strikes With an Impact Hammer and a Vibratory Hammer Pile type/size Relative water depth
  • (m)
  • Max avg dB RMS
    Impact Pile Driving 20 ft/Steel Pipe 15 182. 20 ft/Steel Pipe (`Spin fin') 15 186. Vibratory Pile Driving 24 ft Steel Sheet PZC-16 15 170 (max dB RMS).

    We consider the values presented in Table 6 to be representative of SPLs that may be produced by pile driving in the project area. Distances to the harassment isopleths vary by marine mammal type and pile extraction/driving tool. All calculated distances to and the total area encompassed by the marine mammal sound thresholds are provided in Tables 3 and 4.

    In addition, we generally recognize that pinnipeds occurring within an estimated airborne harassment zone, whether in the water or hauled out (no haul outs within six nmi of the project area), could be exposed to airborne sound that may result in behavioral harassment. However, any animal exposed to airborne sound above the behavioral harassment threshold is likely to also be exposed to underwater sound above relevant thresholds (which are typically in all cases larger zones than those associated with airborne sound). Thus, the behavioral harassment of these animals is already accounted for in the estimates of potential take. Multiple incidents within a day of exposure to sound above NMFS' thresholds for behavioral harassment are not believed to result in increased behavioral disturbance, in either nature or intensity of disturbance reaction. Therefore, we do not believe that authorization of incidental take resulting from airborne sound for pinnipeds is warranted, and airborne sound is not discussed further here.

    Acoustic Impacts

    When considering the influence of various kinds of sound on the marine environment, it is necessary to understand that different kinds of marine life are sensitive to different frequencies of sound. Based on available behavioral data, audiograms have been derived using auditory evoked potentials, anatomical modeling, and other data. Southall et al. (2007) designated hearing groups for marine mammals and estimated the lower and upper frequencies of hearing of the groups. NMFS made modifications to the marine mammal hearing groups proposed in Southall et al. (2007) which is reflected in the new technical guidance (NMFS 2016). The marine mammal hearing groups, pinnipeds, high frequency cetaceans (harbor porpoise), mid-frequency cetaceans (Atlantic white-sided dolphin) and low-frequency cetaceans (minke whale) which are the subject of this project, and their associated generalized hearing range were previous discussed in the Marine Mammal Hearing section.

    As mentioned previously in this document, five marine mammal species (three cetacean and two pinniped species) are likely to occur in the area of the activity. Of the three cetacean species likely to occur in the project area, the minke whale is considered a low-frequency cetacean, the Atlantic white-sided dolphin is classified as a mid-frequency cetacean and the harbor porpoise is classified as a high-frequency cetacean (NMFS 2016). A species' hearing group and its generalized hearing range is a consideration when we analyze the effects of exposure to sound on marine mammals.

    ME DOT and NMFS determined that in-water construction activities involving the use of impact and vibratory pile driving during the EBRP has the potential to result in behavioral harassment of marine mammal species and stocks in the vicinity of the project activity.

    Description of Take Calculation

    The following sections are descriptions of how take was determined for impacts to marine mammals from noise disturbance related to pile driving.

    Incidental take is calculated for each species by estimating the likelihood of a marine mammal being present within the ensonified area above the threshold during pile driving activities, based on information about the presence of the animal (density estimates or the best available occurrence data) and the size of the zones of influence, which in this case is based on previous measurements from the acoustic monitoring in the previous EBRP IHA. Expected marine mammal presence is determined by past observations and general abundance during the construction window. When local abundance is the best available information, in lieu of the density-area method, we may simply multiply some number of animals (as determined through counts of animals hauled-out) by the number of days of activity, under the assumption that all of those animals will be present within the area ensonified by the threshold and incidentally taken on each day of activity.

    There are a number of reasons why estimates of potential incidents of take may be conservative, assuming that available density or abundance estimates and estimated ZOI areas are accurate. We assume, in the absence of information supporting a more refined conclusion, that the output of the calculation represents the number of individuals that may be taken by the specified activity. In fact, in the context of stationary activities such as pile driving and in areas where resident animals may be present, this number more realistically represents the number of incidents of take that may accrue to a smaller number of individuals. While pile driving can occur any day throughout the in-water work window, and the analysis is conducted on a per day basis, only a fraction of that time (typically a matter of hours on any given day) is actually spent pile driving. The potential effectiveness of mitigation measures in reducing the number of takes is typically not quantified in the take estimation process. For these reasons, these take estimates may be conservative.

    For this project, the take requests were estimated using local marine mammal data sets and information from Federal agencies and other experts. The best available data for marine mammals in the vicinity of the project area was derived from three sources including: three years (2007-2010) of marine mammal monitoring data from the Ocean Renewable Power Company (ORPC) tidal generator project that was located between Eastport and Lubec, ME, the 2015-2016 marine mammal monitoring data from the previous EBRP IHA, and communication with marine mammals experts from ME (Stephanie Wood (NOAA Biologist) and Dr. James Gilbert (Wildlife Ecologist, University of ME)). Although the ORPC project was located on the other side of the peninsula from the Eastport pier, the presence of species and timing of their occurrence appears similar between the ORPC data and marine mammal monitoring data from the previous EBRP IHA.

    The calculation for marine mammal exposures is estimated by:

    Exposure estimate = N (number of animals in the area that is ensonified above the thresholds based on the previous sound measurements) * 160 days of pile driving activities from January to August 2017.

    The estimated number of animals in the area was previously determined based on the maximum group size of animals observed during ORPC's marine mammal observation effort (six seals (harbor and gray seals combined), six harbor porpoises, and one Atlantic white-sided dolphin) multiplied by the maximum expected number of pile/sheet installation and sheet removal days. During the winter and spring months we expect lower numbers of harbor porpoise in the Gulf of Maine (including the project area) and therefore take estimates were lower (January through May). Atlantic white-sided dolphins are not expected to frequent the project area, as they are more of a pelagic species. Only two Atlantic white-sided dolphins were observed in four years of marine mammal monitoring (ORPC and EBRP IHA). Harbor and gray seals were combined into one pinniped group because they cannot always be identified by species level. See Tables 7 and 8 for total estimated incidents of take.

    Based on comments provided by the MMC, take estimates are now revised for gray/harbor seal and Atlantic white-side dolphins. Minke whale take has also been added. In the proposed IHA, NMFS estimated 120 pinnipeds per month from January through August would be taken by Level B Harassment. This was calculated using an average group size of six animals per day for a 20-day work period/month. When comparing this to ME DOT's data collected from their previous authorization, the maximum number of seals observed in one month was 190 (July 2015), however; only 11 of those 190 seals were taken as Level B harassment over a 20-day period. The average of all seals observed in July 2015 was 10 seals per day. Therefore, NMFS has revised the take estimate to an average of 10 seals per day, increasing the total number of seals that may be taken by Level B harassment from 120 seals to 200 seals per month (Table 7). Although only two Atlantic white-sided dolphins were observed over the past four years, NMFS has revised the Level B take estimate, recommended by the MMC, from one Atlantic white-sided dolphins per month to nine dolphins per month based on one group (nine dolphins) that may enter the bay each month. NMFS added minke whales to be taken by Level B Harassment over the project period. NMFS recognizes 28 minke whales were observed during ME DOT's previous authorization during a 4-month period (July through October); however, none of these whales were taken by Level B harassment. The maximum number of minkes observed was in December 2015, where 11 animals occurred over an 18-day work period. NMFS will authorize 16 minke whales may be taken by Level B Harassment assuming a group size of two whales may enter the Level B Harassment zone each month over an eight month period.

    Table 7—Marine Mammal Calculated Take for Level B Harassment Month Pile driving days per month Calculated
  • harbor/gray
  • seal take by
  • Level B
  • Harassment
  • Calculated
  • harbor porpoise
  • take by Level B
  • Harassment
  • Calculated
  • Atlantic white-
  • sided dolphin
  • take by Level B
  • Harassment
  • Calculated
  • minke whale
  • take by
  • Level B
  • Harassment
  • Jan 20 200 6 9 2 Feb 20 200 6 9 2 March 20 200 6 9 2 April 20 200 6 9 2 May 20 200 6 9 2 June 20 200 120 9 2 July 20 200 120 9 2 August 20 200 120 9 2 Sept Oct Nov Dec Total 160 1,600 390 72 16
    Table 8—Estimated Marine Mammal Takes by Level B Harassment Species Take
  • authorization
  • Abundance Approximate
  • percentage of
  • estimated stock
  • (takes authorized/
  • population)
  • Population trend
    Harbor seal * 1,600 75,834—Western North Atlantic stock 2.11 unknown. Gray seal Unknown for U.S.—Western North Atlantic stock unknown increasing in the U.S. (EEZ), but the rate of increase is unknown. Harbor porpoise 390 79,883—Gulf of Maine/Bay of Fundy stock 0.48 unknown. Atlantic white-sided dolphin 72 48,819—Western North Atlantic stock 0.15 unknown. Minke whale 16 20,741—Canadian East Coast stock 0.077 unknown. * Note: Any pinnipeds observed/taken by Level B harassment will likely be harbor seals rather than gray seal (as gray seals do not frequent the waters of the project area as much and are found more in Canadian waters/haul out).
    Analysis and Determinations Negligible Impact

    NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.” A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of Level B harassment takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through behavioral harassment, we consider other factors, such as the likely nature of any responses (e.g., intensity, duration), the context of any responses (e.g., critical reproductive time or location, migration), as well as the number and nature of estimated Level A harassment takes, the number of estimated mortalities, and effects on habitat.

    Pile driving activities associated with this project have the potential to disturb or displace marine mammals. Elevated noise levels are expected to be generated as a result of these activities. However, ME DOT will use noise attenuation devices (e.g., pile cushions, bubble curtains) during impact pile driving to ensure that sound levels of 180 dB (rms) do not extend more than 10 m from the pile, which eliminates the potential for injury (PTS) and temporary threshold shift. Serious injury or mortality is not expected at all, and with mitigation, we expect to avoid any potential for Level A harassment as a result of the EBRP activities, and none are authorized by NMFS. The specified activities may result in take, in the form of Level B harassment (behavioral disturbance) only, from in-water noise from construction activities.

    Effects on individuals that are taken by Level B harassment, on the basis reports in the literature as well as monitoring from other similar activities, will likely be limited to reactions from these low intensity, localized, and short-term noise exposures that may cause brief startle reactions or short-term behavioral modifications by the animals. These reactions and behavioral changes are expected to subside quickly when the exposures cease. Moreover, marine mammals are expected to avoid the area during in-water construction because animals generally move away from active sound sources, thereby reducing exposure and impacts. In addition, through mitigation measures including soft start, marine mammals are expected to move away from a sound source that is annoying prior to its becoming potentially injurious and detection of marine mammals by observers will enable the implementation of shutdowns to avoid injury. Repeated exposures of individuals to levels of noise disturbance that may cause Level B harassment are unlikely to result in hearing impairment or to significantly disrupt foraging behavior.

    In-water construction activities will occur in relatively shallow coastal waters of Cobscook Bay. The project area is not considered significant habitat for marine mammals and therefore no adverse effects on marine mammal habitat are expected. Marine mammals approaching the action area will likely be traveling or opportunistically foraging. There are no rookeries or major haul-out sites nearby, foraging hotspots, or other ocean bottom structure of significant biological importance to marine mammals that may be present in the marine waters in the vicinity of the project area. The closest significant pinniped haul out is more than six nmi away, which is well outside the project area's largest harassment zone. The project area is not a prime habitat for marine mammals, nor is it considered an area frequented by marine mammals. Therefore, behavioral disturbances that could result from anthropogenic noise associated with breakwater replacement activities are expected to affect only small numbers of marine mammals on an infrequent basis. Although it is possible that some individual marine mammals may be exposed to sounds from in-water construction activities more than once, the duration of these multi-exposures is expected to be low since animals will be constantly moving in and out of the area and in-water construction activities will not occur continuously throughout the day.

    Harbor and gray seals, harbor porpoise, Atlantic white-sided dolphins and minke whales as the potentially affected marine mammal species under NMFS' jurisdiction in the action area, are not listed as threatened or endangered under the ESA and are not considered strategic under the MMPA. Because of the low level of impact, even repeated Level B harassment of some small subset of the overall stocks is unlikely to result in any significant realized decrease in fitness to those individuals, and thus would not result in any adverse impact to the stocks as a whole. Additionally, Level B harassment will be reduced to the level of least practicable impact through use of mitigation measures described herein and, if sound produced by project activities is sufficiently disturbing, animals are likely to avoid the project area while the activity is occurring.

    In summary, this negligible impact analysis is founded on the following factors: (1) The possibility of injury, serious injury, or mortality may reasonably be considered discountable; (2) The anticipated incidents of Level B harassment consist of, at worst, temporary modifications in behavior; (3) There is no known foraging or reproductive habitat in the project area and the project activities are not expected to result in the alteration of habitat important to these behaviors or substantially impact the behaviors themselves; (4) There is no major haul out habitat within six nmi of the project area; (5) The project area is not a prime habitat for marine mammals, nor will the activity otherwise have adverse effects on marine mammal habitat; and (6) Mitigation measures are expected to be effective in reducing the effects of the specified activity to the level of least practicable impact. In addition, these stocks are not listed under the ESA or considered depleted under the MMPA. In combination, we believe that these factors, as well as the available body of evidence from other similar activities, demonstrate that the potential effects of the specified activities will have only short-term effects on individuals. The specified activities are not expected to have adverse effects on annual rates of recruitment or survival and will therefore not result in population-level impacts.

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the monitoring and mitigation measures, we preliminarily find that the total marine mammal take from the construction activities will have a negligible impact on the affected marine mammal species or stocks.

    Small Numbers

    The amount of take NMFS is authorizing is considered small, less than one percent relative to the estimated populations for harbor porpoises, Atlantic white-sided dolphins, and minke whales and 2.11 percent for harbor seals. Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, NMFS finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.

    Impact on Availability of Affected Species for Taking for Subsistence Uses

    There are no relevant subsistence uses of marine mammals implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

    Endangered Species Act (ESA)

    No ESA-listed marine mammal species under NMFS' jurisdiction or their designated critical habitat are expected to be affected by these activities. Therefore, we have determined that a consultation under the ESA is not required. The applicant consulted with the NMFS' GARFO for federally listed fish species.

    National Environmental Policy Act (NEPA)

    NMFS prepared an EA and analyzed the potential impacts to marine mammals that will result from the EBRP. A Finding of No Significant Impact (FONSI) was signed January 2017. A copy of the EA and FONSI is available upon request (see ADDRESSES).

    Authorization

    NMFS has issued an IHA to ME DOT for the potential harassment of small numbers of marine mammals incidental to the EBRP in Eastport, ME, provided the previously mentioned mitigation, monitoring and reporting.

    Dated: March 8, 2017. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2017-04943 Filed 3-13-17; 8:45 am] BILLING CODE 3510-22-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION Credit Union Advisory Council Meeting AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    This notice sets forth the announcement of a public meeting of the Credit Union Advisory Council (CUAC or Council) of the Consumer Financial Protection Bureau (CFPB or Bureau). The notice also describes the functions of the Council. Notice of the meeting is permitted by section 9 of the CUAC Charter and is intended to notify the public of this meeting.

    DATES:

    The meeting date is Thursday, March 30, 2017, 3:15 p.m. to 4:45 p.m. eastern daylight time.

    ADDRESSES:

    The meeting location is the Consumer Financial Protection Bureau, 1275 First Street NE., Washington, DC 20002.

    FOR FURTHER INFORMATION CONTACT:

    Crystal Dully, Outreach and Engagement Associate, 202-435-9588, [email protected], Consumer Advisory Board and Councils Office, External Affairs, 1275 First Street NE., Washington, DC 20002.

    SUPPLEMENTARY INFORMATION: I. Background

    Under section 9(d) of the CUAC Charter, each meeting of the Council shall be open to public observation, to the extent that a facility is available to accommodate the public, unless the Bureau, in accordance with paragraph (4) of this section, determines that the meeting shall be closed. The Bureau also will make reasonable efforts to make the meetings available to the public through live recording. Notice of the time, place an purpose of each meeting, as well as a summary of the proposed agenda, shall be published in the Federal Register not more than 45 or less than 15 days prior to the scheduled meeting date. Shorter notice may be given when the Bureau determines that the Council's business so requires; in such event, the public will be given notice at the earliest practicable time. Minutes of meetings, records, reports, studies, and agenda of the Council shall be posted on the Bureau's Web site (www.consumerfinance.gov). The Bureau may close to the public a portion of any meeting, for confidential discussion. If the Bureau closes a meeting or any portion of a meeting, the Bureau will issue, at least annually, a summary of the Council's activities during such closed meetings or portions of meetings.

    Section 2 of the CUAC Charter provides that pursuant to the executive and administrative powers conferred on the Consumer Financial Protection Bureau by section 1012 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), the Director established the Credit Union Advisory Council to consult with the Bureau in the exercise of its functions under the Federal consumer financial laws as they pertain to credit unions with total assets of $10 billion or less.

    Section 3(a) of the CUAC Charter states that the CFPB supervises depository institutions and credit unions with total assets of more than $10 billion and their respective affiliates, but other than the limited authority conferred by section 1026 of the Dodd-Frank Act, the CFPB does not have supervisory authority regarding credit unions and depository institutions with total assets of $10 billion or less. As a result, the CFPB does not have regular contact with these institutions, and it would therefore be beneficial to create a mechanism to ensure that their unique perspectives are shared with the Bureau. Small Business Regulatory Enforcement Fairness Act (SBREFA) panels provide one avenue to gather this input, but participants from credit unions must possess no more than $175 million in assets, which precludes the participation of many. Under section 3(b), the Advisory Council shall fill this gap by providing an interactive dialogue and exchange of ideas and experiences between credit union employees and Bureau staff. The Advisory Council shall advise generally on the Bureau's regulation of consumer financial products or services and other topics assigned to it by the Director. To carry out the Advisory Council's purpose, the scope of its activities shall include providing information, analysis, and recommendations to the Bureau. The output of Advisory Council meetings should serve to better inform the CFPB's policy development, rulemaking, and engagement functions.

    II. Agenda

    The Credit Union Advisory Council will discuss alternative data and consumer access to financial records. Persons who need a reasonable accommodation to participate should contact [email protected], 202-435-9EEO, 1-855-233-0362, or 202-435-9742 (TTY) at least ten business days prior to the meeting or event to request assistance. The request must identify the date, time, location, and title of the meeting or event, the nature of the assistance requested, and contact information for the requester. CFPB will strive to provide, but cannot guarantee that accommodation will be provided for late requests.

    Individuals who wish to attend the Credit Union Advisory Council meeting must RSVP to [email protected] by noon, Wednesday, March 29, 2017. Members of the public must RSVP by the due date and must include “CUAC” in the subject line of the RSVP.

    III. Availability

    The Council's agenda will be made available to the public on Wednesday, March 15, 2017, via consumerfinance.gov. Individuals should express in their RSVP if they require a paper copy of the agenda.

    A recording and transcript of this meeting will be available after the meeting on the CFPB's Web site consumerfinance.gov.

    Dated: March 9, 2017. Leandra English, Chief of Staff, Bureau of Consumer Financial Protection.
    [FR Doc. 2017-05045 Filed 3-13-17; 8:45 am] BILLING CODE 4810-AM-P
    DEPARTMENT OF DEFENSE Department of the Air Force U.S. Air Force Scientific Advisory Board Notice of Meeting AGENCY:

    Air Force Scientific Advisory Board, Department of the Air Force, Defense.

    ACTION:

    Meeting notice.

    SUMMARY:

    The United States Air Force Scientific Advisory Board plans to hold its Spring Board meeting in April. This meeting will be closed to the General Public.

    DATES:

    The meeting date is Tuesday, April 11, 2017, from 8:00 a.m. to 11:30 a.m.

    ADDRESSES:

    25th AF Headquarters, 2 Hall Blvd., San Antonio, TX 78243-7072.

    FOR FURTHER INFORMATION CONTACT:

    The Scientific Advisory Board meeting organizer, Major Mike Rigoni at [email protected] or 240-612-5506, United States Air Force Scientific Advisory Board, 1500 West Perimeter Road, Ste. #3300, Joint Base Andrews, MD 20762.

    SUPPLEMENTARY INFORMATION:

    Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the Department of Defense announces the United States Air Force (USAF) Scientific Advisory Board (SAB) Spring Board meeting will take place on Tuesday, 11 April 2017 at the 25th Air Force Headquarters, located at 2 Hall Blvd. Ste. 201, San Antonio, TX, 78243-7072. In accordance with 5 U.S.C. 552b, as amended, and 41 CFR 102-3.155, the meeting will be closed to the general public because the Scientific Advisory Board will discuss classified information and matters covered by Section 552b of Title 5, United States Code, subsection (c), subparagraph (1).

    Any member of the public that wishes to provide input to the Air Force Scientific Advisory Board must contact the Scientific Advisory Board meeting organizer at the phone number or email address listed in this announcement at least five working days prior to the meeting date. Please ensure that you submit your written statement in accordance with 41 CFR 102-3.140(c) and section 10(a)(3) of the Federal Advisory Committee Act. Statements being submitted in response to this notice must be received by the Scientific Advisory Board meeting organizer at least five calendar days prior to the meeting commencement date. The Scientific Advisory Board meeting organizer will review all timely submissions and respond to them prior to the start of the meeting identified in this notice. Written statements received after this date may not be considered by the Scientific Advisory Board until the next scheduled meeting.

    Henry Williams, Acting Air Force Federal Register Liaison Officer.
    [FR Doc. 2017-04956 Filed 3-13-17; 8:45 am] BILLING CODE 5001-10-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0390] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written comments should be submitted on or before May 15, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0390.

    Title: Broadcast Station Annual Employment Report, FCC Form 395-B.

    Form Number: FCC 395-B.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business and other for-profit entities; not-for-profit institutions.

    Number of Respondents and Responses: 14,000 respondents, 14,000 responses.

    Estimated Time per Response: 1 hour.

    Frequency of Response: Annual reporting requirement.

    Total Annual Burden: 14,000 hours.

    Total Annual Cost: None.

    Obligation To Respond: Required to obtain or retain benefits. The statutory authority of this collection of information is contained in Sections 154(i) and 334 of the Communications Act of 1934, as amended.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Impact Assessment(s): No impact(s).

    Needs and Uses: FCC Form 395-B, the “Broadcast Station Annual Employment Report,” is a data collection device used by the Commission to assess industry employment trends and provide reports to Congress. By the form, broadcast licensees and permittees identify employees by gender and race/ethnicity in ten specified major job categories in the form.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2017-04967 Filed 3-13-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0850] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written comments should be submitted on or before May 15, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    As part of its continuing effort to reduce paperwork burdens, and as required by the PRA of 1995 (44 U.S.C. 3501-3520), the FCC 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.

    OMB Control No.: 3060-0850.

    Title: Quick-Form Application for Authorization in the Ship, Aircraft, Amateur, Restricted and Commercial Operator, and General Mobile Radio Services, FCC Form 605.

    Form No.: FCC Form 605.

    Type of Review: Revision of a currently approved collection.

    Respondents: Individuals or households; business or other for-profit; not-for-profit institutions; state, local or tribal government.

    Number of Respondents/Responses: 130,000 respondents; 130,000 responses.

    Estimated Time per Response: 0.17 hours-0.44 hours.

    Frequency of Response: On occasion reporting requirement; third party disclosure requirement, recordkeeping and other (5 and 10 years).

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in 47 CFR 1.913(a)(4).

    Total Annual Burden: 57,218 hours.

    Total Respondent Cost: $2,676,700.

    Privacy Act Impact Assessment: Yes.

    Nature and Extent of Confidentiality: In general there is no need for confidentiality. The Commission is required to withhold from disclosure certain information about the individual such as date of birth or telephone number.

    FCC 605 application is a consolidated application form for Ship, Aircraft, Amateur, Restricted and Commercial Radio Operators, and General Mobile Radio Services and is used to collect licensing data for the Universal Licensing System. The Commission is requesting OMB approval for an extension (no change in the reporting, recordkeeping and/or third party disclosure requirements). The Commission is making minor clarifications to the instructions on the main form and schedule B as well as a clarification to Item 3 on the main form.

    The data collected on this form includes the Date of Birth for Commercial Operator licensees however this information will be redacted from public view.

    The FCC uses the information in FCC Form 605 to determine whether the applicant is legally, technically, and financially qualified to obtain a license. Without such information, the Commission cannot determine whether to issue the licenses to the applicants that provide telecommunication services to the public, and therefore, to fulfill its statutory responsibilities in accordance with the Communications Act of 1934, as amended.

    The Commission is revising the basic qualifications section of the form to include a question regarding whether an application has been convicted of a felony in any state or federal court. Applicants, answering yes must provide an explanation. This item enables the FCC to determine whether an Applicant is eligible under §§ 310(d) and 308(b) of the Communications Act of 1934, as amended, to hold or have ownership interest in a station license.

    In addition we are seeking approval to change the ship application form require the applicant provide the official ship number. Coast Guard requests we change this question from optional to required. Obtaining the ship number is the only way to reliably link a license to a specific vessel.

    The Information provided on this form will also be used to update the database and to provide for proper use of the frequency spectrum as well as enforcement purposes.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2017-04968 Filed 3-13-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0532, 3060-0905] Information Collections 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, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before May 15, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    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.

    OMB Control No.: 3060-0532.

    Title: Section 2.1033 and 15.121, Scanning Receiver Compliance Exhibits.

    Form No.: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit.

    Number of Respondents and Responses: 25 respondents; 25 responses.

    Estimated Time per Response: 1 hour.

    Frequency of Response: One-time reporting requirement and third party disclosure requirement.

    Obligation To Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. Section 154(i), 301, 302, 303(e), 303(f), 303(g), 303(r), 304 and 307.

    Total Annual Burden: 25 hours.

    Total Annual Cost: $1,250.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: The Commission's rules require that certain portions of scanning receiver applications for certification will remain confidential after the effective date of the grant of the application. No other assurances of confidentiality are provided to respondents.

    Needs and Uses: This collection will be submitted as an extension after this 60 day comment period to Office of Management and Budget (OMB) in order to obtain the full three year clearance.

    The FCC rules under 47 CFR 2.1033 and 15.121 require manufacturers of scanning receivers to design their equipment so that it has 38 dB of image rejection for Cellular Service frequencies, tuning, control and filtering circuitry are inaccessible and any attempt to modify the scanning receiver to receive Cellular Service transmissions will likely render the scanning receiver inoperable. The Commission's rules also require manufacturers to submit information with any application for certification that describes the testing method used to determine compliance with the 38 dB image rejection ratio, the design features that prevent modification of the scanning receiver to receive Cellular Service transmissions, and the design steps taken to make tuning, control, and filtering circuitry inaccessible. Furthermore, the FCC requires equipment to carry a statement assessing the vulnerability of the scanning receiver to modification and to have a label affixed to the scanning receiver, similar to the following as described in section 15.121:

    Warning: Modification of this device to receive cellular radiotelephone service signals is prohibited under FCC Rules and Federal Law.

    The Commission uses the information required in this equipment authorization process to determine whether the equipment that is being marketed complies with the Congressional mandate in the Telephone Disclosure and Dispute Resolution Act of 1992 (TDDRA) and applicable Commission rules.

    OMB Control Number: 3060-0905.

    Title: Section 18.213, Information to the User (Regulations for RF Lighting Devices).

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit; not-for-profit institutions.

    Number of Respondents and Responses: 250 respondents; 250 responses.

    Estimated Time per Response: 1 hour.

    Frequency of Response: 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(i), 301, 302, 303(e), 303(f), 303(r), 304 and 307.

    Total Annual Burden: 250 hours.

    Total Annual Cost: $18,750.

    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: This collection will be submitted as an extension after this 60 day comment period to the Office of Management and Budget (OMB) in order to obtain the full three year clearance.

    Section 18.213 (for which the Commission is seeking continued OMB approval) requires information on industrial, scientific and medical equipment shall be provided to the user in the instruction manual or on the packaging of an instruction manual is not provided for any type of ISM equipment. (a) The interference potential of the device or system; (b) maintenance of the system; (c) simple measures that can be taken by the user to correct interference; and (d) manufacturers of RF lighting devices must provide documentation, similar to the following:

    This product may cause interference to radio equipment and should not be installed near maritime safety communications equipment or other critical navigation or communication equipment operating between 0.45-30 MHz. Variations of this language are permitted provided all the points of the statement are addressed and may be presented in any legible font or text style.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2017-04966 Filed 3-13-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION Information Collection Approved by the Office of Management and Budget AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Federal Communications Commission (FCC) has received Office of Management and Budget (OMB) approval for the following public information collections pursuant to the Paperwork Reduction Act of 1995. 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 concerning the accuracy of the burden estimates and any suggestions for reducing the burden should be directed to the person listed as the contact.

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Brian Marenco at (202) 418-0838, or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-1226.

    OMB Approval Date: January 17, 2017.

    OMB Expiration Date: January 31, 2020.

    Title: Receiving Written Consent for Communication with Base Stations in Canada; Issuing Written Consent to Licensees from Canada for Communication with Base Stations in the U.S.; Description of Interoperable Communications with Licensees from Canada.

    Form No.: N/A.

    Respondents: State, Local, or Tribal governments.

    Number of Respondents and Responses: 3,224 respondents; 3,224 responses.

    Estimated Time per Response: 0.5 hours-1 hour.

    Frequency of Response: On occasion reporting requirement.

    Total Annual Burden: 5,642 hours.

    Annual Cost Burden: None.

    Obligation to Respond: Written consent from the licensee of a base station repeater is required before first responders from the other country can begin communicating with that base stations repeater. Applicants are advised to include a description of how they intend to interoperate with licensees from Canada when filing applications to operate under any of the scenarios described in Public Notice DA 16-739 in order to ensure that the application is not inadvertently rejected by Canada. Statutory authority for these collections are contained in 47 U.S.C. 151, 154, 301, 303, 307, 308, 309, 310, 316, 319, 325(b), 332, 336(f), 338, 339, 340, 399b, 403, 534, 535, 1404, 1452, and 1454 of the Communications Act of 1934.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: Applicants who include a description of how they intend to interoperate with licensees from Canada need not include any confidential information with their description. Nonetheless, there is a need for confidentiality with respect to all applications filed with the Commission through its Universal Licensing System (ULS). Although ULS stores all information pertaining to the individual license via an FCC Registration Number (FRN), confidential information is accessible only by persons or entities that hold the password for each account, and the Commission's licensing staff. Information on private land mobile radio licensees is maintained in the Commission's system of records, FCC/WTB-1, “Wireless Services Licensing Records.” The licensee records will be publicly available and routinely used in accordance with subsection (b) of the Privacy Act. TIN Numbers and material which is afforded confidential treatment pursuant to a request made under 47 CFR 0.459 will not be available for Public inspection. Any personally identifiable information (PII) that individual applicants provide is covered by a system of records, FCC/WTB-1, “Wireless Services Licensing Records,” and these and all other records may be disclosed pursuant to the Routine Uses as stated in this system of records notice.

    Needs and Uses: The purpose of requiring an agency to issue written consent before allowing first responders from the other country to communicate with its base station repeater ensures to that the licensee of that base stations repeater (host licensee) maintains control and is responsible for its operation at all times. The host licensee can use the written consent to ensure that first responders from the other country understand the proper procedures and protocols before they begin communicating with its base station repeater. Furthermore, when reviewing applications filed by border area licensees, Commission staff will use any description of how an applicant intends to interoperate with licensees from Canada, including copies of any written agreements, in order to coordinate the application with Innovation, Science and Economic Development Canada (ISED) and reduce the risk of an inadvertent rejection by ISED.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2017-04969 Filed 3-13-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [CC Docket No. 92-237; DA 17-235] Next Meeting of the North American Numbering Council AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice.

    SUMMARY:

    In this document, the Commission released a public notice announcing the meeting and agenda of the North American Numbering Council (NANC). The intended effect of this action is to make the public aware of the NANC's next meeting and agenda.

    DATES:

    Tuesday, March 28, 2017, 10:00 a.m.

    ADDRESSES:

    Requests to make an oral statement or provide written comments to the NANC should be sent to Carmell Weathers, Competition Policy Division, Wireline Competition Bureau, Federal Communications Commission, Portals II, 445 12th Street SW., Room 5-C162, Washington, DC 20554.

    FOR FURTHER INFORMATION CONTACT:

    Carmell Weathers at (202) 418-2325 or [email protected] The fax number is: (202) 418-1413. The TTY number is: (202) 418-0484.

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's document in CC Docket No. 92-237, DA 17-235 released March 9, 2017. The complete text in this document is available for public inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. The document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street SW., Room CY-B402, Washington, DC 20554, telephone (800) 378-3160 or (202) 863-2893, facsimile (202) 863-2898, or via the Internet at http://www.bcpiweb.com. It is available on the Commission's Web site at http://www.fcc.gov.

    The North American Numbering Council (NANC) has scheduled a meeting to be held Tuesday, March 28, 2017, from 10:00 a.m. until 2:00 p.m. The meeting will be held at the Federal Communications Commission, Portals II, 445 12th Street SW., Room TW-C305, Washington, DC.

    This meeting is open to members of the general public. The FCC will attempt to accommodate as many participants as possible. The public may submit written statements to the NANC, which must be received two business days before the meeting. In addition, oral statements at the meeting by parties or entities not represented on the NANC will be permitted to the extent time permits. Such statements will be limited to five minutes in length by any one party or entity, and requests to make an oral statement must be received two business days before the meeting.

    People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty). Reasonable accommodations for people with disabilities are available upon request. Include a description of the accommodation you will need, including as much detail as you can. Also include a way we can contact you if we need more information. Please allow at least five days advance notice; last minute requests will be accepted, but may be impossible to fill.

    Proposed Agenda Tuesday, March 28, 2017, 10:00 a.m.* 1. Welcoming Remarks 2. Remarks by FCC Chairman Ajit Pai 3. Announcements and Recent News 4. Approval of Transcript—December 1, 2016 5. Report of the North American Numbering Plan Administrator (NANPA) 6. Report of the National Thousands Block Pooling Administrator (PA) 7. Report of the Numbering Oversight Working Group (NOWG) 8. Report of the Toll Free Number Administrator (TFNA) 9. Report of the North American Numbering Plan Billing and Collection (NANP B&C) Agent 10. Report of the Billing and Collection Working Group (B&C WG) 11. Report of the North American Portability Management LLC (NAPM LLC) 12. Report of the Local Number Portability Administrator (LNPA) Transition Oversight Manager 13. Report of the Local Number Portability Administration Working Group 14. Report of the Future of Numbering Working Group (FoN WG) 15. Status of the Industry Numbering Committee (INC) activities 16. Robocalls and Spoofing Update from the SIP Forum 17. Summary of Action Items 18. Public Comments and Participation (maximum 5 minutes per speaker) 19. Other Business Adjourn no later than 2:00 p.m.

    * The Agenda may be modified at the discretion of the NANC Chairman with the approval of the DFO.

    Federal Communications Commission. Marilyn Jones, Attorney, Wireline Competition Bureau.
    [FR Doc. 2017-05027 Filed 3-13-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL ELECTION COMMISSION [Notice 2017-08] Filing Dates for the Montana Special Congressional Election AGENCY:

    Federal Election Commission.

    ACTION:

    Notice of filing dates for special election.

    SUMMARY:

    Montana has scheduled a Special General Election on May 25, 2017, to fill the U.S. House of Representatives seat in the At-Large Congressional District vacated by Representative Ryan Zinke.

    Committees required to file reports in connection with the Special General Election on May 25, 2017, shall file a 12-day Pre-General Report, and a 30-day Post-General Report.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Elizabeth S. Kurland, Information Division, 999 E Street NW., Washington, DC 20463; Telephone: (202) 694-1100; Toll Free (800) 424-9530.

    SUPPLEMENTARY INFORMATION:

    Principal Campaign Committees

    All principal campaign committees of candidates who participate in the Montana Special General Election shall file a 12-day Pre-General Report on May 13, 2017, and a 30-day Post-General Report on June 24, 2017. (See charts below for the closing date for each report.)

    Note that these reports are in addition to the campaign committee's regular quarterly filings. (See charts below for the closing date for each report).

    Unauthorized Committees (PACs and Party Committees)

    Political committees not filing monthly in 2017 are subject to special election reporting if they make previously undisclosed contributions or expenditures in connection with the Montana Special General Election by the close of books for the applicable report(s). (See charts below for the closing date for each report.)

    Committees filing monthly that make contributions or expenditures in connection with the Montana Special General Election will continue to file according to the monthly reporting schedule.

    Additional disclosure information in connection with the Montana Special Election may be found on the FEC Web site at http://www.fec.gov/info/report_dates.shtml.

    Disclosure of Lobbyist Bundling Activity

    Principal campaign committees, party committees and Leadership PACs that are otherwise required to file reports in connection with the special election must simultaneously file FEC Form 3L if they receive two or more bundled contributions from lobbyists/registrants or lobbyist/registrant PACs that aggregate in excess of $17,900 during the special election reporting periods. (See charts below for closing date of each period.) 11 CFR 104.22(a)(5)(v), (b).

    Calendar of Reporting Dates for Montana Special General Election Report Close of books 1 Reg./Cert. & overnight
  • mailing
  • deadline
  • Filing deadline
    Campaign Committees Involved in the Special General (05/25/17) Must File: Pre-General 05/05/17 05/10/17 2 05/13/17 Post-General 06/14/17 06/24/17 2 06/24/17 July Quarterly 06/30/17 07/15/17 2 07/15/17 PACs and Party Committees Not Filing Monthly Involved in the Special General (05/25/17) Must File: Pre-General 05/05/17 05/10/17 2 05/13/17 Post-General 06/14/17 06/24/17 2 06/24/17 Mid-Year 06/30/17 07/31/17 07/31/17 1 These dates indicate the end of the reporting period. A reporting period always begins the day after the closing date of the last report filed. If the committee is new and has not previously filed a report, the first report must cover all activity that occurred before the committee registered as a political committee with the Commission up through the close of books for the first report due. 2 Notice that this filing deadline falls on a weekend or federal holiday. Filing deadlines are not extended when they fall on nonworking days. Accordingly, reports filed by methods other than registered, certified or overnight mail must be received by close of business on the last business day before the deadline.

    On behalf of the Commission.

    Dated: March 8, 2017. Steven T. Walther, Chairman, Federal Election Commission.
    [FR Doc. 2017-05057 Filed 3-13-17; 8:45 am] BILLING CODE 6715-01-P
    FEDERAL ELECTION COMMISSION [Notice 2017-07] Filing Dates for the South Carolina Special Elections in the 5th Congressional District AGENCY:

    Federal Election Commission.

    ACTION:

    Notice of filing dates for special election.

    SUMMARY:

    South Carolina has scheduled special elections to fill the U.S. House of Representatives seat in the 5th Congressional District vacated by Representative Mick Mulvaney.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Elizabeth S. Kurland, Information Division, 999 E Street NW., Washington, DC 20463; Telephone: (202) 694-1100; Toll Free (800) 424-9530.

    SUPPLEMENTARY INFORMATION:

    There are three possible special elections, but only two may be necessary.

    • Primary Election: May 2, 2017.

    • Possible Runoff Election: May 16, 2017. In the event that one candidate does not achieve a majority vote in his/her party's Special Primary Election, the top two vote-getters will participate in a Special Runoff Election.

    • General Election: June 20, 2017.

    Principal Campaign Committees Special Primary Only

    All principal campaign committees of candidates only participating in the South Carolina Special Primary shall file a Pre-Primary Report on April 20, 2017. (See charts below for the closing date for the report).

    Special Primary and General Without Runoff

    If only two elections are held, all principal campaign committees of candidates participating in the South Carolina Special Primary and Special General Elections shall file a Pre-Primary Report on April 20, 2017; a Pre-General Report on June 8, 2017; and a Post-General Report on July 21, 2017. (See charts below for the closing date for each report).

    Special Primary and Runoff Elections

    If three elections are held, all principal campaign committees of candidates only participating in the South Carolina Special Primary and Special Runoff Elections shall file a Pre-Primary Report on April 20, 2017; and a Pre-Runoff Report on May 4, 2017. (See charts below for the closing date for each report.)

    Special Primary, Runoff and General Elections

    All principal campaign committees of candidates participating in the South Carolina Special Primary, Special Runoff and Special General Elections shall file a Pre-Primary Report on April 20, 2017; a Pre-Runoff Report on May 4, 2017; a Pre-General Report on June 8, 2017; and a Post-General Report on July 21, 2017. (See charts below for the closing date for each report.)

    Note that these reports are in addition to the campaign committee's regular quarterly filings. (See charts below for the closing date for each report).

    Unauthorized Committees (PACs and Party Committees)

    Political committees not filing monthly in 2017 are subject to special election reporting if they make previously undisclosed contributions or expenditures in connection with the South Carolina Special Primary, Special Runoff or Special General Elections by the close of books for the applicable report(s). (See charts below for the closing date for each report.)

    Committees filing monthly that make contributions or expenditures in connection with the South Carolina Special Primary, Special Runoff or Special General Elections will continue to file according to the monthly reporting schedule.

    Additional disclosure information in connection with the South Carolina Special Elections may be found on the FEC Web site at http://www.fec.gov/info/report_dates.shtml.

    Disclosure of Lobbyist Bundling Activity

    Principal campaign committees, party committees and Leadership PACs that are otherwise required to file reports in connection with the special elections must simultaneously file FEC Form 3L if they receive two or more bundled contributions from lobbyists/registrants or lobbyist/registrant PACs that aggregate in excess of $17,900 during the special election reporting periods. (See charts below for closing date of each period.) 11 CFR 104.22(a)(5)(v), (b).

    Calendar of Reporting Dates for South Carolina Special Elections Report Close of books 1 Reg./Cert. &
  • overnight
  • mailing
  • deadline
  • Filing deadline
    Campaign Committees Involved in Only the Special Primary (05/02/17) Must File: April Quarterly WAIVED Pre-Primary 04/12/17 04/17/17 04/20/17 July Quarterly 06/30/17 07/15/17 2 07/15/17 Participating PACs and Party Committees not Filing Monthly Involved in Only the Special Primary (05/02/17) Must File: Pre-Primary 04/12/17 04/17/17 04/20/17 Mid-Year 06/30/17 07/31/17 07/31/17 If Only Two Elections Are Held, Campaign Committees Involved in Both the Special Primary (05/02/17) and Special General (06/20/17) Must File: April Quarterly WAIVED Pre-Primary 04/12/17 04/17/17 04/20/17 Pre-General 05/31/17 06/05/17 06/08/17 July Quarterly WAIVED Post-General 07/10/17 07/21/17 07/21/17 October Quarterly 09/30/17 10/15/17 2 10/15/17 If Only Two Elections Are Held, PACs and Party Committees not Filing Monthly Involved in Both the Special Primary (05/02/17) and Special General (06/20/17) Must File: Pre-Primary 04/12/17 04/17/17 04/20/17 Pre-General 05/31/17 06/05/17 06/08/17 Post-General 07/10/17 07/21/17 07/21/17 Mid-Year WAIVED Year-End 12/31/17 01/31/18 01/31/18 If Only Two Elections Are Held, Campaign Committees Involved in Only the Special General (06/20/17) Must File: Pre-General 05/31/17 06/05/17 06/08/17 July Quarterly WAIVED Post-General 07/10/17 07/21/17 07/21/17 October Quarterly 09/30/17 10/15/17 2 10/15/17 If Only Two Elections Are Held, PACs and Party Committees not Filing Monthly Involved in Only the Special General (06/20/17) Must File: Pre-General 05/31/17 06/05/17 06/08/17 Post-General 07/10/17 07/21/17 07/21/17 Mid-Year WAIVED Year-End 12/31/17 01/31/18 01/31/18 If Three Elections Are Held, Campaign Committees Involved in Only the Special Primary (05/02/17) and Special Runoff (05/16/17) Must File: April Quarterly WAIVED Pre-Primary 04/12/17 04/17/17 04/20/17 Pre-Runoff 04/26/17 3 05/04/17 05/04/17 July Quarterly 06/30/17 07/15/17 2 07/15/17 If Three Elections Are Held, PACs and Party Committees not Filing Monthly Involved in Only the Special Primary (05/02/17) and Special Runoff (05/16/17) Must File: Pre-Primary 04/12/17 04/17/17 04/20/17 Pre-Runoff 04/26/17 3 05/04/17 05/04/17 Mid-Year 06/30/17 07/31/17 07/31/17 If Three Elections Are Held, Campaign Committees Involved in Only the Special Runoff (05/16/17) Must File: Pre-Runoff 04/26/17 3 05/04/17 05/04/17 July Quarterly 06/30/17 07/15/17 2 07/15/17 If Three Elections Are Held, PACs and Party Committees not Filing Monthly Involved in Only the Special Runoff (05/16/17) Must File: Pre-Runoff 04/26/17 3 05/04/17 05/04/17 Mid-Year 06/30/17 07/31/17 07/31/17 Campaign Committees Involved in the Special Primary (05/02/17), Special Runoff (05/16/17) and Special General (06/20/17) Must File: April Quarterly WAIVED Pre-Primary 04/12/17 04/17/17 04/20/17 Pre-Runoff 04/26/17 3 05/04/17 05/04/17 Pre-General 05/31/17 06/05/17 06/08/17 July Quarterly WAIVED Post-General 07/10/17 07/21/17 07/21/17 October Quarterly 09/30/17 10/15/17 2 10/15/17 PACs and Party Committees not Filing Monthly Involved in the Special Primary (05/02/17), Special Runoff (05/16/17) and Special General (06/20/17) Must File: Pre-Primary 04/12/17 04/17/17 04/20/17 Pre-Runoff 04/26/17 3 05/04/17 05/04/17 Pre-General 05/31/17 06/05/17 06/08/17 Post-General 07/10/17 07/21/17 07/21/17 Mid-Year WAIVED Year-End 12/31/17 01/31/18 01/31/18 If Three Elections Are Held, Campaign Committees Involved in Only the Special General (06/20/17) Must File: Pre-General 05/31/17 06/05/17 06/08/17 July Quarterly WAIVED Post-General 07/10/17 07/21/17 07/21/17 October Quarterly 09/30/17 10/15/17 2 10/15/17 If Three Elections Are Held, PACs and Party Committees not Filing Monthly Involved in Only the Special General (06/20/17) Must File: Pre-General 05/31/17 06/05/17 06/08/17 Post-General 07/10/17 07/21/17 07/21/17 Mid-Year WAIVED Year-End 12/31/17 01/31/18 01/31/18 1 The reporting period always begins the day after the closing date of the last report filed. If the committee is new and has not previously filed a report, the first report must cover all activity that occurred before the committee registered as a political committee up through the close of books for the first report due. 2 Notice that this filing deadline falls on a weekend or federal holiday. Filing deadlines are not extended when they fall on nonworking days. Accordingly, reports filed by methods other than registered, certified or overnight mail must be received by close of business on the last business day before the deadline. 3 The mailing deadline is the same as the filing deadline because the computed mailing deadline would fall one day before the primary is held.

    On behalf of the Commission,

    Dated: February 27, 2017. Steven T. Walther, Chairman, Federal Election Commission.
    [FR Doc. 2017-05055 Filed 3-13-17; 8:45 am] BILLING CODE 6715-01-P
    FEDERAL TRADE COMMISSION Agency Information Collection Activities; Proposed Collection; Comment Request; Extension AGENCY:

    Federal Trade Commission (“Commission” or “FTC”).

    ACTION:

    Notice.

    SUMMARY:

    The FTC is seeking public comments on its proposal to extend for three years, its current Paperwork Reduction Act (“PRA”) clearance for information collection requirements contained in the Fuel Rating Rule (“Rule”), which will expire on July 31, 2017.

    DATES:

    Comments must be filed by May 15, 2017.

    ADDRESSES:

    Interested parties are invited to submit written comments electronically or in paper form by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write “Fuel Rating Rule PRA Comment, FTC File No. P144200” on your comment, and file your comment online at https://ftcpublic.commentworks.com/ftc/fuelratingpra, by following the instructions on the web-based form. If you prefer to file your comment on paper, mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the proposed information requirements should be addressed to Hampton Newsome, Attorney, Division of Enforcement, Federal Trade Commission, Room CC-9528, 600 Pennsylvania Avenue NW., Washington, DC 20580, (202) 326-2889.

    SUPPLEMENTARY INFORMATION:

    The Fuel Rating Rule, 16 CFR part 306 (OMB Control Number: 3084-0068), establishes standard procedures for determining, certifying, and disclosing the octane rating of automotive gasoline and the automotive fuel rating of alternative liquid automotive fuels, as required by the Petroleum Marketing Practices Act. 15 U.S.C. 2822(a)-(c). The Rule also requires refiners, producers, importers, distributors, and retailers to retain records showing how the ratings were determined, including delivery tickets or letters of certification.

    Under the PRA, 44 U.S.C. 3501-3521, federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” means agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. 44 U.S.C. 3502(3); 5 CFR 1320.3(c). As required by section 3506(c)(2)(A) of the PRA, the FTC is providing this opportunity for public comment before requesting that OMB extend the existing paperwork clearance for the regulations noted herein.

    Pursuant to Section 3506(c)(2)(A) of the PRA, the FTC invites comments on: (1) Whether the disclosure and recordkeeping requirements are necessary, including whether the information will be practically useful; (2) the accuracy of our burden estimates, including whether the methodology and assumptions used are valid; (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. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before May 15, 2017.

    Estimated annual hours burden: 33,052 total burden hours (13,500 recordkeeping hours + 19,552 disclosure hours).

    Recordkeeping: Based on industry sources, staff estimates that approximately 162,000 fuel industry members 1 each incur an average annual burden of approximately five minutes to ensure retention of relevant business records 2 for the period required by the Rule, resulting in a total of 13,500 hours.

    1 Staff derived the number of fuel industry members by adding the number of refiners, producers, importers, distributors, and retailers of these types of fuel. Staff consulted government agencies and industry sources in estimating a population of approximately 162,000 fuel industry members, including 156,418 retailers of automotive fuel. Some of the government Web sites reviewed to update these numbers include: http://www.eia.gov/dnav/pet/pet_pnp_cap1_dcu_nus_a.htm (Gasoline Producers); http://www.eia.gov/biofuels/biodiesel/production/ (Biodiesel Producers); http://www.afdc.energy.gov/fuels/ (Alternative Fuel Stations); http://www.nacsonline.com/YourBusiness/FuelsReports/2015/Documents/2015-NACS-Fuels-Report_full.pdf (Petroleum Stations).

    2 Under the Fuel Rating Rule, refiners, producers, importers, distributors, and retailers of automotive fuel must retain, for one year, records of any delivery tickets, letters of certification, or tests upon which they based the automotive fuel ratings that they certify or post. See the Fuel Rating Rule's recordkeeping requirements, 16 CFR 306.7; 306.9; and 306.11.

    Disclosure: Staff estimates that affected industry members incur an average burden of approximately one hour to produce, distribute, and post octane rating labels. Because the labels are durable, only about one of every eight industry member retailers (19,552 of 156,418 industry member retailers) incur this burden each year, resulting in a total annual burden of 19,552 hours.

    Estimated annual labor costs: $390,430.

    Labor costs are derived by applying appropriate hourly cost figures to the burden hours described above. Here, the average hourly wages of refiners, producers, distributors, and importers is $35.12.3 The average hourly wages of retailers is $11.48.4 The recordkeeping component, 13,500 hours, consists of approximately 465 hours for producers, distributors, and importers; 13,035 hours for retailers. Thus, the total annual labor cost for recordkeeping is $165,973 ((465 hours × $35.12) + (13,035 hours × $11.48/hour)). The disclosure component, which concerns retailers, is approximately 19,552 hours. Thus, total annual labor cost for disclosure is $224,457 (19,552 hours × $11.48/hour).

    3See http://www.bls.gov/iag/tgs/iag211.htm#earnings (Bureau of Labor Statistics, December 2016 Current Employment Statistics, Average Hourly Earnings for Oil and Gas Extraction Production and Nonsupervisory Employees).

    4See http://www.bls.gov/iag/tgs/iag447.htm (Bureau of Labor Statistics, December 2016 Current Employment Statistics, Average Hourly Earnings for Gasoline Station Production and Nonsupervisory Employees).

    Estimated annual non-labor costs: $78,209.

    Staff believes that the Rule does not impose any capital costs for producers, importers, or distributors of fuels. Retailers, however, incur the cost of procuring and replacing fuel dispenser labels to comply with the Rule. Staff conservatively estimates that the price per automotive fuel label is two dollars and that the average automotive fuel retailer has six dispensers; thus, $12 labeling cost at inception per retailer.5 Staff has previously estimated a dispenser useful life range of 6 to 10 years and, based on that, assumed a useful life of 8 years for labels, the mean of that range. Given that, replacement labeling will not be necessary for well beyond the relevant period at issue, i.e., the immediate 3-year PRA clearance sought. However, conservatively annualizing the $12 labeling cost at inception per retailer over that shorter period rather than average useful life, annualized labeling cost per retailer will be $4. Cumulative labeling cost would thus be $78,209 (156,418 retailers × 1/8 × $4 each, annualized).

    5See 75 FR 12,470, 12,477 (Mar. 16, 2010) (proposed rulemaking) (estimating the price range per pump to be one to two dollars).

    Request for Comment: You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before May 15, 2017. Write “Fuel Rating Rule PRA Comment, FTC File No. P144200” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

    Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential,” as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

    If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).6 Your comment will be kept confidential only if the FTC General Counsel grants your request in accordance with the law and the public interest. Once your comment is posted, as legally required by FTC Rule 4.9(b), we cannot redact or remove your comment from the FTC's public record, including the FTC's Web site, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request in accordance with the law and the public interest, as explained above.

    6 In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c), 16 CFR 4.9(c).

    Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/fuelratingpra, by following the instructions on the web-based form. When this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that Web site.

    If you file your comment on paper, write “Fuel Rating Rule PRA Comment, FTC File No. P144200” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

    The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before May 15, 2017. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see http://www.ftc.gov/ftc/privacy.htm.

    David C. Shonka, Acting General Counsel.
    [FR Doc. 2017-04964 Filed 3-13-17; 8:45 am] BILLING CODE 6750-01-P
    FEDERAL TRADE COMMISSION [File No. 172 3052] Block Division, Inc.; Analysis of Proposed Consent Order To Aid Public Comment AGENCY:

    Federal Trade Commission.

    ACTION:

    Proposed consent agreement.

    SUMMARY:

    The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.

    DATES:

    Comments must be received on or before April 7, 2017.

    ADDRESSES:

    Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/blockdivisionconsent online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write “In the Matter of Block Division, Inc., File No. 172 3052” on your comment and file your comment online at https://ftcpublic.commentworks.com/ftc/blockdivisionconsent by following the instructions on the Web-based form. If you prefer to file your comment on paper, write “In the Matter of Block Division, Inc., File No. 172 3052” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024.

    FOR FURTHER INFORMATION CONTACT:

    Julia Solomon Ensor, Attorney, (202) 326-2377, or Crystal Ostrum, Attorney, (202) 326-3405, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580.

    SUPPLEMENTARY INFORMATION:

    Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for March 8, 2017), on the World Wide Web at: http://www.ftc.gov/os/actions.shtm.

    You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before April 7, 2017. Write “In the Matter of Block Division, Inc., File No. 172 3052” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

    Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which . . . is privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

    If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).1 Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest.

    1 In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c), 16 CFR 4.9(c).

    Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/blockdivisionconsent by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that Web site.

    If you file your comment on paper, write “In the Matter of Block Division, Inc., File No. 172 3052” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

    Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before April 7, 2017. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

    Analysis of Proposed Consent Order To Aid Public Comment

    The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Block Division, Inc. (“respondent”).

    The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement's proposed order.

    This matter involves respondent's marketing, sale, and distribution of pulley blocks and other products with claims that the products are of U.S.-origin. According to the FTC's complaint, respondent represented that its products are “Made in USA.” In fact, respondent's products incorporate significant imported parts, including imported steel pulley plates that entered the United States from overseas already stamped “Made in USA.”

    The complaint alleges that respondent's claims that its products are “Made in USA” were false or misleading, or not substantiated at the time the representations were made. Accordingly, the complaint alleges that respondent engaged in deceptive acts or practices in violation of Section 5(a) of the FTC Act.

    The proposed consent order contains provisions designed to prevent respondent from engaging in similar acts and practices in the future. Consistent with the FTC's Enforcement Policy Statement on U.S. Origin Claims, Part I prohibits Block Division, Inc. from making U.S.-origin claims for its products unless either: (1) The final assembly or processing of the product occurs in the United States, all significant processing that goes into the product occurs in the United States, and all or virtually all ingredients or components of the product are made and sourced in the United States; or (2) a clear and conspicuous qualification appears immediately adjacent to the representation that accurately conveys the extent to which the product contains foreign parts, ingredients, and/or processing.

    Part II prohibits respondent from making any “Made in USA” or other country-of-origin claim about a product or service unless the claim is true, not misleading, and respondent has a reasonable basis substantiating the representation.

    Parts III through VI are reporting and compliance provisions. Part III requires respondent to acknowledge receipt of the order, to provide a copy of the order to certain current and future principals, officers, directors, and employees, and to obtain an acknowledgement from each such person that they have received a copy of the order. Part IV requires the filing of compliance reports within one year after the order becomes final and within 10 days of any change in respondent that would affect compliance with the order. Part V requires respondent to maintain certain records, including records necessary to demonstrate compliance with the order. Part VI requires respondent to submit additional compliance reports when requested by the Commission and to permit the Commission or its representatives to interview respondent's personnel.

    Finally, Part VII is a “sunset” provision, terminating the order after twenty (20) years, with certain exceptions.

    The purpose of this analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed order or to modify its terms in any way.

    By direction of the Commission.

    Donald S. Clark, Secretary.
    [FR Doc. 2017-04919 Filed 3-13-17; 8:45 am] BILLING CODE 6750-01-P
    FEDERAL TRADE COMMISSION Agency Information Collection Activities; Submission for OMB Review; Comment Request AGENCY:

    Federal Trade Commission (“FTC”).

    ACTION:

    Notice and request for comment.

    SUMMARY:

    In compliance with the Paperwork Reduction Act (PRA) of 1995, the FTC is seeking public comments on its request to OMB for a three-year extension of the current PRA clearance for information collection requirements contained in its Rule Governing Pre-sale Availability of Written Warranty Terms. That clearance expires on March 31, 2017.

    DATES:

    Comments must be received by April 13, 2017.

    ADDRESSES:

    Interested parties may file a comment online or on paper by following the instructions in the Request for Comments part of the SUPPLEMENTARY INFORMATION section below. Write “Warranty Rules: Paperwork Comment, FTC File No. P044403” on your comment, and file your comment online at https://ftcpublic.commentworks.com/ftc/presaleavailabilityrule2pra by following the instructions on the Web-based form. If you prefer to file your comment on paper, mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the proposed information requirements should be addressed to Christine M. Todaro, Attorney, Division of Marketing Practices, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW., CC-8528, Washington, DC 20580, (202) 326-3711.

    SUPPLEMENTARY INFORMATION:

    Title: Pre-sale Availability of Written Warranty Terms (Pre-Sale Availability Rule or Rule), 16 CFR 702.

    OMB Control Number: 3084-0112.

    Type of Review: Extension of a currently approved collection.

    Abstract: On December 29, 2016, the FTC sought public comment on the information collection requirements associated with Regulation O. 81 FR 95995. No germane comments were received.1 Pursuant to the OMB regulations, 5 CFR part 1320, that implement the PRA, 44 U.S.C. 3501 et seq., the FTC is providing this second opportunity for public comment while seeking OMB approval to renew the pre-existing clearance for the Rule.

    1 The Commission received six non-germane comments.

    The Pre-sale Availability Rule, 16 CFR. 702, is one of three rules 2 that the FTC issued as required by the Magnuson Moss Warranty Act, 15 U.S.C. 2301 et seq. (Warranty Act or Act).3 The Pre-sale Availability Rule requires sellers and warrantors to make the text of any written warranty on a consumer product costing more than $15 available to the consumer before sale. Among other things, the Rule requires sellers to make the text of the warranty readily available either by (1) displaying it in close proximity to the product or (2) furnishing it on request and posting signs in prominent locations advising consumers that the warranty is available. The Rule requires warrantors to provide materials to enable sellers to comply with the Rule's requirements and also sets out the methods by which warranty information can be made available before the sale if the product is sold through catalogs, mail order, or door to door sales. In addition, in 2016, the FTC revised the Rule to allow warrantors to post warranty terms on Internet Web sites if they also provide a non-Internet based method for consumers to obtain the warranty terms and satisfy certain other conditions. The revised Rule also allows certain sellers to display warranty terms pre-sale in an electronic format if the warrantor has used the online method of disseminating warranty terms.

    2 The other two rules relate to the information that must appear in a written warranty on a consumer product costing more than $15 if a warranty is offered and minimum standards for informal dispute settlement mechanisms that are incorporated into a written warranty.

    3 40 FR 60168 (Dec. 31, 1975).

    Likely Respondents: Manufacturers and retailers of consumer products.

    Estimated Annual Hours Burden: 2,823,803 hours (221,547 hours for manufacturers + 2,602,256 hours for retailers).

    • Manufacturers account for approximately 221,547 hours ((1,028 large manufacturers × 26.88 hours) + (30,299 small manufacturers × 6.4 hours)) • Retailers account for approximately 2,602,256 hours ((7,745 large retailers × 20.8 burden hours) + (508,575 small retailers × 4.8 burden hours))

    Estimated Annual Cost Burden: $62,123,688 (which is derived from $33,885,648 for sales associates + $28,238,040 for clerical workers).4

    4 The wage rates used in this Notice reflect data from the Bureau of Labor Statistics, Occupational Employment and Wages (May 2015), available at http://www.bls.gov/news.release/pdf/ocwage.pdf.

    • Sales Associates: (1,411,902 hours) ($24/hour) = $33,885,648 • Clerical Workers: (1,411,902 hours) ($20/hour) = $28,238,040

    Total Annual Capital or Other Non-labor Costs: De minimis.

    Request for Comment

    You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before April 13, 2017. Write “Warranty Rules: Paperwork Comment, FTC File No. P044403” on your comment. Your comment, including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

    Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

    If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you are required to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). Your comment will be kept confidential only if the FTC General Counsel grants your request in accordance with the law and the public interest.

    Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comment online, or to send it to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/presaleavailabilityrule2pra, by following the instructions on the Web-based form. If this Notice appears at http://www.regulations.gov, you also may file a comment through that Web site.

    If you file your comment on paper, write “Warranty Rules: Paperwork Comment, FTC File No. P044403” on your comment and on the envelope, and mail it to the following address: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex J), 600 Pennsylvania Avenue NW., Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

    Visit the Commission Web site at http://www.ftc.gov to read this Notice. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before April 13, 2017. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.shtm.

    Comments on the information collection requirements subject to review under the PRA should also be submitted to OMB. If sent by U.S. mail, address comments to: Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street NW., Washington, DC 20503. Comments sent to OMB by U.S. postal mail, however, are subject to delays due to heightened security precautions. Thus, comments instead should be sent by facsimile to (202) 395-5167.

    David C. Shonka, Acting General Counsel.
    [FR Doc. 2017-04929 Filed 3-13-17; 8:45 am] BILLING CODE 6750-01-P
    GULF COAST ECOSYSTEM RESTORATION COUNCIL Notice of Proposed Subaward Under a Council-Selected Restoration Component Award AGENCY:

    Gulf Coast Ecosystem Restoration Council.

    ACTION:

    Notice.

    SUMMARY:

    The Gulf Coast Ecosystem Restoration Council (Council) publishes notice of a proposed subaward from the National Oceanic and Atmospheric Administration National Centers for Coastal Ocean Science (NOAA) to the Gulf of Mexico Alliance (GOMA), a nonprofit organization, for the purpose of supporting the Council Monitoring and Assessment Program (CMAP). The Council and NOAA have entered an interagency agreement for NOAA to carry out CMAP, as approved in the Council's Initial Funded Priorities List.

    FOR FURTHER INFORMATION CONTACT:

    Please send questions by email to [email protected]

    SUPPLEMENTARY INFORMATION:

    Section 1321(t)(2)(E)(ii)(III) of the RESTORE Act (33 U.S.C. 1321(t) and note) and Treasury's implementing regulation at 31 CFR 34.401(b) require that, for purposes of awards made under the Council-Selected Restoration Component, a State or Federal award recipient may make a grant or subaward to or enter into a cooperative agreement with a nongovernmental entity that equals or exceeds 10 percent of the total amount of the award provided to the State or Federal award recipient only if certain notice requirements are met. Specifically, at least 30 days before the State or Federal award recipient enters into such an agreement, the Council must publish in the Federal Register and deliver to specified Congressional Committees the name of the recipient and subrecipient; a brief description of the activity, including its purpose; and the amount of the award. This notice accomplishes the Federal Register publication requirement.

    Description of Proposed Action

    As specified in the Initial Funded Priorities List, which is available on the Council's Web site at https://www.restorethegulf.gov/council-selected-restoration-component/funded-priorities-list, RESTORE Act funds will support the Council Monitoring and Assessment Program (CMAP). Administered jointly by NOAA and the Department of the Interior's United States Geological Survey (USGS), CMAP will build the foundational components for Gulf region-wide monitoring in order to measure impacts of investments in restoration. Through collaboration with the Gulf States, federal and local partners, academia, non-governmental/non-profit organizations, and industry, the program will use a Monitoring Community of Practice coordinated by the Gulf of Mexico Alliance to leverage existing resources, capacities, and expertise and build on existing monitoring programs. These existing programs will be coordinated into a network, to provide efficiency in monitoring and collaborative cross-program review of performance with other Gulf ecosystem recovery efforts.

    The program will: (1) Create an inventory of the existing monitoring programs, data, protocols and standards; (2) determine the minimum monitoring elements needed to evaluate the performance of restoration projects; (3) evaluate monitoring program suitability; (4) combine data from the suitable existing programs into searchable databases for Council use; (5) examine the inventory to determine what data are missing (i.e. identify information gaps) that would be required for the RESTORE Council; (6) document existing baseline assessments of habitat and water quality conditions; and (7) provide recommendations to the Council to supplement and refine the existing monitoring programs to fill-in the information gaps where possible.

    Will D. Spoon, Program Analyst, Gulf Coast Ecosystem Restoration Council.
    [FR Doc. 2017-04937 Filed 3-13-17; 8:45 am] BILLING CODE 6560-58-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2017-0008] Proposed Data Collection Submitted for Public Comment and Recommendations: Survey of Engineered Nanomaterial Occupational Safety and Health Practices; Extension of Public Comment Period AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Extension of public comment period.

    SUMMARY:

    On February 10, 2017, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) published a notice in the Federal Register requesting public comment on the proposed information collection entitled “Survey of Engineered Nanomaterial Occupational Safety and Health Practices”. Written and electronic comments were to be received on or before April 11, 2017. Because of an improper docket opening, CDC is extending the comment period to allow the public a full 60 days to provide comment on this docket. In consideration of this public access issue, HHS/CDC is extending the comment period to May 12, 2017.

    DATES:

    Written comments must be received on or before May 11, 2017.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2017-0008 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

    Please note:

    All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide 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.

    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.

    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. 2017-04942 Filed 3-13-17; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1062] Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; establishment of a public docket; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document.

    DATES:

    The meeting will be held on April 5, 2017, from 8 a.m. to 5 p.m.

    ADDRESSES:

    Tommy Douglas Conference Center, the Ballroom, 10000 New Hampshire Ave., Silver Spring, MD 20903. The conference center's telephone number is 240-645-4000. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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-2017-N-1062 for “Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://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 https://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 https://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:

    Stephanie L. Begansky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: The committees will discuss new drug application (NDA) 209777, for oxycodone hydrochloride immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC., with the proposed indication of management of moderate to severe pain where the use of an opioid analgesic is appropriate. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

    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: On April 5, 2017, from 9:15 a.m. to 5 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees. All electronic and written submissions submitted to the Docket (see the Addresses section) on or before March 22, 2017, will be provided to the committees. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 14, 2017. 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 March 15, 2017.

    Closed Committee Deliberations: On April 5, 2017, from 8 a.m. to 9:15 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the drug development program of an investigational abuse-deterrent opioid product.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-1062. The docket will close on April 4, 2017. Comments received on or before March 22, 2017, will be provided to the committees. Comments received after that date will be taken into consideration by the Agency.

    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 Stephanie L. Begansky 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: March 9, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-04983 Filed 3-13-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1129] Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the class II devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register.

    DATES:

    Submit either electronic or written comments on the notice by May 15, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 15, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 15, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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-2017-N-1129 for “Medical Devices; Exemptions from Premarket Notification: Class II Devices.” Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://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 https://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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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:

    Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), and the amendments of the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls), if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval), if there is insufficient information to support classifying a device into class I or class II and the device is a life sustaining or life supporting device or is for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury.

    Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of the FD&C Act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as postamendments devices) are classified through the premarket notification process under section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of the FD&C Act and the implementing regulations, part 807 of Title 21 of the Code of Federal Regulations (CFR), require persons who intend to market a new device to submit a premarket notification (510(k)) containing information that allows FDA to determine whether the new device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval.

    On December 13, 2016, the President signed into law the 21st Century Cures Act (Pub. L. 114-255). Section 3054 of the 21st Century Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act requires FDA to publish in the Federal Register a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. FDA is required to publish this notice within 90 days of the date of enactment of the 21st Century Cures Act and at least once every 5 years thereafter, as FDA determines appropriate. Additionally, FDA must provide at least a 60-day comment period for any such notice required to be published under section 510(m)(1)(A) of the FD&C Act. Within 210 days of enactment of the 21st Century Cures Act, FDA must publish in the Federal Register a list representing its final determination regarding the exemption of the devices that were contained in the present list published under section 510(m)(1)(A) of the FD&C Act. Section 510(m)(3) of the FD&C Act provides that upon the date of publication of the final list in the Federal Register, a 510(k) will no longer be required for these devices and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.

    In a final action, and after considering comments, FDA intends to amend the codified language for each listed regulation to reflect the final determination with respect to exempt devices. FDA's final action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. Specifically, regulated industry will no longer have to invest time and resources in 510(k) notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.

    II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (Ref. 1).

    III. Limitations on Exemptions

    FDA believes that the types of class II devices listed in this notice should be exempt from the premarket notification requirements found under section 510(k) of the FD&C Act. However, an exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's initial determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness for devices listed in this document is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.

    In addition to being subject to the general limitations to the exemptions found in §§ 862.9 to 892.9) 21 CFR 862.9 to 892.9, FDA may partially limit the exemption from premarket notification requirements to specific devices within a listed device type. In table 1, for example, FDA is listing the exemption of the endoscopic magnetic retriever, but limits the exemption to such devices that are for single use. All other endoscopic magnetic retrievers are still subject to premarket notification requirements because FDA determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices.

    IV. List of Class II Devices

    FDA is identifying the following list of class II devices that, if finalized, would no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in §§ 862.9 to 892.9:

    Table 1—Class II Devices 21 CFR section Device type Product code Partial exemption limitation
  • (if applicable)
  • 862.1020 Acid Phosphatase, Nitrophenylphosphate CJN 862.1020 Acid Phosphatase, Thymol Blue Monophosphate CJR 862.1020 Acid Phosphatase, Disodium Phenylphosphate CJX 862.1020 Acid Phosphatase, Naphthyl Phosphate CKB 862.1020 Acid Phosphatase, Thymolphthale Inmonophosphate CKE 862.1020 Acid Phosphatase, Beta Glycerophosphate CKH 862.1020 Acid Phosphatase (Prostatic), Tartrate Inhibited JFH 862.1090 Radioassay, Angiotensin Converting Enzyme KQN 862.1100 Vanillin Pyruvate, AST/SGOT CIF 862.1100 Diazo, AST/SGOT CIQ 862.1100 Hydrazone Colorimetry, AST/SGOT CIS 862.1100 NADH Oxidation/NAD Reduction, AST/SGOT CIT 862.1150 Calibrator, Primary JIS 862.1150 Calibrator, Secondary JIT 862.1150 Calibrator, Surrogate JIW 862.1150 Calibrator, Multi-Analyte Mixture JIX 862.1345 Drink, Glucose Tolerance MRV 862.1350 Continuous Glucose Monitor Secondary Display PJT 862.1445 Chromatographic Separation, Lactate Dehydrogenase Isoenzymes CEX 862.1445 Electrophoretic, Lactate Dehydrogenase Isoenzymes CFE 862.1445 Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes JGF 862.1509 System, Test, Urinary Methylmalonic Acid LPT 862.1685 Radioimmunoassay, Thyroxine-Binding Globulin CEE 862.1700 Radioimmunoassay, Total Thyroxine CDX 862.1700 Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI 862.2265 High Throughput DNA Sequence Analyzer PFF 862.2570 Instrumentation For Clinical Multiplex Test Systems NSU 862.2570 Real Time Nucleic Acid Amplification System OOI 862.2570 Mass Spectrometer For Clinical Multiplex Test Systems OTA 862.2570 Micro Total Analysis Instrument System OUE 862.2570 Complete Gene Expression Profiling Accessory Reagents OVA 862.2570 DNA Genetic Analyzer PCA 862.2570 Data Acquisition Software PQQ 862.3100 Enzyme Immunoassay, Amphetamine DKZ Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3100 Radioimmunoassay, Amphetamine DJP Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3100 Thin Layer Chromatography, Amphetamine DIT Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3100 Gas Chromatography, Amphetamine DOD Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3100 Liquid Chromatography, Amphetamine DNI Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150 Enzyme Immunoassay, Barbiturate DJL Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150 Enzyme Immunoassay, Barbiturate DIS Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150 Radioimmunoassay, Barbiturate DKN Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150 Thin Layer Chromatography, Barbiturate DKX Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150 Mercury Dithiazone, Colorimetry, Barbiturate DJN Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150 Hemagglutination Inhibition, Barbiturate DLX Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150 Gas Liquid Chromatography, Barbiturate DMF Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150 High Pressure Liquid Chromatography, Barbiturate KZY Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3170 Enzyme Immunoassay, Benzodiazepine JXM Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3170 High Pressure Liquid Chromatography, Benzodiazepine LAA Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3170 Test, Benzodiazepine, Over The Counter NFV Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3170 Gas Chromatography, Benzodiazepine KZZ Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3170 Thin Layer Chromatography, Benzodiazepine LAB Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3200 Calibrators, Drug Mixture DKB 862.3200 Calibrators, Drug Specific DLJ 862.3200 Calibrators, Ethyl Alcohol DNN 862.3250 Enzyme Immunoassay, Cocaine and Cocaine Metabolites DIO Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250 Radioimmunoassay, Cocaine Metabolite KLN Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250 Enzyme Immunoassay, Cocaine JXO Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250 Hemagglutination, Cocaine Metabolites (Benzoylecgonine) DLN Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250 Thin Layer Chromatography, Cocaine DMN Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250 Free Radical Assay, Cocaine DIR Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250 Gas Chromatography, Cocaine DIN Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250 Thin Layer Chromatography, Benzoylecgonine DOM Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250 High Pressure Liquid Chromatography, Cocaine and Cocaine Metabolites LAC Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3270 High Pressure Liquid Chromatography, Codeine LAE Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3270 Thin Layer Chromatography, Codeine DLD Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3270 Gas Chromatography, Codeine LAD Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3580 Radioimmunoassay, LSD (125-I) DLB Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3580 Free Radical Assay, LSD DOL Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3610 Gas Chromatography, Methamphetamine LAF Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3610 Thin Layer Chromatography, Methamphetamine DJC Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3610 High Pressure Liquid Chromatography, Methamphetamine LAG Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3610 Test, Methamphetamine, Over The Counter NGG Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3620 Enzyme Immunoassay, Methadone DJR Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3620 Hemagglutination Inhibition, Methadone DIW Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3620 Gas Chromatography, Methadone DMB Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3620 Thin Layer Chromatography, Methadone DKR Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3620 Liquid Chromatography, Methadone DNT Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3620 Free Radical Assay, Methadone DPP Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3630 Radioimmunoassay, Methaqualone KXS Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640 Thin Layer Chromatography, Morphine DNK Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640 Radioimmunoassay, Morphine (123-I), Goat Antibody Ammonium Sulfate Sep. DOE Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640 Fluorometry, Morphine DJJ Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640 Liquid Chromatography, Morphine DPK Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640 Gas Chromatography, Morphine DMY Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640 Hemagglutination Inhibition, Morphine DLR Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640 Free Radical Assay, Morphine DOK Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640 Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep. DIQ Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640 Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody DNA Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3650 Enzyme Immunoassay, Opiates DJG Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3650 Gas Chromatography, Opiates DJF Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3650 Hemagglutination, Opiates DLT Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3650 Thin Layer Chromatography, Opiates LAI Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3650 Free Radical Assay, Opiates DKT Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3650 High Pressure Liquid Chromatography, Opiates LAH Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3700 Enzyme Immunoassay, Propoxyphene JXN Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3700 Thin Layer Chromatography, Propoxyphene DPN Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3700 Gas Chromatography, Propoxyphene LAJ Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3700 High Pressure Liquid Chromatography, Propoxyphene LAK Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3870 Enzyme Immunoassay, Cannabinoids LDJ Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3870 Reagents, Test, Tetrahydrocannabinol DKE Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3870 Radioimmunoassay, Cannabinoid(S) LAT Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3910 High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs LFI Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3910 U.V. Spectrometry, Tricyclic Antidepressant Drugs LFH Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3910 Thin Layer Chromatography, Tricyclic Antidepressant Drugs MLK Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 864.5400 Fibrometer GIE 864.5400 Timer, Coagulation JBT 864.5425 Control, Plasma, Abnormal GGC 864.5425 Plasma, Coagulation Control GGN 864.5425 Plasma, Control, Normal GIZ 864.6550 Control, Fecal Occult Blood OSL 864.6650 Study, Platelet Adhesive JBZ 864.7275 Test, Euglobulin Lysis JBO 864.7300 Fibrin Monomer Paracoagulation JBN 864.7340 Fibrinogen Standard GFX 864.7340 Plasma, Fibrinogen Control GIL 864.7375 Glutathione, Red-Cell GII 864.7375 Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase JMH 864.7375 Assay, Glutathione Reductase KQF 864.7415 Control, Hemoglobin, Abnormal JCM 864.7455 Stain, Fetal Hemoglobin GHQ 864.7500 Acid Hematin GGF 864.7720 Test, Prothrombin Consumption GGQ 864.7735 Prothrombin-Proconvertin and Thrombotest JPF 864.8150 Calibrator for Cell Indices KRX 864.8165 Calibrator for Hemoglobin and Hematocrit Measurement KRZ 864.8175 Calibrator for Platelet Counting KRY 864.8185 Calibrator for Red-Cell and White-Cell Counting KSA 864.8625 Standards and Controls, Hemoglobin, Normal and Abnormal GFS 864.8625 Control, White-Cell GGL 864.8625 Control, Hemoglobin GGM 864.8625 Control, Platelet GJP 864.8625 Control, Red-Cell GJR 864.8625 Control, Hematocrit GLK 864.8625 Mixture, Control, White-Cell and Red-Cell Indices GLQ 864.8625 Control, Cell Counter, Normal and Abnormal JCN 864.8625 Mixture, Hematology Quality Control JPK 864.8625 Material, Quality Control, Semen Analysis NRF 864.8625 Control Material, Blood Circulating Epithelial Cancer Cell NRS 864.9400 Solution, Stabilized Enzyme KSK 866.3395 Norovirus Serological Reagents OUC 866.5210 Immunochemical, Ceruloplasmin CHN 866.5210 Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control DCT 866.5210 Ceruloplasmin, FITC, Antigen, Antiserum, Control DCY 866.5210 Ceruloplasmin, Antigen, Antiserum, Control DDB 866.5210 P-Phenyl-Enediamine/EDTA (Spectrophotometric), Ceruloplasmin JFQ 866.5210 Indirect Copper Assay, Ceruloplasmin JFR 866.5470 Hemoglobin, Chain Specific, Antigen, Antiserum, Control DAM 866.5620 Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control DDT 866.5620 Alpha-2-Macroglobulin, FITC, Antigen, Antiserum, Control DDY 866.5620 Alpha-2-Macroglobulin, Antigen, Antiserum, Control DEB 866.5630 System, Test, Beta-2-Microglobulin Immunological JZG 866.5750 System, Test, Radioallergosorbent (RAST) Immunological DHB Exemption is limited to devices classified under 21 CFR 866.5750 that are intended to detect any of the allergens included in table 2 of this document. 866.5910 Quality Control Material, Genetics, DNA NZB 868.1040 Algesimeter, Powered BSI 868.1400 Legging, Compression, Non-Inflatable LLK 868.2385 Analyzer, Nitrogen Dioxide MRQ Exemption is limited to standalone nitrogen dioxide analyzers and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy. 868.2500 Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK 868.2500 Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia LPP 868.2550 Pneumotachometer JAX 868.5180 Bed, Rocking, Breathing Assist CCO 868.6250 Compressor, Air, Portable BTI 870.1330 Wire, Guide, Catheter DQX Exemption is limited to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires. 870.1390 Trocar DRC 870.1650 Syringe, Balloon Inflation MAV Exemption is limited to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon. 870.1875 Lung Sound Monitor OCR 870.2675 Oscillometer DRZ 870.2770 Analyzer, Body Composition MNW Exemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition. 870.4280 Filter, Prebypass, Cardiopulmonary Bypass KRJ 870.4290 Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL 870.4340 Monitor and/or Control, Level Sensing, Cardiopulmonary Bypass DTW 870.4400 Reservoir, Blood, Cardiopulmonary Bypass DTN Exemption is limited to cardiopulmonary bypass blood reservoirs that do not contain defoamers or blood filters. 870.4420 Sucker, Cardiotomy Return, Cardiopulmonary Bypass DTS 870.4430 Suction Control, Intracardiac, Cardiopulmonary Bypass DWD 872.1720 Tester, Pulp EAT 872.3260 External Cleaning Solution PME 872.3300 Coating, Denture Hydrophilic, Resin EBE 872.3540 Pad, Denture, Over The Counter EHR 872.3540 Cushion, Denture, Over The Counter EHS 872.3560 Reliner, Denture, Over The Counter EBP 872.3590 Denture, Plastic, Tooth ELM 872.3600 Denture Preformed (Partially Prefabricated Denture) EKO 872.3890 Splint, Endodontic Stabilizing ELS 872.5550 Ring, Teething, Fluid-Filled KKO 872.6770 Syringe, Cartridge EJI 874.1090 Tester, Auditory Impedance ETY Exemption is limited to auditory impedance testers that are in compliance with FDA-recognized consensus standard ANSI S3.39. 874.1090 Tympanometer NAS Exemption is limited to tympanometers that are in compliance with FDA-recognized consensus standard ANSI S3.39. 874.1120 Generator, Electronic Noise (for Audiometric Testing) ETS 874.1325 Electroglottograph KLX 874.3310 Calibrator, Hearing Aid/Earphone and Analysis Systems ETW 874.3320 Hearing Aid, Group and Auditory Trainer EPF 874.3320 Device, Assistive Listening LZI 874.3330 Hearing Aid, Master KHL 874.3430 Mold, Middle-Ear ETC 874.3730 Device, Voice Amplification MCK 876.1500 Endoscopic Magnetic Retriever FCC Exemption is limited to endoscopic magnetic retrievers intended for single use. 876.1500 Light Source, Incandescent, Diagnostic FCQ 876.1500 Light Source, Photographic, Fiberoptic FCR 876.1500 Light Source, Fiberoptic, Routine FCW 876.1500 Carrier, Sponge, Endoscopic FGS 876.1500 Light Source, Endoscope, Xenon Arc GCT 876.1500 Transformer, Endoscope GCW 876.1500 Scissors For Cystoscope KGD Exemption is limited to sterile scissors for cystoscope intended for single use. 876.1500 LED Light Source NTN 876.1500 Endoscopic Guide Wire, Gastroenterology-Urology OCY 876.1500 Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ Exemption is limited to disposable, non-powered endoscopic grasping/cutting instruments intended for single use. 876.4020 Light, Catheter, Fiberoptic, Glass, Ureteral FCS 876.4270 Rod, Colostomy EZP 876.4400 Ligator, Hemorrhoidal FHN 876.4400 Ligator, Esophageal MND 876.4500 Lithotriptor, Biliary Mechanical LQC 876.4770 Urethrotome EZO 876.5010 Bag, Bile Collecting EXF 876.5010 Catheter, Biliary, Surgical GCA Exemption is limited to surgical biliary catheters that do not include a balloon component. 876.5025 Vibrator for Climax Control of Premature Ejaculation PIA 876.5365 Dilator, Esophageal (Metal Olive) Gastro-Urology EZM 876.5365 Bougie, Esophageal, and Gastrointestinal, Gastro-Urology FAT 876.5365 Dilator, Esophageal KNQ 876.5520 Dilator, Urethral KOE 876.5630 Catheter, Peritoneal, Long-Term Indwelling FJS Exemption is limited to non-patient contacting catheter finger grips intended for single use. 876.5630 Catheter, Peritoneal Dialysis, Single Use FKO Exemption is limited to non-patient contacting catheter finger grips intended for single use. 876.5630 System, Peritoneal, Automatic Delivery FKX Exemption is limited to continuous ambulatory peritoneal dialysis (CAPD) belts and catheter stands that do not include weigh scales. 876.5665 Disinfectant, Subsystem, Water Purification NIH 876.5820 Set, Dialyzer Holder FKI 876.5895 Irrigator, Ostomy EXD 876.5980 Catheter, Retention, Barium Enema With Bag FGD 876.5980 Gastrostomy Tube Holder PLI 878.4370 Drape, Surgical, ENT ERY 878.4370 Drape, Pure Latex Sheet, With Self-Retaining Finger Cot EYX 878.4370 Drape, Urological, Disposable EYY 878.4370 Pad, Kelly FNW 878.4370 Drape, Patient, Ophthalmic HMT 878.4370 Drape, Microscope, Ophthalmic HMW 878.4370 Ring (Wound Protector), Drape Retention, Internal KGW 878.4370 Drape, Surgical KKX Exemption is limited to surgical drapes that do not include an antimicrobial agent. 878.4495 Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ Exemption is limited to steel monofilament sutures that are uncoated and do not incorporate barbs. 878.4580 Lamp, Operating-Room FQP 878.4580 Light, Surgical, Instrument FSQ 878.4580 Light, Surgical, Floor Standing FSS 878.4580 Light, Surgical, Endoscopic FSW 878.4580 Light, Surgical, Connector FSX 878.4580 Light, Surgical, Ceiling Mounted FSY 878.4580 Light, Surgical, Carrier FSZ 878.4580 Light, Surgical, Accessories FTA 878.4580 Lamp, Surgical FTD 878.4580 Illuminator, Remote FTG 878.4580 Lamp, Surgical, Incandescent GBC 878.5070 Apparatus, Air Handling, Bench FZG 878.5070 Apparatus, Air Handling, Room FZH 878.5070 Apparatus, Air Handling, Enclosure FZI 880.5580 Locator, Acupuncture Point BWJ 880.5580 Needle, Acupuncture, Single Use MQX 880.5780 Stocking, Medical Support (to Prevent Pooling of Blood in Legs) DWL 882.1020 Analyzer, Rigidity GZM 882.1470 Computerized Cognitive Assessment Aid PKQ Exemption is limited to computerized cognitive assessment aids that are not intended for diagnostic assessment of specific diseases or conditions and rely on inputs from visual cues, auditory cues, and/or functional use of the hand. 882.1540 Device, Galvanic Skin Response Measurement GZO 882.1560 Device, Skin Potential Measurement HCJ 882.1855 Encephalogram Telemetry System GYE 882.5895 Vibratory Counter-Stimulation OVP 884.1630 Colposcope (and Colpomicroscope) HEX Exemption is limited to standard colposcopes (and colpomicroscopes) that use only a white light source, do not use filters other than a green filter, do not include image analysis software, and are not smartphone-based. 884.2990 Sheet, Recording, Breast Examination NHM 884.3200 Drain, Cervical HFL 884.4400 Forceps, Obstetrical HDA 884.4530 Tenaculum, Uterine HDC Exemption is limited to sterile urterine tenaculum devices that do not use suction and are intended for single use. 884.4530 Clamp, Umbilical HFW 884.4530 Speculum, Vaginal, Nonmetal HIB 884.4530 Speculum, Vaginal, Nonmetal, Fiberoptic HIC 884.4530 Clamp and Cutter, Umbilical NBZ 884.4900 Table, Obstetrical, AC-Powered (and Accessories) HDD 884.4900 Table, Obstetrical, Manual (and Accessories) HHP 884.4900 Table, Obstetric (and Accessories) KNC 884.5200 Hemorrhoid Prevention Pressure Wedge OOA 884.5390 Heater, Perineal, Direct Contact HGZ 884.5390 Heater, Perineal, Radiant, Non-Contact HHA 884.5390 Heater, Perineal KND 884.5400 Cup, Menstrual HHE 884.5425 Pad, Menstrual, Scented HHL 884.6120 Accessory, Assisted Reproduction MQG Exemption is limited to single embryo incubators with temperature, gas, and humidity control only; syringe pumps; collection tube warmers; dish/plate/microscope stage warmers; and controlled-rate cryopreservation freezers. 884.6130 Microtools, Assisted Reproduction (Pipettes) MQH Exemption is limited to assisted reproduction microtools (pipettes) manufactured from glass. 884.6150 Micromanipulators and Microinjectors, Assisted Reproduction MQJ 884.6160 Labware, Assisted Reproduction MQK Exemption is limited to dishes and plates that are intended for general assisted reproduction technology procedures. 886.1120 Photorefractor MMF 886.1120 Camera, Ophthalmic, General-Use PJZ 886.1250 Euthyscope, AC-Powered HMK 886.1570 Ophthalmoscope, AC-Powered HLI 886.1570 Ophthalmoscope, Battery-Powered HLJ 886.1570 Ophthalmoscopes, Replacement Batteries, Hand-Held MSG 886.1780 Retinoscope, AC-Powered HKL 886.1850 Biomicroscope, Slit-Lamp, AC-Powered HJO Exemption is limited to slit-lamp, AC-powered biomicroscopes intended only for the visual examination of the anterior segment of the eye, are classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, do not provide any quantitative output, and are not intended for screening or automated diagnostic indications. 886.1945 Transilluminator, AC-Powered HJM 886.3320 Ocular Peg MQU Exemption is limited to ocular pegs supplied sterile. 886.4150 Tubing, Replacement, Phacofragmentation Unit MSR 886.4250 Unit, Electrolysis, AC-Powered, Ophthalmic HRO 886.4335 Headlight, Fiberoptic Focusing FCT 886.4335 Light, Headband, Surgical FSR 886.4335 Headlamp, Operating, AC-Powered HPQ 886.4400 Locator, Metal, Electronic HPM 886.4440 Magnet, AC-Powered HPO 886.4790 Sponge, Ophthalmic HOZ 886.4790 Eye Tray OJK 888.1240 Dynamometer, AC-Powered LBB 888.4580 Instrument, Surgical, Sonic and Accessory/Attachment JDX 888.4580 System, Cement Removal Extraction LZV 890.1450 Hammer, Reflex, Powered IKO 890.5100 Bath, Hydro-Massage ILJ 890.5100 Bath, Sitz, Powered ILM 890.5110 Bath, Paraffin IMC 890.5250 Cabinet, Moist Steam IMB 890.5360 Exerciser, Measuring ISD 890.5500 Lamp, Infrared, Therapeutic Heating ILY 890.5575 Device, Warning, Overload, External Limb, Powered IRN 892.1000 MRI Disposable Kit OIM 892.1560 Biopsy Needle Guide Kit OIJ 892.1610 Aperature, Radiographic IZS 892.1610 Cone, Radiographic IZT 892.1610 Collimator, Automatic, Radiographic IZW 892.1610 Collimator, Manual, Radiographic IZX 892.1610 Device, Beam Limiting, X-Ray, Diagnostic KPW 892.1650 Arthrogram Tray OII 892.1650 Radiology Dental Tray OIK 892.1670 Device, Spot-Film IXL 892.1680 Radiographic Contrast Tray OIO 892.1680 Radiology Diagnostic Kit OIP 892.1730 Discography Kit OIL 892.1820 Chair, Pneumocephalographic HBK 892.1850 Cassette, Radiographic Film IXA 892.1860 Changer, Radiographic Film/Cassette KPX 892.1870 Programmer, Changer, Film/Cassette, Radiographic IZP 892.1900 Controller, Temperature, Radiographic EGT 892.1900 Dryer, Film, Radiographic EGW 892.1900 Processor, Radiographic-Film, Automatic, Dental EGY 892.1900 Processor, Radiographic-Film, Automatic IXW 892.1900 Processor, Cine Film IXX 892.2030 Digitizer, Image, Radiological LMA 892.2030 Digitizer, Images, Ophthalmic NFH 892.2040 Camera, Multi Format, Radiological LMC 892.2040 Device, Hardcopy, Images, Ophthalmic NFI 892.5730 Prostate Seeding Kit OIN

    In table 1, FDA included devices classified under § 866.5750 (Radioallergosorbent (RAST) immunological test system, product code “DHB”). FDA does not believe that all devices with the product code DHB meet the exemption criteria from premarket notification requirements. However, FDA is identifying a substantial amount of these devices for exemption in table 2.

    Table 2—Class II Devices (§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems) Allergen code Allergen product Source
  • (taxonomical name)
  • Grass Pollens g1 Sweet vernal grass Anthoxanthum odoratum. g3 Cocksfoot grass, Orchard grass Dactylis glomerata. g4 Meadow fescue Festuca elatior. g5 Rye-grass (perennial rye grass) Lolium perenne. g7 Common reed (common reed grass) Phragmites communis. g8 Meadow grass, Kentucky blue (June grass) Poa pratensis. g9 Redtop, Bentgrass Agrostis stolonifera, Agrostis gigantea (Agrostis alba). g11 Brome grass Bromus inermis. g12 Cultivated rye (cultivated rye grass) Secale cereale. g13 Velvet grass Holcus lanatus. g14 Cultivated oat (cultivated oat grass) Avena sativa. g15 Cultivated wheat (cultivated wheat grass) Triticum aestivum (Triticum spp.). g16 Meadow foxtail (meadow foxtail grass) Alopecurus pratensis. g17 Bahia grass Paspalum notatum. g24 Wheat grass, Western Agropyron smithii (Elymus smithii). g30 Bluegrass, annual Poa annua. g70 Wild rye grass Elymus triticoides, Elymus condensatus. g71 Canary grass Phalaris arundinacea. g201 Barley, cultivated Hordeum vulgare. g202 Maize, corn (cultivated corn) Zea mays. g203 Salt grass Distichlis spicata. g204 False oat-grass Arrhenatherum elatius. g216 Cyn d 1 Cynodon dactylon. g701 Phl p 1.0102, Phl p 5.0101 Phleum pratense. g702 Phl p 7.0101 Phleum pratense. g703 Phl p 12.0101 Phleum pratense. Weed Pollens w2 Western ragweed Ambrosia psilostachya. w4 False ragweed Ambrosia acanthicarpa (Franseria acanthicarpa). w5 Wormwood Artemisia absinthium, Artemisia annua. w6 Mugwort Artemisia vulgaris. w7 Marguerite, ox-eye daisy Chrysanthemum leucanthemum. w8 Dandelion Taraxacum vulgare, Taraxacum officinale. w9 Plantain (English), Ribwort Plantago lanceolata. w10 Goosefoot, lamb's quarters Chenopodium album. w11 Saltwort (prickly), Russian thistle Salsola kali (Salsola pestifer). w12 Goldenrod Solidago virgaurea (Solidago spp.). w13 Cocklebur, common Xanthium commune. w14 Common pigweed (rough pigweed) Amaranthus retroflexus. w15 Scale, Lenscale Atriplex lentiformis. w16 Rough marsh elder Iva ciliate, Iva annua. w17 Firebush (Kochia) Kochia scoparia. w18 Sheep sorrel Rumex acetosella. w19 Wall pellitory Parietaria officinalis. w20 Nettle (Common stinging nettle) Urtica dioica. w21 Wall pellitory Parietaria judaica. w22 Japanese hop (careless weed) Humulus japonicas (Humulus scandens). w23 Yellow dock, Yellow dockweed Rumex crispus. w24 Spiny pigweed Amaranthus spinosus. w27 Carnation Dianthus spp. w28 Rose Rosa rugosa. w33 Clover Trifolium pratense. w35 Mexican tea Chenopodium ambrosioides. w36 Rabbit bush Ambrosia deltoidea (Franseria deltoides). w37 Salt bush, annual Atriplex wrightii. w39 Water hemp, Western Amaranthus rudis (Acnida tamariscina). w41 Burrobrush Hymenoclea salsola. w42 Poverty weed w43 Common sagebrush Artemisia tridentata. w45 Alfalfa Medicago sativa. w46 Dog fennel Eupatorium capillifolium. w53 Geranium Geranium spp. w67 Groundsel bush Baccharis halimifolia. w69 Iodine bush Allenrolfea occidentalis. w70 Ragweed, slender Ambrosia confertiflora. w75 Wing scale (wingscale) Atriplex canescens. w82 Careless weed Amaranthus palmeri, Amaranthus hybridus. w90 Japanese hop Humulus japonicas (Humulus scandens). w203 Rape (rape pollen) Brassica napus. w204 Sunflower Helianthus annuus. w206 Camomile Matricaria chamomilla. w207 Lupin Lupinus spp. w210 Sugar-beet Beta vulgaris. w211 Par j 2.0101 Parietaria judaica. w231 Art v 1 Artemisia vulgaris (Mugwort). w232 Sal k 1 Salsola kali. w233 Art v 3 Artemisa vulgaris (LTP, Mugwort). w234 Pla l 1 Plantago lanceolata. w235 Che a 1.0101 Chenopodium album. w236 Mer a 1.0101 Mercurialis annua. a753 Art v 1 Artemisia vulgaris (Mugwort weed). Tree Pollens t1 Box-elder (Maple) Acer negundo, Acer saccharum. t2 Gray alder, speckled alder (alder) Alnus incana. t4 Hazel, hazelnut Corylus avellana, Corylus americana. t5 American beech (beech) Fagus grandifolia (Fagus americana). t6 Mountain juniper, Mountain cedar Juniperus ashei (Juniperus sabinoides). t8 Elm Ulmus americana. t9 Olive Olea europaea. t10 Walnut Juglans californica, Juglans nigra. t11 Maple leaf sycamore, London plane, Plane tree Platanus acerifolia. t61 Sycamore Platanus occidentalis. t12 Willow Salix caprea, Salix nigra. t14 Cottonwood (Eastern Cottonwood/Black Cottonwood) Populus deltoides. t15 White ash Fraxinus americana. t16 White pine Pinus strobus. t18 Eucalyptus, gum-tree Eucalyptus globulus (Eucalyptus spp.). t19/t26 Acacia Acacia longifolia (Acacia spp.). t20 Mesquite Prosopis glandulosa/
  • Prosopis juliflora.
  • t21 Melaleuca, cajeput tree Melaleuca quinquenervia (Melaleuca leucadendron). t22 Pecan, hickory Carya illinoinensis (Carya pecan). t23 Italian/Mediterranean/funeral cypress Cupressus sempervirens. t24 Japanese cypress Chamaecyparis obtusa (Chamaecyparis spp.). t25 Ash Fraxinus excelsior. t27 Maple, red Acer rubrum. t29 Acacia Acacia spp. t30 Birch, white Betula populifolia. t32 Willow, black Salix nigra. t33 Ash, Arizona Fraxinus velutina. t35 Cedar, salt Tamarix gallica. t37 Bald cypress (white bald cypress) Taxodium distichum. t38 Elm, Chinese/Siberian Ulmus pumila. t40 Hazelnut tree Corylus americana. t41 White hickory Carya alba (Carya tomentosa). t42 Oak, red Quercus rubra. t43 Loblolly pine Pinus taeda. t44 Hackberry Celtis occidentalis. t45 Cedar elm Ulmus crassifolia. t47 Juniper, one seed Juniperus monosperma. t48 Pine, lodgepole Pinus contorta. t49 Pine, ponderosa Pinus ponderosa. t50 Beech, European Fagus sylvatica. t51 Tree of Heaven Ailanthus altissima. t52 Western white pine Pinus monticola. t54 Russian olive Elaeagnus angustifolia. t55 Scotch broom Cytisus scoparius. t56 Bayberry Myrica cerifera. t57 Red cedar Juniperus virginiana. t60 Western juniper Juniperus occidentalis. t61 Sycamore Platanus occidentalis. t70 Mulberry (white mulberry) Morus alba. t71 Red mulberry Morus rubra. t72 Queen palm Arecastrum romanzoffiamon. t73 Australian pine Casuarina equisetifolia. t77 Oak mix (red, white, black) Quercus spp. t80 Japanese cypress Chamaecyparis obtusa. t81 Japanese alder Alnus japonica. t83 Mango tree Mangifera indica. t90 Walnut, black Juglans nigra. t96 Poplar, white (poplar) Populus alba. t103/t218 Virginia live oak (live oak) Quercus virginiana. t105 Pepper tree Schinus molle. t110 Orange tree Citrus sinensis. t201 Spruce, Norway spruce Picea abies (Picea excelsa). t202 Alder, smooth Alnus incana spp. Rugosa (Alnus rugosa). t203 Horse chestnut Aesculus hippocastanum. t205 Elder Sambucus nigra. t206 Chestnut Castanea sativa. t207 Douglas fir Pseudotsuga menziesii (Pseudotsuga taxifolia). t208 Linden Tilia cordata. t209 Horn beam Carpinus betulus. t210 Privet Ligustrum vulgare. t211 Sweet gum Liquidambar styraciflua. t212 Cedar Libocedrus decurrens. t213 Pine Pinus radiata. t214 Date palm Phoenix canariensis. t215 Lilac Syringa vulgaris. t217 Pepper tree Schinus molle. t217 Red alder Alnus rubra. t218 Virginia live oak Quercus virginiana. t218 Bayberry (bayberry/sweet gale) Myrica gale. t219 Palo verde Cercidium floridum. t219 Red cedar Juniperus virginiana. t220 Bet v 4 Betula verrucosa (Birch). t221 Bet v 2.0101, Bet v 4 Betula verrucosa (Birch). t222 Cypress (Arizona cypress) Cupressus arizonica. t223 Oil palm Elaeis guineensis. t224 Ole e 1 Olea europaea. t225 Bet v 6 Betula verrucosa (Birch). t226 Cup a 1 Cupressus arizonica. t227 Ole e 7 Olea Europaea. t228 Aspen, quaking Populus tremuloides. t229 Eastern hemlock Tsuga canadensis. t230 Redwood (sequoia) Sequoia sempervirens. t232 Pussy willow Salix discolor. t240 Ole e 9.0101 Olea Europaea. t241 Pla a 1.0101 Platanus acerifolia. t242 Pla a 2 Platanus acerifolia. t243 Pla a 3.0101 Platanus acerifolia. t244 Cor a 1.0103 Corylus avellana. t245 Aln g 1.0101 Alnus glutinosa. t246 Cry j 1 Cryptomeria japonica. t280 Locust tree Robinia pseudoacacia. t401 Brazilian peppertree Schinus terebinthifolius. t402 Mastic tree Pistacia lentiscus. t404 Tree of heaven Ailanthus altissima. t406 Date palm Phoenix dactylifera. a482 Ole e 1 Olea europaea (Olive Oil). Mites d207 Blo t 5.0101 Blomia tropicalis. d208 Lep d 2.0101 Lepidoglyphus destructor. Microorganisms, Molds, Yeast m1 Penicillium chrysogenum (Penicillium notatum) Penicillium chrysogenum (Penicillium notatum). m2 Cladosporium herbarum (Hormodendrum) Cladosporium herbarum (Hormodendrum). m3 Aspergillus fumigatus Aspergillus fumigatus. m4 Mucor racemosus Mucor racemosus. m5 Candida albicans Candida albicans. m7 Botrytis cinerea Botrytis cinerea. m8 Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum) Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes). m9 Fusarium moniliforme (Fusarium proliferatum) Fusarium moniliforme (Fusarium proliferatum). m10 Stemphylium botryosum Stemphylium herbarum (Stemphylium botryosum). m11 Rhizopus nigricans Rhizopus nigricans. m12 Aureobasidium pullulans Aureobasidium pullulans. m13 Phoma betae Phoma betae. m14 Epicoccum purpurascens Epicoccum purpurascens (Epicoccum nigrum). m15 Trichoderma viride Trichoderma viride. m16 Curvularia lunata Curvularia lunata Curvularia specifera (K923044). m17 Cladosporium fulvum Cladosporium fulvum. m18 Fusarium culmorum Fusarium culmorum. m19 Aspergillus versicolor Aspergillus versicolor. m20 Mucor mucedo Mucor mucedo. m21 Aspergillus clavatus Aspergillus clavatus. m22 Micropolyspora faeni Saccharopolyspora rectivirgula (Micropolyspora faeni). m23 Thermoactinomyces vulgaris Thermoactinomyces vulgaris. m24 Stachybotrys atra Stachybotrys chartarum (Stachybotrys atra). m24 Paecilomyces spp Paecilomyces spp. m25 Aspergillus versicolor Aspergillus versicolor. m25 Penicillium brevicompactum Penicillium brevicompactum. m26 Cladosporium cladosporioides Cladosporium cladosporioides. m26 Penicillium citrinum Penicillium citrinum. m27 Penicillium spp Penicillium spp. m29 Aspergillus repens Aspergillus repens. m30 Penicillium roqueforti Penicillium roqueforti. m32 Cladosporium cladosporioides Cladosporium cladosporioides. m34 Serpula lacrymans Serpula lacrymans. m36 Aspergillus terreus Aspergillus terreus. m37 Trichophyton mentagrophytes Trichophyton mentagrophytes. m40 Aspergillus amstelodami Aspergillus amstelodami. m43 Saccharomyces carlsberg Saccharomyces carlsbergensis. m44 Saccharomyces cerevisiae Saccharomyces cerevisiae. m45 Hormodendrum hordei Hormodendrum hordei. m46 Bipolaris spicifera Bipolaris spicifera. m47 Aspergillus nidulans Aspergillus nidulans. m48 Aspergillus oryzae Aspergillus oryzae. m49 Fusarium oxysporum Fusarium oxysporum. m50 Micropolyspora faeni Saccharopolyspora rectivirgula (Micropolyspora faeni). m51 Thermoactinomyces vulgaris Thermoactinomyces vulgaris. m53 Microspora canis Microsporum canis (Microspora canis). m54 Aspergillus flavus Aspergillus flavus. m63 Helminthosporium intersemin Helminthosporium intersemin. m66 Mucor plumbeus Mucor plumbeus. m67 Mycogone Mycogone perniciosa. m68 Nigrospora oryzae Nigrospora oryzae. m69 Rhodotorula Rhodotorula rubra (Rhodotorula mucilaginosa). m70 Malassezia furfur (Pityrosporum orbiculare) Malassezia furfur (Pityrosporum orbiculare). m71 Spondylocladium Spondylocladium spp. m72 Epidermophyton Epidermophyton floccosum. m73 Epicoccum nigrum Epicoccum purpurascens (Epicoccum nigrum). m80 Staphylococcal enterotoxin A (Sta a SEA) Staphylococcus aureus. m80 Helminthosporium spp Helminthosporium spp. m81 Staphylococcal enterotoxin B (Sta a SEB) Staphylococcus aureus. m88 Stemphylium solani Stemphylium solani. m93 Gliocladium fimbriatum Gliocladium fimbriatum. m94 Phycomyces blakesleeanus Phycomyces blakesleeanus. m201 Tilletia tritici (Ustilago nuda, Ustilago tritici) (Barley smut) Tilletia tritici (Ustilago nuda, Ustilago tritici). m202 Acremonium kiliense (Cephalosporium acremonium) Acremonium kiliense (Cephalosporium acremonium). m203 Trichosporon pullulans Trichosporon pullulans. m204 Ulocladium chartarum Ulocladium chartarum. m205 Trichophyton rubrum Trichophyton rubrum. m207 Aspergillus niger Aspergillus niger. m208 Chaetomium globosum Chaetomium globosum. m209 Penicillium frequentans Penicillium glabrum (Penicillium frequentans). m209 Stachybotrys chartarum Stachybotrys chartarum (Stachybotrys atra). m210 Trichophyton mentagrophytes var. goetzii Trichophyton mentagrophytes var. goetzii. m211 Trichophyton mentagrophytes var. interdigitale Trichophyton mentagrophytes var. interdigitale. m211 Oat smut Ustilago avenae. m212 Micropolyspora faeni Saccharopolyspora rectivirgula (Micropolyspora faeni). m212 Geotrichum candidum Geotrichum candidum. m213 Bermuda grass smut Ustilago cynodontis. m214 Johnson grass smut Sphacelotheca cruenta. m215 Corn smut Ustilago maydis. m218 Asp f 1.0101 Aspergillus fumigatus. a3050 Asp r 1 Aspergillus restrictus. m219 Asp f 2 Aspergillus fumigatus. m220 Asp f 3.0101 Aspergillus fumigatus. m221 Asp f 4 Aspergillus fumigatus. m222 Asp f 6.0101 Aspergillus fumigatus. m223 Staphylococal enterotoxin C (Sta a SEC) Staphylococus aureus. m224 Staphylococcal enterotoxin D (Sta a SED) Staphylococcus aureus. m226 Staphylococcal enterotoxin TSST (Sta a TSST) Staphylococcus aureus. m227 Malassezia spp. (Pityrosporum spp.) Malassezia spp. (Pityrosporum spp.). m228 Aspergillus flavus. m229 Alt a 1.0101 Alternaria alternata (Alternaria tenuis). m230 Alt a 6.0101 Alternaria alternata (Alternaria tenuis). m231 Cla h 8.0101 Cladosporium herbarum (Hormodendrum). m300 Eurotium spp. Eurotium spp. m304 Aspergillus oryzae Aspergillus oryzae. m305 Penicillium brevicompactum Penicillium brevicompactum. m309 Aspergillus terreus Aspergillus terreus. m310 Aspergillus nidulans Aspergillus nidulans. m311 Aspergillus flavus Aspergillus flavus. m312 Aspergillus clavatus Aspergillus clavatus. Epidermal & Animal e6 Guinea pig epithelium Cavia porcellus. e7 Pigeon droppings Columba palumbus, Columba livia. e25 Chicken serum Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e26 Parrot serum Psittacoidea spp. e62 Camel Camelus dromedaries. e70 Goose feathers Anser anser. e71 Mouse epithelium Mus musculus (Mus spp.). e73 Rat epithelium Rattus norvegicus. e74 Rat urine proteins Rattus norvegicus Rattus rattus. e75 Rat serum proteins Rattus norvegicus Rattus rattus. e76 Mouse serum proteins Mus musculus (Mus spp.). e77 Budgerigar droppings Melopsittacus undulatus. e78 Budgerigar feathers Melopsittacus undulatus. e79 Budgerigar serum proteins Melopsittacus undulatus. e80 Goat epithelium Capra hircus. e81 Sheep epithelium Ovis aries (Ovis spp.). e82 Rabbit epithelium Oryctolagus cuniculus (Oryctolagus spp.). e83 Swine epithelium Sus scrofa (Sus scrofa domesticus; Sus spp.). e84 Hamster epithelium Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus. e85 Chicken feathers Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e86 Duck feathers Anas platyrhynchos. e87 Rat epithelium, serum proteins, and urine proteins Rattus norvegicus Rattus rattus. e88 Mouse epithelium, serum proteins, and urine proteins (mouse) Mus musculus (Mus spp.). e89 Turkey feathers Meleagris gallopavo. e90 Budgerigar serum proteins, feathers, and droppings Melopsittacus undulatus. e91 Pigeon serum proteins, feathers, and droppings Streptopelia roseogrisea Psittacidae spp. e92 Parrot serum proteins, feathers, and droppings Ara spp. e93 Pigeon serum proteins Streptopelia roseogrisea. e94 Fel d 1.0101 Felis domesticus. a345 Fel d 1 Felis domesticus. e98 Parrot droppings Psittacoidea spp. e101 Can f 1.0101 Canis familiaris (Canis domesticus). a174 Can f 1 Canis familiaris (Canis domesticus). e102 Can f 2.0101 Canis familiaris (Canis domesticus). e196 Parakeet feathers Nymphicus hollandicus. e197 Parakeet droppings Nymphicus hollandicus. e198 Parakeet serum Nymphicus hollandicus. e199 Canary bird serum Serinus canarius. e200 Canary bird droppings Serinus canarius. e201 Canary bird feathers (Canary feathers) Serinus canarius. e202 Reindeer epithelium Rangifer tarandus. e203 Mink epithelium Mustela spp. e204 Bos d 6 Bos domesticus (Bos taurus; Bos spp.). e205 Horse, serum proteins Equus caballus (Equus spp.). e206 Rabbit, serum proteins Oryctolagus cuniculus (Oryctolagus spp.). e208 Chinchilla epithelium Chinchilla laniger. e209 Gerbil epithelium Meriones unguiculatus. e210 Fox epithelium Vulpes vulpes. e211 Rabbit, urine proteins Oryctolagus cuniculus (Oryctolagus spp.). e212 Swine, urine proteins Sus scrofa (Sus scrofa domesticus; Sus spp.). e213 Parrot feathers Ara spp. e214 Finch feathers Lonchura domestica. e215 Pigeon feathers Streptopelia roseogrisea (Streptopelia spp.), Columbia spp. e216 Deer epithelium Dama dama. e217 Ferret epithelium Mustela putorius. e218 Chicken droppings Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e219 Chicken, serum proteins Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e220 Fel d 2, Cat serum albumin Felis domesticus. e221 Can f 3 Canis familiaris (Canis domesticus) (Dog serum albumin). e222 Swine serum albumin (Sus s PSA) Sus scrofa (Sus scrofa domesticus; Sus spp.). e225 Lovebird feathers Psittacoidea agapomis. e226 Can f 5.0101 Canis familiaris. e227 Equ c 1.0101 Equus caballus. e228 Fel d 4.0101 Felis domesticus. e230 Equ c 3 Equus caballus. e231 Mus m 1 Mus musculus. Food f9 Rice Oryza sativa. f12 Pea (green pea) Pisum sativum. f15 White bean Phaseolus vulgaris. f19 Cayenne pepper Capsicum frutescens, (Capsicum annum). f21 Sugar cane Saccharum officinarum. f22 Raspberry Rubus idaeus. f26 Pork Sus scrofa (Sus scrofa domesticus; Sus spp.). f29 Watermelon Citrullus lanatus (Citrullus vulgaris). f31 Carrot Daucus carota. f32 Oyster mushroom Pleurotus ostreatus. f33 Orange Citrus sinensis. f35 Potato Solanum tuberosum. f43 Mother's milk Homo sapiens. f44 Strawberry Fragaria vesca (Fragaria spp.). f45 Yeast, baker's Saccharomyces cerevisiae. f46 Pepper, Red Capsicum annuum. f47 Garlic Allium sativum. f48 Onion Allium cepa. f49 Apple Malus x domestica (Malus spp.). f51 Bamboo shoot Phyllostachys pubescens. f52 Cacao/chocolate Theobroma cacao. f54 Sweet potato Ipomoea batatas. f55 Common millet Panicum miliaceum. f56 Foxtail millet Setaria italica. f57 Japanese millet Echinochloa crus-galli. f58 Pacific squid Todarodes pacificus. f59 Octopus Octopus vulgaris (Octopus spp.). f63 Kefir NA. f67 Parmesan cheese NA. f81 Cheese, cheddar type NA. f82 Cheese, mold type NA. f83 Chicken Gallus domesticus (Gallus gallus domesticus; Gallus spp.). f86 Parsley Petroselinum crispum. f87 Melon Cucumis melo Cucumis melo + Citrullus lanatus. f88 Mutton (lamb) Ovis aries (Ovis spp.). f90 Malt Hordeum vulgare. f92 Banana Musa spp. f93 Cacao Theobroma cacao. f94 Pear Pyrus communis (Pyrus spp.). f97 Yam Dioscorea spp., Dioscorea opposita. f97 Chamomile tea Matricaria chamomilla. f98 Gliadin Triticum aestivum (Triticum spp.). f102 Cantaloupe Cucumis melo var. cantalupensis. f105 Chocolate Theobroma cacao. f109 Cottonseed Gossypium hirsutum. f110 Giant radish Raphanus sativus. f118 Zucchini Cucurbita pepo. f119 Radish Raphanus sativus. f120 Venison Capreolus capeolus. f121 Pinto bean Phaseolus vulgaris. f122 Cheese, American NA. f127 Black-eyed pea Vigna unguiculata. f131 Black Olive Olea europaea. f136 Red beet Beta vulgaris var. conditiva. f139 Goat's Cheese Capra aegagrus. f140 Bran NA. f141 Corn (vegetables) Zea mays. f152 Green bell pepper Capsicum annuum. f155 Brewer's yeast Saccharomyces carlsbergensis. f157 Duck Anas domesticus. f158 Goose Anser anser. f160 Camembert cheese NA. f162 Nectarine Prunus persica var. nucipersica. f163 Kohlrabi Brassica oleracea var. gongylodes. f65 Perch f166 Leek Allium porrum. f170 Cheese (Switzerland) (Swiss cheese) NA. f174 Fig Ficus carica. f177 Cranberry Vaccinium macrocarpon. f179 Raisin Vitis spp. f182 Lima bean Phaseolus lunatus. f198 Flaxseed (bruised grain) Linum usitatissimum. f199 Untreated native milk Bos domesticus (Bos taurus; Bos spp.). f208 Lemon Citrus limon. f209 Grapefruit Citrus paradisi. f210 Pineapple Ananas comosus. f211 Blackberry Rubus fruticosus. f212 Mushroom (champignon) Agaricus hortensis (Agaricus spp.). f213 Rabbit Oryctolagus cuniculus (Oryctolagus spp.). f214 Spinach Spinacia oleracea. f215 Lettuce Lactuca sativa. f216 Cabbage Brassica oleracea var. capitata. f217 Brussels sprouts Brassica oleracea var. gem. f218 Paprika, sweet pepper Capsicum annuum. f219 Fennel seed Foeniculum vulgare. f219 Sage Salvia officinalis. f220 Cinnamon Cinnamomum spp. f221 Coffee Coffea spp. f222 Tea Camellia sinensis. f223 Green olive Olea europaea. f225 Summer squash, pumpkin Cucurbita pepo. f225 Pumpkin Cucurbita maxima. f226 Pumpkin seed Cucurbita pepo. f227 Sugar-beet seed Beta vulgaris. f229 Safflower Seed Carthamus tinctorius. f231 Milk, boiled Bos domesticus (Bos taurus; Bos spp.). f234 Vanilla Vanilla planifolia. f237 Apricot Prunus armeniaca. f241 Gouda cheese NA. f242 Cherry Prunus avium. f244 Cucumber Cucumis sativus. f246 Guar, guar gum Cyamopsis tetragonoloba. f247 Honey NA. f248 Rosemary Rosmarinus officinalis. f254 Plaice Pleuronectes platessa. f255 Plum Prunus domestica, Prunus americana. f258 Squid Loligo spp. f259 Grape Vitis vinifera (Vitis spp.). f260 Broccoli Brassica oleracea var. italica (Brassica oleracea var. cultivar). f261 Asparagus Asparagus officinalis. f262 Aubergine, eggplant Solanum melongena. f263 Green pepper Piper nigrum, Capsicum annuum. f264 Eel Anguilla anguilla. f265 Caraway Carum carvi. f265 Cumin Cuminum cyminum. f266 Mace Myristica fragrans. f267 Cardamon Elettaria cardamomum. f268 Clove Syzygium aromaticum. f269 Basil Ocimum basilicum. f270 Ginger Zingiber officinale. f271 Anise Pimpinella anisum. f272 Tarragon Artemisia dracunculus. f273 Thyme Thymus vulgaris. f274 Marjoram Origanum majorana. f275 Lovage Levisticum officinale. f276 Fennel, fresh Foeniculum vulgare. f277 Dill Anethum graveolens. f278 Bay leaf Laurus nobilis. f279 Chili pepper Capsicum frutescens. f280 Black pepper Piper nigrum. f281 Curry (Santa Maria) NA. f282 Nutmeg Myristica fragrans. f283 Oregano Origanum vulgare. f284 Turkey meat Meleagris gallopavo. f285 Elk/moose meat Alces spp. f286 Mare's milk Equus caballus (Equus spp.). f287 Red kidney bean Phaseolus vulgaris. f288 Blueberry Vaccinium myrtillus (Vaccinium spp.). f289 Date Phoenix dactylifera. f291 Cauliflower Brassica oleracea var. botrytis. f292 Guava Psidium guajava. f293 Papaya Carica papaya. f294 Passion fruit, Maracuja Passiflora edulis (Passiflora spp.). f295 Carambola Averrhoa carambola. f296 Carob Ceratonia siliqua. f297 Gum arabic Acacia senegal (Acacia spp.). f298 Tragacanth Astragalus spp. f299 Sweet chestnut (chestnut) Castanea sativa. f300 Pinto bean Phaseolus spp. f301 Persimmon (kaki fruit, sharon) Diospyros kaki. f302 Mandarin (tangerine, clementine, satsumas) Citrus reticulata. f305 Fenugreek Trigonella foenum-graecum. f306 Lime Citrus aurantifolia. f307 Hake Merluccius merluccius. f308 Sardine (pilchard) Sardina pilchardus. f310 Blue vetch Lathyrus sativus. f311 Megrim Lepidorhombus whiffiagonis. f315 Green bean Phaseolus vulgaris. f316 Rape seed Brassica napus. f317 Coriander Coriandrum sativum. f318 Jack fruit Artocarpus heterophyllus. f319 Beetroot Beta vulgaris. f320 Crayfish Astacus astacus. f321 Horse meat Equus caballus (Equus spp.). f322 Red currant Ribes sylvestre. f324 Hop (fruit cone) Humulus lupulus. f325 Saffron Colchicum autumnale. f328 Fig Ficus carica. f329 Watermelon Citrullus lanatus. f330 Rose hip Rosa spp. f331 Saffron Crocus sativus. f332 Mint Mentha piperita. f333 Linseed Linum usitatissimum. f336 Jujube Ziziphus jujuba. f336 Wine vinegar Vitis vinifera (Vitis spp.). f337 Sole Solea solea. f337 English sole Parophrys vetulus. f338 Wine, white Vitis vinifera (Vitis spp.). f339 Allspice Pimenta dioica. f339 Wine, red Vitis vinifera (Vitis spp.). f341 Cranberry Vaccinium oxycoccus, Vaccinium macrocarpon. f342 Olive (black, fresh) Olea europaea. f343 Raspberry Rubus idaeus. f344 Sage Salvia officinalis. f346 Chives Allium schoenoprasum. f347 Quinoa Chenopodium quinoa. f348 Litchi Litchi chinensis. f349 Chum salmon roe Oncorhynchus keta. f358 Artichoke Cynara scolymus. f360 Yogurt NA. f368 Black bass Micropterus dolomieu (Micropterus dolomieui). f374 Karaya gum Sterculia urens. f375 Horseradish Armoracia rusticana. f377 Maple syrup NA. f379 Okra Abelmoschus esculentus. f382 Beet, sugar Beta vulgaris var. altissima. f401 Loquat Eriobotrya japonica. f402 Fig Ficus carica. f403 Brewer's yeast Saccharomyces cerevisiae. f405 Mint Mentha spp. f406 Arugula Eruca vesicaria. House Dust h1 Greer Labs., Inc NA. h2 Hollister-Stier Labs NA. h6 Japan NA. Venoms & Insects i7 Midge Chironomus yoshimatsui. i8 Moth Bombyx mori, Heterocera spp. i47 Water flea Daphnia spp. i49 Deer fly Chrysops spp. i51 Black ant Camponotus pennsylvanicus. i54 Flea mix (dog/cat), common flea Ctenocephalides spp. i71 Mosquito Aedes communis, Aedes spp. and Culex spp. i72 Green nimitti Cladotanytarsus lewisi. i73 Blood worm Chironomus thummi, Chironomusri parius, Chironomus spp. i75 European hornet Vespa crabro. i76 Berlin beetle Trogoderma angustum. i77 European paper wasp Polistes dominulus. i78 Fly Musca domestica. i80 Bumblebee Bombus pennsylvanicus. i201 Horse bot fly Gasterophilus intestinalis. i202 Grain weevil Sitophilus granarius. i203 Mediterranean flour moth Ephestia kuehniella (Anagasta kuehniella). i204 Horse fly Tabanus spp. i205 Bumblebee Bombus terrestris. i208 Api m 1.0101 Apis mellifera. a45 Api m 1 Apis mellifera. i209 Ves v 5.0101 Vespula vulgaris. a670 Ves v 5 Vespula vulgaris. i210 Pol d 5.0101 Polistes dominulus. i211 Ves v 1.0101 Vespula vulgaris. i213 Api m 4 Apis mellifera. i214 Api m 2 Apis mellifera. i215 Api m 3 Apis mellifera. i216 Api m 5 Apis mellifera. i217 Api m 10 Apis mellifera. i220 Bla g 1.0101 Blattella germanica. i221 Bla g 2.0101 Blattella germanica. i222 Bla g 5.0101 Blattella germanica. i223 Bla g 7 Blattella germanica. a46 Api m 2 Apis mellifera. Miscellaneous o1 Cotton, crude fibers Gossypium spp. o3 Cotton (treated) Gossypium spp. o70 Seminal fluid Homo sapiens. o71 Staphylococcus aureus Staphylococcus aureus. o72 Pichia pastoris crude extract customer specific Pichia pastoris. o72 Sperm-sediment Homo sapiens. o73 Pichia pastoris crude extr. vector customer specific Pichia pastoris. o74 Pichia pastoris with vector customer specific Pichia pastoris. o201 Tobacco leaf, tobacco dust Nicotiana tabacum. o202 Artemia salina, fish feed Artemia salina. o203 Tetramin, fish feed NA. o207 Daphnia, fish feed Daphnia spp. o211 Mealworm Tenebrio molitor. o212 Streptavidin Streptomyces avidini. o213 MBP (maltose binding protein) Escherichia coli. o214 CCD; MUXF3 from bromelain Ananas comosus. o72 Enterotoxin A (Sta a SEA) Staphylococcus aureus. o73 Enterotoxin B (Sta a SEB) Staphylococcus aureus. Parasites p1 Ascaris Ascaris suum. p2 Echinococcus Echinococcus granulosus. p3 Schistosoma Schistosoma mansoni. p4 Anisakis (Herring Worm) Anisakis simplex (Anisakis spp.). p5 Toxocara canis Toxocara canis. p10 Ani s 3.0101 Anisakis simplex (Anisakis spp.). p11 Ani s 1 Anisakis simplex (Anisakis spp.). Occupational k4 Threshing dust NA. k5 Flax NA. k7 Hay Dust NA. k8 Hop (hops) Humulus lupulus. k12 Grain mill dust NA. k14 Kapok NA. k20 Sheep's wool (treated) (wool) Ovis aries (Ovis spp.). k21 Sheep's wool (Untreated) Ovis aries (Ovis spp.). k23 Straw Dust NA. k33 Oak NA. k70 Green coffee bean Coffea spp. k71 Castor bean Ricinus communis. k72 Ispaghula Plantago psyllium/Plantago ovata. k73 Silk waste NA. k74 Silk Bombyx mori. k75 Isocyanate TDI (Toluene diisocyanate) NA. k76 Isocyanate MDI (Diphenylmethane diisocyanate) NA. k77 Isocyanate HDI (Hexamethylen diisocyanate) NA. k78 Ethylene oxide NA. k79 Phthalic anhydride NA. k80 Formaldehyde/Formalin NA. k81 Ficus Ficus benjamina (Ficus spp.). k83 Cotton seed Gossypium hirsutum. k84 Sunflower seed Helianthus annuus. k85 Chloramin T NA. k86 Trimellitic anhydride, TMA NA. k87 Asp o 21, alpha-amylase Aspergillus oryzae. k89 Orris root Iris florentina. k99 HSA (Human Serum Albumin) (Hom s HSA) Homo sapiens. k201 Car p 1, Papain Carica papaya. k202 Ana c 2, Bromelain Ananas comosus. k204 Maxatase Bacillus licheniformis. k205 Alcalase Bacillus spp. k206 Savinase, Protease 1 (Bac l Subtilisin) Bacillus spp. k208 Gal d 4, Lysozyme Gallus domesticus (Gallus gallus domesticus; Gallus spp.). k209 Hexahydrophtalic anhydrid NA. k210 Maleic anhydride NA. k211 Methyltetrahydrophtalic anhydrid NA. k212 Abachi wood dust Triplochiton scleroxylon. k213 Pepsin (Sus s Pepsin) Sus scrofa (Sus scrofa domesticus; Sus spp.). k213 TCPA NA. k214 Bougainvillea Bougainvillea spp. k225 Horse radish peroxidase (Arm r HRP) Armoracia rusticana. k226 Ascorbate oxidase (Cuc p ascorbate oxidase) Cucurbita pepo. k301 Flour dust Triticum spp. k501 Savinase customer specific Proprietary knowledge of customer. k502 Lipolase customer specific Proprietary knowledge of customer. k503 Termamyl customer specific Proprietary knowledge of customer. k504 Clazinase customer specific Proprietary knowledge of customer.
    V. Reference

    The following reference is on display in the Division of Dockets Management (see ADDRESSES) 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 https://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    1. FDA Guidance, “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff,” February 19, 1998, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf. Dated: March 8, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-04938 Filed 3-13-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0455] Enhancing Patient Engagement Efforts Across the Food and Drug Administration; Establishment of a Public Docket; Request for Comments ACTION:

    Notice; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is establishing a public docket to solicit input on ongoing efforts to enhance mechanisms for patient engagement at the Agency. Engaging with patients, their caregivers, and advocates has long been a priority of the Agency. In this tradition, FDA intends to enhance future patient engagement by providing a more transparent, accessible, and robust experience for patient communities. To achieve these goals, FDA is considering establishing a new Office of Patient Affairs. This concept was directly informed by the public feedback solicited through the prior public docket regarding FDA's stakeholder engagement responsibilities outlined by the Food and Drug Administration Safety and Innovation Act (FDASIA). The purpose of this notice is to outline FDA's proposal for the future of patient engagement at the Agency so that the perspectives of patient communities can be better captured.

    DATES:

    Submit either electronic or written comments by June 12, 2017.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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-2017-N-0455 for ” Enhancing Patient Engagement Efforts Across FDA; Establishment of a Public Docket; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://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 https://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 https://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:

    Sharnell Ligon, Office of Medical Products and Tobacco, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6125, Silver Spring, MD 20993, 301-796-5253, FAX: 301-847-3532.

    SUPPLEMENTARY INFORMATION:

    FDA has long recognized the importance of engaging with patients, caregivers, and their advocates in the medical product development process. On July 9, 2012, the President signed into law FDASIA (Pub. L. 112-144), which expands FDA's authorities and strengthens the Agency's ability to safeguard and advance public health in several areas, including increasing stakeholder involvement in FDA regulatory processes. Section 1137 of FDASIA, Patient Participation in Medical Product Discussions, codified in section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-8c), directs the Secretary of Health and Human Services to “develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions.”

    On November 4, 2014, FDA issued a Federal Register notice establishing a docket (FDA-2014-N-1698) for public commenters to submit information related to FDA's implementation of FDASIA's Patient Participation in Medical Product Discussions under FDASIA section 1137 (79 FR 65410). In response to public comments, and recognizing a need for improved coordination and support for patient engagement across medical product centers, the Office of the Commissioner launched an effort to enhance mechanisms for patient engagement at FDA.

    As part of this effort, the Agency has identified the following objectives for its patient engagement activities:

    • Develop a nuanced understanding of the patient experience of disease by:

    ○ Gathering patient perspective on what is clinically meaningful,

    ○ assessing attitudes towards benefit-risk and tolerance of uncertainty, and

    ○ enhancing the science of eliciting and integrating patient input.

    • Support patients and their advocates in understanding regulatory processes and navigating the FDA by:

    ○ Communicating relevant FDA positions, procedures, and activities,

    ○ connecting patients and their advocates with the appropriate resources, and

    ○ resolving discrete challenges and needs.

    To achieve these objectives, the Agency is considering establishing a central “Office of Patient Affairs” which will be tasked with supporting and coordinating patient engagement activities across medical product centers and other offices that engage with patients and their advocates on matters pertaining to medical products. In order to improve the transparency, coordination, and implementation of FDA's patient engagement activities, the responsibilities of this central office would include:

    • Offering a single, central entry point to the Agency for the patient community,

    • providing triage and navigation services for inbound inquiries from patient stakeholders,

    • hosting and maintaining robust data management systems that would incorporate and formalize knowledge shared with FDA by patient stakeholders and FDA's relationships with patient communities, and

    • developing a scalable and forward-looking platform for communicating with patient stakeholders, particularly online channels.

    Under this proposal to enhance mechanisms for patient engagement at FDA, a new “Office of Patient Affairs” would be directly accountable to the medical product Centers through clear governance structures. In addition, a regular evaluation of this central office and of FDA's overall patient engagement efforts is proposed. This evaluation will include feedback from external stakeholders (including patients and their advocates) on a biennial basis to best ensure the Agency's ongoing responsiveness to the needs of patient communities.

    Dated: March 9, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-04982 Filed 3-13-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0402] Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Workshop; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled “Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives.” The topics to be discussed will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders—industry, academia, patient advocates, professional societies, and other interested parties—as it fulfills its commitment under the Generic Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing the fiscal year (FY) 2018 Regulatory Science Plan.

    DATES:

    The public workshop will be held on May 3, 2017, from 8:30 a.m. to 4:30 p.m. The registration deadline to attend either in person, or virtually via web cast, is April 5, 2017. Comments regarding this public workshop may be submitted March 2, 2017, through June 2, 2017.

    ADDRESSES:

    The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503, Section A), 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.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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-2013-N-0402 for “Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Workshop; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://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 https://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 https://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:

    Stephanie Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 75, Rm. 4736, Silver Spring, MD 20993, 240-402-7960, [email protected]; or Robert Lionberger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 75, Rm. 4722, Silver Spring, MD 20993, 240-402-7957, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    In July 2012, Congress passed GDUFA (Title III of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144)). GDUFA is designed to enhance public access to safe, high-quality generic drugs and modernize the generic drug program. To support this goal, FDA agreed in the GDUFA commitment letter to work with industry and interested stakeholders on identifying regulatory science research priorities specific to generic drugs for each fiscal year covered by GDUFA. The commitment letter outlines FDA's performance goals and procedures under the GDUFA program for the years 2012-2017. The commitment letter can be found at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.

    II. Topics for Discussion at the Public Workshop

    The purpose of the May public workshop is to obtain input from industry and other interested stakeholders on the identification of generic drug regulatory science priorities for FY 2018. FDA is holding this public workshop because the Agency intends to continue its regulatory science initiatives upon reauthorization of GDUFA (i.e., GDUFA II) for FYs 2018-2022 (see Generic Drug User Fees; Public Meeting; Request for Comments, 81 FR 66035, September 26, 2016). To help fulfill its mission, FDA is particularly interested in receiving input on the following topics:

    • Opportunities for scientific or technical advancements that would help to overcome specific barriers for industry that currently limit the availability of generic drug products.

    • Innovative approaches to pre-approval development of generic drugs, including new methodologies for product design and manufacturing, and design and conduct of in vitro, ex vivo, and clinical studies and identification of scientifically robust strategies for demonstration of bioequivalence for various product classes.

    • Innovation in scientific approaches to evaluating the therapeutic equivalence of generic drug products throughout their life cycle.

    • Identification of high-impact public health issues involving generic drugs that can be addressed by the prioritized allocation of FY 2018 funding for regulatory science research.

    • Identification of specific issues related to generic drug products where scientific recommendations and/or clarifications are needed in developing and/or revising FDA's guidance for industry.

    • Strategies for enhancing quality and equivalence risk management during generic drug product development, during regulatory review, and/or throughout the drug product's life cycle.

    FDA will consider all comments made at this workshop or received through the docket (see ADDRESSES) as it develops its FY 2018 regulatory science priorities. Additional information concerning GDUFA, including the text of the law and the commitment letter, can be found at http://www.fda.gov/gdufa.

    III. Participating in the Public Workshop

    Registration: To register to attend “Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Workshop” in-person, or to attend virtually via web cast, please send an email to [email protected] by April 5, 2017. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Any person without email access can register by contacting Stephanie Choi (see FOR FURTHER INFORMATION CONTACT). If you need special accommodations because of a disability, please contact Stephanie Choi (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the workshop.

    Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by April 5, 2017, midnight eastern standard time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted.

    Requests for Oral Presentations: During online registration you may indicate if you wish to present during the public comment session and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations. Following the close of registration, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by April 19, 2017. All requests to make oral presentations must be received by the close of registration on April 5, 2017, midnight eastern standard time. If selected for presentation, any presentation materials must be emailed to [email protected] no later than April 26, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

    Streaming Webcast of the Public Workshop: This public workshop will also be web cast. To join via the web cast, please go to https://collaboration.fda.gov/gpw517/. Please register in advance for web cast per the instructions provided in this section.

    If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (see ADDRESSES). A link to the transcript will also be available on the Internet at http://www.fda.gov/GDUFARegScience.

    Dated: March 9, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-04981 Filed 3-13-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on the National Health Service Corps AGENCY:

    Health Resources and Service Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Notice of meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for National Advisory Council on the National Health Service Corps (NACNHSC). This meeting will be open to the public.

    DATES:

    The meeting will be held on March 22, 2017 from 1:00 p.m.-4:00 p.m. EDT.

    ADDRESSES:

    This meeting will be held in a webinar and conference call format. Webinar information can be found on the Web site at: http://nhsc.hrsa.gov/corpsexperience/aboutus/nationaladvisorycouncil/meetingsummaries/index.html.

    Agenda: The members of the NACNHSC will discuss provider retention in rural areas, the redesign of Area Health Education Centers, as well as provide an update on Health Professional Shortage Area scoring. Agenda items are subject to change as priorities dictate. The NACNHSC final agenda will be available on the NACNHSC Web site 3 days in advance of the meeting.

    Information about the NACNHSC and the agenda for this meeting can be obtained by accessing the following Web site: http://nhsc.hrsa.gov/corpsexperience/aboutus/nationaladvisorycouncil/meetingsummaries/index.html.

    FOR FURTHER INFORMATION CONTACT:

    Anyone requesting information regarding the NACNHSC should contact CAPT Shari Campbell, Designated Federal Official, Bureau of Health Workforce (BHW), HRSA in one of three ways: (1) Send a request to the following address: CAPT Shari Campbell, Designated Federal Official, BHW, HRSA, 5600 Fishers Lane, Room 14N108, Rockville, Maryland 20857; (2) call (301) 594-4251; or (3) send an email to [email protected]

    SUPPLEMENTARY INFORMATION:

    The NACNHSC makes recommendations with respect to their responsibilities under Subpart II, Part D of Title III of the Public Health Service Act, as amended (National Health Service Corps and Health Professional Shortage Area Designations), and shall review and comment upon regulations promulgated by the Secretary under Subpart II.

    Members of the public will have the opportunity to provide comments. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to make oral comments or provide written comments to the NACNHSC should be sent to Monica-Tia Bullock at [email protected] by March 17, 2017. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should contact Monica-Tia Bullock at [email protected] by March 17.

    Jason E. Bennett, Director, Division of the Executive Secretariat.
    [FR Doc. 2017-04975 Filed 3-13-17; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: HHS-OS-0990-New] 60-Day Notice Template for Request for Generic Clearance for the Collection of Routine Customer Feedback on HHS Communications AGENCY:

    U.S. Department of Health and Human Services (HHS).

    ACTION:

    Notice and request for comments. Office of the Assistant Secretary for Public Affairs is requesting OMB approval for a new Generic Clearance for the Collection of Routine Customer Feedback by OMB.

    SUMMARY:

    Department of Health and Human Services, The Office of the Secretary (OS), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” for approval under the Paperwork Reduction Act (PRA). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection.

    DATES:

    Consideration will be given to all comments received by May 15, 2017.

    ADDRESSES:

    Submit comments by one of the following methods:

    Web site: www.regulations.gov. Direct comments to Docket ID OMB-2010-0021.

    Email: [email protected]

    Phone: (202) 690-6162.

    Comments submitted in response to this notice may be made available to the public through relevant Web sites. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information. If you send an email comment, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. Please note that responses to this public comment request containing any routine notice about the confidentiality of the communication will be treated as public comments that may be made available to the public notwithstanding the inclusion of the routine notice.

    FOR FURTHER INFORMATION CONTACT:

    Sherrette Funn, [email protected] or (202) 795-7714.

    SUPPLEMENTARY INFORMATION:

    Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.

    Abstract: The proposed information collection activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.

    The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on the Agency's services will be unavailable.

    The Agency will only submit a collection for approval under this generic clearance if it meets the following conditions:

    • The collections are voluntary;

    • The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;

    • The collections are non-controversial and do not raise issues of concern to other Federal agencies;

    • Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;

    • Personally identifiable information (PII) is collected only to the extent necessary and is not retained;

    • Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency;

    • Information gathered will not be used for the purpose of substantially informing influential policy decisions; and

    • Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study.

    Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.

    As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.

    Current Actions: New approval for a collection of information.

    Type of Review: New.

    Affected Public: Individuals, households, professionals, public/private sector.

    Estimated Number of Respondents: 3,000,000 over 3 years.

    Below we provide projected average estimates for the next three years:

    Average Expected Annual Number of Activities: 600.

    Average Number of Respondents per Activity: 50.

    Annual Responses: 30,000.

    Frequency of Response: Once per request.

    Average Minutes per Response: 30.

    Burden hours: 500,000.

    Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the 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 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.

    All written comments will be available for public inspection Regulations.gov.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number.

    Darius Taylor, Information Collection Clearance Officer.
    [FR Doc. 2017-04989 Filed 3-13-17; 8:45 am] BILLING CODE 4150-25-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Cancer Institute Council of Research Advocates.

    The meeting will be held as a webinar only and is open to the public to join/dial-in for participation. Individuals who plan to join/dial-in to the meeting and need special assistance or other reasonable accommodations in order to do so, should notify the Contact Person listed below in advance of the meeting.

    Name of Committee: National Cancer Institute Council of Research Advocates.

    Date: March 30, 2017.

    Time: 11:30 a.m. to 1:30 p.m.

    Agenda: NCI Acting Director's Update and Legislative Update.

    Place: National Institutes of Health, 31 Center Drive, Building 31, Room 10A03, Bethesda, MD 20892.

    Webinar Link: https://cbiit.webex.com/cbiit/j.php?MTID=m5ec1d366dbaf4c6f4d7a9c6dbe4c48b0.

    Meeting number (access code): 736 096 397.

    Meeting password: qTgpPZ*6.

    (Join by Phone) 1-855-244-8681 Call-in toll-free number (US/Canada), 1-650-479-3207 Call-in toll number (US/Canada).

    Contact Person: Amy Williams, NCI Office of Advocacy Relations, National Cancer Institute, NIH, 31 Center Drive, Building 31, Room 10A28, Bethesda, MD 20892, 301-594-3194, [email protected]

    Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

    Information is also available on the Institute's/Center's home page: https://deainfo.nci.nih.gov/advisory/ncra/ncra.htm, where an agenda and any additional information for the meeting will be posted when available.

    (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: March 8, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-04917 Filed 3-13-17; 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: Glioblastoma, Multiple Sclerosis, Alzheimer's Disease.

    Date: April 4, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Samuel C. Edwards, Ph.D., Chief, Disorders and Clinical Neuroscience, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435-1246, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR-16-247 Review of Mature Synchrotron Resources for Structural Biology.

    Date: April 6, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Renaissance Washington DC, Dupont Circle, 1143 New Hampshire Avenue NW., Washington, DC 20037.

    Contact Person: David R. Jollie, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4150, MSC 7806, Bethesda, MD 20892, (301)-435-1722, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict-Topics in Virology.

    Date: April 6, 2017.

    Time: 10:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    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: Center for Scientific Review Special Emphasis Panel; Member Conflict Cell Biology.

    Date: April 7, 2017.

    Time: 1:00 p.m. to 4:00 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: John Burch, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institute of Health, 6701 Rockledge Drive, Room 3213, MSC 7808, Bethesda, MD 20892, 301-408-9519, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Infectious Diseases, Reproductive Health, Asthma and Pulmonary Conditions, Member Conflicts.

    Date: April 7, 2017.

    Time: 2:00 p.m. to 5:00 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: Ellen K. Schwartz, EDD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3144, MSC 7770, Bethesda, MD 20892, 301-828-6146, [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: March 8, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-05004 Filed 3-13-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; 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 Environmental Health Sciences Special Emphasis Panel; Maintain and Enrich Resource Infrastructure for Existing Environmental Epidemiology Cohorts (R24).

    Date: April 3-4, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Crystal City, 2799 Jefferson Davis Highway, Arlington, VA 22202.

    Contact Person: Linda K. Bass, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute Environmental Health Sciences, P.O. Box 12233, MD EC-30 Research Triangle Park, NC 27709, (919) 541-1307, [email protected]

    Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; R13 Conference Grant Review of Applications.

    Date: April 4, 2017.

    Time: 11:30 a.m. to 2:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: NIEHS/National Institutes of Health, Building 4401, East Campus 3003, 79 T.W. Alexander Drive, Research Triangle Park, NC 27709 (Telephone Conference Call).

    Contact Person: Laura A., Thomas, Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, National Institute of Environmental Health Sciences, Research Triangle Park, NC 27709, 919-541-2824, [email protected]

    Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Revolutionizing Innovative, Visionary Environmental Health Research (RIVER).

    Date: April 6, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Place Durham-Southpoint, 7840 NC 751 Hwy, Durham, NC 27713.

    Contact Person: Leroy Worth, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute of Environmental Health Sciences, P.O. Box 12233, MD EC-30/Room 3171, Research Triangle Park, NC 27709, (919) 541-0670, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS)
    Dated: March 8, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-05006 Filed 3-13-17; 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; PAR Panel: Fogarty Global Brain Disorders.

    Date: March 23-24, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Fairmont Washington, DC, 2401 M Street NW., Washington, DC 20037.

    Contact Person: Suzan Nadi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5217B, MSC 7846, Bethesda, MD 20892, 301-435-1259, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Autism and Environmental Factors.

    Date: March 28, 2017.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Meenakshisundar Ananthanarayanan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4200, Bethesda, MD 20817, 301-435-1234. [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cardiovascular Sciences.

    Date: April 6, 2017.

    Time: 12:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Yuanna Cheng, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4138, MSC 7814, Bethesda, MD 20892, (301)435-1195, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA-AI-16-064: Understanding HIV Persistence in Infants.

    Date: April 7, 2017.

    Time: 11:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Eduardo A. Montalvo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5108, MSC 7852, Bethesda, MD 20892, (301) 435-1168, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Mechanisms in Cell Biology.

    Date: April 14, 2017.

    Time: 1:00 p.m. to 3:00 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: Michael H. Chaitin, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5202, MSC 7850, Bethesda, MD 20892, (301) 435-0910, [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: March 8, 2017. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-04916 Filed 3-13-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; 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 Aging Special Emphasis Panel, Pro/Anti-Geronic RFA review.

    Date: April 17, 2017.

    Time: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call).

    Contact Person: Bita Nakhai, Ph.D., Scientific Review Branch, National Institute on Aging, Gateway Bldg., 2C/212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301-402-7701, [email protected].

    Name of Committee: National Institute on Aging Special Emphasis Panel, “Peripheral Proteostatsis and AD”.

    Date: April 20, 2017.

    Time: 12:00 p.m. to 5:00 pm.

    Agenda: To review and evalute grant applications.

    Place: National Institute on Aging, Gateway Building, Suite 2C200W, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call).

    Contact Person: Alexander Parsadanian, Ph.D., Scientific Review Officer, National Institute on Aging, Gateway Building 2C/212, 7201Wisconsin Avenue, Bethesda, MD 20892, 301-496-9666, [email protected].

    Name of Committee: National Institute on Aging Special Emphasis Panel, Loan Repayment Review.

    Date: May 5, 2017.

    Time: 9:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call).

    Contact Person: Kimberly Firth, Ph.D., National Institutes of Health, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301-402-7702, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: March 8, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-04918 Filed 3-13-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of 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 National Advisory Neurological Disorders and Stroke Council.

    The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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 Advisory Neurological Disorders and Stroke Council.

    Date: May 18-19, 2017.

    Open: May 18, 2017, 8:00 a.m. to 2:30 p.m.

    Agenda: Report by the Director, NINDS; Report by the Director, Division of Extramural Research; Administrative and Program Developments; and Overview of the NINDS Intramural Program.

    Place: National Institutes of Health, Porter Neuroscience Research Center, Building 35A Convent Drive, Bethesda, MD 20892.

    Closed: May 18, 2017, 2:30 p.m. to 4:45 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Porter Neuroscience Research Center, Building 35A Convent Drive, Bethesda, MD 20892.

    Closed: May 18, 2017, 4:45 p.m. to 5:15 p.m.

    Agenda: To review and evaluate the Division of Intramural Research Board of Scientific Counselors' Reports.

    Place: National Institutes of Health, Porter Neuroscience Research Center, Building 35A Convent Drive, Bethesda, MD 20892.

    Closed: May 19, 2017, 8:00 a.m. to 11:00 a.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Porter Neuroscience Research Center, Building 35A Convent Drive, Bethesda, MD 20892.

    Contact Person: Robert Finkelstein, Ph.D., Director, Division of Extramural Research, National Institute of Neurological Disorders and Stroke, NIH, 6001 Executive Blvd., Suite 3309, MSC 9531, Bethesda, MD 20892, (301) 496-9248, [email protected]

    Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

    In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.

    Information is also available on the Institute's/Center's home page: http://www.ninds.nih.gov, where an agenda and any additional information for the meeting will be posted when available.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS)
    Dated: March 8, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-05005 Filed 3-13-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney 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 Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Small Business Applications Urology and Urogynecology.

    Date: March 22, 2017.

    Time: 3:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications and/or proposals.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Ryan G. Morris, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7015, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, 301-594-4721, [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: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR15-068: Multi-Center Clinical Studies Planning Applications Liver.

    Date: March 24, 2017.

    Time: 3:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate cooperative agreement applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Ryan G. Morris, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7015, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, 301-594-4721, [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: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR15-068: Multi-Center Clinical Studies Planning Applications.

    Date: March 28, 2017.

    Time: 3:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate cooperative agreement applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Ryan G. Morris, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7015, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, 301-594-4721, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS)
    Dated: March 8, 2017. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-04915 Filed 3-13-17; 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; Partnerships for Countermeasures Against Select Pathogens (R01).

    Date: March 31, 2017.

    Time: 11:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: Lynn Rust, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3G42A, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892-9823, (240) 669-5069, [email protected]

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Investigator Initiated Program Project Applications (P01).

    Date: April 10, 2017.

    Time: 11:00 a.m. to 3:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: Tracy A. Shahan, Ph.D., MBA, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room #3F31, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 79823, Bethesda, MD 20892-9823, (240) 669-5030, [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: March 7, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2017-04913 Filed 3-13-17; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request

    In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276-1243.

    Comments are invited on: (a) Whether the proposed collections of information are 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; 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.

    Proposed Project: Cooperative Agreements To Benefit Homeless Individuals (CABHI) Evaluation Client & Stakeholder Surveys (OMB No. 0930-0320)—Revision

    SAMHSA is conducting a cross-site evaluation of the FY2016 cohort of the CABHI grant program. The CABHI Evaluation builds on a previous evaluation of SAMHSA's 2009-2012 homeless services grant programs (i.e., Grants for the Benefit of Homeless Individuals, Services in Supportive Housing, and CABHI), under which the approved client and stakeholder data collection tools were developed and implemented. SAMHSA is requesting approval from OMB to revise the burden inventory, which has been calculated based on the number of FY2016 CABHI grantees and potential future cohorts of grantees to be awarded in FY2017, and to revise some of the measures used on current tools. This collection was previously known as the Cross-Site Evaluation for the Grants for the Benefit of Homeless Individuals (GBHI), but is now known as the CABHI Evaluation Client & Stakeholder Surveys.

    In 2016, SAMHSA awarded 30 CABHI grants across three levels: States (up to $1.5 million per year), local governments (up to $800,000 per year), and communities (up to $400,000 per year). The grantees are united by the goal of enhancing and expanding infrastructure and capacity for mental health and substance abuse treatment and related support services for individuals experiencing chronic homelessness or veterans, families, or youth experiencing homelessness as a result of these conditions. This is accomplished through the provision of permanent supportive housing, behavioral health treatment, and recovery support services, and enrollment in health insurance, Medicaid, or other mainstream benefit programs. Potential grantees awarded in FY2017 will have the same funding options and grant requirements.

    The primary task of the CABHI evaluation is to conduct a comprehensive process and outcome evaluation, addressing questions related to the implementation of the CABHI grant projects and the extent to which they were able to meet the program's goals. Process evaluation primarily represents what is done to and for the client (e.g., services provided); this aspect of the evaluation will also include a focus on structure, or the resources available in the service delivery system, which represent the capacity to deliver quality care, but not the care itself. The outcome evaluation will focus on outputs, which are the most immediate or proximal results of project activities (e.g., changes in partner collaboration, the number of clients enrolled in mainstream benefits), and client outcomes, particularly those related to behavioral health and homelessness and housing instability. Data collection efforts that will support the evaluation are described below.

    The Client Interview—Baseline and the Client Interview—6-Month Follow-up have been developed to provide descriptive information about clients, and assess changes in client outcomes and their association with project characteristics. The tools were developed based on review of the literature and consultation with a panel of national experts, grantees, and SAMHSA. The tools were successfully used with over 7,000 clients during the previous evaluation of SAMHSA's Homeless programs.

    The Client Interview is comprised of questions (unique from SAMHSA's Government Performance and Results Act [GPRA] client-level tool) that measure the outcomes of interest and subpopulations of focus: Homelessness, housing, treatment history, trauma symptoms, housing and treatment choice, burden and satisfaction, and criminal justice involvement. For the CABHI Evaluation, the Client Interview Baseline and 6-Month Follow-up have been updated to (1) reflect changes to the GPRA client-level tool which allowed the questions on military service to be removed, (2) align with the newest version of the Diagnostic and Statistical Manual of Mental Disorders (DSM), (3) remove the Readiness to Change measure, and (4) add detailed housing and homelessness questions. For the 6-Month Follow-up only, questions documenting services and evidence based practices received were added to improve data on client service receipt. Immediately following the SAMHSA-required administration of the GPRA client-level tools, which are completed by enrolled clients for each grantee project at baseline and 6-month follow-up, the paper and pencil Client Interview will be administered face-to-face by the GPRA interviewer. Questions regarding perception of care and treatment coercion will be self-administered by participating clients and returned to the interviewer in a sealed envelope to be included in the full package mailed to the evaluation coordinating center. Client participation is voluntary; gift card incentives will be given at baseline worth a $15 value and at 6-month follow-up worth a $30 value. Clients will be assigned unique identifiers by local projects; responses will be recorded on a paper and pencil answer sheet, mailed by the grantee project to the evaluation coordinating center, and scanned into a secure dataset. This process will eliminate the need for data entry, thereby reducing cost and potential for data entry error, and ensuring privacy for evaluation data.

    The Stakeholder Survey will be conducted with CABHI project stakeholders and partners via a web survey to assess the types of stakeholder partnerships involved in the CABHI projects, the services provided, and the effectiveness of implementation and collaboration in the CABHI projects. For the CABHI Evaluation, the survey has been divided into three waves so that questions are relevant to the current phase of grant implementation (e.g., wave 1 will be administered in year 1 of the project). Also, a section on healthcare services was added and the current section on collaboration was expanded to include new measures on collaboration. One wave of the survey will be administered each year of the three year grants. Each survey respondent will be issued a username and password to login to and complete the secure web-based survey. The web-based survey format will reduce burden on the respondent and minimize potential for measurement error.

    Annual burden has increased from 4,006 to 5,098 hours per year as the response burden times have been revised to reflect real-world experience during the Homeless Programs evaluation and the number of respondents has been increased for the Stakeholder Survey.

    Annualized Burden Hours Instrument/activity Number of
  • respondents
  • Responses per
  • respondent
  • Total number
  • of responses
  • Hours per
  • response
  • Total burden
  • hours
  • Baseline data collection (Clients) 5,827 1 5,827 0.42 2,447 6-month follow-up data collection (Clients) 4,662 1 4,662 0.5 2,331 Client Subtotal b 5,827 10,489 4,778 Stakeholder Survey 780 1 780 0.41 320 Total b 6,607 11,269 5,098 a Total respondent cost is calculated as hourly wage × time spent on survey × total number of responses. b Estimated number of total unique respondents.

    Send comments to Summer King, SAMHSA Reports Clearance Officer, 5600 Fishers Lane, Room 15E57-B, Rockville, MD 20857 OR email a copy to [email protected] Written comments should be received by May 15, 2017.

    Summer King, Statistician.
    [FR Doc. 2017-04914 Filed 3-13-17; 8:45 am] BILLING CODE 4162-20-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2016-1091] Certificate of Alternative Compliance for Gunderson Marine LLC HULL 115 AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice.

    SUMMARY:

    The Coast Guard announces that a Certificate of Alternative Compliance was issued for Gunderson Marine LLC HULL 115. We are issuing this notice because its publication is required by statute.

    DATES:

    The Certificate of Alternative Compliance was issued on January 5, 2017.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this notice, call LCDR Patrick Drayer, Thirteenth Coast Guard District, Prevention Branch, U.S. Coast Guard, telephone 206-220-7275.

    SUPPLEMENTARY INFORMATION: Background and Purpose

    A Certificate of Alternative Compliance, as allowed for under the provisions of the alternative compliance regulations in 33 CFR part 81, has been issued for the Gunderson Marine LLC HULL 115. The vessel's primary purpose is as an Oil Recovery Barge. The unique design of the vessel does not lend itself to full compliance with Annex I, Part 3(b) of the International and Inland Navigational Rules.

    The Commandant, U.S. Coast Guard, certifies that full compliance with the International and Inland Navigational Rules would interfere with the special functions and intent of the vessel and would not significantly enhance the safety of the vessel's operation. Placing the sidelights in the required position would result in the high probability that the lights would be damaged or destroyed during vessel mooring or anchoring operations, and pose a potential hazard to vessel crew during vessel operations.

    The Certificate of Alternative Compliance authorizes the Gunderson Marine LLC HULL 115 to deviate from the requirements set forth in Annex I of the International Navigational Rules and 33 CFR 84.05 of the Inland Navigational Rules by placing its sidelights 39 feet and 4 inches from the vessel's centerline.

    This notice is issued under authority of 33 U.S.C. 1605(c) and 33 CFR 81.18.

    Dated: January 26, 2017. B.S. Gilda, Captain, U.S. Coast Guard, Chief, Prevention Division, Thirteenth Coast Guard District.
    [FR Doc. 2017-04986 Filed 3-13-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2016-1092] Certificate of Alternative Compliance for Conrad Industries HULL C-1148 AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice.

    SUMMARY:

    The Coast Guard announces that a Certificate of Alternative Compliance was issued for Conrad Industries Hull C-1148. We are issuing this notice because its publication is required by statute.

    DATES:

    The Certificate of Alternative Compliance was issued on January 5, 2017.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this notice, call LCDR Patrick Drayer, Thirteenth Coast Guard District, Prevention Branch, U.S. Coast Guard, telephone 206-220-7275.

    SUPPLEMENTARY INFORMATION: Background and Purpose

    A Certificate of Alternative Compliance, as allowed for under the provisions of the alternative compliance regulations in 33 CFR part 81, has been issued for the Conrad Industries Hull C-1148. The vessel's primary purpose is a tank barge intended to operate at all times in Articulated Tug and Barge mode. The unique design of the vessel does not lend itself to full compliance with Rule 24(f) and Annex I, Part 3(b) of the International and Inland Navigational Rules.

    The Commandant, U.S. Coast Guard, certifies that full compliance with the International and Inland Navigational Rules would interfere with the special functions and intent of the vessel and would not significantly enhance the safety of the vessel's operation. Placing the sidelights in the required position would result in the high probability that the lights would be damaged or destroyed and pose a potential personal safety hazard during vessel mooring operations.

    The Certificate of Alternative Compliance authorizes the Conrad Industries Hull C-1148 to deviate from the requirements set forth in Annex I of the International Navigational Rules and 33 CFR 84.05 of the Inland Navigational Rules by placing its sidelights 27 feet and 9 inches from the vessel's centerline.

    This notice is issued under authority of 33 U.S.C. 1605(c) and 33 CFR 81.18.

    Dated: January 26, 2017. B.S. Gilda, Captain, U.S. Coast Guard, Chief, Prevention Division, Thirteenth Coast Guard District.
    [FR Doc. 2017-04985 Filed 3-13-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2016-1085] Certificate of Alternative Compliance for JT Marine Shipyard Hull #005 AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice.

    SUMMARY:

    The Coast Guard announces that a Certificate of Alternative Compliance was issued for JT Marine Shipyard Hull #005. We are issuing this notice because its publication is required by statute.

    DATES:

    The Certificate of Alternative Compliance was issued on January 5, 2017.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this notice, call LCDR Patrick Drayer, Thirteenth Coast Guard District, Prevention Branch, U.S. Coast Guard, telephone 206-220-7275.

    SUPPLEMENTARY INFORMATION: Background and Purpose

    A Certificate of Alternative Compliance, as allowed for under the provisions of the alternative compliance regulations in 33 CFR part 81, has been issued for the JT Marine Shipyard Hull #005. The vessel's primary purpose is as a work boat. The unique design of the vessel does not lend itself to full compliance with Rule 21(c) and Annex I, Part 3(b) of the International and Inland Navigational Rules.

    The Commandant, U.S. Coast Guard, certifies that full compliance with the International and Inland Navigational Rules would interfere with the special functions and intent of the vessel and would not significantly enhance the safety of the vessel's operation. Placing the sidelights and sternlight in the required position would result in the high probability that the lights would be damaged or destroyed during vessel work boat operations.

    The Certificate of Alternative Compliance authorizes the JT Marine Shipyard Hull #005 to deviate from the requirements set forth in Annex I of the International Navigational Rules and 33 CFR 84.05 of the Inland Navigational Rules by placing its sidelights 8 feet and 4 inches from the vessel's centerline and the sternlight on the backside of the rear navigation light mast.

    This notice is issued under authority of 33 U.S.C. 1605(c) and 33 CFR 81.18.

    Dated: January 5, 2017. B.S. Gilda, Captain, U.S. Coast Guard, Chief, Prevention Division, Thirteenth Coast Guard District.
    [FR Doc. 2017-04984 Filed 3-13-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2016-1078] Prince William Sound Regional Citizens' Advisory Council (PWSRCAC) Recertification AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of recertification.

    SUMMARY:

    This notice informs the public that the Coast Guard has recertified the Prince William Sound Regional Citizens' Advisory Council (PWSRCAC) as an alternative voluntary advisory group for Prince William Sound, Alaska. This certification allows the PWSRCAC to monitor the activities of terminal facilities and crude oil tankers under the Prince William Sound Program established by statute.

    DATES:

    This recertification is effective for the period from March 1, 2017 through February 28, 2018.

    FOR FURTHER INFORMATION CONTACT:

    LT P. Grizzle, Seventeenth Coast Guard District (dpi), by phone at (907) 463-2809, email at [email protected]

    SUPPLEMENTARY INFORMATION: Background and Purpose

    As part of the Oil Pollution Act of 1990, Congress passed the Oil Terminal and Oil Tanker Environmental Oversight and Monitoring Act of 1990 (the Act), 33 U.S.C. 2732, to foster a long-term partnership among industry, government, and local communities in overseeing compliance with environmental concerns in the operation of crude oil terminals and oil tankers.

    On October 18, 1991, the President delegated his authority under 33 U.S.C. 2732(o) to the Secretary of Transportation in Executive Order 12777, section 8(g) (see 56 FR 54757; October 22, 1991) for purposes of certifying advisory councils, or groups, subject to the Act. On March 3, 1992, the Secretary redelegated that authority to the Commandant of the USCG (see 57 FR 8582; March 11, 1992). The Commandant redelegated that authority to the Chief, Office of Marine Safety, Security and Environmental Protection (G-M) on March 19, 1992 (letter #5402).

    On July 7, 1993, the USCG published a policy statement, 58 FR 36504, to clarify the factors that shall be considered in making the determination as to whether advisory councils, or groups, should be certified in accordance with the Act.

    The Assistant Commandant for Marine Safety and Environmental Protection (G-M), redelegated recertification authority for advisory councils, or groups, to the Commander, Seventeenth Coast Guard District on February 26, 1999 (letter #16450).

    On September 16, 2002, the USCG published a policy statement, 67 FR 58440, which changed the recertification procedures such that applicants are required to provide the USCG with comprehensive information every three years (triennially). For each of the two years between the triennial application procedures, applicants submit a letter requesting recertification that includes a description of any substantive changes to the information provided at the previous triennial recertification. Further, public comment is not solicited prior to recertification during streamlined years, only during the triennial comprehensive review.

    The Alyeska Pipeline Service Company provides financial support to the PWSRCAC annually in the form of a long term contract. In return for this funding, the PWSRCAC must annually show that it “fosters the goals and purposes” of OPA 90 and is “broadly representative of the communities and interests in the vicinity of the terminal facilities and Prince William Sound.” The PWSRCAC is an independent, nonprofit organization founded in 1989. Though it receives Federal oversight like many independent, non-profit organizations, it is not a Federal agency. The PWSRCAC is a local organization that predates the passage of OPA 90. The existence of the PWSRCAC was specifically recognized in OPA 90 where it is defined as an “alternate voluntary advisory group.”

    Alyeska funds the PWSRCAC, and the Coast Guard makes sure the PWSRCRC operates in a fashion that is broadly consistent with OPA 90.

    Discussion of Comments

    On February 2, 2017 the USCG published a Federal Register Notice; request for comments for recertification of Prince William Sound Regional Citizens' Advisory Council in the Federal Register (82 FR 9214). We received 63 letters commenting on the proposed action. No public meeting was requested. Of the 63 letters received, 62 had positive comments. One comment was received recommending against the recertification of the PWSRCAC, as appropriate regulations are already in place since OPA 90's conception. Of the positive comments, these letters consistently cited PWSRCAC's broad representation of the respective community's interest, appropriate actions to keep the public informed, improvements to both spill response preparation and spill prevention, and oil spill industry monitoring efforts that combat complacency—as intended by the Act.

    Recertification

    By letter dated February 27, 2017, the Commander, Seventeenth Coast Guard certified that the PWSRCAC qualifies as an alternative voluntary advisory group under 33 U.S.C. 2732(o). This recertification terminates on February 28, 2018.

    Dated: February 27, 2017. M.F. McAllister, Rear Admiral, U.S. Coast Guard Commander, Seventeenth Coast Guard District.
    [FR Doc. 2017-04987 Filed 3-13-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Notice of Issuance of Final Determination Concerning Certain Data Storage Products 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 three data storage products. Based upon the facts presented, CBP has concluded that the country of origin of two data storage products is Mexico and the country of origin of the third data storage is Malaysia for purposes of U.S. Government procurement.

    DATES:

    The final determination was issued on March 8, 2017. 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 April 13, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Grace A. Kim, Tariff Classification and Marking Branch, Regulations and Rulings, Office of Trade, (202) 325-7941.

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given that on March 8, 2017, pursuant to subpart B of part 177, U.S. Customs and Border Protection Regulations (19 CFR 177(B)), CBP issued a final determination concerning the country of origin of certain data storage products, which may be offered to the U.S. Government under an undesignated government procurement contract. This final determination, HQ H269185, was issued under procedures set forth at 19 CFR 177(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 for two of the three products, the processing in Mexico results in a substantial transformation. However, for the third product, the processing in Mexico does not result in a substantial transformation. Therefore, the country of origin of two data storage products is Mexico and the country of origin of the third data storage is Malaysia 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: March 8, 2017. Alice A. Kipel, Executive Director, Regulations and Rulings, Office of Trade. Attachment HQ H269185 OT:RR:CTF:VS H269185 GaK CATEGORY: Marking Stuart P. Seidel Baker & McKenzie LLP 815 Connecticut Ave. NW. Washington, DC 20006 RE: Final Determination; Government Procurement; Country of Origin of data storage system; Substantial Transformation Dear Mr. Seidel:

    This is in response to a letter we received dated September 18, 2013, requesting a final determination on behalf of [********] (“the Company”), pursuant to subpart B of Part 177 of the U.S. Customs and Border Protection Regulations (19 CFR part 177) and to two follow-up submissions dated January 6, 2014, and May 30, 2014. You also requested a country of origin marking decision. CBP also received notification on July 21, 2015 that the Company was acquired by another corporation and counsel for the Company was replaced. Under 19 CFR part 177, which implements 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 practice for products offered for sale to the U.S. Government.

    This final determination concerns the country of origin of three data storage products for government procurement. As a U.S. importer, the Company is a party-at-interest within the meaning of 19 CFR 177.22(d)(1) and is entitled to request this final determination. A meeting was held at our office on February 19, 2014.

    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 Company is a data storage technology company headquartered in the United Kingdom with worldwide operations. The Company manufactures a variety of high performance enterprise data storage products that are used for the storage of electronic data onto physical disc drives. These products serve as the building blocks for medium to large corporations with a need to store and access large amounts of data securely and rapidly. Physically, the products operate in large server rooms or similar facilities, managed by trained professional information technology staff.

    Three products are the subject of this ruling and they all apply the Integrated Storage Test Platform (“ISTP”). ISTP is a highly proprietary, Linux-based global hardware and software solution representing approximately 100 man-years of software development time over the past ten years and 6,500,000 lines of code, developed in the United Kingdom and the United States for the Company's manufacturing processes. You state that ISTP is a critical element of the Company's products. As discussed infra, the firmware for the three data storage products is developed and managed in the United Kingdom and a team of 19 United Kingdom-based software engineers manage ISTP. There are also software engineers at each production facility, including a Mexican facility at issue, that are trained by the United Kingdom-based engineers. ISTP-qualified engineers are located at the production site to provide input into the manufacturing and testing processes and all engineers have a high level of competence in “C” programming, test engineering, and the Company's product knowledge. The ISTP undergoes approximately 40 updates a month incorporating customer requirements and design updates that directly affect the manufacturing process in Mexico.

    Product One, the [********] is a storage application platform delivering integrated storage and enterprise server system resources that tailor the amount of processing, memory, storage capacity, and high bandwidth input/output resources to meet customers' requirements. While Product One can be configured based on customer requirements, it generally includes hard disc slots that can carry up to 24 hard disc drivers in drive carrier, server-grade Intel processor(s), memory chips, and seven Peripheral Component Interconnect Express (“PCIe”) input/output slots. It can accept both a base-level operating system and unique storage applications developed by Original Equipment Manufacturers (“OEM”). The chassis subassembly is imported from Malaysia; hard disc drives are imported from China, Singapore, or Thailand; and a power supply included in the chassis subassembly is imported from the Philippines. All of the components are imported into Mexico for assembly, firmware installation, inspection, and testing. The workers at the Mexican facility are stated to be highly trained and many positions require college/technical degrees, in addition to 1-7 years of experience.

    The assembly process in Mexico starts with the chassis subassembly, which is a non-functioning unit that includes certain electronic components (e.g., printed circuit board assemblies, a controller/central processing unit), but not the disc drives, firmware/software, or the ISTP configuration essential to the finished product. The assembly process takes approximately 135 minutes and is as follows:

    1. The chassis subassembly is removed from the packaging, prepared for production, and inspected.

    2. A SAP-trained employee generates labels to be applied to the subassembly to track the subassembly parts through the production.

    3. The individual hard drives from China, Singapore, or Thailand, and drive carriers from Malaysia are assembled to create 24 disc drive assemblies. This process is conducted under stringent electrostatic discharge (“ESD”) controlled conditions and operators must use SAP to determine the assembly process. The installation of each hard drive into the drive carrier takes 12 steps.

    4. The disc drive assemblies are installed into the chassis subassembly in a 15 step process, with SAP-generated labels.

    5. The assembled chassis build undergoes first inspection, in an approximately 80-85 step process, which primarily focuses on the physical condition and the traceability of all the parts.

    6. During the basic assurance test and functional test/firmware and software installation, the chassis build is connected to a custom test server to enable the correct configuration of the unit for customer use. Then, the updated software is loaded, including the specified level of firmware, vital product data, security data, and serialization information. The firmware is developed and managed by engineers in the United Kingdom.

    7. A controlled environment reliability test is conducted to ensure that the chassis build can endure challenging physical environments (excessive heat or cold).

    8. The Hipot test is conducted to verify that the chassis build is electrically safe, which confirms that the electric current used to run the unit is adequately shielded so that neither the operators nor the equipment are harmed by electrical shock and that all insulation is installed correctly.

    9. Customer region-specific power cables, installation, and other customer-specific documentation are added.

    10. Final inspection is performed.

    Product Two, the [********] is a combined storage and server platform on which OEMs can deploy their own data storage software as a storage solution to their end customers. The embedded servers have less memory, processing, and input/output capacity than Product One, but they are designed to provide OEMs with a high availability storage solution that can withstand a server failure. While Product Two can be configured based on customer requirements, it generally includes hard disc drive slots that can carry up to 24 hard disc drives in drive carriers, and two embedded server modules with a low-power server-grade Intel processor, memory chips, and one PCIe input/output slot. It can also accept both a case-level operating system and unique OEM applications. The assembly process is similar to the Product One assembly, in that it starts with the chassis subassembly, but does not include disc drive assemblies and has a different computing capacity. The assembly process takes approximately 76 minutes of labor time.

    Product Three, the [********], is also substantially similar to Product One, but it can incorporate up to 84 disc drives. Otherwise, the assembly in Mexico is substantially similar to that of Product One. The assembly process takes approximately 355 minutes of labor time.

    During the Basic Assurance Test and Functional Test/Firmware and Software Installation process in all three products, the Company loads numerous firmware files onto the system (15 firmware files in Product One and Product Three, and 22 firmware files in Product Two). The specific firmware is said to confer customer specific operational functionality to the system and enable the components to work together. The disc drives are programmed with key codes in order to work with the customer application, and the Company states that the disc drives are not functional without this step. The drives are programmed to set up to 300 custom drive performance characteristics, such as timeouts, error thresholds, and data block size. The Company states that the post-assembly programming and testing enables the operation of each product and customizes it for its customers. The Company's programming process is driven and managed by the ISTP and is as follows:

    1. Initialization and hardware validation is performed to ensure that all necessary physical components are present (disc drives, power units, batteries, motherboards, other printed circuit boards, etc).

    2. Canister master/slave validation is performed to ensure that the “master” canister (controller) is properly communicating with the other canisters (the “slaves”).

    3. Code load and validation are conducted in three phrases to establish the customer-specific operating systems and application code: boot loader (loading code that establish initial functions required by the customer), enclosure configuration (ensuring that hardware is compatible with the software or application that will operate on the product), and virtual product data load and configuration (customizing the product instruction to be specific to the customer's product).

    4. Motherboard Ethernet branding ensures that the Ethernet ports operate correctly.

    5. An SES element test is performed to ensure that sensors are present and communicating with the system.

    6. Hard disc drive presence, code load, and validation is performed to ensure that all hard disc drives have been installed properly and are able to communicate with the system. The Company will load the customer's firmware and establish the operational behavior of the drives.

    7. A hard disc drive rotational vibration test is performed to ensure that the fan vibration does not affect the integrity of data sent to and received by the disc drives.

    8. Hard disc drive performance, link speed, and status are verified to assess the response time between the drives and execute the instruction from the main processing unit.

    9. Hard disc drive branding and validation is performed.

    10. Fan speed test is conducted.

    11. Voltage, battery, and temperature validation is performed.

    12. Log analysis is conducted.

    The Company also states that all three storage products are classified under subheading 8471.70 of the Harmonized Tariff Schedule of the United States (“HTSUS”). As reflected in the General Note (“GN”) 12(u)(6) of the HTSUS, the Company states that the goods are considered originating goods for purposes of the North American Free Trade Agreement (“NAFTA”) when imported into the United States from Mexico. The Company states that the major components imported into Mexico (chassis subassemblies, disc drives, drive carriers, drawer assemblies, etc.) are classified within the subheadings of 8471.60 and 8472.90, HTSUS.

    ISSUES:

    I. What is the country of origin of the three data storage products for purposes of U.S. Government procurement?

    II. What is the proper country of origin marking under the NAFTA Marking Rules of the three storage products?

    LAW AND ANALYSIS: I. Country of Origin for Procurement Purposes

    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 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 U.S. (predecessor to subheading 9802.00.80, HTSUS), 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 project engineer with many years of experience in “designing and building hardware.” 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 determining whether the combining of parts or materials constitutes a substantial transformation, the determinative issue is the extent of operations performed and whether the parts lose their identity and become an integral part of the new article. Belcrest Linens v. United States, 573 F. Supp. 1149 (Ct. Int'l Trade 1983), aff'd, 741 F.2d 1368 (Fed. Cir. 1984). Assembly operations that are minimal or simple, as opposed to complex or meaningful, will generally not result in a substantial transformation.

    In order to determine whether a substantial transformation occurs when components of various origins are assembled into complete products, CBP considers the totality of the circumstances and makes such determinations on a case-by-case basis. The country of origin of the item's components, extent of the processing that occurs within a country, and whether such processing renders a product with a new name, character, and use are primary considerations in such cases. Additionally, factors such as the resources expended on product design and development, the extent and nature of post-assembly inspection and testing procedures, and worker skill required during the actual manufacturing process will be considered when determining whether a substantial transformation has occurred. No one factor is determinative.

    You argue that the country of origin of the three products is Mexico because the components imported into Mexico are substantially transformed as a result of the Mexican assembly operations, as described infra, downloading of the software, programming and customization of the software and firmware, and extensive testing of the data storage products.

    In Headquarters Ruling Letter (“HQ”) H082476, dated May 11, 2010, and in New York Ruling Letter (“NY”) N083979 dated December 3, 2009, the United States was determined to be the country of origin of ICS clustered storage units, when foreign components were assembled into the units and programmed in the United States. In HQ H025023 dated April 1, 2008, CBP determined that the Czech Republic was the country of origin of a fabric switch that was assembled to completion and programmed in that country. See also HQ H089762, dated June 2, 2010 (GTX Mobile and Handheld Computer); and HQ H090115, dated August 2, 2010 (Unified Communications Solution). In HQ H125975 dated January 19, 2011, CBP considered a similar scenario to the one here. In HQ H125975, all of the components were assembled into the data storage system in Mexico and the previously programmed controller assembly was downloaded with software, which was stated to impart the functional intelligence to the system to allow for storage management, performance monitoring and access control. In HQ H125975, CBP found that the major operating hardware components were the controller assembly and the hard drives set, which were of Thai origin. However, the assembly process in Mexico involved multiple countries of origin with development and programming also occurring in two different countries. CBP concluded that the imported components of various origins lost their individual identities and were substantially transformed into a new and different article, as a result of the assembly and programming operations that took place in Mexico.

    In this case, there are also significant assembly operations of the data storage products occurring in Mexico. Similar to HQ H125975, we have various countries involved: Chassis assembly from Malaysia; power supply from the Philippines; software from the United Kingdom; hard disc drives from China, Singapore, or Thailand; and assembly in Mexico. Given the totality of the circumstances in this case, we find that Products One and Three are substantially transformed in Mexico mainly because of the assembly of the various components. However, we find that the origin of Product Two is Malaysia because it lacks the disc drive assemblies, which make up a significant part of the assembly process. For purposes of government procurement, Mexico is the country of origin for Products One and Three, and Malaysia is the country of origin for Product Two.

    II. NAFTA 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 United States shall be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States the English name of the country of origin of the article. By enacting 19 U.S.C. 1304, Congress intended to ensure “that the ultimate purchaser would be able to know by inspecting the marking on the imported goods the country of which the goods are the product. The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will.” United States v. Friedlaender & Co., 27 C.C.P.A. 297, 302 (1940).

    Section 134.1(b), CBP Regulations (19 CFR 134.1(b)), defines “country of origin” as “the country of manufacture, production or growth of any article of foreign origin entering the United States. 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' within the meaning of this part; however, for a good of a NAFTA country, the NAFTA Marking Rules will determine the country of origin.”

    The NAFTA Marking Rules require the application of the country of origin rules per 19 CFR 102.11, in order to determine whether a good qualifies to be marked as a good of a NAFTA country. See 19 CFR 134.1(j). Section 102.11, CBP Regulations (19 CFR 102.11), provides the hierarchical rules for determining the country of origin of imported goods for NAFTA purposes, in part, as follows:

    (1) The good is wholly obtained or produced;

    (2) The good is produced exclusively from domestic materials; or

    (3) Each foreign material incorporated in that good undergoes an applicable change in tariff classification set out in 102.20 and satisfies any other applicable requirements of that section and all other applicable requirements of these rules are satisfied.

    The three data storage products are neither wholly obtained or produced in a single NAFTA country or produced exclusively from domestic materials. You state that the three products are classified under subheading 8471.70, HTSUS. CBP agrees with the Company's classification with regard to Product One and Product Three. However, after consulting with the National Commodity Specialist Division (“NCSD”), we have determined that Product Two is classified in subheading 8471.80, HTSUS. The tariff shift rule for goods of subheading 8471.70 and 8471.80 is set forth in 19 CFR 102.20 as follows:

    8471.60-8472.90 A change to subheading 8471.60 through 8472.90 from any other subheading outside that group, except from subheading 8504.40 or from heading 8473; or A change to subheading 8471.60 through 8472.90 from any other subheading within that group or from subheading 8504.90 or from heading 8473, provided that the change is not the result of simple assembly.

    In all three instances, the Company concedes that the tariff shift rule is not met because the major components are classified in subheadings between 8471.60 and 8472.90, HTSUS, and do not undergo a tariff shift.

    However, the Company states that the products will qualify for preferential tariff treatment under the NAFTA. Assuming the Company plans to make a NAFTA claim at the time of entry, 19 CFR 102.19(a) provides as follows:

    . . . if a good is originating within the meaning of 181.1(q) of this chapter is not determined under 102.11(a) or (b) or 102.21 to be a good of a single NAFTA country, the country of origin of such good is the last NAFTA country in which that good underwent production other than minor processing . . .

    The language of 19 CFR 102.19(a) is applicable because pursuant to GN 12(b)(v), the three products are considered originating because they are classified under subheading 8471.70 and 8471.80, HTSUS.1 Since the three products undergo production other than minor processing in Mexico, the country of origin for marking purposes under the NAFTA Marking Rules will be Mexico.

    1 GN 12(b)(v) states that the goods enumerated in subdivision (u) of GN 12 are originating in the territory of a NAFTA party. GN 12(u) states that automatic data processing machines and parts that are classified under subheading 8471.70 and 8471.80 are considered originating when they are imported into the customs territory of the United States from the territory of Canada or of Mexico.

    HOLDING:

    Based on the facts provided, we find that the country of origin of Products One and Three for purposes of U.S. Government procurement is Mexico. The country of origin of Product Two for purposes of U.S. Government procurement is Malaysia. The country of origin for all three products for marking purposes will be Mexico under the NAFTA Marking Rules.

    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, Alice A. Kipel, Executive Director, Regulations and Rulings, Office of Trade.
    [FR Doc. 2017-04953 Filed 3-13-17; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration [Docket No. TSA-2009-0024] Enforcement Actions Summary AGENCY:

    Transportation Security Administration, DHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Transportation Security Administration (TSA) is providing notice that it has issued an annual summary of all enforcement actions taken by TSA under the authority granted in the Implementing Recommendations of the 9/11 Commission Act of 2007.

    FOR FURTHER INFORMATION CONTACT:

    Emily Su, Assistant Chief Counsel, Civil Enforcement, Office of the Chief Counsel, TSA-2, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598-6002; telephone (571) 227-2305; facsimile (571) 227-1378; email [email protected]

    SUPPLEMENTARY INFORMATION: Background

    On August 3, 2007, section 1302(a) of the Implementing Recommendations of the 9/11 Commission Act of 2007 (the 9/11 Act), Public Law 110-53, 121 Stat. 392, gave TSA new authority to assess civil penalties for violations of any surface transportation requirements under title 49 of the U.S. Code (U.S.C.) and for any violations of chapter 701 of title 46 of the U.S. Code, which governs transportation worker identification credentials (TWICs).

    Section 1302(a) of the 9/11 Act, codified at 49 U.S.C. 114(v), authorizes the Secretary of the Department of Homeland Security (DHS) to impose civil penalties for a violation of any surface transportation requirement under 49 U.S.C. or any requirement related to TWICs under 46 U.S.C. chapter 701. TSA exercises this function under delegated authority from the Secretary. See DHS Delegation No. 7060-2.

    Under 49 U.S.C. 114(v)(7)(A), TSA is required to provide the public with an annual summary of all enforcement actions taken by TSA under this subsection; and include in each such summary the identifying information of each enforcement action, the type of alleged violation, the penalty or penalties proposed, and the final assessment amount of each penalty, if any. This summary is for calendar year 2016. At the beginning of each calendar year, TSA will continue to publish a summary of all enforcement actions taken under the statute during the previous calendar year.

    Document Availability

    You can get an electronic copy of both this notice and the enforcement actions summary on the Internet by—

    (1) Searching the electronic Federal Docket Management System (FDMS) Web page at http://www.regulations.gov, Docket No. TSA-2009-0024; or

    (2) Accessing the Government Printing Office's Web page at http://www.thefederalregister.org/fdsys/browse/collection.action?collectionCode=FR to view the daily published Federal Register edition; or accessing the “Search the Federal Register by Citation” in the “Related Resources” column on the left, if you need to do a Simple or Advanced search for information, such as a type of document that crosses multiple agencies or dates; or

    In addition, copies are available by writing or calling the individual in the FOR FURTHER INFORMATION CONTACT section. Make sure to identify the docket number of this rulemaking.

    Dated: March 7, 2017. Kelly D. Wheaton, Deputy Chief Counsel, Enforcement and Incident Management. March 7, 2017 Annual Summary of Enforcement Actions Taken Under 49 U.S.C. 114(v) Annual Report

    Pursuant to 49 U.S.C. 114(v)(7)(A), TSA provides the following summary of enforcement actions taken by TSA in calendar year 2016 under section 114(v).1

    1 49 U.S.C. 114(v)(7)(A) states: In general. Not later than December 31, 2008, and annually thereafter, the Secretary shall—(i) provide an annual summary to the public of all enforcement actions taken by the Secretary under this subsection; and (ii) include in each such summary the docket number of each enforcement action, the type of alleged violation, the penalty or penalties proposed, and the final assessment amount of each penalty.

    Background

    Section 114(v) of title 49 of the U.S. Code gave the Transportation Security Administration (TSA) new authority to assess civil penalties for violations of any surface transportation requirements under 49 U.S.C. and for any violations of chapter 701 of title 46 of the U.S. Code, which governs transportation worker identification credentials (TWICs). Specifically, section 114(v) authorizes the Secretary of the Department of Homeland Security (DHS) to impose civil penalties for a violation of any surface transportation requirement under title 49 U.S.C. or any requirement related to TWICs under 46 U.S.C. chapter 701.2

    2 TSA exercises this function under delegated authority from the Secretary. See DHS Delegation No. 7060-2.

    Enforcement Actions Taken by TSA in Calendar Year 2016 TSA Case No. Type of violation Penalty proposed/assessed 2016ATL0498 TWIC—Access Control (49 CFR 1570.7(c)) $1,000/Pending. 2016ATL0499 TWIC—Access Control (49 CFR 1570.7(c)) $1,000/$1,000. 2016ATL0922 TWIC—Fraudulent Use (49 CFR 1570.7(a)) $500/Pending. 2016ATL0923 TWIC—Fraudulent Use (49 CFR 1570.7(a)) $500/Pending. 2016BOS0317 TWIC—Access Control (49 CFR 1570.7(d)) None (Warning Notice). 2016BTR0005 TWIC—Access Control (49 CFR 1570.7(d)) $1,000/Pending. 2016BTR0006 TWIC—Access Control (49 CFR 1570.7(c)) $1,000/Pending. 2016EWR0125 TWIC—Fraudulent Use (49 CFR 1570.7(a)) None (Warning Notice). 2016HOU0435 TWIC—False/Altered TWIC (49 CFR 1570.7(b)) $1,000/Pending. 2016JAX0120 TWIC—Access Control (49 CFR 1570.7(d)) None (Warning Notice). 2016JAX0150 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016JAX0159 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016JAX0251 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016JAX0252 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016JFK0212 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016JFK0274 TWIC—Access Control (49 CFR 1570.7(d)) None (Warning Notice). 2016LAX0489 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016LAX0490 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016MSY0093 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016MSY0094 TWIC—Fraudulent Use (49 CFR 1570.7(a)) None (Warning Notice). 2016MSY0184 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016MSY0185 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016OAK0128 TWIC—Access Control (49 CFR 1570.7(c)) $4,000/Pending. 2016OAK0146 TWIC—False/Altered TWIC (49 CFR 1570.7(b)) $5,000/Pending. 2016OAK0152 TWIC—Access Control (49 CFR 1570.7(c) and (d)) $2,000/Pending. 2016OAK0169 TWIC—Access Control (49 CFR 1570.7(c)) $2,000/Pending. 2016OAK0361 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016PDX0212 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016SAN0206 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016SAN0242 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016SAN0356 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2016SAT0142 TWIC—Access Control (49 CFR 1570.7(c)) $1,000/$1,000. 2016SEA0687 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2017JFK0006 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2017OAK0013 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2017OAK0014 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2017OAK0030 TWIC—Fraudulent Use (49 CFR 1570.7(a)) None (Warning Notice). 2017OAK0034 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2017OAK0075 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2017OAK0076 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2017PHL0019 TWIC—False/Altered TWIC (49 CFR 1570.7(b)) $3,000/Pending. 2017RIC0004 TWIC—False/Altered TWIC (49 CFR 1570.7(b)) $3,000/Pending. 2017RIC0005 TWIC—Access Control (49 CFR 1570.7(c)) $1,000/Pending. 2017RIC0006 TWIC—Access Control (49 CFR 1570.7(c)) $1,000/Pending. 2017SAT0005 TWIC—False/Altered TWIC (49 CFR 1570.7(b)) $6,000/Pending. 2017SAT0008 TWIC—False Statement (49 CFR 1570.5(a)) $3,000/Pending. 2017SMF0088 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2017SMF0089 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice). 2017STL0104 TWIC—Access Control (49 CFR 1570.7(c)) None (Warning Notice).
    [FR Doc. 2017-04977 Filed 3-13-17; 8:45 am] BILLING CODE 9110-05-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0075] Agency Information Collection Activities; Revision of a Currently Approved Collection: Affidavit of Support Under Section 213A of the Act, Form I-864; Contract Between Sponsor and Household Member, Form I-864A; EZ Affidavit of Support Under Section 213 of the Act, I-864EZ; Intending Immigrant's Affidavit of Support Exemption, I-864W AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    60-day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

    DATES:

    Comments are encouraged and will be accepted for 60 days until May 15, 2017.

    ADDRESSES:

    All submissions received must include the OMB Control Number 1615-0075 in the body of the letter, the agency name and Docket ID USCIS-2007-0029. To avoid duplicate submissions, please use only one of the following methods to submit comments:

    (1) Online. Submit comments via the Federal eRulemaking Portal Web site at http://www.regulations.gov undere-Docket ID number USCIS-2007-0029;

    (2) Mail. Submit written comments to DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW., Washington, DC 20529-2140.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at http://www.uscis.gov, or call the USCIS National Customer Service Center at 800-375-5283 (TTY 800-767-1833).

    SUPPLEMENTARY INFORMATION:

    Comments

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2007-0029 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

    (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 submission of responses.

    Overview of This Information Collection

    (1) Type of Information Collection: Revision of a Currently Approved Collection.

    (2) Title of the Form/Collection: Affidavit of Support Under Section 213A of the Act; Contract Between Sponsor and Household Member; EZ Affidavit of Support under Section 213 of the Act; Intending Immigrant's Affidavit of Support Exemption.

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: Form I-864; I864A; I-864EZ; I-864W; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households; The data collected on Form I-864 will be used by the USCIS to determine whether the sponsor has the ability to support the sponsored alien under section 213A of the Immigration and Nationality Act. This form serves the purpose of standardizing the evaluations of the sponsor's ability to support the sponsored alien and ensures that basic information required to assess eligibility is provided by petitioners.

    The Form I-864A is a contract between the sponsor and the sponsor's household members. It is only required if the sponsor used income of his or her household members to reach the required 125 percent of the Federal poverty guideline. The contract holds these household members jointly and severally liable for the support of the sponsored immigrant. The information collection required on Form I-864A is necessary for public benefit agencies to enforce the Affidavit of Support in the event the sponsor used income of his or her household members to reach the required income level and the public benefit agencies are requesting reimbursement from the sponsor.

    The Form I-864EZ will be used by the USCIS in exactly the same way as Form I-864, however, the USCIS will collect less information from the sponsors as less information will be needed from those who qualify in order to make a thorough adjudication.

    The Form I-864W is a form that will be used by the USCIS to determine whether the intending immigrant meets the criteria for exemption of section 213A requirements. This form collects the immigrant's basic information, such as name and address, the reason for the exemption, and accompanying documentation in support of the immigrant's claim that they are not subject to section 213A.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection I-864 is 446,313 and the estimated hour burden per response is 6 hours; the estimated total number of respondents for the information collection I-864A is 42,892 and the estimated hour burden per response is 1.75 hours; the estimated total number of respondents for the information collection I-864EZ is 114,860 and the estimated hour burden per response is 2.5 hours; the estimated total number of respondents for the information collection I-864W is 98,119 hours and the estimated hour burden per response is 1 hour.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 3,138,208 hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $161,526,540.

    Dated: March 9, 2017. Samantha Deshommes, Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2017-05020 Filed 3-13-17; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0079] Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Application for Replacement/Initial Nonimmigrant Arrival-Departure Document AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

    DATES:

    Comments are encouraged and will be accepted for 60 days until May 15, 2017.

    ADDRESSES:

    All submissions received must include the OMB Control Number 1615-0079 in the body of the letter, the agency name and Docket ID USCIS-2007-0011. To avoid duplicate submissions, please use only one of the following methods to submit comments:

    (1) Online. Submit comments via the Federal eRulemaking Portal Web site at http://www.regulations.gov under e-Docket ID number USCIS-2007-0011;

    (2) Mail. Submit written comments to DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW., Washington, DC 20529-2140.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at http://www.uscis.gov, or call the USCIS National Customer Service Center at 800-375-5283 (TTY 800-767-1833).

    SUPPLEMENTARY INFORMATION:

    Comments

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2007-0011 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

    (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 submission of responses.

    Overview of This Information Collection

    (1) Type of Information Collection: Extension, Without Change, of a Currently Approved Collection.

    (2) Title of the Form/Collection: Application for Replacement/Initial Nonimmigrant Arrival-Departure Document.

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: I-102; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: I-102; USCIS. Nonimmigrants temporarily residing in the United States can use this form to request a replacement of lost, stolen, or mutilated arrival-departure records, or to request a new arrival-departure record, if one was not issued when the nonimmigrant was last admitted but is now in need of such a record. U.S. Citizenship and Immigration Services (USCIS) uses the information provided by the requester to verify eligibility, as well as his or her status, process the request and issue a new or replacement arrival-departure record.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection I-102 is 6,899 and the estimated hour burden per response is .75 hours.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 5,174 hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $1,892,870.

    Dated: March 9, 2017. Samantha Deshommes, Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2017-05031 Filed 3-13-17; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0053] Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Request for Certification of Military or Naval Service AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

    DATES:

    Comments are encouraged and will be accepted for 60 days until May 15, 2017.

    ADDRESSES:

    All submissions received must include the OMB Control Number 1615-0053 in the body of the letter, the agency name and Docket ID USCIS-2007-0016. To avoid duplicate submissions, please use only one of the following methods to submit comments:

    (1) Online. Submit comments via the Federal eRulemaking Portal Web site at http://www.regulations.gov under e-Docket ID number USCIS-2007-0016;

    (2) Mail. Submit written comments to DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW., Washington, DC 20529-2140.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at http://www.uscis.gov, or call the USCIS National Customer Service Center at 800-375-5283 (TTY 800-767-1833).

    SUPPLEMENTARY INFORMATION: Comments

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2007-0016 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

    (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 submission of responses.

    Overview of This Information Collection

    (1) Type of Information Collection: Extension, Without Change, of a Currently Approved Collection.

    (2) Title of the Form/Collection: Request for Certification of Military or Naval Service.

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: N-426; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. USCIS uses the information collected through Form N-426 to request a verification of the military or naval service claim by an applicant filing for naturalization on the basis of honorable service in the U.S. armed forces.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection N-426 is 10,000 and the estimated hour burden per response is .333 hours.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 3,330 hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $245,000.

    Dated: March 9, 2017. Samantha Deshommes, Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2017-05019 Filed 3-13-17; 8:45 am] BILLING CODE 9111-97-P
    INTERNATIONAL TRADE COMMISSION [Investigation Nos. 701-TA-567-569 and 731-TA-1343-1345 (Preliminary)] Silicon Metal From Australia, Brazil, Kazakhstan, and Norway; Institution of Antidumping and Countervailing Duty Investigations and Scheduling of Preliminary Phase Investigations AGENCY:

    United States International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-567-569 and 731-TA-1343-1345 (Preliminary) pursuant to the Tariff Act of 1930 (“the Act”) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of silicon metal from Australia, Brazil, and Norway, provided for in statistical reporting numbers 2804.69.1000 and 2804.69.5000 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and imports of silicon metal from Australia, Brazil, and Kazakhstan alleged to be subsidized by the Governments of Australia, Brazil, and Kazakhstan. Unless the Department of Commerce extends the time for initiation, the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by April 24, 2017. The Commission's views must be transmitted to Commerce within five business days thereafter, or by May 1, 2017.

    DATES:

    Effective Date: March 8, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Carolyn Carlson (202-205-3002, [email protected]), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (https://www.usitc.gov). The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov.

    SUPPLEMENTARY INFORMATION:

    Background.—These investigations are being instituted, pursuant to sections 703(a) and 733(a) of the Tariff Act of 1930 (19 U.S.C. 1671b(a) and 1673b(a)), in response to a petition filed on March 8, 2017, by Globe Specialty Metals, Inc., Beverly, Ohio.

    For further information concerning the conduct of these investigations and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207).

    Participation in the investigation and public service list.—Persons (other than petitioners) wishing to participate in the investigations as parties must file an entry of appearance with the Secretary to the Commission, as provided in sections 201.11 and 207.10 of the Commission's rules, not later than seven days after publication of this notice in the Federal Register. Industrial users and (if the merchandise under investigation is sold at the retail level) representative consumer organizations have the right to appear as parties in Commission antidumping duty and countervailing duty investigations. The Secretary will prepare a public service list containing the names and addresses of all persons, or their representatives, who are parties to these investigations upon the expiration of the period for filing entries of appearance.

    Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and BPI service list.—Pursuant to section 207.7(a) of the Commission's rules, the Secretary will make BPI gathered in these investigations available to authorized applicants representing interested parties (as defined in 19 U.S.C. 1677(9)) who are parties to the investigations under the APO issued in the investigations, provided that the application is made not later than seven days after the publication of this notice in the Federal Register. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

    Conference.—The Commission's Director of Investigations has scheduled a conference in connection with these investigations for 9:30 a.m. on Wednesday, March 29, 2017, at the U.S. International Trade Commission Building, 500 E Street SW., Washington, DC. Requests to appear at the conference should be emailed to [email protected] and [email protected] (DO NOT FILE ON EDIS) on or before March 27, 2017. Parties in support of the imposition of countervailing and antidumping duties in these investigations and parties in opposition to the imposition of such duties will each be collectively allocated one hour within which to make an oral presentation at the conference. A nonparty who has testimony that may aid the Commission's deliberations may request permission to present a short statement at the conference.

    Written submissions.—As provided in sections 201.8 and 207.15 of the Commission's rules, any person may submit to the Commission on or before April 3, 2017, a written brief containing information and arguments pertinent to the subject matter of the investigations. Parties may file written testimony in connection with their presentation at the conference. All written submissions must conform with the provisions of section 201.8 of the Commission's rules; any submissions that contain BPI must also conform with the requirements of sections 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's Handbook on E-Filing, available on the Commission's Web site at https://www.usitc.gov/secretary/documents/handbook_on_filing_procedures.pdf, elaborates upon the Commission's rules with respect to electronic filing.

    In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.

    Certification.—Pursuant to section 207.3 of the Commission's rules, any person submitting information to the Commission in connection with this/these investigation(s) must certify that the information is accurate and complete to the best of the submitter's knowledge. In making the certification, the submitter will acknowledge that any information that it submits to the Commission during this/these investigation(s) may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this/these or related investigations or reviews, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements.

    Authority:

    These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.12 of the Commission's rules.

    By order of the Commission.

    Issued: March 9, 2017. Katherine M. Hiner, Acting Supervisory Attorney.
    [FR Doc. 2017-04994 Filed 3-13-17; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION [Investigation. No. 337-TA-1043] Certain Electrical Connectors, Components Thereof, and Products Containing the Same; Institution of Investigation AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on February 6, 2017, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of J.S.T. Corporation of Farmington Hills, Michigan. A supplement to the complaint was filed on February 13, 2017. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain electrical connectors, components thereof, and products containing the same by reason of infringement of certain claims of U.S. Patent No. 7,004,766 (“the '766 patent”). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.

    The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

    ADDRESSES:

    The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov.

    FOR FURTHER INFORMATION CONTACT:

    The Office of the Secretary, Docket Services, U.S. International Trade Commission, telephone (202) 205-1802.

    SUPPLEMENTARY INFORMATION:

    Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on March 8, 2017, ordered that—

    (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain electrical connectors, components thereof, and products containing the same by reason of infringement of one or more of claims 2, 4, 9, and 10 of the '766 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;

    (2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:

    (a) The complainant is:

    J.S.T. Corporation, 47879 Interchange Drive, Farmington Hills, MI 48335

    (b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:

    Robert Bosch GmbH, Robert-Bosch-Platz 1, 70839 Gerlingen-Schillerhöhe, Baden-Wuertemberg, Germany Bosch Automotive Products (Suzhou) Co., Ltd., 126 Su Hong Xi Road, Suzshou, Jiangsu 215021, China Robert Bosch LLC, 2800 South 25th Avenue, Broadview, IL 60155 Robert Bosch, Sistemas Automotrices, S.A. de C.V., Prolongación Hermanos Escobar #6965, Parque Industrial Omega, C.P., 32320 Cd. Juárez, Chihuahua, Mexico Robert Bosch Ltda., Via Anhangüera, Km 98, 13065-900 Campinas—SP, Brazil Hon Hai Precision Industry Co., Ltd., No. 2, Zihyou Street, Tucheng District, New Taipei City, 236, Taiwan Foxconn Interconnect Technology, Ltd., No. 2, Zihyou Street, Tucheng District, New Taipei City, 236, Taiwan

    (3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.

    The Office of Unfair Import Investigations will not participate as a party in this investigation.

    Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.

    Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.

    Authority:

    The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2016).

    By order of the Commission.

    Dated: March 9, 2017. Katherine M. Hiner, Acting Supervisory Attorney.
    [FR Doc. 2017-04993 Filed 3-13-17; 8:45 am] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms and Explosives [OMB Number 1140-0098] Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; Prevent All Cigarette Trafficking (PACT) Act Registration Form, ATF F 5070.1 AGENCY:

    Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.

    ACTION:

    60-day notice.

    SUMMARY:

    The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit 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.

    DATES:

    Comments are encouraged and will be accepted for 60 days until May 15, 2017.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any additional information, please contact Keith Krolczky, National Investigative Division, Alcohol and Tobacco Enforcement Branch, either by mail at 99 New York Avenue NE., Washington, DC 20226, by email at [email protected], or by telephone at 202-648-8526.

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —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; —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; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —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. Overview of This Information Collection

    1. Type of Information Collection (check justification or form 83): Revision of a currently approved collection.

    2. The Title of the Form/Collection: Prevent All Cigarette Trafficking (PACT) Act Registration Form.

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection:

    Form number (if applicable): ATF F 5070.1.

    Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.

    4. Affected public who will be asked or required to respond, as well as a brief abstract:

    Primary: Business or other for-profit.

    Other (if applicable): None.

    Abstract: The form is required for any person who sells, transfers, or ships for profit cigarettes or smokeless tobacco in interstate commerce, whereby such cigarettes or smokeless tobacco are shipped into a State, locality, or Indian country of an Indian tribe taxing the sale or use of cigarettes or smokeless tobacco, or who advertises or offers cigarettes or smokeless tobacco for such a sale, transfer, or shipment, shall file first with the Attorney General of the United States.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 400 respondents will utilize the form, and it will take each respondent approximately 1 hour to complete the form.

    6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 400 hours, which is equal to (400 (# of respondents) * 1 (hourly rate to complete the form).

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405A, Washington, DC 20530.

    Dated: March 9, 2017. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2017-04949 Filed 3-13-17; 8:45 am] BILLING CODE 4410-FY-P
    DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms and Explosives [OMB Number 1140-0076] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension Without Change of a Currently Approved Collection; Relief of Disabilities and Application for Restoration of Explosives Privileges (ATF Form 5400.29) AGENCY:

    Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.

    ACTION:

    60-day notice.

    SUMMARY:

    The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit 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.

    DATES:

    Comments are encouraged and will be accepted for 60 days until May 15, 2017.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any additional information, please contact Explosives Relief of Disabilities Program, National Center for Explosives Training and Research (NCETR) either by mail at 3750 Corporal Road, Redstone Arsenal, AL 35898, by email at [email protected], or by telephone at 256-261-7640.

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —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; —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; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —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. Overview of This Information Collection

    1. Type of Information Collection (check justification or form 83): Extension, without change, of a currently approved collection.

    2. The Title of the Form/Collection: Relief of Disabilities and Application for Restoration of Explosives Privileges.

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection:

    Form number (if applicable): ATF Form 5400.29.

    Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.

    4. Affected public who will be asked or required to respond, as well as a brief abstract:

    Primary: Individuals or households.

    Other (if applicable): Business or other for-profit.

    Abstract: Persons who wish to ship, transport, receive, or possess explosive materials, but are prohibited from doing so, will complete this form. The form will be submitted to ATF to determine whether the person who provided the information is likely to act in a manner dangerous to public safety and that the granting of relief is not contrary to the public interest.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 300 respondents will utilize the form, and it will take each respondent approximately 30 minutes to complete the form.

    6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 150 hours which is equal to (300 (total # of respondents) * .5 (30 minutes).

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405A, Washington, DC 20530.

    Dated: March 9, 2017. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2017-04950 Filed 3-13-17; 8:45 am] BILLING CODE 4410-FY-P
    DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms and Explosives [OMB Number 1140-0013] Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; Application for Tax-Exempt Transfer of Firearm and Registration to Special Occupational Taxpayer, ATF Form 3 (5320.3) AGENCY:

    Bureau of Alcohol, Tobacco, Firearms and Explosives, Justice.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit 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.

    DATES:

    Comments are encouraged and will be accepted for 60 days until May 15, 2017.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any additional information, please contact Andrew Ashton, NFA Branch Specialist either by mail at 244 Needy Road, Martinsburg, WV 25405, by email at [email protected], or by telephone at 304-616-4501.

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —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; —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; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —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.

    Overview of this information collection:

    1. Type of Information Collection (check justification or form 83): Revision of a currently approved collection.

    2. The Title of the Form/Collection: Application for Tax-Exempt Transfer of Firearm and Registration to Special Occupational Taxpayer.

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection:

    Form number (if applicable): ATF Form 3 (5320.3).

    Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.

    4. Affected public who will be asked or required to respond, as well as a brief abstract:

    Primary: Business or other for-profit.

    Other (if applicable): Individuals or households.

    Abstract: This form is used to transfer National Firearms Act (NFA) regulated items between Federal firearms licensees (FFL)/Special Occupational Tax (SOT) payers to be exempted from the transfer tax incurred for each item.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 10,500 respondents will utilize the form, and it will take each respondent approximately 30 minutes to complete the form.

    6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 88,750 hours, which is equal to (177,500 (total # of annual responses) * .5 (30 mins).

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405A, Washington, DC 20530.

    Dated: March 9, 2017. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2017-04951 Filed 3-13-17; 8:45 am] BILLING CODE 4410-FY-P
    DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms and Explosives [OMB Number 1140-0049] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension Without Change of a Currently Approved Collection; Application for National Firearms Examiner Academy, ATF F 6330.1 AGENCY:

    Bureau of Alcohol, Tobacco, Firearms and Explosives, Justice.

    ACTION:

    60-day notice.

    SUMMARY:

    The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit 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.

    DATES:

    Comments are encouraged and will be accepted for 60 days until May 15, 2017.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any additional information, please contact Sheila Hopkins, Program Manager, ATF National Laboratory Center, either by mail at 6000 Ammendale Road, Beltsville, MD 20705-1250, by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —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; —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; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —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.

    Overview of this information collection:

    1. Type of Information Collection (check justification or form 83): Extension, without change, of a currently approved collection.

    2. The Title of the Form/Collection: Application for National Firearms Examiner Academy.

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection:

    Form number (if applicable): ATF F 6330.1.

    Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.

    4. Affected public who will be asked or required to respond, as well as a brief abstract:

    Primary: State, Local or Tribal Government.

    Other (if applicable): Federal Government.

    Abstract: The Information requested on this form is necessary to process requests from prospective students to attend the ATF National Firearms Examiner Academy, and to acquire firearms and toolmark examiner training. The information collection is used to determine the eligibility of the applicant.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 75 respondents will utilize the form, and it will take each respondent approximately 12 minutes to complete the form.

    6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 15 hours, which is equal to (75 respondents * .20 (12 minutes).

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405A, Washington, DC 20530.

    Dated: March 9, 2017. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2017-04948 Filed 3-13-17; 8:45 am] BILLING CODE 4410-FY-P
    DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms and Explosives [OMB Number 1140-0002] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection; Application for Restoration of Firearms Privileges, ATF F 3210.1 AGENCY:

    Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit 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.

    DATES:

    Comments are encouraged and will be accepted for 60 days until May 15, 2017.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any additional information, please contact the Explosives Relief of Disabilities Program, National Center for Explosives Training and Research (NCETR) either by mail at 3750 Corporal Road, Redstone Arsenal, AL 35898, by email at [email protected], or by telephone at 256-261-7640.

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —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; —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; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —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.

    Overview of this information collection:

    1. Type of Information Collection (check justification or form 83): Extension of a currently approved collection.

    2. The Title of the Form/Collection: Application for Restoration of Firearms Privileges.

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection:

    Form number (if applicable): ATF F 3210.1

    Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.

    4. Affected public who will be asked or required to respond, as well as a brief abstract:

    Primary: Individuals or households.

    Other (if applicable): Business or other for-profit.

    Abstract: The information requested is collected to fulfill the requirements of 18 U.S.C. Chapter 44. Under Federal law, individuals prohibited from purchasing, possessing, receiving, or transporting firearms are permitted to apply for restoration of their firearms privileges. The information to be supplied must identify the specifics of the applicant's appeal for restoration of privileges. The information is investigated, processed, examined, and stored initially at ATF Headquarters.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 250 respondents will take the survey, and it will take each respondent approximately 30 minutes to complete the survey.

    6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 125 hours, which is equal to (250 hours * .5 (30 mins).

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405A, Washington, DC 20530.

    Dated: March 9, 2017. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2017-04947 Filed 3-13-17; 8:45 am] BILLING CODE 4410-FY-P
    DEPARTMENT OF LABOR Mine Safety and Health Administration [OMB Control No. 1219-0152] Proposed Extension of Information Collection; Periodic Medical Surveillance Examinations for Coal Miners AGENCY:

    Mine Safety and Health Administration, Labor.

    ACTION:

    Request for public comments.

    SUMMARY:

    The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Periodic Medical Surveillance Examinations For Coal Miners.

    DATES:

    All comments must be received on or before May 15, 2017.

    ADDRESSES:

    Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below.

    Federal E-Rulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments for docket number MSHA-2016-0041.

    Regular Mail: Send comments to USDOL-MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, VA 22202-5452.

    Hand Delivery: USDOL—Mine Safety and Health Administration, 201 12th Street South, Suite 4E401, Arlington, VA 22202-5452. Sign in at the receptionist's desk on the 4th floor via the East elevator.

    FOR FURTHER INFORMATION CONTACT:

    Sheila McConnell, Director, Office of Standards, Regulations, and Variances, MSHA, at [email protected] (email); (202) 693-9440 (voice); or (202) 693-9441 (facsimile).

    SUPPLEMENTARY INFORMATION: I. Background

    Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), 30 U.S.C. 813(h), authorizes MSHA to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, Section 101(a) of the Mine Act, 30 U.S.C. 811 authorizes the Secretary to develop, promulgate, and revise as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal and metal and nonmetal mines.

    The Mine Act authorizes the National Institute for Occupational Safety and Health (NIOSH) to study the causes and consequences of coal-related respiratory disease, and in cooperation with MSHA, to carry out a program for early detection and prevention of pneumoconiosis. NIOSH administers the National Coal Workers' Health Surveillance Program, “Specifications for Medical Examinations of Underground Coal Miners,” as specified in 42 CFR part 37. 30 CFR 72.100 contains collection requirements for these activities in paragraphs (d) and (e).

    Section 72.100(d) requires that each mine operator must develop and submit for approval to NIOSH a plan in accordance with 42 CFR part 37 for providing miners with the required periodic examinations specified in 72.100(a) and a roster specifying the name and current address of each miner covered by the plan.

    Section 72.100(e) requires that each mine operator must post on the mine bulletin board at all times the approved plan for providing the examinations specified in 72.100(a).

    Section 72.100(d) and (e) are requirements that mirror NIOSH information collection requirements under 42 CFR 37.4 (existing OMB No. 0920-0020). Including these requirements allows MSHA to use its inspection and enforcement authority to ensure that operators comply with these provisions.

    II. Desired Focus of Comments

    MSHA is soliciting comments concerning the proposed information collection related to Periodic Medical Surveillance Examinations For Coal Miners. MSHA is particularly interested in comments that:

    • Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;

    • Evaluate the accuracy of MSHA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

    • Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are 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.

    The information collection request will be available on http://www.regulations.gov. MSHA cautions the commenter against providing any information in the submission that should not be publicly disclosed. Full comments, including personal information provided, will be made available on www.regulations.gov and www.reginfo.gov.

    The public may also examine publicly available documents at USDOL-Mine Safety and Health Administration, 201 12th South, Suite 4E401, Arlington, VA 22202-5452. Sign in at the receptionist's desk on the 4th floor via the East elevator.

    Questions about the information collection requirements may be directed to the person listed in the FOR FURTHER INFORMATION section of this notice.

    III. Current Actions

    This request for collection of information contains provisions for Periodic Medical Surveillance Examinations For Coal Miners. MSHA has updated the data with respect to the number of respondents, responses, burden hours, and burden costs supporting this information collection request.

    Type of Review: Revision of a currently approved collection.

    Agency: Mine Safety and Health Administration.

    OMB Number: 1219-0152.

    Affected Public: Business or other for-profit.

    Number of Respondents: 1,223.

    Frequency: On occasion.

    Number of Responses: 1,468.

    Annual Burden Hours: 1,142 hours.

    Annual Respondent or Recordkeeper Cost: $441.

    Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.

    Sheila McConnell, Certifying Officer.
    [FR Doc. 2017-04958 Filed 3-13-17; 8:45 am] BILLING CODE 4510-43-P
    MISSISSIPPI RIVER COMMISSION Sunshine Act Meetings AGENCY HOLDING THE MEETINGS:

    Mississippi River Commission.

    TIME AND DATE:

    9:00 a.m., April 3, 2017.

    PLACE:

    On board MISSISSIPPI V at Port of Hickman, Hickman, Kentucky.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    (1) Summary report by President of the Commission on national and regional issues affecting the U.S. Army Corps of Engineers and Commission programs and projects on the Mississippi River and its tributaries; (2) District Commander's overview of current project issues within the St. Louis and Memphis Districts; and (3) Presentations by local organizations and members of the public giving views or comments on any issue affecting the programs or projects of the Commission and the Corps of Engineers.

    TIME AND DATE:

    9:00 a.m., April 4, 2017.

    PLACE:

    On board MISSISSIPPI V at Beale Street Landing, Memphis, Tennessee.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    (1) Summary report by President of the Commission on national and regional issues affecting the U.S. Army Corps of Engineers and Commission programs and projects on the Mississippi River and its tributaries; (2) District Commander's overview of current project issues within the Memphis District; and (3) Presentations by local organizations and members of the public giving views or comments on any issue affecting the programs or projects of the Commission and the Corps of Engineers.

    TIME AND DATE:

    9:00 a.m., April 5, 2017.

    PLACE:

    On board MISSISSIPPI V at City Front, Greenville, Mississippi.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    (1) Summary report by President of the Commission on national and regional issues affecting the U.S. Army Corps of Engineers and Commission programs and projects on the Mississippi River and its tributaries; (2) District Commander's overview of current project issues within the Vicksburg District; and (3) Presentations by local organizations and members of the public giving views or comments on any issue affecting the programs or projects of the Commission and the Corps of Engineers.

    TIME AND DATE:

    9:00 a.m., April 7, 2017.

    PLACE:

    On board MISSISSIPPI V at City Dock, Baton Rouge, Louisiana.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    (1) Summary report by President of the Commission on national and regional issues affecting the U.S. Army Corps of Engineers and Commission programs and projects on the Mississippi River and its tributaries; (2) District Commander's overview of current project issues within the New Orleans District; and (3) Presentations by local organizations and members of the public giving views or comments on any issue affecting the programs or projects of the Commission and the Corps of Engineers.

    CONTACT PERSON FOR MORE INFORMATION:

    Mr. Charles A. Camillo, telephone 601-634-7023.

    Charles A. Camillo, Director, Mississippi River Commission.
    [FR Doc. 2017-05110 Filed 3-10-17; 11:15 am] BILLING CODE 3720-58-P
    NATIONAL SCIENCE FOUNDATION Final Notice of Research Terms and Conditions (RTC) To Address and Implement the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards Issued by the U.S. Office of Management and Budget (OMB) AGENCY:

    National Science Foundation.

    ACTION:

    Final notice of Research Terms and Conditions (RTC) to address and implement the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR 200) issued by the U.S. Office of Management and Budget (OMB).

    SUMMARY:

    Effective with publication of this Notice in the Federal Register, research agencies will be able to utilize the updated Research Terms and Conditions (RTC) that will address and implement the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR 200) issued by the U.S. Office of Management and Budget (OMB).

    DATES:

    The updated Research Terms and Conditions will March 14, 2017.

    FOR FURTHER INFORMATION:

    To view the final Research Terms and Conditions and Appendices, see: https://www.nsf.gov/awards/managing/rtc.jsp. For information on the Research Terms and Conditions, contact Jean Feldman, Head, Policy Office, Division of Institution & Award Support, National Science Foundation, 4201 Wilson Blvd., Arlington, VA, 22230, email: [email protected]; telephone (703) 292-8243; FAX: (703) 292-9171.

    SUPPLEMENTARY INFORMATION:

    In 2000, the Federal Demonstration Partnership (FDP), a cooperative initiative among numerous Federal agencies and institutional recipients of research funds aimed at reducing the administrative burdens associated with research grants and contracts, developed Standard Terms and Conditions as a model implementation of OMB Circular A-110. These terms were an effective set of requirements for many agency research awards. In 2005, following public and agency comment on the original FDP terms, standard research terms and conditions were developed by Research Business Models (RBM), an Interagency Working Group of the Social, Behavioral & Economic Research Subcommittee of the Committee on Science (CoS), a committee of the National Science and Technology Council (NSTC). In 2008, a side-by-side comparison of OMB Circular A-110 and the Research Terms and Conditions was developed; the terms and conditions were updated in 2011.

    This project is an initiative of the Research Business Models (RBM) Interagency Working Group. One of the RBM Subcommittee's priority areas is to create greater consistency in the administration of Federal research awards. Given the increasing complexity of interdisciplinary and interagency research, it has become increasingly important for Federal agencies to manage awards in a similar fashion.

    On June 30, 2014, a proposal was presented to the RBM on behalf of the participating agencies from the RBM Interagency Working Group to develop a revised set of RTCs for implementing the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 2 CFR 200 (Uniform Guidance). The purpose was to develop a revised set of RTCs as they apply to research and research-related grants made by the following awarding agencies to institutions of higher education and non-profit organizations.

    The agencies participating in this activity include the: U. S. Department of Commerce/National Oceanic and Atmospheric Administration and National Institute of Standards and Technology; U.S. Department of Energy; U.S. Environmental Protection Agency; National Aeronautics and Space Administration; National Science Foundation; U.S. Department of Health and Human Services/National Institutes of Health; U.S. Department of Agriculture/National Institute of Food and Agriculture; U.S. Department of Transportation/Federal Aviation Administration; and the U.S. Department of Homeland Security.

    On October 14, 2015 the National Science Foundation asked for public comment on the updated Research Terms and Conditions (RTC) to address and implement the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards issued by the U.S. Office of Management and Budget (OMB) in the Federal Register [80 FR 61849, October 14, 2015]. All comments were considered in developing this final version of the Research Terms and Conditions. A table listing the comments and responses is posted on the NSF Web site at: https://www.nsf.gov/awards/managing/rtc.jsp.

    While the Uniform Guidance outlines provisions that are specific to research, these terms and conditions:

    • Incorporate the entire Uniform Guidance by reference, clarifying or supplementing select provisions where appropriate and consistent with government-wide research policy.

    • Incorporate the latest version of the Frequently Asked Questions for the Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards at 2 CFR 200 (located at https://cfo.gov/cofar-resources).

    • Apply to an award when included as part of the award or when incorporated in the award by reference. Use of the RTCs is envisioned as a streamlined approach that supports the implementation of the Uniform Guidance by providing clarification, supplementary guidance, and, where appropriate, selected options, while meeting the spirit and intent of a uniform implementation.

    The side-by-side RTCs depict pertinent sections of the Uniform Guidance on the left side and clarifications for research and research-related awards on the right side.

    In addition to the RTCs, three companion resources will be developed upon implementation: Appendix A, Prior Approval Matrix, Appendix B, Subaward Requirements Matrix, and Appendix C, National Policy Requirements Matrix. The companion resources, when finalized, will be posted on the NSF Web site at: https://www.nsf.gov/awards/managing/rtc.jsp. The RTCs include flexibility for additional individual agency clarification through the incorporation of Appendices A-C and Agency-Specific Requirements.

    These RTCs will apply to an award when they are included as part of that award, or when incorporated into that award by reference. Each participating agency will develop their own implementation plan, and agency specific requirements to the RTCs, which will be posted on the NSF Web site at: https://www.nsf.gov/awards/managing/rtc.jsp. Since there will be multiple implementation dates, the RTC Web site should be consulted frequently.

    Other agencies not identified above that would like to implement the RTCs are strongly encouraged to do so. In order to provide the necessary documentation to the research community, the following information must be provided to NSF prior to adoption of the RTCs: Prior Approval Matrix, Subaward Requirements Matrix, Agency-Specific Requirements, and agency implementation plan.

    On behalf of the RBM, the National Science Foundation (NSF) has agreed to continue to serve as the sponsor of the updated version of these RTCs.

    Dated: March 9, 2017. Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation.
    [FR Doc. 2017-04955 Filed 3-13-17; 8:45 am] BILLING CODE 7555-01-P
    NATIONAL SCIENCE FOUNDATION Agency Information Collection Activities: Comment Request AGENCY:

    National Science Foundation.

    ACTION:

    Submission for OMB review; comment request.

    SUMMARY:

    The National Science Foundation (NSF) has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. This is the second notice for public comment; the first was published in the Federal Register at 81 FR 91959, and no comments were received. NSF is forwarding the proposed submission to the Office of Management and Budget (OMB) for clearance simultaneously with the publication of this second notice. The full submission (including comments) may be found at: http://www.reginfo.gov/public/do/PRAMain.

    Comments: Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Foundation, including whether the information will have practical utility; (b) the accuracy of the Foundation'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; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Written comments on this notice must be received by April 13, 2017, to be assured consideration. Comments received after that date will be considered to the extent practicable. Send comments to address below.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 4201 Wilson Boulevard, Suite 1265, Arlington, Virginia 22230; telephone (703) 292-7556; or send email to [email protected] Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339, which is accessible 24 hours a day, 7 days a week, 365 days a year (including federal holidays).

    NSF may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    SUPPLEMENTARY INFORMATION:

    Title of Collection: Grantee Reporting Requirements for National User Facilities managed by the NSF Division of Materials Research.

    OMB Number: 3145-0234.

    Expiration Date of Approval: March 31, 2017.

    Type of Request: Intent to seek approval to renew an information collection.

    Overview of This Information Collection:

    The NSF Division of Materials Research (DMR) supports a number of National User Facilities that provide specialized capabilities and instrumentation to the scientific community on a competitive proposal basis. In addition to the user program, these facilities support in-house research, development of new instrumentation or techniques, education, and knowledge transfer.

    The facilities integrate research and education for students and post-docs involved in experiments, and support extensive K-12 outreach to foster an interest in Science Technology Engineering and Mathematics (STEM) and STEM careers. Facilities capitalize on diversity through participation in center activities and demonstrate leadership in the involvement of groups underrepresented in science and engineering.

    National User Facilities will be required to submit annual reports on progress and plans, which will be used as a basis for performance review and determining the level of continued funding. User facilities will be required to develop a set of management and performance indicators for submission annually to NSF via the Research Performance Project Reporting (RPPR) module in Research.gov. These indicators are both quantitative and descriptive and may include, for example, lists of successful proposal and users, the characteristics of facility personnel and students; sources of financial support and in-kind support; expenditures by operational component; research activities; education activities; knowledge transfer activities; patents, licenses; publications; degrees granted to students supported through the facility or users of the facility; descriptions of significant advances and other outcomes of this investment. Such reporting requirements are included in the cooperative agreement which is binding between the academic institution and the NSF.

    Each facility's annual report will address the following categories of activities: (1) Research, (2) education and training, (3) knowledge transfer, (4) partnerships, (5) diversity, (6) management, and (7) budget issues.

    For each of the categories the report will describe overall objectives and metrics for the reporting period, challenges or problems the facility has encountered in making progress towards goals, anticipated problems in the following year, and specific outputs and outcomes.

    Facilities are required to file a final report through the RPPR. Final reports contain similar information and metrics as annual reports, but are retrospective and focus on the period that was not addressed in previous annual reports.

    Use of the Information: NSF will use the information to continue funding of the DMR National User Facilities, and to evaluate the progress of the program.

    Estimate of Burden: 200 hours per facility for three National User Facilities for a total of 600 hours.

    Respondents: Non-profit institutions.

    Estimated Number of Responses per Report: One (1) from each of the DMR user facilities.

    Dated: March 8, 2017. Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation.
    [FR Doc. 2017-04936 Filed 3-13-17; 8:45 am] BILLING CODE 7555-01-P
    NUCLEAR REGULATORY COMMISSION Advisory Committee On Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on NuScale; Notice of Meeting

    The ACRS Subcommittee on NuScale will hold a meeting on March 24, 2017, at 11545 Rockville Pike, Room T-2B1, Rockville, Maryland 20852.

    The meeting will be open to public attendance with the exception of portions that may be closed to protect information that is proprietary pursuant to 5 U.S.C. 552b(c)(4). The agenda for the subject meeting shall be as follows:

    Friday, March 24, 2017—8:30 a.m. Until 12:00 p.m.

    The Subcommittee will review NuScale Topical Report TR-0815-16497, “Safety Classification of Passive Nuclear Power Plant Electrical Systems.” The Subcommittee will hear presentations by and hold discussions with the NRC staff and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.

    Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Michael Snodderly (Telephone 301-415-2241 or Email: [email protected]) five days prior to the meeting, if possible, so that appropriate arrangements can be made. Thirty-five hard copies of each presentation or handout should be provided to the DFO thirty minutes before the meeting. In addition, one electronic copy of each presentation should be emailed to the DFO one day before the meeting. If an electronic copy cannot be provided within this timeframe, presenters should provide the DFO with a CD containing each presentation at least thirty minutes before the meeting. Electronic recordings will be permitted only during those portions of the meeting that are open to the public. Detailed procedures for the conduct of and participation in ACRS meetings were published in the Federal Register on October 17, 2016, (81 FR 71543).

    Detailed meeting agendas and meeting transcripts are available on the NRC Web site at http://www.nrc.gov/reading-rm/doc-collections/acrs. Information regarding topics to be discussed, changes to the agenda, whether the meeting has been canceled or rescheduled, and the time allotted to present oral statements can be obtained from the Web site cited above or by contacting the identified DFO. Moreover, in view of the possibility that the schedule for ACRS meetings may be adjusted by the Chairman as necessary to facilitate the conduct of the meeting, persons planning to attend should check with these references if such rescheduling would result in a major inconvenience.

    If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, Maryland. After registering with Security, please contact Mr. Theron Brown (Telephone 240-888-9835) to be escorted to the meeting room.

    Dated: March 8, 2017. Mark L. Banks, Chief, Technical Support Branch, Advisory Committee on Reactor Safeguards.
    [FR Doc. 2017-04990 Filed 3-13-17; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2017-0071] Biweekly Notice: Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Biweekly notice.

    SUMMARY:

    Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.

    This biweekly notice includes all notices of amendments issued, or proposed to be issued, from February 14 to February 27, 2017. The last biweekly notice was published on February 28, 2017.

    DATES:

    Comments must be filed by April 13, 2017. A request for a hearing must be filed by May 15, 2017.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0071. 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.

    Mail comments to: Cindy Bladey, Office of Administration, Mail Stop: OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Shirley Rohrer, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-5411 email: [email protected]

    SUPPLEMENTARY INFORMATION: I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2017-0071, facility name, unit number(s), plant docket number, application date, and subject 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-2017-0071.

    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] For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

    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.

    B. Submitting Comments

    Please include Docket ID NRC-2017-0071, facility name, unit number(s), plant docket number, application date, and subject in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at http://www.regulations.gov as well as entering the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

    II. Notice of Consideration of Issuance of Amendments to Facility Operating Licenses and Combined Licenses and Proposed No Significant Hazards Consideration Determination

    The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in § 50.92 of title 10 of the Code of Federal Regulations (10 CFR), this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated, or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. The basis for this proposed determination for each amendment request is shown below.

    The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.

    Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period if circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. If the Commission takes action prior to the expiration of either the comment period or the notice period, it will publish in the Federal Register a notice of issuance. If the Commission makes a final no significant hazards consideration determination, any hearing will take place after issuance. The Commission expects that the need to take this action will occur very infrequently.

    A. Opportunity To Request a Hearing and Petition for Leave To Intervene

    Within 60 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at http://www.nrc.gov/reading-rm/doc-collections/cfr/. Alternatively, a copy of the regulations is available at the NRC's Public Document Room, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. If a petition is filed, the Commission or a presiding officer will rule on the petition and, if appropriate, a notice of a hearing will be issued.

    As required by 10 CFR 2.309(d) the petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) The name, address, and telephone number of the petitioner; (2) the nature of the petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest.

    In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to the specific sources and documents on which the petitioner intends to rely to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant or licensee on a material issue of law or fact. Contentions must be limited to matters within the scope of the proceeding. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to satisfy the requirements at 10 CFR 2.309(f) with respect to at least one contention will not be permitted to participate as a party.

    Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that party's admitted contentions, including the opportunity to present evidence, consistent with the NRC's regulations, policies, and procedures.

    Petitions must be filed no later than 60 days from the date of publication of this notice. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii). The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document.

    If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to establish when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of the amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.

    A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission by May 15, 2017. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions set forth in this section, except that under 10 CFR 2.309(h)(2) a State, local governmental body, or federally recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. Alternatively, a State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).

    If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, at the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of his or her position on the issues but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Details regarding the opportunity to make a limited appearance will be provided by the presiding officer if such sessions are scheduled.

    B. Electronic Submissions (E-Filing)

    All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition for leave to intervene (petition), any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities that request to participate under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562, August 3, 2012). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Detailed guidance on making electronic submissions may be found in the Guidance for Electronic Submissions to the NRC and on the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.

    To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at [email protected], or by telephone at 301-415-1677, to (1) request a digital identification (ID) certificate, which allows the participant (or its counsel or representative) to digitally sign submissions and access the E-Filing system for any proceeding in which it is participating; and (2) advise the Secretary that the participant will be submitting a petition or other adjudicatory document (even in instances in which the participant, or its counsel or representative, already holds an NRC-issued digital ID certificate). Based upon this information, the Secretary will establish an electronic docket for the hearing in this proceeding if the Secretary has not already established an electronic docket.

    Information about applying for a digital ID certificate is available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals/getting-started.html. Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit adjudicatory documents. Submissions must be in Portable Document Format (PDF). Additional guidance on PDF submissions is available on the NRC's public Web site at http://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the time the document is submitted through the NRC's E-Filing system. To be timely, an electronic filing must be submitted to the E-Filing system no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of a transmission, the E-Filing system time-stamps the document and sends the submitter an email notice confirming receipt of the document. The E-Filing system also distributes an email notice that provides access to the document to the NRC's Office of the General Counsel and any others who have advised the Office of the Secretary that they wish to participate in the proceeding, so that the filer need not serve the document on those participants separately. Therefore, applicants and other participants (or their counsel or representative) must apply for and receive a digital ID certificate before adjudicatory documents are filed so that they can obtain access to the documents via the E-Filing system.

    A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html, by email to [email protected], or by a toll-free call at 1-866-672-7640. The NRC Electronic Filing Help Desk is available between 9 a.m. and 6 p.m., Eastern Time, Monday through Friday, excluding government holidays.

    Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff. Participants filing adjudicatory documents in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.

    Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at https://adams.nrc.gov/ehd, unless excluded pursuant to an order of the Commission or the presiding officer. If you do not have an NRC-issued digital ID certificate as described above, click cancel when the link requests certificates and you will be automatically directed to the NRC's electronic hearing dockets where you will be able to access any publicly available documents in a particular hearing docket. Participants are requested not to include personal privacy information, such as social security numbers, home addresses, or personal phone numbers in their filings, unless an NRC regulation or other law requires submission of such information. For example, in some instances, individuals provide home addresses in order to demonstrate proximity to a facility or site. With respect to copyrighted works, except for limited excerpts that serve the purpose of the adjudicatory filings and would constitute a Fair Use application, participants are requested not to include copyrighted materials in their submission.

    For further details with respect to these license amendment applications, see the application for amendment which is available for public inspection in ADAMS and at the NRC's PDR. For additional direction on accessing information related to this document, see the “Obtaining Information and Submitting Comments” section of this document.

    Duke Energy Progress, LLC, Docket Nos. 50-325 and 50-324, Brunswick Steam Electric Plant, Units 1 and 2, Brunswick County, North Carolina

    Date of amendment request: October 27, 2016. A publicly-available version is in ADAMS under Accession No. ML16319A128.

    Description of amendment request: The amendments would revise the technical specifications (TSs) to be consistent with Technical Specification Task Force (TSTF) Traveler TSTF-529, “Clarify Use and Application Rules.” The revisions include sections related to completion times, limiting condition for operation (LCO) applicability, and surveillance requirement (SR) applicability, of the TSs to clarify the use and application of the TS usage rules.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed changes to Section 1.3 and LCO 3.0.4 have no effect on the requirement for systems to be Operable and have no effect on the application of TS actions. The proposed change to SR 3.0.3 states that the allowance may only be used when there is a reasonable expectation the surveillance will be met when performed. Since the proposed changes do not significantly affect system Operability, the proposed changes will have no significant effect on the initiating events for accidents previously evaluated and will have no significant effect on the ability of the systems to mitigate accidents previously evaluated.

    Therefore, it is concluded that this change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed change to the TS usage rules does not affect the design or function of any plant systems. The proposed change does not change the Operability requirements for plant systems or the actions taken when plant systems are not operable.

    Therefore, it is concluded that this change does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed change involve a significant reduction in a margin of safety?

    Response: No.

    The proposed change clarifies the application of Section 1.3 and LCO 3.0.4 and does not result in changes in plant operation. SR 3.0.3 is revised to allow application of SR 3.0.3 when an SR has not been previously performed if there is reasonable expectation that the SR will be met when performed. This expands the use of SR 3.0.3 while ensuring the affected system is capable of performing its safety function. As a result, plant safety is either improved or unaffected.

    Therefore, it is concluded that this change does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: Kathryn B. Nolan, Deputy General Counsel, 550 South Tryon Street, M/C DEC45A, Charlotte, NC 28202.

    NRC Branch Chief: Benjamin G. Beasley.

    FirstEnergy Nuclear Operating Company, et al, Docket No. 50-346, Davis-Besse Nuclear Power Station (DBNPS), Unit No. 1, Ottawa County, Ohio

    Date of amendment request: January 11, 2017. A publicly-available version is in ADAMS under Accession No. ML17011A271.

    Description of amendment request: The licensee proposes to change the technical specifications (TSs) for DBNPS, Unit No. 1, to extend the allowed outage time (AOT) for the ultrasonic flow meter (UFM) and to make administrative changes to TS 3.3.1, “Reactor Protection System (RPS) Instrumentation.”

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed amendment would extend the existing UFM AOT to 72 hours. There are no modifications to the plant being made. As there are no modifications to the plant or a change in plant control systems, extending the UFM outage would not significantly increase accident probability.

    Accident consequences are, in part, dependent on the operating power level of the reactor assumed in accident analyses. The UFM is used to obtain information needed to perform a calorimetric heat balance calculation to determine reactor power output and maintain operation within accident analysis limits. The proposed amendment would permit measurements from FW [feedwater] venturis and RTDs [resistance temperature detectors] to be substituted for UFM measurements while maintaining a stable power level during a 72-hour period. Venturi-based FW flow measurements would be normalized to the last UFM-based measurements used as input to a calorimetric heat balance and would have a nearly identical degree of uncertainty as UFM measurements for the duration of the proposed AOT when stable thermal power conditions are maintained. Therefore, calculated reactor power based on normalized FW flow venturi measurements will continue to be maintained within accident analysis limits, ensuring that accident consequences will not be significantly increased.

    Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed amendment would extend the existing UFM AOT to 72 hours. Modifications to the plant are not being made. FW flow venture measurements that are normalized to the last UFM-based measurements used as input to a calorimetric heat balance have a nearly identical degree of uncertainty as UFM measurements for the duration of the proposed AOT when stable thermal power conditions are maintained. Calculated reactor power based on normalized FW flow venturi measurements will continue to be maintained within accident analysis limits.

    Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed amendment would permit the plant to operate at rated thermal power for up to 72 hours after the last calorimetric heat balance based on UFM readings before reducing power. A plant-specific statistical evaluation of the difference between historical UFM-based FW flow measurements and venturi-based FW flow measurements has demonstrated that the average difference does not vary significantly over short periods of time. Therefore, if current venturi-based FW flow measurements are normalized to the last UFM-based measurements used as input to a calorimetric heat balance no greater than 72 hours prior, a nearly identical degree of uncertainty would be obtained with the venturis as with the UFM. The proposed amendment restricts application of the 72-hour AOT to conditions when the plant is operated consistently above 90 percent RTP [rated thermal power] during the 72-hour period to avoid changes in FW flow or temperature that have potential to de-foul venturis and affect measurements.

    As the proposed change will result in the same degree of uncertainty in reactor power calculations using alternate measurements as with using the UFM, there is no significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: David W. Jenkins, Attorney, FirstEnergy Corporation, Mail Stop A-GO-15, 76 South Main Street, Akron, OH 44308.

    NRC Branch Chief: David J. Wrona.

    Florida Power & Light Company, Docket Nos. 50-250 and 251, Turkey Point Nuclear Generating, Unit Nos. 3 and 4, Miami-Dade County, Florida

    Date of application for amendment: December 21, 2016. A publicly-available version is in ADAMS under Accession No. ML17012A084.

    Description of amendment request: The amendments would modify the Technical Specifications (TSs) for the Engineered Safety Features Actuation System (ESFAS) instrumentation. The amendments would modify the completion times of required actions for inoperable instrumentation channels for auxiliary feedwater actuation on bus stripping and on trip of all main feedwater pump breakers.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed change modifies ACTION 23 of TS 3.3.2, Table 3.3-2, to establish a 48-hour completion time for restoring two anticipatory ESFAS functions. The instrumentation associated with the proposed changes are not initiators of any accident previously evaluated, so the probability of accidents previously evaluated is unaffected. The proposed changes will not impact assumptions or conditions previously used in the radiological consequence evaluations. The subject ESFAS functions are not relied upon for accident mitigation and thus the proposed changes cannot affect the radiological consequences. The proposed changes will not impact any plant systems such that previously analyzed SSCs [systems, structures, and components] would be more likely to fail. The subject ESFAS functions will continue to be maintained and operated in a manner consistent with their intended function. The proposed changes do not adversely affect the protective and mitigative capabilities of the plant. The offsite and Control Room doses will continue to meet the requirements of 10 CFR 100, 10 CFR 50.67, and 10 CFR 50 Appendix A.

    Therefore, the proposed changes do not result in a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed change modifies the TS ACTION for two restoring anticipatory ESFAS functions. No new or different interactions with safety-related SSCs are created by the proposed change. The proposed changes will not introduce failure mechanisms, malfunctions, or accident initiators not already considered in the design and licensing bases. The subject ESFAS functions will continue to be operated and maintained such that the possibility of a new or different type of equipment malfunction is not created. No new accident scenarios, transient precursors, or limiting single failures are introduced as a result of the proposed changes.

    Therefore, the proposed changes do not create the possibility of a new or different accident from any accident previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed change modifies the TS ACTION for restoring two anticipatory ESFAS functions. The subject ESFAS functions are not relied upon for accident mitigation and are not credited in design bases accident analyses. Hence the proposed changes cannot alter any safety analyses assumptions, safety limits, limiting safety system settings, or methods of operating the plant. The proposed changes do not adversely impact plant operating margins or the reliability of equipment credited in the safety analyses. No changes in the methods, values or limits of a safety related function or accident analysis result from the proposed changes.

    Therefore, the proposed changes would not involve a significant reduction in the margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: William S. Blair, Managing Attorney—Nuclear, Florida Power & Light Company, 700 Universe Blvd. MS LAW/JB, Juno Beach, FL 33408-0420.

    NRC Branch Chief: Benjamin G. Beasley.

    Florida Power & Light Company, Docket Nos. 50-250 and 50-251, Turkey Point Nuclear Generating Unit Nos. 3 and 4, Miami-Dade County, Florida

    Date of amendment request: December 21, 2016. A publicly-available version is in ADAMS under Accession No. ML17012A085.

    Description of amendment request: The amendments would revise technical specifications (TSs) by deleting high range noble gas effluent monitors' requirements and relocating the requirements to the Turkey Point Offsite Dose Calculation Manual (ODCM).

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The Plant Vent Exhaust, Condenser Air Ejectors Exhaust and Unit 3 Spent Fuel Pit Exhaust high-range noble gas monitoring instrumentation are not an initiator of any accidents previously evaluated, so the probability of accidents previously evaluated is unaffected by the proposed changes. The proposed changes will not impact any plant systems such that previously analyzed structures, systems, and components (SSCs) would be more likely to fail. The proposed changes do not adversely affect the protective and mitigative capabilities of the plant nor the offsite and control room dose projections associated with any design basis accident described in the FSAR [Final Safety Analysis Report].

    Therefore, the proposed changes do not result in a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed change removes the subject instruments from the accident monitoring TS and as such is an administrative change in nature. The Plant Vent Exhaust, Condenser Air Ejectors Exhaust and Unit 3 Spent Fuel Pit Exhaust high-range noble gas monitoring instrumentation will continue to perform their specified function. Removal of the monitors from the TS will not create the possibility of a new or different kind of accident. No new or different interactions with safety related systems or components are created. The proposed changes will not introduce new failure mechanisms, malfunctions, or accident initiators not already considered in the design and licensing bases. The possibility of a new or different malfunction of safety-related equipment is not created. No new accident scenarios, transient precursors, or limiting single failures are introduced as a result of these changes. There will be no adverse effects or challenges imposed on any safety-related system as a result of the proposed changes.

    Therefore, the proposed changes do not create the possibility of a new or different accident from any accident previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed change relocates the Plant Vent Exhaust, Condenser Air Ejectors Exhaust and Unit 3 Spent Fuel Pit Exhaust high-range noble gas monitoring requirements from TS 3.3.3.3, Accident Monitoring, to the Turkey Point ODCM, and as such is an administrative change in nature. The changes do not adversely impact plant operating margins or the reliability of equipment credited in the safety analyses. Consequently, there will be no change in the ability to monitor post-accident plant conditions, radionuclide releases, and public doses. The safety analyses acceptance criteria are not affected by these changes. The proposed changes will not result in plant operation outside of the design basis.

    Therefore, operation in accordance with the proposed amendment would not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: William S. Blair, Managing Attorney—Nuclear, Florida Power & Light Company, 700 Universe Blvd., MS LAW/JB, Juno Beach, FL 33408-0420.

    NRC Branch Chief: Benjamin G. Beasley.

    South Carolina Electric & Gas Company and South Carolina Public Service Authority, Docket Nos. 52-027 and 52-028, Virgil C. Summer Nuclear Station, Units 2 and 3, Fairfield, South Carolina

    Date of amendment request: December 21, 2016. A publicly-available version is in ADAMS under Accession No. ML16357A403.

    Description of amendment request: The requested amendment requires changes to Combined License (COL) Appendix C (and corresponding changes to plant-specific Tier 1 information) to be consistent with information documented in the Updated Final Safety Analysis Report (UFSAR). The requested amendment involves changes to the physical separation requirements between Class 1E division cables and between Class 1E and non-Class 1E cables described in COL Appendix C (and plant-specific Tier 1) Table 3.3-6. The proposed changes add additional acceptable configurations for raceway separation in the main control room (MCR) and remote shutdown room (RSR). Pursuant to the provisions of 10 CFR 52.63(b)(1), an exemption from elements of the design as certified in the 10 CFR part 52, appendix D, design certification rule is also requested for the plant-specific Design Control Document Tier 1 material departures.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    This activity revises the raceway spacing configurations and permits spacing in accordance with existing licensing basis requirements, Regulatory Guide (RG) 1.75 and Institute of Electrical and Electronics Engineers (IEEE) 384 for the MCR and RSR.

    The proposed consistency change to revise separation requirements for MCR and RSR raceways does not inhibit any systems, structures or components (SSCs) from performing their safety-related function, as raceways in the MCR and RSR are installed in accordance with spacing configurations currently specified in the UFSAR or in the code of record, IEEE 384. This proposed amendment does not have an adverse impact on the response to anticipated transients or postulated accident conditions because the functions of the SSCs are not changed. The change does not involve an interface with any SSC accident initiator or initiating sequence of events, and thus, the probabilities of the accidents evaluated in the UFSAR are not affected. Accidents associated with raceway separation are not identified in the safety analysis. The proposed changes do not involve a change to the predicted radiological releases due to postulated accident conditions, thus, the consequences of the accidents evaluated in the UFSAR are not affected.

    Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed changes to the inspection criteria for raceway separation requirements does not adversely affect any safety-related equipment, and does not add any new interfaces to safety-related SSCs. This change provides consistency between the COL Appendix C and the UFSAR and industry standards only. System, design functions and equipment qualification are not adversely affected by these changes. The changes do not introduce a new failure mode, malfunction or sequence of events that could affect plant safety or safety-related equipment as the change is for consistency with existing licensing basis requirements and industry standards. New credible failure modes are not introduced by the changes in separation requirements.

    Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed change maintains compliance with the applicable Codes and Standards, thereby maintaining the margin of safety associated with these SSCs. The proposed change does not alter any applicable design codes, code compliance, design function, or safety analysis. Consequently, no safety analysis or design basis acceptance limit/criterion is challenged or exceeded by the proposed change, thus the margin of safety is not reduced.

    Therefore, the proposed amendment does not involve a significant reduction in the margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: Kathryn M. Sutton, Morgan, Lewis & Bockius, LLC, 1111. Pennsylvania NW., Washington, DC 20004-2514.

    NRC Branch Chief: Jennifer Dixon-Herrity.

    South Carolina Electric & Gas Company and South Carolina Public Service Authority, Docket Nos. 52-027 and 52-028, Virgil C. Summer Nuclear Station, Units 2 and 3, Fairfield, South Carolina

    Date of amendment request: December 21, 2016. A publicly-available version is in ADAMS under Accession No. ML16356A437.

    Description of amendment request: The requested amendment consists of changes to plant-specific Tier 1 (and Combined License Appendix C) Tables 2.7.5-1, 2.7.5-2, and 2.7.7-3 and associated Updated Final Safety Analysis Report (UFSAR) text, tables, and figures related to: (1) Modifying the configuration of the containment recirculation fan coil unit assemblies of the containment recirculation cooling system (VCS) and revising the values for the various design parameters affected by this re-configuration; (2) adding a fourth pressure differential indicator to the radiologically controlled area ventilation system (VAS) to be located in the auxiliary building component cooling system valve room; and (3) reducing the total ventilation flow provided through the VAS fuel handling area ventilation subsystem as a result of a reduction in heat loads in the areas serviced by the VAS.

    Pursuant to the provisions of 10 CFR 52.63(b)(1), an exemption from elements of the design as certified in the 10 CFR part 52, Appendix D, design certification rule is also requested for the plant-specific Design Control Document Tier 1 material departures.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The design functions of the VCS include control of the air temperature and reduction of humidity in the containment to provide a suitable environment for equipment operability during normal power operation, and for personnel accessibility and equipment operability during refueling and shutdown. The proposed changes for the VCS address changes in total required design air flow rates and total design cooling and heating requirements, thereby maintaining these design functions.

    The design functions of the VAS include prevention of the unmonitored release of airborne radioactivity to the atmosphere or adjacent plant areas, by maintaining a negative pressure differential in radiologically controlled areas of the auxiliary building, maintaining occupied areas and access and equipment areas within their design temperature range, and providing outside air for plant personnel. The proposed changes for the VAS enable pressure differential monitoring and control for an area of the auxiliary building that is physically remote and separate from the currently monitored and controlled areas, and provide VAS supply air flow rate and total ventilation flow through the auxiliary building fuel handling area required to maintain occupied areas and access and equipment areas within their design temperature range and to provide outside air for plant personnel, maintaining these design functions.

    The proposed changes do not affect the operation of any systems or equipment that initiate an analyzed accident or alter any structure, system, or component (SSC) accident initiator or initiating sequence of events. There are no inadvertent operations or failures of the VCS or VAS considered as accident initiators or part of an initiating sequence of events for an accident previously evaluated. Therefore, the probabilities of the accidents previously evaluated in the UFSAR are not affected.

    These proposed changes to the VCS and VAS design as described in the current licensing basis do not have an adverse effect on any of the design functions of the systems. The proposed changes do not affect the support, design, or operation of mechanical and fluid systems required to mitigate the consequences of an accident. There is no change to plant systems or the response of systemsto postulated accident conditions. There is no change to the predicted radioactive releases due to postulated accident conditions. The plant response to previously evaluated accidents or external events is not adversely affected, nor do the proposed changes create any new accident precursors. The proposed changes do not affect the prevention and mitigation of other abnormal events, e.g., anticipated operational occurrences, earthquakes, floods and turbine missiles, or their safety or design analyses. Therefore, the consequences of the accidents evaluated in the UFSAR are not affected.

    Therefore, the requested amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed changes do not affect the operation of any systems or equipment that may initiate a new or different kind of accident, or alter any SSC such that a new accident initiator or initiating sequence of events is created. The proposed changes revise the VCS and VAS design as described in the current licensing basis to enable the systems to perform required design functions. These proposed changes do not adversely affect any other SSC design functions or methods of operation in a manner that results in a new failure mode, malfunction, or sequence of events that affect safety-related or nonsafety-related equipment. Therefore, this activity does not allow for a new fission product release path, result in a new fission product barrier failure mode, or create a new sequence of events resulting in significant fuel cladding failures.

    Therefore, the requested amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed changes maintain existing safety margins. The proposed changes to the VCS and VAS do not affect any safety-related design function. These changes do not adversely affect any design code, function, design analysis, safety analysis input or result, or design/safety margin. No safety analysis or design basis acceptance limit/criterion is challenged or exceeded by the proposed changes, and no margin of safety is reduced.

    Therefore, the requested amendment does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: Kathryn M. Sutton, Morgan, Lewis & Bockius, LLC, 111 Pennsylvania NW., Washington, DC 20004-2514.

    NRC Branch Chief: Jennifer Dixon-Herrity.

    Southern Nuclear Operating Company, Docket Nos. 52-025 and 52-026, Vogtle Electric Generating Plant Units 3 and 4, Burke County, Georgia

    Date of amendment request: January 20, 2017. A publicly-available version is in ADAMS under Accession No. ML17020A109.

    Description of amendment request: The amendment request proposes changes to the Updated Final Safety Analysis Report (UFSAR) in the form of departures from plant-specific Design Control Document (PS-DCD) Tier 2 information, Combined License (COL) Appendix A Technical Specifications, and COL Appendix C. The proposed departures consist of in-containment refueling water storage tank (IRWST) minimum volume changes in plant-specific UFSAR Table 14.3-2, COL Appendix A Technical Specifications 3.5.6, 3.5.7 and 3.5.8, Surveillance Requirements 3.5.6.2 and 3.5.8.2 and COL Appendix C (and associated plant-specific Tier 1) Table 2.2.3-4. The proposed changes restore consistency of these sections with the UFSAR IRWST minimum volume value in other locations. Because, this proposed change requires a departure from Tier 1 information in the Westinghouse Electric Company's AP1000 Design Control Document (DCD), the licensee also requested an exemption from the requirements of the Generic DCD Tier 1 in accordance with 10 CFR 52.63(b)(1).

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed changes do not affect the operation of any systems or equipment that initiate an analyzed accident or alter any structure, system, or component (SSC) accident initiator or initiating sequence of events. The proposed changes do not affect the physical design and operation of the in-containment refueling water storage tank (IRWST), including as-installed inspections, testing, and maintenance requirements, as described in the Updated Final Safety Analysis Report (UFSAR). Therefore, the operation of the IRWST is not affected. There are no inadvertent operations or failures of the IRWST considered as accident initiators or part of an initiating sequence of events for an accident previously evaluated. Therefore, the probabilities of the accidents previously evaluated in the UFSAR are not affected.

    The proposed changes do not adversely affect the ability of the IRWST to perform its design functions. The design of the IRWST continues to meet the same regulatory acceptance criteria, codes, and standards as required by the UFSAR. In addition, the proposed changes maintain the capabilities of the IRWST to mitigate the consequences of an accident and to meet the applicable regulatory acceptance criteria. The proposed changes do not affect the prevention and mitigation of other abnormal events; e.g., anticipated operational occurrences, earthquakes, floods and turbine missiles, or their safety or design analyses. Therefore, the consequences of the accidents evaluated in the UFSAR are not affected.

    Therefore, the requested amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed changes do not affect the operation of any systems or equipment that may initiate a new or different kind of accident, or alter any SSC such that a new accident initiator or initiating sequence of events is created. The proposed changes do not affect the physical design and operation of the IRWST, including as-installed inspections, testing, and maintenance requirements, as described in the UFSAR. Therefore, the operation of the IRWST is not affected. These proposed changes do not adversely affect any other SSC design functions or methods of operation in a manner that results in a new failure mode, malfunction, or sequence of events that affect safety-related or nonsafety-related equipment. Therefore, this activity does not allow for a new fission product release path, result in a new fission product barrier failure mode, or create a new sequence of events that results in significant fuel cladding failures.

    Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed changes maintain existing safety margins. The proposed changes maintain the capabilities of the IRWST to perform its design functions. The proposed changes maintain existing safety margin through continued application of the existing requirements of the UFSAR, while updating the acceptance criteria for verifying the design features necessary to ensure the IRWST performs the design functions required to meet the existing safety margins in the safety analyses. Therefore, the proposed changes satisfy the same design functions in accordance with the same codes and standards as stated in the UFSAR. These changes do no adversely affect any design code, function, design analysis, safety analysis input or result, or design/safety margin.

    No safety analysis or design basis acceptance limit/criterion is challenged or exceeded by the proposed changes, and no margin of safety is reduced.

    Therefore, the proposed amendment does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: M. Stanford Blanton, Balch & Bingham LLP, 1710 Sixth Avenue North, Birmingham, AL 35203-2015.

    NRC Branch Chief: Jennifer Dixon-Herrity.

    Southern Nuclear Operating Company, Docket Nos. 52-025 and 52-026, Vogtle Electric Generating Plant, Units 3 and 4, Burke County, Georgia

    Date of amendment request: October 20, 2016. A publicly-available version is in ADAMS under Accession No. ML16294A521.

    Description of amendment request: The amendment request proposes a change to Updated Final Safety Analysis Report (UFSAR) Tier 2* information to specify the supplemental requirement of American Institute of Steel Construction (AISC) N690-1994, “American National Standard Specification for the Design, Fabrication, and Erection of Steel Safety-Related Structures for Nuclear Facilities,” (AISC N690-1994), Section Q1.26.2.2, “Partial-Penetration Welds,” for the demonstration of sufficient strength and quality of the carbon steel embedment plate coupler welds to be credited as justification for the determination that the installed coupler welds are capable of performing their intended design function. The requested amendment proposes a change to Tier 2* information. This submittal requests approval of the license amendment necessary to implement these changes.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed change describes how evaluation of coupler strength, and by extension, weld strength and quality are used to demonstrate the capacity of partial joint penetrate on (PJP) welds with fillet weld reinforcement joining weldable couplers to carbon steel embedment plates as being able to perform their intended design function in lieu of satisfying the American Institute of Steel Construction (AISC) N690-1994, Section Q1.26.2.2 requirement for non-destructive examination (NDE) on 10 percent weld populations. The proposed change does not affect the operation of any systems or equipment that initiate an analyzed accident or alter any structures, systems, and components (SSCs) accident initiator or initiating sequence of events.

    The change has no adverse effect on the design function of the mechanical couplers or the SSCs to which the mechanical couplers are welded. The probabilities of the accidents evaluated in the Updated Final Safety Analysis Report (UFSAR) are not affected.

    The change does not impact the support, design, or operation of mechanical or fluid systems. The change does not impact the support, design, or operation of any safety-related structures. There is no change to plant systems or the response of systems to postulated accident conditions. There is no change to the predicted radioactive releases due to normal operation or postulated accident conditions. The plant response to previously evaluated accidents or external events is not adversely affected, nor does the proposed change create any new accident precursors.

    Therefore, the requested amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed change describes how evaluation of coupler strength, and by extension, weld strength and quality are used to demonstrate the capacity of PJP welds with fillet weld reinforcement joining weldable couplers to carbon steel embedment plates as being able to perform their design function in lieu of satisfying the AISC N690-1994, Section Q1.26.2.2 requirement for non-destructive examination on 10 percent weld populations. The proposed change does not affect the operation of any systems or equipment that may initiate a new or different kind of accident, or alter any SSC such that a new accident initiator or initiating sequence of events is created.

    The proposed change does not adversely affect the design function of the mechanical couplers, the structures in which the couplers are used, or any other SSC design functions or methods of operation in a manner that results in a new failure mode, malfunction, or sequence of events that affect safety-related or nonsafety-related equipment. This activity does not allow for a new fission product release path, result in a new fission product barrier failure mode, or create a new sequence of events that result in significant fuel cladding failures.

    Therefore, the requested amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed change describes how evaluation of coupler strength, and by extension, weld strength and quality are used to demonstrate the capacity of PJP welds with fillet weld reinforcement joining weldable couplers to carbon steel embedment plates as being able to perform their design function in lieu of satisfying the AISC N690-1994, Section Q1.26.2.2 requirement for non-destructive examination on 10 percent weld populations. The proposed change satisfies the same design functions in accordance with the same codes and standards as stated in the UFSAR. This change does not adversely affect compliance with any design code, function, design analysis, safety analysis input or result, or design/safety margin. No safety analysis or design basis acceptance limit/criterion is challenged or exceeded by the proposed change. Because no safety analysis or design basis acceptance limit/criterion is challenged or exceeded by this change, no significant margin of safety is reduced.

    Therefore, the proposed change does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: M. Stanford Blanton, Balch & Bingham LLP, 1710 Sixth Avenue North, Birmingham, AL 35203-2015.

    NRC Branch Chief: Jennifer Dixon-Herrity.

    Southern Nuclear Operating Company, Docket Nos. 52-025 and 52-026, Vogtle Electric Generating Plant, Units 3 and 4, Burke County, Georgia

    Date of amendment request: December 9, 2016. A publicly-available version is in ADAMS under Accession No. ML16344A411.

    Description of amendment request: The requested amendment consist of changes to plant-specific Tier 1 (and Combined License Appendix C) Tables 2.7.5-1, 2.7.5-2, and 2.7.7-3 and associated Updated Final Safety Analysis Report (UFSAR) text, tables, and figures related to: (1) Modifying the configuration of the containment recirculation fan coil unit assemblies of the containment recirculation cooling system (VCS), and revising the values for the various design parameters affected by this re-configuration, (2) adding a fourth pressure differential indicator to the radiologically controlled area ventilation system (VAS) to be located in the auxiliary building component cooling system valve room, and (3) reducing the total ventilation flow provided through the VAS fuel handling area ventilation subsystem as a result of a reduction in heat loads in the areas serviced by the VAS.

    Pursuant to the provisions of 10 CFR 52.63(b)(1), an exemption from elements of the design as certified in the 10 CFR part 52, Appendix D, design certification rule is also requested for the plant-specific Design Control Document Tier 1 material departures.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The design functions of the containment recirculation cooling system (VCS) include control of the air temperature and reduction of humidity in the containment to provide a suitable environment for equipment operability during normal power operation, and for personnel accessibility and equipment operability during refueling and shutdown. The proposed changes for the VCS address changes in total required design air flow rates and total design cooling and heating requirements, thereby maintaining these design functions.

    The design functions of the radiologically controlled area ventilation system (VAS) include prevention of the unmonitored release of airborne radioactivity to the atmosphere or adjacent plant areas, by maintaining a negative pressure differential in radiologically controlled areas of the auxiliary building, maintaining occupied areas and access and equipment areas within their design temperature range, and providing outside air for plant personnel. The proposed changes for the VAS enable pressure differential monitoring and control for an area of the auxiliary building that is physically remote and separate from the currently monitored and controlled areas, and provide VAS supply air flow rate and total ventilation flow through the auxiliary building fuel handling area required to maintain occupied areas and access and equipment areas within their design temperature range and to provide outside air for plant personnel, maintaining these design functions.

    The proposed changes do not affect the operation of any systems or equipment that initiate an analyzed accident or alter any structure, system, or component (SSC) accident initiator or initiating sequence of events. There are no inadvertent operations or failures of the VCS or VAS considered as accident initiators or part of an initiating sequence of events for an accident previously evaluated. Therefore, the probabilities of the accidents previously evaluated in the UFSAR are not affected.

    These proposed changes to the VCS and VAS design as described in the current licensing basis do not have an adverse effect on any of the design functions of the systems. The proposed changes do not affect the support, design, or operation of mechanical and fluid systems required to mitigate the consequences of an accident. There is no change to plant systems or the response of systems to postulated accident conditions. There is no change to the predicted radioactive releases due to postulated accident conditions. The plant response to previously evaluated accidents or external events is not adversely affected, nor do the proposed changes create any new accident precursors. The proposed changes do not affect the prevention and mitigation of other abnormal events, e.g., anticipated operational occurrences, earthquakes, floods and turbine missiles, or their safety or design analyses. Therefore, the consequences of the accidents evaluated in the UFSAR are not affected.

    Therefore, the requested amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed changes do not affect the operation of any systems or equipment that may initiate a new or different kind of accident, or alter any SSC such that a new accident initiator or initiating sequence of events is created. The proposed changes revise the VCS and VAS design as described in the current licensing basis to enable the systems to perform required design functions. These proposed changes do not adversely affect any other SSC design functions or methods of operation in a manner that results in a new failure mode, malfunction, or sequence of events that affect safety-related or nonsafety-related equipment. Therefore, this activity does not allow for a new fission product release path, result in a new fission product barrier failure mode, or create a new sequence of events resulting in significant fuel cladding failures.

    Therefore, the requested amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed changes maintain existing safety margins. The proposed changes to the VCS and VAS do not affect any safety-related design function. These changes do not adversely affect any design code, function, design analysis, safety analysis input or result, or design/safety margin. No safety analysis or design basis acceptance limit/criterion is challenged or exceeded by the proposed changes, and no margin of safety is reduced.

    Therefore, the requested amendment does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: M. Stanford Blanton, Balch & Bingham LLP, 1710 Sixth Avenue North, Birmingham, AL 35203-2015.

    NRC Branch Chief: Jennifer Dixon-Herrity.

    Tennessee Valley Authority, Docket No. 50-391, Watts Bar Nuclear Plant (WBN), Unit 2, Rhea County, Tennessee

    Date of amendment request: February 16, 2017. A publicly-available version is in ADAMS under Accession No. ML17048A514.

    Description of amendment request: The amendment would revise the Technical Specification (TS) Containment Leakage Rate Testing Program to allow a one-time extension for the Type C local leak rate test (LLRT) for certain containment isolation valves (CIVs). The proposed amendment would allow the extension of the test frequency from 30 months to a maximum of 37 months.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed amendment is a change to TS 5.7.2.19 to allow a one-time exception to [Regulatory Guide] (RG) 1.163, “Performance-Based Containment Leak-Test Program,” September 1995 (ADAMS Accession No. ML003740058)] to extend the Type C LLRTs for a limited number of CIVs. The valves for which the extension of the LLRT interval is being requested are leak-tight and in good condition. The total leakage of these valves [i.e., 0.24 standard cubic feet per hour (scfh)] is approximately 0.16 percent (%) of the total allowable leakage (La) for the WBN Unit 2 Type B and C tests (i.e., 147.6 scfh, which is the TS 60% La limit). For comparison purposes, the WBN Unit 2 total leak rate for all penetrations on a minimum path basis is approximately 4.5% of the total allowable leakage (i.e., 6.64 scfh/147.6 scfh).

    The total leakage of the CIVs for which an extension is requested is also approximately 0.39% of the total allowable bypass leakage for the WBN Unit 2 Type B and C bypass tests (61.5 scfh, which is the TS 25% La limit). For comparison purposes, the WBN Unit 2 total leakage for all bypass leakage penetrations on a minimum path basis is approximately 4.4% of the total allowable bypass leakage (i.e., 2.68 scfh/61.5 scfh). The leak-tight condition of these components has been verified by Type C LLRTs. Therefore, the remaining margin is sufficient to ensure any incremental increase in leakage resulting from the extension would not cause unacceptable as-found test results during the WBN U2R1 outage. Therefore, the proposed delay in performance of the LLRTs in this amendment request does not increase the probability of an accident previously evaluated.

    A delay in performing these LLRTs does not result in a system being unable to perform its required function. In the case of this one-time extension request, the short period of additional time that the affected systems and components will be in service before the next performance of the LLRT will not affect the ability of those systems to operate as designed. Therefore, the systems required to mitigate accidents will remain capable of performing their required function. No new failure modes have been introduced because of this action and the consequences remain consistent with previously evaluated accidents. On this basis, the proposed delay in performance of the LLRTs in this amendment request does not involve a significant increase in the consequences of an accident.

    Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any previously evaluated?

    Response: No.

    The proposed amendment does not involve a physical alteration of any system, structure, or component (SSC) or a change in the way any SSC is operated. The proposed amendment does not involve operation of any SSCs in a manner or configuration different from those previously recognized or evaluated. No new failure mechanisms will be introduced by the one-time LLRT extensions being requested.

    Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed amendment is a change to TS 5.7.2.19 to allow a one-time exception to RG 1.163 to extend the Type C LLRTs for a limited number of CIVs. The WBN Unit 2 CIVs, for which an extension is requested, are the same design as those in WBN Unit 1 and operate under the same service conditions. Furthermore, any increase in leakage because of the extension is expected to be within TS limits and will not compromise containment integrity. Extending these LLRTs does not involve a modification of any TS limiting condition for operation. Extending these LLRTs does not involve a change to any limit on accident consequences specified in the license or regulations. Extending these LLRTs does not involve a change in how accidents are mitigated or a significant increase in the consequences of an accident. Extending these LLRTs does not involve a change in a methodology used to evaluate consequences of an accident. Extending these LLRTs does not involve a change in any operating procedure or process.

    Based on the limited additional period of time that the systems and components will be in service before the LLRTs are next performed, as well as the operating experience that demonstrates the reliability of the CIVs, it is reasonable to conclude that the margins of safety associated with the LLRTs for these CIVs will not be affected by the requested extension.

    Therefore, the proposed change does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: Sherry A. Quirk, Executive Vice President and General Counsel, Tennessee Valley Authority, 400 West Summit Hill Drive, 6A West Tower, Knoxville, Tennessee 37902.

    NRC Branch Chief: Benjamin G. Beasley.

    Tennessee Valley Authority, Docket Nos. 50-390 and 50-391, Watts Bar Nuclear Plant, Units 1 and 2, Rhea County, Tennessee

    Date of amendment request: November 23, 2016. A publicly-available version is in ADAMS under Accession No. ML16335A179.

    Description of amendment request: The amendments would revise the Technical Specification (TS) requirements on control and shutdown rods, and rod and bank position indication. The proposed amendments adopt the changes contained in Technical Specification Task Force (TSTF) traveler TSTF-547, Revision 1, “Clarification of Rod Position Requirements,” with minor variations as described in the application.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    Control and shutdown rods are assumed to insert into the core to shut down the reactor in evaluated accidents. Rod insertion limits ensure that adequate negative reactivity is available to provide the assumed shutdown margin (SDM). Rod alignment and overlap limits maintain an appropriate power distribution and reactivity insertion profile.

    Control and shutdown rods are initiators to several accidents previously evaluated, such as rod ejection. The proposed change does change the limiting conditions for operation for the rods and makes technical changes to the Surveillance Requirements (SRs) governing the rods. However, the proposed change has no significant effect on the probability of any accident previously evaluated.

    Revising the TS Actions to provide a limited time to repair rod movement control has no effect on the SDM assumed in the accident analysis as the proposed Action require verification that SDM is maintained. The effects on power distribution will not cause a significant increase in the consequences of any accident previously evaluated as all TS requirements on power distribution continue to be applicable. Revising the TS Actions to provide an alternative to frequent use of the moveable incore detector system to verify the position of rods with inoperable rod position indicator does not change the requirement for the rods to be aligned and within the insertion limits.

    Therefore, the assumptions used in any accidents previously evaluated are unchanged and there is no significant increase in the consequences.

    The consequences of an accident that might occur during the 1-hour period provided for the analog rod position indication to stabilize after rod movement are no different than the consequences of the accident under the existing actions with the rod declared inoperable.

    The proposed change to resolve the conflicts in the TS ensure that the intended Actions are followed when equipment is inoperable. Actions taken with inoperable equipment are not assumptions in the accidents previously evaluated and have no significant effect on the consequences.

    The proposed change to eliminate an unnecessary action has no effect on the consequences of accidents previously evaluated as the analysis of those accidents did not consider the use of the action.

    The proposed change to increase consistency within the TS has no effect on the consequences of accidents previously evaluated as the proposed change clarifies the application of the existing requirements and does not change the intent.

    Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed amendment create the possibility of a new or different kind of accident from any previously evaluated?

    Response: No.

    The proposed change does not involve a physical alteration of the plant (i.e., no new or different type of equipment will be installed). The change does not alter assumptions made in the safety analyses. The proposed change does alter the limiting conditions for operation for the rods and makes technical changes to the SRs governing the rods. However, the proposed change to actions maintains or improves safety when equipment is inoperable and does not introduce new failure modes.

    Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed change to allow time for rod position indication to stabilize after rod movement and to allow an alternative method of verifying rod position has no effect on the safety margin as actual rod position is not affected. The proposed change to provide time to repair rods that are Operable but immovable does not result in a significant reduction in the margin of safety because all rods must be verified to be Operable, and all other banks must be within the insertion limits. The remaining proposed changes to make the requirements internally consistent and to eliminate unnecessary actions do not affect the margin of safety as the changes do not affect the ability of the rods to perform their specified safety function.

    Therefore, the proposed change does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: Sherry A. Quirk, Executive Vice President and General Counsel, Tennessee Valley Authority, 400 West Summit Hill Drive, 6A West Tower, Knoxville, Tennessee 37902.

    NRC Branch Chief: Benjamin G. Beasley.

    Virginia Electric and Power Company, Docket Nos. 50-280 and 50-281, Surry Power Station, Unit Nos. 1 and 2, Surry County, Virginia

    Date of amendment request: January 20, 2017. A publicly-available version is in ADAMS under Accession No. ML17026A174.

    Description of amendment request: The amendments would revise the Technical Specification (TS) 3.5, “Residual Heat Removal System,” requirements, as well as the TS 3.13, “Component Cooling System,” residual heat removal (RHR) support requirements for the component cooling system, for consistency with the design basis of the RHR system. In addition, an RHR surveillance requirement is added in TS Table 4.1-2A, “Minimum Frequency for Equipment Tests,” to test the RHR system in accordance with the inservice testing program, since a TS surveillance does not currently exist for this system.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed license amendment involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed change revises the TS requirements for consistency with the design basis of the RHR System. The proposed change has no impact on the design function of any structures, systems, or components (SSCs), including the RHR System. The proposed change does not impact plant operation and does not change any of the previously evaluated accidents in the Updated Final Safety Analysis Report (UFSAR).

    Thus, this change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed license amendment create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed change does not involve a physical change to any SSCs (i.e., no new or different type of equipment will be installed) and does not impact plant operation. Furthermore, the proposed change does not impose any new or different requirements that could initiate an accident and does not affect initiators of analyzed events.

    Therefore, the proposed change does not introduce any new failures that could create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed amendment involve a significant reduction in a margin of safety?

    Response: No.

    The proposed change does not adversely affect any current plant safety margins or the reliability of the equipment assumed in the safety analysis. There are no changes being made to any safety analysis assumptions, safety limits, or limiting safety system settings that would adversely affect plant safety as a result of the proposed change. The RHR System has no accident mitigation function and its operation is not assumed in any safety analyses. Thus, the proposed change does not impact the condition or performance of SSCs relied upon for accident mitigation or any safety analysis assumptions.

    Therefore, the proposed amendment does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: Lillian M. Cuoco, Senior Counsel, Dominion Resources Services, Inc., 120 Tredegar St., RS-2, Richmond, VA 23219.

    NRC Branch Chief: Michael T. Markley.

    III. Notice of Issuance of Amendments to Facility Operating Licenses and Combined Licenses

    During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendment.

    A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the Federal Register as indicated.

    Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated.

    For further details with respect to the action see (1) the applications for amendment, (2) the amendment, and (3) the Commission's related letter, Safety Evaluation and/or Environmental Assessment as indicated. All of these items can be accessed as described in the “Obtaining Information and Submitting Comments” section of this document.

    Duke Energy Carolinas, LLC, Docket Nos. 50-369 and 50-370, McGuire Nuclear Station, Units 1 and 2, Mecklenburg County, North Carolina

    Date of application for amendments: March 24, 2016 as supplemented by letter dated August 11, 2016.

    Brief description of amendments: The amendments revised TS 3.6.13, “Ice Condenser Doors,” to allow for an alternate method of verifying that the ice condenser doors are closed in addition to that described in the current licensing basis. Specifically, the amendments revised TS 3.6.13 Condition B to add a new alternate Required Action when one or more ice condenser lower inlet doors (LIDs) are inoperable due to having an invalid open LID signal. The new Required Action includes verifying that the affected lower inlet door is closed every 14 days in accordance with an alternate method that does not rely on the faulted alarm.

    Date of issuance: February 24, 2017.

    Effective date: These license amendments are effective as of its date of issuance and shall be implemented within 120 days of issuance.

    Amendment Nos.: 292.

    Renewed Facility Operating License Nos. NPF-9 and NPF-17: Amendments revised the licenses and technical specifications.

    Date of initial notice in Federal Register : June 6, 2016 (81 FR 36617). The supplemental letter dated August 11, 2016, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination as published in the Federal Register.

    The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated February 24, 2017.

    No significant hazards consideration comments received: No.

    Exelon Generation Company, LLC, Docket No. 50-461, Clinton Power Station (CPS), Unit No. 1, DeWitt County, Illinois

    Date of application for amendment: April 4, 2016.

    Brief description of amendment: The amendment revises technical specification (TS) limiting condition of operation (LCO) 3.10.1, “Inservice Leak and Hydrostatic Testing Operation,” to expand its scope to include operations in which reactor coolant system temperature exceeds 200 degrees Fahrenheit (°F) as a consequence of inservice leak and hydrostatic testing, or as a consequence of scram time testing initiated in conjunction with an inservice leak or hydrostatic test when the initial test conditions are below 200 °F, while considering operational conditions to be in Mode 4.

    Date of issuance: February 22, 2017.

    Effective date: As of the date of issuance and shall be implemented within 60 days from the date of issuance.

    Amendment No(s): 211. A publicly-available version is in ADAMS under Accession No. ML17027A038; documents related to this amendment are listed in the Safety Evaluation enclosed with the amendment.

    Facility Operating License No. NPF-62: The amendment revised the Facility Operating License and Technical Specifications.

    Date of initial notice in Federal Register : June 7, 2016 (81 FR 36620).

    The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated February 22, 2017.

    No significant hazards consideration comments received: No.

    Exelon Generation Company, LLC, Docket Nos. 50-237 and 50-249, Dresden Nuclear Power Station, Units 2 and 3, Grundy County, Illinois Exelon Generation Company, LLC, Docket Nos. 50-373 and 50-374, LaSalle County Station, Units 1 and 2, LaSalle County, Illinois Exelon Generation Company, LLC, Docket Nos. 50-254 and 50-265, Quad Cities Nuclear Power Station, Units 1 and 2, Rock Island County, Illinois

    Date of application for amendments: February 3, 2016, as supplemented by letters dated July 28 and December 12, 2016.

    Brief description of amendments: The amendments revise Surveillance Requirement 3.6.4.1.2, for each facility, to provide an allowance for brief, inadvertent, simultaneous opening of redundant secondary containment access doors during normal entry and exit conditions.

    Date of issuance: February 16, 2017.

    Effective date: As of the date of issuance and shall be implemented within 90 days from the date of issuance.

    Amendment Nos.: 253, 246; 222, 208; 265, and 260. A publicly-available version is in ADAMS under Accession No. ML17037D212. Documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

    Renewed Facility Operating License Nos. DPR-19, DPR-25, NPF-11, NPF-18, DPR-29, and DPR-30: Amendments revised the Renewed Facility Operating Licenses and Technical Specifications.

    Date of initial notice in Federal Register : March 29, 2016 (81 FR 17505). The supplemental letters dated July 28 and December 12, 2016, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination as published in the Federal Register.

    The Commission's related evaluation of the amendment is contained in a safety evaluation dated February 16, 2017.

    No significant hazards consideration comments received: No.

    FirstEnergy Nuclear Operating Company, Docket No. 50-440, Perry Nuclear Power Plant, Unit No. 1, Lake County, Ohio

    Date of amendment request: March 15, 2016, as supplemented by letters dated November 7, and December 20, 2016, and February 6, 2017.

    Brief description of amendment: The amendment revised the technical specification (TS) 3.6.2.2, “Suppression Pool Water Level,” as well as TS surveillance requirements (SRs) 3.6.2.4.1 and 3.6.2.4.4 associated with TS 3.6.2.4, “Suppression Pool Makeup (SPMU) System,” to allow installation of the reactor well to steam dryer storage pool gate in the upper containment pool (UCP) in MODEs 1, 2, and 3. The amendment also created new Special Operations TS, TS 3.10.9, “Suppression Pool Makeup—MODE 3 Upper Containment Pool Drain-Down,” to allow draining of the reactor well portion of the UCP in MODE 3.

    Date of issuance: February 16, 2017.

    Effective date: As of the date of issuance and shall be implemented within 60 days of issuance.

    Amendment No.: 174. A publicly-available version is in ADAMS under Accession No. ML17033A014; documents related to this amendment are listed in the Safety Evaluation enclosed with the amendment.

    Facility Operating License No. NPF-58: Amendment revised the Facility Operating License and Technical Specifications.

    Date of initial notice in Federal Register : May 10, 2016 (81 FR 28898). The supplemental letters dated November 7, and December 20, 2016, and February 6, 2017, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination as published in the Federal Register.

    The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated February 16, 2017.

    No significant hazards consideration comments received: No.

    Florida Power & Light Company, Docket Nos. 50-250 and 50-251, Turkey Point Nuclear Generating, Unit Nos. 3 and 4, Miami-Dade County, Florida

    Date of amendment request: June 30, 2016, as supplemented by letter dated November 15, 2016.

    Brief description of amendments: The amendments revised Technical Specifications (TSs) 3/4.7.1.2, “Auxiliary Feedwater System,” to correct a nonconservative TS for Turkey Point Nuclear Generating Unit Nos. 3 and 4.

    Date of issuance: February 14, 2017.

    Effective date: As of the date of issuance and shall be implemented within 60 days of issuance.

    Amendment Nos: 273 and 268. A publicly-available version is in ADAMS under Accession No. ML16335A195; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

    Renewed Facility Operating License Nos. DPR-31 and DPR-41: Amendment revised the Facility Operating License and Technical Specifications.

    Date of initial notice in Federal Register : September 13, 2016 (81 FR 62928). The supplemental letter dated November 15, 2016, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination as published in the Federal Register.

    The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated February 14, 2017.

    No significant hazards consideration comments received: No.

    NextEra Energy, Point Beach, LLC, Docket Nos. 50-266 and 50-301, Point Beach Nuclear Plant, Units 1 and 2, Town of Two Creeks, Manitowoc County, Wisconsin

    Date amendment requests: February 12, 2016, as supplemented by letters dated July 11, 2016, and November 4, 2016.

    Brief description of amendments: The amendments revised the Point Beach Nuclear Plant, Unit 1 and 2 renewed Operating Licenses and Appendix C, “Additional Conditions,” for each license (DPR-24 and DRP-27 respectively), to remove license conditions that have been completed, and are no longer in effect. The amendments also revised a charcoal testing criterion for the control room emergency filtration system.

    Date of issuance: February 22, 2017.

    Effective date: As of the date of issuance and shall be implemented within 60 days of issuance.

    Amendment Nos.: 258 and 262. A publicly-available version is in ADAMS under Accession No. ML17039A300; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

    Renewed Facility Operating License Nos. DPR-24 and DPR-27: Amendments revised the Facility Operating License and Technical Specifications.

    Date of initial notice in Federal Register : April 26, 2016 (81 FR 24662). The supplemental letters dated July 11, 2016, and November 4, 2016, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination as published in the Federal Register.

    The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated February 22, 2017.

    No significant hazards consideration comments received: No.

    Northern States Power Company—Minnesota (NSPM), Docket No. 50-263, Monticello Nuclear Generating Plant, Wright County, Minnesota

    Date of amendment request: October 3, 2014, as supplemented by letters dated January 9, August 26, September 29, and December 8, 2015, and February 29, April 29, August 4, September 14, and September 28, 2016.

    Brief description of amendment: The amendment revised the Technical Specifications (TSs) and Renewed Facility Operating Licenses to allow operation in the extended flow window (EFW) domain.

    Date of issuance: February 23, 2017.

    Effective date: As of the date of issuance and shall be implemented prior to start up from Monticello Nuclear Generating Plant Operating Cycle 29.

    Amendment No.: 191. A publicly-available version is in ADAMS under Accession No. ML17054C394; documents related to this amendment are listed in the Safety Evaluation enclosed with the amendment.

    Renewed Facility Operating License No. DPR-22. Amendment revised the Renewed Facility Operating License and Technical Specifications.

    Date of initial notice in Federal Register: July 7, 2015 (80 FR 38775). The supplemental letters dated January 9, August 26, September 29, and December 8, 2015, and February 29, April 29, August 4, September 14, and September 28, 2016, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination as published in the Federal Register.

    The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated February 23, 2017.

    No significant hazards consideration comments received: No.

    Northern States Power Company—Minnesota (NSPM), Docket No. 50-263, Monticello Nuclear Generating Plant, Wright County, Minnesota

    Date of amendment request: April 4, 2016, as supplemented by letters dated October 3 and November 22, 2016.

    Brief description of amendment: The amendment revises technical specifications (TS) Surveillance Requirement (SR) associated with TS 3.8.4, “DC [direct current] Sources—Operating.” Specifically, the amendment revises SR 3.8.4.2 by increasing the 125 Volt DC battery charger test output current to 75 amperes (amps) from the current test level of 50 amps, and removes the second (alternate) method specified to perform the surveillance requirement.

    Date of issuance: February 27, 2017.

    Effective date: As of the date of issuance and shall be implemented within 120 days of issuance.

    Amendment No.: 192. A publicly-available version is in ADAMS under Accession No. ML17013A435; documents related to this amendment are listed in the Safety Evaluation enclosed with the amendment.

    Renewed Facility Operating License No. DPR-22. Amendment revised the Renewed Facility Operating License and Technical Specifications.

    Date of initial notice in Federal Register: June 7, 2016 (81 FR 36621). The supplemental letters dated October 3 and November 22, 2016, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination.

    The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated February 27, 2017.

    No significant hazards consideration comments received: No.

    Pacific Gas and Electric Company, Docket Nos. 50-275 and 50-323, Diablo Canyon Nuclear Power Plant, Units 1 and 2, San Luis Obispo County, California

    Date of application for amendments: March 23, 2016, as supplemented by letters dated September 28, 2016 and January 18, 2017.

    Brief description of amendments: The amendments revised Technical Specification (TS) 3.4.12, “Low Temperature Overpressure Protection (LTOP) System,” to reflect the mass input transient analysis that assumes an emergency core cooling system centrifugal charging pump and the normal charging pump capable of simultaneously injecting into the reactor coolant system during TS 3.4.12 applicability.

    Date of issuance: February 23, 2017.

    Effective date: As of its date of issuance and shall be implemented within 180 days from the date of issuance.

    Amendment Nos.: Unit 1-229; Unit 2-231. A publicly-available version is in ADAMS under Accession No. ML17018A341; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

    Facility Operating License Nos. DPR-80 and DPR-82: The amendments revised the Facility Operating Licenses and Technical Specifications.

    Date of initial notice in Federal Register: May 10, 2016 (81 FR 28899). The supplemental letters dated September 28, 2016 and January 18, 2017, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination as published in the Federal Register.

    The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated February 23, 2017.

    No significant hazards consideration comments received: No.

    Southern Nuclear Operating Company, Inc., Docket Nos. 52-025 and 50-026, Vogtle Electric Generating Plant, Units 3 and 4, Burke County, Georgia

    Date of amendment request: August 31, 2016.

    Brief description of amendments: The amendments changed Combined License Nos. NPF-91 and NPF-92 for the Vogtle Electric Generating Plant Units 3 and 4. The amendments authorized changes to the Updated Final Safety Analysis Report (UFSAR) in the form of departures from the incorporated plant-specific Design Control Document Tier 2* information. Specifically, the changes revised the combined operating licenses and clarified information in WCAP-17179, “AP1000® Component Interface Module Technical Report,” which demonstrates design compliance with licensing bases requirements. WCAP-17179 is incorporated by reference into the UFSAR to provide additional details regarding the component interface module (CIM) system design. The amendments also authorized a change to the CIM internal power supply that will enable proper functioning of the field programmable gate arrays.

    Date of issuance: February 9, 2017.

    Effective date: As of the date of issuance and shall be implemented within 30 days of issuance.

    Amendment Nos.: 70/69. A publicly-available version is in ADAMS under Accession No. ML16343B021; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

    Facility Operating License No. NPF-91 and NPF-92: Amendments authorized changes to the UFSAR in the form of departures from the incorporated plant-specific DCD Tier 2* information.

    Date of initial notice in Federal Register: October 25, 2016 (81 FR 73440).

    The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated February 9, 2017.

    No significant hazards consideration comments received: No.

    Southern Nuclear Operating Company, Docket Nos. 50-348 and 50-364, Joseph M. Farley Nuclear Plant, Units 1 and 2, Houston County, Alabama

    Date of amendment request: October 11, 2016.

    Brief description of amendments: The amendment revises TS requirements for unavailable barriers by adding Limiting Condition for Operation (LCO) 3.0.9, which allows a delay time for entering a supported system TS, when the inoperability is solely due to an unavailable barrier. The change is consistent with Technical Specification Task Force (TSTF)-427, Revision 2, “Allowance for Non-Technical Specification Barrier Degradation Supported System OPERABILITY.”

    Date of issuance: February 16, 2017.

    Effective date: As of the date of issuance and shall be implemented within 90 days of issuance.

    Amendment Nos.: 208 (Unit 1) and 205 (Unit 2). A publicly-available version is in ADAMS under Accession No. ML17034A193; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

    Renewed Facility Operating License Nos. NPF-2 and NPF-8: The amendments revised the Renewed Facility Operating Licenses and Technical Specifications.

    Date of initial notice in Federal Register: December 6, 2016 (81 FR 87973).

    The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated February 16, 2017.

    No significant hazards consideration comments received: No.

    Tennessee Valley Authority, Docket Nos. 50-390 and 50-391, Watts Bar Nuclear Plant (WBN), Units 1 and 2, Rhea County, Tennessee

    Date of amendment request: March 29, 2016.

    Brief description of amendment: The amendments revise the WBN, Units 1 and 2, Technical Specification (TS) requirements for inoperable dynamic restraints (snubbers) by adding Limiting Condition for Operation (LCO) 3.0.8. The change is consistent with NRC-approved Revision 4 to Technical Specifications Task Force (TSTF) Standard Technical Specifications Change Traveler, TSTF-372, “Addition of LCO 3.0.8, Inoperability of Snubbers.”

    The amendment for WBN, Unit 1, also makes an administrative change to add a reference to LCO 3.0.7 in LCO 3.0.1, consistent with TSTF-6, Revision 1, “Add exception for LCO 3.0.7 to LCO 3.0.1.”

    Date of issuance: February 23, 2017.

    Effective date: As of the date of issuance and shall be implemented within 45 days of issuance.

    Amendment Nos.: 6 and 111. A publicly available version is in ADAMS under Accession No. ML16349A428; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments.

    Facility Operating License Nos. NPF-90 and NPF-96: Amendments revised the Facility Operating Licenses and Technical Specifications.

    Date of initial notice in Federal Register: November 22, 2016 (81 FR 83878).

    The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated February 23, 2017.

    No significant hazards consideration comments received: No.

    Dated at Rockville, Maryland, this 1st day of March 2017.

    For the Nuclear Regulatory Commission.

    Anne T. Boland, Director, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation.
    [FR Doc. 2017-04757 Filed 3-13-17; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2017-0001] Sunshine Act Meeting Notice DATES:

    Weeks of March 13, 20, 27, April 3, 10, 17, 2017.

    PLACE:

    Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.

    STATUS:

    Public and Closed.

    Week of March 13, 2017

    There are no meetings scheduled for the week of March 13, 2017.

    Week of March 20, 2017—Tentative Thursday, March 23, 2017 9:00 a.m. Hearing on Combined License for North Anna Nuclear Plant, Unit 3: Section 189a. of the Atomic Energy Act Proceeding (Public Meeting) (Contact: James Shea: 301-415-1388)

    This meeting will be webcast live at the Web address—http://www.nrc.gov/.

    Friday, March 24, 2017 10:00 a.m. Briefing on the Annual Threat Environment (Closed Ex. 1) Week of March 27, 2017—Tentative

    There are no meetings scheduled for the week of March 27, 2017.

    Week of April 3, 2017—Tentative Tuesday, April 4, 2017 10:00 a.m. Meeting with the Organization of Agreement States and the Conference of Radiation Control Program Directors (Public Meeting) (Contact: Paul Michalak: 301-415-5804)

    This meeting will be webcast live at the Web address—http://www.nrc.gov/.

    Thursday, April 6, 2017 10:00 a.m. Meeting with Advisory Committee on Reactor Safeguards (Public Meeting) (Contact: Mark Banks: 301-415-3718)

    This meeting will be webcast live at the Web address—http://www.nrc.gov/.

    Week of April 10, 2017—Tentative

    There are no meetings scheduled for the week of April 10, 2017.

    Week of April 17, 2017—Tentative

    There are no meetings scheduled for the week of April 17, 2017.

    The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at [email protected]

    The NRC Commission Meeting Schedule can be found on the Internet at: http://www.nrc.gov/public-involve/public-meetings/schedule.html.

    The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (e.g., Braille, large print), please notify Kimberly Meyer, NRC Disability Program Manager, at 301-287-0739, by videophone at 240-428-3217, or by email at [email protected] Determinations on requests for reasonable accommodation will be made on a case-by-case basis.

    Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email [email protected] or [email protected]

    Dated: March 9, 2017. Denise L. McGovern, Policy Coordinator, Office of the Secretary.
    [FR Doc. 2017-05077 Filed 3-10-17; 11:15 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2016-0220] Report on Changes to Low-Level Waste Burial Charges AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    NUREG; issuance.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is issuing NUREG-1307, Revision 16, “Report on Waste Burial Charges: Changes in Decommissioning Waste Disposal Costs at Low-Level Waste Burial Facilities.” This report, which is revised periodically, explains the formula acceptable to the NRC for determining the minimum decommissioning fund requirements for nuclear power reactors, as required by the NRC's regulations. Specifically, this report provides adjustment factors, and updates to these values, for the labor, energy, and waste components of the minimum decommissioning formula.

    DATES:

    NUREG-1307, Revision 16, is available March 14, 2017.

    ADDRESSES:

    Please refer to Docket ID NRC-2016-0220 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2016-0220. 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] NUREG-1307, Revision 16, is available in ADAMS under Accession No. ML17060A362.

    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:

    Emil Tabakov, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-6814; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The NRC is issuing NUREG-1307, Revision 16, “Report on Waste Burial Charges: Changes in Decommissioning Waste Disposal Costs at Low-Level Waste Burial Facilities.” This report, which is revised periodically, explains the formula acceptable to the NRC for determining the minimum decommissioning fund requirements for nuclear power reactors, as required by section 50.75 of title 10 of the Code of Federal Regulations. NUREG-1307, Revision 16, modifies Revision 15 to this report that was issued in January 2013 (ADAMS Accession No. ML13023A030), and incorporates updates to the adjustment factors for the labor, energy, and waste components of the NRC minimum decommissioning formula. This revision also incorporates changes resulting from newly available low-level waste (LLW) disposal capacity at the Andrews County, Texas, facility established in 2012, and changes made to waste disposal costs resulting from a contractor reassessment of the assumptions for LLW classification. As a result of these changes, the minimum decommissioning formula amounts calculated by licensees, based on revised LLW burial factors presented in this report, will likely reflect (on average) lower minimum decommissioning fund requirements than those previously reported by licensees in 2015.

    The NRC published a notice in the Federal Register on November 21, 2016 (81 FR 83287) requesting public comment on draft NUREG-1307, Revision 16, Report on Changes to Low-Level Waste Burial Charges. The NRC received four comments. The responses and comments are presented in a comment resolution matrix available in ADAMS under Accession No. ML17052A677. The NRC took these comments into consideration as staff completed NUREG-1307, Revision 16.

    Dated at Rockville, Maryland, this 28th day of February 2017.

    For the Nuclear Regulatory Commission.

    Anthony R. Bowers, Chief, Financial Analysis and International Projects Branch, Division of Inspection and Regional Support, Office of Nuclear Reactor Regulation.
    [FR Doc. 2017-04991 Filed 3-13-17; 8:45 am] BILLING CODE 7590-01-P
    OFFICE OF PERSONNEL MANAGEMENT Submission for Review: Self-Certification of Full-Time School Attendance for the School Year, RI 25-14 and Information and Instructions for Completing the Self-Certification of Full-Time School Attendance for the School Year, RI 25-14A AGENCY:

    U.S. Office of Personnel Management.

    ACTION:

    30-Day notice and request for comments.

    SUMMARY:

    The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on an extension, without change, of a currently approved information collection request (ICR), Self-Certification of Full-Time School Attendance For The School Year, RI 25-14 and Information and Instructions for Completing the Self-Certification of Full-Time School Attendance For The School Year, RI 25-14A.

    DATES:

    Comments are encouraged and will be accepted until April 13, 2017.

    ADDRESSES:

    Interested persons are invited to submit written comments on the proposed information collection to Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent by email to [email protected] or faxed to (202) 395-6974.

    FOR FURTHER INFORMATION CONTACT:

    A copy of this ICR, with applicable supporting documentation, may be obtained by contacting the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent by email to [email protected] or faxed to (202) 395-6974.

    SUPPLEMENTARY INFORMATION:

    As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. The information collection (OMB No. 3206-0032) was previously published in the Federal Register on September 21, 2016 at 81 FR 64956 allowing for a 60-day public comment period. No comments were received for this information collection.

    The purpose of this notice is to allow an additional 30 days for public comments. The Office of Management and Budget is particularly interested in comments that:

    1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of OPM, including whether the information will have practical utility;

    2. Evaluate the accuracy of OPM'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 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.

    Form RI 25-14 is used to survey survivor annuitants who are between the ages of 18 and 22 to determine if they meet the requirements of Section 8341(a)(4)(C), and Section 8441, title 5, U.S. Code, to receive benefits as a student. RI 25-14A provides instructions for completing the Self-Certification of Full-Time School Attendance for the School Year survey form.

    Analysis

    Agency: Retirement Operations, Retirement Services, Office of Personnel Management.

    Title: Self-Certification of Full-Time School Attendance for the School Year and Information and Instructions for Completing the Self-Certification of Full-Time School Attendance for the School Year.

    OMB Number: 3206-0032.

    Frequency: On occasion.

    Affected Public: Individuals or Households.

    Number of Respondents: 14,000.

    Estimated Time per Respondent: 12 minutes.

    Total Burden Hours: 2,800.

    U.S. Office of Personnel Management. Kathleen McGettigan, Acting Director.
    [FR Doc. 2017-04935 Filed 3-13-17; 8:45 am] BILLING CODE 6325-38-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-80181; File No. SR-CBOE-2017-016] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Complex Order Price Protections

    March 8, 2017.

    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),1 and Rule 19b-4 thereunder,2 notice is hereby given that on February 23, 2017, Chicago Board Options Exchange, Incorporated (the “Exchange” or “CBOE”) filed with the Securities and Exchange Commission (the “Co