Federal Register Vol. 83, No.31,

Federal Register Volume 83, Issue 31 (February 14, 2018)

Page Range6451-6788
FR Document

83_FR_31
Current View
Page and SubjectPDF
83 FR 6458 - Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972PDF
83 FR 6615 - Sunshine Act Meetings; CorrectionPDF
83 FR 6615 - Sunshine Act MeetingPDF
83 FR 6490 - Response to June 1, 2016, Clean Air Act Section 126(b) Petition From ConnecticutPDF
83 FR 6563 - Sunshine Act MeetingPDF
83 FR 6669 - Sunshine Act Meeting NoticePDF
83 FR 6667 - Meeting on United States-Morocco Free Trade Agreement Environment Chapter Implementation, Working Group on Environmental Cooperation, and Public SessionPDF
83 FR 6574 - Submission for OMB Review; Comment RequestPDF
83 FR 6613 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
83 FR 6573 - Submission for OMB Review; Comment RequestPDF
83 FR 6458 - Student Assistance General Provisions, Federal Perkins Loan Program, Federal Family Education Loan Program, William D. Ford Federal Direct Loan Program, and Teacher Education Assistance for College and Higher Education Grant ProgramPDF
83 FR 6665 - Surrender of License of Small Business Investment CompanyPDF
83 FR 6666 - Surrender of License of Small Business Investment CompanyPDF
83 FR 6473 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod in the Bering Sea Subarea of the Bering Sea and Aleutian Islands Management AreaPDF
83 FR 6731 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Terrorism Risk Insurance ProgramPDF
83 FR 6475 - Greater-Than-Class C and Transuranic WastePDF
83 FR 6507 - Notice of Request for Revision to and Extension of an Approval of an Information Collection; Importation of Eggplant From IsraelPDF
83 FR 6619 - Very Low-Level Radioactive Waste Scoping StudyPDF
83 FR 6563 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
83 FR 6520 - Meeting of the Advisory Committee to the United States Delegation to the International Commission for the Conservation of Atlantic TunasPDF
83 FR 6522 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to U.S. Navy 2018 Ice Exercise Activities in the Beaufort Sea and Arctic OceanPDF
83 FR 6496 - Air Plan Approval; KY: Removal of Reliance on Reformulated Gasoline in the Kentucky Portion of the Cincinnati-Hamilton AreaPDF
83 FR 6605 - Changes in Flood Hazard DeterminationsPDF
83 FR 6612 - Proclaiming Certain Lands as Reservation for the Nottawaseppi Huron Band of the PotawatomiPDF
83 FR 6612 - Notice of Deadline for Submitting Completed Applications To Begin Participation in the Tribal Self-Governance Program in Fiscal Year 2019 or Calendar Year 2019PDF
83 FR 6609 - Changes in Flood Hazard DeterminationsPDF
83 FR 6611 - Agency Information Collection Activities: Proposed Collection; Comment Request; Post Disaster Survivor Preparedness ResearchPDF
83 FR 6613 - Indian Gaming; Extension of Tribal-State Class III Gaming Compact (Rosebud Sioux Tribe and the State of South Dakota)PDF
83 FR 6510 - In the Matter of: Justin Gage Jangraw, P.O. Box 601, Key West, Florida 33041; Order Denying Export PrivilegesPDF
83 FR 6673 - Qualification of Drivers; Exemption Applications; HearingPDF
83 FR 6697 - Qualification of Drivers; Exemption Applications; DiabetesPDF
83 FR 6725 - Qualification of Drivers; Exemption Applications; Diabetes MellitusPDF
83 FR 6545 - Combined Notice of FilingsPDF
83 FR 6548 - Combined Notice of Filings #1PDF
83 FR 6716 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure DisordersPDF
83 FR 6694 - Qualification of Drivers; Exemption Applications; VisionPDF
83 FR 6680 - Hours of Service of Drivers: Application for Exemption; National Electrical Contractors AssociationPDF
83 FR 6535 - Proposed Collection; Comment RequestPDF
83 FR 6704 - Qualification of Drivers; Exemption Applications; Diabetes MellitusPDF
83 FR 6729 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure DisordersPDF
83 FR 6685 - Qualification of Drivers; Exemption Applications; Diabetes MellitusPDF
83 FR 6692 - Qualification of Drivers; Exemption Applications; DiabetesPDF
83 FR 6674 - Qualification of Drivers; Exemption Applications; Diabetes MellitusPDF
83 FR 6724 - Qualification of Drivers; Exemption Applications; VisionPDF
83 FR 6509 - Notice of Public Meeting of the Montana Advisory CommitteePDF
83 FR 6732 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple IRS Information Collection RequestsPDF
83 FR 6510 - Foreign-Trade Zone (FTZ) 134-Chattanooga, Tennessee; Authorization of Production Activity; (Passenger Motor Vehicles); Chattanooga, TennesseePDF
83 FR 6510 - Foreign-Trade Zone 76-Bridgeport, Connecticut; Application for Subzone; SDI USA, LLC; Meriden, ConnecticutPDF
83 FR 6510 - Foreign-Trade Zone 102-St. Louis, Missouri; Application for Subzone; Orgill, Inc.; Sikeston, MissouriPDF
83 FR 6670 - Procedures To Consider Additional Requests for Exclusion of Particular Products From the Solar Products Safeguard MeasurePDF
83 FR 6712 - Qualification of Drivers; Exemption Applications; DiabetesPDF
83 FR 6700 - Qualification of Drivers; Exemption Applications; Diabetes MellitusPDF
83 FR 6702 - Qualification of Drivers; Exemption Applications; HearingPDF
83 FR 6701 - Qualification of Drivers; Exemption Applications; HearingPDF
83 FR 6576 - Determination of Regulatory Review Period for Purposes of Patent Extension; BELEODAQPDF
83 FR 6472 - Fisheries Off West Coast States; Coastal Pelagic Species Fisheries; Amendment 16 to the Coastal Pelagic Species Fishery Management PlanPDF
83 FR 6542 - Environmental Management Site-Specific Advisory Board, PortsmouthPDF
83 FR 6541 - Environmental Management Site-Specific Advisory Board, Northern New MexicoPDF
83 FR 6541 - Environmental Management Site-Specific Advisory Board, HanfordPDF
83 FR 6698 - Qualification of Drivers; Exemption Applications; HearingPDF
83 FR 6681 - Qualification of Drivers; Exemption Applications; VisionPDF
83 FR 6718 - Parts and Accessories Necessary for Safe Operation, Lamps and Reflective Devices; Application for an Exemption From STEMCO LPPDF
83 FR 6722 - Qualification of Drivers; Exemption Applications; DiabetesPDF
83 FR 6711 - Qualification of Drivers; Exemption Applications; Diabetes MellitusPDF
83 FR 6715 - Qualification of Drivers; Exemption Applications; DiabetesPDF
83 FR 6581 - Determination of Regulatory Review Period for Purposes of Patent Extension; IBRANCEPDF
83 FR 6730 - Reports, Forms, and Record Keeping Requirements Agency Information Collection Activity Under OMB ReviewPDF
83 FR 6668 - Environmental Impact Statement for 2019 Update to the Integrated Resource PlanPDF
83 FR 6477 - Airworthiness Directives; The Boeing Company AirplanesPDF
83 FR 6553 - ColGreen North Shore, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 6551 - Carlsbad Energy Center LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 6546 - Tristate NLA, LLC; Notice of Petition for Declaratory OrderPDF
83 FR 6547 - Combined Notice of FilingsPDF
83 FR 6552 - Combined Notice of Filings #1PDF
83 FR 6601 - Request for Public Comment: 30 Day Notice for Extension of the Indian Health Service Loan Repayment Program (LRP)PDF
83 FR 6600 - Request for Public Comment: 30 Day Proposed Information Collection: Indian Health Service Information Security Ticketing and Incident ReportingPDF
83 FR 6574 - Determination of Regulatory Review Period for Purposes of Patent Extension; JUVEDERM VOLUMA XCPDF
83 FR 6522 - Mid-Atlantic Fishery Management Council (MAFMC); Public MeetingPDF
83 FR 6521 - Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public MeetingPDF
83 FR 6591 - Privacy Act of 1974; System of RecordsPDF
83 FR 6554 - East Cheyenne Gas Storage, LLC; Notice of Schedule for Environmental Review of the Lewis Creek AmendmentPDF
83 FR 6544 - Kenai Hydro, LLC; Notice of Application Ready for Environmental Analysis and Soliciting Comments, Recommendations, Terms and Conditions, and PrescriptionsPDF
83 FR 6542 - Consumers Energy Company and DTE Electric Company; Notice of Application Accepted for Filing, Soliciting Motions to Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Preliminary Terms and Conditions, and Preliminary Fishway PrescriptionsPDF
83 FR 6547 - ISO New England Inc.; Notice of FilingPDF
83 FR 6549 - EONY Generation Limited; Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving Use of the Traditional Licensing ProcessPDF
83 FR 6550 - Algonquin Power (Beaver Falls), LLC; Notice of Application Accepted for Filing, Soliciting Motions To Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Terms and Conditions, and PrescriptionsPDF
83 FR 6547 - Gulf South Pipeline Company, LP; Notice of ApplicationPDF
83 FR 6555 - Questar Southern Trail Pipeline Company, Navajo Tribal Utility Authority; Notice of Intent To Prepare an Environmental Assessment for the Proposed Southern Trail Pipeline Abandonment Project Request for Comments on Environmental IssuesPDF
83 FR 6621 - Florida Power and Light Company; St. Lucie Plant, Unit Nos. 1 and 2PDF
83 FR 6616 - Notice of Intent To Seek Approval To Renew an Information Collection SystemPDF
83 FR 6559 - Information Collections Being Reviewed by the Federal Communications CommissionPDF
83 FR 6562 - Information Collection Approved by the Office of Management and BudgetPDF
83 FR 6558 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
83 FR 6557 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
83 FR 6560 - Information Collection Being Submitted for Review and Approval to the Office of Management and BudgetPDF
83 FR 6457 - Amendment to the International Traffic in Arms Regulations: Addition of South SudanPDF
83 FR 6455 - Airworthiness Directives; GE Aviation Czech s.r.o. Turboprop EnginesPDF
83 FR 6579 - Determination of Regulatory Review Period for Purposes of Patent Extension; KERYDINPDF
83 FR 6583 - Determination of Regulatory Review Period for Purposes of Patent Extension; JARDIANCEPDF
83 FR 6577 - Determination of Regulatory Review Period for Purposes of Patent Extension; OSURNIAPDF
83 FR 6582 - Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings; Public WorkshopPDF
83 FR 6534 - National Medal of Technology and Innovation Nomination ApplicationPDF
83 FR 6532 - Patent Prosecution Highway ProgramPDF
83 FR 6633 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of Proposed Rule Change To Amend the By-Laws and Make Other ChangesPDF
83 FR 6630 - Self-Regulatory Organizations; Miami International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Its Fee SchedulePDF
83 FR 6654 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing of Proposed Rule Change To Amend the By-Laws and Make Other ChangesPDF
83 FR 6639 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing of Proposed Rule Change To Amend the By-LawsPDF
83 FR 6626 - Self-Regulatory Organizations; The Depository Trust Company; Fixed Income Clearing Corporation; National Securities Clearing Corporation; Notice of Designation of Longer Period for Commission Action on Proposed Rule Changes To Amend the Loss Allocation Rules and Make Other ChangesPDF
83 FR 6653 - Self-Regulatory Organizations; The Depository Trust Company; Fixed Income Clearing Corporation; National Securities Clearing Corporation; Notice of Designation of Longer Period for Commission Action on Proposed Rule Changes To Adopt a Recovery & Wind-Down Plan and Related RulesPDF
83 FR 6626 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Designation of Longer Period for Commission Action on Proposed Rule Change To Permit the Listing and Trading of NQX Index Options on a Pilot BasisPDF
83 FR 6650 - Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to the Options Regulatory FeePDF
83 FR 6662 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to the Options Regulatory FeePDF
83 FR 6629 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change To Restore the Timeframe for Processing Credit Post-Payable AdjustmentsPDF
83 FR 6624 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change To Amend Procedures in the DTC Settlement Service Guide Relating to the Intra-Month Collection of Required Participants Fund DepositsPDF
83 FR 6627 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE Arca Equities Fees and ChargesPDF
83 FR 6664 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to the Options Regulatory FeePDF
83 FR 6660 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change Relating to Amendments to the ICE Clear Europe Collateral and Haircut PolicyPDF
83 FR 6646 - Self-Regulatory Organizations; the Options Clearing Corporation; Order Approving Proposed Rule Change Related to the Options Clearing Corporation's Margin PolicyPDF
83 FR 6651 - Self-Regulatory Organizations; the Options Clearing Corporation; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Revise the Options Clearing Corporation's Schedule of FeesPDF
83 FR 6536 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; OSERS Peer Review Data FormPDF
83 FR 6535 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Quarterly Cumulative Caseload ReportPDF
83 FR 6519 - Hydrographic Services Review PanelPDF
83 FR 6518 - Hydrographic Services Review Panel MeetingPDF
83 FR 6552 - Transparency Provisions of Section 23 of the Natural Gas Act; Notice of Change to Filing InstructionsPDF
83 FR 6544 - Notice of Conference CallPDF
83 FR 6553 - Colorado Interstate Gas Company, L.L.C.; Notice of ApplicationPDF
83 FR 6551 - Columbia Gas Transmission, LLC; Notice of Request Under Blanket AuthorizationPDF
83 FR 6545 - BM Energy Park, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing ApplicationsPDF
83 FR 6537 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and approval; Comment Request; Survey of Postgraduate Outcomes for the Foreign Language and Area Studies (FLAS) Fellowship Program (Survey)PDF
83 FR 6585 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Health Professions Student Loan (HPSL) Program and Nursing Student Loan (NSL) Program Administrative Requirements (Regulations and Policy). OMB No. 0915-0047-RevisionPDF
83 FR 6563 - NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2018PDF
83 FR 6666 - Privacy Act of 1974; Matching ProgramPDF
83 FR 6537 - Eligibility Designations and Applications for Waiver of Eligibility Requirements; Programs Under Parts A and F of Title III of the Higher Education Act of 1965, as Amended (HEA), and Programs Under Title V of the HEAPDF
83 FR 6735 - Proposed Collections; Comment RequestsPDF
83 FR 6602 - National Institute of General Medical Sciences; Notice of Closed MeetingPDF
83 FR 6603 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed MeetingPDF
83 FR 6602 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingsPDF
83 FR 6603 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 6518 - Submission for OMB Review; Comment RequestPDF
83 FR 6520 - Proposed Information Collection; Comment Request; Documentation of Fish HarvestPDF
83 FR 6509 - South Branch Potomac River Subwatershed of the Potomac River Watershed, Highland County, Virginia and Pendleton and Grant Counties, West VirginiaPDF
83 FR 6604 - Merchant Mariner Medical Advisory CommitteePDF
83 FR 6672 - Notice of Opportunity for Public Comment on a Disposal of 17.6 Acres of Airport Land at Manchester-Boston Regional Airport, Manchester, NHPDF
83 FR 6615 - Proposed Collection; Comment RequestPDF
83 FR 6508 - Notice of Intent To Seek Approval To Reinstate an Information CollectionPDF
83 FR 6613 - Royalty Policy Committee; Public MeetingPDF
83 FR 6587 - Privacy Act of 1974; System of Records.PDF
83 FR 6758 - Competitive Postal ProductsPDF
83 FR 6513 - Xanthan Gum From the People's Republic of China: Final Results of the Antidumping Duty Administrative Review and Final Determination of No Shipments; 2015-2016PDF
83 FR 6503 - Head Start Designation Renewal System ImprovementsPDF
83 FR 6506 - CLASS Condition of the Head Start Designation Renewal SystemPDF
83 FR 6516 - Certain Pasta From Turkey: Final Results and Rescission of Antidumping Duty Administrative Review; 2015-2016PDF
83 FR 6511 - Oil Country Tubular Goods From the Republic of Turkey: Final Results of Countervailing Duty Administrative ReviewPDF
83 FR 6515 - Wooden Bedroom Furniture From the People's Republic of China: Final Results of Antidumping Duty Administrative Review and Final Determination of No Shipments in Part; 2016PDF
83 FR 6493 - Approval and Promulgation of Implementation Plans; Texas; Interstate Transport Requirements for the 1997 and 2006 PM2.5PDF
83 FR 6503 - Approval and Promulgation of Implementation Plans; Texas; Disapproval of Interstate Transport State Implementation Plan Revision for the 2006 24-hour PM2.5PDF
83 FR 6470 - Approval and Promulgation of Air Quality Implementation Plans; Arkansas; Infrastructure State Implementation Plan Requirements for the National Ambient Air Quality StandardsPDF
83 FR 6491 - Approval and Promulgation of Implementation Plans; Texas; Revisions to Permitting and Public Participation for Air Quality Permit ApplicationsPDF
83 FR 6451 - Fees for Official Inspection and Official Weighing Services Under the United States Grain Standards Act (USGSA)PDF
83 FR 6480 - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission RequirementsPDF
83 FR 6740 - Senior Corps: Senior Companion Program, Foster Grandparent Program, Retired and Senior Volunteer ProgramPDF

Issue

83 31 Wednesday, February 14, 2018 Contents Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

See

National Agricultural Statistics Service

See

Natural Resources Conservation Service

RULES Fees for Official Inspection and Official Weighing Services under the United States Grain Standards Act, 6451-6455 2018-02884
Animal Animal and Plant Health Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Importation of Eggplant From Israel, 6507 2018-03084 Centers Disease Centers for Disease Control and Prevention NOTICES Proposed Additions to National Institute for Occupational Safety and Health Hazardous Drug List 2018, etc., 6563-6573 2018-02957 Children Children and Families Administration PROPOSED RULES CLASS Condition of Head Start Designation Renewal System; Withdrawal, 6506 2018-02901 Head Start Designation Renewal System Improvements, 6503-6506 2018-02902 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Home Visiting Career Trajectories, 6574 2018-03093 Office of Refugee Resettlement Cash and Medical Assistance Program Quarterly Report on Expenditures and Obligations, 6573-6574 2018-03091 Civil Rights Civil Rights Commission NOTICES Meetings: Montana Advisory Committee, 6509 2018-03053 Coast Guard Coast Guard NOTICES Meetings: Merchant Mariner Medical Advisory Committee, 6604-6605 2018-02943 Commerce Commerce Department See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

Patent and Trademark Office

Corporation Corporation for National and Community Service PROPOSED RULES Senior Corps: Senior Companion Program, Foster Grandparent Program, Retired and Senior Volunteer Program, 6740-6756 2018-01462 Defense Department Defense Department See

Navy Department

Education Department Education Department RULES Student Assistance General Provisions: Federal Perkins Loan Program, Federal Family Education Loan Program, William D. Ford Federal Direct Loan Program, and Teacher Education Assistance for College and Higher Education Grant Program, 6458-6470 2018-03090 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: OSERS Peer Review Data Form, 6536-6537 2018-02971 Quarterly Cumulative Caseload Report, 6535-6536 2018-02970 Survey of Postgraduate Outcomes for Foreign Language and Area Studies Fellowship Program, 6537 2018-02959 Eligibility Designations and Applications for Waiver of Eligibility Requirements: Programs under Parts A and F of Title III of Higher Education Act and Programs under Title V of HEA, 6537-6541 2018-02955 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Meetings: Environmental Management Site-Specific Advisory Board, Hanford, 6541 2018-03037 Environmental Management Site-Specific Advisory Board, Northern New Mexico, 6541-6542 2018-03038 Environmental Management Site-Specific Advisory Board, Portsmouth, 6542 2018-03039
Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Arkansas; Infrastructure State Implementation Plan Requirements for National Ambient Air Quality Standards, 6470-6472 2018-02892 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Kentucky: Removal of Reliance on Reformulated Gasoline in Kentucky Portion of Cincinnati-Hamilton Area, 6496-6503 2018-03078 Texas; Disapproval of Interstate Transport State Implementation Plan Revision for 2006 24-hour Fine Particulate Matter National Ambient Air Quality Standards; Withdrawal, 6503 2018-02893 Texas; Interstate Transport Requirements for 1997 and 2006 Fine Particulate Matter National Ambient Air Quality Standards, 6493-6496 2018-02894 Texas; Revisions to Permitting and Public Participation for Air Quality Permit Applications, 6491-6493 2018-02891 Public Hearings: Response to June 1, 2016, Clean Air Act Petition from Connecticut, 6490-6491 2018-03171 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: GE Aviation Czech s.r.o. Turboprop Engines, 6455-6456 2018-02994 PROPOSED RULES Airworthiness Directives: The Boeing Company Airplanes, 6477-6480 2018-03026 NOTICES Airport Property Disposals: Manchester-Boston Regional Airport, Manchester, NH, 6672 2018-02942 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 6558-6563 2018-02997 2018-02998 2018-02999 2018-03000 2018-03001 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 6563 2018-03166 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Post Disaster Survivor Preparedness Research, 6611-6612 2018-03073 Flood Hazard Determinations; Changes, 6605-6611 2018-03074 2018-03077 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Algonquin Power (Beaver Falls), LLC, 6550-6551 2018-03007 Colorado Interstate Gas Co., LLC, 6553-6554 2018-02962 Consumers Energy Co. and DTE Electric Co., 6542-6544 2018-03010 Gulf South Pipeline Co., LP, 6547-6548 2018-03006 Kenai Hydro, LLC, 6544 2018-03011 Changes to Filing Instructions: Transparency Provisions of Section 23 of Natural Gas Act, 6552 2018-02966 Combined Filings, 6545, 6547-6549, 6552-6553 2018-03020 2018-03021 2018-03066 2018-03067 Environmental Assessments; Availability, etc.: Questar Southern Trail Pipeline Co., Navajo Tribal Utility Authority Southern Trail Pipeline Abandonment Project, 6555-6557 2018-03005 Environmental Reviews: East Cheyenne Gas Storage, LLC; Lewis Creek Amendment, 6554-6555 2018-03012 Filings: ISO New England Inc., 6547 2018-03009 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Carlsbad Energy Center, LLC, 6551 2018-03023 ColGreen North Shore, LLC, 6553 2018-03024 License Applications: EONY Generation, Ltd., 6549-6550 2018-03008 Meetings: American Electric Power Service Corp. v. Midcontinent Independent System Operator, Inc., et al.; Conference Call, 6544-6545 2018-02963 Permit Applications: BM Energy Park, LLC, 6545-6546 2018-02960 Petitions for Declaratory Orders: Tristate NLA, LLC, 6546-6547 2018-03022 Requests Under Blanket Authorizations: Columbia Gas Transmission, LLC, 6551-6552 2018-02961 Federal Motor Federal Motor Carrier Safety Administration NOTICES Hours of Service of Drivers; Exemption Applications: National Electrical Contractors Association, 6680-6681 2018-03063 Parts and Accessories Necessary for Safe Operation, Lamps and Reflective Devices; Exemption Applications: STEMCO LP, 6718-6722 2018-03033 Qualification of Drivers; Exemption Applications: Diabetes, 6692-6694, 6697-6698, 6712-6716, 6722-6724 2018-03030 2018-03032 2018-03047 2018-03056 2018-03069 Diabetes Mellitus, 6674-6680, 6685-6692, 6700-6701, 6704-6712, 6725-6729 2018-03031 2018-03046 2018-03055 2018-03057 2018-03059 2018-03068 Epilepsy and Seizure Disorders, 6716-6718, 6729-6730 2018-03058 2018-03065 Hearing, 6673-6674, 6698-6699, 6701-6704 2018-03035 2018-03044 2018-03045 2018-03070 Vision, 6681-6685, 6694-6697, 6724-6725 2018-03034 2018-03054 2018-03064 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 6563 2018-03082 Food and Drug Food and Drug Administration PROPOSED RULES Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements, 6480-6490 2018-02757 NOTICES Determinations of Regulatory Review Periods for Purposes of Patent Extensions: BELEODAQ, 6576-6577 2018-03041 IBRANCE, 6581-6582 2018-03029 JARDIANCE, 6583-6585 2018-02992 JUVEDERM VOLUMA XC, 6574-6576 2018-03017 KERYDIN, 6579-6581 2018-02993 OSURNIA, 6577-6579 2018-02991 Meetings: Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings; Public Workshop, 6582-6583 2018-02990 Foreign Claims Foreign Claims Settlement Commission NOTICES Meetings; Sunshine Act, 6615 2018-03189 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: Volkswagen Group of America, LLC, Foreign-Trade Zone 134, Chattanooga, TN, 6510 2018-03051 Subzone Applications: Orgill, Inc., Foreign-Trade Zone 102, St. Louis, MO, 6510 2018-03049 SDI USA, LLC, Foreign-Trade Zone 76, Bridgeport, CT, 6510 2018-03050 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Children and Families Administration

See

Food and Drug Administration

See

Health Resources and Services Administration

See

Indian Health Service

See

National Institutes of Health

NOTICES Privacy Act; Systems of Records, 6587-6600 2018-02933 2018-03014
Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Health Professions Student Loan Program and Nursing Student Loan Program Administrative Requirements, 6585-6587 2018-02958 Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

Indian Affairs Indian Affairs Bureau NOTICES Application Deadline: Tribal Self-Governance Program in Fiscal Year 2019 or Calendar Year 2019, 6612 2018-03075 Indian Gaming: Extension of Tribal-State Class III Gaming Compact (Rosebud Sioux Tribe and State of South Dakota), 6613 2018-03072 Proclaiming Certain Lands as Reservations: Nottawaseppi Huron Band of Potawatomi, 6612-6613 2018-03076 Indian Health Indian Health Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Indian Health Service Information Security Ticketing and Incident Reporting, 6600-6601 2018-03018 Indian Health Service Loan Repayment Program, 6601-6602 2018-03019 Industry Industry and Security Bureau NOTICES Denials of Export Privileges: Justin Gage Jangraw, 6510-6511 2018-03071 Interior Interior Department See

Indian Affairs Bureau

NOTICES Meetings: Royalty Policy Committee, 6613 2018-02939
International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Pasta from Turkey, 6516-6518 2018-02899 Oil Country Tubular Goods from Republic of Turkey, 6511-6513 2018-02898 Wooden Bedroom Furniture from the People's Republic of China, 6515-6516 2018-02896 Xanthan Gum from the People's Republic of China, 6513-6515 2018-02915 International Trade Com International Trade Commission NOTICES Complaints: Certain Digital Video Receivers and Related Hardware and Software Components, 6613-6614 2018-03092 Justice Department Justice Department See

Foreign Claims Settlement Commission

National Agricultural National Agricultural Statistics Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 6508-6509 2018-02940 National Council National Council on Disability NOTICES Meetings; Sunshine Act, 6615 2018-03196 National Foundation National Foundation on the Arts and the Humanities NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 6615-6616 2018-02941 National Highway National Highway Traffic Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Reports, Forms, and Record Keeping Requirements, 6730-6731 2018-03028 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 6603-6604 2018-02948 National Heart, Lung, and Blood Institute, 6602 2018-02949 National Institute of Arthritis and Musculoskeletal and Skin Diseases, 6603 2018-02950 2018-02951 National Institute of General Medical Sciences, 6602-6603 2018-02952 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Pacific Cod in Bering Sea Subarea of Bering Sea and Aleutian Islands Management Area, 6473-6474 2018-03087 Fisheries Off West Coast States: Coastal Pelagic Species Fisheries; Amendment 16 to the Coastal Pelagic Species Fishery Management Plan, 6472-6473 2018-03040 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 6518 2018-02947 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Documentation of Fish Harvest, 6520-6521 2018-02946 Meetings: Advisory Committee to United States Delegation to International Commission for Conservation of Atlantic Tunas, 6520 2018-03081 Fisheries of South Atlantic; Southeast Data, Assessment, and Review, 6521-6522 2018-03015 Hydrographic Services Review Panel, 6518-6519 2018-02968 Mid-Atlantic Fishery Management Council, 6522 2018-03016 Requests for Nominations: Hydrographic Services Review Panel, 6519-6520 2018-02969 Takes of Marine Mammals Incidental to Specified Activities: U.S. Navy 2018 Ice Exercise Activities in Beaufort Sea and Arctic Ocean, 6522-6532 2018-03080 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 6616-6619 2018-03002 National Resources Natural Resources Conservation Service NOTICES Deauthorization of Federal Funding: South Branch Potomac River Subwatershed of Potomac River Watershed, Highland County, VA, and Pendleton and Grant Counties, WV, 6509 2018-02944 Navy Navy Department RULES Certifications and Exemptions under International Regulations for Preventing Collisions at Sea, 6458 C1--2018--02554 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 6535 2018-03062 Nuclear Regulatory Nuclear Regulatory Commission PROPOSED RULES Disposal of Greater-than-Class C and Transuranic Waste: Public Meeting, 6475-6477 2018-03085 NOTICES License Amendment Applications: Florida Power and Light Co., St. Lucie Plant, Unit Nos. 1 and 2, 6621-6624 2018-03003 Very Low-Level Radioactive Waste Scoping Study, 6619-6621 2018-03083 Patent Patent and Trademark Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Medal of Technology and Innovation Nomination Application, 6534-6535 2018-02989 Patent Prosecution Highway Program, 6532-6533 2018-02988 Postal Regulatory Postal Regulatory Commission PROPOSED RULES Competitive Postal Products, 6758-6788 2018-02932 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Cboe BZX Exchange, Inc., 6664-6665 2018-02975 Cboe C2 Exchange, Inc., 6650-6651 2018-02980 Cboe Exchange, Inc., 6662-6663 2018-02979 Depository Trust Co., 6624-6627, 6629-6630, 6639-6646, 6653-6654 2018-02977 2018-02978 2018-02982 2018-02983 2018-02984 Fixed Income Clearing Corp., 6654-6660 2018-02985 ICE Clear Europe, Ltd., 6660-6662 2018-02974 Miami International Securities Exchange, LLC, 6630-6633 2018-02986 Nasdaq ISE, LLC, 6626 2018-02981 National Securities Clearing Corp., 6633-6639 2018-02987 NYSE Arca, Inc., 6627-6629 2018-02976 Options Clearing Corp., 6646-6653 2018-02972 2018-02973 Small Business Small Business Administration NOTICES Surrender of Licenses of Small Business Investment Companies: Eagle Fund I, LP, 6666 2018-03088 First New England Capital, LP, 6665 2018-03089 Social Social Security Administration NOTICES Privacy Act; Matching Programs, 6666-6667 2018-02956 State Department State Department RULES International Traffic in Arms: South Sudan, 6457-6458 2018-02995 NOTICES Meetings: United States-Morocco Free Trade Agreement Environment Chapter Implementation, Working Group on Environmental Cooperation, and Public Session, 6667-6668 2018-03117 Tennessee Tennessee Valley Authority NOTICES Environmental Impact Statements; Availability, etc.:, 6668-6669 2018-03027 Meetings; Sunshine Act, 6669-6670 2018-03138 Trade Representative Trade Representative, Office of United States NOTICES Procedures to Consider Additional Requests for Exclusion of Particular Products from Solar Products Safeguard Measure, 6670-6672 2018-03048 Transportation Department Transportation Department See

Federal Aviation Administration

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Federal Motor Carrier Safety Administration

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National Highway Traffic Safety Administration

Treasury Treasury Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 6732-6737 2018-02954 2018-03052 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Terrorism Risk Insurance Program, 6731-6732 2018-03086 Separate Parts In This Issue Part II Corporation for National and Community Service, 6740-6756 2018-01462 Part III Postal Regulatory Commission, 6758-6788 2018-02932 Reader Aids

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83 31 Wednesday, February 14, 2018 Rules and Regulations DEPARTMENT OF AGRICULTURE 7 CFR Part 800 Fees for Official Inspection and Official Weighing Services Under the United States Grain Standards Act (USGSA) AGENCY:

Agricultural Marketing Service, GIPSA, USDA.

ACTION:

Final rule.

SUMMARY:

USDA, on behalf of the Agricultural Marketing Service (AMS) is announcing the fee schedule for official inspection and weighing services performed under the United States Grain Standards Act (USGSA), as amended, in order to comply with FGIS regulations and the Agriculture Reauthorizations Act of 2015, and publishing the annual review of Schedule A fees calculation and the resulting fees that went into effect on January 1, 2018.

DATES:

Effective February 14, 2018.

ADDRESSES:

Submit comments or notice of intent to submit comments by any of the following methods:

Postal Mail: Please send your comment addressed to Kendra Kline, AMS, USDA, 1400 Independence Avenue SW, Room 2043-S, Washington, DC 20250-3614.

Hand Delivery or Courier: Kendra Kline, AMS, USDA, 1400 Independence Avenue SW, Room 2043-S, Washington, DC 20250-3614.

Internet: Go to http://www.regulations.gov. Follow the on-line instructions for submitting comments.

FOR FURTHER INFORMATION CONTACT:

Denise Ruggles, FGIS Executive Program Analyst, USDA AMS; Telephone: (816) 659-8406; Email: [email protected]

SUPPLEMENTARY INFORMATION:

USGSA authorizes the Secretary of Agriculture to provide official grain inspection and weighing services and to charge and collect reasonable fees for performing these services. The fees collected are to cover, as nearly as practicable, costs for performing these services, including associated administrative and supervisory costs. The fees are in the regulations at 7 CFR 800.71.

On December 30, 2016, Grain Inspection, Packers and Stockyards Administration (GIPSA) published in the Federal Register (81 FR 96339) a final rule amending 7 CFR 800.71 in accordance with the Reauthorizations Act of 2015, which requires Federal Grain Inspection Service (FGIS) to conduct an annual review of the fees and operating reserve for the purposes of the annual adjustment of the fees.

GIPSA/AMS Merger

The Secretary delegated to the Under Secretary for Marketing and Regulatory Programs (MRP) authorities “related to grain inspection, packers and stockyards.” 7 CFR 2.22(a)(3)(i)-(vi). In 7 CFR 2.81, the Under Secretary for MRP further delegated these authorities to the Administrator of GIPSA. In a November 14, 2017 Secretary's Memorandum, the Secretary directed that the authorities at 7 CFR 2.81 be re-delegated to the Administrator of AMS, and that the delegations to the Administrator of GIPSA be revoked. The delegations to the Under Secretary of MRP related to grain inspection, packers and stockyards at 7 CFR 2.22(a)(3) remain unchanged. As part of the reorganization, GIPSA (and FGIS) were merged into AMS.

Exemption From Notice and Comment

In publishing this final rule, we are dispensing with the usual notice of proposed rulemaking and public comment procedures contained in 5 U.S.C. 553. We have determined that, under 5 U.S.C. 553(b)(3)(B), good cause exists for dispensing with the notice of proposed rulemaking and public comment procedures for this rule. Specifically the rulemaking comports with and is consistent with the statutory adjustment of fees in section 7 of the USGSA (7 U.S.C. 79(j)) and the regulations at 7 CFR 800.71 with no issue of policy discretion. Accordingly, we have determined that opportunity for prior comment is unnecessary and contrary to the public interest, and we are issuing this revised regulation as a final rule that will apply to all national tonnage fees, local tonnage fees, and fees for service in 2018.

Fee Calculations

The regulations require FGIS annually review the national tonnage fees, local tonnage fees, and fees for service. After calculating the tonnage fees according to the regulatory formula in section 800.71(b)(1), FGIS then reviews the amount of funds in the operating reserve at the end of the fiscal year (FY2017 in this case) to ensure that it has 41/2 months of operating expenses as required by section 800.71(b)(2) of the regulations. If the operating reserve has more, or less than 41/2 months of operating expenses, then FGIS must adjust all Schedule A fees. For each $1,000,000, rounded down, that the operating reserve varies from the target of 4 1/2 months, FGIS will adjust all Schedule A fees by 2 percent. If the operating reserve exceeds the target, all Schedule A fees will be reduced. If the operating reserve does not meet target, all Schedule A fees will be increased. The maximum annual increase or decrease in fees is 5 percent (7 CFR 800.71(b)(2)(i)-(ii)).

(a) Tonnage fees for the 5-year rolling average tonnage were calculated on the previous 5 fiscal years 2013, 2014, 2015, 2016 and 2017. Tonnage fees consist of the national tonnage fee and local tonnage fee and are calculated and rounded to the nearest $0.001 per metric ton. The tonnage fees are calculated as following:

(1) National tonnage fee. The national tonnage fee is the national program administrative costs for the previous fiscal year divided by the average yearly tons of export grain officially inspected and/or weighed by delegated States and designated agencies, excluding land carrier shipments to Canada and Mexico, and outbound grain officially inspected and/or weighed by FGIS during the previous 5 fiscal years.

ER14FE18.012 Fiscal year Metric tons 2013* 81,207,695 2014 117,560,767 2015 118,758,937 2016 122,330,979 2017 135,017,935 5-year Rolling Average 114,975,263 * To provide uniformity in the 5-year Rolling Average calculation, fiscal year 2013 include tons of export grain officially inspected and/or weighed by delegated States and designated agencies prior to the implementation of the fee assessment in the Federal Register (78 FR 22151), effective May 1, 2013.

The national program administrative costs for fiscal year 2017 were $6,906,527. The fiscal year 2018 national tonnage fee, prior to the operating reserve review, is calculated to be at $0.060 per metric ton.

(2) Local tonnage fee. The local tonnage fee is the field office administrative costs for the previous fiscal year divided by the average yearly tons of outbound grain officially inspected and/or weighed by the field office during the previous 5 fiscal years.

ER14FE18.013

The field offices fiscal year tons for the previous 5 fiscal years and calculated 5-year rolling average are as follows:

Field office FY 2013 FY 2014 FY 2015 FY 2016 FY 2017 5-year Rolling Average New Orleans 42,399,760 62,862,914 65,244,517 66,077,535 70,439,862 61,404,918 League City 10,418,686 12,623,510 12,474,343 12,581,236 13,307,780 12,281,111 Portland 3,953,500 6,065,934 4,111,533 4,645,754 5,175,459 4,790,436 Toledo 1,329,718 1,802,339 2,484,604 2,030,506 2,229,920 1,975,417

The local field office administrative costs for fiscal year 2017 and the fiscal year 2018 calculated local field office tonnage fee, prior to the operating reserve review, are as follows:

Field office FY 2017 Local administrative costs Calculated
  • FY 2018
  • local
  • tonnage fee
  • New Orleans $1,722,327 $0.028 League City 800,539 0.065 Portland 409,115 0.085 Toledo 349,374 0.177

    (3) Operating reserve. In order to maintain an operating reserve not less than 3 and not more than 6 months, FGIS reviewed the value of the operating reserve at the end of FY2017 to ensure that an operating reserve of 41/2 months is maintained.

    The program operating reserve at the end of fiscal year 2017 was $23,546,619 with a monthly operating expense of $3,340,024. The target of 4.5 months of operating reserve is $15,030,108 therefore the operating reserve is greater than 4.5 times the monthly operating expenses by $8,516,511. For each $1,000,000, rounded down, above the target level, all Schedule A fees must be reduced by 2 percent. The operating reserve is $8.5 million above the target level resulting in a calculated 16 percent reduction. As required by 800.71(b)(2)(ii), the reduction is limited to 5 percent. Therefore, FGIS is reducing all Schedule A fees for service in Schedule A in paragraph (a)(1) by the maximum 5 percent. All Schedule A fees for service are rounded to the nearest $0.10, except for fees based on tonnage or hundredweight.

    Executive Orders 12866 and 13563

    The Office of Management and Budget (OMB) has reviewed this regulatory action in accordance with the provisions of Executive Order 12866, Regulatory Planning and Review, and has determined that it does not meet the criteria for significant regulatory action. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Guidance Implementing Executive Order 13771, Titled “Reducing Regulation and Controlling Regulatory Costs”” (April 5, 2017).

    Regulatory Flexibility Act

    Since grain export volume can vary significantly from year to year, estimating the total impact in any single year can be difficult. AMS recognizes, however, that the industry needs predictable inspection and weighing fees. The regulations at 7 CFR 800.71(b) set an annual cap of 5 percent for increases or decreases in inspection and weighing fees, and the increases and decreases are fixed according the statutory requirements of the Agriculture Reauthorization Act of 2015. This rulemaking is unlikely to have an annual effect of $100 million or more or adversely affect a significant number of small entities.

    The provisions of the Regulatory Flexibility Act relating to an initial and final regulatory flexibility analysis (5 U.S.C. 603, 604) are not applicable to this final rule because USDA was not required to publish notice of proposed rulemaking under 5 U.S.C. 553 or any other law. Accordingly, a regulatory flexibility analysis is not required.

    Paperwork Reduction Act

    This final rule imposes no new reporting or recordkeeping requirements necessitating clearance by OMB.

    List of Subjects in 7 CFR Part 800

    Administrative practice and procedure, Exports, Grains, Reporting and recordkeeping requirements.

    For the reasons set out in the preamble, USDA amends 7 CFR part 800 as follows:

    PART 800—GENERAL REGULATIONS 1. The authority citation for part 800 continues to read as follows: Authority:

    7 U.S.C. 71-87k.

    2. Section 800.71(a)(1) is amended by revising Tables 1, 2, and 3 of Schedule A to read as follows:
    § 800.71 Fees assessed by the Service.

    (a) * * *

    (1) * * *

    Table 1 of Schedule A—Fees for Official Services Performed at an Applicant's Facility in an Onsite FGIS Laboratory 1 Monday to
  • Friday
  • (6 a.m. to
  • 6 p.m.)
  • Monday to
  • Friday
  • (6 p.m. to
  • 6 a.m.)
  • Saturday,
  • Sunday, and
  • overtime 2
  • Holidays
    (i) Inspection and Weighing Services Hourly Rates (per service representative): 1-year contract ($ per hour) $36.30 $38.00 $43.50 $64.40 Noncontract ($ per hour) 64.40 64.40 64.40 64.40 (ii) Additional Tests (cost per test, assessed in addition to the hourly rate): 3 (A) Aflatoxin (rapid test kit method) 10.30 (B) Aflatoxin (rapid test kit method-applicant provides kit) 4 8.50 (C) All other Mycotoxins (rapid test kit method) 18.80 (D) All other Mycotoxins (rapid test kit method-applicant provides kit) 4 17.00 (E) NIR or NMR Analysis (protein, oil, starch, etc.) 2.50 (F) Waxy corn (per test) 2.50 (G) Fees for other tests not listed above will be based on the lowest noncontract hourly rate (H) Other services (1) Class Y Weighing (per carrier): (i) Truck/container 0.70 (ii) Railcar 1.50 (iii) Barge 2.80 (iii) Tonnage Fee (assessed in addition to all other applicable fees, only one tonnage fee will be assessed when inspection and weighing services are performed on the same carrier): (A) All outbound carriers serviced by the specific Field Office (per-metric ton): (1) League City 0.119 (2) New Orleans 0.084 (3) Portland 0.138 (4) Toledo 0.225 (5) Delegated States 5 0.057 (6) Designated Agencies 5 0.057 1 Fees apply to original inspection and weighing, re-inspection, and appeal inspection service and include, but are not limited to, sampling, grading, weighing, prior to loading stowage examinations, and certifying results performed within 25 miles of an employee's assigned duty station. Travel and related expenses will be charged for service outside 25 miles as found in § 800.72(a). 2 Overtime rates will be assessed for all hours in excess of 8 consecutive hours that result from an applicant scheduling or requesting service beyond 8 hours, or if requests for additional shifts exceed existing staffing. 3 Appeal and re-inspection services will be assessed the same fee as the original inspection service. 4 Applicant must provide the test kit, instrument hardware, calibration control, and all supplies required by the test kit manufacturer. 5 Tonnage fee is assessed on export grain inspected and/or weighed, excluding land carrier shipments to Canada and Mexico.
    Table 2 of Schedule A—Services Performed at Other Than an Applicant's Facility in an FGIS Laboratory 1 2 (i) Original Inspection and Weighing (Class X) Services: (A) Sampling only (use hourly rates from Table 1 of this section) (B) Stationary lots (sampling, grade/factor, & check loading): (1) Truck/trailer/container (per carrier) $20.30 (2) Railcar (per carrier) 30.00 (3) Barge (per carrier) 188.70 (4) Sacked grain (per hour per service representative plus an administrative fee per hundredweight) (CWT) 0.07 (C) Lots sampled online during loading (sampling charge under (1)(i) of this table, plus): (1) Truck/trailer container (per carrier) 12.20 (2) Railcar (per carrier) 25.40 (3) Barge (per carrier) 129.10 (4) Sacked grain (per hour per service representative plus an administrative fee per hundredweight) (CWT) 0.07 (D) Other services: (1) Submitted sample (per sample—grade and factor) 12.20 (2) Warehouseman inspection (per sample) 21.30 (3) Factor only (per factor—maximum 2 factors) 6.00 (4) Check loading/condition examination (use hourly rates from Table 1 of this section, plus an administrative fee per hundredweight if not previously assessed) (CWT) 0.07 (5) Re-inspection (grade and factor only. Sampling service additional, item (1)(i) of this table) 13.20 (6) Class X Weighing (per hour per service representative) 64.40 (E) Additional tests (excludes sampling): (1) Aflatoxin (rapid test kit method) 30.30 (2) Aflatoxin (rapid test kit method—applicant provides kit) 3 28.50 (3) All other Mycotoxins (rapid test kit method) 39.00 (4) All other Mycotoxins (rapid test kit method—applicant provides kit) 3 37.10 (5) NIR or NMR Analysis (protein, oil, starch, etc.) 10.30 (6) Waxy corn (per test) 10.30 (7) Canola (per test-00 dip test) 10.30 (8) Pesticide Residue Testing: 4 (i) Routine Compounds (per sample) 217.50 (ii) Special Compounds (Subject to availability) 115.90 (9) Fees for other tests not listed above will be based on the lowest noncontract hourly rate from Table 1 of this section (ii) Appeal inspection and review of weighing service: 5 (A) Board Appeals and Appeals (grade and factor) 82.60 (1) Factor only (per factor—max 2 factors) 43.50 (2) Sampling service for Appeals additional (hourly rates from Table 1 of this section) (B) Additional tests (assessed in addition to all other applicable tests): (1) Aflatoxin (rapid test kit method) 30.30 (2) Aflatoxin (rapid test kit method—applicant provides kit) 3 28.30 (3) All other Mycotoxins (rapid test kit method) 47.50 (4) All other Mycotoxins (rapid test kit method—applicant provides kit) 3 45.70 (5) NIR or NMR Analysis (protein, oil, starch, etc.) 17.90 (6) Sunflower oil (per test) 17.90 (7) Mycotoxin (per test-HPLC) 141.90 (8) Pesticide Residue Testing: 4 (i) Routine Compounds (per sample) 217.50 (ii) Special Compounds (Subject to availability) 115.90 (9) Fees for other tests not listed above will be based on the lowest noncontract hourly rate from Table 1 of this section (C) Review of weighing (per hour per service representative) 83.30 (iii) Stowage examination (service-on-request): 4 (A) Ship (per stowage space) (minimum $257.50 per ship) 51.50 (B) Subsequent ship examinations (same as original) (minimum $154.50 per ship) 51.50 (C) Barge (per examination) 41.30 (D) All other carriers (per examination) 16.20 1 Fees apply to original inspection and weighing, re-inspection, and appeal inspection service and include, but are not limited to, sampling, grading, weighing, prior to loading stowage examinations, and certifying results performed within 25 miles of an employee's assigned duty station. Travel and related expenses will be charged for service outside 25 miles as found in § 800.72(a). 2 An additional charge will be assessed when the revenue from the services in Schedule A, Table 2, does not cover what would have been collected at the applicable hourly rate as provided in § 800.72(b). 3 Applicant must provide the test kit, instrument hardware, calibration control, and all supplies required by the test kit manufacturer. 4 If performed outside of normal business, 11/2 times the applicable unit fee will be charged. 5 If, at the request of the Service, a file sample is located and forwarded by the Agency, the Agency may, upon request, be reimbursed at the rate of $3.50 per sample by the Service. Table 3 of Schedule A—Miscellaneous Services 1 (i) Grain grading seminars (per hour per service representative) 2 $64.40 (ii) Certification of diverter-type mechanical samplers (per hour per service representative) 2 64.40 (iii) Special weighing services (per hour per service representative):2 (A) Scale testing and certification 83.90 (B) Scale testing and certification of railroad track scales 83.90 (C) Evaluation of weighing and material handling systems 83.90 (D) NTEP Prototype evaluation (other than Railroad Track Scales) 83.90 (E) NTEP Prototype evaluation of Railroad Track Scale 83.90 (F) Use of FGIS railroad track scale test equipment per facility for each requested service. (Track scales tested under the Association of American Railroads agreement are exempt.) 502.90 (G) Mass standards calibration and re-verification 83.90 (H) Special projects 83.90 (iv) Foreign travel (hourly fee) 3 83.90 (v) Online customized data service: (A) One data file per week for 1 year 502.90 (B) One data file per month for 1 year 301.80 (v) Samples provided to interested parties (per sample) 3.10 (vi) Divided-lot certificates (per certificate) 2.00 (vii) Extra copies of certificates (per certificate) 2.00 (viii) Faxing (per page) 2.00 (ix) Special mailing Actual Cost (x) Preparing certificates onsite or during other than normal business hours (use hourly rates from Table 1). 1 Any requested service that is not listed will be performed at $64.40 per hour. 2 Regular business hours—Monday through Friday—service provided at other than regular business hours will be charged at 1-1/2 times the applicable hourly rate. (See the definition of “business day” in § 800.0(b)) 3 Foreign travel charged hourly fee of $83.90 plus travel, per diem, and related expenditures.
    Dated: February 8, 2018. Greg Ibach, Under Secretary, Marketing and Regulatory Programs.
    [FR Doc. 2018-02884 Filed 2-13-18; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-0658; Product Identifier 2017-NE-20-AD; Amendment 39-19195; AD 2018-03-22] RIN 2120-AA64 Airworthiness Directives; GE Aviation Czech s.r.o. Turboprop Engines AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for GE Aviation Czech s.r.o. M601D-11, M601E-11, M601E-11A, M601E-11AS, M601E-11S, and M601F turboprop engines. This AD requires removal of certain power turbine (PT) disks installed on the affected engines. This AD was prompted by a design review by the manufacturer that determined PT rotors with certain disks have less overspeed margin than originally stated during product certification. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective March 21, 2018.

    ADDRESSES:

    For service information identified in this final rule, contact GE Aviation Czech s.r.o., Beranových 65, 199 02 Praha 9—Letňany, Czech Republic; phone: +420 222 538 111; fax: +420 222 538 222. You may view this service information at the FAA, Engine & Propeller Standards Branch, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7759.

    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-2017-0658; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the mandatory continuing airworthiness information (MCAI), the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Document Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Robert Green, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7754; fax: 781-238-7199; email: [email protected].

    SUPPLEMENTARY INFORMATION: Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to GE Aviation Czech s.r.o. M601D-11, M601E-11, M601E-11A, M601E-11AS, M601E-11S, and M601F turboprop engines. The NPRM published in the Federal Register on September 22, 2017 (82 FR 44355). The NPRM was prompted by a design review by the manufacturer that determined PT rotors with certain disks have less overspeed margin than originally stated during product certification. The NPRM proposed to require removal of the affected PT disks. We are issuing this AD to correct the unsafe condition on these products.

    The MCAI states:

    It was identified during a recent design review that power turbine (PT) rotors with certain disks, part number (P/N) M601-3220.6 and P/N M601-3220.7, have a reduction in the declared theoretical PT rotor overspeed limit.

    This condition, if not corrected, may lead to high energy debris release in case of PT rotor overspeed occurrence, possibly resulting in damage to, and/or reduced control of, the aeroplane.

    You may obtain further information by examining the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0658.

    Comments

    We gave the public the opportunity to participate in developing this final rule. We considered the comment received. Cody Hargis (not further identified) supported the NPRM.

    Conclusion

    We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this final rule as proposed.

    Related Service Information

    We reviewed GE Aviation Czech s.r.o. Alert Service Bulletin (ASB) No. ASB-M601E-72-50-00-0069, ASB-M601D-72-50-00-0052, ASB-M601F-72-50-00-0035, ASB-M601T-72-50-00-0028, and ASB-M601Z-72-50-00-0038, (single document), dated February 21, 2017. The ASB describe procedures for replacing the PT disk.

    Costs of Compliance

    We estimate that this AD affects 50 engines installed on airplanes of U.S. registry.

    We estimate the following costs to comply with this AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S. operators
    Disk removal and replacement 56 work-hours × $85 per hour = $4,760 $6,989 $11,749 $587,450
    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.

    This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.

    Regulatory Findings

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

    For the reasons discussed above, I certify this AD:

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [ Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2018-03-22 GE Aviation Czech s.r.o. (Type Certificate previously held by WALTER Engines a.s., Walter a.s., and MOTORLET a.s.): Amendment 39-19195; Docket No. FAA-2017-0658; Product Identifier 2017-NE-20-AD. (a) Effective Date

    This AD is effective March 21, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to GE Aviation Czech s.r.o. M601D-11, M601E-11, M601E-11A, M601E-11AS, M601E-11S, and M601F turboprop engines, with power turbine (PT) rotors with disks, part number (P/N) M601-3220.6 or P/N M601-3220.7, installed.

    (d) Subject

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

    (e) Unsafe Condition

    This AD was prompted by a review by the manufacturer that determined that PT rotors with disks, P/N M601-3220.6 or P/N M601-3220.7, have less overspeed margin than originally declared during product certification. We are issuing this AD to prevent failure of the PT rotor. The unsafe condition, if not addressed, could result in failure of the PT rotor, uncontained release of the PT disk, 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

    After the effective date of this AD, remove the affected PT disk from service during the next engine overhaul or rebuild, or within 5 years, whichever occurs first.

    (h) Installation Prohibition

    After the effective date of this AD, do not install an affected PT disk on any engine.

    (i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve AMOCs for this AD if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j)(1) of this AD. You may email your request to: [email protected]

    (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (j) Related Information

    (1) For more information about this AD, contact Robert Green, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7754; fax: 781-238-7199; email: [email protected]

    (2) Refer to MCAI European Aviation Safety Agency AD 2017-0100, dated June 8, 2017, for more information. You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2017-0658.

    (k) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on February 8, 2018. Robert J. Ganley, Manager, Engine and Propeller Standards Branch, Aircraft Certification Service.
    [FR Doc. 2018-02994 Filed 2-13-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF STATE 22 CFR Part 126 [Public Notice 10306] RIN 1400-AE51 Amendment to the International Traffic in Arms Regulations: Addition of South Sudan AGENCY:

    Department of State.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of State is amending the International Traffic in Arms Regulations (ITAR) to include reference to South Sudan in its regulations on prohibited exports, imports, and sales to and from certain countries, and to update defense trade policy toward South Sudan by applying a policy of denial on the export of defense articles and defense services to South Sudan, except as otherwise provided. This amendment reflects a policy determination made by the Secretary of State.

    DATES:

    The rule is effective on February 14, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Engda Wubneh, Foreign Affairs Officer, Office of Defense Trade Controls Policy, U.S. Department of State, telephone: (202) 663-2816, or email [email protected] ATTN: Regulatory Change, ITAR Section 126.1 Update 2017.

    SUPPLEMENTARY INFORMATION:

    In response to the escalating crisis in South Sudan, the Secretary of State has determined that it is in the best interests of U.S. foreign policy to restrict, with certain exceptions, the export of defense articles and defense services to South Sudan in order to reflect the U.S. government's opposition to the trade of arms to South Sudan and its contribution to the conflict and humanitarian crisis, to promote the cessation of hostilities, and to reinforce international unity in addressing the South Sudan crisis by aligning the United States with existing restrictions on certain exports to South Sudan by the European Union. This action requires the Department to amend ITAR § 126.1(d)(2) to include South Sudan in the list of countries to which a policy of denial applies, and to add a new paragraph (w) to specify the exceptions to the policy of denial for which licenses and other approvals to South Sudan may be approved on a case-by-case basis. Further, in accordance with ITAR § 129.7, no broker, as described in ITAR § 129.2, may engage in or make a proposal to engage in brokering activities subject to the ITAR that involve South Sudan without first obtaining the approval of the Directorate of Defense Trade Controls.

    Regulatory Analysis and Notices Administrative Procedure Act

    The Department of State is of the opinion that controlling the import and export of defense articles and services is a foreign affairs function of the United States Government and that rules implementing this function are exempt from sections 553 (rulemaking) and 554 (adjudications) of the Administrative Procedure Act. Since this rule is exempt from 5 U.S.C. 553, the provisions of § 553(d) do not apply to this rulemaking. Therefore, this rule is effective upon publication. The Department also finds that, given the national security issues surrounding U.S. policy towards the aforementioned countries, there is good cause for the effective date of this rule to be the date of publication, as provided by 5 U.S.C. 553(d)(3).

    Regulatory Flexibility Act

    Since this rule is exempt from the provisions of 5 U.S.C. 553, there is no requirement for an analysis under the Regulatory Flexibility Act.

    Unfunded Mandates Reform Act of 1995

    This rulemaking does not involve a mandate that will result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

    Small Business Regulatory Enforcement Fairness Act of 1996

    The Department does not believe this rulemaking is a major rule within the definition of 5 U.S.C. 804.

    Executive Orders 12372 and 13132

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

    Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributed impacts, and equity). These executive orders stress the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Because the scope of this rule implements a governmental policy limiting defense trade with a country, and does not impose additional regulatory requirements or obligations, the Department believes costs associated with this rule will be minimal. The Department also finds that any costs of this rulemaking are outweighed by the foreign policy benefits, as described in the preamble. This rule has not been designated a “significant regulatory action” by the Office and Information and Regulatory Affairs under Executive Order 12866.

    Executive Order 12988

    The Department of State reviewed this rulemaking in light of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

    Executive Order 13175

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

    Executive Order 13771

    The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs.” See OMB Memorandum M-17-21, “Guidance Implementing Executive Order 13771” of April 5, 2017.

    Paperwork Reduction Act

    This rule does not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35.

    List of Subjects in 22 CFR Part 126

    Arms and munitions, Exports.

    Accordingly, for the reasons set forth above, 22 CFR part 126 is amended as follows:

    PART 126—GENERAL POLICIES AND PROVISIONS 1. The authority citation for part 126 continues to read as follows: Authority:

    Secs. 2, 38, 40, 42, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2780, 2791, and 2797); 22 U.S.C. 2651a; 22 U.S.C. 287c; E.O. 12918, 59 FR 28205; 3 CFR, 1994 Comp., p. 899; Sec. 1225, Pub. L. 108-375; Sec. 7089, Pub. L. 111-117; Pub. L. 111-266; Sections 7045 and 7046, Pub. L. 112-74; E.O. 13637, 78 FR 16129.

    2. Section 126.1 is amended by revising the table in paragraph (d)(2), and adding paragraph (w), and by removing the Note to 126.1.

    The revision and addition read as follows:

    § 126.1 Prohibited exports, imports, and sales to or from certain countries.

    (d) * * *

    (2) * * *

    Country Country specific paragraph location Afghanistan See also paragraph (g) of this section. Central African Republic See also paragraph (u) of this section. Cyprus See also paragraph (r) of this section. Democratic Republic of Congo See also paragraph (i) of this section. Eritrea See also paragraph (h) of this section. Haiti See also paragraph (j) of this section. Iraq See also paragraph (f) of this section. Lebanon See also paragraph (t) of this section. Libya See also paragraph (k) of this section. Somalia See also paragraph (m) of this section. South Sudan See also paragraph (w) of this section. Sudan See also paragraph (v) of this section. Zimbabwe See also paragraph (s) of this section.

    (w) South Sudan. It is the policy of the United States to deny licenses or other approvals for exports of defense articles and defense services destined for South Sudan, except that a license or other approval may be issued, on a case-by-case basis, for:

    (1) Defense articles and defense services for monitoring, verification, or peacekeeping support operations, including those authorized by the United Nations or operating with the consent of the relevant parties;

    (2) Defense articles and defense services intended solely for the support of, or use by, African Union Regional Task Force (AU-RTF) or United Nations entities operating in South Sudan, including but not limited to the United Nations Mission in the Republic of South Sudan (UNMISS), the United Nations Mine Action Service (UNMAS), the United Nations Police (UNPOL), or the United Nations Interim Security Force for Abyei (UNISFA);

    (3) Defense articles and defense services intended solely for the support of or use by non-governmental organizations in furtherance of conventional weapons destruction or humanitarian demining activities;

    (4) Non-lethal defense articles intended solely for humanitarian or protective use and related technical training and assistance;

    (5) Personal protective equipment including flak jackets and helmets, temporarily exported to South Sudan by United Nations personnel, human rights monitors, representatives of the media, and humanitarian and development workers and associated personnel, for their personal use only; or

    (6) Any defense articles and defense services provided in support of implementation of the Comprehensive Peace Agreement, the Agreement on the Resolution of the Conflict in the Republic of South Sudan, or any successor agreement.

    Michael Miller, Office Director, Office of Regional Security and Arms Transfers, Bureau of Political-Military Affairs, U.S. Department of State.
    [FR Doc. 2018-02995 Filed 2-13-18; 8:45 am] BILLING CODE 4710-25-P
    DEPARTMENT OF DEFENSE Department of the Navy 32 CFR Part 706 Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972 Correction

    In rule document 2018-02554 appearing on pages 5536-5537 in the issue of February 8, 2018, make the following correction:

    § 706 .2 [Corrected]
    On page 5537, in Table Four, in the second column, “DDG 115” should read “DDG 116”.
    [FR Doc. C1-2018-02554 Filed 2-13-18; 8:45 am] BILLING CODE 1301-00-P
    DEPARTMENT OF EDUCATION 34 CFR Parts 668, 674, 682, and 685 [Docket ID ED-2017-OPE-0112] RIN 1840-AD28 Student Assistance General Provisions, Federal Perkins Loan Program, Federal Family Education Loan Program, William D. Ford Federal Direct Loan Program, and Teacher Education Assistance for College and Higher Education Grant Program AGENCY:

    Office of Postsecondary Education, Department of Education.

    ACTION:

    Final regulations.

    SUMMARY:

    The Secretary delays, until July 1, 2019, the effective date of selected provisions of the final regulations entitled Student Assistance General Provisions, Federal Perkins Loan Program, Federal Family Education Loan (FFEL) Program, William D. Ford Federal Direct Loan Program, and Teacher Education Assistance for College and Higher Education Grant Program (the 2016 final regulations), published in the Federal Register on November 1, 2016. The Secretary is delaying the 2016 final regulations to ensure that there is adequate time to conduct negotiated rulemaking and develop revised regulations. The provisions for which the effective date is being delayed are listed in the SUPPLEMENTARY INFORMATION section of this document. The original effective date of the 2016 final regulations, published November 1, 2016, was July 1, 2017. The effective date was delayed by a document issued under section 705 of the Administrative Procedure Act (the 705 Document). The Department announced in an interim final rule (IFR) issued on October 24, 2017, that, under the Department's interpretation of the Higher Education Act, the effective date could be no earlier than July 1, 2018.

    DATES:

    As of February 14, 2018, the effective date for the amendments to or additions of: §§ 668.14(b)(30), (31), and (32); 668.41(h) and (i); 668.71(c); 668.90(a)(3); 668.93(h), (i), (j); 668.171; 668.175 (c) and (d) and (f) and (h); Appendix C to Subpart L of Part 668; 674.33(g)(3) and (g)(8); 682.202(b)(1); 682.211(i)(7); 682.402(d)(3), (d)(6)(ii)(B)(1) and (2), (d)(6)(ii)(F) introductory text, (d)(6)(ii)(F)(5), (d)(6)(ii)(G), (d)(6)(ii)(H) through (K), (d)(7)(ii) and (iii), (d)(8), and (e)(6)(iii); 682.405(b)(4); 682.410(b)(4) and (b)(6)(viii); 685.200(f)(3)(v) and (f)(4)(iii); 685.205(b)(6); 685.206(c); 685.212(k); 685.214(c)(2), (f)(4) through (7); 685.215(a)(1), (c)(1) through (c)(8), and (d); 685.222; Appendix A to Subpart B of Part 685; and 685.308(a), published November 1, 2016, at 81 FR 75926, and delayed on June 16, 2017 (82 FR 27621) and October 24, 2017 (82 FR 49114), is further delayed until July 1, 2019.

    FOR FURTHER INFORMATION CONTACT:

    George Alan Smith, U.S. Department of Education, 400 Maryland Ave. SW, Mail Stop 294-34, Washington, DC 20202. Telephone: (202) 453-7757 or by email at: [email protected]

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

    SUPPLEMENTARY INFORMATION:

    On October 24, 2017 (82 FR 49114), the Department of Education (Department) published an IFR giving notice that under its interpretation of section 482 of the Higher Education Act of 1965, as amended (HEA) (20 U.S.C. 1089), also known as the “master calendar requirement,” selected provisions of the 2016 final regulations would have an effective date of July 1, 2018. (82 FR 49114) The original effective date of the 2016 final regulations (November 1, 2016 at 81 FR 75926) was July 1, 2017. On June 16, 2017, a 705 Document (82 FR 27621) delayed the effective date of certain provisions of the 2016 final regulations until a legal challenge by the California Association of Private Postsecondary Schools (CAPPS) is resolved. See Complaint and Prayer for Declaratory and Injunctive Relief, California Association of Private Postsecondary Schools v. DeVos, Civil Action No. 1:17-cv-00999 (D.D.C. May 24, 2017). As explained in the IFR, because the 2016 final regulations have been postponed by the 705 Document beyond July 1, 2017, they cannot become effective earlier than July 1, 2018, to comply with the master calendar requirement. (82 FR 49115-49116).

    Also on June 16, 2017, the Department announced its intent to convene a committee to develop proposed regulations to revise the existing regulations on borrower defense to repayment of Federal student loans and other matters (82 FR 27640), the same topics addressed in the 2016 final regulations. Under the master calendar requirement, a regulatory change that has been published in final form on or before November 1 of the year prior to the start of an award year—which begins on July 1 of any given year—may take effect only at the beginning of the next award year, or in other words, on July 1 of the next year. In light of this requirement, the regulations resulting from negotiated rulemaking could not be effective before, at the earliest, July 1, 2019.

    Accordingly, the Department published a notice of proposed rulemaking (NPRM) proposing to delay the effective date of the 2016 final regulations until July 1, 2019 (October 24, 2017 at 82 FR 49155). This notice adopts that proposal, delaying the effective date of the 2016 final regulations, to continue to preserve the regulatory status quo, until July 1, 2019. The Department will continue to process borrower defense claims under the existing regulations that will remain in effect during the delay so that borrowers may continue to apply for the discharge of all or a part of their loans.

    Based on the above considerations, the Department delays until July 1, 2019, the effective date of the following provisions of the final regulations in title 34 of the Code of Federal Regulations (CFR):

    § 668.14(b)(30), (31), and (32) Program participation agreement.

    § 668.41(h) and (i) Reporting and disclosure of information.

    § 668.71(c) Scope and special definitions.

    § 668.90(a)(3) Initial and final decisions.

    § 668.93(h), (i), and (j) Limitation.

    § 668.171 General.

    § 668.175(c), (d), (f), and (h) Alternative standards and requirements.

    Part 668 subpart L, Appendix C.

    § 674.33(g)(3) and (g)(8) Repayment.

    § 682.202(b)(1) Permissible charges by lenders to borrowers.

    § 682.211(i)(7) Forbearance.

    § 682.402(d)(3), (d)(6)(ii)(B)(1) and (2), (d)(6)(ii)(F) introductory text, (d)(6)(ii)(F)(5), (d)(6)(ii)(G), (d)(6)(ii)(H) through (K), (d)(7)(ii) and (iii), (d)(8), and (e)(6)(iii) Death, disability, closed school, false certification, unpaid refunds, and bankruptcy payments.

    § 682.405(b)(4)(ii) Loan rehabilitation agreement.

    § 682.410(b)(4) and (b)(6)(viii) Fiscal, administrative, and enforcement requirements.

    § 685.200(f)(3)(v) and (f)(4)(iii) Borrower eligibility.

    § 685.205(b)(6) Forbearance.

    § 685.206(c) Borrower responsibilities and defenses.

    § 685.212(k) Discharge of a loan obligation.

    § 685.214(c)(2) and (f)(4) through (7) Closed school discharge.

    § 685.215(a)(1), (c)(1) through (c)(8), and (d) Discharge for false certification of student eligibility or unauthorized payment.

    § 685.222 Borrower defenses.

    Part 685 subpart B, Appendix A Examples of borrower relief.

    § 685.300(b)(11), (b)(12), and (d) through (i) Agreements between an eligible school and the Secretary for participation in the Direct Loan Program.

    § 685.308(a) Remedial actions.

    Note:

    Section 668.90 has been redesignated as § 668.91 and § 668.93 has been redesignated as § 668.94 pursuant to the borrower defense procedural rule, published January 19, 2017 at 82 FR 6253 (the borrower defense procedural rule).

    As noted in the IFR, the Department interprets all references to “July 1, 2017” in the text of the above-referenced regulations to mean the effective date of those regulations. The regulatory text included references to the specific July 1, 2017, date in part to provide clarity to readers in the future as to when the regulations had taken effect. Because the regulations did not take effect on July 1, 2017, we would, in connection with this delay of the effective date, read those regulations as referring to the new effective date established by this rule, i.e., July 1, 2019.

    This delay of the effective date of the 2016 final regulations does not delay the effective dates of the regulatory provisions published in 81 FR 75926 which: (1) Expand the types of documentation that may be used for the granting of a discharge based on the death of the borrower; (2) amend the regulations governing the consolidation of Nursing Student Loans and Nurse Faculty Loans so that they align with the statutory requirements of section 428C(a)(4)(E) of the HEA; (3) amend the regulations governing Direct Consolidation Loans to allow a borrower to obtain a Direct Consolidation Loan regardless of whether the borrower is also seeking to consolidate a Direct Loan Program or FFEL Program loan, if the borrower has a loan type identified in 34 CFR 685.220(b); (4) address severability; and (5) make technical corrections. In the 2016 final regulations, 34 CFR 682.211(i)(7) and 682.410(b)(6)(viii) were designated for early implementation, at the discretion of each lender or guaranty agency. That designation remains effective.

    Public Comment: In response to our invitation in the NPRM, 14 parties submitted comments on the delay of the effective date. We do not discuss comments or recommendations that are beyond the scope of this regulatory action or that would require statutory change.

    Analysis of Comments and Changes

    An analysis of the comments and of any changes to this regulatory action since publication of the NPRM follows.

    A number of commenters opposed the proposed rule to delay the effective date of selected provisions of the 2016 final regulations until July 1, 2019, stating that such delay (1) would harm student loan borrowers and, in some cases, taxpayers; (2) is unnecessary and unaligned with the mission of the Department of Education; (3) is not justifiable on the grounds that there is pending litigation as referenced in the NPRM; and (4) would not be compliant with the Administrative Procedure Act (APA). However, several commenters supported the delay because they believed, collectively, that a further delay would (1) relieve the regulatory burden on institutions; (2) mitigate uncertainty about the potential impact of the current regulations; and (3) prevent unnecessary harm and disruption to postsecondary educational institutions. We discuss and respond to these comments in greater detail below.

    Comments: Several commenters stated that a further delay of the 2016 final regulations would harm borrowers because they would continue to be subject to the predatory practices of certain institutions without those institutions being held accountable through the financial responsibility standards and disclosures and student warnings contained in the 2016 final regulations. The commenters argued that the Secretary should protect and provide relief to borrowers who attended institutions of higher education that misrepresented their program offerings, or that employed deceptive marketing or recruiting tactics, instead of delaying the 2016 final regulations. The commenters claimed that a further delay would ensure that borrowers who apply or have applied for a loan discharge based on a borrower defense would be required to wait for new rules to go into effect before receiving consideration of their claims under the process established by the 2016 final regulations while interest, collection costs and financial distress continued to mount. The commenters also stated that a further delay of the pre-dispute arbitration and class action waiver provisions of the 2016 final regulations would leave students without access to the courts, while statutes of limitation run. Several commenters also argued that a further delay of the rule would harm student loan borrowers because borrowers would be denied access to the many provisions in the 2016 final regulations that are beneficial to borrowers, including provisions that provide:

    —Automatic closed school discharges for borrowers who were enrolled in schools that closed on or after November 13, 2013, and who did not enroll in another school within three years of their school's closure; —A second level of Departmental review for closed school discharge claims that were denied by a guaranty agency; —An expansion of the conditions under which a FFEL or Direct Loan borrower may qualify for a false certification discharge; —A clear process, based on new Federal standards, that establishes a borrower's procedural rights and describes how the Department will consider individual and group borrower defense discharge claims and pending requests for forbearance or suspension of collection on loans that are subject to borrower defense claims; —Prohibitions on schools' ability to enforce pre-dispute arbitration agreements and class action waivers as to borrower defense-related claims for students receiving Direct Loans; —Institutional financial responsibility triggers to protect the Federal government from losses that may arise from borrower defense claims and sudden school closures; and, —Institutional financial protection disclosures for prospective and enrolled students to assist students in making informed choices about where to matriculate.

    One commenter asserted that further delaying the 2016 final regulations would perpetuate existing harms experienced by borrowers, such as poor credit ratings resulting from debt that borrowers accumulated that the borrower may be able to discharge based on a borrower defense.

    One commenter argued that further delay in the effective date harms borrowers because the delay creates uncertainty in how the Department will treat future borrower defense claims. The commenter asserted that while borrowers can wait for the outcome of the new rulemaking effort for clarity on the process, waiting has risks for borrowers as well, including the application of statutes of limitations which may limit the loan amount that may be discharged. The same commenter noted that Direct Loan borrowers with loans issued during the delay cannot avail themselves of the Federal standard in the 2016 final regulations; these borrowers will be limited to the State law standard. Finally, this commenter stated that although the Department claimed that borrowers would not be harmed by the further delay of the effective date of the 2016 final regulations because borrower defense claims would continue to be processed under existing regulations, the Department's own impact analysis estimates a reduction in student loan discharges of nearly two billion as a result of the further delay. Citing a July 2017 letter from the Department's Acting Under Secretary to Senator Richard Durbin, the commenter stated that the Department had not approved borrower defense applications since January 20, 2017, and that there were at least 64,000 outstanding borrower defense applications as of the date of the letter. The commenter noted that the number of unprocessed claims has since risen to 95,000, and that a further delay of the 2016 final regulations will exacerbate the lack of expediency in the Department's borrower defense discharge process to the detriment of borrowers who continue to wait for relief.

    Discussion: The Department does not agree that borrowers will be significantly harmed by changing the effective date of the 2016 final regulations to July 1, 2019. While the Department acknowledges that certain benefits of the 2016 final regulations will be delayed, it has determined that those benefits are outweighed by the administrative and transaction costs for regulated entities and borrowers of having those regulations go into effect only to be changed a short while later. First, the 2016 final regulations did not create the borrower defense regime but modified the pre-existing borrower defense regulations, in place since 1995. Those pre-existing regulations remain in effect, as does the statute that allows borrowers to assert defenses to repayment. Therefore, borrowers can continue to apply for relief from payment of loans under this existing process, and the Department is committed to processing those applications in a timely manner. Second, the instant rule merely delays the marginal benefits of the 2016 final regulations for a brief period of time (an additional year), it does not revoke them.

    The Department does not share the commenters' concern that borrowers will be subject to certain institutions' predatory practices absent the 2016 final regulations. Because the current borrower defense regulations will remain in effect, borrowers will continue to be able to submit claims to the Department and have their claims processed in accordance with the HEA and those current regulations. Borrowers will not need to wait for new rules to go into effect to have a borrower defense claim considered. We do not anticipate that borrowers will be harmed by the current process because we routinely grant forbearances, and stop collection activities on defaulted loans, to borrowers while their discharge claims are under review. We acknowledge the commenter's concern regarding the number of pending claims before the Department. However, in the time since the commenter submitted the comment, the Department has issued decisions on borrower defense claims and we will continue to accept and process borrower defense claims.

    In the event that the borrower defense regulations currently being negotiated result in discharge standards for a borrower defense claim different from the current standards, the new standards would apply only to loans first disbursed on or after the effective date of those regulations. Claims filed as to loans first disbursed before July 1, 2019, which would include currently pending claims and claims filed between the date of this final rule and July 1, 2019, will continue to be processed under the current standard for borrower defense claims.

    We further disagree with commenters who claimed that the July 1, 2019 effective date would harm borrowers because the Federal standard established in the 2016 final regulations would not be in effect. As we noted in the 2016 final regulations, the Federal standard was designed to address much of the conduct covered by the State law-based standard so the vast majority of claims made by borrowers whose loans were first disbursed between July 1, 2017, and July 1, 2019, could be evaluated and discharges provided under the current State law-based standard. (81 FR 75937-75941). Any benefits to borrowers associated with having the Federal standard in place during that time period are outweighed by the confusion and disruption that would result from allowing the 2016 final regulations to take effect during a time when they are subject to a legal challenge and when the Department is reevaluating its borrower defense regulations generally. In addition to causing confusion for borrowers, implementing a different standard for a potentially short period of time could delay the processing of claims. One of the goals of the 2016 final regulations was to provide borrowers with more consistency and clarity about their borrower defense claims. (81 FR 39339-39340). Under the circumstances, the delay of the effective date of the 2016 final regulations provides greater clarity and consistency for borrowers, as well as a more streamlined process, than implementation of the rule under the current schedule.

    With respect to the comment about a two billion dollar reduction in claims based on the difference in the primary and baseline scenarios from the net budget impact in the 2016 final regulations, as noted in the Regulatory Impact Analysis (RIA), the Department estimates the savings resulting from the delay to be much less. The savings resulting from the delay are mainly driven by slight differences between the State law-based standards in the current regulations and the Federal standards from the 2016 final regulations if they were applicable to loans disbursed between July 1, 2018, and July 1, 2019. Since we have always maintained that there would be significant overlap between the State law-based and Federal standards from the 2016 final regulations, the differences are estimated to be minor. The provisions of the 2016 final regulations pertaining to the process for review and determination of claims were not limited to specific cohorts designated by the effective date so the delay will not result in specific cohorts of borrowers being excluded from the process in effect when the claim is made. Additionally, the figures in the Accounting Statement for the 2016 final regulations would more appropriately be characterized as the costs associated with a single cohort and not the costs associated with a fiscal year. As part of its ongoing efforts to improve the utility of student loan information, the Department has updated its Accounting Statement presentation to better align with OMB Circular A-4, so the effects presented in this document do show the impact on the affected cohorts by fiscal year. The Net Budget Impact section of the RIA presents the assumptions about the effect of the delay.

    With regard to the financial protection disclosures, the 2016 final regulations provided that before the disclosures would be required, the Secretary would conduct consumer testing to inform the identification of events for which disclosure would be required and to determine the form of the disclosure. In light of the fact that the 2016 final regulations provided for a future process before the disclosure requirement could be implemented, we do not believe a delayed effective date would significantly change what would occur in this regard during the period of the delay. In other words, because we did not anticipate the financial protection disclosures having a significant impact immediately following the 2016 final regulations' effective date, we believe the incremental effect of delaying those provisions is minimal. We address the comments related to institutional financial responsibility triggers in more detail in the RIA.

    Moreover, there are other existing protections for borrowers, including periodic reviews and site visits by Department employees to title IV participating institutions to monitor regulatory compliance; and the activities of the enforcement unit within FSA charged with taking actions against parties participating in title IV, HEA programs to enforce compliance. In addition to the Department, other entities also act to protect students, borrowers, and taxpayers, such as the States through State law enforcement activities and other Federal agencies whose jurisdictions may overlap with, or affect, the higher education sector.

    Finally, we note that borrowers may continue to apply for closed school and false certification discharges under the current regulations. With regard to the comments relating to the grounds for false certification discharge, as we stated in the notice of proposed rulemaking that preceded the 2016 final regulations, these changes reflect statutory changes relating to false certification discharges for the lack of a high school diploma or its equivalent and for a disqualifying status. As a result, the Department's authority for false certification discharges on these grounds remains unchanged. (81 FR 39377-39378). In addition, under the current regulations, the Secretary has the authority to provide false certification discharges without an application based on information in the Secretary's possession. The 2016 final regulations explicitly provided that such information may include evidence that the school has falsified the Satisfactory Academic Progress of its students. Because the current regulation does not limit the information that may be considered by the Secretary to provide a false certification discharge without an application, we do not believe a delay of the 2016 revision to this provision will harm borrowers. With regard to a second level of review of a guaranty agency's determinations on closed school discharge requests, borrowers may raise any dispute with a guaranty agency to the Department's Federal Student Aid Ombudsman Group.

    The Department acknowledges the commenters' concern that the window under applicable statutes of limitation for some borrowers to file lawsuits may end during the period covered by the delay of the 2016 final regulations' prohibitions on institutions' use of pre-dispute arbitration and class action waiver contractual provisions. However, as acknowledged in the 705 Document, serious questions regarding the legality of these provisions of the final regulations exist and these provisions are among the regulations directly challenged in the CAPPS litigation. The Department thinks that it is likely that the arbitration and class action waiver provisions will be overturned. Should the Department's regulations prohibiting schools from enforcing pre-dispute arbitration agreements and class action waivers be invalidated by the court, there would be significant confusion from borrowers and schools who may have engaged in court litigation on the basis of the prohibitions as to the enforceability of those agreements. We believe the harm from having these provisions take effect in the face of the CAPPS challenge is too great and outweigh any benefits these provisions would have. Further, we note that a borrower may continue to apply for relief, from the Department under the current, State-law based borrower defense to repayment regulations, irrespective of whether the borrower has a pre-dispute arbitration agreement with the school or an agreement to waive involvement in class action lawsuits.

    We also note that the pre-dispute arbitration and class action waiver provisions of the 2016 final regulations would require some institutions to change their policies and procedures and to amend their enrollment agreements. In addition, re-training staff and sending notices to borrowers informing them of the changed class action waivers and pre-dispute arbitration provisions would impose administrative costs on institutions. If pre-dispute arbitration requirements and class action waivers are addressed through the current rulemaking process, institutions would need to repeat or reverse these steps to address any requirements that would go into effect on July 1, 2019. Maintaining the regulatory status quo with respect to pre-dispute arbitration agreements and class action waivers will reduce the administrative burden on schools and lessen confusion for borrowers who would be affected by these changes.

    The Department further believes that implementing the 2016 final regulations at this time would cause significant confusion around borrower defenses generally that would be unfair to students and schools. Without a delay, if the current rulemaking process results in a different standard for borrower defense claims, there would be three separate sets of standards for borrower defense claims: the State-law based standard that is currently in effect; standards for loans disbursed between July 1, 2018, and July 1, 2019; and standards for loans disbursed on or after July 1, 2019. This would be more confusing for borrowers than the potential for two different standards—one for loans disbursed before July 1, 2019, and one for loans disbursed on or after July 1, 2019. Providing for an effective date of July 1, 2019, will allow the Department and the negotiating committee to develop new borrower defense regulations that would protect students from the most serious predatory practices, provide clear and evenhanded rules for students, colleges and universities to follow, and constrain the costs to taxpayers.

    The Department's processing of borrower defense claims is not affected by the effective date of the 2016 final regulations, as the current regulations remain in effect. While the process for reviewing claims and the standard under which they are reviewed would have changed under the 2016 final regulations, the Department does not expect that the length of time required to review individual claims would have changed significantly if the 2016 final regulations had gone into effect as originally scheduled. With regard to group claims, the Department has granted group claims under the existing regulations. While the 2016 final regulations provided a regulatory process for granting group borrower defense claims, the Secretary had and continues to have the authority, and has exercised that authority, to grant group claims under the borrower defense regulations currently in effect.

    Changes: None.

    Comment: Some commenters claimed that the delay hurts American taxpayers because the 2016 final regulations would hold institutions that commit fraud monetarily accountable for their actions in cases of student loan discharges, rather than requiring taxpayers to absorb the costs of borrower defense discharges.

    Discussion: As noted earlier in this section, the delay of the effective date of the 2016 final regulations will allow the Department to develop new borrower defense regulations that may be more beneficial to American taxpayers than the 2016 final regulations. We do not believe the delay will harm American taxpayers because the Department may assess liability for borrower defense claims on schools now, under the current regulations in effect. The financial protection triggers in the 2016 final rule were designed to increase the likelihood of recovering funds from institutions as claims come in over the life of the cohort, especially from institutions that might have significant exposure or that end up closing as a result of the financial risks identified by the triggers. The Department estimated that recovery activity would ramp up as the triggers were implemented, as reflected in the recovery assumption in the 2016 final rule (81 FR 76057), so a delay in the early years of recovery activity is not estimated to have a significant effect, as indicated by the change in the recovery assumption presented in this RIA. With the Department's authority to seek recoveries unchanged because of the change in effective date, we believe the possibility of slightly reduced recovery rates for a short period is warranted to further the goals of providing clarity by maintaining the regulatory status quo during this interim period. We note that the borrower defense procedural rule, which provided a regulatory framework for assessing liabilities against schools for which a borrower defense claim was successful, was published in the Federal Register on January 19, 2017, and those regulations have been effective since that date.

    Changes: None.

    Comment: One commenter asserted that the data provided for the impact of the delays in the effective date of the 2016 final regulations were inadequate because the cost of providing financial protection was not quantified in the RIA of the 2016 final regulations and the NPRM preceding this final rule; and there is no additional data to estimate the costs institutions may avoid from the delayed effective date of the financial protection provisions.

    Another commenter pointed out that if the effective date of the 2016 final regulations was not delayed, the Department estimated that $381 million in loans would be forgiven between July 1, 2017, and July 1, 2019. The commenter noted that the Department does point out that the Federal government will save this money by delaying the effective date but does not point out that borrowers will end up absorbing the cost. The commenter noted that the Department could change the current regulations and not include the new closed school discharge provisions, and noted that even a temporary delay causes financial stress that can trap some borrowers in poverty. Moreover, borrowers who default on their loans because they are not discharged would not be eligible for further financial aid.

    Discussion: The Department appreciates the comments about the RIA for the NPRM preceding this final rule. In that RIA, the Department acknowledged that the costs of providing financial protection were not quantified in the RIA for the 2016 final regulations and that there is no additional data to estimate those costs. That fact, however, does not mean that we have not sufficiently justified this delay.

    As discussed in the RIA for this final rule with respect to the delay of the financial protection provisions, several factors will affect the cost for individual institutions, including: the level of institutional conduct giving rise to borrower defense claims, the applicability of certain financial protection triggers, the financial strength of the institution, the manner in which the institution provides financial protection to the Department, and the potential development of financial products aimed at providing this protection. The Department believes that individual institutions are best positioned to evaluate their potential exposure to borrower defense claims, their financial relationships with parties who could provide financial protection, and the cost of providing protection. Along with the uncertainty about the projected amount of claims as recognized in the different sensitivity runs presented in the RIA for the 2016 final regulations, the Department believes that quantifying the cost of providing financial protection would provide a false sense of precision. Rather than producing a number that would be inapplicable to most institutions, the Department focused on explaining the regulations and providing data about the provisions for which it had information such as the cohort default rate (CDR), 90/10 revenue requirement, fluctuation in title IV aid, withdrawal rate, and accreditor action triggers. The 2016 final regulations did not present information about the provisions related to U.S. Securities and Exchange Commission or stock exchange actions, gainful employment, the withdrawal of owner's equity from an institution, teach-outs, State licensing, financial stress tests, an institution's violation of a loan agreement, or pending borrower defense claims. Additionally, given that the known borrower defense claims at the time were from a small number of institutions and many had not been approved or disapproved, it is unclear how the distribution of successful borrower defense claims at institutions would match up with the distribution of institutions' performance on the financial responsibility triggers for which the Department had some information.

    As is further discussed in the RIA for this final rule, the Department recognizes that the delayed effective date will postpone the impact of the financial protection provisions on institutions. This impact was not quantified for the same reasons described above, but would be a fraction of the total protection expected to be generated under the rule as some of the triggers are tied to the production of certain performance measures and would not have kicked in immediately under the 2016 regulations. Successful claims made by borrowers will be paid regardless of the limited delay in the date for requiring institutions to provide financial protection, and the Department believes the cost to taxpayers of the slightly reduced recoveries described in the Net Budget Impact in the RIA is justified by the benefits of reconsidering the financial protection provisions and appropriately balancing the costs to institutions with protection of borrowers and taxpayers.

    With respect to the comment about closed school discharges, the Department disagrees with the claim that borrowers will bear a $381 million cost because of the delay. As noted in the NPRM, the $364 million savings estimated for FY 2017 occurred because the Department did not execute the modification for cohorts 2014-2016 anticipated in the President's Budget (PB) for 2018 because of the change of the effective date of the 2016 final regulations. The difference in the $381 million estimated for the three-year automatic discharge in the 2016 final regulations and the $364 million estimate for the modification in this rule is that the $381 million was based on PB 2017 loan model assumptions and the modification to be executed was based on the PB 2018 assumptions. Under the credit reform scoring rules applicable to the student loan programs, the unexecuted modification created savings that needed to be recognized. This budget scoring requirement does not affect borrowers or their eligibility for a closed school discharge. Borrowers can avoid any uncertainty about the timing of receiving a closed school discharge or costs associated with a delay in receipt of such discharge by submitting a closed school discharge application at any time. Any costs or savings associated with changes in the automatic discharge provision as a result of the current negotiated rulemaking are outside the scope of the analysis of the delay, and we will address any related issues raised by commenters in response to the NPRM for the proposed rule resulting from the current rulemaking process.

    Changes: None.

    Comment: Some commenters expressed their belief that the delay is not aligned with Congressional intent, citing 20 U.S.C. 3402, and is contrary to the public interest.

    Discussion: In 20 U.S.C. 3402, Congress states that the establishment of a Department of Education is in the public interest, will promote the general welfare of the United States, will help ensure that education issues receive proper treatment at the Federal level, and will enable the Federal government to coordinate its education activities more effectively.

    In its execution of these responsibilities, and consistent with 20 U.S.C. 3402, the Department has determined that the public interest is best served by a delay in the effective date of the 2016 final regulations.

    Changes: None.

    Comments: Some commenters expressed concerns that the Department did not follow required rulemaking processes in delaying the effective date of the 2016 final regulations. These concerns alleged specific statutory and APA violations. First, commenters stated that the Department's justification to waive negotiated rulemaking was insufficient. Second, commenters wrote that we did not provide sufficient justification for the delay. One commenter said that the NPRM fails to identify any specific deficiencies in the 2016 final regulations, or findings and rationale that support revising those regulations. Third, a commenter stated that the minor cost savings detailed in the RIA were insufficient justification to delay the rule. In addition, one commenter stated that further negotiated rulemaking on the 2016 final regulations was redundant and wasteful.

    Discussion: The Department adhered to all applicable laws in promulgating this final rule. First, with regard to waiver of negotiated rulemaking, section 492(b)(2) of the HEA provides that the Secretary may waive negotiated rulemaking if she determines that there is good cause to do so, and publishes the basis for such determination in the Federal Register at the same time as the proposed regulations in question are first published. In the NPRM, the Department properly articulated the good cause supporting our waiver of the HEA's negotiated rulemaking requirement. The NPRM explained that the original catalyst for the delay was the CAPPS litigation, filed on May 24, 2017, and that it would not have been possible for the Department to engage in negotiated rulemaking and publish final regulations after that date (much less after October 24, 2017, the date the NPRM was published), and prior to July 1, 2018 (the current effective date of the 2016 final regulations). Negotiated rulemaking on this discrete issue simply was not practicable. It is a time-consuming and resource-intensive process, and could not practicably be completed by July 1, 2018.

    Negotiated rulemaking typically takes the Department well over 12 months to complete. The statute requires the Department to hold public hearings before commencing any negotiations. Based upon the feedback the Department receives during the hearings, the Department then identifies those issues on which it will conduct negotiated rulemaking, announces those, and solicits nominations for non-Federal negotiators. Negotiations themselves are typically held over a 3 month period. Following the negotiations, the Department then prepares a notice of proposed rulemaking and submits the proposed rule to OMB for review. The proposed rules are then open for public comment for 30-60 days. Following the receipt of public comments, the Department then prepares a final regulation and submits it to OMB for review.

    With the completion of all of these steps taking well over 12 months, it would not have been feasible for the Department to complete negotiated rulemaking on the delayed effective date by July 1, 2018. Indeed, it would not have been feasible even if the Department had commenced the process on May 24, 2017, when it learned of the CAPPS litigation. Thus, the Department had good cause to waive that requirement.

    Regarding the comment that we did not provide sufficient justification to propose delay of the effective date of the 2016 final regulations, the Department is in the process of developing proposed revisions to the borrower defense regulations through the negotiated rulemaking process. As a result of the timing of the negotiated rulemaking and the effect of the master calendar requirement, any regulations resulting from the negotiated rulemaking cannot become effective before July 1, 2019. Therefore, the Department proposed in the NPRM to delay the effective date of the 2016 final regulations to July 1, 2019. This would prevent a scenario in which the 2016 final regulations might become effective for a short period of time before new regulations resulting from the current borrower defense rulemaking process take effect, a result which likely would lead to a great deal of confusion and difficulty for borrowers and schools alike. Accordingly, the Department articulated a reasonable and sufficient justification to propose a delay of a final rule.

    Also with regard to the comment that the NPRM fails to identify any specific deficiencies in the 2016 final regulations, the APA and applicable case law require only that an agency's rulemaking justify the particular action or actions to be taken by that rule. This final rule does not amend the substance of the 2016 final regulations; it merely changes the effective date of the 2016 final regulations and is fully supported based on the information provided in the NPRM and in this final rule. Amending the substance of the 2016 final regulations (or prior borrower defense regulations) would require a separate rationale. We are separately conducting a negotiated rulemaking process to address the substance of the borrower defense regulations, and any resulting NPRM will provide a rationale for proposed changes.

    The NPRM at issue here proposed only a delay of the effective date of the 2016 final regulations; it did not propose any other changes and therefore the Department was not required to solicit comment on any matters other than the effective date. Also contrary to the commenter's assertions, the number of comments received in response to an NPRM has no bearing on the sufficiency of the Department's solicitation of public engagement. The APA requires the Department to “give interested persons an opportunity to participate” and consider “the relevant matter presented,” not to reach a certain threshold of comments before it may proceed with the rulemaking process. 5 U.S.C. 553(c). The Department requested comments that covered the scope of our rulemaking—delay of an effective date—and considered each applicable comment received in promulgating this final rule.

    The regulatory impact analysis in the NPRM estimated the quantified economic effects and net budget impact of the delay, and projected that the delay would result in a net cost savings. However, the delay was not proposed solely on the basis of those calculations. Executive Order 13563 requires the Department to, in part, “propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify).” Just as the commenters note harms to borrowers that cannot be definitively quantified, not all benefits of the delay are measurable in monetary terms. Delaying the effective date as proposed in the NPRM will preserve the regulatory status quo while the Department reconsiders the substance of its regulations governing borrower defense, preventing borrowers and institutions alike from being subject to an uncertain, quickly changing set of regulatory requirements. The Department undertook the required analysis and determined that the benefits of the delay would justify the costs.

    With regard to the comment about redundancy and wastefulness, we have substantive concerns about the 2016 final regulations. In light of that, negotiated rulemaking and publication of an NPRM with request for further public comment is the statutorily required path to ensure public input and potentially make substantive changes to the Department's regulations. After careful consideration, we determined the benefits of proceeding with negotiated rulemaking to properly analyze the borrower defense regulations outweighed the costs of doing so.

    Changes: None.

    Comment: Some commenters also argued that the CAPPS lawsuit is an inappropriate basis for the delay because CAPPS' litigation addresses only some of the regulatory provisions being delayed, but the notices effectuating the delay included many regulatory provisions, including those related to closed school discharge.

    Discussion: The CAPPS litigation is not the basis for the delay proposed in the NPRM, although it was the reason for the initial delay of the 2016 final regulations' effective date. We further note that contrary to the commenter's assertion, CAPPS' complaint expressly prays for an order declaring “that the entirety of the Final Rule is contrary to the Constitution,” and asks that the Court enjoin the Department from “taking any action whatsoever pursuant to the final regulations,” indicating that its challenge is broader than the commenters portray.

    Changes: None.

    Comment: Some commenters supported the proposal in the NPRM. One commenter asserted that the 2016 final regulations' intention missed the mark and created an unnecessarily complex and costly system that is confusing to students, unfair to institutions, and puts taxpayers on the hook for huge costs. The commenter also suggested that maintaining the regulatory status quo under the 1994-95 standard is critical to the public interest and that requiring institutions to use their time and finances to implement the expensive 2016 final regulations while another rulemaking is occurring would be burdensome and contrary to the goals of Executive Order 13777, which is intended to help alleviate the regulatory burdens on the American people. This same commenter emphasized that the delay will help to maintain an existing, easily understood process—especially for students seeking redress under the current State law-based standard.

    Commenters asserted that the delay of selected provisions of the 2016 final regulations would mitigate uncertainty about the potential impact of the regulations, especially in light of ongoing litigation, the master calendar requirement, and ongoing negotiated rulemaking.

    One commenter asserted that the Department properly used Section 705 of the APA to avoid substantial harm to students. The commenter suggested that if some of the provisions of the 2016 final regulations went into effect and were quickly struck down by a court, the result would be chaotic, particularly if the subsequent regulatory framework change occurred in the course of an award year. The commenter asserted further that the ongoing negotiated rulemaking is justified based on the need to improve the borrower defense regulations as part of a regulatory reset. This commenter argued that because the reset could lead to significant changes, it would be nonsensical, even aside from the litigation, to implement new regulations for a full or for part of an award year only to change them after the current negotiated rulemaking process is complete.

    One commenter asserted that the arbitration and class action provisions in the 2016 final regulations would require institutions to incur significant costs in changing multiple policies and procedures and amending existing and future enrollment agreements, re-training staff, litigating new cases, and sending notices to borrowers that existing class action waivers or arbitration provisions will not be enforced. According to the commenter, the implementation of these requirements would divert resources from students and would require the further diversion of resources if schools were required to retrain staff and litigate the effects of the temporary ban on past agreements with students, including those signed during the interim period, if the regulations were to change as a result of the current rulemaking process.

    The commenter also stated that the financial responsibility provisions that require, in some circumstances, an institution to obtain a letter of credit or some type of financial protection would impose a significant burden on schools because a letter of credit is difficult to obtain and the additional cost could cause many schools, including some historically black colleges and universities, to close. The commenter also argued that the delay is appropriate because schools may need to establish different compliance measures if the current negotiated rulemaking process modifies the financial responsibility provisions. In such event, the commenter stated that the temporary implementation of these provisions would lead to potentially unnecessary compliance and training costs for schools to accommodate different rules.

    The commenter also argued that the repayment rate provisions which would require proprietary schools with a certain loan repayment rate to distribute a warning to students and prospective students might damage the reputation of such schools and impact such schools' ability to draw students and raise funds. The commenter argued that the delay would prevent any disruptions as changes to the requirements are considered during the negotiated rulemaking process.

    Finally, the commenter stated its view that given the significant expansion of borrower defense under the 2016 final regulations and the changes to the borrower defense regulations that may result from the Department's current rulemaking effort, the additional delay is required to prevent confusion for students and the expenditure of school resources on implementing the different borrower defense standards and procedures when those resources could otherwise be used to enhance student experiences.

    Discussion: While comments regarding the effect of the 2016 final regulations are outside of the scope of the NPRM, the Department agrees that the delay will provide clarity for institutions and students, as well as save institutions from incurring the costs and expending the resources necessary to comply with the requirements under the 2016 final regulations that would potentially be in effect for only a short period of time.

    Changes: None.

    Executive Orders 12866, 13563, and 13771 Regulatory Impact Analysis

    Under Executive Order 12866, it must be determined whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive Order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

    (1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities in a material way (also referred to as an “economically significant” rule);

    (2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

    (3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

    (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.

    The Department estimates the quantified annualized economic and net budget impacts of the delay of the effective date to be −$26.9 million in reduced costs to institutions and the Federal government. These reduced costs result from the delay of the borrower defense provisions of the 2016 final regulations as they would apply to the 2017 to 2019 loan cohorts, as well as from the delayed paperwork burden on institutions and the delayed execution of the closed school automatic discharge. This final regulatory action is a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

    We have also reviewed this final rule under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

    (1) Propose or adopt regulations only on a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

    (2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

    (3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

    (4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

    (5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

    Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

    We are issuing this final rule only on a reasoned determination that its benefits justify its costs. Based on the analysis that follows, the Department believes that this final rule is consistent with the principles in Executive Order 13563.

    We also have determined that this regulatory action does not unduly interfere with State, local, or Tribal governments in the exercise of their governmental functions.

    In accordance with both Executive Orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action.

    The quantified economic effects and net budget impact associated with the delayed effective date are not expected to be economically significant.

    Effects of Delay

    As indicated in the RIA published with the 2016 final regulations on November 1, 2016, those final regulations were economically significant with a total estimated net budget impact of $16.6 billion over the 2017-2026 loan cohorts in the primary estimate scenario, including a cost of $381 million for cohorts 2014-2016 attributable to the provisions for a three-year automatic closed school discharge.

    However, as noted in the RIA for the NPRM published October 24, 2017, the analysis of the net budget impact in this final rule is limited to the effect of delaying the effective date of the 2016 final regulations from July 1, 2018, to July 1, 2019, and does not account for any potential changes in the 2016 final regulations or administrative updates to existing processes and procedures related to borrower defense claims.

    As the net budget impact is based on the net present value of the cash flows of the relevant cohorts over 40 years, delaying the 2016 final regulations until July 1, 2019, will have limited effect, as discussed below.

    Even with the change in the effective date to July 1, 2019, borrowers will still be able to submit claims. The provisions of the 2016 final regulations pertaining to the process for review and determination of claims were not limited to specific cohorts designated by the effective date so the delay will not result in specific cohorts of borrowers being excluded from the process in effect when the claim is made. Loans made before July 1, 2017, were always subject to the State law-based standard, and borrowers' ability to bring claims under that standard is unchanged by the delay. For claims filed after the effective date of the regulations for loans made on or after July 1, 2019, the Federal standard established in the 2016 final regulations would apply. As discussed previously, the Department interprets all references to “July 1, 2017” in the text of the final regulations to mean the effective date of the final regulations. As a result, the delay in the effective date means that loans made between July 1, 2018, and June 30, 2019, will be subject to the current State law-based standard. As we noted in the 2016 final regulations, the Federal standard was designed to address much of the conduct already covered by the State law-based standard, so the vast majority of discharge claims associated with loans made between July 1, 2017, and the delayed effective date could be made under the current, State law-based standard as well. (81 FR 76057)

    Some commenters suggested that borrowers will be harmed by the delay, either through uncertainty as to how claims will be handled, the application of statutes of limitation, or processing delays. Commenters also expressed concerns about the processing of existing claims and the effect of the delay on their resolution. The Department does not agree that the delay of the effective date of the 2016 final regulations will affect the processing of existing claims. Existing claims were always subject to the State law-based standard in the current regulations. Efforts to improve the efficiency of claims processing are ongoing and are not contingent upon implementation of the 2016 final regulations.

    The Department maintains that the loans affected by the delay from July 1, 2018 to July 1, 2019 are those issued between those dates and for which any potential borrower defense claims will now be evaluated under the State law-based standard. These loans have not been made yet, and the NPRM and this final rule clarify that the State law-based standard will apply to them—this provides borrowers certainty regarding the standard that will be applied to their claims. Some commenters noted the difference in the annualized estimate for the primary and baseline scenarios and suggested the delay will cost borrowers approximately two billion dollars. As explained in the Net Budget Impact, the Department estimates the cost of the delay to be much less than two billion dollars given that there is significant overlap between the current State law-based standard and the Federal standard from the 2016 final regulations and that claims associated with these loans will be handled under the process in place when their claim is made. The Department does not believe that the delay will result in reversion to the baseline scenario assumptions for the borrower percentage so the effect on borrowers will be much lower than the commenters suggested. Additionally, the figures in the Accounting Statement for the 2016 final regulations would more appropriately be characterized as the costs associated with a single loan cohort and not the costs associated with a fiscal year, so the change in the effective date would not result in the two billion dollar difference as it reflects just one year of the 40-year life of the cohort. The Department has updated its Accounting Statement in this final rule so the effects presented in this RIA show the impact on the affected loan cohorts by fiscal year.

    As discussed in the Analysis of Comments and Changes the potential effects on borrowers include possible reduced access to courts from the delay in the arbitration and class action waiver provisions while statutes of limitation are running. We think it is likely that these provisions will be overturned in the CAPPS litigation and are concerned about the confusion to borrowers that would result. We believe the harm that would occur outweighs any benefits of these provisions. We note that a borrower may submit a borrower defense claim to the Department with respect to his or her Federal loans at any time without regard to arbitration agreements or class action waiver clauses in agreements between the borrower and the school, as the loan is between the Federal government and the borrower.

    In addition to borrowers, institutions are also affected by the delayed effective date. As indicated in the RIA for the 2016 final regulations, institutions would bear the major costs of compliance, paperwork burden, and providing financial protection to the Department. In terms of cost savings for institutions, the estimated annual paperwork burden was approximately $9.4 million in the first year after the 2016 final regulations were to take effect. In the revised scenario developed to estimate the effect of this delay in the effective date, estimated transfers from institutions to students, via the Federal government, would be reduced by approximately $9.3 million for the 2017 and 2018 loan cohorts because of the slight reduction in claims from the application of the State law-based standard and the change in the effective date of the financial protection provisions as reflected in the assumptions presented in Table 1. The costs of providing financial protection were not quantified in the RIA for the 2016 final regulations, and the Department has no additional data to estimate costs institutions may avoid from the delayed effective date of the financial protection provisions. Given the limited history of borrower defense claims and recovery actions and numerous factors that affect the cost for individual institutions, the Department believed that quantifying the cost of providing financial protection would provide a false sense of precision. As noted in the 2016 final regulations and the NPRM, there are several ways for institutions to provide financial protection to the Department, including some that may be developed in the future. The price of this protection would likely vary by the size of the institution and the institution's existing financial relationships with parties who could provide the financial protection. Other key elements that contribute to the uncertain cost of financial protection overall are the distribution of borrower defense claims, the type of institutions involved, the applicability of specific financial protection triggers, and the Department's pursuit of recoveries. The Department recognizes that the delayed effective date will postpone the impact of the financial protection provisions on institutions. This would be a fraction of the total protection expected to be generated under the rule as some of the triggers are tied to the production of certain performance measures such as gainful employment rates and there would be some time, possibly months, between the effective date and the next release of rates. The recovery assumption always assumed some ramping up of financial protection as different metrics became available for application, so the change in effective date will affect the early years when recoveries were assumed to be smaller. Borrowers are not affected by institutions' delay in incurring the costs of financial protection, and the Department believes it is worth the cost to taxpayers from reduced recoveries described in the Net Budget Impact in the RIA to reconsider the financial protection provisions and appropriately balance the costs to institutions with protection of borrowers and taxpayers.

    Net Budget Impact

    As described in the NPRM, to estimate the net budget impact of the delay in the effective date to July 1, 2019, the Department developed a scenario that revised the primary estimate assumptions from the 2016 final regulations for the affected 2017 to 2019 cohorts, as was done for the one-year delay described in the IFR. The Department has reviewed the comments it received, particularly those about the potential impacts and estimation of the effects of the delay and responded in the Analysis of Comments and Changes section and this RIA. However, the Department believes that the assumptions for the scenario to estimate the net budget impact on the student loan program from the delay from July 2018 to July 2019 remain appropriate and reasonable.

    As before, the Department applies an assumed level of school conduct that could generate borrower defense claims, borrower claims success, and recoveries from institutions (respectively labeled as Conduct Percent, Borrower Percent, and Recovery Percent in Table 1) to the PB 2018 loan volume estimates to generate the estimated net borrower defense claims for each loan cohort, loan type, and sector. The assumptions for the primary scenario from the 2016 final regulations were the basis for the PB2018 baseline that assumed the final regulations would go into effect on July 1, 2017. The scenario developed for the NPRM is designed to capture the incremental change from the one-year delay in the IFR associated with the further one-year delay in the effective date to July 1, 2019. Compared to the scenario developed for the IFR, recoveries are reduced by an additional two percent for the 2017 and 2018 cohorts, all of the 2018 cohort is subject to the State law-based standard, and the affected portion of the 2019 cohort is subject to the current, State law-based standard and reduced recoveries at the five percent level used for the one-year delay in the IFR. Table 1 presents assumptions for the primary estimate from the final regulations and the revised estimate for the delay from July 1, 2018 to July 1, 2019, in the effective date. In this scenario, the conduct percent is 90 percent of the primary scenario from the final regulations and the borrower percent is the same. The financial protection provided was always expected to increase over time, so the delayed effective date in the near term is not expected to significantly affect the amount of recoveries over the life of any particular loan cohort, limiting any net budget impact from the delay. To estimate the potential reduction in recoveries related to the proposed delayed effective date, we reduced recoveries for the affected portion of the 2017 and 2018 cohorts by seven percent for the private not-for-profit and proprietary sectors and by five percent for the 2019 cohort. As in the 2016 final regulations and the IFR, recoveries from public institutions were held constant at 75 percent across scenarios.

    Table 1—Revised Assumptions for One-Year Delay From July 1, 2018 to July 1, 2019 Cohort 2017 Pub/Priv NFP Prop 2018 Pub/Priv NFP Prop 2019 Pub/Priv NFP Prop Conduct Percent: Final Primary 3.0 20 2.4 16 2.0 13.6 Delay to 2019 2.7 18 2.16 14.4 1.8 12.24 Borrower Percent: Final Primary 35 45 36.8 47.3 36.8 47.3 Delay to 2019 35 45 36.8 47.3 36.8 47.3 Pub Priv/Prop Public Priv/Prop Pub Priv/Prop Recovery Percent: Final Primary 75 23.8 75 23.8 75 23.8 Delay to 2019 75 22.134 75 22.134 75 24.871

    The net budget impact associated with these effects of the one-year delay in the effective date on the borrower defense provisions only is approximately −$46.1 million from the 2017 to 2019 loan cohorts.

    As the amount and composition of borrower defense claims and estimated recoveries over the lifetime of the relevant loan cohorts are not expected to change greatly due to the delayed effective date, the Department does not estimate an economically significant net budget impact from the delay itself, with a potential net budget impact related to borrower defense claims of −$46.1 million in reduced costs for the affected cohorts. This represents the incremental change associated with the one-year delay from July 1, 2018, to July 1, 2019. If compared to the PB 2018 baseline, the savings would be approximately −$78.8 million.

    The closed school automatic discharge provisions were the other significant source of estimated net budget impact in the 2016 final regulations. Under credit reform scoring, the modification to older cohorts for the automatic discharge provision estimated to cost $364 million was expected to occur in FY 2017 in the PB 2018. As a result of the delay in the effective date, the Department will not execute the modification in FY 2017.

    Moving the execution of the modification beyond FY 2017 will require a new cost analysis with economic assumptions from the fiscal year of the execution. This will result in a change of cost, but at this point it is not possible to know the discount rates in future fiscal years, so the cost of the modification will be determined in the year that it is executed. While the actual cost of the future modification cannot be determined at this time, the Department did approximate the effect of the delay by shifting the timing of the relevant discharges back by a year and recalculating a modification using the discount rates and economic assumptions used for the calculation of the PB2018 modification. When calculated in this manner, the delay in the modification to July 2018 described in the IFR resulted in estimated savings of less than $10 million. Using the same approach, the delay to July 2019 is expected to save approximately $15 million above the savings from the initial one-year delay.

    As the delay does not change the substance of the automatic discharge, we would expect the amount and composition of loans affected by the automatic discharge not to change significantly. The closed school three-year automatic discharge provisions were applicable to loans made on or after November 1, 2013, and were not linked to the effective date of the final regulations. Therefore, delaying the effective date of those provisions will not change the set of loans eligible for this automatic discharge. Additionally, borrowers would have the ability to apply for a closed school discharge before July 1, 2019, if they did not want to wait for the automatic discharge to be implemented. For future cohorts, the delay is not significant as the three-year period will fall beyond the delayed effective date. Any significant change to the estimated net budget impact associated with the closed school automatic discharge depends on any substantive changes made to the provisions as a result of the current rulemaking process and changes to economic assumptions when the modification is executed.

    Consistent with Executive Order 13771 (82 FR 9339, February 3, 2017), we have determined that this rule will result in cost savings. Therefore, this rule would be considered an Executive Order 13771 deregulatory action.

    Accounting Statement

    In evaluating whether a regulation is economically significant, a key consideration is whether the annual effect in any given year is over $100 million.

    To evaluate this, the Department looked at the difference in the undiscounted cash flows related to the death, disability, and bankruptcy (DDB) claims in which borrower defense claims are included for the one-year delay established in the IFR and the one-year delay scenario established in this notice and described under the heading “Net Budget Impact”. The difference from subtracting this delay scenario from the IFR one-year delay scenario for the 2017 to 2019 loan cohorts is summarized in Table 2.

    Table 2—Difference in Undiscounted Net Cashflows for the 2017 to 2019 Loan Cohorts From the One-Year Delay in 2016 Borrower Defense Rule to July 1, 2019 FY 2017 FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 FY 2023 FY 2024 FY 2025 FY 2026 Change in DDB Cashflow 159 7,489 496,637 637,361 538,468 6,004,802 9,525,520 4,668,143 2,156,009 3,003,657

    Table 3 shows the effects when those differences in the DDB cashflows are discounted at 7 and 3 percent and annualized.

    Category Benefits Institutions may not incur compliance costs or costs of obtaining financial protection until the rule is in effect Not Quantified Category Costs 7% 3% Continued use of State-law based standard Delay in providing consumer information about institutions' performance and practices Not Quantified Potential decreased awareness and usage of closed school and false certification discharges Savings associated with delay in compliance with paperwork requirements −9.5 −9.51 Category Transfers 7% 3% Reduction in transfers from the Federal government to affected borrowers in the 2017 to 2019 cohorts that would have been partially borne by affected institutions via reimbursements −3.5 −3.8 Reduced reimbursements from affected institutions to affected students, via the Federal government as loan cohorts 2017 to 2019 are subject to the existing borrower defense regulation −1.2 −1.3 Delay in closed school automatic discharge implementation from 2018 to 2019 −14.8 −14.8 Paperwork Reduction Act of 1995

    As indicated in the Paperwork Reduction Act section published in the 2016 final regulations, the assessed estimated burden was 253,136 hours, affecting both institutions and individuals, with an estimated cost of $9,458,484. The table below identifies the regulatory sections, OMB Control Numbers, estimated burden hours, and estimated costs of those final regulations.

    Regulatory section OMB Control No. Burden hours Estimated cost
  • $36.55/hour
  • institution,
  • $16.30/hour
  • individual
  • 668.14 1845-0022 1,953 71,382 668.41 1845-0004 5,346 195,396 668.171 1845-0022 3,028 110,673 668.175 1845-0022 60,560 2,213,468 682.211 1845-0020 5,784 211,405 682.402 1845-0020 1,838 67,179 685.222 1845-0142 249 (Individuals) 4,059 685.222 1845-0142 800 (Institutions) 29,240 685.300 1845-0143 179,362 6,555,681 Total 258,920 9,458,484 Cost savings due to delayed effective date excluding 682.211 early implementation allowed 253,136 9,247,079 Burden remaining 5,784 211,405

    This final rule delays the effective date of the implementation of all of the cited regulations and will result in a cost savings in the total amount of $9,458,484. However, 34 CFR 682.211(i)(7) which was included in the 2016 final regulations, regarding mandatory forbearance based on a borrower defense claim, with an estimated 5,784 hours and $211,405 cost, was designated for early implementation. Lenders may have elected early implementation and, therefore, those specific costs and hours remain applicable and have been subtracted from the overall estimated cost savings. Based on the delayed effective date of July 1, 2019, the revised estimated annual cost savings to institutions and individuals is $9,247,079 ($9,458,484−$211,405) with an estimated burden hours savings of 253,136 (258,920−5,784).

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

    Electronic Access to this Document: The official version of this document is the document published in the Federal Register. Free internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site, you can view this document, as well as all other documents of this Department published in the Federal Register, in text or PDF. To use PDF, you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    List of Subjects 34 CFR Part 668

    Administrative practice and procedure, Colleges and universities, Consumer protection, Grant programs—education, Loan programs—education, Reporting and recordkeeping requirements, Selective Service System, Student aid, Vocational education.

    34 CFR Part 674

    Loan programs—education, Reporting and recordkeeping requirements, Student aid.

    34 CFR Parts 682 and 685

    Administrative practice and procedure, Colleges and universities, Loan programs—education, Reporting and recordkeeping requirements, Student aid, Vocational education.

    Dated: February 9, 2018. Betsy DeVos, Secretary of Education.
    [FR Doc. 2018-03090 Filed 2-9-18; 4:15 pm] BILLING CODE 4000-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2017-0435; FRL-9973-23—Region 6] Approval and Promulgation of Air Quality Implementation Plans; Arkansas; Infrastructure State Implementation Plan Requirements for the National Ambient Air Quality Standards AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is approving State Implementation Plan (SIP) revisions submitted by the State of Arkansas to address the requirements of sections 110(a)(1) and (2) of the Clean Air Act (CAA or Act) for the 2006 and 2012 fine particulate matter (PM2.5) National Ambient Air Quality Standards (NAAQS), 2008 lead (Pb) NAAQS, 2008 ozone (O3) NAAQS, 2010 nitrogen dioxide (NO2) NAAQS, and the 2010 sulfur dioxide (SO2) NAAQS. Under CAA sections 110(a)(1) and 110(a)(2), each state is required to submit a SIP that provides for the implementation, maintenance, and enforcement of a revised primary or secondary NAAQS. CAA sections 110(a)(1) and (2) require each state to make a new SIP submission within three years after EPA promulgates a new or revised NAAQS for approval into the existing federally-approved SIP to assure that the SIP meets the applicable requirements for such new and revised NAAQS. This type of SIP submission is commonly referred to as an “infrastructure SIP or “i-SIP.”

    DATES:

    This final rule is effective on March 16, 2018.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2017-0435. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733.

    FOR FURTHER INFORMATION CONTACT:

    Nevine Salem, (214) 665-7222, [email protected] To inspect the hard copy materials, please schedule an appointment with her or Bill Deese at (214) 665-7253.

    SUPPLEMENTARY INFORMATION:

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

    I. Background

    The background for this action is discussed in detail in our November 20, 2017 proposal (82 FR 55065). In that action, we proposed to approve the Arkansas i-SIP submittal dated March 24, 2017 to address the requirements of sections 110(a)(1) and (2) of the Act for the 2006 and 2012 PM2.5 NAAQS, 2008 lead (Pb) NAAQS, 2008 ozone (O3) NAAQS, 2010 nitrogen dioxide (NO2) NAAQS, and the 2010 sulfur dioxide (SO2) NAAQS. Under CAA sections 110(a)(1) and 110(a)(2), each state is required to submit a SIP that provides for the implementation, maintenance, and enforcement of a revised primary or secondary NAAQS. CAA sections 110(a)(1) and (2) require each state to make a new SIP submission within three years after EPA promulgates a new or revised NAAQS for approval into the existing federally-approved SIP to assure that the SIP meets the applicable requirements for such new and revised NAAQS.

    We received an anonymous public comment on December 18, 2017 on the proposed rulemaking action. The comment is posted to the docket (EPA-R06-OAR-2017-0435). The commenter raised concerns about the accuracy of agricultural and wild fires emissions inventory. Such comment is irrelevant and is outside the scope of this specific rule making action.

    II. Final Action

    As detailed in the proposal action, EPA is approving the majority of the March 24, 2017, Arkansas i-SIP submittal, which addresses the requirements of CAA sections 110(a)(1) and (2) as applicable to the 2006 PM2.5, 2008 Pb, 2008 O3, 2010 SO2, 2010 NO2, and 2012 PM2.5 NAAQS. Table 1 outlines the specific actions 1 we are approving in this final rulemaking.

    1 Note that regarding CAA 110(D)(i)(II) Visibility Protection—(“prong 4”) for the 2006 PM2.5, EPA previously proposed disapproval at 80 FR 38419 (July 6, 2015) for an earlier SIP submittal dated September 21, 2009. However, in the State's March 24, 2017 submittal, Arkansas submitted revisions to address CAA 110(D)(i)(II) (“prong 4”) for the 2006 PM2.5 that supersede the September 21, 2009 submittal. In Table 1 below, we are making an administrative correction to the table as was originally proposed. We are making an administrative correction to note a minor change from “No submittal” to “No action” for the 2006 PM2.5 (“prong 4”). We will address the 2006 PM2.5 NAAQs 110(a)(2)(D)(i)(II)(“prong 4”) element in a future rule making.

    Table 1—Final Actions on the Arkansas Infrastructure SIP Submittal for Various NAAQS Element 2006 PM2.5 2008 Pb 2008 Ozone 2010 NO2 2010 SO2 2012 PM2.5 (A): Emission limits and other control measures A* A A A A A (B): Ambient air quality monitoring and data system A* A A A A A (C)(i): Enforcement of SIP measures A* A A A A A (C)(ii): PSD program for major sources and major modifications A* A A A A A (C)(iii): Permitting program for minor sources and minor modifications A* A A A A A (D)(i)(I): Contribute to nonattainment/interfere with maintenance of NAAQS (prongs 1 and 2) A* A *No submittal A No action No action (D)(i)(II): PSD (requirement 3) A* A A A A A (D)(i)(II): Visibility Protection (requirement 4) No action A No action No action No action No action (D)(ii): Interstate and International Pollution Abatement A A A A A A (E)(i): Adequate resources A* A A A A A (E)(ii): State boards A* A A A A A (E)(iii): Necessary assurances with respect to local agencies A* A A A A A (F): Stationary source monitoring system A* A A A A A (G): Emergency power A* A A A A A (H): Future SIP revisions A* A A A A A (I): Nonattainment area plan or plan revisions under part D + + + + + + (J)(i): Consultation with government officials A* A A A A A (J)(ii): Public notification A* A A A A A (J)(iii): PSD A* A A A A A (J)(iv): Visibility protection + + + + + + (K): Air quality modeling and data A* A A A A A (L): Permitting fees A* A A A A A (M): Consultation and participation by affected local entities A* A A A A A Key to Table 1: Final actions on AR infrastructure SIP submittals for various NAAQS. A—Approve. A*—Previously approved for an earlier submittal. +—Not germane to infrastructure SIPs. No action—EPA is taking no action on these infrastructure requirements in this rulemaking. EPA may address in separate future rulemaking action(s). *—No submittal *FIP in place. III. Statutory and Executive Order Reviews

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

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

    • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

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

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

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

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

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

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

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

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

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

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

    Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 16, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Interstate transport of pollution, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.

    Dated: February 7, 2018. Anne Idsal, Regional Administrator, Region 6.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart E—Arkansas 2. In § 52.170, in paragraph (e), the third table titled “EPA-Approved Nonregulatory Provisions and Quasi-Regulatory Measures in the Arkansas SIP” is amended by adding the following entries at the end:
    § 52.170 Identification of plan.

    (e) * * *

    EPA Approved Nonregulatory Provisions and Quasi-Regulatory Measures in the Arkansas SIP Name of SIP provision Applicable
  • geographic
  • or
  • nonattainment
  • area
  • State
  • submittal/
  • effective
  • date
  • EPA approval date Explanation
    *         *         *         *         *         *         * Infrastructure for the 2006 PM2.5 NAAQS Statewide 3/24/2017 2/14/2018, [Insert Federal Register citation] Approval for 110(a)(2)(D)(ii). Infrastructure for the 2008 Pb NAAQS Statewide 3/24/2017 2/14/2018, [Insert Federal Register citation] Approval for 110(a)(2)(A), (B), (C), (D), (E), (F), (G), (H), (J), (K), (L) and (M). Infrastructure for the 2008 O3 NAAQS Statewide 3/24/2017 2/14/2018, [Insert Federal Register citation] Approval for 110(a)(2)(A), (B), (C), (D)(i) (portions pertaining and PSD), (D)(ii), (E), (F), (G), (H), (J), (K), (L) and (M). Infrastructure for the 2010 NO2 NAAQS Statewide 3/24/2017 2/14/2018, [Insert Federal Register citation] Approval for 110(a)(2)(A), (B), (C), (D)(i)(portion pertaining to nonattainment interference with maintenance and PSD), (D)(ii), (E), (F), (G), (H), (J), (K), (L) and (M). Infrastructure for the 2010 SO2 NAAQS Statewide 3/24/2017 2/14/2018, [Insert Federal Register citation] Approval for 110(a)(2)(A), (B), (C), (D)(i)(portion pertaining to PSD), (D)(ii), (E), (F), (G), (H), (J), (K), (L) and (M). Infrastructure for the 2012 PM2.5 NAAQS Statewide 3/24/2017 2/14/2018, [Insert Federal Register citation] Approval for 110(a)(2)(A), (B), (C), (D)(i) (portion pertaining to PSD), (D)(ii), (E), (F), (G), (H), (J), (K), (L) and (M).
    [FR Doc. 2018-02892 Filed 2-13-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 660 [Docket No. 170322302-8104-02] RIN 0648-BG74 Fisheries Off West Coast States; Coastal Pelagic Species Fisheries; Amendment 16 to the Coastal Pelagic Species Fishery Management Plan AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    NMFS is publishing this final rule to implement Amendment 16 of the Coastal Pelagic Species (CPS) Fishery Management Plan (FMP). This rule will allow for very small amounts of directed, non-live bait fishing (referred to as “minor directed fishing”) on CPS finfish to occur when a fishery is otherwise closed to directed fishing. Currently, when directed fishing is closed, a small sector of the CPS fishery that is not part of the primary commercial directed fishery has been precluded from landing even minor amounts because this activity does not fall under the existing exemptions for incidental harvest or for harvesting CPS to be sold as live bait. This rule allows this sector to continue directed fishing after other directed fisheries are closed, unless otherwise specified in a closure notice published by NMFS or if an applicable annual catch limit (ACL) is anticipated to be exceeded. To prevent exploitation of this rule to make large aggregate harvests, “minor directed fishing” would not be allowed to exceed landings of 1 metric ton (mt) per day per vessel or person or one fishing trip per day by any vessel. The purpose of this rule is to provide greater flexibility to small fishing operations, while continuing to conserve the target CPS fish stocks.

    DATES:

    Effective March 16, 2018.

    ADDRESSES:

    Copies of the CPS FMP as amended through Amendment 16, with notations showing how Amendment 16 will change the FMP are available via the Federal eRulemaking Portal: http://www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0135, or by contacting the Pacific Fisheries Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384.

    FOR FURTHER INFORMATION CONTACT:

    Joshua B. Lindsay, Sustainable Fisheries Division, NMFS, at 562-980-4034; or Kerry Griffin, Pacific Fishery Management Council, at 503-820-2280.

    SUPPLEMENTARY INFORMATION:

    The CPS fishery in the U.S. exclusive economic zone (EEZ) off the West Coast is managed under the CPS FMP, which was developed by the Council pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (MSA), 16 U.S.C. 1801 et seq. Species managed under the CPS FMP include Pacific sardine, Pacific mackerel, jack mackerel, northern anchovy, market squid and krill. The CPS FMP was approved by the Secretary of Commerce and was implemented by regulations at 50 CFR part 660, subpart I.

    At its April 2017 meeting, the Pacific Fishery Management Council (Council) voted to submit Amendment 16 to NMFS for review and approval. On November 6, 2017, NMFS published a Notice of Availability for Amendment 16 in the Federal Register (82 FR 51381), with a comment period ending January 5, 2018. On November 22, 2017, NMFS published a proposed rule to implement Amendment 16 in the Federal Register (82 FR 55551), with a comment period ending December 22, 2017. NMFS approved Amendment 16 on February 1, 2018.

    This final rule implements Amendment 16 by allowing “minor directed fishing” for CPS finfish after a directed fishery has been closed. Current regulations allow live bait fishing and incidental landings to continue even after a directed fishery closure; this rule allows a small sector of the CPS fishery that is not part of the primary commercial directed fishery to harvest minor amounts of CPS even during a directed fishery closure. This minor directed fishery intentionally targets CPS and typically sells the catch as specialty dead bait to recreational and commercial fisheries, or as fresh fish to restaurants and the public. Total landings from this sector typically make up less than one percent of the total landings of any particular CPS stock. Currently, directed fishing closures apply even to minor directed fisheries.

    This final rule will allow minor directed fishing to continue after a directed fishery is closed. Minor directed fishing will be allowed unless otherwise specified by NMFS when closing the directed fishery, or if an applicable ACL is anticipated to be exceeded. To prevent this rule from being exploited by those who would make large aggregate harvests, “minor directed fishing” is limited to landings that do not exceed 1 mt per day per vessel or person or one fishing trip per day by any vessel. The intent of distinguishing between a “vessel” and “person” in these regulations is that some minor directed fishermen target CPS from a platform other than a vessel (e.g., beach seine); in that case, a single fishing trip (e.g., a single haul of a beach seine) may only land a few hundred pounds. Therefore, Amendment 16 allows a person not using a vessel to make multiple fishing trips in a single day as long as the person's total landings do not exceed 1 mt in a day. Vessels are limited to a single trip per day as their typical landings are much greater per trip. For vessels, the 1-mt daily landing restriction functions like a trip limit.

    This rule also updates the definition of “Regional Administrator” to reflect the absorption of the former NMFS Southwest Region into the West Coast Region, and to explicitly reference the fact that directed “live bait” fisheries may continue to operate after most other directed fishing is prohibited (which is an original provision of the FMP, not a change made by Amendment 16).

    A total of 10 public comments relevant to this action were received on Amendment 16 and the proposed rule. Commenters consisted of West Coast fishing industry representatives, seafood companies, fishermen, and charter boat owners/operators. All comments expressed support for Amendment 16, primarily noting that the ability to harvest small amounts of sardine will provide new business opportunities to small-scale fishermen, including sale to specialty markets, restaurants, and as dead bait. No changes were made from the proposed rule.

    Classification

    Pursuant to section 304(b)(1)(A) of the MSA, the NMFS Assistant Administrator has determined that this final rule is consistent with the FMP as revised by Amendment 16, other provisions of the MSA, and other applicable law.

    This final rule has been determined to be not significant for purposes of Executive Order 12866.

    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.

    List of Subjects in 50 CFR Part 660

    Fisheries, Fishing, Reporting and recordkeeping requirements.

    Dated: February 8, 2018. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 660 is amended as follows:

    PART 660—FISHERIES OFF WEST COAST STATES 1. The authority citation for part 660 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq., 16 U.S.C. 773 et seq., and 16 U.S.C. 7001 et seq.

    2. In § 660.502, revise the definition of “Regional Administrator” to read as follows:
    § 660.502 Definitions.

    Regional Administrator means the Regional Administrator, West Coast Region, NMFS, 501 W. Ocean Boulevard, Suite 4200, Long Beach, CA 90802-4213, or a designee.

    3. In § 660.505, revise paragraph (i) to read as follows:
    § 660.505 Prohibitions.

    (i) When a directed fishery has been closed, take and retain, possess, or land more than the incidental trip limit announced in the Federal Register, or a directed trip limit as described in § 660.511(d).

    4. In § 660.511, revise paragraph (d) to read as follows:
    § 660.511 Catch restrictions.

    (d) After the directed fishery for a CPS is closed under § 660.509, no person may take and retain, possess or land more of that species than the incidental trip limit set by the Regional Administrator, except the following directed fisheries may continue until the effective date of a Federal Register document published by the Regional Administrator that the annual catch limit has been reached or is projected to be reached:

    (1) Fishing exclusively for live bait;

    (2) Minor directed fishing for finfish that does not exceed 1 mt per day per vessel or person, and which is limited to 1 fishing trip per day by any vessel.

    [FR Doc. 2018-03040 Filed 2-13-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 161020985-7181-02] RIN 0648-XG023 Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod in the Bering Sea Subarea of the Bering Sea and Aleutian Islands Management Area AGENCY:

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

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS is prohibiting directed fishing for Pacific cod by trawl catcher vessels in the Bering Sea subarea of the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2018 Pacific cod allocation of the total allowable catch (TAC) for the Bering Sea Trawl Catcher Vessel A-Season Sector Limitation in the Bering Sea subarea of the BSAI.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), February 11, 2018, through 1200 hours, A.l.t., April 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Josh Keaton, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

    The 2018 allocation of Pacific cod total allowable catch (TAC) for the Bering Sea Trawl Catcher Vessel A-Season Sector Limitation in the Bering Sea subarea of the BSAI is 24,768 metric tons (mt) as established by the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 26, 2017) and inseason adjustment (82 FR 60329, December 20, 2017).

    In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2018 allocation of Pacific cod TAC for the Bering Sea Trawl Catcher Vessel A-Season Sector Limitation in the Bering Sea subarea of the BSAI will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 23,268 mt and is setting aside the remaining 1,500 mt as incidental catch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by trawl catcher vessels in the Bering Sea subarea of the BSAI.

    After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for Pacific cod by trawl catcher vessels in the Bering Sea subarea of the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of February 8, 2018.

    The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

    This action is required by § 679.20 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: February 9, 2018. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-03087 Filed 2-9-18; 4:15 pm] BILLING CODE 3510-22-P
    83 31 Wednesday, February 14, 2018 Proposed Rules NUCLEAR REGULATORY COMMISSION 10 CFR Part 61 [NRC-2017-0081] RIN 3150-AK00 Greater-Than-Class C and Transuranic Waste AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Public meeting; request for comment.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is seeking stakeholder participation and involvement in identifying the various technical issues that should be considered in the development of a regulatory basis for the disposal of Greater-than-Class C (GTCC) and transuranic radioactive waste through means other than a deep geologic disposal, including near surface disposal. To assist in this process, the NRC is holding a public meeting and is requesting that stakeholders respond to the questions discussed in Section IV, “Specific Request for Comments,” of this document.

    DATES:

    Submit comments by April 16, 2018. Comments received after this date will be considered if it is practical to do so, but the NRC is only able to ensure consideration of comments received on or before this date.

    ADDRESSES:

    You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):

    Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2017-0081. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions contact the individual(s) listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Email comments to: [email protected] If you do not receive an automatic email reply confirming receipt, then contact us at 301-415-1677.

    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.

    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (EST) Federal workdays; telephone: 301-415-1677.

    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:

    Cardelia H. Maupin, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-4127; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2017-0081 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 Website: Go to https://www.regulations.gov and search for Docket ID NRC-2017-0081.

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

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

    B. Submitting Comments

    Please include Docket ID NRC-2017-0081 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket. If your comment contains proprietary or sensitive information, please contact the individual listed in the FOR INFORMATION CONTACT section of this document to determine the most appropriate method for submitting your comment.

    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 will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into ADAMS, and 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 into ADAMS.

    II. Discussion

    On December 22, 2015, the Commission, in Staff Requirements Memorandum (SRM)-SECY-15-0094, “Historical and Current Issues Related to Disposal of GTCC Low Level Radioactive Waste (LLRW)” (ADAMS Accession No. ML15356A623), directed the NRC staff to develop a regulatory basis for disposal of GTCC and transuranic waste through means other than a deep geologic disposal, including near surface disposal, within six months of the completion of the final rule for part 61 of title 10 of the Code of Federal Regulations (10 CFR), “Low-Level Radioactive Waste Disposal,” RIN 3150-AI92; Docket ID NRC-2011-0012. The Commission also directed the staff to conduct a public workshop during the development of the regulatory basis to receive input from stakeholders. On September 8, 2017, the Commission, in SRM-SECY-16-0106, “Final Rule: Low-Level Radioactive Waste Disposal (10 CFR part 61) (RIN 3150-AI92)” (ADAMS Accession No. ML17251B147), revised its earlier directions regarding the development of the GTCC and transuranic waste regulatory basis. The Commission directed the staff to develop the regulatory basis six months after the publication of the supplemental proposed rule for the 10 CFR part 61 rulemaking.

    The NRC staff is in the initial phase of implementing the Commission's directions in SRM-SECY-15-0094 and SRM-SECY-16-0106. The process of potentially amending the NRC's regulations is very thoughtful and deliberative because it can have significant impacts on members of the public, States, licensees, and other stakeholders. The regulatory basis describes the various scientific, technical, and legal issues associated with a potential rulemaking. Therefore, as a part of the initial steps in implementing the Commission's directions, the staff has planned a public meeting with stakeholders to identify the various technical issues that should be considered in the development of a regulatory basis for the disposal of GTCC and transuranic waste. The staff is also requesting that stakeholders respond to the questions discussed in Section IV, “Specific Request for Comments,” of this notice. When this initial phase is completed, staff plans to develop a regulatory basis, which will be provided for public review. Staff plans to hold public meetings on the draft regulatory basis as well. After which, the staff will develop a final regulatory basis.

    III. Background

    The NRC's “Licensing Requirements for Land Disposal of Radioactive Waste” are provided in 10 CFR part 61. Section 10 CFR 61.2, “Definitions,” provides that waste as used in part 61 means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. The definition also indicates that low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraphs (2), (3), and (4) of the definition of byproduct material in § 20.1003.

    The Statements of Consideration (SOC) for the 10 CFR part 61 proposed rule explained that not all waste may be suitable for disposal in the near surface. Specifically, Section IV Purpose and Scope of the SOC (46 FR 38082; July 24, 1981) indicates that, while 10 CFR part 61 was intended to deal with the disposal of most LLRW defined by the Low-Level Radioactive Waste Policy Act, the 10 CFR part 61`waste classification system identified some LLRW that are not suitable for disposal under its regulatory framework, and alternative methods would have to be used.

    In § 61.55, “Waste classification,” the NRC developed a classification system for waste for near surface disposal, which categorizes waste as Class A, B, or C. This provision also describes waste that is not generally acceptable for near-surface disposal, whose disposal methods must be more stringent than those specified for Class C waste. This waste is referred to as GTCC waste.

    The GTCC waste is generated by nuclear power reactors, facilities supporting the nuclear fuel cycle, and other facilities and licensees outside of the nuclear fuel cycle. This class of wastes include (1) plutonium-contaminated nuclear fuel cycle wastes; (2) activated metals; (3) sealed sources; and (4) radioisotope product manufacturing wastes (i.e., wastes “occasionally generated as part of manufacture of sealed sources, radiopharmaceutical products and other materials used for industrial, education, and medical applications”).

    With regards to transuranic waste, as mentioned earlier, transuranic waste is not included in the § 61.2 definition of LLRW. In a 1988 amendment to the Atomic Energy Act of 1954, as amended, a definition for transuranic was added. Transuranic waste 1 is defined as “material contaminated with elements that have an atomic number greater than 92, including neptunium, plutonium, americium, and curium, and that are in concentrations greater than 10 nanocuries per gram [(nCi/g)], or in such other concentrations as the [U.S.] Nuclear Regulatory Commission may prescribe to protect the public health and safety.” Transuranic waste is a byproduct of nuclear research and power production and is primarily produced from spent fuel recycling, medical isotope production, or nuclear weapons fabrication. The waste may consist of rags, tools, and laboratory equipment contaminated with organic and inorganic residues.

    1 Defense waste containing more than 100 nCi of alpha emitting transuranic isotopes per gram of waste, with half-lives greater than 20 years can be disposed of at the Waste Isolation Pilot Plant.

    The identification and evaluation of regulatory concerns associated with land disposal of GTCC and transuranic waste will largely depend on the characteristics of the wastes (e.g., isotopes, concentrations and volumes of waste, physical and chemical properties). The variable characteristics of the waste can influence the decision regarding the appropriate regulatory approach to use for management and disposal of these wastes. Overly conservative assumptions for the inventory and characteristics could significantly limit disposal options, whereas, overly optimistic assumptions with respect to characteristics could lead to a disposal facility that may not provide adequate protection of public health and safety, and security.

    IV. Specific Request for Comment

    The NRC is seeking stakeholder participation and involvement in identifying the various technical issues that should be considered in the development of a draft regulatory basis for the disposal of GTCC and transuranic radioactive waste through means other than a deep geologic disposal, including near surface disposal. To assist in this process, the NRC staff is requesting that stakeholders respond to the questions below. In addition, the NRC staff has conducted some initial technical analyses to assist its understanding of potential hazards with near surface disposal of GTCC and transuranic wastes, which are contained in draft “NRC Staff Analyses Identifying Potential Issues Associated with the Disposal of Greater-Than-Class C Low-Level Radioactive Waste,” (ADAMS Accession No. ML17362A012). The draft analyses should assist in providing responses to the following questions:

    Question 1: What are the important radionuclides that need to be considered for the disposal of the GTCC and transuranic wastes?

    The U.S. Department of Energy has described three broad categories of GTCC wastes, including a range of transuranic radionuclides, in its “Final Environmental Impact Statement for the Disposal of Greater-Than-Class C (GTCC) Low-Level Radioactive Waste and GTCC-Like Waste” (http://www.gtcceis.anl.gov/documents/index.cfm). The three categories are entitled activated metals, sealed sources, and other wastes. The attributes (e.g., radionuclide concentrations, heat generation, and waste form) vary significantly between the three categories. Certain waste streams represent a very specific waste form (e.g., stainless steel for most activated metals; very concentrated amounts in sealed sources) that may require specific treatment to mitigate potential safety, security and criticality concerns. Some waste streams may contain sufficient quantities of specific radionuclides that will present a significant thermal output and/or gas generation through radiolysis. Still other waste streams may contain a significant quantity of fissile radionuclides (e.g., some isotopes of uranium and plutonium). The NRC is interested in identifying those radionuclides that could be important for evaluating the safety and security of: (1) Storage associated with the operational period at a disposal facility, and (2) the post-closure period, including inadvertent intruder protection. Additionally, the NRC is interested in obtaining available data and information to support the characteristics of GTCC and transuranic wastes.

    Question 2: How might GTCC and transuranic wastes affect the safety and security of a disposal facility during operations (i.e., pre-closure period)?

    The presence of sufficient quantities of high activity radionuclides and/or fissile radionuclides in GTCC and transuranic wastes may impact the design and operational activities associated with a disposal facility prior to disposal. The NRC is interested in identifying those design and operational activities at a disposal facility that may be impacted by GTCC and transuranic wastes. For example, the requirements in 10 CFR part 73 would require licensees to develop safeguards systems to protect against acts of radiological sabotage and to prevent the theft or diversion of Special Nuclear Material (i.e., transuranic waste such as plutonium, uranium-233, or uranium enriched in the isotopes uranium-233 or uranium-235) if a sufficient amount of Special Nuclear Material were present above ground at the disposal facility.

    Question 3: How might GTCC and transuranic wastes affect disposal facility design for post-closure safety including protection of an inadvertent intruder?

    The NRC is considering disposal units (e.g., a single trench, borehole, and vault) that would contain a single category of waste (e.g., sealed sources) as well as disposal units that contain a mixture of all three waste types. However, the NRC believes the best approach for understanding the issues would be to assume that waste within a disposal unit would be separated by the waste category and not be co-mingled. Such an approach could provide a clear understanding of the issues associated with how a specific waste category might affect disposal facility design. Certain waste streams associated with GTCC and transuranic wastes have larger inventories and concentrations of radionuclides than was typically considered at LLRW disposal facilities. For example, certain GTCC and transuranic wastes in sufficient quantities have the potential for: (1) Significant thermal output that could affect degradation processes within a disposal unit, and (2) hydrogen gas generation through radiolysis that could also affect degradation processes of the waste package and waste form. Additionally, waste streams associated with GTCC and transuranic wastes may have fissile materials that require facilities to be designed to limit the potential for a criticality event or limit the amount of fissile material that can be disposed. There is a potential balance between security/safety and economic feasibility of design, construction, and operation. The NRC would like to hear from the stakeholders on these aspects as well. The information provided on economic feasibility would be in concert with the NRC's strategies on examining the cumulative effects of potential regulatory actions. The NRC is interested in identifying the various scenarios that should be considered in evaluating the post-closure safety for the disposal of GTCC and transuranic wastes especially scenarios associated with specific issues and concerns that may not have been previously considered for commercial disposal facilities (e.g., synergistic effects of the thermal output on geochemical processes affecting release of radionuclides).

    V. Public Meeting

    To facilitate the understanding of the public and other stakeholders of these issues and the submission of comments, the NRC staff has scheduled a public meeting for February 22, 2018, from 1:00 p.m. to 3:00 p.m. (EST) in the NRC Auditorium at 11545 Rockville, Pike, Rockville, MD. In addition, those wishing to participate by Webinar will be able to view the presentation slides prepared by the NRC and electronically submit comments during the meeting. Participants must register to participate in the Webinar. Registration information may be found in the meeting notice (https://www.nrc.gov/pmns/mtg?do=details&Code=20180033). The meeting notice can also be accessed through the NRC's public website under the headings Public Meetings & Involvement > Public Meeting Schedule; see web page https://www.nrc.gov/public-involve/publicmeetings/index.cfm.

    Additionally, the final agenda for the public meeting will be posted no fewer than 10 days prior to the Webinar at this website. Those who are unable to participate in person or via Webinar may also participate via teleconference. For details on how to participate via teleconference, please contact Sarah Achten; telephone: 301-415-6009; email: [email protected]

    Dated at Rockville, Maryland, this day of February 9, 2018.

    For the Nuclear Regulatory Commission.

    Gregory F. Suber, Acting Deputy Director, Division of Decommissioning, Uranium Recovery, and Waste Programs, Office of Nuclear Material Safety and Safeguards.
    [FR Doc. 2018-03085 Filed 2-13-18; 8:45 am] BILLING CODE 7590-01-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0078; Product Identifier 2017-NM-107-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to supersede Airworthiness Directive (AD) 2017-01-02, which applies to certain The Boeing Company Model 787-8 and 787-9 airplanes. AD 2017-01-02 requires an inspection for discrepant inboard and outboard trailing edge flap rotary actuators. Since we issued AD 2017-01-02, we have determined that it is necessary to revise the applicability to include additional airplanes, and to reduce the number of affected actuators. This proposed AD would continue to require an inspection of the inboard and outboard trailing edge flap rotary actuator for any discrepant rotary actuator, and corrective actions if necessary. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by April 2, 2018.

    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 Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet https://www.myboeingfleet.com. You may view this service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW, Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0078.

    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-2018-0078; 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 NPRM, 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:

    Douglas Tsuji, Senior Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 1601 Lind Avenue SW, Renton, WA 98057-3356; phone: 425-917-6546; fax: 425-917-6590; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0078; Product Identifier 2017-NM-107-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 proposed AD.

    Discussion

    We issued AD 2017-01-02, Amendment 39-18769 (82 FR 4775, January 17, 2017) (“AD 2017-01-02”), for certain The Boeing Company Model 787-8 and 787-9 airplanes. AD 2017-01-02 requires an inspection for discrepant inboard and outboard trailing edge flap rotary actuators. AD 2017-01-02 resulted from a report that indicated that some rotary actuators of the inboard and outboard trailing edge flap may have been assembled with an incorrect no-back brake rotor-stator stack sequence during manufacturing. We issued AD 2017-01-02 to detect and replace incorrectly assembled rotary actuators, which could cause accelerated unit wear that will eventually reduce braking performance. This degradation could lead to loss of no-back brake function and reduced controllability of the airplane.

    Actions Since AD 2017-01-02 Was Issued

    Since we issued AD 2017-01-02, we have determined that it is necessary to revise the applicability to include additional airplanes, and to reduce the number of affected actuators.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017. The service information describes procedures for an inspection of the inboard and outboard trailing edge flap rotary actuator for any discrepant rotary actuator, and corrective actions if necessary. The related investigative action includes a functional test of the trailing edge flap no-back brake. The corrective actions include replacement of the discrepant rotary actuator with a non-discrepant rotary actuator. 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 the same type design.

    Proposed AD Requirements

    This proposed AD would retain all requirements of AD 2017-01-02 and add airplanes to the applicability. This proposed AD would require accomplishing the actions specified in the service information described previously. For information on the procedures and compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0078.

    The phrase “related investigative actions” is used in this proposed AD. Related investigative actions are follow-on actions that (1) are related to the primary action, and (2) further investigate the nature of any condition found. Related investigative actions in an AD could include, for example, inspections.

    The phrase “corrective actions” is used in this proposed AD. Corrective actions correct or address any condition found. Corrective actions in an AD could include, for example, repairs.

    Differences Between This Proposed AD and the Service Information

    To support operations, many operators have put processes in place that, given certain conditions, allow them to rotate or transfer parts or equipment within their fleets to different aircraft than what is defined in the manufacturer's type design. We have determined that the parts or equipment subject to the unsafe condition may have been rotated or transferred in this manner, due to similarity with parts or equipment not subject to the unsafe condition. Therefore, the applicability of this proposed AD is for all The Boeing Company Model 787 series airplanes.

    The effectivity specified in Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015, consists of only certain Boeing Model 787-8 and 787-9 airplanes. In this proposed AD, the actions required by paragraphs (g) and (h) of this AD would be accomplished on any The Boeing Company Model 787 series airplane with an original Certificate of Airworthiness or an original Export Certificate of Airworthiness dated on or before the effective date of the final rule. Expanding the applicability of this proposed AD addresses the rotability issue of the trailing edge flap rotary actuators. We have confirmed with the manufacturer that the accomplishment instructions in the following service information are applicable to the expanded group of airplanes:

    • Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015.

    • Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 002, dated November 3, 2016.

    • Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017.

    The Boeing Company Model 787 series airplanes with an original Certificate of Airworthiness or an original Export Certificate of Airworthiness dated after the effective date of the final rule are not required to complete the actions specified in paragraphs (g) and (h) of this AD, but must comply with the parts installation prohibition in paragraph (i) of this AD.

    Costs of Compliance

    We estimate that this proposed AD affects 89 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S. operators
    Inspection 5 work-hours × $85 per hour = $425 $0 $425 $37,825

    We estimate the following costs to do any necessary on-condition actions that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft or the number of rotary actuators (up to 8 per shipset) that might need these on-condition actions:

    On-Condition Costs Action Labor cost Parts cost Cost per product Check to determine flight cycles on the rotary actuator 1 work-hour × $85 per hour = $85 $0 $85 per rotary actuator. Functional Test per rotary actuator 2 work-hours × $85 per hour = $170 0 $170 per rotary actuator. Replacement per rotary actuator 2 work-hours × $85 per hour = $170 0 $170 per rotary actuator. System Test after rotary actuator replacement(s) per airplane 24 work-hours × $85 per hour = $2,040 0 $2,040 per airplane. 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.

    This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

    Regulatory Findings

    We have 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 that the proposed regulation:

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by removing Airworthiness Directive (AD) 2017-01-02, Amendment 39-18769 (82 FR 4775, January 17, 2017), and adding the following new AD: The Boeing Company: Docket No. FAA-2018-0078; Product Identifier 2017-NM-107-AD. (a) Comments Due Date

    The FAA must receive comments on this AD action by April 2, 2018.

    (b) Affected ADs

    This AD replaces AD 2017-01-02, Amendment 39-18769 (82 FR 4775, January 17, 2017) (“AD 2017-01-02”).

    (c) Applicability

    This AD applies to all The Boeing Company Model 787 series airplanes, certificated in any category.

    (d) Subject

    Air Transport Association (ATA) of America Code 27, Flight control systems.

    (e) Unsafe Condition

    This AD was prompted by a report indicating that some inboard and outboard trailing edge flap rotary actuators may have been assembled with an incorrect no-back brake rotor-stator stack sequence during manufacturing. We are issuing this AD to detect and replace incorrectly assembled rotary actuators, which could cause accelerated unit wear that will eventually reduce braking performance. This degradation could lead to loss of no-back brake function and reduced controllability of the airplane.

    (f) Compliance

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

    (g) Retained Inspection and Other Actions

    For The Boeing Company Model 787-8 and 787-9 airplanes identified in Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015: Within 60 months after February 21, 2017 (the effective date of AD 2017-01-02), do an inspection of the inboard and outboard trailing edge flap rotary actuator for any discrepant rotary actuator, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015; or Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017. If any discrepant rotary actuator is found, within 60 months after February 21, 2017, do the actions specified in paragraph (g)(1) or (g)(2) of this AD, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015; or Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017. After the effective date of this AD only Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017, may be used.

    (1) Replace the discrepant rotary actuator.

    (2) Check the maintenance records to determine the flight cycles of each discrepant rotary actuator and, within 60 months after February 21, 2017 (the effective date of AD 2017-01-02), do all applicable related investigative and corrective actions.

    (h) New Requirements: Inspection, Related Investigative and Corrective Actions

    For airplanes not identified in Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015, which have an Original Certificate of Airworthiness or Export Certificate of Airworthiness with a date on or before the effective date of this AD: Within 60 months after the effective date of this AD, do an inspection of the inboard and outboard trailing edge flap rotary actuator for any discrepant rotary actuator, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017. If any discrepant rotary actuator is found, within 60 months after the effective date of this AD, do the actions specified in paragraph (h)(1) or (h)(2) of this AD, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017.

    (1) Replace the discrepant rotary actuator.

    (2) Check the maintenance records to determine the flight cycles of each discrepant rotary actuator and, within 60 months after the effective date of this AD, do all applicable related investigative and corrective actions.

    (i) Parts Installation Limitation

    As of the effective date of this AD, no person may install, on any airplane, a rotary actuator with a part number and serial number identified in Appendix A of Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017, unless the actuator has been permanently marked in accordance with Task 2 of Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 003, dated July 28, 2017, with “B787-81205-SB270032-00 INCORPORATED.”

    (j) Credit for Previous Actions

    (1) This paragraph provides credit for the actions specified in paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 002, dated November 3, 2016.

    (2) This paragraph provides credit for the actions specified in paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015, or Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 002, dated November 3, 2016.

    (k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (l)(1) of this AD. Information may be emailed to: [email protected]

    (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO Branch, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.

    (4) AMOCs approved previously for AD 2017-01-02 are approved as AMOCs for the corresponding provisions of this AD.

    (5) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (k)(5)(i) and (k)(5)(ii) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

    (ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

    (l) Related Information

    (1) For more information about this AD, contact Douglas Tsuji, Senior Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 1601 Lind Avenue SW, Renton, WA 98057-3356; phone: 425-917-6546; fax: 425-917-6590; email: [email protected]

    (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW, Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on January 30, 2018. Michael Kaszycki, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-03026 Filed 2-13-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 [Docket No. FDA-2017-N-6381] RIN 0910-AH51 Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Food and Drug Administration (FDA, Agency, or we) is proposing to amend its postmarketing safety reporting regulations for approved new animal drugs to require that certain adverse drug experience and product/manufacturing defect reports be submitted to FDA in an electronic format that we can process, review, and archive. This action is intended to improve our systems for collecting and analyzing postmarketing safety reports. The proposed change would help us to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of our public health mission. In addition, the proposed amendments would facilitate international harmonization and exchange of safety information.

    DATES:

    Submit either electronic or written comments on the proposed rule by April 30, 2018. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 16, 2018.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 30, 2018. 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.

    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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-6381 for “Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) to the Office of Management and Budget (OMB) in the following ways:

    • Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or email to [email protected] All comments should be identified with the title, “Records and Reports Concerning Experience with Approved New Animal Drugs.”

    FOR FURTHER INFORMATION CONTACT:

    With regard to the proposed rule: Linda Walter-Grimm, Center for Veterinary Medicine (HFV-240), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5762, [email protected]

    With regard to the information collection: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Background A. Need for the Regulation B. Current Regulatory Framework III. Legal Authority IV. Description of the Proposed Rule A. Scope B. Proposed Provisions V. Proposed Effective and Compliance Dates VI. Economic Analysis of Impacts VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. Federalism I. Executive Summary A. Purpose of the Proposed Rule

    FDA is issuing this proposed rule to amend our regulations under § 514.80 (21 CFR 514.80) to require electronic submission of certain postmarketing safety reports for approved new animal drugs and to provide a procedure for requesting a temporary waiver of the requirement. This action is intended to improve our systems for collecting and analyzing postmarketing safety reports. The proposed change would help us to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of our public health mission. In addition, the proposed amendments would facilitate international harmonization and exchange of safety information.

    B. Summary of the Major Provisions of the Proposed Rule

    We require applicants to submit to us postmarketing safety reports of adverse drug experiences and product/manufacturing defects for approved new animal drugs (see § 514.80). An applicant is defined as “a person or entity who owns or holds on behalf of the owner the approval for an NADA [new animal drug application] or an ANADA [abbreviated new animal drug application], and is responsible for compliance with applicable provisions of the act and regulations.” (§ 514.3 (21 CFR 514.3)) In addition, nonapplicants, defined in § 514.3 as “any person other than the applicant whose name appears on the label and who is engaged in manufacturing, packing, distribution, or labeling of the product,” may elect to submit adverse drug experience reports directly to us (§ 514.80(b)(3)).

    We propose to require electronic submission for the following reports for approved new animal drugs: 3-day alert reports that applicants elect to submit directly to FDA's Center for Veterinary Medicine (CVM) in addition to the requirement they have to submit these reports on paper Form FDA 1932 to the appropriate FDA District Office or local FDA resident post; 15-day alert reports and followup reports; product/manufacturing defect and adverse drug experience reports submitted by nonapplicants who elect to report adverse drug experiences directly to CVM in addition to providing these reports to the applicant; product/manufacturing defect and adverse drug experience reports (including reports of previously not reported adverse drug experiences that occur in postapproval studies) required to be submitted as part of the periodic drug experience report. We propose to replace the current paper submission process with the electronic submission requirement and a procedure for requesting a temporary waiver of the electronic submission requirement. Finally, we propose to clarify where to submit reports not required to be submitted electronically. Under the proposed rule, we would continue to require 3-day alert reports to be submitted to the appropriate FDA District Office or local FDA resident post. However, as noted, if in addition to the report an applicant submits on paper Form FDA 1932 to the appropriate FDA District Office or local FDA resident post, an applicant elects to submit a 3-day field alert report directly to CVM, the applicant would be required to submit the report to CVM electronically.

    C. Legal Authority

    Our legal authority to require electronic submission of postmarketing safety reports for approved new animal drugs derives from sections 201, 301, 501, 502, 512, and 701 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321, 331, 351, 352, 360b, and 371).

    D. Costs and Benefits

    The purpose of this proposed rule is to require electronic submission of certain postmarketing safety reports for approved new animal drugs. The rule, if finalized, would also provide a procedure for requesting a temporary waiver of the electronic reporting requirement for “good cause” shown, such as a natural disaster. As currently proposed, this rule would not change the content of the postmarketing safety reports or the frequency of the reporting requirements. Currently, most submitters have chosen, voluntarily, to use electronic submission for the reports that would be affected by this proposed rule. As of 2016, approximately 99.7 percent of postmarketing safety reports eligible for electronic submission were electronically submitted. Thus, this proposed rule would affect a small proportion of these reports.

    The major benefits of this proposed rule, if finalized, would be to animal health and the Agency in the form of quicker access to postmarketing safety information. The annual cost savings to the Agency is estimated at $7,535. The present value of these benefits over 10 years is $64,272 at a 3 percent discount rate, and $52,920 at a 7 percent discount rate.

    Total one-time costs to industry would be $61,311 for changing standard operating procedures (SOPs) and training employees to electronically submit postmarketing safety reports in accordance with the new SOPs. Recurring costs to the Agency would be $153 per year, for processing the waivers to the electronic reporting requirement. Annualizing these costs over a 10-year period, we estimate total annualized costs to be $7,131 at a 3 percent discount rate, and $8,310 at a 7 percent discount rate. The present value of these costs over 10 years is $60,823 at a 3 percent discount rate, and $58,368 at a 7 percent discount rate.

    II. Background

    When a new animal drug is approved and enters the market, the product is introduced to a larger population in settings different from the controlled studies required by the approval process. New information generated during the postmarketing period offers further insight into the benefits and/or risks of the product, and evaluation of this information is important to ensure the safe and effective use of these products.

    A. Need for the Regulation

    CVM receives information regarding adverse drug experiences for approved new animal drugs from postmarketing safety reports. For over 25 years, we have received these safety reports on paper. However, the majority of submitters have chosen, voluntarily, to utilize electronic submission as electronic means became available. As of 2016, approximately 99.7 percent of postmarketing safety reports eligible for electronic submission were electronically submitted. The proposed rule would require electronic submission of the remaining 0.3 percent of postmarketing safety reports eligible for electronic submission.

    Electronic submission improves our ability to process and archive postmarketing safety reports in a timely manner, and to make postmarketing reports more readily available for analysis. Information from electronic and paper reports is entered into our computerized database, which is designed to support our postmarketing safety surveillance program for animal drug products. Scientists at CVM use the database to make decisions about product safety, which may include regulatory action. Electronically submitted reports are available for analysis as soon as they have been processed, generally within 2 days of receipt. Safety reports submitted to us on paper must be physically received, reviewed, and then manually entered into our computerized database, a process that can take several weeks. Paper reports increase the time it takes us to review safety information, impede our ability to analyze the data comprehensively, and hinder our ability to quickly identify problems. Voluntary electronic submission of safety reports has been an important step in improving our postmarketing surveillance capabilities.

    The proposed rule, which would require electronic submission of certain postmarketing safety reports, would further improve our systems for collecting and analyzing these reports and would save FDA an expected $7,459 annually, primarily in the cost of processing paper submissions. The proposal would:

    • Expedite our access to safety information and provide us data in a format that would support more efficient and comprehensive reviews;

    • Enhance our ability to rapidly communicate information about suspected problems to animal owners, veterinarians, consumers, and industry within the United States and internationally in support of our public health mission; and

    • Eliminate or reduce the time and costs to industry associated with submitting paper reports, and the time, costs, errors, and physical storage needs of the Agency associated with manually entering data from paper reports into the electronic system for review and analysis.

    The proposed rule would allow us to be more responsive to rapidly occurring changes in the technological environment. Consistent with our current practice for voluntarily provided electronic submissions, the proposed rule would require that data in electronic submissions conform to the data elements in Form FDA 1932 and our technical documents on how to provide electronic submissions (e.g., method of transmission and processing, media, file formats, preparation and organization of files). The proposed rule would allow us to issue updated technical documents, as necessary. The most current information on submitting postmarketing safety reports to us in electronic format can be found on our web page at http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm212682.htm (see, e.g., “Instructions for Electronic Submission of Mandatory Adverse Event Reports to FDA CVM”). As necessary, we will revise the technical specifications referenced in our technical documents to address changing technical specifications or any additional specifications needed for electronic submission. Using guidance documents and technical documents to communicate these technical specifications will permit us to be more responsive to rapidly occurring changes in the technological environment.

    The proposed rule is also an important step in our continuing efforts to harmonize our postmarketing safety reporting regulations with international standards for submitting safety information. Currently, the technical specifications referenced in our guidance documents supporting the voluntary electronic submission processes rely upon and adopt certain safety reporting and transmission standards recommended by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). VICH was formed to facilitate the harmonization of technical requirements for the marketing authorization or “registration” of veterinary medicinal products among three regions: The European Union, Japan, and the United States. Our electronic submission specifications allow applicants or nonapplicants to submit postmarketing safety reports using the Health Level 7 (HL7) Individual Case Safety Report (ICSR) standard that has been adopted worldwide by VICH. In this proposed rule, we reaffirm our intention to continue to rely on these VICH-recommended standards. We believe the continued use of VICH standards will promote harmonization of safety reporting among regulatory agencies and facilitate the international exchange of postmarketing safety information. Accordingly, this proposed rule is consistent with our ongoing initiatives to encourage the widest possible use of electronic submission and to promote international harmonization of safety reporting for animal drug products through reliance on VICH standards. We anticipate that the proposed rule would enhance industry's global pharmacovigilance practices by allowing it to use common data elements and transmission standards when submitting ICSRs to multiple regulators.

    B. Current Regulatory Framework

    The current postmarketing safety reports required under § 514.80 for approved NADAs and approved ANADAs are summarized below. The proposed electronic submission requirement would leave the substantive aspects of these reports largely unchanged.

    1. Description and Timing of Safety Reports

    Under section 512(l) of the FD&C Act, we may require holders of approved NADAs to submit reports regarding postapproval experiences with their animal drugs. Our implementing regulation at § 514.80 requires applicants to submit to us postmarketing safety reports of adverse drug experiences and product/manufacturing defects. As stated previously, an applicant is defined as “a person or entity who owns or holds on behalf of the owner the approval for an NADA or an ANADA, and is responsible for compliance with applicable provisions of the act and regulations.” (See § 514.3.) In addition, nonapplicants, defined in § 514.3 as “any person other than the applicant whose name appears on the label and who is engaged in manufacturing, packing, distribution, or labeling of the product,” may elect to submit adverse drug experience reports directly to us (§ 514.80(b)(3)).

    Specifically, § 514.80(b) requires the following adverse drug experience reports, among other reports:

    • Three-day field alert reports (§ 514.80(b)(1)). Applicants must submit a report to the appropriate FDA District Office or local resident post with information pertaining to product and manufacturing defects that may result in serious adverse drug events within 3 working days of first becoming aware that a defect may exist.

    • Fifteen-day alert reports (§ 514.80(b)(2)(i)) and followup reports (§ 514.80(b)(2)(ii)). Applicants must submit a report to us for each postmarketing adverse drug event that is both serious and unexpected within 15 working days of first receiving the information about the adverse drug event. A followup report must be submitted within 15 working days of receipt of significant new information or as requested by us.

    • Nonapplicant reports (§ 514.80(b)(3)). Nonapplicants are required to forward reports of adverse drug experiences to the applicant within 3 working days of first receiving the information. A nonapplicant may choose to also submit an additional report directly to us within 15 working days of first receiving the information, but must still provide the report to the applicant. (As noted above, a “nonapplicant” is any person other than the applicant whose name appears on the label of the approved new animal drug product and who is engaged in the manufacturing, packing, distribution, or labeling of that drug product. 21 CFR 514.3.)

    • Reports of product/manufacturing defects and adverse drug experiences submitted as part of the periodic drug experience report (§ 514.80(b)(4)(iv)(A) and (C)). Applicants are required to submit a periodic report every 6 months for the first 2 years following approval (6-month periodic drug experience reports) and yearly thereafter (yearly periodic drug experience report). The periodic drug experience report must contain, among other things, reports for each product/manufacturing defect and adverse drug experience not previously reported as 3-day field alert reports under § 514.80(b)(1) or 15-day alert or followup reports under § 514.80 (b)(2) (i.e., the periodic drug experience report must contain reports of all expected or nonserious adverse drug events and product/manufacturing defects that did not result in an adverse drug event report). This also includes previously not reported adverse drug experiences that occur in postapproval studies.

    2. Current Methods for the Submission of Postmarketing Safety Reports

    As noted, for over 25 years we have received postmarketing safety reports on paper. Currently, § 514.80 requires that applicants and nonapplicants submit to us reports of adverse drug experiences and product/manufacturing defects on paper Form FDA 1932. It further requires that 3-day field alert reports must be submitted to the appropriate FDA District Field Office or local FDA resident post while 15-day alert reports and followup reports, periodic drug experience reports, and nonapplicant reports must be submitted to CVM (§ 514.80(b)(1) to (3), (b)(4)(iv)(A) and (C), and (g)).

    As noted earlier in this preamble, since May 2010 we have provided industry with the option of submitting certain postmarketing safety reports electronically. Since that time, the majority of submitters have chosen, voluntarily, to utilize electronic submission. As of 2016, approximately 99.7 percent of postmarketing safety reports eligible for electronic submission were electronically submitted.

    Reports that may be submitted electronically include 15-day alert reports and followup reports (§ 514.80(b)(2)(i) and (ii)); nonapplicant reports of adverse drug experiences submitted directly to FDA (§ 514.80(b)(3)); and reports of product/manufacturing defects and adverse drug experiences submitted as part of the periodic drug experience report (§ 514.80(b)(4)(iv)(A) and (C)). At this time, 3-day field alert reports (§ 514.80(b)(1)) must be submitted on paper Form FDA 1932 to the appropriate FDA District Office or local resident post. CVM collaborates with the FDA District Office or local resident post to follow up as appropriate in response to 3-day field alert reports. If an applicant elects to submit a 3-day field alert report directly to CVM, the applicant would be required to submit the report electronically. However, this would not alleviate the applicant's responsibility to submit this report to the FDA District Field Office or local FDA resident post on paper Form FDA 1932.

    Electronic reports may be submitted through FDA's Electronic Submission Gateway or through the FDA-National Institutes of Health Safety Reporting Portal (Safety Reporting Portal). The Electronic Submission Gateway allows applicants or nonapplicants to submit postmarketing safety reports using the HL7 ICSR standard, which, as discussed earlier in this preamble, has been adopted worldwide by VICH. The Electronic Submission Gateway provides industry with gateway-to-gateway access to transmit an HL7 ICSR message using the FDA electronic submission standard. The Safety Reporting Portal provides applicants or nonapplicants a means to submit individual postmarketing safety reports without having to make financial investments in the technical infrastructure needed to access the Electronic Submission Gateway. Any person who has internet access can use the Safety Reporting Portal to submit reports through a user-friendly, interactive questionnaire available at https://www.safetyreporting.hhs.gov/.

    For applicants or nonapplicants that submit large numbers of reports, sending an HL7 ICSR electronic file is more cost effective because the information from the reports is transmitted directly from the submitter's database to FDA, eliminating the need for additional resources for collating, copying, storing, retrieving, and mailing paper copies. For applicants or nonapplicants that submit a small number of reports, the use of the web-based Safety Reporting Portal may be more cost effective than implementing a system to send an HL7 ICSR message through the FDA Electronic Submission Gateway.

    III. Legal Authority

    Section 512(l) of the FD&C Act requires that, following approval of a NADA or ANADA, applicants must establish and maintain records and make reports to the Agency of data related to experience, as prescribed by regulation or order. FDA has general rulemaking authority under section 701(a) of the FD&C Act, which permits the Secretary of Health and Human Services to promulgate regulations for the efficient enforcement of the FD&C Act. In order to implement section 512(l) of the FD&C Act, FDA promulgated regulations for records and updates concerning experience with new animal drugs (see § 514.80). The proposed amendments to this regulation will further efficient enforcement of section 512(l) by permitting records and reports to be reported electronically.

    IV. Description of the Proposed Rule

    We are proposing to amend our regulations in part 514 (21 CFR part 514). The proposed rule would require electronic submission of certain postmarketing safety reports for approved new animal drugs and provide a procedure for requesting a temporary waiver of the requirement. This action is intended to improve our systems for collecting and analyzing postmarketing safety reports.

    A. Scope

    The proposed rule would amend § 514.80 to require electronic submission of the following postmarketing safety reports for approved new animal drugs:

    • Three-day alert reports that applicants elect to submit directly to CVM in addition to the requirement they have to submit these reports on paper Form FDA 1932 to the appropriate FDA District Office or local FDA resident post (§ 514.80(b)(1);

    • Fifteen-day alert reports (§ 514.80(b)(2)(i)) and followup reports (§ 514.80(b)(2)(ii));

    • Product/manufacturing defects and adverse drug experience reports submitted by nonapplicants who elect to report adverse drug experiences directly to FDA under § 514.80(b)(3) in addition to providing these reports to the applicant; and

    • Product/manufacturing defects and adverse drug experience reports (including reports of previously not reported adverse drug experiences that occur in postapproval studies) required to be submitted as part of the periodic drug experience report (§ 514.80(b)(4)(iv)(A) and (C)).

    At this time, we are not proposing to require electronic submission of 3-day field alert reports (§ 514.80(b)(1)) to the appropriate FDA District Office or local resident post because, as noted previously, we currently do not have the information technology systems in place to share with FDA District Offices or local resident posts reports submitted electronically through the Electronic Submission Gateway or Safety Reporting Portal. Under this proposed rule, these reports would continue to be submitted on paper Form FDA 1932 directly to the appropriate FDA District Office or local resident post. CVM will continue to collaborate with the FDA District Office or local resident post to follow up as appropriate in response to 3-day field alert reports submitted directly to the FDA District Office or local resident post. However, as noted, if an applicant elects to submit a 3-day field alert report directly to CVM, the applicant would be required to submit the report electronically. This would not alleviate the applicant's responsibility to submit this report to the FDA District Field Office or local FDA resident post on paper Form FDA 1932.

    B. Proposed Provisions 1. Electronic Submission Requirement

    We are proposing that applicants would continue to have the obligation to submit 3-day field alert reports directly to the appropriate FDA District Office or local resident post within 3 working days of first becoming aware that a defect may exist. However, if applicants choose to also report directly to CVM in addition to reporting to the appropriate FDA District Office or local resident post, they would be required to submit the report to CVM electronically, unless we grant a waiver permitting an alternate submission method or we otherwise request an alternate submission method. (See proposed § 514.80(b)(1).)

    We are proposing that 15-day alert reports and followup reports would be required to be submitted to us electronically, unless we grant a waiver permitting an alternate submission method (see section IV.B.2 of this document) or we otherwise request an alternate submission method (see section IV.B.3 of this document). (See proposed § 514.80(b)(2)(i) and (ii).)

    We are proposing that nonapplicants would continue to have the obligation of forwarding reports of adverse drug experiences to the applicant within 3 working days of first receiving the information. Nonapplicants would also continue to have the option of choosing to report directly to us in addition to reporting to the applicant. However, if nonapplicants opt to report directly to us, they would be required to submit the report electronically, unless we grant a waiver permitting an alternate submission method or we otherwise request an alternate submission method. (See proposed § 514.80(b)(3).)

    We are proposing that reports of product/manufacturing defects and adverse drug experiences required to be submitted as part of the periodic drug experience report would be required to be submitted to us electronically, unless we grant a waiver permitting an alternate submission method or we otherwise request an alternate submission method. (See proposed § 514.80(b)(4)(iv)(A) and (C).) This includes reports of defects and experiences not previously reported under § 514.80(b)(1) and (2) and previously not reported adverse drug experiences that occur in postapproval studies. These reports could be submitted individually at any time within the timeframe for submitting the periodic drug experience report under current § 514.80(b)(4).

    We are proposing that reports submitted to us under § 514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and (C) be submitted in an electronic format that FDA can process, review, and archive, and that data submitted in electronic submissions conform to the data elements in Form FDA 1932 and our technical documents on how to provide electronic submissions (e.g., method of transmission and processing, media, file formats, preparation and organization of files). The proposed rule would allow us to issue updated technical documents, as necessary. (See proposed § 514.80(d)(1).)

    2. Waivers

    We are proposing to allow applicants or nonapplicants to request a temporary waiver from the electronic submission requirement for “good cause” shown. Examples of circumstances that could constitute “good cause” for granting waivers of the electronic submission requirement include crisis situations that impact an applicant's or nonapplicant's ability to report electronically, such as natural disasters, pandemics, and terrorism. The proposed rule would require applicants and nonapplicants to submit a waiver request to us in writing. The initial request, however, could be made by telephone or email to CVM's Division of Veterinary Product Safety, with prompt written followup submitted as a letter to the application. If we grant the request for a temporary waiver, the applicant or nonapplicant would be required to follow the conditions for reporting that we specify upon granting the waiver. (See proposed § 514.80(d)(2).)

    We anticipate that temporary waivers of the electronic submission requirement will only be needed in rare circumstances such as natural disasters, pandemics, and terrorism, as noted. An applicant or nonapplicant experiencing technical difficulties that temporarily prevent use of the Electronic Submission Gateway could, as a backup, electronically submit reports using the Safety Reporting Portal. An applicant or nonapplicant that relies on the Safety Reporting Portal but experiences a short-term, temporary interruption of internet services could, as a backup, electronically submit reports from any other computer with access to a working internet connection.

    3. FDA Request for Alternate Submission Method

    We may require an applicant or nonapplicant to submit reports that would otherwise be required to be submitted electronically to be submitted in an alternate format, such as on paper using Form FDA 1932. We anticipate that we would request the submission of reports through an alternate method only in the event that we experience a prolonged system outage or other major technical problem. During such an event, we would provide advice on the desired method for submission (most likely on paper using Form FDA 1932) and the types of reports that should be submitted using the alternate method. Applicants and nonapplicants should be prepared to comply with such a request by maintaining the capability to submit paper reports using Form FDA 1932 if needed. (See proposed § 514.80(b)(1) to (3), and (b)(4)(iv)(A) and (C).)

    4. Mailing Addresses

    Finally, we propose to clarify where to submit reports not required to be submitted electronically. Under the proposed rule, we would continue to require 3-day alert reports to be submitted to the appropriate FDA District Office or local FDA resident post. (See proposed § 514.80(g).)

    V. Proposed Effective and Compliance Dates

    We propose that any final rule based on this proposal become effective 30 days after the date on which it is published in the Federal Register. Although we are proposing that the final rule become effective 30 days after the date of publication in the Federal Register, we are proposing to provide additional time before applicants and nonapplicants would be required to comply with the electronic submission requirement. We propose that the compliance date would be 12 months after the publication date of the final regulation. The Safety Reporting Portal currently is capable of receiving all of the affected reports and is available to any applicant or nonapplicant with access to the internet. We tentatively conclude that applicants and nonapplicants not currently submitting the affected reports electronically would, in 12 months, be able to make changes to their business practices that would be needed to come into compliance with the proposed requirements.

    VI. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13771 requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.

    The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the costs of the rule are minimal in both absolute value and in comparison to average yearly sales of small firms in this industry, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.

    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $148 million, using the most current (2016) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

    The purpose of this proposed rule is to require electronic submission of certain postmarketing safety reports for approved new animal drugs. The rule, if finalized, would also provide a procedure for requesting a temporary waiver of the electronic reporting requirement for “good cause” shown, such as a natural disaster. As currently proposed, this rule would not change the content of the postmarketing safety reports or the frequency of the reporting requirements.

    The major benefits of this proposed rule, if finalized, would be to animal health and the Agency in the form of quicker access to postmarketing safety information; the annual cost savings to the Agency is estimated at $7,535. The present value of these benefits over 10 years is $64,272 at a 3 percent discount rate, and $52,920 at a 7 percent discount rate.

    Total one-time costs to industry would be $61,311 for changing SOPs and training employees to electronically submit postmarketing safety reports in accordance with the new SOPs. Recurring costs to the Agency would be $153 per year, for processing the waivers to the electronic reporting requirement. Annualizing these costs over a 10-year period, we estimate total annualized costs to be $7,131 at a 3 percent discount rate, and $8,310 at a 7 percent discount rate. The present value of these costs over 10 years is $60,823 at a 3 percent discount rate, and $58,368 at a 7 percent discount rate.

    Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule Category Primary
  • estimate
  • Low
  • estimate
  • High
  • estimate
  • Units Year
  • dollars
  • Discount
  • rate
  • (%)
  • Period
  • covered (years)
  • Notes
    Benefits: Annualized $7,535 2016 7 10 Monetized $/year 7,535 2016 3 10 Annualized 7 Quantified 3 Qualitative Costs: Annualized 7,131 2016 7 10 Monetized $/year 8,310 2016 3 10 Annualized 7 Quantified 3 Qualitative Transfers: Federal 7 Annualized Monetized $millions/year 3 From/To From: To: Other Annualized 7 Monetized $millions/year 3 From/To From: To: Effects: State, Local or Tribal Government: Small Business: Will not have a significant impact on a substantial number of small entities. Wages: Growth:
    We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full analysis of economic impacts is available in the docket (FDA-2017-N-6381) for this proposed rule and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) 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.

    VIII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that are subject to review by OMB under the PRA (44 U.S.C. 3501-3520). A description of these provisions is given in the Description section of this document with an estimate of the one-time and recurring reporting burdens. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

    FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Title: Records and Reports Concerning Experience with Approved New Animal Drugs—OMB Control Number 0910-0284—Revision

    Description: This proposed rule would revise the existing information collection requirements in the postmarketing safety reporting regulations for approved new animal drugs to require electronic submission of certain postmarketing safety reports for approved new animal drugs. This rule does not change the content of these postmarketing reports. It only proposes to require that they be submitted in an electronic form. We are also proposing to provide a procedure for requesting a temporary waiver of the requirement.

    Description of Respondents: Respondents to the information collection provisions of this proposed rule are applicants and nonapplicants.

    Reporting: Currently, the postmarketing safety reporting regulations for approved new animal drugs include requirements to submit to us postmarketing safety reports of adverse drug experiences and product/manufacturing defects. Section 514.80 requires applicants and nonapplicants to keep records of and report to us data, studies, and other information concerning experience with new animal drugs for each approved NADA and ANADA. Following complaints from animal owners or veterinarians, or following their own detection of a problem, applicants or nonapplicants are required to submit adverse event reports and product/manufacturing defect reports under § 514.80(b)(1) to (3) and (b)(4)(iv)(A) and (C) on Form FDA 1932. Form FDA 1932 may be submitted on paper or electronically via the Electronic Submission Gateway or Safety Reporting Portal. Form FDA 1932a (the voluntary reporting form) is used by veterinarians and the public to submit adverse event reports, product defects, and lack of effectiveness complaints directly to FDA. Form FDA 1932a may be submitted on paper or may be submitted electronically by completing and emailing a fillable PDF form. Form FDA 2301 is used to submit the required transmittal of periodic reports (§ 514.80(b)(4)); special drug experience reports (§ 514.80(b)(5)(i)); promotional material for new animal drugs (§ 514.80(b)(5)(ii)); and distributor statements (§ 514.80(b)(5)(iii)). Form FDA 2301 may be submitted on paper, may be submitted electronically by completing and emailing a fillable PDF form, or may be submitted electronically via CVM's eSubmitter. We review the records and reports required in § 514.80 and the voluntary reports to facilitate a determination under section 512(e) of the FD&C Act as to whether there may be grounds for suspending or withdrawing approval of the new animal drug.

    The proposed rule will revise these requirements to require electronic submission of the following postmarketing safety reports for approved new animal drugs:

    • Three-day alert reports that applicants elect to submit directly to CVM in addition to the requirement that they have to submit these reports on paper Form FDA 1932 to the appropriate FDA District Office or local FDA resident post (§ 514.80(b)(1);

    • Fifteen-day alert reports (§ 514.80(b)(2)(i)) and followup reports (§ 514.80(b)(2)(ii));

    • Product/manufacturing defects and adverse drug experience reports submitted by nonapplicants who elect to report adverse drug experiences directly to FDA under § 514.80(b)(3) in addition to providing these reports to the applicant; and

    • Product/manufacturing defects and adverse drug experience reports (including reports of previously not reported adverse drug experiences that occur in postapproval studies) required to be submitted as part of the periodic drug experience report (§ 514.80(b)(4)(iv)(A) and (C)).

    At this time, we are not proposing to require electronic submission of 3-day field alert reports (§ 514.80(b)(1)) to the appropriate FDA District Office or local resident post because, as noted previously, we currently do not have the information technology systems in place to share with the FDA District Office or local resident post reports submitted electronically through the Electronic Submission Gateway or Safety Reporting Portal. These reports would continue to be submitted on paper Form FDA 1932 directly to the appropriate FDA District Office or local resident post. CVM will continue to collaborate with the FDA District Office or local resident post to follow up as appropriate in response to 3-day field alert reports submitted directly to the FDA District Office or local resident post. However, as noted, if an applicant elects to submit a 3-day field alert report directly to CVM, the applicant would be required to submit the report electronically. This would not alleviate the applicant's responsibility to submit this report to the FDA District Field Office or local FDA resident post on paper Form FDA 1932.

    The proposed rule will also revise these requirements to allow applicants or nonapplicants to request a temporary waiver from the electronic submission requirement for “good cause” shown. Examples of circumstances that could constitute “good cause” for granting waivers of the electronic submission requirement include crisis situations that impact an applicant's or nonapplicant's ability to report electronically, such as natural disasters, pandemics, and terrorism. The proposed rule would require applicants and nonapplicants to submit a waiver request to us in writing. The initial request, however, could be made by telephone or email to CVM's Division of Veterinary Product Safety, with prompt written followup submitted as a letter to the application.

    The continuous monitoring of new animal drugs affords the primary means by which we obtain information regarding problems with the safety and efficacy of marketed approved new animal drugs, as well as product/manufacturing problems. Postapproval marketing surveillance is important to ensure the continued safety and effectiveness of new animal drugs. Drug effects can change over time and other effects may not manifest until years after the approval.

    We estimate the reporting burden of this collection of information as follows:

    Table 1—Estimated Recurring Reporting Burden 1 21 CFR section Form FDA
  • No.
  • Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • Total hours
    Electronic submission of postmarketing safety reports under proposed § 514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and (C) 1932 15 18 270 1 270 Request for waiver, proposed § 514.80(d)(2) N/A 1 1 1 1 1 Total 271 271 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 1 shows the estimated recurring reporting burden associated with the proposed rule. In section II.C. of the Preliminary Regulatory Impact Analysis (PRIA), we estimated that 15 firms submitted a paper Form FDA 1932 report from 2011 to 2015 and thus would be affected by the proposed rule's requirement to submit electronically. As stated in the PRIA, we estimate that in 2016 CVM received 270 of the affected postmarketing safety reports on paper. We calculate the number of responses per respondent as the total annual responses divided by the number of respondents. We estimate that, on average, it will take 1 hour to submit electronic postmarketing safety reports for approved new animal drugs, for a total of 270 hours. We base our estimate of 1 hour per report on our experience with electronic postmarketing safety reporting. In the PRIA, we also estimated the burdens associated with submission of waiver requests. We expect very few waiver requests (see section II.E. of the PRIA), estimating that approximately one firm would request a waiver annually under proposed § 514.80(d)(2). We estimate that a waiver request would take approximately 1 hour to prepare and submit to us. Together, this results in a total of 271 hours and 271 responses. If this rule is finalized as proposed, we would reduce the paper reporting collection approved under OMB control number 0910-0284 by 270 hours and increase the electronic reporting collection approved under OMB control number 0910-0645 by 270 hours.

    Recordkeeping: We estimate the recordkeeping burden of this collection of information as follows:

    Table 2—Estimated One-Time Recordkeeping Burden 1 Activity Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total annual
  • records
  • Average
  • burden per
  • recordkeeping
  • Total hours
    Write New SOPs 15 1 15 20 300 Training 15 1 15 20 300 Total 30 600 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 2 shows the estimated one-time recordkeeping burden associated with the proposed rule. This burden includes both the one-time burden of creating new SOPs to submit the reports electronically and the one-time cost of training employees to electronically submit postmarketing safety reports to CVM in accordance with the new SOPs. In section II.E. of the PRIA, we estimated that approximately 15 firms would be affected by this proposed rule, if finalized. We also estimated that it would take approximately 20 hours per firm to create new SOPs for electronic submission of postmarketing safety reports and approximately 20 hours per firm to complete the training of employees to electronically submit postmarketing safety reports in accordance with the new SOPs. Together, this results in a total of 600 hours and 30 records. We assume that there are no capital costs associated with firms implementing this proposed rule (i.e., applicants and nonapplicants in the pharmaceutical industry already have the computer and internet capacity necessary to electronically submit postmarketing safety reports).

    To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB (see ADDRESSES). All comments should be identified with the title of the information collection.

    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review. These requirements will not be effective until FDA obtains OMB approval. FDA will publish a notice concerning OMB approval of these requirements in the Federal Register.

    IX. Federalism

    We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that this proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.

    List of Subjects in 21 CFR Part 514

    Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR part 514 be amended as follows:

    PART 514—NEW ANIMAL DRUG APPLICATIONS 1. The authority citation for part 514 continues to read as follows: Authority:

    21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 360ccc, 371, 379e, 381.

    2. Section 514.80 is amended as follows: a. Revise the entries in the table for paragraphs (b)(4), (d), (e), and (g); b. Add a fifth sentence to paragraph (b)(1); and c. Revise the last sentence of paragraph (b)(2)(i); the third sentence of paragraph (b)(2)(ii); the last sentence of paragraph (b)(3); paragraphs (b)(4)(iv)(A) and (C); paragraph (b)(4)(v); and paragraphs (d) and (g).

    The addition and revisions read as follows:

    § 514.80 Records and reports concerning experience with approved new animal drugs. Purpose 21 CFR paragraph and title *         *         *         *         *         * What are the general requirements for submission of periodic drug experience reports, e.g., method of submission, submission date and frequency, when is it to be submitted, how many copies? 514.80(b)(4) Periodic drug experience report. How do I petition to change the date of submission or frequency of submissions? *         *         *         *         *         * What reports must be submitted to FDA electronically? 514.80(d) Format for Submissions. How can I apply for a waiver from the electronic reporting requirements? How do I obtain Form FDA 1932 and Form FDA 2301? How long must I maintain records and reports required by this section? 514.80(e) Records to be maintained. *         *         *         *         *         * Where do I mail reports that are not required to be submitted electronically? 514.80(g) Mailing addresses. *         *         *         *         *         *

    (b) * * *

    (1) * * * If the applicant elects to also report directly to the FDA's Center for Veterinary Medicine (CVM), the applicant must submit the report to CVM in electronic format as described in paragraph (d)(1) of this section, unless the applicant obtains a waiver under paragraph (d)(2) of this section or FDA requests the report in an alternate format.

    (2) * * *

    (i) * * * The report must be submitted to FDA in electronic format as described in paragraph (d)(1) of this section, unless the applicant obtains a waiver under paragraph (d)(2) of this section or FDA requests the report in an alternate format.

    (ii) * * * A followup report must be submitted to FDA in electronic format as described in paragraph (d)(1) of this section, unless the applicant obtains a waiver under paragraph (d)(2) of this section or FDA requests the report in an alternate format. * * *

    (3) * * * If the nonapplicant elects to also report directly to FDA, the nonapplicant must submit the report to FDA in electronic format as described in paragraph (d)(1) of this section, unless the nonapplicant obtains a waiver under paragraph (d)(2) of this section or FDA requests the report in an alternate format.

    (4) * * *

    (iv) * * *

    (A) Product/manufacturing defects and adverse drug experiences not previously reported under § 514.80(b)(1) and (b)(2) must be reported individually to FDA in electronic format as described in paragraph (d)(1) of this section, unless the applicant obtains a waiver under paragraph (d)(2) of this section or FDA requests the report in an alternate format.

    (B) * * *

    (C) Reports of previously not reported adverse drug experiences that occur in postapproval studies must be reported individually to FDA in electronic format as described in paragraph (d)(1) of this section, unless the applicant obtains a waiver under paragraph (d)(2) of this section or FDA requests the report in an alternate format.

    (v) * * * The summaries must state the time period on which the increased frequency is based, time period comparisons in determining increased frequency, references to any reports previously submitted under paragraphs (b)(1), (b)(2), (b)(3), and (b)(4)(iv)(A) and (C) of this section, the method of analysis, and the interpretation of the results. The summaries must be submitted in a separate section within the periodic drug experience report.

    (d) Format for submissions.—(1) Electronic submissions. Except as provided in paragraph (d)(2), reports submitted to FDA under paragraphs (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and (C) of this section and reports submitted to CVM under paragraph (b)(1) of this section must be submitted in an electronic format that FDA can process, review, and archive. Data provided in electronic submissions must be in conformance with the data elements in Form FDA 1932 and FDA technical documents describing transmission. As necessary, FDA will issue updated technical documents on how to provide the electronic submission (e.g., method of transmission and processing, media, file formats, preparation, and organization of files). Unless requested by FDA, paper copies of reports submitted electronically should not be submitted to FDA.

    (2) Waivers. An applicant or nonapplicant may request, in writing, a temporary waiver of the electronic submission requirements in paragraph (d)(1) of this section. The initial request may be by telephone or email to CVM's Division of Veterinary Product Safety, with prompt written followup submitted as a letter to the application(s). FDA will grant waivers on a limited basis for good cause shown. If FDA grants a waiver, the applicant or nonapplicant must comply with the conditions for reporting specified by FDA upon granting the waiver.

    (3) Paper forms. If approved by FDA before use, a computer-generated equivalent of Form FDA 1932 may be used for reports submitted to the appropriate FDA District Office or local FDA resident post under paragraph (b)(1) and to FDA under (d)(2), and a computer-generated equivalent of Form FDA 2301 may be used for reports submitted to FDA under paragraph (b)(4). Form FDA 1932 may be obtained on the FDA website, by telephoning CVM's Division of Veterinary Product Safety, or by submitting a written request to the following address: Food and Drug Administration, Center for Veterinary Medicine, Division of Veterinary Product Safety (HFV-240), 7500 Standish Pl., Rockville, MD 20855-2764. Form FDA 2301 may be obtained on the FDA website, by telephoning CVM's Division of Surveillance (HFV-210), or by submitting a written request to the following address: Food and Drug Administration, Center for Veterinary Medicine, Division of Surveillance (HFV-210), 7500 Standish Pl., Rockville, MD 20855-2764.

    (g) Mailing addresses. Three-day alert reports must be submitted to the appropriate FDA District Office or local FDA resident post. Addresses for District Offices and resident posts may be obtained on the FDA website. Other reports not required to be submitted to FDA in electronic format must be submitted to the following address: Food and Drug Administration, Center for Veterinary Medicine, Document Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD 20855-2764.

    Dated: February 6, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02757 Filed 2-13-18; 8:45 am] BILLING CODE 4164-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 50 and 51 [EPA-HQ-OAR-2016-0347; FRL-9974-55-OAR] RIN 2060-AT35 Response to June 1, 2016, Clean Air Act Section 126(b) Petition From Connecticut AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of public hearing.

    SUMMARY:

    The Environmental Protection Agency (EPA) is announcing that a public hearing will be held on the EPA's proposed response to a June 1, 2016, petition submitted by the state of Connecticut pursuant to section 126 of the Clean Air Act (CAA). The petition requests that the EPA make a finding that the Brunner Island Steam Electric Station located in York County, Pennsylvania, emits air pollution in amounts that significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone national ambient air quality standard (NAAQS) in Connecticut. The hearing will be held on February 23, 2018, in Washington, DC. The EPA will issue its proposed response in the near future.

    DATES:

    The public hearing will be held on February 23, 2018, in Washington, DC. Please refer to SUPPLEMENTARY INFORMATION for additional information on the public hearing.

    ADDRESSES:

    Public Hearing. The February 23, 2018 public hearing will be held at the EPA, William Jefferson Clinton East Building, Room 1153, 1201 Constitution Avenue NW, Washington, DC 20004. Identification is required. If your driver's license is issued by Michigan, Minnesota, New York, Vermont or the state of Washington, you must present an additional form of identification to enter (see SUPPLEMENTARY INFORMATION for additional information on this location).

    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at EPA Docket Center Reading Room, William Jefferson Clinton West Building, 1301 Constitution Avenue NW, Washington, DC 20004. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The phone number for the Public Reading Room is (202) 566-1744.

    FOR FURTHER INFORMATION CONTACT:

    If you would like to speak at the public hearing, please contact Ms. Pamela Long, U.S. Environmental Protection Agency, Office of Air Quality Planning and Standards (OAQPS), Air Quality Planning Division (C504-01), Research Triangle Park, NC 27711, telephone (919) 541-0641, fax number (919) 541-5509, email address [email protected], no later than February 21, 2018. If you have any questions relating to the public hearing, please contact Ms. Long at the above number.

    If you have questions concerning the June 1, 2016 petition, please contact Mr. Lev Gabrilovich, U.S. Environmental Protection Agency, Office of Air Quality Planning and Standards (OAQPS), Air Quality Planning Division, (C539-01), Research Triangle Park, NC 27711, telephone (919) 541-1496, email address gab[email protected]

    SUPPLEMENTARY INFORMATION:

    The public hearing will provide interested parties the opportunity to present data, views, or arguments concerning the EPA's proposed response to the June 1, 2016, petition. The EPA may ask clarifying questions during the oral presentations, but will not respond to the presentations at that time. Written statements and supporting information that are submitted during the comment period will be considered with the same weight as any oral comments and supporting information presented at the public hearing. Written comments must be postmarked by the last day of the comment period.

    The public hearing will convene at 9:00 a.m. and end at 6:00 p.m. Eastern Time (ET) or at least two hours after the last registered speaker has spoken. The EPA will make every effort to accommodate all individuals interested in providing oral testimony. A lunch break is scheduled from 12:00 p.m. until 1:00 p.m. Please note that this hearing will be held at a U.S. government facility. Individuals planning to attend the hearing should be prepared to show valid picture identification to the security staff in order to gain access to the meeting room. The REAL ID Act, passed by Congress in 2005, established new requirements for entering federal facilities. These requirements took effect July 21, 2014. If your driver's license is issued by the states of Michigan, Minnesota, New York, Vermont or Washington, you must present an additional form of identification to enter the federal building where the public hearing will be held. Acceptable alternative forms of identification include: Federal employee badges, passports, enhanced driver's licenses and military identification cards. For additional information for the status of your state regarding REAL ID, go to http://www.dhs.gov/real-id-enforcement-brief. In addition, you will need to obtain a property pass for any personal belongings you bring with you. Upon leaving the building, you will be required to return this property pass to the security desk. No large signs will be allowed in the building, and demonstrations will not be allowed on federal property for security reasons.

    If you would like to present oral testimony at the hearing, please notify Ms. Pamela Long, U.S. Environmental Protection Agency, OAQPS, Air Quality Planning Division, (C504-01), Research Triangle Park, NC 27711, telephone (919) 541-0641, fax number (919) 541-5509, email address [email protected], no later than 4:00 p.m. ET on February 21, 2018. Ms. Long will arrange a general time slot for you to speak. The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing.

    Oral testimony will be limited to 5 minutes for each commenter. The EPA encourages commenters to provide the EPA with a copy of their oral testimony electronically (via email) or in hard copy form. The EPA will not provide audiovisual equipment for presentations unless we receive special requests in advance. Commenters should notify Ms. Long if they will need specific equipment. Commenters should also notify Ms. Long if they need specific translation services for non-English speaking commenters.

    The hearing schedule, including the list of speakers, will be posted on the EPA's Web at site https://www.epa.gov/ozone-pollution/connecticut-126-petition prior to the hearing. Verbatim transcripts of the hearing and written statements will be included in the docket for the action.

    How can I get copies of this document and other related information?

    The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2016-0347 (available at http://www.regulations.gov). The EPA has made available information related to the proposed action at this website: https://www.epa.gov/ozone-pollution/connecticut-126-petition.

    Panagiotis E. Tsirigotis, Director, Office of Air Quality Planning and Standards.
    [FR Doc. 2018-03171 Filed 2-13-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2017-0124; FRL-9973-35—Region 6] Approval and Promulgation of Implementation Plans; Texas; Revisions to Permitting and Public Participation for Air Quality Permit Applications AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is proposing to approve four revisions to the Texas State Implementation Plan (SIP) on December 12, 2016 and February 21, 2017, specific to air quality permitting and public notice for air quality permit applications.

    DATES:

    Written comments should be received on or before March 16, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket No. EPA-R06-OAR-2017-0124, at http://www.regulations.gov or via email to [email protected] Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, please contact Adina Wiley, 214-665-2115, [email protected] For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    Docket: The index to the docket for this action is available electronically at www.regulations.gov and in hard copy at EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available at either location (e.g., CBI).

    FOR FURTHER INFORMATION CONTACT:

    Adina Wiley, 214-665-2115, [email protected] To inspect the hard copy materials, please schedule an appointment with Ms. Adina Wiley or Mr. Bill Deese at 214-665-7253.

    SUPPLEMENTARY INFORMATION:

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

    I. Background

    The Act at Section 110(a)(2)(C) requires states to develop and submit to EPA for approval into the SIP, preconstruction review and permitting programs applicable to certain new and modified stationary sources of air pollutants for attainment and nonattainment areas that cover both major and minor new sources and modifications, collectively referred to as the NSR SIP. The CAA NSR SIP program is composed of three separate programs: Prevention of Significant Deterioration (PSD), Nonattainment New Source Review (NNSR), and Minor NSR. The EPA codified minimum requirements for these State permitting programs including public participation and notification requirements at 40 CFR 51.160-51.164. Requirements specific to construction of new stationary sources and major modifications in nonattainment areas are codified at 40 CFR 51.165 for the NNSR program. Requirements for permitting of new stationary sources and major modifications in attainment areas subject to PSD, including additional public participation requirements, are found at 40 CFR 51.166. This proposed approval action will address four separate revisions to the Texas NSR SIP submitted on December 12, 2016 and February 21, 2017. On December 12, 2016, the Texas Commission on Environmental Quality (TCEQ) submitted a revision to the major NSR program to remove from the Texas SIP the Compliance History provisions at 30 TAC Sections 116.120-116.123, 116.125 and 116.126. On February 21, 2017, the TCEQ submitted three separate revisions to the Texas SIP revising the public notice provisions applicable to air quality permit applications.

    II. The EPA's Evaluation

    The accompanying Technical Support Documents for this action include a detailed analysis of the submitted revisions to the Texas SIP. In many instances the revisions are minor or non-substantive in nature and do not change the intent of the originally approved SIP requirements. Following is a summary of our analysis for the submitted revisions.

    A. Evaluation of the Repeal of Chapter 116 Compliance History Requirements

    The Chapter 116 Compliance History provisions were initially adopted by the State on June 17, 1998, at 30 TAC Sections 116.120-116.126. These revisions were submitted to the EPA as a SIP revision on July 22, 1998. The EPA approved these requirements into the SIP on September 18, 2002 at 67 FR 58697.

    The TCEQ repealed the requirements of 30 TAC Section 116.124 on September 2, 1999. The EPA approved this repeal on January 6, 2014 at 79 FR 551. The TCEQ repealed the remaining provisions at 30 TAC Sections 116.120-116.123, 116.125 and 116.126 on August 7, 2002 and replaced the requirements with media neutral compliance history requirements under 30 TAC Chapter 60 pursuant to the requirements of Texas House Bill 2912. The TCEQ did not submit the repeal of 30 TAC Sections 116.120-116.123, 116.125 and 116.126 at the time of the state rulemaking. The repeal of these requirements was submitted on December 12, 2016 as Rule Project Number 2016-028-SIP-NR.

    The repeal of the remaining compliance history provisions at 30 TAC Sections 116.120-116.123, 116.125 and 116.126 is approvable. This repeal was developed in accordance with the CAA and the State provided reasonable notice and public hearing. The repeal of these provisions will remove obsolete requirements from the Texas SIP. The EPA has determined it is appropriate to approve the repeal and removal of these provisions from the SIP since there are no federal requirements to include comparable provisions in a SIP. This repeal will have no negative impact on the Texas New Source Review program because the SIP-approved permit programs do not rely on the repealed Compliance History provisions. Therefore, we conclude that this repeal maintains consistency with federal requirements for SIP development and New Source Review permitting, and therefore, will not interfere with attainment or reasonable further progress.

    B. Evaluation of the Revisions to Texas Public Notice Requirements

    On February 21, 2017, the TCEQ submitted three separate revisions to the Texas SIP revising the public notice provisions applicable to air quality permit applications. The revisions to 30 TAC Chapters 39 and 55 submitted under Rule Project No 2015-018-080-LS make non-substantive revisions to the existing SIP requirements. The revisions to repeal the Chapter 116 public notice provisions submitted under Rule Project No. 2016-026-116-AI remove obsolete requirements that have been replaced with the existing SIP public notice provisions in Chapter 39. The revisions to 30 TAC Chapter 39 and 55 submitted under Rule Project No. 2016-030-039-LS substantively revise the existing public notice SIP requirements for concrete batch plant standard permits such that the notice requirements are consolidated into one 30-day notice period that satisfies the requirements of minor NSR public participation. The EPA has determined it is appropriate to approve these three revisions to the Texas SIP because these revisions continue to be consistent with federal requirements for public notice and therefore, will not interfere with attainment or reasonable further progress.

    III. Proposed Action

    We are proposing to approve revisions to the Texas SIP that revise the NSR permitting and public notice requirements. We have determined that the revisions submitted on December 12, 2016 were developed in accordance with the CAA and EPA's regulations, policy and guidance for NSR permitting. Therefore, under section 110 of the Act, the EPA proposes approval of the following revisions to the Texas SIP:

    • Repeal of 30 TAC Section 116.120—Applicability—adopted on November 2, 2016, and submitted on December 12, 2016;

    • Repeal of 30 TAC Section 116.121—Exemptions—adopted on November 2, 2016, and submitted on December 12, 2016;

    • Repeal of 30 TAC Section 116.122—Contents of Compliance History—adopted on November 2, 2016, and submitted on December 12, 2016;

    • Repeal of 30 TAC Section 116.123—Effective Dates—adopted on November 2, 2016, and submitted on December 12, 2016;

    • Repeal of 30 TAC Section 116.125—Preservation of Existing Rights and Procedures—adopted on November 2, 2016, and submitted on December 12, 2016; and

    • Repeal of 30 TAC Section 116.126—Voidance of Permit Applications—adopted on November 2, 2016, and submitted on December 12, 2016.

    Additionally, we have determined that the revisions submitted on February 21, 2017, were developed in accordance with the CAA and EPA's regulations, policy and guidance for public notice for air permitting. Under section 110 of the Act, the EPA proposes to approve the following revisions into the Texas SIP:

    • Revisions to 30 TAC Section 39.405 adopted on December 9, 2015, and submitted on February 21, 2017;

    • Revisions to 30 TAC Section 39.411 adopted on December 7, 2016, and submitted on February 21, 2017;

    • Revisions to 30 TAC Section 39.419 adopted on December 9, 2015, and submitted on February 21, 2017;

    • Revisions to 30 TAC Section 39.603 adopted on December 7, 2016, and submitted on February 21, 2017;

    • Revisions to 30 TAC Section 55.152 adopted on December 7, 2016, and submitted on February 21, 2017;

    • Withdrawal of 30 TAC Section 55.156(e) from the Texas SIP as adopted on December 9, 2015, and submitted on February 21, 2017; and the

    • Repeal of 30 TAC Sections 116.130-116.134, 116.136, and 116.137 from the Texas SIP as adopted on November 2, 2016 and submitted on February 21, 2017.

    We also propose to revise the amendatory language at 40 CFR 52.2270(c) to identify specific provisions adopted by the State were not submitted for inclusion in the Texas SIP. We propose to revise the language at 40 CFR 52.2270(c) to clearly indicate that the Texas SIP does not include the revisions to 30 TAC Sections 39.405(h(1)(A) and 39.602(c) as adopted on December 9, 2015, or 30 TAC Section 39.411(e)(10) as adopted on December 7, 2016.

    IV. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the revisions to the Texas regulations as described in the Final Action section above. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov or at the EPA Region 6 Office (please contact Adina Wiley for more information).

    V. Statutory and Executive Order Reviews

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

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

    • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

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

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

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

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

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

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

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

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

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

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: February 7, 2018. Anne Idsal, Regional Administrator, Region 6.
    [FR Doc. 2018-02891 Filed 2-13-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2016-0716; FRL-9973-42—Region 6] Approval and Promulgation of Implementation Plans; Texas; Interstate Transport Requirements for the 1997 and 2006 PM2.5 NAAQS AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    Pursuant to the Federal Clean Air Act (CAA or Act), the Environmental Protection Agency (EPA) is proposing to approve portions of three Texas State Implementation Plan (SIP) submittals pertaining to CAA requirements to prohibit emissions which will significantly contribute to nonattainment or interfere with maintenance of the 1997 and 2006 fine particulate matter (PM2.5) National Ambient Air Quality Standards (NAAQS) in other states.

    DATES:

    Written comments must be received on or before March 16, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket No. EPA-R06-OAR-2016-0716, at http://www.regulations.gov or via email to [email protected] Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, please contact Carl Young, 214-665-6645, [email protected] For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    Docket: The index to the docket for this action is available electronically at www.regulations.gov and in hard copy at the EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available at either location (e.g., CBI).

    FOR FURTHER INFORMATION CONTACT:

    Carl Young, 214-665-6645, [email protected] To inspect the hard copy materials, please schedule an appointment with Mr. Young or Mr. Bill Deese at 214-665-7253.

    SUPPLEMENTARY INFORMATION:

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

    I. Background A. The PM2.5 NAAQS and Interstate Transport of Air Pollution

    Under section 109 of the CAA, we establish NAAQS to protect human health and public welfare. In 1997, we established a new annual NAAQS for PM2.5 of 15 micrograms per cubic meter (μg/m3), and a new 24-hour NAAQS for PM2.5 of 65 μg/m3 (62 FR 38652, July 18, 1997). In 2006, we revised the 24-hour PM2.5 NAAQS to 35 μg/m3 (71 FR 61144, October 17, 2006).1 The CAA requires states to submit, within three years after promulgation of a new or revised standard, SIPs meeting the applicable “infrastructure” elements of sections 110(a)(1) and (2). One of these applicable infrastructure elements, CAA section 110(a)(2)(D)(i), requires SIPs to contain “good neighbor” provisions to prohibit certain adverse air quality effects on neighboring states due to interstate transport of pollution. There are four sub-elements within CAA section 110(a)(2)(D)(i). This action reviews how the first two sub-elements of the good neighbor provisions at CAA section 110(a)(2)(D)(i)(I) were addressed in an infrastructure SIP submission from Texas for the 1997 and 2006 PM2.5 NAAQS. These sub-elements require that each SIP for a new or revised NAAQS contain adequate provisions to prohibit any emissions activity within the state from emitting air pollutants that will “contribute significantly to nonattainment” or “interfere with maintenance” of the applicable air quality standard in any other state.

    1 In 2012, we revised the annual PM2.5 NAAQS to 12 μg/m3 (78 FR 3086, January 15, 2013). This proposal pertains to the 1997 and 2006 PM2.5 NAAQS only.

    The EPA has addressed the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) with respect to PM2.5 in several past regulatory actions. Most recently, in 2011 we promulgated the Cross-State Air Pollution Rule (CSAPR) in order to address the obligations of states—and of the EPA when states have not met their obligations—under CAA section 110(a)(2)(D)(i)(I) to prohibit air pollution contributing significantly to nonattainment in, or interfering with maintenance by, any other state with regard to several NAAQS, including the 1997 annual and 2006 24-hour PM2.5 NAAQS.2

    2 Federal Implementation Plans; Interstate Transport of Fine Particulate Matter and Ozone and Correction of SIP Approvals, 76 FR 48208 (August 8, 2011) (codified as amended at 40 CFR 52.38 and 52.39 and 40 CFR part 97).

    CSAPR replaced the Clean Air Interstate Rule (CAIR) which was promulgated in 2005 for the 1997 PM2.5 and 1997 ozone NAAQS (May 12, 2005, 70 FR 25172). CAIR was remanded to the EPA by the D.C. Circuit in North Carolina v. EPA, 531 F.3d 896 (D.C. Cir. 2008), modified on reh'g, 550 F.3d 1176. For more discussion on CSAPR and CAIR, please see EPA's August 8, 2011 CSAPR final rulemaking action (76 FR 48208).

    To address Texas' transport obligation under CAA section 110(a)(2)(D)(i)(I) with regard to the 1997 annual PM2.5 NAAQS, CSAPR established Federal Implementation Plan (FIP) requirements for affected electric generating units (EGUs) in Texas, including emissions budgets that apply to the EGUs' collective annual emissions of sulfur dioxide (SO2) and nitrogen oxides (NOX).3 In July 2015, the D.C. Circuit issued a decision on a range of challenges to CSAPR in EME Homer City Generation, L.P. v. EPA (EME Homer City II) denying most claims but remanding several CSAPR emissions budgets to the EPA for reconsideration, including the Phase 2 SO2 budget for Texas.4 To address the Phase 2 SO2 budget remand we issued a final rule withdrawing the FIP provisions that required affected EGUs in Texas to participate in Phase 2 of the CSAPR trading programs for annual emissions of SO2 and NOX (82 FR 45481, September 29, 2017). In that final rule we also determined that emissions 5 from sources in Texas will not contribute significantly to nonattainment in, or interfere with maintenance by, any other state with regard to the 1997 PM2.5 NAAQS and that we therefore have no obligation to issue new FIP requirements for Texas sources to address transported PM2.5 pollution under CAA section 110(a)(2)(D)(i)(I) with regard to that NAAQS.

    3 With regard to the 2006 24-hour PM2.5 NAAQS, we noted in the CSAPR final rule that (1) analysis shows that Texas would significantly contribute to nonattainment of the 24-hour PM2.5 NAAQS in another state, but we did not promulgate a CSAPR FIP for Texas EGUs with respect to that standard; and (2) the CSAPR FIP requirements for Texas with regard to the 1997 annual standard would address the emissions in Texas that significantly contribute to nonattainment and interfere with maintenance of the 24-hour PM2.5 NAAQS in another state (76 FR at 48243, 48214, August 8, 2011).

    4EME Homer City Generation, L.P. v. EPA (EME Homer City II), 795 F.3d 118, 138 (D.C. Cir. 2015). The court also remanded the Phase 2 SO2 budgets for three other states and the Phase 2 ozone-season NOX budgets for eleven states, including Texas. Id.

    5 The term “emissions” refers to all anthropogenic emissions originating from the state, including EGU emissions.

    B. Texas SIP Submittals Pertaining to the PM2.5 NAAQS and Interstate Transport of Air Pollution

    Relevant to this proposed action, Texas made the following SIP submittals to address CAA requirements to prohibit emissions which will significantly contribute to nonattainment or interfere with maintenance of the 1997 and 2006 PM2.5 NAAQS in other states: (1) An April 4, 2008 submittal stating that the State had addressed any potential CAA section 110(a)(2) infrastructure issues associated with the 1997 PM2.5 NAAQS, including the four sub-elements for interstate transport (CAA section 110(a)(2)(D)(i)), (2) a separate but similar May 1, 2008 submittal which discussed how the four sub-elements of the good neighbor provision were addressed with respect to the 1997 PM2.5 NAAQS, and (3) a November 23, 2009 submittal which addressed all the CAA section 110(a)(2) infrastructure elements, including the four sub-elements of the good neighbor provision, for the 2006 PM2.5 NAAQS. The SIP submittals may be accessed through the www.regulations.gov website (Docket EPA-R06-OAR-2016-0716). In these SIP revisions, Texas relied on its participation in the CAIR program to conclude that the State had addressed its obligation to prohibit emissions which will significantly contribute to nonattainment or interfere with maintenance of the 1997 and 2006 PM2.5 NAAQS in other states.

    For the reasons described below, this action proposes to approve the state's three SIP submittals with respect to the state's conclusions regarding the first two sub-elements of the good neighbor provisions at CAA section 110(a)(2)(D)(i)(I) for the 1997 and 2006 PM2.5 NAAQS. In 2011, we originally proposed to disapprove the portion of the November 23, 2009 submittal that intended to demonstrate that the SIP met the requirements of CAA section 110(a)(2)(D)(i)(I) for the 2006 PM2.5 NAAQS (71 FR 20602, April 13, 2011). However, in a separate Federal Register action published in conjunction with this current proposal we are withdrawing that original proposal and in this notice we now are proposing to approve the same portion of the submittal. See Docket No. EPA-R06-OAR-2011-0335 in www.regulations.gov.

    II. The EPA's Evaluation

    Each of the above-referenced Texas SIP submittals relied on the State's participation in the CAIR allowance trading programs to support a conclusion that the Texas SIP had adequate provisions to prohibit emissions which will significantly contribute to nonattainment or interfere with maintenance of the 1997 and 2006 PM2.5 NAAQS in any other state. While CAIR was still in place at the time the State submitted its SIPs, the CAIR rule had been remanded by the D.C. Circuit in 2008 based on the Court's conclusion that the rule was “fundamentally flawed” and must be replaced “from the ground up.” North Carolina, 531 F.3d 929-30, modified, 550 F.3d 1176 (2008). Moreover, we began implementation of CSAPR in 2015, and therefore neither the states nor EPA are currently implementing the annual SO2 and NOX trading program promulgated in CAIR. Accordingly, we cannot approve the State's SIP submissions based on the implementation of CAIR that sought to address the provisions of the good neighbor provision for any NAAQS. However, more recent information discussed in detail below, provides support for our proposed approval of the conclusions in the SIP submittals that the State will not significantly contribute to nonattainment or interfere with maintenance of these NAAQS in any other state.

    Air quality modeling conducted for the 2011 CSAPR rulemaking projected the effect of emissions on ambient air quality monitors (receptors). The modeling projected that a receptor located in Madison County, Illinois (monitor ID 171191007) would have difficulty attaining and maintaining both the 1997 and 2006 PM2.5 NAAQS in 2012 (76 FR 48208, 48233 and 48235). The modeling also showed that Texas emissions were projected to contribute more than the threshold amount of PM2.5 pollution necessary in order to be considered “linked” to the Madison County receptor for the 1997 and 2006 PM2.5 NAAQS (76 FR 48208, 48239-43). This was the only PM2.5 receptor with projected air quality problems to which Texas was found to be linked.

    In CSAPR we used air quality projections for the year 2012, which was also the intended start year for implementation of the CSAPR Phase 1 EGU emission budgets, to identify receptors projected to have air quality problems. The CSAPR final rule record also contained air quality projections for 2014, which was the intended start year for implementation of the CSAPR Phase 2 EGU emission budgets. The 2014 modeling results projected that the Madison County receptor would have maximum “design values” of 15.02 μg/m3 for annual PM2.5 of and 35.3 μg/m3 for 24-hour PM2.5 before considering the emissions reductions anticipated from implementation of CSAPR.6 These values are below the values of 15.05 and 35.5 μg/m3 that we used to determine whether a particular PM2.5 receptor should be identified as having air quality problems that may trigger transport obligations in upwind states with regard to the 1997 annual or 2006 24-hour PM2.5 NAAQS, respectively (82 FR 45481, 45485-86, September 29, 2017).

    6 Design values are used to determine whether a NAAQS is being met. See projected 2014 base case maximum design values for Madison County, Illinois receptor 171191007 at pages B-41 and B-70 of the June 2011 Air Quality Modeling Final Rule Technical Support Document for CSAPR, Document ID No. EPA-HQ-OAR-2009-0491-4140, available in the docket for this proposed action.

    As noted above, in our September 29, 2017 final rule addressing the remand for the annual SO2 and NOX emissions budgets we determined that emissions from Texas sources will not contribute significantly to nonattainment in, or interfere with maintenance by, any other state with regard to the 1997 PM2.5 NAAQS (82 FR 45481, September 29, 2017). As explained in the separate September 29, 2017 action, our 2014 base case modeling in the CSAPR final rule also showed that (1) the Madison County receptor was projected to no longer have air quality problems sufficient to trigger transport obligations with regard to the 2006 24-hour PM2.5 NAAQS and (2) no other 24-hour PM2.5 receptors with projected air quality problems were linked to Texas. Due to those findings, we now propose to determine that emissions from Texas sources will not contribute significantly to nonattainment in, or interfere with maintenance by, any other state with regard to the 2006 24-hour PM2.5 NAAQS. Given the determination for the 1997 annual PM2.5 NAAQS made in the September 29, 2017 final rule and our proposed determination for the 2006 24 PM2.5 NAAQS, we are now proposing to approve the portions of three Texas SIP submittals to the extent they conclude that the state has addressed interstate transport of air pollution which will significantly contribute to nonattainment or interfere with maintenance of the 1997 and 2006 PM2.5 NAAQS in other states.

    Based on our analysis of the modeling data from the 2011 CSAPR rulemaking provided above, we are proposing to approve the relevant portions of the Texas SIP submittals that Texas emissions will not significantly contribute to nonattainment or interfere with maintenance of the 1997 and 2006 PM2.5 NAAQS in other states. It should be noted, as discussed above, that we are not proposing to approve the State's analyses to the extent they rely on the State's prior participation in the CAIR allowance trading program, nor are we are proposing to approve any Texas SIP revisions that pertain to implementation of CAIR.

    III. Proposed Action

    We are proposing to approve portions of three Texas SIP submittals pertaining to the CAA section 110(a)(2)(D)(i)(I) requirements based on our conclusion, which is consistent with the state's ultimate conclusion, that emissions from Texas will not significantly contribute to nonattainment or interfere with maintenance of the 1997 and 2006 PM2.5 NAAQS in other states. Specifically, we propose to approve (1) the portions of the April 4, 2008 and May 1, 2008 SIP submittals for the 1997 PM2.5 NAAQS and (2) the portion of the November 23, 2009 submittal for the 2006 PM2.5 NAAQS, as they pertain to CAA section 110(a)(2)(D)(i)(I).

    IV. Statutory and Executive Order Reviews

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

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

    • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

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

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

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

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

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

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

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

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

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

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Particulate matter.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: February 7, 2018. Anne Idsal, Regional Administrator, Region 6.
    [FR Doc. 2018-02894 Filed 2-13-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2017-0389; FRL-9974-45—Region 4] Air Plan Approval; KY: Removal of Reliance on Reformulated Gasoline in the Kentucky Portion of the Cincinnati-Hamilton Area AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted on September 13, 2017, by the Commonwealth of Kentucky, through the Kentucky Division for Air Quality (KDAQ) in support of the Commonwealth's separate petition requesting that EPA remove the federal reformulated gasoline (RFG) requirements for Boone, Campbell, and Kenton counties in the Kentucky portion of the Cincinnati-Hamilton, Ohio-Kentucky-Indiana 2008 8-hr ozone maintenance area (hereinafter referred to as the “Northern Kentucky Area” or “Area”). The SIP revision revises the Commonwealth's maintenance plan emissions inventory and associated motor vehicle emissions budgets (MVEBs) to remove reliance on emissions reductions from the federal RFG program requirements; a program that the Commonwealth voluntarily opted into in 1995. The SIP revision also includes a non-interference demonstration evaluating whether removing reliance on the RFG requirements in the Northern Kentucky Area would interfere with the requirements of the Clean Air Act (CAA or Act). EPA is proposing to approve this SIP revision and the corresponding non-interference demonstration because EPA has preliminarily determined that the revision is consistent with the applicable provisions of the CAA.

    DATES:

    Comments must be received on or before March 7, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R04-OAR-2017-0389 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Dianna Myers, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. Ms. Myers can be reached via telephone at (404) 562-9207 or via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. What action is being proposed?

    This rulemaking proposes to approve Kentucky's September 13, 2017, SIP revision in support of Kentucky's petition to opt-out of the federal RFG requirements in Boone, Campbell, and Kenton Counties.1 Specifically, EPA is proposing to approve Kentucky's changes to the maintenance plan mobile emissions inventory and the associated MVEBs related to its redesignation request for the Kentucky portion of the Cincinnati-Hamilton 2008 8-hour ozone maintenance area to reflect removal of reliance on federal RFG requirements. As part of this proposed approval, EPA is also proposing to find that the Commonwealth has demonstrated that removing the federal RFG requirements in Boone, Campbell, and Kenton Counties will not interfere with attainment or maintenance of any national ambient air quality standards (NAAQS or standard) or with any other applicable requirement of the CAA.

    1 Pursuant to 40 CFR 80.72(b), the Governor must submit a petition to the EPA Administrator requesting removal of any opt-in areas from the federal RFG program. The petition must include certain specified information and any additional information requested by the Administrator. As fully described in section III below, if RFG is relied upon as a control measure in any approved SIP or plan revision, the federal RFG program opt-out regulations require that a SIP revision must be submitted. Kentucky's maintenance plan relied upon RFG; as a result, Kentucky submitted this SIP revision. The decision on whether to grant the opt-out petition pursuant to 40 CFR 80.72(b) is at the discretion of the Administrator and will be made through a separate action.

    On August 26, 2016, Kentucky submitted a 2008 8-hour ozone redesignation request and maintenance plan for the Cincinnati-Hamilton Area, which EPA approved on July 5, 2017 (82 FR 30976).2 With its redesignation request, Kentucky included a maintenance demonstration plan that estimates emissions through 2030 that modeled RFG because Kentucky previously opted into the RFG program. However, through this SIP revision, KDAQ is updating the mobile (on-road and non-road) emissions inventory for that maintenance plan (including the MVEBs) to reflect Kentucky's petition to opt-out of the RFG requirements for Boone, Campbell, and Kenton counties in the Northern Kentucky Area. The updates are summarized in Kentucky's submittal.

    2 The Cincinnati-Hamilton, OH-KY-IN Area is composed of portions of Boone, Campbell, and Kenton Counties in Kentucky; Butler, Clermont, Clinton, Hamilton and Warren Counties in Ohio; and a portion of Dearborn County in Indiana. This action only pertains to the Kentucky portion of the maintenance area.

    In support of the September 13, 2017, SIP revision, Kentucky has evaluated whether removing reliance on the federal RFG requirements would interfere with air quality in the Area. To make this demonstration of noninterference, Kentucky completed a technical analysis, including modeling, to estimate the change in emissions that would result from removing RFG from Boone, Campbell, and Kenton Counties in the Northern Kentucky Area.

    In the noninterference demonstration, Kentucky used EPA's Motor Vehicle Emissions Simulator (MOVES) to develop its projected emissions inventory according to EPA's guidance for on-road mobile sources using MOVES version 2014a.3 Future-year on-road mobile source emissions estimates for volatile organic compounds (VOC) and nitrogen oxides (NOX) for years 2020 and 2030 were generated with MOVES2014a without RFG. Emissions estimates were interpolated for the year 2025. The noninterference demonstration showed compliance with and maintenance of the 2008 8-hour ozone NAAQS by showing that current and future emissions of NOX and VOC remain at or below the 2014 base year emissions inventory without the use of RFG. For more detailed information on the current approved maintenance plan, see EPA's May 1, 2017 (82 FR 20297), proposed approval of Kentucky's maintenance plan for the 2008 8-hour ozone NAAQS.

    3 Kentucky used the NONROAD 2008 model within MOVES2014a to develop the non-road emissions inventory to reflect the emissions changes from removing RFG from the Northern Kentucky Area. Table 1 reflects the emissions changes.

    In this action, EPA is proposing to approve the revision to the Commonwealth's maintenance plan emissions inventory and associated MVEBs to remove reliance on emissions reductions from the federal RFG program requirements, and to find that Kentucky's noninterference demonstration supports the conclusion that removal of reliance on federal RFG requirements in Boone, Campbell, and Kenton Counties in the Northern Kentucky Area will not interfere with attainment or maintenance of any NAAQS or with any other applicable requirement of the CAA.

    II. What is the background for the Northern Kentucky area?

    Northern Kentucky was included in the Cincinnati-Hamilton Area which was originally designated as a moderate nonattainment area for the 1-hour ozone standard on November 6, 1991 (56 FR 56694). In 1995, Kentucky voluntarily opted into the RFG program under Phase I of a two-phase nationwide program to reduce the volatility of commercial gasoline during the summer ozone season. Kentucky elected to stay in the program under Phase II which was more stringent than Phase I.

    On July 18, 1997, EPA promulgated a revised 8-hr ozone standard of 0.08 parts per million (ppm). This standard was more stringent than the 1-hour ozone standard. On June 19, 2000 (65 FR 37879), the Cincinnati-Hamilton 1-hour nonattainment Area was redesignated as attainment for the 1-hour ozone NAAQS, and was considered to be a maintenance area subject to a CAA section 175A maintenance plan for the 1-hour ozone NAAQS. On April 30, 2004, EPA designated the Cincinnati-Hamilton OH-KY-IN Area under subpart 1 as a “basic” 1997 8-hour ozone NAAQS nonattainment area (69 FR 23857).4 On August 5, 2010 (75 FR 47218), the Kentucky portion of the Cincinnati-Hamilton 1997 8-hour ozone area was redesignated to attainment. On March 12, 2008, EPA revised both the primary and secondary NAAQS for ozone to a level of 0.075 ppm to provide increased protection of public health and the environment. See 73 FR 16436 (March 27, 2008). The 2008 ozone NAAQS retains the same general form and averaging time as the 0.08 ppm NAAQS set in 1997, but is set at a more protective level. Under EPA's regulations at 40 CFR part 50, the 2008 8-hour ozone NAAQS is attained when the 3-year average of the annual fourth highest daily maximum 8-hour average ambient air quality ozone concentrations is less than or equal to 0.075 ppm. See 40 CFR 50.15.

    4 The 1997 8-hour ozone area included in its entirety Boone, Campbell, and Kenton Counties in Kentucky and Butler, Clermont, Clinton, Hamilton and Warren Counties in Ohio; and a portion of Dearborn County in Indiana.

    Effective July 20, 2012, EPA designated any area that was violating the 2008 8-hour ozone NAAQS based on the three most recent years (2008-2010) of air monitoring data as a nonattainment area. See 77 FR 30088 (May 21, 2012). The Cincinnati-Hamilton, OH-KY-IN Area was designated as a marginal ozone nonattainment area.5 See 40 CFR 81.318. Areas that were designated as marginal nonattainment areas were required to attain the 2008 8-hour ozone NAAQS as expeditiously as possible but no later than July 20, 2015, based on 2012-2014 monitoring data. On May 4, 2016 (81 FR 26697), EPA published its determination that the Cincinnati-Hamilton, OH-KY-IN Area had attained the 2008 8-hour ozone NAAQS by the attainment deadline.

    5 The 2008 8-hr ozone area included portions of Boone, Campbell, and Kenton Counties; Butler, Clermont, Clinton, Hamilton and Warren Counties in its entirety in Ohio; and a portion of Dearborn County in Indiana.

    III. What is the history of the reformulated gasoline requirement?

    The 1990 amendments to the CAA designed the RFG program to reduce ozone levels in the largest metropolitan areas in the country with the worst ground-level ozone or smog problems by reducing vehicle emissions of compounds that form ozone, specifically VOC. The 1990 CAA amendments, specifically section 211(k)(5), directed EPA to issue regulations that specify how gasoline can be “reformulated” so as to result in significant reductions in vehicle emissions of ozone-forming and toxic air pollutants relative to the 1990 baseline fuel, and to require the use of such reformulated gasoline in certain “covered areas.” The Act defined certain nonattainment areas as “covered areas” which are required to use RFG and provided other areas with an ability to “opt-in” to the federal RFG program.6 Of relevance here is CAA section 211(k)(6), which provides that upon application of the Governor of a State, the Administrator shall apply the prohibition contained in section 211(k)(5) for areas to “opt-in” to the federal RFG program. In 1993,7 the Governor of the Commonwealth of Kentucky petitioned the Administrator to “opt-in” to the RFG program for the Northern Kentucky Area which consisted of Boone, Campbell, and Kenton Counties.

    6 CAA section 211(k)(5) prohibits the sale of conventional gasoline (i.e., gasoline that the EPA has not certified as reformulated) in certain ozone nonattainment areas beginning January 1, 1995. CAA section 211(k)(10)(D) defines the areas initially covered by the federal RFG program as ozone nonattainment areas having a 1980 population in excess of 250,000 and having the highest ozone design values during the period 1987 through 1989. In addition, under CAA section 211(k)(10)(D), any area reclassified as a severe ozone nonattainment area under CAA section 181(b) is also included in the federal RFG program.

    7 A copy of Kentucky's letter is included in the docket.

    EPA first published regulations for the federal RFG program on February 16, 1994 (59 FR 7716). These regulations constituted Phase I of a two-phase nationwide program. A current listing of the RFG requirements for states can be found on EPA's website at: https://www.epa.gov/gasoline-standards. The federal RFG regulations also contain provisions, at 40 CFR 80.72, establishing criteria and procedures for opting out of the program for those states that had previously voluntarily opted into the program (“opt-out provisions”). For example, the opt-out provisions require that a governor, or his or her authorized representative, submit an opt-out petition to the Administrator of the Agency. The opt-out petition must include certain information, including a description of how, if at all, reformulated gasoline has been relied upon as a control measure in any state or local implementation plan or in any proposed plan that is pending before EPA. This would include, for example, attainment as well as maintenance plans. The petition must also include an explanation of whether the state is intending to submit a revision to an approved or pending plan that does not use RFG as a control measure, and a description of alternative air quality measures, if any, that will replace the use of RFG; a description of the current status of any proposed revision to an approved or pending plan that uses RFG; and a projected schedule for the plan revision submission. See 40 CFR 80.72(b)(3) and (b)(4).

    On April 18, 2017, Kentucky submitted a petition to the EPA Administrator requesting to opt-out of the federal RFG program in the Northern Kentucky Area and as stated above, this SIP revision is submitted in support of that petition (particularly the requirements of 40 CFR 80.72(b)(3) and (b)(4)).8 Kentucky's opt-out petition will be acted on by the Administrator in a separate action, and if approved in that separate action, will establish the effective date of the opt-out, which cannot be less than 90 days from the effective date of the approval of the SIP revision that is the subject of today's proposal. EPA will also publish a notice in the Federal Register to notify the public of the effective date of any opt-out approval.

    8 A copy of the opt-out petition is included in the docket.

    IV. What are the section 110(l) requirements?

    The modeling associated with KDAQ's maintenance plan for the 2008 8-hour ozone NAAQS is premised upon the future-year emissions estimates for 2017, 2020, and 2030, which are based on the RFG requirement. To support Kentucky's requested SIP revision to remove the maintenance plan's reliance on the federal RFG requirements in Boone, Campbell, and Kenton Counties, the Commonwealth must demonstrate that the requested change will satisfy section 110(l) of the CAA. Section 110(l) requires that a revision to the SIP not interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in section 171), or any other applicable requirement of the Act. Kentucky submitted a non-interference demonstration with this SIP revision and EPA is proposing to find that the analysis demonstrates noninterference based on an evaluation of current air quality monitoring data and the information provided in the noninterference demonstration.

    EPA evaluates each section 110(l) noninterference demonstration on a case-by-case basis considering the circumstances of each SIP revision. EPA interprets section 110(l) as applying to all NAAQS that are in effect, including those that have been promulgated but for which EPA has not yet made designations. The degree of analysis focused on any particular NAAQS in a noninterference demonstration varies depending on the nature of the emissions associated with the proposed SIP revision. EPA's section 110(l) analysis of the noninterference demonstration included as part of Kentucky's September 13, 2017, SIP revision is provided below.

    V. What is EPA's analysis of Kentucky's submittal? a. Overall Preliminary Conclusions Regarding Kentucky's Noninterference Analyses

    The RFG program is designed to reduce ozone levels and air toxics in areas that are required to or volunteered to adopt the program. RFG gasoline reduces motor vehicle emissions of the ozone precursors, NOX and VOC (mainly VOC), through fuel reformulation. On September 13, 2017, KDAQ submitted a SIP revision along with a corresponding noninterference demonstration to support Kentucky's separate petition to opt-out of the RFG requirements for Boone, Campbell, and Kenton Counties. This noninterference demonstration includes an evaluation of the impact that removing RFG from these counties would have on the Area's ability to attain or maintain the 2008 ozone NAAQS and any other NAAQS in the Kentucky Area.9 Kentucky's noninterference analysis also evaluated the impact of the removal of RFG on the Area's ability to attain or maintain the ozone, particulate matter (PM),10 nitrogen dioxide (NO2), sulfur dioxide (SO2), and carbon monoxide (CO) NAAQS.

    9 The six NAAQS for which EPA establishes health and welfare based standards are CO, lead, NO2, ozone, PM, and SO2. RFG requirements do not have an impact on actual or modeled lead emissions.

    10 PM is composed of PM2.5 and PM10.

    KDAQ's noninterference analysis utilized EPA's MOVES2014a emission modeling system to estimate emissions for years 2017, 2020, and 2030 for on-road and non-road mobile sources. See Appendix E-1 and E-2 of the September 13, 2017, submittal for detailed modeling protocol.11 The NONROAD2008 model within MOVES2014a was used to model the non-road sources. These mobile source emissions are used as part of the evaluation of the potential impacts to the NAAQS that might result exclusively from removing the RFG requirements. NOX and VOC emissions were calculated for a typical summer July day.

    11 The modeling results and original emissions inventories for the 2008 8-hr Redesignation Request and Maintenance Plan is included in the docket.

    As summarized in Tables 1 and 2, below, the MOVES model projects small increases in on-road mobile source VOC and NOX emissions in the Northern Kentucky portion of the Cincinnati-Hamilton OH-IN-KY 2008 8-hour Ozone Area from removing the federal RFG requirements. On-road mobile sources include vehicles used on roads for transportation of passengers or freight. Daily on-road mobile VOC emissions are projected to increase by 0.25 ton in 2017 down to 0.05 ton in 2030 during the high ozone season.12 Daily on-road NOX emissions are projected to increase by 0.29 ton in 2017 down to 0.06 ton in 2030. The modeling shows an overall downward trend in on-road emissions from removing RFG from the area. Daily VOC emissions decrease by 64.5 percent and daily NOX emissions decrease by 74.6 percent.

    12 High ozone season begins June 1st and ends September 15th of each year.

    Table 1—On-Road VOC Emissions RFG vs. Non-RFG Tons per Summer Day [TSD] Counties 2014 RFG 2017 RFG Non-RFG 2020 RFG Non-RFG 2025 RFG Non-RFG 2030 RFG Non-RFG Boone 2.53 2.00 2.09 1.53 1.58 1.19 1.23 0.86 0.87 Campbell 1.58 1.18 1.23 0.90 0.93 0.70 0.73 0.51 0.52 Kenton 2.39 2.10 2.21 1.61 1.66 1.25 1.29 0.90 0.92 NKY Totals 13 6.50 5.28 5.53 4.03 4.18 3.14 3.25 2.26 2.31 Emissions Increase 0.25 0.15 0.11 0.05 Table 2—On-Road NOX Emissions RFG vs. Non-RFG Tons per Summer Day [TSD] Counties 2014 RFG 2017 RFG Non-RFG 2020 RFG Non-RFG 2025 RFG Non-RFG 2030 RFG Non-RFG Boone 5.46 4.49 4.58 3.20 3.26 2.28 2.32 1.36 1.38 Campbell 3.41 2.55 2.60 1.82 1.86 1.30 1.32 0.77 0.78 Kenton 5.17 4.54 4.69 3.24 3.30 2.30 2.35 1.37 1.40 NKY Totals 14.04 11.58 11.87 8.26 8.42 5.88 5.99 3.50 3.56 Emissions Increase 0.29 0.16 0.11 0.06

    Tables 3 and 4, below, show the total projected emissions of VOC and NOX from all sectors in the Northern Kentucky portion of the Cincinnati-Hamilton OH-KY-IN 2008 8-hour Ozone Area. Kentucky's emissions inventory for its portion of the Area provides 2011 anthropogenic emissions data for NOX and VOC for the following general source categories: Point (Electric Generating Units and Non-Electric Generating Units and aircraft emissions),14 area, non-road mobile, and on-road mobile. All emissions information provided is based on the partial county boundaries, through the applicable census tracts, that comprise the Kentucky portion of the Area. Tables 3 and 4, below, provides a summary of the emissions inventory.

    13 The totals in the column may differ slightly from the submittal due to how the decimal places were truncated.

    14 The emissions inventories in Kentucky's submission identify aircraft emissions as a standalone category and refer to these emissions as “air emissions” for consistency with the inventories provided by Indiana and Ohio for their respective portions of the Area. Indiana Department of Environmental Management (IDEM) provided aircraft emissions data for Kentucky, and Kentucky included these emissions in Boone County where the Cincinnati/Northern Kentucky International Airport is located. EPA has included these emissions within the point source category per the AERR.

    Emissions reported for 2014 assume the use of RFG for Boone, Campbell, and Kenton Counties whereas emissions from 2017 through 2030 assume no RFG.

    Table 3—Total VOC Emissions Projections All Sectors Northern Kentucky Area [TSD] VOC 2014 2017 2020 2025 2030 BOONE: EGU 0.16 0.16 0.16 0.16 0.16 Non-EGU 1.57 1.57 1.57 1.57 1.57 Air 0.42 0.44 0.45 0.26 0.06 Non-road * 1.30 ** 2.25 ** 2.06 ** 2.04 ** 2.01 Area 2.56 2.46 2.41 2.38 2.36 On-road * 2.53 ** 2.09 ** 1.58 ** 1.23 ** 0.87 Total 8.54 8.97 8.23 7.63 7.03 CAMPBELL: EGU 0.00 0.00 0.00 0.00 0.00 Non-EGU 0.22 0.22 0.22 0.22 0.21 Air 0.00 0.00 0.00 0.00 0.00 Non-road * 0.34 ** 0.55 ** 0.50 ** 0.49 ** 0.48 Area 1.26 1.23 1.22 1.21 1.19 On-road * 1.58 ** 1.23 ** .93 ** 0.73 ** 0.52 Total 3.4 3.23 2.87 2.65 2.40 KENTON: EGU 0.00 0.00 0.00 0.00 0.00 Non-EGU 0.51 0.50 0.49 0.48 0.47 Air 0.00 0.00 0.00 0.00 0.00 Non-road * 0.55 ** 1.01 ** 1.00 ** 1.05 ** 1.09 Area 2.43 2.35 2.31 2.28 2.25 On-road * 2.39 ** 2.21 ** 1.66 ** 1.29 ** 0.92 Total 5.88 6.07 5.46 5.10 4.73 NKY Total 17.82 18.27 16.56 15.38 14.16 * With RFG. ** Without RFG. Table 4—Total NOX Emissions Projections All Sectors Northern Kentucky Area [TSD] NOX 2014 2017 2020 2025 2030 BOONE: EGU 7.23 7.46 7.71 7.96 8.33 Non-EGU 0.14 0.15 0.15 0.18 0.18 Air 2.07 2.18 2.29 1.29 0.29 Non-road * 0.88 ** 1.60 ** 1.33 ** 1.17 ** 1.00 Area 0.43 0.43 0.43 0.44 0.44 On-road * 5.46 ** 4.58 ** 3.26 ** 2.32 ** 1.38 Total 16.21 16.40 15.17 13.35 11.62 CAMPBELL: EGU 0.00 0.00 0.00 0.00 0.00 Non-EGU 0.17 0.17 0.17 0.17 0.17 Air 0.00 0.00 0.00 0.00 0.00 Non-road * 0.32 ** 0.53 ** 0.45 ** 0.40 ** 0.35 Area 0.49 0.49 0.49 0.49 0.49 On-road * 3.41 ** 2.60 ** 1.86 ** 1.32 ** 0.78 Total 4.39 3.79 2.97 2.38 1.79 KENTON: EGU 0.00 0.00 0.00 0.00 0.00 Non-EGU 0.01 0.01 0.01 0.01 0.01 Air 0.00 0.00 0.00 0.00 0.00 Non-road * 0.64 ** 1.12 ** 0.93 ** 0.83 ** 0.73 Area 1.02 1.02 1.02 1.02 1.02 On-road * 5.17 ** 4.69 ** 3.30 ** 2.35 ** 1.40 Total 6.84 6.84 5.26 4.20 3.15 NKY Total 27.44 27.03 23.40 19.93 16.56 * With RFG. ** Without RFG.

    There were little to no changes in NOX and VOC emissions from the point source categories that would impact the RFG removal in the Northern Kentucky Area. The original point source categories inventory contains actual point source emissions data for facilities located within the nonattainment boundary for the Kentucky portion of the Area based on the Kentucky Emissions Inventory database.15

    15 As discussed above, EPA has included aircraft emissions within the point source category per the AERR.

    Area sources are small emission stationary sources which, due to their large number, collectively have significant emissions (e.g., dry cleaners, service stations). The modeling results show a reduction in VOC emissions and little to no change in NOX emissions by removing RFG from these sources

    Non-road mobile sources include vehicles, engines, and equipment used for construction, agriculture, recreation, and other purposes that do not use roadways (e.g., lawn mowers, construction equipment, and railroad locomotives). Modeling results indicate there are slight VOC emissions increases from removing RFG. From 2017 to 2030, the VOC emissions increases fall within a range of 0.22 tsd to 0.24 tsd in the Northern Kentucky Area. The NOX emissions remain the same from 2017 to 2030 when RFG is removed. See Appendix E-2 of the submittal.16

    16 Appendix E-2 of the September 13, 2017 submittal details the increases in non-road emissions with and without RFG.

    Overall, the modeling shows VOC emissions decrease from the 2014 attainment year to the 2030 “out year” by 3.66 tsd which is a 20.5 percent reduction. NOX emissions also decrease from the 2014 attainment year to the 2030 “out year” by 10.88 tsd which is a 39.7 percent NOX reduction without RFG in the Northern Kentucky portion of the Cincinnati-Hamilton OH-KY-IN Area 2008 8-hour Ozone Area.

    b. Noninterference Analysis for the Ozone NAAQS

    As a previous 1-hour ozone nonattainment area, Kentucky opted Boone, Campbell, and Kenton Counties into the federal RFG requirements for high ozone season gasoline to help bring the area into attainment for the 1-hour ozone NAAQS. This control measure continues to apply in the Northern Kentucky Area because the Commonwealth did not, until now, petition for the removal of the federal RFG requirements. The RFG program has contributed toward lowering VOC and NOX emissions in the Northern Kentucky Area. Implementation of federal control measures such as Tier 3 Motor Vehicle Emissions and Fuel Standards,17 Heavy-Duty Engine and Vehicle Standards and Highway Diesel Fuel Sulfur Control Requirements,18 Greenhouse Gas Emissions and Fuel Efficiency Standards for Medium and Heavy-Duty Engines and Vehicles-Phase 2,19 and Model Year 2017 and Later Light-Duty Vehicle Greenhouse Gas Emissions and Corporate Average Fuel Economy Standards,20 along with fleet turnover, further reduced NOX and VOC emissions in the area. As a result, the Northern Kentucky Area was redesignated to attainment for the 1-hour ozone NAAQS, the 1997 8-hour ozone NAAQS, and the 2008 8-hour ozone NAAQS. The Northern Kentucky Area is continuing to meet the 1-hour ozone NAAQS and the 1997 8-hour ozone NAAQS, even though these NAAQS have been revoked,21 as well as the 2008 8-hour ozone NAAQS, based on recent air quality monitoring data.22 The 2008 ozone NAAQS is met when the annual fourth-highest daily maximum 8-hour average concentration, averaged over 3 years is 0.075 ppm or less. The 2015 ozone NAAQS, as published in a final rule on October 26, 2015 (80 FR 65292), is met when the annual fourth-highest daily maximum 8-hour average concentration, averaged over 3 years is 0.070 ppm or less. The trend in monitoring levels for ozone for the Northern Kentucky portion of the Cincinnati-Hamilton OH-KY-IN Area is shown in Table 5, with the current monitoring levels for the Boone and Kenton County monitors for the period of 2014-2016 being 0.062 ppm and 0.070 ppm, respectively.

    17 79 FR 23414.

    18 66 FR 5002.

    19 81 FR 73478.

    20 77 FR 62624.

    21 70 FR 44470 and 80 FR 12264, respectively.

    22 On May 4, 2016 (81 FR 26697), EPA determined the Cincinnati-Hamilton, OH-KY-IN Area attained the 2008 8-hr ozone NAAQS by the attainment date.

    Table 5—Monitoring Level Concentrations for the Northern Kentucky Area [ppm] Location Site ID 4th Highest 8-hour ozone value
  • (ppm)
  • 2013 2014 2015 2016 3-Year
  • design
  • values
  • (ppm)
  • 2013-2015 3-Year
  • design
  • values
  • (ppm)
  • 2014-2016
    Boone, KY 21-015-0003 0.059 0.062 0.063 0.061 0.061 0.062 Campbell, KY 21-037-3002 0.072 0.071 0.071 0.068 0.071 0.070

    EPA also evaluated the potential increase in the VOC and NOX precursor emissions and whether it is reasonable to conclude that the requested removal of the RFG requirements in Northern Kentucky during the high ozone season would cause the Area to violate any ozone NAAQS. Table 5 shows that there is an overall downward trend in ozone concentrations in the Northern Kentucky Area. This decline can be attributed to federal and state programs in addition to those mentioned above that have led to significant emissions reductions in ozone precursors, such as the federal interstate transport rule known as the Cross State Air Pollution Rule (CSAPR), federal standards in on-road and non-road mobile source sectors such as the Corporate Average Fuel Economy (CAFÉ) standards (See 75 FR 25324), and Tier Motor Vehicle Emissions and Fuel Standards (79 FR 23414). Given the results of Kentucky's emissions analysis, the downward trend in precursor emissions, and the current ozone concentrations in the Northern Kentucky Area, EPA is proposing to find that removing reliance on RFG requirements in Boone, Campbell, and Kenton Counties will not interfere with Kentucky's ability to maintain the 2008 8-hour ozone NAAQS.

    c. Noninterference Analysis for the Carbon Monoxide NAAQS

    EPA initially established NAAQS for CO on April 30, 1971 (36 FR 8186). The standards were set at 9 ppm as an 8-hour average and 35 ppm as a 1-hour average, neither to be exceeded more than once per year. On November 6, 1971 (56 FR 56694), EPA designated areas for the 8-hour CO NAAQS. The Northern Kentucky counties of Boone, Campbell, and Kenton have never been designated nonattainment for any CO NAAQS. EPA retained the 1-hour and 8-hour CO NAAQS on August 31, 2011, and Kentucky has continued to maintain compliance with the NAAQS due to non-RFG federal control measures put in place. RFG requirements will have little to no impacts on CO emissions because, as mentioned earlier, the RFG program was developed to address emissions of the ozone precursors, NOX and VOC. As a result, EPA is proposing to find that removing reliance on RFG requirements in Boone, Campbell, and Kenton Counties will not interfere with Kentucky's ability to continue attaining the CO NAAQS.

    d. Noninterference Analysis for the Particulate Matter NAAQS

    The main precursor pollutants for PM2.5 are NOX, SO2, VOC, and ammonia. As mentioned above, the federal RFG requirements result in emissions benefits for VOC, NOX and air toxics. Over the course of several years, EPA has reviewed and revised the PM2.5 NAAQS a number of times. On July 16, 1997, EPA established an annual PM2.5 NAAQS of 15.0 micrograms per cubic meter (μg/m3), based on a 3-year average of annual mean PM2.5 concentrations, and a 24-hour PM2.5 NAAQS of 65 μg/m3, based on a 3-year average of the 98th percentile of 24-hour concentrations. See 62 FR 36852 (July 18, 1997). On September 21, 2006, EPA retained the 1997 Annual PM2.5 NAAQS of 15.0 μg/m3 but revised the 24-hour PM2.5 NAAQS to 35 μg/m3, based again on a 3-year average of the 98th percentile of 24-hour concentrations. See 71 FR 61144 (October 17, 2006). The 1997 Annual PM2.5 NAAQS has been revoked for all purposes effective October 24, 2016 (81 FR 58010). On December 14, 2012, EPA retained the 2006 24-hour PM2.5 NAAQS of 35 μg/m3 but revised the annual primary PM2.5 NAAQS to 12.0 μg/m3, based again on a 3-year average of annual mean PM2.5 concentrations. See 78 FR 3086 (January 15, 2013). The Northern Kentucky area was designated as unclassifiable/attainment on April 15, 2015 (80 FR 18535).

    PM2.5 levels across Kentucky declined from 1999 to 2016. In 2016, there were 19 PM2.5 monitors in Kentucky including one in Campbell County. The Campbell County PM2.5 monitor calculated a 3-weighted average design value of 8.9 μg/m3. The largest sources of PM2.5 in Kentucky are from fires, agriculture, dust, fuel combustion, and industrial processes.23 Moreover, there have been a number of studies which have indicated that SO2 is the primary driver of PM2.5 formation in the Southeast.24 Opting out of the RFG requirements in the Area will have little to no impact on the precursor emissions as indicated by the decline in VOC and NOX emissions in Tables 3 and 4 above.

    23https://www.epa.gov/air-emissions-inventories/air-emissions-sources.

    24See, e.g., Quantifying the sources of ozone, fine particulate matter, and regional haze in the Southeastern United States, Journal of Environmental Engineering (June 24, 2009), available at: http://www.sciencedirect.com/science/article/pii/S0301479709001893?via%3Dihub.

    Based on this information and the current attainment status of the Cincinnati-Hamilton OH-KY-IN 2012 p.m.2.5 Area, EPA is proposing to find that removing reliance on RFG requirements in Boone, Campbell, and Kenton Counties will not interfere with Northern Kentucky's ability to maintain the 2012 PM2.5 NAAQS.

    e. Noninterference Analysis for the 2010 NO2 NAAQS

    On February 9, 2010 (75 FR 6474), EPA strengthen the NO2 standards. All of the counties in Kentucky were designated unclassifiable/attainment for the 2010 NO2 NAAQS on February 17, 2012 (77 FR 9532). There are both primary and secondary standards for NO2. The primary NAAQS is an annual arithmetic mean that must not exceed 53 parts per billion (ppb). A 3-year average of the 98th percentile of daily maximum 1-hr averages must not exceed 100 ppb. The secondary standard is an annual arithmetic mean that must not exceed 53 ppb. In 2016, Kentucky operated seven NO2 monitors, including one in Campbell County. The 2014-2016 1-hr average design value for the Campbell County NO2 monitor is 30 ppb, with an annual mean of 2.31 ppb. Both of these values are significantly below the respective standards of 100 ppb and 53 ppb. Based on the technical analysis in Kentucky's September 13, 2017, noninterference demonstration, as shown in Table 4, there is a reduction in NOX emissions from the 2014 attainment year to the 2030 “out year” from 27.44 tsd to 16.56 tsd which is a 39.7 percent reduction overall.

    Based on the amount of NOX reductions, the use of pollution control devices on power plants, industrial boilers, fleet turnover, and other federal control measures for motor vehicles, EPA is proposing to find that removing reliance on RFG requirements in Boone, Campbell and Kenton Counties will not interfere with Kentucky's ability to continue attaining the 2010 NO2 NAAQS in the Northern Kentucky Area.

    f. Noninterference Analysis for the SO2 NAAQS

    On June 22, 2010 (75 FR 35520), EPA revised the SO2 standard. There are both primary and secondary standards for SO2. The primary SO2 NAAQS is a 3-year average of the 99th percentile of the daily maximum 1-hour concentration not to exceed 75 ppb. The secondary standard is a 3-hour concentration not to exceed 0.5 ppm more than once per year. In 2016, Kentucky operated 12 SO2 monitors, including one in Campbell County. The Campbell County SO2 monitor has a 2014-2016 design value of 30 ppb for the 1-hour SO2 NAAQS.

    Based on the monitoring/modeling data, EPA is proposing to find that removing reliance on RFG requirements in Boone, Campbell, and Kenton Counties will not interfere with Kentucky's ability to maintain the SO2 NAAQS.

    VI. Proposed Action

    EPA is proposing to approve Kentucky's revision to its maintenance plan and corresponding noninterference demonstration, submitted on September 13, 2017, in support of Kentucky's separate petition to opt-out of the federal RFG requirements for Boone, Campbell, and Kenton Counties. Specifically, EPA is proposing to find that this change in removing reliance on the federal RFG requirements for Boone, Campbell, and Kenton Counties will not interfere with attainment or maintenance of the NAAQS or with any other applicable requirement of the CAA. Kentucky's September 13, 2017, SIP revision updates its maintenance plan and the associated MVEBs related to Kentucky's redesignation request for the Kentucky portion of the 2008 Cincinnati-Hamilton OH-IN-KY 8-hour Ozone Area to reflect emissions changes for opting out of the federal RFG requirements. EPA is proposing to approve the changes to update the 2008 maintenance plan and associated 2020 and 2030 MVEBs. The same criteria used to develop the MVEBs in the original SIP are used for this SIP revision. See Table 6 below.

    Table 6—Updated MVEBs for the Kentucky Portion of Cincinnati-Hamilton, OH-KY-IN Area [TSD] 2020 NOX VOC 2030 NOX VOC On-Road Emissions 8.42 4.17 3.56 2.31 Safety Margin .61 .19 1.63 .55 MVEBs with Safety Margin 9.03 4.36 5.19 2.86

    EPA has preliminarily determined that Kentucky's September 13, 2017, SIP revision is consistent with the applicable provisions of the CAA, including section 110(l). In this action, EPA is not proposing to act on the Commonwealth's opt-out petition to the EPA Administrator to remove the federal RFG requirement for Boone, Campbell, and Kenton Counties. Any decision by the Administrator on the opt-out petition would occur in a separate action.

    VII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. This action merely proposes to approve changes to the Commonwealth's maintenance plan emissions inventory and associated MVEBs to remove reliance on emissions reductions from the federal RFG program requirements. For that reason, this proposed action:

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

    • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

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

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

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

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

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

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

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

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

    The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rulemaking does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law. List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: February 6, 2018. Onis “Trey” Glenn, III, Regional Administrator, Region 4.
    [FR Doc. 2018-03078 Filed 2-13-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2011-0335; FRL-9973-43—Region 6] Approval and Promulgation of Implementation Plans; Texas; Disapproval of Interstate Transport State Implementation Plan Revision for the 2006 24-hour PM2.5 NAAQS; Withdrawal of Proposed Rule AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Withdrawal of proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is withdrawing its proposed rule to disapprove the portion of the November 23, 2009 Texas State Implementation Plan (SIP) submittal that intended to demonstrate that the SIP met Clean Act (CAA) requirements to prohibit emissions which will significantly contribute to nonattainment or interfere with maintenance of the 2006 24-hour PM2.5 National Ambient Air Quality Standards (NAAQS) in other states.

    DATES:

    The proposed rule published on April 13, 2011 (76 FR 20602) is withdrawn as of February 14, 2018.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2011-0335. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733.

    FOR FURTHER INFORMATION CONTACT:

    Carl Young, (214) 665-6645, [email protected]

    SUPPLEMENTARY INFORMATION:

    In an April 13, 2011 action EPA proposed to disapprove the portion of a November 23, 2009 Texas SIP submittal that intended to demonstrate that the SIP met the requirements of CAA section 110(a)(2)(D)(i)(I) to prohibit emissions which will significantly contribute to nonattainment or interfere with maintenance of the 2006 24-hour PM2.5 NAAQS in other states (76 FR 20602). EPA is now withdrawing the proposal. In a separate Federal Register action published in conjunction with this withdrawal EPA is proposing to approve this portion of the SIP submittal. The rationale for the proposed approval is detailed in that proposal.

    Dated: February 7, 2018. Anne Idsal, Regional Administrator, Region 6.
    [FR Doc. 2018-02893 Filed 2-13-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families 45 CFR Part 1304 RIN 0970-AC63 Head Start Designation Renewal System Improvements AGENCY:

    Office of Head Start (OHS), Administration for Children and Families (ACF), Department of Health and Human Services (HHS).

    ACTION:

    Request for comments; re-issue.

    SUMMARY:

    OHS issues this request for comments to invite public feedback on information we inadvertently omitted from the “CLASS Condition of the Head Start Designation Renewal System,” request for comments, published on December 8, 2017. The document withdrawing the “CLASS Condition of the Head Start Designation Renewal System” request for comments is published elsewhere in this issue of the Federal Register. This request for comments is similar to the withdrawn publication in that it invites the public to comment on specific changes OHS is considering for the CLASS condition, as well as other Designation Renewal System (DRS) conditions and processes more broadly. Additionally, OHS seeks comments on ways it can: Incentivize robust competition to include new applicants, facilitate smooth transitions when there is a new grantee as a result of competition, and improve the DRS processes. The comment period is 30 days to allow for the public to address the additional issues in this reissued request for comments. We will consider comments submitted under the “CLASS Condition of the Head Start Designation Renewal System” request for comments.

    DATES:

    Submit comments by March 16, 2018.

    ADDRESSES:

    You may send comments, identified by [docket number and/or RIN number], by either of the following methods:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow instructions for sending comments. We prefer to receive comments via this method.

    Mail: Office of Head Start, Attention: Colleen Rathgeb, Director, Division of Planning, Oversight and Policy, 330 C Street SW, Washington, DC 20024.

    Instructions: All submissions received must include our agency name and the docket number or Regulatory Information Number (RIN) for this notice. All comments will be posted without change to https://www.regulations.gov, including any personal information provided. We accept anonymous comments. If you wish to remain anonymous, enter “N/A” in the required fields.

    FOR FURTHER INFORMATION CONTACT:

    Colleen Rathgeb, Director, Division of Planning, Oversight and Policy, Office of Head Start, [[email protected]], (202) 358-3263 (not a toll-free call). Deaf and hearing impaired individuals may call the Federal Dual Party Relay Service at 1-800-877-8339 between 8 a.m. and 7 p.m. Eastern Standard Time.

    SUPPLEMENTARY INFORMATION:

    Consistent with the December 8, 2017, publication (82 FR 57905), OHS invites public comment on several specific changes being considered for the CLASS condition of the DRS as outlined in the Head Start Program Performance Standards. We also invite public comment on other improvements to the DRS based on feedback from stakeholders, grantees, and the results of the DRS implementation evaluation. In particular, we are considering changes to the CLASS condition with a goal of improving implementation and transparency of the DRS. Changes being considered include removal of the “lowest 10 percent” provision of the CLASS condition, an increase of the minimum thresholds for the Emotional Support and Classroom Organization domains to a score of 5, removal of the minimum threshold for the Instructional Support domain, and establishment of authority for the Secretary to set an absolute minimum threshold for the Instructional Support domain prior to the start of each fiscal year to be applied for DRS CLASS reviews in the same fiscal year. OHS requests feedback on these possible changes and alternative changes to the CLASS condition. Particularly in ways the Instructional Support and other thresholds could be set and/or adjusted that would incentivize continuous program improvement while acknowledging the current state of the field. OHS also invites feedback on other conditions of the DRS and the way it is implemented.

    Background Information

    The Head Start program provides grants to local public and private non-profit and for-profit agencies to provide comprehensive education and child development services to economically disadvantaged children, from birth to age five, and families and to help young children develop the skills they need to be successful in school. Our agencies provide these families comprehensive services to support children's cognitive, social, and emotional development. In addition to education services, agencies provide children and their families with health, nutrition, social, and other services.

    To drive program quality improvement, the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, (the Act) required HHS to develop a system to facilitate designation of Head Start grantees delivering a high-quality and comprehensive program for a period of 5 years and required grantees not delivering high-quality and comprehensive services to enter open competition for continued funding. Prior to the Act, when HHS designated a Head Start agency, it remained a Head Start grantee indefinitely unless the grantee either relinquished funding or HHS terminated its grant.

    To meet the requirement in the Act, HHS established the DRS, which is described in 45 CFR 1304.10 through 16. The DRS includes seven conditions. If an agency meets any of the seven conditions, it must compete with other providers in the community for renewed grant funding. The seven conditions are: (1) A deficiency under section 641A(c)(1)(A), (C), or (D) of the Act; (2) failure to establish, utilize, and analyze children's progress on agency-established School Readiness goals; (3) scores below minimum thresholds in the Classroom Assessment Scoring System: Pre-K (CLASS) domains or in the lowest 10 percent in any of the three domains of the agencies monitored in a given year unless the average score is equal to or above the standard of excellence; (4) revocation of a license to operate a center or program; (5) suspension from the program; (6) debarment from receiving federal or state funds or disqualified from the Child and Adult Care Food Program; or (7) an audit finding of at risk for failing to continue as “a going concern.” The Act also requires HHS to periodically evaluate whether or not the DRS criteria are applied in a manner that is transparent, reliable, and valid.

    Section 641(c)(1)(D) of the Act requires the DRS to be based in part on classroom quality as measured under section 641A(c)(2)(F), which refers to a valid and reliable research-based observational instrument, implemented by qualified individuals with demonstrated reliability that assesses classroom quality. To include assessing multiple dimensions of teacher-child interactions that is linked to positive child development and later achievement. The third condition of the DRS is based on use of the CLASS, which is an observational measurement tool for assessing the quality of teacher-child interactions and classroom processes in three broad domains that support children's learning and development: Emotional Support, Classroom Organization, and Instructional Support.

    Changes to DRS Under Consideration

    Since HHS established the DRS, all grantees that had indefinite project periods have completed the DRS process. Based on CLASS data, observations collected throughout these cohorts, results of a recent evaluation, and feedback from the community, we are considering changes to the DRS in order to better improve implementation of the system, including changes to the CLASS condition.

    The CLASS Condition

    There are concerns about some aspects of the CLASS condition of the DRS that have been raised by Head Start grantees as well as in the recent evaluation. First, the requirement for grantees with the lowest 10 percent of scores on any of the three CLASS domains to compete may not be optimally targeting the grantees for competition with the lowest measures of classroom quality. For example, grantees have been required to compete due to an Emotional Support score of 5.69, which is very close to the Standard of Excellence (a 6—which developers of the CLASS deem the highest quality). In addition, grantees scoring slightly higher than the minimum threshold in Instructional Support (e.g., score of 2.3) do not have to compete unless they fall into the lowest 10 percent of all grantees' scores for Instructional Support, which has been very close to the minimum threshold. We are considering an approach to establish higher specific thresholds that demonstrate an established acceptable level of quality in Emotional Support and Classroom Organization and an adjustable threshold for the Instructional Support domain where there is the greatest potential and need for program improvement.

    Second, we understand that the delay between completion of the CLASS review and grantees knowing their DRS designation status, due to the need to collect and analyze a full monitoring year's CLASS scores to determine the lowest 10 percent. This creates uncertainty, stress, and concern among grantees, grantee staff, and families. Because classroom quality in Head Start programs is improving as demonstrated by recent analysis of data from the 2006, 2009, and 2014, cohorts of the Head Start Family and Child Experiences Survey (FACES),1 we are exploring options for the CLASS condition that would better balance an ability to drive quality improvement over time with an approach that would be more transparent, timely, and less burdensome for programs.

    1 Aikens, N., Bush, C., Gleason, P., Malone, L., & Tarullo, L. (2016). Tracking Quality in Head Start Classrooms: FACES 2006 to FACES 2014. Washington, DC: U.S. Department of Health and Human Services.

    To inform our development of a notice of proposed rulemaking to change the DRS CLASS condition to meet the objectives described above, we are requesting public comments on several specific changes being considered. The changes under consideration are as follows:

    1. Remove the “lowest 10 percent” provision of the CLASS condition described in 45 CFR 1304.11(c)(2).

    2. Increase the minimum threshold described in 45 CFR 1304.11(c)(1)(i) for the Emotional Support domain from 4 to 5.

    3. Increase the minimum threshold described in 45 CFR 1304.11(c)(1)(ii) for Classroom Organization from 3 to 5.

    4. Remove the minimum threshold for the Instructional Support domain described in 45 CFR 1304.11(c)(1)(iii) and instead provide authority for the Secretary to set an absolute minimum threshold for the Instructional Support domain, considering the most recent CLASS data, by August 1 of each year to be used for CLASS Reviews conducted in the following fiscal year (October 1 through September 30).

    Together, these changes would allow grantees to know by August 1, before CLASS Reviews are conducted for the coming fiscal year, the exact threshold of classroom quality in each of the three domains that will be used to determine which grantees will be subject to an open competition for funding and which grantees will receive renewed funding non-competitively. Grantees would no longer have to wait until several months following the conclusion of the CLASS reviews for the fiscal year (September 30) to learn the lowest 10 percent cutoff in each of the 3 domains. Setting minimum thresholds of 5 in the Emotional Support and Classroom Organization domains would set a clear and consistent expectation of quality for all Head Start programs. Allowing the Secretary to set the minimum threshold in the Instructional Support domain prior to the start of each program year and monitoring year would allow for consideration of the most recent CLASS data for Head Start grantees while still supporting continuous quality improvement across the program as a whole.

    Other Areas of Improvement

    In addition to the CLASS condition, we are interested in receiving feedback about other conditions and improvements that could be made to DRS. This includes actions we can take without regulatory changes to ensure the DRS process is transparent, timely, and results in higher quality programs.

    To inform our development of a notice of proposed rulemaking and continue improving the DRS, we are specifically requesting comments on:

    • Changes OHS can make to incentivize robust competition, including ways OHS can ensure there are new and quality applicants at the local level;

    • Changes OHS can make to facilitate an orderly transition between grantees without disrupting services for children (when recompetition is required and the incumbent does not regain its grant); and,

    • Any other administrative changes OHS can make to the system that do not require regulatory changes, including changes to monitoring processes and timing of notifications and awards.

    What We Are Looking for in Public Comments

    We invite comments about the specific changes being considered for the DRS CLASS condition as well as alternatives to these changes that would continue to improve program quality, while balancing the need to continue to provide transparency to grantees about what they will be measured on and being mindful of burden on grantees. We also invite comments about any unintended consequences of removing the lowest 10 percent condition and whether an absolute threshold could influence scores. We are particularly interested in recommendations related to how the Secretary would consider establishing the minimum threshold for Instructional Support, including in what increments to raise the threshold, what data to base the absolute thresholds on, and how often to revise the threshold. For example, the regulation could establish an initial Instructional Support threshold (e.g., 2.3 or 2.5) that could be raised in increments of 0.1 based on certain criteria related to the available CLASS data from all prior years of Head Start monitoring, or the threshold could be set one standard deviation below the mean Instructional Support score over the 3 or 5 previous fiscal years. We are interested in other ideas of ways the Instructional Support threshold could be set and/or adjusted that would incentivize program improvement while acknowledging the current state of the field. We are also interested in feedback on another potential change to establish or maintain a minimum absolute threshold (such as a 2) that would require competition and a higher threshold (such as 2.5 or 3) and require grantees to focus on quality improvement before they were reevaluated to see if their Instructional Support score has improved. Only grantees without improvement or still below the threshold would then have to compete. We are also interested in whether we should align the approach for Instructional Support with the other CLASS domains. We are interested in feedback on each of these possible approaches as well as others suggested by the field.

    If commenters do not support the changes being considered, comments offering alternative proposals to the CLASS condition, whether changes to the absolute thresholds or the relative 10 percent threshold, or to other conditions of the DRS would be particularly helpful.

    We are also particularly interested in soliciting feedback on other changes to DRS implementation that would spur local competition and improve the DRS process for grantees.

    Ann Linehan, Acting Director, Office of Head Start.
    [FR Doc. 2018-02902 Filed 2-13-18; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families 45 CFR Part 1304 RIN 0970-AC63 CLASS Condition of the Head Start Designation Renewal System AGENCY:

    Office of Head Start (OHS), Administration for Children and Families (ACF), Department of Health and Human Services (HHS).

    ACTION:

    Request for comments; withdrawal

    SUMMARY:

    OHS withdraws the “CLASS Condition of the Head Start Designation Renewal System” request for comments, published in the Federal Register on December 8, 2017. OHS simultaneously issues the “Head Start Designation Renewal System Improvements” request for comments, located elsewhere in the same issue of the Federal Register. The “Head Start Designation Renewal System Improvements” request for comments contains information we inadvertently omitted from the “CLASS Condition of the Head Start Designation Renewal System” request for comment publication.

    DATES:

    As of February 14, 2018, the proposed rule published December 8, 2017, at 82 FR 57905, is withdrawn.

    ADDRESSES:

    Division of Planning, Oversight and Policy, Office of Head Start, 330 C Street SW, Washington, DC 20024.

    FOR FURTHER INFORMATION CONTACT:

    Colleen Rathgeb, Director, Division of Planning, Oversight and Policy, Office of Head Start, [[email protected]], (202) 358-3263 (not a toll-free call). Deaf and hearing impaired individuals may call the Federal Dual Party Relay Service at 1-800-877-8339 between 8 a.m. and 7 p.m. Eastern Standard Time.

    SUPPLEMENTARY INFORMATION:

    OHS published the “CLASS Condition of the Head Start Designation Renewal System” request for comments on December 8, 2017, to solicit comments from the public on changes we are considering to the Designation Renewal System (DRS). We unintentionally omitted language from the document that specifically asks the public to consider what changes OHS can make to incentivize robust competition and to facilitate orderly transitions between grantees when an incumbent does not regain its grant after competition, as well as any other administrative changes that do not require regulatory action.

    We believe public feedback on the omitted language is important and can help us make better informed decisions about the DRS. For that reason, we withdraw the “CLASS Condition of the Head Start Designation Renewal System” request for comments, and we are publishing a new request for comments, titled “Head Start Designation Renewal System Improvements,” elsewhere in this issue of the Federal Register.

    Dated: February 7, 2018. Ann Linehan, Acting Director, Office of Head Start.
    [FR Doc. 2018-02901 Filed 2-13-18; 8:45 am] BILLING CODE 4184-01-P
    83 31 Wednesday, February 14, 2018 Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2018-0005] Notice of Request for Revision to and Extension of an Approval of an Information Collection; Importation of Eggplant From Israel AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Revision to and extension of an approval of an information collection; comment request.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the importation of eggplant from Israel into the continental United States.

    DATES:

    We will consider all comments that we receive on or before April 16, 2018.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0005.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2018-0005, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.

    Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0005 or in our reading room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call 202-799-7039 before coming.

    FOR FURTHER INFORMATION CONTACT:

    For information on the importation of eggplant from Israel, contact Mr. Hesham Abuelnaga, Trade Director, Africa and the Middle East, PIM, PPQ, APHIS, 4700 River Road, Unit 140, Riverdale, MD 20737; (301) 851-2010. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

    SUPPLEMENTARY INFORMATION:

    Title: Importation of Eggplant From Israel.

    OMB Control Number: 0579-0350.

    Type of Request: Revision to and extension of approval of an information collection.

    Abstract: The Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) authorizes the Secretary of Agriculture to restrict the importation, entry, or interstate movement of plants, plant products, and other articles to prevent the introduction of plant pests into the United States or their dissemination within the United States. As authorized by the PPA, the Animal and Plant Health Inspection Service regulates the importation of fruits and vegetables into the United States from certain parts of the world as provided in “Subpart-Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-81).

    Section 319.56-49 of the regulations provides the requirements for the importation of eggplant from Israel into the continental United States under specified conditions intended to prevent the introduction of certain quarantine pests. These requirements include the use of information collection activities such as trapping records, box labeling, grower registration and approval of production sites, inspection of pest-exclusionary structures, treatment approval, pest detection notification, and a phytosanitary certificate issued by the national plant protection organization (NPPO) of Israel with an additional declaration confirming that the eggplant has been produced in accordance with the regulations.

    We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years.

    The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

    (1) Evaluate 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) Evaluate the accuracy of our estimate of the burden of the 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, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

    Estimate of burden: The public burden for this collection of information is estimated to average 0.0008 hours per response.

    Respondents: Eggplant importers and growers, packinghouses, and the NPPO of Israel.

    Estimated annual number of respondents: 4.

    Estimated annual number of responses per respondent: 5,003.

    Estimated annual number of responses: 20,011.

    Estimated total annual burden on respondents: 16 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

    All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

    Done in Washington, DC, this 9th day of February 2018. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2018-03084 Filed 2-13-18; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE National Agricultural Statistics Service Notice of Intent To Seek Approval To Reinstate an Information Collection AGENCY:

    National Agricultural Statistics Service, USDA.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the National Agricultural Statistics Service (NASS) to seek reinstatement of an information collection, the Farm and Ranch Irrigation Survey (FRIS). Revision to previous burden hours will be needed due to changes in the size of the target population, sampling design, and questionnaire length.

    DATES:

    Comments on this notice must be received by April 16, 2018 to be assured of consideration.

    ADDRESSES:

    You may submit comments, identified by docket number 0535-0234, by any of the following methods:

    Email: [email protected] Include the docket number above in the subject line of the message.

    E-fax: (855) 838-6382.

    Mail: Mail any paper, disk, or CD-ROM submissions to: David Hancock, NASS Clearance Officer, U.S. Department of Agriculture, Room 5336 South Building, 1400 Independence Avenue SW, Washington, DC 20250-2024.

    Hand Delivery/Courier: Hand deliver to: David Hancock, NASS Clearance Officer, U.S. Department of Agriculture, Room 5336 South Building, 1400 Independence Avenue SW, Washington, DC 20250-2024.

    FOR FURTHER INFORMATION CONTACT:

    Kevin L. Barnes, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, (202) 720-2707. Copies of this information collection and related instructions can be obtained without charge from David Hancock, NASS—OMB Clearance Officer, at (202) 690-2388 or at [email protected]

    SUPPLEMENTARY INFORMATION:

    Title: 2018 Farm and Ranch Irrigation Survey.

    OMB Control Number: 0535-0234.

    Expiration Date of Previous Approval: September 30, 2016.

    Type of Request: Intent to Seek Approval to Reinstate and Revise an Information Collection.

    Abstract: The 2018 Farm and Ranch Irrigation Survey is conducted every 5 years as authorized by the Census of Agriculture Act of 1997 (Pub. L. 105-113). The 2018 Farm and Ranch Irrigation Survey (FRIS) will use a combined probability sample of all farms, ranches, greenhouses, nurseries, and other horticultural operations that reported irrigation on the 2017 Census of Agriculture. This irrigation survey aims to provide a comprehensive inventory of agricultural irrigation practices with detailed data relating to acres irrigated by category of land use, acres and yields of irrigated and non-irrigated crops, quantity of water applied, and method of application to selected crops. Also included will be 2018 expenditures for maintenance and repair of irrigation equipment and facilities; purchase of energy for on-farm pumping of irrigation water; investment in irrigation equipment, facilities, and land improvement; cost of water received from off-farm water supplies; and questions related to water reuse and security. The irrigation questions for horticultural specialties will provide the area irrigated in the open and under protection, source of water, and the irrigation method used at the State level and by 20 Water Resource Regions (WRR). A table will be published showing the total estimated quantity of water applied for crops including horticultural specialties. Irrigation data are used by the farmers, their representatives, government agencies, and many other groups concerned with the irrigation industry and water use issues. This survey will provide the only source of dependable, comparable irrigation data by State and Water Resources Region (WRR). The National Agricultural Statistics Service will use the information collected only for statistical purposes and will publish the data only as aggregate totals. NASS is also considering a possible name change to this long running data collection. The proposed name that is being considered is “Irrigation and Water Management Survey”.

    Authority: The census of agriculture and subsequent follow-on censuses are required by law under the “Census of Agriculture Act of 1997,” Pub. L. 105-113, 7 U.S.C. 2204(g). Individually identifiable data collected under this authority are governed by Section 1770 of the Food Security Act of 1985 as amended, 7 U.S.C. 2276, which requires USDA to afford strict confidentiality to non-aggregated data provided by respondents. This Notice is submitted in accordance with the Paperwork Reduction Act of 1995, Pub. L. 104-13 (44 U.S.C. 3501, et seq.) and Office of Management and Budget regulations at 5 CFR part 1320.

    NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),” Federal Register, Vol. 72, No. 115, June 15, 2007, p. 33362. The law guarantees farm operators that their individual information will be kept confidential. NASS uses the information only for statistical purposes and publishes only aggregate data. These data are used by Congress when developing or changing farm programs. Many national and state programs are designed or allocated based on census data, i.e., soil conservation projects, funds for cooperative extension programs, and research funding. Private industry uses the data to provide more effective production and distribution systems for the agricultural community.

    Estimate of Burden: Public reporting burden for this collection of information is estimated to average 30-60 minutes per response. Publicity materials and instruction sheets will account for about 15 minutes of additional burden per respondent. Respondents who refuse to complete the survey will be allotted 2 minutes of burden per attempt to collect the data.

    Respondents: Farmers, Ranchers, Farm Managers, and producers of Nursery, Greenhouse and Floricultural Products.

    Estimated Number of Respondents: 35,000.

    Estimated Total Annual Burden on Respondents: 26,000 hours.

    Comments: Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) 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; (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 those who are to respond, including through the use of appropriate automated, electronic, mechanical, technological, or other forms of information technology collection methods; and (e) comments relating to the proposed name change.

    All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.

    Signed at Washington, DC, January 29, 2018. Kevin L. Barnes, Associate Administrator.
    [FR Doc. 2018-02940 Filed 2-13-18; 8:45 am] BILLING CODE 3410-20-P
    DEPARTMENT OF AGRICULTURE Natural Resources Conservation Service [Docket No. NRCS-2017-0004] South Branch Potomac River Subwatershed of the Potomac River Watershed, Highland County, Virginia and Pendleton and Grant Counties, West Virginia AGENCY:

    Natural Resources Conservation Service, Department of Agriculture.

    ACTION:

    Notice of intent to deauthorize Federal funding.

    SUMMARY:

    Pursuant to the Flood Control Act and the Natural Resources Conservation Service (NRCS) Guidelines (7 CFR part 622), NRCS gives notice of the intent to deauthorize Federal funding for the South Branch Potomac River Subwatershed of the Potomac River Watershed project, Highland County, Virginia and Pendleton and Grant Counties, West Virginia.

    DATES:

    Interested persons are invited to submit comments within 60 days of this notice being published in the Federal Register.

    ADDRESSES:

    Comments submitted in response to this notice should be sent to either John Bricker, VA State Conservationist, 1606 Santa Rosa Road, Suite 209, Richmond, Virginia 23229. Telephone: (804) 287-1691 or email: [email protected] or Louis Aspey, WV State Conservationist, 1550 Earl L. Core Road, Suite 200, Morgantown, West Virginia 26505. Telephone: (304) 284-7540 or email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For specific questions about this notice, please contact Wade Biddix, (804) 287-1675 or [email protected]

    SUPPLEMENTARY INFORMATION:

    A determination has been made by John Bricker, NRCS State Conservationist in Virginia, and Louis Aspey, NRCS State Conservationist in West Virginia, that the proposed works of improvement for the South Branch Potomac River Subwatershed of the Potomac River Watershed project will not be installed. The sponsoring local organizations have concurred in this determination and agree that Federal funding should be deauthorized for the project. Information regarding this determination may be obtained from John Bricker, NRCS State Conservationist in Virginia, and Louis Aspey, NRCS State Conservationist in West Virginia, at the above addresses and telephone numbers.

    No administrative action on implementation of the proposed deauthorization will be taken until 60 days after the date of this publication in the Federal Register.

    (Catalog of Federal Domestic Assistance Program No. 10.904, Watershed Protection and Flood Prevention. Executive Order 12372 regarding State and local clearinghouse review of Federal and federally assisted programs and project is applicable) Dated: December 21, 2017. John A. Bricker, VA State Conservationist. Dated: December 14, 2017. Louis Aspey, WV State Conservationist.
    [FR Doc. 2018-02944 Filed 2-13-18; 8:45 am] BILLING CODE 3410-16-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Montana Advisory Committee AGENCY:

    U.S. Commission on Civil Rights

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Montana Advisory Committee (Committee) to the Commission will be held at 11:00 a.m. (Mountain Time) Wednesday, February 21, 2018. The purpose of the meeting is for the Committee to discuss preparations to hear testimony on border town discrimination.

    DATES:

    The meeting will be held on Wednesday, February 21, 2018 at 11:00 a.m. MT.

    Public Call Information: Dial: 888-713-3590, Conference ID: 2355188.

    FOR FURTHER INFORMATION CONTACT:

    Angelica Trevino at [email protected] or (213) 894-3437.

    SUPPLEMENTARY INFORMATION:

    This meeting is available to the public through the following toll-free call-in number: 888-713-3590, conference ID number: 2355188. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

    Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed to Angelica Trevino at [email protected] Persons who desire additional information may contact the Regional Programs Unit at (213) 894-3437.

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https://facadatabase.gov/committee/meetings.aspx?cid=259. Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's website, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

    Agenda I. Welcome and Rollcall II. Approval of minutes from February 1, 2018 meeting III. Discussion of panelists and logistics for hearing testimony on border town discrimination IV. Public Comment V. Adjournment

    Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstance of this Committee preparing for its upcoming public meeting to hear testimony.

    Dated: February 9, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-03053 Filed 2-13-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-25-2018] Foreign-Trade Zone 76—Bridgeport, Connecticut; Application for Subzone; SDI USA, LLC; Meriden, Connecticut

    An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Bridgeport Port Authority, grantee of FTZ 76, requesting subzone status for the facilities of SDI USA, LLC, located in Meriden, Connecticut. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on February 8, 2018.

    The proposed subzone (27 acres) is located at 160 Corporate Court, Meriden, Connecticut. No authorization for production activity has been requested at this time. The proposed subzone would be subject to the existing activation limit of FTZ 76.

    In accordance with the FTZ Board's regulations, Kathleen Boyce 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 March 26, 2018. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to April 10, 2018.

    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 website, which is accessible via www.trade.gov/ftz.

    For further information, contact Kathleen Boyce at [email protected] or (202) 482-1346.

    Dated: February 8, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-03050 Filed 2-13-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-66-2017] Foreign-Trade Zone (FTZ) 134—Chattanooga, Tennessee; Authorization of Production Activity; (Passenger Motor Vehicles); Chattanooga, Tennessee

    On October 13, 2017, Volkswagen Group of America—Chattanooga Operations, LLC submitted a notification of proposed production activity to the FTZ Board for its facility within FTZ 134—Site 3, in Chattanooga, Tennessee.

    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 (82 FR 49177-49178, October 24, 2017). On February 9, 2018, the applicant was notified of the FTZ Board's decision that no further review of the activity is warranted at this time. The production activity described in the notification was authorized, subject to the FTZ Act and the FTZ Board's regulations, including Section 400.14.

    Dated: February 9, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-03051 Filed 2-13-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-29-2018] Foreign-Trade Zone 102—St. Louis, Missouri; Application for Subzone; Orgill, Inc.; Sikeston, Missouri

    An application has been submitted to the Foreign-Trade Zones Board (the Board) by the St. Louis County Port Authority, grantee of FTZ 102, requesting subzone status for the facility of Orgill, Inc., located in Sikeston, Missouri. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on February 9, 2018.

    The proposed subzone (73 acres) is located at 2727 North Main Street in Sikeston, Missouri. The proposed subzone would be subject to the existing activation limit of FTZ 102. No authorization for production activity has been requested at this time.

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

    Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is March 26, 2018. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to April 10, 2018.

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

    For further information, contact Camille Evans at [email protected] or (202) 482-2350.

    Dated: February 9, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-03049 Filed 2-13-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security In the Matter of: Justin Gage Jangraw, P.O. Box 601, Key West, Florida 33041; Order Denying Export Privileges

    On November 21, 2014, in the U.S. District Court for the District of Columbia, Justin Gage Jangraw (“Jangraw”) was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Jangraw was convicted of knowingly and willfully exporting, attempting to export, and causing to be exported from the United States to Austria three Magpul angled fore grips and two Magpul battery-assisted device levers designated as defense articles on the United States Munitions List, without the required U.S. Department of State licenses. Jangraw was sentenced to eight months in prison, one year of supervised release, and a $125 assessment.

    Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”) 1 provides, in pertinent part, that “[t]he Director of the Office of Exporter Services, in consultation with the Director of the Office of Export Enforcement, may deny the export privileges of any person who has been convicted of a violation of the EAA [Export Administration Act], the EAR, or any order, license, or authorization issued thereunder; any regulation, license or order issued under the International Emergency Economic Powers Act (50 U.S.C. 1701-1706); 18 U.S.C. 793, 794 or 798; section 4(b) of the Internal Security Act of 1950 (50 U.S.C. 783(b)); or section 38 of the Arms Export Control Act (22 U.S.C. 2778).” 15 CFR 766.25(a); see also Section 11(h) of the the Export Administration Act (“EAA” or “the Act”), 50 U.S.C. 4610(h). The denial of export privileges under this provision may be for a period of up to 10 years from the date of the conviction. 15 CFR. 766.25(d); see also 50 U.S.C. 4610(h). In addition, Section 750.8 of the Regulations states that the Bureau of Industry and Security's Office of Exporter Services may revoke any Bureau of Industry and Security (“BIS”) licenses previously issued pursuant to the Act or the Regulations in which the person had an interest at the time of his/her conviction.

    1 The Regulations are currently codified in the Code of Federal Regulations at 15 CFR parts 730-774 (2017). The Regulations issued pursuant to the Export Administration Act (50 U.S.C. 4601-4623 (Supp. III 2015) (available at http:// uscode.house.gov)) (“EAA” or “the Act”). Since August 21, 2001, the Act has been in lapse and the President, through Executive Order 13222 of August 17, 2001 (3 CFR, 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 15, 2017 (82 FR 39005 (Aug. 16, 2017)), has continued the Regulations in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701, et seq. (2012)).

    BIS has received notice of Jangraw's conviction for violating Section 38 of the AECA, and has provided notice and an opportunity for Jangraw to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Jangraw.

    Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Jangraw's export privileges under the Regulations for a period of five years from the date of Jangraw's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Jangraw had an interest at the time of his conviction.

    Accordingly, it is hereby ordered:

    First, from the date of this Order until November 21, 2019, Justin Gage Jangraw, with a last known address of P.O. Box 601, Key West, FL 33041, and when acting for or on his behalf, his successors, assigns, employees, agents or representatives (“the Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, including, but not limited to:

    A. Applying for, obtaining, or using any license, license exception, or export control document;

    B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or

    C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.

    Second, no person may, directly or indirectly, do any of the following:

    A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;

    B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;

    C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;

    D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or

    E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.

    Third, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any other person, firm, corporation, or business organization related to Jangraw by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order in order to prevent evasion of this Order.

    Fourth, in accordance with Part 756 of the Regulations, Jangraw may file an appeal of this Order with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

    Fifth, a copy of this Order shall be delivered to Jangraw and shall be published in the Federal Register.

    Sixth, this Order is effective immediately and shall remain in effect until November 21, 2019.

    Issued this 7th day of February 2018. Karen H. Nies-Vogel, Director, Office of Exporter Services.
    [FR Doc. 2018-03071 Filed 2-13-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE International Trade Administration [C-489-817] Oil Country Tubular Goods From the Republic of Turkey: Final Results of Countervailing Duty Administrative Review AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) has completed its administrative review of the countervailing duty (CVD) order on oil country tubular goods (OCTG) from the Republic of Turkey (Turkey). The period of review (POR) is January 1, 2015, through December 31, 2015. We have determined that Borusan Mannesmann Boru Sanayi ve Ticaret A.S. (Borusan), the only mandatory respondent, received countervailable subsidies at de minimis levels during the POR.

    DATES:

    Applicable February 14, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Shore or Aimee Phelan, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2778 or (202) 482-0697, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On October 6, 2017, Commerce published the Preliminary Results of this CVD administrative review in the Federal Register.1 For a description of the events that occurred since the Preliminary Results, see the Issues and Decision Memorandum.2 Commerce has exercised its discretion to toll deadlines for the duration of the closure of the Federal Government from January 20 through 22, 2018. If the new deadline falls on a non-business day, in accordance with Commerce's practice, the deadline will become the next business day. The revised deadline for the final results of this review is now February 6, 2018.3

    1See Oil Country Tubular Goods from the Republic of Turkey: Preliminary Results of Countervailing Duty Review and Rescission of Countervailing Duty Administrative Review, in Part, 82 FR 46767 (October 6, 2017) (Preliminary Results) and accompanying Preliminary Decision Memorandum.

    2See Memorandum, “Issues and Decision Memorandum for the Final Results of Countervailing Duty Administrative Review of Oil Country Tubular Goods from the Republic of Turkey; 2015,” dated concurrently with, and hereby adopted by, this notice (Issues and Decision Memorandum).

    3See Memorandum for The Record from Christian Marsh, Deputy Assistant Secretary for Enforcement and Compliance, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, “Deadlines Affected by the Shutdown of the Federal Government” (Tolling Memorandum), dated January 23, 2018. All deadlines in this segment of the proceeding have been extended by 3 days.

    Scope of the Order

    The merchandise covered by the order is certain OCTG, which are hollow steel products of circular cross-section, including oil well casing and tubing, of iron (other than cast iron) or steel (both carbon and alloy), whether seamless or welded, regardless of end finish (e.g., whether or not plain end, threaded, or threaded and coupled) whether or not conforming to American Petroleum Institute (API) or non-API specifications, whether finished (including limited service OCTG products) or unfinished (including green tubes and limited service OCTG products), whether or not thread protectors are attached. The scope of the order also covers OCTG coupling stock. A full description of the scope of the order is contained in the Issues and Decision Memorandum.4

    4See Issues and Decision Memorandum at 2-3.

    Analysis of Comments Received

    The only issue raised by interested parties, “Whether to Include Exchange Rate Income or Loss in the Sales Denominator,” is addressed in the Issues and Decision Memorandum. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and CVD Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov; the Issues and Decision Memorandum is available to all parties in the Central Records Unit, Room B8024 of the main Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the internet http://enforcement.trade.gov/frn/. The signed and electronic versions of the Issues and Decision Memorandum are identical in content.

    Methodology

    We conducted this review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found to be countervailable during the POR, we find that there is a subsidy, i.e., a government-provided financial contribution that gives rise to a benefit to the recipient, and that the subsidy is specific.5 For a full description of the methodology underlying our conclusions, see the Issues and Decision Memorandum.

    5See sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and, section 771(5A) of the Act regarding specificity.

    Final Results of the Review

    In accordance with 19 CFR 351.221(b)(5), we determine the following net countervailable subsidy rate for Borusan, for the period January 1, 2015, through December 31, 2015:

    Company Subsidy rate
  • (percent ad valorem)
  • Borusan Mannesmann Boru Sanayi ve Ticaret A.S.6 0.48 percent (de minimis).
    Disclosure

    6 As discussed in the Issues and Decision Memorandum, Commerce has found the following company to be cross-owned with Borusan: Borusan Istikbal Ticaret.

    We will disclose to the parties in this proceeding the calculations performed for these final results within five days of the date of publication of this notice in the Federal Register.7

    7See 19 CFR 351.224(b).

    Assessment Rates

    In accordance with 19 CFR 351.212(b)(2), Commerce intends to issue appropriate assessment instructions to U.S. Customs and Border Protection (CBP) 15 days after publication of these final results of review, to liquidate shipments of subject merchandise produced by Borusan entered, or withdrawn from warehouse, for consumption on or after January 1, 2015, through December 31, 2015, without regard to countervailing duties.

    Cash Deposit Requirements

    In accordance with section 751(a)(1) of the Act, we intend to instruct CBP to collect cash deposits at a rate of zero percent, because the rate calculated for Borusan in these final results is de minimis. For all non-reviewed firms, we will instruct CBP to continue to collect cash deposits at the most recent company-specific or all-others rate applicable to the company, as appropriate. These cash deposit requirements, when imposed, shall remain in effect until further notice.

    Administrative Protective Orders

    This notice also serves as a reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

    We are issuing and publishing these final results of review in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.221(b)(5).

    Dated: February 6, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix I—List of Topics Discussed in the Issues and Decision Memorandum I. Summary II. Background III. Comments Raised by the Parties IV. Scope of the Order V. Subsidies Valuation Information VI. Benchmark Interest Rates VII. Analysis of Programs VIII. Analysis of Comment IX. Recommendation
    [FR Doc. 2018-02898 Filed 2-13-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-985] Xanthan Gum From the People's Republic of China: Final Results of the Antidumping Duty Administrative Review and Final Determination of No Shipments; 2015-2016 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) determines that Deosen Biochemical Ltd./Deosen Biochemical (Ordos) Ltd. (collectively, Deosen) made sales of xanthan gum from the People's Republic of China (China) at prices below normal value (NV) and that Neimenggu Fufeng Biotechnologies Co., Ltd./Shandong Fufeng Fermentation Co., Ltd./Xinjiang Fufeng Biotechnologies Co., Ltd. (collectively, Fufeng) did not. We continue to find that the four companies which were not selected for individual examination have demonstrated their eligibility for separate rates in the final results. These four companies are CP Kelco (Shandong) Biological Company Limited (CP Kelco Shandong, Jianlong Biotechnology Co., Ltd. (a.k.a. Inner Mongolia Jianlong Biochemical Co., Ltd.) (Jianlong), Meihua Group International Trading (Hong Kong) Limited/Xinjiang Meihua Amino Acid Co., Ltd./Langfang Meihua Bio-Technology Co., Ltd. (collectively, Meihua), and Shanghai Smart Chemicals Co., Ltd. (Shanghai Smart). We also continue to find that A.H.A. International Co., Ltd. (AHA) made no shipments of subject merchandise during the period of review (POR), i.e., July 1, 2015, through June 30, 2016.

    DATES:

    Applicable February 14, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Brian Smith or Michael Bowen, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1766 and (202) 482-0768, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On August 7, 2017, Commerce published the Preliminary Results. 1 For events occurring subsequent to the Preliminary Results, see the Issues and Decision Memorandum.2 Commerce conducted this administrative review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act).

    1See Xanthan Gum from the People's Republic of China: Preliminary Results of the Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2015-2016, 82 FR 36746 (August 7, 2017) (Preliminary Results), and accompanying Preliminary Decision Memorandum.

    2See Memorandum, “Xanthan Gum from the People's Republic of China: Issues and Decision Memorandum for the Final Results of the Third Antidumping Duty Administrative Review,” dated concurrently with this notice (Issues and Decision Memorandum).

    Commerce exercised its discretion to toll all deadlines affected by the closure of the Federal Government from January 20 through 22, 2018. If the new deadline falls on a non-business day, in accordance with Commerce's practice, the deadline will become the next business day. The revised deadline for the final results of this review is now February 6, 2018.3

    3See Memorandum for The Record from Christian Marsh, Deputy Assistant Secretary for Enforcement and Compliance, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, “Deadlines Affected by the Shutdown of the Federal Government” (Tolling Memorandum) dated January 23, 2018. All deadlines in this segment of the proceeding have been extended by 3 days.

    Scope of the Order 4

    4 A full description of the scope of the order is contained in the Issues and Decision Memorandum.

    The product covered by the order includes dry xanthan gum, whether or not coated or blended with other products. Xanthan gum is included in this order regardless of physical form, including, but not limited to, solutions, slurries, dry powders of any particle size, or unground fiber.

    Merchandise covered by the scope of the order is classified in the Harmonized Tariff Schedule of the United States at subheading 3913.90.20. This tariff classification is provided for convenience and customs purposes; however, the written description of the scope is dispositive.

    Analysis of Comments Received

    All issues raised in the case and rebuttal briefs filed by interested parties are addressed in the Issues and Decision Memorandum, which is hereby adopted by this notice. A list of the issues that parties raised, and to which we responded in the Issues and Decision Memorandum, follows as an appendix to this notice. The Issues and Decision Memorandum is a public document, and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/. The paper copy and electronic copy of the Issues and Decision Memorandum are identical in content.

    Changes Since the Preliminary Results

    Based on a review of the record and comments received from interested parties regarding our Preliminary Results, and for the reasons explained in the Issues and Decision Memorandum, we made one change to our preliminary calculation of the weighed-average dumping margin for the mandatory respondent, Fufeng.5

    5See Issues and Decision Memorandum at Comment 6.

    Final Determination of No Shipments

    In the Preliminary Results, Commerce determined that AHA had no shipments of subject merchandise during the POR.6 As we have not received any information to contradict our preliminary finding, we determine that AHA had no shipments of subject merchandise during the POR, and we intend to issue appropriate instructions to U.S. Customs and Border Protection (CBP) that are consistent with our “automatic assessment” clarification for these final results of review.7 8

    6See Preliminary Results, 82 FR at 36746.

    7See Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694, 65694-95 (October 24, 2011) (Assessment Notice); see also “Assessment Rates” section of this notice.

    8 For any shipment made by Deosen during the POR, which involved AHA, we intend to liquidate those entries at Deosen's importer-specific assessment rate. See Issues and Decision Memorandum for further discussion.

    Methodology

    In the Preliminary Results, Commerce determined that two mandatory respondents, Deosen and Fufeng, and four other companies 9 not selected for individual review demonstrated their eligibility for separate rates. We continue to find that these six companies, listed in the table in the “Final Results” section of this notice, are eligible for separate rate status. We assigned the non-selected companies a weighted-average dumping margin of 9.30 percent—the rate calculated for Deosen in this review.10 Fufeng has a weighted-average margin of zero; accordingly, no antidumping duty liability will apply to Fufeng for the POR. Additionally, the Department relied, in part, on facts otherwise available with an adverse inference pursuant to sections 776(a) and (b) of the Act in determining Deosen's weighted-average dumping margin for the POR. See Issues and Decision Memorandum for further discussion.

    9 These four companies are: CP Kelco Shandong, Jianlong, Meihua, and Shanghai Smart.

    10See Stainless Steel Bar from India: Final Results of the Antidumping Duty Administrative Review, 77 FR 39467 (July 3, 2012), and accompanying Issues and Decision Memorandum at 12.

    Final Results of Review

    We determine that the following weighted-average dumping margins exist for the period July 1, 2015, through June 30, 2016:

    Exporters Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Deosen Biochemical Ltd./Deosen Biochemical (Ordos) Ltd 9.30 Neimenggu Fufeng Biotechnologies Co., Ltd. (aka Inner Mongolia Fufeng Biotechnologies Co., Ltd.)/Shandong Fufeng Fermentation Co., Ltd./Xinjiang Fufeng Biotechnologies Co., Ltd 0.00 CP Kelco (Shandong) Biological Company Limited 9.30 Jianlong Biotechnology Co., Ltd. (aka Inner Mongolia Jianlong Biochemical Co., Ltd.) 9.30 Meihua Group International Trading (Hong Kong) Limited/Langfang Meihua Bio-Technology Co., Ltd./Xinjiang Meihua Amino Acid Co., Ltd 9.30 Shanghai Smart Chemicals Co., Ltd 9.30
    Assessment Rates

    Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce determined, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with these final results of review. We intend to issue appropriate assessment instructions directly to CBP 15 days after publication of these final results.

    For Deosen, which has a weighted-average dumping margin above zero or de minimis (i.e., less than 0.5 percent), we calculated importer- (or customer-) specific duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's (or customer's) examined sales to the total entered value of those sales, in accordance with 19 CFR 351.212(b)(1). For Fufeng, whose weighted-average dumping margin is zero, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

    For the respondents which were not selected for individual examination in this administrative review and which qualified for a separate rate, the assessment rate is equal to the weighted-average dumping margin assigned to Deosen, or 9.30 percent.

    Consistent with Commerce's assessment practice in non-market economy cases, for entries that were not reported in the U.S. sales databases submitted by Deosen or Fufeng, Commerce will instruct CBP to liquidate such entries at the China-wide rate.11 Additionally, as noted above, Commerce determines that AHA had no shipments of the subject merchandise during the POR. As a result, any suspended entries of subject merchandise from AHA (which do not involve Deosen) will be liquidated at the China-wide rate.

    11 For a full discussion of this practice, see Assessment Notice.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For the companies listed above that have a separate rate, the cash deposit rate will be that rate established in the final results of this review (except, if the rate is zero or de minimis, then the cash deposit rate will be zero required); (2) for previously investigated or reviewed Chinese and non-Chinese exporters that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (3) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the rate for the China-wide entity, which is 154.07 percent; and (4) for all non-Chinese exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the Chinese exporter(s) that supplied that non-Chinese exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Importers

    This notice serves as the only reminder to importers of their responsibility, under 19 CFR 351.402(f)(2), to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Notification Regarding Administrative Protective Order

    This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

    Notification to Interested Parties

    We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.221(b)(5).

    Dated: February 6, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix—List of Topics Discussed in the Issues and Decision Memorandum I. Summary II. Background III. Scope of the Order IV. Changes Since the Preliminary Results V. Discussion of the Issues Comment 1: Separate Rate Status for Jianlong Comment 2: Separate Rate Status for Meihua Comment 3: Application of Partial Adverse Facts Available to Deosen Comment 4: Rate Assignment for Meihua Based on Its Voluntary Respondent Status Request Comment 5: Rate Assignment for Separate Rate Applicants Comment 6: Clerical Error Regarding Fufeng's U.S. Packing Expenses VI. Recommendation
    [FR Doc. 2018-02915 Filed 2-13-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-890] Wooden Bedroom Furniture From the People's Republic of China: Final Results of Antidumping Duty Administrative Review and Final Determination of No Shipments in Part; 2016 AGENCY:

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

    SUMMARY:

    On October 11, 2017, the Department of Commerce (Commerce) published its Preliminary Results for the January 1, 2016, through December 31, 2016, administrative review of the antidumping duty order on wooden bedroom furniture (WBF) from the People's Republic of China (China). Although invited to do so, interested parties did not comment on our Preliminary Results. We have adopted the Preliminary Results as the final results.

    DATES:

    Applicable February 14, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Eli Lovely, AD/CVD Operations, Office IV, Enforcement & Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1593.

    Background

    On October 11, 2017, Commerce published its Preliminary Results of the review of the antidumping duty order on WBF from China for one mandatory respondent, Decca Furniture Ltd. (Decca), and twelve other companies covering the period January 1, 2016, through December 31, 2016 (the period of review (POR)).1 No parties commented on the Preliminary Results.

    1See Wooden Bedroom Furniture from the People's Republic of China: Preliminary Results and Partial Rescission of Antidumping Duty Administrative Review and Preliminary Determination of No Shipments in Part; 2016, 82 FR 47172 (October 11, 2017) (Preliminary Results).

    Commerce has exercised its discretion to toll deadlines for the duration of the closure of the Federal Government from January 20 through 22, 2018. If the new deadline falls on a non-business day, in accordance with Commerce's practice, the deadline will become the next business day. The revised deadline for the final results of this review is now February 15, 2018.2

    2See Memorandum for The Record from Christian Marsh, Deputy Assistant Secretary for Enforcement and Compliance, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, “Deadlines Affected by the Shutdown of the Federal Government” (Tolling Memorandum), dated January 23, 2018. All deadlines in this segment of the proceeding have been extended by 3 days.

    Scope of the Order

    The product covered by the Order is wooden bedroom furniture, subject to certain exceptions.3 Based on a U.S. Customs and Border Protection (CBP) ruling indicating that CBP would no longer use certain harmonized tariff schedule subheadings to classify items that are within the scope of the Order, 4 Commerce preliminarily revised the scope to include the harmonized tariff schedule numbers under which subject merchandise is entered.5 No parties commented on this revision. Hence, we have adopted this revision in these final results. Under this revision, imports of subject merchandise are classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 9403.90.7005, 9403.90.7080, 9403.50.9041, 9403.60.8081, 9403.20.0018, 9403.90.8041, 7009.92.1000 or 7009.92.5000. Although the HTSUS subheadings are provided for convenience and customs purposes, the written product description in the Order remains dispositive.6

    3See Notice of Amended Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order: Wooden Bedroom Furniture from the People's Republic of China, 70 FR 329 (January 4, 2005) (Order).

    4See letter from the petitioners, re: “Wooden Bedroom Furniture from China: Petitioners' Comments Regarding the Upcoming Preliminary Results,” dated August 29, 2017.

    5See Preliminary Results, at 47173.

    6 For a complete description of the scope of the Order and a discussion of the revisions to the HTSUS numbers in the scope, see Decision Memorandum for the Preliminary Results of the Antidumping Duty Administrative Review: Wooden Bedroom Furniture from the People's Republic of China, from James Maeder, Senior Director, performing the duties of Deputy Assistant Secretary for Antidumping Duty and Countervailing Duty Operations, to Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance (Preliminary Decision Memorandum), dated October 11, 2017.

    Analysis

    As noted above, no parties commented on the Preliminary Results. Therefore, we are adopting the decisions in the Preliminary Decision Memorandum for these final results of review. In the Preliminary Results, Commerce: (1) Determined that four companies, including Decca, did not establish their eligibility for a separate rate and are part of the China-wide entity; 7 (2) determined that eight companies had no shipments of subject merchandise; 8 and (3) rescinded the review for Nanhai Jiantai Woodwork Co., Ltd., Fortune Glory Industrial, Ltd. (HK Ltd.) (collectively, Fortune Glory), for whom all review requests were withdrawn.9 For these final results of review, we have continued to treat the four companies, including Decca, as part of the China-wide entity and have continued to find that eight companies had no shipments during the POR. Because no party requested a review of the China-wide entity, we are not conducting a review of the China-wide entity.10 Thus, there is no change to the rate for the China-wide entity from the Preliminary Results. The existing rate for the China-wide entity is 216.01 percent.

    7 The other three companies are: (1) Changshu HTC Import & Export Co., Ltd.; (2) Starwood Industries Ltd.; and (3) U-Rich Furniture (Zhangzhou) Co., Ltd.; U-Rich Furniture Ltd.

    8 The eight companies/company groupings are: (1) Dongguan Sunrise Furniture Co., Taicang Sunrise Wood Industry, Co., Ltd., Shanghai Sunrise Furniture Co., Ltd., Fairmont Designs; (2) Dongguan Sunrise Furniture Co., Taicang Sunrise Wood Industry, Co., Ltd., Taicang Fairmont Designs Furniture Co., Ltd., Meizhou Sunrise Furniture Co., Ltd.; (3) Eurosa (Kunshan) Co., Ltd.; Eurosa Furniture Co., (PTE) Ltd.; (4) Golden Well International (HK) Limited; Zhangzhou Xym Furniture Product Co., Ltd.; (5) RiZhao Sanmu Woodworking Co., Ltd.; (6) Shenyang Shining Dongxing Furniture Co., Ltd.; (7) Woodworth Wooden Industries (Dong Guan) Co., Ltd.; and (8) Yeh Brothers World Trade Inc.

    9See Preliminary Results, at 47172.

    10See Antidumping Proceedings: Announcement of Change in Department Practice for Respondent Selection in Antidumping Duty Proceedings and Conditional Review of the Nonmarket Economy Entity in NME Antidumping Duty Proceedings, 78 FR 65963, 65969-70 (November 4, 2013).

    For additional details, see the Preliminary Decision Memorandum, which is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Results Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/index.html. The signed and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    Assessment Rates

    Pursuant to section 751(a)(2)(C) Tariff Act of 1930, as amended (the Act), and 19 CFR 351.212(b), the Department has determined, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. Commerce intends to issue assessment instructions to CBP 15 days after the publication date of the final results of this review. Commerce intends to instruct CBP to liquidate any entries of subject merchandise exported during this POR by Decca and the other three companies noted above which did not qualify for separate rate status, at the China-wide rate.

    Additionally, pursuant to Commerce's practice in NME cases, if there are any suspended entries of subject merchandise during the POR under the case numbers of the eight companies that claimed no shipments of subject merchandise, they will be liquidated at the China-wide rate.11

    11 For a full discussion of this practice, see Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011).

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this administrative review for shipments of subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date in the Federal Register of the final results of this review, as provided by section 751(a)(2)(C) of the Act: (1) For previously investigated or reviewed China and non-China exporters which are not under review in this segment of the proceeding but which received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (2) for all China exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the rate for the China-wide entity, which is 216.01 percent; and (3) for all non-China exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the Chinese exporter that supplied that non-China exporter.

    These deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Interested Parties

    This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of double antidumping duties.

    This notice also serves as a reminder to parties subject to administrative protective orders (APOs) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation that is subject to sanction.

    This notice of the final results of this antidumping duty administrative review is issued and published in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.213 and 19 CFR 351.221(b)(5).

    Dated: January 24, 2018. Christian Marsh, Deputy Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2018-02896 Filed 2-13-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-489-805] Certain Pasta From Turkey: Final Results and Rescission of Antidumping Duty Administrative Review; 2015-2016 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) determines that Mutlu Makarnacilik Sanayi ve Ticaret A.S. (Mutlu), an exporter of certain pasta (pasta) from Turkey and the sole respondent subject to this administrative review, had no bona fide sales during the period of review (POR) July 1, 2015 through June 30, 2016. Therefore, we are rescinding this administrative review.

    DATES:

    Applicable February 14, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Fred Baker, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2924.

    SUPPLEMENTARY INFORMATION: Background

    On August 7, 2017, Commerce published the Preliminary Results of this review in the Federal Register.1 We invited parties to comment on the Preliminary Results. On September 6, 2017, we received case briefs from petitioners American Italian Pasta Company, Dakota Growers Pasta Company, and New World Pasta Company (the petitioners) and from the respondent, Mutlu. On September 19, 2017, we received rebuttal briefs from the petitioners and Mutlu. On September 21, 2017, Commerce rejected Mutlu's case brief because it contained new factual information after the deadline for such information.2 Mutlu subsequently removed the new factual information from its case brief, and resubmitted the case brief on September 23, 2017.

    1See Certain Pasta from Turkey: Preliminary Results of Antidumping Duty Administrative Review, 82 FR 36737 (August 7, 2017) (Preliminary Results), and accompanying Preliminary Decision Memorandum.

    2See Commerce Letter dated September 21, 2017.

    Commerce exercised its discretion to toll deadlines affected by the closure of the Federal Government from January 20 through 22, 2018. If the new deadline falls on a non-business day, in accordance with Commerce's practice, the deadline will become the next business day. The revised deadline for the final results of this review is now February 6, 2018.3

    3See Memorandum for The Record from Christian Marsh, Deputy Assistant Secretary for Enforcement and Compliance, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, “Deadlines Affected by the Shutdown of the Federal Government” (Tolling Memorandum), dated January 23, 2018. All deadlines in this segment of the proceeding have been extended by 3 days.

    Commerce conducted this review in accordance with section 751(a)(1) of the Tariff Act of 1930, as amended (the Act).

    Scope of the Order

    Imports covered by this order are shipments of certain non-egg dry pasta in packages of five pounds four ounces or less, whether or not enriched or fortified or containing milk or other optional ingredients such as chopped vegetables, vegetable purees, milk, gluten, diastases, vitamins, coloring and flavorings, and up to two percent egg white.4

    4 A full written description of the scope of the order is contained in the memorandum to Gary Taverman, “Issues and Decision Memorandum for the Final Results of the Antidumping Duty Administrative Review: Certain Pasta from Turkey,” (Issues and Decision Memorandum), dated concurrently with this notice and incorporated herein by reference.

    Analysis of the Comments Received

    All issues raised in the case and rebuttal briefs submitted in this review are addressed in the Issues and Decision Memorandum, which is hereby adopted by this notice. A list of the issues raised is attached as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and it is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/index.html. The signed Issues and Decision Memorandum and the electronic versions of the Issues and Decision Memorandum are identical in content.

    Bona Fides Analysis

    For the Preliminary Results, the Department analyzed the bona fides of Mutlu's single sale and preliminarily found it was not a bona fide sale.5 Based on Commerce's complete analysis of all the information and comments on the record of this review, Commerce continues to find that Mutlu's sale is not a bona fide sale. Commerce reached this conclusion based on its consideration of the totality of circumstances, including: (a) The atypical nature of both the sales price and quantity; (b) reason to question the arm's-length nature of the transaction; and (c) the atypical sales terms. In addition to the above factors, which Commerce determined are a sufficient basis to find Mutlu's sale to be non-bona fide, it determined that additional factors—i.e., the lack of record information normally considered in making a bona fides determination due to the importer's failure to respond to the importer questionnaire (e.g., whether a profit was realized on the resale of the subject merchandise, whether there were any unusual expenses), and the limited history from which to infer the respondent's future selling practices due to there being only one sale during the POR—constituted additional support for its non-bona fides finding. Because much of the factual information used in our analysis of Mutlu's sale involves business proprietary information, a full discussion of the basis for our final determination is set forth in the Bona Fides Analysis Memorandum.6

    5See Memorandum, “2015-2016 Antidumping Duty Administrative Review of Certain Pasta from Turkey: Preliminary Bona Fides Sales Analysis for Mutlu Makarnacilik Sanayi ve Ticaret A.S.,” dated August 1, 2017.

    6See Memorandum, “2015-2016 Antidumping Duty Administrative Review of Certain Pasta from Turkey: Final Bona Fides Sales Analysis for Mutlu Makarnacilik Sanayi ve Ticaret A.S.,” dated February 5, 2018. See also Issues and Decision Memorandum.

    Because we have determined that Mutlu had no bona fide sales during the POR, we are rescinding this administrative review.

    Assessment

    As Commerce is rescinding this administrative review, we have not calculated a company-specific dumping margin for Mutlu. Mutlu's entries will be liquidated at the “all-others” rate applicable to Turkish exporters who do not have their own company-specific rate. That rate is 51.49 percent.7

    7See Notice of Antidumping Duty Order and Amended Final Determination of Sales at Less Than Fair Value: Certain Pasta from Turkey, 61 FR 38545 (July 24, 1996).

    Cash Deposit Requirements

    Because we did not calculate a dumping margin for Mutlu, Mutlu continues to be subject to the “all-others” rate. The all-others cash deposit rate is 51.49 percent.8 These cash deposit requirements shall remain in effect until further notice.

    8Id.

    Administrative Protective Order

    This notice also serves as a reminder to parties subject to Administrative Protective Order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in these segments of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    Notification to Importers

    This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Administrative Protective Orders

    This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

    We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(h) and 351.221(b)(5).

    Dated: February 6, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix—List of Topics Discussed in the Issues and Decision Memorandum Summary Background Scope of the Order Discussion of the Issues 1. Whether “Bona Fides” Testing is Statutorily Limited to New Shipper Reviews, and is Not Applicable in an Administrative Review 2. Whether Record Evidence Confirms that Mutlu's Sale was a Bona Fide Sale 3. Whether Rescinding the Administrative Review Amounts to an Imposition of Adverse Facts Available Based on the Failure to Cooperate of an Unaffiliated Third Party Recommendation
    [FR Doc. 2018-02899 Filed 2-13-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: West Coast Region U.S. Pacific Highly Migratory Species Hook and Line Logbook.

    OMB Control Number: 0648-0223.

    Form Number(s): NOAA 88-197.

    Type of Request: Regular (extension of a currently approved information collection).

    Number of Respondents: 850.

    Average Hours per Response: One hour.

    Burden Hours: 3,400.

    Needs and Uses: This request is for extension of a currently approved collection.

    Under the Fishery Management Plan for United States (U.S.) West Coast Fisheries for Highly Migratory Species (HMS FMP) U.S. fishermen, participating in the Pacific Hook and Line fishery (also known as the albacore troll and pole-and-line fishery), are required to obtain a Highly Migratory Species (HMS) permit. Permit holders are required to complete and submit logbooks documenting their daily fishing activities, including catch and effort for each fishing trip. Logbook forms must be completed within 24 hours of the completion of each fishing day and submitted to the Southwest Fisheries Science Center (SWFSC) within 30 days of the end of each trip. These data and associated analyses help the SWFSC provide fisheries information to researchers and the needed management advice to the U.S. in its negotiations with foreign fishing nations exploiting HMS.

    Affected Public: Business or other for-profit organizations.

    Frequency: For each fishing trip.

    Respondent's Obligation: Mandatory.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: February 8, 2018. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2018-02947 Filed 2-13-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Hydrographic Services Review Panel Meeting AGENCY:

    National Ocean Service, National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.

    ACTION:

    Notice of open public meeting.

    SUMMARY:

    The Hydrographic Services Review Panel (HSRP) will hold a meeting that will be open to the public and public comments are requested in advance and/or during the meeting. Information about the HSRP meeting, agenda, presentations, webinar registration, and other background documents will be posted online at: https://www.nauticalcharts.noaa.gov/hsrp/hsrp.htm.

    DATES:

    The meeting is April 4-5, 2018. The dates, agenda, and times are subject to change. For updates, please check online at: https://www.nauticalcharts.noaa.gov/hsrp/hsrp.htm.

    ADDRESSES:

    Miami, Florida, with meeting venue to be announced online in March at: https://www.nauticalcharts.noaa.gov/hsrp/hsrp.htm.

    FOR FURTHER INFORMATION CONTACT:

    Lynne Mersfelder-Lewis, HSRP program manager, National Ocean Service, Office of Coast Survey, NOAA (N/NSD), 1315 East-West Highway, SSMC3 #6305, Silver Spring, Maryland 20910; telephone: 301-533-0064; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The meeting is open to the public, seating will be available on a first-come, first-served basis, and public comment is encouraged. There are public comment periods scheduled each day and noted in the agenda. Each individual or group making verbal comments will be limited to a total time of five (5) minutes and will be recorded. For those not onsite, comments can be submitted via the webinar chat function or via email in writing. Individuals who would like to submit written statements in advance, during or after the meeting should email their comments to [email protected] The HSRP will provide webinar capability. Pre-registration is required to access the webinar and is at the following: https://attendee.gotowebinar.com/register/6210294947783426818.

    The Hydrographic Services Review Panel (HSRP) is a Federal Advisory Committee established to advise the Under Secretary of Commerce for Oceans and Atmosphere, the NOAA Administrator, on matters related to the responsibilities and authorities set forth in section 303 of the Hydrographic Services Improvement Act of 1998, as amended, and such other appropriate matters that the Under Secretary refers to the Panel for review and advice. The charter and other information are located online at: https://www.nauticalcharts.noaa.gov/hsrp/CharterBylawsHSIAStatute.htm. Past HSRP public meeting summary reports, agendas, presentations, transcripts, webinars, and other information is available online at: https://www.nauticalcharts.noaa.gov/hsrp/meetings.htm.

    Matters to be considered: The panel is convening to hear federal, state, regional and local partners and stakeholders on issues relevant to NOAA's navigation services, focusing on Florida and the U.S. Caribbean region as well as national issues. Navigation services include the data, products, and services provided by the NOAA programs and activities that undertake geodetic observations, gravity modeling, shoreline mapping, bathymetric mapping, hydrographic surveying, nautical charting, tide and water level observations, current observations, and marine modeling. This suite of NOAA products and services support safe and efficient navigation, resilient coasts and communities, and the nationwide positioning information infrastructure to support America's commerce. The Panel will hear from state and federal agencies, non-federal organizations, and partners about their missions and use of NOAA's navigation services, the value these services bring, and what improvements could be made. Other administrative matters may be considered. The agenda is subject to change.

    Special accommodations: This meeting is physically accessible to people with disabilities. Please direct requests for sign language interpretation or other auxiliary aids to [email protected] by March 15, 2018.

    Dated: February 1, 2018. Kathryn Ries, Deputy Director, Office of Coast Survey, National Ocean Service, National Oceanic and Atmospheric Administration.
    [FR Doc. 2018-02968 Filed 2-13-18; 8:45 am] BILLING CODE 3510-JE-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Hydrographic Services Review Panel AGENCY:

    National Ocean Service, National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.

    ACTION:

    Notice of membership solicitation for Hydrographic Services Review Panel.

    SUMMARY:

    The National Oceanic and Atmospheric Administration is seeking nominations for members to serve on the Hydrographic Services Review Panel.

    DATES:

    Nominations are sought to fill five vacancies that occur on January 1, 2019. Nominations should be submitted by no later than May 25, 2018. Nominations will be accepted and kept on file on an ongoing basis regardless of date submitted for use with current and future vacancies. HSRP maintains a pool of candidates and advertises once a year to fulfill the HSIA requirements on membership solicitation. Current members who may be eligible for a second term must reapply.

    ADDRESSES:

    Nominations will be accepted by email and should be sent to: [email protected] and [email protected] You will receive a confirmation response.

    FOR FURTHER INFORMATION CONTACT:

    Lynne Mersfelder-Lewis, NOAA HSRP program manager, email [email protected] or phone: 240-523-0064.

    SUPPLEMENTARY INFORMATION:

    In accordance with the Hydrographic Service Improvements Act Amendments of 2002, Public Law 107-372, the Administrator of the National Oceanic and Atmospheric Administration (NOAA) is required to solicit nominations for membership at least once a year for the Hydrographic Services Review Panel (HSRP). The HSRP, a Federal advisory committee, advises the Administrator on matters related to the responsibilities and authorities set forth in section 303 of the Hydrographic Services Improvement Act and such other appropriate matters as the Administrator refers to the Panel for review and advice. Those responsibilities and authorities include, but are not limited to: Acquiring and disseminating hydrographic data and providing hydrographic services, as those terms are defined in the Act; promulgating standards for hydrographic data and services; ensuring comprehensive geographic coverage of hydrographic services; and testing, developing, and operating vessels, equipment, and technologies necessary to ensure safe navigation and maintain operational expertise in hydrographic data acquisition and hydrographic services.

    The Act states “the voting members of the Panel shall be individuals who, by reason of knowledge, experience, or training, are especially qualified in one or more of the disciplines and fields relating to hydrographic data and hydrographic services, marine transportation, port administration, vessel pilotage, coastal and fishery management, and other disciplines as determined appropriate by the Administrator.” The NOAA Administrator seeks and encourages individuals with expertise in marine navigation and technology, port administration, marine shipping or other intermodal transportation industries, cartography and geographic information systems, geodesy, physical oceanography, coastal resource management, including coastal preparedness and emergency response, and other related fields. To apply for membership, applicants are requested to submit five items including a cover letter that responds to the five questions below. The entire package should be a maximum length of eight pages or fewer. NOAA is an equal opportunity employer.

    (1) A cover letter that responds to the five questions listed below and serves as a statement of interest to serve on the panel. Please see “Short Response Questions” below.

    (2) Highlight the nominee's specific area(s) of expertise relevant to the purpose of the Panel from the list in the Federal Register Notice.

    (3) A short biography of 300 to 400 words.

    (4) A current resume.

    (5) The nominee's full name, title, institutional affiliation, mailing address, email, phone, fax and contact information.

    Short Response Questions

    (1) List the area(s) of expertise, as listed above, which you would best represent on this Panel.

    (2) List the geographic region(s) of the country with which you primarily associate your expertise.

    (3) Describe your leadership or professional experiences which you believe will contribute to the effectiveness of this panel.

    (4) Describe your familiarity and experience with NOAA NOS navigation data, products, and services.

    (5) Generally describe the breadth and scope of your knowledge of stakeholders, users, or other groups who interact with NOAA and whose views and input you believe you can share with the panel.

    Under 33 U.S.C. 883a, et seq., NOAA's National Ocean Service (NOS) is responsible for providing nautical charts and related information for safe navigation. NOS collects and compiles hydrographic, tidal and current, geodetic, and a variety of other data in order to fulfill this responsibility. The HSRP provides advice on current and emerging oceanographic and marine science technologies relating to operations, research and development; and dissemination of data pertaining to:

    (a) Hydrographic surveying;

    (b) Shoreline surveying;

    (c) Nautical charting;

    (d) Water level measurements;

    (e) Current measurements;

    (f) Geodetic measurements;

    (g) Geospatial measurements;

    (h) Geomagnetic measurements; and

    (i) Other oceanographic/marine related sciences.

    The Panel has fifteen voting members appointed by the NOAA Administrator in accordance with 33 U.S.C. 892c. Members are selected on a standardized basis, in accordance with applicable Department of Commerce guidance. The Co-Directors of the Center for Coastal and Ocean Mapping/Joint Hydrographic Center and two other NOAA employees serve as nonvoting members of the Panel. The Director, NOAA Office of Coast Survey, serves as the Designated Federal Official (DFO).

    Voting members are individuals who, by reason of knowledge, experience, or training, are especially qualified in one or more disciplines relating to hydrographic surveying, tides, currents, geodetic and geospatial measurements, marine transportation, port administration, vessel pilotage, coastal or fishery management, and other oceanographic or marine science areas as deemed appropriate by the Administrator. Full-time officers or employees of the United States may not be appointed as a voting member. Any voting member of the Panel who is an applicant for, or beneficiary of (as determined by the Administrator) any assistance under 33 U.S.C. 892c shall disclose to the Panel that relationship, and may not vote on any other matter pertaining to that assistance.

    Voting members of the Panel serve a four-year term, except that vacancy appointments are for the remainder of the unexpired term of the vacancy. Members serve at the discretion of the Administrator and are subject to government ethics standards. Any individual appointed to a partial or full term may be reappointed for one additional full term. A voting member may serve until his or her successor has taken office. The Panel selects one voting member to serve as the Chair and another to serve as the Vice Chair. The Vice Chair acts as Chair in the absence or incapacity of the Chair but will not automatically become the Chair if the Chair resigns. Meetings occur at least twice a year, and at the call of the Chair or upon the request of a majority of the voting members or of the Administrator. Voting members receive compensation at a rate established by the Administrator, not to exceed the maximum daily rate payable under section 5376 of title 5, United States Code, when engaged in performing duties for the Panel. Members are reimbursed for actual and reasonable expenses incurred in performing such duties.

    Past HSRP public meeting summary reports, agendas, presentations, transcripts, webinars, and other information is available online at: https://www.nauticalcharts.noaa.gov/hsrp/meetings.htm.

    Individuals Selected for Panel Membership

    Upon selection and agreement to serve on the HSRP Panel, you become a Special Government Employee (SGE) of the United States Government. 18 U.S.C. 202(a) an SGE (s) is an officer or employee of an agency who is retained, designated, appointed, or employed to perform temporary duties, with or without compensation, not to exceed 130 days during any period of 365 consecutive days, either on a fulltime or intermittent basis. After the selection process is complete, applicants selected to serve on the Panel must complete the following actions before they can be appointed as a Panel member:

    (a) Security Clearance (on-line Background Security Check process and fingerprinting conducted through NOAA Workforce Management); and

    (b) Confidential Financial Disclosure Report—As an SGE, you are required to file a Confidential Financial Disclosure Report to avoid involvement in a real or apparent conflict of interest. You may find the Confidential Financial Disclosure Report at the following website. http://www.usoge.gov/forms/form_450.aspx.

    Dated: February 1, 2018. Kathryn Ries, Deputy Director, Office of Coast Survey, National Ocean Service, National Oceanic and Atmospheric Administration.
    [FR Doc. 2018-02969 Filed 2-13-18; 8:45 am] BILLING CODE 3510-JE-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG008 Meeting of the Advisory Committee to the United States Delegation to the International Commission for the Conservation of Atlantic Tunas AGENCY:

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

    ACTION:

    Notice of Advisory Committee meeting.

    SUMMARY:

    The Advisory Committee (Committee) to the U.S. Section to the International Commission for the Conservation of Atlantic Tunas (ICCAT) announces its annual spring meeting to be held March 5-6, 2018.

    DATES:

    The open sessions of the Committee meeting will be held on March 5, 2018, 8:30 a.m. to 2:30 p.m. and March 6, 2018, 9 a.m. to 4 p.m. Closed sessions will be held on March 5, 2018, 3 p.m. to 6 p.m., and on March 6, 2018, 8 a.m. to 9 a.m.

    ADDRESSES:

    The meeting will be held at the Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910.

    FOR FURTHER INFORMATION CONTACT:

    Terra Lederhouse at (301) 427-8360.

    SUPPLEMENTARY INFORMATION:

    The Advisory Committee to the U.S. Section to ICCAT will meet in open session to receive and discuss information on recreational fisheries in ICCAT; management strategy evaluation and harvest control rules; ICCAT stock assessment methods; the 2017 ICCAT meeting results and U.S. implementation of ICCAT decisions; NMFS research and monitoring activities; global and domestic initiatives related to ICCAT; the Atlantic Tunas Convention Act-required consultation on any identification of countries that are diminishing the effectiveness of ICCAT; the results of the meetings of the Committee's Species Working Groups; and other matters relating to the international management of ICCAT species. The public will have access to the open sessions of the meeting, but there will be no opportunity for public comment. The agenda is available from the Committee's Executive Secretary upon request (see FOR FURTHER INFORMATION CONTACT).

    The Committee will meet in its Species Working Groups for part of the afternoon of March 5, 2018, and for one hour on the morning of March 6, 2018. These sessions are not open to the public, but the results of the Species Working Group discussions will be reported to the full Advisory Committee during the Committee's open session on March 6, 2018.

    Special Accommodations

    The meeting location is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Terra Lederhouse at (301) 427-8360 at least 5 days prior to the meeting date.

    Dated: February 9, 2018. John Henderschedt, Director, Office of International Affairs and Seafood Inspection, National Marine Fisheries Service.
    [FR Doc. 2018-03081 Filed 2-13-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Documentation of Fish Harvest AGENCY:

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

    ACTION:

    Notice.

    SUMMARY:

    The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

    DATES:

    Written comments must be submitted by April 16, 2018.

    ADDRESSES:

    Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the internet at [email protected]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Adam Bailey, National Marine Fisheries Service, Southeast Regional Office, 263 13th Avenue South, St. Petersburg, FL 33701, or [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    This request is for extension of a currently approved information collection. The seafood dealers who process red porgy, greater amberjack, gag grouper, black grouper, red grouper, scamp, red hind, rock hind, yellowmouth grouper, yellowfin grouper, graysby or coney during seasonal fishery closures for applicable species must maintain documentation, as specified in 50 CFR part 300 subpart K and 50 CFR 622.192(i), that such fish were harvested from areas other than state or Federal waters in the South Atlantic. The documentation includes information on the vessel that harvested the fish, and where and when the fish were offloaded. NMFS requires the information for the enforcement of fishery regulations.

    II. Method of Collection

    The information is in the form of a paper affidavit, which remains with the respondent.

    III. Data

    OMB Control Number: 0648-0365.

    Form Number(s): None.

    Type of Review: Regular submission—extension of a current information collection.

    Affected Public: Business or other for-profit organizations; individuals or households.

    Estimated Number of Respondents: 25.

    Estimated Time per Response: 30 minutes.

    Estimated Total Annual Burden Hours: 50.

    Estimated Total Annual Cost to Public: $0.

    IV. Request for Comments

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

    Dated: February 8, 2018. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2018-02946 Filed 2-13-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF988 Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public Meeting AGENCY:

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

    ACTION:

    Notice of SEDAR 56 Assessment Webinars III.

    SUMMARY:

    The SEDAR 56 assessment of the South Atlantic stock of Black Seabass will consist of a series webinars. See SUPPLEMENTARY INFORMATION.

    DATES:

    SEDAR 56 Assessment webinar III will be held on Friday, March 2, 2018 from 9 a.m. until 1 p.m.

    ADDRESSES:

    Meeting address: The meeting will be held via webinar. The webinar is open to members of the public. Those interested in participating should contact Julia Byrd at SEDAR (see FOR FURTHER INFORMATION CONTACT) to request an invitation providing webinar access information. Please request webinar invitations at least 24 hours in advance of each webinar.

    SEDAR address: South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N. Charleston, SC 29405; www.sedarweb.org.

    FOR FURTHER INFORMATION CONTACT:

    Julia Byrd, SEDAR Coordinator, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. The product of the SEDAR webinar series will be a report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses, and describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.

    The items of discussion in the Assessment webinars are as follows:

    1. Participants will continue discussions to develop population models to evaluate stock status, estimate population benchmarks, and project future conditions, as specified in the Terms of Reference.

    2. Participants will recommend the most appropriate methods and configurations for determining stock status and estimating population parameters.

    3. Participants will prepare a workshop report and determine whether the assessment(s) are adequate for submission for review.

    Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

    Special Accommodations

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

    Note:

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

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: February 9, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-03015 Filed 2-13-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG020 Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The Scientific and Statistical Committee (SSC) of the Mid-Atlantic Fishery Management Council's (Council) will hold a meeting.

    DATES:

    The meeting will be held on Tuesday, March 13, 2018, from 1 p.m. through 5:30 p.m. and on Wednesday, March 14, 2018, from 8:30 a.m. to 12:30 p.m. See SUPPLEMENTARY INFORMATION for agenda details.

    ADDRESSES:

    The meeting will take place at the Royal Sonesta Harbor Court Baltimore, 550 Light Street, Baltimore, MD 21202; telephone: (410) 234-0550.

    Council address: Mid-Atlantic Fishery Management Council, 800 N. State Street, Suite 201, Dover, DE 19901; telephone: (302) 674-2331; website: www.mafmc.org.

    FOR FURTHER INFORMATION CONTACT:

    Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.

    SUPPLEMENTARY INFORMATION:

    The purpose of this meeting is to make multi-year ABC recommendations for the blueline tilefish stock north of the VA/NC border based on updated stock assessment results and recommendations from the blueline tilefish Working Group. A review the most recent survey, fishery data, and the currently implemented 2019 ABC for golden tilefish will also be conducted. The SSC will also review and provide recommendations regarding the Northeast Fisheries Science Center clam dredge survey redesign, approve the OFL CV discussion document that would establish decision rules for specifying the CV of the OFL distribution, and review the most recent Mid-Atlantic State of the Ecosystem report. In addition, other topics the SSC may discuss include outcomes from the most recent National SSC meeting, SSC species and topic leads and any other business as necessary.

    A detailed agenda and background documents will be made available on the Council's website (www.mafmc.org) prior to the meeting.

    Special Accommodations

    These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

    Dated: February 9, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-03016 Filed 2-13-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF470 Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to U.S. Navy 2018 Ice Exercise Activities in the Beaufort Sea and Arctic Ocean 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 United States Department of the Navy (Navy) to incidentally harass, by Level B harassment, marine mammals during Ice Exercise 2018 (ICEX18) activities within the Beaufort Sea and Arctic Ocean north of Prudhoe Bay, Alaska. The Navy's activities are considered a military readiness activity pursuant to the Marine Mammal Protection Act (MMPA), as amended by the National Defense Authorization Act for Fiscal Year 2004 (NDAA).

    DATES:

    This authorization is applicable from February 1, 2018 through May 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Rob Pauline, Office of Protected Resources, NMFS, (301) 427-8408. Electronic copies of the 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/military.htm. In case of problems accessing these documents, please call the contact listed above.

    SUPPLEMENTARY INFORMATION: Background

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

    An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.

    NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

    The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.

    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, or sheltering (Level B harassment).The NDAA (Pub. L. 108-136) removed the “small numbers” and “specified geographical region” limitations indicated above and amended the definition of “harassment” as it applies to a “military readiness activity” to read as follows (Section 3(18)(B) of the MMPA): (i) Any act that injures or has the significant potential to injure a marine mammal or marine mammal stock in the wild (Level A Harassment); or (ii) Any act that disturbs or is likely to disturb a marine mammal or marine mammal stock in the wild by causing disruption of natural behavioral patterns, including, but not limited to, migration, surfacing, nursing, breeding, feeding, or sheltering, to a point where such behavioral patterns are abandoned or significantly altered (Level B Harassment).

    National Environmental Policy Act

    To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq.) and NOAA Administrative Order (NAO) 216-6A, NMFS must review the proposed action (i.e. the issuance of an incidental harassment authorization) with respect to environmental consequences on the human environment.

    The Navy has prepared an environmental assessment (EA) titled Environmental Assessment/Overseas Environmental Assessment for Ice Exercise. NMFS has adopted the Navy's EA/OEA, after an independent evaluation of the document found that it included adequate information analyzing the effects on the human environment of issuing incidental take authorizations. NMFS issued a Finding of No Significant Impact (FONSI), which is available for review at http://www.nmfs.noaa.gov/pr/permits/incidental/military.htm.

    Summary of Request

    On April 12, 2017, NMFS received a request from the Navy for the taking of marine mammals incidental to submarine training and testing activities including establishment of a tracking range on an ice floe in the Beaufort Sea and Arctic Ocean north of Prudhoe Bay, Alaska. The Navy's request is for take of ringed seals (Pusa hispida hispida) by Level B harassment. Neither the Navy nor NMFS expects Level A harassment or mortality to result from this activity and, therefore, an IHA is appropriate.

    Description of Specified Activity Overview

    The Navy proposes to conduct submarine training and testing activities from an ice camp stationed on an ice floe in the Beaufort Sea and Arctic Ocean for six weeks between February and April 2018. Submarine activities associated with ICEX18 are classified, but generally entail safety maneuvers, active sonar use and exercise torpedo use. These maneuvers and sonar use are similar to submarine activities conducted in other undersea environments. They are being conducted in the Arctic to test their performance in a cold environment. A detailed description of the planned project is provided in the Federal Register notice for the proposed IHA (82 FR 48683; October 19, 2017). 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's proposal to issue an IHA to the Navy was published in the Federal Register on October 19, 2017 (82 FR 48683). That notice describes the Navy'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 (Commission) and the Office of the Mayor of North Slope Borough (NSB).

    Comment 1: The Commission noted that the Navy did not use Bayesian biphasic dose response functions (BRFs) to inform take estimates, but used cut-off distances instead. The Commission stated that the cut-off distances used by the Navy are unsubstantiated and the Navy arbitrarily set a cut-off distance of 10 kilometers (km) which could effectively eliminate a large portion of the estimated numbers of takes. The Commission, therefore, recommended that the Navy refrain from using cut-off distances in conjunction with the Bayesian BRFs.

    Response: The derivation of the behavioral response functions and associated cut-off distances is provided in the Phase III technical report (Navy, 2017a). The consideration of proximity (distance cutoff) was part of the criteria developed in consultation with NMFS and was applied within the Navy's acoustic effects model. Distance cutoffs beyond which the potential of significant behavioral responses were considered to be unlikely were used in conducting analysis for ringed seals for ICEX 18.

    As stated in the Criteria and Thresholds Technical Report (Navy, 2017a), Southall et al. (2007) report that pinnipeds do not exhibit strong reactions to sound pressure levels (SPLs) up to 140 decibels (dB) re 1 micro Pascal (μPa) (which occurs at about 400m from the sources used here) from steady state (non-impulsive) sources. In some cases, pinnipeds tolerate impulsive exposures up to 180 dB re 1 μPa with limited avoidance noted (Southall et al., 2007), and no avoidance noted at distances as close as 42 m (Jacobs & Terhune, 2002). Though there are limited data on pinniped behavioral responses beyond about 3 km in the water, there is evidence that there is a lack of strong reactions at shorter distances. The available data suggest that most pinnipeds likely do not exhibit significant behavioral reactions to sonar and other transducers beyond a few kilometers, independent of received levels of sound. Further, 160 dB rms, which is used as the behavioral harassment threshold for non-tactical intermittent sonar use, will not be received farther than a couple of hundred meters from the source (140 dB is received at 400m). Therefore, NMFS believes that the 10 km distance cutoff for pinnipeds is both conservative and adequate to evaluate the Level B harassment impacts for military readiness activities.

    Comment 2: Although the Office of Naval Research funded seal tagging studies indicate that most ice seals migrate southward at the onset of winter; NSB is aware of traditional ecological knowledge that provides evidence that there are resident ringed and bearded seal populations in the Beaufort Sea.

    Response: The Navy reached out to the Inupiat Community of the Arctic Slope (ICAS), Nuiqsut, and Kaktovic communities on September 28, 2017, providing them a CD containing the draft Environmental Assessment/Overseas Environmental Assessment (EA/OEA) for ICEX 2018 and also sent emails to tribal representatives with an internet link to the document. The Navy was not provided with any information or data pertaining to resident and bearded seal populations in the Beaufort Sea that far offshore in late winter. There was also a public comment period, which ran from September 29 to October 16, 2017. A complete discussion of potential impacts from ICEX 18 is contained in the ICEX 2018 (EA/OEA) (http://www.aftteis.com/ICEX). The Navy used the best available science and data to assess potential impacts in the EA/OEA. NMFS also used best available science and data to make their determination regarding the issuance of the IHA. The Navy and NMFS are not aware of other data that would alter their findings.

    Furthermore, the Navy is funding Duke University to develop species density models for the Arctic region and would welcome any data the NSB and Arctic research community have available to incorporate into density models and impacts analysis.

    Comment 3: NSB expressed concern that potential creation of unseasonal leads due to submarine surfacing, possible destruction of winter lairs of ringed seals during encampment preparation, and use of motorized vehicles during the exercises may impact seals.

    Response: As part of the planned ICEX18 activities submarines will surface through the ice. In the area where the submarines will surface, ice leads are a frequent and natural occurrence, opening up and refreezing due to ocean currents and shifting ice. Submarine surfacing will occur in either open leads or first year ice as there is less potential to damage a submarine. While surfacing submarines may create small leads in some instances, each U.S. Navy submarine will surface no more than five times per ICEX. Therefore, potential impacts to seals would be minor and temporary. Furthermore, seal lairs are not expected to occur close to open leads or on first year ice. Additionally, mitigation and monitoring requirements listed in the IHA (e.g. no ice camp construction near ice ridges; avoidance of pressure ridges by snowmobiles and researchers) should prevent destruction of lairs and adverse impacts to seals. These issues were also evaluated in the EA/OEA were not found to be not significant.

    Comment 4: NSB feels that the lack of available species-specific data (e.g. ice seal, arctic fish species, polar bears) precludes assessment of the consequences of sonar use on Arctic protected marine mammal species.

    Response: The Navy conducts numerous types of research to better understand how sound may affect marine mammals, and though not specifically Arctic species, the knowledge gained from those studies is transferable to Arctic species. This type of research has focused on the development of better tags and attachment mechanisms for monitoring, development and testing of new autonomous hardware platforms for detection of marine mammals, and ways to better understand and characterize the behavioral, physiological (hearing and stress response), and potentially population-level consequences of sound exposure on marine life.

    The Navy uses the best available science when analyzing the impacts of training and testing on the environment, including animals. To do this the Navy continually reviews published scientific literature, incorporates data from regulatory agencies such as National Oceanic and Atmospheric Administration and U.S. Fish and Wildlife Service, and funds or conducts research where data gaps exist. Furthermore, NMFS utilizes the best available science when making determinations regarding the issuance of IHAs and concluded that there was adequate information available to support the findings.

    Comment 5: NSB is concerned that the planned submarine exercises, which will employ sonar, have the potential to negatively impact marine mammals and affect the food chain. As a result, the Inupiaq subsistence life style may also be affected. Therefore, NSB recommends that the Navy initiate engagement with the North Slope leadership and the Arctic research community to develop studies that address the missing information needed for a better understanding of the effects of military sonar use on Arctic marine mammals and their prey.

    Response: The Navy's marine species monitoring website provides information on current and past monitoring projects and allows for the submittal of ideas or concepts for projects to be considered under the U.S Navy's Marine Species Monitoring Program at: https://www.navymarinespeciesmonitoring.us/project-submission-form/. The Navy's Living Marine Resources Program also solicits proposals for funding of research projects (http://greenfleet.dodlive.mil/environment/lmrproposals/), as well as the Office of Naval Research (https://www.onr.navy.mil/Science-Technology/Departments/Code-32/All-Programs/Atmosphere-Research-322/Marine-Mammals-Biology). These sites include a list of research projects the Navy is currently funding to improve the Navy's understanding of marine species and how Navy activities may affect those species. These websites offer NSB and the Arctic research community the opportunity to engage with the Navy through the submission of research proposals.

    Description of Marine Mammals in the Area of Specified Activities

    Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history, of ringed seals (Pusa hispida hispida), which is the only potentially affected species. Total sea ice coverage is expected across the study area during the study period which precludes the presence of other arctic marine mammal species. Ringed seals temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur, and therefore we have authorized take after considering the anticipated amount and type of take and making the required findings. Additional information regarding population trends and threats may be found in NMFS's Stock Assessment Reports (Muto et al., 2016; www.nmfs.noaa.gov/pr/sars/) and more general information about this species (e.g., physical and behavioral descriptions) may be found on NMFS's website (www.nmfs.noaa.gov/pr/species/mammals/).

    Table 2—Marine Mammal Species Potentially Present in the Project Area Common name Scientific name Stock ESA/MMPA status;
  • Strategic
  • (Y/N) 1
  • Stock abundance (CV, Nmin,
  • most recent
  • abundance survey) 2
  • PBR Annual M/SI 3
    Order Cetartiodactyla—Cetacea—Superfamily Mysticeti (baleen whales) Family Balaenidai Bowhead whale Balaena mysticetus Western Arctic E/D;Y 16,982 (0.058, 16,091, 2011) 161 44 Superfamily Odontoceti (toothed whales, dolphins, and porpoises) Family Delphinidae Beluga whale Delphinapterus leucas Beaufort Sea -/-;N 39,258 (0.229, 32,453, 1992) 649 166 Order Carnivora—Superfamily Pinnipedia Family Phocidae (earless seals) Ringed seal Pusa hispida hispida Alaska -/-;N 170,000 (Bering Sea and Sea of Okhotsk only)—2013) 5,100 (Bearing Sea-U.S. portion only) 1,054 Bearded seal Erignathus barbatus nauticus Alaska -/-;N 299,174 (-, 273,676, 2012) (Bearing Sea-U.S. portion only) 8,210 (Bearing Sea-U.S. portion only) 1.4 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 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 NMFS marine mammal stock assessment reports online at: www.nmfs.noaa.gov/pr/sars/. CV is coefficient of variation; Nmin is the minimum estimate of stock abundance. In some cases, CV is not applicable [explain if this is the case]. 3 These values, found in NMFS's SARs, represent annual levels of human-caused mortality plus serious injury from all sources combined (e.g., commercial fisheries, ship strike). Annual M/SI often cannot be determined precisely and is in some cases presented as a minimum value or range. A CV associated with estimated mortality due to commercial fisheries is presented in some cases. NoteItalicized species are not expected to be taken.
    Potential Effects of the Specified Activity on Marine Mammals and Their Habitat

    The effects of underwater noise from Navy's testing and training activities have the potential to result in behavioral harassment of marine mammals in the vicinity of the action area. The Federal Register notice for the proposed IHA (82 FR 48683; October 19, 2017) included a discussion of the effects of anthropogenic noise on marine mammals and no new information has been received since publication of the proposed IHA, therefore that information is not repeated here; please refer to the Federal Register notice (82 FR 48683; October 19, 2017) for that information.

    Estimated Take

    This section provides an estimate of the number of incidental takes anticipated to occur and therefore authorized through this IHA, which will inform the negligible impact determination.

    Harassment is the only type of take expected to result from these activities. For this military readiness activity, the MMPA defines “harassment” as: (i) Any act that injures or has the significant potential to injure a marine mammal or marine mammal stock in the wild (Level A Harassment); or (ii) Any act that disturbs or is likely to disturb a marine mammal or marine mammal stock in the wild by causing disruption of natural behavioral patterns, including, but not limited to, migration, surfacing, nursing, breeding, feeding, or sheltering, to a point where such behavioral patterns are abandoned or significantly altered (Level B Harassment).

    Authorized takes would be by Level B harassment only, in the form of disruption of behavioral patterns and TTS, for individual marine mammals resulting from exposure to acoustic transmissions. Based on the nature of the activity, Level A harassment is neither anticipated nor authorized. In addition, no serious injury or mortality is anticipated or authorized for this activity. Source levels of acoustic transmission will not be at levels which would cause serious injury, or mortality. Deployment of the ice camp could potentially affect ringed seal habitat by physically damaging or crushing subnivean lairs, resulting in seal injury or mortality. However, seals usually choose to locate lairs near pressure ridges and the ice camp will be deployed in an area without pressure ridges in order to allow operation of an aircraft runway. Further, portable tents will be erected for lodging and operations purposes. Tents do not require building materials or typical construction methods. The tents are relatively easy to mobilize and will not be situated near areas featuring pressure ridges. Finally, the camp buildup will be gradual, with activity increasing over the first five days. This approach allows seals to move to different lair locations outside the ice camp area. Based on this information, we do not anticipate any damage to subnivean lairs that could result in ringed seal injury or mortality.

    Below we describe how the take is estimated.

    Described in the most basic way, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities. For the proposed IHA, the Navy employed a sophisticated model known as the Navy Acoustic Effects Model (NAEMO) for assessing the impacts of underwater sound.

    Acoustic Thresholds

    Using the best available science, NMFS recommends acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to incur PTS of some degree (equated to Level A harassment), TTS, or behavioral harassment (Level B harassment). The thresholds used to predict occurrences of each type of take are described below.

    Behavioral harassment—In coordination with NMFS, the Navy developed behavioral harassment thresholds to support Phase III environmental analyses for the Navy's testing and training military readiness activities; these behavioral harassment thresholds are used here to evaluate the potential effects of this planned action. The response of a marine mammal to an anthropogenic sound will depend on the frequency, duration, temporal pattern and amplitude of the sound as well as the animal's prior experience with the sound and the context in which the sound is encountered (i.e. what the animal is doing at the time of the exposure). The distance from the sound source and whether it is perceived as approaching or moving away can also affect the way an animal responds to a sound (Wartzok et al., 2003). For marine mammals, a review of responses to anthropogenic sound was first conducted by Richardson et al. (1995). Reviews by Nowacek et al. (2007) and Southall et al. (2007) address studies conducted since 1995 and focus on observations where the received sound level of the exposed marine mammal(s) was known or could be estimated. Multi-year research efforts have conducted sonar exposure studies for odontocetes and mysticetes (Miller et al., 2012; Sivle et al., 2012). Several studies with captive animals have provided data under controlled circumstances for odontocetes and pinnipeds (Houser et al., 2013a; Houser et al., 2013b). Moretti et al. (2014) published a beaked whale dose-response curve based on passive acoustic monitoring of beaked whales during U.S. Navy training activity at Atlantic Underwater Test and Evaluation Center during actual Anti-Submarine Warfare exercises. This new information necessitated the update of the Navy's behavioral response criteria for the Phase III environmental analyses.

    Southall et al. (2007) synthesized data from many past behavioral studies and observations to determine the likelihood of behavioral reactions at specific sound levels. While in general, the louder the sound source the more intense the behavioral response, it was clear that the proximity of a sound source and the animal's experience, motivation, and conditioning were also critical factors influencing the response (Southall et al., 2007). After examining all of the available data, the authors felt that the derivation of thresholds for behavioral response based solely on exposure level was not supported because context of the animal at the time of sound exposure was an important factor in estimating response. Nonetheless, in some conditions, consistent avoidance reactions were noted at higher sound levels depending on the marine mammal species or group allowing conclusions to be drawn. Phocid seals showed avoidance reactions at or below 190 dB re 1 μPa @1m; thus, seals may actually receive levels adequate to produce TTS before avoiding the source.

    The Navy's Phase III proposed pinniped behavioral threshold has been updated based on controlled exposure experiments on the following captive animals: hooded seal, gray seal, and California sea lion (Götz et al., 2010; Houser et al., 2013a; Kvadsheim et al., 2010). Overall exposure levels were 110-170 dB re 1 μPa for hooded seals, 140-180 dB re 1 μPa for gray seals and 125-185 dB re 1 μPa for California sea lions; responses occurred at received levels ranging from 125 to 185 dB re 1 μPa. However, the means of the response data were between 159 and 170 dB re 1 μPa. Hooded seals were exposed to increasing levels of sonar until an avoidance response was observed, while the grey seals were exposed first to a single received level multiple times, then an increasing received level. Each individual California sea lion was exposed to the same received level ten times. These exposure sessions were combined into a single response value, with an overall response assumed if an animal responded in any single session. Because these data represent a dose-response type relationship between received level and a response, and because the means were all tightly clustered, the Bayesian biphasic Behavioral Response Function for pinnipeds most closely resembles a traditional sigmoidal dose-response function at the upper received levels and has a 50 percent probability of response at 166 dB re 1 μPa. Additional details regarding the Phase III criteria may be found in the technical report, Criteria and Thresholds for U.S. Navy Acoustic and Explosive Effects Analysis (2017a) which may be found at: http://aftteis.com/Portals/3/docs/newdocs/Criteria%20and%20Thresholds_TR_Submittal_05262017.pdf. This technical report was as part of the Navy's Atlantic Fleet Training and Testing Draft Environmental Impact Statement/Overseas Environmental Impact Statement (EIS/OEIS) (Navy 2017b) which is located at: http://www.aftteis.com/. NMFS is proposing the use of this dose response function to predict behavioral harassment of pinnipeds for this activity.

    Level A harassment and TTS—NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Technical Guidance, 2016) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive).

    These thresholds were developed by compiling and synthesizing the best available science and soliciting input multiple times from both the public and peer reviewers to inform the final product. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2016 Technical Guidance, which may be accessed at: http://www.nmfs.noaa.gov/pr/acoustics/guidelines.htm.

    The PTS/TTS analyses begins with mathematical modeling to predict the sound transmission patterns from Navy sources, including sonar. These data are then coupled with marine species distribution and abundance data to determine the sound levels likely to be received by various marine species. These criteria and thresholds are applied to estimate specific effects that animals exposed to Navy-generated sound may experience. For weighting function derivation, the most critical data required are TTS onset exposure levels as a function of exposure frequency. These values can be estimated from published literature by examining TTS as a function of sound exposure level (SEL) for various frequencies.

    To estimate TTS onset values, only TTS data from behavioral hearing tests were used. To determine TTS onset for each subject, the amount of TTS observed after exposures with different SPLs and durations were combined to create a single TTS growth curve as a function of SEL. The use of (cumulative) SEL is a simplifying assumption to accommodate sounds of various SPLs, durations, and duty cycles. This is referred to as an “equal energy” approach, since SEL is related to the energy of the sound and this approach assumes exposures with equal SEL result in equal effects, regardless of the duration or duty cycle of the sound. It is well known that the equal energy rule will over-estimate the effects of intermittent noise, since the quiet periods between noise exposures will allow some recovery of hearing compared to noise that is continuously present with the same total SEL (Ward 1997). For continuous exposures with the same SEL but different durations, the exposure with the longer duration will also tend to produce more TTS (Finneran et al., 2010; Kastak et al., 2007; Mooney et al., 2009a).

    As in previous acoustic effects analysis (Finneran and Jenkins 2012; Southall et al., 2007), the shape of the PTS exposure function for each species group is assumed to be identical to the TTS exposure function for each group. A difference of 20 dB between TTS onset and PTS onset is used for all marine mammals including pinnipeds. This is based on estimates of exposure levels actually required for PTS (i.e. 40 dB of TTS) from the marine mammal TTS growth curves, which show differences of 13 to 37 dB between TTS and PTS onset in marine mammals. Details regarding these criteria and thresholds can be found in NMFS' Technical Guidance (NMFS 2016).

    Table 3 below provides the weighted criteria and thresholds used in this analysis for estimating quantitative acoustic exposures of marine mammals from the planned action.

    Table 3—Injury (PTS) and Disturbance (TTS, Behavioral) Thresholds for Underwater Sounds Group Species Behavioral criteria Physiological criteria Onset TTS Onset PTS Phocid (in water) Ringed seal Pinniped Dose Response Function 181 dB SEL cumulative 201 dB SEL cumulative. Quantitative Modeling

    The Navy performed a quantitative analysis to estimate the number of mammals that could be harassed by the underwater acoustic transmissions during the planned action. Inputs to the quantitative analysis included marine mammal density estimates, marine mammal depth occurrence distributions (Navy 2017a), oceanographic and environmental data, marine mammal hearing data, and criteria and thresholds for levels of potential effects.

    The density estimate used to estimate take is derived from habitat-based modeling by Kaschner et al., (2006) and Kaschner (2004). The area of the Arctic where the action will occur (100-200 nm north of Prudhoe Bay, Alaska) has not been surveyed in a manner that supports quantifiable density estimation of marine mammals. In the absence of empirical survey data, information on known or inferred associations between marine habitat features and the likelihood of the presence of specific species have been used to predict densities using model-based approaches. These habitat suitability models include relative environmental suitability (RES) models. Habitat suitability models can be used to understand the possible extent and relative expected concentration of a marine species distribution. These models are derived from an assessment of the species occurrence in association with evaluated environmental explanatory variables that results in defining the RES suitability of a given environment. A fitted model that quantitatively describes the relationship of occurrence with the environmental variables can be used to estimate unknown occurrence in conjunction with known habitat suitability. Abundance can thus be estimated for each RES value based on the values of the environmental variables, providing a means to estimate density for areas that have not been surveyed. Use of the Kaschner's RES model resulted in a value of 0.3957 animals per km2 in the cold season (defined as December through May). The density numbers are assumed static throughout the ice camp action area for this species. The density data generated for this species was based on environmental variables known to exist within the planned ice camp action area during the late winter/early springtime period.

    Note that while other surveys by Frost et al. (2004) and Bengston et al. (2005) provided ringed seal density estimates for areas near or within the Beaufort Sea, the Navy felt that those findings were not applicable to the planned action area. Frost et al. (2004) only surveyed ringed seals out to 40 km from shore in the Beaufort Sea. A small portion of the surveys from Bengston et al. (2005) were out to a maximum extent of 185 km (100 nm) from shore, but the surveys were located within the Chukchi Sea, not the Beaufort Sea. Frost et al. (2004) also stated the highest densities of ringed seals were in water depths from 5-25 m (1-1.33 seals per km2). Lower densities were seen in waters greater than 35 m in depth (0-0.77 seals per km2). The planned action area where acoustic transmissions would occur is 3,000 to 4,000 m deep (International Bathymetric Chart of the Arctic Ocean 2015), which makes the bathymetric nature of the areas different enough to be non-comparable. Furthermore, the ice camp is located on multi-year ice and would not be located near the ice edge. Frost et al. (2004), and Bengston et al. (2005) both had a high percentage of fast or pack ice in their survey area which would not be present in the planned action area. Additionally, there were areas of cracked ice that were part of the surveys. As previously noted, the ice camp needs to be situated in an area without cracks in the ice. After reviewing both Frost et al. (2004) and Bengston et al. (2005) NMFS agrees with the Navy that the density data from the RES model provides the most appropriate density values to be assessed for acoustic transmissions during ICEX18.

    The quantitative analysis consists of computer modeled estimates and a post-model analysis to determine the number of potential animal exposures. The model calculates sound energy propagation from the planned active acoustic sources, the sound received by animat (virtual animal) dosimeters representing marine mammals distributed in the area around the modeled activity, and whether the sound received by a marine mammal exceeds the thresholds for effects.

    The Navy developed a set of software tools and compiled data for estimating acoustic effects on marine mammals without consideration of behavioral avoidance or Navy's standard mitigations. These tools and data sets serve are integral components of NAEMO. In NAEMO, animats are distributed non-uniformly based on species-specific density, depth distribution, and group size information and animats record energy received at their location in the water column. A fully three-dimensional environment is used for calculating sound propagation and animat exposure in NAEMO. Site-specific bathymetry, sound speed profiles, wind speed, and bottom properties are incorporated into the propagation modeling process. NAEMO calculates the likely propagation for various levels of energy (sound or pressure) resulting from each source used during the training event.

    NAEMO then records the energy received by each animat within the energy footprint of the event and calculates the number of animats having received levels of energy exposures that fall within defined impact thresholds. Predicted effects on the animats within a scenario are then tallied and the highest order effect (based on severity of criteria; e.g., PTS over TTS) predicted for a given animat is assumed. Each scenario or each 24-hour period for scenarios lasting greater than 24 hours is independent of all others, and therefore, the same individual marine animal could be impacted during each independent scenario or 24-hour period. In few instances, although the activities themselves all occur within the study area, sound may propagate beyond the boundary of the study area. Any exposures occurring outside the boundary of the study area are counted as if they occurred within the study area boundary. NAEMO provides the initial estimated impacts on marine species with a static horizontal distribution.

    There are limitations to the data used in the acoustic effects model, and the results must be interpreted within these context. While the most accurate data and input assumptions have been used in the modeling, when there is a lack of definitive data to support an aspect of the modeling, modeling assumptions believed to overestimate the number of exposures have been chosen:

    • Animats are modeled as being underwater, stationary, and facing the source and therefore always predicted to receive the maximum sound level (i.e. no porpoising or pinnipeds' heads above water);

    • Animats do not move horizontally (but change their position vertically within the water column), which may overestimate physiological effects such as hearing loss, especially for slow moving or stationary sound sources in the model;

    • Animats are stationary horizontally and therefore do not avoid the sound source, unlike in the wild where animals would most often avoid exposures at higher sound levels, especially those exposures that may result in PTS;

    • Multiple exposures within any 24-hour period are considered one continuous exposure for the purposes of calculating the temporary or permanent hearing loss, because there are not sufficient data to estimate a hearing recovery function for the time between exposures; and

    • Mitigation measures that are implemented were not considered in the model. In reality, sound-producing activities would be reduced, stopped, or delayed if marine mammals are detected by submarines via passive acoustic monitoring.

    Because of these inherent model limitations and simplifications, model-estimated results must be further analyzed, considering such factors as the range to specific effects, avoidance, and the likelihood of successfully implementing mitigation measures. This analysis uses a number of factors in addition to the acoustic model results to predict acoustic effects on marine mammals.

    For non-impulsive sources, NAEMO calculates the sound pressure level (SPL) and SEL for each active emission over the entire duration of an event. These data are then processed using a bootstrapping routine to compute the number of animats exposed to SPL and SEL in 1 dB bins across all track iterations and population draws. (Bootstrapping is a type of resampling where large numbers of smaller samples of the same size are repeatedly drawn, with replacement, from a single original sample.) SEL is checked during this process to ensure that all animats are grouped in either an SPL or SEL category. A mean number of SPL and SEL exposures are computed for each 1 dB bin. The mean value is based on the number of animats exposed at that dB level from each track iteration and population draw. The behavioral risk function curve is applied to each 1 dB bin to compute the number of behaviorally exposed animats per bin. The number of behaviorally exposed animats per bin is summed to produce the total number of behavior exposures.

    Mean 1 dB bin SEL exposures are then summed to determine the number of PTS and TTS exposures. PTS exposures represent the cumulative number of animats exposed at or above the PTS threshold. The number of TTS exposures represents the cumulative number of animats exposed at or above the TTS threshold and below the PTS threshold. Animats exposed below the TTS threshold were grouped in the SPL category.

    Platforms such as a submarine using one or more sound sources are modeled in accordance with relevant vehicle dynamics and time durations by moving them across an area whose size is representative of the training event's operational area. For analysis purposes, the Navy uses distance cutoffs, which is the maximum distance a Level B take would occur, beyond which the potential for significant behavioral responses is considered unlikely. For animals located beyond the range to effects, no significant behavioral responses are predicted. This is based on the Navy's Phase III environmental analysis (Navy 2017a). The Navy referenced Southall et al. (2007) who reported that pinnipeds do not exhibit strong reactions to SPLs up to 140 dB re 1 μPa from steady state (non-impulsive) sources. In some cases, pinnipeds tolerate impulsive exposures up to 180 dB re 1 μPa with limited avoidance noted (Southall et al., 2007), and no avoidance noted at distances as close as 42 m (Jacobs & Terhune 2002). While limited data exists on pinniped behavioral responses beyond 3 km in the water, the data that is available suggest that most pinnipeds likely do not exhibit significant behavioral reactions to sonar and other transducers beyond a few kilometers, independent of received levels of sound (Navy 2017a). Therefore, in the Navy's Phase III environmental analysis, the range to effects for pinnipeds is set at 5 km for moderate source level, single platform training and testing events and 10 km for all other events with multiple sonar platforms or sonar with source levels at or exceeding 215 dB re 1 µPa @1 m. Regardless of the source level, take beyond 10 km is not anticipated. These ranges are expected to reasonably contain the anticipated effects predicted by the behavioral response dose curve threshold reference above.

    For ICEX18 unclassified sources (i.e. Autonomous Reverberation Measurement System and MIT/Lincoln Labs continuous wave/chirp), the Navy models calculated a propagation loss measurement of 13.5 km from the source to the 120 dB re 1 μPa SPL isopleth; 1.5 km from the source to the 130 dB re 1 μPa SPL isopleth; and 400 m from the source to the 140 dB dB re 1 μPa SPL isopleth. Propagation loss measurements cannot be provided for classified sources. However, the ranges in Table 4 provide realistic maximum distances over which the specific effects from the use of all active acoustic sources during the planned action would be possible. Based on the information provided, NMFS is confident that the 10km zone safely encompasses the area in which Level B harassment can be expected from all active acoustic sources.

    Table 4—Range to Temporary Threshold Shift and Behavioral Effects in the ICEX18 Study Area Source/exercise Maximum range to Level B takes cold season
  • (m)
  • Behavioral TTS
    Submarine Exercise 10,000 100 Autonomous Reverberation Measurement System 10,000 <50 Massachusetts Institute of Technology/Lincoln Labs Continuous Wave/chirp 10,000 <50 Naval Research Laboratory Synthetic Aperture Sonar 10,000 90

    As discussed above, within NAEMO animats do not move horizontally or react in any way to avoid sound. Furthermore, mitigation measures that are implemented during training or testing activities that reduce the likelihood of physiological impacts are not considered in quantitative analysis. Therefore, the current model overestimates acoustic impacts, especially physiological impacts near the sound source. The behavioral criteria used as a part of this analysis acknowledges that a behavioral reaction is likely to occur at levels below those required to cause hearing loss (TTS or PTS). At close ranges and high sound levels approaching those that could cause PTS, avoidance of the area immediately around the sound source is the assumed behavioral response for most cases.

    In previous environmental analyses, the Navy has implemented analytical factors to account for avoidance behavior and the implementation of mitigation measures. The application of avoidance and mitigation factors has only been applied to model-estimated PTS exposures given the short distance over which PTS is estimated. Given that no PTS exposures were estimated during the modeling process for this planned action, the implementation of avoidance and mitigation factors were not included in this analysis.

    Utilizing the NAEMO model, the Navy projected that there will be 1,665 behavioral Level B harassment takes and an additional 11 Level B takes due to TTS for a total of 1,676 takes of ringed seals. All takes would be underwater. Note that these quantitative results should be regarded as conservative estimates that are strongly influenced by limited marine mammal population data.

    Mitigation

    In order to issue an IHA 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 and their habitat (50 CFR 216.104(a)(11)). The NDAA for FY 2004 amended the MMPA as it relates to military readiness activities and the incidental take authorization process such that “least practicable adverse impact” shall include consideration of personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.

    In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, we carefully weigh two primary factors:

    (1) The manner in which, and the degree to which, implementation of the measure(s) is expected to reduce impacts to marine mammal species or stocks, their habitat, and their availability for subsistence uses (where relevant). This analysis will consider such things as the nature of the potential adverse impact (such as likelihood, scope, and range), the likelihood that the measure will be effective if implemented, and the likelihood of successful implementation; and

    (2) The practicability of the measures for applicant implementation. Practicability of implementation may consider such things as cost, impact on operations, and, in the case of a military readiness activity, specifically considers personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity (16 U.S.C. 1371(a)(5)(A)(ii)).

    Mitigation for Marine Mammals and Their Habitat

    The following general mitigation actions are planned for ICEX18 to avoid any take of ringed seals on the ice floe:

    • Camp deployment would begin in mid-February and would be completed by March 15. Based on the best available science, Arctic ringed seal whelping is not expected to occur prior to mid-March. Construction of the ice camp would be completed prior to whelping in the area of ICEX18. As such, pups are not anticipated to be in the vicinity of the camp at commencement, and mothers would not need to move newborn pups due to construction of the camp. Additionally, if a seal had a lair in the area they would be able to relocate. Completing camp deployment before ringed seal pupping begins will allow ringed seals to avoid the camp area prior to pupping and mating seasons, reducing potential impacts;

    • Camp location will not be in proximity to pressure ridges in order to allow camp deployment and operation of an aircraft runway. This will minimize physical impacts to subnivean lairs;

    • Camp deployment will gradually increase over five days, allowing seals to relocate to lairs that are not in the immediate vicinity of the camp;

    • Passengers on all on-ice vehicles would observe for marine and terrestrial animals; any marine or terrestrial animal observed on the ice would be avoided by 328 ft (100 m). On-ice vehicles would not be used to follow any animal, with the exception of actively deterring polar bears if the situation requires;

    • Personnel operating on-ice vehicles would avoid areas of deep snowdrifts near pressure ridges, which are preferred areas for subnivean lair development; and

    • All material (e.g., tents, unused food, excess fuel) and wastes (e.g., solid waste, hazardous waste) would be removed from the ice floe upon completion of ICEX18.

    The following mitigation actions are planned for ICEX18 activities involving acoustic transmissions:

    For activities involving active acoustic transmissions from submarines and torpedoes, passive acoustic sensors on the submarines will listen for vocalizing marine mammals for 15 minutes prior to the initiation of exercise activities. If a marine mammal is detected, the submarine will delay active transmissions, including the launching of torpedoes, and not restart until after 15 minutes have passed with no marine mammal detections. If there are no animal detections, it is assumed that the vocalizing animal is no longer in the immediate area and is unlikely to be subject to harassment. Ramp up procedures will not be required as they would result in an unacceptable impact on readiness and on the realism of training.

    Based on our evaluation of the applicant's planned measures, NMFS has determined that the planned mitigation measures provide the means effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Monitoring and Reporting

    In order to issue an IHA for an activity, Section 101(a)(5)(D) of the MMPA states that NMFS must set forth, requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for 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 action area. Effective reporting is critical both to compliance as well as to ensuring that the most value is obtained from the required monitoring.

    Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:

    • Occurrence of marine mammal species or stocks in the area in which take is anticipated (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 marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;

    • How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;

    • Effects on marine mammal habitat (e.g., marine mammal prey species, acoustic habitat, or other important physical components of marine mammal habitat); and

    • Mitigation and monitoring effectiveness.

    The U.S. Navy has coordinated with NMFS to develop an overarching program plan in which specific monitoring would occur. This plan is called the Integrated Comprehensive Monitoring Program (ICMP) (U.S. Department of the Navy 2011). The ICMP has been created in direct response to Navy permitting requirements established in various MMPA Final Rules, ESA consultations, Biological Opinions, and applicable regulations. As a framework document, the ICMP applies by regulation to those activities on ranges and operating areas for which the Navy is seeking or has sought incidental take authorizations. The ICMP is intended to coordinate monitoring efforts across all regions and to allocate the most appropriate level and type of effort based on set of standardized research goals, and in acknowledgement of regional scientific value and resource availability.

    The ICMP is focused on Navy training and testing ranges where the majority of Navy activities occur regularly as those areas have the greatest potential for being impacted. ICEX18 in comparison is a short duration exercise that occurs approximately every other year. Due to the location and expeditionary nature of the ice camp, the number of personnel onsite is extremely limited and is constrained by the requirement to be able to evacuate all personnel in a single day with small planes. As such, a dedicated monitoring project would not be feasible as it would require additional personnel and equipment to locate, tag and monitor the seals.

    The Navy is committed to documenting and reporting relevant aspects of training and research activities to verify implementation of mitigation, comply with current permits, and improve future environmental assessments. All sonar usage will be collected via the Navy's Sonar Positional Reporting System database and reported. If any injury or death of a marine mammal is observed during the ICEX18 activity, the Navy will immediately halt the activity and report the incident consistent with the stranding and reporting protocol in the Atlantic Fleet Training and Testing stranding response plan (Navy 2013). This approach is also consistent with other Navy documents including the Atlantic Fleet Training and Testing Environmental Impact Statement/Overseas Environmental Impact Statement.

    The Navy will provide NMFS with a draft exercise monitoring report within 90 days of the conclusion of the planned activity. The draft exercise monitoring report will include data regarding sonar use and any mammal sightings or detection will be documented. The report will also include information on the number of sonar shutdowns recorded. If no comments are received from NMFS within 30 days of submission of the draft final report, the draft final report will constitute the final report. If comments are received, a final report must be submitted within 30 days after receipt of comments.

    Negligible Impact Analysis and Determination

    NMFS has defined negligible impact 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 (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e. population-level effects). An estimate of the number of takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through harassment, NMFS considers 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 effects on habitat, and the likely effectiveness of the mitigation. We also assess the number, intensity, and context of estimated takes by evaluating this information relative to population status. Consistent with the 1989 preamble for NMFS's implementing regulations (54 FR 40338; September 29, 1989), the impacts from other past and ongoing anthropogenic activities are incorporated into this analysis via their impacts on the environmental baseline (e.g., as reflected in the regulatory status of the species, population size and growth rate where known, ongoing sources of human-caused mortality, or ambient noise levels).

    Underwater acoustic transmissions associated with ICEX18, as outlined previously, have the potential to result in Level B harassment of ringed seals in the form of TTS and behavioral disturbance. No serious injury, mortality or Level A takes are anticipated to result from this activity. At close ranges and high sound levels approaching those that could cause PTS, avoidance of the area immediately around the sound source would be ringed seals' likely behavioral response. NMFS anticipates that there will be 11 Level B takes due to TTS and 1,665 Level B behavioral harassment takes, for a total of 1,676 ringed seal takes.

    Note that there are only 11 Level B takes due to TTS since the TTS range to effects is small at only 100 meters or less while the behavioral effects range is significantly larger extending up to 10 km. TTS is a temporary impairment of hearing and TTS can last from minutes or hours to days (in cases of strong TTS). In many cases, however, hearing sensitivity recovers rapidly after exposure to the sound ends. Though TTS may occur in up to 11 animals out of a stock of 170,000 animals, the overall fitness of these individuals is unlikely to be affected and negative impacts to the entire stock are not anticipated.

    Effects on individuals that are taken by Level B harassment could include alteration of dive behavior, alteration of foraging behavior, effects to breathing, interference with or alteration of vocalization, avoidance, and flight. More severe behavioral responses are not anticipated due to the localized, intermittent use of active acoustic sources and mitigation by passive acoustic monitoring which will limit exposure to sound sources. Most likely, individuals will simply be temporarily displaced by moving away from the sound source. As described previously in the behavioral effects section seals exposed to non-impulsive sources with a received sound pressure level within the range of calculated exposures, (142-193 dB re 1 μPa), have been shown to change their behavior by modifying diving activity and avoidance of the sound source (Götz et al., 2010; Kvadsheim et al., 2010). Although a minor change to a behavior may occur as a result of exposure to the sound sources associated with the planned action, these changes would be within the normal range of behaviors for the animal (e.g., the use of a breathing hole further from the source, rather than one closer to the source, would be within the normal range of behavior). Thus, even repeated Level B harassment of some small subset of the overall stock is unlikely to result in any significant realized decrease in fitness for the affected individuals, and would not result in any adverse impact to the stock as a whole.

    The Navy's planned activities are localized and of relatively short duration. While the total project area is large, the Navy expects that most activities will occur within the ice camp action area in relatively close proximity to the ice camp. The larger study area depicts the range where submarines may maneuver during the exercise. The ice camp will be in existence for up to six weeks with acoustic transmission occurring intermittently over four weeks. The Autonomous Reverberation Measurement System would be active for up to 30 days; the vertical line array would be active for up to four hours per day for no more than eight days, and; the unmanned underwater vehicle used for the deployment of a synthetic aperture source would transmit for 24 hours per day for up to eight days.

    The project is not expected to have significant adverse effects on marine mammal habitat. The project activities are limited in time and would not modify physical marine mammal habitat. While the activities may cause some fish to leave a specific area ensonified by acoustic transmissions, temporarily impacting marine mammals' foraging opportunities, these fish would likely return to the affected area.. As such, the impacts to marine mammal habitat are not expected to cause significant or long-term negative consequences.

    For on-ice activity, serious injury and mortality are not anticipated. Level B harassment could occur but is unlikely due to mitigation measures followed during the exercise. Foot and snowmobile movement on the ice will be designed to avoid pressure ridges, where ringed seals build their lairs; runways will be built in areas without pressure ridges; snowmobiles will follow established routes; and camp buildup is gradual, with activity increasing over the first five days providing seals the opportunity to move to a different lair outside the ice camp area. The Navy will also employ its standard 100-meter avoidance distance from any arctic animals. Implementation of these measures should ensure that ringed seal lairs are not crushed or damaged during ICEX18 activities and minimize the potential for seals and pups to abandon lairs and relocate.

    The ringed seal pupping season on the ice lasts for five to nine weeks during late winter and spring. Ice camp deployment would begin in mid-February and be completed by March 15, before the pupping season. This will allow ringed seals to avoid the ice camp area once the pupping season begins, thereby reducing potential impacts to nursing mothers and pups. Furthermore, ringed seal mothers are known to physically move pups from the birth lair to an alternate lair to avoid predation. If a ringed seal mother perceives the acoustic transmissions as a threat, the local network of multiple birth and haul-out lairs would allow the mother and pup to move to a new lair.

    The estimated population of the Alaska stock of ringed seals in the Bering Sea is 170,000 animals (Muto et al., 2016). The estimated population in the Alaska Chukchi and Beaufort Seas is at least 300,000 ringed seals, which is likely an underestimate since the Beaufort Sea surveys were limited to within 40 km from shore (Kelly et al., 2010). Given these population estimates, only a limited percent of the stock affected would be taken (i.e. between 0.98 and 0.56 percent).

    In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect the species or stock through effects on annual rates of recruitment or survival:

    • No serious injury or mortality is anticipated or authorized;

    • Impacts will be limited to Level B harassment;

    • A small percentage (<1 percent) of the Alaska stock of ringed seals would be subject to Level B harassment;

    • TTS is expected to affect only a limited number of animals;

    • There will be no loss or modification of ringed seal habitat and minimal, temporary impacts on prey;

    • Physical impacts to ringed seal subnivean lairs will be avoided; and

    • Mitigation requirements for ice camp activities would minimize impacts to animals during the pupping season.

    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 planned monitoring and mitigation measures, NMFS finds that the total marine mammal take from the planned activity will have a negligible impact on all affected marine mammal species or stocks.

    Unmitigable Adverse Impact Analysis and Determination

    Impacts to subsistence uses of marine mammals resulting from the planned action are not anticipated. The planned action would occur outside of the primary subsistence use season (i.e. summer months), and the study area is 100-200 nmi seaward of known subsistence use areas. Harvest locations for ringed seals extend up to 80 nmi from shore during the summer months while winter harvest of ringed seals typically occurs closer to shore. Based on this information, NMFS has determined that there will not be an unmitigable adverse impact on subsistence uses from the Navy's planned activities.

    Endangered Species Act (ESA)

    Section 7(a)(2) of the ESA of 1973 (16 U.S.C. 1531 et seq.) requires that each Federal agency insure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of IHAs, NMFS consults internally with our ESA Interagency Cooperation Division whenever we propose to authorize take for endangered or threatened species.

    No incidental take of ESA-listed species is authorized or expected to result from this activity. Therefore, NMFS has determined that consultation under section 7 of the ESA is not required for this action.

    Authorization

    NMFS has issued an IHA to the Navy for the potential harassment of ringed seals incidental to the ICEX18 submarine test and training activities in the Beaufort Sea and Arctic Ocean, provided the previously described mitigation, monitoring and reporting requirements are incorporated.

    Dated: February 8, 2018. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-03080 Filed 2-13-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE Patent and Trademark Office Patent Prosecution Highway Program ACTION:

    Proposed collection; comment request.

    SUMMARY:

    The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)), invites comments on a proposed extension of an existing information collection: 0651-0058 (Patent Prosecution Highway (PPH) Program).

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    SUPPLEMENTARY INFORMATION: I. Abstract

    The Patent Prosecution Highway (PPH) is a framework in which an application whose claims have been determined to be patentable by an Office of Earlier Examination (OEE) is eligible to go through an accelerated examination in an Office of Later Examination with a simple procedure upon an applicant's request. By leveraging the search and examination work product of the OEE, PPH programs (1) deliver lower prosecution costs, (2) support applicants in their efforts to obtain stable patent rights efficiently around the world, and (3) reduce the search and examination burden, while improving the examination quality, of participating patent offices.

    Originally, the PPH programs were limited to the utilization of search and examination results of national applications between cross filings under the Paris Convention. Later, the potential of the PPH was greatly expanded by Patent Cooperation Treaty-Patent Prosecution Highway (PCT-PPH) programs, which permitted participating patent offices to draw upon the positive results of the PCT work product from another participating office. The PCT-PPH programs used international written opinions and international preliminary examination reports developed within the framework of the PCT, thereby making the PPH available to a larger number of applicants. Information collected for the PCT is approved under OMB control number 0651-0021.

    In 2014, the USPTO and several other offices acted to consolidate and replace existing PPH and PCT-PPH programs, with the goal of streamlining the PPH process for both offices and applicants. To that end, the USPTO and other offices established the Global PPH pilot program and the IP5 PPH pilot program. The Global PPH and IP5 PPH pilot programs are running concurrently and are substantially identical, differing only with regard to their respective participating offices. The USPTO is participating in both the Global PPH pilot program and the IP5 PPH pilot program. For USPTO applications, the Global PPH and IP5 PPH pilot programs supersede any prior PPH program between the USPTO and each Global PPH and IP5 PPH participating office. Any existing PPH programs between the USPTO and offices that are not participating in either the Global PPH pilot program or the IP5 PPH pilot program remain in effect. Regardless of the pilot program used, the Global PPH pilot program, the IP5 PPH pilot program, and the other existing PPH programs, all provide pathways for patent applications to receive the benefits of coordinated patent review across intellectual property offices.

    The information gathered in this collection is integral to the PPH programs that USPTO participates in by identifying patent applications being filed at multiple intellectual property offices across the globe, including at the USPTO. This includes declaring the OEE with whom the application has been filed, identifying information for the application at the OEE, and providing the necessary supporting documentation for the application. The forms also identify the correspondence between the claims being made at the USPTO with claims filed in the OEE and an explanation for that correspondence.

    The ten forms used to gather the information described above are: The Global Form (PTO/SB/20GLBL) and nine individual country forms allowing participants to file in a U.S. application to request to make the U.S. applicants special under a PPH or PCT-PPH program. The thirty-four forms in this collection that previously operated under individual countries' Requests for Participation are being removed as they have been consolidated under the Global Form (PTO/SB/20GLBL).

    For more complete information on the PPH, including (1) a complete identification of participating countries and offices and the programs under which each country's patent office is participating, (2) the forms needed to request entry into the PPH, both at the USPTO and other participating offices, and (3) information as to which of the PPH program remain pilots and which have been made permanent, please visit http://www.uspto.gov/patents/init_events/pph/index.jsp.

    II. Method of Collection

    Requests to participate in the PPH program must be submitted online under EFS-Web, the USPTO's web-based electronic filing system.

    III. Data

    OMB Number: 0651-0058.

    IC Instruments and Forms: PTO/SB/20GLBL, PTO/SB/20AR, PTO/SB/20BR, PTO/SB/20CZ, PTO/SB/20EA, PTO/SB/20MX, PTO/SB/20NI, PTO/SB/20PH, PTO/SB/20RO, and PTO/SB/20TW.

    Type of Review: Revision of a currently approved collection.

    Affected Public: Individuals or households; business or other for-profits; and not-for-profit institutions.

    Estimated Number of Respondents: 8,110 responses per year.

    Estimated Time per Response: The USPTO estimates that it will take the public approximately two hours to gather the necessary information, prepare the appropriate form, and submit a completed request to the USPTO.

    Estimated Total Annual Respondent Burden Hours: 16,200 hours.

    Estimated Total Annual Respondent Cost Burden: $7,104,360. The USPTO expects that the information in this collection will be prepared by attorney. The professional hourly rate for attorneys is $438. The rate is established by estimates in the 2017 Report on the Economic Survey, published by the Committee on Economics of Legal Practice of the American Intellectual Property Law Association. Using this hourly rate, the USPTO estimates that the total respondent cost burden for this collection is $7,104,360 per year.

    IC No. Item Response time
  • (hours)
  • Responses Burden hours Rate Respondent cost burden;
    (a) (b) (c) = (a) × (b) (d) (e) = (c) × (d) 1 Request for Participation in the Global/IP5 PPH Pilot Program in the USPTO (PTO/SB/20GLBL) 2 (120 minutes) 8,000 16,000 $438.00 $7,008,000.00 2 National Institute of Industrial Property of Argentina (INPI-Argentina (PTO/SB/20AR) 2 (120 minutes) 10 20 438.00 8,760.00 3 Instituto Nacional da Propriedade Industrial (Brazil) (INPI) (PTO/SB/20BR) 2 (120 minutes) 10 20 438.00 8,760.00 4 Industrial Property Office of the Czech Republic (IPOCZ) (PTO/SB/20CZ) 2 (120 minutes) 10 20 438.00 8,760.00 5 Eurasian Patent Office of the Eurasian Patent Organization (EAPO) (PTO/SB/20EA) 2 (120 minutes) 10 20 438.00 8,760.00 6 Mexican Institute of Industrial Property (TMPI) (PTO/SB/20MX) 2 (120 minutes) 10 20 438.00 8,760.00 7 Nicaraguan Registry of Intellectual Property (NRIP) (PTO/SB/20NI) 2 (120 minutes) 10 20 438.00 8,760.00 8 Intellectual Property Office of the Philippines (IPOPH) (PTO/SB/20PH) 2 (120 minutes) 10 20 438.00 8,760.00 9 Romanian State Office of Inventions and Trademarks (OSIM) (PTO/SB/20RO) 2 (120 minutes) 10 20 438.00 8,760.00 10 Taiwan Intellectual Property Office (TIPO) (PTO/SB/20TW) 2 (120 minutes) 30 60 438.00 26,280.00 Totals 8,110 16,220 7,104,360.00

    Estimated Total Annual Non-hour Respondent Cost Burden: $0. There are no capital start-up, maintenance, or postage costs associated with this collection. This collection also has no filing fees or recordkeeping costs.

    IV. Request for Comments

    Comments submitted in response to this notice will be summarized or included in the request for OMB approval of this information collection; they also will become a matter of public record.

    Comments are invited on:

    (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

    (b) The accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information;

    (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and

    (d) Ways to minimize the burden of the collection of information on respondents, e.g., the use of automated collection techniques or other forms of information technology.

    Marcie Lovett, Records and Information Governance Division Director, OCTO, United States Patent and Trademark Office.
    [FR Doc. 2018-02988 Filed 2-13-18; 8:45 am] BILLING CODE 3510-16-P
    DEPARTMENT OF COMMERCE Patent and Trademark Office National Medal of Technology and Innovation Nomination Application ACTION:

    Proposed collection; comment request.

    SUMMARY:

    The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995, invites comments on a proposed extension of an existing information collection: 0651-0060 (National Medal of Technology and Innovation Nomination Application).

    DATES:

    Written comments must be submitted on or before April 16, 2018.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Email: [email protected] Include “0651-0060 comment” in the subject line of the message.

    Federal Rulemaking Portal: http://www.regulations.gov.

    Mail: Marcie Lovett, Records and Information Governance Division Director, Office of the Chief Technology Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information should be directed to John Palafoutas, Program Manager, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450, by telephone at 571-272-8400, or by email at [email protected] with “0651-0060 comment” in the subject line. Additional information about this information is also available at http://www.reginfo.gov under “Information Collection Review.”

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    The National Medal of Technology and Innovation is the highest honor for technological achievement bestowed by the President of the United States of America's leading innovations. Established by an Act of Congress in 1980, the medal of Technology was first awarded in 1985. The Medal is awarded annually to individuals, teams (of up to four individuals), companies, or divisions of companies. The Medal recognizes outstanding contributions to the Nation's economic, environmental and social well-being through the development and commercialization of technology products, processes and concepts, technological innovation, and development of the Nation's technological workforce.

    The purpose of the National Medal of Technology and Innovation is to recognize those who have made lasting contributions to America's competitiveness, standard of living, and quality of life through technological innovation, and to recognize those who have made substantial contributions to strengthening the Nation's technological workforce. By highlighting the national importance of technological innovation, the Medal also seeks to inspire future generations of Americans to prepare for and pursue technical careers to keep America at the forefront of global technology and economic leadership.

    The National Medal of Technology and Innovation Nomination Evaluation Committee, a distinguished independent committee appointed by the Secretary of Commerce, reviews and evaluates the merit of all candidates nominated through an open, competitive solicitation process. The committee makes its recommendations for Medal candidates to the Secretary of Commerce who, in turn, makes recommendations to the President for final selection. The National Medal of Technology and Innovation Laureates are announced by the White House once the Medalists are notified of their selection.

    The public uses the online National Medal of Technology and Innovation Nomination Application to nominate an individual's, team's, or company's extraordinary leadership and innovation in technological achievement and outstanding contribution to strengthening the nation's technological workforce. The application collects general and biographical information about the nominee, general information about the nominator, and a discussion of the nominee's contribution/achievements, and must be accompanied by six letters of recommendation or support from individuals who have first-hand knowledge of the cited achievement(s).

    II. Method of Collection

    The nomination application and instructions can be accessed from the USPTO website. All nominations should be submitted via the online portal on www.uspto.gov/nmti.

    III. Data

    OMB Number: 0651-0060.

    IC Instruments and Forms: N/A.

    Type of Review: Revision of an existing information collection.

    Affected Public: Businesses or other for-profit organizations; not-for-profit institutions; individuals or households.

    Estimated Number of Respondents: 50 responses per year.

    Estimated Time Per Response: The USPTO estimates that it will take approximately 40 hours to gather the necessary information, prepare the nomination form, write the recommendations, and submit the request for the nomination to the USPTO.

    Estimated Total Annual Respondent Burden Hours: 2000 hours.

    Estimated Total Annual Respondent (Hourly) Cost Burden: $84,020. The USPTO expects that professors, public relations specialists, civil engineers and research managers will complete this information. The professional hourly rates for these occupations, based on the 2017 rates released by the Bureau of Labor Statistics, are $37.00 for professors (OES 25-1199), $31.99 for public relations specialists (OES 27-3031), $43.14 for civil engineers (OES 17-2051), and $55.92 for research managers (15-1111). Using the average combined hourly rate of $42.01, the USPTO estimates that the total respondent cost burden for this collection is $84,020 per year.

    IC No. Item Estimated time for response Estimated responses Estimated
  • annual burden
  • Rate
  • ($/hr)
  • Estimated
  • annual
  • respondent
  • cost burden;
  • (a) (b) (c) = (a) × (b) (d) (e) = (c) × (d) 1 National Medal of Technology and Innovation Nomination Form 40 50 2,000 $42.01 $84,020.00 Totals 50 2,000 84,020.00

    Estimated Total Annual (Non-hour) Respondent Cost Burden: $0.

    There are no filing fees, capital start-up, maintenance, or operation costs associated with this collection. As the USPTO expects that 100% percent of the responses in this collection will be submitted electronically there are no postage costs associated with the collection.

    IV. Request for Comments

    Comments submitted in response to this notice will be summarized or included in the request for OMB approval of this information collection. They also will become a matter of public record.

    Comments are invited on:

    (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

    (b) The accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information

    (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and

    (d) Ways to minimize the burden of the collection of information on respondents, e.g., the use of automated collection techniques or other forms of information technology.

    Marcie Lovett, Records and Information Governance Division Director, OCTO United States Patent and Trademark Office.
    [FR Doc. 2018-02989 Filed 2-13-18; 8:45 am] BILLING CODE 3510-16-P
    DEPARTMENT OF DEFENSE Department of the Navy [Docket ID: USN-2016-HQ-0004] Proposed Collection; Comment Request AGENCY:

    Department for Deployment Health, Naval Health Research Center, DON.

    ACTION:

    60-day information collection notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the Department for Deployment Health, Naval Health Research Center announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by April 16, 2018.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    Mail: Department of Defense, Office of the Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24 Suite 08D09B, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name, docket number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at http://www.regulations.gov for submitting comments. Please submit comments on any given form identified by docket number, form number, and title.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Naval Health Research Center, DoD Center for Deployment Health Research, Department 164, ATTN: Millennium Cohort Program Principal Investigators, 140 Sylvester Rd., San Diego, CA, 92106-3521, or call (619) 553-7335.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Prospective Department of Defense Studies of US Military Forces: The Millennium Cohort Study; OMB Control Number 0703-0064.

    Needs and Uses: The information collection requirement is necessary to respond to recommendations by Congress and by the Institute of Medicine to perform investigations that systematically collect population-based demographic and health data so as to track and evaluate the health of military personnel throughout the course of their careers and after leaving military service. The Millennium Cohort Family Study also evaluates the impact of military life on military families.

    Affected Public: Individuals or households.

    Annual Burden Hours: 100,764.

    Number of Respondents: 134,352.

    Responses per Respondent: 1.

    Average Burden per Response: 45 minutes.

    Frequency: On occasion.

    Persons eligible to respond to this survey are those civilians now separated from military service who initially enrolled, gave consent and participated in the Millennium Cohort Study while on active duty in the Army, Navy, Air Force, Marine Corps, or US Coast Guard during the first, second, third, or fourth panel enrollment periods in 2001-2003, 2004-2006, 2007-2008, or 2011-2012 respectively, as well as those civilians that choose to participate in the Millennium Cohort Family Study.

    Dated: February 9, 2018. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-03062 Filed 2-13-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0148] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Quarterly Cumulative Caseload Report AGENCY:

    Office of Special Education and Rehabilitative Services (OSERS), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 16, 2018.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2017-ICCD-0148. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW, LBJ, Room 216-44, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Melinda Giancola, 202-245-7312.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Quarterly Cumulative Caseload Report.

    OMB Control Number: 1820-0013.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 316.

    Total Estimated Number of Annual Burden Hours: 316.

    Abstract: State agencies that administer vocational rehabilitation programs provide key caseload data on this form, including numbers of persons who are applicants, determined eligible/ineligible, waiting for services, and their program outcomes. The Rehabilitation Services Administration collects this information quarterly from states and reports it in the Annual Report to Congress on the Rehabilitation Act.

    Dated: February 8, 2018. Tomakie Washington, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-02970 Filed 2-13-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0151] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; OSERS Peer Review Data Form AGENCY:

    Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing a reinstatement of a previously approved information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 16, 2018.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2017-ICCD-0151. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW, LBJ, Room 216-44, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Patricia Wright, 202-245-7620.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: OSERS Peer Review Data Form.

    OMB Control Number: 1820-0583.

    Type of Review: A reinstatement of a previously approved information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 1,500.

    Total Estimated Number of Annual Burden Hours: 250.

    Abstract: The OSERS Peer Reviewer Data Form (OPRDF) is used by OSERS staff to identify potential reviewers who would be qualified to review specific types of grant applications for funding; to provide background contact information for each potential reviewer; and to provide information on any reasonable accommodations that might be required by the individual. The previous version of the OPRDF, 1820-0583, expired on September 30, 2017. The revised version of the OSERS Peer Data Form included in this information collection request contains additional questions to better match field experts with the review of OSERS funding opportunities. There are also additional questions aimed to better meet the needs of peer reviewers who require reasonable accommodations.

    Dated: February 8, 2018. Tomakie Washington, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-02971 Filed 2-13-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0146] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and approval; Comment Request; Survey of Postgraduate Outcomes for the Foreign Language and Area Studies (FLAS) Fellowship Program (Survey) AGENCY:

    Office of Postsecondary Education (OPE), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing a reinstatement of a previously approved information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 16, 2018.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2017-ICCD-0146. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW, LBJ, Room 216-34, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Sara Starke, 202-453-7681.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Survey of Postgraduate Outcomes for the Foreign Language and Area Studies (FLAS) Fellowship Program (Survey).

    OMB Control Number: 1840-0829.

    Type of Review: A reinstatement of a previously approved information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 2,400.

    Total Estimated Number of Annual Burden Hours: 600.

    Abstract: This survey is used by the Foreign Language and Area Studies (FLAS) grantee institutions and fellows to comply with 20 U.S.C. 1121(d). Fellows complete the survey online, and the Department accesses and reports on the collected data regarding fellows' postgraduate employment. The survey is required by statute.

    Dated: February 8, 2018. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-02959 Filed 2-13-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION Eligibility Designations and Applications for Waiver of Eligibility Requirements; Programs Under Parts A and F of Title III of the Higher Education Act of 1965, as Amended (HEA), and Programs Under Title V of the HEA AGENCY:

    Office of Postsecondary Education, Department of Education (Department).

    ACTION:

    Notice.

    SUMMARY:

    The Department announces the process for designation of eligible institutions and invites applications for waiver of eligibility requirements for fiscal year (FY) 2018, for the following programs:

    1. Programs authorized under Part A, Title III of the HEA: Strengthening Institutions Program (Part A SIP), Alaska Native and Native Hawaiian-Serving Institutions (Part A ANNH), Predominantly Black Institutions (Part A PBI), Native American-Serving Nontribal Institutions (Part A NASNTI), and Asian American and Native American Pacific Islander-Serving Institutions (Part A AANAPISI).

    2. Programs authorized under Part F, Title III of the HEA: Hispanic-Serving Institutions STEM and Articulation (Part F, HSI STEM and Articulation), Predominantly Black Institutions (Part F PBI), Alaska Native and Native Hawaiian-Serving Institutions (Part F ANNH), Native American-Serving Nontribal Institutions (Part F NASNTI), and Asian American and Native American Pacific Islander-Serving Institutions (Part F AANAPISI).

    3. Programs authorized under Title V of the HEA: Developing Hispanic-Serving Institutions (HSI) and Promoting Postbaccalaureate Opportunities for Hispanic Americans (PPOHA).

    DATES:

    Applications Available: February 14, 2018.

    Deadline for Transmittal of Applications: March 16, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Christopher Smith, Institutional Service, U.S. Department of Education, 400 Maryland Avenue SW., Room 250-10, Washington, DC 20202. Telephone: (202)453-7946, or by email: [email protected]

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

    Special Note: Section 312 of the HEA and 34 CFR 607.2-607.5 include most of the basic eligibility requirements for grant programs authorized under Titles III and V of the HEA. Section 312(b)(1)(B) of the HEA provides that, to be eligible for these programs, an institution of higher education's (IHE's or institution's) average “educational and general expenditures” (E&G) per full-time equivalent (FTE) undergraduate student must be less than the average E&G expenditures per FTE undergraduate student of institutions that offer similar instruction in that year.

    Since 2004, the National Center for Educational Statistics (NCES) has calculated Core Expenses per FTE of institutions, a statistic similar to E&G per FTE. Both E&G per FTE and Core Expenses per FTE are based on regular operational expenditures of institutions (excluding auxiliary enterprises, independent operations, and hospital expenses). They differ only in that E&G per FTE is based on fall undergraduate enrollment, while Core Expenses per FTE is based on 12-month undergraduate enrollment for the academic year.

    To avoid inconsistency in the data submitted to, and produced by, the Department, for the purpose of section 312(b)(1)(B) of the HEA, E&G per FTE is calculated using the same methodology as Core Expenses per FTE. Accordingly, with regard to this and future notices inviting applications for waivers of eligibility requirements, to calculate E&G per FTE for the purpose of determining institutional eligibility for programs under Title V and Part A and Part F of Title III of the HEA, the Department will apply the NCES methodology for calculating Core Expenses per FTE. Institutions requesting an eligibility waiver determination must use the Core Expenses per FTE data reported to NCES' Integrated Postsecondary Education Data System (IPEDS) for the most currently available academic year, in this case academic year 2015-2016.

    Full Text of Announcement I. Funding Opportunity Description

    Purpose of Programs:

    The Part A SIP, Part A ANNH, Part A PBI, Part A NASNTI, and Part A AANAPISI programs are authorized under Title III, Part A, of the HEA. The HSI and PPOHA programs are authorized under Title V of the HEA. The Part F, HSI STEM and Articulation, Part F PBI, Part F AANAPISI, Part F ANNH, and Part F NASNTI programs are authorized under Title III, Part F of the HEA. Please note that certain programs in this notice have the same or similar names as other programs that are authorized under a different statutory authority. For this reason, we specify the statutory authority as part of the acronym for certain programs.

    Under the programs discussed above, institutions are eligible to apply for grants if they meet specific statutory and regulatory eligibility requirements. An IHE that is designated as an eligible institution may also receive a waiver of certain non-Federal cost-sharing requirements for one year under the Federal Supplemental Educational Opportunity Grant (FSEOG) program authorized by Part A, Title IV of the HEA and the Federal Work-Study (FWS) program authorized by section 443 of the HEA. Qualified institutions may receive the FSEOG and FWS waivers for one year even if they do not receive a grant under the Title III or Title V programs. An applicant that receives a grant from the Student Support Services (SSS) program that is authorized under section 402D of the HEA, 20 U.S.C. 1070a-14, may receive a waiver of the required non-Federal cost share for institutions for the duration of the grant. An applicant that receives a grant from the Undergraduate International Studies and Foreign Language (UISFL) program that is authorized under section 604 of the HEA, 20 U.S.C. 1124, may receive a waiver or reduction of the required non-Federal cost share for institutions for the duration of the grant.

    Special Note: To qualify as an eligible institution under the grant programs listed in this notice, your institution must satisfy several criteria. For most of these programs, these criteria include those that relate to the enrollment of needy students and to Core Expenses per FTE student count for a specified base year. The most recent data available in IPEDS for Core Expenses per FTE are for base year 2015-2016. In order to award FY 2018 grants in a timely manner, we will use these data to evaluate eligibility.

    Accordingly, all institutions interested in either applying for a new grant under the Title III or Title V programs addressed in this notice, or requesting a waiver of the non-Federal cost share, must be designated as an eligible institution for FY 2018. Under the HEA, any IHE interested in applying for a grant under any of these programs must first be designated as an eligible institution. (34 CFR 606.5 and 607.5).

    Eligible Applicants:

    The eligibility requirements for the programs authorized under Part A of Title III of the HEA are in sections 312 and 317-320 of the HEA (20 U.S.C. 1058, 1059d-1059g) and in 34 CFR 607.2 through 607.5. The regulations may be accessed at: www.ecfr.gov/cgi-bin/text-idx?SID=bc12bf5d685021e069cd1a15352b381a&mc=true&node=pt34.3.607&rgn=div5.

    The eligibility requirements for the programs authorized by Part F of Title III of the HEA are in section 371 of the HEA (20 U.S.C. 1067q). There are currently no specific regulations for these programs.

    The eligibility requirements for the Title V HSI program are in Part A of Title V of the HEA and in 34 CFR 606.2 through 34 CFR 606.5. The regulations may be accessed at: www.ecfr.gov/cgi-bin/text-idx?SID=bc12bf5d685021e069cd1a15352b381a&mc=true&node=pt34.3.606&rgn=div5l.

    The requirements for the PPOHA program are in Part B of Title V of the HEA and in the notice of final requirements published in the Federal Register on July 27, 2010 (75 FR 44055), and in 34 CFR 606.2(a) and (b), and 606.3 through 606.5.

    The Department has instituted a process known as the Eligibility Matrix (EM), under which we will use information submitted by IHEs to IPEDS to determine which institutions meet the basic eligibility requirements for the programs authorized by Title III or Title V of the HEA listed above. We will use enrollment and fiscal data for the 2015-2016 year submitted by institutions to IPEDS to make eligibility determinations for FY 2018. Beginning February 14, 2018, an institution will be able to review the Department's decision on whether it is eligible for the grant programs authorized by Titles III or V of the HEA through this process by checking the institution's eligibility in the Eligibility system linked through the Department's Institutional Service Eligibility website at: http://www2.ed.gov/about/offices/list/ope/idues/eligibility.html.

    The EM is part of the Department's Eligibility system. The EM is a read-only worksheet that lists all potentially eligible postsecondary institutions, as determined by the Department using the data described above. If the entry for your institution in the EM shows that your institution is eligible to apply for a grant for a particular program, and you plan to submit an application for a grant in that program, you will not need to apply for eligibility or for a waiver through the process described in this notice. Rather, you may print out the eligibility letter directly. However, if the EM does not show that your institution is eligible for a program in which you plan to apply for a grant, you must submit a waiver request as discussed in this notice before the March 16, 2018 deadline.

    To check your institution's eligibility in the EM, go to the website https://hepis.ed.gov/title3and5/, click the “Application for Designation as an Eligible Institution” link, and then click the “Check Eligibility” link. You may search the EM by institution name, IPEDS unit ID number, or OPE ID number. If you are inquiring about general eligibility, look up your institution's name under the SIP column. If you are inquiring about specific program eligibility, look under that program's column.

    If the EM does not show that your institution is eligible for a program, or if your institution does not appear in the EM data system, or if you disagree with the eligibility determination reflected in the EM data system, you can apply for a waiver or reconsideration through the process described in this notice. The waiver application process is the same as in previous years; you will choose the waiver option on the website at https://hepis.ed.gov/title3and5/ and submit your institution's waiver request.

    Enrollment of Needy Students: For the Title III and V programs (excluding the PBI programs), an institution is considered to have an enrollment of needy students if: (1) At least 50 percent of its degree-seeking students received financial assistance under the Federal Pell Grant, FSEOG, FWS, or the Federal Perkins Loan programs; or (2) the percentage of its undergraduate degree-seeking students who were enrolled on at least a half-time basis and received Federal Pell Grants exceeded the average percentage of undergraduate degree students who were enrolled on at least a half-time basis and received Federal Pell Grants at comparable institutions that offer similar instruction.

    To qualify under this latter criterion, an institution's Federal Pell Grant percentage for base year 2015-2016 must be more than the average for its category of comparable institutions provided in the 2015-2016 Average Pell Grant and Core Expenses per FTE Student table in this notice. If your institution qualifies under the first criterion, under which at least 50 percent of its degree-seeking students received financial assistance under one of several Federal student aid programs (the Federal Pell Grant, FSEOG, FWS, or the Federal Perkins Loan programs), but not the second criterion, under which an institution's Federal Pell Grant percentage for base year 2015-2016 must be more than the average for its category of comparable institutions provided in the 2015-2016 Average Pell Grant and Core Expenses per FTE Student table in this notice, you must submit a waiver request including the requested data, which is not available in IPEDS.

    For the definition of “Enrollment of Needy Students,” for purposes of the Part A PBI program see section 318(b)(2) of the HEA, and for purposes of the Part F PBI program see section 371(c)(9)of the HEA.

    Core Expenses per FTE Student: For the Title III, Part A SIP; Part A ANNH; Part A PBI; Part A NASNTI; Part A AANAPISI; Title III, Part F HSI STEM and Articulation; Part F PBI; Part F AANAPISI; Part F ANNH; Part F NASNTI; Title V, Part A HSI, and Title V, Part B PPOHA programs, an institution should compare its base year 2015-2016 Core Expenses per FTE student to the average Core Expenses per FTE student for its category of comparable institutions in the base year 2015-2016 Average Pell Grant and Average Core Expenses per FTE Student Table in this notice. The institution meets this eligibility requirement under these programs if its Core Expenses for the 2015-2016 base year are less than the average for its category of comparable institutions.

    Core Expenses are defined as the total expenses for the essential education activities of the institution. Core Expenses for public institutions reporting under the Governmental Accounting Standards Board (GASB) requirements include expenses for instruction, research, public service, academic support, student services, institutional support, operation and maintenance of plant, depreciation, scholarships and fellowships, interest, and other operating and non-operating expenses. Core Expenses for institutions reporting under the Financial Accounting Standards Board (FASB) standards (primarily private, not-for-profit, and for-profit) include expenses for instruction, research, public service, academic support, student services, institutional support, net grant aid to students, and other expenses. Do NOT include Federal student financial aid. For both FASB and GASB institutions, core expenses exclude expenses for auxiliary enterprises (e.g., bookstores, dormitories), hospitals, and independent operations. The following table identifies the relevant average Federal Pell Grant percentages for the base year 2015-2016 and the relevant Core Expenses per FTE student for the base year 2015-2016 for the four categories of comparable institutions:

    Type of institution Base year
  • 2015-2016
  • average Pell Grant
  • percentage
  • Base year
  • 2015-2016
  • average core expenses per FTE student
  • Two-year Public Institutions 38 $13,154 Two-year Non-profit Private Institutions 59 14,349 Four-year Public Institutions 38 30,044 Four-year Non-profit Private Institutions 39 38,307

    Waiver Information: IHEs that do not meet the needy student enrollment requirement or the Core Expenses per FTE requirement may apply to the Secretary for a waiver of these requirements, as described in sections 392 and 522 of the HEA, and the implementing regulations at 34 CFR 606.3(b), 606.4(c) and (d), 607.3(b), and 607.4(c) and (d).

    IHEs requesting a waiver of the needy student enrollment requirement or the Core Expenses per FTE requirement must include in their application detailed information supporting the waiver request, as described in the instructions for completing the application.

    The regulations governing the Secretary's authority to waive the needy student requirement, 34 CFR 606.3(b)(2) and (3) and 607.3(b)(2) and (3), refer to “low-income” students or families. The regulations at 34 CFR 606.3(c) and 607.3(c) define “low-income” as an amount that does not exceed 150 percent of the amount equal to the poverty level, as established by the U.S. Census Bureau.

    For the purposes of this waiver provision, the following table sets forth the low-income levels (at 150%) for various sizes of families:

    2016 Annual Low-Income Levels Size of family unit Family income for the 48
  • contiguous
  • states, DC, and outlying
  • jurisdictions
  • Family income for Alaska Family income for Hawaii
    1 $17,820 $22,260 $20,505 2 24,030 30,030 27,645 3 30,240 37,800 34,785 4 36,450 45,570 41,925 5 42,660 53,340 49,065 6 48,870 61,110 56,205 7 55,095 68,880 63,345 8 61,335 76,680 70,515

    Note: We use the 2016 annual low-income levels because those are the amounts that apply to the family income reported by students enrolled for the fall 2015 semester. For family units with more than eight members, add the following amount for each additional family member: $6,240 for the contiguous 48 States, the District of Columbia, and outlying jurisdictions; $7,800 for Alaska; and $7,170 for Hawaii.

    The figures shown under family income represent amounts equal to 150 percent of the family income levels established by the U.S. Census Bureau for determining poverty status. The poverty guidelines were published on January 25, 2016, in the Federal Register by the U.S. Department of Health and Human Services (81 FR 4036).

    Information about “metropolitan statistical areas” referenced in 34 CFR 606.3(b)(4) and 607.3(b)(4) may be obtained at:

    www.census.gov/prod/2010pubs/10smadb/appendixc.pdf,

    www.census.gov/prod/2008pubs/07ccdb/appd.pdf.

    Electronic Submission of Waiver Applications:

    If your institution does not appear in the EM data system as one that is eligible for the program under which you plan to apply for a grant, you must submit an application for a waiver of the eligibility requirements. To request a waiver, you must upload a waiver narrative at: https://hepis.ed.gov/title3and5/.

    Exception to the Electronic Submission Requirement: You qualify for an exception to the electronic submission requirement, and may submit your application in paper format, if you are unable to submit an application electronically because—

    • You do not have access to the internet; or

    • You do not have the capacity to upload documents to the website;

    and

    • No later than two weeks before the waiver application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the internet to submit your application. If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.

    Mail or fax your statement to: Christopher Smith or Jason Cottrell, U.S. Department of Education, 400 Maryland Avenue SW, Room 250-10, Washington, DC 20202. Fax: (202) 401-8466.

    Your paper waiver application must be submitted in accordance with the mail or hand delivery instructions described in this notice.

    Submission of Paper Applications by Mail.

    If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: Christopher Smith, U.S. Department of Education, 400 Maryland Avenue SW, Room 250-10, Washington, DC 20202.

    You must show proof of mailing consisting of one of the following:

    (1) A legibly dated U.S. Postal Service postmark.

    (2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.

    (3) A dated shipping label, invoice, or receipt from a commercial carrier.

    (4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.

    If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:

    (1) A private metered postmark.

    (2) A mail receipt that is not dated by the U.S. Postal Service.

    Note: The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.

    We will not consider waiver applications postmarked after the application deadline date.

    Submission of Paper Applications by Hand Delivery.

    If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the application, on or before the application deadline date, to the Department at the following address: Christopher Smith, U.S. Department of Education, 400 Maryland Avenue SW, Room 250-10, Washington, DC 20202.

    We accept hand deliveries daily between 8:00 a.m. and 4:30 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.

    Applicable Regulations: (a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 75, 77, 79, 82, 84, 86, 97, 98, and 99. (b) The OMB Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted in 2 CFR part 3474. (d) The regulations for certain Title III programs in 34 CFR part 607, and for the HSI program in 34 CFR part 606. (e) The notice of final requirements for the PPOHA program, published in the Federal Register on July 27, 2010 (75 FR 44055).

    Note:

    The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian Tribes.

    Note:

    The regulations in 34 CFR part 86 apply to IHEs only.

    Note:

    There are no program-specific regulations for the Part A AANAPISI, Part A NASNTI, and Part A PBI programs or any of the Part F, Title III programs. Also, there have been amendments to the HEA since the Department last issued regulations for the programs established under Titles III and V of the statute. Accordingly, we encourage each potential applicant to read the applicable sections of the HEA in order to fully understand the eligibility requirements for the program for which they are applying.

    II. Other Information

    Accessible Format: Individuals with disabilities can obtain this document and a copy of the waiver application in an accessible format (e.g., braille, large print, audio tape, or compact disc) on request to the contact person listed under FOR FURTHER INFORMATION CONTACT.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Frank T. Brogan, Principal Deputy Assistant Secretary and delegated the duties of the Assistant Secretary, Office of Planning, Evaluation and Policy Development delegated the duties of the Assistant Secretary, Office of Postsecondary Education.
    [FR Doc. 2018-02955 Filed 2-13-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Hanford AGENCY:

    Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Hanford. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Wednesday, March 7, 2018—8:30 a.m.-5:00 p.m. Thursday, March 8, 2018—8:30 a.m.-12:00 p.m. ADDRESSES:

    Red Lion Hanford House, 802 George Washington Way, Richland, WA 99352.

    FOR FURTHER INFORMATION CONTACT:

    Mark Heeter, Federal Coordinator, Department of Energy Richland Operations Office, P.O. Box 550, H5-20, Richland, WA, 99352; Phone: (509) 373-1970; or Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

    Tentative Agenda • Potential Draft Advice System 8 Planning • Discussion Topics Tri-Party Agreement Agencies' Updates Hanford Advisory Board Committee of the Whole Meeting Hanford Advisory Board Committee Reports Board Business

    Public Participation: The meeting is open to the public. The EM SSAB, Hanford, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Mark Heeter at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Mark Heeter at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

    Minutes: Minutes will be available by writing or calling Mark Heeter's office at the address or phone number listed above. Minutes will also be available at the following website: http://www.hanford.gov/page.cfm/hab/FullBoardMeetingInformation.

    Issued at Washington, DC, on February 9, 2018. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2018-03037 Filed 2-13-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Northern New Mexico AGENCY:

    Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a combined meeting of the Environmental Monitoring and Remediation Committee and Waste Management Committee of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico (known locally as the Northern New Mexico Citizens' Advisory Board [NNMCAB]). The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Wednesday, February 28, 2018, 1:00 p.m.-4:00 p.m.

    ADDRESSES:

    NNMCAB Office, 94 Cities of Gold Road, Pojoaque, NM 87506.

    FOR FURTHER INFORMATION CONTACT:

    Menice Santistevan, Northern New Mexico Citizens' Advisory Board, 94 Cities of Gold Road, Santa Fe, NM 87506. Phone (505) 995-0393; Fax (505) 989-1752 or Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

    Purpose of the Environmental Monitoring and Remediation Committee (EM&R): The EM&R Committee provides a citizens' perspective to NNMCAB on current and future environmental remediation activities resulting from historical Los Alamos National Laboratory (LANL) operations and, in particular, issues pertaining to groundwater, surface water and work required under the New Mexico Environment Department Order on Consent. The EM&R Committee will keep abreast of DOE-EM and site programs and plans. The committee will work with the NNMCAB to provide assistance in determining priorities and the best use of limited funds and time. Formal recommendations will be proposed when needed and, after consideration and approval by the full NNMCAB, may be sent to DOE-EM for action.

    Purpose of the Waste Management (WM) Committee: The WM Committee reviews policies, practices and procedures, existing and proposed, so as to provide recommendations, advice, suggestions and opinions to the NNMCAB regarding waste management operations at the Los Alamos site.

    Tentative Agenda • Call to Order and Introductions • Approval of Agenda • Approval of Minutes from October 25, 2017 • Old Business • New Business • Update from NNMCAB Chair • Federal Advisory Committee Act Training from EM SSAB Designated Federal Officer • Public Comment Period • Update from Ad Hoc Committee on Energy Communities Alliance's Waste Disposition Report and Discussion of NNMCAB Recommendation(s) • Adjourn

    Public Participation: The NNMCAB's Committees welcome the attendance of the public at their combined committee meeting and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Menice Santistevan at least seven days in advance of the meeting at the telephone number listed above. Written statements may be filed with the Committees either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Menice Santistevan at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

    Minutes: Minutes will be available by writing or calling Menice Santistevan at the address or phone number listed above. Minutes and other Board documents are on the internet at: http://energy.gov/em/nnmcab/meeting-materials.

    Issued at Washington, DC on February 9, 2018. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2018-03038 Filed 2-13-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY:

    Department of Energy (DOE).

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Thursday, March 1, 2018, 6:00 p.m.

    ADDRESSES:

    Ohio State University, Endeavor Center, 1862 Shyville Road, Piketon, Ohio 45661.

    FOR FURTHER INFORMATION CONTACT:

    Greg Simonton, Alternate Deputy Designated Federal Officer, Department of Energy Portsmouth/Paducah Project Office, Post Office Box 700, Piketon, Ohio 45661, (740) 897-3737, [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and related activities.

    Tentative Agenda • Call to Order, Introductions, Review of Agenda • Approval of January 2018 Minutes • Deputy Designated Federal Officer's Comments • Federal Coordinator's Comments • Liaison's Comments • Presentation • Administrative Issues • Subcommittee Updates • Public Comments • Final Comments from the Board • Adjourn

    Public Participation: The meeting is open to the public. The EM SSAB, Portsmouth, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Greg Simonton at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Greg Simonton at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

    Minutes: Minutes will be available by writing or calling Greg Simonton at the address and phone number listed above. Minutes will also be available at the following website: http://www.ports-ssab.energy.gov/index.html.

    Issued at Washington, DC on February 9, 2018. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2018-03039 Filed 2-13-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2680-113] Consumers Energy Company and DTE Electric Company; Notice of Application Accepted for Filing, Soliciting Motions to Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Preliminary Terms and Conditions, and Preliminary Fishway Prescriptions

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.

    a. Type of Application: New Major License.

    b. Project No.: 2680-113.

    c. Date filed: June 28, 2017.

    d. Applicant: Consumers Energy Company and DTE Electric Company (Consumers Energy and DTE Companies).

    e. Name of Project: Ludington Pumped Storage Project.

    f. Location: The existing project is located on the east shore of Lake Michigan in the townships of Pere Marquette and Summit, Mason County, Michigan, and in Port Sheldon, Ottawa County, Michigan. The Ottawa County portion is a 1.8-acre satellite recreation site, located about 70 miles south of the project. The project does not affect federal lands.

    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).

    h. Applicant Contact: David McIntosh, Consumers Energy Company, Hydro and Renewable Generation, 330 Chestnut Street, Cadillac, MI 49601; Telephone (231) 779-5506, email [email protected].

    i. FERC Contact: Shana Wiseman, Telephone (312) 596-4468 and email [email protected].

    j. Deadline for filing motions to intervene and protests, comments, recommendations, preliminary terms and conditions, and preliminary prescriptions: 60 days from the issuance date of this notice; reply comments are due 105 days from the issuance date of this notice.

    The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, recommendations, preliminary terms and conditions, and preliminary fishway prescriptions using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first page of any filing should include docket number P-2680-113.

    The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.

    k. This application has been accepted for filing and is now ready for environmental analysis.

    l. The Ludington Project is a pumped storage project that consists of: (1) An 842-acre upper reservoir with a gross storage capacity of 82,300 acre-feet at an elevation of 942 feet National Geodetic Vertical Datum (NGVD); (2) a concrete intake structure located in the upper reservoir; (3) six, 1,300-foot-long steel penstocks varying in diameter from 28.5 feet at the intake to 24 feet at the powerhouse; (4) a concrete powerhouse with six bays each housing a pump-turbine/motor-generator unit; (5) a lower reservoir (Lake Michigan) with a surface area of about 22,300 square miles and a mean depth of 279 feet; (6) two 1,600-foot-long jetties; (7) an approximately 1,700-foot-long breakwater located about 2,700 feet from the shore; and (8) appurtenant facilities. Additionally, a satellite recreation site (Pigeon Lake North Pier) is located about 70 miles south of the project. The recreation facility includes a parking area and a 4,600-foot-long boardwalk.

    The existing Ludington Project is operated to generate during peak demand periods. Generation usually occurs during the day with the upper reservoir partially replenished at night during pumping. The project has an installed capacity of 1,785 megawatts with an average annual generation of approximately 2,624,189 megawatt hours.

    m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the eLibrary link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support. A copy is also available for inspection and reproduction at the address in item h above.

    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

    All filings must (1) bear in all capital letters the title PROTEST, MOTION TO INTERVENE, COMMENTS, REPLY COMMENTS, RECOMMENDATIONS, PRELIMINARY TERMS AND CONDITIONS, or PRELIMINARY FISHWAY PRESCRIPTIONS; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    o. Procedural Schedule: The application will be processed according to the following revised Hydro Licensing Schedule. Revisions to the schedule may be made as appropriate.

    Milestone Target date Filing of recommendations, preliminary terms and conditions, and preliminary fishway prescriptions April 2018. Commission issues Non-Draft Environmental Assessment (EA) September 2018. Comments on EA October 2018. Modified terms and conditions December 2018.

    p. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.

    q. A license applicants must file no later than 60 days following the date of issuance of the notice of acceptance and ready for environmental analysis provided for in 5.22: (1) A copy of the water quality certification; (2) a copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) evidence of waiver of water quality certification.

    Dated: February 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-03010 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13212-005] Kenai Hydro, LLC; Notice of Application Ready for Environmental Analysis and Soliciting Comments, Recommendations, Terms and Conditions, and Prescriptions

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.

    a. Type of Application: Application for Original License for Major Project—Unconstructed.

    b. Project No.: P-13212-005.

    c. Date filed: April 18, 2016, and amended on January 16, 2018.

    d. Applicant: Kenia Hydro, LLC.

    e. Name of Project: Grant Lake Hydroelectric Project.

    f. Location: On Grant Creek, near the Town of Moose Pass, Kenai Peninsula Borough, Alaska. The proposed project would occupy 1,741.3 acres of federal land within the Chugach National Forest managed by the U.S. Forest Service.

    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).

    h. Applicant Contact: Mikel Salzetti, Manager of Fuel Supply & Renewable Energy Development, 280 Airport Way, Kenai, AK 99611. (907) 283-2375.

    i. FERC Contact: Kenneth Hogan, (202) 502-8434; [email protected] .

    j. Deadline for filing comments, recommendations, terms and conditions, and prescriptions: 60 days from the issuance date of this notice; reply comments are due 105 days from the issuance date of this notice.

    The Commission strongly encourages electronic filing. Please file comments, recommendations, terms and conditions, and prescriptions using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first page of any filing should include docket number P-13212-005.

    The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.

    k. This application has been accepted and is now ready for environmental analysis.

    l. The proposed Grant Lake Hydroelectric Project would consists of: (1) An intake structure within Grant Lake; (2) a 3,300-foot-long water conveyance; (3) a 72-inch-diameter, 150-feet-long, welded steel penstock; (3) a power house containing two 2.5 megawatt Francis turbine/generator units; (4) a 95-foot-long open channel tailrace; (5) a 3.6-acre tailrace detention pond; (6) a 1.1-mile-long, 115-kilovolt transmission line; and (7) appurtenant facilities. The project is estimated to generate an average of 18,600 megawatt hours (MWh) annually

    m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support. A copy is also available for inspection and reproduction at the address in item h above.

    All filings must (1) bear in all capital letters the title COMMENTS, REPLY COMMENTS, RECOMMENDATIONS, TERMS AND CONDITIONS, or PRESCRIPTIONS; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person submitting the filing; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. Each filing must be accompanied by proof of service on all persons listed on the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b), and 385.2010.

    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    n. Public notice of the filing of the initial development application, which has already been given, established the due date for filing competing applications or notices of intent. Under the Commission's regulations, any competing development application must be filed in response to and in compliance with public notice of the initial development application. No competing applications or notices of intent may be filed in response to this notice.

    o. A license applicant must file no later than 60 days following the date of issuance of this notice: (1) A copy of the water quality certification; (2) a copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) evidence of waiver of water quality certification.

    p. Procedural schedule: The application will be processed according to the following schedule. Revisions to the schedule will be made as appropriate (project coordinator will replace the days with actual months/years according to the specific project).

    Commission issues draft EIS, October 2018.

    Comments on draft EIS, December 2018.

    Commission issues final EIS, April 2019.

    Dated: February 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-03011 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Conference Call Docket Nos. American Electric Power Service Corporation v. Midcontinent Independent System Operator, Inc. EL18-7-000 Midwest Independent Transmission System Operator, Inc. ER05-6-118 Midwest Independent Transmission System Operator, Inc. PJM Interconnection, LLC, et al. EL04-135-120 Midwest Independent Transmission System Operator, Inc. PJM Interconnection, LLC, et al. EL02-111-139 Ameren Services Company, et al. EL03-212-134 Midwest Independent Transmission System Operator, Inc. ER10-2283-000, ER10-2283-001

    On Wednesday, February 14, 2018, Commission staff will hold a conference call with Midcontinent Independent System Operator, Inc. (MISO) beginning at 1:30 p.m. (Eastern Time). The call is intended to address factual questions related to the identification of replacement suppliers for the Nicor Energy, L.L.C., Engage Energy America LLC, and New Power Company Seams Elimination Charge/Cost Adjustments/Assignments (SECA) sub-zones and the calculation of MISO-assessed “Variable SECA” charges. The discussion at the conference call will be limited to informational, factual questions.

    Any party, as defined by 18 CFR 385.102(c), or any participant as defined by 18 CFR 385.102(b), is invited to listen to the conference call. Persons wishing to become a party must move to intervene and receive intervenor status pursuant to the Commission's regulations (18 CFR 385.214).

    The conference call will not be webcasted or transcribed. However, an audio listen-only line will be provided. Those wishing to access the listen-only line must email Andre Goodson ([email protected]) by 5:00 p.m. (Eastern Time) on Friday, February 9, 2018, with your name, email, and phone number, in order to receive the call-in information the day before the conference call. Please use the following text for the subject line, EL18-7-000 listen-only line registration.

    Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations, please send an email to [email protected] or call toll free 1 (866) 208-3372 (voice) or (202) 208-1659 (TTY), or send a FAX to (202) 208-2106 with the required accommodations.

    For additional information, please contact Andre Goodson at (202) 502-8560, [email protected]

    Dated: February 7, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-02963 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP18-415-000.

    Applicants: Petition for Initiation of Show Cause Proceedings.

    Description: Industry Petition for Initiation of Show Cause Proceedings Directed To Interstate Natural Gas Pipelines and Storage Companies.

    Filed Date: 1/31/18.

    Accession Number: 20180131-5345.

    Comments Due: 5 p.m. ET 2/12/18.

    Docket Numbers: RP18-413-001.

    Applicants: Gulf South Pipeline Company, LP.

    Description: Tariff Amendment: Amendment to Filing in Docket No. RP18-413-000 to be effective 2/1/2018.

    Filed Date: 2/1/18.

    Accession Number: 20180201-5113.

    Comments Due: 5 p.m. ET 2/13/18.

    Docket Numbers: RP18-422-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Negotiated Rates—4-1-2018 releases to Twin Eagle to be effective 4/1/2018.

    Filed Date: 2/5/18.

    Accession Number: 20180205-5050.

    Comments Due: 5 p.m. ET 2/20/18.

    Docket Numbers: RP18-426-000.

    Applicants: Columbia Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Settlement Base Rates and CCRM 2017 Adjustment to be effective 1/1/2018.

    Filed Date: 2/5/18.

    Accession Number: 20180205-5101.

    Comments Due: 5 p.m. ET 2/20/18.

    Docket Numbers: RP18-427-000.

    Applicants: Columbia Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Adjusted CCRM 2018 to be effective2/1/2018.

    Filed Date: 2/5/18.

    Accession Number: 20180205-5106.

    Comments Due: 5 p.m. ET 2/20/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 7, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-03067 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14863-000] BM Energy Park, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications

    On November 29, 2017, BM Energy Park, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act, proposing to study the feasibility of the Banner Mountain Pumped Storage Hydro Project (project) to be located near Casper in Converse County, Wyoming. On January 19 and 29, 2018, the application was amended with a new project boundary. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.

    The proposed project will be closed-loop. Water to initially fill the reservoirs will be diverted from Deer Creek via a temporary diversion, pump system, and pipeline. Required make-up water will be provided from a new well that will be drilled near the lower reservoir. The proposed project would consist of upper and lower reservoirs, a penstock connecting the two reservoirs, a powerhouse, a transmission line, and an access road to each reservoir. Both reservoirs would be formed by earthen and/or roller compacted concrete embankments with a maximum height of 50-75 feet, and would be lined with impervious geotextile or pavement. The lower reservoir would have a storage capacity of 4,050 acre-feet at its normal maximum water surface elevation of 6,000 feet, and surface area of 80 acres. The upper reservoir would have a storage capacity of 4,050 acre-feet at its normal maximum water surface elevation of 7,125 feet and surface area of 50 acres. Water would be conveyed from the upper reservoir to the lower reservoir via a 5,000-foot-long, 18-foot diameter steel-lined penstock. The powerhouse would contain three Ternary turbine generator units with a total installed capacity of 400 MW. Project power would be transmitted through either a new single circuit 230-kilovolt (kV) transmission line from the proposed powerhouse 0.4 miles northwest to a new substation on the planned Energy Gateway West 500-kV transmission line, or via a new 230-kV transmission line running 16 miles north to PacifiCorp's Windstar substation.

    The estimated average annual generation of the project would be 1,300 gigawatt-hours.

    Applicant Contact: Carl Borgquist, President and CEO, BM Energy Park, LLC, 209 S. Willson Ave., P.O. Box 309, Bozeman, MT 59771, phone (406) 585-3006.

    FERC Contact: Peter McBride, (202) 502-8132, [email protected].

    Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.

    The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first page of any filing should include docket number P-14863-000.

    More information about this project, including a copy of the application, can be viewed or printed on the eLibrary link of Commission's website at http://www.ferc.gov/docs-filing/elibary.asp. Enter the docket number (P-14863) in the docket number field to access the document. For assistance, contact FERC Online Support.

    Dated: February 7, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-02960 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP18-69-000] Tristate NLA, LLC; Notice of Petition for Declaratory Order

    Take notice that on January 26, 2018, Tristate NLA, LLC (Tristate), 9901 Valley Ranch Parkway East, Suite 2000, Irving, Texas 75063, filed in Docket No. CP18-69-000 a petition for declaratory order pursuant to Rule 207 of the Commission's Rules of Practice and Procedure (18 CFR 385.207), seeking a ruling that upon the abandonment and sale to Tristate of approximately 189.8 miles of various diameter pipelines and appurtenant facilities proposed by Gulf South Pipeline Company, LP (Gulf South) in Docket No. CP18-66-000 approximately (i) 155.8 miles of pipelines and appurtenant facilities will perform a gathering function, and therefore will be exempt from the Commission's jurisdiction pursuant to section 1(b) of the Natural Gas Act (NGA); (ii) 15.2 miles of pipelines and appurtenant facilities will be operated as Hinshaw, and therefore will be exempt from the Commission's jurisdiction pursuant to section 1(c) of the NGA; and (iii) 18.8 miles as intrastate pipelines subject to the jurisdiction of the Texas Railroad Commission, all as more fully set forth in the petition which is on file with the Commission and open to public inspection.

    The filing may also be viewed on the web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or TTY, contact (202) 502-8659.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit five copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit original and five copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    Comment Date: 5:00 p.m. Eastern Time on March 1, 2018.

    Dated: February 8, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-03022 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Number: PR18-28-000.

    Applicants: Columbia Gas of Ohio, Inc.

    Description: Tariff filing per 284.123(b),(e): COH Rates effective1-31-2018.

    Filed Date: 2/2/18.

    Accession Number: 201802025058.

    Comments/Protests Due: 5 p.m. ET2/23/18.

    Docket Numbers: RP18-298-001.

    Applicants: Columbia Gas Transmission, LLC.

    Description: Compliance filing Adjusted CCRM 2018—Compliance to be effective 2/1/2018.

    Filed Date: 2/6/18.

    Accession Number: 20180206-5046.

    Comments Due: 5 p.m. ET 2/20/18.

    Docket Numbers: RP18-428-000.

    Applicants: Enstor Energy Services, LLC, Castleton Commodities International LLC.

    Description: Joint Petition of Enstor Energy Services, LLC, et al. for Temporary Waiver of Capacity Release Regulations and Policies and Request for Expedited Treatment.

    Filed Date: 2/6/18.

    Accession Number: 20180206-5129.

    Comments Due: 5 p.m. ET 2/13/18.

    Docket Numbers: RP18-429-000.

    Applicants: Rover Pipeline LLC.

    Description: § 4(d) Rate Filing: Non-Conforming Agreements—2 in compliance with CP15-93 Order to be effective 3/1/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5006.

    Comments Due: 5 p.m. ET 2/20/18.

    Docket Numbers: RP18-430-000.

    Applicants: Rover Pipeline LLC.

    Description: § 4(d) Rate Filing: Non-Conforming Agreement List—2 to be effective 3/1/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5005.

    Comments Due: 5 p.m. ET 2/20/18.

    Docket Numbers: RP18-431-000.

    Applicants: Bear Creek Storage Company, L.L.C.

    Description: Compliance filing Annual Report on Operational Transactions 2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5007.

    Comments Due: 5 p.m. ET 2/20/18.

    Docket Numbers: RP18-432-000.

    Applicants: Natural Gas Pipeline Company of America.

    Description: § 4(d) Rate Filing: Amended Negotiated Rate Agreement—Tenaska Mktg Ventures to be effective2/7/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5008.

    Comments Due: 5 p.m. ET 2/20/18.

    Docket Numbers: RP18-433-000.

    Applicants: Transcontinental Gas Pipe Line Company.

    Description: § 4(d) Rate Filing: List of Non-Conforming Service Agreements (VSS II and Clean-Up) to be effective8/1/2017.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5146.

    Comments Due: 5 p.m. ET 2/20/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 8, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-03021 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. NJ18-10-000] ISO New England Inc.; Notice of Filing

    Take notice that on January 30, 2018, ISO New England Inc. submitted its tariff filing: ISO-NE and VEC Service Agreement under Schedule 21-VEC of ISO-NE OATT to be effective 1/1/2018.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the eLibrary link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern Time on February 20, 2018.

    Dated: February 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-03009 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP18-66-000] Gulf South Pipeline Company, LP; Notice of Application

    Take notice that on January 26, 2018, Gulf South Pipeline Company, LP (Gulf South), 9 Greenway Plaza, Suite 2800, Houston, Texas 77046, filed in Docket No. CP18-66-000 an application pursuant to section 7(b) of the Natural Gas Act (NGA) and Part 157 of the Commission's Regulations, requesting authorization to abandon by sale to Tristate NLA, LLC approximately 189.8 miles of various diameter gathering and transmission pipelines, associated meter and regulator stations, and appurtenant facilities located in Gregg, Harrison, and Panola Counties, Texas and Caddo, Bossier, and Webster Parishes, Louisiana, all as more fully set forth in the application which is on file with the Commission and open to public inspection.

    The filing may also be viewed on the web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or TTY, contact (202) 502-8659.

    Any questions concerning this application may be directed to J. Kyle Stephens, Vice President, Regulatory Affairs, Gulf South Pipeline Company, LP, 9 Greenway Plaza, Suite 2800, Houston, Texas 77046; by telephone at (713) 479-8033; by fax at (713) 479-1846; or by email at [email protected]

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit five copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit original and five copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    Comment Date: 5:00 p.m. Eastern Time on March 1, 2018.

    Dated: February 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-03006 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC18-23-000.

    Applicants: Dynegy Inc., Vistra Energy Corp.

    Description: Supplement to Joint Application of Dynegy Inc., et al. for Authorization for Merger of Jurisdictional Assets and Purchase of Securities (Delivered Price Test for MISO Region).

    Filed Date: 2/5/18.

    Accession Number: 20180205-5179.

    Comments Due: 5 p.m. ET 2/26/18.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER05-6-118.

    Applicants: Midwest Independent Transmission System Operator, Inc., PJM Interconnection, L.L.C.

    Description: Update to September 18, 2017 Refund Report of Midcontinent Independent System Operator, Inc. and PJM Interconnection, L.L.C.

    Filed Date: 2/2/18.

    Accession Number: 20180202-5222.

    Comments Due: 5 p.m. ET 2/23/18.

    Docket Numbers: ER18-816-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Original WMPA SA No. 4916; Queue No. AC2-070 to be effective 1/26/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5009.

    Comments Due: 5 p.m. ET 2/28/18.

    Docket Numbers: ER18-817-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Original WMPA SA No. 4918; Queue No. AC2-072 to be effective 1/30/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5040.

    Comments Due: 5 p.m. ET 2/28/18.

    Docket Numbers: ER18-818-000.

    Applicants: KCP&L Greater Missouri Operations Company.

    Description: § 205(d) Rate Filing: Rate Schedules 141 to be effective 4/8/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5050.

    Comments Due: 5 p.m. ET 2/28/18.

    Docket Numbers: ER18-819-000.

    Applicants: Kansas City Power & Light Company.

    Description: § 205(d) Rate Filing: Rate Schedules 141 to be effective 4/8/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5071.

    Comments Due: 5 p.m. ET 2/28/18.

    Docket Numbers: ER18-820-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Revised ISA, Service Agreement No. 2181, Queue No. AB2-175 to be effective 1/8/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5076.

    Comments Due: 5 p.m. ET 2/28/18.

    Docket Numbers: ER18-821-000.

    Applicants: Binghamton BOP LLC.

    Description: Notice of Cancellation of Market-Based Rate Tariff of Binghamton BOP LLC.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5082.

    Comments Due: 5 p.m. ET 2/28/18.

    Docket Numbers: ER18-822-000.

    Applicants: Kansas City Power & Light Company.

    Description: § 205(d) Rate Filing: Rate Schedules 142 to be effective 4/8/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5105.

    Comments Due: 5 p.m. ET 2/28/18.

    Docket Numbers: ER18-823-000.

    Applicants: ColGreen North Shore, LLC.

    Description: Baseline eTariff Filing: Baseline new to be effective 2/8/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5110.

    Comments Due: 5 p.m. ET 2/28/18.

    Docket Numbers: ER18-824-000.

    Applicants: Kansas City Power & Light Company.

    Description: § 205(d) Rate Filing: Rate Schedules 143 to be effective 4/8/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5116.

    Comments Due: 5 p.m. ET 2/28/18.

    Docket Numbers: ER18-825-000.

    Applicants: Kansas City Power & Light Company.

    Description: § 205(d) Rate Filing: Rate Schedules 144 to be effective 4/8/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5120.

    Comments Due: 5 p.m. ET 2/28/18.

    Docket Numbers: ER18-827-000.

    Applicants: Alabama Power Company.

    Description: § 205(d) Rate Filing: Cooperative Energy Second Amended and Restated NITSA Filing to be effective 4/1/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5122.

    Comments Due: 5 p.m. ET 2/28/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 7, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-03066 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 4334-016] EONY Generation Limited; Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving Use of the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and Request to Use the Traditional Licensing Process.

    b. Project No.: 4334-016.

    c. Date Filed: December 13, 2017.

    d. Submitted By: EONY Generation Limited (EONY).

    e. Name of Project: Philadelphia Hydroelectric Project.

    f. Location: On the Indian River, in the Village of Philadelphia in Jefferson County, New York. No Federal lands are occupied by the project works or located within the project boundary.

    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.

    h. Applicant Contacts: Franz Kropp, Director, Generation, EONY, 7659 Lyonsdale Road, Lyons Falls, NY 13368; (613) 225-0418, ext. 7498. Murray Hall, Manager, Generation, EONY, 7659 Lyonsdale Road, Lyons Falls, NY 13368; (613) 382-7312.

    i. FERC Contact: Emily Carter at (202) 502-6512; or email at [email protected]

    j. EONY filed its request to use the Traditional Licensing Process on December 13, 2017. EONY provided public notice of its request on December 10, 2017. In a letter dated February 8, 2018, the Director of the Division of Hydropower Licensing approved EONY's request to use the Traditional Licensing Process.

    k. With this notice, we are initiating informal consultation with the U.S. Fish and Wildlife Service under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 C.F.R. part 402. We also are initiating consultation with the New York State Historic Preservation Officer, as required by section 106, National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.

    l. With this notice, we are designating EONY as the Commission's non-Federal representative for carrying out informal consultation pursuant to section 7 of the Endangered Species Act; and consultation pursuant to section 106 of the National Historic Preservation Act.

    m. EONY filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.

    n. A copy of the PAD is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website (http://www.ferc.gov), using the eLibrary link. Enter the docket number, excluding the last three digits, in the docket number field to access the document. For assistance, contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). A copy is also available for inspection and reproduction at the address in paragraph h. The licensee states its unequivocal intent to submit an application for a new license for Project No. 4334. Pursuant to 18 CFR 16.8, 16.9, and 16.10, each application for a new license and any competing license applications must be filed with the Commission at least 24 months prior to the expiration of the existing license. All applications for license for this project must be filed by January 31, 2021.

    o. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    Dated: February 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-03008 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project Nos. 2593-031; 2823-020] Algonquin Power (Beaver Falls), LLC; Notice of Application Accepted for Filing, Soliciting Motions To Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Terms and Conditions, and Prescriptions

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.

    a. Type of Application: Subsequent Major License.

    b. Project Nos.: 2593-031 and 2823-020.

    c. Date filed: December 30, 2015, supplemented by a settlement agreement filed August 24, 2017.

    d. Applicant: Algonquin Power (Beaver Falls), LLC.

    e. Name of Project: Upper Beaver Falls and Lower Beaver Falls Hydroelectric Projects.

    f. Location: On the Beaver River, in the towns of Croghan and New Bremen, Lewis County, New York. The projects do not occupy lands of the United States.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)-825(r).

    h. Applicant Contact: Robert Gates, Executive Vice President, Eagle Creek Renewables Energy, LLC, 116 N. State Street P.O. Box 167, Neshkoro, WI 54960-0167; (973) 998-8400; [email protected]

    i. FERC Contact: Andy Bernick, (202) 502-8660 or [email protected]

    j. Deadline for filing motions to intervene and protests, comments, recommendations, terms and conditions, and prescriptions: 60 days from the issuance date of this notice; reply comments are due 105 days from the issuance date of this notice.

    The Commission strongly encourages electronic filing. Please file motions to intervene and protests, comments, recommendations, terms and conditions, and prescriptions using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first page of any filing should include docket numbers P-2593-031 and P-2823-020.

    The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.

    k. This application has been accepted for filing and is now ready for environmental analysis.

    l. The existing project works are as follows:

    The Upper Beaver Falls Project consists of: (1) A 328-foot-long, 25-foot-high concrete gravity dam with an uncontrolled overflow spillway; (2) a 48-acre reservoir with a storage capacity of 800 acre-feet at elevation 799.4 feet North American Vertical Datum of 1988 (NAVD 88); (3) a 17-foot-high, 26.5-foot-wide, 27.5-foot-long intake structure with a steel trash rack ; (4) a 90-foot-long, 16-foot-wide, 8-foot-high concrete penstock; (5) a powerhouse containing one turbine-generator with a nameplate rating of 1,500 kilowatts (kW); (6) a tailrace excavated in the riverbed; (7) a 2,120-foot-long, 2.4-kilovolt (kV) overhead transmission line connecting to an existing National Grid substation; and (8) other appurtenances. The project generates about 8,685 megawatt-hours (MWh) annually.

    The Lower Beaver Falls Project consists of: (1) A 400-foot-long concrete gravity dam with a maximum height of 14 feet, including: (i) a 240-foot-long non-overflow section containing an 8-foot-wide spillway topped with flashboards ranging from 6 to 8 inches in height and (ii) a 160-foot-long overflow section with an ice sluice opening; (2) a 4-acre reservoir with a storage capacity of 27.9 acre-feet at a normal elevation of 769.6 feet NAVD 88; (3) an intake structure with a steel trash rack, integral with a powerhouse containing two 500-kW turbine and generator units; (4) a tailrace; (5) a 250-foot-long, 2.4-kV transmission line connected to the Upper Beaver Falls powerhouse; and (6) appurtenant facilities. The project generates about 5,617 MWh annually.

    The Lower Beaver Falls Project is located approximately 600 feet downstream of the Upper Beaver Falls Project. The dams and existing project facilities for both projects are owned by the applicant. As described in its August 24, 2017, settlement agreement with the U.S. Fish and Wildlife Service (FWS) and New York State Department of Environmental Conservation (New York DEC), the applicant proposes the following changes to project facilities and operation: (1) both projects would be consolidated under a single license; (2) the consolidated project would operate in strict run-of-river mode; (3) a year-round minimum flow of 30 cubic feet per second (cfs) would be maintained in the Upper Project bypassed reach and at the Lower Project; (4) trash racks would be replaced at the Upper Project to provide 1-inch clear spacing, and a seasonal overlay system would be placed at the Lower Project; and (5) recreational enhancements, including a boat launch, fishing access, canoe take-out, and parking area, would be provided at a location determined through consultation with FWS and New York DEC.

    m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the eLibrary link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support. A copy is also available for inspection and reproduction at the address in item h above.

    n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, 385.211, and 385.214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified deadline date for the particular application.

    All filings must (1) bear in all capital letters the title PROTEST, MOTION TO INTERVENE, COMMENTS, REPLY COMMENTS, RECOMMENDATIONS, TERMS AND CONDITIONS, or PRESCRIPTIONS; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application.

    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    o. A license applicant must file no later than 60 days following the date of issuance of this notice: (1) A copy of the water quality certification; (2) a copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) evidence of waiver of water quality certification.

    p. Procedural Schedule:

    The application will be processed according to the following revised Hydro Licensing Schedule. Revisions to the schedule may be made as appropriate.

    Milestone Target date Filing of comments, recommendations, terms and conditions, and prescriptions April 2018. Reply comments due May 2018. Commission issues EA October 2018. Comments on EA due November 2018. Dated: February 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-03007 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER18-814-000] Carlsbad Energy Center LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding Carlsbad Energy Center LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 28, 2018.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 8, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-03023 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP18-70-000] Columbia Gas Transmission, LLC; Notice of Request Under Blanket Authorization

    Take notice that on January 29, 2018, Columbia Gas Transmission, LLC (Columbia), 700 Louisiana Street, Houston, Texas 77002-2700, filed in Docket No. CP18-70-000 a prior notice request pursuant to sections 157.205 and 157.213(b) of the Federal Energy Regulatory Commission's (Commission) regulations under the Natural Gas Act (NGA) and Columbia's blanket authorizations issued in Docket No. CP83-76-000. Columbia seeks authorization to construct and operate two new horizontal wells, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing may also be viewed on the web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at [email protected] or call toll-free, (866) 208-3676 or TTY, (202) 502-8659.

    Columbia proposes to construct and operate in Ashland County, Ohio, two new horizontal storage wells, designated Well 12601 and Well 12602, and related pipelines and appurtenances at Columbia's Pavonia Storage Field, located in Ashland and Richland Counties, Ohio. Columbia states that the new wells are focused on improving the field's late season deliverability. There will be no change in the certificated physical parameters of the field, including existing boundary, total inventory, reservoir pressure, reservoir and buffer boundaries, or the certificated storage capacity, as a result of the proposed project. The total cost is approximately $6,000,000.

    Any questions regarding this Application should be directed to Linda Farquhar, Manager, Project Determinations & Regulatory Administration, Columbia Gas Transmission, LLC, 700 Louisiana Street, Suite 700, Houston, Texas 77002-2700, by phone (832) 320-5685, by fax (832) 320-6685, or by email at [email protected]

    Any person or the Commission's Staff may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and, pursuant to section 157.205 of the Commission's Regulations under the NGA (18 CFR 157.205) a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests, and interventions via the internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's website (www.ferc.gov) under the e-Filing link. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    Dated: February 7, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-02961 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM07-10-000] Transparency Provisions of Section 23 of the Natural Gas Act; Notice of Change to Filing Instructions

    Take notice that the filing instructions for the FERC Form No. 552: Annual Report of Natural Gas Transactions1 have been updated to clarify what transactions must be reported in Line 2 of Page 6 of FERC Form No. 552, consistent with the revised NAESB WGQ standards 2 incorporated by reference in Order No. 809.3 Specifically, the filing instructions now clarify that next-day natural gas transactions must be reported in Line 2 of Page 6 of FERC Form No. 552 using the Timely Nomination Cycle deadline for scheduling natural gas transportation of 1:00 p.m. Central Clock Time (CCT) rather than 11:30 a.m. CCT. There are no other changes to the FERC Form No. 552 filing instructions.

    1See 18 CFR 260.401 (2017).

    2See 18 CFR 284.12(a) and (b) (2017).

    3Coordination of the Scheduling Processes of Interstate Natural Gas Pipelines and Public Utilities, Order No. 809, FERC Stats. & Regs. 31,368 (2015).

    The updated filing instructions are available at: http://www.ferc.gov/docs-filing/forms/form-552/form-552.pdf. For more information, please contact John Collins at (202) 502-8981, or email [email protected]

    Dated: February 7, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-02966 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC18-54-000.

    Applicants: Twin Eagle Resource Management, LLC,TERM Holdings, LLC.

    Description: Application under FPA Section 203 of Twin Eagle Resource Management, LLC, et al.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5153.

    Comments Due: 5 p.m. ET 2/28/18.

    Take notice that the Commission received the following exempt wholesale generator filings:

    Docket Numbers: EG18-45-000.

    Applicants: ColGreen North Shore, LLC.

    Description: Self-Certification of EWG Status of ColGreen North Shore, LLC.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5126.

    Comments Due: 5 p.m. ET 2/28/18.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER17-1567-002.

    Applicants: PJM Interconnection, L.L.C.

    Description: Compliance filing: Amended Compliance Filing RE: November 9, 2017 Order in Docket No. ER17-1567-001 to be effective 12/31/9998.

    Filed Date: 2/8/18.

    Accession Number: 20180208-5047.

    Comments Due: 5 p.m. ET 3/1/18.

    Docket Numbers: ER18-815-001.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Amendment: Errata to Attachment Q re: Regulation Resource Credit filing-Docket No. ER18-815 to be effective 4/9/2018.

    Filed Date: 2/7/18.

    Accession Number: 20180207-5128.

    Comments Due: 5 p.m. ET 2/28/18.

    Docket Numbers: ER18-828-000.

    Applicants: Pacific Gas and Electric Company.

    Description: § 205(d) Rate Filing: E&P Agreement for Avenal Solar Holdings LLC to be effective 2/9/2018.

    Filed Date: 2/8/18.

    Accession Number: 20180208-5110.

    Comments Due: 5 p.m. ET 3/1/18.

    Take notice that the Commission received the following PURPA 210(m)(3) filings:

    Docket Numbers: QM18-9-000.

    Applicants: Indiana Municipal Power Agency.

    Description: Application of Indiana Municipal Power Agency to Terminate Mandatory Purchase Obligation Under the Public Utility Regulatory Policies Act of 1978.

    Filed Date: 2/8/18.

    Accession Number: 20180208-5088.

    Comments Due: 5 p.m. ET 3/8/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 8, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-03020 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER18-823-000] ColGreen North Shore, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding ColGreen North Shore, LLC`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 28, 2018.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 8, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-03024 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP18-71-000] Colorado Interstate Gas Company, L.L.C.; Notice of Application

    Take notice that on January 30, 2018, Colorado Interstate Gas Company, L.L.C. (CIG), Post Office (P.O.) Box 1087, Colorado Springs, Colorado 80944, filed in Docket No. CP18-71-000 an application pursuant to section 7(b) of the Natural Gas Act (NGA) for authorization to abandon by sale to El Paso Natural Gas Company, L.L.C. approximately 40.4 miles of three interconnected pipeline segments, certain metering stations, and ancillary facilities as part of its CIG-Big Blue South Abandonment Project located in Moore and Potter Counties, Texas, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website web at http://www.ferc.gov using the eLibrary link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at [email protected] or call toll-free, (886) 208-3676 or TYY, (202) 502-8659.

    Any questions concerning this application may be directed to Francisco Tarin, Director, Regulatory Affairs, Colorado Interstate Gas Company, L.L.C., P.O. Box 1087, Colorado Springs, Colorado 80944, by telephone at (719) 667-7517, or by fax at (719) 520-4697; or Dave Dewey, Assistant General Counsel, Colorado Interstate Gas Company, L.L.C., P.O. Box 1087, Colorado Springs, Colorado 80944, by telephone at (719) 520-4227, or by fax at (719) 520-4898.

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit seven copies of filings made in the proceeding with the Commission and must mail a copy to the applicant and to every other party. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 7 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    Comment Date: February 28, 2018.

    Dated: February 7, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-02962 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP18-11-000] East Cheyenne Gas Storage, LLC; Notice of Schedule for Environmental Review of the Lewis Creek Amendment

    On October 27, 2017, East Cheyenne Gas Storage, LLC (East Cheyenne) filed an application in Docket No. CP18-11-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct and operate certain natural gas pipeline facilities. The proposed project, known as the Lewis Creek Amendment Project (Project), would combine the working gas capacity and cushion gas capacity for the West Peetz and Lewis Creek Storage Fields and utilize the same maximum bottom-hole pressure, thus eliminating separately certified capacities for each field. East Cheyenne requests this amendment because recent geologic information shows that the West Peetz and Lewis Creek D-sands in the storage field are a single integrated reservoir. As part of this consolidation, East Cheyenne would reconfigure certain natural gas facilities in the Lewis Creek Storage Field; and expand the authorized buffer zone of the East Cheyenne Project.

    On November 8, 2017, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the Project. Among other things, that notice alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's Environmental Assessment (EA) for the Project. This instant notice identifies the FERC staff's planned schedule for the completion of the EA for the Project.

    Schedule for Environmental Review

    Issuance of EA, March 30, 2018.

    90-day Federal Authorization Decision Deadline, June 28, 2018.

    If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.

    Project Description

    East Cheyenne is requesting authorization to amend its certificate previously issued in Docket No. CP10-34-000, for the East Cheyenne Gas Storage Project in Logan County, Colorado. As part of the West Peetz and Lewis Creek Field consolidation, East Cheyenne would reconfigure the well layout on the Lewis Creek portion of the Project by reducing the number of injection/withdrawal (I/W) wells by consolidating the wells on a single well pad, and reconfiguring the currently certificated Lewis Creek monitoring wells. Specifically, East Cheyenne would reconfigure the I/W well in the Lewis Creek portion of the project by converting one existing non-jurisdictional well to an I/W well (LC-D021) and collocating five directionally drilled I/W wells (LC-D022, LC-D023, LC-D024, LC-D025, and LC-D026) on the LC-2021 well pad. Additionally, East Cheyenne would decrease the total cushion gas capacity to 12.1 billion cubic feet and increase the total working gas capacity to 22.5 billion cubic feet. East Cheyenne would also reconfigure its existing pipelines and reduce the diameter of the existing 20-inch-diameter natural gas mainline to a 16-inch-diameter pipeline. Furthermore, East Cheyenne would reconfigure the existing 16-inch diameter Lewis Creek natural gas mainline and the 6-inch-diameter water disposal pipeline to connect directly to the reconfigured I/W wells LC-D021 through LC-D026 on a single well pad.

    Background

    On December 8, 2017, the Commission issued a Notice of Intent to Prepare an Environmental Assessment for the Proposed Lewis Creek Amendment and Request for Comments on Environmental Issues (NOI). The NOI was sent to affected landowners; federal, state, and local government agencies; elected officials; environmental and public interest groups; Native American tribes; other interested parties; and local libraries and newspapers. In response to the NOI, the Commission received comments from the Bureau of Land Management and the Logan County Economic Development Corporation support the applicant's request.

    Additional Information

    In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC website (www.ferc.gov). Using the eLibrary link, select General Search from the eLibrary menu, enter the selected date range and Docket Number excluding the last three digits (i.e., CP18-11), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at [email protected]

    The eLibrary link on the FERC website also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.

    Dated: February 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-03012 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos: CP18-39-000; CP18-40-000] Questar Southern Trail Pipeline Company, Navajo Tribal Utility Authority; Notice of Intent To Prepare an Environmental Assessment for the Proposed Southern Trail Pipeline Abandonment Project Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the Southern Trail Pipeline Abandonment Project (Project) involving abandonment in place and by sale of facilities by Questar Southern Trail Pipeline Company (Questar). On December 22, 2017, Questar Southern Trails Pipeline Company (Questar), filed an application, in Docket No. CP18-39-000, pursuant to section 7(b) of the Natural Gas Act (NGA) to abandon its certificate of public convenience and necessity, including its blanket certificate authorities. Questar also requests to abandon, part by sale and part in-place, all of its certificated facilities dedicated to providing jurisdictional transportation service including approximately 488 miles of natural gas pipeline and related facilities located in California, Arizona, Utah, and New Mexico.

    In a related filing, on December 22, 2017, the Navajo Tribal Utility Authority (NTUA), filed an application, in Docket No. CP18-40-000, pursuant to section 7(f) of the NGA and Part 157 of the Commission's regulations, requesting a service area determination within which NTUA may, without further Commission authorization, enlarge or expand its natural gas distribution facilities and a waiver of all reporting, accounting, and other rules and regulations normally applicable to natural gas companies. NTUA would utilize those acquired facilities to provide its own service, replacing the service historically provided to it by Questar. The remaining facilities not sold to the NTUA would be abandoned in-place.

    About 220 miles of pipeline facilities that would be abandoned in place are in San Bernardino County, California; Mohave, Yavapai, Coconino and Apache Counties, Arizona; and San Yuan, Utah. About 268 miles would be abandoned by sale and are in Coconino, Navajo and Apache Counties, Arizona; San Yuan County, Utah; and San Yuan County, New Mexico. The Commission will use this EA in its decision-making process to determine whether the project is in the public convenience and necessity.

    This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies on the project. You can make a difference by providing us with your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the EA. To ensure that your comments are timely and properly recorded, please send your comments so that the Commission receives them in Washington, DC on or before March 5, 2018.

    If you sent comments on this project to the Commission before the opening of this docket on December 22, 2017, of the CP filing, you will need to file those comments in Docket No. CP18-39-000 and CP18-40-000 to ensure they are considered as part of this proceeding.

    This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.

    If you are a landowner receiving this notice, a pipeline company representative may contact you about the abandonment by sale and in place of the proposed facilities. The company would seek to negotiate a mutually acceptable agreement.

    Questar provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” This fact sheet addresses a number of typically asked questions, including how to participate in the Commission's proceedings. It is also available for viewing on the FERC website (www.ferc.gov).

    Public Participation

    For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or [email protected] Please carefully follow these instructions so that your comments are properly recorded.

    (1) You can file your comments electronically using the eComment feature on the Commission's website (www.ferc.gov) under the link to Documents and Filings. This is an easy method for submitting brief, text-only comments on a project;

    (2) You can file your comments electronically by using the eFiling feature on the Commission's website (www.ferc.gov) under the link to Documents and Filings. With eFiling, you can provide comments in a variety of formats by attaching them as a file with your submission. New eFiling users must first create an account by clicking on eRegister. If you are filing a comment on a particular project, please select “Comment on a Filing” as the filing type; or

    (3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket number (CP18-39-000 and CP18-40-000 with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426.

    Summary of the Proposed Project

    The Project would consist of abandonment by sale approximately 268 miles of pipeline facilities and abandon in-place another approximately 220 miles of pipeline facilities, totaling approximately 488 miles of existing mainline natural gas pipeline located between the Essex Meter Facility with Pacific Gas & Electric (PG&E) in San Bernardino County, California and extending northeast to the Milagro Plant in San Juan County, New Mexico. Specifically Questar proposes to:

    • Abandon in place the following:

    —About 220 miles of 16-inch diameter pipeline extending northeast from the current Questar Essex metering and regulating (M&R) Facility with PG&E in San Bernardino County, California to its Grey Mountain main line block valve in Coconino County, Arizona. —Mohave Valley Compressor Station in Mohave County, Arizona; —two delivery interconnects and associated M&R facilities, and all other appurtenant facilities, as necessary; and —affiliated facilities in San Bernardino County, California; Mohave, Yavapai, Coconino and Apache Counties, Arizona; and San Yuan, Utah.

    Abandon by sale to NTUA approximately 268 miles of its interstate pipeline, three compressor stations, and related facilities. Specifically, Questar proposes to:

    • Abandon by sale the following:

    —approximately 41.3 miles of 20-inch diameter pipeline extending east from Quastar's Chinde Wash Launcher and Receiver facility in San Juan County, New Mexico to its Milagro Plant Interconnect in San Juan County, New Mexico; —about 58.9 miles of 12-inch diameter pipeline extending southeast from Questar's Red Mesa Compressor Station in San Juan County Utah to its Chinde Wash Launcher and Receiver facility in San Juan County, New Mexico; —about 168.0 miles of 16-inch diameter pipeline extending northeast from Questar's Grey Mountain block valve in Coconino County, Arizona to its Red Mesa Compressor Station in San Juan County, Utah; —three compressor stations including Shiprock Compressor Station in San Juan County, New Mexico; Red Mesa Compressor Station in San Juan County, Utah; Cameron Compressor Station in Coconino County, Arizona; and —six interconnects: three receipt point interconnects and three delivery point interconnects with associated M&R facilities, and other appurtenant facilities, as necessary.

    The general location of the project facilities is shown in appendix 1.1

    1 The appendices referenced in this notice will not appear in the Federal Register. Copies of appendices were sent to all those receiving this notice in the mail and are available at www.ferc.gov using the link called eLibrary or from the Commission's Public Reference Room, 888 First Street NE, Washington, DC 20426, or call (202) 502-8371. For instructions on connecting to eLibrary, refer to the last page of this notice.

    Land Requirements for Construction

    There is no construction involved in this project. About 27.25 acres of land would be disturbed during removal of minor aboveground facilities and all work would be limited to existing permanent right-of way and existing access roads. All disturbed areas would be restored to preexisting conditions.

    The EA Process

    The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us 2 to discover and address concerns the public may have about proposals. This process is referred to as scoping. The main goal of the scoping process is to focus the analysis in EA. We will consider all filed comments during the preparation of the EA.

    2 We, us, and our refer to the environmental staff of the Commission's Office of Energy Projects.

    In the EA we will discuss impacts that could occur as a result of the facilities to be abandoned in place and removal of minor facilities proposed under these general headings:

    • Geology and soils;

    • land use;

    • water resources, fisheries, and wetlands;

    • cultural resources;

    • vegetation and wildlife;

    • air quality and noise;

    • endangered and threatened species;

    • public safety; and

    • cumulative impacts.

    We will also evaluate reasonable alternatives to the proposed project or portions of the project and make recommendations on how to lessen or avoid impacts on the various resource areas.

    The EA will present our independent analysis of the issues. The EA will be available in the public record through eLibrary. Depending on the comments received during the scoping process, we may also publish and distribute the EA to the public for an allotted comment period. We will consider all comments on the EA before making our recommendations to the Commission. To ensure we have the opportunity to consider and address your comments, please carefully follow the instructions in the Public Participation section, beginning on page 2.

    With this notice, we are asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate with us in the preparation of the EA.3 Agencies that would like to request cooperating agency status should follow the instructions for filing comments provided under the Public Participation section of this notice. Currently, no agency has expressed intention to participate as a cooperating agency in the preparation of the EA to satisfy its NEPA responsibilities related to this project.

    3 The Council on Environmental Quality regulations addressing cooperating agency responsibilities are at Title 40, Code of Federal Regulations, Part 1501.6.

    Consultations Under Section 106 of the National Historic Preservation Act

    In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, we are using this notice to initiate consultation with the applicable State Historic Preservation Office(s) (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.4 We will define the project-specific Area of Potential Effects (APE) in consultation with the SHPO(s) as the project develops. On natural gas facility projects, the APE at a minimum encompasses all areas subject to ground disturbance (examples include construction right-of-way, contractor/pipe storage yards, compressor stations, and access roads). Our EA for this project will document our findings on the impacts on historic properties and summarize the status of consultations under section 106.

    4 The Advisory Council on Historic Preservation's regulations are at Title 36, Code of Federal Regulations, Part 800. Those regulations define historic properties as any prehistoric or historic district, site, building, structure, or object included in or eligible for inclusion in the National Register of Historic Places.

    Environmental Mailing List

    The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American Tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. We will update the environmental mailing list as the analysis proceeds to ensure that we send the information related to this environmental review to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project.

    If we publish and distribute the EA, copies/Copies of the EA will be sent to the environmental mailing list for public review and comment. If you would prefer to receive a paper copy of the document instead of the CD version or would like to remove your name from the mailing list, please return the attached Information Request (appendix 2).

    Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want to become an intervenor which is an official party to the Commission's proceeding. Intervenors play a more formal role in the process and are able to file briefs, appear at hearings, and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene. Instructions for becoming an intervenor are in the “Document-less Intervention Guide” under the “e-filing” link on the Commission's website. Motions to intervene are more fully described at http://www.ferc.gov/resources/guides/how-to/intervene.asp.

    Additional Information

    Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at www.ferc.gov using the eLibrary link. Click on the eLibrary link, click on General Search and enter the docket number, excluding the last three digits in the Docket Number field (i.e., CP18-39 or CP18-40). Be sure you have selected an appropriate date range. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or for TTY, contact (202) 502-8659. The eLibrary link also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rulemakings.

    In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Finally, public sessions or site visits will be posted on the Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: February 8, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-03005 Filed 2-13-18; 8:45 am] BILLING CODE 6717-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0723] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, 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 April 16, 2018. 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 Number: 3060-0723.

    Title: 47 U.S.C. Section 276, Public Disclosure of Network Information by Bell Operating Companies (BOCs).

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit.

    Number of Respondents and Responses: 3 respondents; 3 responses.

    Estimated Time per Response: 120 hours.

    Frequency of Response: On occasion reporting requirement and third party disclosure requirement.

    Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. 276 of the Telecommunications Act of 1996.

    Total Annual Burden: 360 hours.

    Total Annual Cost: No cost.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: If the Commission requests respondents to submit information to the Commission or to USAC that the respondents believe is confidential, the respondents may request confidential treatment of such information pursuant to 47 CFR 0.459 of the Commission's rules.

    Needs and Uses: The Commission will submit this information collection to the Office of Management and Budget (OMB) after this 60-day comment period in order to obtain the full three year clearance from OMB. Under 47 U.S.C. 276(b)(1)(C), the Bell Operating Companies (BOCs) are required to publicly disclose changes in their networks or new network services. Sections 276(b)(1)(C) directs the Commission to “prescribe a set of nonstructural safeguards for BOC payphone service to implement the provisions of paragraphs (1) and (2) of subsection (a), which safeguards shall, at a minimum, include the nonstructural safeguards equal to those adopted in the Computer Inquiry-III (CC Docket No. 90-623) proceeding.” The Computer Inquiry-III network information disclosure requirements specifically state that the disclosure would occur at two different points in time. First, disclosure would occur at the make/buy point: When a BOC decides to make for itself, or procure from an unaffiliated entity, any product whose design affects or relies on the network interface. Second, a BOC would publicly disclose technical information about a new service 12 months before it is introduced. If the BOC can introduce the service within 12 months of the make/buy point, it would make a public disclosure at the make/buy point. In no event, however, would the public disclosure occur less than six months before the introduction of the service. While the scope and applicability of the Computer III safeguards has changed with the Commission's 2015 decision regarding forbearance from enforcement of the Computer III requirements (Petition of USTelecom for Forbearance Pursuant to 47 U.S.C. Section 160(c) from Enforcement of Obsolete ILEC Regulations that Inhibit Deployment of Next Generation Networks, Memorandum Opinion and Order, FCC 15-166 (2015)), these are minimum requirements under section 276(b)(1)(C). Without information disclosures, the industry would be unable to ascertain whether the BOCs are designing new network services or changing network technical specifications to the advantage of their own payphones, or in a manner that might disadvantage BOC payphone competitors. These requirements ensure that BOCs comply with their obligations under the Telecommunications Act of 1996.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-02998 Filed 2-13-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1198] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, 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 April 16, 2018. 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 Number: 3060-1198.

    Title: Section 90.525, Administration of Interoperability Channels; Section 90.529, State Licenses; and Section 90.531, Band Plan.

    Form No.: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: State, Local or Tribal Government, and Not-for- profit institutions.

    Number of Respondents and Responses: 2,271 respondents; 2,271 responses.

    Estimated Time per Response: 1-2 hours.

    Frequency of Response: On occasion reporting and one-time reporting requirements; third party disclosure requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this collection of information is contained in sections 4(i), 11, 303(g), 303(r), and 332(c)(7) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 161, 303(g), 303(r), 332(c)(7), unless otherwise noted.

    Total Annual Burden: 2,312 hours.

    Total Annual Cost: No Cost.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality.

    Needs and Uses: Section 90.525 of the Commission's rules requires approval of license applications for Interoperability channels in the 769-775 MHz and 799-805 MHz frequency bands by state-level agency or organization responsible for administering emergency communications. Section 90.529 of the Commission's rules provides that each state license will be granted subject to the condition that the state certifies on or before each applicable benchmark date that it is providing or prepared to provide “substantial service.” Section 90.531 of the Commission's rules sets forth the band plan for the 769-775 MHz and 799-805 MHz public safety bands. This section covers channel designations for base and mobile use, narrowband segments, combined channels, channel pairing, internal guard band, and broadband. Narrowband general use channels, including the former narrowband reserve channels, and low power channels require regional planning committee concurrence and narrowband air-ground channels require state or regional planning committee concurrence.

    Commission staff will use the information to assign licenses for interoperability and General Use channels, as well as renewal of State licenses. The information will also be used to determine whether prospective licensees operate in compliance with the Commission's rules. Without such information, the Commission could not accommodate State interoperability or regional planning requirements or provide for the efficient use of State frequencies. This information collection includes rules to govern the operation and licensing of 700 MHz band systems to ensure that licensees continue to fulfill their statutory responsibilities in accordance with the Communications Act of 1934, as amended. Such information will continue to be used to verify that applicants are legally and technically qualified to hold licenses, and to determine compliance with Commission rules.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-02999 Filed 2-13-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0174 and 3060-0580] Information Collections Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (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 PRA comments should be submitted on or before April 16, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

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

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0174.

    Title: Sections 73.1212, 76.1615 and 76.1715, Sponsorship Identification.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for profit entities; Individuals or households.

    Number of Respondents and Responses: 22,900 respondents and 1,877,000 responses.

    Estimated Time per Response: .0011 to .2011 hours.

    Frequency of Response: Recordkeeping requirement; Third party disclosure requirement; On occasion reporting requirement.

    Total Annual Burden: 249,043 hours.

    Total Annual Cost: $34,623.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in sections 4(i), 317 and 507 of the Communications Act of 1934, as amended.

    Nature and Extent of Confidentiality: The FCC is preparing a system of records, FCC/MB-2, “Broadcast Station Public Inspection Files,” to cover the personally identifiable information (PII) that may be included in the broadcast station public inspection files. Respondents may request materials or information submitted to the Commission be withheld from public inspection under 47 CFR 0.459 of the Commission's rules.

    Privacy Impact Assessment(s): The FCC is preparing a PIA.

    Needs and Uses: The information collection requirements that are approved under this collection are as follows:

    47 CFR 73.1212 requires a broadcast station to identify at the time of broadcast the sponsor of any matter for which consideration is provided. For advertising commercial products or services, generally the mention of the name of the product or service constitutes sponsorship identification. In the case of television political advertisements concerning candidates for public office, the sponsor shall be identified with letters equal to or greater than four (4) percent of the vertical height of the television screen that airs for no less than four (4) seconds. In addition, when an entity rather than an individual sponsors the broadcast of matter that is of a political or controversial nature, licensee is required to retain a list of the executive officers, or board of directors, or executive committee, etc., of the organization paying for such matter. Sponsorship announcements are waived with respect to the broadcast of “want ads” sponsored by an individual but the licensee shall maintain a list showing the name, address and telephone number of each such advertiser. These lists shall be made available for public inspection.

    47 CFR 73.1212(e) states that, when an entity rather than an individual sponsors the broadcast of matter that is of a political or controversial nature, the licensee is required to retain a list of the executive officers, or board of directors, or executive committee, etc., of the organization paying for such matter in its public file. Pursuant to the changes contained in 47 CFR 73.1212(e) and 47 CFR 73.3526(e)(19), this list, which could contain personally identifiable information, would be located in a public inspection file to be located on the Commission's website instead of being maintained in the public file at the station. Burden estimates for this change are included in OMB Control Number 3060-0214.

    47 CFR 76.1615 states that, when a cable operator engaged in origination cablecasting presents any matter for which money, service or other valuable consideration is provided to such cable television system operator, the cable television system operator, at the time of the telecast, shall identify the sponsor. Under this rule section, when advertising commercial products or services, an announcement stating the sponsor's corporate or trade name, or the name of the sponsor's product is sufficient when it is clear that the mention of the name of the product constitutes a sponsorship identification. In the case of television political advertisements concerning candidates for public office, the sponsor shall be identified with letters equal to or greater than four (4) percent of the vertical height of the television screen that airs for no less than four (4) seconds.

    47 CFR 76.1715 state that, with respect to sponsorship announcements that are waived when the broadcast/origination cablecast of “want ads” sponsored by an individual, the licensee/operator shall maintain a list showing the name, address and telephone number of each such advertiser. These lists shall be made available for public inspection.

    OMB Control Number: 3060-0580.

    Title: Section 76.1710, Operator Interests in Video Programming.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents and Responses: 1,500 respondents; 1,500 responses.

    Estimated Time per Response: 15 hours.

    Frequency of Response: Recordkeeping requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 Section 154(i) of the Communications Act of 1934, as amended.

    Total Annual Burden: 22,500 hours.

    Total Annual Cost: None.

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

    Nature and Extent of Confidentiality: There is no need for confidentiality and respondents are not being asked to submit confidential information to the Commission.

    Needs and Uses: The information collection requirements contained in 47 CFR 76.1710 require cable operators to maintain records in their public file for a period of three years regarding the nature and extent of their attributable interests in all video programming services. The records must be made available to members of the public, local franchising authorities and the Commission on reasonable notice and during regular business hours. The records will be reviewed by local franchising authorities and the Commission to monitor compliance with channel occupancy limits in respective local franchise areas.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-03001 Filed 2-13-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1210] Information Collection Being Submitted for Review and Approval to the Office of Management and Budget 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 Commission 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 March 16, 2018. 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 listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicholas A. Fraser, OMB, via email [email protected]; and to Nicole Ongele, FCC, via email [email protected] and to [email protected] Include in the comments the OMB control number as shown in the SUPPLEMENTARY INFORMATION below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page <http://www.reginfo.gov/public/do/PRAMain>, (2) look for the section of the web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of FCC ICRs currently under review appears, look for the OMB control number of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

    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 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.

    OMB Control Number: 3060-1210.

    Title: Wireless E911 Location Accuracy Requirements.

    Form Number: Not applicable.

    Type of Review: Revision of a currently approved collection.

    Respondents: Business or other for-profit entities; State, local or tribal governments.

    Number of Respondents and Responses: 4,394 respondents; 29,028 responses.

    Estimated Time per Response: 2-10 hours.

    Frequency of Response: Recordkeeping, on occasion; one-time; quarterly and semi-annual reporting requirements, and third-party disclosure requirements.

    Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47. U.S.C. Sections 1, 2, 4(i), 7, 10, 201, 214, 222, 251(e), 301, 302, 303, 303(b), 303(r), 307, 307(a), 309, 309(j)(3), 316, 316(a), and 332 of the Communications Act of 1934, as amended.

    Total Annual Burden: 143,138 hours.

    Total Annual Cost: No Cost.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: The Commission is requesting that respondents submit confidential information to the Commission in the context of the test bed. Nationwide Commercial Mobile Radio Service (CMRS) providers must make data from the test bed available to small and regional CMRS providers so that the smaller providers can deploy technology throughout their networks that is consistent with a deployment that was successfully tested in the test bed. CMRS providers also may request confidential treatment of live 911 call data reports, but the Commission reserves the right to release aggregate or anonymized data on a limited basis to facilitate compliance with its rules.

    Needs and Uses: The Commission has developed a proposed reporting template to assist CMRS providers in submitting aggregate live 911 call data as required under Section 20.18(i)(3)(ii) of the rules and seeks Office of Management and Budget (OMB) approval of the proposed template. The Commission also is requesting OMB to extend its approval of these collections for an additional three years. The information collections are described below. The proposed reporting template for live 911 call data is described below in the discussion of Section 20.18(i)(3)(ii). The proposed template will not change the paperwork burden associated with this collection, and there is no change to any other reporting obligation in this collection.

    The information sought in this collection is necessary and vital to the effective implementation of improved location accuracy, which will enable Public Safety Answering Points (PSAPs) to dispatch to and first responders to respond to emergencies.

    Section 20.18(i)(2)(ii)(A) requires that, within three years of the effective date of rules, CMRS providers shall deliver to uncompensated barometric pressure data from any device capable of delivering such data to PSAPs. This requirement is necessary to ensure that PSAPs are receiving all location information possible to be used for dispatch. This requirement is also necessary to ensure that CMRS providers implement a vertical location solution in the event that the proposed “dispatchable location” solution does not function as intended by the three-year mark and beyond.

    Section 20.18(i)(2)(ii)(B) requires that the four nationwide providers submit to the Commission for review and approval a reasonable metric for z-axis (vertical) location accuracy no later than 3 years from the effective date of rules. The requirement is critical to ensure that the vertical location framework adopted in the Fourth Report and Order is effectively implemented.

    Section 20.18(i)(2)(iii) requires CMRS providers to certify compliance with the Commission's rules at various benchmarks throughout implementation of improved location accuracy. This requirement is necessary to ensure that CMRS providers remain “on track” to reach the goals that they themselves agreed to.

    Section 20.18(i)(3)(i) requires that within 12 months of the effective date, the four nationwide CMRS providers must establish the test bed described in the Fourth Report and Order, which will validate technologies intended for indoor location. The test bed is necessary for the compliance certification framework adopted in the Fourth Report and Order.

    Section 20.18(i)(3)(ii) requires that beginning 18 months from the effective date of the rules, CMRS providers providing service in any of the six Test Cities identified by ATIS (Atlanta, Denver/Front Range, San Francisco, Philadelphia, Chicago, and Manhattan Borough of New York City) or portions thereof must collect and report aggregate data on the location technologies used for live 911 calls. Nationwide CMRS providers must submit call data on a quarterly basis; non-nationwide CMRS providers need only submit this data every six months. Non-nationwide providers that do not provide service in any of the Test Cities may satisfy this requirement by collecting and reporting data based on the largest county within the carrier's footprint. This reporting requirement is necessary to validate and verify the compliance certifications made by CMRS providers.

    The Commission has developed a proposed reporting template to assist CMRS providers in collecting, formatting, and submitting aggregate live 911 call data in accordance with the requirements in the rules. The proposed template will also assist the Commission in evaluating the progress CMRS providers have made toward meeting the 911 location accuracy benchmarks. The proposed template is an Excel spreadsheet and will be available for downloading on the Commission's website. The Commission may also develop an online filing mechanism for these reports in the future.

    Section 20.18(i)(4)(ii) requires that no later than 18 months from the effective date, each CMRS provider shall submit to the Commission a report on its progress toward implementing improved indoor location accuracy. Non-nationwide CMRS providers will have an additional 6 months to submit their progress reports. All CMRS providers shall provide an additional progress report no later than 36 months from the effective date of the adoption of this rule. The 36-month reports shall indicate what progress the provider has made consistent with its implementation plan.

    Section 20.18(i)(4)(iii) requires that prior to activation of the NEAD but no later than 18 months from the effective date of the adoption of this rule, the nationwide CMRS providers shall file with the Commission and request approval for a security and privacy plan for the administration and operation of the NEAD. This requirement is necessary to ensure that the four nationwide CMRS providers are building in privacy and security measures to the NEAD from its inception.

    Section 20.18(i)(4)(iv) requires that before use of the NEAD or any information contained therein, CMRS providers must certify that they will not use the NEAD or associated data for any non-911 purpose, except as otherwise required by law. This requirement is necessary to ensure the privacy and security of any personally identifiable information that may be collected by the NEAD.

    Section 20.18(j) requires CMRS providers to provide standardized confidence and uncertainty (C/U) data for all wireless 911 calls, whether from outdoor or indoor locations, on a per-call basis upon the request of a PSAP. This requirement will serve to make the use of C/U data easier for PSAPs

    Section 20.18(k) requires that CMRS providers must record information on all live 911 calls, including, but not limited to, the positioning source method used to provide a location fix associated with the call, as well as confidence and uncertainty data. This information must be made available to PSAPs upon request, as a measure to promote transparency and accountability for this set of rules.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-02997 Filed 2-13-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1251] Information Collection Approved by the Office of Management and Budget AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Federal Communications Commission (Commission) has received Office of Management and Budget (OMB) approval, on an emergency basis, for a new, one-time information collection 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 in the FOR FURTHER INFORMATION CONTACT section below.

    FOR FURTHER INFORMATION CONTACT:

    Contact Cathy Williams, [email protected], (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    The total annual reporting burdens and costs for the respondents are as follows:

    OMB Control Number: 3060-1251.

    OMB Approval Date: February 7, 2018.

    OMB Expiration Date: February 28, 2021.

    Title: Mobility Fund Phase II Challenge Process.

    Form Number: N/A.

    Respondents: Business or other for-profit entities, not-for-profit institutions, and state, local or tribal governments.

    Number of Respondents and Responses: 500 respondents; 500 responses.

    Estimated Time per Response: 204 hours for challengers; 71 for challenged parties.

    Frequency of Response: One-time reporting requirement.

    Total Annual Burden: 78,725 hours.

    Total Annual Cost: None.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for the currently approved information collection is contained in sections 154, 254, and 303(r) of the Communications Act, as amended, 47 U.S.C. 4, 254, 303(r).

    Nature and Extent of Confidentiality: To the extent the information submitted pursuant to this information collection is determined to be confidential, it will be protected by the Commission. If a respondent seeks to have information collected pursuant to this information collection withheld from public inspection, the respondent may request confidential treatment pursuant to section .459 of the Commission's rules for such information. See 47 CFR 0.459.

    Privacy Act Impact Assessment: No impact(s).

    Needs and Uses: In 2011, the Commission established the Mobility Fund, which consists of two phases. Mobility Fund Phase I provided one-time universal service support payments to immediately accelerate deployment of mobile broadband services. MF-II will use a reverse auction to provide ongoing universal service support payments to continue to advance deployment of such services. In its February 2017 Mobility Fund II Report and Order and Further Notice of Proposed Rulemaking (MF-II Report and Order and/or FNPRM) (FCC 17-11), the Commission adopted the rules and framework for moving forward expeditiously with the MF-II auction and stated that, prior to the auction, it would establish a map of areas presumptively eligible for MF-II support based on the most recently available FCC Form 477 mobile wireless coverage data, and provide a limited timeframe for parties to challenge those initial determinations during the pre-auction process. The Commission sought comment in the accompanying Mobility Fund II FNPRM on how to best design a robust, targeted MF-II challenge process that efficiently resolves disputes about the areas eligible for MF-II support.

    In its August 2017 Order on Reconsideration and Second Report and Order (Challenge Process Order) (FCC 17-102), the Commission (1) reconsidered its earlier decision to use FCC Form 477 data to compile the map of areas presumptively eligible for MF-II support and decided it would instead conduct a new, one-time data collection with specified data parameters tailored to MF-II to determine the areas in which there is deployment of qualified LTE that will be used (together with high-cost disbursement data available from the Universal Service Administrative Company (USAC)) for this purpose, and (2) adopted a streamlined challenge process that will efficiently resolve disputes about areas deemed presumptively ineligible for MF-II support. The map of areas presumptively eligible for MF-II support will serve as the starting point for the challenge process pursuant to which an interested party (challenger) may initiate a challenge with respect to one or more areas initially deemed ineligible for MF-II support (i.e., areas not listed on the Commission's map of areas presumptively eligible for MF-II support) and challenged parties can respond to challenges.

    A challenger seeking to initiate a challenge of one or more areas initially deemed ineligible in the Commission's map of areas presumptively eligible for MF-II support may do via the online challenge portal developed by USAC for this purpose (the USAC portal). For each state, a challenger must (1) identify the area(s) it seeks to challenge, (2) submit detailed proof of a lack of unsubsidized, qualified 4G LTE coverage in each challenged area in the form of actual outdoor speed test data collected using the standardized parameters specified by the Commission in the Challenge Process Order and any other parameters the Commission or the Wireless Telecommunications Bureau and Wireline Competition Bureau (the Bureaus) may implement, and (3) certify its challenge. The USAC system will validate a challenger's evidence using an automated challenge validation process. Once all valid challenges have been identified, a challenged party that chooses to respond to any valid challenge(s) may submit additional data via the online USAC portal during the established response window. A challenged party may submit technical information that is probative regarding the validity of a challenger's speed tests, including speed test data and other device-specific data collected from transmitter monitoring software or, alternatively, may submit its own speed test data that conforms to the same standards and requirements specified by the Commission and the Bureaus for challengers.

    In conjunction with the qualified 4G LTE data separately collected pursuant to OMB 3060-1242 that will be used to create the map of areas presumptively eligible for MF-II support, the information collected under this MF-II challenge process collection will enable the Commission to efficiently resolve disputes concerning the eligibility or ineligibility of an area initially deemed ineligible for MF-II support and establish the final map of areas eligible for such support, thereby furthering the Commission's goal of targeting MF-II support to areas that lack adequate mobile voice and broadband coverage absent subsidies through a transparent process.

    The Commission received approval from OMB for the information collection requirements contained in OMB 3060-1251 on February 7, 2018.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-03000 Filed 2-13-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meeting TIME AND DATE:

    Thursday, February 15, 2018 at 10:00 a.m.

    PLACE:

    999 E Street NW, Washington, DC (Ninth Floor).

    STATUS:

    This Meeting, open to the public, has been cancelled.

    CONTACT PERSON FOR MORE INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Signed: Dayna C. Brown, Secretary and Clerk of the Commission.
    [FR Doc. 2018-03166 Filed 2-12-18; 4:15 pm] BILLING CODE 6715-01-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than March 7, 2018.

    A. Federal Reserve Bank of Atlanta (Kathryn Haney, Director of Applications) 1000 Peachtree Street NE, Atlanta, Georgia 30309. Comments can also be sent electronically to [email protected]:

    1. Brandt J. Dufrene, Sr., individually and as trustee for The FSC Trust No. 1, and Brandt J. Dufrene, Jr., individually and as the trustee for The FSC Trust No. 2 and the Brandt J. Dufrene, Jr. Trust No. 1, all of Metairie, Louisiana; to retain voting shares of First St. Charles Bancshares, Inc., and thereby indirectly retain First National Bank USA, both Boutte, Louisiana.

    Board of Governors of the Federal Reserve System, February 9, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-03082 Filed 2-13-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [CDC-2018-0004; NIOSH-233-B] NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2018 AGENCY:

    Centers for Disease Control and Prevention, HHS.

    ACTION:

    Notice of draft document available for public comment.

    SUMMARY:

    The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability for public comment on the drugs proposed for placement on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018 (List), as well as the NIOSH Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.

    DATES:

    Comments must be received by April 16, 2018.

    ADDRESSES:

    Comments may be submitted, identified by docket numbers CDC-2018-0004 and NIOSH-233-B, by either of the following two methods:

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

    Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226-1998.

    Instructions: All information received in response to this notice must include the agency name and the docket numbers (CDC-2018-0004; NIOSH-233-B). All relevant comments received will be posted without change to www.regulations.gov, including any personal information provided.

    FOR FURTHER INFORMATION CONTACT:

    Barbara MacKenzie, NIOSH, Robert A. Taft Laboratories, 1090 Tusculum Avenue, MS-C26, Cincinnati, OH 45226, telephone (513) 533-8132 (not a toll free number), Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Public Participation

    Interested parties are invited to participate in this action by submitting written views, opinions, recommendation, and/or data. Comments are invited on any topic related to the drugs identified in this notice, including those evaluated for placement on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018. NIOSH also seeks comment on the draft Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, available in the docket for this action. NIOSH invites comments specifically on the following questions related to this action:

    1. Has NIOSH appropriately identified and categorized the drugs considered for placement on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018?

    2. Is information available from FDA or other Federal agencies or in the published, peer-reviewed scientific literature about a specific drug or drugs identified in this notice that would justify the reconsideration of NIOSH's categorization decision?

    3. Does the draft Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings include a methodology for reviewing toxicity information that is appropriate for this activity?

    II. Background

    In September 2004, NIOSH published NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings (Alert).1 The 2004 Alert set out a general NIOSH policy for the identification of hazardous drugs and contained examples of U.S. Food and Drug Administration (FDA)-approved drugs that were deemed to be hazardous to workers in health care and other settings and may require special handling. This initial list of hazardous drugs was updated in 2010,2 2012,3 2014,4 and 2016.5 The latest publication, entitled NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 (2016 Update), covered all new approved drugs and drugs with new warnings through December 2013.

    1See https://www.cdc.gov/niosh/docs/2004-165/.

    2See https://www.cdc.gov/niosh/docs/2010-167/.

    3See https://www.cdc.gov/niosh/docs/2012-150/.

    4See https://www.cdc.gov/niosh/docs/2014-138/default.html.

    5See https://www.cdc.gov/niosh/docs/2016-161/default.html.

    III. Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings

    The NIOSH Director has developed draft policy and procedures, entitled Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, to formalize the methodology NIOSH uses to guide the addition of hazardous drugs to the List (see https://www.cdc.gov/niosh/topics/hazdrug/default.html). The draft document clarifies and details the purpose of the List, which is to assist employers in providing safe and healthful workplaces by offering a list of drugs that meet the NIOSH definition of a hazardous drug, and sets out the procedures used by NIOSH to identify such drugs. The draft policy and procedures will be finalized after consideration of comments to this docket and from peer reviewers.6

    6See https://www.cdc.gov/niosh/topics/hazdrug/peer-review-plan.html for the charge to peer reviewers.

    According to the draft hazardous drugs policy and procedures, NIOSH defines a hazardous drug as a drug that is:

    1. Approved for use in humans 7 by the FDA; 8 and

    7 Although only drugs approved by the FDA for use in humans are included in the definition of a hazardous drug, some of those drugs may be used in veterinary settings for treatment of animals and may be a hazard for veterinary care workers.

    8 21 U.S.C. 301 et seq.

    2. Not otherwise regulated by the U.S. Nuclear Regulatory Commission; 9 and

    9 10 CFR parts 19, 20, and 35. See https://www.nrc.gov/materials/miau/med-use.html.

    3. Either:

    a. Accompanied by prescribing information in the “package insert” 10 that includes special handling information to protect workers handling the drug; or

    10See Drug Advertising: A Glossary of Terms at https://www.fda.gov/drugs/resourcesforyou/consumers/prescriptiondrugadvertising/ucm072025.htm. “Prescribing information is also called product information, product labeling, or the package insert (“the PI”). It is generally drafted by the drug company and approved by the FDA. This information travels with a drug as it moves from the company to the pharmacist. It includes the details and directions healthcare providers need to prescribe the drug properly. It is also the basis for how the drug company can advertise its drug. The prescribing information includes such details about the drug as: Its chemical description; how it works; how it interacts with other drugs, supplements, foods, and beverages; what condition(s) or disease(s) it treats; who should not use the drug; serious side effects, even if they occur rarely; commonly occurring side effects, even if they are not serious; effects on specific groups of patients, such as children, pregnant women, or older adults and how to use it in these populations.”

    b. Exhibits one or more of the following types of toxicity in humans, animal models, or in vitro systems: Carcinogenicity; teratogenicity or other developmental toxicity; reproductive toxicity; organ toxicity at low doses; genotoxicity; or structure and toxicity profile that mimics existing drugs determined hazardous by exhibiting any one of the previous five toxicity types.

    In accordance with the draft hazardous drugs policy and procedures, NIOSH uses FDA databases to identify new drug approvals and drugs with new safety warnings.

    Information pertaining to each new drug and drugs with new safety warnings is screened to determine whether a specific drug is potentially hazardous. Potentially hazardous drugs are those for which the manufacturer has provided special handling information intended to protect workers, or for which available toxicity information suggests that a drug may exhibit one of the types of toxicity in the NIOSH definition of a hazardous drug. Drugs for which insufficient toxicity information is available and drugs for which the available information suggests no toxic effect or a toxic effect that does not meet the NIOSH definition of a hazardous drug are not proposed for placement on the List and are not further considered. Drugs for which special handling information is available are published on the NIOSH website and proposed for placement on the List; these drugs are not further evaluated.

    Drugs for which the available information suggests that the drug exhibits one or more toxic effects that meet the NIOSH definition of a hazardous drug are further evaluated to determine whether the drug should be proposed for placement on the List. To conduct the evaluation of drugs for which information suggests a toxic effect, NIOSH may consult the following sources of information to determine whether each screened drug might exhibit at least one type of toxicity in the NIOSH definition of a hazardous drug:

    a. Information in the drug package insert;

    b. FDA information pertaining to new drug safety labeling changes; 11

    11See https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/.

    c. When available, relevant information about carcinogenicity from:

    (1) The National Toxicology Program (NTP) within the U.S. Department of Health and Human Services; 12

    12 NTP (National Toxicology Program, DHHS) [2016]. 14th report on carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. See https://ntp.niehs.nih.gov/pubhealth/roc/index-1.html.

    (2) U.S. Environmental Protection Agency (EPA); 13

    13 EPA (Environmental Protection Agency). Integrated Risk Information System (IRIS) Assessments. See https://cfpub.epa.gov/ncea/iris2/atoz.cfm.

    (3) World Health Organization's International Agency for Research on Cancer (IARC); 14 and

    14 IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Lyon, France. See http://monographs.iarc.fr/ENG/Classification/index.php.

    (4) NIOSH.15

    15 NIOSH Carcinogen List. See https://www.cdc.gov/niosh/topics/cancer/npotocca.html.

    d. When available, relevant information about reproductive toxicity, teratogenicity, or developmental toxicity from the NTP Center for the Evaluation of Risks to Human Reproduction (CERHR), and from its successor, the Office of Health Assessment and Translation (OHAT);

    e. When available, published, peer-reviewed scientific literature about the hazard potential of a particular drug for workers in a healthcare setting, including any relevant studies cited in the drug package insert; and

    f. When available, toxicity information from Safety Data Sheets (SDSs) provided by the manufacturer.

    Reviewing the available human, animal, and in vitro data from those sources, NIOSH uses criteria included in the hazardous drugs policy and procedures to determine whether the available evidence demonstrates or supports any of the types of toxicity in the NIOSH definition of a hazardous drug. NIOSH makes an initial determination about each drug and then requests review and comment from independent peer reviewers.

    After consideration of the peer reviews, NIOSH sorts all screened and evaluated drugs into one of five categories:

    • Category 1—Special handling information • Category 2—Insufficient toxicity information available to meet the NIOSH definition of a hazardous drug • Category 3—Available information shows no toxic effect or shows a toxic effect that does not meet the NIOSH definition of a hazardous drug • Category 4—Available toxicity information demonstrates or supports a determination that the drug does not meet the NIOSH definition of a hazardous drug • Category 5—Available toxicity information demonstrates or supports a determination that the drug meets the NIOSH definition of a hazardous drug

    The categorized drugs are identified in a Federal Register notice available for public and stakeholder comment for 60 days.

    After consideration of all public and stakeholder comments received, NIOSH makes a final determination about the disposition of all identified drugs and publishes a notice in the Federal Register announcing publication of the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018 on the NIOSH website.

    IV. Identifying Potentially Hazardous Drugs

    Consistent with the hazardous drugs policy and procedures described above, NIOSH consulted two FDA databases on a monthly basis since the 2016 Update to identify newly-approved drugs and biologics 16 and already-approved drugs for which the manufacturer has issued a new safety warning.17 Through the monthly FDA database search, conducted from January 2014 through December 2015, NIOSH identified 74 new drugs that had received FDA approval and 199 drugs with new safety warnings. In addition to the drugs identified by the FDA database searches, the NIOSH Director received a request to evaluate two drugs, dihydroergotamine and isotretinoin, for placement on the List by an interested party. In sum, 275 drugs were identified between January 2014 and December 2015 and screened.

    16[email protected]: FDA Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/.

    17Drug Safety Labeling Changes. https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/.

    V. Screening of Potentially Hazardous Drugs

    Upon identification by NIOSH, each drug was screened to determine whether the manufacturer specified special handling information in the package insert or if information in the package insert suggests that a drug may exhibit at least one of the types of toxicity in the NIOSH definition of a hazardous drug. For 18 drugs, existing toxicity information did not support placement on the List (see Table 1) and for 211 drugs and combination drugs, the available information suggests no toxic effect or a toxic effect that does not meet the NIOSH definition of a hazardous drug (see Table 2); those drugs are not proposed for placement on the List.

    Table 1—Insufficient Toxicity Information Available To Meet NIOSH Definition of Hazardous Drug [Category 2] Belimumab Dinutuximab Protriptyline Betamethasone Elosulfase Sebelipase alfa Cholic acid Mepolizumab Secukinumab Daratumumab Obinutuzumab Siltuximab Desipramine Omalizumab Vedolizumab Dexamethasone Pegaspargase Velaglucerase Table 2—Available Information Shows a Toxic Effect That Does Not Meet the NIOSH Definition of Hazardous Drug [Category 3] Abatacept Desvenlafaxine Ketoconazole Rasagiline Aclidinium Dexlansoprazole Lamivudine Regadenosone Adalimumab Diclofenac Lansoprazole Rifaximin Adenosine Diltiazem Ledipasvir/Sofosbuvir Rilpivirine Aflibercept Dimethyl fumarate Lesinurad Risedronate Albiglutide Dolasetron Levetiracetam Rivaroxaban Alcaftadine Doripenem Levomilnacipran Rivastigmine Alirocumab Doxazosin Linaclotide Rocuronium Almotriptan Doxepin Linagliptin Rolapitant Anagrelide Doxycycline Lincomycin Ropinirole Apixaban Droxidopa Lisinopril Rufinamide Aripiprazole Dulaglutide Losartan Ruxolitinib Asenapine Duloxetine Lovastatin Sacubitril/Valsartan Asparaginase erwinia Edoxaban Lumacaftor/Ivacaftor Sapropterin Avanafil Efavirenz Maraviroc Saquinavir Baclofen Efinaconazole Methadone Saxagliptin Beclomethasone Eliglustat Methoxy polyethylene glycol-epoetin beta Selegiline Bedaquiline Eltrombopag Methylphenidate Selexipag Benazepril Eluxadoline Methylprednisolone Sertraline Bimatoprost Empagliflozin Minocycline Sildenafil Boceprevir Escitalopram Mirabegron Simeprevir Brexpiprazole Esomeprazole Mirtazapine Simvastatin Bupivacaine Etidronate Morphine Sitagliptin Buprenorphine Evolocumab Moxifloxacin Sofosbuvir Bupropion Ezopiclone Naloxegol Somatropin Calcitonin Fentanyl Natalizumab Sugammadex Canagliflozin Ferumoxytol Necitumumab Sulfasalazine Canakinumab Filgrastim Netupitant/Palonosetron Sulfur hexafluoride lipid type-A Cangrelor Flibanserin Nivolumab Suvorexant Captopril Fluoxetine Nortriptyline Tadalafil Carbidopa Fluvoxamine Olanzapine Taligucerase Cariprazine Fondaparinux Olodaterol Tamsulosin Cefepime Gabapentin Omeprazole Tapentadol Cefoperazone Galantamine Ondasetron Tavaborole Ceftazidime/Avibactam Gemfibrozil Oritavancin Tedizolide Ceftriaxone Granisetron Oxybutynin Telithromycin Cinacalcet Hydrocodone Oxycodone Telmisartan Citalopram Hydrocortisone Oxymorphone Ticagrelor Clindamycin Hydromorphone Palbociclib Tolvaptan Clomipramine Ibandronate Palonosetron Trazodone Clozapine Ibrutinib Panitumumab Triamcinolone Collagenase clostridium histolytica Imipramine Pantoprazole Trimipramine Dabigatran Infliximab Paricalcitol Trypan blue Daclatasvir Ingenol Pegfilgrastim Uridine Dalbavancin Insulin degludec Peginterferon alpha-2A Vardenafil Dalteparin Insulin glargine Peginterferon alpha-2B Varenicline Dapagliflozin Insulin glulisine Pembrolizumab Venlafaxine Dapsone Interferon alfa-2b Peramivir Vigabatrin Daptomycin Interferon beta-1a Pramlintide Vilazodone Darunavir Interferon gamma-1b Prazosin Vorapaxar Deferasirox Ipilimumab Rabeprazole Vortioxetine Denosumab Ivacaftor Ramipril Zolpidem Deoxycholic acid Ivermectin Ramucirumab

    Finally, the information available for 44 drugs suggests one or more toxic effects; those drugs were evaluated by NIOSH, as discussed below, and were shared with peer reviewers and stakeholders.18

    18 Historically, NIOSH has conducted peer review and stakeholder review concurrently, prior to publication of the list of drugs proposed for addition to the List. Beginning with the 2020 Update, NIOSH will conduct peer review prior to publication of the list of drugs proposed for addition, and will conduct public comment and stakeholder review concurrently.

    VI. Evaluation of Potentially Hazardous Drugs

    Consistent with the draft hazardous drugs policy and procedures, NIOSH evaluated the 44 drugs identified as potentially hazardous to determine whether each meets the NIOSH definition of a hazardous drug by exhibiting one or more of the following types of toxicity in humans, animal models, or in vitro systems: Carcinogenicity; teratogenicity or other developmental toxicity; reproductive toxicity; organ toxicity at low doses; genotoxicity; and/or a structure and toxicity profile of an isomer or close chemical analog of a drug on the List. Using criteria articulated in the draft hazardous drugs policy and procedures,19 NIOSH reviewed the available information and sought to determine whether the evidence for each drug either demonstrates or supports a determination of toxicity. Initial determinations were made about each evaluated drug and then the list of evaluated drugs was given to peer reviewers and stakeholders for additional evaluation.

    19See section VII.C.

    VII. Peer and Stakeholder Review of Potentially Hazardous Drugs

    NIOSH conducted peer and stakeholder review of all evaluated drugs.20 Four independent peer reviewers and eight stakeholders reviewed and commented on the 44 drugs. De-identified peer and stakeholder reviews will be placed in the docket for this action.

    20See https://www.cdc.gov/niosh/review/peer/isi/hazdrug2018-pr.html for the charge to peer reviewers.

    VIII. Evaluated Drugs That Do Not Meet the NIOSH Definition of a Hazardous Drug

    After consideration of the peer and stakeholder reviews, NIOSH determined that the available toxicity information for 23 drugs does not meet the NIOSH definition of a hazardous drug (Category 4). These drugs are not proposed for placement on the List and are identified in Table 3.

    Table 3—Available Toxicity Information Does Not Demonstrate or Support a Determination That the Drug Meets the NIOSH Definition of a Hazardous Drug [Category 4] Aglucosidase Diazoxide Lanreotide Alectinib Elotuzumab Metreleptin Alendronate Finafloxacin Milnacipran Alogliptin Golimumab Nintedanib Apremilast Idelalisib Peginterferon beta-1A Calcipotriene Isavuconazonium Pirfenidone Cetuximab Itraconazole Tasimelteon Clarithromycin Lamotrigine IX. Drugs Proposed for Placement on the NIOSH List of Hazardous Drugs

    NIOSH determined that the available toxicity information for 20 drugs and one class of drug demonstrates or supports a NIOSH determination that they meet the NIOSH definition of a hazardous drug are proposed for placement on the List (Category 5). These drugs are proposed for placement on the list and are identified in Table 4.

    Two additional drugs have special handling information specified by the manufacturer and are proposed for placement on the List (see Table 4).21

    21 The manufacturers of trabectedin and inotuzumab ozogamicin added special handling information to the package inserts after publication of the 2016 Update. Although these drugs have been categorized by NIOSH as “hazardous” since April 10, 2017, they will be formally added to the 2018 Update unless compelling evidence in support of not placing them on the List is offered by public commenters. See https://www.cdc.gov/niosh/docs/2016-161/default.html.

    BILLING CODE 4163-19-P EN14FE18.000 EN14FE18.001 EN14FE18.002 EN14FE18.003 EN14FE18.004 BILLING CODE 4163-19-C X. Drugs Removed From the NIOSH List of Hazardous Drugs

    In a petition to NIOSH in February 2017, the pharmaceutical company Theravance Biopharma requested the removal of the drug telavancin from the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. 22 The petition included an analysis of animal developmental toxicity studies and argued that “[p]lacing telavancin in the NIOSH category of a hazardous drug greatly overstates the occupational risk to healthcare workers handling telavancin.” In response, NIOSH evaluated the information provided in the petition as well as other sources provided to NIOSH by the manufacturer and determined that telavancin does not meet the NIOSH definition of a hazardous drug. NIOSH informed users of the 2016 List of this determination via a web posting and responded to Theravance Biopharma with a letter dated April 12, 2017.23 Accordingly, telavancin does not appear in the 2018 update to the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. This decision is considered final.

    22 Harstad EB and Coleman R. Petition of Theravance Biopharma US, Inc. to Remove Telavancin from the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. February 28, 2017.

    23 NIOSH letter to Eric Harstad and Rebecca Coleman. April 12, 2017.

    XI. Final List of Drugs Proposed for Placement on the NIOSH List of Hazardous Drugs

    After consideration of all public comments received in the docket for this action, NIOSH will develop a final list of drugs to be placed on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018. The 2018 Update will be published on the NIOSH website and announced in a Federal Register notice.

    Dated: February 8, 2018. John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.
    [FR Doc. 2018-02957 Filed 2-13-18; 8:45 am] BILLING CODE 4163-19-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request

    Title: Office of Refugee Resettlement Cash and Medical Assistance Program Quarterly Report on Expenditures and Obligations.

    OMB No.: 0970-0407.

    Description: The Office of Refugee Resettlement (ORR) reimburses, to the extent of available appropriations, certain non-federal costs for the provision of cash and medical assistance to refugees and other eligible persons, along with allowable expenses for the administration of the refugee resettlement program at the State level. States, Wilson/Fish projects (alternative projects for the administration of the refugee resettlement program), and State Replacement Designees currently submit the ORR-2 Financial Status Report in accordance with 45 CFR part 92 and 45 CFR part 74. This proposed data collection would collect financial status data (i.e., amounts of expenditures and obligations) broken down by the four program components: Refugee cash assistance, refugee medical assistance, health screening, and services for unaccompanied refugee minors as well as by program administration. This breakdown of financial status data on expenditures and obligations allows ORR to track program expenditures in greater detail to anticipate any funding issues and to meet the requirements of ORR regulations at 45 CFR 400.211 to collect these data for use in estimating annual costs of the refugee resettlement program. ORR must implement the methodology at 45 CFR 400.211 each year after receipt of its annual appropriation to ensure that the appropriated funds will be adequate for assistance to entering refugees. The estimating methodology prescribed in the ORR regulations requires the use of actual past costs by program component. In the event that the methodology indicates that appropriated funds are inadequate, ORR must take steps to reduce federal expenses, such as by limiting the number of months of eligibility for Refugee Cash Assistance and Refugee Medical Assistance. This proposed single-page report on expenditures and obligations will allow ORR to collect the necessary data to ensure that funds are adequate for the projected need and thereby meet the requirements of both the Refugee Act and ORR regulations.

    Respondents: State Agencies, the District of Columbia, Replacement Designees under 45 CFR 400.301(c), and Wilson-Fish Grantees (State 2 Agencies) administering or supervising the administration of programs under Title IV of the Act.

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses
  • per
  • respondent
  • Average
  • burden hours
  • per response
  • Total burden
  • hours
  • ORR Financial Status Report Cash and Medical Assistance Program, Quarterly Report on Expenditures and Obligations 57 4 1.50 342

    Estimated Total Annual Burden Hours: 342.

    Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]

    OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected], Attn: Desk Officer for the Administration for Children and Families.

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2018-03091 Filed 2-13-18; 8:45 am] BILLING CODE 4184-45-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request

    Title: Home Visiting Career Trajectories.

    OMB No.: New Collection.

    Description: The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS), in collaboration with the Health Resources and Services Administration (HRSA), seeks approval to collect information from home visiting program staff in programs receiving funding through the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program as part of the Home Visiting Career Trajectories study. ACF is interested in collecting information about the state of the home visiting workforce, career trajectories of home visitors, and strategies for building a pipeline of qualified home visitors and supervisors.

    Through the proposed information collection, the researchers will obtain information about the characteristics, qualifications, and career trajectories of home visiting staff. The study will include a national survey of the MIECHV workforce, interviews with training and technical assistance experts, and site visits to home visiting programs in eight states that vary in terms of geography, population demographics, labor markets, and home visiting program offerings.

    Respondents: Home visiting program managers, supervisors, home visitors, and training and technical assistance experts.

    Annual Burden Estimates Instrument Total/annual
  • number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Annual
  • burden hours
  • Home visitor and supervisor survey 3,000 1 0.38 1,140 Program manager survey 700 1 0.33 231 Focus group moderator's guide 480 1 2 960 Self-administered questionnaire for focus group participants 480 1 0.03 14 Key informant interview guide—management and supervisory staff 80 1 1.5 120 Key informant interview guide—training and technical assistance experts 30 1 1.5 45

    Estimated Total Annual Burden Hours: 2,510.

    Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]

    OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected], Attn: Desk Officer for the Administration for Children and Families.

    Mary Jones, ACF/OPRE Certifying Officer.
    [FR Doc. 2018-03093 Filed 2-13-18; 8:45 am] BILLING CODE 4184-74-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-2336] Determination of Regulatory Review Period for Purposes of Patent Extension; JUVEDERM VOLUMA XC AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) has determined the regulatory review period for JUVEDERM VOLUMA XC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

    DATES:

    Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 2018. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 16, 2018. 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. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 13, 2018. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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

    Instructions: All submissions received must include the Docket No. FDA-2014-E-2336 for “Determination of Regulatory Review Period for Purposes of Patent Extension; JUVEDERM VOLUMA XC.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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 § 10.20 (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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993-0002, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: a testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).

    FDA has approved for marketing the medical device JUVEDERM VOLUMA XC. JUVEDERM VOLUMA XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the midface in adults over the age of 21. Subsequent to this approval, the USPTO received a patent term restoration application for JUVEDERM VOLUMA XC (U.S. Patent No. 7,741,476) from Pierre Lebreton, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 30, 2015, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of JUVEDERM VOLUMA XC represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for JUVEDERM VOLUMA XC is 1,896 days. Of this time, 1,110 days occurred during the testing phase of the regulatory review period, while 786 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: August 15, 2008. The applicant claims that the investigational device exemption (IDE) required under section 520(g) of the FD&C act for human tests to begin became effective on July 24, 2009. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on August 15, 2008, which represents the IDE effective date.

    2. The date an application was initially submitted with respect to the device under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e): August 29, 2011. FDA has verified the applicant's claim that the premarket approval application (PMA) for JUVEDERM VOLUMA XC (PMA P110033) was initially submitted August 29, 2011.

    3. The date the application was approved: October 22, 2013. FDA has verified the applicant's claim that PMA P110033 was approved on October 22, 2013.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 567 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 8, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-03017 Filed 2-13-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-2598] Determination of Regulatory Review Period for Purposes of Patent Extension; BELEODAQ AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) has determined the regulatory review period for BELEODAQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

    DATES:

    Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 2018. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 16, 2018. 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. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 13, 2018. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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

    Instructions: All submissions received must include the Docket No. FDA-2015-E-2598 for “Determination of Regulatory Review Period for Purposes of Patent Extension; BELEODAQ.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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 § 10.20 (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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human drug product BELEODAQ (belinostat). BELEODAQ is a histone deacetylase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Subsequent to this approval, the USPTO received a patent term restoration application for BELEODAQ (U.S. Patent No. 6,888,027) from Spectrum Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of BELEODAQ represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for BELEODAQ is 3,488 days. Of this time, 3,281 days occurred during the testing phase of the regulatory review period, while 207 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: December 16, 2004. FDA has verified the Spectrum Pharmaceuticals, Inc. claim that December 16, 2004, is the date the investigational new drug application (NDA) became effective.

    2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: December 9, 2013. The applicant claims December 8, 2013 as the date the NDA for BELEODAQ was initially submitted. However, FDA records indicate that NDA 206256 was submitted on December 9, 2013.

    3. The date the application was approved: July 3, 2014. FDA has verified the applicant's claim that NDA 206256 was approved on July 3, 2014.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,779 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 8, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-03041 Filed 2-13-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-3813] Determination of Regulatory Review Period for Purposes of Patent Extension; OSURNIA AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OSURNIA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.

    DATES:

    Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 13, 2018. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 16, 2018. 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.

    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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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

    Instructions: All submissions received must include the Docket No. FDA-2015-E-3813 for “Determination of Regulatory Review Period for Purposes of Patent Extension; OSURNIA.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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 § 10.20 (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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For animal drug products, the testing phase begins on the earlier date when either a major environmental effects test was initiated for the drug or when an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the animal drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for an animal drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(4)(B).

    FDA has approved for marketing the animal drug product OSURNIA (terbinafine, florfenicol and betamethasone acetate). OSURNIA is indicated for the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis). Subsequent to this approval, the USPTO received a patent term restoration application for OSURNIA (U.S. Patent No. 7,854,943) from IDEXX, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated December 17, 2015, FDA advised the USPTO that this animal drug product had undergone a regulatory review period and that the approval of OSURNIA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for OSURNIA is 4,034 days. Of this time, 3,980 days occurred during the testing phase of the regulatory review period, while 54 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the FD&C Act (21 U.S.C. 355(i)) became effective: October 21, 2003. The applicant claims September 20, 2013, as the date the investigational new animal drug application (INAD) became effective. However, FDA records indicate that the INAD effective date was October 21, 2003, which was the date on which the Agency acknowledges the filing of a notice of claimed investigational exemption for a new animal drug.

    2. The date the application was initially submitted with respect to the animal drug product under section 512 of the FD&C Act (21 U.S.C. 360b): September 12, 2014. The applicant claims September 9, 2014, as the date the new animal drug application (NADA) for OSURNIA (NADA 141-437) was initially submitted. However, FDA records indicate that NADA 141-437 was submitted on September 12, 2014.

    3. The date the application was approved: November 4, 2014. FDA has verified the applicant's claim that NADA 141-437 was approved on November 4, 2014.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 235 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 8, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02991 Filed 2-13-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-3488] Determination of Regulatory Review Period for Purposes of Patent Extension; KERYDIN AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KERYDIN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

    DATES:

    Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 13, 2018. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 16, 2018. 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.

    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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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

    Instructions: All submissions received must include the Docket No. FDA-2015-E-3488 for “Determination of Regulatory Review Period for Purposes of Patent Extension; KERYDIN.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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 § 10.20 (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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human drug product KERYDIN (tavaborole). KERYDIN is indicated for the topical treatment of onychomycosis of the toenails due to Tricophyton rubrum or Tricophyton mentagrophytes. Subsequent to this approval, the USPTO received a patent term restoration application for KERYDIN (U.S. Patent No. 7,582,621) from Anacor Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of KERYDIN represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for KERYDIN is 3,112 days. Of this time, 2,768 days occurred during the testing phase of the regulatory review period, while 344 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: December 31, 2005. FDA has verified the applicant's claim that December 31, 2005, is the date the investigational new drug application became effective.

    2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: July 29, 2013. The applicant claims July 26, 2013, as the date the new drug application (NDA) for KERYDIN (NDA 204427) was initially submitted. However, FDA records indicate that NDA 204427 was submitted on July 29, 2013.

    3. The date the application was approved: July 7, 2014. FDA has verified the applicant's claim that NDA 204427 was approved on July 7, 2014.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 408 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 8, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02993 Filed 2-13-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-E-1184 and FDA-2016-E-1183] Determination of Regulatory Review Period for Purposes of Patent Extension; IBRANCE AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IBRANCE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

    DATES:

    Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 13, 2018. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 16, 2018. 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.

    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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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

    Instructions: All submissions received must include the Docket Nos. FDA-2016-E-1184 and FDA-2016-E-1183 for “For Determination of Regulatory Review Period for Purposes of Patent Extension; IBRANCE.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the dockets and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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 § 10.20 (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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human drug product IBRANCE (palbociclib). IBRANCE is indicated for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in combination with:

    • An aromatase inhibitor as initial endocrine based therapy in postmenopausal women; or

    • fulvestrant in women with disease progression following endocrine therapy.

    Subsequent to this approval, the USPTO received patent term restoration applications for IBRANCE (U.S. Patent Nos. 6,936,612 and 7,208,489) from Warner-Lambert Company, LLC, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated July 12, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of IBRANCE represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for IBRANCE is 3,954 days. Of this time, 3,779 days occurred during the testing phase of the regulatory review period, while 175 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: April 9, 2004. FDA has verified the Warner-Lambert Company, LLC, claim that April 9, 2004, is the date the investigational new drug application (IND) became effective.

    2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: August 13, 2014. FDA has verified the applicant's claim that the new drug application (NDA) for IBRANCE (NDA 207103) was initially submitted on August 13, 2014.

    3. The date the application was approved: February 3, 2015. FDA has verified the applicant's claim that NDA 207103 was approved on February 3, 2015.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,810 days or 1,509 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 8, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-03029 Filed 2-13-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0001] Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings; Public Workshop AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the following 1-day public workshop entitled “Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings.” This workshop is convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public workshop is to bring rare disease stakeholders together to discuss the challenges associated with the development and regulatory decision-making for rare disease treatments and to also discuss promising study designs and analytical methods that can help overcome these challenges.

    DATES:

    The public workshop will be held on March 19, 2018, from 9 a.m. to 5 p.m. Eastern Daylight Time (EDT). See the SUPPLEMENTARY INFORMATION section for registration date and information.

    ADDRESSES:

    The public workshop will be held at the DoubleTree by Hilton Hotel Washington DC-Silver Spring, 8727 Colesville Rd., Silver Spring, MD 20910. For additional travel and hotel information, please refer to the Duke Margolis Center for Health Policy website at: https://healthpolicy.duke.edu/events/innovative-tools-and-statistical-methods-treatment-development-rare-disease-settings.

    FOR FURTHER INFORMATION CONTACT:

    Robyn Bent, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-2572, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Rare disease settings pose several significant challenges for clinical research, drug development, and regulatory review. Small population sizes, possible limited scientific understanding of the disease of interest, and a lack of market incentives often preclude more traditional clinical trial or analytical approaches from being pursued. To help collaboratively address these barriers, FDA is working with stakeholders to solicit feedback on promising designs and methodologies for use in the development of rare disease treatments that can form the basis of formal guidance documents.

    II. Topics for Discussion at the Public Workshop

    During the public workshop, speakers and participants will discuss a range of tools and methods that can be used in the development of treatments for rare diseases and small patient populations. The meeting will include both presentations by panelists and dedicated time for questions and comments from attendees. Topics will include: Master protocols, use of external controls in single-arm trials, analytical tools for trials with multiple or novel endpoints, and best practices for leveraging Bayesian statistics and adaptive study designs.

    III. Participating in the Public Workshop

    Registration: To register for the public workshop, visit the following website: https://healthpolicy.duke.edu/events/innovative-tools-and-statistical-methods-treatment-development-rare-disease-settings. If you are unable to attend the meeting in person, you can register to view a live webcast of the meeting. There will be no onsite registration. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

    Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by 5 p.m. EDT on Thursday, March 15, 2018. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization.

    If you need special accommodations due to a disability, please contact Sarah Supsiri at the Duke-Margolis Center for Health Policy (phone: 202-791-9561, email: [email protected]) no later than March 12, 2018.

    Streaming webcast of the public workshop: This public workshop will also be webcast. Archived video footage will also be available at the Duke-Margolis website following the workshop (https://healthpolicy.duke.edu/events/innovative-tools-and-statistical-methods-treatment-development-rare-disease-settings). Persons interested in viewing the live webcast must register online before 5 p.m. EDT on March 18, 2018 (see Registration). Early registration is recommended because webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location whenever possible. Webcast participants will be sent technical system requirements in advance of the event. Prior to joining the streaming webcast of the public workshop, it is recommended that you review these technical system requirements.

    Transcripts: Please be advised that transcripts will not be available.

    Other Issues for Consideration: A 1-hour lunch break is scheduled, but food will not be provided. There are multiple restaurants within walking distance of the DoubleTree by Hilton Hotel, 8727 Colesville Rd., Silver Spring, MD 20910.

    All event materials will be provided to registered attendees via email prior to the workshop and will be publicly available at the Duke-Margolis Center for Health Policy website (https://healthpolicy.duke.edu/events/innovative-tools-and-statistical-methods-treatment-development-rare-disease-settings).

    Dated: February 7, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02990 Filed 2-13-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-2576] Determination of Regulatory Review Period for Purposes of Patent Extension; JARDIANCE AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for JARDIANCE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

    DATES:

    Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 2018. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 16, 2018. 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. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 13, 2018. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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

    Instructions: All submissions received must include the Docket No. FDA-2015-E-2576 for “Determination of Regulatory Review Period for Purposes of Patent Extension; JARDIANCE.” Received comments, those filed in a timely manner (see ADDRESSES),will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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 § 10.20 (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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human drug product JARDIANCE (empagliflozin). JARDIANCE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval, the USPTO received a patent term restoration application for JARDIANCE (U.S. Patent No. 7,579,449) from Boehringer Ingelheim International GmbH, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of JARDIANCE represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for JARDIANCE is 2,275 days. Of this time, 1,760 days occurred during the testing phase of the regulatory review period, while 515 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: May 11, 2008. The applicant claims May 10, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was May 11, 2008, which was 30 days after FDA receipt of the IND.

    2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: March 5, 2013. FDA