Federal Register Vol. 83, No.28,

Federal Register Volume 83, Issue 28 (February 9, 2018)

Page Range5681-5869
FR Document

83_FR_28
Current View
Page and SubjectPDF
83 FR 5771 - Sunshine Act MeetingPDF
83 FR 5816 - Sunshine Act Meeting; National Science BoardPDF
83 FR 5770 - Sunshine Act MeetingPDF
83 FR 5844 - Allocations, Common Application, Waivers, and Alternative Requirements for 2017 Disaster Community Development Block Grant Disaster Recovery GranteesPDF
83 FR 5803 - Notice of Public Meeting for the Northwest Oregon Resource Advisory CouncilPDF
83 FR 5802 - Notice of Application for a Recordable Disclaimer of Interest for Lands Underlying the Kanektok River System Including Pegati and Kagati Lakes, AlaskaPDF
83 FR 5793 - Designation of a Class of Employees for Addition to the Special Exposure CohortPDF
83 FR 5826 - Notice of Receipt of Petition for Decision That Nonconforming Model Year 2017 UKANG FT-200 Trailers Are Eligible for ImportationPDF
83 FR 5827 - Notice of Receipt of Petition for Decision That Nonconforming Model Year 2006 Penman Lightweight GS Cargo Trailers Are Eligible for ImportationPDF
83 FR 5720 - Endangered and Threatened Wildlife and Plants; Endangered Species Status for Texas HornshellPDF
83 FR 5711 - Cyflufenamid; Pesticide TolerancesPDF
83 FR 5717 - Zoxamide; Pesticide TolerancesPDF
83 FR 5785 - Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; AvailabilityPDF
83 FR 5787 - Determination of Regulatory Review Period for Purposes of Patent Extension; IDELVIONPDF
83 FR 5796 - Homeland Security Science and Technology Advisory CommitteePDF
83 FR 5768 - Certain New Chemicals or Significant New Uses; Statements of Findings for November 2017PDF
83 FR 5769 - Certain New Chemicals or Significant New Uses; Statements of Findings for October 2017PDF
83 FR 5735 - Fisheries of the Northeastern United States; Summer Flounder Fishery; Quota TransferPDF
83 FR 5815 - NASA Advisory Council; Aeronautics Committee; MeetingPDF
83 FR 5780 - Determination of Regulatory Review Period for Purposes of Patent Extension; ODOMZOPDF
83 FR 5840 - Advisory Committee on Disability Compensation, Notice of MeetingPDF
83 FR 5830 - Quarterly Publication of Individuals, Who Have Chosen To Expatriate, as Required by Section 6039GPDF
83 FR 5801 - Announcement of the Housing Counseling Federal Advisory Committee; Notice of Public MeetingPDF
83 FR 5796 - Notice of Regulatory Waiver Requests Granted for the Third Quarter of Calendar Year 2017PDF
83 FR 5815 - Earth Science Advisory Committee; MeetingPDF
83 FR 5759 - Procurement List; DeletionsPDF
83 FR 5759 - Procurement List; Proposed Additions and DeletionsPDF
83 FR 5812 - Agency Information Collection Activities; Proposed eCollection eComments Requested; COPS Application PackagePDF
83 FR 5751 - Safety Zone; Navy Underwater Detonation (UNDET) Exercise, Apra Outer Harbor, GUPDF
83 FR 5810 - Importer of Controlled Substances Application: Meridian Medical Technologies Inc.PDF
83 FR 5810 - Importer of Controlled Substances Application: Noramco, Inc.PDF
83 FR 5808 - Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.PDF
83 FR 5808 - Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.PDF
83 FR 5810 - Bulk Manufacturer of Controlled Substances Application: INSYS Manufacturing LLCPDF
83 FR 5812 - Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics Inc.PDF
83 FR 5811 - Importer of Controlled Substances Application: Mylan Technologies Inc.PDF
83 FR 5811 - Importer of Controlled Substances Application: Johnson Matthey Inc.PDF
83 FR 5809 - Bulk Manufacturer of Controlled Substances Application: Cerilliant CorporationPDF
83 FR 5809 - Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc.PDF
83 FR 5771 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
83 FR 5762 - Charter Amendment of Department of Defense Federal Advisory CommitteesPDF
83 FR 5804 - Acadia National Park Advisory Commission 2018 Meeting SchedulePDF
83 FR 5816 - Notice of Permits Issued Under the Antarctic Conservation Act of 1978PDF
83 FR 5756 - Foreign-Trade Zone 31-Granite City, Illinois; Application for Reorganization and Expansion Under Alternative Site FrameworkPDF
83 FR 5755 - Correction Notice; Foreign-Trade Zone (FTZ) 127-West Columbia, South Carolina; Authorization of Limited Production Activity; BGM America, Inc.; Subzone 127C (Sailboats, Cabin Cruiser Powerboats, Outboard Motor Boats); Marion, South CarolinaPDF
83 FR 5756 - Certain Steel Nails From the United Arab Emirates: Rescission of 2016-2017 Antidumping Duty Administrative ReviewPDF
83 FR 5757 - Certain Steel Nails From Malaysia: Final Results of Antidumping Duty Administrative Review; 2014-2016PDF
83 FR 5818 - New Postal ProductsPDF
83 FR 5767 - Application To Export Electric Energy; ENGIE Energy Marketing NA, Inc.PDF
83 FR 5776 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
83 FR 5807 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
83 FR 5760 - Agency Information Collection Activities Under ReviewPDF
83 FR 5736 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Non-American Fisheries Act Crab Vessels Operating as Catcher Vessels Using Pot Gear in the Central Regulatory Area of the Gulf of AlaskaPDF
83 FR 5763 - Request for Proposals for Beneficial Use of Dredged Material Pursuant to Section 1122 of the Water Resources Development Act, Beneficial Use of Dredged MaterialPDF
83 FR 5825 - Notice of Final Federal Agency Actions of Proposed Highway/Interchange Improvement in California; Statute of Limitations on ClaimsPDF
83 FR 5824 - Environmental Impact Statement: I-80/I-215 Parley's Interchange, Salt Lake County, UtahPDF
83 FR 5767 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; College Affordability and Transparency Explanation Form (CATEF) 2018-2020PDF
83 FR 5816 - Submission of Information Collection for OMB Review; Comment Request; Termination of Single-Employer Plans, Missing ParticipantsPDF
83 FR 5824 - Rescinding the Notice of Intent for an Environmental Impact Statement (EIS): 14th Street Bridge Corridor, Arlington County, Virginia and Washington, DCPDF
83 FR 5824 - Rescinding the Notice of Intent for an Environmental Impact Statement (EIS): Manassas National Battlefield Park Bypass, Loudon, Fairfax, Fauquier and Prince William Counties, VAPDF
83 FR 5762 - Opportunity for Public Comment on Proposed Definition of “Procurement Administrative Lead Time” or “PALT” and the Plan for Measuring and Publically Reporting Data on PALT for Department of Defense Contracts and Task Orders Above the Simplified Acquisition ThresholdPDF
83 FR 5772 - Announcement of Requirements and Registration for the 2018 Million Hearts® Hypertension Control ChallengePDF
83 FR 5823 - Aviation Rulemaking Advisory Committee; MeetingPDF
83 FR 5793 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: National Survey of Organ Donation Attitudes and Practices, OMB No. 0915-0290-Reinstatement With ChangePDF
83 FR 5791 - Agency Information Collection Activities: Proposed Collection: Public Comment Request, Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System, OMB Number: 0906-0017-RevisionPDF
83 FR 5783 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary MedicinePDF
83 FR 5781 - Determination of Regulatory Review Period for Purposes of Patent Extension; ENTRESTOPDF
83 FR 5788 - Determination of Regulatory Review Period for Purposes of Patent Extension; LYNPARZAPDF
83 FR 5790 - Determination of Regulatory Review Period for Purposes of Patent Extension; ONIVYDEPDF
83 FR 5784 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission RequirementsPDF
83 FR 5776 - Determination of Regulatory Review Period for Purposes of Patent Extension; STRENSIQPDF
83 FR 5771 - Submission for OMB Review; Prohibition of Acquisition of Products Produced by Forced or Indentured Child LaborPDF
83 FR 5794 - Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Zika Virus Pilot Project, OMB No. 0906-XXXX-NewPDF
83 FR 5754 - Submission for OMB Review; Comment RequestPDF
83 FR 5828 - Agency Information Collection Activities; Comment Request; Renewal Without Change of Bank Secrecy Act Currency Transaction Reporting Requirements RegulationsPDF
83 FR 5829 - Agency Information Collection Activities; Comment Request; Renewal Without Change of Bank Secrecy Act Regulations Requiring Depository Institutions and Insurance Companies To Report Suspicious ActivityPDF
83 FR 5778 - Determination of Regulatory Review Period for Purposes of Patent Extension; KAMRA INLAYPDF
83 FR 5755 - Proposed Information Collection; Comment Request; Annual Survey of School System FinancesPDF
83 FR 5768 - Environmental Impact Statements; Notice of AvailabilityPDF
83 FR 5765 - Agency Information Collection Activities; Comment Request; Fiscal Operations Report for 2017-2018 and Application To Participate 2019-2020 (FISAP) and Reallocation FormPDF
83 FR 5804 - Certain Shaving Cartridges, Components Thereof and Products Containing Same; Commission Determination Not To Review an Initial Determination Terminating Investigation Based on a Settlement Agreement; Termination of the InvestigationPDF
83 FR 5805 - Certain Composite Aerogel Insulation Materials and Methods for Manufacturing the Same; Commission's Final Determination Finding a Violation of Section 337; Issuance of a Limited Exclusion Order; Termination of the InvestigationPDF
83 FR 5764 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; U.S. Department of Education Green Ribbon Schools Nominee Presentation FormPDF
83 FR 5765 - Agency Information Collection Activities; Comment Request; Privacy Act Request FormPDF
83 FR 5817 - Civil Service Retirement System Board of Actuaries MeetingPDF
83 FR 5806 - Certain Pool Spa Enclosures; Notice of Commission Determination Not To Review an Initial Determination (Order No. 9) Terminating the Investigation; Termination of the InvestigationPDF
83 FR 5761 - Agency Information Collection Activities: Notice of Intent To Extend Collection 3038-0095; Large Trader Reporting for Physical Commodity SwapsPDF
83 FR 5817 - Hispanic Council on Federal EmploymentPDF
83 FR 5818 - Product Change-Priority Mail Negotiated Service AgreementPDF
83 FR 5840 - Agency Information Collection Under OMB Review: Insurance Customer Satisfaction SurveysPDF
83 FR 5822 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Designation of Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change, as Modified by Amendment Nos. 1 and 2, To Adopt the Midpoint Extended Life OrderPDF
83 FR 5818 - Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Exchange Rules 7030, 7034, and 7051PDF
83 FR 5795 - National Institute on Drug Abuse; Notice of Closed MeetingsPDF
83 FR 5795 - National Eye Institute; Amended Notice of MeetingPDF
83 FR 5813 - MET Laboratories, Inc.: Application for Expansion of Recognition and Proposed Modification to the NRTL Program's List of Appropriate Test StandardsPDF
83 FR 5823 - Overseas Security Advisory Council (OSAC) Meeting Notice; Closed MeetingPDF
83 FR 5766 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Implementation of Title I/II Program InitiativesPDF
83 FR 5839 - Open Meeting of the Federal Advisory Committee on InsurancePDF
83 FR 5700 - Airworthiness Directives; Rosemount Aerospace, Inc. Pitot ProbesPDF
83 FR 5681 - Freedom of Information Act ImplementationPDF
83 FR 5774 - Notice of Availability of Draft Environmental Impact Statement, Public Meeting, and Request for Comments; Site Acquisition and Campus Consolidation for the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH), Cincinnati, OhioPDF
83 FR 5706 - Establishment of Class E Airspace, Spanish Fork, UTPDF
83 FR 5705 - Establishment of Class E Airspace; Johnson City, TNPDF
83 FR 5741 - Airworthiness Directives; The Boeing Company AirplanesPDF
83 FR 5746 - Airworthiness Directives; Bombardier, Inc., AirplanesPDF
83 FR 5738 - Airworthiness Directives; The Boeing Company AirplanesPDF
83 FR 5743 - Airworthiness Directives; The Boeing Company AirplanesPDF
83 FR 5748 - Proposed Amendment of Class E Airspace, Hamilton, NYPDF
83 FR 5750 - Proposed Amendment of Class D Airspace and Class E Airspace, and Removal of Class E Airspace; Binghamton, NYPDF
83 FR 5707 - Amendment of Class D and E Airspace for the Following Missouri Towns; Cape Girardeau, MO; St. Louis, MO; and Macon, MOPDF
83 FR 5710 - Revocation of Class E Airspace; Pulaski, WIPDF
83 FR 5685 - Airworthiness Directives; The Boeing Company AirplanesPDF
83 FR 5689 - Airworthiness Directives; Airbus AirplanesPDF

Issue

83 28 Friday, February 9, 2018 Contents Agriculture Agriculture Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 5754 2018-02585 Census Bureau Census Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Annual Survey of School System Finances, 5755 2018-02581 Centers Disease Centers for Disease Control and Prevention NOTICES Announcement of Requirements and Registration for the 2018 Million Hearts Hypertension Control Challenge, 5772-5774 2018-02598 Environmental Impact Statements; Availability, etc.: Site Acquisition and Campus Consolidation for the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health, Cincinnati, OH, 5774-5776 2018-02327 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 5776 2018-02617 Coast Guard Coast Guard PROPOSED RULES Safety Zones: Navy Underwater Detonation Exercise, Apra Outer Harbor, GU, 5751-5753 2018-02648 Commerce Commerce Department See

Census Bureau

See

Foreign-rade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 5759-5760 2018-02651 2018-02652 Commodity Futures Commodity Futures Trading Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 5760-5761 2018-02615 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Large Trader Reporting for Physical Commodity Swaps, 5761-5762 2018-02572 Defense Acquisition Defense Acquisition Regulations System NOTICES Proposed Definition of Procurement Administrative Lead Time or PALT and the Plan for Measuring and Publically Reporting Data on PALT for Department of Defense Contracts and Task Orders Above the Simplified Acquisition Threshold, 5762 2018-02599 Defense Department Defense Department See

Defense Acquisition Regulations System

See

Engineers Corps

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Prohibition of Acquisition of Products Produced by Forced or Indentured Child Labor, 5771-5772 2018-02587 Charter Amendments: Department of Defense Federal Advisory Committees, 5762 2018-02634
Drug Drug Enforcement Administration NOTICES Bulk Manufacturers of Controlled Substances; Applications: Cerilliant Corp., 5809 2018-02638 INSYS Manufacturing LLC, 5810 2018-02643 Importers of Controlled Substances; Applications: Johnson Matthey Inc., 5811 2018-02639 Meridian Medical Technologies Inc., 5810-5811 2018-02647 Mylan Pharmaceuticals, Inc., 5809-5810 2018-02637 Mylan Technologies Inc., 5811-5812 2018-02641 Noramco, Inc., 5810 2018-02646 Manufacturers of Controlled Substances; Applications: AMRI Rensselaer, Inc., 5808 2018-02644 Noramco, Inc., 5808 2018-02645 Siemens Healthcare Diagnostics Inc., 5812 2018-02642 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: College Affordability and Transparency Explanation Form 2018-2020, 5767 2018-02607 Fiscal Operations Report for 2017-2018 and Application to Participate 2019-2020 and Reallocation Form, 5765-5766 2018-02579 Green Ribbon Schools Nominee Presentation Form, 5764 2018-02576 Implementation of Title I/II Program Initiatives, 5766-5767 2018-02561 Privacy Act Request Form, 5765 2018-02575 Energy Department Energy Department NOTICES Applications to Export Electric Energy: ENGIE Energy Marketing NA, Inc., 5767-5768 2018-02619 Engineers Engineers Corps NOTICES Requests for Proposals: Beneficial Use of Dredged Material Pursuant to the Water Resources Development Act, 5763 2018-02613 Environmental Protection Environmental Protection Agency RULES Pesticide Tolerances: Cyflufenamid, 5711-5717 2018-02670 Zoxamide, 5717-5720 2018-02668 NOTICES Certain New Chemicals or Significant New Uses: Statements of Findings for November 2017, 5768-5769 2018-02662 Statements of Findings for October 2017, 5769-5770 2018-02661 Environmental Impact Statements; Availability, etc.: Weekly Receipts, 5768 2018-02580 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Airbus Airplanes, 5689-5700 2018-01803 Rosemount Aerospace, Inc. Pitot Probes, 5700-5705 2018-02550 The Boeing Company Airplanes, 5685-5689 2018-01807 Amendment of Class D and E Airspace: Cape Girardeau, MO; St. Louis, MO; and Macon, MO, 5707-5710 2018-02139 Establishment of Class E Airspace: Johnson City, TN, 5705-5706 2018-02324 Spanish Fork, UT, 5706-5707 2018-02325 Revocation of Class E Airspace: Pulaski, WI, 5710-5711 2018-02137 PROPOSED RULES Airworthiness Directives: Bombardier, Inc., Airplanes, 5746-5748 2018-02198 The Boeing Company Airplanes, 5738-5746 2018-02193 2018-02197 2018-02199 Amendment of Class D Airspace and Class E Airspace, and Removal of Class E Airspace: Binghamton, NY, 5750-5751 2018-02140 Amendment of Class E Airspace: Hamilton, NY, 5748-5749 2018-02143 NOTICES Meetings: Aviation Rulemaking Advisory Committee, 5823-5824 2018-02596 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 5770 2018-02708 Federal Highway Federal Highway Administration NOTICES Environmental Impact Statements; Availability, etc.: 14th Street Bridge Corridor, Arlington County, Virginia and Washington, DC; Rescission, 5824 2018-02605 I-80/I-215 Parley's Interchange, Salt Lake County, UT, 5824-5825 2018-02609 Manassas National Battlefield Park Bypass, Loudon, Fairfax, Fauquier and Prince William Counties, VA, 5824 2018-02602 Final Federal Agency Actions of Proposed Highway/Interchange Improvement in California, 5825-5826 2018-02610 Federal Housing Finance Agency Federal Housing Finance Agency RULES Freedom of Information Act Implementation, 5681-5685 2018-02338 Federal Maritime Federal Maritime Commission NOTICES Meetings; Sunshine Act, 5771 2018-02822 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 5771 2018-02635 Financial Crimes Financial Crimes Enforcement Network NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Bank Secrecy Act Currency Transaction Reporting Requirements Regulations, 5828-5829 2018-02584 Bank Secrecy Act Regulations Requiring Depository Institutions and Insurance Companies to Report Suspicious Activity, 5829-5830 2018-02583 Fish Fish and Wildlife Service RULES Endangered and Threatened Species: Endangered Species Status for Texas Hornshell, 5720-5735 2018-02672 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine, 5783-5784 2018-02593 Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements, 5784-5785 2018-02589 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: ENTRESTO, 5781-5783 2018-02592 IDELVION, 5787-5788 2018-02666 KAMRA INLAY, 5778-5780 2018-02582 LYNPARZA, 5788-5790 2018-02591 ODOMZO, 5780-5781 2018-02658 ONIVYDE, 5790-5791 2018-02590 STRENSIQ, 5776-5778 2018-02588 Product-Specific Guidances, 5785-5786 2018-02667 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: BGM America, Inc., Foreign-Trade Zone 127, West Columbia, SC, 5755-5756 2018-02630 Reorganizations and Expansions under Alternative Site Framework: Foreign-Trade Zone 31, Granite City, IL, 5756 2018-02631 General Services General Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Prohibition of Acquisition of Products Produced by Forced or Indentured Child Labor, 5771-5772 2018-02587 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

NOTICES Designation of a Class of Employees for Addition to the Special Exposure Cohort, 5793 2018-02675
Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Survey of Organ Donation Attitudes and Practices, 5793-5794 2018-02595 The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System, 5791-5793 2018-02594 Zika Virus Pilot Project, 5794-5795 2018-02586 Homeland Homeland Security Department See

Coast Guard

NOTICES Meetings: Homeland Security Science and Technology Advisory Committee, 5796 2018-02665
Housing Housing and Urban Development Department NOTICES Community Development Block Grant Disaster Recovery Grantees: Allocations, Common Application, Waivers, and Alternative Requirements for 2017, 5844-5869 2018-02693 Meetings: Housing Counseling Federal Advisory Committee, 5801-5802 2018-02655 Regulatory Waiver Requests; Granted: Third Quarter of Calendar Year 2017, 5796-5801 2018-02654 Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

See

National Park Service

Internal Revenue Internal Revenue Service NOTICES Quarterly Publication of Individuals Who Have Chosen to Expatriate, 5830-5839 2018-02656 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Steel Nails from Malaysia, 5757-5759 2018-02628 Certain Steel Nails from the United Arab Emirates, 5756-5757 2018-02629 International Trade Com International Trade Commission NOTICES Complaints: Certain Light Engines and Components Thereof, 5807-5808 2018-02616 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Composite Aerogel Insulation Materials and Methods for Manufacturing the Same, 5805-5806 2018-02577 Certain Pool Spa Enclosures, 5806-5807 2018-02573 Certain Shaving Cartridges, Components Thereof and Products Containing Same, 5804 2018-02578 Justice Department Justice Department See

Drug Enforcement Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: COPS Application Package, 5812-5813 2018-02650
Labor Department Labor Department See

Occupational Safety and Health Administration

Land Land Management Bureau NOTICES Applications for a Recordable Disclaimers of Interest: Alaska Kanektok River System including Pegati and Kagati Lakes, 5802-5803 2018-02679 Meetings: Northwest Oregon Resource Advisory Council, 5803 2018-02680 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Prohibition of Acquisition of Products Produced by Forced or Indentured Child Labor, 5771-5772 2018-02587 Meetings: Advisory Council; Aeronautics Committee, 5815 2018-02659 Earth Science Advisory Committee, 5815-5816 2018-02653 National Highway National Highway Traffic Safety Administration NOTICES Petitions for Import Eligibility: Nonconforming Model Year 2006 Penman Lightweight GS Cargo Trailers, 5827-5828 2018-02673 Nonconforming Model Year 2017 UKANG FT-200 Trailers, 5826-5827 2018-02674 National Institute National Institutes of Health NOTICES Meetings: National Eye Institute; Amendment, 5795 2018-02565 National Institute on Drug Abuse, 5795-5796 2018-02566 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone off Alaska: Pacific Cod by Non-American Fisheries Act Crab Vessels Operating as Catcher Vessels Using Pot Gear in the Central Regulatory Area of the Gulf of Alaska, 5736-5737 2018-02614 Fisheries of the Northeastern United States Summer Flounder Fishery; Quota Transfer, 5735-5736 2018-02660 National Park National Park Service NOTICES Meetings: Acadia National Park Advisory Commission 2018 Schedule, 5804 2018-02633 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 5816 2018-02820 Permits Issued under the Antarctic Conservation Act, 5816 2018-02632 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Application for Expansion of Recognition and Proposed Modification to the NRTL Program's List of Appropriate Test Standards: MET Laboratories, Inc, 5813-5815 2018-02563 Pension Benefit Pension Benefit Guaranty Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Termination of Single-Employer Plans, Missing Participants, 5816-5817 2018-02606 Personnel Personnel Management Office NOTICES Meetings: Civil Service Retirement System Board of Actuaries, 5817-5818 2018-02574 Hispanic Council on Federal Employment, 5817 2018-02571 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 5818 2018-02627 Postal Service Postal Service NOTICES Product Changes: Priority Mail Negotiated Service Agreement, 5818 2018-02570 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Nasdaq BX, Inc., 5818-5822 2018-02567 The Nasdaq Stock Market, LLC, 5822-5823 2018-02568 State Department State Department NOTICES Meetings: Overseas Security Advisory Council, 5823 2018-02562 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department See

Financial Crimes Enforcement Network

See

Internal Revenue Service

NOTICES Meetings: Federal Advisory Committee on Insurance, 5839-5840 2018-02559
Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Insurance Customer Satisfaction Surveys, 5840 2018-02569 Meetings: Advisory Committee on Disability Compensation, 5840-5841 2018-02657 Separate Parts In This Issue Part II Housing and Urban Development Department, 5844-5869 2018-02693 Reader Aids

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

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83 28 Friday, February 9, 2018 Rules and Regulations FEDERAL HOUSING FINANCE AGENCY 12 CFR Part 1202 RIN 2590-AA86 Freedom of Information Act Implementation AGENCY:

Federal Housing Finance Agency.

ACTION:

Final rule.

SUMMARY:

The Federal Housing Finance Agency (FHFA) is finalizing its interim final rule that amended its Freedom of Information Act (FOIA) regulation. The amendments to FHFA's regulation incorporate the requirements of the FOIA Improvement Act of 2016 by giving notice of the circumstances under which FHFA may extend the time limit for responding to a FOIA request due to unusual circumstance; notifying a requester of their right to seek dispute resolution services; affording a requester a minimum of 90 days to file an administrative appeal; and clarifying and updating the existing regulation. The interim final rule became effective on March 15, 2017. This final rule finalizes the interim final rule with minor revisions for consistency and clarification.

DATES:

The final regulation is effective on February 9, 2018. For additional information, see SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:

David A. Lee, Chief FOIA Officer, (202) 649-3803, or Stacy J. Easter, FOIA Officer (202) 649-3803, (not toll free numbers), Federal Housing Finance Agency, 400 Seventh Street SW, Eighth Floor, Washington, DC 20219, or [email protected] The telephone number for the Telecommunications Device for the Deaf is (800) 877-8339.

SUPPLEMENTARY INFORMATION:

I. Background and the Interim Final Rule

The FOIA Improvement Act of 2016, Public Law 114-185, 130 Stat. 538 (June 30, 2016) (Act), amended the FOIA, 5 U.S.C. 552, and required agencies to review their FOIA regulations and issue certain amendments by December 27, 2016. On March 15, 2017, FHFA published an interim final rule to revise its FOIA regulation at 12 CFR part 1202 to incorporate changes made to the FOIA by the Act, and to make general updates to the regulation. See 82 FR 13743 (Mar. 15, 2017). The primary changes to the FOIA made by the Act include codifying the foreseeable harm standard when making a determination whether to release agency records under Exemption 5; notifying requesters of the availability of dispute resolutions services at various times throughout the FOIA process; providing a minimum of 90 days for requesters to file an administrative appeal; incorporating the new statutory restrictions on charging fees in certain circumstances, and reflecting recent developments in the case law.

The interim final rule also made general updates to the regulation to remove the FHFA-OIG individual component procedures from the body of FHFA's regulation, adding them to the newly created appendices, as well as to make clarifying technical revisions to the regulation.

The interim final rule became effective on March 15, 2017. FHFA accepted public comments, however, until May 15, 2017. This final rule finalizes the interim final rule with minor revisions for consistency and clarification.

II. Summary of Public Comments and Final Rule

The Federal Housing Finance Agency received four public comments on the interim final rule, including comments from two Federal agencies, the National Archives and Records Administration (NARA) and the Department of Justice. FHFA has given consideration to each of the comments received and has made several modifications that will be adopted in the final rule. Discussion of each of the comments and FHFA's response follows.

General Comments

One commenter suggested that FHFA's interim final rule is “fairly vague” without providing further comments. FHFA disagrees. FHFA's interim final rule incorporates the requirements of the FOIA Improvement Act of 2016 as well as clarifies and updates its existing FOIA regulation. As such, no changes will be made in the final rule other than those described below.

One commenter asked, “who declares an `unusual circumstance,' and how does he/she do so?” The commenter also stated that, “every agency is busy, and we cannot simply allow for such an extension with the potential for abuse.” Because the circumstance in which an agency can invoke “unusual circumstance” is adequately covered in § 1202.7(g) and is in line with the FOIA, FHFA declines to address this comment.

Section 1202.2—What do the terms in this regulation mean?

One commenter suggested that the “discretionary release” definition is not necessary and that it could create confusion with the foreseeable harm standard. FHFA agrees and has removed this definition from the final rule.

One commenter suggested that, under the definition of “Direct costs,” the words “federal records center” or “records center” should be added to the NARA reference to prevent confusion in regards to the two types of records handled by NARA. FHFA has determined that including “federal records center” would be helpful. As such, FHFA has included this reference in the definition in the final rule.

Section 1202.4—What information is exempt from disclosure?

One commenter suggested that § 1202.4(b) should be removed because the FOIA exemptions are inherently discretionary. FHFA agrees and has removed this section from the final rule.

One commenter suggested that § 1202.4(d) should be removed or revised to include a statement on how a Vaughn index is not required during the administrative stage of processing a request. FHFA agrees and has revised this section in the final rule to state that a Vaughn index will not be provided during the administrative stage.

One commenter stated that § 1202.4(e) is “not necessary because it simply restates the statutory provision.” FHFA agrees and has removed this section from the final rule.

Section 1202.5—How do I request information from FHFA under the FOIA?

One commenter suggested that § 1202.5(f) should be revised to “may state in what form or format . . .” because requiring a requester to state a format is unnecessary. FHFA agrees and has revised this section in the final rule.

One commenter raised concern with § 1202.5(g), which provides that all requesters agree to pay fees up to $100.00. The commenter suggested that this section should be revised to ask the requester to specify an amount, if any, that they are willing to pay but not require them to agree to pay fees up front. The commenter also suggested that FHFA add language to this section indicating that the Agency will notify requesters of any fees above $25. To conform to OMB Guidelines, FHFA agrees and has revised this section in the final rule to include the suggested language. FHFA has also revised the regulation text for clarity.

Section 1202.6—What if my request does not have all the information FHFA requires?

One commenter suggested that “overly broad, unduly burdensome to process” should be removed. The commenter states that both are covered under “does not reasonably describe the records you seek.” The commenter also suggested that “tolling” should be removed because it suggests that the clock has started when in fact it has not started for unperfected request. FHFA agrees and has removed “overly broad, unduly burdensome to process” from the final rule. FHFA has also revised the regulation text for clarity.

One commenter suggested that the deadline for clarification is short and should be extended from 15 calendar days to 30 days. Given the fact that most clarification requests are transmitted electronically, FHFA believes that 15 calendar days gives a requester sufficient time to respond. Therefore, FHFA declines to make the suggested change in the final rule.

One commenter raised concern that the wording in § 1202.6(b) could confuse a requester. The commenter suggested removing “or if the additional information you provide is still incomplete or insufficient” as not to confuse the requester that their request was withdrawn when in fact the request was closed. FHFA understands how this may be confusing and has revised this section in the final rule to replace “withdrawn” with “closed.”

Section 1202.7—How will FHFA respond to my FOIA request?

One commenter suggested changing the search cut-off date in § 1202.7(b) from the “date of the FOIA request” to “date of the search.” FHFA declines to make the suggested change in the final rule. Using the date of the FOIA request as the cut-off date provides clarity to requesters. Further, since FHFA receives a small number of FOIA request in a given year, the timeframe from when a request is received and when a search is conducted is, in most cases, within days apart and therefore there is little to no impact on the search results.

One commenter suggested revising § 1202.7(d) to reference “records” that are being referred instead of “requests.” FHFA agrees and has revised this section in the final rule to indicate that records are being referred not the FOIA request.

One commenter suggested that language should be added addressing consultations with other agencies. FHFA agrees and has included a provision with the suggested language under § 1202.7 in the final rule.

One commenter suggested that the specific tracks in § 1202.7(g) should be deleted and that unusual circumstances should only be discussed in general terms, noting that the requirement of unusual circumstances applies regardless of the track. FHFA agrees and has removed the specific track reference from this section in the final rule.

Two commenters suggested that a reference should be added about notifying a requester of the availability of the Office of Government Information Services (OGIS) for dispute resolutions services when notice is given that a request will take longer than 30 days. FHFA agrees and has included an OGIS reference in this section in the final rule.

Section 1202.8—If the requested records contain confidential commercial information, what procedures will FHA follow?

One commenter suggested revising § 1202.8(d)(1) to remove “confidential” since at this point it may not be clear whether the information is confidential. FHFA agrees and has revised this section in the final rule to remove “confidential.”

One commenter suggested that language from Executive Order 12600 is missing at § 1202.8(e)(4). FHFA agrees and has revised this section in the final rule to include “unless the agency has substantial reason to believe that disclosure of the information would result in competitive harm.”

Section 1202.9—How do I appeal a response denying my FOIA request?

One commenter suggested that the last sentence of § 1202.9(e) be removed because there is no legal grounds to prevent a requester from filing a lawsuit. FHFA agrees and has removed the last sentence of this section in the final rule.

One commenter suggested that, in § 1202.9(g), in order to help clarify for requesters that they may engage in various types of dispute resolution approaches to resolve disputes, that the description of OGIS services should be changed from “mediation services to resolve FOIA disputes” to “services to resolve FOIA disputes.” FHFA agrees and has revised this section in the final rule.

It has also been suggested that the last sentence in § 1202.9(g) be removed because the phrase “mediation decision” may confuse a requesters on the role of OGIS. FHFA agrees and has removed the last sentence of this section in the final rule.

Section 1202.10—Will FHFA expedite my request or appeal?

One commenter suggested revising § 1202.10(c) by changing “10 days” to “10 calendar days.” FHFA agrees with the commenter. Ten calendar days conforms to OMB guidelines; therefore, FHFA has revised this section in the final rule.

Section 1202.11—What will it cost to get the records I requested?

One commenter suggested revising § 1202.11(d) to include notification to requesters if fees exceed $25. To conform to OMB guidelines, FHFA agrees and has included a statement regarding fee notifications in this section in the final rule. This statement has also be included in § 1202.5(g).

Section 1202.11(e) would allow FHFA to request advance payment if fees are likely to exceed a certain amount and if a requester has a history of not paying. One commenter suggested that this section was unclear. FHFA agrees and has revised the final rule to make clear in what instance it would require advance payment.

Finally, in keeping in line with OMB's most recent guidelines, FHFA has updated § 1202.11(h) and (j) of the final rule.

III. Regulatory Impacts Paperwork Reduction Act

This final regulation does not contain any information collection requirement that requires the approval of OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires that a regulation that has a significant economic impact on a substantial number of small entities, small businesses, or small organizations must include an initial regulatory flexibility analysis describing the regulation's impact on small entities. Such an analysis need not be undertaken if the agency has certified that the regulation does not have a significant economic impact on a substantial number of small entities (5 U.S.C. 605(b)). FHFA has considered the impact of this final regulation under the Regulatory Flexibility Act. FHFA certifies that the regulation is not likely to have a significant economic impact on a substantial number of small business entities because the regulation is applicable only to the internal operations and legal obligations of FHFA.

List of Subjects in 12 CFR Part 1202

Appeals, Confidential commercial information, Disclosure, Exemptions, Fees, Final action, Freedom of Information Act, Judicial review, Records, Requests.

Authority and Issuance

Accordingly, for the reasons stated in the Preamble, the Interim Final Rule published at 82 FR 13743 on March 15, 2017 is adopted as a final rule with the following changes:

PART 1202—FREEDOM OF INFORMATION ACT 1. The authority citation for part 1202 continues to read as follows: Authority:

Pub. L. 110-289, 122 Stat. 2654; 5 U.S.C. 301, 552; 12 U.S.C. 4526; E.O. 12600, 52 FR 23781, 3 CFR, 1987 Comp., p. 235; E.O. 13392, 70 FR 75373-75377, 3 CFR, 2006 Comp., p. 216-200.

§ 1202.2 [Amended]
2. Amend § 1202.2 by: a. Removing the definition of “Discretionary release”; b. Adding the words “at a Federal records center operated by the” before the word “National” in the definition of “Direct costs”; and

c. Adding a definition for “Vaughn index” in alphabetical order.

The addition reads as follows:

§ 1202.2 What do the terms in this regulation mean?

Vaughn index means an itemized index, used in litigation, correlating each withheld document (or portion) with a specific FOIA exemption and the relevant part of the agency's nondisclosure justification.

§ 1202.4 [Amended]
3. Amend § 1202.4 by: a. Removing paragraph (b); b. Redesignating paragraphs (c) and (d) as paragraphs (b) and (c) respectively; c. Revising newly redesignated paragraphs (b) and (c); and d. Removing paragraph (e).

The revisions read as follows:

§ 1202.4 What information is exempt from disclosure?

(b) Redacted portion. If a requested record contains exempt information and information that can be disclosed and the portions can reasonably be segregated from each other, the disclosable portion of the record will be released to the requester after FHFA redacts the exempt portions. If it is technically feasible, FHFA will indicate the amount of the information redacted at the place in the record where the redaction is made and include a notation identifying the exemption that was applied, unless including that indication would harm an interest protected by an exemption.

(c) Exempt and redacted material. FHFA is not required to and will not provide a Vaughn index during the administrative stage of processing your FOIA request.

4. Amend § 1202.5 by revising paragraphs (f) and (g) to read as follows:
§ 1202.5 How do I request information from FHFA under the FOIA?

(f) How you want the records produced to you. Your request may state in what form or format you want FHFA to furnish the releasable records, e.g., hardcopy, or electronic.

(g) Agreement to pay fees. In your FOIA request you must acknowledge that you are aware of the applicable fees charged under § 1202.11, and specify an amount, if any, you are willing to pay without consultation. Your inability to pay a fee does not justify granting a fee waiver. The fact that FHFA withholds all responsive documents or does not locate any documents responsive to your request, does not mean that you are not responsible for paying applicable fees. Your FOIA request will not be considered received by FHFA until your acknowledgement of the applicable fees, in writing, is received. FHFA will notify a requester of any fees above $25.00.

5. Amend § 1202.6 by revising the introductory text and paragraph (b) to read as follows:
§ 1202.6 What if my request does not have all the information FHFA requires?

If FHFA determines that your request does not reasonably describe the records you seek, cannot be processed for reasons related to fees, or lacks required information, you will be informed in writing why your request cannot be processed. You will be given 15 calendar days to meet all requirements. If you are notified that your request cannot be processed for the reasons cited herein, your request will be placed on hold and will not be considered as being received by FHFA for the purpose of processing your request under this part.

(b) If you do not respond or provide additional information within the time period allowed, or if the additional information you provide is still incomplete or insufficient, FHFA will consider your request closed and will notify you that it will not be processed.

§ 1202.7 [Amended]
6. Amend § 1202.7 by: a. Removing the reference “paragraph (g)” and adding in its place the reference “paragraph (h)” in paragraphs (c) introductory text and (c)(1); b. Revising paragraph (d); c. Redesignating paragraphs (e), (f), and (g) as paragraphs (f), (g), and (h) respectively; d. Adding new paragraph (e); e. Removing the words “Standard Track” and adding in their place the word “statutory” in newly redesignated paragraph (h)(1) introductory text; and f. Revising newly redesignated paragraphs (f)(2) and (h)(2).

The revisions and addition read as follows:

§ 1202.7 How will FHFA respond to my FOIA request?

(d) Referrals to other agencies. If you submit a FOIA request that seeks records originating in another Federal Government agency, FHFA will refer those records, as applicable, to the other agency for a direct response. FHFA will provide you notice of the referral, what records were referred, and the name of the other agency and relevant contact information.

(e) Consultation with other agencies. When records originate with FHFA, but contain within them information of interest to another agency, FHFA will consult with the other agency(ies) prior to making a determination on your request.

(f) * * *

(2) Requests that are denied, or granted and denied in part. If FHFA denies your request in whole or in part because a requested record does not exist or cannot be located, is not readily reproducible in the form or format you sought, is not subject to the FOIA, or is exempt from disclosure, the written response will include the requested releasable records, if any, the amount of any fees charged, the reasons for denial, and a notice and description of your right to file an administrative appeal under § 1202.9. FHFA will not provide you with a Vaughn index during the administrative stage of processing your request.

(h) * * *

(2) When a request requires more than 30 days to process, FHFA will make available its FOIA Public Liaison or other FOIA contact to assist you in modifying or reformulating your request. If the request cannot be modified or reformulated, FHFA will notify you regarding an alternative time period for processing the request. FHFA will also notify you of the availability of the Office of Government Information Services to provide dispute resolution service.

7. Amend § 1202.8 by revising paragraphs (d)(1) and (e)(4) to read as follows:
§ 1202.8 If the requested records contain confidential commercial information, what procedures will FHFA follow?

(d) * * *

(1) A description of the commercial information requested or copies of the records or portions thereof containing the business information; and

(e) * * *

(4) The information requested is not designated by the submitter as confidential commercial information pursuant to this section, unless the agency has substantial reason to believe that disclosure of the information would result in competitive harm; or

8. Amend § 1202.9 by revising paragraphs (e) and (g) to read as follows:
§ 1202.9 How do I appeal a response denying my FOIA request?

(e) Notice of delayed determinations on appeal. If FHFA cannot send a final determination on your appeal within the 20-day time limit, the designated component Appeals Officer will continue to process the appeal and upon expiration of the time limit, will inform you of the reason(s) for the delay and the date on which a determination may be expected.

(g) Additional resource. To aid the requester, the FOIA Public Liaison is available and will assist in the resolution of any disputes. Also, the National Archives and Records Administration (NARA), Office of Government Information Services (OGIS) offers non-compulsory, non-binding services to resolve FOIA disputes. If you need information regarding the OGIS and/or the services it offers, please contact OGIS directly at Office of Government Information Services, National Archives and Records Administration, 8601 Adelphi Road-OGIS, College Park, MD 20740-6001; email: [email protected]; phone: (202) 741-5770; toll-free: 1 (877) 684-6448; or facsimile at (202) 741-5769. This information is provided as a public service only.

§ 1202.10 [Amended]
9. Amend § 1202.10 in paragraph (c) by adding the word “calendar” after the number “10”. 10. Amend § 1202.11 by revising paragraphs (d), (e), (h), (i), (j), and (k) to read as follows:
§ 1202.11 What will it cost to get the records I requested?

(d) Notice of anticipated fees in excess of $25.00. When FHFA determines or estimates that the fees chargeable to you will exceed $25.00, you will be notified of the actual or estimated amount of fees you will incur, unless you earlier indicated your willingness to pay fees as high as those anticipated. When you are notified that the actual or estimated fees exceed $25.00, your request will be tolled until you agree to pay, in writing, the anticipated total fee.

(e) Advance payment of fees. FHFA may request that you pay estimated fees or a deposit in advance of responding to your request. If FHFA requests advance payment or a deposit, your request will be tolled by FHFA until the advance payment or deposit is received. FHFA may request advance payment or a deposit if—

(1) The fees are likely to exceed $250.00;

(2) You do not have a history of payment;

(3) You previously failed to pay a FOIA fee to FHFA in a timely fashion, i.e., within 30 calendar days of the date of a billing; or

(4) You have an outstanding balance due from a prior request. FHFA will require you to pay the full amount owed plus any applicable interest, as provided in paragraph (f) of this section, or demonstrate that the fee owed has been paid, as well as payment of the full amount of anticipated fees before processing your request.

(h) Fee waiver requests. You may request a fee waiver in accordance with the FOIA and this regulation. Requests for a waiver of fees must be made in writing and should be made at the time you submit your FOIA request. However, your fee waiver may be submitted at a later time so long as the underlying record request is pending or on administrative appeal. FHFA may grant your fee waiver request or a reduction of fees if disclosure of the information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the Federal Government and is not primarily in your commercial interest. In submitting a fee waiver request, you must address the following six factors—

(1) Whether the subject of the requested records concerns the operations or activities of the Federal Government. The subject of the request must concern identifiable operations or activities of the Federal Government with a connection that is direct and clear, not remote or attenuated;

(2) Whether the disclosure is likely to contribute significantly to the public understanding of Federal Government operations or activities. This factor is satisfied when the following criteria are met:

(i) Disclosure of the requested information must be meaningfully informative about government operations or activities. The disclosure of information that already is in the public domain, in either the same or a substantially identical form, would not be meaningfully informative if nothing new would be added to the public's understanding; and

(ii) The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to your individual understanding. Your expertise in the subject area as well as your ability and intention to effectively convey information to the public must be considered. FHFA will presume that a representative of the news media will satisfy this consideration.

(3) The disclosure must not be primarily in your commercial interest. To determine whether disclosure of the requested information is primarily in your commercial interest FHFA will consider the following criteria:

(i) FHFA will determine whether you have any commercial interest that would be furthered by the requested disclosure. A commercial interest includes any commercial, trade, or profit interest. You will be given an opportunity to provide explanatory information regarding this consideration; and

(ii) If there is an identified commercial interest, FHFA will determine whether that is the primary interest furthered by the request.

(i) Fee Waiver determination. FHFA will notify you within 20 days of receipt of your request whether the fee waiver has been granted. Where only some of the records to be released satisfy the requirements for a waiver of fees, a waiver will be granted for those records. For those records that do not satisfy the requirements for a waiver of fees, you may be charged for those records. When you have committed to pay fees and subsequently ask for a waiver of those fees and that waiver is denied, you must pay any costs incurred up to the date the fee waiver request was received. A request for fee waiver that is denied may only be appealed when a final decision has been made on the initial FOIA request.

(j) Restrictions on charging fees. (1) When FHFA determines that you are an educational institution, non-commercial scientific institution, or representative of the news media, and the records are not sought for commercial use, FHFA will not charge search fees.

(2)(i) If FHFA fails to comply with the FOIA's time limits in which to respond to your request, FHFA will not charge search fees, or, in the instances of requests from requesters described in paragraph (j)(1) of this section, will not charge duplication fees, except as described in paragraphs (j)(2)(ii) through (iv) of this section.

(ii) If FHFA has determined that unusual circumstances as defined by the FOIA apply and FHFA has provided timely written notice to you in accordance with the FOIA, FHFA's failure to comply with the time limit will be excused for an additional 10 days.

(iii) If FHFA determines that unusual circumstances, as defined by the FOIA, apply and more than 5,000 pages are necessary to respond to your request, FHFA may charge search fees, or, in the case of a requester described in paragraph (j)(1) of this section, may charge duplication fees, if the following steps are taken. FHFA must have provided timely written notice of unusual circumstances to you in accordance with the FOIA and FHFA must have discussed with you via written mail, email, or telephone (or made not less than three good-faith attempts to do so) how you could effectively limit the scope of your request in accordance with 5 U.S.C. 552(a)(6)(B)(ii). If this exception is satisfied, FHFA may charge all applicable fees incurred in the processing of the request.

(iv) If a court has determined that exceptional circumstances exist, as defined by the FOIA, a failure to comply with the time limits shall be excused for the length of time provided by the court order.

(3) No search or review fees will be charged for a quarter-hour period unless more than half of that period is required for search or review.

(4) If you seek records for a commercial use, FHFA will provide without charge:

(i) The first 100 pages of duplication (or the cost equivalent for other media); and

(ii) The first two hours of search.

(5) No fee will be charged when the total fee, after deducting the 100 free pages (or its cost equivalent) and the first two hours of search, is equal to or less than $25.00.

(k) Additional resource. The FOIA Public Liaison or other FOIA contact is available to assist you in modifying or reformulating a request to meet your needs at a lower cost. FHFA will also notify you of the availability of OGIS to provide dispute resolution service.

Appendix A to Part 1202 [Amended] 11. Amend Appendix A to Part 1202: a. In paragraph 2 by adding the word “only” after the word “Headquarters” and adding the language “on FHFA's public website” after the word “located”; and b. In paragraphs 3 and 4 by removing the comma before the website hyperlink text and adding in its place “. You can find additional information on FHFA's FOIA program at”. Dated: January 30, 2018. Melvin L. Watt, Director, Federal Housing Finance Agency.
[FR Doc. 2018-02338 Filed 2-8-18; 8:45 am] BILLING CODE 8070-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-0630; Product Identifier 2017-NM-058-AD; Amendment 39-19173; AD 2018-02-20] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 777-200, -200LR, -300, and -300ER series airplanes. This AD was prompted by reports of corrosion in the aft fuselage. This AD requires a one-time review of the operator's maintenance procedures, repetitive detailed internal and external inspections for corrosion or cracking, and applicable on-condition actions. This AD also includes an optional terminating action for the inspections. We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD is effective March 16, 2018.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of March 16, 2018.

ADDRESSES:

For service information identified in this final rule, 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-2017-0630.

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-2017-0630; 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 final rule, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Eric Lin, Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 1601 Lind Avenue SW, Renton, WA 98057-3356; phone: 425-917-6412; fax: 425-917-6590; 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 certain The Boeing Company Model 777-200, -200LR, -300, and -300ER series airplanes. The NPRM published in the Federal Register on July 14, 2017 (82 FR 32507). The NPRM was prompted by reports of corrosion in the aft fuselage. The NPRM proposed to require a one-time review of the operator's maintenance procedures, repetitive detailed internal and external inspections for corrosion or cracking, and applicable on-condition actions. The NPRM also included an optional terminating action for the inspections.

We are issuing this AD to detect and correct untreated vacuum waste system spills or leaks, which could cause corrosion of the airplane structure, which could lead to fatigue cracks, and could ultimately result in rapid decompression and loss of structural integrity.

Comments

We gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.

Support for the NPRM

Boeing expressed its support for the NPRM.

Request To Extend the Inspection Compliance Time

Cathay Pacific expressed concern that it would not be able to demonstrate that it has performed an acceptable records review, which is required to demonstrate that all prior vacuum waste system spills or leaks were cleaned and neutralized using the acceptable procedure. Cathay Pacific noted that some airplanes in its fleet have been in service for more than 20 years, so an older record could easily be missed when doing this review. Cathay Pacific stated that because of this concern, it has opted to treat all airplanes as having inadequate records and perform inspections on them. Cathay Pacific stated that the applicable inspection compliance times do not allow waiting for the next scheduled maintenance check, leading to additional downtime.

We infer that Cathay Pacific is requesting that we extend the compliance time for the initial and repetitive inspections. We disagree with the commenter's request. We have determined that the compliance times specified in this AD are necessary to address the identified unsafe condition. However, under the provisions of paragraph (j) of this AD, we will consider requests for approval of an alternative method of compliance (AMOC), including extension of the compliance times, if sufficient data is submitted to substantiate that a different compliance time will provide an acceptable level of safety. We have not changed this AD in this regard.

Request To Extend the Compliance Times for Certain Airplanes

United Airlines (UAL) and Air France (AF) requested that we revise the compliance times for airplanes on which certain inspections have been done. UAL requested that the compliance time be extended for airplanes on which corrosion prevention and control program (CPCP) inspections have already been done. UAL noted that many operators have proven corrosion control programs that do not have corrosion findings greater than CPCP level 1, which mitigates the corrosion risk factor. UAL suggested that the initial inspection compliance time be extended for airplanes on which maintenance records show that no corrosion findings greater than CPCP level 1 have occurred in the inspection area in the 10 years prior to the effective date of the AD.

AF requested that the compliance times be extended for airplanes on which maintenance planning document (MPD) inspections have been done. AF noted that existing MPD items require general visual inspections of certain areas below the aft and bulk cargo compartment floor panels. AF stated that because the majority of its fleet has already been inspected under the MPD items, the compliance times in the NPRM are too restrictive. AF noted that the initial compliance times cannot be accommodated into its 777 C or heavy checks interval. AF suggested compliance times based on the number of days since the date of issuance of the original airworthiness certificate or date of issuance of the original export certificate of airworthiness instead of days after the effective date of the AD as specified in the proposed AD.

We disagree with the commenters' requests to extend the compliance times. The CPCP has three different levels of corrosion damage, as defined within the MPD, based on the severity and frequency of corrosion findings and requires operators to adjust their individual programs to limit corrosion findings to level 1 if they have level 2 or higher findings. However, operators have reported finding recurring corrosion damage in-between scheduled CPCP or MPD inspections that was due to untreated vacuum waste system residue. Additionally, we have reviewed the existing MPD inspections and have determined that the MPD inspections do not repeat at adequate intervals to address the unsafe condition. The determinations of the unsafe condition, mitigating actions, and compliance times were coordinated with the manufacturer. Under the provisions of paragraph (j) of this AD, we will consider requests for approval of AMOCs, including extensions of the compliance times, if sufficient data, such as an operator's individual CPCP and practices for treating vacuum waste system residue, is submitted to substantiate that a different compliance time will provide an acceptable level of safety. We have not changed this AD in this regard.

Request To Allow the Use of a Different Sodium Bicarbonate Compound

Japan Airlines (JAL) and AF requested that we revise the NPRM to allow the use of a different sodium bicarbonate compound than the ASTM D928 specified in Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017. JAL noted it had difficulty finding the specified sodium bicarbonate compound, but could find an equivalent product. AF noted that is has a corresponding product.

We partially agree with the commenters' request. We agree that an equivalent sodium bicarbonate compound is acceptable. Boeing has issued Boeing Information Notice 777-53A0083 IN 01, dated September 1, 2017, to clarify that a commercially available sodium bicarbonate compound is acceptable for compliance. However, we do not agree to revise this AD because it does not require the use of ASTM D928 sodium bicarbonate compound. As indicated in the Accomplishment Instructions and Figure 2 of Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017, sodium bicarbonate must be used, but a specific compound type is not identified.

Request To Define a Neutral pH

American Airlines (AAL) requested that we revise the NPRM to define a neutral pH as one that has a value between 6.5 and 8.5, to account for natural variations in tap water. AAL stated that the NPRM does not define a tolerance from the common definition of neutral pH, which is a pH of 7.

We disagree with the commenter's request. Paragraph 3.A., General Information, Note 19, of Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017, defines neutralization as making the vacuum waste system spill or leak contents non-acidic or non-corrosive. No specific pH value is defined in the service information or required by this AD. Therefore, operators can include tolerances for a neutral pH. One way for operators to account for pH variances of their local clean water supply is to measure the pH level of their clean water supply in order to establish a baseline pH level, that can then be used to compare against samples taken from the fuselage structure. We have not changed this AD in this regard.

Request To Define a Standard Litmus Paper

AAL and Cathay Pacific requested that we revise the NPRM to define a standard part number for the litmus paper to use in determining if the acid is neutralized. AAL noted that the NPRM does not specify a resolution or range for the litmus paper. Cathay Pacific claimed that because Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017, does not list a specific litmus paper, the instruction to “use litmus paper” is ambiguous and operators would not be able to determine if an acceptable litmus paper is used.

We disagree with the commenters' request. Litmus paper is a commonly available tool. Accomplishing the cleaning and neutralization steps in Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017, does not specify the use of a specific brand or type of litmus paper. We have not changed this AD in this regard.

Request To Define the Location and Quantity of Litmus Paper Testing Points

AAL and Cathay Pacific requested that we revise the NPRM to define the locations where litmus paper testing must be done, as well as the number of samples that must be taken. AAL pointed out that the structural features that must be chemically neutralized are specified in Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017, while the litmus paper testing spots are not. Cathay Pacific suggested that Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017, implies that operators should do litmus paper testing on all the structural features in the inspection and neutralization area, but stated it does not believe this is the intent.

We agree to provide clarification on the number and location of litmus paper testing spots and confirm that paragraph (i) of this AD does not require testing with litmus paper at all structural features in the neutralization area. However, we do not agree that it is necessary to provide a specific number of samples or testing locations. The objective of the litmus paper testing is to verify that there are no remaining acidic or corrosive substances on the structure. The appropriate level of testing may vary between airplanes depending on factors such as maintenance records, previous spills or leaks, or repairs that obstruct access. Samples should be tested at enough locations within the affected area of the structure for the operator to determine that there are no residual acidic or corrosive contents on primary structural elements in the inspection area, including any locations where the sodium bicarbonate solution visibly reacted when applied, which indicates the presence of acidic or corrosive substances, and any locations where there are signs of corrosion damage. We have not changed this AD in this regard.

Request To Allow the Use of Alternative Corrosion Inhibiting Compounds

AAL requested that we allow the use of alternative corrosion inhibiting compounds (which are applied to the cleaned and neutralized areas as part of the required restoration) as specified in Boeing Aircraft Maintenance Manual (AMM) Task 51-05-01-210-803. AAL noted that Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017, specifies BMS3-29 compound and does not allow the use of alternative compounds.

We agree with the commenter's request. Boeing AMM Task 51-05-01-210-803 specifies the application of a single coat of water displacing/anti-corrosion compound BMS3-29 or BMS3-35 at a minimum, with an option to layer different compounds in areas with high potential for severe corrosion. We have added paragraph (h)(3) of this AD to specify acceptable alternative corrosion inhibiting compounds.

Request To Update the Costs of Compliance

Cathay Pacific requested that we update the work-hours estimate for cleaning and neutralization in the NPRM. Cathay Pacific stated that the area to be neutralized covers 13 frames and 15 stringers, so it will require more work-hours to complete this task.

We disagree with the commenter's request. The work-hours estimate is determined by Boeing and provided for informational and planning purposes only. In addition, Cathay Pacific did not provide any alternative estimates for the work-hours. We have not changed this AD in this regard.

Conclusion

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

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

Related Service Information Under 1 CFR Part 51

We reviewed Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017. The service information describes procedures for a one-time review of the operator's maintenance procedures, repetitive detailed internal and external inspections for corrosion or cracking, cleaning and neutralization of the internal inspection area (an optional terminating action), and applicable on-condition actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

We estimate that this AD affects 161 airplanes of U.S. registry. The cost to review an operator's maintenance procedures varies depending on the operator's recordkeeping system and fleet size so we did not include a specific estimate for that action. We estimate the following costs to comply with the remaining actions of this AD:

Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Inspections 75 work-hours × $85 per hour = $6,375 per inspection cycle $0 $6,375 per inspection cycle $1,026,375 per inspection cycle.
    Estimated Costs for Optional Terminating Actions Action Labor cost Parts cost Cost per
  • product
  • Cleaning and neutralization 30 work-hours × $85 per hour = $2,550 $0 $2,550

    We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.

    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 transport category airplanes to the Director of the System Oversight 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 that this AD:

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

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

    (3) Will not affect intrastate aviation in Alaska, 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): 2018-02-20 The Boeing Company: Amendment 39-19173; Docket No. FAA-2017-0630; Product Identifier 2017-NM-058-AD. (a) Effective Date

    This AD is effective March 16, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to The Boeing Company Model 777-200, -200LR, -300, and -300ER series airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017.

    (d) Subject

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

    (e) Unsafe Condition

    This AD was prompted by reports of corrosion in the aft fuselage. We are issuing this AD to detect and correct untreated vacuum waste system spills or leaks, which could cause corrosion of the airplane structure, which could lead to fatigue cracks, and could ultimately result in rapid decompression and loss of structural integrity.

    (f) Compliance

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

    (g) Required Actions

    Except as required by paragraphs (h)(1) through (h)(3) of this AD: At the applicable times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017, do all applicable actions identified as “RC” (required for compliance) in, and in accordance with, the Accomplishment Instructions of Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017.

    (h) Exceptions To Service Information Specifications

    (1) Where Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017, uses the phrase “after the original issue date of this service bulletin,” for purposes of determining compliance with the requirements of this AD, the phrase “after the effective date of this AD” must be used.

    (2) Where Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017, specifies contacting Boeing, and specifies that action as RC: This AD requires using a method approved in accordance with the procedures specified in paragraph (j) of this AD.

    (3) Where Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017, specifies to apply corrosion inhibiting compound BMS3-29 to the cleaned and neutralized area, and specifies that action as RC: This AD allows operators to apply BMS3-29, BMS3-35, or a base coat of BMS3-29 or BMS3-35 with a top coat of BMS3-26.

    (i) Optional Terminating Action for Repetitive Inspections

    Accomplishment of “PART 5: CLEANING AND NEUTRALIZATION,” as specified in the Accomplishment Instructions of Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017, terminates the repetitive inspections required by paragraph (g) of this AD.

    (j) 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 (k) 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) Except as required by paragraphs (h)(2) and (h)(3) of this AD: For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (j)(4)(i) and (j)(4)(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.

    (k) Related Information

    For more information about this AD, contact Eric Lin, Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 1601 Lind Avenue SW, Renton, WA 98057-3356; phone: 425-917-6412; fax: 425-917-6590; email: [email protected]

    (l) Material Incorporated by Reference

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

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

    (i) Boeing Alert Service Bulletin 777-53A0083, dated April 20, 2017.

    (ii) Reserved.

    (3) 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.

    (4) 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.

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

    Issued in Renton, Washington, on January 19, 2018. Michael Kaszycki, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-01807 Filed 2-8-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-0713; Product Identifier 2016-NM-199-AD; Amendment 39-19170; AD 2018-02-17] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    We are superseding Airworthiness Directive (AD) 2012-12-12 and AD 2013-16-26, which applied to all Airbus Model A330-200, A330-200 Freighter, A330-300, A340-200, and A340-300 series airplanes. AD 2012-12-12 required repetitive inspections of the outer skin rivets of the cargo doors, repair if necessary, and other repetitive inspections. AD 2013-16-26 required repetitive inspections of certain cargo doors, and repair if necessary. This new AD continues to require repetitive inspections, and repair if necessary. This new AD revises the applicability; adds a one-time inspection and adjustment of certain hook gaps; reinforcement of the door frame structure; related investigative and corrective actions if necessary; and a modification, which allows deferring reinforcement of the cargo door structure. This AD was prompted by a determination that a new inspection procedure is necessary to address the unsafe condition. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective March 16, 2018. The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of March 16, 2018.

    ADDRESSES:

    For service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email: [email protected]; internet: http://www.airbus.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. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0713.

    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-2017-0713; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (telephone 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Vladimir Ulyanov, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW, Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149.

    SUPPLEMENTARY INFORMATION: Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2012-12-12, Amendment 39-17092 (77 FR 37797, June 25, 2012) (“AD 2012-12-12”); and AD 2013-16-26, Amendment 39-17564 (78 FR 53640, August 30, 2013) (“AD 2013-16-26”). AD 2012-12-12 and AD 2013-16-26 applied to all Airbus Model A330-200 series airplanes, Model A330-200 Freighter series airplanes, Model A330-300 series airplanes, Model A340-200 series airplanes, and Model A340-300 series airplanes. The NPRM published in the Federal Register on August 10, 2017 (82 FR 37360). The NPRM was prompted by a determination that a new inspection procedure is necessary to address the unsafe condition. The NPRM proposed to continue to require repetitive inspections, and repair if necessary. The NPRM also proposed to add a one-time inspection and adjustment of certain hook gaps; reinforcement of the door frame structure; related investigative and corrective actions if necessary; and a modification, which would allow deferring reinforcement of the cargo door structure. We are issuing this AD to detect and correct cracked or ruptured cargo door frames, which could result in reduced structural integrity of the forward or aft cargo door.

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2016-0188, dated September 21, 2016; corrected September 22, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”); to correct an unsafe condition for certain Airbus Model A330-200 and -300 series airplanes; Model A330-200 Freighter series airplanes; and Model A340-200, -300, -500, and -600 series airplanes. The MCAI states:

    Several cases of cracked forward (FWD) and aft (AFT) cargo door frames, as well as loose, lost, or sheared rivets, have been reported by operators. Investigation showed that these findings are due to the low margins with respect to fatigue requirements for the AFT/FWD cargo door internal structure. Further analysis determined that the cargo door hook adjustment is a contributing factor to this issue. In case of a cracked or ruptured (FWD or AFT) cargo door frame, the loads will be transferred to the remaining structural elements. However, the secondary load path is able to sustain those loads only for a limited number of flight cycles (FC).

    This condition, if not detected and corrected, could lead to rupture of adjacent vertical frames and consequent reduced structural integrity of the FWD or AFT cargo door, possibly resulting in a cargo door failure, decompression of the aeroplane and injury to occupants.

    To initially address this potential unsafe condition, Airbus issued Service Bulletin (SB) A330-52-3043 and SB A340-52-4053 and, consequently, DGAC [Direction Générale de l'Aviation Civile] France issued AD 2001-124(B) and AD 2001-126(B), requiring a special detailed inspection of A330 and A340 AFT cargo doors. Since those [DGAC] ADs were issued, prompted by new occurrences, Airbus issued Alert Operators Transmission (AOT) A330-52A3085, AOT A340-52A4092, AOT A330-52A3084, AOT A340-52A4091, AOT A330-A52L003-12, AOT 340-A52L004-12, AOT A330-A52L001-12 and AOT A340-A52L002-12, providing instructions to inspect the affected areas of both FWD and AFT cargo doors.

    Consequently, EASA issued AD 2011-0007 (later revised) [which corresponds to FAA AD 2012-12-12], and AD 2012-0274 [which corresponds to FAA AD 2013-16-26], to require repetitive detailed visual inspections of AFT and FWD cargo doors at specific frames and outer skin at all frame fork ends. Since these EASA ADs were issued, Airbus published SB A330-52-3087, SB A330-52-3095, SB A340-52-4095, SB A340-52-4101, SB A340-52-5020 and SB A340-52-5023, which took over the instructions of the above mentioned AOTs, and introduced revised thresholds and intervals. In addition, the inspection program was expanded to A340-500/-600 aeroplanes. Taking into account experience from inspections accomplished in accordance with the applicable Airbus SBs at original issue (listed above), Airbus issued Revision 01 of these SBs.

    Consequently, EASA issued AD 2015-0192, which superseded EASA AD 2011-0007R1 and EASA AD 2012-0274, to require for each FWD and AFT cargo door, a one-time inspection/adjustment of the hook gaps “U” and “V”, repetitive detailed inspections (DET) of all frame fork areas, frame head areas and outer skin areas to detect cracks or loose/sheared/missing fasteners, and, depending on findings, accomplishment of applicable corrective action(s). In addition, EASA AD 2015-0192 expanded the Applicability to Airbus A340-500/-600 aeroplanes.

    Since EASA AD 2015-0192 was issued, Airbus published Revision 02 of the inspection SBs, introducing high-frequency eddy-current inspection method for the frame forks structure. Airbus also determined that the interval for these repetitive inspections could be increased. In addition, Airbus released some modifications (mod) introducing reinforcements to the cargo door structure improving the fatigue characteristics. These modifications and associated SBs constitute terminating action for the required repetitive inspections. Furthermore, Airbus also published other SBs, introducing cold working after oversizing of the fastener holes as a means for structural reinforcement. Accomplishment of these SBs allows postponement of the required Point of Embodiment (Structural Modification Point) for the structural reinforcement modification SBs which terminate the repetitive inspection requirement.

    For the reasons described above, this [EASA] AD partially retains the requirements of EASA AD 2015-0192, which is superseded, and requires for each FWD and AFT cargo door initial and repetitive special detailed inspections (SDI) of all frame fork areas and detailed inspections (DET) of frame head areas and outer skin areas, and a one-time inspection/adjustment of the hook gaps “U” and “V” and, depending on findings, the accomplishment of applicable corrective action(s). Additionally, this [EASA] AD requires reinforcement of the cargo door frame structure, while accomplishment of a cold working modification allows to defer the reinforcement of the cargo door structure.

    It should be noted that additional inspections exist for the cargo doors, as specified in Airbus A330 ALS [Airworthiness Limitation Section] Part 2 task 523211-02-01 and task 523211-02-02, and in Airbus A340 ALS Part 2 Task 523211-02-01.

    This [EASA] AD is re-published to correct typographical errors when referencing Airbus SB A340-52-4118.

    Related investigative actions include detailed inspections and high frequency non-destructive test inspections. Corrective actions include reaming holes, bushing holes, replacing affected parts, and repairing cracks. Additional work includes a one-time inspection of the “U” and “V” hook gaps, and, if necessary, an adjustment of the hook gaps.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0713.

    Comments

    We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

    Request To Allow Alternative Fastener

    American Airlines (AAL) asked that we allow use of an alternative fastener when doing repairs of the cargo doors. AAL stated that paragraph (l) of the proposed AD allows credit for aft cargo doors inspected in accordance with Airbus Service Bulletin A330-52-3095, Revision 01, dated July 28, 2014. AAL noted that this service information could not be accomplished due to the non-availability of fasteners having part number “ANSA2657” that are necessary to repair findings in the door beam 1 and 4 areas of the aft cargo door. AAL added that, as a result of this parts issue, Airbus provided Technical Advisory (TA) Reference 80016786/003/2014, Issue 03, for all affected A330 operators, which allows using an alternative HST11 series fastener; Airbus also issued Operators Information Transmission SBIT-15-0085, dated October 9, 2015, to identify this substitution and AALs compliance paperwork was written with this deviation added. AAL asked that this deviation to Airbus Service Bulletin A330-52-3095, Revision 01, dated July 28, 2014, be acceptable for compliance with the proposed AD.

    We agree with the commenter's request for the reasons provided. However, AAL transposed the part number in their comment, the correct part number is ASNA2657. We have added paragraph (s)(5) to this AD to include this exception.

    Request To Revise Terminating Action Requirements

    Delta Airlines (DAL) asked that the terminating actions specified in paragraphs (j), (n), and (o) of the proposed AD be revised. DAL stated that the actions in those paragraphs specify that doing the modification constitutes terminating action for the repetitive inspections. DAL noted that this implies that an operator must do the initial inspection prior to or concurrently with the initial requirements; and if the modification is done prior to the repetitive requirements that action would not comply with the requirements. DAL added that the terminating action should be for both the initial and repetitive inspections.

    We agree with the commenter's request because the intent of the terminating modification is to terminate all inspections. Although the EASA AD also specifies that the terminating action is for repetitive inspections, EASA confirmed that it applies to all inspections. Therefore, we have revised paragraphs (j), (n), and (o) of this AD to include the initial inspection as terminated actions.

    Request To Include a No-Reporting Provision

    DAL asked that a paragraph that specifically addresses that there are no reporting requirements for the inspections be included in the proposed AD. DAL stated that there are reporting instructions within the “RC” (Required for Compliance) Accomplishment Instructions in Airbus Service Bulletin A330-52-3087, Revision 02, including Appendix 01, dated February 18, 2016; and Airbus Service Bulletin A330-52-3095, Revision 02, including Appendices 01 and 02, dated February 19, 2016. DAL noted that operators must request an alternative method of compliance if they deviate from an RC task, so a no-reporting paragraph in the proposed AD would clarify that reporting would not be required by the proposed AD.

    We agree with the commenter's request because the terminating action will eliminate the unsafe condition, so reporting areas of difficulty during accomplishment of the required inspections is not necessary. We have added paragraph (r) to this AD to include a no-reporting requirement, and re-redesignated subsequent paragraphs accordingly.

    Request To Revise Heading

    Delta requested that we revise the heading for paragraph (m) of the proposed AD by removing “For Pre-modified airplanes.” Delta stated that paragraph (m) specifies it pertains to the modification of pre-modified airplanes. Paragraph (n) of the proposed AD specifies that accomplishing (m)(1) or (m)(3) serves as terminating action for pre-modified airplanes. However, for post-modified airplanes, paragraph (o) of the proposed AD states that paragraphs (m)(1)(i) thru (m)(1)(vi) of the proposed AD serve as terminating action—therefore, paragraph (m) serves as terminating for both pre- and modified airplanes. Delta therefore requested that we revise the heading to remove “for pre-modified airplanes”

    We agree to clarify the heading to paragraph (m) of this AD. We acknowledge that the actions for the modification accomplished by the service information in paragraph (m)(l)(i) through (m)(1)(iv) of this AD are terminating actions to the inspections required by paragraph (l)(1) and (l)(2) of this AD when accomplished on a pre- or post-modified airplane. However, the actions for the modification accomplished by the service information in paragraph (m)(1)(i) through (m)(1)(iv) of this AD are optional for post-modified airplanes, whereas, these actions are required for pre-modified airplanes. Furthermore, the requirements of paragraph (m)(2) and (m)(3) of this AD are not applicable to post-modified airplanes. For these reasons, the heading of paragraph (m) of this AD is stated as “Modification for Pre-Modification Airplanes.” We have not changed this AD in this regard.

    Request To Specify Modification Locations

    DAL asked that the word “aft” be included in the header for paragraph (k) of the proposed AD. DAL stated that this would clarify that the actions in that paragraph apply only to the aft cargo door modification. DAL added that it would also align with the headers for paragraphs (k) and (l) of the proposed AD.

    DAL also asked that the word “aft” be added to the first sentence in paragraph (n) of the proposed AD. DAL stated that this would clarify that the actions in that paragraph apply only to pre-modified aft cargo doors.

    In addition, DAL asked that the header for paragraph (n) of the proposed AD be revised from “Aft Cargo Door Terminating Action” to include “pre-modified airplanes” in the header. DAL stated that this would clarify that the requirements in that paragraph apply only to pre-modified aft cargo doors.

    We agree with the commenter's requests to include the word “aft” in the header for paragraph (k) and the first sentence of paragraph (n) of this AD for the reasons provided. We have included the word “aft” in the subject language for clarification.

    We agree to change the header for paragraph (n) of this AD. That header for that paragraph merely gives information about the content of the paragraph. We have changed the header for paragraph (n) of this AD accordingly.

    Request To Provide Credit for Certain Actions

    AAL asked that paragraphs (h)(2) and (l)(2) of the proposed AD be revised to provide credit for previously accomplishing the check of the forward and aft cargo door hook gaps, in accordance with Airbus Service Bulletin A330-52-3087, Revision 01, dated July 9, 2014; or Airbus Service Bulletin A330-52-3095, Revision 01, dated July 28, 2014. AAL stated that it accomplished the check in accordance with the referenced service information.

    We agree with the commenter's request. However, paragraphs (s)(2) and (s)(4) of this AD already provide the requested credit. Therefore, we have not changed this AD in this regard.

    Conclusion

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

    • Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

    • Do not add any additional burden upon the public than was already proposed in the NPRM.

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

    Related Service Information Under 1 CFR Part 51

    Airbus has issued the following service information.

    The following service information describes procedures for inspecting and repairing the frame fork area at beam 4 and frame head area at beam 1 from frame 20B to frame 25 of the forward cargo door, and adjusting the hook gaps “U” and “V.” This service information is distinct since it applies to different airplane models.

    • Service Bulletin A330-52-3087, Revision 02, including Appendix 01, dated February 18, 2016.

    • Service Bulletin A340-52-4095, Revision 02, including Appendix 01, dated November 29, 2015.

    • Service Bulletin A340-52-5020, Revision 02, including Appendices 01 and 02, dated November 27, 2015.

    The following service information describes procedures for modifying the frame fork area at beam 4 and frame head area at beam 1 from frame 20B to frame 25 of the forward cargo door frame. This service information is distinct since it applies to different airplane models and configurations.

    • Service Bulletin A330-52-3105, dated February 24, 2016.

    • Service Bulletin A330-52-3110, dated February 15, 2016.

    • Service Bulletin A330-52-3111, dated February 15, 2016.

    • Service Bulletin A340-52-4108, dated February 15, 2016.

    • Service Bulletin A340-52-4113, dated February 15, 2016.

    • Service Bulletin A340-52-4114, dated February 15, 2016.

    The following service information describes procedures for modifying the fastener holes in the forward cargo door frame structure by cold working and changing the fastener type and size. This service information is distinct since it applies to different airplane models and configurations.

    • Service Bulletin A330-52-3116, dated April 20, 2016.

    • Service Bulletin A330-52-3117, dated April 20, 2016.

    • Service Bulletin A330-52-3118, dated April 20, 2016.

    • Service Bulletin A340-52-4119, dated April 20, 2016.

    • Service Bulletin A340-52-4120, dated April 20, 2016.

    • Service Bulletin A340-52-4121, dated April 20, 2016.

    The following service information describes procedures for inspecting the frame fork area at beam 4 and frame head area at beam 1 of the aft cargo door from frame 60 to frame 64A, adjusting the hook gaps “U” and “V,” and doing corrective actions. This service information is distinct since it applies to different airplane models and configurations.

    • Service Bulletin A330-52-3095, Revision 02, including Appendices 01 and 02, dated February 19, 2016.

    • Service Bulletin A340-52-4101, Revision 02, including Appendices 01 and 02, dated November 27, 2015.

    • Service Bulletin A340-52-5023, Revision 02, including Appendices 01 and 02, dated November 27, 2015.

    The following service information describes procedures for modifying the frame fork and head of the aft cargo door frame from frame 59A to frame 65. This service information is distinct since it applies to different airplane models and configurations.

    • Service Bulletin A330-52-3106, dated February 24, 2016.

    • Service Bulletin A330-52-3112, dated February 24, 2016.

    • Service Bulletin A330-52-3113, dated February 15, 2016.

    • Service Bulletin A330-52-3114, dated February 15, 2016.

    • Service Bulletin A340-52-4109, dated February 25, 2016.

    • Service Bulletin A340-52-4115, dated February 19, 2016.

    The following service information describes procedures for modifying the fastener holes in the aft cargo door frame structure by cold working and changing the fastener type and size. This service information is distinct since it applies to different airplane models.

    • Service Bulletin A330-52-3115, dated April 20, 2016.

    • Service Bulletin A340-52-4118, dated April 20, 2016.

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

    Costs of Compliance

    We estimate that this AD affects 73 airplanes of U.S. registry.

    We estimate that it takes up to 888 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost up to $126,420 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be up to $14,738,700, or up to $201,900 per product.

    We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.

    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 transport category airplanes to the Director of the System Oversight Division.

    Regulatory Findings

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

    For the reasons discussed above, I certify that this AD:

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by: a. Removing Airworthiness Directive (AD) 2012-12-12, Amendment 39-17092 (77 FR 37797, June 25, 2012); and AD 2013-16-26, Amendment 39-17564 (78 FR 53640, August 30, 2013); and b. Adding the following new AD: 2018-02-17 Airbus: Amendment 39-19170; Docket No. FAA-2017-0713; Product Identifier 2016-NM-199-AD. (a) Effective Date

    This AD is effective March 16, 2018.

    (b) Affected ADs

    This AD replaces AD 2012-12-12, Amendment 39-17092 (77 FR 37797, June 25, 2012); and AD 2013-16-26, Amendment 39-17564 (78 FR 53640, August 30, 2013).

    (c) Applicability

    This AD applies to the Airbus airplanes identified in paragraphs (c)(1) and (c)(2) of this AD, certified in any category, all manufacturer serial numbers, except those on which Airbus Modification 202702 and Modification 202790 have been embodied in production; and the Airbus airplanes identified in paragraphs (c)(3) through (c)(5) of this AD, certified in any category, all manufacturer serial numbers.

    (1) Model A330-201, -202, -203, -223, -223F, -243, and -243F airplanes.

    (2) Model A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.

    (3) Model A340-211, -212, and -213 airplanes.

    (4) Model A340-311, -312, and -313 airplanes.

    (5) Model A340-541 and -642 airplanes.

    (d) Subject

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

    (e) Reason

    This AD was prompted by reports of cracked forward and aft cargo door frames, and loose, missing, or sheared rivets. We are issuing this AD to detect and correct cracked or ruptured cargo door frames, which could result in reduced structural integrity of the forward or aft cargo door.

    (f) Compliance

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

    (g) Affected Cargo Doors

    For the purpose of this AD, the affected cargo doors are pre-modification 202702 (forward cargo door) and pre-modification 202790 (aft cargo door), and are listed by part number (P/N) in the applicable service information identified in paragraph (h)(1) or (l)(1) of this AD. For post-modification doors, which are not affected by this AD, the P/Ns are identified as F52370900XXX (forward cargo door) and F52372315XXX (aft cargo door), where “XXX” can be a combination of any three numerical digits.

    (h) Forward Cargo Door Repetitive Inspections

    (1) Before exceeding 5,300 total flight cycles since first installation of the forward cargo door on an airplane, or within the applicable compliance time specified in table 1 to paragraph (h)(1) of this AD, whichever occurs later, except as specified in paragraph (q) of this AD: Do all applicable detailed and high frequency eddy current (HFEC) inspections of all frame fork areas, frame head areas, and outer skin areas of each affected forward cargo door, as applicable; in accordance with the Accomplishment Instructions of the applicable service information specified in paragraph (h)(1)(i), (h)(1)(ii), or (h)(1)(iii) of this AD. Do all applicable related investigative actions and corrective actions before further flight in accordance with the Accomplishment Instructions of the applicable service information specified in paragraph (h)(1)(i), (h)(1)(ii), or (h)(1)(iii) of this AD, except as required by paragraph (p) of this AD. Repeat the applicable inspections of the frame fork areas, frame head areas, and outer skin areas of each affected forward cargo door thereafter at intervals not to exceed 1,400 flight cycles.

    BILLING CODE 4910-13-P ER09FE18.000 ER09FE18.001 BILLING CODE 4910-13-C

    (i) Airbus Service Bulletin A330-52-3087, Revision 02, including Appendix 01, dated February 18, 2016 (“SB A330-52-3087, R02”).

    (ii) Airbus Service Bulletin A340-52-4095, Revision 02, including Appendix 01, dated November 29, 2015 (“SB A340-52-4095, R02”).

    (iii) Airbus Service Bulletin A340-52-5020, Revision 02, including Appendices 01 and 02, dated November 27, 2015 (“SB A340-52-5020, R02”).

    (2) Concurrently with the first inspection required by paragraph (h)(1) of this AD: Do a one-time detailed inspection of the hook gaps “U” and “V” of each affected forward cargo door for proper adjustment, and, depending on findings, adjust the hook(s), in accordance with the Accomplishment Instructions of the applicable service information specified in paragraph (h)(2)(i), (h)(2)(ii), or (h)(2)(iii) of this AD. Do all the required hook gap adjustments before further flight.

    (i) SB A330-52-3087, R02.

    (ii) SB A340-52-4095, R02.

    (iii) SB A340-52-5020, R02.

    (i) Forward Cargo Door Modification

    (1) Except as specified in paragraph (i)(2) of this AD, before exceeding 18,500 total flight cycles since first installation of the forward cargo door on an airplane, or within 12 months after the effective date of this AD, whichever occurs later: Do reinforcement modifications on the frame structure of each affected forward cargo door, in accordance with the Accomplishment Instructions of the applicable service information specified in paragraphs (i)(1)(i) through (i)(1)(vi) of this AD, except as required by paragraph (p) of this AD.

    (i) Airbus Service Bulletin A330-52-3105, dated February 24, 2016 (for certain Model A330-202, -223, and -243 airplanes; and Model A330-301, -321, -322, -341, and -342 airplanes).

    (ii) Airbus Service Bulletin A330-52-3110, dated February 15, 2016 (for certain Model A330-202, -203, -223, and -243 airplanes; and Model A330-303, -323, and -343 airplanes).

    (iii) Airbus Service Bulletin A330-52-3111, dated February 15, 2016 (for certain Model A330-202, -203, -223, -223F, -243, and -243F airplanes; and Model A330-302, -303, -323, -342, and -343 airplanes).

    (iv) Airbus Service Bulletin A340-52-4108, dated February 15, 2016 (for certain Model A340-211, -212, and -213 airplanes; and Model A340-311, -312, and -313 airplanes).

    (v) Airbus Service Bulletin A340-52-4113, dated February 15, 2016 (for certain Model A340-312 and -313 airplanes).

    (vi) Airbus Service Bulletin A340-52-4114, dated February 15, 2016 (for certain Model A340-313 airplanes).

    (2) Accomplishment of the reinforcement modifications required by paragraph (i)(1) of this AD may be deferred, provided that, before exceeding 18,500 total flight cycles since first installation of the forward cargo door on an airplane, or within 12 months after the effective date of this AD, whichever occurs later, but not earlier than 14,500 total flight cycles for Model A330 airplanes, or 12,500 total flight cycles for Model A340 airplanes, cold working is accomplished on the frame structure of each affected forward cargo door, in accordance with the Accomplishment Instructions of the applicable service information specified in paragraphs (i)(2)(i) through (i)(2)(vi) of this AD, except as required by paragraph (p) of this AD. Modification of an airplane by accomplishment of the cold working specified in this paragraph does not constitute terminating action for the repetitive inspections required by paragraph (h)(1) of this AD.

    (i) Airbus Service Bulletin A330-52-3116, dated April 20, 2016 (for certain Model A330-202, -223, and -243 airplanes; and Model A330-301, -321, -322, -341, and -342 airplanes).

    (ii) Airbus Service Bulletin A330-52-3117, dated April 20, 2016 (for certain Model A330-202, -203, -223, and -243 airplanes; and Model A330-303, -323, and -343 airplanes).

    (iii) Airbus Service Bulletin A330-52-3118, dated April 20, 2016 (for certain Model A330-202, -203, -223, -223F, -243, and -243F airplanes; and Model A330-302, -303, -323, -342, and -343 airplanes).

    (iv) Airbus Service Bulletin A340-52-4119, dated April 20, 2016 (for certain Model A340-211, -212, and -213 airplanes; and Model A340-311, -312, and -313 airplanes).

    (v) Airbus Service Bulletin A340-52-4120, dated April 20, 2016 (for certain Model A340-312 and -313 airplanes).

    (vi) Airbus Service Bulletin A340-52-4121, dated April 20, 2016 (for certain Model A340-313 airplanes).

    (3) Within 18,500 flight cycles after cold working is accomplished on the frame structure of each affected forward cargo door as specified in paragraph (i)(2) of this AD: Do the reinforcement modifications on the frame structure of each affected forward cargo door, using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

    (j) Forward Cargo Door Terminating Action

    Modification of an airplane by reinforcement of the forward cargo door frame structure required by paragraph (i)(1) or (i)(3) of this AD constitutes terminating action for the inspections required by paragraph (h)(1) and (h)(2) of this AD for that airplane.

    (k) Definitions of Pre-Modified and Post-Modified Airplanes of Aft Cargo Door

    (1) For the purpose of this AD, pre-modified Model A330-200 series airplanes, Model A330-200 Freighter series airplanes, Model A330-300 series airplanes, Model A340-200 series airplanes, and Model A340-300 series airplanes are defined as those not having Airbus Modification 44852, or Modification 44854 applied in production, or being in pre-Airbus Service Bulletin A330-52-3044 or pre-Airbus Service Bulletin A340-52-4054 configuration, as applicable.

    (2) For the purpose of this AD, post-modification Model A330-200 series airplanes, Model A330-200 Freighter series airplanes, Model A330-300 series airplanes, Model A340-200 series airplanes, and Model A340-300 series airplanes are defined as those having Airbus Modification 44852 or Modification 44854 applied in production, or modified in service as specified in Airbus Service Bulletin A330-52-3044 or Airbus Service Bulletin A340-52-4054, as applicable.

    (l) Aft Cargo Door Repetitive Inspections

    (1) Before exceeding 4,000 total flight cycles for pre-modified airplanes, or 12,000 total flight cycles for post-modified airplanes, since first installation of the aft cargo door on an airplane, as applicable, or within the compliance time specified in table 2 to paragraph (l)(1) of this AD or table 3 to paragraph (l)(1) of this AD, as applicable, whichever occurs later, except as specified in paragraph (q) of this AD: Do all applicable inspections of all frame fork areas, frame head areas, and outer skin area of each affected aft cargo door, in accordance with the Accomplishment Instructions of the applicable service information specified in paragraph (l)(1)(i), (l)(1)(ii), or (l)(1)(iii) of this AD. Do all applicable related investigative actions and corrective actions before further flight in accordance with the Accomplishment Instructions of the applicable service information specified in paragraph (l)(1)(i), (l)(1)(ii), or (l)(1)(iii) of this AD, except as required by paragraph (p) of this AD. Repeat the applicable inspections thereafter at intervals not to exceed 1,400 flight cycles.

    BILLING CODE 4910-13-P ER09FE18.002 ER09FE18.003 BILLING CODE 4910-13-C

    (i) Airbus Service Bulletin A330-52-3095, Revision 02, including Appendices 01 and 02, dated February 19, 2016 (“SB A330-52-3095, R02”).

    (ii) Airbus Service Bulletin A340-52-4101, Revision 02, including Appendices 01 and 02, dated November 27, 2015 (“SB A340-52-4101, R02”).

    (iii) Airbus Service Bulletin A340-52-5023, Revision 02, including Appendices 01 and 02, dated November 27, 2015 (“SB A340-52-5023, R02”).

    (2) Concurrently with the first inspection required by paragraph (l)(1) of this AD: Do a one-time detailed inspection of the hook gaps “U” and “V” of each affected aft cargo door for proper adjustment and, depending on findings, adjust the hook(s) in accordance with the Accomplishment Instructions of the applicable service information specified in paragraph (l)(2)(i), (l)(2)(ii), or (l)(2)(iii) of this AD. Do all the required hook gap adjustments before further flight.

    (i) SB A330-52-3095, R02.

    (ii) SB A340-52-4101, R02.

    (iii) SB A340-52-5023, R02.

    (m) Modification for Pre-Modified Airplanes

    (1) For pre-modified airplanes, except as specified in paragraph (m)(2) of this AD: Before exceeding 18,500 total flight cycles since first installation of the aft cargo door on an airplane, or within 12 months after the effective date of this AD, whichever occurs later, do reinforcement modifications, in accordance with the Accomplishment Instructions of the applicable service information specified in paragraphs (m)(1)(i) through (m)(1)(vi) of this AD, except as required by paragraph (p) of this AD.

    (i) Airbus Service Bulletin A330-52-3106, dated February 24, 2016 (for certain Model A330-301, -321, -322, -341, and -342 airplanes).

    (ii) Airbus Service Bulletin A330-52-3112, dated February 24, 2016 (for certain Model A330-202 and -223 airplanes; and Model A330-301, -322, -341, and -342 airplanes).

    (iii) Airbus Service Bulletin A330-52-3113, dated February 15, 2016 (for certain Model A330-223 and -243 airplanes; and Model A330-322 and -342 airplanes).

    (iv) Airbus Service Bulletin A330-52-3114, dated February 15, 2016 (for certain Model A330-202, -203, -223, -223F, -243, and -243F airplanes; and Model A330-302, -303, -323, -342, and -343 airplanes).

    (v) Airbus Service Bulletin A340-52-4109, dated February 25, 2016 (for certain Model A340-211, -212, and -213 airplanes; and Model A340-311, -312, and -313 airplanes).

    (vi) Airbus Service Bulletin A340-52-4115, dated February 19, 2016 (for certain Model A340-212, -213, and -313 airplanes).

    (2) Accomplishment of the reinforcement modifications required by paragraph (m)(1) of this AD may be deferred provided that before exceeding 18,500 total flight cycles since first installation of the aft cargo door on an airplane, or within 12 months after the effective date of this AD, whichever occurs later, but not earlier than 14,500 total flight cycles, cold working is accomplished on the frame structure of each affected aft cargo door, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-52-3115, dated April 20, 2016; or Airbus Service Bulletin A340-52-4118, dated April 20, 2016; as applicable. Modification of an airplane by accomplishment of the cold working specified in this paragraph does not constitute terminating action for the repetitive inspections required by paragraph (l)(1) of this AD.

    (3) For an airplane on which the cold working on the cargo door frame structure is accomplished, as specified in paragraph (m)(2) of this AD: Within 18,500 flight cycles after the application of cold working, do reinforcement modifications, in accordance with the Accomplishment Instructions of the service information specified in paragraphs (m)(1)(i) through (m)(1)(vi) of this AD, as applicable, or using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or EASA; or Airbus's EASA DOA. If approved by the DOA, the approval must include the DOA-authorized signature.

    (n) Terminating Action Aft Cargo Doors for Pre-Modified Airplanes

    Modification of an airplane by reinforcement of the aft cargo door frame structure required by paragraph (m)(1) or (m)(3) of this AD constitutes terminating action for the inspections required by paragraph (l)(1) and (l)(2) of this AD for that airplane.

    (o) Optional Terminating Action Modification for Post-Modified Airplanes

    For post-modified airplanes, modification of an airplane by reinforcement of the aft cargo door frame structure, in accordance with the Accomplishment Instructions of the applicable service information specified in paragraphs (m)(1)(i) through (m)(1)(vi) of this AD, or using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or EASA; or Airbus's EASA DOA, constitutes terminating action for the inspections required by paragraph (l)(1) and (l)(2) of this AD for that airplane. If approved by the DOA, the approval must include the DOA-authorized signature.

    (p) Exceptions to Service Information

    Where the service information specified in paragraphs (h)(1), (i)(1), (i)(2), (l)(1), and (m) of this AD specifies to contact Airbus for instructions or repair, before further flight, accomplish corrective actions in accordance with the procedures specified in paragraph (t)(2) of this AD.

    (q) Exception to Initial Inspection Compliance Time

    For the purposes of table 1 to paragraph (h)(1) of this AD, table 2 to paragraph (l)(1) of this AD, and table 3 to paragraph (l)(1) of this AD: As soon as a cargo door is inspected using any applicable service information specified in this AD, the previous inspections accomplished in accordance with any alert operator transmission can be disregarded for the determination of the compliance time for the initial inspection required by this AD.

    (r) Exception to Reporting in the Service Information

    Although the Airbus service bulletins specified in paragraphs (r)(1) through (r)(6) of this AD specify to submit certain information to the manufacturer, and specify that action as “RC” (Required for Compliance), this AD does not include that requirement.

    (1) SB A330-52-3087, R02.

    (2) SB A330-52-3095, R02.

    (3) SB A340-52-4095, R02.

    (4) SB A340-52-4101, R02.

    (5) SB A340-52-5020, R02.

    (6) SB A340-52-5023, R02.

    (s) Credit for Previous Actions

    (1) This paragraph provides credit for the initial inspection required by paragraph (h) of this AD, if that inspection was performed before the effective date of this AD using Airbus Service Bulletin A330-52-3087, dated August 29, 2013; Airbus Service Bulletin A340-52-4095, dated August 29, 2013; or Airbus Service Bulletin A340-52-5020, dated August 29, 2013; as applicable; provided that the actions identified as “additional work” in the Accomplishment Instructions of Airbus Service Bulletin A330-52-3087, Revision 01, dated July 9, 2014; Airbus Service Bulletin A340-52-4095, Revision 01, dated July 28, 2014; or Airbus Service Bulletin A340-52-5020, Revision 01, dated July 9, 2014; as applicable; are accomplished within 1,100 flight cycles after that inspection; and provided the next inspection of all frame fork areas, frame head areas, and outer skin area of each affected forward cargo door is accomplished within 1,100 flight cycles after that inspection, in accordance with the Accomplishment Instructions of SB A330-52-3087, R02; SB A340-52-4095, R02; or SB A340-52-5020, R02, as applicable.

    (2) This paragraph provides credit for the initial inspection required by paragraph (h) of this AD, if that inspection was performed before the effective date of this AD using Airbus Service Bulletin A330-52-3087, Revision 01, dated July 9, 2014; Airbus Service Bulletin A340-52-4095, Revision 01, dated July 28, 2014; or Airbus Service Bulletin A340-52-5020, Revision 01, dated July 9, 2014; as applicable; provided that the next inspection of all frame fork areas, frame head areas, and outer skin area of each affected forward cargo door, is accomplished within 1,100 flight cycles after that inspection in accordance with the Accomplishment Instructions of SB A330-52-3087, R02; SB A340-52-4095, R02; or SB A340-52-5020, R02, as applicable.

    (3) This paragraph provides credit for the initial inspection required by paragraph (l) of this AD, if that inspection was performed before the effective date of this AD using Airbus Service Bulletin A330-52-3095, dated August 29, 2013; Airbus Service Bulletin A340-52-4101, dated August 29, 2013; or Airbus Service Bulletin A340-52-5023, dated August 29, 2013; provided that the actions identified as “additional work” in the Accomplishment Instructions of Airbus Service Bulletin A330-52-3095, Revision 01, dated July 28, 2014; Airbus Service Bulletin A340-52-4101, Revision 01, dated July 28, 2014; or Airbus Service Bulletin A340-52-5023, Revision 01, dated July 28, 2014; as applicable; are accomplished within 550 flight cycles after that inspection, and provided the next inspection of all frame fork areas, frame head areas, and outer skin area of each affected aft cargo door is accomplished within 550 flight cycles after that inspection in accordance with the Accomplishment Instructions of SB A330-52-3095, R02; SB A340-52-4101, R02; or SB A340-52-5023, R02, as applicable.

    (4) This paragraph provides credit for the initial inspection required by paragraph (l) of this AD, if that inspection was performed before the effective date of this AD using Airbus Service Bulletin A330-52-3095, Revision 01, dated July 28, 2014; Airbus Service Bulletin A340-52-4101, Revision 01, dated July 28, 2014; or Airbus Service Bulletin A340-52-5023, Revision 01, dated July 28, 2014; as applicable; provided that the next inspection of all frame fork areas, frame head areas, and outer skin area of each affected aft cargo door is accomplished within 550 flight cycles after that inspection in accordance with the Accomplishment Instructions of SB A330-52-3095, R02; SB A340-52-4101, R02; or SB A340-52-5023, R02, as applicable.

    (5) Where Airbus Service Bulletins A330-52-3095, Revision 01, dated July 28, 2014; A340-52-4101, Revision 01, dated July 28, 2014; A340-52-5020, Revision 01, dated July 9, 2014; and A340-52-5023, Revision 01, dated July 28, 2014; refers to using fasteners having P/N ASNA2657, this AD also allows the use of alternative HST11 series fasteners.

    (t) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Section, Transport Standards 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 (u)(2) of this AD. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (2) Contacting the Manufacturer: As of the effective date of this AD, for any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or the EASA; or Airbus's EASA DOA. If approved by the DOA, the approval must include the DOA-authorized signature.

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

    (u) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2016-0188, dated September 21, 2016; corrected September 22, 2016, for related information. This MCAI may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0713.

    (2) For more information about this AD, contact Vladimir Ulyanov, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW, Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149.

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

    (v) Material Incorporated by Reference

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

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

    (i) Airbus Service Bulletin A330-52-3087, Revision 02, including Appendix 01, dated February 18, 2016.

    (ii) Airbus Service Bulletin A330-52-3095, Revision 02, including Appendices 01 and 02, dated February 19, 2016.

    (iii) Airbus Service Bulletin A330-52-3105, dated February 15, 2016.

    (iv) Airbus Service Bulletin A330-52-3106, dated February 24, 2016.

    (v) Airbus Service Bulletin A330-52-3110, dated February 15, 2016.

    (vi) Airbus Service Bulletin A330-52-3111, dated February 15, 2016.

    (vii) Airbus Service Bulletin A330-52-3112, dated February 24, 2016.

    (viii) Airbus Service Bulletin A330-52-3113, dated February 15, 2016.

    (ix) Airbus Service Bulletin A330-52-3114, dated February 15, 2016.

    (x) Airbus Service Bulletin A330-52-3115, dated April 20, 2016.

    (xi) Airbus Service Bulletin A330-52-3116, dated April 20, 2016.

    (xii) Airbus Service Bulletin A330-52-3117, dated April 20, 2016.

    (xiii) Airbus Service Bulletin A330-52-3118, dated April 20, 2016.

    (xiv) Airbus Service Bulletin A340-52-4095, Revision 02, including Appendix 01, dated November 27, 2015.

    (xv) Airbus Service Bulletin A340-52-4101, Revision 02, including Appendices 01 and 02, dated November 27, 2015.

    (xvi) Airbus Service Bulletin A340-52-4108, dated February 15, 2016.

    (xvii) Airbus Service Bulletin A340-52-4109, dated February 25, 2016.

    (xviii) Airbus Service Bulletin A340-52-4113, dated February 15, 2016.

    (xix) Airbus Service Bulletin A340-52-4114, dated February 15, 2016.

    (xx) Airbus Service Bulletin A340-52-4115, dated February 19, 2016.

    (xxi) Airbus Service Bulletin A340-52-4118, dated April 20, 2016.

    (xxii) Airbus Service Bulletin A340-52-4119, dated April 20, 2016.

    (xxiii) Airbus Service Bulletin A340-52-4120, dated April 20, 2016.

    (xxiv) Airbus Service Bulletin A340-52-4121, dated April 20, 2016.

    (xxv) Airbus Service Bulletin A340-52-5020, Revision 02, including Appendices 01 and 02, dated November 27, 2015.

    (xxvi) Airbus Service Bulletin A340-52-5023, Revision 02, including Appendices 01 and 02, dated November 27, 2015.

    (3) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email: [email protected]; internet: http://www.airbus.com.

    (4) 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.

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

    Issued in Renton, Washington, on January 11, 2018. John P. Piccola, Jr., Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-01803 Filed 2-8-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6616; Product Identifier 2016-CE-004-AD; Amendment 39-19177; AD 2018-03-04] RIN 2120-AA64 Airworthiness Directives; Rosemount Aerospace, Inc. Pitot Probes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for Rosemount Aerospace Model 851AK pitot probes that were repaired by CSI Aerospace, Inc. between January 2013 and July 2014 that are installed on airplanes. This AD was prompted by a report that certain pitot probes are indicating the wrong airspeed during flight. This AD requires inspecting the airplane to determine the number of affected pitot probes installed and replacing the affected pitot probes. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective March 16, 2018.

    Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6616; or in person at the Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The street address for Docket Operations (phone: 800-647-5527) is 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:

    Jonathan Kim, Aerospace Engineer, Fort Worth ACO Branch, FAA, 10101 Hillwood Parkway, Fort Worth, Texas 76177-1524; telephone: (817) 222-5131; fax: (817) 222-5245; 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 Rosemount Aerospace Model 851AK pitot probes that were repaired by CSI Aerospace, Inc. between January 2013 and July 2014 that are installed on airplanes. The NPRM was published in the Federal Register on May 11, 2016 (81 FR 29193). The NPRM was prompted by a report that certain pitot probes are indicating the wrong airspeed during flight. The NPRM proposed to require inspecting the airplane to determine the number of affected pitot probes installed and replacing the affected pitot probes. We are issuing this AD to prevent incorrect airspeed indications during flight, which could lead to loss of control. Due to design redundancy, this is only applicable if more than one deficient probe is installed.

    Comments

    We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

    Support for the AD

    Air Line Pilots Association, International (ALPA) supported the proposed AD as written.

    We have not changed this AD action based on this comment.

    Request To Revise the Description of the Unsafe Condition

    Andy Feely of CSI Aerospace, Inc. (CSI) stated that they do not have any data which confirms that the inaccurate airspeed occurred during flight “in icing conditions.”

    The commenter also stated that in the proposed AD, in the Summary, Discussion, and paragraph (e) Unsafe Condition sections, several references are made to the reported problem occurring “in icing conditions.” CSI does not have any data to support this statement. This statement is inconsistent with the field data that CSI has been able to collect. CSI has communicated with affected operators and has been unable to confirm experiences of inaccurate airspeed reporting during flight “in icing conditions.” CSI has a service difficulty report (SDR) where the airplane had varying airspeed indications from the airspeed indication systems (pitot probes), however, it does not contain a report of icing conditions.

    The commenter requested removing all references to “icing conditions” throughout the final rule AD action.

    We partially agree with the commenter. We agree to remove the language “icing conditions” from the Summary, Discussion, and paragraph (e) of the AD because the SDR report that prompted the AD action does not provide meteorological conditions. However, we disagree that icing conditions do not contribute to the unsafe condition. There is evidence that the migrated braze material may present a non-conforming, forward facing surface inside the pitot throat on which ice crystals may accumulate when they make contact and could lead to the incorrect airspeed indications.

    We have changed the AD as indicated above.

    Request To Clarify Summary

    Andy Feely of CSI stated that there is a specific time period that the affected pitot probes were repaired by CSI.

    The commenter requested that the specific time period of between January 2013 and July 2014 be added in the Summary section of the final rule AD action to clarify the applicability of the affected pitot probes and to be consistent with the dates in the Discussion section of the proposed AD.

    We agree with the commenter. We have changed this AD action based on this comment.

    Request To Revise the FAA's Determination Section

    Andy Feely of CSI stated that the FAA's Determination section in the proposed AD does not accurately reflect the scope of the unsafe condition. It implies a more widespread problem. Through CSI's immediate actions taken, once notified of the initial report (March 2014), all suspect serial numbers of the affected pitot probes were identified and located. All affected customers were notified and were provided instructions to inspect, scrap, return and/or replace the suspect probes. The commenter also stated that it is his opinion that this condition is not “likely to exist or develop in other products of the same type design” because the probes were located, contained, and monitored.

    The commenter requested a revision to this section to more accurately indicate the scope of the unsafe condition.

    We do not agree with the commenter. In 14 CFR, section 39.5, the FAA is required to issue an AD when we find that an unsafe condition exists in a product and the condition is likely to exist or develop in other products of the same type design. We have determined that this AD meets these requirements.

    We have not changed this AD action based on this comment.

    Request To Revise the Applicability Section

    Andy Feely of CSI stated that the Applicability section should include a statement to clarify the time period to narrow the actual scope of the problem and to be consistent with the dates stated in the Discussion section of the proposed AD. The commenter also stated that pitot probes re-repaired after August 1, 2014, are no longer part of the affected probes.

    The commenter requested that paragraph (c) of the final rule AD be revised to add the specific time period the affected probes were repaired by CSI and to specify the serial numbers of pitot probes repaired after August 1, 2014, which are no longer part of the affected probes.

    We partially agree with the commenter. We agree with including a statement in the Applicability section that suspect probes that were re-repaired by CSI Aerospace, Inc. after August 1, 2014, are not at risk because corrective actions have been taken to address the unsafe condition. We have changed the final rule AD action to add the serial numbers of the re-repaired probes to the Applicability section. Because we are relaxing the requirement to allow probes to be re-repaired after August 2014 and CSI is confident that these probes were re-repaired after August 2014, this does not add any additional burden to operators.

    We disagree with removing the serial numbers of re-repaired pitot probes from the Applicability section because we do not want to omit serial numbers from the final rule AD action based on claims that affected parts are already in compliance with the actions of the proposed AD. The original list of serial numbers provided in the proposed AD did not include serial numbers of re-repaired probes, but we have added them to the final rule AD action. Again, adding these serial numbers does not impose a burden on the public and this AD only documents those serial numbers that originally had the unsafe condition. All airplanes that had probes previously repaired would not be subject to any actions of this AD other than the requirement to assure that no suspect probe is installed in the future.

    We have not changed this AD action based on this part of the comment.

    Request To Correct Serial Number of Affect Pitot Probe

    Andy Feely of CSI stated that the serial number of pitot probe 88912 in the proposed AD is incorrect.

    The commenter requested the serial number be corrected to 88192 in the final rule AD action.

    We agree with the commenter and have changed this AD action based on this comment.

    Request To Allow Maintenance Records Review

    Andy Feely of CSI and Ryan Hall of Delta Air Lines stated that operators who have serial number traceability of the affected pitot probes fully documented in their maintenance records should be permitted to do a records review in order to determine location and number of affected probes installed on their airplane(s).

    The commenters requested that paragraph (g) of the final rule AD action be changed to include a review of the maintenance records in lieu of a physical inspection of the airplane if the serial number and repair date of the pitot probe can be positively identified.

    We agree with the commenter. Many operators keep thorough maintenance records that make it possible to positively identify the serial number of the affected probe and the repair date from a review their maintenance records.

    We have changed this AD action based on this comment.

    Request To Clarify Compliance

    Andy Feely of CSI stated it is not initially clear to owners/operators who have determined, either through inspection of the airplane, through maintenance records review, or that action was already taken before the effective date of this AD to assure that no more than one affected probe remains on the airplane and that two out of the three pitot probes installed on their airplane are not affected are in compliance with certain portions of the proposed AD.

    The commenter requested an additional statement be added to paragraph (g) of the final rule AD action to clarify that no further action is required except for the ongoing requirement in paragraph (h)(2) of this final rule AD action if airplane inspection or maintenance records review reveals that no more than one affected probe remains on the airplane.

    We agree with the commenter and have changed this AD action based on this comment.

    Request To Clarify Replacement Requirement

    Andy Feely of CSI stated that in the proposed AD it is unclear when the replacement of the affected pitot probes is required.

    The commenter requested to have the words “after the effective date of this AD” removed from paragraph (h)(1) of the final rule AD action.

    We do not agree with the commenter. If it is determined that the pitot probes are required to be replaced, as specified in paragraph (h)(1) of the proposed AD, the operator will have two months after the effective date of the final rule AD action to do so.

    We have not changed this AD action based on this comment.

    Request To Remove Certain Pitot Probes From the Applicability

    Andy Feely of CSI stated that as a result of the aggressive voluntary corrective action plan by CSI and the airlines, the serial number listing of the affected pitot probes has been greatly reduced.

    The commenter stated that robust traceability by serial number, delivery date, and customer, have allowed CSI and its customers the ability to proactively remove the affected probes for re-repair or scrap. CSI maintains very tight coordination with the affected customers and is aware of the status of all affected pitot probes.

    The commenter has requested that many of the pitot probes listed in the Applicability section be removed from the final rule AD action.

    We do not agree with the commenter. We disagree with removing the serial numbers of re-repaired or scrapped pitot probes from the Applicability section of the final rule AD action because we do not want to omit serial numbers based on claims that affected parts are already in compliance. We acknowledge that CSI has made significant efforts to remove all affected pitot probes from the fleet and to communicate their efforts to the FAA; however, after their effort was complete, approximately 100 pitot probes could not be accounted for.

    We have not changed this AD action based on this comment.

    Request To Extend Compliance Time for Replacement

    Robert Holcomb of American Airlines stated that the final rule AD should take into account the burden of costs associated with acquiring additional spares to meet the two-month replacement compliance time.

    The commenter stated that American Airlines owns 197 of the affected pitot probes. Of the 197 affected pitot probes, 83 are on active airplanes and 21 of those have been re-repaired. The commenter also stated that American Airlines has not had any failures of the affected pitot probes and currently has 87 active airplanes with potential to have an affected pitot probe installed.

    The commenter requested increasing the replacement compliance time to 6 months based on lack of failures on the MD80 fleet, current spare constraints, and turnaround time of re-repaired pitot probes.

    We do not agree with the commenter. We received a report about erroneous airspeed data being transmitted from multiple Rosemount Aerospace Model 851AK pitot probes repaired by CSI when installed on a Boeing Aircraft Company Model B717 airplane. Because we cannot say with certainty when or where this unsafe condition will manifest in the pitot probe, we are unable to increase the replacement compliance time to six months without additional justification. If operators have substantiating data to demonstrate that an acceptable level of safety has been met with a change in compliance time or other changes to this AD, we will consider an alternative method of compliance (AMOC) to the final rule AD action on a case by case basis. We do not provide costs beyond initial work hours and parts costs. Therefore, accounting for costs associated with acquiring spares is beyond the scope of our policy.

    We have not changed this AD action based on this comment.

    Request To Clarify Exclusion of Certain Pitot Probes From the Applicability

    Ryan Hall of Delta Air Lines stated that it is not clear in the Applicability section of the proposed AD that pitot probes repaired by CSI on or after August 1, 2014, are not part of the applicability.

    The commenter stated that paragraph (c) of proposed rule AD applies to pitot probes that were repaired by CSI and have a serial number listed in paragraph (c)(1) of this AD that are known to be installed on aircraft. However, paragraph (h)(3) of the proposed AD contains the phrase, `unless it has been repaired by CSI and has a date of August 1, 2014, or later.

    The commenter requested that the Applicability section of the final rule AD action be revised to include the statement excluding pitot probes repaired by CSI Aerospace, Inc. after August 1, 2014, from the applicability.

    We agree with the commenter and have changed this AD action based on this comment.

    Request To Add Removal Requirement

    Ralph Isaacson stated that the laser etching, which identifies the manufacturer and serial number, is eventually worn off by environmental conditions, usage, and age.

    The commenter stated that in some instances the pitot probes will require removal from the fuselage to clearly identify the mechanically stamped serial number at the inner base of the probe.

    The commenter requested that a requirement for removing the pitot probes in order to identify the overhauled pitot probes serial numbers should be added to the final rule AD action.

    We partially agree with the commenter. We agree with the possibility that the serial number may not be legible on the outside of the pitot probe because of environmental conditions, usage, age, etc. However, we disagree with adding a requirement to remove the pitot probe during every inspection. If the serial number is legible from the outside of the pitot probe, this may add an unnecessary burden to the operators. Also, some operators are capable of positively identifying the serial number of the affected pitot probe and the repair date from a review of maintenance records. We have not changed this AD action based on this comment.

    Conclusion

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

    • Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

    • Do not add any additional burden upon the public than was already proposed in the NPRM.

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

    Costs of Compliance

    We estimate that this AD affects 679 products 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
  • Inspect to determine the number of defective pitot probes installed on the airplane 1 work-hour × $85 per hour = $85 N/A N/A $57,715

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

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Replace defective pitot probe 1 work-hour × $85 per hour = $85 $6,750 $6,835
    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 small airplanes, gliders, balloons, airships, domestic business jet transport airplanes, and associated appliances to the Director of the 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 that this AD:

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

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

    (3) Will not affect intrastate aviation in Alaska, 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): 2018-03-04 Rosemount Aerospace, Inc.: Amendment 39-19177; Docket No. FAA-2016-6616; Product Identifier 2016-CE-004-AD. (a) Effective Date

    This AD is effective March 16, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Rosemount Aerospace, Inc. Model 851AK pitot probes that were repaired by CSI Aerospace Inc. and have a serial number listed in paragraph (c)(1) of this AD that are known to be installed on but not limited to the airplanes listed in paragraph (c)(2) of this AD. Pitot probes that were repaired by CSI Aerospace Inc. that have a repair date of August 1, 2014, or later, are excluded from the applicability.

    (1) 24352, 53257, 61568, 68168, 69913, 69953, 71007, 71802, 71820, 73010, 73406, 75549, 75555, 80489, 80491, 83809, 84200, 84495, 84911, 84922, 85317, 85731, 87225, 87234, 87235, 87241, 87272, 87512, 87551, 87909, 88192, 88622, 90538, 91606, 93291, 93292, 93293, 93305, 93941, 93948, 93960, 94258, 94304, 94559, 94814, 94819, 95150, 95849, 97405, 98194, 99498, 99509, 100105, 100111, 100127, 100313, 100741, 101374, 101500, 102037, 102054, 102309, 102502, 104604, 106134, 106139, 106381, 106905, 107251, 107405, 107406, 107450, 107887, 108174, 108302, 108858, 108859, 108967, 108970, 109119, 109122, 109124, 109128, 109383, 109393, 109394, 109467, 109474, 109488, 109521, 109524, 109537, 109577, 109795, 109798, 109799, 109808, 109810, 109946, 109954, 109958, 109962, 109996, 110323, 110324, 110327, 110338, 110611, 110626, 110880, 110895, 110956, 111061, 111066, 111315, 111320, 111432, 111561, 111571, 111578, 111802, 111807, 112229, 112280, 112343, 112497, 112646, 112657, 112677, 112779, 112781, 112783, 112979, 112993, 113025, 113026, 113129, 113151, 113382, 113721, 113758, 113837, 113838, 113843, 113845, 113920, 113934, 114130, 114147, 114152, 114157, 114223, 114239, 114376, 114572, 114813, 114869, 114872, 114959, 114962A, 114966, 115428, 115713, 116046, 116249, 116253, 116255, 116271, 116424, 116557, 116734, 116792, 116994, 117022, 117144, 117164, 117310, 117412, 117414, 117426, 117427, 117428, 117587, 117961, 118111, 118119, 118234, 118331, 118637, 118639, 118770, 118938, 119115, 119281, 119290, 119414, 119441, 119496, 119587, 119593, 119694, 119695, 119737, 119852, 120456, 120461, 120728, 120823, 120825, 120826, 120829, 121040, 121041, 121110, 121116, 121145, 121172, 121320, 121322, 121524, 121661, 121834, 121852, 122286, 122662, 122843,122934, 122935, 123286, 123289, 123330, 123745, 123746, 123753, 123767, 124144, 124385, 124390, 124396, 124890, 125016, 125021, 125077, 125163, 125174, 126785, 127449, 127894, 127899, 128302, 128307, 129503, 130371, 130377, 130688, 131422, 131423, 131752, 132065, 132067, 132297, 132825, 133103, 133161, 133220, 133291, 133310, 133313, 133394, 133396, 133512, 133521, 134100, 134102, 134403, 134535, 134537, 134639, 134675, 134681, 135136, 135234, 135246, 135250, 135554, 135561, 135568, 135735, 135743, 136075, 136208, 137049, 137398, 137543, 137544, 137642, 139076, 139081, 139433, 139444, 139691, 139694, 139759, 139763, 139971, 139976, 140188, 140563, 140565, 140643, 140649, 140650, 141161, 141356, 141362, 141497, 141501, 141605, 141607, 142426, 142765, 142774, 142775, 143070, 143405, 143409, 143411, 143418, 143816, 143818, 143988, 143992, 143999, 144591, 144814, 144816, 144976, 144977, 146116, 146835, 147421, 148524, 148765, 148777, 149460, 149464, 149510, 149941, 150196, 150206, 150211, 150212, 150214, 150542, 150725, 151077, 151086, 151095, 151493, 152097, 152819, 152922, 152969, 152974, 152981, 153232, 153233, 153453, 153454, 153625, 153628, 153635, 153641, 153956, 153962, 153966, 153984, 154007, 154156, 154704, 154721, 154738, 154741, 155003, 155042, 155045, 155238, 155278, 155517, 156022, 156025, 156222, 156526, 156529, 156672, 157023, 157137, 157143, 158393, 158790, 158797, 159033, 159036, 159413, 159440, 159891, 160000, 160002, 160006, 160456, 160459, 160463, 160466, 160468, 161137, 161139, 161159, 161177, 161184, 161185, 161363, 161364, 161366, 162376, 162384, 162674, 162682, 162685, 162688, 163176, 163178, 163181, 163557, 163559, 163602, 164217, 164279, 164746, 164750, 164907, 164908, 165135, 165259, 165459, 165805, 166235, 166324, 166325, 166326, 166331, 166477, 166481, 166608, 166671, 166673, 166892, 167029, 167030, 167035, 167037, 167182, 167341, 167556, 167559, 167705, 167707, 167709, 167763, 167764, 167765, 167766, 167811, 195627, 195628, 195706, 195707, 195710, 195796, 195833, 195876, 196041, 196042, 196045, 196137, 196234, 196397, 196400, 196401, 196403, 196498, 196500, 196761, 197097, 197137, 197140, 197143, 197238, 197657, 197874, 198528, 198687, 198775, 198780, 198788, 198872, 198878, 199034, 199042, 199187, 199441, 199613, 199616, 199669, 200293, 200324, 200534, 200535, 200538, 200556, 200737, 200738, 200739, 200793, 200830, 200834, 200872, 201576, 201685, 201733, 201892, 201893, 201964, 202053, 202305, 202306, 202469, 202471, 202472, 202596, 202625, 202633, 202760, 202381, 202879, 202901, 203010, 203016, 203147, 204629, 204665, 204714, 204820, 204821, 204822, 205249, 205253, 205329, 205335, 205526, 205527, 205529, 205700, 205882, 205967, 206273, 206406, 206436, 206441, 206646, 207019, 207020, 207021, 207364, 207369, 207683, 207684, 207837, 207849, 207850, 208206, 208381, 208394, 208396, 208543, 209148, 209698, 209704, 209707, 212176, 212525, 212697, 212700, 213952, 213953, 214085, 214089, 214144, 214795, 214803, 215392, 215476, 216214, 216509, 216515, 216951, 216955, 216957, 217368, 217369, 217382, 217441, 217708, 217805, 218112, 218610, 218613, 218757, 218761, 218958, 218965, 218967, 218970, 218976, 219226, 219228, 219233, 219236, 219411, 219418, 219832, 219840, 219842, 219915, 220990, 220991, 221197, 221286, 221635, 224540, 224700, 224701, 224704, 224707, 224876, 225257, 225262, 225586, 225907, 225910, 225974, 226133, 226136, 226465, 226466, 226467, 227159, 227174, 227836, 227837, 229277, 230190, 230191, 230192, 230193, 231082, 232015, 232681, 232684, 234534, 235621, 235628, 238097, 238179, 239755, 239760, 239956, 239964, 242109, 242998, 243347, 243350, 243351, 245230, 246442, 246792, 246851, 247007, 247302, 250747, 253132, 256326, 256327, 258614, 258861, 258865, 260508, 262743, 262744, 263643, 263644, 263645, 263651, 263700, 264117, 264119, 264122, 264123, 264125, 264193, 264738, 265208, 265210, 265655, 265656, 265657, 265658, 268055, 268562, 268564, 268565, 268566, 272372, 272592, 273833, 273835, 275276, 275658, 275663, 277554, 280433, 280435, 296902, 298059, and 298843.

    (2) DC-9-11, DC-9-12, DC-9-13, DC-9-14, DC-9-15, DC-9-15F, DC-9-21, DC-9-31, DC-9-32, DC-9-32 (VC-9C), DC-9-32F, DC-9-32F (C-9A, C-9B), DC-9-33F, DC-9-34, DC-9-34F, DC-9-41, DC-9-51, DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), MD-88, MD-90-30, and 717-200.

    (d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 3414, Airspeed/Mach Indicator.

    (e) Unsafe Condition

    This AD was prompted by a report that the pitot probes are indicating the wrong airspeed during flight. We are issuing this AD to prevent incorrect airspeed indications during flight, which could lead to loss of control. Due to design redundancy, this is only applicable if more than one deficient probe is installed.

    (f) Compliance

    Comply with this AD within the compliance times specified. If the actions required in paragraphs (g) and (h)(1) of this AD have already been done before March 16, 2018 (the effective date of this AD), then only paragraph (h)(2) of this AD applies.

    (g) Determine Number of Affected Pitot Probes Installed

    Within 30 days after March 16, 2018 (the effective date of this AD), inspect the airplane to determine the number of pitot probes identified in paragraph (c)(1) of this AD that are installed on the airplane. This inspection can be performed through a review of maintenance records in lieu of a physical inspection of the product if the serial number and repair date can be positively identified from the review. If the serial number cannot be positively identified from a review of the aircraft's maintenance records or from the outside of the airplane, this may require the pitot probe to be removed from the fuselage to view the serial number at the inner base of the probe. If it is determined that no more than one pitot probe identified in paragraph (c)(1) of this AD is installed on the airplane, no further action is required except for the ongoing requirement in paragraph (h)(2) of this AD.

    (h) Replace Affected Pitot Probes

    (1) If it is determined that more than one pitot probe identified in paragraph (c)(1) of this AD is installed on the airplane during the inspection required in paragraph (g) of this AD, within the next 2 months after March 16, 2018 (the effective date of this AD), do one of the following so that no more than one pitot probe identified in paragraph (c)(1) of this AD is installed on any aircraft simultaneously.

    (i) Replace the pitot probes that are listed with pitot probes that do not have a serial number listed in paragraph (c)(1) of this AD; or

    (ii) Replace the pitot probes that are listed with one that has been properly repaired, and if repaired by CSI, has a repair date of August 1, 2014, or later. This can be done by having the existing pitot probe repaired by CSI Aerospace, Inc.

    (2) As of March 16, 2018 (the effective date of this AD), do not install on any airplane a pitot probe having a serial number listed in paragraph (c)(1) of this AD, unless it has been properly repaired, and if repaired by CSI Aerospace, Inc., has a repair date of August 1, 2014, or later.

    (i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Fort Worth 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 ACO Branch, send it to the attention of the person identified in paragraph (j) of this AD.

    (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.

    (i) Related Information

    For more information about this AD, contact Jonathan Kim, Aerospace Engineer, Fort Worth ACO Branch, FAA, 10101 Hillwood Parkway, Fort Worth, Texas 76177-1524; telephone: (817) 222-5131; fax: (817) 222-5245; email: [email protected]

    Issued in Kansas City, Missouri, on February 2, 2018. Melvin J. Johnson, Deputy Director, Policy & Innovation Division, Aircraft Certification Service.
    [FR Doc. 2018-02550 Filed 2-8-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0279; Airspace Docket No. 17-ASO-10] Establishment of Class E Airspace; Johnson City, TN AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This action establishes Class E airspace extending upward from 700 feet above the surface at Johnson City, TN, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures (SIAPs) serving Johnson City Medical Center Heliport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the heliport.

    DATES:

    Effective 0901 UTC, March 29, 2018. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

    ADDRESSES:

    FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11B at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace at Johnson City Medical Center Heliport, Johnson City, TN, to support IFR operations under standard instrument approach procedures at the heliport.

    History

    The FAA published a notice of proposed rulemaking in the Federal Register (82 FR 24268, May 26, 2017) for Docket No. FAA-2017-0279 to establish Class E airspace extending upward from 700 feet above the surface at Johnson City Medical Center Heliport, Johnson City, TN, due to the new RNAV (GPS) standard instrument approach procedures for IFR operations at the heliport. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

    Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Johnson City Medical Center Heliport, Johnson City, TN. This action provides the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for IFR operations at Johnson City Medical Center Heliport.

    Regulatory Notices and Analyses

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

    Environmental Review

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

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    Adoption of the Amendment

    In consideration of the foregoing, the FAA amends 14 CFR part 71 as follows:

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, effective September 15, 2017, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO KY E5 Johnson City, TN [New] Johnson City Medical Center Heliport, TN (Lat. 36°18′26″ N, long. 82°23′10″ W)

    That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Johnson City Medical Center Heliport.

    Issued in College Park, Georgia, on January 30, 2018. Ryan W. Almasy, Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2018-02324 Filed 2-8-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0897; Airspace Docket No. 17-ANM-22] Establishment of Class E Airspace, Spanish Fork, UT AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This action establishes Class E airspace extending upward from 700 feet above the surface, at Spanish Fork Airport Springville-Woodhouse Field, Spanish Fork, UT, to accommodate new area navigation (RNAV) procedures at the airport. This action ensures the safety and management of Instrument Flight Rules (IFR) operations within the National Airspace System.

    DATES:

    Effective 0901 UTC, March 29, 2018. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

    ADDRESSES:

    FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 2200 S 216th Street, Des Moines, WA 98198-6547; telephone (206) 223-2253.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace extending upward from 700 feet above the surface at Spanish Fork Airport Springville-Woodhouse Field, Spanish Fork, UT, to support standard instrument approach procedures for IFR operations at the airport.

    History

    The FAA published a notice of proposed rulemaking in the Federal Register (82 FR 55965; November 27, 2017) for Docket No. FAA-2017-0897 to establish Class E airspace extending upward from 700 feet above the surface at Spanish Fork Airport Springville-Woodhouse Field, Spanish Fork, UT. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

    Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

    Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Spanish Fork Airport Springville-Woodhouse Field.

    Regulatory Notices and Analyses

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

    Environmental Review

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

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    Adoption of the Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ANM UT E5 Spanish Fork, UT [New] Spanish Fork Airport Springville-Woodhouse Field, UT (Lat. 40°08′42″ N, long. 111°40′04″ W)

    That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Spanish Fork Airport Springville-Woodhouse Field.

    Issued in Seattle, Washington, on January 29, 2018. Shawn M. Kozica, Manager, Operations Support Group, Western Service Center.
    [FR Doc. 2018-02325 Filed 2-8-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2016-9559; Airspace Docket No. 16-ACE-11] Amendment of Class D and E Airspace for the Following Missouri Towns; Cape Girardeau, MO; St. Louis, MO; and Macon, MO AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This action modifies Class D airspace at Spirit of St. Louis Airport, St. Louis, MO; Class E airspace designated as a surface area at Cape Girardeau Regional Airport, Cape Girardeau, MO, and Spirit of St. Louis Airport; Class E airspace designated as an extension at Cape Girardeau Regional Airport; and Class E airspace extending upward from 700 feet above the surface at Cape Girardeau Regional Airport, Spirit of St. Louis Airport, and Macon-Fower Memorial Airport, Macon, MO. Cancellation of standard instrument approach procedures at these airports prompted the FAA to conduct a review of the airspace. Additionally, the name of Cape Girardeau Regional Airport (formerly Cape Girardeau Municipal Airport) and the geographic coordinates of St. Louis Regional Airport; Alton/St. Louis, IL; the OBLIO Locator Outer Marker (LOM); and the Macon-Fower Memorial Airport are being adjusted to coincide with the FAA's aeronautical database. The airspace designation for Macon-Fower, MO, in Class E airspace extending upward from 700 feet above the surface is being removed as it is a duplicate entry of the Macon, MO, airspace designation.

    DATES:

    Effective 0901 UTC, May 24, 2018. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

    ADDRESSES:

    FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11B at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class D airspace at Spirit of St. Louis Airport, St. Louis, MO; Class E airspace designated as a surface area at Cape Girardeau Regional Airport and Spirit of St. Louis Airport; Class E airspace designated as an extension at Cape Girardeau Regional Airport; and Class E airspace extending upward from 700 feet above the surface at Cape Girardeau Regional Airport, Spirit of St. Louis Airport, and Macon-Fower Memorial Airport, Macon, MO, to support IFR operations at these airports.

    History

    The FAA published a notice of proposed rulemaking in the Federal Register (82 FR 28426; June 22, 2017) for Docket No. FAA-2016-9559 to modify Class D airspace at Spirit of St. Louis Airport, St. Louis, MO; Class E airspace designated as a surface area at Cape Girardeau Regional Airport and Spirit of St. Louis Airport; Class E airspace designated as an extension at Cape Girardeau Regional Airport; and Class E airspace extending upward from 700 feet above the surface at Cape Girardeau Regional Airport, Spirit of St. Louis Airport, and Macon-Fower Memorial Airport, Macon, MO. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

    Subsequent to publication, the FAA discovered that the geographic coordinates for the St. Louis Lambert International runway 24, 12R, and 30L localizers were omitted in the Class E airspace extending upward from 700 feet above the surface at St. Louis, MO. These facilities and geographic coordinates have been included in the airspace description in this action. The Spirit of St. Louis localizer has also been correctly named the Spirit of St. Louis Runway 26L Localizer to correspond with the FAA's aeronautical database. Additionally, in the airspace description of Class E airspace extending upward from 700 feet or more above the surface for Lambert-St. Louis International Airport, the reciprocal bearing (259° vice 079°) from the Spirit of St. Louis localizer was listed incorrectly and has been corrected in this action. Also, the state referencing St Louis Regional Airport is corrected from MO to IL.

    Finally, to comply with a recent change to FAA Order 7400, 2L, Procedures for Handling Airspace Matters, this action amends the headers to the city and state only and removes the names of the cities that precede the airport name.

    Except for the changes noted above, this rule is the same as published in the NPRM.

    Class D and E airspace designations are published in paragraph 5000, 6002, 6004 and 6005, respectively, of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.

    Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies:

    Class D airspace at Cape Girardeau Regional Airport (formerly Cape Girardeau Municipal Airport) by updating the name of the airport to coincide with the FAA's aeronautical database;

    Class D airspace to within a 4.4-mile radius (increased from a 4.3-mile radius) at Spirit of St. Louis Airport, St. Louis, MO, adding an extension within 1 mile each side of the 079° bearing from the airport extending from the 4.4-mile radius to 4.6 miles east of the airport, adjusts the extension west of the airport to within 1 mile each side of the 259° bearing (previously 258°) from the airport extending from the 4.4-mile radius to 4.6 miles west of the airport, and updates the header of the airspace description to St. Louis, MO (previously St. Louis, Spirit of St. Louis Airport, MO) to comply with FAA Order 7400.2L;

    Class E airspace designated as a surface area at Cape Girardeau Regional Airport (formerly Cape Girardeau Municipal Airport) by adding the vertical limits from the surface to and including 2,800 feet, adding the part time language to the description, and updating the name of the airport to coincide with the FAA's aeronautical database;

    Class E airspace designated as a surface area to within a 4.4-mile radius (increased from a 4.3-mile radius) at Spirit of St. Louis Airport, St. Louis, MO, adding an extension to within 1 mile each side of the 079° bearing from the airport extending from the 4.4-mile radius to 4.6 miles east of the airport, adding an extension within 1 mile each side of the 259° bearing from the airport extending from the 4.4-mile radius to 4.6 miles west of the airport, and updating the header of the airspace description to St. Louis, MO (previously St. Louis, Spirit of St. Louis Airport, MO) to comply with FAA Order 7400.2L;

    Class E airspace designated as an extension to Class E surface area at Cape Girardeau Regional Airport (formerly Cape Girardeau Municipal Airport), Cape Girardeau, MO, by adding an extension 1 mile each side of the 023° bearing from the airport from the 4.1-mile radius of the airport to 4.4 miles to the north of the airport, adjusting the extension to the east of the airport to within 1 mile (decreased from 2.6 miles) each side of the 108° bearing from the Cape Girardeau Regional Localizer (previously the Cape Girardeau VOR/DME) from the 4.1-mile radius to 4.4 miles east of the airport, adjusting the extension to the south of the airport to within 2.4 miles (previously 2.6 miles) each side of the 196° (previously 194°) radial of the Cape Girardeau VOR/DME from the 4.1-mile radius of the airport extending to 7.2 miles (increased from 5.7 miles), adjusting the extension west of the airport to within 1 mile (decreased from 2.6 miles) each side of the 287° (previously 279°) radial from the Cape Girardeau VOR/DME from the 4.1-mile radius to 4.4 miles (decreased from 7.4 miles) west of the airport, and updating the name of the airport to coincide with the FAA's aeronautical database;

    Class E airspace areas extending upward from 700 feet above the surface:

    At Cape Girardeau Regional Airport, Cape Girardeau, MO, by adding an extension to the north of the airport within 2 miles each side of the 203° bearing from the airport from the 6.6-mile radius of the airport to 7.3 miles, adjusting the extension to the east to within 3.8 miles (increased from 2.5 miles) each side of the 108° bearing from the Cape Girardeau Localizer (previously from the Cape Girardeau VOR/DME) extending from the 6.6-mile radius to 14 miles (increased from 8.7 miles), adjusting the extension to the south of the airport to within 2.4 miles (reduced from 3 miles) each side of the 196° radial (previously 194°) from the Cape Girardeau VOR/DME from the 6.6-mile radius to 7.2 miles (decreased from 10 miles) south of the airport, adding an extension within 1.9 miles each side of the 023° bearing from the airport from the 6.6-mile radius of the airport to 7.5 miles south of the airport, adjusting the extension to the west of the airport to within 2 miles (reduced from 3 miles) each side of the 280° (previously 279°) bearing from the airport (previously the Cape Girardeau VOR/DME) extending from the 6.6-mile radius to 7.4 miles (decreased from 8.7 miles) west of the airport, and updating the name of the airport to coincide with the FAA's aeronautical database;

    By removing the Class E airspace areas extending upward from 700 feet above the surface at Macon-Fower, MO, as it is a duplicate entry of the Macon, MO, Class E airspace areas extending upward from 700 feet above the surface;

    Within a 6.7-mile radius (increased from a 6.5-mile radius) of Macon-Fower Memorial Airport, Macon, MO, and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database.

    And within a 6.9-mile radius (increased from a 6.8-mile radius) of the Spirit of St. Louis Airport, St. Louis, MO, adding an extension 4.2 miles north and 6.4 miles south of the 079° bearing from the Spirit of St. Louis Runway 26L Localizer extending from the 6.6-mile radius of the airport to 11.3 miles east of the Spirit of St. Louis Runway 26L Localizer, adding an extension within 2.5 miles each side of the 079° bearing from the airport from the 6.9-mile radius to 8.1 miles east of the airport, adjusting the extension to the west of the airport to within 3.9 miles each side of the 259° (previously 258°) bearing from the airport extending from the 6.9-mile radius to 10.6 miles west of the airport, removing an extension west of the airport referencing the Foristell VORTAC, removing the Foristell VORTAC from the description, and updating the geographic coordinates for St. Louis Regional Airport, Alton/St. Louis, IL, and the OBLIO LOM to coincide with the FAA's aeronautical database.

    This action also makes an editorial change in the airspace description for Class D and Class E airspace designated as a surface area replacing Airport/Facility Directory with the current term Chart Supplement.

    Lastly, to comply with recent changes to FAA Order 7400.2L, this action removes the city name from the airport name in the airspace designations for Spirit of St. Louis Airport, St. Louis Regional Airport, Lambert-St. Louis International Airport, and St. Charles County Smartt Airport to comply with FAA Order 7400.2L.

    Airspace reconfiguration is necessary due to the cancellation of standard instrument approach procedures at these airports, and for the safety and the management of IFR operations.

    Regulatory Notices and Analyses

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

    Environmental Review

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

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    Adoption of the Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017, is amended as follows: Paragraph 5000 Class D Airspace. ACE MO D Cape Girardeau, MO [Amended] Cape Girardeau Regional Airport, MO (Lat. 37°13′31″ N, long. 89°34′15″ W)

    That airspace extending upward from the surface to and including 2,800 feet within a 4.1-mile radius of Cape Girardeau Regional Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

    ACE MO D St. Louis, MO [Amended] Spirit of St. Louis Airport, MO (Lat. 38°39′44″ N, long. 90°39′07″ W)

    That airspace extending upward from the surface to and including 3,000 feet within a 4.4-mile radius of Spirit of St. Louis Airport, and within 1 mile each side of the 079° bearing from the airport extending from the 4.4-mile radius to 4.6 miles east of the airport, and within 1 mile each side of the 259° bearing from the airport extending from the 4.4-mile radius to 4.6 miles west of the airport, excluding that airspace within the St. Louis, MO Class B airspace area. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective dates and times will thereafter be continuously published in the Chart Supplement.

    Paragraph 6002 Class E Surface Airspace. ACE MO E2 Cape Girardeau, MO [Amended] Cape Girardeau Regional Airport, MO (Lat. 37°13′31″ N, long. 89°34′15″ W)

    That airspace extending upward from the surface to and including 2,800 feet within a 4.1-mile radius of the Cape Girardeau Regional Airport. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

    ACE MO E2 St. Louis, MO [Amended] Spirit of St. Louis Airport, MO (Lat. 38°39′44″ N, long. 90°39′07″ W)

    That airspace extending upward from the surface to and including 3,000 feet within a 4.4-mile radius of Spirit of St. Louis Airport, and within 1 mile each side of the 079° bearing from the airport extending from the 4.4-mile radius to 4.6 miles east of the airport, and within 1 mile each side of the 259° bearing from the airport extending from the 4.4-mile radius to 4.6 miles west of the airport, excluding that airspace within the St. Louis, MO Class B airspace area. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective dates and times will thereafter be continuously published in the Chart Supplement.

    Paragraph 6004 Class E Airspace Designated as an Extension to Class E Surface Area. ACE MO E4 Cape Girardeau, MO [Amended] Cape Girardeau Regional Airport, MO (Lat. 37°13′31″ N, long. 89°34′15″ W) Cape Girardeau Regional Localizer (Lat. 37°13′18″ N, long. 89°33′25″ W) Cape Girardeau VOR/DME (Lat. 37°13′39″ N, long. 89°34′21″ W)

    That airspace extending upward from the surface within 1 mile each side of the 023° bearing from the airport extending from the 4.1-mile radius to 4.4 miles north of the airport, and within 1 mile each side of the 108° bearing from the Cape Girardeau Localizer extending from the 4.1-mile radius to 4.4 miles east of the airport, and within 2.4 miles each side of the 196° radial of the Cape Girardeau VOR/DME extending from the 4.1-mile radius of the airport to 7.2 miles south of the airport, and within 1 mile each side of the 287° radial of the Cape Girardeau VOR/DME extending from the 4.1-mile radius of the airport to 4.4 miles west of the airport.

    Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ACE MO E5 Cape Girardeau, MO [Amended] Cape Girardeau Regional Airport, MO (Lat. 37°13′31″ N, long. 89°34′15″ W) Cape Girardeau Regional Localizer (Lat. 37°13′18″ N, long. 89°33′25″ W) Cape Girardeau VOR/DME (Lat. 37°13′39″ N, long. 89°34′21″ W)

    That airspace extending upward from 700 feet above the surface within a 6.6-mile radius of the airport, and within 1.9 miles each side of the 023° bearing from the airport extending from the 6.6-mile radius to 7.3 miles north of the airport, and within 3.8 miles each side of the 108° bearing from the Cape Girardeau Localizer extending from the 6.6-mile radius to 14 miles east of the airport, and within 2.4 miles each side of the 196° radial of the Cape Girardeau VOR/DME extending from the 6.6-mile radius to 7.2 miles south of the airport, and within 2 miles each side of the 203° bearing from the airport from the 6.6-mile radius to 7.5 miles south of the airport, and within 2 miles each side of the 280° bearing from the airport extending from the 6.6-mile radius to 7.4 miles west of the airport.

    ACE MO E5 Macon-Fower, MO [Removed] ACE MO E5 Macon, MO [Amended] Macon-Fower Memorial Airport, MO (Lat. 39°43′47″ N, long. 92°27′24″ W)

    That airspace extending upward from 700 feet above the surface within a 6.7-mile radius of Macon-Fower Memorial Airport.

    ACE MO E5 St. Louis, MO [Amended] Lambert-St. Louis International Airport, MO (Lat. 38°44′55″ N, long. 90°22′12″ W) Spirit of St. Louis Airport, MO (Lat. 38°39′44″ N, long. 90°39′07″ W) St. Louis Regional Airport, IL (Lat. 38°53′24″ N, long. 90°02′46″ W) St. Charles County Smartt Airport, MO (Lat. 38°55′47″ N, long. 90°25′48″ W) St. Louis Lambert International Runway 24 Localizer (Lat. 38°44′44″ N, long. 90°23′04″ W) St. Louis Lambert International Runway 12R Localizer (Lat. 38°44′10″ N, long. 90°20′36″ W) St. Louis Lambert International Runway 30L Localizer (Lat. 38°45′44″ N, long. 90°22′56″ W) St. Louis VORTAC (Lat. 38°51′38″ N, long. 90°28′57″ W) ZUMAY LOM (Lat. 38°47′17″ N, long. 90°16′44″ W) OBLIO LOM (Lat. 38°48′01″ N, long. 90°28′29″ W) Spirit of St. Louis Runway 26L Localizer (Lat. 38°39′26″ N, long. 90°39′48″ W) Civic Memorial NDB (Lat. 38°53′32″ N, long. 90°03′23″ W)

    That airspace extending upward from 700 feet above the surface within a 7.1-mile radius of Lambert-St. Louis International Airport, and within 4 miles southeast and 7 miles northwest of the Lambert-St. Louis International Airport Runway 24 ILS Localizer course extending from the airport to 10.5 miles northeast of the ZUMAY LOM, and within 4 miles southwest and 7.9 miles northeast of the Lambert-St. Louis International Airport Runway 12R ILS Localizer course extending from the airport to 10.5 miles northwest of the OBLIO LOM, and within 4 miles southwest and 7.9 miles northeast of the Lambert-St. Louis International Airport Runway 30L ILS localizer course extending from the airport to 8.7 miles southeast of the airport, and within a 6.9-mile radius of Spirit of St. Louis Airport, and within 2.5 miles each side of the 079° bearing from the Spirit of St. Louis Airport extending from the 6.9-mile radius of the airport to 8.1 miles east of the airport, and within 4.2 miles north and 6.4 miles south of the 079° bearing from the Spirit of St. Louis Runway 26L Localizer extending from the 6.9-mile radius of the Spirit of St. Louis Airport to 11.3 miles east of the Spirit of St. Louis Runway 26L Localizer, and within 3.9 miles each side of the 259° bearing from the Spirit of St. Louis Airport extending from the 6.9-mile radius of the airport to 10.6 miles west of the airport, and within a 6.4-mile radius of St. Charles County Smartt Airport, and within a 6.9-mile radius of St. Louis Regional Airport, and within 4 miles each side of the 014° bearing from the Civic Memorial NDB extending from the 6.9-mile radius of St. Louis Regional Airport to 7 miles north of the airport, and within 4.4 miles each side of the 190° radial of the St. Louis VORTAC extending from 2 miles south of the VORTAC to 22.1 miles south of the VORTAC.

    Issued in Fort Worth, Texas, on January 29, 2018. Christopher L. Southerland, Acting Manager, Operations Support Group, ATO Central Service Center.
    [FR Doc. 2018-02139 Filed 2-8-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0818; Airspace Docket No. 17-AGL-19] Revocation of Class E Airspace; Pulaski, WI AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This action removes Class E airspace extending upward from 700 feet above the surface at Carter Airport, Pulaski, WI. The FAA is proposing this action due to the cancellation of the instrument procedures into the airport, resulting in the airport no longer qualifying for controlled airspace.

    DATES:

    Effective 0901 UTC, May 24, 2018. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

    ADDRESSES:

    FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11B at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX, 76177; telephone (817) 222-5711.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it supports the removal of Class E airspace extending upward from 700 feet above the surface at Carter Airport, Pulaski, WI.

    History

    The FAA published a notice of proposed rulemaking in the Federal Register (82 FR 45749; October 2, 2017) for Docket No. FAA-2017-0818 to remove Class E airspace extending upward from 700 feet above the surface at Carter Airport, Pulaski, WI. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

    Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

    Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Rule

    This amendment to title 14, Code of Federal Regulations (14 CFR) part 71 removes the Class E airspace area extending upward from 700 feet above the surface within a 6.9-mile radius of Carter Airport, Pulaski, WI.

    This action is necessary due to the cancellation of the instrument procedures at Carter Airport. The removal of these procedures results in the airport no longer qualifying for controlled airspace.

    Regulatory Notices and Analyses

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

    Environmental Review

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

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    Adoption of the Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AGL WI E5 Pulaski, WI [Removed] Issued in Fort Worth, Texas, on January 29, 2018. Christopher L. Southerland, Acting Manager, Operations Support Group, ATO Central Service Center.
    [FR Doc. 2018-02137 Filed 2-8-18; 8:45 am] BILLING CODE 4910-13-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0649; FRL-9972-61] Cyflufenamid; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of cyflufenamid in or on cherry crop subgroup 12-12A, hops dried cones, and fruiting vegetable crop group 8-10; and amends the tolerance for cucurbit vegetable crop group 9. Nisso America, on behalf of Nippon Soda Co., Ltd. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective February 9, 2018. Objections and requests for hearings must be received on or before April 10, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0649, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

    B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl

    C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0649 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 10, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0649, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 23, 2017 (82 FR 14846) (FRL-9957-99), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F8512) by Nisso America on behalf of Nippon Soda Co., Ltd., 88 Pine Street, 14th Floor, New York, NY 10005. The petition requested that 40 CFR 180.667 be amended by establishing tolerances for residues of the fungicide cyflufenamid, in or on cherry crop subgroup 12-12A at 0.6 parts per million (ppm), hops at 5.0 ppm, and fruiting vegetable crop group 8-10 at 0.2 ppm. Then in the Federal Register of September 15, 2017 (82 FR 43352) (FRL-9965-43), EPA issued another document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing that this petition also requested the amendment of the existing tolerance for residues of cyflufenamid in or on cucurbit vegetable group 9, increasing the tolerance level from 0.07 ppm to 0.10 ppm. Those documents referenced a summary of the petition prepared by Nisso America on behalf of Nippon Soda Co., Ltd., the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notices of filing. EPA's response to these comments is discussed in Unit IV.C.

    III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

    Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for cyflufenamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with cyflufenamid follows.

    A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

    Cyflufenamid has low acute toxicity via the oral, dermal, and inhalation routes of exposure. Though slightly irritating to the eye, cyflufenamid is not a skin irritant or sensitizer. In the mammalian toxicology database, the liver was the primary target organ for cyflufenamid toxicity. Across species, duration and gender, changes in weight, clinical chemistry, and pathology indicated treatment-related perturbations in and adverse effects on liver function.

    Thyroid effects due to treatment with cyflufenamid, seen only in the rat, included increased follicular cell hypertrophy (as well as increased organ weight) and neoplastic thyroid follicular adenomas. Kidney effects related to treatment included increased kidney weight accompanied by tubular vacuolation and slight decreases in sodium and chloride concentrations.

    Treatment-related cardiotoxicity was noted in the rat and mouse feeding studies. Observed myocardial vacuolation and lipidosis may be attributed to decreased lipid metabolism; cyflufenamid caused an approximately 50% inhibition of carnitine palmitoyltransferase in both rat and mouse heart microsomal fractions in a non-guideline mechanistic study. Carnitine palmitoyltransferase is involved in the transport of long chain fatty acids into the mitochondrial matrix for oxidation. Fatty acid oxidation is an important source of energy for adenosine triphosphate (ATP) production in the mitochondria.

    Cyflufenamid-induced brain vacuolation was specific to the dog and not associated with any apparent clinical sign of neurotoxicity. Supplementary studies investigating this phenomenon determined that vacuolation was due to myelin edema affecting the white matter of the cerebrum and thalamus. Furthermore, this brain lesion was partially reversed after a 13-week recovery period (following 90-day exposure) and fully reversed after a 26-week recovery period. This effect was not observed in any other species. A subchronic neurotoxicity study in rats showed no evidence of neurotoxicity.

    Effects on reproductive organs and/or parameters have been previously noted in several subchronic studies; however, the effects occurred at doses above the respective lowest observed adverse effect level (LOAELs) from the studies used to derive the point of departures (POD)s. The PODs are protective of these effects. The developmental studies in rats and rabbits do not indicate any concern for increased susceptibility to offspring. Although offspring effects of decreased body weight and incomplete ossification were observed in rabbits, those effects occurred at doses higher than doses resulting in maternal effects and are believed to be related to maternal toxicity. Furthermore, the current PODs are protective of the effects seen on reproductive parameters in offspring. In addition, mating performance and fertility in the Parent/Filial (P/F)0 generation were both unaffected by treatment with cyflufenamid in the 2-generation reproductive toxicity study in rats. Sex ratio, sexual maturation, estrous cyclicity, sperm quantity and quality, mating performance and fertility, gestation and viability indices in the filial 1 (F1) generation were all unaffected by treatment.

    When tolerances were last established for cyflufenamid (77 FR 38204, June 27, 2012), EPA had classified cyflufenamid as “likely to be carcinogenic to humans” based on the presence of thyroid follicular cell tumors in male rats and liver tumors in male mice. Since that time, EPA has reevaluated the carcinogenic potential of cyflufenamid and based on available data has reclassified cyflufenamid as having “suggestive evidence of carcinogenicity.” A well-established non-mutagenic mode of action (MOA) for thyroid follicular cell tumors in male rats was tested and found acceptable. In summary, EPA has determined that because of the thyroid hormone imbalance, thyroid follicular cell tumors in male rats are likely to occur. That lead to an increase in the size (hypertrophy) and number (hyperplasia) of the thyroid follicular cells and eventually to thyroid neoplasia (or tumors). Because of marked quantitative differences between rats and humans in their inherent susceptibility for thyroid tumors in response to an imbalance in thyroid hormones, EPA concludes that cyflufenamid is not likely to pose a risk for thyroid follicular cell tumors in humans. As a result, the database contains the following data concerning carcinogenicity: (1) There is no evidence of carcinogenicity in female rats and mice; (2) the MOA data indicates that thyroid follicular cell tumors may not be relevant to humans; (3) tumors were only found in the liver in one gender of one species, i.e., male mice; and (4) there is no concern for mutagenicity or clastogenicity based on the results of the battery of genotoxicity studies. Therefore, EPA concludes that the chronic reference dose (cRfD) (0.044 mg/kg/day) will adequately account for all chronic toxicity, including carcinogenicity (which occurred only at a dose over 5000x higher than the cRfD) that could result from exposure to cyflufenamid.

    Specific information on the studies received and the nature of the adverse effects caused by cyflufenamid as well as the no-observed-adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies can be found at http://www.regulations.gov in document: “Cyflufenamid. Human Health Risk Assessment for Proposed Uses on Fruiting Vegetable Group 8-10, Cherry crop Subgroup 12-12A, and Hops; and a Revised Tolerance on Cucurbit Vegetable Group 9” on page 16 in docket ID number EPA-HQ-OPP-2016-0649.

    B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA identifies toxicological POD and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are based on a careful analysis of each toxicological study to determine the values of the NOAEL and the LOAEL. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

    A summary of the toxicological endpoints for cyflufenamid used for human risk assessment is shown in the Table of this unit.

    Table Summary of Points of Departure and Toxicity Endpoints Used in Human Risk Assessment Table—Summary of Toxicological Doses and Endpoints for Cyflufenamid for Use in Dietary, Non-Occupational and Occupational Human Health Risk Assessments Exposure/
  • scenario
  • Point of
  • departure
  • Uncertainty/FQPA safety factors RfD, PAD, level of concern for risk dssessment Study and toxicological effects
    Acute Dietary (All Populations) There were no appropriate toxicological effects attributable to a single exposure (dose) observed in appropriate toxicity studies. Therefore, a dose and endpoint were not identified for this risk assessment. Chronic Dietary (All Populations) NOAEL = 4.4 mg/kg/day UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Chronic RfD = 0.044 mg/kg/day
  • cPAD = 0.044 mg/kg/day
  • Combined Chronic Toxicity/Carcinogenicity Study in Rats.
  • LOAEL = 22 mg/kg/day based on increased thyroid/parathyroid weight, increased liver weight and centrilobular hepatocytic hypertrophy.
  • Dermal Short-Term (1-30 days) and Intermediate-Term (1-6 months) No adverse effects were observed in the dermal toxicity study and there are no concerns for developmental or neurological toxicities; therefore, no hazards are expected from these exposure scenarios. Inhalation Short-Term (1-30 days) and Intermediate-Term (1-6 months) NOAEL = 5 mg/kg/day UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Residential/Occupational LOC for MOE = 100 Prenatal Developmental Study in Rabbits.
  • Maternal LOAEL = 10 mg/kg/day based on decreased body weight, body weight gains and food consumption.
  • Cancer (oral, dermal, inhalation) Classification: “Suggestive evidence of carcinogenic potential” and quantification of risk using a non-linear approach (i.e., RfD approach) is appropriate. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to cyflufenamid, EPA considered exposure under the petitioned-for tolerances as well as all existing cyflufenamid tolerances in 40 CFR 180.667. EPA assessed dietary exposures from cyflufenamid in food as follows:

    i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

    No such effects were identified in the toxicological studies for cyflufenamid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

    ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America (USDA's NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100% crop treated (100% CT) for all commodities.

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to cyflufenamid. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.

    iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and PCT information in the dietary assessment for cyflufenamid. Tolerance-level residues and 100% CT were assumed for all food commodities.

    2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for cyflufenamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of cyflufenamid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

    The Agency used Tier II surface water and Tier I ground water simulations for all proposed cyflufenamid uses and label modifications. The estimated drinking water concentrations (EDWCs) of cyflufenamid for chronic exposures are 1.15 parts per billion (ppb) for surface water and 29.6 ppb for ground water.

    Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, no toxic effects attributable to a single exposure to cyflufenamid have been identified; therefore, an acute reference dose (aRfD) has not been established and an acute dietary exposure assessment was not conducted. For chronic and cancer dietary risk assessments, the ground water concentration value of 29.6 ppb was used to assess the contribution to drinking water.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

    Although the Agency previously assessed residential handler exposure and risk estimates from the use of cyflufenamid on ornamental use sites, the Agency now assumes that cyflufenamid is only used by commercial applicators based on labeling requiring handlers to use personal protective equipment (PPE). Therefore, the Agency concludes that there are no residential handler exposures to assess.

    The Agency has also determined that there are no post-application residential exposures to assess. Although there is a potential for residential dermal post-application exposure from the existing uses of cyflufenamid, there is no adverse systemic hazard via the dermal route of exposure. Moreover, there is no incidental oral exposure expected from cyflufenamid use on ornamental plants.

    Therefore, the Agency has concluded that there are no residential exposure scenarios to aggregate with dietary exposures for cyflufenamid.

    Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

    4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

    EPA has not found cyflufenamid to share a common mechanism of toxicity with any other substances, and cyflufenamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cyflufenamid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

    D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

    2. Prenatal and postnatal sensitivity. There is no evidence of susceptibility following in utero and/or postnatal exposure in the developmental toxicity studies in rats or rabbits, and in the 2-generation rat reproduction study. Neither the rat nor rabbit developmental studies identified teratogenic effects. The marginally higher incidence of incompletely ossified epiphyses and metacarpals/phalanges seen in rabbits may be associated with low fetal weight and are indicative of delayed embryo-fetal development. The combined offspring effects of decreased body weight and incomplete ossification are believed to be related to the observed maternal toxicity. Furthermore, the PODs selected for all exposure scenarios are lower than those doses causing adverse effects in offspring.

    There are no residual uncertainties concerning pre- and postnatal toxicity and no neurotoxicity concerns.

    3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

    i. The toxicity database for cyflufenamid is complete.

    ii. There is no indication that cyflufenamid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

    iii. There is no evidence that cyflufenamid results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

    iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to cyflufenamid in drinking water. These assessments will not underestimate the exposure and risks posed by cyflufenamid.

    E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

    1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, cyflufenamid is not expected to pose an acute risk.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to cyflufenamid from food and water will utilize 2.8% of the cPAD for the general U.S. population and 6.1% for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding the lack of residential use patterns, chronic residential exposure to residues of cyflufenamid is not expected.

    3. Short-term risk. A short-term adverse effect was identified for inhalation and oral exposures; however, cyflufenamid is not registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for cyflufenamid.

    4. Intermediate-term risk. An intermediate-term adverse effect was identified; however, cyflufenamid is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for cyflufenamid.

    5. Aggregate cancer risk for U.S. population. EPA has determined that quantification of risk using the RfD approach is appropriate and will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to cyflufenamid. Based on the conclusions of the chronic dietary assessment, EPA concludes that exposure to cyflufenamid is unlikely to pose an aggregate cancer risk.

    6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to cyflufenamid residues.

    IV. Other Considerations A. Analytical Enforcement Methodology

    Adequate enforcement methodology (High-Performance Liquid Chromatography Method with tandem mass spectrometry detection (LC/MS/MS), Method No. RD-01307) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]

    B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for cyflufenamid.

    C. Response to Comments

    Several comments were received on the publication. While some comments raised issues outside the scope of the FFDCA analysis, the remaining comments primarily expressed general concerns about the potential health effects of pesticides residues in or on food and one comment asked that the combined effects of multiple pesticides be considered on food commodities. None of the comments specifically mentioned any particular safety concerns with cyflufenamid nor did any commenters provide supporting information for the Agency to evaluate or on which the Agency could rely to support a finding on the petitioned-for tolerances.

    EPA recognizes that some individuals believe that pesticides should be banned on agricultural crops. The existing legal framework provided by section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), however, states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. EPA has assessed the effects of cyflufenamid on human health and determined that aggregate exposure to it will be safe. These comments provide no information to support an alternative conclusion.

    As noted in Unit III.C.4., Congress has directed EPA to consider the cumulative risk of pesticide residues with residues of “other substances that have a common mechanism of toxicity.” FFDCA section 408(b)(2)(D)(v). At this time, EPA has not concluded that cyflufenamid has a common mechanism of toxicity with any other pesticides. The petitioner has not provided any other information to support a different conclusion.

    D. Revisions to Petitioned-for Tolerances

    EPA is establishing tolerances that vary slightly from requests in the petition by adding another significant figure to the tolerance levels for subgroup 12-12A and group 8-10 and revising commodity term for hops to match the Agency's commodity vocabulary.

    V. Conclusion

    Therefore, tolerances are established for residues of cyflufenamid, in or on cherry crop subgroup 12-12A at 0.60 ppm; hop, dried cones at 5.0 ppm; and fruiting vegetable group 8-10 at 0.20 ppm; and the tolerance for residues in or on cucurbit vegetable group 9 is increased to 0.10 ppm.

    VI. Statutory and Executive Order Reviews

    This action establishes and amends tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997)), or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

    This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

    VII. Congressional Review Act

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

    List of Subjects in 40 CFR Part 180

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

    Dated: January 24, 2018. Michael Goodis, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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

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

    2. In § 180.667, amend the table in paragraph (a) by: i. Adding alphabetically the commodities “Cherry subgroup 12-12A”, “Hop, dried cones”, and “Vegetable, fruiting, group 8-10”, and ii. Revising the commodity “Vegetable, cucurbit, group 9”.

    The additions and revisions read as follows:

    §  180.667 Cyflufenamid; tolerances for residues.

    (a) * * *

    Commodity Parts per
  • million
  • *    *    *    *    *     Cherry subgroup 12-12A 0.60 *    *    *    *    *     Hop, dried cones 5.0 Vegetable, cucurbit, group 9 0.10 Vegetable, fruiting, group 8-10 0.20
    [FR Doc. 2018-02670 Filed 2-8-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0681; FRL-9972-69] Zoxamide; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of zoxamide in or on banana. Gowan Company, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective February 9, 2018. Objections and requests for hearings must be received on or before April 10, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0681, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

    B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

    C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0681 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 10, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0681, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9661-14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E8524) by Gowan Company, LLC, P.O. Box 556, Yuma, AZ 85366. The petition requested that 40 CFR 180.567 be amended by establishing a tolerance for residues of the fungicide zoxamide (3, 5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide), in or on banana at 0.3 parts per million (ppm). That document referenced a summary of the petition prepared by Gowan Company, LLC, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. EPA's response is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA has determined that a tolerance of 0.20 ppm on banana is appropriate rather than the petitioned-for 0.3 ppm tolerance. The reason for this change is explained in Unit IV.D.

    III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

    Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for zoxamide including exposure resulting from the import tolerance established by this action.

    A. Risk Assessment

    In the Federal Register of March 8, 2016 (81 FR 12011) (FRL-9942-18), EPA established tolerances for residues of zoxamide in or on several commodities. Because much of the safety assessment of zoxamide for the current action remains the same, EPA is incorporating several aspects of that previous rule and relying in part upon the findings made in the March 8, 2016 final rule in support of this action.

    A summary of the toxicological profile and endpoints used for human risk assessment is discussed in Units III.A. and III.B of the March 8, 2016 final rule. In evaluating dietary exposure for this action, EPA considered exposure under the petitioned-for tolerances as well as all existing zoxamide tolerances in 40 CFR 180.567. The residue data used for the acute and chronic dietary exposure assessments have not changed since the assessment supporting the March 8, 2016 final rule, except to incorporate the exposure associated with the tolerance on banana, for which the Agency assumed tolerance-level residues, default processing factors, and 100 percent crop treated. For a summary of how EPA assessed these dietary exposures, see Unit III.C.1 of the March 8, 2016 final rule. In addition, because there is no U.S. registration associated with the use of zoxamide on banana, the estimated drinking water exposures reported in the 2016 final rule remain the same for this rule. A summary of EPA's assessment of drinking water exposure is discussed in Unit III.C.2. of the March 8, 2016 final rule. Similarly, the Agency's assessment of cumulative risks remains the same as in the March 8, 2016 final rule.

    Because there have been no changes to the potential for prenatal and postnatal toxicity or in the completeness of data with respect to toxicity and exposure, EPA has determined that reliable data show the safety of infants and children would be adequately protected if the additional tenfold (10X) margin of safety required under section 408(b)(2)(C) (“FQPA safety factor”) were reduced to 1X. A summary of EPA's rationale for this determination is discussed in Unit III.D. of the March 8, 2016 final rule.

    B. Determination of Safety

    EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population-adjusted dose (aPAD) and chronic population-adjusted dose (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure exists.

    No acute effects were identified in the toxicological studies for zoxamide; therefore, a quantitative acute dietary exposure assessment is unnecessary. The chronic dietary risk is 1.8% of the chronic population adjusted dose (cPAD) for the general U.S. population and 6.4% of the cPAD for children 1 to 2 years old, the population subgroup with the highest estimated chronic dietary exposure to zoxamide. The Agency level of concern are percentage numbers greater than 100% of the cPAD. Because there are no existing or proposed residential uses for zoxamide, there are no exposures expected via the residential exposure pathway. Therefore, all aggregate risk estimates are expected to be equivalent only to dietary (food and drinking water) risk estimates mentioned above.

    Therefore, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to zoxamide residues.

    For a detailed discussion of the aggregate risk assessments and determination of safety for these tolerances, please refer both to the March 8, 2016 final rule and its supporting documents, available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2014-0922, and to the risk assessment for this current action “Zoxamide: Human Health Risk Assessment for the Petition for a Tolerance Without U.S. Registration for Residues in/on Banana.” in docket ID number EPA-HQ-OPP-2016-0681.

    IV. Other Considerations A. Analytical Enforcement Methodology

    A gas chromatography/mass selective detection (GC/MSD) method, modified Rohm and Haas Method #34-99-85, was previously submitted and concurrently revalidated with the submission of the current petition for the determination of residues of zoxamide in/on samples of banana. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

    B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

    The Codex has not established a MRL for zoxamide.

    C. Response to Comments

    One comment was received from an anonymous respondent. The comment is general to all pesticides and is against tolerances being approved for any chemical on any commodity. Although the Agency recognizes that some individuals believe that no residue of pesticides should be allowed in or on food, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) authorizes the establishment of pesticide tolerances or exemptions where the Agency determines that tolerance or exemption meets the safety standard imposed by the statute. EPA has sufficient data to support a safety determination for the tolerance for residues of zoxamide in or on banana. The commenter provided no additional information supporting a determination that the exemption is not safe.

    D. Revisions to Petitioned-For Tolerances

    The Agency is establishing a tolerance for residues of zoxamide in or on banana at 0.20 ppm, which is lower than the 0.30 ppm tolerance requested. This is because there is a difference between how the petitioner calculated the proposed tolerance and how the Agency calculates the tolerance. The 0.20 ppm tolerance being set on banana was calculated using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures and available field-trial residue data. The field-trial data on unbagged, whole fruit banana residues with a 0-day pre-harvest interval (PHI) were used from each field trial to calculate the tolerance.

    V. Conclusion

    Therefore, a tolerance is established for residues of zoxamide, (3, 5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide), in or on banana at 0.20 ppm.

    VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

    This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

    VII. Congressional Review Act

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

    List of Subjects in 40 CFR Part 180

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

    Dated: January 23, 2018. Michael Goodis, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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

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

    2. In § 180.567, add alphabetically the entry “Banana” to the table in paragraph (a) and add footnote 1 to the table to read as follows:
    § 180.567 Zoxamide; tolerances for residues.

    (a) * * *

    (1) * * *

    Commodity Parts per million Banana 1 0.20 *    *    *    *    * 1 There are no U.S. registrations allowing use of zoxamide on banana as of February 9, 2018.
    [FR Doc. 2018-02668 Filed 2-8-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R2-ES-2016-0077; 4500030113] RIN 1018-BB34 Endangered and Threatened Wildlife and Plants; Endangered Species Status for Texas Hornshell AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Final rule.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), determine endangered species status under the Endangered Species Act of 1973 (Act), as amended, for the Texas hornshell (Popenaias popeii), a freshwater mussel species from New Mexico, Texas, and Mexico. The effect of this regulation will be to add this species to the List of Endangered and Threatened Wildlife.

    DATES:

    This rule becomes effective March 12, 2018.

    ADDRESSES:

    This final rule is available on the internet at http://www.regulations.gov in Docket No. FWS-R2-ES-2016-0077 and in https://www.fws.gov/southwest/es/TexasCoastal/. Comments and materials we received, as well as supporting documentation we used in preparing this rule, are available for public inspection at http://www.regulations.gov. Comments, materials, and documentation that we considered in this rulemaking will be available by appointment, during normal business hours at the address shown in FOR FURTHER INFORMATION CONTACT.

    FOR FURTHER INFORMATION CONTACT:

    Charles Ardizzone, U.S. Fish and Wildlife Service, Texas Coastal Ecological Services Field Office, 17629 El Camino Real #211, Houston, TX 77058; or by telephone 281-286-8282. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service at 800-877-8339. Website: https://www.fws.gov/southwest/es/TexasCoastal/.

    SUPPLEMENTARY INFORMATION:

    Executive Summary

    Why we need to publish a rule. Under the Endangered Species Act, a species is added to the Federal List of Endangered and Threatened Wildlife if it is endangered or threatened throughout all or a significant portion of its range. Listing a species as an endangered or threatened species can only be completed by issuing a rule. The Lists of Endangered and Threatened Wildlife and Plants are located in title 50 of the Code of Federal Regulations (CFR) in part 17.

    What this rule does. This rule finalizes the listing of the Texas hornshell (Popenaias popeii) as an endangered species. The species will be added to the List of Endangered and Threatened Wildlife at 50 CFR 17.11(h).

    The basis for our action. Under the Endangered Species Act, we can determine that a species is an endangered or threatened species based on any of the following factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) Overutilization for commercial, recreational, scientific, or educational purposes; (C) Disease or predation; (D) The inadequacy of existing regulatory mechanisms; or (E) Other natural or manmade factors affecting its continued existence.

    The Texas hornshell is an endangered species based on impairment of water quality, loss of flowing water, and accumulation of fine sediment (Factor A), predation (Factor C), and barriers to host fish movement and the effects of climate change (Factor E).

    Peer review and public comment. We prepared a species status assessment report (SSA report) for the Texas hornshell. The SSA report documents the results of the comprehensive biological status review for the Texas hornshell and provides an account of the species' overall viability through forecasting of the species' condition in the future (Service 2018, entire). We sought comments on the SSA report from independent specialists to ensure that our analysis was based on scientifically sound data, assumptions, and analyses. We received feedback from four scientists with expertise in freshwater mussel biology, ecology, and genetics. During the comment period for the proposed rule, we reached out to an additional five peer reviewers, and we received responses from three. We incorporated peer review suggestions and comments into the SSA report and the final listing rule. The SSA report and other materials relating to this proposal can be found at http://www.regulations.gov under Docket No. FWS-R2-ES-2016-0077.

    Previous Federal Actions

    On August 10, 2016, we published a proposed rule (81 FR 52796) to list the Texas hornshell as an endangered species under the Endangered Species Act of 1973, as amended (Act; 16 U.S.C. 1531 et seq.). The publication of this proposed rule complied with a deadline established in a court-approved settlement agreement (Endangered Species Act Section 4 Deadline Litigation, No. 10-377 (EGS), MDL Docket No. 2165 (D.D.C. May 10, 2011)). That proposal had a 60-day comment period, ending October 11, 2016. We reopened the comment period for 30 days on May 30, 2017 (82 FR 24654), in order to hold two public hearings on the proposed rule. We then extended the final listing determination for 6 months due to substantial scientific disagreement about the species' status in Mexico and reopened the comment period for an additional 30 days (82 FR 37397). For a description of previous Federal actions concerning the Texas hornshell, please refer to the August 10, 2016, proposed listing rule (81 FR 52796).

    Background

    A thorough review of the taxonomy, life history, and ecology of Texas hornshell (Popenaias popeii) is presented in the SSA report (Service 2018, entire).

    Species Description

    The Texas hornshell is a medium-sized (3 to 4 inches long) freshwater mussel with a dark brown to green, elongate, laterally compressed shell (Howells et al. 1996, p. 93; Carman 2007, p. 2). The Texas hornshell was described by Lea (1857, p. 102) from the Devils River in Texas and Rio Salado in Mexico. Currently, the Texas hornshell is classified in the unionid subfamily Ambleminae (Campbell et al. 2005, pp. 140, 144) and is considered a valid taxon by the scientific community (Williams et al. 2017, p. 42).

    Freshwater mussels, including the Texas hornshell, have a complex life history. Males release sperm into the water column, which are taken in by the female through the incurrent siphon (the tubular structure used to draw water into the body of the mussel). The sperm fertilize the eggs, which are held during maturation in an area of the gills called the marsupial chamber. The developing larvae remain in the gill chamber until they mature and are ready for release. These mature larvae, called glochidia, are obligate parasites (cannot live independently of their hosts) on the gills, head, or fins of fishes (Vaughn and Taylor 1999, p. 913). Glochidia die if they fail to find a host fish, attach to a fish that has developed immunity from prior infestations, or attach to the wrong location on a host fish (Neves 1991, p. 254; Bogan 1993, p. 599). Glochidia encyst (enclose in a cyst-like structure) on the host's tissue, draw nutrients from the fish, and develop into juvenile mussels weeks or months after attachment (Arey 1932, pp. 214-215).

    For the Texas hornshell, spawning generally occurs from March through August (Smith et al. 2003, p. 335), and fertilized eggs are held in the marsupial chambers of females for 4 to 6 weeks (Smith et al. 2003, p. 337). Glochidia are released in a sticky mucous net or string (Carman 2007, p. 9); the host fish likely swim into the nets, and the glochidia generally attach to the face or gills of the fish and become encysted in its tissue (Levine et al. 2012, p. 1858). The glochidia will remain encysted for about a month through transformation to the juvenile stage. Once transformed, the juveniles will excyst from the fish and drop to the substrate. The known primary host fishes for the Texas hornshell are river carpsucker (Carpiodes carpio), grey redhorse (Moxostoma congestum), and red shiner (Cyprinella lutrensis) (Levine et al. 2012, pp. 1857-1858).

    Mussels are generally immobile but experience their primary opportunity for dispersal and movement within the stream as glochidia attached to a mobile host fish (Smith 1985, p. 105). Upon release from the host, newly transformed juveniles drop to the substrate on the bottom of the stream. Those juveniles that drop in unsuitable substrates die because their immobility prevents them from relocating to more favorable habitat. Juvenile freshwater mussels burrow into interstitial substrates and grow to a larger size that is less susceptible to predation and displacement from high-flow events (Yeager et al. 1994, p. 220). Throughout the rest of their life cycle, mussels generally remain within the same small area where they excysted from the host fish.

    The actual lifespan is not known for the Texas hornshell, although two adult individuals were captured and marked in the Black River in New Mexico in 1997 and were recaptured 15 years later (Inoue et al. 2014, p. 5). Species in the subfamily Ambleminae, which includes Texas hornshell, commonly live more than 20 years (Carman 2007, p. 9), so we believe the Texas hornshell can live at least 20 years.

    Little is known about the specific feeding habits of Texas hornshell. Like all adult freshwater mussels, Texas hornshell are filter feeders, siphoning suspended phytoplankton and detritus from the water column (Yeager et al. 1994, p. 221; Carman 2007, p. 8).

    Habitat and Range

    Adult Texas hornshell occur in medium to large rivers, in habitat not typical for most mussel species: In crevices, undercut riverbanks, travertine shelves, and under large boulders adjacent to runs (Carman 2007, p. 6; Randklev et al. 2015, p. 8), although in the Devils River, the species is found in gravel beds at the heads of riffles and rapids (Randklev et al. 2015, p. 8). Small-grained material, such as clay, silt, or sand, gathers in these crevices and provides suitable anchoring substrate. These crevices are considered to be flow refuges from the large flood events that occur regularly in the rivers this species occupies. Texas hornshell are able to use these flow refuges to avoid being swept away as large volumes of water move through the system, as there is relatively little particle movement in the flow refuges, even during flooding (Strayer 1999, p. 472). Texas hornshell are not known to occur in lakes, ponds, or reservoirs.

    The Texas hornshell historically ranged throughout the Rio Grande drainage in the United States (New Mexico and Texas) and Mexico. Individuals that had previously been identified as Texas hornshell in Mexican Gulf Coastal streams (Johnson 1999, p. 23), including in our proposed rule to list the species, have recently been determined to belong to a different, undescribed species (Inoue 2017, p. 1). Currently, five known populations of Texas hornshell remain in the United States: Black River (Eddy County, New Mexico), Pecos River (Val Verde County, Texas), Devils River (Val Verde County, Texas), Lower Canyons of the Rio Grande (Brewster and Terrell Counties, Texas), and Lower Rio Grande near Laredo (Webb County, Texas) (Map 1). They are described briefly below.

    ER09FE18.004

    Black River: The Black River, in Eddy County, New Mexico, originates from several groundwater-fed springs and flows approximately 30 miles (mi) (48 kilometers (km)) through the Chihuahuan Desert until its confluence with the Pecos River (Inoue et al. 2014, p. 3) near Malaga, New Mexico. Extensive population monitoring (Lang 2001, entire; 2006, entire; 2010, entire; 2011, entire) and a long-term mark-recapture study (Inoue et al. 2014, entire) have yielded significant information about the population size and extent. Texas hornshell occur in approximately 8.7 mi (14.0 km) of the middle Black River, between two low-head (small) dams (Lang 2001, p. 20). The total population size has been estimated at approximately 48,000 individuals (95 percent confidence interval: 28,849-74,127) (Inoue et al. 2014, p. 7), with a diversity of size classes, primarily aggregated in flow refuges within narrow riffles. The population remained relatively stable over the 15-year study period from 1997 to 2012 (Inoue et al. 2014, p. 6).

    Pecos River: In the Pecos River, inundation from Amistad Reservoir has resulted in the extirpation of Texas hornshell from the lower reaches of the river. Additionally, salinity levels are too high for freshwater mussel habitation in much of the Pecos River from the confluence with the Black River in New Mexico, downstream to the confluence with Independence Creek. However, in 2016, researchers collected three old, live Texas hornshell and 37 shells from a small section of the Pecos River downstream of the confluence with Independence Creek and upstream of Amistad Reservoir near Pandale in Val Verde County, Texas (Bosman et al. 2016, p. 6; Randklev et al. 2016, p. 9). Numerous dead shells were found farther downstream in the Pecos River in 2016 (Bosman et al. 2016, p. 6; Randklev et al. 2016, p. 9). Prior to this collection, live individuals had not been collected in the Pecos River since 1973 (Randklev et al. 2016, p. 4).

    Because the number of live individuals detected is so small (three live individuals found in 2016), it is difficult to draw many conclusions about the overall abundance and health of the population. The population appears to be extremely small, the live individuals were old, and no evidence of reproduction such as young individuals or gravid females (females with mature larvae within the gills) was noted.

    Devils River: Texas hornshell were historically found in the Devils River and were known to occupy only the lower reaches of the river, which are currently inundated by Amistad Reservoir (Neck 1984, p. 11; Johnson 1999, p. 23; Burlakova and Karatayev 2014, p. 19). Between 2008 and 2014, researchers collected 11 individuals from upstream in the Devils River (Burlakova and Karatayev 2014, p. 16; Karatayev et al. 2015, p. 4). More intensive surveys conducted in 2014, 2015, and 2017, including 20 sites, have yielded more than 150 individuals in approximately 29 mi (47 km) of the river—all from The Nature Conservancy's Dolan Falls Preserve and the Devils River State Natural Area's Dan A. Hughes Unit (formerly known as the Big Satan Unit) (Randklev et al. 2015, pp. 6-7; Diaz 2017, p. 1). Because of the increased number of individuals collected since 2014, it is likely that the Devils River population is more numerous than previously thought, although we do not expect that this population is particularly large based on the limited number of collections to date. Interestingly, Texas hornshell in the Devils River occupy different habitats than those in the rest of the range; instead of being found under rock slabs and in travertine shelves, they occupy gravel beds at the heads of riffles or in clean-swept pools with bedrock (Randklev et al. 2015, p. 8). Even though the number of collected individuals is small, several young individuals were found, as well as gravid females (Randklev et al. 2015, p. 8), indicating reproduction and recruitment (offspring survive to join the reproducing population) are occurring in the Devils River population.

    Rio Grande-Lower Canyons: One of two remaining populations of Texas hornshell in the Rio Grande is found in the Lower Canyons, just downstream of Big Bend National Park, in Terrell County, Texas. The species is found in low density (approximately 40 individuals per km) in this region of the Rio Grande (Burlakova and Karatayev 2014, p. 16). Subsequent surveys confirmed the presence of Texas hornshell in approximately 18.5 mi (30 km) of the Lower Canyons in two sections, finding that the species occupies approximately 63 percent of sites with suitable (rocky) habitat (Randklev et al. 2015, entire). For purposes of this analysis, we believe the species is present in the entire section between these collections, approximately 62 mi (100 km). Sites in the Rio Grande-Lower Canyons reach vary in density, with the densest sites near Sanderson Canyon, Terrell County, Texas, and decreasing downstream (Randklev et al. 2015, p. 13); the average density of Texas hornshell at each site is lower compared to the Black River and Rio Grande-Laredo (5 ± 14 individuals per site). We expect Texas hornshell to occur between the known occupied sections where we have documented presence of the species, near the confluence with San Francisco Creek (Howells 2001a, p. 6), but limited access has prevented recent surveys for the species. Young individuals and gravid females have been found throughout the Lower Canyons reach, indicating recruitment is occurring (Randklev et al. 2015, p. 8). Scientific modeling reveals that Texas hornshell are found in areas near spring inflows in rocky habitats in the Lower Canyons reach (Randklev et al. 2017, pp. 5-6).

    Rio Grande-Laredo: The largest Texas hornshell population occurs from Laredo, Texas (near La Bota Ranch just northwest of Laredo), upstream approximately 56 mi (90 km) (Randklev et al. 2015, p. 7). The density in this reach is high, with some habitat patches containing more than 8,000 individuals (Karatayev et al. 2015, p. 4) and 100 percent of surveyed patches of suitable habitat containing Texas hornshell (Randklev et al. 2015, p. 7). Throughout this reach, the density of Texas hornshell was estimated 170 ± 131 individuals per suitable (rocky) habitat site (Randklev et al. 2015, p. 7). Young individuals and gravid females have been found throughout the Laredo reach, indicating reproduction and recruitment are occurring (Randklev et al. 2015, p. 8). Within this reach, Texas hornshell are found in rocky habitats in areas with appropriate water quality (Randklev et al. 2017, pp. 5-6). No live Texas hornshell have been found downstream of the city of Laredo in recent years.

    Mexico: The species historically occurred in the Rio Salado basin, which is a tributary to the Rio Grande in Mexico. Rio Salado and several tributaries were surveyed in the early 2000s, with several recently dead shells collected in 2001 and 2002 in a tributary to Rio Salado, the Rio Sabinas (Strenth et al. 2004, p. 225). The surveyed portions of riverbed were reported to be dry with no evidence of recent water flow, so it is unlikely these shells represent an abundant Texas hornshell population.

    In the mainstem Rio Salado, several old shells and one recently dead shell were collected at two sites in 2002 (Strenth et al. 2004, p. 227). As with the Rio Sabinas, the river exhibited no flow; at one site, household waste was reported. These rivers, and many others in this region of Mexico, have been noted as losing flow and becoming dry or intermittent since the mid-1990s (Contreras-B. and Lozano-V. 1994, p. 381).

    In 2017, eight sites in four rivers in the Rio Salado basin were surveyed for Texas hornshell. No live individuals were found at any site, and three long dead shells were found at one site in the Rio Nadadores (Hein et al. 2017, p. 3), further indicating that the species may be extirpated from the Rio Salado basin.

    Separately, Texas hornshell were thought to occur in approximately 15 rivers that flow into the Gulf of Mexico and are not tributaries to the Rio Grande. Recent genetic analysis of museum samples indicates that individuals that had previously been identified as Texas hornshell in these Mexican Gulf Coastal streams belong to a different, undescribed species (Inoue 2017, p. 1). Therefore, we conclude that the Texas hornshell was never native to Gulf Coastal rivers outside of the Rio Grande basin, and it is endemic to the Rio Grande basin in the United States and Mexico.

    Species Needs

    Texas hornshell need seams of fine sediment in crevices, undercut riverbanks, travertine shelves, and large boulders in riverine ecosystems with flowing water and periodic cleansing flows to keep the substrate free of excess fine sediment accumulation. They need water quality parameters to be within a suitable range (Randklev et al. 2017, p. 5) (i.e., dissolved oxygen above 3 milligrams/liter (mg/L), salinity below 0.9 parts per thousand, and ammonia below 0.7 mg/L (Sparks and Strayer 1998, p. 132; Augspurger et al. 2003, p. 2574; Augspurger et al. 2007, p. 2025; Carman 2007, p. 6)), and phytoplankton and bacteria as food. Finally, Texas hornshell need host fish to be present during times of spawning.

    We describe the Texas hornshell's viability by characterizing the status of the species in terms of its resiliency (ability of the populations to withstand stochastic events), redundancy (ability of the species to withstand large-scale, catastrophic events), and representation (the ability of the species to adapt to changing environmental conditions). Using various timeframes and the current and projected resiliency, redundancy, and representation, we describe the species' level of viability over time. For the Texas hornshell to maintain viability, its populations or some portion thereof must be resilient. A number of factors influence the resiliency of Texas hornshell populations, including occupied stream length, abundance, and recruitment. Elements of Texas hornshell habitat that determine whether Texas hornshell populations can grow to maximize habitat occupancy influence those factors, thereby increasing the resiliency of populations. These resiliency factors and habitat elements are discussed here.

    Occupied Stream Length: Most freshwater mussels, including Texas hornshell, are found in aggregations, called mussel beds, that vary in size from about 50 to greater than 5,000 square meters (m2) (540 to greater than 53,800 square feet (ft2)), separated by stream reaches in which mussels are absent or rare (Vaughn 2012, p. 983). Resilient Texas hornshell populations must occupy stream reaches sufficient in length such that stochastic events that affect individual mussel beds do not eliminate the entire population. Repopulation by fish infested with Texas hornshell glochidia from other mussel beds within the reach, if present and hydrologically connected, can allow the population to recover from these events.

    Abundance: Mussel abundance in a given stream reach is a product of the number of mussel beds and the density of mussels within those beds. For populations of Texas hornshell to be resilient, there must be many mussel beds of sufficient density (~200 individuals per 150 m2 (1,614 ft2); see SSA report for more discussion) such that local stochastic events do not necessarily eliminate the bed(s), allowing the mussel bed and the overall population in the stream reach to recover from any single event. We measure Texas hornshell abundance by the number of beds within the population, and the estimated density of Texas hornshell within each.

    Reproduction: Resilient Texas hornshell populations must also be reproducing and successfully recruiting young individuals into the reproducing population. Population size and abundance reflects previous influences on the population and habitat, while reproduction and recruitment indicate population trends that may be stable, increasing, or decreasing. Detection of very young juvenile mussels during routine abundance and distribution surveys happens extremely rarely due to sampling bias; sampling for this species involves tactile searches, and mussels below about 35 millimeters (mm) (1.4 inches (in)) are very hard to detect. Therefore, reproduction is verified by repeatedly capturing small-sized individuals near the low end of the detectable size range (about 35 mm (1.4 in)) over time and by capturing gravid females during the reproductively active time of year (generally, March through August (Smith et al. 2003, p. 335)).

    Substrate: Texas hornshell occur in flow refuges such as crevices, undercut riverbanks, travertine shelves, and large boulders. These refuges must have seams of clay or other fine sediments within which the mussels may anchor, but not so much excess sediment that the mussels are smothered. Those areas with clean-swept substrate with seams of fine sediments are considered to have suitable substrate, and those with copious fine sediment both in crevices and on the stream bottom are considered less suitable.

    Flowing Water: Texas hornshell need flowing water for survival. They are not found in lakes or in pools without flow, or in areas that are regularly dewatered. River reaches with continuous flow are considered suitable habitat, while those with little or no flow are considered not suitable.

    Water Quality: Freshwater mussels, as a taxonomic group, are sensitive to changes in water quality parameters such as dissolved oxygen, salinity, ammonia, and pollutants (i.e., dissolved oxygen above 3 mg/L, salinity below 0.9 parts per thousand, and ammonia below 0.7 mg/L (Sparks and Strayer 1998, p. 132; Augspurger et al. 2003, p. 2574; Augspurger et al. 2007, p. 2025; Carman 2007, p. 6)). Habitats with appropriate levels of these parameters are considered suitable, while those habitats with levels outside of the appropriate ranges are considered less suitable.

    Maintaining representation in the form of genetic or ecological diversity is important to maintain Texas hornshell's capacity to adapt to future environmental changes. Texas hornshell populations in the Rio Grande and Devils River (and, presumably, the Pecos River, due to its proximity to Rio Grande populations) have distinct variation in allele frequencies from those in the Black River (Inoue et al. 2015, p. 1916). Mussels, like Texas hornshell, need to retain populations throughout their range to maintain the overall potential genetic and life-history attributes that can buffer the species' response to environmental changes over time (Jones et al. 2006, p. 531). The Texas hornshell has likely lost genetic diversity as populations have been extirpated. As such, maintaining the remaining representation in the form of genetic diversity may be important for the capacity of the Texas hornshell to adapt to future environmental change.

    Finally, the Texas hornshell needs to have multiple resilient populations distributed throughout its range to provide for redundancy, the ability of the species to withstand catastrophic events. The more populations, and the wider the distribution of those populations, the more redundancy the species will exhibit. Redundancy reduces the risk that a large portion of the species' range will be negatively affected by a catastrophic natural or anthropogenic event at a given point in time. Species that are well-distributed across their historical range are considered less susceptible to extinction and have higher viability than species confined to a small portion of their range (Carroll et al. 2010, entire; Redford et al. 2011, entire).

    Summary of Biological Status and Threats

    Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species is an “endangered species” or a “threatened species.” The Act defines an endangered species as a species that is “in danger of extinction throughout all or a significant portion of its range,” and a threatened species as a species that is “likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” The Act directs us to determine whether any species is an endangered species or a threatened species because of one or more of the following factors affecting its continued existence: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence.

    We completed a comprehensive assessment of the biological status of the Texas hornshell and prepared a report, which provides a thorough account of the species' overall viability. We define viability as the ability of the Texas hornshell to sustain populations in natural river systems over time. In this section, we summarize the conclusions of that assessment, which can be accessed at Docket No. FWS-R2-ES-2016-0077 on http://www.regulations.gov. Please refer to Chapter 4 of the SSA report for a more detailed discussion of the factors affecting the Texas hornshell.

    Risk Factors

    We reviewed the potential risk factors (i.e., threats, stressors) that could be affecting the Texas hornshell now and in the future. In this final rule, we will discuss only those factors in detail that could meaningfully impact the status of the species. Those risks that are not known to have effects on Texas hornshell populations, such as collection and disease, are not discussed here. The primary risk factors affecting the status of the Texas hornshell are: (1) Increased fine sediment (Factor A), (2) water quality impairment (Factor A), (3) loss of flowing water (Factor A), (4) barriers to fish movement (Factor E), and (5) increased predation (Factor C). These factors are all exacerbated by the effects of climate change (Factor E). We also factored into our analysis the degree to which existing regulatory mechanisms either ameliorate or exacerbate these risk factors (Factor D). We also reviewed the conservation efforts being undertaken for the species.

    Increased Fine Sediment

    Texas hornshell require seams of fine sediment under boulders and bedrock and in streambanks in order to anchor themselves into place on the stream bottom; however, too much fine sediment can fill in these crevices and smother any mussels inhabiting those spaces. Under natural conditions, fine sediments collect on the streambed and in crevices during low flow events, and they are washed downstream during high flow events (also known as cleansing flows).

    However, the increased frequency of low flow events (from groundwater extraction, instream surface flow diversions, and drought), combined with a decrease in cleansing flows (from reservoir management and drought), has caused sediment to accumulate to some degree at all populations. When water velocity decreases, which can occur from reduced streamflow or inundation, water loses its ability to carry sediment in suspension, and sediment falls to the substrate, eventually smothering mussels that cannot adapt to soft substrates (Watters 2000, p. 263). Sediment accumulation can be exacerbated when there is a concurrent increase in the sources of fine sediments in a watershed. In the range of Texas hornshell, these sources include streambank erosion from agricultural activities, livestock grazing, and roads, among others.

    Interstitial spaces (small openings between rocks and gravels) in the substrate provide essential habitat for juvenile mussels. Juvenile freshwater mussels burrow into interstitial substrates, making them particularly susceptible to degradation of this habitat feature. When clogged with sand or silt, interstitial flow rates and spaces may become reduced (Brim Box and Mossa 1999, p. 100), thus reducing juvenile habitat availability.

    All populations of Texas hornshell face the risk of fine sediment accumulation to varying degrees. Elimination of Texas hornshell from mussel beds due to large amounts of sediment deposition has been documented on the Black River in two locations in recent years. In the future, we expect this deposition may continue to occur sporadically. Fine sediments are also accumulating at the Rio Grande-Laredo population. Low water levels in the Devils River will likely lead to additional sediment accumulation at this population, as well. In the future, we expect lower flows to occur more often at all populations and for longer periods due to the effects of climate change (Nohara et al. 2006, p. 1087; Bren School of Environmental Management 2014, p. 91; Miyazono et al. 2015, p. A-3).

    Water Quality Impairment

    Water quality can be impaired through contamination or alteration of water chemistry. Chemical contaminants are ubiquitous throughout the environment and are a major reason for the current declining status of freshwater mussel species nationwide (Augspurger et al. 2007, p. 2025). Chemicals enter the environment through both point and nonpoint discharges, including spills, industrial sources, municipal effluents, and agricultural runoff. These sources contribute organic compounds, nutrients, heavy metals, pesticides, herbicides, and a wide variety of newly emerging contaminants to the aquatic environment. Ammonia is of particular concern below wastewater treatment plants because freshwater mussels have been shown to be particularly sensitive to increased ammonia levels (Augspurger et al. 2003, p. 2569). It is likely for this reason that Texas hornshell are not found for many miles downstream of two wastewater treatment plants that discharge into the Rio Grande at Nuevo Laredo, Mexico, and at Eagle Pass, Texas (Karatayev et al. 2015, p. 14; Randklev et al. 2017, p. 5).

    An additional type of water quality impairment is alteration of water quality parameters such as dissolved oxygen, temperature, and salinity levels. Dissolved oxygen levels may be reduced from increased nutrients in the water column from runoff or wastewater effluent, and juveniles seem to be particularly sensitive to low dissolved oxygen (Sparks and Strayer 1998, pp. 132-133). Increased water temperature from climate change and from low flows during drought can exacerbate low dissolved oxygen levels as well as change the timing of spawning and glochidial release. Finally, salinity appears to be particularly limiting to Texas hornshell. The aquifer near Malaga, New Mexico, contains saline water. As the saline water emerges from the ground, it is diluted by surface flow. As surface flow decreases, however, the concentration of salinity in the river increases. Additionally, aquifers have become increasingly saline due to salinized water recharge (Hoagstrom 2009, p. 35). Irrigation return flows exacerbate salinity levels as salts accumulate on irrigated lands and then are washed into the riverway. The Pecos River from the confluence with the Black River to the confluence with Independence Creek has become particularly saline in the past few decades, with levels at 7 parts per million (ppm) or higher, which is too high for freshwater mussel habitation. Additionally, the Black River downstream of the Texas hornshell population has had salinity levels in the range of 6 ppm, which may be one reason the population has been extirpated from the downstream reach.

    Contaminant spills are also a concern. In particular, the Black River population is vulnerable to spills from the high volume of truck traffic crossing the river at low water access points (Bren School of Environmental Management 2014, p. 26). Due to the topography and steep slopes of these areas, spilled contaminants and contaminated soils could directly enter the surface water of the river and negatively impact the species (Boyer 1986, p. 300) and downstream habitat. For the smaller populations (Black, Devils, and Pecos Rivers), a single spill could eliminate the entire population.

    In August of 2017, 18,000 barrels of wastewater from oil and gas production and 11 barrels of oil were spilled from a ruptured pipeline into the Delaware River, upstream of the Texas hornshell reintroduction site (Eaton 2017, p. 1), demonstrating a risk of contaminant spills in this area. A boom was deployed to collect some of the oil, but wastewater mixes with river water and cannot be collected (Onsurez 2017, p. 1). An Administrative Order was issued by the Environmental Protection Agency (EPA) on October 16, 2017 (EPA 2017), directing that a pollution prevention plan be created to prevent such spills in the future, but no other regulatory action was taken. Safety concerns due to poor water quality from the spill have prevented surveys to determine if the reintroduced individuals survived the event.

    Any reduction in surface flow from drought, instream diversion, or groundwater extraction results in concentrated contaminant and salinity levels, increased water temperatures in streams, and exacerbated effects to Texas hornshell individuals and populations.

    Poor water quality currently affects most Texas hornshell populations to some degree, and future water quality is expected to decrease due to decreasing river flow and increasing temperatures. The Pecos River experiences very high salinity levels upstream of the existing population, and we expect that the observed high mortality of the Pecos River population is due to salinity pulses. Rangewide, as water flow is expected to decrease due to climate change, water quality will decline.

    Loss of Flowing Water

    Texas hornshell populations need flowing water in order to survive. Low flow events (including stream drying) and inundation can eliminate appropriate habitat for Texas hornshell, and while the species can survive these events if they last for only a short time (days or weeks, depending on the time of year), populations that experience these events regularly will not persist.

    Inundation has primarily occurred upstream of dams, both large (such as Amistad, Falcon, and Red Bluff Dams) and small (low water crossings and diversion dams, such as those on the Black River). Inundation causes an increase in sediment deposition, eliminating the crevices this species inhabits. In large reservoirs, deep water is very cold and often devoid of oxygen and necessary nutrients. Cold water (less than 11 degrees Celsius (°C) (52 degrees Fahrenheit (°F))) has been shown to stunt mussel growth (Hanson et al. 1988, p. 352). Because glochidial release may be temperature dependent, it is likely that relict individuals living in the constantly cold hypolimnion (deepest portion of the reservoir) in these reservoirs may never reproduce, or reproduce less frequently. Additionally, the effects of these reservoirs extend beyond inundation and fragmentation of populations; the reservoirs are managed for flood control and water delivery, and the resultant downstream releases rarely mimic natural flow regimes, tempering the natural fluctuations in flow that flush fine sediments from the substrate.

    At the Rio Grande-Laredo population, a low-water weir has been proposed for construction (Rio Grande Regional Water Planning Group 2016, p. 8-8). The dam would be located just downstream of the La Bota area, which contains the largest known and most dense Texas hornshell bed within the Rio Grande-Laredo population and rangewide. The impounded area would extend approximately 14 mi (22.5 km) upstream, effectively eliminating habitat for Texas hornshell from 25 percent of the currently occupied area and likely leading to extirpation of the densest sites within this population.

    Very low water levels are also detrimental to Texas hornshell populations. Effects of climate change have already begun to affect the regions of Texas and New Mexico where the Texas hornshell occurs, resulting in higher air temperatures, increased evaporation, and changing precipitation patterns such that water levels rangewide have already reached historic lows (Dean and Schmidt 2011, p. 336; Bren School of Environmental Management 2014, p. 50). These changes are exacerbated by increased groundwater pumping resulting from increased water demand in response to changes in water availability. The rivers inhabited by Texas hornshell have some resiliency to drought because they are spring-fed (Black and Devils Rivers) or very large (Rio Grande), but drought in combination with increased groundwater pumping and regulated reservoir releases may lead to lower river flows of longer duration than have been recorded in the past.

    Streamflow in the Rio Grande downstream of the confluence with the Rio Conchos (near the Rio Grande-Lower Canyons population) has been declining since the 1980s (Miyazono et al. 2015, p. A-3), and overall river discharge for the Rio Grande is projected to continue to decline due to increased drought as a result of climate change (Nohara et al. 2006, p. 1087). The Rio Conchos contributes more than 90 percent of the flow of the lower Rio Grande (Dean and Schmidt 2011, p. 4). However, during times of drought (such as between 1994 and 2003), the contribution of the Rio Conchos has fallen to as low as 40 percent (Carter et al. 2015, p. 15). The Rio Grande-Lower Canyons population is downstream of the confluence with the Rio Conchos and is at risk from these reduced flows. The Rio Grande-Lower Canyons is very incised (in other words, has vertical banks), and the population occurs in crevices along the steep banks. Due to the habitat characteristics of this population, reductions in discharge in this area may lead to a higher proportion of the Texas hornshell population being exposed to desiccation than would be found in other populations experiencing similar flow decreases.

    In the Black River, surface water is removed from the river for irrigation, including the Carlsbad Irrigation District's Black River Canal at the diversion dam. Studies have shown that flows in the river are affected by groundwater withdrawals, particularly those from the Black River Valley. Groundwater in the Black River watershed is also being used for hydraulic fracturing for oil and gas activities. Between 4.3 acre-feet (187,308 ft3 (5,304 m3)) and 10.7 acre-feet (466,091 ft3 (13,198 m3)) of water is used for each hydraulic fracturing job (Bren School of Environmental Management 2014, p. 91). Overall, mean monthly discharge has already declined since the mid-1990s, and mean monthly temperatures have increased over the past 100 years (Inoue et al. 2014, p. 7). In the Black River, Texas hornshell survivorship is positively correlated with discharge (Inoue et al. 2014, p. 9); as mean monthly discharge decreases, we expect Texas hornshell survivorship to decrease, as well. The Black River is expected to lose streamflow in the future due to air temperature increases, groundwater extraction, and reduced precipitation.

    In the Devils River, future water withdrawals from aquifers that support spring flows in the range of the Texas hornshell could result in reduction of critical spring flows and river drying (Toll et al. 2017, pp. 46-47). In particular, there have been multiple proposals to withdraw water from the nearby aquifer and deliver the water to municipalities (e.g., Val Verde Water Company 2013, pp. 1-2). To date, however, none have been approved.

    As spring flows decline due to drought or groundwater lowering from pumping, habitat for the Texas hornshell is reduced and could eventually cease to exist. While Texas hornshell may survive short periods of low flow, as low flows persist, mussels face oxygen deprivation, increased water temperature, and, ultimately, stranding and death.

    Barriers to Fish Movement

    Two of the Texas hornshell's primary host fish species (river carpsucker and red shiner) are common, widespread species. We do not expect the distribution of host fish to be a limiting factor in Texas hornshell distribution. However, the barriers that prevent fish movement upstream and downstream affect the viability of Texas hornshell as described below.

    Texas hornshell were likely historically distributed throughout the Rio Grande, Pecos River, Devils River, and Black River basins in Texas, New Mexico, and Mexico when few natural barriers existed to prevent migration (via host species) among suitable habitats. The species colonized new areas through movement of infested host fish, and newly metamorphosed juveniles would excyst from host fish in new locations. The loss of historical range has resulted in remaining populations that are significantly isolated from one another such that recolonization of areas previously extirpated is extremely unlikely if not impossible due to existing contemporary barriers to host fish movement. The primary reason for this isolation is reservoir construction and unsuitable water quality. The Black River is isolated from the rest of the populations by high salinity reaches of the Pecos River, as well as by Red Bluff Reservoir, and is hundreds of river miles from the nearest extant population. Amistad Reservoir separates the three Texas populations from each other, isolating the Rio Grande-Lower Canyons, Devils River, and Rio Grande-Laredo populations. No opportunity for natural interaction currently exists among any of the five extant U.S. populations.

    The overall distribution of mussels is, in part, a function of the dispersal of their host fish. Small populations are more affected by this limited immigration potential because they are susceptible to genetic drift (random loss of genetic diversity) and inbreeding depression. At the species level, populations that are eliminated due to stochastic events cannot be recolonized naturally, leading to reduced overall redundancy and representation.

    Increased Predation

    Predation on freshwater mussels is a natural ecological interaction. Raccoons, snapping turtles, and fish all prey upon Texas hornshell. Under natural conditions, the level of predation occurring within Texas hornshell populations is not likely to pose a significant risk to any given population. However, during periods of low flow, terrestrial predators have increased access to portions of the river that are otherwise too deep under normal flow conditions. High levels of predation during drought have been observed on the Devils River, and muskrat predation has also been reported on the Black River (Lang 2001, p. 26; Robertson 2016, p. 1). As drought and low flow conditions are projected to occur more often and for longer periods due to the effects of climate change, the Devils River in particular is expected to experience additional predation pressure into the future. Predation is expected to be less of a concern for the Rio Grande populations, as the river is significantly larger than the Black and Devils Rivers, and Texas hornshell are less likely to be found in exposed or very shallow portions of the stream.

    Effects of Climate Change

    Climate change in the form of the change in timing and amount of precipitation and air temperature increase is occurring, and continued greenhouse gas emissions at or above current rates will cause further warming (Intergovernmental Panel on Climate Change (IPCC) 2013, pp. 11-12). Warming in the Southwest is expected to be greatest in the summer (IPCC 2013, pp. 11-12), and annual mean precipitation is very likely to decrease in the Southwest (Ray et al. 2008, p. 1; IPCC 2013, pp. 11-12). In Texas, the number of extreme hot days (high temperatures exceeding 95 °F (35 °C) are expected to double by around 2050 (Kinniburgh et al. 2015, p. 83), and Texas is projected to be one of the areas most affected by climate change in North America. West Texas is an area expected to show greater responsiveness to the effects of climate change (Diffenbaugh et al. 2008, p. 3). Even if precipitation and groundwater recharge remain at current levels, increased groundwater pumping and resultant aquifer shortages due to increased temperatures are nearly certain (Loaiciga et al. 2000, p. 193; Mace and Wade 2008, pp. 662, 664-665; Taylor et al. 2012, p. 3). Increased water temperature can cause stress to individuals, decrease dissolved oxygen levels, and increase toxicity of contaminants and ammonia. Effects of climate change, such as air temperature increases and an increase in drought frequency and intensity, have been shown to be occurring throughout the range of Texas hornshell (Kinniburgh et al. 2015, p. 88), and these effects are expected to exacerbate several of the stressors discussed above, such as increased water temperature and flow loss (Wuebbles et al. 2013, p. 16). As we projected the future condition of the Texas hornshell and which stressors are likely to occur, we considered climate change to be an exacerbating factor in the increase of fine sediments, declines in water quality, and loss of flowing water.

    Due to the effects of ongoing climate change, we expect the frequency and duration of cleansing flows to decrease, leading to the increase in fine sediments and reduced water levels at all populations. More extreme climate change projections lead to further increases in fine sediment within the populations. Similarly, as lower water levels concentrate contaminants and cause unsuitable temperature and dissolved oxygen levels, we expect water quality to decline to some degree in the future as a result of the effects of climate change.

    Conservation Actions and Regulatory Mechanisms

    About 7 percent of known occupied habitat for the Texas hornshell is in New Mexico, and the Service collaborated with water users, oil and gas developers, landowners, and other partners to develop candidate conservation agreements (CCAs) and candidate conservation agreements with assurances (CCAAs) for the species on State, Federal, and private lands (Regulations pertaining to these types of agreements are at 50 CFR 17.22 and 17.32.). These agreements provide voluntary conservation that will, if executed properly, reduce threats to the species while improving physical habitat and water quality. The key conservation measures in the agreements are designed to limit oil and gas development to areas outside of the Black and Delaware River floodplains, minimize erosion, and maintain minimum water flows in the rivers. Along with these measures, the partners to the agreement are evaluating alternatives to the multiple low water crossings on the Black River. Partners are considering alternate crossing locations, which could include bridges designed to allow host fishes to pass through in addition to decreasing potential contamination events. These agreements were approved by the Service in October 2017. Enrollment in the agreements is available until this rule becomes effective. Because enrollment under these agreements is just beginning, the conservation measures have not yet become effective at reducing or eliminating threats to the species. As discussed elsewhere in this decision, we do not expect these agreements to modify the overall conservation status of the species because of the relatively small amount of habitat subject to these agreements; however, they will provide good conservation benefits to the hornshell populations within the covered area.

    In 2013, the New Mexico Department of Game and Fish (NMDGF) began Texas hornshell reintroduction efforts into the Delaware River, which is within the historical range of the species. Adults and infested host fish were released in suitable habitat in the Delaware River in 2013 and 2015. Many of the released adults have been subsequently located, and success of the reintroduction will be determined in the coming years, as well as the effect of the produced water and oil spill in 2017 on these individuals. Mussel reintroductions take many years to show success, because the size of the juvenile mussel prevents detecting natural reintroduction for at least 3 years or more. As a positive sign, NMDGF biologists captured two gray redhorse from the Delaware River that appeared to be infested with Texas hornshell glochidia (NMDGF 2017, p. 1). We expect the reintroduction effort to continue over the next several years, but we are not considering the population to have been successfully reestablished until progeny from the reintroduced adults have been found in the river.

    In Texas, The Nature Conservancy and Texas Parks and Wildlife Department manage lands under their purview in the Devils River watershed for native fish, wildlife, and plant communities, including Texas hornshell. The large amount (over 200,000 acres) of land in conservation management in the Devils River watershed reduces the risks to Texas hornshell from sediment inputs and contaminants.

    In the Rio Grande, we are not aware of any management actions for Texas hornshell. The Texas Comptroller of Public Accounts has established an Endangered Species Task Force and has funded much of the recent research in Texas on Texas hornshell, which has led to greater understanding of the species' distribution in the State.

    Summary of Risks to Texas Hornshell

    Our analysis of the past, current, and future influences on what the Texas hornshell needs for long-term viability revealed that five influences pose the largest risk to future viability of the species. These risks are primarily related to habitat changes: The accumulation of fine sediments, the loss of flowing water, and impairment of water quality; these are all exacerbated by the effects of climate change. Additionally, predation and barriers to fish movement exacerbate the effects of these risks. We did not assess overutilization for scientific and commercial purposes or disease in detail, because these risks do not appear to be occurring at a level that affects Texas hornshell populations. The accumulation of fine sediments, the loss of flowing water, impairment of water quality, predation, and barriers to fish movement, as well as conservation and management efforts, are acting individually and cumulatively to affect the current and future viability of the Texas hornshell.

    Current Condition

    Overall, five known populations of Texas hornshell remain, comprising approximately 15 percent of the species' historical range in the United States (see Map 1, above). Historically, most Texas hornshell populations were likely connected by fish migration throughout the Rio Grande, upstream through the Pecos River, and throughout the tributaries, but due to impoundments and river reaches with unsuitable water quality (for example, high salinity) they are currently isolated from one another, and repopulation of extirpated locations is unlikely to occur without human assistance. Here we discuss the current condition of each known population, taking into account the risks to those populations that are currently occurring, as well as management actions that are currently occurring to address those risks. We consider low levels of climate change to be currently occurring, resulting in reduced timing and amount of streamflow, increased stream temperatures, and increased accumulation of fine sediments.

    Black River: The Black River population is quite dense and recruitment appears to be high, but the short length (8.7 mi (14.0 km)) of the occupied reach limits this population's resiliency. Accumulation of fine sediment in the substrate has already occurred due to increased sediment input into the river from road crossings, culverts, and cattle grazing, combined with a decreased frequency of cleansing river flows. The current level of climate impacts will continue to reduce flow in the river from groundwater extraction and drought, resulting in fewer cleansing flows and increased fine sediments. The distribution of Texas hornshell in the Black River will remain small, and the risk of a contaminant spill will remain high, resulting in a high likelihood that water quality will become unsuitable and reduce abundance of Texas hornshell significantly.

    The CCA/CCAA being implemented for the Black River will help reduce the likelihood of a spill and help maintain water flows, but extended droughts are nevertheless likely, resulting in low water flows. Therefore, taking into account the current threats to the population and its distribution within the river, the Texas hornshell population in the Black River has low to moderate resiliency.

    Pecos River: The Pecos River population is extremely small and exhibits no evidence of reproduction. The age, poor condition, and small number of live individuals found among the very high number of dead shells indicates a population in severe decline; this situation is likely due to high salinity levels in the river upstream of the population. There is a high likelihood this population will be extirpated in the near future due to water quality alone. Therefore, the Pecos River population of Texas hornshell has very low resiliency.

    Devils River: The Devils River population has low abundance and has exhibited some evidence of reproduction. The current level of climate change impacts will continue to reduce flow in the Devils River due to groundwater extraction and drought. The low flows this population experiences during dry times will continue to become more frequent and prolonged. Because Texas hornshell in the Devils River occur at the heads of riffles, they are vulnerable to complete flow loss when water levels drop. The reduction in cleansing flows will also result in the accumulation of fine sediments, reducing substrate quality. Low flows will also affect water quality parameters such as temperature and dissolved oxygen, causing them to become unsuitable for Texas hornshell. Additionally, the species is already vulnerable to predation from terrestrial predators during times of low flow; predation will occur more frequently as periods of low flow become more common. Overall, because the population is currently small and would be unlikely to grow, the Devils River population has low resiliency.

    Rio Grande-Lower Canyons: The Lower Canyons population has relatively high abundance and evidence of recruitment. Drought and groundwater extraction resulting from currently observed levels of climate change will continue to lower water levels in the Rio Grande-Lower Canyons population of Texas hornshell. We expect that the Rio Conchos will continue to be an unreliable source of water. This section of the Rio Grande is relatively deep and incised, and the population of Texas hornshell primarily occurs in crevices along the banks. Water flow reductions would expose a high proportion of the existing population; therefore, this reduction in flow will likely have a larger effect on the population size than in other populations, although at a small to moderate decrease in water flow we still expect abundance to be maintained at moderate levels. Overall, the Rio Grande-Lower Canyons population exhibits moderate resiliency.

    Rio Grande-Laredo: Similar to the Lower Canyons population, the Laredo population has numerous mussel beds with high Texas hornshell abundance and evidence of reproduction. However, drought and upstream water management will continue to reduce flows in the Rio Grande. Water quality will continue to decrease due to lower flows, and fine sediments will accumulate. Declining water flow will cause fine sediments to accumulate and water quality to decline, leading to a decline in population abundance. Overall, the Rio Grande-Laredo population has moderate resiliency.

    Mexico: The Rio Salado basin has not yielded any evidence of an existing population despite several surveys since 2000. Texas hornshell is presumed to be extirpated from this basin. There are no other historical locations of Texas hornshell in Mexico.

    Future Condition

    As part of the SSA, we also developed multiple future condition scenarios to capture the range of uncertainties regarding future threats and the projected responses by the Texas hornshell. Our scenarios included a status quo scenario, which incorporated the current risk factors continuing on the same trajectory that they are on now. We also evaluated four additional future scenarios that incorporated varying levels of increasing risk factors with elevated negative effects on hornshell populations. The additional future scenarios project conditions that are worse for the Texas hornshell than the current condition or status quo projection. Because we determined that the current condition of the Texas hornshell and the associated status quo projections were consistent with an endangered species (see Determination of Species Status, below), we are not presenting the results of the other future scenarios in this final rule. Since the status quo scenario was determined to be endangered, other projected scenarios would also be endangered, as they forecast conditions that are more at risk of extinction than the status quo. Please refer to the SSA report (Service 2018) for the full analysis of future scenarios.

    Summary of Changes From the Proposed Rule

    We made no changes from the proposed rule to the text of the rule itself. Since the publication of the August 10, 2016, proposed rule to list the Texas hornshell as endangered (81 FR 52796), we have made the following substantive changes in our supporting materials:

    (1) Genetic analysis of individuals from the Rio Panuco basin in Mexico (representing the Mexican Gulf Coastal streams) indicates that they are not Texas hornshell; instead, they are a different, as yet undescribed species. The Rio Panuco basin contained the majority of historical records of Texas hornshell in the Mexican Gulf Coastal area. In light of this information, it is unlikely Texas hornshell occurred in the remainder of the Mexican Gulf Coastal streams. We have incorporated this information into the historical, current, and future conditions of the species in our SSA analysis and report.

    (2) The Office of the Texas Comptroller of Public Accounts provided additional survey information regarding the Delaware River, which we have incorporated into our SSA report.

    Summary of Comments and Recommendations

    In the proposed rule published on August 10, 2016 (81 FR 52796), we requested that all interested parties submit written comments on the proposal by October 11, 2016. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. Newspaper notices inviting general public comment were published in the San Antonio Express News and the Carlsbad Current-Argus. We received requests for public hearings, and we held two public hearings: in Laredo, Texas, on June 13, 2017, and in Carlsbad, New Mexico, on June 15, 2017. The comment period was reopened for 30 days on May 30, 2017 (82 FR 24654), until June 29, 2017, and for another 30 days on August 10, 2017 (82 FR 37397), until September 11, 2017.

    During the first comment period, we received 24 comment letters directly addressing the proposal. During the second comment period and at the public hearings, we received 16 comment letters and statements directly addressing the proposal. During the third comment period, we received 697 comment letters—including 685 form letters—directly addressing the proposal. All substantive information provided during the comment periods has either been incorporated directly into this final determination, into the SSA report, or addressed below. We received several comments that clarified various topics within the SSA report or this rule, and we incorporated them as appropriate. Comments received were grouped into 10 general issues specifically relating to the proposed listing status for the Texas hornshell and are addressed in the following summary and incorporated into the final rule as appropriate.

    Peer Reviewer Comments

    In accordance with our peer review policy published on July 1, 1994 (59 FR 34270), we solicited expert opinion from five knowledgeable individuals with scientific expertise that included familiarity with Texas hornshell and its habitat, biological needs, and threats. During development of the SSA report, we reached out to five peer reviewers and received responses from four; all comments were incorporated into the SSA report prior to the proposed rule. During the comment period for the proposed rule, we reached out to an additional five peer reviewers, and we received responses from three. We reviewed all comments received from the peer reviewers for substantive issues and new information regarding the listing of the Texas hornshell. The reviewers were generally supportive of our approach and made suggestions and comments that strengthened our analysis. Peer reviewer comments are addressed in the following summary and incorporated into the SSA report and this final rule as appropriate.

    (1) Comment: One peer reviewer, NMDGF, the New Mexico State Lands Office (NMSLO), and five commenters stated that we should not presume the species has been extirpated from all locations in Mexico, given the lack of surveys particularly from the Gulf Coastal region.

    Our Response: We recently learned that the populations in the Gulf Coastal region in Mexico previously identified as Texas hornshell are a different species, and we have updated our analysis accordingly. The remaining historical Texas hornshell populations in Mexico are in the Rio Salado basin in Nuevo Leon. This population was originally reported in 1891 (Mussel Project 2015). When this area was revisited in 2004 (Strenth et al. 2004, p. 227), household waste was found throughout the river and no live individuals were found. This basin was visited again in 2017, with surveys at eight sites in four rivers, and no live individuals were found (Hein et al. 2017, p. 3). Therefore, we have no evidence that any populations of Texas hornshell persist in Mexico. We have updated the SSA report to reflect the new genetic information and survey findings.

    (2) Comment: One peer reviewer suggested we incorporate the effects of population fragmentation and isolation on the species.

    Our Response: We discussed population isolation in our analysis of barriers to fish movement. Because the host fish may no longer move between populations of Texas hornshell, there is no immigration of individuals to increase genetic diversity and recolonize after stochastic events. The effect of this isolation is incorporated into our analysis of the current and future condition of populations.

    Comments From States

    (3) Comment: We received one comment from the Texas Commission on Environmental Quality (TCEQ) clarifying the surface water rights and treaty obligations in the rivers inhabited by Texas hornshell.

    Our Response: In the SSA report, we have clarified water management responsibilities of inland rivers occupied by Texas hornshell, as well as obligations under the 1944 Treaty between the United States and Mexico, which governs water management in the mainstem Rio Grande.

    (4) Comment: We received comments from NMDGF, NMSLO, and one commenter expressing concern that listing may affect relationships with landowners along the Black River and that we have not adequately considered the conservation being implemented in the Black and Delaware River watersheds. In particular, NMSLO suggested that the Policy for Evaluation of Conservation Efforts when Making Listing Decisions (PECE) (68 FR 15100, March 28, 2003) requires “the Service to evaluate the conservation efforts of state and foreign governments or federal agencies, among others.”

    Our Response: We share the commenters' desire to maintain relationships with landowners along the Black River. NMDGF has spent considerable time and effort developing relationships with the private landowners on the Black River in order to access the river, survey for Texas hornshell, and implement conservation measures for the species. In the Black and Delaware River watersheds, the Service, NMDGF, NMSLO, Bureau of Land Management (BLM), and private landowners have developed CCAs/CCAAs for Texas hornshell, which will provide voluntary conservation that will reduce threats to the species while improving physical habitat and water quality. A notice of availability on the permit application packages, including the draft CCA, draft CCAAs, and draft environmental assessment was published in the Federal Register on July 7, 2017, and was available for public comment for 30 days (82 FR 31625, July 7, 2017). The final agreements were signed by the Service, BLM, the New Mexico Land Commissioner, and the Center of Excellence on October 19, 2017. For private landowners who choose to enroll in these agreements, the agreements support the conservation of Texas hornshell while providing the landowner with a permit for incidental take of the species during the course of otherwise lawful activities. It is our intent that these agreements will help maintain landowner relationships in the Black and Delaware River watersheds.

    We have addressed all relevant conservation efforts, as required by the Act, in this decision. Consistent with the PECE we find that the potential reduction in threats resulting from the CCAs/CCAAs in the Black and Delaware River watersheds limited to these watersheds and is not widespread enough to preclude listing the Texas hornshell as an endangered species. The PECE does not set standards for how much conservation is needed to make listing unnecessary. The PECE explains that we evaluate the significance of plans that address only a portion of a species' range in the context of the species' overall status. While a formalized conservation effort may be effective in reducing or removing threats in a portion of the species' range, that effort may or may not be sufficient to remove the need to list the species as threatened or endangered. Although the CCAs/CCAAs are expected to improve the status of the Texas hornshell in the Black and Delaware Rivers, four populations of Texas hornshell will not be affected by the agreements. Therefore, the agreements, even if fully implemented and effective, will not improve the status of Texas hornshell such that it does not meet the Act's definition of a threatened or endangered species. Because of the limited scope of the agreements, it was unnecessary to conduct a PECE analysis.

    (5) Comment: TCEQ and four commenters stated that our population survey information is limited and that we need to delay a final determination until more surveys are conducted and more data are collected.

    Our Response: The Act requires the Service to publish a final rule within 1 year from the date we propose to list a species. This 1-year timeframe can be extended only if there is substantial disagreement regarding the sufficiency or accuracy of the available data relevant to the determination or revision concerned, but only for 6 months and only for purposes of soliciting additional data. In such a case, under section 4(b)(6)(B)(i) of the Act, the Secretary may extend the 1-year period to make a final determination by up to 6 months for the purposes of soliciting additional data. In light of this comment, due to disagreements about the species' status in the Gulf Coastal region of Mexico, we extended the final determination by 6 months (82 FR 37397, August 10, 2017).

    In accordance with section 4 of the Act, we are required to determine whether a species warrants listing on the basis of the best scientific and commercial data available. Further, our Policy on Information Standards under the Act (published in the Federal Register on July 1, 1994 (59 FR 34271)), the Information Quality Act (section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Pub. L. 106-554; H.R. 5658)), and our associated Information Quality Guidelines (www.fws.gov/informationquality/), provide criteria and guidance, and establish procedures to ensure that our decisions are based on the best scientific data available. They require our biologists, to the extent consistent with the Act and with the use of the best scientific data available, to use primary and original sources of information as the basis for determining whether a species warrants listing as an endangered or threatened species.

    Science is a cumulative process, and the body of knowledge is ever-growing. In light of this fact, the Service will always take new research into consideration. If plausible new research supports amendment or revision of this rule in the future, the Service will modify the rule consistent with the Act and our established work priorities at that time.

    (6) Comment: We received two comments from NMDGF regarding our analysis of the current and future influences on Texas hornshell viability. They cautioned us not to presume all sedimentation is detrimental to Texas hornshell; some sedimentation is part of the natural state of the watershed. Additionally, they did not agree that predation is a significant risk to the species, stating that low water levels would cause mortality before predation levels increase.

    Our Response: Texas hornshell require seams of fine sediment under boulders and bedrock and in streambanks in order to anchor themselves into place. However, too much sedimentation, which can cause smothering, is a significant risk to the species rangewide. Chapter 4.1 and Appendix B of the SSA report contain more discussion of the risks of sedimentation.

    In most of the streams occupied by Texas hornshell, we agree that low water levels would affect populations before predation is a significant factor. This scenario is because the species occupies crevices in streambanks and under boulders, which provide protection from predators. However, in the Devils River, Texas hornshell are found in gravel and cobble substrate in riffles. These habitats become easily accessible to terrestrial predators, such as raccoons (Procyon lotor), when water levels drop, and significant levels of predation on Texas hornshell have been observed during times of low water levels. We have clarified in the SSA report and above in this preamble that this situation is primarily a concern for the population in the Devils River.

    Public Comments

    (7) Comment: Three commenters stated that existing laws and policies related to oil and gas production and surface water rights, such as the Clean Water Act, Oil Pollution Act, Resource Conservation and Recovery Act, and Pollution Prevention Act, will provide sufficient protection to Texas hornshell populations. According to the commenters, these laws and subsequent regulations provide many protections for freshwater systems including spill prevention measures, stormwater measures, and hazardous waste management, among others, which prevent the Texas hornshell in the Black River from being affected by oil and gas exploration. Further, the commenters state that groundwater use in Texas is governed by the Texas Groundwater Act, and ground and surface water rights in New Mexico are permitted by the Office of the State Engineer, and that these laws and policies provide at least as much protection as listing under the Act.

    Our Response: While the laws and regulations related to water quality have reduced the risk of contamination of the Black River in New Mexico from oil and gas production, the risk from the high volume of truck traffic crossing the river at low-water access points remains high. In particular, one highly used crossing occurs at the upper end of the range of Texas hornshell in the Black River; a spill of water that has been collected as a byproduct of oil and gas production at this location could eliminate the entire population. For example, an overturned truck at a road crossing on the Clinch River in Virginia in 1998 resulted in the extirpation of three endangered species of mussels for 6 miles downstream (Jones et al. 2001, p. 28). While not from a road crossing, a spill of 18,000 barrels of produced water and 11 barrels of oil from a ruptured pipeline occurred on the Delaware River, which is adjacent to the Black River, in August 2017, demonstrating the high risk of a spill in this area. Produced water mixes with river water and cannot be absorbed by boom lines, and so once a spill has happened, there is little clean up that can occur. In this case, the only regulatory response was the issuance of an Administrative Order by EPA (EPA 2017) directing the development of a pollution prevention plan.

    Regarding water law, while extraction of water is regulated by the States of New Mexico and Texas, instream flow is affected by many factors, including local precipitation, high-altitude groundwater recharge, surface water-groundwater interactions, local groundwater table elevation, evapotranspiration, and anthropogenic water use. The Black River is expected to lose streamflow due to increased air temperature and reduced precipitation alone (Bren School of Environmental Management 2014, p. 91). Appropriate water management can help ensure sufficient streamflow, but if the amount of water entering the system decreases and anthropogenic water use remains at the same rate, streamflow levels will decrease. Therefore, although existing water law may mitigate water flow reductions, it is not sufficient to protect Texas hornshell from the effects of reduced streamflow.

    (8) Comment: One commenter requested we provide data on water flow, water quality, the risk of spills, and on the Pecos River population of Texas hornshell.

    Our Response: This information is provided in the SSA report in the following locations: Water flow (Chapter 4.3 and Appendix B); water quality and spill risk (Chapter 4.2 and Appendix B); and Pecos River population data (Chapter 3.2.2). References cited are available at www.regulations.gov in Docket No. FWS-R2-ES-2016-0077.

    (9) Comment: Two commenters stated that climate change does not exacerbate the risk factors in our analysis, and that our analysis is based on opinion rather than fact.

    Our Response: We recognize that there are scientific differences of opinion on many aspects of climate change, including the role of natural variability in climate and the uncertainties involved with climate change projections and how local ecosystems may respond. We relied on synthesis documents (e.g., IPCC 2013) that present the consensus view of a very large number of experts on climate change from around the world. Additionally, we relied on downscaled climate change projections (e.g., Nohara 2006, CH2MHILL 2008, Mace and Wade 2008, Bren School of Environmental Management 2014) that forecast what is expected to occur to landscapes in New Mexico and Texas. We have found that these reports, as well as the scientific papers used in those reports or resulting from those reports, represent the best available scientific information we can use to inform our decision and have relied upon them and provided citations within our analysis. Climate change impacts are expected to result in lower stream flows, poorer water quality, increased accumulation of fine sediments, and, in the Devils River, increased predation.

    (10) Comment: Two commenters expressed that the risks to the Black River from low flows and contamination are high.

    Our Response: The Texas hornshell population in the Black River is at risk of reduction or extirpation from low flows or contamination. The CCA/CCAA for the Black and Delaware Rivers with water users, oil and gas developers, landowners, and other partners will be critical to reduce threats to the species in this area while improving physical habitat and water quality.

    Determination of Species Status

    Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species meets the definition of “endangered species” or “threatened species.” The Act defines an “endangered species” as a species that is “in danger of extinction throughout all or a significant portion of its range,” and a “threatened species” as a species that is “likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” The Act requires that we determine whether a species meets the definition of “endangered species” or “threatened species” because of any of the following factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence.

    Texas Hornshell Determination of Status Throughout All of Its Range

    Our analysis of the past, current, and future influences on what the Texas hornshell needs for long-term viability revealed that there are five influences that pose a meaningful risk to the viability of the species. These are primarily related to habitat changes (Factor A from the Act): The accumulation of fine sediments, the loss of flowing water, and impairment of water quality, all of which are exacerbated by the effects of climate change (Factor E). Predation (Factor C) is also affecting those populations already experiencing low stream flow, and barriers to host fish movement (Factor E) prevent gene flow and recolonization after stochastic events. The regulatory mechanisms we considered include the Clean Water Act, Oil Pollution Act, Texas Endangered Species Act, and New Mexico Wildlife Conservation Act (Factor D) and were not enough to remove these influences on the viability of Texas hornshell.

    The Texas hornshell has declined significantly in overall distribution and abundance, with the species currently occupying approximately 15 percent of its historical range in the United States. The resulting remnant populations occupy shorter reaches compared to likely historical populations, and they are all isolated from one another.

    The primary historical reason for this reduction in range was reservoir construction and unsuitable water quality. Large reservoirs have been constructed on the Rio Grande and Pecos River, and much of the Pecos River upstream of the confluence with Independence Creek now has salinity levels too high for mussel habitation (Hoagstrom 2009, p. 28). The effects of these reservoirs extend beyond fragmentation of populations; the resultant downstream water releases do not mimic natural flow regimes, and the change in timing and frequency of cleansing flows results in increases in fine sediments, increases in predation, and decreases in water quality. The effects of climate change—increased temperature and decreased stream flow—exacerbate these impacts. Because of these threats acting in combination, the remaining Texas hornshell populations currently face moderate to high levels of risk of extirpation. For the populations occupying the smaller reaches (such as the Black River, Devils River, and Pecos River populations), a single stochastic event such as a contaminant spill or drought could eliminate an entire population of Texas hornshell. These effects are heightened at the species level because the isolation of the populations prohibits natural recolonization from host fish carrying Texas hornshell glochidia, which likely happened in the past and allowed for the species to ebb and flow from suitable areas.

    Populations in both large and small reaches face risks from natural and anthropogenic sources. Climate change has already begun to affect the regions of Texas and New Mexico where Texas hornshell occurs, resulting in higher air temperatures, increased evaporation, increased groundwater pumping, and changing precipitation patterns such that water levels rangewide have already reached historic lows (Wuebbles et al. 2013, p. 16; Bren School of Environmental Management 2014, p. 91; Kinniburgh et al. 2015, p. 88; Miyazono et al. 2015, appendix A; Toll et al. 2017, pp. 46-47). These low water levels put the populations at risk of habitat loss from increased fine sediments, poor water quality, and increased predation risk. These risks, alone or in combination, are expected to result in the extirpation of additional populations, further reducing the overall redundancy and representation of the species.

    Historically, the species, with a large range of interconnected populations, would have been resilient to stochastic events such as drought and sedimentation because even if some populations were extirpated by such events, they could be recolonized over time by dispersal from nearby surviving populations. This connectivity would have made for a highly resilient species overall. However, under current conditions, connectivity is prevented due to large reservoirs and unsuitably high salinity levels between populations. As a consequence of these current conditions, the viability of the Texas hornshell now primarily depends on maintaining the remaining isolated populations.

    Of the five known remaining isolated populations in the United States, three are small in abundance and occupied stream length and have low to no resiliency. The remaining two are larger, with increased abundance and occupied stream length; however, flow reduction, water quality decline, and habitat loss from sedimentation reduce the abundance and distribution of those populations. Therefore, the Texas hornshell has no populations that are currently considered highly resilient. The high risk of extirpation of these populations leads to low levels of redundancy (few populations will persist to withstand catastrophic events) and representation (little to no ecological or genetic diversity will persist to respond to changing environmental conditions). Overall, these low levels of resiliency, redundancy, and representation result in the Texas hornshell having low viability, and the species currently faces a high risk of extinction.

    Thus, after assessing the best available information, we conclude that the Texas hornshell is in danger of extinction throughout all of its range. We find that the Texas hornshell is presently in danger of extinction throughout its entire range based on the severity and immediacy of threats currently impacting the species. The overall current range has been significantly reduced from the historical range of the species, and the remaining habitat and populations face a multitude of threats acting in combination to reduce the overall viability of the species. The risk of extinction is high because the remaining populations have a high risk of extirpation, are isolated, and have limited potential for recolonization. Therefore, on the basis of the best available scientific and commercial information, we list the Texas hornshell as an endangered species in accordance with sections 3(6) and 4(a)(1) of the Act. We find that a threatened species status is not appropriate for the Texas hornshell because of the currently contracted range (loss of 85 percent of its historic range), because the threats are occurring across the entire range of the species, and because the threats are ongoing currently and are expected to continue or worsen into the future. Because the species is already in danger of extinction throughout its range, a threatened status is not appropriate.

    Because we found that the species is an endangered species because of its status throughout all of its range, we do not need to conduct an analysis of it status in any portions of its range. This is consistent with the Act because the species is currently in danger of extinction throughout all of its range due to high-magnitude threats across its range, or threats that are so high in particular areas that they severely affect the species across its range. Therefore, the species is in danger of extinction throughout every portion of its range, and an analysis of whether the species is in danger of extinction or likely to become so throughout any significant portion of its range would be redundant and unnecessary. See the Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species” (79 FR 37577).

    Texas Hornshell Determination of Status

    We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to the Texas hornshell. Because the species is in danger of extinction throughout all of its range, the species meets the definition of an endangered species.

    Available Conservation Measures

    Conservation measures provided to species listed as endangered or threatened species under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness, and conservation by Federal, State, Tribal, and local agencies, private organizations, and individuals. The Act encourages cooperation with the States and requires that recovery actions be carried out for all listed species. The protection required by Federal agencies and the prohibitions against certain activities are discussed, in part, below.

    The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Subsection 4(f) of the Act requires the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The recovery planning process involves the identification of actions that are necessary to halt or reverse the species' decline by addressing the threats to its survival and recovery. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.

    Recovery planning includes the development of a recovery outline shortly after a species is listed and preparation of a draft and final recovery plan. The recovery outline guides the immediate implementation of urgent recovery actions and describes the process to be used to develop a recovery plan. Revisions of the plan may be done to address continuing or new threats to the species, as new substantive information becomes available. The recovery plan identifies site-specific management actions that set a trigger for review of the five factors that control whether a species remains endangered or may be downlisted (reclassified from endangered to threatened) or delisted (removed from the Lists of Endangered and Threatened Wildlife and Plants), and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Recovery teams (composed of species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) are often established to develop recovery plans. When completed, the recovery outline, draft recovery plan, and the final recovery plan will be available on our website (http://www.fws.gov/endangered) or from our Texas Coastal Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

    Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, Tribes, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (e.g., restoration of native vegetation), research, captive propagation and reintroduction, and outreach and education. The recovery of many listed species cannot be accomplished solely on Federal lands because their range may occur primarily or solely on non-Federal lands. To achieve recovery of these species requires cooperative conservation efforts on private, State, and Tribal lands.

    Following publication of this final listing rule, funding for recovery actions will be available from a variety of sources, including Federal budgets, State programs, and cost share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, pursuant to section 6 of the Act, the States of New Mexico and Texas will be eligible for Federal funds to implement management actions that promote the protection or recovery of the Texas hornshell. Information on our grant programs that are available to aid species recovery can be found at: http://www.fws.gov/grants.

    Please let us know if you are interested in participating in recovery efforts for the Texas hornshell. Additionally, we invite you to submit any new information on this species whenever it becomes available and any information you may have for recovery planning purposes (see FOR FURTHER INFORMATION CONTACT).

    Section 7(a) of the Act requires Federal agencies to evaluate their actions with respect to any species that is listed as an endangered or threatened species and with respect to its critical habitat, if any is designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of any endangered or threatened species or destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service.

    Federal agency actions within the species' habitat that may require conference or consultation or both as described in the preceding paragraph include management and any other landscape-altering activities on Federal lands administered by the National Park Service (Big Bend National Park and Rio Grande Wild and Scenic River); issuance of section 404 Clean Water Act permits by the Army Corps of Engineers; and construction and maintenance of roads or highways by the Federal Highway Administration.

    The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to endangered wildlife. The prohibitions of section 9(a)(1) of the Act, codified at 50 CFR 17.21, make it illegal for any person subject to the jurisdiction of the United States to take (which includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these) endangered wildlife within the United States or on the high seas. In addition, it is unlawful to import; export; deliver, receive, carry, transport, or ship in interstate or foreign commerce in the course of commercial activity; or sell or offer for sale in interstate or foreign commerce any listed species. It is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. Certain exceptions apply to employees of the Service, the National Marine Fisheries Service, other Federal land management agencies, and State conservation agencies.

    We may issue permits to carry out otherwise prohibited activities involving endangered wildlife under certain circumstances. Regulations governing permits are codified at 50 CFR 17.22. With regard to endangered wildlife, a permit may be issued for the following purposes: For scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities. There are also certain statutory exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.

    It is our policy, as published in the Federal Register on July 1, 1994 (59 FR 34272), to identify to the maximum extent practicable at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the Act. The intent of this policy is to increase public awareness of the effect of a final listing on proposed and ongoing activities within the range of a listed species. Based on the best available information, the following actions are unlikely to result in a violation of section 9, if these activities are carried out in accordance with existing regulations and permit requirements; this list is not comprehensive:

    (1) Normal agricultural and silvicultural practices, including herbicide and pesticide use, which are carried out in accordance with any existing regulations, permit and label requirements, and best management practices; and

    (2) Normal residential landscape activities.

    Based on the best available information, the following activities may potentially result in a violation of section 9 of the Act; this list is not comprehensive:

    (1) Unauthorized handling or collecting of the species;

    (2) Modification of the channel or water flow of any stream in which the Texas hornshell is known to occur;

    (3) Livestock grazing that results in direct or indirect destruction of stream habitat; and

    (4) Discharge of chemicals or fill material into any waters in which the Texas hornshell is known to occur.

    Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed to the Texas Coastal Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

    Critical Habitat for the Texas Hornshell Background

    Critical habitat is defined in section 3 of the Act as:

    (1) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with the Act, on which are found those physical or biological features:

    (a) Essential to the conservation of the species, and

    (b) Which may require special management considerations or protection; and

    (2) Specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.

    Conservation, as defined under section 3 of the Act, means to use and the use of all methods and procedures that are necessary to bring an endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Such methods and procedures include, but are not limited to, all activities associated with scientific resources management such as research, census, law enforcement, habitat acquisition and maintenance, propagation, live trapping, and transplantation, and, in the extraordinary case where population pressures within a given ecosystem cannot be otherwise relieved, may include regulated taking.

    Critical habitat receives protection under section 7 of the Act through the requirement that Federal agencies ensure, in consultation with the Service, that any action they authorize, fund, or carry out is not likely to result in the destruction or adverse modification of critical habitat. The designation of critical habitat does not affect land ownership or establish a refuge, wilderness, reserve, preserve, or other conservation area. Such designation does not allow the government or public to access private lands. Such designation does not require implementation of restoration, recovery, or enhancement measures by non-Federal landowners. Where a landowner requests Federal agency funding or authorization for an action that may affect a listed species or critical habitat, the consultation requirements of section 7(a)(2) of the Act would apply, but even in the event of a destruction or adverse modification finding, the obligation of the Federal action agency and the landowner is not to restore or recover the species, but to implement reasonable and prudent alternatives to avoid destruction or adverse modification of critical habitat.

    Section 4 of the Act requires that we designate critical habitat on the basis of the best scientific data available. Further, our Policy on Information Standards Under the Endangered Species Act (published in the Federal Register on July 1, 1994 (59 FR 34271)), the Information Quality Act (section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Pub. L. 106-554; H.R. 5658)), and our associated Information Quality Guidelines, provide criteria, establish procedures, and provide guidance to ensure that our decisions are based on the best scientific data available. They require our biologists, to the extent consistent with the Act and with the use of the best scientific data available, to use primary and original sources of information as the basis for recommendations to designate critical habitat.

    Prudency Determination

    Section 4(a)(3) of the Act, as amended, and implementing regulations (50 CFR 424.12), require that, to the maximum extent prudent and determinable, the Secretary designate critical habitat at the time the species is determined to be endangered or threatened. Our regulations (50 CFR 424.12(a)(1)) state that the designation of critical habitat is not prudent when one or both of the following situations exist: (1) The species is threatened by taking or other human activity, and identification of critical habitat can be expected to increase the degree of threat to the species, or (2) such designation of critical habitat would not be beneficial to the species.

    There is currently no imminent threat of take attributed to collection or vandalism under Factor B for the Texas hornshell, and identification and mapping of critical habitat is not likely to increase any such threat. In the absence of finding that the designation of critical habitat would increase threats to a species, if there are any benefits to a critical habitat designation, then a prudent finding is warranted. The potential benefits of designation include: (1) Triggering consultation under section 7 of the Act for actions in which there may be a Federal nexus where it would not otherwise occur because, for example, it is or has become unoccupied or the occupancy is in question; (2) focusing conservation activities on the most essential features and areas; (3) providing educational benefits to State or county governments or private entities; and (4) preventing people from causing inadvertent harm to the species. Therefore, because we have determined that the designation of critical habitat will not likely increase the degree of threat to these species and may provide some measure of benefit, we find that designation of critical habitat is prudent for the Texas hornshell.

    Critical Habitat Determinability

    Having determined that designation is prudent, under section 4(a)(3) of the Act we must find whether critical habitat for the species is determinable. Our regulations at 50 CFR 424.12(a)(2) state that critical habitat is not determinable when one or both of the following situations exist: (i) Information sufficient to perform required analyses of the impacts of the designation is lacking, or (ii) The biological needs of the species are not sufficiently well known to permit identification of an area as critical habitat.

    As discussed above, we have reviewed the available information pertaining to the biological needs of this species and habitat characteristics where this species is located. We are completing the required analyses of the impacts related to possible exclusions to the designation of critical habitat and anticipate publishing a proposed critical habitat rule in the near future. Therefore, we conclude that critical habitat is not determinable for the Texas hornshell at this time.

    Required Determinations National Environmental Policy Act (42 U.S.C. 4321 et seq.)

    We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq.), need not be prepared in connection with listing a species as an endangered or threatened species under the Endangered Species Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

    Government-to-Government Relationship With Tribes

    In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to tribes.

    The Kickapoo Indian Reservation of Texas owns 1.3 km (0.8 mi) adjacent to the Rio Grande, downstream of Eagle Pass, Texas. We sent notification letters to the tribe on August 10, 2016, and June 1, 2017, inviting their review and comment on the proposed rule. We did not receive a response. We also sent notification letters on August 10, 2016, to the following tribes with interests in the Black and Delaware River watersheds: Comanche, Hopi, Isleta, Mescalero Apache, Oklahoma Apache, Tesuque, and Ysleta del Sur tribes, and we did not receive a response.

    References Cited

    A complete list of references cited is available in Appendix A of the SSA report (U.S. Fish and Wildlife Service. 2018. Species status assessment report for the Texas hornshell (Popenaias popeii), Version 1.2. Albuquerque, NM), available online at http://www.regulations.gov under Docket Number FWS-R2-ES-2016-0077.

    Authors

    The primary authors of this final rule are the staff members of the Texas Coastal Ecological Services Field Office.

    List of Subjects in 50 CFR Part 17

    Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.

    Regulation Promulgation

    Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as follows:

    PART 17—ENDANGERED AND THREATENED WILDLIFE AND PLANTS 1. The authority citation for part 17 continues to read as follows: Authority:

    16 U.S.C. 1361-1407; 1531-1544; and 4201-4245; unless otherwise noted.

    2. Amend § 17.11(h) by adding an entry for “Hornshell, Texas” to the List of Endangered and Threatened Wildlife in alphabetical order under CLAMS to read as follows:
    § 17.11 Endangered and threatened wildlife.

    (h) * * *

    Common name Scientific name Where listed Status Listing citations and applicable rules *         *         *         *         *         *         * CLAMS *         *         *         *         *         *         * Hornshell, Texas Popenaias popeii Wherever found E 83 FR [insert Federal Register page where the document begins], 2/9/2018. *         *         *         *         *         *         *
    Dated: December 19, 2017. James W. Kurth, Deputy Director, U.S. Fish and Wildlife Service, Exercising the Authority of the Director for the U.S. Fish and Wildlife Service.
    [FR Doc. 2018-02672 Filed 2-8-18; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 170828822-70999-02] RIN 0648-XG001 Fisheries of the Northeastern United States; Summer Flounder Fishery; Quota Transfer AGENCY:

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

    ACTION:

    Temporary rule; quota transfer.

    SUMMARY:

    NMFS announces that the State of North Carolina is transferring a portion of its 2018 commercial summer flounder quota to the State of Rhode Island. This quota adjustment is necessary to comply with the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan quota transfer provisions. This announcement informs the public of the revised commercial quotas for North Carolina and Rhode Island.

    DATES:

    Effective February 6, 2018, through December 31, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Cynthia Hanson, Fishery Management Specialist, (978) 281-9180.

    SUPPLEMENTARY INFORMATION:

    Regulations governing the summer flounder fishery are found in 50 CFR 648.100 through 648.110. These regulations require annual specification of a commercial quota that is apportioned among the coastal states from Maine through North Carolina. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.102, and the initial 2018 allocations were published on December 22, 2017 (82 FR 60682), and corrected January 30, 2018 (83 FR 4165).

    The final rule implementing Amendment 5 to the Summer Flounder Fishery Management Plan, as published in the Federal Register on December 17, 1993 (58 FR 65936), provided a mechanism for transferring summer flounder commercial quota from one state to another. Two or more states, under mutual agreement and with the concurrence of the NMFS Greater Atlantic Regional Administrator, can transfer or combine summer flounder commercial quota under § 648.102(c)(2). The Regional Administrator is required to consider the criteria in § 648.102(c)(2)(i)(A) through (C) in the evaluation of requests for quota transfers or combinations.

    North Carolina is transferring 5,008 lb (2,272 kg) of summer flounder commercial quota to Rhode Island. This transfer was requested to repay landings by North Carolina-permitted vessels that landed in Rhode Island under safe harbor agreements. The revised summer flounder quotas for calendar year 2018 are now: North Carolina, 1,761,439 lb (798,975 kg); and Rhode Island, 1,001,381 lb (454,219 kg); based on the initial quotas published in the 2018 Summer Flounder, Scup, and Black Sea Bass Specifications and subsequent adjustments.

    Classification

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

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: February 6, 2018. Jennifer M. Wallace, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-02660 Filed 2-6-18; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 160920866-7167-02] RIN 0648-XF940 Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Non-American Fisheries Act Crab Vessels Operating as Catcher Vessels Using Pot Gear in the Central Regulatory Area of the Gulf of Alaska 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 non-American Fisheries Act (AFA) crab vessels that are subject to sideboard limits, and operating as catcher vessels (CVs) using pot gear, in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2018 Pacific cod sideboard limit established for non-AFA crab vessels that are operating as CVs using pot gear in the Central Regulatory Area of the GOA.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), February 6, 2018, through 1200 hours, A.l.t., June 10, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Obren Davis, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (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. Regulations governing sideboard protections for GOA groundfish fisheries appear at subpart B of 50 CFR part 680.

    The A season allowance of the 2018 Pacific cod sideboard limit established for non-AFA crab vessels, and that are operating as CVs using pot gear in the Central Regulatory Area of the GOA, is 174 metric tons (mt), as established by the final 2017 and 2018 harvest specifications for groundfish of the GOA (82 FR 12032, February 27, 2017) and one inseason adjustment (82 FR 60327, December 20, 2017).

    In accordance with § 680.22(e)(2)(i), the Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the A season allowance of the 2018 Pacific cod sideboard limit established for non-AFA crab vessels that are operating as CVs using pot gear in the Central Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a sideboard directed fishing allowance of 164 mt, and is setting aside the remaining 10 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 680.22(e)(3), the Regional Administrator finds that this sideboard directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by non-AFA crab vessels that are operating as CVs using pot gear in the Central Regulatory Area of the GOA.

    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 sideboard directed fishing closure of Pacific cod for non-AFA crab vessels that are subject to sideboard limits, and that are operating as CVs using pot gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of February 5, 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 § 680.22 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: February 6, 2018. Jennifer M. Wallace, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-02614 Filed 2-6-18; 4:15 pm] BILLING CODE 3510-22-P
    83 28 Friday, February 9, 2018 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0073; Product Identifier 2017-NM-100-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 adopt a new airworthiness directive (AD) for certain The Boeing Company Model 767-300 and -300F series airplanes. This proposed AD was prompted by reports of fatigue cracking in the lower outboard wing skin at the farthest outboard fastener of the inboard segment of a certain stringer. This proposed AD would require repetitive high frequency eddy current (HFEC) inspections for cracking of the lower outboard wing skin at the inboard segment of a certain stringer, and repair 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 March 26, 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 proposed AD, contact Aviation Partners Boeing, 2811 S. 102nd Street, Suite 200, Seattle, WA 98168; telephone 206-762-1171; internet https://www.aviationpartnersboeing.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. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0073.

    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-2018-0073; 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:

    Allen Rauschendorfer, Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 1601 Lind Avenue SW, Renton, WA 98057-3356; phone: 425-917-6450; 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-2018-0073; Product Identifier 2017-NM-100-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

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

    Discussion

    We have received reports of fatigue cracking in the lower outboard wing skin at the farthest outboard fastener of the inboard segment of stringer L-9.5 on Model 767-300 airplanes with Aviation Partners Boeing winglets installed. The cracks were found at the fastener holes common to the stringer on the left- and right-hand wings. Investigation revealed that these were fatigue cracks related to Aviation Partners Boeing supplemental type certificate (STC) ST01920SE winglet retrofit kit installations. If not corrected, these cracks could extend to adjacent structure and could lead to reduced load carrying capability in the lower skin. These conditions, if not corrected, could result in failure and subsequent separation of the wing and winglet, and consequent reduced controllability of the airplane.

    Related Service Information Under 1 CFR Part 51

    We reviewed Aviation Partners Boeing (APB) Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017. The service information describes procedures for an HFEC inspection for cracking of the lower outboard wing skin at the inboard segment of stringer L-9.5, and on-condition actions that include repetitive HFEC inspections; a preventative modification (repair) that includes installing new stringers; repetitive post-modification (repair) HFEC inspections for cracking; and repair. 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 require accomplishing the actions specified in the service information described previously, except as discussed under “Difference Between this Proposed Rule and the Service Information.”

    Difference Between Proposed Rule and Service Information

    Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017, specifies to contact the manufacturer for instructions on how to repair certain conditions, but this proposed AD would require repairing those conditions in one of the following ways:

    • In accordance with a method that we approve; or

    • Using data that meet the certification basis of the airplane, and that have been approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) whom we have authorized to make those findings.

    Compliance Times

    The initial compliance time is the later of: 1,500 flight cycles or 7,500 flight cycles after winglet installation, whichever occurs first; or 18 months after the effective date of the AD.

    The repetitive compliance times vary depending on inspection findings. The shortest repetitive interval is 1,500 flight cycles or 7,500 flight hours, whichever occurs first. The longest repetitive interval is 6,000 flight cycles or 18,000 flight hours, whichever occurs first.

    Costs of Compliance

    We estimate that this proposed AD affects 140 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

    Estimated Costs—Required Actions Action Labor cost Parts cost Cost per product Cost on U.S. operators HFEC Inspections 1 work-hour × $85 per hour = $255, per inspection cycle $0 $85, per inspection cycle $11,900, per inspection cycle. Estimated Costs—On-Condition Actions Action Labor cost Parts cost Cost per
  • product
  • Preventative Modification (Repair) 50 work-hours × $85 per hour = $4,250 $0 $4,250 Post-modification (repair) Inspections 1 work-hour × $85 per hour = $255 0 85

    We have received no definitive data that would enable us to provide cost estimates for on-condition repairs that might be necessary as a result of the post-modification (repair) inspections specified in this proposed AD.

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

    Authority for This Rulemaking

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

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

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): The Boeing Company: Docket No. FAA-2018-0073; Product Identifier 2017-NM-100-AD. (a) Comments Due Date

    We must receive comments by March 26, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to The Boeing Company Model 767-300 and -300F series airplanes, certificated in any category, with Aviation Partners Boeing winglets installed; as identified in Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017.

    (d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

    (e) Unsafe Condition

    This AD was prompted by reports of fatigue cracking in the lower outboard wing skin at the farthest outboard fastener of the inboard segment of stringer L-9.5 on airplanes with winglets installed per Supplemental Type Certificate ST01920SE. We are issuing this AD to prevent fatigue cracking in the lower outboard wing skin, which could result in failure and subsequent separation of the wing and winglet and consequent reduced controllability of the airplane.

    (f) Compliance

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

    (g) Repetitive Inspections, Preventative Modification (Repair), Repetitive Post-Modification (Repair) Inspections, and Repair

    At the applicable time specified in paragraph 1.E., “Compliance,” of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017, except as required by paragraph (h) of this AD: Do a high frequency eddy current (HFEC) inspection for cracking of the lower outboard wing skin at the inboard segment of stringer L-9.5, in accordance with Part 1 of the Accomplishment Instructions of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017.

    (1) For airplanes on which “Condition 1” is found, as defined in the Accomplishment Instructions of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017, during any inspection required by paragraph (g) or (g)(1)(i) of this AD: Do the actions required by paragraph (g)(1)(i) or (g)(1)(ii) of this AD.

    (i) Repeat the inspection specified in paragraph (g) of this AD thereafter at the applicable times specified in paragraph 1.E., “Compliance,” of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017.

    (ii) Do the actions required by paragraphs (g)(1)(ii)(A) and (g)(1)(ii)(B) of this AD:

    (A) Before further flight, do the preventative modification in accordance with Part 2 of the Accomplishment Instructions of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017.

    (B) At the applicable time specified in paragraph 1.E., “Compliance,” of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017, do an HFEC inspection for cracking, in accordance with Part 3 of the Accomplishment Instructions of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017; and repeat the inspection thereafter at the applicable times specified in paragraph 1.E., “Compliance,” of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017.

    (2) For airplanes on which “Condition 2” is found as defined in the Accomplishment Instructions of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017, during any inspection required by paragraph (g) or (g)(1)(i) of this AD: Do the actions required by paragraph (g)(2)(i) and (g)(2)(ii) of this AD.

    (i) Before further flight, repair in accordance with Part 2 of the Accomplishment Instructions of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017.

    (ii) At the applicable time specified in paragraph 1.E., “Compliance,” of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017, do an HFEC inspection for cracking, in accordance with Part 3 of the Accomplishment Instructions of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017; and repeat the inspection thereafter at the applicable times specified in paragraph 1.E., “Compliance,” of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017.

    (3) If any crack is found during any inspection required by paragraph (g)(1)(ii)(B) or (g)(2)(ii) of this AD, repair before further flight using a method approved in accordance with the procedures specified in paragraph (j) of this AD. Although Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017, specifies to contact Boeing for repair instructions, and specifies that action as “RC” (Required for Compliance), this AD requires repair as specified in this paragraph.

    (h) Exception to Service Information Specifications

    Where paragraph 1.E., “Compliance,” of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017, specifies a compliance time of “after the initial issue date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.

    (i) Credit for Previous Actions

    For Group 2 airplanes: This paragraph provides credit for the actions specified in Part 1 and Part 2 of the Accomplishment Instructions of Aviation Partners Boeing Service Bulletin AP767-57-013, Revision 1, dated April 11, 2017, that are required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Aviation Partners Boeing Service Bulletin AP767-57-013, dated November 30, 2016.

    (j) 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 (k)(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) Except as required by paragraph (g)(3) of this AD: For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (j)(4)(i) and (j)(4)(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.

    (k) Related Information

    (1) For more information about this AD, contact Allen Rauschendorfer, Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 1601 Lind Avenue SW, Renton, WA 98057-3356; phone: 425-917-6450; fax: 425-917-6590; email: [email protected]

    (2) For service information identified in this AD, contact Aviation Partners Boeing, 2811 S. 102nd Street, Suite 200, Seattle, WA 98168; telephone 206-762-1171; internet https://www.aviationpartnersboeing.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 25, 2018. Michael Kaszycki, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-02197 Filed 2-8-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0027; Product Identifier 2017-NM-118-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 adopt a new airworthiness directive (AD) for all The Boeing Company Model 787 series airplanes. This proposed AD was prompted by reports that, under certain conditions, the automatic dependent surveillance—broadcast (ADS-B) out function and air traffic control/traffic alert and collision avoidance system (ATC/TCAS) functions can transmit incorrect data. This proposed AD would require an inspection or records review to determine if certain software is installed, the installation of new software for the integrated surveillance system (ISS) operational program software (OPS) if necessary, a software check, and applicable on-condition actions. For certain airplanes, this proposed AD would also require the installation of new software for the ISS OPS and the displays and crew alerting (DCA) database. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by March 26, 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 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. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0027.

    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-2018-0027; 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:

    Nelson O. Sanchez, Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 1601 Lind Avenue SW, Renton, WA 98057-3356; phone: 425-917-6489; 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-2018-0027; Product Identifier 2017-NM-118-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 have received reports indicating that the ADS-B out function and ATC/TCAS functions can transmit incorrect position and pressure altitude information in the data that is used by ATC to coordinate aircraft separation. Under certain conditions, the ADS-B out function has been shown to transmit non-current aircraft data (including latitude, longitude, and pressure altitude) based on coasting from a previous global positioning system (GPS) position. In addition, the ATC/TCAS functions can transmit non-current pressure altitude information on both mode C and mode S transmissions based on coasting from a previous pressure altitude. This condition, if not corrected, could result in potential mid-air collisions.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin B787-81205-SB340036-00, Issue 001, dated June 30, 2017. This service information describes procedures for the installation of new software for the ISS OPS (which includes main input/output (IO) software and traffic transponder (XPDR) airborne collision avoidance system (ACAS) software), a software check, and applicable on-condition actions.

    We also reviewed Boeing Service Bulletin B787-81205-SB340005-00, Issue 002, dated April 27, 2016. This service information describes procedures for the installation of new software for the ISS OPS and for the DCA database.

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

    FAA's Determination

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

    Proposed AD Requirements

    This proposed AD would require, for certain airplanes, an inspection or records review to determine if certain software is installed, and if necessary, accomplishment of the actions identified as “RC” (required for compliance) in the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB340036-00, Issue 001, dated June 30, 2017, described previously, except for any differences identified as exceptions in the regulatory text of this proposed AD.

    This proposed AD would also require, for certain airplanes, accomplishing the actions specified in Boeing Service Bulletin B787-81205-SB340005-00, Issue 002, dated April 27, 2016, 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-2018-0027.

    Differences Between Proposed AD and the Service Information

    The effectivity of Boeing Alert Service Bulletin B787-81205-SB340036-00, Issue 001, dated June 30, 2017, and Boeing Service Bulletin B787-81205-SB340005-00, Issue 002, dated April 27, 2016, is limited to Model 787-8 and 787-9 airplanes with certain line numbers. However, the applicability of this proposed AD includes all Boeing Model 787 series airplanes, because the affected software part numbers, identified in paragraph (j) of this proposed AD, are rotable parts. We have determined that these part numbers could later be installed on airplanes that were initially delivered with acceptable software, thereby subjecting those airplanes to the unsafe condition.

    Costs of Compliance

    We estimate that this proposed AD affects 136 airplanes of U.S. registry. We also estimate that 115 airplanes will require installation and check of new software, and 54 airplanes will require the concurrent installation of other software. We estimate the following costs to comply with this proposed AD:

    Estimated Costs for Required Actions Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Records Review/Inspection (136 airplanes) 1 work-hour × $85 per hour = $85 $0 $85 $11,560 Installation and Check (115 airplanes) 4 work-hours × $85 per hour = $340 0 340 39,100 Concurrent Installation (54 airplanes) 1 work-hour × $85 per hour = $85 0 85 4,590

    We estimate the following costs to do any necessary on-condition actions that would be required. We have no way of determining the number of aircraft that might need these on-condition actions:

    Estimated Costs of On-Condition Actions Labor cost Parts
  • cost
  • Cost
  • per
  • product
  • 4 work-hours × $85 per hour = $340 $0 $340

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

    Authority for This Rulemaking

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

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

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): The Boeing Company: Docket No. FAA-2018-0027; Product Identifier 2017-NM-118-AD. (a) Comments Due Date

    We must receive comments by March 26, 2018.

    (b) Affected ADs

    None.

    (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 34, Navigation.

    (e) Unsafe Condition

    This AD was prompted by reports that, under certain conditions, the automatic dependent surveillance—broadcast (ADS-B) out and air traffic control (ATC)/traffic alert and collision avoidance system (TCAS) functions can transmit incorrect position and pressure altitude information in the data that is used by ATC to coordinate aircraft separation. We are issuing this AD to prevent the transmission of incorrect position and pressure altitude data, which could result in potential mid-air collisions.

    (f) Compliance

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

    (g) Inspection or Records Review

    For airplanes that have an original certificate of airworthiness or export certificate of airworthiness issued on or before the effective date of this AD: Within 12 months after the effective date of this AD, inspect to determine if integrated surveillance system (ISS) operational program software (OPS) part number COL40-0010-0100 or COL46-0007-0100 is installed. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number of the software can be conclusively determined from that review.

    (h) Required Actions

    If, during any inspection or records review required by paragraph (g) of this AD, any ISS OPS part number COL40-0010-0100 or COL46-0007-0100 is found: Within 12 months after the effective date of this AD, do all applicable actions identified as “RC” (required for compliance) in, and in accordance with, the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB340036-00, Issue 001, dated June 30, 2017.

    (i) Additional Actions for Group 1 Airplanes

    For Group 1 airplanes identified in Boeing Alert Service Bulletin B787-81205-SB340036-00, Issue 001, dated June 30, 2017: Prior to accomplishment of the actions required by paragraph (h) of this AD, install new software for the ISS OPS and the displays and crew alerting (DCA) database, in accordance with the Accomplishment Instructions of Boeing Service Bulletin B787-81205-SB340005-00, Issue 002, dated April 27, 2016.

    (j) Parts Installation Prohibition

    As of the effective date of this AD, no person may install ISS OPS part number COL40-0010-0100 or COL46-0007-0100 on any airplane, except in accomplishment of the actions required by paragraph (i) of this AD.

    (k) Credit for Previous Actions

    This paragraph provides credit for the actions specified in paragraph (i) of this AD, if those actions were performed before the effective date of this AD using Boeing Service Bulletin B787-81205-SB340005-00, Issue 001, dated December 11, 2015.

    (l) 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 (m)(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) For service information that contains steps that are labeled as RC, the provisions of paragraphs (l)(4)(i) and (l)(4)(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.

    (m) Related Information

    (1) For more information about this AD, contact Nelson O. Sanchez, Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 1601 Lind Avenue SW, Renton, WA 98057-3356; phone: 425-917-6489; 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 25, 2018. Michael Kaszycki, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-02199 Filed 2-8-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0074; Product Identifier 2017-NM-148-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 adopt a new airworthiness directive (AD) for all The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. This proposed AD was prompted by reports of cracks found in the rear spar web and lower chord on the left and right wings. This proposed AD would require repetitive detailed inspections for cracking of the rear spar web and lower chord, and applicable on-condition actions. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by March 26, 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 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. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0074.

    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-2018-0074; 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:

    Payman Soltani, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5313; fax: 562-627-5210; 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-2018-0074; Product Identifier 2017-NM-148-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 have received a report indicating that cracks were found at fastener holes in the rear spar web and lower chord on the left and right wings between wing buttock line (WBL) 93 and WBL 146 on ten airplanes. The cracks were found on airplanes with total flight cycles between 46,190 and 55,633. Cracks in the rear spar web were reported on six airplanes. Cracks in the lower chord of the rear spar were reported on four airplanes. On one airplane, cracks were found at multiple locations in the rear spar web and in the lower chord. The largest reported cracks were 0.059 inch in the upper rear spar web, 0.045 inch in the lower rear spar web, and 0.063 inch in the lower chord. This condition, if not corrected, could lead to the inability of a principal structural element to sustain required flight load, which could adversely affect the structural integrity of the airplane.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Requirements Bulletin 737-57A1337 RB, dated September 14, 2017. The service information describes procedures for repetitive detailed or surface High Frequency Eddy Current (HFEC) inspections for cracking of the rear spar web and lower chord, and applicable on-condition actions. 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

    For Group 2 airplanes (line numbers 292 through 3132), this proposed AD would require accomplishment of the actions identified in the Boeing Alert Requirements Bulletin 737-57A1337 RB, dated September 14, 2017, described previously, except for any differences identified as exceptions in the regulatory text of this proposed AD. 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-2018-0074.

    Group 1 airplanes (line numbers 1 through 291) have a limit of validity (LOV) of 34,000 total flight cycles, and the actions specified in Boeing Alert Requirements Bulletin 737-57A1337 RB, dated September 14, 2017, would be required at a compliance time occurring after that LOV. Although operation of an airplane beyond its LOV is prohibited by 14 CFR 121.1115 and 129.115, this NPRM would include those airplanes so they are tracked in the event the LOV is extended in the future.

    Explanation of “RB” (Requirements Bulletin)

    The FAA has worked in conjunction with industry, under the Airworthiness Directives Implementation Aviation Rulemaking Committee (AD ARC), to enhance the AD system. One enhancement is a process for annotating which steps in the service information are “required for compliance” (RC) with an AD. Boeing has implemented this RC concept into Boeing service bulletins.

    In an effort to further improve the quality and flow time for AD-related Boeing service information, a joint process improvement initiative was worked between the FAA and Boeing. The initiative resulted in the development of a new process in which the service information more clearly identifies the actions needed to address the unsafe condition in the “Accomplishment Instructions.” The new process results in a Boeing Requirements Bulletin (RB), which contains only the actions needed to address the unsafe condition (i.e., only RC actions).

    Costs of Compliance

    We estimate that this proposed AD affects 160 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

    Estimated Costs for Required Actions Action Labor cost Parts cost Cost per product Cost on U.S. operators Inspections Up to 22 work-hours × $85 per hour = up to $1,870 per inspection cycle $0 Up to $1,870 per inspection cycle Up to $299,200 per inspection cycle.

    We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): The Boeing Company: Docket No. FAA-2018-0074; Product Identifier 2017-NM-148-AD. (a) Comments Due Date

    We must receive comments by March 26, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, certificated in any category.

    (d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

    (e) Unsafe Condition

    This AD was prompted by reports of cracks found in the rear spar web and lower chord on the left and right wings. We are issuing this AD to detect and correct cracks in the rear spar of the left and right wing between wing buttock line (WBL) 91 and WBL 155, which could lead to the inability of a principal structural element to sustain required flight load and adversely affect the structural integrity of the airplane.

    (f) Compliance

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

    (g) Required Actions for Group 1 Airplanes

    For airplanes identified in Group 1 in Boeing Alert Requirements Bulletin 737-57A1337 RB, dated September 14, 2017: Within 120 days after the effective date of this AD, inspect the airplane and do all applicable corrective actions using a method approved in accordance with the procedures specified in paragraph (j) of this AD.

    (h) Required Actions for Group 2 Airplanes

    For airplanes identified as Group 2 in Boeing Alert Requirements Bulletin 737-57A1337 RB, dated September 14, 2017: Except as required by paragraph (i) of this AD, at the applicable times specified in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 737-57A1337 RB, dated September 14, 2017, do all applicable actions identified in, and in accordance with, the Accomplishment Instructions of Boeing Alert Requirements Bulletin 737-57A1337 RB, dated September 14, 2017.

    Note 1 to paragraph (h) of this AD:

    Guidance for accomplishing the actions required by this AD is included in Boeing Alert Service Bulletin 737-57A1337, dated September 14, 2017, which is referred to in Boeing Alert Requirements Bulletin 737-57A1337 RB, dated September 14, 2017.

    (i) Exceptions to Service Information Specifications

    (1) For purposes of determining compliance with the requirements of this AD: Where Boeing Alert Requirements Bulletin 737-57A1337 RB, dated September 14, 2017, uses the phrase “the original issue date of Requirements Bulletin 737-57A1337 RB,” this AD requires using “the effective date of this AD.”

    (2) Where Boeing Alert Requirements Bulletin 737-57A1337 RB, dated September 14, 2017, specifies contacting Boeing, this AD requires repair using a method approved in accordance with the procedures specified in paragraph (j) of this AD.

    (j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles 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 (k)(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, Los Angeles 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.

    (k) Related Information

    (1) For more information about this AD, contact Payman Soltani, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5313; fax: 562-627-5210; 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 26, 2018. Michael Kaszycki, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-02193 Filed 2-8-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0072; Product Identifier 2017-NM-082-AD] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc., Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to supersede Airworthiness Directive (AD) 2014-05-28, for certain Bombardier, Inc., Model DHC-8-400 series airplanes. AD 2014-05-28 requires revising the maintenance or inspection program, as applicable. Since we issued AD 2014-05-28, we have determined that the interval from maintenance review board (MRB) task number 323100-202 should not be escalated, and that Certification Maintenance Requirements (CMR) task number 323100-102 should be applicable to all Model DHC-8-400 series airplanes, regardless of which main landing gear (MLG) up-lock assembly is installed. This proposed AD would require revising the maintenance or inspection program, as applicable. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by March 26, 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 Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone: 416-375-4000; fax: 416-375-4539; email: [email protected]ombardier.com; internet: http://www.bombardier.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.

    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-2018-0072; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Erin Hulverson, Aerospace Engineer, FAA, Boston ACO Branch, 1200 District Avenue, Burlington, MA 01803; telephone: 781-238-7655.

    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-2018-0072; Product Identifier 2017-NM-082-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

    Discussion

    We issued AD 2014-05-28, Amendment 39-17800 (79 FR 18611, April 3, 2014) (“AD 2014-05-28”), for certain Bombardier, Inc., Model DHC-8-400 series airplanes.

    AD 2014-05-28 resulted from reports of excessive wear on the lower latch surface of the MLG up-lock hook. AD 2014-05-28 requires revising the maintenance or inspection program, as applicable. We issued AD 2014-05-28 to detect and correct up-lock hooks worn beyond the wear limit, which could prevent the successful extension of the MLG using the primary landing gear extension system, which in combination with an alternate extension system failure could result in the inability to extend the MLG.

    Since we issued AD 2014-05-28, we have determined that the interval from MRB task number 323100-202 should not be escalated, and that MRB task number 323100-202 should be applicable to all Model DHC-8-400 series airplanes, regardless of which MLG up-lock assembly is installed.

    This revised applicability has resulted in CMR task number 323100-102 also being made applicable to all Model DHC-8-400 series airplanes, regardless of MLG up-lock assembly part number installation.

    Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2017-15, dated May 29, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or ”the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model DHC-8-400 series airplanes. The MCAI states:

    [Canadian] AD CF-2012-21 [which corresponds to FAA AD 2014-05-28] was issued to mandate the incorporation of Maintenance Review Board (MRB) task number 323100-202. As in-service experience has shown that the interval for MRB task number 323100-202 should not be escalated, Bombardier has introduced one-star CMR task number 323100-102 to prevent task escalation. Bombardier has also revised the applicability of MRB task number 323100-202 to be applicable to the entire DHC-8-400/-401/-402 fleet, regardless of which main landing gear (MLG) up-lock assembly part number is installed. This revised applicability has resulted in CMR task number 323100-102 also being made applicable to the entire DHC-8-400/-401/-402 fleet, regardless of MLG up-lock assembly part number installation.

    This [Canadian] AD mandates the incorporation of CMR task number 323100-102 [into the maintenance or inspection program, as applicable].

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0072.

    Related Service Information Under 1 CFR Part 51

    Bombardier, Inc., has issued Q400 Dash 8 Temporary Revision ALI-0168, dated October 31, 2016, to Section 1-32, Landing Gear Maintenance Program, of Maintenance Review Board (MRB) Report Part 2, Bombardier Q400 Dash 8 Maintenance Requirements Manual, Product Support Manual (PSM) 1-84-7. The service information describes CMR task number 323100-102, “Functional Check of the Main Landing Gear Uplock Assembly Latch.” This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

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

    Costs of Compliance

    We estimate that this proposed AD affects 69 airplanes of U.S. registry.

    We estimate that it would take about 1 work-hour per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $5,865, or $85 per product.

    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 transport category airplanes to the Director of the System Oversight Division.

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by removing Airworthiness Directive (AD) 2014-05-28, Amendment 39-17800 (79 FR 18611, April 3, 2014), and adding the following new AD: Bombardier, Inc.: Docket No. FAA-2018-0072; Product Identifier 2017-NM-082-AD. (a) Comments Due Date

    We must receive comments by March 26, 2018.

    (b) Affected ADs

    This AD replaces AD 2014-05-28, Amendment 39-17800 (79 FR 18611, April 3, 2014).

    (c) Applicability

    This AD applies to Bombardier, Inc., Model DHC-8-400, -401, and -402 airplanes, certificated in any category, serial numbers 4001, 4003 and subsequent.

    (d) Subject

    Air Transport Association (ATA) of America Code 32, Landing gear.

    (e) Reason

    This AD was prompted by reports of excessive wear on the lower latch surface of the main landing gear (MLG) up-lock hook. We are issuing this AD to detect and correct up-lock hooks worn beyond the wear limit, which could prevent the successful extension of the MLG using the primary landing gear extension system, which in combination with an alternate extension system failure could result in the inability to extend the MLG.

    (f) Compliance

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

    (g) Maintenance or Inspection Program Revision

    Within 30 days after the effective date of this AD, revise the maintenance or inspection program, as applicable, to incorporate the information specified in Certification Maintenance Requirements (CMR) task number 323100-102 of Q400 Dash 8 (Bombardier) Temporary Revision (TR) ALI-0168, dated October 31, 2016 (“Bombardier TR ALI-0168”), to Section 1-32, Landing Gear Maintenance Program, of Maintenance Review Board (MRB) Report Part 2, Bombardier Q400 Dash 8 Maintenance Requirements Manual, Product Support Manual (PSM) 1-84-7. The applicable maintenance or inspection program revision required by this paragraph may be done by inserting a copy of Bombardier TR ALI-0168, to Section 1-32, Landing Gear Maintenance Program, of MRB Report Part 2, Bombardier Q400 Dash 8 Maintenance Requirements Manual, PSM 1-84-7. When this temporary revision has been included in general revisions of the PSM, the general revisions may be inserted in the maintenance or inspection program, as applicable, provided the relevant information in the general revision is identical to that in Bombardier TR ALI-0168.

    (h) Initial Functional Check Compliance Times

    For MLG up-lock assembly latches that have accumulated flight cycles which exceed the CMR task number 323100-102 interval specified in Bombardier TR ALI-0168: Perform the initial CMR task number 323100-102 functional check as specified in Bombardier TR ALI-0168, to Section 1-32, Landing Gear Maintenance Program, of MRB Report Part 2, Bombardier Q400 Dash 8 Maintenance Requirements Manual, PSM 1-84-7, using the applicable compliance time specified in paragraph (h)(1), (h)(2), or (h)(3) of this AD.

    (1) For MLG up-lock assembly latches that have 14,200 total flight cycles or more as of the effective date of this AD: The compliance time for doing the initial functional check is within 800 flight cycles after the effective date of this AD.

    (2) For MLG up-lock assembly latches that have 11,600 total flight cycles or more, but fewer than 14,200 total flight cycles, as of the effective date of this AD: The compliance time for doing the initial functional check is within 1,600 flight cycles after the effective date of this AD, but not to exceed 15,000 total flight cycles on the up-lock assembly latch.

    (3) For MLG up-lock assembly latches with fewer than 11,600 total flight cycles as of the effective date of this AD: The compliance time for doing the initial functional check is within 3,000 flight cycles after the effective date of this AD, but not to exceed 13,200 total flight cycles on the up-lock assembly latch.

    (i) Method of Compliance for Initial Functional Check

    Accomplishing MRB task number 323100-202 of Bombardier TR MRB-66, dated December 7, 2011, to Section 1-32, Landing Gear Maintenance Program, of MRB Report Part 1, Bombardier Q400 Dash 8 Maintenance Requirements Manual, PSM 1-84-7, within 3,000 flight cycles before the effective date of this AD, is a method of compliance for the initial functional check required by CMR task number 323100-102 as specified in Bombardier TR ALI-0168, to Section 1-32, Landing Gear Maintenance Program, of MRB Report Part 2, Bombardier Q400 Dash 8 Maintenance Requirements Manual, PSM 1-84-7.

    (j) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New York 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 ACO, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7300; fax: 516-794-5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO Branch, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc., TCCA Design Approval Organization (DAO). If approved by the DAO, the approval must include the DAO-authorized signature.

    (k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian AD CF-2017-15, dated May 29, 2017, for related information. This MCAI may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0072.

    (2) For more information about this AD, contact Erin Hulverson, Aerospace Engineer, FAA, Boston ACO Branch, 1200 District Avenue, Burlington, MA 01803; telephone: 781-238-7655.

    (3) For service information identified in this AD, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone: 416-375-4000; fax: 416-375-4539; email: [email protected]; internet: http://www.bombardier.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.

    Issued in Renton, Washington, on January 25, 2018. Michael Kaszycki, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-02198 Filed 2-8-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-1089; Airspace Docket No. 17-AEA-21] Proposed Amendment of Class E Airspace, Hamilton, NY AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend Class E airspace at Hamilton Municipal Airport (formerly Elisha Payne Airport), Hamilton, NY, to accommodate airspace reconfiguration due to the decommissioning of the Georgetown VHF omni-directional radio range tactical air navigation aid (VORTAC), and cancellation of the VORTAC approach. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport. This action also would update the geographic coordinates of the airport, and update the airport name.

    DATES:

    Comments must be received on or before March 26, 2018.

    ADDRESSES:

    Send comments on this proposal to: The U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590-0001; Telephone: (800) 647-5527, or (202) 366-9826. You must identify the Docket No. FAA-2017-1089; Airspace Docket No. 17-AEA-21, at the beginning of your comments. You may also submit comments through the internet at http://www.regulations.gov.

    FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC, 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11B at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Ave., College Park, GA 30337; telephone (404) 305-6364.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

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

    Comments Invited

    Interested persons are invited to comment on this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

    Communications should identify both docket numbers (Docket No. FAA-2017-1089 and Airspace Docket No. 17-AEA-21) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for the address and phone number.) You may also submit comments through the internet at http://www.regulations.gov.

    Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2017-1089; Airspace Docket No. 17-AEA-21.” The postcard will be date/time stamped and returned to the commenter.

    All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this document may be changed in light of the comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined between 8:00 a.m. and 4:30 p.m., Monday through Friday, except federal holidays at the office of the Eastern Service Center, Federal Aviation Administration, room 350, 1701 Columbia Avenue, College Park, GA 30337.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA proposes an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to increases Class E airspace extending upward from 700 feet or more above the surface within an 11.2-mile radius (increased from a 6.5-mile radius) of Hamilton Municipal Airport, Hamilton, NY, due to the decommissioning of the Georgetown VORTAC, and cancellation of the VOR approach. The changes would enhance the safety and management of IFR operations at the airport. The geographic coordinates of the airport also would be adjusted to coincide with the FAAs aeronautical database, and the airport name would be updated to Hamilton Municipal Airport from Elisha Payne Airport.

    Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

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

    Environmental Review

    This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AEA NY E5 Hamilton, NY [Amended] Hamilton Municipal Airport, NY (Lat. 42°50′36″ N, long. 75°33′40″ W)

    That airspace extending upward from 700 feet above the surface within an 11.2-mile radius of Hamilton Municipal Airport.

    Issued in College Park, Georgia, on January 29, 2018. Ryan W. Almasy, Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2018-02143 Filed 2-8-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-1061; Airspace Docket No. 17-AEA-20] Proposed Amendment of Class D Airspace and Class E Airspace, and Removal of Class E Airspace; Binghamton, NY AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend Class D airspace, Class E surface airspace, and Class E airspace extending upward from 700 feet above the surface; and remove Class E airspace designated as an extension to a Class D surface area; at Greater Binghamton Airport/Edwin A. Link Field (formerly Binghamton Regional Airport/Edwin A. Link Field), Binghamton, NY. This action would accommodate airspace reconfiguration due to the decommissioning of the Binghamton VHF omni-directional radio range tactical air navigation aid (VORTAC), and cancellation of the VOR approaches. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport. This action also would update the geographic coordinates of the airport, and correct the airport's name. Additionally, this action would replace the outdated term “Airport/Facility Directory” with the term “Chart Supplement” in Class D and E surface airspace descriptions.

    DATES:

    Comments must be received on or before March 26, 2018.

    ADDRESSES:

    Send comments on this proposal to: U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; Telephone: (800) 647-5527, or (202) 366-9826. You must identify the Docket No. FAA-2017-1061; Airspace Docket No. 17-AEA-20, at the beginning of your comments. You may also submit comments through the internet at http://www.regulations.gov.

    FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11B at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Ave., College Park, GA 30337; telephone (404) 305-6364.

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class D and Class E airspace at Greater Binghamton Airport/Edwin A. Link Field, Binghamton, NY, to support IFR operations at the airport.

    Comments Invited

    Interested persons are invited to comment on this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

    Communications should identify both docket numbers (Docket No. FAA-2017-1061 and Airspace Docket No. 17-AEA-20) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for the address and phone number.) You may also submit comments through the internet at http://www.regulations.gov.

    Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2017-1061; Airspace Docket No. 17-AEA-20.” The postcard will be date/time stamped and returned to the commenter.

    All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this document may be changed in light of the comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined between 8:00 a.m. and 4:30 p.m., Monday through Friday, except federal holidays at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, GA 30337.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to amend Class D airspace, Class E surface airspace, and Class E airspace extending upward from 700 feet or more above the surface at Greater Binghamton Airport/Edwin A. Link Field, Binghamton, NY (formerly Binghamton Regional Airport/Edwin A. Link Field), due to the decommissioning of the Binghamton VORTAC, and cancellation of the VOR approaches. These changes would enhance the safety and management of IFR operations at the airport.

    The Class D airspace area would be amended to within a 4.4-mile radius (from a 4.3-mile radius) of Greater Binghamton Airport/Edwin A. Link Field.

    The Class E surface area airspace would be amended to within a 4.4-mile radius (increased from a 4.3-mile radius) of Greater Binghamton Airport/Edwin A. Link Field. The Binghamton VORTAC would be removed as it is being decommissioned. The SMITE LOM, and ILS Runway 34 Localizer navigation aids are no longer needed in the airspace redesign.

    The Class E airspace designated as an extension to a Class D surface area would be removed as this airspace was only necessary for the cancelled approaches. Class E airspace extending upward from 700 feet above the surface would be amended to within a 7-mile radius (initially from a boundary line formed by the geographic coordinates) of the airport. The exclusionary language contained in the legal description would be removed to comply with FAA Order 7400.2L, Procedures for Handling Airspace Matters. Also, an editorial change would be made by adding the airport's geographic coordinates to the airspace designation.

    The geographic coordinates of the airport also would be adjusted in the classes of airspace listed above to coincide with the FAA's aeronautical database, and the airport name would be updated to Greater Binghamton Airport/Edwin A. Link Field, formerly Binghamton Regional Airport/Edwin A. Link Field.

    Class E airspace designations are published in paragraphs 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

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

    Environmental Review

    This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017, is amended as follows: Paragraph 5000 Class D Airspace. AEA NY D Binghamton, NY [Amended] Greater Binghamton Airport/Edwin A. Link Field, NY (Lat. 42°12′30″ N, long. 75°58′47″ W) That airspace extending upward from the surface to and including 4,100 feet MSL within a 4.4-mile radius of Greater Binghamton Airport/Edwin A. Link Field. This Class D airspace area is effective during the specific days and times established in advance by a Notice to Airmen. The effective days and times will thereafter be continuously published in the Chart Supplement. Paragraph 6002 Class E Surface Area Airspace. AEA NY E2 Binghamton, NY [Amended] Greater Binghamton Airport/Edwin A. Link Field, NY (Lat. 42°12′30″ N, long. 75°58′47″ W) That airspace extending upward from the surface within a 4.4-mile radius of Greater Binghamton Airport/Edwin A. Link Field. This Class E airspace area is effective during the specific days and times established in advance by a Notice to Airmen. The effective days and times will thereafter be continuously published in the Chart Supplement. Paragraph 6004 Class E Airspace Designated as an Extension to a Class D Surface Area. AEA NY E4 Binghamton, NY [Removed] Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AEA NY E5 Binghamton, NY [Amended] Greater Binghamton Airport/Edwin A. Link Field, NY (Lat. 42°12′30″ N, long. 75°58′47″ W) That airspace extending upward from 700 feet above the surface within a 7-mile radius of Greater Binghamton Airport/Edwin A. Link Field. Issued in College Park, Georgia, on January 29, 2018. Ryan W. Almasy, Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2018-02140 Filed 2-8-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0651] RIN 1625-AA00 Safety Zone; Navy Underwater Detonation (UNDET) Exercise, Apra Outer Harbor, GU AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to establish two recurring safety zones for navigable waters of Apra Outer Harbor and Piti, Guam. The safety zones will encompass sites designated for U.S. Navy underwater detonation (UNDET) exercises. The Coast Guard believes this safety zone regulation is necessary to protect the public and exercise participants within the affected area from possible safety hazards associated with these exercises. These safety zones will impact a small designated area of navigable waters in Apra Harbor and Piti during periods of times, many of which are of short duration, on days requested by the Navy for UNDET exercises. With the exception of exercise participants, entry of vessels or persons into the zone is prohibited unless specifically authorized by the Captain of the Port Guam. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before March 26, 2018. Requests for public meetings must be received by the Coast Guard on or before March 6, 2018.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2017-0651 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this proposed rulemaking, call or email Petty Officer Robin Branch, Sector Guam, U.S. Coast Guard; telephone (671) 355-4835, email [email protected]

    SUPPLEMENTARY INFORMATION:

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

    U.S. Navy UNDET exercises occur multiple times throughout the year to train and prepare personnel for operational missions. We have established safety zones for these Navy UNDETs in past years through a temporary final rulemaking for each exercise. For all subsequent exercises, we propose to establish recurring safety zones through this regulation to safeguard the public and exercise participants within the affected area from possible safety hazards associated with the exercises.

    The legal basis and authorities for this rule are found in 33 U.S.C. 1231. The purpose of these proposed safety zones is to protect the public and exercise participants from possible safety hazards associated with the exercises.

    III. Discussion of Proposed Rule

    The COTP proposes to establish these recurring safety zones for periods of time, many of which are of short duration, on days requested by the Navy for UNDET exercises. The safety zones will cover all navigable waters within a 700 yard radius above and below the surface for the Apra Outer Harbor site and a 700 yard radius above and below the surface for the Piti site. The duration of the safety zones are intended to protect personnel, vessels, and the marine environment in these navigable waters during the UNDET exercise. With the exception of exercise participants, no vessel or person will be permitted to enter the safety zones without obtaining permission from the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.

    IV. Regulatory Analysis

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

    A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

    This regulatory action determination is based on the size, location, and duration of the safety zones. Vessel traffic will be able to safely transit around these safety zones, which will impact a small designated area of waters off of Piti, Guam, and in Apra Outer Harbor for periods of time, many of which are of short duration, on days requested by the Navy for UNDET exercises. The UNDET exercises occur approximately 10 times a year, although additional exercises may be required based on Navy training needs. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the safety zones and the rule allows vessels to seek permission to enter the zone.

    B. Impact on Small Entities

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

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves two safety zones for periods of time, many of which are of short duration, on days requested by the Navy for UNDET exercises that would prohibit entry within a 700 yard radius above and below the surface for the Apra Outer Harbor site and a 700 yard radius above and below the surface for the Piti site. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    G. Protest Activities

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

    V. Public Participation and Request for Comments

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

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

    We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacyNotice.

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

    List of Subjects in 33 CFR Part 165

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

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

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

    33 U.S.C. 1231; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

    2. Add § 165.1402 to read as follows:
    § 165.1402 Safety Zone; Navy Underwater Detonation (UNDET) Exercise, Apra Outer Harbor, GU.

    (a) Location. The following areas, within the Guam Captain of the Port (COTP) Zone (See 33 CFR 3.70-15), from the surface of the water to the ocean floor, are safety zones:

    (1) Apra Outer Harbor, Guam. All waters above and below the surface bounded by a circle with a 700 yard radius centered at 13 degrees 27 minutes 42 seconds North Latitude and 144 degrees 38 minutes 30 seconds East Longitude, (NAD 1983).

    (2) Piti, Guam. All waters above and below the surface bounded by a circle with a 700-yard radius centered at 13 degrees 29 minutes 03 seconds North Latitude and 144 degrees 40 minutes 03 seconds East Longitude, (NAD 1983).

    (b) Enforcement periods. This section will be enforced for designated periods of time, many of which are of short duration, on days requested by the Navy for purpose of UNDET exercises.

    (c) Regulations. The general regulations governing safety zones contained in 33 CFR 165.23 apply. With the exception of exercise participants, no vessels may enter or transit safety zones (a)(1) and no persons in the water may enter or transit safety zone (a)(2) unless authorized by the COTP or a designated representative thereof.

    (d) Enforcement. Any Coast Guard commissioned, warrant, or petty officer, and any other COTP representative permitted by law, may enforce these safety zones.

    Dated: December 11, 2017. Christopher M. Chase, Captain, U.S. Coast Guard, Captain of the Port, Guam.
    [FR Doc. 2018-02648 Filed 2-8-18; 8:45 am] BILLING CODE 9110-04-P
    83 28 Friday, February 9, 2018 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request February 6, 2018.

    The Department of Agriculture will submit the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13 on or after the date of publication of this notice. Comments are requested regarding: (1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, Washington, DC; New Executive Office Building, 725 17th Street NW, Washington, DC 20503. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602.

    Comments regarding these information collections are best assured of having their full effect if received by March 12, 2018. Copies of the submission(s) may be obtained by calling (202) 720-8681.

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

    30-Day Federal Register Notice Agricultural Marketing Service

    Title: Beef Research and Promotion: Producer Request for State to Retain Checkoff Assessment Form.

    OMB Control Number: 0581-0302.

    Summary of Collection: Congress has delegated to the U.S. Department of Agriculture (USDA) the responsibility for implementing and overseeing the Beef Research and Promotion Program. The enabling legislation for the Beef Research and Promotion Program is the Beef Promotion and Research Act of 1985 (Act) (7 U.S.C. 2901-2911).

    On June 21, 2017, a U.S. District Court Judge in Montana issued a preliminary injunction enjoining USDA from continuing to allow MBC to use the assessments that it is qualified to collect under the Beef Checkoff Program to fund advertising campaigns, unless a cattle producer provides prior affirmative consent authorizing MBC to retain a portion of the cattle producer's assessment. As a result of this preliminary injunction, MBC must begin forwarding all Beef Checkoff Program funds directly to the Cattlemen's Beef Promotion and Research Board (Beef Board), the entity that administers the National Beef Checkoff Program, absent proof that a producer has provided advance affirmative consent authorizing MBC to retain a portion of that producer's assessment.

    The Beef Checkoff Program carries out projects relating to research, consumer information, advertising, sales promotion, producer information, market development, and product research to assist, improve, or promote the marketing, distribution, and utilization of beef. The Beef Checkoff Program is directed by a national industry board whose members are appointed by the Secretary of Agriculture, who also approves the Beef Boards' budgets, plans, and projects. The latter responsibility has been delegated to AMS. The funding for the Beef Checkoff Program is industry-specific, with assessments generated by producers and importers each time cattle are sold.

    Need and Use of the Information: The Beef Promotion and Research Order (Order) and regulations governing the Beef Research and Promotion Program authorize the Qualified State Beef Councils (QSBCs) to collect and submit certain information as required. The information will be used by some beef producers in Montana (and any other State subject to a similar court order) who seek to have a portion of the Federal assessments remain with MBC (and any other State subject to a similar court order) instead of the full assessment collected being forwarded to the Beef Board. QSBCs administer the State beef program.

    AMS developed the LPS-2 Producer Request to Retain Beef Checkoff Assessments form so that producers have an option to allow MBC (and any other State subject to a similar court order) to retain a portion of the assessment collected instead of forwarding the full assessment collected to the Beef Board. The LPS-2 form gives the producer the option to (1) submit the form once a year or (2) submit the form each time cattle are sold.

    Without the producer's permission for the State to retain a portion of the Federal assessment under the Beef Checkoff Program, MBC will likely have insufficient funds to pay for ongoing projects, contracts, staff salaries, and other administrative functions and, therefore, could be forced to cease operations and potentially leave current staff unemployed.

    Description of Respondents: Business or other for-profit.

    Number of Respondents: 100.

    Frequency of Responses: Reporting: On occasion; Annually.

    Total Burden Hours: 8.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2018-02585 Filed 2-8-18; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF COMMERCE Census Bureau Proposed Information Collection; Comment Request; Annual Survey of School System Finances AGENCY:

    U.S. Census Bureau, 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:

    To ensure consideration, written comments must be submitted on or before April 10, 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(s) and instructions should be directed to David J. Gromos, U.S. Census Bureau, Economic Reimbursable Surveys Division, Room 6H151, Washington, DC 20233; (301) 763-4659 (or via the internet at [email protected]).

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    The U.S. Census Bureau plans to continue the current Office of Management and Budget clearance for the Annual Survey of School System Finances. The Annual Survey of School System Finances is the only comprehensive source of public elementary-secondary school system finance data collected on a nationwide scale using uniform definitions, concepts, and procedures. The collection covers the revenues, expenditures, debt, and assets of all public elementary-secondary school systems. This data collection has been coordinated with the National Center for Education Statistics (NCES). The NCES uses this collection to satisfy its need for school finance data.

    Fiscal data provided by respondents aid data users in measuring the effectiveness of resource allocation. The products of this data collection make it possible for data users to search a single database to obtain information on such things as per pupil expenditures and the percent of state, local, and federal funding for each school system. Elementary-secondary education related spending is the single largest financial activity of state and local governments. Education finance statistics provided by the Census Bureau allow for analyses of how public elementary-secondary school systems receive their funding and how they are spending their funds.

    II. Method of Collection

    A letter is mailed electronically at the beginning of each survey period to solicit the assistance of the state education agencies. This letter officially announces the opening of the data collection period and requests some administrative data, such as the estimated date of submission, any change to the reporting format from prior year, and updated contact information for the state coordinator.

    The survey form (F-33) contains item descriptions and definitions of the elementary-secondary education finance items collected jointly by the Census Bureau and NCES. It is used primarily as a worksheet and instruction guide by the state education agencies providing school finance data centrally for the school systems in their respective states. The Census Bureau collects almost all of the finance data for local school systems from state education agency databases through central collection arrangements with the state education agencies. The states transfer this information in electronic format over the internet via file transfer protocol. The Census Bureau has also facilitated central collection of school system finance data by accepting data in multiple formats.

    Supplemental forms are sent to local school systems in states where the state education agency cannot centrally provide information on assets (F-33-L1), indebtedness (F-33-L2), or both (F-33-L3).

    III. Data

    OMB Control Number: 0607-0700.

    Form Number(s): F-33, Supplemental forms: F-33-L1, F-33-L2 and F-33-L3.

    Type of Review: Regular submission.

    Affected Public: State and local governments.

    Estimated Number of Respondents: F-33: 51, Supplement: 3,630.

    Estimated Time per Response: F-33: 59 hrs. 41 minutes, Supplemental: 15 minutes.

    Estimated Total Annual Burden Hours: 3,951.

    Estimated Total Annual Cost to Public: $0. (This is not the cost of respondents' time, but the indirect costs respondents may incur for such things as purchases of specialized software or hardware needed to report, or expenditures for accounting or records maintenance services required specifically by the collection.)

    Respondent's Obligation: Voluntary.

    Legal Authority: Census: Title 13 U.S.C. Sections 8(b), 161, and 182. NCES: Title 20 U.S.C. Sections 9543-44.

    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.

    Sheleen Dumas, Departmental Lead PRA Officer, Office of the Chief Information Officer.
    [FR Doc. 2018-02581 Filed 2-8-18; 8:45 am] BILLING CODE 3510-07-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-62-2017] Correction Notice; Foreign-Trade Zone (FTZ) 127—West Columbia, South Carolina; Authorization of Limited Production Activity; BGM America, Inc.; Subzone 127C (Sailboats, Cabin Cruiser Powerboats, Outboard Motor Boats); Marion, South Carolina

    On September 27, 2017, the Richland-Lexington Airport District, grantee of FTZ 127, submitted a notification of proposed production activity to the FTZ Board on behalf of BGM America, Inc., within Subzone 127C, in Marion, South Carolina.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (82 FR 46216-46217, October 4, 2017). On January 25, 2018, the applicant was notified of the FTZ Board's decision that further review of part of the proposed activity is warranted. The FTZ Board authorized the production activity described in the notification on a limited basis, subject to the FTZ Act and the Board's regulations, including Section 400.14, and further subject to a restriction requiring that the following foreign-sourced materials/components be admitted to the subzone in privileged foreign status (PF) (19 CFR 146.41): Acrylic vessel covers; plastic and woven fabric blinds; woven nylon strips; rubber thread and cord bungee cords; synthetic fiber braided cord cut to length; cotton netting; twine, cordage and rope safety ladders; twine and cordage rope; nylon woven ribbons; marine vinyl composed of polyvinyl chloride, polyester and cotton (coated with over 70 percent polyvinyl chloride); rubberized textile adhesive tape; textile felt seals & gaskets; synthetic fiber curtains; synthetic fiber textile blinds; synthetic fiber table covers; synthetic fiber textile wheel covers; sails of synthetic fibers; cotton dust cloths; polyester web fabric straps; nonwoven fiberglass mats; woven fiberglass with fibers; fiberglass in bulk; mattresses; and, cotton seat cushions and pillows.

    Dated: February 5, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-02630 Filed 2-8-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-9-2018] Foreign-Trade Zone 31—Granite City, Illinois; Application for Reorganization and Expansion Under Alternative Site Framework

    An application has been submitted to the Foreign-Trade Zones (FTZ) Board by America's Central Port District, grantee of FTZ 31, requesting authority to reorganize the zone under the alternative site framework (ASF) adopted by the FTZ Board (15 CFR Sec. 400.2(c)). The ASF is an option for grantees for the establishment or reorganization of zones and can permit significantly greater flexibility in the designation of new subzones or “usage-driven” FTZ sites for operators/users located within a grantee's “service area” in the context of the FTZ Board's standard 2,000-acre activation limit for a zone. The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on February 5, 2018.

    FTZ 31 was approved by the FTZ Board on September 6, 1977 (Board Order 122, 42 FR 46568; September 16, 1977) and expanded on January 16, 1985 (Board Order 289, 50 FR 3371; January 24, 1985) and October 3, 2003 (Board Order 1304, (68 FR 59162; October 14, 2003).

    The current zone includes the following sites: Site 1 (47 acres)—Tri-City Regional Port Complex, 2801 Rock Road, Granite City; Site 3 (4.79 acres)—Fox Industries, 1100 Niedringhaus Avenue, Granite City; Site 4 (2.82 acres)—Port District Industrial Park and Transportation Center, 1000 and 2000 Access Road, Madison; Site 5 (2,254 acres)—Gateway Commerce Center, Intersection of 270 and I-255, Edwardsville; Site 6 (458 acres)—River's Edge Industrial Park, 1635 West First Street, Granite City; and, Site 7 (3,851 acres)—MidAmerica Airport, Intersection of I-64 and Route 4, Mascoutah.

    The grantee's proposed service area under the ASF would be Bond, Calhoun, Clinton, Greene, Jersey, Macoupin, Madison, Monroe, Montgomery, Randolph, St. Clair, and Washington Counties, Illinois, as described in the application. If approved, the grantee would be able to serve sites throughout the service area based on companies' needs for FTZ designation. The application indicates that the proposed service area is within and adjacent to the St. Louis Customs and Border Protection port of entry.

    The applicant is requesting authority to reorganize its zone to include existing Sites 1, 5 and 7 as “magnet” sites. The applicant requests that existing Site 1 be expanded to include the full port area and that existing Sites 4 and 6 be included as part of the expanded Site 1. As requested, the expanded Site 1 would total 1,530.6 acres. The ASF allows for the possible exemption of one magnet site from the “sunset” time limits that generally apply to sites under the ASF, and the applicant proposes that Site 1 be so exempted. The applicant is also requesting the removal of Site 3 as well as Subzones 31A and 31C. The application would have no impact on Subzone 31B.

    In accordance with the FTZ Board's regulations, Elizabeth Whiteman of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the FTZ Board.

    Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is April 10, 2018. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to April 25, 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 Elizabeth Whiteman at [email protected] or (202) 482-0473.

    Dated: February 5, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-02631 Filed 2-8-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-520-804] Certain Steel Nails From the United Arab Emirates: Rescission of 2016-2017 Antidumping Duty Administrative Review AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) is rescinding the administrative review of the antidumping duty order on certain steel nails from the United Arab Emirates (UAE) for the period of review (POR), May 1, 2016, through April 30, 2017.

    DATES:

    Applicable February 9, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Annathea Cook, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-0250

    SUPPLEMENTARY INFORMATION:

    Background

    On July 6, 2017, based on a timely request for review by Mid Continent Steel & Wire, Inc. (the petitioner), Commerce published in the Federal Register a notice of initiation of an administrative review of the antidumping duty order on certain steel nails from the UAE, covering the POR.1 On August 2, 2017, Commerce placed evidence on the record that the antidumping duty questionnaire was undeliverable to Overseas Distribution Services, Inc., (ODS), the sole respondent subject to the review, at the address provided.2 We requested an alternate address from the petitioner, but the petitioner was unable to provide one.3 Although we re-sent the questionnaire to the original and two available alternate addresses from other segments of this proceeding,4 it continued to be undeliverable.5 Moreover, for two of the failed delivery attempts, the delivery company stated the business was closed.

    1See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 82 FR 31292 (July 6, 2017); Petitioner's Letter, “Certain Steel Nails from the United Arab Emirates: Request for Administrative Review,” dated May 31, 2017.

    2See Memorandum, “Certain Steel Nails from the United Arab Emirates: Tracking of Documents to Overseas Distribution Services, Inc.,” dated August 2, 2017.

    3See Petitioner's Letter, “Re: Certain Steel Nails from the United Arab Emirates: Comments on August 2, 2017 Memorandum to the File,” dated August 14, 2017.

    4See Memorandum, “Certain Steel Nails from the United Arab Emirates: Alternate Contact Information for Overseas Distribution Services, Inc.,” dated concurrently with this notice.

    5See Memorandum, “Certain Steel Nails from the United Arab Emirates: Second Tracking of Documents to Overseas Distribution Services, Inc.,” dated January 24, 2018.

    On January 23, 2018, Commerce 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 preliminary determination of this review is now February 5, 2018.6

    6See Memorandum, “Deadlines Affected by the Shutdown of the Federal Government,” dated January 23, 2018 (Tolling Memorandum). All deadlines in this segment of the proceeding have been extended by three days.

    Rescission of Administrative Review

    In instances when a questionnaire is returned because of an undeliverable address and the petitioner is unable to provide an alternative address, Commerce's practice is to rescind the review of the company.7 While Commerce understands the concerns raised by the petitioner,8 it would be futile to conduct a review of a closed company. Because the questionnaire was undeliverable with indications that the business was closed, ODS being the only respondent under review, and the petitioner is unable to provide an alternative address, we are rescinding the administrative review of certain steel nails from the UAE for the 2016-2017 POR.

    7See, e.g., Certain Steel Concrete Reinforcing Bars from Turkey; Final Results and Rescission of Antidumping Duty Administrative Review in Part, 71 FR 65082 (November 7, 2006); Certain Frozen Warmwater Shrimp from Thailand; Partial Rescission of Antidumping Duty Administrative Review, 72 FR 50931 (September 5, 2007); Uncovered Innerspring Units from the People's Republic of China: Preliminary Results and Rescission, in Part, of the Antidumping Duty Administrative Review; 2016-2017, 82 FR 51602 (November 7, 2017).

    8See Petitioner's Letter, “Re: Certain Steel Nails from the United Arab Emirates: Comments on January 24, 2018 Memorandum to the File,” dated January 31, 2018.

    Assessment

    We will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. Because Commerce is rescinding this administrative review in its entirety, the entries to which this administrative review pertained shall be assessed antidumping duties at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions to CBP 15 days after the publication of this notice.

    Notifications

    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 Commerce's presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

    This notice also serves as a final 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 this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).

    Dated: February 5, 2018. James Maeder, Associate Deputy Assistant Secretary performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2018-02629 Filed 2-8-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-557-816] Certain Steel Nails From Malaysia: Final Results of Antidumping Duty Administrative Review; 2014-2016 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) determines that Inmax Sdn. Bhd. and Inmax Industries Sdn. Bhd. (collectively, Inmax), and Region International Co. Ltd. and Region System Sdn. Bhd. (collectively, Region) made sales of certain steel nails (steel nails) from Malaysia at prices below normal value during the period of review of December 29, 2014, through June 30, 2016.

    DATES:

    Applicable February 9, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Edythe Artman or Madeline Heeren, 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) 482-3931 or (202) 482-9179, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On August 7, 2017, Commerce published the Preliminary Results. 1 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, 2018.2 A summary of the events that occurred since Commerce published these results, as well as a full discussion of the issues raised by parties for this final determination, may be found in the Issues and Decision Memorandum, which is hereby adopted by this notice.3

    1See Issues and Decision Memorandum for the Final Results of the Administrative Review of the Antidumping Duty Order on Certain Steel Nails from Malaysia; 2014-2016, 82 FR 36741 (August 7, 2017) (Preliminary Results).

    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.

    3See Memorandum, “Issues and Decision Memorandum for the Final Results of the Administrative Review of the Antidumping Duty Order on Certain Steel Nails from Malaysia; 2014-2016”, dated concurrently with this notice (Issues and Decision Memorandum).

    Scope of the Order

    The merchandise covered by this order is certain steel nails. The certain steel nails subject to the order are currently classifiable under HTSUS subheadings 7317.00.55.02, 7317.00.55.03, 7317.00.55.05, 7317.00.55.07, 7317.00.55.08, 7317.00.55.11, 7317.00.55.18, 7317.00.55.19, 7317.00.55.20, 7317.00.55.30, 7317.00.55.40, 7317.00.55.50, 7317.00.55.60, 7317.00.55.70, 7317.00.55.80, 7317.00.55.90, 7317.00.65.30, 7317.00.65.60 and 7317.00.75.00. Certain steel nails subject to these orders also may be classified under HTSUS subheadings 7907.00.60.00, 8206.00.00.00 or other HTSUS subheadings.

    For a complete description of the scope of the order, see the Issues and Decision Memorandum

    Analysis of Comments Received

    All issues raised in the case and rebuttal briefs by parties to this administrative review are addressed in the Issues and Decision Memorandum. A list of the issues raised by parties is attached to this notice as an Appendix. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov and 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 and electronic versions of the Issues and Decision Memorandum are identical in content.

    Changes Since the Preliminary Results

    Based on our review of the record and comments received from interested parties, we made certain changes to the margin calculations for Region. For a discussion of these changes, see the “Margin Calculations” section of the Issues and Decision Memorandum. As a result of these changes, the weighted-average dumping margin also changed for the company not selected for individual examination.

    4 As we did not have a publicly ranged total U.S. sales value for Region for the period December 29, 2014, through June 30, 2016, in accordance with our practice, to calculate a weighted-average dumping margin for the non-examined company, Tag Fasteners Sdn. Bhd., the rate applied to this company is a simple average of the weighted-average dumping margins calculated for Inmax and Region.

    Final Results of the Review

    The final weighted-average dumping margins are as follows: 4

    Producer or exporter Weighted-average dumping margin
  • (percent)
  • Inmax Sdn. Bhd. and Inmax Industries Sdn. Bhd 1.03 Region International Co. Ltd. and Region System Sdn. Bhd 1.87 Tag Fasteners Sdn. Bhd 1.45
    Disclosure

    We will disclose the calculations performed to parties in this proceeding within five days of the date of publication of this notice, in accordance with 19 CFR 351.224(b).

    Duty Assessment

    Commerce shall determine and U.S. Customs and Border Protection (CBP) shall assess antidumping duties on all appropriate entries.5 For any individually examined respondents whose weighted-average dumping margin is above de minimis, we calculated importer-specific ad valorem duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). Upon issuance of the final results of this administrative review, if any importer-specific assessment rates calculated in the final results are above de minimis (i.e., at or above 0.5 percent), Commerce will issue instructions directly to CBP to assess antidumping duties on appropriate entries.

    5 In these final results, Commerce applied the assessment rate calculation method adopted in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101 (February 14, 2012).

    To determine whether the duty assessment rates covering the period were de minimis, in accordance with the requirement set forth in 19 CFR 351.106(c)(2), for each respondent we calculated importer (or customer)-specific ad valorem rates by aggregating the amount of dumping calculated for all U.S. sales to that importer or customer and dividing this amount by the total entered value of the sales to that importer (or customer). Where an importer (or customer)-specific ad valorem rate is greater than de minimis, and the respondent has reported reliable entered values, we will apply the assessment rate to the entered value of the importer's/customer's entries during the review period.

    We intend to issue assessment instructions directly to CBP 15 days after publication of the final results of this review.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of this notice for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication of these final results, as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for respondents noted above will be the rate established in the final results of this administrative review; (2) for merchandise exported by manufacturers or exporters not covered in this administrative review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the manufacturer of the subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 2.66 percent, the all-others rate established in the antidumping investigation.6 These cash deposit requirements, when imposed, shall remain in effect until further notice.

    6See Certain Steel Nails from the Republic of Korea, Malaysia, the Sultanate of Oman, Taiwan, and the Socialist Republic of Vietnam: Antidumping Duty Orders, 80 FR 39994 (July 13, 2015).

    Notification to Importers Regarding the Reimbursement of Duties

    This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during the period of review. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties did occur and the subsequent assessment of doubled antidumping duties.

    Administrative Protective Order

    This notice also serves as a reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

    We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h).

    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 Final Issues and Decision Memorandum I. Summary II. List of Issues III. Background IV. Scope of the Order V. Rate for Unexamined Respondents VI. Discussion of the Issues A. Inmax Comment 1: Revision of G&A Expenses B. Region Comment 2: Application of the Transactions Disregarded Analysis Comment 3: Revision of Interest Expense Ratio Comment 4: Correction of Clerical Errors in Its Preliminary Results VII. Recommendation
    [FR Doc. 2018-02628 Filed 2-8-18; 8:45 am] BILLING CODE 3510-DS-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Proposed Additions and Deletions AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Proposed additions to and deletions from the Procurement List.

    SUMMARY:

    The Committee is proposing to add services to the Procurement List that will be provided by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products previously furnished by such agency.

    DATES:

    Comments must be received on or before March 11, 2018.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    For further information or to submit comments contact: Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

    Additions

    If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the services listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.

    The following services are proposed for addition to the Procurement List for production by the nonprofit agencies listed:

    Services Service Type: Grounds Maintenance Service Mandatory for: U.S. Army Garrison Miami, U.S. Special Operations Command South 29401 SW 125th Avenue, Bldg. 600, Homestead Air Reserve Base, FL U.S. Army Garrison Miami, 3501 Granada Blvd., Coral Gables, FL Mandatory Source of Supply: Goodwill Industries of South Florida, Inc., Miami, FL Contracting Activity: DEPT OF THE ARMY, 0410 AQ HQ Service Type: Custodial Service Mandatory for: National Park Service, Colonial National Historical Park, 10815 George Washington Memorial Highway, Yorktown, VA Mandatory Source of Supply: VersAbility Resources, Inc., Hampton, VA Contracting Activity: National Park Service, NER Construction/IA/AE MABO (42000) Deletions

    The following products are proposed for deletion from the Procurement List:

    Products NSN(s)—Product Name(s): 7920-01-615-6967—Scrub Brush, Wire, Black Tempered, Ergonomic, 5″ 7920-01-615-6968—Wire Brush, Wire, Knuckle Guard, Long Handle, Ergonomic, 6″ x 11/8 7920-01-615-6971—Scrub Brush, Wire, Knuckle Guard, Long Handle, Ergonomic, 6″ x 11/8″, w/built-in scraper 7920-01-615-6972—Scrub Brush, Polypropylene Bristles, Extension Pole-Compatible, 2″ x 8″ 7920-01-615-6973—Scrub Brush, Wire, Stainless, Ergonomic, 5″ Mandatory Source of Supply: Industries for the Blind, Inc., West Allis, WI Contracting Activity: General Services Administration, Fort Worth, TX Amy B. Jensen, Director, Business Operations.
    [FR Doc. 2018-02651 Filed 2-8-18; 8:45 am] BILLING CODE 6353-01-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Deletions AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Deletions from the Procurement List.

    SUMMARY:

    This action deletes products from the Procurement List previously furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

    DATES:

    Date deleted from the Procurement List: March 11, 2018.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    Deletions

    On 1/5/2018 (83 FR 4), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.

    After consideration of the relevant matter presented, the Committee has determined that the products listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

    Regulatory Flexibility Act Certification

    I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

    1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

    2. The action may result in authorizing small entities to furnish the products to the Government.

    3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products deleted from the Procurement List.

    End of Certification

    Accordingly, the following products are deleted from the Procurement List:

    Products NSN—Product Name: 3920-00-000-8908—Shelf Assembly, Top Mandatory Source of Supply: Rauch, Inc., New Albany, IN Contracting Activity: USPS, Topeka Purchasing Center, Topeka, KS NSN(s)—Product Name(s): 8455-00-NSH-0001—Logo, BDU Coat and Shirt 8455-00-NSH-0002—Logo, BDU Coat and Shirt Mandatory Source of Supply: Southeastern Kentucky Rehabilitation Industries, Inc., Corbin, KY Contracting Activity: Defense Logistics Agency Troop Support Amy B. Jensen, Director, Business Operations.
    [FR Doc. 2018-02652 Filed 2-8-18; 8:45 am] BILLING CODE 6353-01-P
    COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities Under Review AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act (“PRA”), this notice announces that the Information Collection Request (“ICR”) abstracted below has been forwarded to the Office of Management and Budget (“OMB”) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.

    DATES:

    Comments must be submitted on or before March 12, 2018.

    ADDRESSES:

    Comments regarding the burden estimate or any other aspect of the information collection, including suggestions for reducing the burden, may be submitted directly to the Office of Information and Regulatory Affairs (“OIRA”) in OMB within 30 days of the notice's publication by either of the following methods. Please identify the comments by “OMB Control No. 3038-0082.”

    By email addressed to: [email protected] or

    By mail addressed to: the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention Desk Officer for the Commodity Futures Trading Commission, 725 17th Street NW, Washington DC 20503.

    A copy of all comments submitted to OIRA should be sent to the Commodity Futures Trading Commission (the “Commission”) by either of the following methods. The copies should refer to “OMB Control No. 3038-0082.”

    The Agency's website, via its Comments Online process: http://comments.cftc.gov. Follow the instructions for submitting comments through the website.

    Mail: Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581.

    Hand Delivery/Courier: Same as Mail above.

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

    Please submit your comments using only one method.

    All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http://www.cftc.gov. You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations.1

    1 17 CFR 145.9.

    The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from http://www.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the ICR will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act.

    FOR FURTHER INFORMATION CONTACT:

    Christopher Ehrman, Director, Whistleblower Office, Commodity Futures Trading Commission, (202) 418-7650; email: [email protected]; and refer to OMB Control No. 3038-0082.

    SUPPLEMENTARY INFORMATION:

    Title: Renewal for Whistleblower Provision, OMB Control Number 3038-0082. This is a request for extension of a currently approved information collection.

    Abstract: 17 CFR 165.3(a) requires the submission of information to the Commission on a Form TCR. The Form TCR, “Tip, Complaint, or Referral,” and the instructions thereto, are designed to capture basic identifying information about a complainant and elicit sufficient information to determine whether the conduct alleged suggests a violation of the Commodity Exchange Act. 17 CFR 165.7(b)(1) requires the submission of information to the Commission on a Form WB-APP. The Form WB-APP, “Application for Award for Original Information Provided Pursuant to Section 23 of the Commodity Exchange Act,” and the instructions thereto, are designed to elicit sufficient information to determine whether and to what extent a claimant qualifies for a whistleblower award.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the CFTC's regulations were published on December 30, 1981. See 46 FR 63035 (Dec. 30, 1981). The Federal Register notice with a 60-day comment period soliciting comments on this collection of information was published on November 28, 2017 (82 FR 56222).

    The Commission received one comment, the thrust of which was to urge that information from whistleblowers be fully evaluated before award determinations are made. The purpose of this information collection is to permit such complete evaluation of whistleblower information.

    Burden Statement: The respondent burden for this collection is estimated to be 0.5 hours per response.

    Respondents/Affected Entities: Individuals.

    Estimated Number of Respondents: 600 per year.

    Estimated Total Annual Burden on Respondents: 300 hours.

    Frequency of Collection: Once.

    (Authority: 44 U.S.C. 3501 et seq.) Dated: February 6, 2018. Robert N. Sidman, Deputy Secretary of the Commission.
    [FR Doc. 2018-02615 Filed 2-8-18; 8:45 am] BILLING CODE 6351-01-P
    COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities: Notice of Intent To Extend Collection 3038-0095; Large Trader Reporting for Physical Commodity Swaps AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Commodity Futures Trading Commission (CFTC) is announcing an opportunity for public comment on the proposed extension of a collection of certain information by the agency. Under the Paperwork Reduction Act (“PRA”), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment. This notice solicits comments on the information collection requirements set out in part 20 of the Commission's regulations concerning large trader reporting for physical commodity swaps.

    DATES:

    Comments must be submitted on or before April 10, 2018.

    ADDRESSES:

    You may submit comments, identified by “3038-0095” by any of the following methods:

    • The Agency's website, at http://comments.cftc.gov/. Follow the instructions for submitting comments through the website.

    Mail: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581.

    Hand Delivery/Courier: Same as Mail above.

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

    Please submit your comments using only one method. All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http://www.cftc.gov.

    FOR FURTHER INFORMATION CONTACT:

    Owen J. Kopon, Special Counsel, Division of Market Oversight, Commodity Futures Trading Commission, (202) 418-5360; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. To comply with this requirement, the CFTC is publishing notice of the proposed collection of information listed below.

    Title: Large Trader Reporting for Physical Commodity Swaps, (OMB Control No. 3038-0095). This is a request for extension of a currently approved information collection.

    Abstract: Part 20 of the Commission's regulations (“Reporting Rules”) requires clearing organizations and any persons that are “reporting entities” to file swaps position data with the Commission. The Reporting Rules collect clearing member reports from clearing organizations. The Reporting Rules also require position reports from reporting entities for principal and counterparty positions in cleared and uncleared physical commodity swaps. Reporting entities are those persons that are either “clearing members” or “swap dealers” that are otherwise not clearing members. For purposes of part 20, reporting parties are required to submit data on positions on a futures equivalent basis so as to allow the Commission to assess a trader's market impact across differently structured but linked derivatives instruments and markets. This renewal updates the total requested burden based on available reported data.

    With respect to the collection of information, the CFTC invites comments on:

    • Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;

    • The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Ways to enhance the quality, usefulness, and clarity of the information to be collected; and

    • Ways to minimize the burden of collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses.

    All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http://www.cftc.gov. You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations.1

    1 17 CFR 145.9.

    The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from http://www.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the ICR will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act.

    Burden Statement

    The annual respondent burden for this collection during the renewal period is estimated to be as follows:

    Estimated Number of Respondents: 4,824.

    Estimated Average Annual Burden Hours per Respondent: 1.55.

    Estimated Total Annual Number of Responses: 56,088.

    Estimated Total Annual Burden Hours: 86,902.

    Type of Respondents: Respondents may include clearing organizations, persons that are clearing members or swap dealers that are reporting entities, and large swap counterparties.

    (Authority: 44 U.S.C. 3501 et seq.) Dated: February 5, 2018. Robert N. Sidman, Deputy Secretary of the Commission.
    [FR Doc. 2018-02572 Filed 2-8-18; 8:45 am] BILLING CODE 6351-01-P
    DEPARTMENT OF DEFENSE Defense Acquisition Regulations System [Docket DARS-2018-0005] Opportunity for Public Comment on Proposed Definition of “Procurement Administrative Lead Time” or “PALT” and the Plan for Measuring and Publically Reporting Data on PALT for Department of Defense Contracts and Task Orders Above the Simplified Acquisition Threshold AGENCY:

    Defense Acquisition Regulations System (DARS), Department of Defense (DoD).

    ACTION:

    Notice; request for public comments.

    SUMMARY:

    In accordance with section 886 of the National Defense Authorization Act for Fiscal Year 2018, DoD is requesting public comments on a proposed definition of “Procurement Administrative Lead Time” or “PALT”, that will be applied DoD-wide, and DoD's plan for measuring and publicly reporting data on PALT for DoD contracts and task orders above the simplified acquisition threshold.

    DATES:

    Interested parties should submit written comments to the address shown below on or before March 12, 2018, to be considered.

    ADDRESSES:

    Submit comments identified by “DARS-2018-0005” using any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by entering “DARS-2018-0005” under the heading “Enter keyword or ID” and selecting “Search.” Select the link “Submit a Comment” that corresponds with “DARS-2018-0005.” Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “DARS-2018-0005” on your attached document.

    Mail: Defense Procurement and Acquisition Policy, Attn: Mr. Greg Snyder, 3060 Defense Pentagon, Room 5E621, Washington, DC 20301-3060.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Greg Snyder, Senior Procurement Analyst, Office of the Under Secretary of Defense for Acquisition and Sustainment (OUSD(A&S)), Defense Procurement and Acquisition Policy, Contract Policy and International Contracting; telephone 703-614-0719.

    SUPPLEMENTARY INFORMATION:

    Section 886 of the National Defense Authorization Act for Fiscal Year 2018 (Pub. L. 115-91), requires DoD to develop and make available for public comment a definition of the term “Procurement Administrative Lead Time” or “PALT” and a plan for measuring and publicly reporting data on PALT for DoD contracts and task orders above the simplified acquisition threshold. DoD is proposing to define PALT as “the time between the date on which the initial solicitation for a contract or task order of the Department of Defense is issued and the date of the award of the contract or task order.” The Department plans to use Federal Procurement Data System—Next Generation (FPDS-NG), the authoritative source for Governmentwide contract award data, to measure PALT and make PALT data available to the public. The Department plans to submit a Change Control Board request to the General Services Administration to update FPDS-NG by adding a new data field that reflects when the solicitation for a contract or task order valued above the simplified acquisition threshold is issued. Once the FPDS-NG system is updated (estimated to be completed in fiscal year 2019), the public will be able to utilize FPDS-NG to obtain the PALT information for any contract or task order issued by the DoD that is valued above the simplified acquisition threshold. The public is invited to submit comments on this proposed definition and the plan as instructed in the addresses section of this notice.

    Jennifer L. Hawes, Regulatory Control Officer, Defense Acquisition Regulations System.
    [FR Doc. 2018-02599 Filed 2-8-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Charter Amendment of Department of Defense Federal Advisory Committees AGENCY:

    Department of Defense.

    ACTION:

    Amendment of Federal Advisory Committee.

    SUMMARY:

    The Department of Defense (DoD) is publishing this notice to announce that it is amending the charter for the Defense Acquisition University Board of Visitors, the Defense Science Board, the Strategic Environmental Research and Development Program Scientific Advisory Board, and the Threat Reduction Advisory Committee.

    FOR FURTHER INFORMATION CONTACT:

    Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.

    SUPPLEMENTARY INFORMATION:

    Each committee's charter is being amended in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(d). Pursuant to statutory changes that took effect on February 1, 2018, the DoD disestablished the Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics (OUSD(AT&L)), and established the Office of the Under Secretary of Defense for Acquisition and Sustainment (OUSD(A&S)) and the Office of the Under Secretary of Defense for Research and Engineering (OUSD(R&E)). The DoD is amending the charters for each of these advisory committees to reflect a change in the committee's DoD Sponsor. The USD(A&S) will be the DoD Sponsor for the Defense Acquisition University Board of Visitors, and the Threat Reduction Advisory Committee. The USD(R&E) will be the DoD Sponsor for the Defense Science Board, and the Strategic Environmental Research and Development Program Scientific Advisory Board. The amended charter and contact information for the Designated Federal Officer (DFO) can be obtained at http://www.facadatabase.gov/.

    Dated: February 6, 2018. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-02634 Filed 2-8-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Army, U.S. Army Corps of Engineers Request for Proposals for Beneficial Use of Dredged Material Pursuant to Section 1122 of the Water Resources Development Act, Beneficial Use of Dredged Material AGENCY:

    U.S. Army Corps of Engineers, DoD.

    ACTION:

    Notice; request for proposals.

    SUMMARY:

    Section 1122 of the Water Resources Development Act (WRDA) of 2016 requires the U.S. Army Corps of Engineers (USACE) establish a pilot program to recommend ten projects for the beneficial use of dredged material. The USACE is requesting proposals for beneficial use of dredged material projects.

    DATES:

    Proposals must be submitted to Headquarters U.S. Army Corps of Engineers on or before March 12, 2018.

    ADDRESSES:

    You may submit proposals by any of the following methods:

    Mail: Headquarters, U.S. Army Corps of Engineers, Directorate of Civil Works, Operations and Regulatory Community of Practice, Attn: CECW-CO-OD, 441 G Street NW, Washington, DC 20314.

    Email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Mr. Joseph Wilson, Environmental Dredging Program Manager, at 202-761-7697, or email: [email protected].

    SUPPLEMENTARY INFORMATION:

    Section 1122 of WRDA 2016 requires the USACE establish a pilot program to carry out 10 projects for the beneficial use of dredged material, including projects for the purposes of—

    (1) Reducing storm damage to property and infrastructure;

    (2) promoting public safety;

    (3) protecting, restoring, and creating aquatic ecosystem habitats;

    (4) stabilizing stream systems and enhancing shorelines;

    (5) promoting recreation;

    (6) supporting risk management adaptation strategies; and

    (7) reducing the costs of dredging and dredged material placement or disposal, such as projects that use dredged material for—

    (A) construction or fill material;

    (B) civic improvement objectives; and

    (C) other innovative uses and placement alternatives that produce public economic or environmental benefits.

    The USACE has developed implementation guidance for carrying out the provisions of Section 1122. That implementation guidance can be obtained at http://www.usace.army.mil/Missions/Civil-Works/Project-Planning/Legislative-Links/wrda2016/wrda2016_impguide. Search Section 1122(a)-(h) for links to the implementation guidance and other Section 1122 information.

    The USACE is required to carry out the pilot program in consultation with relevant state agencies and to establish regional beneficial use teams to identify and assist in the implementation of projects.

    Projects identified under Section 1122 must maximize the beneficial placement of dredged material from Federal and non-Federal navigation channels and incorporate, to the maximum extent practicable, two or more Federal navigation, flood control, storm damage reduction, or environmental restoration projects. Section 1122 also requires coordination and mobilization of dredges and related equipment, including the use of efficiencies in contracting and environmental approvals as can be implemented under existing laws and regulations.

    Implementation must foster Federal and State and local collaboration; implement best practices to maximize the beneficial use of dredged sand and other sediments; and ensure that the use of dredged material is consistent with all applicable environmental laws.

    Projects carried out under Section 1122 will be subject to the cost-sharing requirements applicable to projects carried out under Section 204 of the Continuing Authorities Program. However, for projects under the pilot program that use dredged material from federal navigation projects, Section 1122(e)(2) provides the incremental costs above the federal standard for transportation and depositing such dredged material will be borne entirely by the federal government. If such pilot projects involve additional activities other than transportation and placement of dredged material, such as wetland plantings or mechanical shaping of dunes and beach berms, those project costs will be shared in accordance with the cost sharing requirements of Section 204. If additional material is dredged from a federal navigation project solely for purposes of a pilot project, the costs associated with the additional dredging will be cost-shared with the non-federal sponsor of the pilot project in accordance with Section 204. If a pilot project relies on dredged material from a non-federal navigation project, the dredging and transportation costs will be 100 percent non-federal; all other costs associated with the pilot project will be cost-shared in accordance with Section 204.

    Within two years the Secretary is to submit a report to the Congress that includes:

    (1) A description of the projects selected to be carried out under the pilot program;

    (2) documentation supporting each of the projects selected;

    (3) the findings of regional beneficial use teams regarding project selection; and

    (4) any recommendations of the Secretary or regional beneficial use teams with respect to the pilot program.

    The pilot program terminates after completion of the 10 beneficial use projects.

    Entities submitting proposals for a project must include the following information:

    1. Name and location of the proposed project.

    2. Purpose of the proposed project (see paragraph 5 of the Implementation Guidance).

    3. Description of the proposed project, including more detail on how material will be used beneficially to meet project purposes identified in 2 above.

    4. The name of all non-federal interests planning to act as the sponsor, including any non-federal interest that has contributed to or is expected to contribute toward the non-federal share of the proposed beneficial use project.

    5. List the authorized U.S. Army Corps of Engineers (Corps) water resources development project(s) that the proposed beneficial use project is associated with.

    6. Provide an estimate, to the extent practicable, of the total beneficial use project cost, and the federal and non-federal share of those costs.

    7. Describe, to the extent practicable, an estimate of the anticipated monetary and non-monetary benefits of the proposed beneficial use project with regard to the environmental, economic, and social benefits of the project.

    8. Describe if local support exists for the proposal.

    9. Statement of the non-federal interest's financial ability to provide a share of the project costs.

    Dated: February 5, 2018. Thomas P. Smith, Chief Operations and Regulatory Division, U.S. Army Corps of Engineers.
    [FR Doc. 2018-02613 Filed 2-8-18; 8:45 am] BILLING CODE 3720-58-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0143] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; U.S. Department of Education Green Ribbon Schools Nominee Presentation Form AGENCY:

    Office of Communications and Outreach (OCO), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 12, 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-0143. 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 216-32, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Andrea Falken, 202-503-8985.

    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: U.S. Department of Education Green Ribbon Schools Nominee Presentation Form.

    OMB Control Number: 1860-0509.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 30.

    Total Estimated Number of Annual Burden Hours: 1,350.

    Abstract: Begun in 2011-2012, U.S. Department of Education Green Ribbon Schools (ED-GRS) is a recognition award that honors schools, districts, and postsecondary institutions that are making great strides in three Pillars: (1) Reducing environmental impact and costs, including waste, water, energy use, and transportation; (2) improving the health and wellness of students and staff, including environmental health of premises, nutrition, and fitness; and (3) providing effective sustainability education, including STEM, civic skills, and green career pathways.

    The award is a tool to encourage state education agencies, stakeholders and higher education officials to consider matters of facilities, health and environment comprehensively and in coordination with state health, environment and energy counterparts. In order to be selected for federal recognition, schools, districts and postsecondary institutions must be high achieving in all three of the above Pillars, not just one area. Schools, districts, colleges and universities apply to their state education authorities. State authorities can submit up to six nominees to ED, documenting achievement in all three Pillars. This information is used at the Department to select the awardees.

    ED collects information on nominees from state nominating authorities regarding their schools, districts, and postsecondary nominees. State agencies are provided sample applications for all three types of nominees for their use and adaptation. Most states adapt the sample to their state competition. There is no one federal application for the award, but rather various applications determined by states. They do use a required two-page Nominee Submission Form as a cover sheet, which ED provides. This document, in school, district, and postsecondary submission formats is attached. The burden varies greatly from state authority to authority and how they chose to approach the award.

    The recognition award is part of a U.S. Department of Education (ED) effort to identify and communicate practices that result in improved student engagement, academic achievement, graduation rates, and workforce preparedness, and reinforce federal efforts to increase energy independence and economic security.

    Encouraging resource efficient schools, districts, and IHEs allows administrators to dedicate more resources to instruction rather than operational costs. Healthy schools and wellness practices ensure that all students learn in an environment conducive to achieving their full potential, free of the health disparities that can aggravate achievement gaps. Sustainability education helps students engage in hands-on learning, hone critical thinking skills, learn many disciplines and develop a solid foundation in STEM subjects. It motivates postsecondary students in many disciplines, and especially those underserved in STEM subjects, to persist and graduate with sought after degrees and robust civic skills.

    So that the Administration can receive states' nominations, ED seeks to provide the Nominee Presentation Form to states—essentially a cover sheet for states' evaluation of their nominees to ED—in three versions; one for school nominees, another for district nominees, and a third form for postsecondary nominees.

    Dated: February 5, 2018. Tomakie Washington, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-02576 Filed 2-8-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0162] Agency Information Collection Activities; Comment Request; Privacy Act Request Form AGENCY:

    Office of Management (OM), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.

    DATES:

    Interested persons are invited to submit comments on or before April 10, 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-0162. 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 216-32, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Elise Cook, 202-401-3769.

    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: Privacy Act Request Form.

    OMB Control Number: 1880—NEW.

    Type of Review: A new information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 130.

    Total Estimated Number of Annual Burden Hours: 65.

    Abstract: The collection is necessary under 5 U.S.C. Section 552a(b) to collect information from individuals requesting information under the Privacy Act (PA). The Department will use the information to provide documents that are responsive to a Privacy Act or FOIA/Privacy Act request under the Freedom of Information Act.

    Dated: February 5, 2018. Tomakie Washington, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-02575 Filed 2-8-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2018-ICCD-0012] Agency Information Collection Activities; Comment Request; Fiscal Operations Report for 2017-2018 and Application To Participate 2019-2020 (FISAP) and Reallocation Form AGENCY:

    Federal Student Aid (FSA), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before April 10, 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-2018-ICCD-0012. 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 Beth Grebeldinger, 202-377-4018.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Fiscal Operations Report for 2017-2018 and Application to Participate 2019-2020 (FISAP) and Reallocation Form.

    OMB Control Number: 1845-0030.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments; Private Sector.

    Total Estimated Number of Annual Responses: 4,162.

    Total Estimated Number of Annual Burden Hours: 94,916.

    Abstract: The Higher Education Opportunity Act (HEOA) (Pub. L. 110-315) was enacted on August 14, 2008 and reauthorized the Higher Education Act of 1965, as amended, (HEA). It requires participating Title IV institutions to apply for funds and report expenditures for the Federal Perkins Loan (Perkins), the Federal Supplemental Educational Opportunity Grant (FSEOG) and the Federal Work-Study (FWS) Programs on an annual basis.

    The data submitted electronically in the Fiscal Operations Report and Application to Participate (FISAP) is used by the Department of Education to determine the institution's funding need for the award year and monitor program effectiveness and accountability of fund expenditures. The data is used in conjunction with institutional program reviews to assess the administrative capability and compliance of the applicant. There are no other resources for collecting this data.

    The HEA requires that if an institution anticipates not using all of its allocated funds for the FWS, and FSEOG programs by the end of an award year, it must specify the anticipated remaining unused amount to the Secretary, who reduces the institution's allocation accordingly.

    The changes to the Perkins Loan Program in this annual update reflect the immediate reporting needs. There will be more extensive changes to the FISAP in next year's iteration to accommodate the continuing Perkins program close out.

    Dated: February 6, 2018. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-02579 Filed 2-8-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0124] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Implementation of Title I/II Program Initiatives AGENCY:

    Institute of Education Sciences (IES), 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 12, 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-0124. 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 216-32, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Erica Johnson, 202-245-7676.

    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: Implementation of Title I/II Program Initiatives.

    OMB Control Number: 1850-0902.

    Type of Review: A reinstatement of a previously approved information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments Total Estimated Number of Annual Responses: 770.

    Total Estimated Number of Annual Burden Hours: 872.

    Abstract: The second round of data collection for the Implementation of Title I/II-A Program Initiatives study will continue to examine the implementation of policies promoted through the Elementary and Secondary Education Act (ESEA) at the state and district levels, in four core areas: School accountability and support for low-performing schools, improving teacher and leader effectiveness, state content standards, and assessments. The first round of data collection for this study was conducted in Spring and Summer 2014.

    The purpose of this follow-up data collection is to provide policy makers with detailed information on the core policies promoted by Title I and Title II-A being implemented at the state and district levels, and the resources and supports they provide to schools and teachers. The timing of the data collection is critical to provide early information on the implementation of the Every Student Succeeds Act (ESSA) in the 2017-18 school year.

    This study will rely on information collected from existing sources, for which there are no respondents or burden, and on a set of revised state and district surveys based on the 2014 data collection in order to address the study's research questions. Extant data sources include (a) the National Assessment of Educational Progress (NAEP) and (b) EDFacts data.

    The revised surveys of states and school districts will begin in March 2018. All respondents will have the opportunity to complete an electronic (e.g., web-based) survey (or paper survey, if preferred). The survey respondents are described briefly below:

    State Surveys: The state survey will be sent to the chief state school officer in each of the 50 states and the District of Columbia. The state surveys will be administered using an electronic instrument divided into modules corresponding to the four core areas.

    School District Surveys. The school district survey will be sent to school superintendents from the same nationally representative sample of 570 school districts that participated in the 2014 survey, as well as a new nationally representative sample of 149 charter school districts. The district survey will be web-based and modularized, corresponding to the four core areas, to allow for completion by one or multiple respondents.

    Dated: February 5, 2018. Tomakie Washington, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-02561 Filed 2-8-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0152] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; College Affordability and Transparency Explanation Form (CATEF) 2018-2020 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 an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 12, 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-0152. 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 Freddie Cross, 202-453-7224.

    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: College Affordability and Transparency Explanation Form (CATEF) 2018-2020.

    OMB Control Number: 1840-0822.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 631.

    Total Estimated Number of Annual Burden Hours: 2,063.

    Abstract: The Office of Postsecondary Education (OPE) is seeking a renewed three-year clearance for the College Affordability and Transparency Explanation Form (CATEF) data collection. OPE has collected this information since 2011-12 and the collection of information through CATEF is required by § 132 of the Higher Education Act of 1965 as amended (HEA), 20 U.S.C. 1015a with the goal of increasing the transparency of college tuition prices for consumers. This submission is for the 2017-18, 2018-19, and 2019-20 collection years. CATEF collects follow-up information from institutions that appear on the tuition and fees and/or net price increase College Affordability and Transparency Center (CATC) Lists for being in the five percent of institutions in their institutional sector that have the highest increases, expressed as a percentage change, over the three-year time period for which the most recent data are available. The information collected through CATEF is used to write a summary report for Congress which is also posted on the CATC website (accessible through the College Navigator).

    Dated: February 6, 2018. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-02607 Filed 2-8-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY [OE Docket No. EA-386-B] Application To Export Electric Energy; ENGIE Energy Marketing NA, Inc. AGENCY:

    Office of Electricity Delivery and Energy Reliability, DOE.

    ACTION:

    Notice of application.

    SUMMARY:

    ENGIE Energy Marketing NA, Inc. (EEMNA or Applicant) has applied to renew its authority to transmit electric energy from the United States to Mexico pursuant to the Federal Power Act.

    DATES:

    Comments, protests, or motions to intervene must be submitted on or before March 12, 2018.

    ADDRESSES:

    Comments, protests, motions to intervene, or requests for more information should be addressed to: Office of Electricity Delivery and Energy Reliability, Mail Code: OE-20, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585-0350. Because of delays in handling conventional mail, it is recommended that documents be transmitted by overnight mail, by electronic mail to [email protected], or by facsimile to 202-586-8008.

    SUPPLEMENTARY INFORMATION:

    Exports of electricity from the United States to a foreign country are regulated by the Department of Energy (DOE) pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 7151(b), 7172(f)) and require authorization under section 202(e) of the Federal Power Act (16 U.S.C. 824a(e)).

    On March 27, 2003, DOE issued Order No. EA-386 to IPR-GDF Suez Energy Marketing North America, Inc. (GSEMNA), which authorized the Applicant to transmit electric energy from the United States to Mexico as a power marketer for a five-year term using existing international transmission facilities. On May 3, 2017, GSEMNA changed its name to EEMNA in Order No. EA-386-A. That authority expires on March 27, 2018. On January 26, 2018, EEMNA filed an application with DOE for renewal of the export authority contained in Order No. EA-386 for an additional five-year term.

    In its application, EEMNA states that it does not own or operate any electric generation or transmission facilities, and it does not have a franchised service area. The electric energy that EEMNA proposes to export to Mexico would be purchased from third parties such as electric utilities and Federal power marketing agencies pursuant to voluntary agreements. The existing international transmission facilities to be utilized by EEMNA have previously been authorized by Presidential Permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.

    Procedural Matters: Any person desiring to be heard in this proceeding should file a comment or protest to the application at the address provided above. Protests should be filed in accordance with Rule 211 of the Federal Energy Regulatory Commission's (FERC) Rules of Practice and Procedures (18 CFR 385.211). Any person desiring to become a party to these proceedings should file a motion to intervene at the above address in accordance with FERC Rule 214 (18 CFR 385.214). Five copies of such comments, protests, or motions to intervene should be sent to the address provided above on or before the date listed above.

    Comments and other filings concerning EEMNA's application to export electric energy to Mexico should be clearly marked with OE Docket No. EA-386-B. An additional copy is to be provided directly to both Adam Roth, ENGIE Energy Marketing NA, Inc., 1900 Post Oak Blvd., Suite 1900, Houston, TX 77056, and Catherine P. McCarthy, Bracewell LLP, 2001 M Street NW, Suite 900, Washington, DC 20036.

    A final decision will be made on this application after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after a determination is made by DOE that the proposed action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system.

    Copies of this application will be made available, upon request, for public inspection and copying at the address provided above, by accessing the program website at http://energy.gov/node/11845, or by emailing Angela Troy at [email protected]

    Issued in Washington, DC, on February 2, 2018. Christopher Lawrence, Electricity Policy Analyst, Office of Electricity Delivery and Energy Reliability.
    [FR Doc. 2018-02619 Filed 2-8-18; 8:45 am] BILLING CODE 6450-01-P
    ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-9037-5] Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General Information (202) 564-7146 or http://www2.epa.gov/nepa/.

    Weekly receipt of Environmental Impact Statements Filed 01/29/2018 Through 02/02/2018 Pursuant to 40 CFR 1506.9. Notice

    Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at: http://cdxnodengn.epa.gov/cdx-nepa-public/action/eis/search.

    EIS No. 20180011, Final, USACE, CA, San Joaquin River Basin Lower San Joaquin River, CA, FINAL Integrated Interim Feasibility Report/Environmental Impact Statement/Environmental Impact Report, Review Period Ends: 03/12/2018, Contact: Tanis Toland 916-557-6717. EIS No. 20180012, Draft, NSF, NM, Environmental Impact Statement for the Sacramento Peak Observatory, Sunspot, New Mexico, Comment Period Ends: 03/26/2018, Contact: Elizabeth Pentecost 703-292-4907. EIS No. 20180013, Draft, USFS, CO, Crested Butte Mountain Resort (CBMR) Ski Area Projects, Comment Period Ends: 05/10/2018, Contact: Aaron Drendel 719-657-6019. EIS No. 20180014, Draft, HHS, OH, Draft Environmental Impact Statement for Site Acquisition and Campus Consolidation for NIOSH, Comment Period Ends: 03/26/2018, Contact: Harry Marsh (770) 488-8170. EIS No. 20180015, Final, BLM, ID, Bruneau-Owhyhee Sage-grouse Habitat Project, Review Period Ends: 03/12/2018, Contact: Michael McGee (208) 384-3464. EIS No. 20180016, Final, FHWA, IN, I69 Section 6 Martinsville to Indianapolis, Under MAP-21 section 1319, FHWA has issued a single FEIS and ROD. Therefore, the 30-day wait/review period under NEPA does not apply to this action. Contact: Michelle Allen 317-226-7344. Dated: February 6, 2018. Kelly Knight, Director, NEPA Compliance Division, Office of Federal Activities.
    [FR Doc. 2018-02580 Filed 2-8-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2017-0141; FRL-9972-07] Certain New Chemicals or Significant New Uses; Statements of Findings for November 2017 AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    Section 5(g) of the Toxic Substances Control Act (TSCA) requires EPA to publish in the Federal Register a statement of its findings after its review of TSCA section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to premanufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) submitted to EPA under TSCA section 5. This document presents statements of findings made by EPA on TSCA section 5(a) notices during the period from November 1, 2017 to November 30, 2017.

    FOR FURTHER INFORMATION CONTACT:

    For technical information contact: Greg Schweer, Chemical Control Divison (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-564-8469; email address: [email protected]

    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitters of the PMNs addressed in this action.

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

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2017-0141, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    II. What action is the agency taking?

    This document lists the statements of findings made by EPA after review of notices submitted under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. This document presents statements of findings made by EPA during the period from November 1, 2017 to November 30, 2017.

    III. What is the agency's authority for taking this action?

    TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a) notice and make one of the following specific findings:

    • The chemical substance or significant new use presents an unreasonable risk of injury to health or the environment;

    • The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the chemical substance or significant new use;

    • The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects and the chemical substance or significant new use may present an unreasonable risk of injury to health or the environment;

    • The chemical substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance; or

    • The chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

    Unreasonable risk findings must be made without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant under the conditions of use. The term “conditions of use” is defined in TSCA section 3 to mean “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”

    EPA is required under TSCA section 5(g) to publish in the Federal Register a statement of its findings after its review of a TSCA section 5(a) notice when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to PMNs, MCANs, and SNUNs submitted to EPA under TSCA section 5.

    Anyone who plans to manufacture (which includes import) a new chemical substance for a non-exempt commercial purpose and any manufacturer or processor wishing to engage in a use of a chemical substance designated by EPA as a significant new use must submit a notice to EPA at least 90 days before commencing manufacture of the new chemical substance or before engaging in the significant new use.

    The submitter of a notice to EPA for which EPA has made a finding of “not likely to present an unreasonable risk of injury to health or the environment” may commence manufacture of the chemical substance or manufacture or processing for the significant new use notwithstanding any remaining portion of the applicable review period.

    IV. Statements of Administrator Findings Under TSCA Section 5(a)(3)(C)

    In this unit, EPA provides the following information (to the extent that such information is not claimed as Confidential Business Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this period, EPA has made findings under TSCA section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:

    • EPA case number assigned to the TSCA section 5(a) notice.

    • Chemical identity (generic name, if the specific name is claimed as CBI).

    • website link to EPA's decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA section 5(a)(3)(C).

    EPA Case Number: P-17-0390; Chemical identity: Carbomonocyclic dicarboxylic acid, polymer with alkenedioic acid, substituted heteropolycycle, substituted heteromonocycle, alkanediol, alkanedioic acid, alkoxylated substituted dicarbomonocycle, alkoxylated substituted dicarbomonocycle and alkanetriol, carbomonocyclic carboxylate alkanoate (generic name); website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-77.

    Authority:

    15 U.S.C. 2601 et seq.

    Dated: January 24, 2018. Greg Schweer, Chief, New Chemicals Management Branch, Chemical Control Division, Office of Pollution Prevention and Toxics.
    [FR Doc. 2018-02662 Filed 2-8-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2017-0141; FRL-9972-05] Certain New Chemicals or Significant New Uses; Statements of Findings for October 2017 AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    Section 5(g) of the Toxic Substances Control Act (TSCA) requires EPA to publish in the Federal Register a statement of its findings after its review of TSCA section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to premanufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) submitted to EPA under TSCA section 5. This document presents statements of findings made by EPA on TSCA section 5(a) notices during the period from October 1, 2017 to October 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    For technical information contact: Greg Schweer, Chemical Control Divison (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-564-8469; email address: [email protected]

    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitters of the PMNs addressed in this action.

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

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2017-0141, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    II. What action is the Agency taking?

    This document lists the statements of findings made by EPA after review of notices submitted under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. This document presents statements of findings made by EPA during the period from October 1, 2017 to October 31, 2017.

    III. What is the Agency's authority for taking this action?

    TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a) notice and make one of the following specific findings:

    • The chemical substance or significant new use presents an unreasonable risk of injury to health or the environment;

    • The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the chemical substance or significant new use;

    • The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects and the chemical substance or significant new use may present an unreasonable risk of injury to health or the environment;

    • The chemical substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance; or

    • The chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

    Unreasonable risk findings must be made without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant under the conditions of use. The term “conditions of use” is defined in TSCA section 3 to mean “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”

    EPA is required under TSCA section 5(g) to publish in the Federal Register a statement of its findings after its review of a TSCA section 5(a) notice when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to PMNs, MCANs, and SNUNs submitted to EPA under TSCA section 5.

    Anyone who plans to manufacture (which includes import) a new chemical substance for a non-exempt commercial purpose and any manufacturer or processor wishing to engage in a use of a chemical substance designated by EPA as a significant new use must submit a notice to EPA at least 90 days before commencing manufacture of the new chemical substance or before engaging in the significant new use.

    The submitter of a notice to EPA for which EPA has made a finding of “not likely to present an unreasonable risk of injury to health or the environment” may commence manufacture of the chemical substance or manufacture or processing for the significant new use notwithstanding any remaining portion of the applicable review period.

    IV. Statements of Administrator Findings Under TSCA Section 5(a)(3)(C)

    In this unit, EPA provides the following information (to the extent that such information is not claimed as Confidential Business Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this period, EPA has made findings under TSCA section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:

    • EPA case number assigned to the TSCA section 5(a) notice.

    • Chemical identity (generic name, if the specific name is claimed as CBI).

    • Website link to EPA's decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA section 5(a)(3)(C).

    EPA Case Number: J-17-0014; Chemical identity: organic acid producing yeast, modified, genetically stable; website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-75.

    Authority:

    15 U.S.C. 2601 et seq.

    Dated: January 24, 2018. Greg Schweer, Chief, New Chemicals Management Branch, Chemical Control Division, Office of Pollution Prevention and Toxics.
    [FR Doc. 2018-02661 Filed 2-8-18; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meeting FEDERAL REGISTER CITATION NOTICE OF PREVIOUS ANNOUNCEMENT:

    83 FR 2639

    PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING:

    Tuesday, January 23, 2018 at 10:00 a.m.

    CHANGES IN THE MEETING:

    This meeting was continued on Tuesday, February 6, 2018.

    CONTACT FOR MORE INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Laura E. Sinram, Deputy Secretary of the Commission.
    [FR Doc. 2018-02708 Filed 2-7-18; 11:15 am] BILLING CODE 6715-01-P
    FEDERAL MARITIME COMMISSION Sunshine Act Meeting AGENCY HOLDING THE MEETING:

    Federal Maritime Commission.

    TIME AND DATE:

    Wednesday, February 14, 2018; 10:00 a.m. EST.

    PLACE:

    800 N. Capitol Street NW, First Floor Hearing Room, Washington, DC.

    STATUS:

    This meeting will be closed to the public.

    MATTERS TO BE CONSIDERED:

    Closed Session 1. Commission Discussion on Petition P4-16, Petition of the Coalition for Fair Port Practices for Rulemaking CONTACT PERSON FOR MORE INFORMATION:

    Rachel E. Dickon, Assistant Secretary, (202) 523 5725.

    Rachel E. Dickon, Assistant Secretary.
    [FR Doc. 2018-02822 Filed 2-7-18; 4:15 pm] BILLING CODE 6731-AA-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than March 8, 2018.

    A. Federal Reserve Bank of Richmond (Adam M. Drimer, Assistant Vice President) 701 East Byrd Street, Richmond, Virginia 23261-4528. Comments can also be sent electronically to [email protected]:

    1. AsheCo MHC, Inc. and LifeStore Financial Group, Inc., both of West Jefferson, North Carolina; to become bank holding companies upon the conversion of LifeStore Bank, West Jefferson, North Carolina, from a federal savings bank, to a commercial state-member bank.

    Board of Governors of the Federal Reserve System, February 6, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-02635 Filed 2-8-18; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000-0155; Docket 2017-0053; Sequence 18] Submission for OMB Review; Prohibition of Acquisition of Products Produced by Forced or Indentured Child Labor AGENCY:

    Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).

    ACTION:

    Notice.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division (MVCB) will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding prohibition of acquisition of products produced by forced or indentured child labor.

    DATES:

    Submit comments on or before March 12, 2018.

    ADDRESSES:

    Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number 9000-0155. Select the link that corresponds with “Information Collection 9000-0155, Prohibition of Acquisition of Products Produced by Forced or Indentured Child Labor”. Follow the instructions provided on the screen.

    Please include your name, company name (if any), and “Information Collection 9000-0155, Prohibition of Acquisition of Products Produced by Forced or Indentured Child Labor” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405. ATTN: Ms. Mandell/IC 9000-0155, Prohibition of Acquisition of Products Produced by Forced or Indentured Child Labor.

    Instructions: Please submit comments only and cite Information Collection 9000-0155, Prohibition of Acquisition of Products Produced by Forced or Indentured Child Labor, in all correspondence related to this collection. All comments received will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Zenaida Delgado, Procurement Analyst, Federal Acquisition Policy Division, GSA, at 202-969-7207, or email [email protected]

    SUPPLEMENTARY INFORMATION: A. Purpose

    This information collection complies with Executive Order 13126, Prohibition of Acquisition of Products Produced by Forced or Indentured Child Labor.

    This information is used by Government contracting officers to ensure that a good faith effort has been made to determine whether forced or indentured child labor was used to mine, produce, or manufacture any product on the List furnished under the contract per Executive Order 13126.

    The information collection requirements of the Executive Order are evidenced via the certification requirements delineated at FAR 52.212-3 paragraph (i), and 52.222-18.

    B. Annual Reporting Burden

    DoD, GSA and NASA analyzed the FY 2017 data from the System for Award Management (SAM) to develop the estimated burden hours for this information collection. The following is a summary of the FY 2017 data:

    Respondents: 1,104.

    Responses per Respondent: 1.

    Total Annual Responses: 1,104.

    Hours per Response: 0.18.

    Total Burden Hours: 198.

    Affected Public: Businesses or other for-profit and not-for-profit.

    Respondent's Obligation: Required to obtain or retain benefits.

    Type of Request: Revision of a currently approved collection.

    Reporting Frequency: On occasion.

    C. Public Comment

    A 60 day notice was published in the Federal Register at 82 FR 55842, on November 24, 2017. No comments were received.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405.

    Please cite OMB Control No. 9000-0155, Prohibition of Acquisition of Products Produced by Forced or Indentured Child Labor, in all correspondence.

    Dated: February 2, 2018. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.
    [FR Doc. 2018-02587 Filed 2-8-18; 8:45 am] BILLING CODE 6820-EP-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Announcement of Requirements and Registration for the 2018 Million Hearts® Hypertension Control Challenge AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    Authority: 15 U.S.C. 3719.

    Award Approving Official: Anne Schuchat, M.D. (RADM, USPHS), Acting Director, Centers for Disease Control and Prevention, and Acting Administrator, Agency for Toxic Substances and Disease Registry.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the 2018 Million Hearts® Hypertension Control Challenge.

    Million Hearts® is a national initiative to prevent one million heart attacks and strokes by 2022. In order to prevent one million events, we need to decrease smoking, sodium consumption and physical inactivity by 20%; improve performance on appropriate aspirin use, blood pressure control, cholesterol management, and smoking cessation to 80%; and improve outcomes for priority populations. Over the last five years we have seen tremendous progress by provider and health care systems that focus on improving their performance in controlling blood pressure. Getting to 80% control would mean that 10 million more Americans would have their blood pressure under control, and be at substantially lower risk for strokes, heart attacks and other cardiovascular events. For more information about the initiative, visit https://millionhearts.hhs.gov/.

    The Million Hearts Hypertension Control challenge is an important way to call attention to the need for improved blood pressure control, provides a powerful motivation and target for clinicians, and will improve understanding of successful implementation strategies at the health system level. The Million Hearts Hypertension Control Challenge will identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as 2018 Million Hearts® Hypertension Control Champions. To support improved quality of care delivered to patients with hypertension, Million Hearts® will document and further disseminate the systems, strategies, processes, and staffing that contribute to the exceptional blood pressure control rates achieved by Champions.

    DATES:

    The Challenge will accept applications from February 20, 2018 through April 6, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Mary George, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Hwy. NE, Mailstop F-73, Chamblee, GA 30341, Telephone: 770-488-2424, Email: [email protected]; subject line of email: Million Hearts Hypertension Control Challenge.

    SUPPLEMENTARY INFORMATION:

    Subject of Challenge Competition: The challenge is authorized by Public Law 111-358, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science Reauthorization Act of 2010 (COMPETES Act).

    Applicants for the 2018 Million Hearts® Hypertension Control Challenge will be asked to provide two hypertension control rates for the practice's or health system's hypertensive population: A current rate for the most recent 12-month reporting period (e.g., 1/1/2017-12/31/2017) and a previous rate for a 12 month period 1 year before the most recent reporting period (e.g., 1/1/2016-12/31/2016). Applicants will also be asked to provide the prevalence of hypertension in their population, describe some population characteristics that present significant challenges in attaining hypertension control (such as percent minority, percent enrolled in Medicaid, percent with no health insurance or who are homeless, and percent whose primary language is not English) and strategies used by the practice or health system that support continued improvements in blood pressure control. Further details are provided in the application form.

    Eligibility Rules for Participating in the Competition: To be eligible to be recognized as a Million Hearts® Hypertension Control Champion under this challenge, an individual or entity—

    (1) Shall have completed the application form in its entirety to participate in the competition under the rules developed by HHS/CDC;

    (2) Shall have complied with all the requirements in this section and;

    a. Be a U.S. licensed clinician, practicing in any U.S. setting, who provides continuing care for adult patients with hypertension. The individual must be a citizen or permanent resident of the U.S. “[I]n the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States. The United States means a State, the District of Columbia, the Commonwealth of Puerto Rico, and any other territory or possession of the United States.

    b. Or be a U.S. incorporated clinical practice, defined as any practice with two or more U.S. licensed clinicians who by formal arrangement share responsibility for a common panel of patients, practice at the same physical location or street address, and provide continuing medical care for adult patients with hypertension;

    c. Or be a health system, incorporated in and maintaining a primary place of business in the U.S. that provides continuing medical care for adult patients with hypertension. We encourage large health systems (those that are comprised of a large number of geographically dispersed clinics and/or have multiple hospital locations) to consider having one or a few of the highest performing clinics or regional affiliates apply individually instead of the health system applying as a whole;

    (3) Must treat all adult patients with hypertension in the practice seeking care, not a selected subgroup of patients;

    (4) Must have a data management system (electronic or paper) that allows CDC or their contractor to verify data submitted;

    (5) Must treat a minimum of 500 adult patients annually and have a hypertension control rate of at least 80%;

    (6) May not be a Federal entity or Federal employee acting within the scope of their employment;

    (7) An HHS employee must not work on their application(s) during assigned duty hours;

    (8) Shall not be an employee of or contractor at/within CDC;

    (9) Must agree to participate in a data validation process to be conducted by a reputable independent contractor. Data will be kept confidential by the contractor to the extent applicable law allows and will be shared with the CDC, in aggregate form only (e.g., the hypertension control rate for the practice not individual patients' hypertension values);

    (10) Must agree to sign, without revisions, a Business Associate Agreement with the contractor conducting the data validation.

    (11) Must have a written policy in place about conducting periodic background checks on all providers and taking appropriate action based on the results of the check. CDC's contractor may also request to review the policy and any supporting information deemed necessary. In addition, a health system background check will be conducted by CDC or a CDC contractor that includes a search for The Joint Commission sanctions and current investigations for serious institutional misconduct (e.g., attorney general investigation). Eligibility status, based upon the above-referenced written policy, appropriate action, and background check, will be determined at the discretion of CDC consistent with CDC's public health mission.

    (12) Must agree to be recognized if selected and agree to participate in an interview to develop a success story that describes the systems and processes that support hypertension control among patients. Champions will be recognized on the Million Hearts® website. Strategies used by Champions that support hypertension control may be written into a success story, placed on the Million Hearts® website, and attributed to Champions.

    Federal funds may not be used to develop COMPETES Act challenge applications or to fund efforts in support of a COMPETES Act challenge.

    Individual applicants and individuals in a group practice must be free from convictions or pending investigations of criminal and health care fraud offenses such as felony health care fraud, patient abuse or neglect; felony convictions for other health care-related fraud, theft, or other financial misconduct; and felony convictions relating to unlawful manufacture, distribution, prescribing, or dispensing of controlled substances as verified through the Office of the Inspector General List of Excluded Individuals and Entities. http://oig.hhs.gov/exclusions/background.asp.

    Individual applicants must be free from serious sanctions, such as those for misuse or mis-prescribing of prescription medications. Eligibility status of individual applicants with serious sanctions will be determined at the discretion of CDC. CDC's contractor may perform background checks on individual clinicians or medical practices.

    Champions previously recognized through the 2013, 2014, 2015, and 2017 Million Hearts® Hypertension Control Challenges retain their designation as a “Champion” and are not eligible to be named a Champion in the 2018 challenge.

    An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equal basis.

    By participating in this challenge, an individual or organization agrees to assume any and all risks related to participating in the challenge. Individuals or organizations also agree to waive claims against the Federal Government and its related entities, except in the case of willful misconduct, when participating in the challenge, including claims for injury; death; damage; or loss of property, money, or profits, and including those risks caused by negligence or other causes.

    By participating in this challenge, individuals or organizations agree to protect the Federal Government against third party claims for damages arising from or related to challenge activities.

    Participants are required to obtain liability insurance or demonstrate financial responsibility in the amount of $0, for claims by a third party for death, bodily injury, or property damage, or loss resulting from an activity carried out in connection with participation in a challenge.

    No cash prize will be awarded. Champions will receive national recognition.

    Registration Process for Participants

    To participate and submit an application, interested parties should go to https://millionhearts.hhs.gov or https://www.challenge.gov. On this site, applicants will find the application form and the rules and guidelines for participating. Information required of the applicants on the application form includes:

    • The size of the applicant's adult primary care patient population, a summary of known patient demographics (e.g., age distribution), and any noteworthy patient population characteristics.

    • The number of the applicant's adult primary care patients, ages 18-85 who were seen during the measurement year and had a hypertension diagnosis (i.e., hypertension prevalence).

    • The applicant's current hypertension control rate for their hypertensive population ages 18-85 during the measurement year is required. In determining the hypertension control rate, CDC defines “hypertension control” as a blood pressure reading <140 mmHg systolic and <90 mmHg diastolic among patients ages 18-85 with a diagnosis of hypertension.

    • The hypertension control rate should be for the provider's or health system's entire adult hypertensive patient population ages 18-85, and not limited to a sample. The provider's or health system's hypertensive population ages 18-85 should include only patients in primary care or in cardiology care in the case of a cardiology clinic. Patients seen only in dental care or behavioral health care should not be included. Examples of ineligible data submissions include hypertension control rates that are limited to treatment cohorts from research studies or pilot studies, patients limited to a specific age range (such as 18-35 only), or patient enrolled in limited scale quality improvement projects.

    • Completion of a checklist of sustainable clinic systems or processes that support hypertension control. These may include provider or patient incentives, dashboards, staffing characteristics, electronic record keeping systems, reminder or alert systems, clinician reporting, service modifications, etc.

    The estimated burden for completing the application form is 30 minutes.

    Amount of the Prize

    Up to 35 of the highest scoring clinical practices or health systems will be recognized as Million Hearts® Hypertension Control Champions. No cash prize will be awarded. Champions will receive national recognition.

    Basis Upon Which Winner Will Be Selected

    The application will be scored based on the hypertension control rate for your most recent 12-month reporting period ending not earlier than December 31, 2017; and the degree to which the patient populations' characteristics present significant challenges in attaining hypertension control (up to 5% of score).

    Phase 1 of the validation process includes verification of the hypertension prevalence and blood pressure control rate data submitted and a background check. For applicants whose Phase 1 data is verified as accurate, phase 2 consists of a medical chart review. The medical chart review will verify the diagnosis of hypertension during the reporting year as well as blood pressure being controlled to <140 mm Hg systolic and <90 mm Hg diastolic.

    A CDC-sponsored panel of three to five experts consisting of CDC staff will review the applications that pass phase 2 to select Champions. Final selection of Champions will take into account all the information from the application form, the background check, and data verification and validation. In the event of tied scores at any point in the selection process, geographic location may be taken into account to ensure a broad distribution of champions.

    Some Champions will participate in a post-challenge telephone interview. The interview will include questions about the strategies employed by the individual practice or organization to achieve high rates of hypertension control, including barriers and facilitators for those strategies. The interview will focus on systems and processes and should not require preparation time by the Champion. The estimated time for the interview is two hours, which includes time for the interviewer to review the interview protocol with the Champion, time for the Champion to respond to the interview questions, and time to review a summary about the Champion's hypertension control strategies. The summary may be written as a success story and will be posted on the Million Hearts® website.

    Additional Information

    Information received from applicants will be stored in a password protected file on a secure server. The challenge website may post the number of applications received but will not include confidential or proprietary information about individual applicants. The database of information submitted by applicants will not be posted on the website. Information collected from applicants will include general details, such as the business name, address, and contact information of the applicant. This type of information is generally publicly available. The application will collect and store only aggregate clinical data through the application process; no individually identifiable patient data will be collected or stored. Confidential or propriety data, clearly marked as such, will be secured to the full extent allowable by law.

    Information for selected Champions, such as the provider, practice, or health system's name, location, hypertension control rate, and clinic practices that support hypertension control will be shared through press releases, the challenge website, and Million Hearts® and CDC resources.

    Summary data on the types of systems and processes that all applicants use to control hypertension may be shared in documents or other communication products that describe generally used practices for successful hypertension control. CDC will use the summary data only as described.

    Compliance With Rules and Contacting Contest Winners

    Finalists and the Champions must comply with all terms and conditions of these Official Rules, and winning is contingent upon fulfilling all requirements herein. The initial finalists will be notified by email, telephone, or mail after the date of the judging.

    Privacy

    If Contestants choose to provide HHS/CDC with personal information by registering or filling out the submission form through the Challenge.gov website, that information is used to respond to Contestants in matters regarding their submission, announcements of applicants, finalists, and winners of the Contest.

    General Conditions

    HHS/CDC reserves the right to cancel, suspend, and/or modify the Contest, or any part of it, for any reason, at HHS/CDC's sole discretion.

    Participation in this Contest constitutes a contestants' full and unconditional agreement to abide by the Contest's Official Rules found at https://www.Challenge.gov and https://millionhearts.hhs.gov/.

    Authority:

    15 U.S.C. 3719.

    Dated: February 6, 2018. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention.
    [FR Doc. 2018-02598 Filed 2-8-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2017-0059] Notice of Availability of Draft Environmental Impact Statement, Public Meeting, and Request for Comments; Site Acquisition and Campus Consolidation for the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH), Cincinnati, Ohio AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice of Availability; announcement of public meeting; and request for comments.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), in cooperation with the General Services Administration (GSA), announces the availability of a Draft Environmental Impact Statement (EIS) for the proposed acquisition of a site in Cincinnati, Ohio, and the development of this site into a new, consolidated CDC/National Institute for Occupational Safety and Health (NIOSH) campus (Proposed Action). The site being considered for acquisition and development is bounded by Martin Luther King Drive East to the south, Harvey Avenue to the west, Ridgeway Avenue to the north, and Reading Road to the east.

    The Draft EIS and this notice are published pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR parts 1500-1508). In parallel with the NEPA process, CDC is also conducting consultation under Section 106 of the National Historic Preservation Act to evaluate the potential effects, if any, of the Proposed Action on historic properties.

    DATES:

    Public Meeting: A public meeting in open house format will be held on March 14, 2018, in Cincinnati, Ohio to present the findings of the Draft EIS and to solicit comments. The meeting will begin at 6:00 p.m. and end no later than 9:00 p.m. In case of inclement weather, send an email to [email protected] or call (770) 488-8170 to check on the status of the meeting.

    Written comments: Written comments must be submitted by March 26, 2018.

    Deadline for Requests for Special Accommodations: Persons wishing to attend the public meeting who need special accommodations should contact Harry Marsh at 770-488-8170 by 5:00 p.m. Eastern Time, March 8, 2018.

    ADDRESSES:

    The public meeting will be held at the Walnut Hills High School, 3250 Victory Parkway, Cincinnati, Ohio 45207. Attendees should use the Parking Lot D entrance, located off Jonathan Avenue.

    Copies of the Draft EIS can be obtained at:

    Federal eRulemaking Portal: http://www.regulations.gov (reference Docket No. CDC-2017-0059)

    • The Public Library of Cincinnati and Hamilton County—Avondale Branch, 3566 Reading Road, Cincinnati, Ohio 45229.

    • The Public Library of Cincinnati and Hamilton County—Corryville Branch, 2802 Short Vine Street, Cincinnati, Ohio 45219.

    • The Public Library of Cincinnati and Hamilton County—Main Library, 800 Vine Street, Cincinnati, Ohio 45202.

    • The University of Cincinnati Walter C. Langsam Library, 2911 Woodside Drive, Cincinnati 45219.

    • By written request (electronic copies only) to: [email protected]

    In addition to attending the public meeting, comments on the Draft EIS may be submitted by either of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov (Refer to Docket No. CDC-2017-0059; follow the instructions for submitting comments).

    U.S. Mail: Harry Marsh, Architect, Office of Safety, Security and Asset Management (OSSAM), Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-K80, Atlanta, Georgia 30329-4027.

    Instructions: All U.S. Mail submissions must include the agency name and Docket Number. All relevant comments received will be posted to http://www.regulations.gov (personally identifiable information, except for first and last names, will be redacted). For access to the docket to review the comments received, go to http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Harry Marsh, Architect, Office of Safety, Security and Asset Management (OSSAM), Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-K80, Atlanta, Georgia 30329-4027, phone: (770) 488-8170, or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background: CDC is dedicated to protecting health and promoting quality of life through the prevention and control of disease, injury, and disability. NIOSH, one of CDC's Centers, Institute, and Offices, was established by the Occupational Safety and Health Act of 1970. NIOSH plans, directs, and coordinates a national program to develop and establish recommended occupational safety and health standards; conduct research and training; provide technical assistance; and perform related activities to assure safe and healthful working conditions for every working person in the United States.

    Currently, three NIOSH research facilities—the Robert A. Taft Campus, Taft North Campus, and the Alice Hamilton Laboratory Campus—are located in Cincinnati, Ohio. These facilities no longer meet the research needs required to support occupational safety and health in the modern workplace. The facilities' deficiencies adversely affect NIOSH's ability to conduct occupational safety and health research in Cincinnati. The facilities' outdated designs create health and safety challenges for NIOSH laboratory employees and administrative staff. It is not possible to renovate the facilities located on the three campuses to meet current standards and requirements. Additionally, the current distribution of NIOSH activities across separate campuses in Cincinnati results in inefficiencies in scientific collaboration and the duplication of operational support activities. Therefore, CDC is proposing to relocate and consolidate its Cincinnati-based functions and personnel (approximately 550 employees) currently housed at the three existing campuses to a new, consolidated campus in Cincinnati.

    Potential locations for the proposed new campus were identified through a comprehensive site selection process conducted by GSA on behalf of CDC. In June 2016, GSA issued a Request for Expressions of Interest (REOI) seeking potential sites capable of accommodating the proposed new campus. In response to the REOI, GSA received seven expressions of interest. Following an assessment of each site, GSA found that only one site qualified for further consideration (The Site). The Site encompasses all land between Martin Luther King Drive East to the south, Harvey Avenue to the west, Ridgeway Avenue to the north, and Reading Road to the east in Cincinnati, Ohio.

    In accordance with NEPA, as implemented by the CEQ regulations (40 CFR parts 1500-1508), CDC, with GSA as a cooperating agency, has prepared a Draft EIS for the proposed acquisition of the Site and construction of a new, consolidated CDC/NIOSH campus on the Site. Under NEPA, Federal agencies are required to evaluate the environmental effects of their proposed actions and a range of reasonable alternatives to the proposed action before making a decision. The Draft EIS evaluates the potential impacts of two alternatives: The Proposed Action Alternative (acquisition of the Site and construction of a new, consolidated CDC/NIOSH campus) and the No Action Alternative (continued use of the existing campuses for the foreseeable future). No other alternatives were considered because only one qualifying site was identified through the site selection process briefly described above.

    Impacts on the following resources are considered in the Draft EIS: Land use, zoning, and plans; community facilities; socioeconomics and environmental justice; utilities and infrastructure; visual quality; cultural resources; transportation; geology, topography, and soils; air quality; noise; and hazardous substances. The status of the Section 106 consultation process to date is documented in the Cultural Resources section of the Draft EIS.

    The purpose of this Notice is to inform interested parties regarding the availability of the Draft EIS for review and to solicit comments. To facilitate public comments, a public meeting will be held on March 14, 2018 at the Walnut Hills High School, 3250 Victory Parkway, Cincinnati, Ohio 45207, from 6:00 p.m. to 9:00 p.m. Eastern Time. Attendees should use the Parking Lot D entrance, located off Jonathan Avenue. In case of inclement weather, email [email protected] or call (770) 488-8170 to check on the status of the meeting. The public meeting will be in open house format. Copies of the Draft EIS will be available at the meeting. Poster stations and fact sheets will provide a summary of the NEPA process and the findings of the Draft EIS. Representatives of CDC and GSA will be available to answer one-on-one questions. There will be no presentation or formal testimonies.

    Participants may arrive at any time between 6:00 p.m. and 9:00 p.m. Eastern Time. Comment forms will be provided for written comments and a stenographer will be available to transcribe one-on-one oral comments.

    After the public comment period ends, CDC and GSA will consider all comments received, revise the Draft EIS to address these comments, select a preferred alternative, and issue a Final EIS. CDC will consider the Final EIS when deciding whether to proceed with the proposed site acquisition and campus development.

    Dated: February 1, 2018. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention.
    [FR Doc. 2018-02327 Filed 2-8-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS-10631] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments on the collection(s) of information must be received by the OMB desk officer by March 12, 2018.

    ADDRESSES:

    When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 OR Email: [email protected].

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected].

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    William Parham at (410) 786-4669.

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

    1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: The PACE Organization Application Process in 42 CFR part 460; Use: Initial application requirements for the PACE program are currently set forth in 42 CFR 460.12 and in the PACE Manual, Ch. 17. Until recently, the submission of initial and SAE PACE applications and supporting information was in paper format. These applications are often hundreds of pages long, expensive to reproduce and transmit, and administratively inefficient, as staff reviewing different parts of the application are located in different physical locations and must receive hard copies of the material. However, beginning in 2016 and 2017, initial and SAE PACE applications, respectively, are being submitted via a new automated, electronic submission process. As with initial applications, an application also must be submitted for a PO that seeks to expand its service area and/or add a new service site, and with OMB approval, an automated application process will now also be required of PACE organizations submitting service area expansion applications. Form Number: CMS-10631 (OMB control number: 0938-1326); Frequency: Once and occasionally; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions) and State, Local, or Tribal Governments; Number of Respondents: 72; Total Annual Responses: 109; Total Annual Hours: 7,226. (For policy questions regarding this collection contact Debbie Van Hoven at 410-786-6625.)

    Dated: February 6, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2018-02617 Filed 2-8-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-2390] Determination of Regulatory Review Period for Purposes of Patent Extension; STRENSIQ 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 STRENSIQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

    DATES:

    Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 10, 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 8, 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 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 10, 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-2016-E-2390 for “Determination of Regulatory Review Period for Purposes of Patent Extension; STRENSIQ.” 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 biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human biologic product STRENSIQ (asfotase alfa). STRENSIQ is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia. Subsequent to this approval, the USPTO received a patent term restoration application for STRENSIQ (U.S. Patent No. 7,763,712) from Alexion Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated August 31, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of STRENSIQ 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 STRENSIQ is 2,670 days. Of this time, 2,365 days occurred during the testing phase of the regulatory review period, while 305 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: July 3, 2008. The applicant claims July 4, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was July 3, 2008, which was 30 days after FDA receipt of the IND.

    2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): December 23, 2014. FDA has verified the applicant's claim that the biologics license application (BLA) for STRENSIQ (BLA 125513) was initially submitted on December 23, 2014.

    3. The date the application was approved: October 23, 2015. FDA has verified the applicant's claim that BLA 125513 was approved on October 23, 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 application for patent extension, this applicant seeks 1,109 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 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02588 Filed 2-8-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-1271] Determination of Regulatory Review Period for Purposes of Patent Extension; KAMRA INLAY 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 KAMRA INLAY 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 10, 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 8, 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 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 10, 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-2016-E-1271 for “Determination of Regulatory Review Period for Purposes of Patent Extension; KAMRA INLAY.” 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 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 KAMRA INLAY. KAMRA INLAY is indicated for intrastromal corneal implantation to improve near vision by extending the depth of focus in the non-dominant eye of phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0.50 diopters (D) to−0.75 D with less than or equal to 0.75 D of refractive cylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1.00 D to +2.50 D of reading add. Subsequent to this approval, the USPTO received a patent term restoration application for KAMRA INLAY (U.S. Patent No. 8,460,374) from AcuFocus, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated July 12, 2016, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of KAMRA INLAY 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 KAMRA INLAY is 2,347 days. Of this time, 1,541 days occurred during the testing phase of the regulatory review period, while 806 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: November 14, 2008. FDA has verified the applicant's claim that the date the investigational device exemption (IDE) required under section 520(g) of the FD&C Act for human tests to begin became effective was November 14, 2008.

    2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): February 1, 2013. The applicant claims December 7, 2012, as the date the premarket approval application (PMA) for KAMRA INLAY (PMA P120023) was initially submitted. However, FDA records indicate that PMA P120023 was submitted on February 1, 2013.

    3. The date the application was approved: April 17, 2015. FDA has verified the applicant's claim that PMA P120023 was approved on April 17, 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 application for patent extension, this applicant seeks 676 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 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02582 Filed 2-8-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-1289] Determination of Regulatory Review Period for Purposes of Patent Extension; ODOMZO 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 ODOMZO 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 10, 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 8, 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 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 10, 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-2016-E-1289 for “Determination of Regulatory Review Period for Purposes of Patent Extension; ODOMZO.” 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 ODOMZO (sonidegib phosphate). ODOMZO is indicated for the treatment of adult patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Subsequent to this approval, the USPTO received a patent term restoration application for ODOMZO (U.S. Patent No. 8,178,563) from Novartis AG, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated July 28, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ODOMZO 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 ODOMZO is 2,414 days. Of this time, 2,112 days occurred during the testing phase of the regulatory review period, while 302 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 15, 2008. FDA has verified the applicant's claim that December 15, 2008, is the date the investigational new drug application (IND) became effective.

    2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: September 26, 2014. FDA has verified the applicant's claim that the new drug application (NDA) for ODOMZO (NDA 205266) was initially submitted on September 26, 2014.

    3. The date the application was approved: July 24, 2015. FDA has verified the applicant's claim that NDA 205266 was approved on July 24, 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 application for patent extension, this applicant seeks 169 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 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 6, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02658 Filed 2-8-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-E-1851; FDA-2016-E-1878; FDA-2016-E-1879; FDA-2016-E-1880; and FDA-2016-E-1882] Determination of Regulatory Review Period for Purposes of Patent Extension; ENTRESTO 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 ENTRESTO 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 10, 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 8, 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 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 10, 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-1851; FDA-2016-E-1878; FDA-2016-E-1879; FDA-2016-E-1880; and FDA-2016-E-1882 for “Determination of Regulatory Review Period for Purposes of Patent Extension; ENTRESTO.” 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 ENTRESTO (sacubitril and valsartan). ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (New York Heart Association Class II-IV) and reduced ejection fraction. Subsequent to this approval, the USPTO received patent term restoration applications for ENTRESTO (U.S. Patent Nos. 7,468,390; 8,101,659; 8,404,744; 8,796,331; and 8,877,938) from Novartis Pharmaceuticals Corporation, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated August 25, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ENTRESTO 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 ENTRESTO is 3,148 days. Of this time, 2,945 days occurred during the testing phase of the regulatory review period, while 203 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: November 25, 2006. Novartis Pharmaceuticals Corporation claims that April 8, 2007, is the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was November 25, 2006, which was 30 days after FDA receipt of an earlier 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: December 17, 2014. FDA has verified the applicant's claim that the new drug application (NDA) for ENTRESTO (NDA 207620) was initially submitted on December 17, 2014.

    3. The date the application was approved: July 7, 2015. FDA has verified the applicant's claim that NDA 207620 was approved on July 7, 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 1,296 days, 732 days, 519 days, 270 days or 225 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 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02592 Filed 2-8-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6145] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by March 12, 2018.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-0566. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine—21 CFR 10.75 OMB Control Number 0910-0566—Extension

    The Center for Veterinary Medicine's (CVM's) Guidance for Industry (GIF) #79, “Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine” (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052393.pdf), describes the process by which CVM formally resolves disputes relating to scientific controversies. A scientific controversy involves issues concerning a specific product regulated by CVM related to matters of technical expertise and requires specialized education, training, or experience to be understood and resolved. The guidance details information on how CVM intends to apply provisions of existing regulations regarding internal review of Agency decisions. In addition, the guidance outlines the established procedures for persons who are sponsors, applicants, or manufacturers of animal drugs or other products regulated by CVM that wish to submit a request for review of a scientific dispute. When a sponsor, applicant, or manufacturer has a scientific disagreement with a written decision by CVM, they may submit a request for a review of that decision by following the established procedures discussed in the guidance.

    CVM encourages applicants to begin the resolution of science-based disputes with discussions with the review team/group, including the Team Leader or Division Director. The Center prefers that differences of opinion regarding science or science-based policy be resolved between the review team/group and the applicant. If the matter is not resolved by this preferred method then CVM recommends that the applicant follow the procedures in GFI #79.

    In the Federal Register of October 27, 2017 (82 FR 49836), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received no comments.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 21 CFR section Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total
  • annual
  • responses
  • Average
  • burden per
  • response
  • Total
  • hours
  • 10.75, Request for review of a scientific dispute 1 4 4 10 40 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the next 3 years, CVM anticipates receiving one or fewer requests for review of a scientific dispute per year, on average. We base our estimate on CVM's experience over the past 6 years in handling formal appeals for scientific disputes. The burden of this collection has changed. The number of respondents decreased from two to one annually, the number of responses per respondent remained at four annually, the hours per response remained at 10 annually, and the total number of hours decreased from 80 to 40. This decrease in the total hours is the result of a natural fluctuation in the number of respondents taking advantage of this dispute resolution process.

    Dated: February 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02593 Filed 2-8-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0334] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by March 12, 2018.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-0770. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    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:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Postmarketing Safety Reports for Human Drug and Biological Products: Waivers From Electronic Submission Requirements OMB Control Number 0910-0770—Extension

    This information collection supports information collection found in FDA regulations. In the Federal Register of June 10, 2014 (79 FR 33072), FDA published a final rule entitled “Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements.” The final rule amended FDA's postmarketing safety reporting regulations for human drug and biological products under 21 CFR parts 310, 314, and 600 and added part 329 to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. Specifically, this includes:

    • Manufacturers; packers; distributors; applicants with approved new drug applications, abbreviated new drug applications, and biologics licensing applications (BLAs); and those that market prescription drugs for human use without an approved application must submit postmarketing safety reports to the Agency (§§ 310.305, 314.80, 314.98, and 600.80);

    • manufacturers, packers, or distributors whose name appears on the label of nonprescription human drug products marketed without an approved application must report serious adverse events associated with their products (section 760 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379aa)); and

    • applicants with approved BLAs must submit biological lot distribution reports to the Agency (§ 600.81).

    Under §§ 310.305(e)(2), 314.80(g)(2), 329.100(c)(2), 600.80(h)(2), and 600.81(b)(2), of the regulations, those who are subject to these postmarketing safety reporting requirements may request a waiver from the electronic format requirement. While FDA currently has OMB approval for the collection of postmarketing safety reports,1 this information collection supports respondents seeking waivers from submitting those reports in electronic format as required by the regulations.

    1 FDA currently has OMB approval for submission of postmarketing safety reports under parts 310, 314, and 600. The information collection for parts 310 and 314 is approved under OMB Control Numbers 0910-0291 and 0910-0230. The information collection for part 600 is approved under OMB Control Numbers 0910-0291 and 0910-0308. Submissions required by section 760 of the FD&C Act have been approved under OMB Control Number 0910-0636.

    In the Federal Register of October 30, 2017 (82 FR 50141), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received in response to the notice.

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

    Table 1—Estimated Annual Reporting Burden  1 21 CFR section Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • Total
  • hours
  • 310.305(e)(2) 1 1 1 1 1 314.80(g)(2) 5 1 5 1 5 329.100(c)(2) 1 1 1 1 1 600.80(h)(2) 5 1 5 1 5 600.81(b)(2) 1 1 1 1 1 Total 13 1 There are no capital or operating and maintenance costs associated with this collection of information.

    In table 1, we estimate the burden associated with the submission of waiver requests for postmarketing safety reports in electronic format under §§ 310.305(e)(2), 314.80(g)(2), 329.100(c)(2), 600.80(h)(2), and 600.81(b)(2). We expect few waiver requests. We estimate only one manufacturer will request a waiver annually under §§ 310.305(e)(2), 329.100(c)(2), and 600.81(b)(2), and approximately five manufacturers will request waivers annually under §§ 314.80(g)(2) and 600.80(h)(2). We estimate that each waiver request takes 1 hour to prepare and submit. The burden for this information collection has not increased since the last collection.

    Dated: February 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02589 Filed 2-8-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

    DATES:

    Submit either electronic or written comments on the draft guidance by April 10, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): 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-2007-D-0369 for “Product-Specific Guidances; Draft and Revised Draft Guidances for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at 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.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of the draft guidances to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance documents.

    FOR FURTHER INFORMATION CONTACT:

    Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final guidances or publishes revised draft guidances for comment. Guidances were last announced in the Federal Register on October 20, 2017. This notice announces draft product-specific guidances, either new or revised, that are posted on FDA's website.

    II. Drug Products for Which New Draft Product-Specific Guidances Are Available

    FDA is announcing the availability of new draft product-specific guidances for industry for drug products containing the following active ingredients:

    Table 1—New Draft Product- Specific Guidances for Drug Products Alcaftadine. Amitriptyline hydrochloride; Chlordiazepoxide. Amphetamine sulfate. Barium sulfate (multiple Reference Listed Drugs). Betamethasone dipropionate. Bimatoprost (multiple Reference Listed Drugs). Bupivacaine. Buprenorphine hydrochloride. Cabozantinib S-malate (multiple Reference Listed Drugs). Crisaborole. Desonide. Doxycycline hyclate. Fluocinonide. Hydrocortisone valerate. Ixazomib citrate. Ketoconazole. Leuprolide acetate; Norethindrone acetate. Levetiracetam. Levocetirizine dihydrochloride. Loteprednol etabonate. Mebendazole. Naldemedine tosylate. Naproxen sodium; Pseudoephedrine hydrochloride. Niraparib tosylate. Olopatadine hydrochloride. Prasterone. Rucaparib camsylate. Safinamide mesylate. Simvastatin; Sitagliptin phosphate. Soybean oil (multiple Reference Listed Drugs). III. Drug Products for Which Revised Draft Product-Specific Guidances Are Available

    FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients:

    Table 2—Revised Draft Product- Specific Guidances for Drug Products Aspirin; omeprazole. Cysteamine bitartrate. Daclatasvir dihydrochloride. Dexlansoprazole (multiple Reference Listed Drugs). Esomeprazole magnesium (multiple Reference Listed Drugs). Felbamate (multiple Reference Listed Drugs). Fluconazole. Gatifloxacin. Gentamicin sulfate. Ketorolac tromethamine. Lansoprazole. Loteprednol etabonate. Morphine sulfate. Naloxegol oxalate. Oxycodone. Pantoprazole sodium. Potassium citrate. Sulfamethoxazole; Trimethoprim. Triamcinolone acetonide.

    For a complete history of previously published Federal Register notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.

    These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    IV. Electronic Access

    Persons with access to the internet may obtain the draft guidances at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: February 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02667 Filed 2-8-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-2379] Determination of Regulatory Review Period for Purposes of Patent Extension; IDELVION 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 IDELVION and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

    DATES:

    Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 10, 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 8, 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 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 10, 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-2016-E-2379 for “Determination of Regulatory Review Period for Purposes of Patent Extension; IDELVION.” 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 biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human biologic product IDELVION (Coagulation Factor IX (recombinant), albumin fusion protein). IDELVION is indicated for the following: (1) On-demand control and prevention of bleeding episodes, (2) perioperative management of bleeding, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Subsequent to this approval, the USPTO received a patent term restoration application for IDELVION (U.S. Patent No. 7,939,632) from CSL Behring GmbH, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated August 26, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of IDELVION 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 IDELVION is 1,479 days. Of this time, 1,023 days occurred during the testing phase of the regulatory review period, while 456 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: February 17, 2012. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on February 17, 2012.

    2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): December 5, 2014. FDA has verified the applicant's claim that the biologics license application (BLA) for IDELVION (BLA 125582/0) was initially submitted on December 5, 2014.

    3. The date the application was approved: March 4, 2016. FDA has verified the applicant's claim that BLA 125582/0 was approved on March 4, 2016.

    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 531 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 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02666 Filed 2-8-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-0632] Determination of Regulatory Review Period for Purposes of Patent Extension; LYNPARZA 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 LYNPARZA 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 10, 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 8, 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 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 10, 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-2016-E-0632 for “Determination of Regulatory Review Period for Purposes of Patent Extension; LYNPARZA.” 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 LYNPARZA (olaparib). LYNPARZA is indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer whom have been treated with three or more prior lines of chemotherapy. Subsequent to this approval, the USPTO received a patent term restoration application for LYNPARZA (U.S. Patent No. 7,449,464) from Kudos Pharmaceuticals Limited, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 2, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of LYNPARZA 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 LYNPARZA is 3,012 days. Of this time, 2,692 days occurred during the testing phase of the regulatory review period, while 320 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: September 22, 2006. FDA has verified the applicant's claim that September 22, 2006, 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: February 3, 2014. FDA has verified the applicant's claim that the new drug application (NDA) for LYNPARZA (NDA 206162) was initially submitted on February 3, 2014.

    3. The date the application was approved: December 19, 2014. FDA has verified the applicant's claim that NDA 206162 was approved on December 19, 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 1,275 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 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02591 Filed 2-8-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-E-2267 and FDA-2016-E-2269] Determination of Regulatory Review Period for Purposes of Patent Extension; ONIVYDE 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 ONIVYDE 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 10, 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 8, 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 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 10, 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-2267 and FDA-2016-E-2269 for “Determination of Regulatory Review Period for Purposes of Patent Extension; ONIVYDE.” 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 ONIVYDE (irinotecan sucrose octasulfate). ONIVYDE in combination with fluorouracil and leucovorin, is indicated for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Subsequent to this approval, the USPTO received patent term restoration applications for ONIVYDE (U.S. Patent Nos. 8,147,867 and 8,329,213) from Merrimack Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated August 12, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ONIVYDE 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 ONIVYDE is 2,536 days. Of this time, 2,354 days occurred during the testing phase of the regulatory review period, while 182 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: November 13, 2008. FDA has verified the applicant's claim that November 13, 2008, 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: April 24, 2015. FDA has verified the applicant's claim that the new drug application (NDA) for ONIVYDE (NDA 207793) was initially submitted on April 24, 2015.

    3. The date the application was approved: October 22, 2015. FDA has verified the applicant's claim that NDA 207793 was approved on October 22, 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 613 days or 1,215 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 5, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-02590 Filed 2-8-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request, Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System, OMB Number: 0906-0017—Revision AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

    DATES:

    Comments on this ICR should be received no later than April 10, 2018.

    ADDRESSES:

    Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, 14N39, 5600 Fishers Lane, Rockville, MD 20857.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (301) 443-1984.

    SUPPLEMENTARY INFORMATION:

    When submitting comments or requesting information, please include the information request collection title for reference.

    Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System, OMB Control Number: 0906-0017—Revision.

    Abstract: This clearance request is for continued approval of the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program Performance Measurement Information System. The MIECHV Program, administered by HRSA in partnership with the Administration for Children and Families, supports voluntary, evidence-based home visiting services during pregnancy women and to parents with young children up to kindergarten entry. States, certain non-profit organizations, and Tribal entities are eligible to receive funding from the MIECHV Program and have the flexibility to tailor the program to serve the specific needs of their communities. HRSA is revising the data collection forms for the MIECHV Program by making the following changes:

    • Form 1: Update all tables to include specific guidance to account for and report missing data.

    • Form 1, Tables 1 and 2: Update table titles to reflect “participants served by MIECHV.”

    • Form 1, Table 5: Update to reflect correct age categories of “<1 year”; “1-2 years”; “3-4 years”; and “5-6 years.”

    • Form 1, Table 8: Revise the category of “Never Married” to read “Never Married (excluding not married but living together with partner).”

    • Form 1, Table 10: Delete.

    • Form 1, Table 18: Delete.

    • Form 1, Table 22: Revise to only include children greater than or equal to 12 months of age. Title will be updated to “Index Children (≥12 months of age) by Usual Source of Dental Care.”

    • Form 1, Notes: Revise to include Table-specific notes.

    • Form 1, Definition of Key Terms: Update definitions for Tables 1, 3, 5, 12, 13, 15, 17, 20, 21, and 22.

    • Form 2: Update all measures to include specific guidance to account for and report missing data.

    • Form 2, Measure 3: Update denominator to reflect correct inclusion criteria.

    • Form 2, Measure 4: Update measure to benchmark receipt of well-child visits to specific ages.

    • Form 2, Measure 9: Update numerator to clarify that investigated cases of maltreatment must have occurred within the reporting period.

    • Form 2, Measure 10: Update denominator to clarify the appropriate unit of analysis is the index child.

    • Form 2, Measure 14: Update measure to reflect current terminology and the timing within which screenings should be reported.

    • Form 2, Measure 15: Update measure and numerator to include primary caregivers enrolled in middle school.

    • Form 2, Measure 16: Update numerator to reflect correct inclusion criteria.

    • Form 2, Measure 17: Update denominator to reflect correct inclusion criteria.

    • Form 2, Measure 19: Update denominator to reflect correct inclusion criteria.

    • Form 2, Definitions of Key Terms: Update definitions for measures 1-19.

    HRSA is also requesting an extension of this information collection request through November 30, 2021.

    Need and Proposed Use of the Information: HRSA uses performance information to demonstrate program accountability with legislative and program requirements and continuously monitor and provide oversight to MIECHV Program awardees. The information is also used to provide quality improvement guidance and technical assistance to awardees and help inform the development of early childhood systems at the national, state, and local level. HRSA is seeking to revise demographic, service utilization, and select clinical indicators for participants enrolled in home visiting services. In addition, HRSA will collect a set of standardized performance and outcome indicators that correspond with the statutorily identified benchmark areas. In the future, HRSA anticipates that MIECHV funding decisions may be allocated, in part, based on this data. This notice is subject to the appropriation of funds, and is a contingency action taken to ensure that, should funds become available for this purpose, information can be collected in a timely manner.

    Likely Respondents: MIECHV Program awardees.

    Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

    Total Estimated Annualized Burden Hours Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total
  • responses
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden
  • hours
  • Form 1: Demographic, Service Utilization, and Select Clinical Indicators 56 1 56 560 31,360 Form 2: Performance Indicators and Systems Outcome Measures 56 1 56 200 11,200 Total 56 56 42,560

    HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    Amy McNulty, Acting Director, Division of the Executive Secretariat.
    [FR Doc. 2018-02594 Filed 2-8-18; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY:

    National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    SUMMARY:

    HHS gives notice of a decision to designate a class of employees from the Ames Laboratory in Ames, Iowa, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

    FOR FURTHER INFORMATION CONTACT:

    Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, NIOSH, 1090 Tusculum Avenue, MS C-46, Cincinnati, OH 45226-1938, Telephone 1-877-222-7570. Information requests can also be submitted by email to [email protected]

    SUPPLEMENTARY INFORMATION:

    Authority:

    42 U.S.C. 7384q(b). 42 U.S.C. 7384l(14)(C).

    On February 1, 2018, as provided for under 42 U.S.C. 7384l(14)(C), the Secretary of HHS designated the following class of employees as an addition to the SEC:

    All employees of the Department of Energy, its predecessor agencies, and their contractors or subcontractors who worked in any area of the Ames Laboratory in Ames, Iowa, during the period from January 1, 1971, through December 31, 1989, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort.

    This designation will become effective on March 3, 2018, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the Federal Register reporting the addition of this class to the SEC or the result of any provision by Congress regarding the decision by HHS to add the class to the SEC.

    John Howard, Director, National Institute for Occupational Safety and Health.
    [FR Doc. 2018-02675 Filed 2-8-18; 8:45 am] BILLING CODE 4163-19-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: National Survey of Organ Donation Attitudes and Practices, OMB No. 0915-0290—Reinstatement With Change AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement with change of a previously approved information collection, assigned OMB control number 0915-0290, which expired on March 31, 2015. Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate below or any other aspect of the ICR.

    DATES:

    Comments on this ICR should be received no later than April 10, 2018.

    ADDRESSES:

    Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, 14N39, 5600 Fishers Lane, Rockville, MD 20857.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (301) 443-1984.

    SUPPLEMENTARY INFORMATION:

    When submitting comments or requesting information, please include the information request collection title for reference, in compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995.

    Information Collection Request Title: National Survey of Organ Donation Attitudes and Practices, OMB No. 0915-0290—Reinstatement With Change

    Abstract: HRSA is requesting approval from OMB for a reinstatement with change of a previously approved collection of information (OMB control number 0915-0290). The National Survey of Organ Donation Attitudes and Practices (NSODAP) is conducted approximately every 6-7 years and serves a critical role in providing HRSA and the donation community with data regarding why Americans choose to donate organs, current barriers to donation, and potential new approaches to increasing donations. Survey data and derived analytic insights inform HRSA's public outreach and educational initiatives. HRSA is improving the quality and relevance of the data collected by making the following changes:

    (1) HRSA is increasing the ability to produce more precise results by targeting 10,000 completed surveys (increased from 3,250 in 2012). This increase will allow for a more accurate and robust analysis of the attitudes and donation practices of important subgroups such as Americans over the age of 50 and various minority populations. While the precision of the results from the survey will increase, respondent burden will be reduced and survey completion costs will be lower resulting in a cost neutral change.

    (2) HRSA is streamlining the data collection process to minimize respondent burden. Of the 10,000 targeted completed surveys, 8,000 will be completed online by a nationally representative web panel composed of Americans over the age of 18 who have already agreed to participate in a survey. Web panels target a representative section of a population used by other approved surveys. HRSA will complete the remaining 2,000 surveys by telephone. In 2012, all 3,250 surveys were conducted by telephone and respondents were contacted using random-digit dialing, a process that yielded a low response rate. Contacting respondents by telephone will remain a part of the survey protocol to compare current data to the 2012 data. However, for this survey, identification of a sample of adults over the age of 18 for a telephone survey will be from a national list of home addresses. Prior to contact, those selected for the telephone survey will receive a mailed pre-notification letter with information about the survey. This mailing will improve survey cooperation and reduce the number of people contacted for the survey. Additionally, it is more time and cost effective to take the survey online than taking the survey by phone as the average response will be 0.1 hour shorter, and the cost of online survey can range $3-$4 per survey compared to $50-$100 for a high quality phone survey.

    To improve the relevance of the data collected, HRSA solicited approximately 40 organ donation subject matter experts for their feedback on making changes to the survey. Based on their expert advice, HRSA is revising the instrument to add, remove, or edit a few questions as noted in the draft survey instrument. Example changes include removing certain questions that were only relevant for a random-digit-dialing sample design, editing certain questions to add clarity, and adding questions to highlight emerging topics such as receiving organ donation information through a hand-held device or mobile apps.

    Need and Proposed Use of the Information: HRSA is the primary federal entity responsible for oversight of the solid organ and blood stem cell transplant systems and initiatives to increase organ donor registration and donation in the United States. This survey is the primary method by which HRSA can obtain information from Americans about organ donation attitudes and beliefs. OMB previously approved this survey and HRSA fielded it during 2005 and 2012. Results of the data collected from this survey will inform the development of appropriate messages for future public outreach and educational initiatives. Increasing the number of completed cases via a web panel for online survey completion and modifying the survey instrument without increasing the survey length will dramatically improve the quality and accuracy of the results while minimizing respondent burden as much as possible. The revised instrument and survey fielding methods will allow research on the attitudes and behaviors of important subgroups of Americans as well as research on emerging topics related to organ donation.

    Likely Respondents: A nationally representative sample of adults over the age of 18 with a higher number of responses from populations of interest such as racial-ethnic minorities, including African American, Asian, Native American, and Hispanic respondents, as well as respondents of all age groups and education levels.

    Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. A summary of the total annual burden hours estimated for this ICR is in the table below.

    Total Estimated Annualized Burden Hours Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total
  • responses
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden
  • hours
  • NSODAP Revised Survey—Telephone 2,000 1 2,000 0.3 600 NSODAP Revised Survey—Online Panel 8,000 1 8,000 0.2 1,600 Total 10,000 10,000 2,200

    HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    Amy McNulty, Acting Director, Division of the Executive Secretariat.
    [FR Doc. 2018-02595 Filed 2-8-18; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Zika Virus Pilot Project, OMB No. 0906-XXXX—New AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

    DATES:

    Comments on this ICR must be received no later than April 10, 2018.

    ADDRESSES:

    Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, Room 14N39, 5600 Fishers Lane, Rockville, MD 20857.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (301) 443-1984.

    SUPPLEMENTARY INFORMATION:

    When submitting comments or requesting information, please include the information request collection title for reference, in compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995.

    Information Collection Request Title: Zika Virus Pilot Project, OMB No. 0906-XXXX—New.

    Abstract: HRSA is requesting the Organ Procurement and Transplantation Network (OPTN) perform a federally sponsored data collection as part of a pilot project to monitor the testing of deceased potential donors possibly exposed to the Zika virus (ZIKV). The Zika Pilot Project will have a 12-month performance period enabling OPTN to develop a plan to collect data on ways for organ procurement organizations (OPOs) to deploy ZIKV donor screening tests of blood products. The testing is available under an investigational new drug application for use on a voluntary basis in the evaluation of deceased persons as potential solid organ donors. OPTN will conduct an analysis of the data collected under this project to determine the potential effect of making available screening tests for ZIKV, when appropriate, to improve transplant safety. OPTN will convene a group of stakeholders to provide guidance and monitor progress on the ZIKV pilot project.

    Need and Proposed Use of the Information: ZIKV is prevalent in several areas of the United States. Currently, there is not a ZIKV screening procedure for OPOs to implement during the organ allocation process. HRSA requested OPTN to conduct a pilot project to monitor the testing of deceased donors potentially exposed to ZIKV. The goals of the pilot project are to:

    • Collaborate with experts to define necessary data elements to understand the impact of ZIKV testing in deceased organ donors;

    • Deploy a data collection tool to a limited number of OPOs that agree to participate in the pilot project; and

    • Assess the ability of OPTN to respond to a public health situation by collecting data from impacted members of the transplant community to assess the national experience.

    Likely Respondents: Organ Procurement Organizations.

    Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

    Total Estimated Annualized Burden Hours Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total
  • responses
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden hours
    ZIKV Data Collection Tool 20 167 3,340 .508 1,696.7 Total 20 3,340 1,696.7 * Total number of responses determined by applying the percentage of OPOs participating to the total number of deceased donors in 2016. Based on OPTN Data as of 11/09/2017. ** Donors screened for ZIKV will be based on OPO specific screening criteria.

    HRSA specifically requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    Amy McNulty, Acting Director, Division of the Executive Secretariat.
    [FR Doc. 2018-02586 Filed 2-8-18; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the National Eye Institute Special Emphasis Panel, January 22, 2018, 08:30 a.m. to January 22, 2018, 05:00 p.m., Hilton Garden Inn Bethesda, 7301 Waverly Street, Bethesda, MD 20814 which was published in the Federal Register on December 28, 2017, 82 FR 61577. This meeting is being amended to change the date from January 22, 2018 to February 23, 2018. The time has not changed. The meeting is closed to the public.

    Dated: February 5, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-02565 Filed 2-8-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Multi-site Clinical Trials.

    Date: February 16, 2018.

    Time: 1:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Hiromi Ono, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, National Institute on Drug Abuse, National Institutes of Health, DHHS, 6001 Executive Boulevard, Room 4238, MSC 9550, Bethesda, MD 20892, 301-827-5820, [email protected].

    Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; R13 Conference Grant Review.

    Date: February 23, 2018.

    Time: 1:00 p.m. to 2:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Ivan K. Navarro, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, Division of Extramural Research, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Boulevard, Room 4242, MSC 9550, Bethesda, MD 20892, 301-827-5833, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS)
    Dated: February 5, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-02566 Filed 2-8-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2018-0007] Homeland Security Science and Technology Advisory Committee AGENCY:

    Science and Technology Directorate, DHS.

    ACTION:

    Committee management; notice of open Federal Advisory Committee meeting.

    SUMMARY:

    The Homeland Security Science and Technology Advisory Committee (HSSTAC) will meet via teleconference on Thursday, February 22, 2018. The meeting will be an open session.

    DATES:

    The HSSTAC teleconference meeting will take place Thursday, February 22, 2018 from 11:00 a.m. to 12:00 p.m. The meeting may close early if the committee has completed its business.

    ADDRESSES:

    Members of the public may participate by teleconference but you must register. Please see the “REGISTRATION” section below.

    FOR FURTHER INFORMATION CONTACT:

    Michel Kareis, HSSTAC Designated Federal Official, S&T Interagency Office (IAO), STOP 0205, Department of Homeland Security, 245 Murray Lane, Washington, DC 20528-0205, 202-254-8778 (Office), 202-254-6176 (Fax), [email protected] (Email).

    SUPPLEMENTARY INFORMATION:

    I. Background

    Notice of this meeting is given under the Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix (Pub. L. 92-463). The committee addresses areas of interest and importance to the Under Secretary for Science and Technology (S&T), such as new developments in systems engineering, cyber-security, knowledge management and how best to leverage related technologies funded by other Federal agencies and by the private sector. It also advises the Under Secretary on policies, management processes, and organizational constructs as needed.

    II. Registration

    To pre-register for the teleconference please send an email to: [email protected] with the following subject line: RSVP to HSSTAC meeting. The email should include the name(s), title, organization/affiliation, email address, and telephone number of those interested in attending. You must RSVP by February 20, 2018.

    For information on services for individuals with disabilities or to request special assistance at the meeting, please contact Michel Kareis as soon as possible. Her contact information is listed above in the FOR FURTHER INFORMATION CONTACT section.

    III. Public Comment

    At the end of the open session, there will be a period for oral statements. Please note that the comments period may end before the time indicated, following the last call for oral statements. To register as a speaker, contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

    To facilitate public participation, we invite public comment on the issues to be considered by the committee as listed in the “Agenda” below. Anyone is permitted to submit comments at any time, including orally at the meeting. However, those who would like their comments reviewed by committee members prior to the meeting must submit them in written form no later than February 19, 2018. Please include the docket number (DHS-2018-0007) and submit via one of the following methods:

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

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

    Fax: 202-254-6176.

    Mail: Michel Kareis, HSSTAC Designated Federal Official, S&T IAO, STOP 0205, Department of Homeland Security, 245 Murray Lane, Washington, DC 20528-0205.

    Instructions: All submissions received must include the words “Department of Homeland Security” and the docket number. Comments received will be posted without alteration at http://www.regulations.gov.

    Docket: For access to the docket to read the background documents or comments received by the HSSTAC, go to http://www.regulations.gov and enter the docket number into the search function: DHS-2018-0007.

    Agenda: The session will begin with remarks from the Designated Federal Official, Michel Kareis, and the Committee Chair, Dr. Vincent Chan. Next the Social Media Working Group for Emergency Services and Disaster Management Subcommittee will discuss their report, “Countering Misinformation, Rumors, and Fake News on Social Media in Emergencies and Disasters”, followed by a full committee vote to accept the report. To request a copy of the report prior to the meeting please send an email to: [email protected] The last item on the agenda will be the announcement of a new subcommittee on Systems Engineering Feasibility.

    A public comment period will be held at the end of the open session.

    Dated: February 6, 2018. Michel Kareis, Designated Federal Official for the HSSTAC.
    [FR Doc. 2018-02665 Filed 2-8-18; 8:45 am] BILLING CODE 9110-9F-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-6035-N-03] Notice of Regulatory Waiver Requests Granted for the Third Quarter of Calendar Year 2017 AGENCY:

    Office of the General Counsel, HUD.

    ACTION:

    Notice.

    SUMMARY:

    Section 106 of the Department of Housing and Urban Development Reform Act of 1989 (the HUD Reform Act) requires HUD to publish quarterly Federal Register notices of all regulatory waivers that HUD has approved. Each notice covers the quarterly period since the previous Federal Register notice. The purpose of this notice is to comply with the requirements of section 106 of the HUD Reform Act. This notice contains a list of regulatory waivers granted by HUD during the period beginning on July 1, 2017, and ending on September 30, 2017.

    FOR FURTHER INFORMATION CONTACT:

    For general information about this notice, contact Ariel Pereira, Associate General Counsel for Legislation and Regulations, Department of Housing and Urban Development, 451 Seventh Street SW, Room 10282, Washington, DC 20410-0500, telephone 202-708-3055 (this is not a toll-free number). Persons with hearing- or speech-impairments may access this number through TTY by calling the toll-free Federal Relay Service at 800-877-8339.

    For information concerning a particular waiver that was granted and for which public notice is provided in this document, contact the person whose name and address follow the description of the waiver granted in the accompanying list of waivers that have been granted in the third quarter of calendar year 2017.

    SUPPLEMENTARY INFORMATION:

    Section 106 of the HUD Reform Act added a new section 7(q) to the Department of Housing and Urban Development Act (42 U.S.C. 3535(q)), which provides that:

    1. Any waiver of a regulation must be in writing and must specify the grounds for approving the waiver;

    2. Authority to approve a waiver of a regulation may be delegated by the Secretary only to an individual of Assistant Secretary or equivalent rank, and the person to whom authority to waive is delegated must also have authority to issue the particular regulation to be waived;

    3. Not less than quarterly, the Secretary must notify the public of all waivers of regulations that HUD has approved, by publishing a notice in the Federal Register. These notices (each covering the period since the most recent previous notification) shall:

    a. Identify the project, activity, or undertaking involved;

    b. Describe the nature of the provision waived and the designation of the provision;

    c. Indicate the name and title of the person who granted the waiver request;

    d. Describe briefly the grounds for approval of the request; and

    e. State how additional information about a particular waiver may be obtained.

    Section 106 of the HUD Reform Act also contains requirements applicable to waivers of HUD handbook provisions that are not relevant to the purpose of this notice.

    This notice follows procedures provided in HUD's Statement of Policy on Waiver of Regulations and Directives issued on April 22, 1991 (56 FR 16337). In accordance with those procedures and with the requirements of section 106 of the HUD Reform Act, waivers of regulations are granted by the Assistant Secretary with jurisdiction over the regulations for which a waiver was requested. In those cases in which a General Deputy Assistant Secretary granted the waiver, the General Deputy Assistant Secretary was serving in the absence of the Assistant Secretary in accordance with the office's Order of Succession.

    This notice covers waivers of regulations granted by HUD from July 1, 2017 through September 30, 2017. For ease of reference, the waivers granted by HUD are listed by HUD program office (for example, the Office of Community Planning and Development, the Office of Fair Housing and Equal Opportunity, the Office of Housing, and the Office of Public and Indian Housing, etc.). Within each program office grouping, the waivers are listed sequentially by the regulatory section of title 24 of the Code of Federal Regulations (CFR) that is being waived. For example, a waiver of a provision in 24 CFR part 58 would be listed before a waiver of a provision in 24 CFR part 570.

    Where more than one regulatory provision is involved in the grant of a particular waiver request, the action is listed under the section number of the first regulatory requirement that appears in 24 CFR and that is being waived. For example, a waiver of both § 58.73 and § 58.74 would appear sequentially in the listing under § 58.73.

    Waiver of regulations that involve the same initial regulatory citation are in time sequence beginning with the earliest-dated regulatory waiver.

    Should HUD receive additional information about waivers granted during the period covered by this report (the third quarter of calendar year 2017) before the next report is published (the fourth quarter of calendar year 2017), HUD will include any additional waivers granted for the third quarter in the next report.

    Accordingly, information about approved waiver requests pertaining to HUD regulations is provided in the Appendix that follows this notice.

    Dated: January 31, 2018. J. Paul Compton, Jr., General Counsel. Appendix Listing of Waivers of Regulatory Requirements Granted by Offices of the Department of Housing and Urban Development July 1, 2017 Through September 30, 2017

    Note to Reader: More information about the granting of these waivers, including a copy of the waiver request and approval, may be obtained by contacting the person whose name is listed as the contact person directly after each set of regulatory waivers granted.

    The regulatory waivers granted appear in the following order:

    I. Regulatory waivers granted by the Office of Community Planning and Development. II. Regulatory waivers granted by the Office of Housing. III. Regulatory waivers granted by the Office of Public and Indian Housing. I. Regulatory Waivers Granted by the Office of Community Planning and Development

    For further information about the following regulatory waivers, please see the name of the contact person that immediately follows the description of the waiver granted.

    Regulation: 24 CFR 576.106(d).

    Project/Activity: The Commonweath of Massachusetts requested a waiver to allow its Emergency Solutions Grants (ESG) subrecipient Craig's Doors to provide rental assistance for higher cost units in, Amherst, Massachusetts.

    Nature of Requirement: HUD's regulation at 24 CFR 576.106(d)(1) prohibits ESG rental assistance from being provided for a unit with rent that exceeds the HUD-established Fair Market Rent (FMR), as provided under 24 CFR part 888, or the HUD-established rent reasonableness standard at 24 CFR 982.507.

    Granted By: Ralph Gaines, Principal Deputy Assistant Secretary, D.

    Date Granted: September 18, 2017.

    Reason Waived: Amherst, Massachusetts is home to several colleges and universities. Apartment rental costs have risen due to increased demand of the student population for off-campus housing. The high rental costs and low vacancy rates in the service areas has resulted in a shortage of affordable housing units for extremely low-income renters. As a result, Craig's Doors is experiencing difficulty providing much-needed short- and medium-term rental assistance to eligible individuals. Providing ESG rental assistance for units with rents up to the 120 percent payment standard adopted by the local housing authority will increase housing options for ESG program participants allowing for greater coordination with local housing resources.

    Contact: Robert Shumeyko, Director, Boston Field Office, Thomas P. O'Neill, Jr. Federal Building, Department of Housing Development, 10 Causeway Street, Boston, MA 02222-1092, telephone (617) 994-8376.

    II. Regulatory Waivers Granted by the Office of Housing—Federal Housing Administration (FHA)

    For further information about the following regulatory waivers, please see the name of the contact person that immediately follows the description of the waiver granted.

    Regulation: 24 CFR 200.6 and 5.216(d)(1) and (2).

    Project/Activity: Highgate Senior Living-Billings, FHA Project Number 093-22039 is an assisted living facility in Billings, Montana. With the exception of the Chief Operating Officer, the project owners are foreign nationals who do not have Social Security Numbers, but have individual tax identification numbers issued by the Internal Revenue Service.

    Nature of Requirement: The regulations at 24 CFR 200.6 and 5.216(d)(1) and (2) set forth certain disclosure and verification requirements for Social Security Numbers and Employer Identification Numbers for applicants and participants in assisted and insured loan insurance and related programs.

    Granted By: Dana T. Wade, General Deputy Assistant Secretary for Housing, H.

    Date Granted: July 17, 2017.

    Reason Waived: The Office of Residential Care Facilities recognizes that foreign nationals and corporate entities may participate as principals in the Section 232 program as long as at least one principal with operational decision-making authority is a United States Citizen. As the project has met these requirements, allowing use of the tax identification numbers in lieu of Social Security Numbers will allow the project to participate in the Section 232 program.

    Contact: Vance T. Morris, Operations Manager, Office of Healthcare Programs, Office of Housing, Department of Housing and Urban Development, 451 7th Street SW, Room 2337, Washington, DC 20401, telephone (202) 402-2419.

    Regulation: 24 CFR 219.220(b).

    Project/Activity: Luther Towers I, FHA Project Number 032-SH002, Wilmington, Delaware. Lutheran Senior Services, Incorporated (owner) seeks approval to defer repayment of the Flexible Subsidy Operating Assistance Loan on the subject project.

    Nature of Requirement: The regulation at 24 CFR 219.220(b) (1995), which governs the repayment of operating assistance provided under the Flexible Subsidy Program for Troubled Properties, states “Assistance that has been paid to a project owner under this subpart must be repaid at the earlier of the expiration of the term of the mortgage, termination of mortgage insurance, prepayment of the mortgage, or a sale of the project.”

    Granted by: Dana T. Wade, Principal Deputy Assistant Secretary for Housing, H.

    Date Granted: August 29, 2017.

    Reason Waived: The owner requested and was granted a waiver of the requirement to repay the Flexible Subsidy Operating Assistance Loan in full when it became due. Deferring the loan payment will preserve this affordable housing resource for an additional 35 years through the execution and recordation of a Rental Use Agreement.

    Contact: Cindy Bridges, Senior Account Executive, Office of Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 6168, Washington, DC 20410, telephone (202) 402-2603.

    Regulation: 24 CFR 232.7.

    Project/Activity: Portland Center for Assisted Living, FHA Project Number 022-22036, is an Assisted Living facility with memory care units. The facility does not meet the requirements of 24 CFR 232.7 “Bathroom” of FHA's regulations. The project is located in Portland, ME.

    Nature of Requirement: The regulation at 24 CFR 232.7 mandates in a board and care home or assisted living facility that not less than one full bathroom must be provided for every four residents. Also, the bathroom cannot be accessed from a public corridor or area.

    Granted By: Dana T. Wade, General Deputy Assistant Secretary for Housing.

    Date Granted: July 13, 2017.

    Reason Waived: The project has both assisted living units and a secured, locked memory care area. The 71 assisted living units (142 beds) are in full compliance with the CFR 232.7, bathroom requirements. There are 14 memory care units (28 beds). For this space, there are 8 half bathrooms to serve for the 14 units with 28 beds. Currently, there is one full bathroom and one additional will be added prior to loan closing. Access to the shower rooms pass through hallways that are within the secured locked unit, with each resident being near one of the two full bathing rooms. The ratio of residents to full bathroom rooms is 14 to one. The memory care residents need assistance with bathing and this arrangement is considered by the facility as safer for the residents. The project meets the State of Maine's licensing requirements for bathing and toileting facilities.

    Contact: Vance T. Morris, Operations Manager, Office of Healthcare Programs, Office of Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 2337, Washington, DC 20401, telephone (202) 402-2419.

    Regulation: 24 CFR 232.7.

    Project/Activity: Sodalis at Buda, FHA Project Number 115-22324, is an existing assisted living facility with memory care units. The facility does not meet the requirements of 24 CFR 232.7 “Bathroom” of FHA's regulations. The project is located in Buda, Texas.

    Nature of Requirement: The regulation at 24 CFR 232.7 mandates in a board and care home or assisted living facility that not less than one full bathroom must be provided for every four residents. Also, the bathroom cannot be accessed from a public corridor or area.

    Granted By: Dana T. Wade, General Deputy Assistant Secretary for Housing.

    Date Granted: August 24, 2017.

    Reason Waived: The project contains a secured, locked memory care area of 22 units. Each of the 22 memory care units (22 beds) includes a half bathroom. Access to the shower rooms passes through hallways that are within the secured locked unit, with each resident being near one of the three shower rooms. The ratio of residents to full bathroom rooms is 7 to one and the owner plans on adding one additional large bathroom prior to loan closing. The memory care residents need assistance with bathing and this arrangement is considered by the facility as safer for the residents. The residents do not reside in three or four-bedroom wards. The facility is licensed as a Type B large facility for Alzheimer's and related disorders and meets the State of Texas's licensing requirements for bathing and toileting facilities.

    Contact: Vance T. Morris, Operations Manager, Office of Healthcare Programs, Office of Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 2337, Washington, DC 20401, telephone (202) 402-2419.

    Regulation: 24 CFR 232.1005.

    Project/Activity: Texas Skilled Nursing Facilities with Hospital Operators Participating in the Quality Incentive Payment Program; Senior Living Properties Portfolio.

    Nature of Requirement: The regulation at 24 CFR 232.1005 requires that all accounts deriving from the operation of the property, including operator accounts and including all funds received from any source or derived from the operation of the facility, are project assets subject to control under the insured mortgage loan's transactional documents, including, without limitation, the operator's regulatory agreement. For projects participating in the Texas Health and Human Services Commission Quality Incentive Payment Program, the State funds a portion of the supplemental payments to a non-State governmental entity (as an Operating Partner), a portion of which is retained by the Operating Partner, under contractual agreement and pledged as collateral for revenue bonds or other financing used to make the upfront inter-governmental transfer payments.

    Granted By: Dana T. Wade, General Deputy Assistant Secretary for Housing.

    Date Granted: July 19, 2017.

    Reason Waived: Waiver of the 24 CFR 232.1005 requirement for the portion of the inter-governmental transfer funds to be retained by the Operating Partner will allow the portfolio of projects to participate in the supplemental payment program. This will add additional cash-flow to the project, allowing for an increased ability to attract, retain and train a quality workforce and invest in programming and technology that will drive quality outcomes at the facilities. It will also improve security for the FHA-insured loans.

    Contact: Vance T. Morris, Operations Manager, Office of Healthcare Programs, Office of Housing, Department of Housing and Urban Development, 451 7th Street SW, Room 2337, Washington, DC 20401, telephone (202) 402-2419.

    Regulation: 24 CFR 232.1005.

    Project/Activity: Texas Skilled Nursing Facilities with Hospital Operators Participating in the Quality Incentive Payment Program; Regency Portfolio.

    Nature of Requirement: The regulation at 24 CFR 232.1005 requires that all accounts deriving from the operation of the property, including operator accounts and including all funds received from any source or derived from the operation of the facility, are project assets subject to control under the insured mortgage loan's transactional documents, including, without limitation, the operator's regulatory agreement. For projects participating in the Texas Health and Human Services Commission Quality Incentive Payment Program, the State funds a portion of the supplemental payments to a non-State governmental entity (as an Operating Partner), a portion of which is retained by the Operating Partner, under contractual agreement and pledged as collateral for revenue bonds or other financing used to make the upfront inter-governmental transfer payments.

    Granted By: Dana T. Wade, General Deputy Assistant Secretary for Housing.

    Date Granted: July 19, 2017.

    Reason Waived: Waiver of the 24 CFR 232.1005 requirement for the portion of the inter-governmental transfer funds to be retained by the Operating Partner will allow the portfolio of projects to participate in the supplemental payment program. This will add additional cash-flow to the project, allowing for an increased ability to attract, retain and train a quality workforce and invest in programming and technology that will drive quality outcomes at the facilities. It will also improve security for the FHA-insured loans.

    Contact: Vance T. Morris, Operations Manager, Office of Healthcare Programs, Office of Housing, Department of Housing and Urban Development, 451 7th Street SW, Room 2337, Washington, DC 20401, telephone (202) 402-2419.

    Regulation: 24 CFR 290.30(a).

    Project/Activity: E.C. Reems Garden Apartments, FHA Project Number 121-11054, Oakland, California. The Multifamily West Regional Center seeks approval to waive the non-competitive sale of a HUD-held multifamily mortgage.

    Nature of Requirement: The regulation at 24 CFR 290.30(a), which governs the sale of HUD-held mortgages, states that “[e]xcept as otherwise provided in Section 290.31(a)(2), HUD will sell HUD-held multifamily mortgages on a competitive basis.”

    Granted by: Dana Wade, General Deputy Assistant Secretary for Housing, H.

    Date Granted: July 25, 2017.

    Reason Waived: The Multifamily West Regional Center requested and was granted a waiver of the non-competitive sale of a HUD-held multifamily mortgage. A waiver allows the Department to assign the mortgage to the Owner's new mortgagee to avoid paying mortgage recording tax in the State of California.

    Contact: Isabella Cabbagestalk, Supervisory Account Executive, Office of Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 6168, Washington, DC 20410, telephone (202) 402-2535.

    IV. Regulatory Waivers Granted by the Office of Public and Indian Housing

    For further information about the following regulatory waivers, please see the name of the contact person that immediately follows the description of the waiver granted.

    Regulation: 24 CFR 982.161(a)(3).

    Project/Activity: Stuttgart Housing Authority (SHA) in Stuttgart, Arkansas, requested a waiver of this regulation so that the SHA could continue its housing assistance payments contract with a City Councilman for the City of Stuttgart.

    Nature of Requirement: This regulation states that neither the public housing agency nor any of its contractors or subcontractors may enter into a contract or arrangement in connection with the tenant-based programs with any public official, member of a governing body, or State or local legislator who exercises functions or responsibilities with respect to the tenant-based programs during tenure or for one year thereafter.

    Granted By: Dominique Blom, General Deputy Assistant Secretary for Public and Indian Housing.

    Date Granted: September 15, 2017.

    Reason Waived: This regulation was waived to avoid the hardship of requiring the assisted family to move. The assisted family was living in the unit prior to the mayoral election.

    Contact: Becky Primeaux, Housing Voucher Management and Operations Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4216, Washington, DC 20410, telephone (202) 708-0477.

    Regulation: 24 CFR 982.207(b)(3).

    Project/Activity: The Housing Authority of the City of Augusta (HACA) in Augusta, Georgia, requested a waiver of this regulation to assist the State of Georgia in fulfilling the requirements set forth in the State of Georgia Americans with Disabilities Act/Section 504 of the Rehabilitation Act Settlement Agreement with the Department of Justice, which stems from the Olmstead v. L.C. litigation.

    Nature of Requirement: This regulation allows a PHA t adopt a preference for admission of families that include a person with a disability. However, a PHA may not adopt a preference for the admission of persons with a specific disability.

    Granted By: Jemine A. Bryon, General Deputy Assistant Secretary for Public and Indian Housing.

    Date Granted: July 10, 2017.

    Reason Waived: This waiver allows the HACA to establish a limited preference in order to assist the State of Georgia comply with the remedial requirements stated in the Georgia Settlement Agreement.

    Contact: Becky Primeaux, Housing Voucher Management and Operations Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4216, Washington, DC 20410, telephone (202) 708-0477.

    Regulation: 24 CFR 982.305(c)(4).

    Project/Activity: The Josephine Housing and Community Development Council (JHCDC) in Grants Pass, Oregon, requested a waiver of this regulation so that the JHCDC could pay a landlord from the period starting when the unit selected by the family passed the housing quality standards inspection.

    Nature of Requirement: This regulation states that any housing assistance payments (HAP) contract executed after 60 days from the beginning of the lease term is void and the PHA may not pay any HAP to the owner.

    Granted By: Jemine A. Bryon, General Deputy Assistant Secretary for Public and Indian Housing.

    Date Granted: July 10, 2017.

    Reason Waived: Due to unforeseen circumstances, this regulation was waived so that the family would not be responsible for the full amount of the rent since the beginning of the lease.

    Contact: Becky Primeaux, Housing Voucher Management and Operations Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4216, Washington, DC 20410, telephone (202) 708-0477.

    Regulation: 24 CFR 982.305(c)(4).

    Project/Activity: The Washington County Department of Housing Services (WCDHS) in Hillsboro, Oregon, requested a waiver of this regulation so that the WCDHA could pay a landlord from the period starting when the unit selected by the family passed the housing quality standards inspection.

    Nature of Requirement: This regulation states that any housing assistance payments (HAP) contract executed after 60 days from the beginning of the lease term is void and the PHA may not pay any HAP to the owner.

    Granted By: Jemine A. Bryon, General Deputy Assistant Secretary for Public and Indian Housing.

    Date Granted: July 10, 2017.

    Reason Waived: Due to unforeseen circumstances, this regulation was waived so that the family would not be responsible for the full amount of the rent since the beginning of the lease.

    Contact: Becky Primeaux, Housing Voucher Management and Operations Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4216, Washington, DC 20410, telephone (202) 708-0477.

    Regulation: 24 CFR 982.505(d).

    Project/Activity: Colorado Division of Housing (CDH) in Denver, Colorado, requested a waiver of 24 CFR 982.505(d) so that it could approve an exception payment standard amount above 120 percent of the fair market rents (FMR) as a reasonable accommodation.

    Nature of Requirement: This regulation states that a public housing agency may only approve a higher payment standard for a family as a reasonable accommodation if the higher payment standard is no more than 120 percent of the FMR for the unit size.

    Granted By: Jemine A. Bryon, General Deputy Assistant Secretary for Public and Indian Housing.

    Date Granted: July 28, 2017.

    Reason Waived: This regulation was waived as a reasonable accommodation to allow a disabled participant to receive housing assistance and pay no more than 40 percent of its adjusted income toward the family share.

    Contact: Becky Primeaux, Housing Voucher Management and Operations Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4216, Washington, DC 20410, telephone (202) 708-0477.

    Regulation: 24 CFR 982.505(d).

    Project/Activity: Housing Authority of the City of Los Angeles (HACLA) in Lost Angeles, California, requested a waiver of 24 CFR 982.505(d) so that it could approve an exception payment standard amount above 120 percent of the fair market rents (FMR) as a reasonable accommodation.

    Nature of Requirement: This regulation states that a public housing agency may only approve a higher payment standard for a family as a reasonable accommodation if the higher payment standard is no more than 120 percent of the FMR for the unit size.

    Granted By: Dominique Blom, General Deputy Assistant Secretary for Public and Indian Housing.

    Date Granted: August 7, 2017.

    Reason Waived: This regulation was waived as a reasonable accommodation to allow a disabled applicant to receive housing assistance and pay no more than 40 percent of its adjusted income toward the family share.

    Contact: Becky Primeaux, Housing Voucher Management and Operations Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4216, Washington, DC 20410, telephone (202) 708-0477.

    Regulation: 24 CFR 982.505(d).

    Project/Activity: Mendocino County Community Development Commission (MCCDC) in Ukiah, California, requested a waiver of 24 CFR 982.505(d) so that it could approve an exception payment standard amount above 120 percent of the fair market rents (FMR) as a reasonable accommodation.

    Nature of Requirement: This regulation states that a public housing agency may only approve a higher payment standard for a family as a reasonable accommodation if the higher payment standard is no more than 120 percent of the FMR for the unit size.

    Granted By: Dominique Blom, General Deputy Assistant Secretary for Public and Indian Housing.

    Date Granted: September 8, 2017.

    Reason Waived: This regulation was waived as a reasonable accommodation to allow a disabled applicant to receive housing assistance and pay no more than 40 percent of its adjusted income toward the family share.

    Contact: Becky Primeaux, Housing Voucher Management and Operations Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4216, Washington, DC 20410, telephone (202) 708-0477.

    Regulation: 24 CFR 982.505(d).

    Project/Activity: Boston Housing Authority (BHA) in Boston, Massachusetts, requested a waiver of 24 CFR 982.505(d) so that it could approve an exception payment standard amount above 120 percent of the fair market rents (FMR) as a reasonable accommodation.

    Nature of Requirement: This regulation states that a public housing agency may only approve a higher payment standard for a family as a reasonable accommodation if the higher payment standard is no more than 120 percent of the FMR for the unit size.

    Granted By: Dominique Blom, General Deputy Assistant Secretary for Public and Indian Housing.

    Date Granted: August 21, 2017.

    Reason Waived: This regulation was waived as a reasonable accommodation to allow a disabled participant to receive housing assistance and pay no more than 40 percent of its adjusted income toward the family share.

    Contact: Becky Primeaux, Housing Voucher Management and Operations Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4216, Washington, DC 20410, telephone (202) 708-0477.

    Regulation: 24 CFR 983.391(f)(2)(ii).

    Project/Activity: The Florence Housing Authority (FHA) in Florence, Alabama, requested a waiver of this regulation so that the FHA could establish site-specific utility allowances in connection with four Rental Assistance Demonstration (RAD) sites.

    Nature of Requirement: This regulation states that the PHA may not establish or apply different utility allowance amounts for the project-based voucher (PBV) program. The same PHA utility allowance schedule applies to both the tenant-based and PBV programs.

    Granted By: Jemine A. Bryon, General Deputy Assistant Secretary for Public and Indian Housing.

    Date Granted: July 10, 2017.

    Reason Waived: This regulation was waived since due to utility efficient upgrades at four RAD projects, the consumption rates were less than projected by the FHA's tenant-based utility allowances

    Contact: Becky Primeaux, Housing Voucher Management and Operations Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4216, Washington, DC 20410, telephone (202) 708-0477.

    Regulation: 24 CFR 985.101(a).

    Project/Activity: Village of Greenport Housing Authority (VGHA) in Greenport, NY, requested a waiver of 24 CFR 985.101(a) so that it could submit its Section Eight Management Assessment Program (SEMAP) certification after the deadline.

    Nature of Requirement: 24 CFR 985.101(a) states a PHA must submit the HUD-required SEMAP certification form within 60 calendar days after the end of its fiscal year.

    Granted By: Dominique Blom, General Deputy Assistant Secretary for Public and Indian Housing.

    Date Granted: August 2, 2017.

    Reason Waived: This waiver was granted for the VGHA's fiscal year ending March 31, 2017. The waiver was approved because of circumstances beyond the PHA's control and to prevent additional administrative burdens for the PHA and field office.

    Contact: Becky Primeaux, Housing Voucher Management and Operations Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4216, Washington, DC 20410, telephone (202) 708-0477.

    Regulation: 24 CFR 985.101(a).

    Project/Activity: Village of Greenport Housing Authority (VGHA) in Greenport, NY, requested a waiver of 24 CFR 985.101(a) so that it could submit its Section Eight Management Assessment Program (SEMAP) certification after the deadline.

    Nature of Requirement: 24 CFR 985.101(a) states a PHA must submit the HUD-required SEMAP certification form within 60 calendar days after the end of its fiscal year.

    Granted By: Dominique Blom, General Deputy Assistant Secretary for Public and Indian Housing.

    Date Granted: August 2, 2017.

    Reason Waived: This waiver was granted for the VGHA's fiscal year ending March 31, 2017. The waiver was approved because of circumstances beyond the PHA's control and to prevent additional administrative burdens for the PHA and field office.

    Contact: Becky Primeaux, Housing Voucher Management and Operations Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4216, Washington, DC 20410, (202) 708-0477.

    Regulation: 24 CFR 985.101(a).

    Project/Activity: Housing Authority of the Town of Guttenberg (HATG) in Guttenberg, New Jersey, requested a waiver of 24 CFR 985.101(a) so that it could submit its Section Eight Management Assessment Program (SEMAP) certification after the deadline.

    Nature of Requirement: 24 CFR 985.101(a) states a PHA must submit the HUD-required SEMAP certification form within 60 calendar days after the end of its fiscal year.

    Granted By: Dominique Blom, General Deputy Assistant Secretary for Public and Indian Housing.

    Date Granted: August 2, 2017.

    Reason Waived: This waiver was granted for the HATG's fiscal year ending March 31, 2017. The waiver was approved because of circumstances beyond the PHA's control and to prevent additional administrative burdens for the PHA and field office.

    Contact: Becky Primeaux, Housing Voucher Management and Operations Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4216, Washington, DC 20410, telephone (202) 708-0477.

    Regulation: 24 CFR 985.101(a).

    Project/Activity: Schoolcraft County Housing Commission (SCHC) in Manistique, Michigan, requested a waiver of 24 CFR 985.101(a) so that it could submit its Section Eight Management Assessment Program (SEMAP) certification after the deadline.

    Nature of Requirement: 24 CFR 985.101(a) states a PHA must submit the HUD-required SEMAP certification form within 60 calendar days after the end of its fiscal year.

    Granted By: Dominique Blom, General Deputy Assistant Secretary for Public and Indian Housing.

    Date Granted: August 7, 2017.

    Reason Waived: This waiver was granted for the SCHC's fiscal year ending March 31, 2017. The waiver was approved because of circumstances beyond the PHA's control and to prevent additional administrative burdens for the PHA and field office.

    Contact: Becky Primeaux, Housing Voucher Management and Operations Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4216, Washington, DC 20410, telephone (202) 708-0477.

    Regulation: 24 CFR 905.400(i)(5)(i).

    Project/Activity: Mississippi Regional Housing Authority No. V (MRHA) in Newton, MS.

    Nature of Requirement: PHAs use Replacement Housing Factor (RHF) grant funds for the development of replacement housing only.

    Granted by: Dominique Blom, General Deputy Assistant Secretary.

    Date Granted: August 18, 2017.

    Reason Waived: The waiver was granted to allow MRHA to use RHF grant funds for modernization. MRHA is currently under a Voluntary Compliance Agreement with HUD's Office of Fair Housing and Equal Opportunity to make Section 504 renovations to its properties. Recent funding cuts have made these renovations difficult to fund. The RHF grants total is not enough to develop replacement units. Instead, the MRHA will use these funds to contribute to the costs of Section 504 renovations on 30 units. In accordance with 24 CFR 5.110, good cause exists, and HUD approves MRHA's request for a waiver of 24 CFR 905.400(i)(5)(i) for the use of RHF funds to pay for modernization work.

    Contact: Susan A. Wilson, Acting Deputy Assistant Secretary for the Office of Public Housing Investments, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4130, Washington, DC 20140, telephone (202) 402-4500.

    Regulation: 24 CFR 905.400(i)(5)(i).

    Project/Activity: The Edinburg Housing Authority (EHA) in Edinburg, TX.

    Nature of Requirement: PHAs use Replacement Housing Factor (RHF) grant funds for the development of replacement housing only.

    Granted by: Dominique Blom, General Deputy Assistant Secretary.

    Date Granted: August 21, 2017.

    Reason Waived: The waiver was granted to allow EHA to use RHF grant funds for modernization. EHA states having difficulties finding suitable development locations, which can be obtained at a reasonable price and in enough time to obtain HUD approval of a Development Proposal. EHA had similar problems developing with its First Increment RHF Funds. Most of the EHA's units are at least 40 years old, and with decreasing Capital and Operating Funds, the housing authority is in need of modernization beyond its funding sources. EHA would therefore like to use its Second Increment RHF Funds to preserve its existing inventory, rather than develop new units. In accordance with 24 CFR 5.110, good cause exists, and HUD approves EHA's request for a waiver of 24 CFR 905.400(i)(5)(i) for the use of RHF funds to pay for modernization work.

    Contact: Susan A. Wilson, Acting Deputy Assistant Secretary for the Office of Public Housing Investments, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4130, Washington, DC 20140, telephone (202) 402-4500.

    Regulation: 24 CFR 905.400(i)(5)(i).

    Project/Activity: Decatur Housing Authority (DHA) in Decatur, IL.

    Nature of Requirement: PHAs use Replacement Housing Factor (RHF) grant funds for the development of replacement housing only.

    Granted by: Dominique Blom, General Deputy Assistant Secretary.

    Date Granted: August 22, 2017.

    Reason Waived: The waiver was granted to allow DHA to use RHF grant funds for modernization. The DHA has indicated that due to a misunderstanding in funding allocation for units eligible for RHF grants, the DHA can no longer conduct the activities approved in its 2nd Increment RHF plan. The DHA will no longer receive its anticipated FY 2015 and 2016 2nd Increment grants (approximately $576,000). The DHA is left with a balance of $102,116.71 remaining in 2nd Increment RHF funds, which is not enough to construct replacement units. DHA will use the RHF funds to address the physical needs and make repairs of its existing units. This will enable DHA to increase the supply of affordable housing through increased occupancy. In accordance with 24 CFR 5.110, good cause exists, and HUD hereby approve DHA's request for a waiver of 24 CFR 905.400(i)(5)(i) for the use of RHF funds to pay for modernization work.

    Contact: Susan A. Wilson, Acting Deputy Assistant Secretary for the Office of Public Housing Investments, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4130, Washington, DC 20140, telephone (202) 402-4500.

    Regulation: 24 CFR 905.400(i)(5)(i).

    Project/Activity: Springfield Housing Authority (SHA) in Springfield, TN.

    Nature of Requirement: PHAs use Replacement Housing Factor (RHF) grant funds for the development of replacement housing only.

    Granted by: Dominique Blom, General Deputy Assistant Secretary.

    Date Granted: August 22, 2017.

    Reason Waived: The waiver was granted to allow SHA to use RHF grant funds for modernization. SHA intended to use the RHF grants to construct a residential duplex. However, the combined funding is insufficient to construct the 2-bedroom duplex building. Rather than returning the funds, the SHA would use the RHF grants to install central heat and air in its existing units. This will assist in addressing its vacancy problem. In accordance with 24 CFR 5.110, good cause exists, and HUD hereby approve SHA's request for a waiver of 24 CFR 905.400(i)(5)(i) for the use of RHF funds to pay for modernization work.

    Contact: Susan A. Wilson, Acting Deputy Assistant Secretary for the Office of Public Housing Investments, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh Street SW, Room 4130, Washington, DC 20140, telephone (202) 402-4500.

    [FR Doc. 2018-02654 Filed 2-8-18; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5858-N-08] Announcement of the Housing Counseling Federal Advisory Committee; Notice of Public Meeting AGENCY:

    Office of the Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Development (HUD).

    ACTION:

    Notice of Housing Counseling Federal Advisory Committee (HCFAC) Public Meeting.

    SUMMARY:

    This gives notice of a Housing Counseling Federal Advisory Committee (HCFAC) meeting and sets forth the proposed agenda. The Committee meeting will be held on Thursday, March 1, 2018. The meeting is open to the public and is accessible to individuals with disabilities.

    DATES:

    The in-person meeting will be held on Thursday, March 1, 2018 starting at 9:00 a.m. Eastern Standard Time (ET) at HUD Headquarters, 451 7th Street SW, Washington, DC 20410 and via conference phone.

    FOR FURTHER INFORMATION CONTACT:

    Virginia F. Holman, Housing Specialist, Office of Housing Counseling, U.S. Department of Housing and Urban Development, 600 East Broad Street, Richmond, VA 23219; telephone number 804-822-4911 (this is not a toll-free number); email [email protected] Persons who have difficulty hearing or speaking may access this number via TTY by calling the toll-free Federal Relay Service at (800) 877-8339 (toll-free number). Individuals may also email [email protected]

    SUPPLEMENTARY INFORMATION:

    HUD is convening the meeting of the HCFAC on Thursday, March 1, 2018 from 9:00 a.m. to 4:00 p.m. ET. The meeting will be held at HUD Headquarters, 451 7th Street SW, Washington, DC 20410 and via conference phone. This meeting notice is provided in accordance with the Federal Advisory Committee Act, 5 U.S.C. App. 10(a)(2).

    Draft Agenda—Housing Counseling Federal Advisory Committee Meeting—March 1, 2018 I. Welcome II. Advisory Committee deliberation and recommendations III. Public Comment IV. Next Steps V. Adjourn Registration

    The public is invited to attend this one-day meeting in-person or by phone. Advance registration is required to participate. To register to attend, please visit the following link: https://pavr.wufoo.com/forms/hcfac-meeting-registration-03012018/.

    After completing the pre-registration process at the above link, in-person attendees will receive details about the meeting location and how to access the building. The meeting is also open to the public with limited phone lines available on a first-come, first-served basis. Phone attendees can call-in to the one-day meeting by using the following number in the United States: 800-231-0316 (toll-free number). An operator will ask callers to provide their names and their organizational affiliations (if applicable) prior to placing callers into the conference line to ensure they are part of the pre-registration list. Callers can expect to incur charges for calls they initiate over wireless lines and HUD will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free phone number. Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service (FRS): (800) 977-8339 (toll-free number) and providing the FRS operator with the conference call number: 800-231-0316.

    Comments

    With advance registration, members of the public will have an opportunity to provide oral and written comments relative to agenda topics for the Committee's consideration. To provide oral comments, please be sure to indicate this on the registration link. The total amount of time for oral comments will be 15 minutes with each commenter limited to two minutes to ensure pertinent Committee business is completed. Written comments must be provided no later than February 19, 2018 to [email protected] Please note, written statements submitted will not be read during the meeting. The Committee will not respond to individual written or oral statements; but, will take all public comments into account in its deliberations.

    Meeting Records

    Records and documents discussed during the meeting, as well as other information about the work of this Committee, will be available for public viewing as they become available at: http://www.facadatabase.gov/committee/committee.aspx?cid=2492&aid=77 by clicking on the “Committee Meetings” link. Information on the Committee is also available on HUD Exchange at https://www.hudexchange.info/programs/housing-counseling/federal-advisory-committee/.

    Dated: January 30, 2018. Dana Wade, General Deputy Assistant, Secretary for Housing.
    [FR Doc. 2018-02655 Filed 2-8-18; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [12X.LLAK942000.L54200000.FR0000. LVDIL0490000; AA093210] Notice of Application for a Recordable Disclaimer of Interest for Lands Underlying the Kanektok River System Including Pegati and Kagati Lakes, Alaska AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The State of Alaska (State) has filed an application with the Bureau of Land Management (BLM) for a Recordable Disclaimer of Interest (RDI) from the United States in those lands underlying the Kanektok River System, including Pegati and Kagati Lakes, a major drainage into Kuskokwim Bay in southwestern Alaska. The State asserts that the Kanektok River System, including Pegati and Kagati Lakes, was navigable and unreserved at the time of Alaska Statehood in 1959.

    DATES:

    The BLM should receive all comments to this action on or before May 10, 2018.

    ADDRESSES:

    You may submit comments by mail or email on the State of Alaska's application for an RDI or on the BLM draft “Summary Report on the Federal Interest in Lands underlying the Kanektok River System (including Pegati and Kagati Lakes).” To file comments by mail, send to: RDI Program Manager (AK-942), Division of Lands and Cadastral, BLM Alaska State Office, 222 West 7th Avenue, #13, Anchorage, AK 99513. To submit comments by email, send to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Angie Nichols, RDI Program Manager, 222 West 7th Avenue, #13, Anchorage, AK 99513; 907-271-3359; [email protected]; or visit the BLM RDI website at https://www.blm.gov/programs/lands-and-realty/regional-information/alaska/RDI/kuskokwim.

    People who use a telecommunications device for the deaf (TDD) may call the Federal Relay System (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, seven days a week, to leave a message or a question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    On Feb. 28, 2012, the State filed an application (AA-93210) for an RDI pursuant to Section 315 of the Federal Land Policy and Management Act of 1976 (FLPMA) and the regulations contained in 43 CFR Subpart 1864 for the lands underlying the Kanektok River System, including Pegati and Kagati Lakes. The State asserts that this river system was navigable at the time of Alaska Statehood. As such, the State contends that ownership of the lands underlying this river system automatically passed from the United States to the State in 1959 at the time of Statehood under the Equal Footing Doctrine; the Submerged Lands Act of 1953; the Alaska Statehood Act; and other title navigability law. Section 315 of FLPMA authorizes the BLM to issue an RDI when it determines that a record interest of the United States in lands has terminated by law or is otherwise invalid, and a disclaimer will help remove a cloud on title to such lands.

    The State's application is for an RDI for all submerged lands underlying the portion of the Kanektok River System, including Pegati and Kagati Lakes. Specifically, these are the submerged lands and bed up to, and including, the ordinary high water line of Pegati and Kagati Lakes within: Townships 3-4 south, range 63 west, Seward Meridian, Alaska and for the submerged lands and bed of the Kanektok River lying between the ordinary high water lines of the right and left banks of that river from the outlet of Pegati Lake within township 3 south, range 63 west, Seward Meridian, Alaska, downstream to the location where the river enters the Kuskokwim Bay within township 5 south, range 74 west, Seward Meridian, Alaska, USGS 1:63,360 series topographic map Goodnews C-5, 6, 8, and D-3-8. The State's application for the Kanektok River System starting at Pegati and Kagati Lakes downstream to Kuskokwim Bay flows through the following area: Townships 3-4 south, range 63 west; township 3 south, range 64 west; township 3 south, range 65 west; township 3 south, range 66 west; township 4 south, range 66 west; township 4 south, range 67 west; township 5 south, range 68 west; township 5 south, range 69 west; township 4 south, range 69 west; township 4 south, range 70 west; township 4 south, range 71 west; township 4 south, range 72 west; township 4 south, range 73 west; township 5 south, range 73 west; township 5 south, range 74 west, Seward Meridian, Alaska. Over time, the precise location of the submerged lands described above may vary between townships due to the ambulatory nature of these water bodies. An RDI is a legal document through which the BLM disclaims the United States' interest in, or ownership of, specified lands, but the disclaimer does not grant, convey, transfer, or renounce any title or interest in the lands, nor does it release any tax, judgment, or lien. This Notice of Application is to inform the public of the pending application and the State supporting evidence, as well as to provide the opportunity to comment or provide additional information to the BLM.

    The BLM will not make a final decision on the merits of the State's application before May 10, 2018. During this 90-day period, interested parties may comment on the State's application, AA-93210, and supporting evidence.

    During this 90-day comment period, interested parties may also comment on the BLM's draft “Summary Report on the Federal Interest in Lands underlying the Kanektok River System including Pegati and Kagati Lakes” for the State's application for a RDI, which is available on the BLM's RDI website (see FOR FURTHER INFORMATION CONTACT above).

    Copies of the State application, supporting evidence, the BLM Draft Summary Report, and comments, including names and street addresses of commenters, will be available for public review at the Alaska State Office, Public Room, 222 West 7th Avenue, #13, Anchorage, AK 99513, during regular business hours 7:30 a.m. to 4:30 p.m., Monday through Friday, except holidays. Before including your address, phone number, email address, or other personally identifying information in your comment, you should be aware that your entire comment—including your personally identifying information—may be made publicly available at any time. While you can ask the BLM in your comment to withhold your personally identifying information from public review, we cannot guarantee that we will be able to do so.

    If the BLM determines the State's evidence and any additional information the agency receives concerning the State's application is sufficient to find a favorable determination, and neither the records nor a valid objection discloses a reason not to disclaim, the BLM may decide to approve the application for the RDI.

    Authority:

    43 CFR 1864.2.

    Erika L. Reed, Deputy State Director, Division of Lands and Cadastral, Alaska.
    [FR Doc. 2018-02679 Filed 2-8-18; 8:45 am] BILLING CODE 4310-JA-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLORN00100.L63340000.PH0000.18XL1116AF.LXSSH1020000.HAG 18-0024] Notice of Public Meeting for the Northwest Oregon Resource Advisory Council AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    In accordance with the Federal Land Policy and Management Act of 1976, the Federal Advisory Committee Act of 1972, and the Federal Lands Recreation Enhancement Act of 2004, the U.S. Department of the Interior, Bureau of Land Management's (BLM) Northwest Oregon Resource Advisory Council (RAC) will meet as indicated below.

    DATES:

    The Northwest Oregon RAC will hold a public meeting on Thursday, February 22, 2018, from 9:00 a.m. to 4:30 p.m. Pacific Daylight Time.

    ADDRESSES:

    The Northwest Oregon RAC will meet at the BLM Northwest Oregon District Office, 1717 Fabry Road SE, Salem, OR 97306. Written comments may also be sent to the Northwest Oregon District office.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Velez, Public Affairs Officer, 1717 Fabry Road SE, Salem, OR 97306; (541) 222-9241; [email protected] Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1 (800) 877-8339 to contact the above individuals during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individuals. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    The Northwest Oregon RAC consists of 15 members chartered and appointed by the Secretary of the Interior to serve in an advisory capacity concerning the planning and management of the public land resources located within the BLM's Northwest Oregon District. Members represent an array of stakeholder interests in the land and resources from within the local area and statewide.

    All advisory council meetings are open to the public. The public comment period will begin at 3:30 p.m. and continue to 4:00 p.m. Depending on the number of people wishing to comment and the time available, the amount of time for individual oral comments may be limited. Persons wishing to make comments during the public comment period should register in person with the BLM, at the meeting location, preceding that meeting day's comment period. The public may also submit written comments to Jennifer Velez, Public Affairs Officer, 1717 Fabry Road SE, Salem, OR 97306; by telephone (541) 222-9241; or by email [email protected], no later than Wednesday, February 21, 2018. All written comments received prior to the meeting will be provided to the council members.

    At the February 22 meeting, RAC members will receive an orientation of the Federal Lands Recreation Enhancement Act and may make recommendations on recreation fee proposals for a variety of sites within the Northwest Oregon District. Other topics will include general updates and a review of minutes from the July 2017 meeting.

    Before including your address, phone number, email address, or other personal identifying information in your comments, please be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Authority:

    43 CFR 1784.4-2.

    Jose Linares, Northwest Oregon District Manager.
    [FR Doc. 2018-02680 Filed 2-8-18; 8:45 am] BILLING CODE 4310-33-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-NERO-ACAD-24432; PPNEACADSO, PPMPSPDIZ.YM0000] Acadia National Park Advisory Commission 2018 Meeting Schedule AGENCY:

    National Park Service, Interior.

    ACTION:

    Meeting notice.

    SUMMARY:

    The National Park Service is hereby giving notice of the 2018 meeting schedule for the Acadia National Park Advisory Commission.

    DATES:

    All meetings will begin 1:00 p.m. (EASTERN). The meetings are scheduled for: Monday, March 12, 2018; Monday, June 4, 2018; and Monday, September 10, 2018.

    ADDRESSES:

    For the March 12, 2018, and June 4, 2018, meetings, the Commission will meet at the Acadia National Park headquarters conference room, 20 McFarland Hill Drive, Bar Harbor, Maine 04609. For the September 10, 2018, meeting, the Commission will meet at Schoodic Education and Research Center, Winter Harbor, Maine 04693.

    FOR FURTHER INFORMATION CONTACT:

    Michael Madell, Deputy Superintendent, Acadia National Park, P.O. Box 177, Bar Harbor, Maine 04609, telephone (207) 288-3338 or via email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Acadia National Park Advisory Commission was established by Section of 103 of Public Law 99-420, September 25, 1986, to consult with the Secretary of the Interior on matters relating to the management and development of Acadia National Park including, but not limited to, the acquisition of lands and interests in lands (including conservation easements on islands) and termination of rights of use and occupancy.

    The meetings are open to the public. Interested persons may make oral or written presentations to the Commission or file written statements. Such requests should be made to the Superintendent at least seven days prior to the meeting.

    The Commission meeting locations may change based on inclement weather or exceptional circumstances. If a meeting location is changed, the Superintendent will issue a press release and use local newspapers to announce the change.

    Agenda: The Commission meeting will consist of the following proposed agenda items:

    1. Committee Reports: • Land Conservation • Park Use • Science and Education • Historic 2. Old Business 3. Superintendent's Report 4. Chairman's Report 5. Public Comments 6. Adjournment

    Before including your address, telephone number, email address, or other personal identifying information in your comments, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Alma Ripps, Chief, Office of Policy.
    [FR Doc. 2018-02633 Filed 2-8-18; 8:45 am] BILLING CODE 4312-52-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-1079] Certain Shaving Cartridges, Components Thereof and Products Containing Same; Commission Determination Not To Review an Initial Determination Terminating Investigation Based on a Settlement Agreement; Termination of the Investigation AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 7) of the presiding administrative law judge (“ALJ”), granting a joint motion to terminate the above-captioned investigation based on a settlement agreement. The investigation is terminated in its entirety.

    FOR FURTHER INFORMATION CONTACT:

    Cathy Chen, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2392. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.

    SUPPLEMENTARY INFORMATION:

    The Commission instituted this investigation on October 30, 2017, based on a complaint filed by The Gillette Company LLC of Boston, Massachusetts (“Gillette”). 82 FR 50158 (Oct. 30, 2017). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain shaving cartridges, components thereof and products containing same by reason of infringement of U.S. Patent No. 9,193,077 (“the '077 patent”). The complaint further alleges that an industry in the United States exists as required by 19 U.S.C. 1337(a)(2). The notice of investigation named Edgewell Personal Care Company of Chesterfield, Missouri; Edgewell Personal Care Brands, LLC of Shelton, Connecticut; Edgewell Personal Care, LLC of Shelton, Connecticut; Schick Manufacturing, Inc. of Shelton, Connecticut; and Schick (Guangzhou) Co., Limited of Guangzhou, China, as respondents.

    On January 19, 2018, Gillette and respondents filed a joint motion to terminate the investigation in its entirety on the basis of a settlement agreement. The ALJ issued the subject ID granting the motion on January 23, 2018. The ALJ found that the motion complies with Commission Rules and termination of the investigation will not adversely affect the public interest. No petitions for review were filed.

    The Commission has determined not to review the ID.

    The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in Part 210 of the Commission's Rules of Practice and Procedure, 19 CFR part 210.

    By order of the Commission.

    Issued: February 5, 2018. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2018-02578 Filed 2-8-18; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-1003] Certain Composite Aerogel Insulation Materials and Methods for Manufacturing the Same; Commission's Final Determination Finding a Violation of Section 337; Issuance of a Limited Exclusion Order; Termination of the Investigation AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission has found a violation of Section 337 of the Tariff Act of 1930, as amended, in the unlawful importation, sale for importation, and sale after importation by respondents Nano Tech Co., Ltd. (“Nano”) of Zhejiang, China, and Guangdong Alison Hi-Tech Co., Ltd. (“Alison”) of Guangzhou, China, of certain composite aerogel insulation materials by reason of infringement of certain claims of U.S. Patent No. 7,078,359 (“the '359 patent”); U.S. Patent No. 6,989,123 (“the '123 patent”); and U.S. Patent No. 7,780,890 (“the '890 patent”). The Commission's determination is final, and the investigation is terminated.

    FOR FURTHER INFORMATION CONTACT:

    Cathy Chen, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2392. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.

    SUPPLEMENTARY INFORMATION:

    The Commission instituted this investigation on June 8, 2016, based on a complaint filed by Aspen Aerogels, Inc. (“Aspen”) of Northborough, Massachusetts. 81 FR 36955-956 (Jun. 8, 2016). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain composite aerogel insulation materials and methods for manufacturing the same by reason of infringement of certain claims of U.S. Patent No. 7,399,439 (“the '439 patent”); U.S. Patent No. 9,181,486 (“the '486 patent”); the '359 patent; the '123 patent; and the '890 patent. The complaint further alleges that an industry in the United States exists as required by 19 U.S.C. 1337(a)(2). The notice of investigation named Nano and Alison as respondents. The Office of Unfair Import Investigations (“OUII”) is also a party in this investigation.

    All asserted claims of the '439 patent and the '486 patent and certain asserted claims of the '359 have been terminated from the investigation. See Comm'n Notice (Nov. 2, 2016); Comm'n Notice (Feb. 9, 2017). Only claims 15-17, and 19 of the '123 patent; claims 1, 5, 7, 9, 12, 15, and 16 of the '359 patent; and claims 11-13, 15, 17-19, and 21 of the '890 patent (“the Asserted Claims”) remain in the investigation.

    On November 15, 2016, the presiding administrative law judge (“ALJ”) issued Order No. 19, granting Aspen's motion for summary determination that the economic prong of the domestic industry requirement has been satisfied under section 337(a)(3)(A) and (B). The Commission determined to review in part Order No. 19. See Comm'n Notice (Dec. 7, 2016). On review, the Commission affirmed with modification the summary determination that Aspen satisfies the economic prong of the domestic industry requirement. See id. at 1-2.

    On September 29, 2017, the ALJ issued the final initial determination (“ID”), finding a violation of section 337 by Respondents Alison and Nano in connection with claims 1, 5, 7, and 9 of the '359 patent; claims 15-17, and 19 of the '123 patent; and claims 11-13, 15, 17-19, and 21 of the '890 patent. The ID also found a violation of section 337 by Respondent Nano in connection with claims 12, 15, and 16 of the '359 patent. In addition, the ID found that Aspen has shown that its domestic industry products satisfy the technical prong of the domestic industry requirement for the Asserted Patents. The ID further found that Respondents have not shown that the Asserted Claims are invalid. The ID also contained the ALJ's Recommended Determination on remedy and bonding.

    On October 16, 2017, Respondents and OUII each filed a timely petition for review of the final ID. Respondents and OUII challenged certain of the ID's findings with respect to the validity of the Asserted Claims and the ID's findings with respect to claim 5 of the '359 patent. Respondent Alison separately challenged the ID's finding of infringement with respect to claim 9 of the '359 patent. That same day, Aspen filed a contingent petition for review of the final ID, challenging the ALJ's construction of two claim limitations in the '359 patent. On October 24, 2017, the parties filed timely responses to the petitions for review. On October 31, 2017, the parties filed their public interest comments pursuant to Commission Rule 210.50(a)(4).

    On November 30, 2017, the Commission determined to review the ID in part and requested briefing on issues it determined to review, and on remedy, the public interest, and bonding. 82 FR 57611-13 (Dec. 6, 2017). Specifically, with respect to the '359 patent, the Commission determined to review the ALJ's construction of the “lofty fibrous batting” limitation in claim 1 of the '359 patent. The Commission's review of the “lofty fibrous batting” limitation did not include the ID's finding that Respondents have not proven that the term is invalid for indefiniteness. The Commission also determined to review the ALJ's constructions of the additional limitations in claims 5 and 9, and the “total surface area of that cross section” limitation of claim 12 of the '359 patent, and the ID's associated findings on infringement and the technical prong of the domestic industry requirement with respect to those claims and claims 15 and 16 of the '359 patent. In addition, the Commission determined to review the ID's findings that the asserted claims of the '359 patent are not invalid in view of Ramamurthi by itself or in combination with other prior art. With respect to the '123 and the '890 patents, the Commission determined to review the ID's finding that claim 15 of the '123 patent and claims 11-13, 15, 17, and 21-23 of the '890 patent are not obvious in view of Ramamurthi and either Uchida or Yada.

    On December 15, 2017, Aspen and OUII each filed initial written submissions regarding issues on review, remedy, the public interest, and bonding. On the same day, Respondents jointly filed their initial written submission regarding issues on review, remedy, the public interest, and bonding. Responses to the initial written submissions were filed on December 22, 2017.

    Having examined the record of this investigation, including the parties' submissions and responses thereto, the Commission has determined that Aspen has proven a violation of section 337: (1) Based on infringement of claims 1, 7, and 9 of the '359 patent; claims 15-17, and 19 of the '123 patent; and claims 11-13, 15, 17-19, and 21 of the '890 patent by Respondents Alison and Nano; and (2) based on infringement of claims 12, 15, and 16 of the '359 patent by Respondent Nano.

    Specifically, with respect to the '359 patent, the Commission affirms with modifications the ALJ's constructions of the “lofty fibrous batting” limitation in claim 1 and the “about 1 to 20%” limitation in claim 9. The Commission modifies the ALJ's constructions of the additional limitation in claim 5 and the “the total surface area of that cross section” limitation in claim 12. Applying these claim constructions, the Commission affirms the ID's findings that Respondents infringe claims 1, 7 and 9, and that Respondent Nano infringes claims 12, 15, and 16, but reverses the ID's finding that Respondents infringe claim 5. The Commission also reverses the ID's finding that Aspen's domestic industry products practice claim 5, but affirms the ID's finding that Aspen's domestic industry products practice the other asserted claims of the '359 patent. The Commission further affirms with modifications the ID's findings that claims 1, 5, 7, 9, and 12 of the '359 patent are not anticipated by Ramamurthi and that claims 9 and 16 are not rendered obvious in view of Ramamurthi and other prior art. The Commission takes no position on the ID's findings on secondary considerations of nonobviousness,

    With respect to the '123 patent and the '890 patent, the Commission affirms with modifications the ID's findings that claim 15 of the '123 patent and claims 11-13, 15, 17, and 21-23 of the '890 patent are not obvious in view of Ramamurthi and either Uchida or Yada. As with the '359 patent, the Commission takes no position on the ID's findings on secondary considerations of nonobviousness.

    The Commission has determined that the appropriate form of relief is a limited exclusion order prohibiting the unlicensed entry of infringing composite aerogel insulation materials that are manufactured abroad by or on behalf of, or imported by or on behalf of Respondents or any of their affiliated companies, parents, subsidiaries, or other related business entities, or their successors or assigns. The Commission has carefully considered the submissions of the parties and has determined that the public interest factors enumerated in section 337(d) do not preclude issuance of its order.

    Finally, the Commission has determined that excluded composite aerogel insulation materials may be imported and sold in the United States during the period of Presidential review (19 U.S.C. 1337(j)) with the posting of a bond of one-hundred (100) percent of the entered value for all infringing products manufactured by, for, or on behalf of Respondents. The Commission's Order and Opinion were delivered to the President and to the United States Trade Representative on the day of their issuance.

    The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

    By order of the Commission.

    Issued: February 5, 2018. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2018-02577 Filed 2-8-18; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-1069] Certain Pool Spa Enclosures; Notice of Commission Determination Not To Review an Initial Determination (Order No. 9) Terminating the Investigation; Termination of the Investigation AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission (the “Commission”) has determined not to review a January 23, 2018, initial determination (Order No. 9) (the “ID”) granting a joint motion to terminate this investigation based on a settlement agreement. This investigation is terminated.

    FOR FURTHER INFORMATION CONTACT:

    Ron Traud, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-3427. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (https://www.usitc.gov). The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal at 202-205-1810.

    SUPPLEMENTARY INFORMATION:

    On September 15, 2017, the Commission instituted this investigation under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”), based on a complaint and an amended complaint filed by Aqua Shield, Inc. of West Babylon, NY (“Aqua Shield”). 82 FR 43402, 43402-03 (Sept. 15, 2017). The complaint, as amended, alleges a violation of section 337 by reason of infringement of certain claims of U.S. Patent No. U.S. Patent No. 6,637,160. The complaint named as respondents Inter Pool Cover Team of the Czech Republic; Alukov HZ Spol. S.R.O. of the Czech Republic; Alukov, Spol. S.R.O. of Slovakia; Pool & Spa Enclosures, LLC, of Monroe Township, NJ; and Poolandspa.com of Las Vegas, NV (collectively, “Respondents”). Id. The Office of Unfair Import Investigations (“OUII”) is also a party in this investigation. Id.

    On January 5, 2018, Aqua Shield and Respondents filed a joint motion to terminate this investigation as to all respondents based on a settlement agreement (the “Agreement”). OUII filed a response supporting the motion.

    On January 23, 2018, the presiding administrative law judge (Chief Judge Bullock) issued the ID, which grants the motion. The ID finds that the private parties' motion complies with Commission Rule 210.21(b), finding that the parties have provided a confidential and a public version of the Agreement, and also finding that the parties' motion states that “[t]here are no other agreements, written or oral, express or implied, regarding the subject matter of this Investigation.” The ID further considers the public interest, as is required under Commission Rule 210.50(b)(2), and determines that the “termination of this Investigation does not impose any undue burdens on the public health and welfare, competitive conditions in the United States economy, production of like or directly competitive articles in the United States, or United States consumers.” Accordingly, the ID grants the motion. No petitions for review of the ID were filed.

    The Commission has determined not to review the ID. This investigation is terminated.

    The authority for the Commission's determination is contained in Section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

    By order of the Commission.

    Issued: February 5, 2018. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2018-02573 Filed 2-8-18; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Light Engines and Components Thereof, DN 3293; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.

    FOR FURTHER INFORMATION CONTACT:

    Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at https://edis.usitc.gov, and will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000.

    General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's Electronic Document Information System (EDIS) at https://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.

    SUPPLEMENTARY INFORMATION:

    The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Lumencor, Inc. on February 02, 2018. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain light engines and components thereof. The complaint names as respondents: Excelitas Technologies Corp. of Waltham, MA; and Lumen Dynamics Group, Inc. of Canada. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).

    Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

    In particular, the Commission is interested in comments that:

    (i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;

    (ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;

    (iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;

    (iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and

    (v) explain how the requested remedial orders would impact United States consumers.

    Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register. There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation.

    Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3293) in a prominent place on the cover page and/or the first page. (See Handbook for Electonic Filing Procedures, Electronic Filing Procedures 1 ). Persons with questions regarding filing should contact the Secretary (202-205-2000).

    1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf.

    Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel,2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.3

    2 All contract personnel will sign appropriate nondisclosure agreements.

    3 Electronic Document Information System (EDIS): https://edis.usitc.gov.

    This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).

    By order of the Commission.

    Issued: February 6, 2018. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2018-02616 Filed 2-8-18; 8:45 am] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Noramco, Inc. ACTION:

    Notice of application.

    DATES:

    Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 10, 2018.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

    SUPPLEMENTARY INFORMATION:

    The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

    In accordance with 21 CFR 1301.33(a), this is notice that on July 6, 2017, Noramco, Inc., 1440 Olympic Drive, Athens, Georgia 30601 applied to be registered as a bulk manufacturer for the basic classes of controlled substances:

    Controlled substance Drug code Schedule Cathinone 1235 I Gamma Hydroxybutyric Acid 2010 I Marihuana Extract 7350 I Marihuana 7360 I Tetrahydrocannabinols 7370 I Codeine-N-oxide 9053 I Dihydromorphine 9145 I Hydromorphinol 9301 I Morphine-N-oxide 9307 I Amphetamine 1100 II Lisdexamfetamine 1205 II Methylphenidate 1724 II Nabilone 7379 II Codeine 9050 II Dihydrocodeine 9120 II Oxycodone 9143 II Hydromorphone 9150 II Hydrocodone 9193 II Morphine 9300 II Oripavine 9330 II Thebaine 9333 II Opium tincture 9630 II Oxymorphone 9652 II Noroxymorphone 9668 II Alfentanil 9737 II Sufentanil 9740 II Carfentanil 9743 II Tapentadol 9780 II Fentanyl 9801 II

    The company plans to manufacture bulk active pharmaceutical ingredients (APIs) and reference standards for distribution to their customers.

    In reference to drug codes 7360 (marihuana) and 7370 (tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration.

    Dated: January 31, 2018. Susan A. Gibson, Deputy Assistant Administrator.
    [FR Doc. 2018-02645 Filed 2-8-18; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc. ACTION:

    Notice of application.

    DATES:

    Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 10, 2018.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

    SUPPLEMENTARY INFORMATION:

    The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

    In accordance with 21 CFR 1301.33(a), this is notice that on December 6, 2017, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New York 12144 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

    Controlled substance Drug code Schedule Marihuana 7360 I Tetrahydrocannabinols 7370 I Amphetamine 1100 II Lisdexamfetamine 1205 II Pentobarbital 2270 II 4-Anilino-N-phenethyl-4-piperidine (ANPP) 8333 II Codeine 9050 II Oxycodone 9143 II Hydromorphone 9150 II Hydrocodone 9193 II Meperidine 9230 II Morphine 9300 II

    The company plans to manufacture bulk controlled substances for use in product development and for distribution to its customers.

    In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration.

    Dated: January 31, 2018. Susan A. Gibson, Deputy Assistant Administrator.
    [FR Doc. 2018-02644 Filed 2-8-18; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation ACTION:

    Notice of application.

    DATES:

    Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 10, 2018.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

    SUPPLEMENTARY INFORMATION:

    The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

    In accordance with 21 CFR 1301.33(a), this is notice that on July 19, 2017, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665-2402 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

    Controlled substance Drug code Schedule ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) 7010 I MDMB-FUBINACA (Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) 7020 I MAB-CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) 7032 I 5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) 7033 I 5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) 7034 I MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) 7042 I 5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) 7049 I U-47700 (3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide) 9547 I Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide) 9811 I 4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide) 9824 I Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide) 9834 I

    The company plans to manufacture small quantities of the listed controlled substances to make reference standards which will be distributed to its customers.

    Dated: January 31, 2018. Susan A. Gibson, Deputy Assistant Administrator.
    [FR Doc. 2018-02638 Filed 2-8-18; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc. ACTION:

    Notice of application.

    DATES:

    Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before March 12, 2018. Such persons may also file a written request for a hearing on the application on or before March 12, 2018.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

    SUPPLEMENTARY INFORMATION:

    The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

    In accordance with 21 CFR 1301.34(a), this is notice that on December 9, 2016, Mylan Pharmaceuticals, Inc., 3711 Collins Ferry Road, Morgantown, West Virginia 26505 applied to be registered as an importer of the following basic classes of controlled substances:

    Controlled substance Drug code Schedule Amphetamine 1100 II Methylphenidate 1724 II Oxycodone 9143 II Hydromorphone 9150 II Methadone 9250 II Morphine 9300 II Fentanyl 9801 II

    The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company's own domestically-manufactured FDF. This analysis is required to allow the company to export domestically-manufactured FDF to foreign markets.

    Authorization will not extend to the import of Food and Drug Administration approved or non-approved finished dosage forms for commercial sale.

    Dated: February 2, 2018. Susan A Gibson, Deputy Assistant Administrator.
    [FR Doc. 2018-02637 Filed 2-8-18; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Noramco, Inc. ACTION:

    Notice of application.

    DATES:

    Registered bulk manufacturer of the affected basic classes and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before March 12, 2018. Such persons may also file a written request for a hearing on the application on or before March 12, 2018.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007).

    SUPPLEMENTARY INFORMATION:

    The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

    In accordance with 21 CFR 1301.34(a), this is notice that on July 6, 2017, Noramco, Inc., 1550 Olympic Drive, Athens, Georgia 30601 applied to be registered as an importer of the following basic controlled substances:

    Controlled substance Drug
  • code
  • Schedule
    Marihuana Extract 7350 I Marihuana 7360 I Tetrahydrocannabinols 7370 I Nabilone 7379 II Phenylacetone 8501 II Thebaine 9333 II Opium, raw 9600 II Poppy Straw Concentrate 9670 II Tapentadol 9780 II

    The company plans to import phenylacetone (8501), opium, raw (9600), and poppy straw concentrate (9670) to bulk manufacture other controlled substances for distribution to its customers. The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol (9780) for distribution to its customers. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.

    Dated: January 31, 2018. Susan A. Gibson, Deputy Assistant Administrator.
    [FR Doc. 2018-02646 Filed 2-8-18; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: INSYS Manufacturing LLC ACTION:

    Notice of application.

    DATES:

    Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 10, 2018.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

    SUPPLEMENTARY INFORMATION:

    The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

    In accordance with 21 CFR 1301.33(a), this is notice that on November 13, 2017, INSYS Manufacturing LLC, 811 Paloma Drive, Suite C, Round Rock, TX 78665-2402 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

    Controlled substance Drug
  • code
  • Schedule
    Marihuana 7360 I Tetrahydrocannabinols 7370 I

    The company plans to manufacture the above listed controlled substances in bulk for distribution to its customers.

    In reference to drug codes 7360 (marihuana), and 7370 (THC), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration.

    Dated: January 31, 2018. Susan A. Gibson, Deputy Assistant Administrator.
    [FR Doc. 2018-02643 Filed 2-8-18; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Meridian Medical Technologies Inc. ACTION:

    Notice of application.

    DATES:

    Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before March 12, 2018. Such persons may also file a written request for a hearing on the application March 12, 2018.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

    SUPPLEMENTARY INFORMATION:

    The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

    In accordance with 21 CFR 1301.34(a), this is notice that on December 29, 2017, Meridian Medical Technologies Inc., 2555 Hermelin Drive, Saint Louis, Missouri 63144 applied to be registered as an importer of the Schedule II control substance for Morphine (9300) the basic class of controlled substance.

    The company plans to import the listed controlled substance in finished dosage form for internal analytical purposes only. No other activity for this drug code is authorized for this registration. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.

    Dated: January 31, 2018. Susan A. Gibson, Deputy Assistant Administrator.
    [FR Doc. 2018-02647 Filed 2-8-18; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Johnson Matthey Inc. ACTION:

    Notice of application.

    DATES:

    Registered importers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before March 12, 2018. Such persons may also file a written request for a hearing on the application on or before March 12, 2018.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

    SUPPLEMENTARY INFORMATION:

    The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

    In accordance with 21 CFR 1301.34(a), this is notice that on November 9, 2017, Johnson Matthey Inc., Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742 applied to be registered as an importer of the following basic classes of controlled substances:

    Controlled substance Drug
  • code
  • Schedule
    Coca leaves 9040 II Thebaine 9333 II Opium, raw 9600 II Noroxymorophone 9668 II Poppy Straw Concentrate 9670 II Fentanyl 9801 II

    The company plans to import coca leaves (9040), raw opium (9600), and poppy straw concentrate (9670) in order to bulk manufacture active pharmaceutical ingredients (API) for distribution to its customers. The company plans to also import thebaine (9333), noroxymorophone (9668), and fentanyl (9801) to use as analytical reference standards, both internally and to be sold to their customers to support testing of Johnson Matthey Inc.'s API's only.

    Dated: January 31, 2018. Susan A. Gibson, Deputy Assistant Administrator.
    [FR Doc. 2018-02639 Filed 2-8-18; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Mylan Technologies Inc. ACTION:

    Notice of application.

    DATES:

    Registered bulk importers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before March 12, 2018. Such persons may also file a written request for a hearing on the application on or before March 12, 2018.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007).

    SUPPLEMENTARY INFORMATION:

    The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

    In accordance with 21 CFR 1301.34(a), this is notice that on November 10, 2017, Mylan Technologies Inc., 110 Lake St., Saint Albans, VT 05478 applied to be registered as an importer of the following basic classes of controlled substances:

    Controlled substance Drug
  • code
  • Schedule
    Methylphenidate 1724 II Fentanyl 9801 II

    The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company's own domestically-manufactured FDF. This analysis is required to allow the company to export domestically manufactured FDF to foreign markets.

    Authorization will not extend to the import of Food and Drug Administration approved or non-approved finish dosage forms for commercial sale.

    Dated: February 1, 2018. Susan A Gibson, Deputy Assistant Administrator.
    [FR Doc. 2018-02641 Filed 2-8-18; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics Inc. ACTION:

    Notice of application.

    DATES:

    Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 10, 2018.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

    SUPPLEMENTARY INFORMATION:

    The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

    In accordance with 21 CFR 1301.33(a), this is notice that on December 13, 2017, Siemens Healthcare Diagnostics Inc., 100 GBC Drive, Mailstop 514, Newark, DE 19702 applied to be registered as a bulk manufacturer of the following basic class of controlled substance:

    Controlled substance Drug code Schedule Ecgonine 9180 II

    The company plans to bulk manufacture a material used in the manufacture of reagents for a Cocaine in vitro diagnostic test system.

    Dated: February 1, 2018. Susan A. Gibson, Deputy Assistant Administrator.
    [FR Doc. 2018-02642 Filed 2-8-18; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE [OMB Number 1103-0098] Agency Information Collection Activities; Proposed eCollection eComments Requested; COPS Application Package AGENCY:

    Community Oriented Policing Services, Department of Justice.

    ACTION:

    30-Day notice.

    SUMMARY:

    The Department of Justice (DOJ) Office of Community Oriented Policing Services (COPS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the Federal Register on December 1, 2017, to obtain comments from the public and affected agencies.

    DATES:

    The purpose of this notice is to allow for an additional 30 days for public comment March 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Lashon M. Hilliard, Department of Justice Office of Community Oriented Policing Services, 145 N Street NE, Washington, DC 20530 or at (202) 514-6563. Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20530 or sent to [email protected]

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Enhance the quality, utility, and clarity of the information to be collected; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection

    (1) Type of Information Collection: Revision of a currently approved collection.

    (2) Title of the Form/Collection: COPS Application Package.

    (3) Agency form number: 1103-0098 U.S. Department of Justice Office of Community Oriented Policing Services.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract:

    Primary: COPS Office grantees.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond/reply: The estimated total number of respondents is 5,000. The estimated hourly burden to the applicant is 11 hours for each respondent to review the instructions and complete the application.

    (6) An estimate of the total public burden (in hours) associated with the collection: There are an estimated 55,000 total annual burden hours associated with this collection.

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, Room 3E.405B, Washington, DC 20530.

    Dated: February 6, 2018. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2018-02650 Filed 2-8-18; 8:45 am] BILLING CODE 4410-AT-P
    DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2006-0028] MET Laboratories, Inc.: Application for Expansion of Recognition and Proposed Modification to the NRTL Program's List of Appropriate Test Standards AGENCY:

    Occupational Safety and Health Administration (OSHA), Labor.

    ACTION:

    Notice.

    SUMMARY:

    In this notice, OSHA announces the application of MET Laboratories, Inc. for expansion of its recognition as a Nationally Recognized Testing Laboratory (NRTL) and presents the Agency's preliminary finding to grant the application. Additionally, OSHA proposes to add two new test standards to the NRTL Program's List of Appropriate Test Standards.

    DATES:

    Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before February 26, 2018.

    ADDRESSES:

    Submit comments by any of the following methods:

    1. Electronically: Submit comments and attachments electronically at http://www.regulations.gov, which is the Federal eRulemaking Portal. Follow the instructions online for making electronic submissions.

    2. Facsimile: If submissions, including attachments, are not longer than 10 pages, commenters may fax them to the OSHA Docket Office at (202) 693-1648.

    3. Regular or express mail, hand delivery, or messenger (courier) service: Submit comments, requests, and any attachments to the OSHA Docket Office, Docket No. OSHA-2006-0028, Technical Data Center, U.S. Department of Labor, 200 Constitution Avenue NW, Room N-3653, Washington, DC 20210; telephone: (202) 693-2350 (TTY number: (877) 889-5627). Note that security procedures may result in significant delays in receiving comments and other written materials by regular mail. Contact the OSHA Docket Office for information about security procedures concerning delivery of materials by express mail, hand delivery, or messenger service. The hours of operation for the OSHA Docket Office are 10:00 a.m.-2:30 p.m., ET.

    4. Instructions: All submissions must include the Agency name and the OSHA docket number (OSHA-2006-0028). OSHA places comments and other materials, including any personal information, in the public docket without revision, and these materials will be available online at http://www.regulations.gov. Therefore, the Agency cautions commenters about submitting statements they do not want made available to the public, or submitting comments that contain personal information (either about themselves or others) such as Social Security numbers, birth dates, and medical data.

    5. Docket: To read or download submissions or other material in the docket, go to http://www.regulations.gov or the OSHA Docket Office at the address above. All documents in the docket are listed in the http://www.regulations.gov index; however, some information (e.g., copyrighted material) is not publicly available to read or download through the website. All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office. Contact the OSHA Docket Office for assistance in locating docket submissions.

    6. Extension of comment period: Submit requests for an extension of the comment period on or before February 26, 2018 to the Office of Technical Programs and Coordination Activities, Directorate of Technical Support and Emergency Management, Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Avenue NW, Room N-3653, Washington, DC 20210, or by fax to (202) 693-1644.

    FOR FURTHER INFORMATION CONTACT:

    Information regarding this notice is available from the following sources:

    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office of Communications, phone: (202) 693-1999; email: [email protected]

    General and technical information: Contact Mr. Kevin Robinson, Director, Office of Technical Programs and Coordination Activities, Directorate of Technical Support and Emergency Management, Occupational Safety and Health Administration, phone: (202) 693-2110 or email: