Federal Register Vol. 83, No.35,

Federal Register Volume 83, Issue 35 (February 21, 2018)

Page Range7357-7591
FR Document

83_FR_35
Current View
Page and SubjectPDF
83 FR 7591 - Honoring the Victims of the Tragedy in Parkland, FloridaPDF
83 FR 7473 - Sunshine Act NoticePDF
83 FR 7474 - Sunshine Act NoticePDF
83 FR 7499 - Sunshine Act MeetingPDF
83 FR 7526 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “King Tut: Treasures of the Golden Pharaoh” ExhibitionPDF
83 FR 7524 - Sunshine Act MeetingsPDF
83 FR 7504 - Sunshine Act Meeting NoticePDF
83 FR 7474 - Proposed Agency Information Collection Activities; Comment RequestPDF
83 FR 7475 - Proposed Agency Information Collection Activities; Comment RequestPDF
83 FR 7456 - Proposed Information Collection; Comment Request; Socio-Economic Survey of Hired Captains and Crew in New England and Mid-Atlantic Commercial FisheriesPDF
83 FR 7455 - Marine Mammals; File No. 21251PDF
83 FR 7454 - Marine Mammals; File No. 21419PDF
83 FR 7490 - National Register of Historic Places; Notification of Pending Nominations and Related ActionsPDF
83 FR 7460 - Request for Information on Evaluating Undue Hardship Claims in Adversary Actions Seeking Student Loan Discharge in Bankruptcy ProceedingsPDF
83 FR 7538 - Notice of Funding Opportunity for the Restoration and Enhancement Grants ProgramPDF
83 FR 7495 - Notice of a Public Meeting of the Task Force on Apprenticeship ExpansionPDF
83 FR 7528 - Notice of Funding Opportunity for Consolidated Rail Infrastructure and Safety ImprovementsPDF
83 FR 7477 - Proposed Agency Information Collection Activities; Comment RequestPDF
83 FR 7492 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; eForm Access RequestPDF
83 FR 7496 - MET Laboratories, Inc.: Application for Expansion of Recognition and Proposed Modification to the NRTL Program's List of Appropriate Test StandardsPDF
83 FR 7452 - Proposed Information Collection; Comment Request; Request for Investigation Under Section 232 of the Trade Expansion ActPDF
83 FR 7450 - Submission for OMB Review; Comment RequestPDF
83 FR 7462 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Consolidated State Performance Report Part I and Part IIPDF
83 FR 7458 - Charter Renewal of Department of Defense Federal Advisory CommitteesPDF
83 FR 7462 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 2008/18 Baccalaureate and Beyond (B&B: 08/18) Full-ScalePDF
83 FR 7479 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
83 FR 7451 - Foreign-Trade Zone 135-Palm Beach, Florida; Application for Reorganization and Expansion Under Alternative Site FrameworkPDF
83 FR 7453 - Certain Cold-Rolled Steel Flat Products From the United Kingdom: Rescission of Antidumping Duty Administrative Review; 2016-2017PDF
83 FR 7545 - Request for Approval of a New Information CollectionPDF
83 FR 7493 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection; Application for Registration, Application for Registration Renewal, Affidavit for Chain; Renewal DEA Forms 225, 225a and 225bPDF
83 FR 7494 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection; Application for Registration, Application for Registration Renewal; DEA Forms 363, 363aPDF
83 FR 7508 - Excepted Service; September 2017PDF
83 FR 7505 - Excepted Service; August 2017PDF
83 FR 7411 - Federal Employees Health Benefits Program Regulations: Revised Guaranteed Issue Conversion Requirements and Technical UpdatesPDF
83 FR 7455 - Marine Mammals and Endangered SpeciesPDF
83 FR 7549 - Office of the Assistant Secretary for Research and Technology (OST-R); Agency Information Collection Activity; Notice of Reinstatement To Collect Information: Barrier Failure Reporting in Oil and Gas Operations on the Outer Continental Shelf; OMB Number CorrectionPDF
83 FR 7471 - Panoche Valley Solar, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
83 FR 7471 - Notice of Effectiveness of Exempt Wholesale Generator StatusPDF
83 FR 7471 - Combined Notice of FilingsPDF
83 FR 7472 - Combined Notice of Filings #1PDF
83 FR 7459 - Charter Establishment of Department of Defense Federal Advisory CommitteesPDF
83 FR 7527 - Agency Information Collection Activities: Notice of Request for Reinstatement of a Previously Approved Information CollectionPDF
83 FR 7527 - Agency Information Collection Activities: Notice of Request for Extension of Currently Approved Information CollectionPDF
83 FR 7357 - Pecans Grown in the States of Alabama, Arkansas, Arizona, California, Florida, Georgia, Kansas, Louisiana, Missouri, Mississippi, North Carolina, New Mexico, Oklahoma, South Carolina, and Texas; Establishment of Reporting Requirements and New Information CollectionPDF
83 FR 7527 - Determination Under Section 620(q) of the Foreign Assistance Act of 1961, Relating to Assistance to Antigua and BarbudaPDF
83 FR 7459 - Charter Renewal of Department of Defense Federal Advisory CommitteesPDF
83 FR 7423 - Airworthiness Directives; AgustaWestland S.p.A. HelicoptersPDF
83 FR 7464 - Notice of Intent To Prepare a Supplemental Environmental Impact Statement for Decommissioning and/or Long-Term Stewardship at the West Valley Demonstration Project and Western New York Nuclear Service Center, Notice of Floodplain and Wetlands Involvement, and Draft ScopePDF
83 FR 7473 - Notice to All Interested Parties of Intent To Terminate ReceivershipsPDF
83 FR 7511 - Proposed Collection; Comment RequestPDF
83 FR 7361 - Civil Monetary Penalties Inflation AdjustmentsPDF
83 FR 7526 - Administrative Declaration of a Disaster for the State of New YorkPDF
83 FR 7551 - Proposed Collection; Comment Request for Form 982PDF
83 FR 7552 - Proposed Information Collection; Comment RequestPDF
83 FR 7459 - Defense Advisory Committee on Women in the Services; Notice of Federal Advisory Committee MeetingPDF
83 FR 7468 - DOE/NSF Nuclear Science Advisory CommitteePDF
83 FR 7463 - Basic Energy Sciences Advisory CommitteePDF
83 FR 7553 - Open Meeting of the Taxpayer Advocacy Panel's Notices and Correspondence Project Committee; ChangePDF
83 FR 7554 - Open meeting of the Taxpayer Advocacy Panel's Special Projects Committee; ChangePDF
83 FR 7554 - Open Meeting of the Taxpayer Advocacy Panel's Notices and Correspondence Project Committee; ChangePDF
83 FR 7553 - Open Meeting of the Taxpayer Advocacy Panel's Tax Forms and Publications Project Committee; ChangePDF
83 FR 7553 - Open Meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project Committee; ChangePDF
83 FR 7553 - Open Meeting of the Taxpayer Advocacy Panel's Toll-Free Phone Line Project Committee; ChangePDF
83 FR 7487 - A Strategic Roadmap for Establishing New Approaches To Evaluate the Safety of Chemicals and Medical Products in the United States; Availability of ReportPDF
83 FR 7483 - National Institute of Nursing Research; Notice to Close MeetingPDF
83 FR 7487 - National Institute of Neurological Disorders and Stroke: Notice of Closed MeetingsPDF
83 FR 7483 - National Eye Institute; Notice of Closed MeetingsPDF
83 FR 7488 - Draft NTP Research Report on the CLARITY-BPA Core Study; Availability of Document; Request for Comments; Notice of Peer-Review MeetingPDF
83 FR 7483 - Proposed Collection; 60-Day Comment Request; CTEP Branch and Support Contracts Forms and Surveys (National Cancer Institute)PDF
83 FR 7395 - Drawbridge Operation Regulation; Mianus River, Greenwich, CTPDF
83 FR 7498 - Notice of Intent To Seek Approval To Establish an Information CollectionPDF
83 FR 7476 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
83 FR 7497 - Notice of Information CollectionPDF
83 FR 7450 - Codex Alimentarius Commission: Codex Committee on Pesticide Residues (CCPR)PDF
83 FR 7447 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Amendment 36APDF
83 FR 7478 - Solicitation of Nominations for Appointment to the Lead Exposure and Prevention Advisory CommitteePDF
83 FR 7550 - Notice of OFAC Sanctions ActionsPDF
83 FR 7470 - Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving Use of the Traditional Licensing Process; Natco Products CorporationPDF
83 FR 7472 - California Department of Water Resources; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and ProtestsPDF
83 FR 7469 - Commission Information Collection Activities (FERC-598); Comment Request; ExtensionPDF
83 FR 7481 - Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Quarterly Data Collection, OMB Number: 0906-0016-RevisionPDF
83 FR 7500 - Tennessee Valley Authority; Watts Bar Nuclear Plant, Units 1 and 2PDF
83 FR 7482 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Family-to-Family Health Information Center Feedback Surveys, OMB No.: 0906-xxxx-NewPDF
83 FR 7517 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Temporarily Amend Rule 7.35-E(a)(8) Relating to the Auction Reference Price for the Trading Halt Auction for ProShares Short VIX Short-Term Futures ETFPDF
83 FR 7524 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Temporarily Amend Rule 11.23(d)(2)(E) Relating to the Halt Auction Collar for a Halt Auction for REX VolMAXX Short Weekly Futures Strategy ETFPDF
83 FR 7521 - Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend INET Port Fees at Section II, C To Indicate Those Fees Are Not ProratedPDF
83 FR 7519 - Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Port FeesPDF
83 FR 7512 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Exchange's INET Port Fees To Indicate That Those Fees Are ProratedPDF
83 FR 7513 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Expand the Short Term Option Series ProgramPDF
83 FR 7522 - Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Exchange's Schedule of FeesPDF
83 FR 7503 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Future Plant Designs; Notice of MeetingPDF
83 FR 7504 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on APR1400; Notice of MeetingPDF
83 FR 7491 - Certain Microfluidic Systems and Components Thereof and Products Containing Same Institution of InvestigationPDF
83 FR 7545 - Petition for Waiver of CompliancePDF
83 FR 7460 - Notice of Availability of Government-Owned Inventions; Available for LicensingPDF
83 FR 7490 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingsPDF
83 FR 7488 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 7504 - Submission for Review: Reinstatement of a Previously Approved Information Collection Without Change, Standard Form 2812, 2812-A, and OPM Form 1523PDF
83 FR 7457 - Pacific Fishery Management Council; Public MeetingsPDF
83 FR 7454 - Pacific Fishery Management Council; Public MeetingPDF
83 FR 7425 - Airworthiness Directives; The Boeing Company AirplanesPDF
83 FR 7493 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation and Liability ActPDF
83 FR 7480 - Submission for OMB Review; Comment Request; Head Start Child and Family Experiences Survey (FACES)PDF
83 FR 7435 - Proposed Amendment of Class D and Class E Airspace, and Removal of Class E Airspace; Lompoc, CAPDF
83 FR 7433 - Proposed Amendment of Class E Airspace; Kamuela, HIPDF
83 FR 7363 - Amendment of Class E Airspace; Hanford, CAPDF
83 FR 7428 - Proposed Amendment of Class D and Class E Airspace; Aurora, ORPDF
83 FR 7432 - Proposed Revocation of Class E Airspace; Sunol, CAPDF
83 FR 7430 - Proposed Removal of Class E Airspace; Mercury, NVPDF
83 FR 7365 - Establishment of Class E Airspace, Rangely, COPDF
83 FR 7388 - Streamlining the Office of Inspector General's Freedom of Information Act Regulations and Implementing the FOIA Improvement Act of 2016PDF
83 FR 7366 - Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical DevicesPDF
83 FR 7437 - Short-Term, Limited-Duration InsurancePDF
83 FR 7401 - Revise and Streamline VA Acquisition Regulation To Adhere to Federal Acquisition Regulation Principles (VAAR Case 2014-V002)PDF
83 FR 7413 - Margin and Capital Requirements for Covered Swap Entities; Proposed RulePDF
83 FR 7395 - Requirements for Licensees To Overcome a CMRS PresumptionPDF
83 FR 7556 - Financial Responsibility Requirements Under CERCLA Section 108(b) for Classes of Facilities in the Hardrock Mining IndustryPDF

Issue

83 35 Wednesday, February 21, 2018 Contents Agricultural Marketing Agricultural Marketing Service RULES Pecans Grown in the States of Alabama, Arkansas, Arizona, California, Florida, Georgia, Kansas, Louisiana, Missouri, Mississippi, North Carolina, New Mexico, Oklahoma, South Carolina, and Texas: Establishment of Reporting Requirements and New Information Collection, 7357-7361 2018-03500 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Food Safety and Inspection Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7450 2018-03522
Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: eForm Access Request, 7492-7493 2018-03530 Centers Disease Centers for Disease Control and Prevention NOTICES Requests for Nominations: Lead Exposure and Prevention Advisory Committee, 7478-7479 2018-03462 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7479-7480 2018-03518 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Head Start Child and Family Experiences Survey, 7480-7481 2018-03431 Coast Guard Coast Guard RULES Drawbridge Operations: Mianus River, Greenwich, CT, 7395 2018-03470 Commerce Commerce Department See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Comptroller Comptroller of the Currency PROPOSED RULES Margin and Capital Requirements for Covered Swap Entities, 7413-7423 2018-02560 Defense Department Defense Department See

Navy Department

NOTICES Charter Establishments: Government-Industry Advisory Panel, 7459 2018-03503 Charter Renewals: Advisory Committee on Military Personnel Testing, 7459 2018-03497 Federal Advisory Committees, 7458-7459 2018-03520 Meetings: Defense Advisory Committee on Women in the Services, 7459-7460 2018-03485
Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: 2008/18 Baccalaureate and Beyond Full-Scale, 7462-7463 2018-03519 Consolidated State Performance Report Part I and Part II, 7462 2018-03521 Requests for Information: Evaluating Undue Hardship Claims in Adversary Actions Seeking Student Loan Discharge in Bankruptcy Proceedings, 7460-7462 2018-03537 Employee Benefits Employee Benefits Security Administration PROPOSED RULES Short-Term, Limited-Duration Insurance, 7437-7447 2018-03208 Employment and Training Employment and Training Administration NOTICES Meetings: Task Force on Apprenticeship Expansion, 7495-7496 2018-03535 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Environmental Impact Statements; Availability, etc.: Decommissioning and/or Long-Term Stewardship, West Valley Demonstration Project and Western New York Nuclear Service Center: Notice of Floodplain and Wetlands Involvement, and Draft Scope, 7464-7468 2018-03493 Meetings: Basic Energy Sciences Advisory Committee, 7463-7464 2018-03483 DOE/NSF Nuclear Science Advisory Committee, 7468-7469 2018-03484
Environmental Protection Environmental Protection Agency RULES Financial Responsibility Requirements Under CERCLA Section 108(b) for Classes of Facilities in Hardrock Mining Industry, 7556-7588 2017-26514 Farm Credit Farm Credit Administration PROPOSED RULES Margin and Capital Requirements for Covered Swap Entities, 7413-7423 2018-02560 Federal Aviation Federal Aviation Administration RULES Amendment of Class E Airspace: Hanford, CA, 7363-7365 2018-03409 Establishment of Class E Airspace: Rangely, CO, 7365-7366 2018-03401 PROPOSED RULES Airworthiness Directives: AgustaWestland S.p.A. Helicopters, 7423-7425 2018-03494 The Boeing Company Airplanes, 7425-7428 2018-03433 Amendment of Class D and Class E Airspace, and Removal of Class E Airspace: Lompoc, CA, 7435-7437 2018-03415 Amendment of Class D and Class E Airspace: Aurora, OR, 7428-7430 2018-03408 Amendment of Class E Airspace: Kamuela, HI, 7433-7435 2018-03411 Removal of Class E Airspace: Mercury, NV, 7430-7431 2018-03405 Revocation of Class E Airspace: Sunol, CA, 7432-7433 2018-03406 Federal Communications Federal Communications Commission RULES Requirements for Licensees To Overcome Commercial Mobile Radio Services Presumption, 7395-7401 2018-00919 Federal Deposit Federal Deposit Insurance Corporation PROPOSED RULES Margin and Capital Requirements for Covered Swap Entities, 7413-7423 2018-02560 NOTICES Terminations of Receivership: 10092, Community First Bank, Prineville, OR; 10252, High Desert State Bank, Albuquerque, NM, 7473 2018-03492 Federal Energy Federal Energy Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7469-7470 2018-03458 Combined Filings, 2018-03504 7471-7472 2018-03505 Effectiveness of Exempt Wholesale Generator Status: Panda Hummel Station, LLC; Wildwood Lessee, LLC; Red Dirt Wind Project, LLC; et al., 7471 2018-03506 Hydroelectric Applications: California Department of Water Resources, 7472-7473 2018-03459 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Panoche Valley Solar, LLC, 7471 2018-03507 License Applications: Natco Products Corp., 7470-7471 2018-03460 Federal Highway Federal Highway Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7527-7528 2018-03501 2018-03502 Federal Housing Finance Agency Federal Housing Finance Agency PROPOSED RULES Margin and Capital Requirements for Covered Swap Entities, 7413-7423 2018-02560 Federal Mine Federal Mine Safety and Health Review Commission NOTICES Meetings; Sunshine Act, 2018-03640 7473-7474 2018-03641 Federal Railroad Federal Railroad Administration NOTICES Funding Opportunities: Consolidated Rail Infrastructure and Safety Improvements, 7528-7538 2018-03534 Restoration and Enhancement Grants Program, 7538-7545 2018-03536 Petitions for Waivers of Compliance, 7545 2018-03444 Federal Reserve Federal Reserve System PROPOSED RULES Margin and Capital Requirements for Covered Swap Entities, 7413-7423 2018-02560 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7474-7478 2018-03532 2018-03543 2018-03544 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 7476-7477 2018-03468 Food and Drug Food and Drug Administration RULES Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices, 7366-7388 2018-03244 Food Safety Food Safety and Inspection Service NOTICES Meetings: Codex Alimentarius Commission: Codex Committee on Pesticide Residues, 7450-7451 2018-03465 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 7550-7551 2018-03461 Foreign Trade Foreign-Trade Zones Board NOTICES Reorganizations and Expansions Under Alternative Site Framework: Foreign-Trade Zone 135, Palm Beach, FL, 7451-7452 2018-03517 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

PROPOSED RULES Short-Term, Limited-Duration Insurance, 7437-7447 2018-03208
Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Family-to-Family Health Information Center Feedback Surveys, 7482-7483 2018-03455 Maternal, Infant, and Early Childhood Home Visiting Program Quarterly Data Collection, 7481-7482 2018-03457 Homeland Homeland Security Department See

Coast Guard

Housing Housing and Urban Development Department RULES Streamlining Office of Inspector General's Freedom of Information Act Regulations and Implementing FOIA Improvement Act, 7388-7394 2018-03400 Industry Industry and Security Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Request for Investigation Under Section 232 of Trade Expansion Act, 7452-7453 2018-03523 Interior Interior Department See

National Park Service

Internal Revenue Internal Revenue Service PROPOSED RULES Short-Term, Limited-Duration Insurance, 7437-7447 2018-03208 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7551-7553 2018-03487 2018-03488 Meetings: Taxpayer Advocacy Panel Taxpayer Communications Project Committee; Change, 7553-7554 2018-03478 Taxpayer Advocacy Panel's Notices and Correspondence Project Committee; Change, 7553-7554 2018-03480 2018-03482 Taxpayer Advocacy Panel's Special Projects Committee; Change, 7554 2018-03481 Taxpayer Advocacy Panel's Tax Forms and Publications Project Committee; Change, 7553 2018-03479 Taxpayer Advocacy Panel's Toll-Free Phone Line Project Committee; Change, 7553 2018-03477 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Cold-Rolled Steel Flat Products From United Kingdom, 7453 2018-03516 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Microfluidic Systems and Components Thereof and Products Containing Same, 7491-7492 2018-03445 Justice Department Justice Department See

Alcohol, Tobacco, Firearms, and Explosives Bureau

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7493-7495 2018-03513 2018-03514 Proposed Consent Decrees: CERCLA, 7493 2018-03432
Labor Department Labor Department See

Employee Benefits Security Administration

See

Employment and Training Administration

See

Occupational Safety and Health Administration

NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7497-7498 2018-03466 National Highway National Highway Traffic Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7545-7549 2018-03515 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: CTEP Branch and Support Contracts Forms and Surveys, 7483-7487 2018-03471 Interagency Coordinating Committee on Validation of Alternative Methods: Strategic Roadmap for Establishing New Approaches To Evaluate Safety of Chemicals and Medical Products in United States, 7487 2018-03476 Meetings: Center for Scientific Review, 7488 2018-03440 Draft NTP Research Report on CLARITY-BPA Core Study, 7488-7490 2018-03472 National Eye Institute, 7483 2018-03473 National Heart, Lung, and Blood Institute, 7490 2018-03441 National Institute of Neurological Disorders and Stroke, 7487-7488 2018-03474 National Institute of Nursing Research, 7483 2018-03475 National Oceanic National Oceanic and Atmospheric Administration PROPOSED RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Reef Fish Fishery of Gulf of Mexico; Amendment 36A, 7447-7449 2018-03463 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Socio-Economic Survey of Hired Captains and Crew in New England and Mid-Atlantic Commercial Fisheries, 7456-7457 2018-03542 Meetings: Pacific Fishery Management Council, 7454-7455, 7457-7458 2018-03435 2018-03436 Permit Applications: Marine Mammals; File No. 21251, 7455 2018-03541 Marine Mammals; File No. 21419, 7454 2018-03540 Permits: Marine Mammals and Endangered Species, 7455-7456 2018-03509 National Park National Park Service NOTICES National Register of Historic Places: Pending Nominations and Related Actions, 7490-7491 2018-03539 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7498-7499 2018-03469 National Transportation National Transportation Safety Board NOTICES Meetings; Sunshine Act, 7499-7500 2018-03625 Navy Navy Department NOTICES Government-Owned Inventions; Available for Licensing, 7460 2018-03442 Nuclear Regulatory Nuclear Regulatory Commission NOTICES License Amendments: Tennessee Valley Authority Watts Bar Nuclear Plant, Units 1 and 2, 7500-7503 2018-03456 Meetings: Advisory Committee on Reactor Safeguards Subcommittee on Apr1400, 7504 2018-03446 Advisory Committee on Reactor Safeguards Subcommittee on Future Plant Designs, 7503-7504 2018-03447 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Applications for Expansions of Recognition and Proposed Modifications to Nationally Recognized Testing Laboratory Program's List of Appropriate Test Standards: MET Laboratories, Inc., 7496-7497 2018-03529 Overseas Overseas Private Investment Corporation NOTICES Meetings; Sunshine Act, 7504 2018-03572 Personnel Personnel Management Office PROPOSED RULES Federal Employees Health Benefits Program Regulations: Revised Guaranteed Issue Conversion Requirements and Technical Updates, 7411-7413 2018-03510 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7504-7505 2018-03439 Excepted Service, 7505-7511 2018-03511 2018-03512 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Honoring the Victims of the Tragedy in Parkland, FL (Proc. 9697), 7589-7591 2018-03728 Railroad Retirement Railroad Retirement Board NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7511-7512 2018-03491 Securities Securities and Exchange Commission NOTICES Meetings; Sunshine Act, 7524 2018-03582 Self-Regulatory Organizations; Proposed Rule Changes: Cboe BZX Exchange, Inc., 7524-7526 2018-03453 Nasdaq GEMX, LLC, 7519-7524 2018-03448 2018-03451 Nasdaq ISE, LLC, 7512-7513 2018-03450 Nasdaq MRX, LLC, 7521-7522 2018-03452 Nasdaq Stock Market, LLC, 7513-7516 2018-03449 NYSE Arca, Inc., 7517-7519 2018-03454 Small Business Small Business Administration RULES Civil Monetary Penalties Inflation Adjustments, 7361-7363 2018-03490 NOTICES Disaster Declarations: New York; Administrative, 7526 2018-03489 State Department State Department NOTICES Culturally Significant Objects Imported for Exhibition: King Tut: Treasures of the Golden Pharaoh, 7526-7527 2018-03595 Determinations Under the Foreign Assistance Act: Assistance to Antigua and Barbuda, 7527 2018-03499 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Railroad Administration

See

National Highway Traffic Safety Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Barrier Failure Reporting in Oil and Gas Operations on Outer Continental Shelf; OMB Number Correction, 7549-7550 2018-03508
Treasury Treasury Department See

Comptroller of the Currency

See

Foreign Assets Control Office

See

Internal Revenue Service

Veteran Affairs Veterans Affairs Department RULES Revising and Streamlining VA Acquisition Regulations To Adhere to Federal Acquisition Regulation Principles, 7401-7410 2018-03164 Separate Parts In This Issue Part II Environmental Protection Agency, 7556-7588 2017-26514 Part III Presidential Documents, 7589-7591 2018-03728 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 35 Wednesday, February 21, 2018 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 986 [Doc. No. AMS-SC-17-0039; SC17-986-3 FR] Pecans Grown in the States of Alabama, Arkansas, Arizona, California, Florida, Georgia, Kansas, Louisiana, Missouri, Mississippi, North Carolina, New Mexico, Oklahoma, South Carolina, and Texas; Establishment of Reporting Requirements and New Information Collection AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Final rule.

SUMMARY:

This rule implements a recommendation made by the American Pecan Council (Council) to establish reporting requirements under the Federal marketing order for pecans (Order). These reporting requirements will enable collection of information from handlers on: Pecans received; pecans purchased outside the United States; shipments and inventory of pecans; pecans exported by country of destination; and pecans exported for shelling and returned to the United States. This information will be used to provide important statistical reports to the industry, meet requirements under the Order, and to help guide future marketing efforts.

DATES:

Effective March 23, 2018.

FOR FURTHER INFORMATION CONTACT:

Jennie M. Varela, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email: [email protected] or [email protected]

Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected]

SUPPLEMENTARY INFORMATION:

This final rule, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This final rule is issued under Marketing Agreement and Order No. 986, (7 CFR part 986), regulating the handling of pecans grown in the states of Alabama, Arkansas, Arizona, California, Florida, Georgia, Kansas, Louisiana, Missouri, Mississippi, North Carolina, New Mexico, Oklahoma, South Carolina, and Texas. Part 986 (referred to as “the order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) has exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the Order now in effect, pecan handlers are subject to assessments. Funds to administer the Order are derived from these assessments. The reporting requirements established herein will be applicable to all assessable pecans beginning October 1, 2017.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an Order may file with USDA a petition stating that the Order, any provision of the Order, or any obligation imposed in connection with the Order is not in accordance with law and request a modification of the Order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This final rule establishes reporting requirements under the Order. This action will require all pecan handlers to submit to the Council reports on pecans received, shipped, held in inventory, exported for sale or shelling, and purchased from outside the United States. This information will be used by the Council to provide statistical reports to the industry, meet requirements under the Order, and help guide future marketing efforts. This action was unanimously recommended by the Council at its April 17, 2017, meeting.

Section 2(4) of the Act specifies that one of its stated policies is to establish and maintain orderly marketing conditions for certain agricultural commodities that will provide, in the interests of producers and consumers, an orderly flow of the supply of such commodities to market to avoid unreasonable fluctuations in supply and prices. Section 8(d)(1) of the Act specifies that the Secretary may require all handlers subject to a marketing order to provide USDA with such information as is necessary for it to ascertain and determine the degree to which the agreement has been carried out or effectuated the declared policy of the Act.

Sections 986.75, 986.76, and 986.77 of the Order provide authority to the Council to require handlers to submit reports of inventory, merchantable pecans handled, and pecans received by handlers, respectively, on such dates as the Council may prescribe. Section 986.78 further provides, with the approval of the Secretary, authority for the Council to collect other reports and information from handlers needed to perform its duties. This rule uses these authorities to establish new §§ 986.177 and 986.178 under the administrative provisions of the Order. These new sections will require handlers of pecans to report to the Council on a monthly basis: Pecans received, shipped, held in inventory, exported for sale or shelling, and purchased from outside the United States, using five specific Council forms.

At its November 16, 2016, meeting, the first meeting following the promulgation of the Order, the Council discussed its initial budget, assessment rates, and necessary reporting requirements to establish a program that is efficient and responsive to industry needs. During these discussions, the Council appointed a Statistics and Reporting Committee (Committee) to develop reporting requirements.

Members of the Committee discussed the reporting needs of the industry, reviewed examples of reporting forms from other marketing orders, and met and worked with the staff of another marketing order in developing the proposed reporting requirements. The Committee also worked with USDA to ensure the recommended information collection would provide the information necessary to facilitate the administration of the Order.

At its February 23, 2017, meeting, the Council reviewed drafts of seven reporting forms as developed and recommended by the Committee. The Council expressed its interest in having as much electronic reporting as possible, but recognized that many handlers may prefer a paper submission. The Council also considered the timing of when forms would be due and submission dates that would work for all parts of the industry. After a thorough review and some modifications, seven forms were approved by the Council.

At a meeting on April 17, 2017, the Council revisited the recommended reporting requirements and the accompanying forms. Acknowledging that the industry was more than halfway through the fiscal year at that time, the Council recommended dividing the reporting requirements into the five forms needed beginning with the 2017-2018 fiscal year and the two forms needed beginning with the 2016-2017 fiscal year. The two forms required for the 2016-2017 fiscal year were established in a separate rulemaking action.

This final rule adds five new reporting requirements and five new forms to the administrative provisions under the Order by adding §§ 986.177 and 986.178. During the formal rulemaking hearing to promulgate the Order, it was stated that the data collection component was one of the most important aspects of the Order. Concerns were also expressed regarding the accuracy and availability of industry data, and the impact those have on making good business decisions.

Currently, most available reports on domestic pecan production are issued annually and often long after the marketing year has been completed. The reporting of this information is currently voluntary, so not all handlers are reporting, which impacts the accuracy of the available information. Some aggregate import and export data are available, but this information is usually available on an annual basis, or reported several months after the shipments have been made. Additionally, some domestic production is shipped outside of the country for shelling and then returned to the United States for sale or further processing. There is concern this volume is not being properly accounted for, and is negatively impacting the accuracy of the industry information currently available.

The Council agreed these reporting requirements would be necessary to develop accurate reports for the industry regarding pecans being produced and handled in the United States, and recognized the value to the industry of such reports. Having accurate and timely information on the total supply of pecans moving into and out of the country will also assist the industry in managing available supply and in making marketing decisions. Further, collecting this information monthly will allow the Council to provide key data regarding total supply and inventory to the industry in a more timely fashion throughout the season.

The Council also recognized that § 986.65 of the Order requires the Council to provide a report and recommendation to the Secretary on the Council's proposed marketing policy for the next fiscal year. The report is required to include, in part, an estimate of production; improved, native, and substandard pecans; handler inventory; and trade supply, taking into consideration imported pecans. In addition to providing important information for industry reports, the reporting requirements covered in this action would provide the information needed to develop the marketing policy.

Two specific monthly reporting requirements will be added to the administrative provisions under the Order in a new § 986.177, a summary report of domestic pecans received, and a report of pecans purchased outside the United States. The summary report of domestic pecans received includes information on the handler submitting the form, the month covered by the report, the total weight and type of inshell pecans received, and the weight by variety of improved pecans received. In addition, the form also includes information regarding total assessments owed and total pounds reported to date.

The information on this form will provide the Council with the volume of pecans received by handlers each month throughout the season. This information will be used to track the available supply of pecans each month, and the overall crop as it is delivered to handlers. The Council will then be able to use the information to develop its own reports that would provide the industry with an overview of market information for the predominant varieties, including volume by variety, which will assist in the development of marketing strategies.

The Council also intends to use this form to facilitate the collection of assessments on a monthly basis throughout the season. Using the form, handlers will be able to calculate their assessments due each month based on the pecans received as listed on the report. Handlers will be required to pay to the Council the assessments owed on the pecans received by the due date of the summary report.

In its discussion of the report of pecans purchased outside the United States, the Council agreed it would be important to have information regarding the volume of pecans being imported by production area. The monthly report of pecans purchased outside the United States includes the name of the handler importing pecans, the month covered by the report, the date imported, country of origin, volume, and variety of pecans imported.

As production of pecans abroad has increased, there has been an increase in pecans imported into the United States. One Council member stated that the domestic industry is currently shelling and processing as much as 70 to 75 percent of Mexican-grown pecans, and that Mexican pecans now account for nearly 50 percent of sales in the United States. Consequently, having information regarding the volume of imported pecans is essential when calculating available supply. Collecting this information will greatly improve the accuracy of reports to the industry as it includes information regarding both domestic and imported pecans.

One of the Council's main goals in developing these reporting requirements is to deliver to the industry accurate reports regarding the marketplace and supply of pecans to assist the industry in making its marketing decisions throughout the year. The Council believes having accurate information regarding imported pecans is an essential part of reaching this goal. Further, collecting this information will provide the industry with valuable data regarding the timing and volume of pecans imported into the United States. Members also agreed having this information will assist the Council in developing its marketing policy as required under the Order.

Three additional reporting requirements will be added to the administrative provisions in a new § 986.178: Reports of shipments and inventory, exports by country of destination, and inshell pecans exported to Mexico for shelling. The report of shipments and inventory will include information on the handler submitting the form, the month covered by the report, shipments of shelled and inshell pecans, current inventory, and pecans in inventory already committed for shipment.

The Council believes this form will provide beneficial information regarding shipments completed and volume in inventory. While there is currently some limited information available regarding pecans in cold storage, this information does not delineate between available inventory and inventory that is already committed for shipment. By collecting this information from handlers, this report, in conjunction with the data regarding pecans received, will allow the Council to provide the industry with inventory reports that are more accurate, and that provide a clearer picture of available supply. This data on the available volume of pecans will provide the industry with the information needed to make better marketing decisions.

When discussing a reporting requirement for exported pecans, the Council expressed the industry's need for more information concerning international trade markets and export trends. The report of exports by country of destination includes information on the handler submitting the report, the month of the report, and the weight of all shipments of pecans, inshell or shelled, by classification, and by country of destination.

The Council estimated that prior to 2005, around 10 percent of domestic production was being exported. Since then, exports have grown considerably and now account for between 40 and 50 percent of production. The recommended form will be used to generate reports throughout the season providing industry members with information on where product is being sold and in what volume. Further, the Council could use this information to determine the effectiveness of any international promotional efforts and to consider opportunities for promotion and market expansion.

Some of the pecans shipped outside the United States are exported just for shelling and then returned to the United States for further use. The Council recommended an additional reporting form to capture this information. Specifically, the Council recommended collecting information on pecans exported to Mexico for shelling and then returned to the United States. The Council decided to limit the reporting to Mexico since the vast majority of pecans exported for this purpose are being sent to Mexico because of its proximity and cost efficiencies. The report of inshell pecans exported to Mexico for shelling includes information on the handler submitting the report, the month covered by the report, dates of shipments, the total weight of inshell pecans shipped for shelling, and the weight of shelled pecans returned to the United States.

In discussing this reporting requirement, the Council recognized that in addition to shelling some pecans from the production area, Mexico also exports pecans to the United States. This makes it difficult to determine how much of the import volume reported from Mexico is represented by domestic product after shelling. It was expressed that without this report, the accuracy of data regarding both reported exported and imported product could be compromised. Pecans exported for shelling could be counted as exports, and then counted again as imports when returned to the United States. This reporting requirement will help reduce the possibility of double counting of these pecans, and will help improve the accuracy of the overall information on supply.

The Council selected the tenth day of the month following the month of the activity as the due date for all five reports. Should the tenth day of the month fall on a weekend or holiday, reports will be due by the first business day following the tenth day of the month. The five monthly reports will be used during the 2017-2018 and subsequent seasons.

This action requires pecan handlers to provide the Council with monthly reports on pecans received, shipped, held in inventory, exported for sale or shelling, and purchased from outside the United States. By establishing these reporting requirements, the Council will be able to gather and disseminate this information in accurate market reports. Further, this information will be used to create a marketing policy each year as required under the Order.

Final Regulatory Flexibility Analysis

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 2,500 growers of pecans in the production area and approximately 250 handlers subject to regulation under the pecan marketing Order. Small agricultural growers are defined by the Small Business Administration as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

According to information from the National Agricultural Statistics Service (NASS), the average grower price for pecans during the 2015-2016 season was $2.20 per pound and 254 million pounds were utilized. The value for pecans that year totaled $558.8 million ($2.20 per pound multiplied by 254 million pounds). Taking the total value of production for pecans and dividing it by the total number of pecan growers provides an average return per grower of $223,520. Using the average price and utilization information, and assuming a normal bell-curve distribution of receipts among growers, the majority of growers receive less than $750,000 annually.

Evidence presented at the formal rulemaking hearing indicates an average handler margin of $0.58 per pound. Adding this margin to the average grower price of $2.20 per pound of inshell pecans results in an estimated handler price of $2.78 per pound. With a total 2015 production of 254 million pounds, ($2.78 per pound multiplied by 254 million pounds) the total value of production in 2015 was $706.12 million. Taking the total value of production for pecans and dividing it by the total number of pecan handlers provides an average return per handler of $2,824,480. Using this estimated price, the utilization volume, number of handlers, and assuming a normal bell-curve distribution of receipts among handlers, the majority of handlers have annual receipts of less than $7,500,000. Thus, the majority (a substantial number) of growers and handlers of pecans grown in the states of Alabama, Arkansas, Arizona, California, Florida, Georgia, Kansas, Louisiana, Missouri, Mississippi, North Carolina, New Mexico, Oklahoma, South Carolina, and Texas may be classified as small entities.

This final rule establishes reporting requirements under the Order. This action requires pecan handlers to provide the Council with reports of pecans received, shipped, held in inventory, exported for sale or shelling, and purchased from outside the United States. The Council will use this information to provide important statistical reports to the industry, to meet requirements under the Order, and to help guide future marketing efforts. This rule establishes new §§ 986.177 and 986.178 under the administrative provisions of the Order. The authority for this action is provided for in Section 8(d)(1) of the Act and §§ 986.75, 986.76, 986.77, and 986.78 of the Order.

Requiring monthly reports of pecans received, shipped, held in inventory, exported for sale or shelling, and purchased from outside the United States will impose an increase in the reporting burden on all pecan handlers. However, this data is already recorded and maintained by handlers as a part of their daily business. Handlers, regardless of size, should be able to readily access and submit this information. Consequently, any additional costs associated with this change would be minimal (not significant) and apply equally to all handlers.

This action should also help the entire industry by providing comprehensive data on pecans received, shipped, held in inventory, exported for sale or shelling, and purchased from outside the United States. Collection of this data was one of the industry's goals in promulgating the Order as there is no other source for this type of data. This information should provide accurate information regarding available inventory, help with marketing and planning for the industry, provide important information for the collection of assessments, and assist with preparing the annual marketing policy required by the Order. The benefits of this action are expected to be equally available to all pecan growers and handlers, regardless of their size.

The Council discussed other alternatives to this action. The Council considered listing additional varieties on the summary report of pecans received. However, after discussion the Council determined a simpler version with the major commercial varieties and room for handlers to enter additional varieties as needed would be less burdensome. The Council also considered different due dates for these monthly reports, including a due date of the first, the third and the fifth day after the month of the activity. However, after some discussion, it was determined some handlers may have difficulty meeting these time frames. The 15th day of the month was also suggested, but Council members thought this would delay the issuance of reports, and negatively impact their value. Consequently, the Council agreed to set the due date for all five forms at the tenth of the month. The Council also considered the value and importance of each of the forms, and if all should be recommended. However, the Council agreed each of the recommended forms provides important information for the industry and for administering the Order. Therefore, the alternatives were rejected.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this collection has been submitted to OMB with the reference number 0581—NEW. Upon approval, the collection will be merged with OMB No. 0581-0291, “Federal Marketing Order for Pecans.” This final rule establishes the use of five new Council forms, which impose a total annual burden increase of 2,234.4 hours. The forms, “Summary Report U.S. Pecans Received for Your Own Account,” “Pecans Purchased Outside the United States,” “Report of Shipments and Inventory on Hand,” “Exports by Country of Destination,” and “Inshell Pecans Exported to Mexico for Shelling and Returned to the United States as Shelled Meats,” require the minimum information necessary to effectively carry out the requirements of the Order. The information would enable the Council to provide statistical reports to the industry, meet requirements under the Order, and help guide future marketing efforts.

As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule. Further, the public comments received concerning the proposal did not address the initial regulatory flexibility analysis.

AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

Further, the Council's meetings were widely publicized throughout the pecan industry and all interested persons were invited to attend the meetings and participate in Council deliberations on all issues. Additionally, the Council's Committee meetings held February 23, 2017, and April 17, 2017, were also public meetings and all entities, both large and small, were able to express views on this issue.

A proposed rule concerning this action was published in the Federal Register on December 4, 2017 (82 FR 57166). Copies of the rule were sent via email to Council members and known pecan handlers. Finally, the rule was made available through the internet by USDA and the Office of the Federal Register. A 60-day comment period ending February 2, 2018, was provided to allow interested persons to respond to the proposal. Two comments were received in support of the proposed information collection. One commenter stated that, while he worried about the cost of pecans going up, he would consider the cost worthwhile if the information made the pecan industry more transparent. The other commenter stated she appreciates that the regulation could help improve the production and transportation of pecans.

Accordingly, no changes will be made to the rule as proposed, based on the comments received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously-mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant matter presented, including the information and recommendation of the Council and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

List of Subjects in 7 CFR Part 986

Marketing agreements, Nuts, Pecans, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, 7 CFR part 986 is amended as follows:

PART 986—PECANS GROWN IN THE STATES OF ALABAMA, ARKANSAS, ARIZONA, CALIFORNIA, FLORIDA, GEORGIA, KANSAS, LOUISIANA, MISSOURI, MISSISSIPPI, NORTH CAROLINA, NEW MEXICO, OKLAHOMA, SOUTH CAROLINA, AND TEXAS 1. The authority citation for 7 CFR part 986 continues to read as follows: Authority:

7 U.S.C. 601-674.

2. Add § 986.177 to subpart B to read as follows:
§ 986.177 Reports of pecans received by handlers.

(a) Summary report U.S. pecans received for your own account. Handlers shall submit to the Council, by the tenth day of the month, a summary report of inshell domestic pecans received during the preceding month. Should the tenth day of the month fall on a weekend or holiday, reports are due by the first business day following the tenth day of the month. The report shall be submitted to the Council on APC Form 1 and contain the following information:

(1) The name and address of the handler;

(2) The month covered by the report;

(3) The total weight and type of inshell pecans received, and the weight by variety for improved pecans received during the reporting period;

(4) The total weight and type of inshell pecans received, and the weight by variety for improved pecans received year to date; and,

(5) Assessments due on pecans received during the reporting period to be paid by the due date of the report.

(b) Pecans purchased outside the United States. Handlers shall submit to the Council, by the tenth day of the month, a summary report of shelled and inshell pecans imported during the preceding month. Should the tenth day of the month fall on a weekend or holiday, reports are due by the first business day following the tenth day of the month. The report shall be submitted to the Council on APC Form 6 and contain the following information:

(1) The name and address of the handler;

(2) The month covered by the report;

(3) The date the pecans were imported;

(4) The country of origin; and,

(5) The total weight of shelled and inshell pecans received, and the weight by variety for improved pecans received.

3. Add § 986.178 to subpart B to read as follows:
§ 986.178 Other reports.

(a) Report of shipments and inventory on hand. Handlers shall submit to the Council, by the tenth day of the month following the month of activity, a report of all shipments, inventory, and committed inventory for pecans. Should the tenth day of the month fall on a weekend or holiday, reports are due by the first business day following the tenth day of the month. The report shall be submitted to the Council on APC Form 2 and contain the following information:

(1) The name and address of the handler;

(2) The month covered by the report;

(3) The weight of all shipments of pecans, inshell and shelled, and inter-handler transfers shipped and received during the reporting period;

(4) The weight of all shipments of pecans, inshell and shelled, and inter-handler transfers shipped and received in the previous month and year to date;

(5) Total inventory held by handler;

(6) All the inventory committed (pecans not shipped, but sold or otherwise obligated) whether for domestic sale or export; and,

(7) The weight of all shelled or inshell pecans under contract for purchase from other handlers.

(b) Exports by country of destination. Handlers shall submit to the Council, by the tenth day of the month following the month of shipment, a report of exports. Should the tenth day of the month fall on a weekend or holiday, reports are due by the first business day following the tenth day of the month. The report shall be reported to the Council on APC Form 3 and contain the following information:

(1) The name and address of the handler;

(2) The month covered by the report;

(3) The total weight of pecans shipped for export, whether inshell, shelled, or substandard during the reporting period;

(4) The total weight of pecans shipped for export, whether inshell, shelled, or substandard during the previous period and year to date; and,

(5) The destination(s) of such exports.

(c) Inshell pecans exported to Mexico for shelling and returned to the United States as shelled meats. Handlers shall submit to the Council, by the tenth day of the month following the month of shipment, a report of all inshell pecans exported to Mexico for shelling and returned to the United States as shelled pecans. Should the tenth day of the month fall on a weekend or holiday, reports are due by the first business day following the tenth day of the month. The report shall be submitted to the Council on APC Form 5 and contain the following information:

(1) The name and address of the handler;

(2) The month covered by the report;

(3) The date of inshell shipment(s);

(4) The weight of pecans exported for shelling;

(5) The date shelled pecans returned to the United States after shelling;

(6) The weight of shelled pecans returned to the United States after shelling; and

(7) The total weight of inshell pecans exported to Mexico for shelling, and shelled pecans returned from Mexico, year to date.

Dated: February 15, 2018. Bruce Summers, Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2018-03500 Filed 2-20-18; 8:45 am] BILLING CODE 3410-02-P
SMALL BUSINESS ADMINISTRATION 13 CFR Parts 107, 120, 142, and 146 RIN 3245-AG96 Civil Monetary Penalties Inflation Adjustments AGENCY:

U.S. Small Business Administration.

ACTION:

Final rule.

SUMMARY:

The Small Business Administration (SBA) is amending its regulations to adjust for inflation the amount of certain civil monetary penalties that are within the jurisdiction of the agency. These adjustments comply with the requirement in the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, to make annual adjustments to the penalties.

DATES:

Effective Date: This rule is effective February 21, 2018.

FOR FURTHER INFORMATION CONTACT:

Arlene Embrey, 202-205-6976, or at [email protected]

SUPPLEMENTARY INFORMATION: I. Background

On November 2, 2015, the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Inflation Adjustment Improvements Act), Public Law 114-74, 129 Stat. 584, was enacted. This act amended the Federal Civil Penalties Inflation Adjustment Act of 1990, Public Law 101-410, 104 Stat 890 (the 1990 Inflation Adjustment Act), to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The 2015 Inflation Adjustment Improvements Act required agencies to issue an interim final rule by August 1, 2016, to adjust the level of civil monetary penalties with an initial “catch-up” adjustment, and to annually adjust these monetary penalties for inflation by January 15 of each subsequent year. The act authorizes agencies to implement the annual adjustments without regard to the requirements for public notice and comment or delayed effective date under the Administrative Procedures Act (the APA), 5 U.S.C. 553(b)(3)(B) and (d)(3), respectively.

In addition, based on the definition of a “civil monetary penalty” in the 1990 Inflation Adjustment Act, agencies are to make adjustments only to the civil penalties that (i) are for a specific monetary amount as provided by Federal law or have a maximum amount provided for by Federal law; (ii) are assessed or enforced by an agency; and (iii) are enforced or assessed in an administrative proceeding or a civil action in the Federal courts. Therefore, penalties that are stated as a percentage of an indeterminate amount or as a function of a violation (penalties that encompass actual damages incurred) are not to be adjusted.

On May 19, 2016, SBA published an interim final rule with its initial adjustments to the civil monetary penalties, including an initial “catch-up” adjustment. 81 FR 31489. These adjusted penalties became effective on August 1, 2016. SBA published its first annual adjustments to the monetary penalties in the Federal Register on February 9, 2017 (82 FR 9967), with an immediate effective date. This rule will establish the adjusted penalty amounts for 2018.

According to the 2015 Inflation Adjustment Improvements Act and the Office of Management and Budget implementing guidance in M-18-03, Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, (December 15, 2017), the formula for calculating the annual adjustments is based on the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October preceding the adjustment, and specifically on the change between the October CPI-U preceding the date of adjustment and the prior year's CPI-U. Based on this methodology, the 2018 civil monetary penalty adjustment is 1.02041 (October 2017 CPI-U (246.663)/October 2016 CPI-U (241.729) = 1.02041). The annual adjustments identified in this rule were obtained by applying this multiplier to the most recently adjusted penalty amounts that were published on February 9, 2017 (82 FR 9967).

II. Civil Money Penalties Adjusted by This Rule

This rule makes adjustments to civil monetary penalties authorized by the Small Business Act, the Small Business Investment Act of 1958 (SBIAct), the Program Fraud Civil Remedies Act, and the Byrd Amendment to the Federal Regulation of Lobbying Act. These penalties and the implementing regulations are discussed below.

1. 13 CFR 107.665—Civil Penalties

SBA licenses, regulates and provides financial assistance to financial entities called small business investment companies (SBICs). Pursuant to section 315 of the SBIAct, 15 U.S.C. 687g, SBA may impose a penalty on any SBIC for each day that it fails to comply with SBA's regulations or directives governing the filing of regular or special reports. The penalty for non-compliance is incorporated in § 107.665 of the SBIC program regulations.

This rule amends § 107.665 to adjust the current civil penalty from $254 to $259 for each day an SBIC fails to file a required report. The current civil penalty amount of $254 was multiplied by the multiplier of 1.02041 to reach a product of $259, rounded to the nearest dollar.

2. 13 CFR 120.465—Civil Penalty for Late Submission of Required Reports

According to the regulations at § 120.465, any SBA Supervised Lender, as defined in 13 CFR 120.10, that violates a regulation or written directive issued by the SBA Administrator regarding the filing of any regular or special report is subject to the civil penalty amount stated in § 120.465(b) for each day the company fails to file the report, unless the SBA Supervised Lender can show that there is reasonable cause for its failure to file. This penalty is authorized by section 23(j)(1) of the Small Business Act, 15 U.S.C. 650(j)(1).

This rule amends § 120.465 to adjust the current civil penalty to $6,460 per day for failure to file. The current civil penalty of $6,331 was multiplied by the multiplier of 1.02041 to reach a product of $6,460, rounded to the nearest dollar.

3. 13 CFR 142.1—Overview of Regulations

SBA has promulgated regulations at 13 CFR part 142 to implement the civil penalties authorized by the Program Fraud Civil Remedies Act of 1986 (PFCRA), 31 U.S.C. 3801-3812. The current electronic Code of Federal Regulations (eCFR) at § 142.1(b) states that a person who submits, or causes to be submitted, a false claim or a false statement to SBA is subject to a civil penalty of not more than $10,781, for each statement or claim. However, this amount reflected in the eCFR is incorrect. Rather, the correct adjusted amount for 2017, as published in the February 9, 2017 rule, was $10,957 (the product of $10,781 and the multiplier of 1.10636). Therefore, this final rule makes the required adjustment for 2018 based on the correct published amount of $10,957. Accordingly, the rule amends § 142.1(b) to adjust the current civil penalty to $11,181 per statement or claim. The adjusted civil penalty amount was calculated by multiplying the civil penalty amount of $10,957 by the multiplier of 1.02041 to reach a product of $11,181, rounded to the nearest dollar.

4. 13 CFR 146.400—Penalties

SBA's regulations at 13 CFR part 146 govern lobbying activities by recipients of federal financial assistance. These regulations implement the authority in 31 U.S.C. 1352, which was established in 1989, and impose penalties on any recipient that fails to comply with certain requirements in the part. Specifically, under § 146.400(a) and (b), penalties may be imposed on those who make prohibited expenditures or fail to file the required disclosure forms or to amend such forms, if necessary.

This rule amends § 146.400(a) and (b), to adjust the current civil penalty amounts to “not less than $19,639 and not more than $196,387.” The current civil penalty amounts of $19,246 and $192,459 were multiplied by the multiplier of 1.02041 to reach a product of $19,639 and $196,387, respectively, rounded to the nearest dollar.

This rule also amends § 146.400(e) to adjust the civil penalty that may be imposed for a first time violation of § 146.400(a) and (b) to a maximum of $19,639 and to adjust the civil penalty that may be imposed for second and subsequent offenses to “not less than $19,639 and not more than $196,387.” The current civil penalty amounts of $19,246 and $192,459 were multiplied by the multiplier of 1.02041 to reach a product of $19,639 and $196,387, respectively, rounded to the nearest dollar.

III. Justification for Final Rule

The Inflation Adjustment Act provides that agencies shall annually adjust civil monetary penalties for inflation notwithstanding Section 553 of the APA. Additionally, the Inflation Adjustment Act provides a nondiscretionary cost-of-living formula for annual adjustment of the civil monetary penalties. For these reasons, the requirements in sections 553(b), (c), and (d) of the APA, relating to notice and comment and requiring that a rule be effective 30 days after publication in the Federal Register, are inapplicable.

IV. Justification for Immediate Effective Date

Section 553(d) requires agencies to publish their rules at least 30 days before their effective dates, except if the agency finds for good cause that the delay is impracticable, unnecessary, or contrary to the public interest. By expressly exempting this rule from section 553, the 2015 Inflation Adjustment Improvements Act has provided SBA with the good cause justification for this rule to become effective on the date it is published in the Federal Register.

Compliance With Executive Orders 12866, 12988, 13132, 13771, and the Paperwork Reduction Act (44 U.S.C. Ch. 35) and the Regulatory Flexibility Act (5 U.S.C. 601-612) Executive Order 12866

The Office of Management and Budget has determined that this final rule is not a significant regulatory action under Executive Order 12866. This is also not a major rule under the Congressional Review Act, 5 U.S.C. 800.

Executive Order 12988

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

Executive Order 13132

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

Executive Order 13771

This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.

Paperwork Reduction Act

SBA has determined that this rule does not impose additional reporting or recordkeeping requirements.

Regulatory Flexibility Act (RFA)

The RFA requires agencies to consider the effect of their regulatory actions on small entities, including small non-profit businesses, and small local governments. Pursuant to the RFA, when an agency issues a rule the agency must prepare an analysis that describes whether the impact of the rule will have a significant economic impact on a substantial number of such small entities. However, the RFA requires such analysis only where notice and comment rulemaking is required. As stated above, SBA has express statutory authority to issue this rule without regard to the notice and comment requirement of the Administrative Procedure Act. Since notice and comment is not required before this rule is issued, SBA is not required to prepare a regulatory analysis.

List of Subjects 13 CFR Part 107

Investment companies, Loan programs—business, Reporting and recordkeeping requirements, Small businesses.

13 CFR Part 120

Loan programs—business, Reporting and recordkeeping requirements, Small businesses.

13 CFR Part 142

Administrative practice and procedure, Claims, Fraud, Penalties.

13 CFR Part 146

Government contracts, Grant programs, Loan programs, Lobbying, Penalties, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, SBA amends 13 CFR parts 107, 120, 142, and 146 as follows:

PART 107—SMALL BUSINESS INVESTMENT COMPANIES 1. The authority citation for part 107 continues to read as follows: Authority:

15 U.S.C. 681, 683, 687(c), 687b, 687d, 687g, 687m.

§ 107.665 [Amended]
2. In § 107.665, remove “$254” and add in its place “$259”. PART 120—BUSINESS LOANS 3. The authority citation for part 120 continues to read as follows: Authority:

15 U.S.C. 634(b)(6), (b)(7), (b)(14), (h) and note, 636(a), (h) and (m), 650, 687(f), 696(3) and 697(a) and (e); Pub. L. 111-5, 123 Stat. 115; Pub. L. 111-240, 124 Stat. 2504; Pub. L. 114-38, 129 Stat. 437.

§ 120.465 [Amended]
4. In § 120.465, amend paragraph (b) by removing “$6,331” and adding in its place “$6,460”. PART 142—PROGRAM FRAUD CIVIL REMEDIES ACT REGULATIONS 5. The authority citation for part 142 continues to read as follows: Authority:

15 U.S.C. 634(b); 31 U.S.C. 3803(g)(2).

§ 142.1 [Amended]
6. In § 142.1, amend paragraph (b) by removing “$10,781” and adding in its place “$11,181”. PART 146—NEW RESTRICTIONS ON LOBBYING 7. The authority citation for part 146 continues to read as follows: Authority:

Section 319, Pub. L. 101-121 (31 U.S.C. 1352); 15 U.S.C. 634(b)(6).

§ 146.400 [Amended]
8. In § 146.400, amend paragraphs (a), (b), and (e) by removing “$19,246” wherever it appears and adding in its place “$19,639” and by removing “$192,459” and adding in its place “$196,387”. Dated: February 12, 2018. Linda E. McMahon, Administrator.
[FR Doc. 2018-03490 Filed 2-20-18; 8:45 am] BILLING CODE 8025-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0856; Airspace Docket No. 17-AWP-10] Amendment of Class E Airspace; Hanford, CA AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action amends Class E airspace extending upward from 700 feet above the surface at Hanford Municipal Airport, Hanford, CA, by enlarging the airspace to accommodate area navigation (RNAV) procedures at the airport, removing the Visalia VHF omnidirectional range/distance measuring equipment (VOR/DME) from the airspace description, and amending the geographic coordinates of the airport. This action also removes Blair Airport from the airport description as the airport no longer exists. This action is necessary for the safety and management of instrument flight rules (IFR) operations at the airport.

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 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, 1601 Lind Avenue SW, Renton, WA 98057; telephone (425) 203-4511.

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 E airspace at Hanford Municipal Airport, Hanford, CA, to support instrument flight rules (IFR) operations at the airport.

History

The FAA published a notice of proposed rulemaking (NPRM) in the Federal Register for Docket No. FAA-2017-0856 (82 FR 50594; November 1, 2017) proposing to amend Class E airspace extending upward from 700 feet above the surface at Hanford Municipal Airport, Hanford, CA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

The FAA inadvertently omitted in the NPRM that the geographic coordinates of the airport are adjusted and makes the notation in the rule. Except for this notation, this rule is the same as published in the NPRM.

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

The FAA is amending title 14 Code of Federal Regulations (14 CFR) part 71 by amending Class E airspace extending upward from 700 feet above the surface at Hanford Municipal Airport, Hanford, CA, to accommodate area navigation (RNAV) procedures at the airport. The Class E airspace area is modified to within 1.8 miles southwest and 3.2 miles northeast of the 332° bearing from the airport extending to 6.2 miles northwest of the airport (from within a 2.6-mile radius), and within 1.8 miles southwest and 3.2 miles northeast (from within 1.5 miles each side) of the 152° bearing from the airport extending to 6.2 miles southeast of the airport (from 5 miles southeast), and within 1.3 miles each side of the 067° bearing from the airport (from 1.8 miles north and 2.3 miles south of the Visalia VOR/DME) extending to 7.7 miles northeast of the airport.

Also, this action amends the geographic coordinates for the airport, removes the reference to the Visalia VOR/DME in the legal description as the FAA transitions from ground-based to satellite-based navigation; and removes Blair Airport from the legal description as the airport no longer exists.

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. AWP CA E5 Hanford, CA [Amended] Hanford Municipal Airport, CA (Lat. 36°19′00″ N, long. 119°37′40″ W)

That airspace extending upward from 700 feet above the surface within 1.8 miles southwest and 3.2 miles northeast of a 332° bearing from Hanford Municipal Airport extending to 6.2 miles northwest of the airport, and within 1.8 miles southwest and 3.2 miles northeast of a 152° bearing from the airport extending to 6.2 miles southeast of the airport, and within 1.3 miles each side of a 067° bearing from the airport extending to 7.7 miles northeast of the airport.

Issued in Seattle, Washington, on February 7, 2018. B.G. Chew, Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2018-03409 Filed 2-20-18; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0972; Airspace Docket No. 16-ANM-9] Establishment of Class E Airspace, Rangely, CO 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 Rangely Airport, Rangely, CO, 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, 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 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; telephone (206) 231-2253.

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 earth at Rangely Airport, Rangely, CO, to support IFR operations at the airport.

History

The FAA published a notice of proposed rulemaking in the Federal Register (82 FR 57554; December 6, 2017) for Docket No. FAA-2017-0972 to establish Class E airspace extending upward from 700 feet above the surface at Rangely Airport, Rangely, CO. 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

The FAA is amending Title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace extending upward from 700 feet above the surface at Rangely Airport, Rangely, CO, within an area approximately 10 miles wide, from north to south, and extending to approximately 10 miles east and 12 miles west of the airport.

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 CO E5 Rangely, CO [New] Rangely Airport, CO (Lat. 40°05′38″ N, long. 108°45′47″ W)

That airspace extending upward from 700 feet above the surface of Rangely Airport within the area bounded by lat. 40°04′58″ N, long. 109°01′51″ W; to lat. 40°12′20″ N, long. 108°35′41″ W; to lat. 40°09′07″ N, long. 108°32′59″ W; to lat. 40°01′42″ N, long. 108°36′14″ W; to lat. 39°59′18″ N, long. 108°45′09″ W; to lat. 40°00′25″ N, long. 109°01′00″ W; thence to the point of beginning.

Issued in Seattle, Washington, on February 7, 2018. B.G. Chew, Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2018-03401 Filed 2-20-18; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 807, 812, and 814 [Docket No. FDA-2013-N-0080] RIN 0910-AG48 Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be from investigations conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of subjects, which includes individuals whose specimens are used in investigations of medical devices. The final rule updates the criteria for FDA acceptance of data from clinical investigations conducted outside the United States to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects. As part of this final rule, we are also amending the IDE, 510(k), and HDE regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The final rule provides consistency in FDA requirements for acceptance of data from clinical investigations, whatever the application or submission type.

DATES:

This rule is effective February 21, 2019. See section III of this document for additional explanation of the effective date of this final rule.

FOR FURTHER INFORMATION CONTACT:

Soma Kalb, Director, Investigational Device Exemptions Staff, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1534, Silver Spring, MD 20993, 301-796-6359; and Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

Executive Summary Purpose of the Final Rule

Through this rule, FDA is updating the standards for FDA acceptance of data from clinical investigations conducted outside the United States to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects. In this rule, FDA is amending the regulations for PMA applications, HDE applications, IDE applications, and premarket notification submissions. As part of this rule, FDA also is amending the IDE regulations and the premarket notification regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type.

Legal Authority

FDA is issuing this rule under the authority of the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to medical devices (21 U.S.C. 301 et seq.), including section 520(g) regarding IDEs (21 U.S.C. 306j(g)), section 515(c)(1)(A) and (d)(2) regarding PMAs (21 U.S.C. 360e(c)(1)(A) and (d)(2)), sections 510(k) and 513(i) regarding premarket notifications and determinations of substantial equivalence (21 U.S.C. 360(k) and 360c(i), respectively), section 520(m) regarding HDEs, section 513(f)(2) regarding De Novo classifications, section 569B regarding acceptance of data from clinical investigations conducted outside the United States (21 U.S.C. 360bbb-8b), and section 701(a) regarding regulations for the efficient enforcement of the FD&C Act (21 U.S.C. 371(a)).

Summary of the Major Provisions of the Final Rule

This rule requires that sponsors and applicants of submissions and applications that include clinical investigations conducted outside the United States and submitted to support an IDE or device marketing application or submission provide statements and information regarding how the investigations conform with GCP. FDA defines GCP as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical investigations in a way that provides assurance that the data and results are credible and accurate and that the rights, safety, and well-being of subjects are protected. GCP includes review and approval by an IEC before initiating an investigation, continuing IEC review of ongoing investigations, and obtaining and documenting the freely given informed consent of subjects. FDA also is including requirements for the acceptance of data from clinical investigations conducted in the United States submitted to support an IDE application, an HDE application, or a premarket notification submission. The changes require a statement regarding compliance with FDA regulations for human subject protection, institutional review boards, and IDEs when the investigations are conducted in the United States. With the above described changes, the rule is intended to update the standards for FDA acceptance of data from clinical investigations and to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects.

Summary of Costs and Benefits

The total estimated annualized costs of complying with these requirements, over 10 years, range from $0.8 million to $22.1 million with a 7 percent discount rate and range from $0.7 million to $22.0 million with a 3 percent discount rate. We lack data to quantify benefits, but expect the final rule will provide greater assurance of clinical data quality and integrity and human subject protection.

Table of Contents I. Background II. Overview of the Final Rule III. Effective Date IV. Comments on the Proposed Rule A. International Harmonization B. Application of the Rule C. Non-Compliant Studies D. In Vitro Diagnostic (IVD) Devices E. Independent Ethics Committee F. Acceptance of Data From Clinical Investigations Conducted Outside the United States G. Onsite Inspection H. Supporting Information I. Record Retention J. Denial or Withdrawal of PMA K. Implementation L. Guidance Needed V. Legal Authority VI. Analysis of Environmental Impact VII. Economic Analysis of Impacts VIII. Paperwork Reduction Act of 1995 IX. Federalism X. Reference I. Background

In the Federal Register of February 25, 2013 (78 FR 12664), FDA issued a proposed rule to revise the regulations in parts 807, 812, and 814 (21 CFR parts 807, 812, and 814) on the conditions under which FDA will accept data from clinical studies as support for an IDE application, a 510(k) submission, a PMA application, a PDP application, or an HDE application. The proposed rule addressed revisions to update the criteria for acceptance of data from clinical studies to help ensure the quality and integrity of data obtained from those studies and the protection of human subjects. In particular, the proposed rule addressed revisions to part 814 to update the criteria for acceptance of data from clinical studies conducted outside the United States. The proposed rule also addressed revisions to parts 807, 812, and 814, subpart H, to identify criteria for acceptance of data from clinical studies conducted both inside and outside the United States. The proposed rule identified similar criteria for acceptance of clinical data for all application and submission types for medical devices.

FDA received comments on the proposed rule from 13 entities: 7 medical device manufacturers, 2 academia, 2 associations, 1 drug manufacturer, and 1 consumer. The comments were supportive of GCP for medical devices as a mechanism to help ensure the quality and integrity of the data obtained from clinical investigations and human subject protection. Comments generally supported FDA's efforts to clarify the criteria for acceptance of clinical data submitted to FDA to support an IDE or a device marketing application or submission. Many comments, however, raised concerns about the proposed rule and some believed the rule was premature.

II. Overview of the Final Rule

FDA considered all comments received on the proposed rule and we have made several important changes, primarily for clarity and accuracy, to reduce burden, and to provide flexibility in meeting regulatory requirements. The main changes from the proposed rule include:

• Deleting proposed § 812.2(e) because comments received indicated confusion regarding the scope of the rule. Proposed § 812.2(e) described the principles of good clinical practice applicable to studies conducted outside the United States that will be submitted to FDA in support of an IDE or device marketing application or submission. Including this information within the applicability section of the IDE regulations led some to believe that FDA intended for part 812 to apply to all clinical investigations conducted outside the United States. We have deleted proposed § 812.2(e) and included the supporting information requirements for clinical investigations conducted outside the United States in new § 812.28(a)(2).

• Clarifying that the rule applies to clinical data from “investigations” as defined in § 812.3(h) rather than using other terms, such as “clinical study” and “clinical trial,” in an interchangeable manner.

• Clarifying that the rule applies to the acceptance of data from clinical investigations conducted outside the United States when submitted to support an IDE or a device marketing application or submission rather than to all clinical data contained in such applications or submissions.

• Adding new § 812.28(a)(2), which identifies different supporting information requirements based on whether the investigation is for a significant risk device or a non-significant risk device, or meets the exemption criteria in § 812.2(c). Also, for investigations meeting the exemption criteria in § 812.2(c), the specified supporting information is required to be maintained and be made available for Agency review upon request by FDA.

• Adding a requirement in new § 812.28(a)(2) that the sponsor's or applicant's rationale for considering an investigation to be of a non-significant risk device or to meet the exemption criteria in § 812.2(c) be made available upon request by FDA. We also clarify in the preamble that we do not expect foreign IECs to provide oversight of the significant risk versus non-significant risk device determination and that sponsors and applicants may proceed based upon their own determination or based on a determination by FDA.

• Changing the requirements related to supporting information on incentives provided to subjects to require that the information be maintained for all clinical investigations but only require submission for significant risk device investigations. For investigations of non-significant risk devices and investigations meeting the exemption criteria in § 812.2(c), the final rule requires that information on incentives be made available upon FDA's request. We made this change because of concerns that incentives can affect data integrity for all investigations. We do not believe this requirement will be overly burdensome. Informed consent documents usually describe incentives and the IEC reviews this information. Therefore, providing the description of incentives to FDA should not be a burden. FDA will allow some flexibility in how sponsors or applicants comply with this provision. If the informed consent form includes an explanation of any incentives provided to subjects, a sponsor or applicant could submit a model consent form to meet the requirement. Alternatively, a sponsor or applicant could also satisfy the requirement by submitting a description of any incentives provided to subjects to participate in the investigation.

• Adding a waiver provision in new § 812.28(c) to allow sponsors and applicants to request a waiver of any applicable requirements under § 812.28(a)(1) and (b) if adequate justification can be provided. Although we believe the rule is flexible enough to address concerns about compliance with the laws and regulations of other countries and in situations when the sponsor or applicant did not initiate or conduct the clinical investigations, this revision will allow sponsors and applicants to request a waiver if they can provide adequate justification. Although the proposed rule included provisions that would allow a sponsor or applicant to explain why a clinical investigation was not conducted in accordance with GCP when submitted in support of an IDE or a device marketing application or submission, addition of the waiver provision would allow sponsors and applicants to request a waiver prior to submitting an application or submission supported by clinical data from investigations conducted outside the United States. A waiver may be requested prior to initiation of an investigation. The waiver provision requires a sponsor or applicant to justify a waiver request and allows FDA to decide whether to grant or deny a waiver on a case-by-case basis, taking into account all appropriate circumstances, based on whether or not the waiver would be in the interest of public health.

• Adding a provision in new § 812.28(e) to clarify that, for clinical investigations conducted outside the United States that do not meet the conditions under § 812.28(a), FDA may accept the information from such clinical investigations to support an IDE or a device marketing application or submission if FDA believes that the data and results from such clinical investigations are credible and accurate and that the rights, safety, and well-being of subjects have been adequately protected. Although this was implied in the provisions of the proposed rule allowing a sponsor or applicant to explain why a clinical investigation was not conducted in accordance with GCP, new § 812.28(e) makes this clear.

• Modifying the definition of an IEC in § 812.3(t) by changing the reference to the definition of an institutional review board (IRB). In the proposed rule, we referenced § 56.102(g) (21 CFR 56.102(g)). In the final rule, we reference § 812.3(f), which incorporates § 56.102(g), because § 812.3(f) is specific to devices. While these definitions vary slightly, we interpret the definitions as having the same meaning. We have elected to reference the definition in § 812.3(f) in order to reference definitions in part 812 whenever possible.

• Changing the requirement in proposed § 812.28(a)(2), now § 812.28(a)(3), that a statement is provided assuring the availability of the data from the study to FDA for validation through an onsite inspection to a requirement that FDA is able to validate the data from the investigation through an onsite inspection if the Agency deems it necessary.

• Amending §§ 812.28 and 812.140(d) to clarify that these provisions apply to requests for De Novo classifications, which are a type of device marketing submission. FDA intended for §§ 812.28 and 812.140(d) to encompass all device marketing applications and submissions. As stated in the proposed rule, “FDA believes that the requirements for FDA's acceptance of data from clinical studies should be consistent regardless of the type of submission or application in which the data are submitted to FDA” (78 FR 12664 at 12665). This amendment will provide for consistency by ensuring that FDA requirements for acceptance of data from clinical investigations conducted outside the United States are the same for all device marketing applications and submissions, and will help to provide greater assurance of the quality and integrity of the data from such investigations submitted in support of this type of device marketing submission.

III. Effective Date

In response to comments, and after consideration of the intent and purpose of the new requirements, we have determined that the effective date will be 1 year after the publication of this final rule in the Federal Register. This final rule will apply to all clinical investigations that enroll the first subject on or after the effective date of this rule and that support an IDE or a device marketing application or submission to FDA. For the purposes of this rule, a subject is considered enrolled when the subject, or the subject's legally authorized representative, agrees to participate in a clinical investigation as indicated by signing of the informed consent document(s), or participates in an investigation meeting the requirements of § 50.24 (21 CFR 50.24).

If an investigation conducted outside the United States enrolled the first subject prior to the rule's effective date, then the requirements in § 814.15 (21 CFR 814.15) prior to the rule's effective date would apply. Specifically, if data from clinical investigations conducted outside the United States that enrolled the first subject prior to the effective date of this rule are submitted in support of a PMA application, FDA will accept the data if the data are valid and the investigator has conducted the studies in conformance with the “Declaration of Helsinki” or the laws and regulations of the country in which the research is conducted, whichever accords greater protection to the human subjects. If the standards of the country are used, the applicant shall state in detail any differences between those standards and the “Declaration of Helsinki” and explain why they offer greater protection to the human subjects. (See § 814.15(b).)

In section IV.K of this document, we discuss the effective date further in our response to the comments concerning the implementation of the rule.

IV. Comments on the Proposed Rule

A summary of the comments submitted to the docket and our responses follow. To make it easier to identify comments and our responses, the word “Comment,” in parentheses, will appear before each comment; and the word “Response,” in parentheses, will appear before each response. We have numbered the comments to make it easier to distinguish between comments. The numbers are for organizational purposes only and do not reflect the order in which we received the comments or any value associated with them. We have combined similar comments under one numbered comment.

A. International Harmonization

Section 812.28(a) of the proposed rule would identify criteria for FDA acceptance of data from clinical studies conducted outside the United States and submitted in support of an IDE or a device marketing application or submission. Those criteria would require that such studies be conducted in accordance with GCP. This requirement would replace the requirement in the PMA regulations that studies be conducted in conformance with the Declaration of Helsinki or the laws and regulations of the country in which the research is conducted, whichever accord greater protection to human subjects. The requirement would be new for IDE applications and other device marketing applications and submissions that previously did not address acceptance of data from clinical studies conducted outside the United States.

(Comment 1) Several comments raised concerns that FDA was not seeking a harmonized global approach to the regulation of medical devices. Comments raised concerns with various aspects of the proposed rule, such as a harmonized GCP standard, definitions of various terms, and expectations for requirements.

(Response) FDA disagrees. The rule only addresses the criteria for FDA acceptance of clinical data submitted to FDA that support an IDE or a device marketing application or submission. The rule does not address other aspects of medical device regulations, such as when an application or submission must be supported by clinical data, the type of clinical data needed, etc.

FDA has and will continue to promote global harmonization in many aspects of medical device development and regulation. With respect to medical device good clinical practice, FDA's international activities include harmonizing regulatory requirements with our foreign counterparts, industry, and other international stakeholders. For example, FDA plays a key role in forums such as the International Medical Device Regulators Forum (IMDRF) where global medical device good clinical practice was discussed during the IMDRF meeting in Florianopolis, Brazil, in September 2016. Additionally, FDA continues to be directly involved in good clinical practice standard development, including those of the International Organization for Standardization (ISO) and the International Conference on Harmonisation (ICH).

(Comment 2) Several comments raised concerns that an internationally accepted GCP standard for medical devices does not exist and the rule should not be finalized until harmonized international GCP guidelines for medical devices have been established. They note that the ICH E6 GCP guidelines for pharmaceuticals were developed through a collaborative approach involving international regulators and drug and biological product manufacturers with all stakeholders having an equal voice. They state that such guidelines do not exist for medical devices and that FDA should first seek a collaborative global approach and establishment of a harmonized guidance through the IMDRF organization, or similar group, with industry participation.

(Response) FDA disagrees that there has not been global collaboration in the development of a GCP standard for medical devices. The “Clinical Investigation of Medical Devices for Human Subjects-Good Clinical Practice” standard, ISO 14155:2011, represents an international GCP standard for medical devices that FDA has recognized (March 16, 2012, 77 FR 15765). FDA acknowledges that the standard development processes are different between ICH and ISO, but notes that several countries participated in the development of ISO 14155:2011, including Australia, Belgium, Brazil, Canada, China, France, Ireland, Italy, Japan, Spain, the United Kingdom, and the United States. Several medical device companies also participated in the standard development process. Additionally, ISO 14155:2011 is recognized by most of the members of the IMDRF (Australia, Brazil, Canada, European Union, Japan, and the United States) as well as other countries, including Indonesia, Malaysia, Singapore, Thailand, and Taiwan.

FDA's rule does not identify a specific GCP standard for sponsors and applicants to follow. Instead, the rule includes a definition of GCP in § 812.28(a)(1), which is consistent with the definition in § 312.120 (21 CFR 312.120), that embodies well recognized GCP principles and has been generally accepted. This allows sponsors of clinical investigations conducted outside the United States to determine an appropriate GCP standard to use for clinical investigations that will produce data to support an IDE or a device marketing application or submission to FDA. The rule helps to ensure that the data and results from such investigations are credible and accurate and that the rights, safety, and well-being of human subjects are adequately protected, while also being sufficiently flexible to accommodate differences in how countries regulate the conduct of clinical investigations.

(Comment 3) One comment suggested that once a harmonized GCP guideline is adopted, many of the requirements should be waived for countries that adopt the harmonized GCP guideline.

(Response) FDA disagrees with this suggestion. For FDA acceptance of data from clinical investigations conducted outside the United States to support an IDE or a device marketing application or submission, the rule requires, among other things, that sponsors and applicants provide a statement that the investigation was conducted in accordance with GCP and provide supporting information. If these requirements were waived, a submission or application would not contain information regarding the sponsor's or applicant's conformity with GCP. The fact that the country where the investigation is conducted had adopted a GCP guideline would only identify the GCP guideline that should be followed but would not provide information regarding conformity of the clinical investigation with the GCP guideline.

(Comment 4) Two comments raised a concern that the rule may run into resistance from foreign regulators and clinical communities who may interpret the rule as FDA unilaterally imposing FDA GCP standards on them. Two other comments were concerned that the rule may conflict with the rules and regulations of other countries. A fifth comment stated that FDA does not have the authority to regulate the conduct of studies conducted outside the United States.

(Response) FDA does not intend to regulate clinical investigations conducted outside the United States. The rule only identifies the criteria for FDA acceptance of clinical data submitted to FDA to support an IDE or a device marketing application or submission. We have modified the rule by removing proposed § 812.2(e) to clarify that the rule does not apply part 812 to investigations conducted outside the United States but rather addresses the conditions for FDA acceptance of clinical data when submitted to support an IDE or device marketing application or submission. FDA expects that foreign clinical investigations will be conducted in accordance with local laws and regulations. The application of a GCP standard would be in addition to the local laws and regulations to the extent that the local laws and regulations do not incorporate such a standard.

FDA's rule does not identify a specific GCP standard for sponsors and applicants to follow. Instead, the rule includes a definition of GCP in § 812.28(a)(1), which is consistent with the definition in § 312.120, that embodies well recognized GCP principles and has been generally accepted. Although the rule does not identify a specific GCP standard, we note that ISO 14155:2011, a GCP standard for medical devices that FDA has recognized, includes provisions for meeting local requirements. FDA believes that sponsors and applicants who follow ISO 14155:2011 in the conduct of clinical investigations will be able to meet the requirement in § 812.28(a)(1) of this rule as well as the local laws and regulations of the countries where the investigations are conducted.

FDA believes the requirements outlined in the rule allow the flexibility needed to accommodate the laws and regulations of other countries. We also believe that conducting a clinical investigation according to a standard that meets the definition of GCP as provided in the rule will help to ensure the integrity and quality of the data and the protection of subjects. If needed, the rule allows sponsors and applicants to explain why GCP was not followed and to describe the steps taken to ensure that the data and results are credible and accurate and that the rights, safety, and well-being of human subjects have been adequately protected. Additionally, we have added a waiver provision to allow sponsors and applicants to request a waiver from any applicable requirement in § 812.28(a)(1) and (b) of the rule (see new § 812.28(c)). If a country's clinical investigation requirements are not congruent with the GCP definition in this rule or with a GCP standard and the sponsor or applicant cannot meet GCP for the investigation, they may provide an explanation of the departure from GCP or request a waiver. FDA will take this information into account when considering the extent to which the Agency can rely on the data from these clinical investigations on a case-by-case basis.

B. Application of the Rule

(Comment 5) Several comments raised concerns that the rule may be interpreted as expanding the types of studies required to be included in applications and submissions and requiring GCP for all studies. Some comments requested clarification of the use of the terms “clinical investigation,” “clinical study,” and “clinical trial” in a seemingly interchangeable manner. The comments noted that the terms “clinical study” and “clinical trial” are not defined but the term “investigation” is defined in § 812.3(h).

(Response) While FDA intended that “clinical study” and “clinical trial” have the same meaning as “clinical investigation,” to avoid any confusion, FDA has revised the rule to use the term “clinical investigation” with the meaning as defined in § 812.3(h) (“Investigation means a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device.”). We have also revised the rule to clarify that it applies when data from clinical investigations are provided to support an IDE or a device marketing application or submission; for example, when clinical data are submitted in: (1) A 510(k) submission to demonstrate substantial equivalence, (2) a PMA application to demonstrate a reasonable assurance of safety and effectiveness, or (3) an HDE application to demonstrate reasonable assurance of safety and probable benefit. When clinical data from investigations are included in applications and submissions as supplementary information and not as support, demonstration of conformity with GCP is not required.

(Comment 6) One comment noted that the proposed rule identified different requirements for acceptability of results from clinical investigations depending on the location of the study, that is, inside or outside the United States. The comment indicated applying this differential regimen would be difficult when a multicenter clinical investigation has sites both inside and outside the United States. The comment recommended that the requirements should not apply to clinical investigations per se but to clinical data. This would allow data originating from within the United States to be subject to existing GCP regulations (for example, parts 50, 56, and 812 (21 CFR parts 50, 56, and 812)) and data originating from outside the United States to be subject to the new GCP provisions even if the data were part of the same clinical investigation.

(Response) FDA notes that for a multicenter investigation with sites both inside and outside the United States, each site would need to comply with the local requirements. Clinical investigations conducted in the United States to determine the safety or effectiveness of a device are subject to parts 50, 56, and 812. The rule does not govern investigational sites located outside the United States, but rather specifies the criteria for FDA acceptance of data from investigations conducted outside the United States to support an IDE or device marketing application or submission. When a multicenter investigation includes sites both inside and outside the United States, the sponsor or applicant may provide a statement regarding the international nature of the investigation, the compliance of sites with their applicable local requirements, and a statement regarding conformance with GCP along with the required supporting information.

(Comment 7) Two comments noted that § 812.2(e) identifies requirements for non-significant risk device investigations but IECs from other countries may not be familiar with this terminology and classification and may be unable to provide oversight of the sponsor's determination as in the United States. One comment recommended that sponsors use their own determinations.

(Response) FDA agrees with these comments and notes that the significant risk versus non-significant risk determination in the rule relates only to the supporting information required to be submitted and maintained by sponsors and applicants while the requirement to follow GCP applies to all investigations submitted to FDA in support of device applications and submissions. As discussed previously, we have removed proposed § 812.2(e) but we have maintained the provisions for different supporting information requirements in new § 812.28(a)(2).

FDA does not intend that foreign IECs provide oversight of the significant risk versus non-significant risk determination. FDA recognizes that IECs outside the United States may not be familiar with FDA's terminology related to significant risk and non-significant risk device investigations. Under the IDE regulations, sponsors may make an initial determination. Similarly, sponsors and applicants may make an initial determination for investigations conducted outside the United States. If the sponsor or applicant proceeds based on their own determination, they should maintain documentation of the rationale for their determination because FDA may request it, as stipulated at § 812.28(a)(2).

For multinational investigations that include sites in the United States, the determination of the IRBs overseeing the sites in the United States should be used. In addition, sponsors and applicants may request a determination from FDA, just as they may for investigations conducted in the United States.

Note that any determination made by FDA, whether requested or not, will supersede any determination made by the sponsor or applicant (or IRB, if the sponsor or applicant relied on an IRB's determination). If FDA determines that an investigation is of a significant risk device that was submitted as an investigation of a non-significant risk device or exempt investigation, FDA may request the additional supporting information required for significant risk device investigations. Likewise, if FDA determines that an investigation is of a non-significant risk device that was submitted as an exempt investigation, FDA may request the additional supporting information required for non-significant risk device investigations.

(Comment 8) One comment recommended that the same requirements for IDE exempt studies apply regardless of where the study sites are located. The comment stated that studies exempt under § 812.2(c) are not required to meet any requirements of part 812 except § 812.119 when conducted in the United States, while the proposed rule levies a long list of requirements for these same studies when conducted outside the United States.

(Response) FDA agrees in principle with the comment. We acknowledge that the supporting information to be submitted in an application or submission could be viewed as greater when data from clinical investigations conducted outside the United States are provided to support an IDE or device marketing application or submission than when data from clinical investigations conducted inside the United States that meet the exemption criteria in § 812.2(c) are provided to support an IDE or device marketing application or submission. While we have deleted proposed § 812.2(e), new § 812.28(a)(2) includes a paragraph that addresses the supporting information requirements for device investigations that would meet the exemption criteria in § 812.2(c), as well as paragraphs addressing the supporting information to be provided for significant risk and non-significant risk device investigations. The supporting information requirements for investigations that meet the exemption criteria now only require that this information be made available upon request. That is, the information is not required to be included in an IDE or device marketing application or submission unless FDA requests the information.

In § 812.28(a), we require that clinical investigations conducted outside the United States and submitted to support an IDE or device marketing application or submission be conducted in accordance with GCP as defined in § 812.28(a)(1). GCP includes review and approval (or provision of a favorable opinion) by an IEC and obtaining and documenting the freely given informed consent of the subject (or the subject's legally authorized representative if the subject is unable to provide informed consent). Similarly, FDA notes that investigations conducted in the United States that are exempt under § 812.2(c) are still required to comply with parts 50 and 56, regarding informed consent and IRB review, when the data support applications or submissions to FDA.

C. Non-Compliant Studies

(Comment 9) One comment questioned the need for a statement in IDE applications and 510(k) submissions regarding compliance of clinical studies conducted in the United States with parts 50, 56, and 812. The comment stated that FDA must approve IDE applications, so it is not clear why data from a study that is run according to an approved IDE would not be acceptable for clinical studies conducted inside the United States.

(Response) FDA disagrees with the comment. Not all clinical investigations of medical devices in the United States require an IDE application to be submitted to FDA. Investigations conducted under the abbreviated IDE requirements in § 812.2(b) or under the exemptions in § 812.2(c) do not require submission of an IDE application to FDA. Therefore, a clinical investigation could be conducted in the United States without FDA's review and approval of an IDE application. The statement required in §§ 807.87(j)(1) and 812.27(b)(4)(i) mirrors the statement required in § 814.20(b)(6)(ii) for PMA applications supported by clinical data from investigations conducted in the United States. Requiring this statement also provides consistency with the new requirements that apply when data from clinical investigations conducted outside the United States are provided to support an IDE or device marketing application or submission by providing assurance that the investigations conducted inside the United States were conducted in compliance with FDA's GCP regulations. These statements will aid FDA in assessing the quality and integrity of the clinical data and the protection of human subjects.

(Comment 10) A comment noted that compliance with the IDE, IRB, and informed consent regulations are not always required for all clinical studies but if a study should have complied and did not, this is a compliance matter and FDA's determination on an application or submission should not be held up.

(Response) FDA disagrees that a clinical investigation that was not conducted in compliance with regulatory requirements is solely a compliance matter. As a result of noncompliance there may be serious concerns related to data quality or integrity, the safety of subjects, or with the device itself that would prevent FDA's review of the application from moving forward. FDA does not intend to withhold a determination on an application or submission when it is possible to render a determination irrespective of an outstanding compliance issue. However, data from a clinical investigation that was not conducted in a manner that ensures that the data and results are credible and accurate and that the rights, safety, and well-being of human subjects have been adequately protected can impact FDA's ability to render a determination. The information required by the rule will assist FDA in determining whether the clinical data are unreliable and may not be used to support an application or submission.

(Comment 11) Several comments indicated that FDA should not exclude from consideration data from studies that were not conducted in accordance with GCP. These comments identified a number of reasons why a study may not comply with GCP or the sponsor or applicant may not have information on how the study was conducted. Many comments did not object to providing information describing the extent to which the principles of GCP were followed and suggested alternative language for the rule.

(Response) FDA agrees, in general, that data from clinical investigations that were not conducted in conformity with GCP may still provide useful information and could be relied upon to make regulatory decisions. The intent of the rule is not to disallow the use of data from certain investigations but rather to ensure FDA's decisions are based on scientifically valid and ethically derived data. Conformance with GCP is one way to help ensure clinical data are credible, accurate, and ethically procured.

The rule includes provisions that allow a sponsor or applicant to provide an explanation if the investigation was not conducted in accordance with GCP. These provisions are in §§ 807.87(j), 812.27(b)(4), and 814.20(b)(6)(ii). If an investigation was not conducted in accordance with GCP, these provisions allow a sponsor or applicant to provide a brief statement of the reason for not conducting the investigation in accordance with GCP and to describe the steps taken to ensure that the data and results are credible and accurate and that the rights, safety, and well-being of human subjects have been adequately protected.

FDA has also added a waiver provision as an alternative option that allows sponsors and applicants to request a waiver from any applicable requirement under § 812.28(a)(1) and (b). (See § 812.28(c).) The request must provide an explanation of why the sponsor's or applicant's compliance with the requirement is unnecessary or cannot be achieved; a description of an alternative submission or course of action that satisfies the purpose of the requirement; or other information justifying a waiver.

Through these mechanisms, sponsors and applicants can provide information for FDA's consideration in deciding whether to accept, on a case-by-case basis, data from a clinical investigation that is not conducted in accordance with GCP or for which the sponsor or applicant does not have information on how the investigation was conducted.

(Comment 12) Two comments noted that sponsors and applicants may not be able to conduct all studies according to GCP due to requirements in the country where the study is conducted. The comments noted that in at least one country, ethics committees will not review post-market on-label studies because their scope is limited to investigational studies even though such studies may be submitted in support of applications and submissions to FDA.

(Response) FDA agrees that there may be situations where full conformity with GCP may be difficult or not feasible. FDA believes that conducting a clinical investigation in accordance with GCP will help to ensure that the data and results are credible and accurate and that the rights, safety, and well-being of human subjects are adequately protected. If the sponsor or applicant cannot meet GCP for the investigation, the sponsor or applicant may provide an explanation of the departure from GCP or request a waiver, as noted previously. FDA will take this information into account when considering the extent to which the Agency can rely on the data from these investigations on a case-by-case basis.

D. In Vitro Diagnostic (IVD) Devices

(Comment 13) Several comments recommended that FDA exempt from the informed consent provisions IVD studies conducted with de-identified samples consistent with FDA's “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable.” The comments state that application of GCP in this context would provide no additional protection and could deter innovation. One comment suggested that the concepts in the guidance be codified in the final rule.

(Response) The “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable” does not exempt any clinical investigations from the informed consent requirements. In that guidance, FDA stated that we intend to exercise enforcement discretion with regard to the requirement for informed consent under the circumstances described in section 4 of the guidance. FDA issued the guidance to address concerns about obstacles to the development of IVDs and to facilitate development in a manner consistent with the principles of good clinical practice, including human subject protection. In addition to sponsors being able to apply the guidance to certain IVD investigations conducted in the United States, FDA does not intend to object if sponsors and applicants follow this guidance for similar IVD investigations conducted outside the United States provided there is no conflict with local laws and regulations.

The 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was enacted on December 13, 2016. Title III, section 3023 of the Cures Act requires the Secretary of Health and Human Services (HHS), to the extent practicable and consistent with other statutory provisions, to harmonize the differences between the HHS human subject regulations and FDA's human subject regulations. FDA will be working with others at HHS in carrying out this statutory directive, including with respect to de-identified human specimens.

(Comment 14) Three comments indicated that the rule should not apply to technical and analytical (or bench) studies that support IVD devices, especially when de-identified leftover specimens are used. Two comments indicated that these studies are subject to Good Laboratory Practices regulations and are conducted with IRB oversight and informed consent except under the circumstances described in the FDA's “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable.” These comments stated that application of GCP would provide no additional protection and would slow or deter innovation.

(Response) FDA disagrees with these comments. FDA considers investigations that use human specimens, including leftover specimens that are de-identified, to be clinical investigations. The definition of subject in § 812.3(p) includes individuals on whose specimens an investigational device is used. Data from investigations using human specimens are subject to the GCP rule when submitted to FDA in support of an IDE or a device marketing application or submission. FDA disagrees that the application of GCP would provide no additional protection. The application of GCP helps to ensure the quality and integrity of data from investigations using human specimens. We agree that these investigations should be conducted with IEC oversight and informed consent. However, as stated previously, in addition to sponsors being able to apply the “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable” to certain IVD investigations conducted in the United States, FDA does not intend to object to sponsors and applicants following the guidance for similar IVD investigations conducted outside the United States, provided that there is no conflict with local laws and regulations.

As noted above, investigations using human specimens are considered clinical investigations. The Good Laboratory Practices regulation (part 58 (21 CFR part 58)) does not apply to clinical investigations, including investigations using human specimens. Further explanation of the applicability of part 58 is provided in FDA's “Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies—Frequently Asked Questions.”

(Comment 15) One comment noted that there is no harmonized, international IVD GCP guideline.

(Response) FDA recognizes that the ISO 14155:2011 standard states that it does not apply to IVD medical devices. FDA, however, considers conformity with the principles of GCP important for all clinical investigations, including those of IVD devices, to help ensure that the data and results from clinical investigations are credible and accurate and that the rights, safety, and well-being of human subjects are adequately protected. As stated above, FDA does not intend to object to sponsors and applicants following the “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable,” provided that there is no conflict with local laws and regulations.

(Comment 16) One comment noted that the United States classifies IVDs as medical devices but other countries, for example, countries within the European Union, have separate directives governing medical devices and IVDs. Additionally, the Global Harmonization Task Force guidance documents on Clinical Evidence for IVD Medical Devices differentiate IVDs from other medical devices and the proposed regulations do not reflect these differences.

(Response) FDA agrees that there are differences in how other countries regulate medical devices and IVDs. The rule, however, does not address when evidence obtained from using human specimens is needed or what clinical evidence is required for a medical device, including an IVD. Instead, the rule only addresses the conditions for FDA acceptance of data from clinical investigations to support an IDE or a device marketing application or submission to FDA, including data from clinical investigations conducted outside the United States. Conformity with GCP helps to ensure that the data and results are credible and accurate and that the rights, safety, and well-being of human subjects are adequately protected. This is equally important for investigations of IVDs as it is for other medical devices. FDA believes the rule allows for the flexibility needed to accommodate the rules and regulations of other countries.

E. Independent Ethics Committee

Proposed § 812.3(t) would add a definition for IEC. We proposed to define IEC to mean a review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection.

(Comment 17) Three comments were concerned with the use of the term “adequately constituted” in the definition of IEC because the term is not defined. One comment noted that a global, harmonized definition of “adequately constituted” does not exist, nor is there agreement on the makeup of an IEC. Another comment recommended that existing definitions of IEC, such as in ICH E6 and ISO 14155:2011, be used.

(Response) FDA disagrees with the comments. The proposed definition of IEC is at a level of specificity and detail appropriate for regulation. We recognize that the organization and membership of IECs may differ among countries because of the local needs of the host country. We believe that such variation should not affect an IEC's ability to perform its functions of protecting the rights, safety, and well-being of human subjects involved in the clinical investigation. Further, we intended for the rule to be sufficiently flexible to accommodate differences in how countries regulate the conduct of clinical research, including the composition of an IEC. Therefore, we have not specifically defined IEC membership requirements in the regulations.

Although we have not identified specific requirements for the membership of an IEC in the rule, we note that the definition of an IEC references an IRB subject to the requirements of part 56 as one type of IEC. Another example would be the description provided in ICH E6.

F. Acceptance of Data From Clinical Investigations Conducted Outside the United States

Proposed § 812.28(a) would identify requirements for the acceptance of information from clinical investigations conducted outside the United States as support for an IDE or a device marketing application or submission, including a requirement that a statement be provided that the investigation was conducted in accordance with GCP, which we defined in § 812.28(a)(1).

(Comment 18) One comment questioned whether there are data to support concern with data integrity and human subject protection from studies of medical devices conducted outside the United States, similar to the Office of Inspector General (OIG) June 2010 report, “Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials,” for drug and biological product marketing applications (see https://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf).

(Response) FDA notes that there is no similar OIG report for devices, but FDA does have experience with investigations conducted outside the United States through the foreign sites we have inspected. From this experience, we are aware of instances of misconduct of clinical investigations that could compromise data integrity and human subject protection. For more information, please see our Bioresearch Monitoring (BIMO) Metrics available at https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm261409.htm.

(Comment 19) One comment noted that proposed § 812.28(a)(1) defines GCP to include “obtaining and documenting the freely given informed consent of the subject . . . before initiating a study” and suggested we change the sentence to “obtaining and documenting the freely given informed consent of the subject before that subject participates in the study” because subjects will enroll in a clinical study throughout the enrollment phase of a study, so stating that informed consent will be obtained from a subject before initiating a study is not realistic.

(Response) FDA declines to make this change to the definition of GCP in § 812.28(a)(1) because the definition is consistent with the definition in § 312.120(a)(1)(i). The intention of the sentence is that informed consent is obtained before initiating the subject's participation in the study.

(Comment 20) One comment suggested adding to the end of proposed 812.28(a)(1): “For the purpose of definition, device GCP does not include a requirement for sponsor collection and analysis of (i) adverse events beyond those specified in the protocol and those that would meet the definition of a UADE, (ii) concomitant medications and concomitant therapies beyond those specified in the protocol, (iii) any other data not specifically required of clinical investigations conducted under an IDE or not specified in the protocol.” The change is intended to clarify that the requirements for a drug clinical study are not being systematically required for medical device studies conducted outside the United States.

(Response) FDA disagrees with the suggested change. FDA has written the rule to be flexible to accommodate the laws and regulations of the countries where investigations are conducted. FDA expects that clinical investigations will be conducted in compliance with the local laws and regulations of the countries where the investigations take place and such laws and regulations may address collection and analysis of adverse events, concomitant medications and therapies, and other data. FDA considers the suggested language too restrictive because, during the course of an investigation, additional data may be collected that would be important to establishing the safety and effectiveness of a medical device or to subject safety. Moreover, the suggested language relies on FDA's investigational device exemptions regulations by using a term (unanticipated adverse device effect or UADE) used in FDA's regulations and limits “collection and analysis” by not requiring “any other data not specifically required of clinical investigations conducted under an IDE or not specified in the protocol.” These changes would modify the definition of GCP based on FDA's regulations and it may appear that FDA is imposing its own GCP regulations on other countries. Additionally, the revisions could raise problems for investigations of combination products.

Adverse event reporting is an important aspect of GCP. The requirements related to collection and analysis of adverse events would be those identified in the GCP standard the sponsor uses. For example, ISO 14155:2011 includes discussion of adverse event documentation, reporting, and analysis in several sections, including sections 6.4, 8.2.4, 8.2.5, and 9.8. A sponsor could request a waiver from any applicable requirement if the sponsor can justify why it is unnecessary, cannot be achieved, or can be satisfied through an alternative course of action.

(Comment 21) One comment noted that the text in proposed § 812.28(a) uses the term “data are valid” but stated this term is vague and recommends changing it to “relevant and credible.”

(Response) FDA agrees that the language in proposed § 812.28(a) regarding “data are valid” should be revised but disagrees with the suggested revision. The term “data are valid” was used in previous § 814.15(b) to indicate the data must represent valid scientific evidence, which is appropriate for PMA applications. Section 812.28, however, addresses data supporting other applications and submissions, including clinical data supporting an IDE application. Therefore, we have revised § 812.28(a) to read “FDA will accept information on clinical investigations conducted outside the United States to support an IDE or a device marketing application or submission if the investigations are well-designed and well-conducted . . .” consistent with § 312.120, which similarly applies to investigational applications in addition to marketing applications for drugs and biological products.

(Comment 22) One comment stated that phrases like “compliance with good clinical practice” might lead the reader to interpret FDA as expecting compliance with ICH E6 versus the phrase “compliance with the principles of good clinical practice,” which more readily relates to the concepts described in ISO 14155:2011.

(Response) FDA disagrees with this comment. Both ICH E6 and ISO 14155:2011 use the term “principles of good clinical practice.” FDA did use the term “principles of good clinical practice” in proposed § 812.2(e); however, we have removed this proposed section from the final rule to eliminate potential misinterpretation that part 812 applies to clinical investigations conducted outside the United States. Section 812.28(a)(1) uses the phrase “conducted in accordance with good clinical practice.” This section defines GCP and requires a sponsor or applicant to provide a statement regarding the conduct of the investigation submitted. The sponsor or applicant would indicate conformity with a specific GCP standard but the rule does not specify the GCP standard to use. Therefore, FDA believes the language in the rule is appropriate in the context in which it is used.

(Comment 23) One comment asked whether the Agency looked at the differences between ICH E6 and ISO 14155:2011, related to device stakeholders' requirements, to identify if there are any differences and considered the potential burden to adopt both standards.

(Response) FDA has not identified a specific GCP standard that sponsors must follow. Instead, FDA is allowing sponsors of device clinical investigations conducted outside the United States to follow a GCP standard of their choice, provided it meets the definition provided in § 812.28(a)(1). Although FDA believes that ICH E6 and ISO 14155:2011 represent similar approaches to GCP, we note that ICH E6 addresses drug and biological products, while ISO 14155:2011 addresses medical devices. We believe the differences are appropriate to the different products addressed.

G. Onsite Inspection

Proposed § 812.28(a)(2), as a condition for acceptance of data from a clinical investigation submitted under this section, would require a statement assuring the availability of the data from the clinical investigation to FDA for validation through an onsite inspection if the Agency deems it necessary or through other appropriate means.

(Comment 24) One comment stated that FDA has no authority to inspect foreign clinical study institutions and recommended that proposed § 812.28(a)(2) be struck. Another comment indicated that providing a statement as required by proposed § 812.28(a)(2) would be problematic because of foreign privacy laws.

(Response) FDA disagrees with striking proposed § 812.28(a)(2), now § 812.28(a)(3), because, in some cases (for example, to resolve any uncertainties about whether the investigation was conducted in accordance with GCP), to accept the data from a clinical investigation conducted outside the United States, FDA may need to validate the data through an onsite inspection. Historically, when needed to validate data from clinical investigations conducted outside the United States, FDA has been able to inspect the records of these investigations. When conducting foreign inspections, FDA obtains the consent of foreign governments.

FDA understands that a sponsor cannot disclose foreign records that are prohibited from disclosure by foreign law. If the Agency believes that access to records is necessary to verify certain data or to validate the investigation, and such records are not available because of foreign law, the sponsor and FDA will need to agree upon an alternative means for validation if the Agency is to rely on the data. Such alternative means for validation might entail FDA partnering with other regulatory authorities or other mutually agreed upon means for validation.

(Comment 25) One comment recommended keeping the language the same as in § 312.120(a)(1)(ii): That is, “FDA is able to validate the data from the study through an onsite inspection if the agency deems it necessary.” Another comment recommended modifying the language to “authorized by local law” and deleting “or through other appropriate means” unless FDA can clarify what it means and what types of activities would satisfy this requirement.

(Response) FDA partially agrees and has modified the language in proposed § 812.28(a)(2), now § 812.28(a)(3), to more closely follow the language in § 312.120. We have modified the requirement that a statement be provided assuring the availability of the data from the study to FDA for validation through an onsite inspection to a requirement that FDA is able to validate the data from the investigation through an onsite inspection. We have also determined that the phrase “if otherwise authorized by law” is unnecessary because FDA obtains the consent of foreign governments to do inspections. Therefore, the phrase has been deleted.

We are keeping the phrase “or through other appropriate means.” Essentially the same phrase is used in current § 814.15(d)(3) regarding validation of foreign clinical data. This language recognizes that foreign data present unique challenges not usually associated with domestic data. One such challenge may be that FDA is unable to conduct an onsite inspection. If the Agency believes that validation is necessary but is unable to conduct an onsite inspection, the sponsor and FDA will need to agree upon an alternative means for validation if the Agency is to rely on the data. Such alternative means for validation might entail FDA partnering with other regulatory authorities or other mutually agreed upon means for validation. If an agreement cannot be reached that satisfies FDA's need for validation, then the data might not be accepted to support the application or submission.

(Comment 26) One comment noted that the preamble of the proposed rule identified documents that articulate GCP principles but that these documents have broad differences in the scope, level of detail, and formulation of actual requirements and that no individual document was identified as the authoritative set of enforceable requirements. The comment stated that, if GCP compliance will be subject to FDA inspection, the rule must clearly identify not only the applicable requirements in terms of general principles but also provide a sufficient level of detail to allow an objective basis for a uniform assessment of compliance by the sponsor as well as the Agency.

(Response) FDA disagrees with this comment. Similar to § 312.120, the rule does not identify a specific GCP standard that sponsors must follow. Instead, the rule includes a definition of GCP in § 812.28(a)(1), which is consistent with the definition in § 312.120, and embodies well recognized GCP principles. FDA is allowing sponsors of clinical investigations conducted outside the United States to follow a GCP standard of their choice, provided it meets the definition provided in § 812.28(a)(1). One example of a GCP standard that meets the definition provided in § 812.28(a)(1) is ISO 14155:2011, “Clinical Investigation of Medical Devices for Human Subjects—Good Clinical Practice.” FDA has recognized this standard (77 FR 15765). In addition to following a GCP standard, sponsors would need to comply with the local requirements where the investigational sites are located.

H. Supporting Information

Proposed § 812.28(b) would require a sponsor or applicant submitting data from clinical investigations conducted outside the United States in support of an IDE or device marketing application or submission to submit, in addition to information required elsewhere in parts 807, 812, and 814, supporting information that describes the actions taken to ensure that the research conformed to GCP.

1. General Comments

(Comment 27) One comment stated that the list of supporting information in § 812.28(b) should reflect the approval standard for devices, which is a reasonable assurance of safety and effectiveness.

(Response) FDA disagrees with the comment. The supporting information is not used to establish a reasonable assurance of safety and effectiveness. Instead, the supporting information is used to assess whether the investigation conformed to GCP, which helps to ensure that the data and results submitted are credible and accurate and that the rights, safety, and well-being of human subjects are adequately protected. Data from clinical investigations conducted in accordance with GCP may be used to establish a reasonable assurance of safety and effectiveness for purposes of a PMA application, but may also be used to support other device applications and submissions, including an IDE. Section 812.28(a)(2) of the rule identifies different supporting information requirements based on the level of risk of the clinical investigation, with significant risk device investigations requiring more supporting information and device investigations presenting less risk, as well as those that meet the exemption criteria in § 812.2(c), requiring less supporting information.

(Comment 28) One comment noted that the preamble to the proposed rule states that many of the requirements in § 812.28(b) parallel the requirements in § 312.120(b) for drug applications but the list, in many cases, is more restrictive than the requirements for drug studies, and identified the request for certified copies in § 812.28(b)(4) as an example.

(Response) FDA, in general, disagrees with the comment. Although the comment indicates that the list of supporting information in § 812.28(b) is more restrictive in many cases than in § 312.120(b), only one example is provided, the request for “certified copies” in § 812.28(b)(4). Based on concerns raised by this and other similar comments, we have removed the term “certified copies” from § 812.28(b)(4), as further discussed in response to comment 33 below.

There are only a few other differences between §§ 812.28(b) and 312.120(b). In § 312.120(b)(1) and (2), the investigator's qualifications and a description of the research facilities are required, respectively. In § 812.28(b)(1), we require the names of investigators and the names and addresses of research facilities and sites where records relating to the investigation are maintained, separate from the requirement for the investigators' qualifications in § 812.28(b)(2) and the description of the research facilities in § 812.28(b)(3). We believe this difference is appropriate because the information on names of investigators and names and addresses of research facilities and sites where records relating to the investigation are maintained is needed for all clinical investigations of medical devices. However, the information on investigators' qualifications and the description of the research facilities is needed for significant risk device investigations but not for exempt and non-significant risk device investigations. These items are discussed further in comments 29 and 30 below.

The required information in § 812.28(b)(5), describing the device used in the investigation, is also different from § 312.120(b)(4), describing the drug substance and drug product. The difference is appropriate because it relates to the differences in information needed to adequately describe devices and drugs.

The difference between §§ 812.28(b)(6) and 312.120(b)(5) is related to different regulatory requirements for FDA decisions on device applications, as described in § 860.7 (21 CFR 860.7), and drug applications, as described in § 314.126. Therefore, FDA believes this difference is appropriate.

The last difference concerns the information required for the IEC that reviewed the investigation. In § 812.28(b)(7), we do not specify that records of the IEC members' names be maintained as required in § 312.120(b)(6). We decided not to require that records of the IEC members' names be maintained because drug sponsors and applicants reported occasional problems fulfilling this requirement due to foreign laws.

Therefore, FDA considers the supporting information identified in § 812.28(b) to be similar to the supporting information required for drug applications in § 312.120(b), with the few differences being appropriate and not more restrictive.

2. Investigators and Research Facilities

Proposed § 812.28(b)(1) would require the names and addresses of the investigators and research facilities; proposed § 812.28(b)(2) would require the qualifications of investigators; and proposed § 812.28(b)(3) would require a description of the research facilities.

(Comment 29) One comment disagreed with providing investigators' addresses and noted that personal details like this are not usually obtained and could be subject to more stringent foreign regulations. A second comment stated that the European Union Privacy Directive would protect from transfer to the United States the names and addresses of foreign investigators and that investigators would have to agree to this information sharing in advance or at the time of submission to FDA. The comment further stated that difficulties currently exist with obtaining investigators' names from certain foreign sites, even when the data collection is part of an IDE.

(Response) FDA believes that some clarification is needed but disagrees that investigators' names should not be required. We did not intend to imply that investigators' personal addresses would be required. We have reworded this element to require “names of investigators and names and addresses of research facilities and sites where records relating to the investigation are maintained.” This change clarifies that the investigators' personal addresses are not required, but that the names and addresses of all facilities that took part in the investigation are required, such as the investigational sites, laboratories, and specimen collection sites. Additionally, if study records are maintained at other locations, such as an investigator's office, the names and addresses of those locations must also be provided.

We also note that the European Commission has recognized ISO 14155:2011, which includes providing names and addresses of investigators to regulatory authorities. ISO 14155:2011, Annex A, describes the clinical investigation plan (CIP) and includes, in section A.1.4, the name, addresses, and professional position of principal investigator(s). The CIP is included in the clinical investigation report as described in section D.13 of Annex D. The clinical investigation report includes “the list of principal investigators and their affiliated investigation sites, including a summary of their qualifications or a copy of their CVs” (see Annex D.13 c). This report is provided to regulatory authorities per section 7.3f.

(Comment 30) One comment stated that the items in § 812.28(b)(2) and (3) are vague and sponsors or applicants will have difficulty knowing how to comply with the requirements.

(Response) In general, the information provided on investigator qualifications should be adequate to show that the investigator is qualified to serve as an investigator based on his or her training and experience specifically related to the clinical investigation (for example, such information could include a curriculum vitae (CV) or summary of training and experience). The description of the research facilities should include enough information to enable FDA to determine the adequacy of the facilities to execute the investigation and meet its requirements (for example, whether the site is appropriately staffed and equipped to conduct the investigation and is able to provide the appropriate emergent or specialized care, if required). Additionally, the GCP standard the sponsor or applicant follows may address information to maintain on investigator and research facility selection. For example, ISO 14155:2011 addresses verification and documentation of the qualifications of the principal investigator(s) and the adequacy of the research facility and the rationale for selecting the facility in sections 5.8, 9.2, and 9.3.

The investigator's qualifications and the description of the research facilities will also help us to assess the need for an onsite inspection.

3. Detailed Summary of Protocol and Results of Investigation

Proposed § 812.28(b)(4) would require submission of a detailed summary of the protocol and results of the investigation. In addition, the sponsor or applicant would be required to submit certified copies of case records maintained by the investigator or additional background data, such as hospital records or other institutional records, if requested by FDA.

(Comment 31) Several comments stated that stricter privacy laws outside the United States may partially or completely restrict the ability of sponsors and applicants to provide copies of patient records to FDA. The comments noted that investigational sites typically archive the originals of completed case records and these records would generally not be available to sponsors. Two comments noted that the records may be available through an inspection at the investigational site. One comment noted that providing redacted patient information to a regulatory authority may be possible but would require changes to clinical trial agreements and informed consent documents and would impose significant burden and costs. Comments recommended modifying or deleting the requirement for providing records.

(Response) FDA acknowledges that in some instances there may be difficulties providing records should FDA request them but disagrees with deleting the requirement. FDA understands that a sponsor cannot disclose foreign records that are prohibited from disclosure by foreign law. If FDA requests case records or other records but these documents cannot be provided as required by § 812.28(b)(4) because disclosure is prohibited by governing law, the sponsor or applicant should document this disclosure prohibition by the foreign entity. For example, the sponsor or applicant should document the countries that prohibit such disclosure, the nature of the prohibitions, and the extent to which these prohibitions may impede sponsors or applicants in carrying out other obligations regarding record access. The sponsor or applicant can then submit such information in a waiver request to FDA. For FDA to rely on the affected data, the sponsor or applicant and FDA would need to agree on an alternative means for validation. Such alternative means for validation might entail FDA partnering with other regulatory authorities or other mutually agreed upon means for validation.

Additionally, in the informed consent documents, it may be helpful to notify subjects that regulatory authorities will have direct access to the subject's medical records for verification of clinical investigation procedures and data, which is consistent with ISO 14155:2011, section 4.7.4(d)3.

If FDA needs source documents such as hospital records to verify certain data or to validate the investigation and such records are not available because of foreign law, and an alternative means for validation is not available, FDA might not accept the data from the clinical investigation as support for an IDE or device marketing application or submission.

(Comment 32) Two comments requested clarification of the term “case record.”

(Response) FDA clarifies that the term “case record” as used in § 812.28(b)(4) is used to indicate records investigational sites commonly maintain in relation to clinical investigations. The term includes records as described in § 812.140(a)(3).

(Comment 33) Two comments requested that the term “certified copies” be defined.

(Response) FDA has reevaluated the provision related to “certified copies.” We acknowledge that the term has different meanings in other countries and have determined that this term is not needed. We have amended the rule accordingly.

(Comment 34) One comment recommended modifying § 812.28(b)(4) to require that the clinical investigation report, as described in ISO 14155:2011 Annex D, be included in the supporting information because it provides the relevant information from the protocol as well as the results of the clinical investigation.

(Response) FDA disagrees with modifying the requirement to specify providing the clinical investigation report as described in ISO 14155:2011. We believe that the supporting information required by the rule is sufficient for its purpose. Additionally, the rule does not require following ISO 14155:2011; however, if a sponsor or applicant chooses, FDA would accept the full clinical investigation report as described in Annex D of ISO 14155:2011 as a detailed summary of the protocol and results of the investigation.

(Comment 35) One comment asked about FDA's procedure and methods for review, retention, and destruction of the detailed summaries and records identified in § 812.28(b)(4) and the reasons why records would be needed and the intent of review.

(Response) FDA may request records to help understand the conduct of the investigation, to verify certain data, and to validate the investigation and the results obtained. When records from investigations conducted outside the United States are submitted, FDA will review and handle those records in the same manner as records from investigations conducted in the United States.

4. Valid Scientific Evidence

Proposed § 812.28(b)(6) would require a discussion demonstrating that the data and information, when intended to support the safety and effectiveness of a device, constitute valid scientific evidence.

(Comment 36) One comment stated that § 812.28(b)(6) is redundant and should be struck. A study complying with the principles of GCP is a well-controlled study conducted by qualified experts.

(Response) FDA disagrees that § 812.28(b)(6) is redundant. Section 812.28(b)(6) requires that the sponsor or applicant provide a discussion demonstrating that the data and information constitute valid scientific evidence within the meaning of § 860.7. FDA relies upon only valid scientific evidence to determine whether there is reasonable assurance that the device is safe and effective (see § 860.7). Although there may be some overlap, the principles addressing valid scientific evidence more readily relate to the types of evidence that may support the safety and effectiveness of a device, while the principles of GCP relate more to the conduct of the investigation.

5. IEC Information

Proposed § 812.28(b)(7) would require the name and address of the IEC that reviewed the study and a statement that the IEC meets the definition in § 812.3(t). The sponsor or applicant would be required to maintain records supporting such statement, including records describing the qualifications of IEC members, and would be required to make these records available for Agency review upon request.

(Comment 37) Two comments opposed the requirement that a statement be provided that the IEC meets the definition in § 812.3(t). One comment indicated that sponsors may not know whether an IEC meets a given definition. Another comment recommended requiring a statement obtained from the IEC that it meets the definition in § 812.3(t) and is organized and operates according to applicable laws and regulations.

(Response) FDA agrees that a statement from the IEC would also be acceptable. To satisfy this requirement, FDA will accept a statement from the IEC indicating it meets the definition of an IEC in the rule. We also added a waiver provision (see new § 812.28(c)) to the rule that sponsors and applicants may consider using when they are unable to meet the requirements in § 812.28(a)(1) and (b) of the rule. For example, a waiver may be requested when the sponsor cannot submit a statement that the IEC meets the definition in § 812.3(t). A waiver request could identify, as an alternative to the statement that the IEC meets the definition in § 812.3(t), a statement that the IEC is organized and operates according to the applicable laws and regulations of the country where it operates and provide a description of the laws and regulations under which the IEC is organized and operates. FDA will decide whether to grant or deny a waiver on a case-by-case basis, taking into account all appropriate circumstances.

(Comment 38) Three comments stated that the proposed rule requires sponsors to qualify IECs but there is no parallel requirement for a sponsor to qualify an IRB for a study in the United States. One comment noted that no rationale was provided for requiring greater regulation outside the United States than is required in the United States. Another comment indicated the requirement is likely because FDA recognized it does not have the authority to verify and document the adequacy of a foreign IEC but failed to recognize that sponsors do not have such authority and would face legal challenges to meet this requirement.

(Response) FDA acknowledges that the sponsor of an investigation under an IDE is not required to qualify and submit information on the adequacy of the reviewing IRBs. FDA routinely obtains information about IRBs in the United States through onsite inspections of the IRBs. To obtain information on the adequacy of the reviewing IEC for foreign investigations, given that inspections of foreign IECs are usually not feasible, FDA believes it is appropriate to ask the sponsor to document the adequacy of the reviewing IEC because the sponsor already interacts with the IEC, either directly or through the investigators, to obtain IEC review.

FDA believes that the oversight of a clinical investigation by an adequately constituted IEC is an essential component of human subject protection. Information about the adequacy of an IEC is important in assessing the competence of the committee to protect the rights, safety, and well-being of human subjects. To satisfy this requirement, FDA will accept a statement from the IEC indicating it meets the definition of an IEC in the rule. We also added a waiver provision to the rule that sponsors and applicants may consider using when they are unable to meet the requirements in § 812.28(a)(1) and (b) of the rule. For example, a waiver may be requested when the sponsor cannot submit a statement that the IEC meets the definition in § 812.3(t).

(Comment 39) Several comments indicated sponsors may have difficulty obtaining and documenting the qualifications of IEC members and making the records available to the Agency upon request. One comment noted that the term “qualification” is open to interpretation. Another comment indicated it may not be feasible to obtain the names of IEC members. A third comment noted that the European Union Privacy Directive may protect from transfer to the United States the information sought for the IEC.

(Response) FDA believes that oversight of a clinical investigation by an adequately constituted IEC is an essential component of human subject protection. Information about the adequacy of an IEC is important in assessing the competence of the committee to protect the rights, safety, and well-being of human subjects. Recognizing that privacy laws in some countries may not allow the release of personal information, FDA is requiring that sponsors or applicants maintain records describing the qualifications of IEC members and not their names. Qualifications would include, for example, information on occupation, training, and experience.

Additionally, we have added a waiver provision to the rule that sponsors and applicants may consider using when they are unable to meet the requirements in § 812.28(a)(1) and (b) of the rule. If sponsors or applicants cannot obtain IEC member qualifications as required by § 812.28(b)(7), FDA recommends that the sponsor or applicant clearly document attempts made to obtain the qualifications of IEC members along with an explanation as to why the qualifications cannot be obtained. Such information can be submitted to FDA in a waiver request.

(Comment 40) One comment questioned how FDA would review information on the qualifications of IEC members stating that, without a harmonized, globally accepted definition of “qualification,” there will be variability in interpretation of acceptable qualification based on reviewer interpretation or bias and may place FDA in the position of accepting or rejecting qualifications of IEC members from foreign nations.

(Response) FDA disagrees with the comment. We recognize that the membership of IECs may differ among countries because of local needs of the host country. Such variation is acceptable as long as the IEC can ensure the protection of the rights, safety, and well-being of human subjects involved in the clinical investigation. As we do for IRBs located in the United States, in its review FDA will be looking to see that, collectively, the IEC members have the qualifications needed to review and evaluate the science, medical aspects, and ethics of the proposed clinical investigation.

6. Summary of IEC's Decision

Proposed § 812.28(b)(8) would require submission of a summary of the IEC's decision to approve or modify and approve the study, or to provide a favorable opinion.

(Comment 41) One comment recommended changing proposed § 812.28(b)(8) to require the correspondence relating to the IEC's decision to approve the investigation because the approval letter would be clearer and less ambiguous than a summary, which could be interpreted differently by different people.

(Response) FDA disagrees with the comment; however, FDA believes that providing the approval letter(s) from the IEC(s) would be one way to provide a summary of the IEC's decision to approve or provide a favorable opinion. We note that these letters are usually issued in the local language of the country in which the investigation is conducted and official translations may need to be provided.

7. Description of Informed Consent Process

Proposed § 812.28(b)(9) would require submission of a description of how informed consent was obtained.

(Comment 42) One comment recommended that § 812.28(b)(9) require that the blank informed consent document approved by the IEC or IRB be submitted instead of a “description of how” consent was obtained.

(Response) FDA disagrees that the blank informed consent document approved by each IEC or IRB should be submitted instead of a description of how consent was obtained. Providing information about how informed consent is obtained is important in ensuring transparency and accountability for the ethical conduct of the investigation. The description should address such concerns as who obtained informed consent (ensuring that the person obtaining informed consent was knowledgeable about the investigation and capable of answering all questions), when was consent obtained (ensuring that consent was obtained prior to a subject's participation in the investigation, for example, prior to any research procedures), and the conditions under which consent was obtained (ensuring that consent was obtained under conditions that minimized coercion or undue influence).

(Comment 43) One comment recommended revising § 812.28(b)(9) to state “a description of how informed consent was obtained, and that this method was approved by the IEC.”

(Response) FDA disagrees with the comment. FDA defines GCP to include the review and approval (or provision of a favorable opinion) by an IEC that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation. Ensuring the protection of human subjects would include review and approval of how informed consent is obtained. An applicant's statement that an investigation was conducted in accordance with GCP would indicate that an IEC had approved (or provided a favorable opinion) of how informed consent was obtained. Therefore, FDA believes the proposed revision is unnecessary.

8. Description of Incentives to Subjects

Proposed § 812.28(b)(10) would require submission of a description of what incentives, if any, were provided to subjects to participate in the study.

(Comment 44) One comment recommended deleting § 812.28(b)(10) because this is a new requirement, not required for investigations in the United States, and may lead to unnecessary burden of review for FDA. The comment stated that the information is reviewed by the IRB or IEC as part of consent and is held by the sponsor as part of their records and subject to audit by the Agency.

(Response) FDA disagrees with the comment and does not believe this requirement will be overly burdensome. Informed consent documents usually describe incentives and the IEC reviews this information. Therefore, providing the description of incentives to FDA should not be a burden. FDA will allow some flexibility in how sponsors or applicants comply with § 812.28(b)(10). If the informed consent form includes a description of any incentives provided to subjects, a sponsor or applicant could submit a model consent form to meet the requirement. Alternatively, a sponsor or applicant could also satisfy the requirement by submitting a description of any incentives provided to subjects to participate in the investigation, or if such a description was included elsewhere, such as in the detailed summary of the protocol required under § 812.28(b)(4), the sponsor or applicant could reference where the description may be found to meet the requirement under § 812.28(b)(10).

FDA is requiring this information because incentives can affect data integrity. In the proposed rule, FDA only required the submission of information about incentives for significant risk device investigations. In the final rule, FDA is requiring that information about incentives be made available upon request for non-significant risk and exempt device investigations. FDA has made this change because incentives could affect the integrity of all investigations.

(Comment 45) One comment recommended revising § 812.28(b)(10) to state, “a description of what incentives, if any, were provided to subjects to participate in the study, and that these incentives, if any, were approved by the IEC.”

(Response) FDA disagrees with the comment. FDA defines GCP to include the review and approval (or provision of a favorable opinion) by an IEC that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation. Ensuring the protection of human subjects would include review and approval of the incentives to be provided to subjects. An applicant's statement that an investigation was conducted in accordance with GCP would indicate that an IEC had approved (or provided a favorable opinion) of the incentives provided to subjects. Therefore, FDA believes the proposed revision is unnecessary.

9. Description of Study Monitoring

Proposed § 812.28(b)(11) would require submission of a description of how the sponsor monitored the study and ensured that the study was carried out consistently with the study protocol.

(Comment 46) One comment recommended including a statement supporting a sponsor's performance of a risk assessment to determine the approach to monitoring for sites outside the United States, as they would for sites in the United States, because standardization may cause more burdens (for example, resources, time, and cost) related to the requirement to increase monitoring.

(Response) FDA has not identified a specific GCP standard that sponsors and applicants must follow. Instead, the rule defines GCP and allows sponsors and applicants to determine an appropriate GCP standard for their investigations that produce data to support device research and marketing applications and submissions to FDA. Sponsors and applicants may use a risk-based approach to monitoring, as described in FDA's guidance document entitled “Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring,” provided it is consistent with the laws and regulations of the countries where the investigation takes place.

10. Description of Investigator Training and Signed Written Commitments

Proposed § 812.28(b)(12) would require submission of a description of how investigators were trained to comply with GCP and to conduct the study in accordance with the study protocol, and a statement on whether written commitments by investigators to comply with GCP and the protocol were obtained.

(Comment 47) One comment recommended that § 812.28(b)(12) only require that the investigator agree to comply with the protocol and with institutional and legal requirements. The principles of GCP do not require the sponsor to train investigators in GCP compliance.

(Response) FDA disagrees. Simply obtaining the investigator's agreement to comply with the protocol and institutional and legal requirements may not be adequate. Protocols may be complex and additional steps may be needed to prepare investigators and to standardize performance of the investigation. A description of the steps taken to ensure consistent conduct of the investigation and recording of data among investigators is needed. Such a description may identify investigator meetings or other steps that the sponsor took to ensure compliance with GCP and the protocol.

I. Record Retention

Proposed § 812.28(c), now § 812.28(d) in the final rule, would require a sponsor or applicant to maintain records for a clinical investigation conducted outside the United States. If the investigation supported an IDE, the records would be retained for 2 years after the termination or completion of the IDE. If the investigation supported a device marketing application or submission, the records would be retained for 2 years after an Agency decision on that submission or application.

The proposed rule would amend § 812.140(d) to include humanitarian device exemption applications and premarket notification submissions as types of applications and submissions that would require the maintenance of IDE records.

(Comment 48) One comment indicated that FDA should clarify in § 812.28(c)(2) (now § 812.28(d)(2)) that the requirement only applies to studies sponsored by the sponsor or applicant of the submission or application in which the data were submitted.

(Response) FDA disagrees with the comment. The requirement to maintain appropriate records is to ensure that FDA will be able to validate an investigation through an onsite inspection, if necessary. Therefore, the record retention requirement must apply to all investigations from which clinical data are submitted to FDA in support of an application or submission, whether or not the investigation was sponsored by the sponsor or applicant. If a sponsor or applicant submits data from a clinical investigation they did not sponsor, they should obtain the commitment of the sponsor and investigators to retain the records. If FDA needs access to the records and the records are not available, FDA may not accept the data in support of an IDE or device marketing application or submission.

(Comment 49) One comment recommended that proposed § 812.140(d) be changed to read similarly to proposed § 812.28(c), namely, “The date on which the investigation is terminated or completed or for 2 years after an agency decision on that submission or application.”

(Response) FDA disagrees with the proposed change. As noted in the preamble to the proposed rule, we are revising § 812.140(d) to indicate that retention requirements for IDE records apply to those records used to support HDE applications and 510(k) submissions, as well as the application types already listed. In the final rule, we also clarify that the retention requirements apply to records used to support requests for De Novo classifications. We do not intend to further change the record retention requirements for IDEs.

J. Denial or Withdrawal of PMA

Proposed §§ 814.45(a)(5) and 814.46(a)(4) would allow FDA to deny or withdraw, respectively, approval of a PMA if any clinical investigation subject to GCP referenced in § 814.15(a) and described in § 812.28(a) was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected or the supporting data were determined to be otherwise unreliable.

(Comment 50) Several comments stated that the proposed rule should allow denial or withdrawal of a PMA based only on those investigations relied on for a determination of safety and effectiveness. One comment noted that, for PMAs, reporting of all prior studies is required despite not relying on all studies for a determination of safety and effectiveness. Two comments indicated that denial and withdrawal of approval should not be extended to other applications and submissions such as IDEs and 510(k)s.

(Response) FDA agrees that the rule should allow denial or withdrawal of a PMA for noncompliance with GCP referenced in § 814.15(a) and described in § 812.28(a) with respect to those clinical investigations conducted outside the United States that were relied upon for a determination of the safety and effectiveness of the device. FDA notes that the PMA regulations (see § 814.20(b)(8)) require the applicant to provide, among other things, an identification, discussion, and analysis of any other data, information, or report relevant to an evaluation of the safety and effectiveness of the device, known to or that should reasonably be known to the applicant from any source, foreign or domestic, including information derived from investigations other than those proposed in the application and from commercial marketing experience. While this information is required to be submitted, the applicant or sponsor may not have been involved in the conduct of the investigation and may not know the conditions under which the investigation was conducted (for example, a previous developer or competitor may have been involved in the conduct of the investigation).

As explained elsewhere in this document, § 812.28(a) requires demonstration of conformity with GCP when data from clinical investigations conducted outside the United States are provided to support an IDE or a device marketing application or submission; for example, when clinical data are submitted in a PMA application to demonstrate a reasonable assurance of safety and effectiveness. When clinical data from investigations are included in applications and submissions as supplementary information and not as support, demonstration of conformity with GCP is not required.

FDA also notes that the rule only addresses denial and withdrawal of approval related to PMAs and does not address denial or withdrawal of authorization for other types of applications and submissions. However, if FDA determines that any clinical investigation conducted outside the United States and submitted in support of an IDE or a device marketing application or submission was represented to have been conducted in conformity with GCP but was not, FDA may take appropriate action under the FD&C Act and FDA regulations.

(Comment 51) Two comments noted data collected outside the United States but not in compliance with the principles of GCP may nevertheless be relevant data for determining the safety and effectiveness of a device. One comment noted that, elsewhere in the proposed rule, the use of non-GCP compliant studies is allowed where appropriate justification is provided.

(Response) As discussed in section IV.C, FDA agrees that clinical data from investigations conducted outside the United States that were not conducted in conformity with GCP may be relevant. FDA believes, however, that clinical data that are submitted to support a PMA should be credible, accurate, and ethically derived and that conducting a clinical investigation in accordance with GCP will help to ensure the integrity and quality of the data and the protection of subjects. If a country's laws require less than GCP and the applicant does not or cannot meet GCP for the investigation, the applicant may provide an explanation of the departure from GCP or request a waiver. FDA will take this information into account when considering the extent to which it will rely on the data from these investigations in support of a premarket submission or application on a case-by-case basis, depending on whether the clinical data are credible, accurate, and ethically derived. In such situations, when an applicant requests a waiver and FDA grants the waiver and accepts for support of a PMA clinical data from an investigation that was not conducted in conformity with GCP, FDA generally will not deny or withdraw approval of the PMA under § 814.45(a)(5) or § 814.46(a)(4).

(Comment 52) One comment stated that the sections on denial and withdrawal of a PMA use the term “unreliable” without clarifying this term and could make a determination of “unreliable” potentially arbitrary, variable, and inconsistent.

(Response) FDA disagrees with this comment. FDA has used the term “unreliable” in regulations such as in §§ 812.119 and 312.70 regarding investigator disqualification. FDA uses the term according to its common meaning and may consider data unreliable, for example, if the data are fraudulent or if there was a lack of rigor in the conduct of the investigation, such as not following the protocol.

K. Implementation

(Comment 53) Several comments raised concerns with the implementation of the rule and recommended that the rule not be applied retrospectively to investigations begun prior to the effective date. Two comments recommended that the effective date be established as 18 months after publication. The comments noted that adequate time will be needed to allow for preparation for implementation, such as to revise internal operating procedures, for training, for study planning, and for negotiating and contracting with the necessary parties for future studies conducted outside the United States that are intended to support an application or submission to FDA. One comment recommended that FDA allow requests for waivers of certain requirements for investigations conducted prior to the effective date that are technically out of compliance but did not compromise public health or patient safety.

(Response) FDA agrees that the rule should not be applied to clinical investigations begun prior to the effective date. FDA is implementing the rule for clinical investigations that enroll the first subject on or after the effective date of the rule. FDA also agrees that sponsors may need additional time to prepare to meet the new requirements. Therefore, the effective date is established as 1 year after the publication of the rule in the Federal Register to provide additional time for sponsors and applicants to make any changes necessary, for example, to their internal operating procedures, study planning, etc., to incorporate the principles of GCP and compliance with the requirements of the rule for investigations that will support an IDE or device marketing application or submission. We believe that this will provide adequate time for sponsors and applicants to implement changes in their processes to accommodate the new requirements.

In addition, FDA has added a waiver provision to § 812.28. Under this provision, a sponsor or applicant may submit waiver requests and FDA will decide whether to grant or deny waivers on a case-by-case basis, taking into account all appropriate circumstances.

For the purposes of this rule, we will consider a subject enrolled when the subject agrees to participate in a clinical investigation as indicated by the subject (or a subject's legally authorized representative, if the subject is unable to provide informed consent) signing the informed consent document(s) or participating in a clinical investigation meeting the requirements of § 50.24.

If an investigation conducted outside the United States enrolled the first subject prior to the rule's effective date, then the requirements in § 814.15 prior to the rule's effective date would apply. Specifically, if data from clinical investigations conducted outside the United States that enrolled the first subject prior to the effective date of this rule are submitted in support a PMA application, FDA will accept the data if the data are valid and the investigator has conducted the studies in conformance with the “Declaration of Helsinki” or the laws and regulations of the country in which the research is conducted, whichever accords greater protection to the human subjects. If the standards of the country are used, the applicant shall state in detail any differences between those standards and the “Declaration of Helsinki” and explain why they offer greater protection to the human subjects. (See § 814.15(b).)

L. Guidance Needed

(Comment 54) Two comments recommended that FDA develop guidance and training on GCP and compliance with the requirements. One comment recommended that FDA develop a guidance document similar to the one available for investigational new drug applications (INDs), “Guidance for Industry and FDA Staff: Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions,” to provide clarification and definitions to the regulations. Another comment suggested that FDA develop guidance documents and training programs, or sanction third-party training of physicians, sponsors, and IRBs on GCP as it relates to medical devices. The training programs should provide opportunities to eliminate misinterpretations while raising the standard for GCPs.

(Response) FDA agrees with some of these comments and believes our responses to comments on the proposed rule provide clarification on many issues. FDA intends to issue guidance that explains the requirements of the rule in plain language and how sponsors and applicants can comply with the requirements.

On its website, FDA has provided materials related to GCP training opportunities, including information about the annual GCP training course that FDA has conducted.1 All of these training materials focus on the regulations governing FDA-regulated clinical investigations. In addition, FDA has been participating, through the Clinical Trials Transformation Initiative, in the development of recommendations identifying principles for GCP training for investigators.2

1 Further information is available at: https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/EducationalMaterials/ucm112925.htm.

2https://www.ctti-clinicaltrials.org/what-we-do/study-start/gcp-training.

V. Legal Authority

We are issuing this rule under the authority of the provisions of the FD&C Act that apply to medical devices (21 U.S.C. 301 et seq.).

To permit devices to be shipped for investigational use, section 520(g) of the FD&C Act authorizes the exemption of investigational devices from otherwise applicable provisions of the FD&C Act relating to misbranding, registration, premarket notification, performance standards, premarket approval, banned devices, records and reporting requirements, good manufacturing practice requirements, and requirements relating to the use of color additives in devices. Under section 520(g) of the FD&C Act, the procedures and conditions that FDA 3 is authorized to prescribe for granting an IDE include the requirement that an application be submitted to FDA, in such form and manner as the Agency shall specify, and other requirements necessary for the protection of the public health and safety. Section 520(g) also requires that the information submitted in support of an IDE application be “adequate to justify the proposed clinical testing.” In investigations involving human subjects, the person applying for the exemption (the sponsor) must comply with a number of requirements to ensure that the rights and safety of subjects are adequately protected. To provide for flexibility in regulatory requirements, section 520(g) of the FD&C Act permits variations in the procedures and conditions governing IDEs, depending on the nature, scope, duration, and purpose of the clinical investigation.

3 In light of section 1003(d) of the FD&C Act (21 U.S.C. 393(d)) and the Secretary of Health and Human Services' delegation to the Commissioner of Food and Drugs, statutory references to “the Secretary” in the discussion of legal authority have been changed to “FDA” or the “Agency.”

Section 515(c)(1)(A) of the FD&C Act requires that PMA applications contain, among other information, full reports of all information, published or known to or which should reasonably be known to the PMA applicant, concerning investigations bearing on the safety or effectiveness of the device for which premarket approval is sought. Section 515(d)(2) of the FD&C Act states that FDA shall deny approval of a PMA application if the Agency finds that “there is a lack of a showing of reasonable assurance that such device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof” or “there is a lack of a showing of reasonable assurance that the device is effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof,” among other reasons. Whether data from an investigation involving human subjects support the safety or effectiveness of a device depends, in part, on whether the investigation was conducted in accordance with ethical and other principles that provide assurance of the quality and integrity of clinical data and adequate protection of human subjects. Even if the data derive from improperly conducted clinical investigations, the data must be submitted in a PMA application under section 515(c)(1)(A) of the FD&C Act.

Under section 510(k) of the FD&C Act, device manufacturers are required to submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution a device, unless the device is exempt from premarket notification. FDA reviews a premarket notification submission to determine whether the device is substantially equivalent to a legally marketed (predicate) device. Under section 513(i) of the FD&C Act, determinations of substantial equivalence include some inquiry into the comparable safety and effectiveness of the device, where appropriate. For devices that have the same intended use as the predicate device but different technological characteristics, information submitted to demonstrate substantial equivalence must include “appropriate clinical or scientific data[,] if deemed necessary” by FDA, showing that “the device is as safe and effective as a legally marketed device” and “does not raise different questions of safety and effectiveness than the predicate device.” As described in this document, whether data from a clinical investigation support the safety or effectiveness of a device—or, in the context of some premarket notifications, the comparable safety and effectiveness of a device as part of a substantial equivalence demonstration—depends in part on whether the investigation was conducted in accordance with ethical and other principles that provide assurance of the quality and integrity of clinical data and adequate protection of human subjects.

Under section 520(m) of the FD&C Act, as amended by the Cures Act in 2016, FDA may grant an HDE if FDA finds that the device: (1) Is designed to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the United States; (2) would not be available to a person with such disease or condition unless FDA grants the exemption and there is no comparable device, other than under this exemption, available to treat or diagnose such disease or condition; and (3) will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from the use of the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Again, whether data from clinical investigations submitted in an HDE application support that the probable benefits of the device outweigh its risks depends, in part, on whether the investigation was conducted in accordance with ethical and other principles that provide assurance of the quality and integrity of clinical data and adequate protection of human subjects.

Section 513(f)(2) of the FD&C Act authorizes the submission of a request for De Novo classification for a device for which there is no legally marketed device upon which to base a substantial equivalence determination, and authorizes FDA to classify the device subject to the request under the criteria set forth in section 513(a)(1) of the FD&C Act. Whether data from clinical investigations submitted in a request for De Novo classification support the recommended classification depends, in part, on whether the investigation was conducted in accordance with ethical and other principles that provide assurance of the quality and integrity of clinical data and adequate protection of human subjects.

Section 569B of the FD&C Act, which was added by the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) in 2012, requires FDA to accept data from clinical investigations conducted outside the United States, if the applicant demonstrates that such data are adequate under FDA's applicable standards to support clearance or approval of the device.

Section 701(a) of the FD&C Act authorizes the Agency to issue regulations for the efficient enforcement of the FD&C Act.

These statutory provisions authorize us to issue regulations describing when we may consider data from clinical investigations, whether conducted inside or outside the United States, as reliable evidence supporting an IDE, PMA, 510(k), PDP, request for De Novo classification, or HDE application or submission.

VI. Analysis of Environmental Impact

The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

VII. Economic Analysis of Impacts

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

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because small entities are not likely to incur more than one percent of their revenue in costs to comply with the final rule, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.

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

We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. The full analysis of economic impacts is available in the docket for this final rule (Ref. 1, Docket No. FDA-2013-N-0080) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

The final rule will require that data submitted by sponsors and applicants from clinical investigations conducted outside the United States to support an IDE application, a 510(k) submission, a request for De Novo classification, a PMA application, a PDP application, or an HDE application be from investigations conducted in accordance with GCP. We define GCP as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical investigations in a way that provides assurance that the data and results are credible and accurate and that the rights, safety, and well-being of subjects are protected. GCP includes the review and approval by an IEC before initiating an investigation, continuing IEC review of ongoing investigations, and obtaining and documenting the freely given informed consent of subjects. The changes require a statement regarding compliance with our regulations for human subject protection, IRBs, and IDEs when the investigations are conducted in the United States. With the above described changes, the rule is intended to update our standards of acceptance of data from clinical investigations and to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects.

We have not quantified the benefits of the final rule that would come from the greater assurance of clinical data quality and integrity and human subject protection, particularly as it pertains to clinical investigations conducted outside the United States. One-time costs would arise to learn the requirements of the rule, and annually recurring costs would arise from increased labor associated with obtaining, documenting, and maintaining records to meet the rule's requirements for those that did not already meet the requirements. Total estimated annualized costs of complying with these requirements, over 10 years, range from $0.8 million to $22.1 million with a 7 percent discount rate and range from $0.7 million to $22.0 million with a 3 percent discount rate.

Table 1 summarizes our estimate of the annualized costs and the annualized benefits of the final rule.

Table 1—Summary of Benefits, Costs and Distributional Effects of the Rule [$ millions] Category Primary
  • estimate
  • Low
  • estimate
  • High
  • estimate
  • Units Year
  • dollars
  • Discount
  • rate
  • (%)
  • Period
  • covered
  • (years)
  • Notes
    Benefits: Annualized 2016 7 10 Monetized $millions/year 2016 3 10 Annualized 2016 7 10 Quantified 2016 3 10 Qualitative Increased collection of information that provides greater assurance of clinical data quality and integrity and human subject protection. Costs: Annualized $7.4 $0.8 $22.1 2016 7 10 Monetized $millions/year 7.3 0.7 22.0 2016 3 10 Annualized 2016 7 10 Quantified 2016 3 10 Qualitative Transfers: Federal 2016 7 10 Annualized 2016 3 10 Monetized $millions/year From: To: Other 2016 7 10 Annualized 2016 3 10 Monetized $millions/year From: To: Effects: State, Local or Tribal Government: None. Small Business: None. Wages: None. Growth: None.

    Table 2 presents a summary of the Executive Order 13771 impacts of the final rule over an infinite time horizon.

    Table 2—E.O. 13771 Summary Table [In $ millions 2016 dollars, over an infinite time horizon] Primary
  • (7%)
  • Lower bound
  • (7%)
  • Upper bound
  • (7%)
  • Primary
  • (3%)
  • Lower bound
  • (3%)
  • Upper bound
  • (3%)
  • Present Value of Costs 101.7 7.9 311.6 232.0 13.0 721.7 Present Value of Cost Savings 0.0 0.0 0.0 0.0 0.0 0.0 Present Value of Net Costs 101.7 7.9 311.6 232.0 13.0 721.7 Annualized Costs 7.1 0.6 21.8 7.0 0.4 21.7 Annualized Cost Savings 0.0 0.0 0.0 0.0 0.0 0.0 Annualized Net Costs 7.1 0.6 21.8 7.0 0.4 21.7
    VIII. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

    Title: Human Subject Protection; Data Requirements for Medical Device Related Clinical Investigations (OMB control number 0910-0741)

    Description: In this document is a discussion of the regulatory provisions we believe are subject to the PRA and the probable information collection burden associated with these provisions.

    Description of Respondents: The reporting and recordkeeping requirements referenced in this document are imposed on a medical device sponsor or applicant.

    Section 807.87—Information Required in a Premarket Notification Submission (OMB Control Number 0910-0120)

    Section 807.87 is being amended to address requirements for 510(k) submissions supported by clinical data. For clinical investigations conducted in the United States, submitters will be required to submit a statement as described in § 807.87(j)(1). For clinical investigations conducted outside the United States, submitters will be required to submit the information as described in § 807.87(j)(2).

    Section 812.27—Report of Prior Investigations (OMB Control Number 0910-0078)

    Section 812.27 is being amended to address requirements for IDE applications supported by clinical data. For clinical investigations conducted in the United States, sponsors will be required to submit a statement as described in § 812.27(b)(4)(i). For clinical investigations conducted outside the United States, sponsors will be required to submit the information as described in § 812.27(b)(4)(ii).

    Section 812.28—Acceptance of Data From Clinical Investigations Conducted Outside the United States (OMB Control Number 0910-0078)

    Section 812.28 is being added to address the requirements for acceptance of foreign clinical data to support an IDE or a device marketing application or submission. The sponsor or applicant will be required to submit a statement as described in § 812.28(a)(1); provide a description of the actions the sponsor or applicant took to ensure that the research conformed to GCP that includes the information in § 812.28(b)(1) through (12) or a cross-reference to another section of the application or submission where the information is located; submit requests for waivers as described in § 812.28(c); and retain the records as described in § 812.28(d).

    Section 812.140—Records Retention (OMB Control Number 0910-0078)

    Section 812.140 is being amended to address record retention requirements for investigators and sponsors. An investigator or sponsor will be required to maintain records as described in § 812.140(d).

    Section 814.20—Application (OMB Control Number 0910-0231)

    Section 814.20 is being amended to address requirements for a PMA application supported by data from clinical investigations conducted outside the United States. The applicant will be required to submit the information as described in § 814.20(b)(6)(ii)(C).

    Section 814.104—Original Applications (OMB Control Number 0910-0332)

    Section 814.104 is being amended to address submission of data from clinical investigations in an HDE application. To the extent the applicant includes data from clinical investigations, the applicant will be required to include the information and statements as described in § 814.104(b)(4)(i).

    Table 3—Estimated Annual Reporting Burden 1 21 CFR section/activity Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average burden
  • per response
  • Total hours
    807.87(j)—Human subject protection statement and information in a premarket notification submission supported by clinical data 1,500 1 1,500 .25 (15 minutes) 375 812.27(b)(4)(i)—Report of prior investigations; U.S 400 1 400 1 400 812.27(b)(4)(ii)—Report of prior investigations; outside the U.S 100 1 100 .25 (15 minutes) 25 812.28(a)(1)—Data from clinical investigations 2 1,500 1 1,500 .25 (15 minutes) 375 812.28(b)—Description regarding GCP 2 1,500 1 1,500 10 15,000 812.28(c)—Waivers 2 10 1 10 1 10 814.20—Application information 10 1 10 .50 (30 minutes) 5 814.104—Original applications statements and information 10 1 10 8 80 Total 16,270 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 No precise data is available for requests for De Novo classifications.
    Table 4—Estimated Annual Recordkeeping Burden 1 21 CFR section/activity Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total annual
  • records
  • Average
  • burden per
  • recordkeeping
  • Total hours
    812.28(d)—Records from clinical investigations conducted outside the United States 2 1,500 1 1,500 1 1,500 812.140—Retention period 10 1 10 1 10 Total 1,510 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 No precise data is available for requests for De Novo classifications.

    The total estimated burden imposed by these information collection requirements is 17,780 annual hours. The estimated burden is based on the most recent empirical data in the relevant collections with the numbers updated to reflect the current burden of these requirements.

    It should be noted that while the information collection requirements referenced in this document are revisions to current approved information collections, these collection requirements are being submitted to OMB as a new information collection (OMB control number 0910-0741), with the expectation the currently approved requirements will be amended. As such the following collections of information will be amended and submitted to OMB for approval as revisions to currently approved information collections once the rule is finalized and the collections are due for renewal. The collections to be amended include: Investigational Device Exemptions Reports and Records—21 CFR part 812, OMB control number 0910-0078; Premarket Notification—21 CFR part 807, subpart E, OMB control number 0910-0120; Premarket Approval of Medical Devices—21 CFR part 814, subparts A through E, OMB control number 0910-0231; and Medical Devices: Humanitarian Use Devices—21 CFR part 814, subpart H, OMB control number 0910-0332.

    The information collection provisions in this final rule have been submitted to OMB for review as required by section 3507(d) of the PRA.

    Before the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. 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.

    IX. Federalism

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

    X. Reference

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

    1. Regulatory Impact Analysis of the Final Rule to Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices, Docket No. FDA-2013-N-0080. List of Subjects 21 CFR Part 807

    Confidential business information, Imports, Medical devices, Reporting and recordkeeping requirements.

    21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and recordkeeping requirements.

    21 CFR Part 814

    Administrative practice and procedure, Confidential business information, Medical devices, Medical research, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 807, 812, and 814 are amended as follows:

    PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 1. The authority citation for part 807 is revised to read as follows: Authority:

    21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 360j, 360bbb-8b, 371, 374, 381, 393; 42 U.S.C. 264, 271.

    2. Section 807.87 is amended by redesignating paragraphs (j), (k), and (l) as paragraphs (k), (l), and (m), respectively, and by adding new paragraph (j) to read as follows:
    § 807.87 Information required in a premarket notification submission.

    (j) For a submission supported by clinical data:

    (1) If the data are from clinical investigations conducted in the United States, a statement that each investigation was conducted in compliance with applicable requirements in the protection of human subjects regulations in part 50 of this chapter, the institutional review boards regulations in part 56 of this chapter, or was not subject to the regulations under § 56.104 or § 56.105, and the investigational device exemptions regulations in part 812 of this chapter, or if the investigation was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance.

    (2) If the data are from clinical investigations conducted outside the United States, the requirements under § 812.28 of this chapter apply. If any such investigation was not conducted in accordance with good clinical practice (GCP) as described in § 812.28(a) of this chapter, include either a waiver request in accordance with § 812.28(c) of the chapter or a brief statement of the reason for not conducting the investigation in accordance with GCP and a description of steps taken to ensure that the data and results are credible and accurate and that the rights, safety, and well-being of subjects have been adequately protected.

    PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS 3. The authority citation for part 812 is revised to read as follows: Authority:

    21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360bbb-8b, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b-263n.

    4. Section 812.3 is amended by adding paragraph (t) to read as follows:
    § 812.3 Definitions.

    (t) Independent ethics committee (IEC) means an independent review panel that is responsible for ensuring the protection of the rights, safety, and well-being of subjects involved in a clinical investigation and is adequately constituted to ensure that protection. An institutional review board (IRB), as defined in paragraph (f) of this section and subject to the requirements of part 56 of this chapter, is one type of IEC.

    5. Section 812.27 is amended by adding paragraph (b)(4) to read as follows:
    § 812.27 Report of prior investigations.

    (b) * * *

    (4)(i) If data from clinical investigations conducted in the United States are provided, a statement that each investigation was conducted in compliance with applicable requirements in the protection of human subjects regulations in part 50 of this chapter, the institutional review boards regulations in part 56 of this chapter, or was not subject to the regulations under § 56.104 or § 56.105, and the investigational device exemptions regulations in this part, or if any such investigation was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance. Failure or inability to comply with these requirements does not justify failure to provide information on a relevant clinical investigation.

    (ii) If data from clinical investigations conducted outside the United States are provided to support the IDE, the requirements under § 812.28 apply. If any such investigation was not conducted in accordance with good clinical practice (GCP) as described in § 812.28(a), the report of prior investigations shall include either a waiver request in accordance with § 812.28(c) or a brief statement of the reason for not conducting the investigation in accordance with GCP and a description of steps taken to ensure that the data and results are credible and accurate and that the rights, safety, and well-being of subjects have been adequately protected. Failure or inability to comply with these requirements does not justify failure to provide information on a relevant clinical investigation.

    6. Section 812.28 is added to subpart B to read as follows:
    § 812.28 Acceptance of data from clinical investigations conducted outside the United States.

    (a) Acceptance of data from clinical investigations conducted outside the United States to support an IDE or a device marketing application or submission (an application under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act, a premarket notification submission under section 510(k) of the Federal Food, Drug, and Cosmetic Act, or a request for De Novo classification under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act). FDA will accept information on a clinical investigation conducted outside the United States to support an IDE or a device marketing application or submission if the investigation is well-designed and well-conducted and the following conditions are met:

    (1) A statement is provided that the investigation was conducted in accordance with good clinical practice (GCP). For the purposes of this section, GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical investigations in a way that provides assurance that the data and results are credible and accurate and that the rights, safety, and well-being of subjects are protected. GCP includes review and approval (or provision of a favorable opinion) by an independent ethics committee (IEC) before initiating an investigation, continuing review of an ongoing investigation by an IEC, and obtaining and documenting the freely given informed consent of the subject (or a subject's legally authorized representative, if the subject is unable to provide informed consent) before initiating an investigation. GCP does not require informed consent in life-threatening situations when the IEC reviewing the investigation finds, before initiation of the investigation, that informed consent is not feasible and either that the conditions present are consistent with those described in § 50.23 or § 50.24(a) of this chapter, or that the measures described in the protocol or elsewhere will protect the rights, safety, and well-being of subjects.

    (2) In addition to the information required elsewhere in parts 807, 812, and 814 of this chapter, as applicable, the information in paragraph (b) of this section is submitted, as follows:

    (i) For an investigation of a significant risk device, as defined in § 812.3(m), the supporting information as described in paragraph (b) of this section is submitted.

    (ii) For an investigation of a device, other than a significant risk device, the supporting information as described in paragraphs (b)(1), (4), (5), (7) through (9), and (11) of this section is submitted, and the supporting information as described in paragraph (b)(10) of this section and the rationale for determining the investigation is of a device other than a significant risk device are made available for agency review upon request by FDA.

    (iii) For a device investigation that meets the exemption criteria in § 812.2(c), the supporting information as described in paragraphs (b)(1), (4), (5), (7) through (11) of this section and the rationale for determining the investigation meets the exemption criteria in § 812.2(c) are made available for agency review upon request by FDA.

    (3) FDA is able to validate the data from the investigation through an onsite inspection, or through other appropriate means, if the agency deems it necessary.

    (b) Supporting information. A sponsor or applicant who submits data from a clinical investigation conducted outside the United States to support an IDE or a device marketing application or submission, in addition to information required elsewhere in parts 807, 812, and 814 of this chapter, as applicable, shall provide a description of the actions the sponsor or applicant took to ensure that the research conformed to GCP as described in paragraph (a)(1) of this section. The description is not required to duplicate information already submitted in the application or submission. Instead, the description must provide either the following information, as specified in paragraph (a)(2) of this section, or a cross-reference to another section of the application or submission where the information is located:

    (1) The names of the investigators and the names and addresses of the research facilities and sites where records relating to the investigation are maintained;

    (2) The investigator's qualifications;

    (3) A description of the research facility(ies);

    (4) A detailed summary of the protocol and results of the investigation and, should FDA request, case records maintained by the investigator or additional background data such as hospital or other institutional records;

    (5) Either a statement that the device used in the investigation conducted outside the United States is identical to the device that is the subject of the submission or application, or a detailed description of the device and each important component (including all materials and specifications), ingredient, property, and principle of operation of the device used in the investigation conducted outside the United States and a comparison to the device that is the subject of the submission or application that indicates how the device used in the investigation is similar to and/or different from the device that is the subject of the submission or application;

    (6) If the investigation is intended to support the safety and effectiveness of a device, a discussion demonstrating that the data and information constitute valid scientific evidence within the meaning of § 860.7 of this chapter;

    (7) The name and address of the IEC that reviewed the investigation and a statement that the IEC meets the definition in § 812.3(t). The sponsor or applicant must maintain records supporting such statement, including records describing the qualifications of IEC members, and make these records available for agency review upon request;

    (8) A summary of the IEC's decision to approve or modify and approve the investigation, or to provide a favorable opinion;

    (9) A description of how informed consent was obtained;

    (10) A description of what incentives, if any, were provided to subjects to participate in the investigation;

    (11) A description of how the sponsor(s) monitored the investigation and ensured that the investigation was carried out consistently with the protocol; and

    (12) A description of how investigators were trained to comply with GCP (as described in paragraph (a)(1) of this section) and to conduct the investigation in accordance with the protocol, and a statement on whether written commitments by investigators to comply with GCP and the protocol were obtained. Any signed written commitments by investigators must be maintained by the sponsor or applicant and made available for agency review upon request.

    (c) Waivers. (1) A sponsor or applicant may ask FDA to waive any applicable requirements under paragraphs (a)(1) and (b) of this section. A waiver request may be submitted in an IDE or in an amendment or supplement to an IDE, in a device marketing application or submission (an application under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act, a premarket notification submission under section 510(k) of the Federal Food, Drug, and Cosmetic Act, or a request for De Novo classification under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act) or in an amendment or supplement to a device marketing application or submission, or in a pre-submission. A waiver request is required to contain at least one of the following:

    (i) An explanation why the sponsor's or applicant's compliance with the requirement is unnecessary or cannot be achieved;

    (ii) A description of an alternative submission or course of action that satisfies the purpose of the requirement; or

    (iii) Other information justifying a waiver.

    (2) FDA may grant a waiver if it finds that doing so would be in the interest of the public health.

    (d) Records. A sponsor or applicant must retain the records required by this section for a clinical investigation conducted outside the United States as follows:

    (1) If the investigation is submitted in support of an IDE, for 2 years after the termination or completion of the IDE; and

    (2) If the investigation is submitted in support of a premarket approval application, a notice of completion of a product development protocol, a humanitarian device exemption application, a premarket notification submission, or a request for De Novo classification, for 2 years after an agency decision on that submission or application.

    (e) Clinical investigations conducted outside of the United States that do not meet conditions. For clinical investigations conducted outside the United States that do not meet the conditions under paragraph (a) of this section, FDA may accept the information from such clinical investigations to support an IDE or a device marketing application or submission if FDA believes that the data and results from such clinical investigation are credible and accurate and that the rights, safety, and well-being of subjects have been adequately protected.

    7. Section 812.140 is amended by revising paragraph (d) to read as follows:
    § 812.140 Records.

    (d) Retention period. An investigator or sponsor shall maintain the records required by this subpart during the investigation and for a period of 2 years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application, a notice of completion of a product development protocol, a humanitarian device exemption application, a premarket notification submission, or a request for De Novo classification.

    PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES 8. The authority citation for part 814 is revised to read as follows: Authority:

    21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 381.

    9. Section 814.15 is amended by revising paragraph (a); by removing paragraphs (b) and (c); by redesignating paragraphs (d) and (e) as paragraphs (b) and (c), respectively; and by removing the parenthetical sentence at the end of the section to read as follows:
    § 814.15 Research conducted outside the United States.

    (a) Data to support PMA. If data from clinical investigations conducted outside the United States are submitted to support a PMA, the applicant shall comply with the provisions in § 812.28 of this chapter, as applicable.

    10. Section 814.20 is amended by revising paragraphs (b)(6)(ii)(A) and (B) and adding paragraph (b)(6)(ii)(C) to read as follows:
    § 814.20 Application.

    (b) * * *

    (6) * * *

    (ii) * * *

    (A) For clinical investigations conducted in the United States, a statement with respect to each investigation that it either was conducted in compliance with the institutional review board regulations in part 56 of this chapter, or was not subject to the regulations under § 56.104 or § 56.105, and that it was conducted in compliance with the informed consent regulations in part 50 of this chapter; or if the investigation was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance. Failure or inability to comply with these requirements does not justify failure to provide information on a relevant clinical investigation.

    (B) For clinical investigations conducted in the United States, a statement that each investigation was conducted in compliance with part 812 of this chapter concerning sponsors of clinical investigations and clinical investigators, or if the investigation was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance. Failure or inability to comply with these requirements does not justify failure to provide information on a relevant clinical investigation.

    (C) For clinical investigations conducted outside the United States that are intended to support the PMA, the requirements under § 812.28 of this chapter apply. If any such investigation was not conducted in accordance with good clinical practice (GCP) as described in § 812.28(a), include either a waiver request in accordance with § 812.28(c) or a brief statement of the reason for not conducting the investigation in accordance with GCP and a description of steps taken to ensure that the data and results are credible and accurate and that the rights, safety, and well-being of subjects have been adequately protected. Failure or inability to comply with these requirements does not justify failure to provide information on a relevant clinical investigation.

    11. Section 814.45 is amended by revising paragraph (a)(5) to read as follows:
    § 814.45 Denial of approval of a PMA.

    (a) * * *

    (5) Any clinical investigation involving human subjects described in the PMA, subject to the institutional review board regulations in part 56 of this chapter or informed consent regulations in part 50 of this chapter or GCP referenced in § 814.15(a) and described in § 812.28(a) of this chapter, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected or the supporting data were determined to be otherwise unreliable.

    12. Section 814.46 is amended by revising paragraph (a)(4) to read as follows:
    § 814.46 Withdrawal of approval of a PMA.

    (a) * * *

    (4) Any clinical investigation involving human subjects described in the PMA, subject to the institutional review board regulations in part 56 of this chapter or informed consent regulations in part 50 of this chapter or GCP referenced in § 814.15(a) and described in § 812.28(a) of this chapter, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected or the supporting data were determined to be otherwise unreliable.

    13. Section 814.104 is amended by revising paragraph (b)(4)(i) to read as follows:
    § 814.104 Original applications.

    (b) * * *

    (4) * * *

    (i) In lieu of the summaries, conclusions, and results from clinical investigations required under § 814.20(b)(3)(v)(B), (b)(3)(vi), and the introductory text of (b)(6)(ii), the applicant shall include the summaries, conclusions, and results of all clinical experience or investigations (whether adverse or supportive) reasonably obtainable by the applicant that are relevant to an assessment of the risks and probable benefits of the device and to the extent the applicant includes data from clinical investigations, the applicant shall include the statements described in § 814.20(b)(6)(ii)(A) and (B) with respect to clinical investigations conducted in the United States and the information described in § 814.20(b)(6)(ii)(C) with respect to clinical investigations conducted outside the United States; and

    Dated: February 13, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-03244 Filed 2-20-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 2002 [Docket No. FR-6048-F-01] Streamlining the Office of Inspector General's Freedom of Information Act Regulations and Implementing the FOIA Improvement Act of 2016 AGENCY:

    Office of Inspector General, HUD.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule amends the Freedom of Information Act (FOIA) regulations for the U.S. Department of Housing and Urban Development (HUD) Office of Inspector General (OIG) to align with HUD's FOIA regulations, to implement the FOIA Improvement Act of 2016, and to explain current OIG policies and practices with respect to FOIA.

    DATES:

    Effective: March 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Maura Malone; Deputy Counsel to the Inspector General; Department of Housing and Urban Development; 451 Seventh Street SW, Room 8260, Washington, DC 20410; 202-708-1613 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).

    SUPPLEMENTARY INFORMATION:

    I. Background

    In July 1967, HUD issued regulations at 24 CFR part 15 containing the policies and procedures governing public access to HUD records under the Freedom of Information Act (FOIA) (5 U.S.C. 552) (Pub. L. 89-487, approved July 4, 1966). The Inspector General Act of 1978 (5 U.S.C. App. 3) was enacted to “create independent and objective units” to perform investigative and monitoring functions within Executive agencies of the Federal Government, including HUD. HUD's regulations regarding public access to HUD records under the FOIA are at 24 CFR part 15. To further its independence, OIG officials, as opposed to HUD officials, make determinations concerning the release of OIG records. In 1984, the HUD OIG published 24 CFR part 2002, which explains the procedures for requesting information from the OIG under the FOIA. Part 2002 cross referenced several of HUD's regulations at 24 CFR part 15. The OIG last amended its FOIA regulations in July 2002 (67 FR 47216). Subsequently, HUD made several changes to its FOIA regulation, which has affected some of the regulations referenced in part 2002 (80 FR 49140).

    On June 30, 2016, the President signed into law the FOIA Improvement Act of 2016 (2016 Act) (Pub. L. 114-185). The 2016 Act addresses a range of procedural issues, including requirements that agencies establish a minimum of 90 days for requesters to file an administrative appeal and that agencies provide dispute resolution services at various times throughout the FOIA process. The 2016 Act also codifies a “foreseeable harm” standard, amends a FOIA disclosure exemption, creates a new Chief FOIA Officer Council within the Executive Branch, and adds two new elements to agency Annual FOIA Reports. The amendments apply to any request made after the date of enactment. The 2016 Act also requires agencies to review and issue updated regulations on procedures for the disclosure of records under FOIA, in accordance with the amendments made by the 2016 Act. On January 12, 2017, HUD issued a direct final rule amending its FOIA regulation to reflect the 2016 Act amendments (82 FR 3619).

    II. Changes Made in This Final Rule

    In this final rule, the HUD OIG seeks to amend its FOIA regulations to address the 2016 Act changes, conform its regulations with HUD's, and simplify its regulations to make the process clearer to the requesting public. The following is an overview of nontechnical changes made in this final rule:

    Section 2002.3 OIG's Overall Policy Concerning Disclosable Records

    The OIG adds the title and contact information for the FOIA Public Liaison that is available to answer questions for FOIA requesters, as required by the 2016 Act.

    Section 2002.5 How To Make a Request for OIG Records; Records Produced

    This section is updated to provide for requests to be made in writing, which aligns with HUD's FOIA regulations, and provides that such requests may be made using the OIG public website. The regulations also reflect the requirement that the requestor, when requesting records on themselves, may be required to identify themselves when making a request or such a request may be found insufficient and closed. Lastly, the OIG also clarifies that for purposes of reasonably describing a record, a more specific FOIA request will likely result in the OIG locating the records requested. The OIG notes that a request for “any and all” records over an extended period of time may be rejected for not reasonably describing the record.

    Section 2002.7 OIG Processing of Requests, Multi-Tracking, and Expedited Processing

    This rule provides the tracking process for requests that qualify as unusual circumstance under the definition at 5 U.S.C. 552(a)(6)(B)(iii). In adding the definition, the OIG adds an example of audit work papers under the definition of “unusual circumstances” to clarify that requests for audit work papers usually qualify as unusual circumstances and take longer than 20 working days to process because work papers related to an audit, if it is accepted for processing as a proper request, generally take weeks or months to process.

    Section 2002.9 Proactive Disclosures of Records

    The 2016 Act requires agencies to “make available for public inspection in an electronic format” records that, because of their subject matter, the agency determines “have become or are likely to become the subject of subsequent requests for substantially the same records,” or that have been requested 3 or more times. The 2016 Act also adds new reporting requirements for agencies by requiring that agencies submit an Annual FOIA Report, which covers the preceding fiscal year, to be submitted to the Director of the Office of Government Information Services.1 The raw statistical data used in each report must be made available without charge, license, or registration requirement; in an aggregated, searchable format, and in a format that may be downloaded in bulk. Both the report and the raw statistical data used in the report must be made available for public inspection in an electronic format. In response, the OIG is amending § 2002.9 to comply with these requirements.

    1 Under FOIA, agencies are also required to submit an Annual FOIA Report to the Attorney General of the United States (5 U.S.C. 552(e)(1)).

    Section 2002.13 Fee Schedule, Advance Payment, Interest Charges, and Waiving or Reducing Fees

    This rule amends § 2002.13 to adopt HUD's fee schedule and policies in their entirety through cross-reference to HUD's FOIA regulation at § 15.106. Incorporated in HUD's regulations are the 2016 Act new provisions regarding agencies' ability to assess search and duplication fees. First, the 2016 Act provides that an agency shall not assess any search fees, or in some cases, duplication fees, if the agency has failed to comply with any time limit described at 5 U.S.C. 552(a)(6), which are set out in OIG's FOIA regulations at § 2002.15, with limited exceptions. Second, if an agency determines that unusual circumstances apply to the processing of a FOIA request, and the agency has provided timely written notice to the requester, then a delayed response time is excused for an additional 10 days; however, if the agency fails to comply with the extended time limit, it may not charge search fees, or, in some cases, duplication fees, with limited exceptions. Third, the 2016 Act provides an exception allowing agencies to charge search fees, or in some cases, duplication fees, if unusual circumstances apply, more than 5,000 pages are necessary to respond to the request, timely written notice has been made to the requester, and the agency has discussed with the requester via written mail, electronic mail, or telephone (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request. Fourth, the 2016 Act maintains that if a court determines that “exceptional circumstances” exist, as defined in 5 U.S.C. 552(a)(6)(C), the agency's failure to comply with a time limit “shall be excused for the length of time provided by the court order.”

    As for the definition of “commercial requesters” adopted from HUD's regulation, the OIG clarifies that as a policy, it will treat owners of websites that contain advertisements, or that charge fees in any way, to be “commercial requesters,” if they do not use editorial skills to turn the posted materials into a distinct work, or provide significant editorial comments. Owners of websites that do not contain advertisements, but that post requested documents without altering such documents or providing editorial comments, will be considered “other requesters,” unless the websites are used to advertise or publicize the skills or expertise of the owners.

    This rule also removes OIG's existing FOIA regulations at § 2002.13 because the collecting of interest charges on any unpaid bills is consistent with HUD's FOIA regulations at § 15.106(g).

    Section 2002.15 Time Limitations

    When a FOIA request involves “unusual circumstances,” agencies have long been required to provide written notice to the requester, and in those instances where an extension of time of more than 10 working days is specified, agencies have been required to provide the requester with an opportunity to limit the scope of the request so that it can be processed more quickly or to arrange an alternative time to respond. The 2016 Act adds an additional requirement that when unusual circumstances exist and an agency extends the time limits by more than 10 additional working days, in the written notice to the requester they must notify the requester of their right to seek dispute resolution services from the FOIA Public Liaison of the agency or the Office of Government Information Services. To address this requirement, the OIG is revising § 2002.15 to incorporate the change enacted by the 2016 Act.

    The OIG is also using this final rule to update several specific provisions of § 2002.15 to more accurately reflect the statutory language in 5 U.S.C. 552(a)(6)(A)(i). First, the OIG is amending § 2002.15(a) to state that OIG will generally “make a determination whether to comply with a FOIA request within 20 working days.” Second, the OIG is amending the provision that addresses when OIG may extend the time periods for processing a FOIA request, to remove the sentence that limits extensions to 10 working days. The OIG is removing this language as inconsistent with the plain reading of the statute, the logic of the rest of the language in § 2002.15, and Department of Justice guidance.2 Finally, in accordance with 5 U.S.C. 552(a)(6)(B)(ii), the OIG is updating § 2002.15 to include the provision that the OIG shall make available its FOIA Public Liaison, who shall assist in the resolution of any disputes between the requester and the OIG.

    2See Department of Justice Guide to the Freedom of Information Act, https://www.justice.gov/oip/doj-guide-freedom-information-act-0.

    When an agency makes a determination regarding whether to comply with a FOIA request, the 2016 Act provides that the agency is required to immediately notify the requester of such determination and the reasons therefore, and notify the requester that they have a right to seek assistance from the agency's FOIA Public Liaison. For adverse determinations, the 2016 Act requires that agencies afford the requester no less than 90 days from the date of the adverse determination on the request to file an appeal. In addition, the 2016 Act requires that agencies notify the requester that they may seek dispute resolution services from the FOIA Public Liaison or from the Office of Government Information Services. Consistent with this requirement, the OIG has revised § 2002.15 to provide that, once OIG makes a determination regarding compliance, the OIG will immediately notify the requester of such determination, the reasons therefore, and their right to seek assistance from the FOIA Public Liaison.

    Section 2002.19 Authority To Deny Requests for Records and Form of Denial, Exemptions, and Exclusions

    The 2016 Act requires that agencies withhold information under FOIA “only if the agency reasonably foresees that disclosure would harm an interest protected by an exemption” or if disclosure is prohibited by law. The 2016 Act further directs agencies to consider whether partial disclosure of information is possible whenever the agency determines that a full disclosure of a requested record is not possible, and to take reasonable steps necessary to segregate and release nonexempt information. The 2016 Act does not require disclosure of information that is otherwise prohibited from disclosure by law or otherwise exempted from disclosure under Exemption 3.

    Consistent with these changes, the OIG is amending § 2002.19 to provide that the OIG shall withhold information only if it is reasonably foreseeable that disclosure would harm an interest protected by an exemption, or if disclosure is prohibited by law. The OIG will also consider whether partial disclosure of information is possible if it determines that a full disclosure of a requested record is not possible and will take reasonable steps necessary to segregate and release nonexempt information.

    In addition, the 2016 Act amends Exemption 5 of FOIA to provide that the deliberative process privilege does not apply to records created 25 years or more before the date on which the records were requested. In accordance with the 2016 Act, the OIG is revising § 2002.19 to state that the deliberative process privilege “shall not apply to records created 25 years or more before the date on which the records were requested.”

    For adverse determinations, the OIG is amending § 2002.19 to provide that the OIG will notify the requester of their right to file an appeal no less than 90 days after the date of receiving the adverse determination. Finally, the OIG is amending § 2002.19 to provide that the OIG will notify the requester of their right to seek dispute resolution services from the FOIA Public Liaison or from the Office of Government Information Services.

    Section 2002.23 Administrative Review

    The OIG amends § 2002.23, consistent with the 2016 Act to provide that the OIG will notify requesters of dispute resolution services in its FOIA appeal determination response letter and that they have 90 days to seek an appeal. The OIG is also amending § 2002.23 to clarify that appeals may be submitted electronically and lists the items that a requestor should include in an appeal, such as a copy of the original request and the written denial.

    III. Justification for Final Rulemaking

    In general, OIG publishes a rule for public comment before issuing a rule for effect, in accordance with OIG's regulations on rulemaking at 24 CFR part 10. Section 10.1, however, provides an exception from that general rule where OIG finds good cause to omit advance notice and public participation. The good cause requirement is satisfied when the prior public procedure is “impracticable, unnecessary or contrary to the public interest.”

    The OIG finds that good cause exists to publish this rule for effect without first soliciting public comment because prior public comment is unnecessary. This final rule follows the statutory directive in section 3 of the 2016 Act, which requires agencies to review and issue updated regulations on procedures for the disclosure of records under FOIA, in accordance with the amendments made by the 2016 Act. The 2016 Act codifies a number of transparency and openness principles and enacts a number of procedural requirements, including requiring that agencies establish a minimum of 90 days for requesters to file an administrative appeal and that they provide dispute resolution services at various times throughout FOIA process. This final rule reflects the changes required by the 2016 Act. Additionally, this final rule makes technical amendments to align the OIG's FOIA regulation with HUD's FOIA regulation at 24 CFR part 15 and clarifies current OIG FOIA procedures to streamline and simplify the process of filing FOIA requests.

    IV. Findings and Certifications Executive Order 12866 and Executive Order 13563

    Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if the regulation is necessary, to select the regulatory approach that maximizes net benefits. This final rule incorporates changes enacted by the 2016 Act and makes other minor procedural changes that align this OIG regulation to HUD's FOIA regulation at 24 CFR part 15. As a result, this rule was determined to not be a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and therefore was not reviewed by OMB.

    Environmental Review

    This final rule is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321). The revision of the FOIA-related provisions of 24 CFR part 2002 falls within the exclusion provided by 24 CFR 50.19(c)(1), in that it does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern or regulate real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction; or establish, revise, or provide for standards for construction or construction materials, manufactured housing, or occupancy.

    Regulatory Flexibility Act

    The Secretary, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this final rule before publication and by approving it certifies that this rule does not have a significant economic impact on a substantial number of small entities. This final rule contains no anti-competitive discriminatory aspects with regard to small entities nor are there any unusual procedures that would need to be complied with by small entities.

    Executive Order 13132, Federalism

    Executive Order 13132 (entitled “Federalism”) prohibits an agency, to the extent practicable and permitted by law, from promulgating a regulation that has federalism implications and either imposes substantial direct compliance costs on State and local governments and is not required by statute, or preempts State law, unless the agency meets the relevant requirements of section 6 of the Executive Order. This final rule does not have federalism implications and does not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.

    Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This final rule does not impose any Federal mandates on any State, local, or tribal governments or the private sector within the meaning of the Unfunded Mandates Reform Act of 1995.

    List of Subjects in 24 CFR Part 2002

    Release of information under the Freedom of Information Act.

    Accordingly, for the reasons stated above, OIG revises 24 CFR part 2002 to read as follows: PART 2002—AVAILABILITY OF INFORMATION TO THE PUBLIC Sec. 2002.1 Scope of this part and applicability of other HUD regulations. 2002.3 OIG's overall policy concerning disclosable records and requests for OIG records. 2002.5 How to make a request for OIG records; records produced. 2002.7 OIG processing of requests, multi-tracking, and expedited processing. 2002.9 Proactive disclosures of records. 2002.11 Agency review of records and aggregating requests. 2002.13 Fee schedule, advance payment, and waiving or reducing fees. 2002.15 Time limitations. 2002.17 Authority to release records or duplications. 2002.19 Authority to deny requests for records and form of denial, exemptions, and exclusions. 2002.21 Effect of denial of request. 2002.23 Administrative review. Authority:

    5 U.S.C. 552; 5 U.S.C. App. 3; 42 U.S.C. 3535(d); Delegation of Authority, 46 FR 2389.

    § 2002.1 Scope of this part and applicability of other HUD regulations.

    (a) General. This part contains the regulations of the Office of Inspector General (OIG) that implement the Freedom of Information Act (FOIA) (5 U.S.C. 552). It informs the public how to request records and information from the OIG and explains the procedure to use if a request is denied. Requests made by individuals for records about themselves under the Privacy Act of 1974, 5 U.S.C. 552a, are processed in accordance with 24 CFR part 2003 as well as this part. Requests for documents made by subpoena or other demands of courts or other authorities are governed by procedures contained in part 2004 of this chapter. These rules should be read in conjunction with the text of the FOIA and the Uniform Freedom of Information Fee Schedule and Guidelines published by the Office of Management and Budget. This policy does not create any right enforceable in court.

    (b) Applicability of HUD's FOIA regulations. In addition to the regulations in this part, §§ 15.2 and 15.106 of this title apply to the production or disclosure of information in the possession of the OIG, except as limited in paragraph (c) of this section or otherwise expressly stated in this part.

    (c) Limited applicability of §§ 15.2 and 15.106 of this title. The OIG has different people and entities involved in the FOIA process than those defined in § 15.2 and these people and entities are specifically identified in this part. For purposes of this part, when the words “HUD” or “Department” are used in § 15.2 or § 15.106, the term means the OIG. The OIG will follow the fee schedule at § 15.106 except as otherwise provided in this part. Where § 15.106 references § 15.103, the OIG reference in this part is § 2002.15.

    § 2002.3 OIG's overall policy concerning disclosable records.

    (a) The OIG will administer its FOIA program with a presumption of openness. This policy does not create any right enforceable in court. The OIG will fully and responsibly disclose its identifiable records and information consistent with competing public interests, such as national security, personal privacy, grand jury and investigative secrecy, complainant confidentiality, and agency deliberative process, as are recognized by FOIA and other Federal statutes. The OIG will apply the FOIA exemptions if release could foreseeably harm an interest protected by a FOIA exemption. Release of records will be made as promptly as possible.

    (b) The OIG FOIA Public Liaison is the Deputy Counsel to the Inspector General. Requesters who have questions or comments concerning their FOIA request may contact the FOIA Public Liaison at 202-708-1613, or through the FOIA email at [email protected]

    § 2002.5 How to make a request for OIG records; records produced.

    (a) Any request for OIG records must be made in writing. The easiest way to make a FOIA request is electronically through our public website at www.hudoig.gov. A request may also be made by submitting the written request to The Office of Inspector General; Department of Housing and Urban Development; 451 Seventh Street SW, Suite 8260, Washington, DC 20410. The envelope should indicate it is a FOIA request. A request for OIG records may also be made in person during normal business hours at any office where OIG employees are permanently stationed.

    (b) Each request must reasonably describe the desired record, including the title or name, author, subject matter, and number or date, where possible, so that the record may be identified and located. The more specific the FOIA request for records, the more likely OIG officials will be able to locate the records requested. The request should also include the name, address and telephone number of the requester, the fee category that the requester believes applies to the request, and the form or format in which the requester would like the desired record to be reproduced, if the requester has a preference. In order to enable the OIG to comply with the time limitations set forth in § 2002.15, both the envelope containing a written request and the letter itself should clearly indicate that the subject is a Freedom of Information Act request.

    (c) The request must be accompanied by the fee or an offer to pay the fee as determined in § 15.106 of this title and § 2002.13.

    (d) The OIG may require information verifying the requester's identity, if the requester requests agency records pertaining to the requester, a minor, or an individual who is legally incompetent. Failure to provide the information when requested will result in the request being found insufficient and closed. It will not prevent the future refiling of the request.

    (e) Duplication of available records will be made as promptly as possible. Such duplication can take the form of paper copy, audiovisual materials, or machine-readable documentation (e.g., electronic documents on CD, DVD, flash drive, etc.). Records that are published or available for sale will not be reproduced.

    (f) The OIG shall honor a requester's specified preference of form or format of disclosure if the record is readily reproducible with reasonable efforts in the requested form or format by the office responding to the request.

    (g) If the requester makes a request for expedited processing, the request must provide a detailed explanation of the basis for the request. The requester should also include a statement certifying the truth of the circumstances supporting the requester's compelling need. Requests for expedited processing that simply recite the statutory language are generally not granted.

    § 2002.7 OIG processing of requests, multi-tracking, and expedited processing.

    (a) Tracking number. FOIA requests will be logged in the order that they are received and be assigned a tracking number, except as provided in paragraph (c) of this section. A requester should use the tracking number to identify his or her request when contacting the FOIA office for any reason. An acknowledgement of receipt of the request, with the assigned tracking number, will be sent to the requester by the FOIA office.

    (b) Multi-track processing—(1) Types of tracks. For requests that do not qualify for expedited processing, the OIG places each request in one of two tracks, simple or complex, based on the amount of work and time involved in processing the request. In doing so, the OIG will consider whether the request involves the processing of voluminous documents or responsive documents from more than one organizational unit. Within each track, the OIG processes requests in the order in which they are received.

    (2) Unusual circumstances. Requests for audit work papers are considered complex requests and generally qualify as an unusual circumstance under 5 U.S.C. 552(a)(6)(B)(iii), taking longer than 20 working days to process. Requests for “all” specified records over a span of time, if they are accepted as reasonably describing a specific group of records, are considered complex requests and usually qualify as an unusual circumstance under 5 U.S.C. 552(a)(6)(B)(iii), taking longer than 20 working days to process. Requesters who make requests qualifying as unusual circumstances will be offered an opportunity to narrow the scope of their request or arrange for an alternative time period.

    (3) Misdirected requests. For requests that have been sent to the wrong office, the OIG will assign the request within each track using the earlier of either:

    (i) The date on which the request was referred to the appropriate office; or

    (ii) The end of the 10 working-day period in which the request should have been referred to the appropriate office.

    (c) Expedited processing. (1) The OIG may take your request or appeal out of normal order if the OIG determines that you have a compelling need for the records or in other cases as determined by the OIG. Any requester may ask for expedited processing at any time. If expedited processing is requested, the OIG will notify the requester within 10 working days whether it will grant expedited processing.

    (2) The OIG will grant requests for expedited processing if it finds a compelling need under 5 U.S.C. 552(a)(6)(E). Evidence of a compelling need by a person making a request for expedited processing must be made in a statement certified by such person to be true and correct to the best of such person's knowledge and belief. A compelling need exists if:

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

    (ii) You are primarily engaged in disseminating information and there is an urgency to inform the public concerning actual or alleged Federal Government activity; or

    (iii) Your failure to obtain the requested records on an expedited basis could result in the loss of substantial due process rights.

    (3) If the OIG grants the request for expedited processing, the OIG will give the request priority and will process it as soon as practicable.

    § 2002.9 Proactive disclosures of records.

    (a) You may review records that section 552(a)(2) of FOIA requires the OIG to make available to the public in the electronic reading rooms identified in paragraph (b) of this section. That is the preferable method; however, you may also ask to review those documents that are in hardcopy at the Headquarters offices at HUD's Library, 451 Seventh Street SW, Suite 8141, Washington, DC 20410. This request should be coordinated through Office of Legal Counsel, Office of Inspector General, Suite 8254. Local offices may coordinate local requests for hardcopy reviews.

    (b) As required by 5 U.S.C. 552(a)(2), the OIG makes records created on or after November 1, 1996, available through its Electronic FOIA Reading Room, located at https://www.hudoig.gov/foia. These records include:

    (1) Copies of all records, regardless of form or format that have been released to any person under this part: and

    (i) Because of the nature of their subject matter, the agency determines that the records have become or are likely to become the subject of subsequent requests for substantially the same records; or

    (ii) Have been requested three or more times.

    (2) Report for the preceding fiscal year submitted to the U.S. Attorney General and the Director of the Office of Government Information Services as required by 5 U.S.C. 552(e) and the raw statistical data used in each report. This report will be made available:

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

    (ii) In an aggregated, searchable format; and

    (iii) In a format that may be downloaded in bulk.

    (c) The OIG also makes other documents, such as audits and semiannual reports, available to the public at https://www.hudoig.gov/.

    § 2002.11 Agency review of records and aggregating requests.

    (a) Review of records. Only requesters who are seeking documents for commercial use may be charged for the time the OIG spends reviewing records to determine whether the records are exempt from mandatory disclosure. Charges will be assessed only for the initial review; i.e., the review undertaken the first time the OIG reviews a particular record or portion of a record to apply an exemption. The OIG will not charge for review at the administrative appeal level of an exemption already applied. However, records or portions of records withheld under an exemption that is subsequently determined not to apply may be reviewed again to determine the applicability of other exemptions not previously considered. The costs for such a subsequent review would be properly assessable. Review time will be assessed at the same rates established for search time in §§ 2002.13 and 15.106 of this title.

    (b) Aggregating requests. (1) The OIG may aggregate multiple requests in cases where unusual circumstances exist and the OIG determines that:

    (i) Certain requests from the same requester or from a group of requesters acting in concert actually constitute a single request; and

    (ii) The requests involve clearly related matters.

    (2) Aggregation of requests for this purpose will be conducted independent of aggregation of requests for fee purposes under § 15.106(h) of this title.

    § 2002.13 Fee schedule, advance payment, interest charges, and waiving or reducing fees.

    The OIG will charge for processing requests under the FOIA in accordance with § 15.106 of this title, except where those provisions conflict with provisions of this part; more specifically, where § 15.106 references § 15.103 of this title replace such reference with § 2002.15.

    § 2002.15 Time limitations.

    (a) General. Upon receipt of a request for records, the appropriate Assistant Inspector General or an appointed designee will generally make a determination whether to comply with a FOIA request within 20 working days. The Assistant Inspector General or designee will immediately notify the requestor in writing of the determination and the reason(s) for such determination and the right of the person to request assistance from the FOIA Public Liaison. The 20-day period will begin on the day the request is received by the OIG, but in any event not later than 10 working days after the request is received by any component designated to receive FOIA requests, and after any fees or advance payment of fees under § 2002.13 has been made.

    (b) Scope of responsive records. In determining which records are responsive to a request, an agency ordinarily will include only records in its possession as of the date that it begins its search. If any other date is used, the agency must inform the requester of that date. A record that is excluded from the requirements of the FOIA pursuant to 5 U.S.C. 552(c) is not considered responsive to a request.

    (c) Unusual circumstances. Under unusual circumstances, as specified in this paragraph (c), the OIG may extend the time period for processing a FOIA request. In such circumstances, the OIG will provide the requester with written notice setting forth the unusual circumstances for the extension and the date on which a determination is expected to be made. This date will not exceed 10 working days beyond the general time established in paragraph (a) of this section. If processing a request would require more than 10 working days beyond the general time limit established in paragraph (a) of this section, the OIG will offer the requester an opportunity to reduce or limit the scope of the request in order to allow the OIG to process it within the extra 10-day working period or arrange an alternative time period within which the FOIA request will be processed. To aid the requester, the OIG shall make available its FOIA Public Liaison, who shall assist in the resolution of any disputes between the requester and the OIG, and notify the requester of the right of the requester to seek dispute resolution services from the Office of Government Information Services. Unusual circumstances mean that there is a need:

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

    (2) To search for, collect, and appropriately examine a voluminous amount of separate and distinct records that are demanded in a single request (e.g. audit work papers); or

    (3) For consultation, which shall be conducted with all practicable speed, with another agency having a substantial interest in the determination of the request or among two or more offices of the Office of Inspector General having a substantial interest in the subject matter of the request.

    § 2002.17 Authority to release records or duplications.

    Any Assistant Inspector General or an appointed designee is authorized to release any record (or duplication) pertaining to activities for which he or she has primary responsibility, unless disclosure is clearly inappropriate under this part. No authorized person may release records for which another officer has primary responsibility without the consent of the officer or his or her designee.

    § 2002.19 Authority to deny requests for records and form of denial, exemptions, and exclusions.

    (a) Process for denying requests. An Assistant Inspector General or the Counsel to the Inspector General, or their designees, may deny a request for a record. Any denial will:

    (1) Be in writing;

    (2) State simply the reasons for the denial;

    (3) Provide an estimate of the volume of records or information withheld, when appropriate, in number of pages or in some other reasonable form of estimation. This estimate does not need to be provided if the volume is otherwise indicated through deletions on records disclosed in part, or if providing an estimate would harm an interest protected by an applicable exemption;

    (4) Identify the person(s) responsible for the denial by name and title;

    (5) Provide notice of the right of the requester to appeal to the Deputy Inspector General, within a period determined by the head of the agency that is not less than 90 days after the date of such adverse determination, consistent with § 2002.23; and

    (6) Provide notice of the right of the requester to seek dispute resolution services from the FOIA Public Liaison of the agency or the Office of Government Information Services.

    (b) Denying requests generally. The OIG shall withhold information only if the OIG reasonably foresees that disclosure would harm an interest protected by an exemption as provided in this section, or disclosure is prohibited by law. The OIG will consider whether partial disclosure of information is possible whenever the OIG determines that a full disclosure of a requested record is not possible and will take reasonable steps necessary to segregate and release nonexempt information. Nothing in this section requires disclosure of information that is otherwise prohibited from disclosure by law or otherwise exempted from disclosure as provided in this section.

    (c) FOIA exemptions. The FOIA contains nine exemptions (5 U.S.C. 552(b)) that authorize agencies to withhold various records from disclosure, and two exclusions to the statute that may be used by the OIG. With regard to the records normally requested, the OIG generally applies the exemptions and exclusions as follows:

    (1) Classified documents. Exemption 1 (5 U.S.C. 552(b)(1)) protects classified national defense and foreign relations information. The OIG seldom relies on this exception to withhold documents. However, where applicable, the OIG will refer a request for records classified under Executive Order 13526 and the pertinent records to the originating agency for processing. The OIG may refuse to confirm or deny the existence of the requested information if the originating agency determines that the fact of the existence of the information itself is classified.

    (2) Internal agency rules and practices. Exemption 2 (5 U.S.C. 552(b)(2)) protects records relating to internal personnel rules and practices.

    (3) Information prohibited from disclosure by another statute. Exemption 3 (5 U.S.C. 552(b)(3)) protects information that is prohibited from disclosure by another Federal law. Some investigative records contain information that could reveal grand jury proceedings, which are protected from disclosure by Federal Rule of Criminal Procedure 6(e). Section 7 of the Inspector General Act of 1978 prohibits the OIG from disclosing the identity of employees who make protected disclosures. The OIG generally will not disclose competitive proposals prior to contract award, competitive proposals that are not set forth or incorporated by reference into the awarded contract, (see 41 U.S.C. 4702), or, during the selection process, any covered selection information regarding such selection, either directly or indirectly (see 42 U.S.C. 3537a).

    (4) Commercial or financial information. Exemption 4 (5 U.S.C. 552(b)(4)) protects trade secrets and commercial or financial information obtained from a person that is privileged and confidential. The OIG frequently obtains this information through its audits. The OIG will process the release of this category of information pursuant to Executive Order 12600 and give notice to the affected business and an opportunity for the business to present evidence of its confidentiality claim. If the OIG is sued by a requester under the FOIA for nondisclosure of confidential business information, the OIG expects the affected business to cooperate to the fullest extent possible in defending such a decision.

    (5) Certain interagency or intra-agency communications. Exemption 5 (5 U.S.C. 552(b)(5)) protects interagency or intra-agency communications that are protected by legal privileges, such as the attorney-client privilege, attorney work-product privilege, or communications reflecting the agency's deliberative process. These communications may include communications with the Department of Justice and with HUD. The deliberative process privilege shall not apply to records created 25 years or more before the date on which the records were requested.

    (6) Personal privacy. Exemption 6 (5 U.S.C. 552(b)(6)) protects information involving matters of personal privacy. This information may be found in personnel, medical, and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Names, addresses, telephone numbers, and email addresses of persons identified in audits or complaints generally will not be disclosed. The OIG has learned through experience that some of its employees (i.e. Hotline employees) will be harassed if their identities are known, and the OIG will protect the identities of these employees. As a law enforcement agency, the OIG finds individuals generally have a heightened privacy interest for not having their identities associated with the OIG.

    (7) Law enforcement records. Exemption 7 (5 U.S.C. 552(b)(7)) protects certain records or information compiled for law enforcement purposes. This exemption protects records where the production could reasonably be expected to interfere with enforcement proceedings. The protection of this exemption also encompasses, but is not limited to, information in law enforcement files that could reasonably be expected to constitute an unwarranted invasion of personal privacy; the names of confidential informants; and techniques and procedures for law enforcement investigations, or guidelines for law enforcement investigations if such disclosure could reasonably be expected to risk circumvention of the law. It is the policy of the OIG in responding to all FOIA requests for investigative records pertaining to specifically named individuals to refuse to confirm or deny the existence of such records. Lacking the subject individuals consent, proof of death, an official acknowledgement of an investigation, or an overriding public interest, even to acknowledge the existence of such records could reasonably be expected to constitute an unwarranted invasion of personal privacy.

    (8) Supervision of financial institutions. Exemption 8 (5 U.S.C. 552(b)(8)) protects information relating to the supervision of financial institutions. It is unlikely that the OIG will have these documents.

    (9) Wells. Exemption 9 (5 U.S.C. 552(b)(9)) protects geological information on wells. It is unlikely that the OIG will have these documents.

    (d) FOIA exclusion. Some law enforcement records are excluded from the FOIA. 5 U.S.C. 552(c)(1) permits a law enforcement agency to exclude a document from the FOIA if there is reason to believe that:

    (1) The subject of the investigation or proceeding is not aware of its pendency; and

    (2) Disclosure of the existence of the records could reasonably be expected to interfere with enforcement proceedings, in which case the agency may, during only such time as that circumstance continues, treat the records as not subject to the requirements of the FOIA. Section 552(c)(2) of FOIA allows the exclusion of informant records, unless the existence of the informant has been officially confirmed.

    § 2002.21 Effect of denial of request.

    Denial of a request shall terminate the authority of the Assistant Inspector General or his or her designee to release or disclose the requested record, which thereafter may not be made publicly available except with express authorization of the Inspector General, Deputy Inspector General, or Counsel to the Inspector General.

    § 2002.23 Administrative review.

    (a) Review is available only from a written determination denying a request for a record and only if a written request for review is filed within 90 days after issuance of the written determination. If mailed, the requester's letter of appeal must be postmarked within 90 calendar days of the date of the letter of determination. If the letter of appeal is transmitted electronically or by a means other than the United States Postal Service, it must be received in the appropriate office by the close of business on the 90th calendar day after the date of the letter of determination. Before seeking court review of an adverse determination, a requester must exhaust their administrative remedies under this section.

    (b) A review may be initiated by sending a request for review to the Office of Inspector General; Department of Housing and Urban Development; 451 Seventh Street SW, Room 8256, Washington, DC 20410 or to [email protected] In order to enable the OIG to comply with the time limitations set forth in § 2002.17, both the envelope containing the request for review and the letter itself should clearly indicate that the subject is a Freedom of Information Act request for review. Each request for review must contain the following:

    (1) A copy of the original request;

    (2) A copy of the written denial; and

    (3) A statement of the circumstances, reasons, or arguments advanced in support of disclosure of the original records requested.

    (c) Review will be made promptly by the Deputy Inspector General, or designee, on the basis of the written record. The OIG will decide an appeal of a denial of a request to expedite processing of a FOIA request within 10 working days of receipt of the appeal. The OIG will make a determination on all other appeals within 20 working days of receipt, unless unusual circumstances require the OIG to extend the time for an additional 10 working days.

    (d) The time of receipt for processing of a request is the time it is received by the Inspector General. If a request is misdirected by the requester and is received by one other than the Inspector General, the OIG official who receives the request will forward it promptly to the Inspector General and will advise the requester about the delayed time of receipt.

    (e) The decision after review will be in writing, will constitute final agency action on the request, and, if the denial of the request for records is in full or in part upheld, the Inspector General will notify the person making the request of his or her right to seek judicial review under 5 U.S.C. 552(a)(4).

    (f) Adverse decisions will include the name and contact information of dispute resolution services that offer mediation services to resolve disputes between FOIA requesters and Federal agencies as a nonexclusive alternative to litigation.

    Dated: January 18, 2018. Helen M. Albert, Acting Inspector General.
    [FR Doc. 2018-03400 Filed 2-20-18; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0097] Drawbridge Operation Regulation; Mianus River, Greenwich, CT AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Metro-North Bridge across the Mianus River, mile 1.0 at Greenwich, Connecticut. The deviation is necessary to repair the superstructure and replace timber ties. This deviation allows the bridge to be closed to navigation.

    DATES:

    This deviation is effective from 8 a.m. on April 10, 2018 to 8 a.m. on May 14, 2018.

    ADDRESSES:

    The docket for this deviation, USCG-2018-0097 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Mr. Jeffrey Stieb, First Coast Guard District Bridge Branch, Coast Guard; telephone 617-223-8364, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The owner of the bridge, the Connecticut Department of Transportation (CT DOT), requested a temporary deviation to conduct superstructure repair and timber ties replacement. The Metro-North Bridge across the Mianus River, mile 1.0, at Greenwich Connecticut has a vertical clearance in the closed position of 20 feet at mean high water and 27 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.209.

    This temporary deviation allows the bridge to operate from 8 a.m. April 10, 2018 to 8 a.m. on Monday, May 14, 2018 as follows: From 8 a.m. Monday through 4 p.m. Friday, the draw is authorized to remain closed to navigation; from 4:01 p.m. Friday to 7:59 a.m. Monday, the draw shall open with 24 hours advance notice.

    The deviation will have negligible effect on vessel navigation. The waterway is transited primarily by seasonal recreational vessels and small commercial fishing vessels. In 2016 there were six openings and in 2017 there were 19 openings between the effective dates. CT DOT has notified waterway users, the harbormaster, and town officials of the requested deviation. No objections to the proposed closure were received. Vessels that can pass through the bridge in the closed position may continue to do so. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass. CT DOT will issue a press release announcing the closure. The Coast Guard will inform waterway users of the closure through Local and Broadcast Notices to Mariners.

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

    Dated: February 14, 2018. Christopher J. Bisignano, Supervisory Bridge Management Specialist, First Coast Guard District.
    [FR Doc. 2018-03470 Filed 2-20-18; 8:45 am] BILLING CODE 9110-04-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 1, 4, 9, and 20 [WT Docket No. 16-240; FCC 17-167] Requirements for Licensees To Overcome a CMRS Presumption AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule.

    SUMMARY:

    In this document, the Federal Communications Commission adopts rules to harmonize and streamline the Commission's regulations regarding the classification of commercial and private mobile radio services, primarily by removing provisions in the Commission's rules that were outdated or unnecessary. The rules in question list various services or subservices that the Commission had classified as “mobile services” and determined to be “commercial mobile radio services” (or “CMRS”) (in accordance with the definitions set forth in the Communications Act). These rules also establish in certain instances a presumption that some services are private mobile radio services (or “PMRS”), and set out a process by which that presumption can be rebutted. This action also removes any presumptions about whether mobile services are regulated as commercial or private, and instead allows licensees to rely on the statutory definitions of those terms to identify the nature and regulatory treatment of their mobile services, consistent with applicable service rules.

    DATES:

    Effective March 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Thomas Reed at [email protected], of the Wireless Telecommunications Bureau, Mobility Division, (202) 418-0531.

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's Report and Order (Order) in WT Docket No. 16-240, FCC 17-167, released on December 18, 2017. The complete text of the Order, including all Appendices, is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street SW, Room CY-A157, Washington, DC 20554, or by downloading the text from the Commission's website at http://transition.fcc.gov/Daily_Releases/Daily_Business/2017/db1218/FCC-17-167A1.pdf.

    Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format), by sending an email to [email protected] or calling the Consumer and Government Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

    The Commission will send a copy of the Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

    I. Report and Order

    1. The Commission adopted §§ 20.7 and 20.9 in 1994 as part of its implementation of Sections 3(n) and 332 of the Communications Act, which Congress amended in the Omnibus Budget Reconciliation Act of 1993 (OBRA). Congress, seeking to bring mobile services that were similar in nature under a consistent regulatory framework, created the statutory classifications of “commercial mobile services” and “private mobile services” (referred to in Commission rules as commercial mobile radio service and private mobile radio service, respectively). The Communications Act defines commercial mobile service as “any mobile service . . . that is provided for profit and makes interconnected service available (A) to the public or (B) to such classes of eligible users as to be effectively available to a substantial portion of the public[.]” “Private mobile service” is defined in the negative as “any mobile service . . . that is not a commercial mobile service or the functional equivalent of a commercial mobile service[.]” In the 1994 CMRS Second Report and Order (GN Docket No. 93-252) (59 FR 18493), the Commission mirrored these definitions in § 20.3 of its rules. Thus, § 20.3 defines “commercial mobile radio service” as a for-profit, interconnected mobile service that is available to the public; or to such classes of eligible users as to be effectively available to a substantial portion of the public; or the functional equivalent of such a for-profit, interconnected mobile service. “Private mobile radio service” is defined as a mobile service that is neither a commercial mobile radio service nor the functional equivalent of a commercial mobile radio service. Similarly, the Commission largely mirrored the statutory definition of “mobile services” in its definition in the rules.

    2. The Commission, in adopting §§ 20.7 and 20.9, conducted an extensive review of the 1993 OBRA, its legislative history, and developments in the regulation of wireless services. The Commission noted that Congress “replaced the common carrier and private radio definitions that evolved under the prior version of section 332 of the Act with two newly defined categories of mobile services: Commercial mobile radio service (CMRS) and private mobile radio service (PMRS),” and “replaced traditional regulation of mobile services with an approach that brings all mobile service providers under a comprehensive, consistent regulatory framework and gives the Commission flexibility to establish appropriate levels of regulation for mobile radio service providers.” Two Congressional objectives appeared to drive these statutory changes: (1) Ensuring that “similar [mobile] services would be subject to consistent regulatory classification[,]” and (2) establishing and administering for CMRS providers “an appropriate level of regulation.”

    3. Applying the purpose of the legislation to include all existing mobile services within the ambit of section 332 and in view of the goal of achieving regulatory symmetry, the Commission stated that all existing mobile services will be included within the ambit of section 332 as well as all auxiliary services and ancillary fixed communications offered by such service providers. In addition, the Commission stated that “unlicensed PCS and part 15 devices will not be included under the definition of mobile services,” but other unlicensed services meeting the definition of CMRS, such as the resale of CMRS, are mobile services within the meaning of sections 3(n) and 332 of the Communications Act. Section 20.7 memorialized these and listed the existing mobile services.

    4. In addition, applying the statutory criteria to the existing common carrier mobile services at the time, the Commission identified in § 20.9(a) thirteen specific mobile service bands (or subsets thereof) that met the definition of CMRS and would be treated as common carrier services. At the time, in the wake of the 1993 OBRA, the list served as a clear, easily applied tool for implementing the new CMRS classification and creating certainty about which regulatory regime would apply to a given license band. The primary reason this approach worked well was because many of the service-specific wireless rule parts drew clear lines between commercial and private operation in terms of service rules, obligations, and usage, and the licensed operations within a given service were often limited by rule either to common or private carriage. If a licensee of a service band identified in § 20.9(a) wished to provide service on a private basis, it would have needed to seek a waiver of § 20.9(a). Section 20.9(b) identifies three services that are specifically presumed to be CMRS (rather than deemed to be regulated as CMRS in § 20.9(a)) and prescribes a certification process for overcoming that presumption in cases where the provider intends to operate on a PMRS basis.

    5. In crafting the § 20.9(a) approach, the Commission also noted that Congress was concerned with the “disparate regulatory treatment” that had evolved across services, and it observed that Congress's intent for the Commission to establish consistent regulations was reflected in the statutory requirement that any service that amounted to the “functional equivalent” of CMRS be treated as such, even if it did not meet the strict definition. At the same time, the Commission “anticipat[ed] that very few mobile services that do not meet the definition of CMRS will be a close substitute for a [CMRS].” Because the Commission expected that the functional equivalency test would be applied only rarely, it decided to create another presumption—i.e., to “presume that a mobile service that does not meet the definition of CMRS is a [PMRS].” To rebut that presumption, a challenger to a PMRS claim could file a petition for declaratory ruling attempting to show that the service at issue met the definition of CMRS or was the functional equivalent of CMRS. Section 20.9(a)(14) memorializes this presumption and the process for overcoming the presumption.

    6. For the services listed in § 20.9(b), the rules state that service may be provided on a PMRS basis only if the licensee or applicant overcomes the presumption that those services are CMRS through a specific certification process. Specifically, § 20.9(b) requires licensees of, or applicants for, Personal Communications Service (PCS), VHF Public Coast Stations, and Automated Maritime Telecommunications Systems (AMTS) that want to operate on a PMRS basis to include a certification as part of an authorization, modification, transaction, or spectrum leasing application demonstrating that the proposed service does not fall within the definition of CMRS. The application is placed on public notice for 30 days, during which interested parties may file petitions to deny.

    7. While § 20.9's regulatory treatment of certain service bands may well have been a reasonable tool when it was adopted, it was based on assumptions that no longer apply—namely that a licensee would offer a service restricted either to CMRS or PMRS use rather than seek to have the flexibility to operate as both. In recent years, the Commission's spectrum regulation has turned toward a flexible use model that no longer supports this particular treatment embedded in the Commission's rules. Section 20.9 was adopted at a time when there were far fewer wireless licensees and services than exist today. Dramatic changes have occurred in the wireless industry since then. Notably, licensees of spectrum bands not identified in § 20.9 are governed by service-specific rules that afford entities greater flexibility in how operations can be provided and that do not presume them to be CMRS or PMRS. Applicants and licensees in these newer services can select whether they will be providing common carrier service, non-common carrier service, and/or private, internal communications on FCC Form 601 or in other applications. Moreover, the continuing demand for PMRS use of spectrum—including spectrum that providers, in the past, had primarily sought for CMRS use—has altered another of the underlying assumptions of § 20.9(a), i.e., that the demand to operate services referenced in § 20.9 is primarily a demand to offer such services on a CMRS basis.

    8. In light of the broadened interest in and need for spectrum covered by § 20.9 by an increased diversity of licensees, the Commission has sought to provide greater flexibility to applicants, licensees, and spectrum lessees 1 subject to § 20.9, but these efforts have nonetheless left some entities with burdens that their counterparts in other spectrum bands do not face. In 2005, for example, the Commission eliminated the restriction that entities must operate as common carriers in order to hold a part 22 license. Despite this change, part 22 applicants, licensees, and spectrum lessees are still required to seek a waiver of § 20.9(a) if they plan to operate on a non-CMRS basis. In recent years, applicants, licensees, and spectrum lessees in many services presumed to be CMRS have requested waiver of § 20.9(a) as part of an initial authorization, modification, transaction, or spectrum leasing application, and the inclusion of the waiver request often increases the time it takes the Commission to process the application. For example, a paging assignment application in which the assignee includes a waiver request must go on public notice for a minimum of 14 days. Absent the waiver request, the application otherwise might be subject to overnight grant under the Commission's processing rules. Similarly, the § 20.9(b) process for PCS, VHS Public Coast station services, and AMTS licensees to certify that their proposed operations are not commercial is cumbersome and time-consuming. Applications that include a § 20.9(b) certification often could be granted on an overnight basis absent § 20.9(b)'s public notice requirement.

    1 The Commission's references to spectrum lessees also include spectrum sublessees.

    9. To address these inefficiencies, the Commission in July 2016 released a Notice of Proposed Rulemaking (WT Docket No. 16-240) (NPRM) (81 FR 55161) recognizing that § 20.9's approach to the regulatory status of certain bands was not the only way to administer the CMRS/PMRS statutory framework, and seeking comment on whether to eliminate this approach by removing § 20.9 from its rules. The Commission tentatively concluded that doing so would streamline application processing and promote comparable treatment of wireless applicants and licensees operating in different spectrum bands. The Commission anticipated that this revision of its rules would shorten the processing time for a number of applications and eliminate the obligation of licensees and applicants in the specified § 20.9 bands to make a showing—even if brief—regarding their intent to operate on a PMRS-basis. It tentatively concluded that this, in turn, would lead to more efficient and timely use of spectrum, without imposing more regulatory burdens than necessary for the Commission to oversee spectrum usage. The Commission sought comment on its tentative conclusions and on the costs and benefits of its proposed rule elimination. Five parties filed comments and two parties filed reply comments in response to the NPRM, all of which generally support elimination of § 20.9.

    10. The Commission also sought comment in the NPRM on eliminating § 20.7's list of certain services that meet the statutory definition of “mobile service” as used in sections 3(n) and 332 of the Act. This list is under-inclusive—it does not include all the services that are, in fact, “mobile services” under the statutory language and the § 20.3 definition. The Commission tentatively concluded that § 20.7 no longer serves a useful purpose and stressed that eliminating § 20.7 would not change the definition of “mobile service” contained in § 20.3 of the rules.

    II. Streamlining Part 20 of the Commission's Rules

    11. Elimination of § 20.9. The Commission removes § 20.9 from its rules, eliminating that section's approach for determining whether services provided in the specified frequency bands are CMRS. There is unanimous support for this rule change, with every commenter addressing this issue supportive of the Commission removing § 20.9 in its entirety. This action is also consistent with the Commission's recent steps in the WRS Second Report and Order and Further Notice of Proposed Rulemaking, released on August 3, 2017 (WT Docket No. 10-112) (82 FR 41580), to harmonize renewal and other regulatory requirements across services and to simplify regulatory processes. Going forward, licensees and applicants whose services were subject to § 20.9 can rely on the relevant definitions in the Communications Act and the Commission's rules—which articulate with sufficient clarity what constitutes CMRS and PMRS—to identify the nature of their services in relevant Commission applications. Akin to their counterparts operating in other frequency bands that already accommodate flexible use, these entities may provide any service that is consistent with the technical rules of the band in which they operate. Licensees will no longer need to seek waivers or submit certifications to the Commission before they can provide non-commercial services; they need only look to the definitions of CMRS and PMRS to determine their regulatory status and proceed accordingly.

    12. Eliminating § 20.9 is consistent with the Commission's ongoing efforts to facilitate flexible use of spectrum, and will allow licensees to respond more quickly to consumer demand and competitive forces. Moreover, removing § 20.9 will help eliminate uneven and disparate regulation of wireless applicants and licensees in different spectrum bands. The Commission finds that the public interest is best served by treating similarly situated entities on a more equal, comparable basis. As previously discussed, Congress's intent in creating the CMRS and PMRS umbrella service definitions was to ensure that similarly situated service providers were operating on the same regulatory footing, and the Commission aimed to effectuate this intent by adopting § 20.9. But as a result of the changes that have occurred in the preceding two decades, entities operating in frequency bands subject to § 20.9 are not treated the same as their competitors in other bands. Rather, if they wish to use the spectrum for non-commercial services, this subset of licensees and applicants must file requests for waivers of § 20.9(a) or certifications that operations are not CMRS under § 20.9(b), and they must endure delays associated with the required public notice periods, even though the requests and certifications are usually granted on a routine basis. Several commenters highlight how elimination of § 20.9 will reduce burdens for such entities, enabling them to put their spectrum to efficient use more quickly.

    13. The Commission also expects that removing § 20.9 will enable service providers to more easily meet the continuing demand for PMRS and other non-traditional CMRS operations that serve the public interest. The Commission concludes that elimination of § 20.9 will help bring beneficial services to businesses, state and local governments, and the public safety community, while reducing the administrative burdens and processing delays that certain providers of these services currently face.

    14. A few commenters caution the Commission that any rule changes should not substantively alter CMRS and PMRS licensees' respective regulatory obligations or expectations regarding their licenses. Nothing here is intended to substantively change the definitions of CMRS and PMRS in § 20.3 of the Commission's rules, which generally track the statutory definitions and which provide sufficiently clear guidance to enable providers to continue to determine the nature of their services accurately. Nor does the Commission take any action in this Order to change the regulatory obligations that attach to CMRS operations 2 or to PMRS operations. Entities may continue to provide both CMRS and PMRS under the same license, to the extent allowed by, and subject to, the statutes, rules, and requirements that otherwise apply to the particular service at issue.

    2 As the Commission explained in the NPRM, such CMRS obligations include, but are not limited to, roaming obligations, provision of E911 services, obligations pursuant to the Communications Assistance for Law Enforcement Act, and compliance with hearing aid compatibility requirements.

    15. As the Commission proposed in the NPRM, applicants and licensees that were subject to § 20.9 and that utilize ULS can inform Commission staff in initial, modification, transaction, or spectrum leasing applications whether they seek authorization to provide or use their service for any of the applicable service offerings—“common carrier,” “non-common carrier,” and/or “private, internal communications”—without any additional showing, as applicants and licensees already do in spectrum bands that already accommodate flexible use. In other words, they can select “non-common carrier” and/or “private, internal communications,” as applicable, without needing to include a waiver request or certification to prove that their service is not CMRS. There is no opposition to this approach from commenters. Importantly, this will not place any additional burdens on applicants and licensees. The Commission's rules already permit entities to self-identify their regulatory status but, because of § 20.9, entities using spectrum in identified frequency bands had to go through the additional administrative processes discussed above. Based on the forgoing, the Commission eliminates the need for them to do so.

    16. PMRS Presumption and Rebuttal Process. As discussed above, § 20.9(a)(14) sets forth a rebuttable presumption that “[a] mobile service that does not meet the definition of commercial mobile radio service is presumed to be a private mobile radio service,” 3 and it sets out the process for rebutting such a presumption. This only acts as a presumption, however, with respect to an “interested party's” challenge to a provider's claim that its service is PMRS, in light of the implicit factual assertion that the service does not meet the definition of CMRS. If the challenger cannot overcome the presumption of the validity of the provider's claim that its service does not, as a factual matter, meet the § 20.3 definition of CMRS,4 then the PMRS status of the operation at issue has been established as a definitional matter under the rule and statute, and this challenge will fail.5

    3 This subsection's reference to the definition of CMRS is stated without limitation and therefore includes a service that is defined as CMRS under either the “(a)” or “(b)” paragraphs of the § 20.3 definition of CMRS.

    4 Note that this definition includes services meeting the three elements of the definition's (a) paragraph and services meeting the definition's (b) paragraph covering services that are the functional equivalent of those satisfying the three elements of paragraph (a).

    5 47 CFR 20.3 (defining Private Mobile Radio Service as a “mobile service that is neither a commercial mobile radio service nor the functional equivalent of a service that meets the definition of commercial mobile radio service”); 47 U.S.C. 332(d)(3) (defining “private mobile service” as “any mobile service . . . that is not a commercial mobile service or the functional equivalent of a commercial mobile service, as specified by regulation by the Commission”).

    17. In the NPRM, the Commission observed that the rules do not need to identify service bands that will be treated as CMRS in order to establish a framework within which a provider can claim PMRS status (presumptively or otherwise). There are other approaches for identifying whether a licensee's proposed or existing operations should be classified one way or another, such as allowing the licensee, in the first instance, to make that determination with respect to its individualized operations, based on the existing definitions of PMRS and CMRS. The Commission suggested that changes to its approach of using a rebuttable PMRS presumption “may now be warranted based on the development of CMRS and PMRS services and [the Commission's] experience with the application of the presumption, such as how parties have used it, how often and how successfully it has been challenged, and whether it tends to streamline the licensing processes or encumber them.” The Commission observed that § 20.3 of the rules defines CMRS to include mobile services that are the “functional equivalent” of CMRS, and therefore—in combination with other Commission rules and processes—ensures that any service that amounts to the “functional equivalent” of CMRS is treated as such.

    18. The Commission recognized, however, that elimination of § 20.9 in its entirety would also include deletion of § 20.9(a)(14)(ii), which enumerates several factors that the Commission may consider in determining whether a mobile service is the “functional equivalent” of CMRS in cases where an interested party challenges a claim that operations are presumptively classified as PMRS. The Commission sought comment on whether retaining § 20.9(a)(14) or any of its subsections would be useful “as a practical and procedural set of guidelines” for both mobile service providers and the Commission when applying the definitions of CMRS and PMRS, and whether it should move this language to § 20.3 or another section in part 20. Only two commenters addressed the issue. One argued for the removal of the PMRS presumption while the other requested that the Commission maintain sufficient clarity in the definition of, and requirements for, PMRS and CMRS classifications.

    19. The Commission retains the key aspects of the PMRS presumption by revising its definition of Private Mobile Radio Service in § 20.3 to provide a party with a presumption that it meets that definition (as against a challenge that the service is CMRS), if the service in question does not meet the three specific elements for qualifying as a CMRS under paragraph (a) of the § 20.3 CMRS definition. In such case, a challenger would bear the burden of proving that the service meets paragraph (b) of the CMRS definition (i.e., that it is the functional equivalent of a service that satisfies the paragraph (a) elements) and therefore does not qualify as PMRS. While the rules thus continue to recognize that a service not meeting the specific paragraph (a) elements of the CMRS definition is presumptively PMRS, the Commission declines otherwise to carve out the rebuttal process from its elimination of section 20.9. The Commission anticipates that the CMRS and PMRS definitions in § 20.3 as revised in this Order will provide sufficient clarity to enable the Commission, licensees and spectrum lessees, and members of the public to differentiate between CMRS and PMRS and, relatedly, to assess whether a licensee is offering a service that is the “functional equivalent” of CMRS. At the same time, The Commission has identified various benefits of eliminating the use of the scheme embodied in § 20.9, which has discouraged the flexible use of spectrum in the identified frequency bands and created unnecessary hurdles for a subset of mobile service providers.

    20. In sum, the Commission sees no need to retain any of the § 20.9 provisions about whether service being provided in a particular frequency band is commercial or private, or to retain rebuttal procedures crafted as part of the § 20.9 approach. Even without § 20.9(a)(14), interested parties will continue to have avenues available to challenge whether an entity's operation is “non-common carrier” or “private, internal communications.” Elimination of the § 20.9(a)(14) process thus neither materially affects the opportunity for interested parties to challenge an entity's claim of private status, nor alters the distribution of the burden of proof in adjudicating such a challenge (i.e., a party challenging a licensee's claim of private status bears the burden of presenting sufficient allegations of fact to overcome the presumptive validity of that claim). Similarly, the exemplary factors for determining whether a service is the “functional equivalent” of CMRS, discussed in the CMRS Second Report and Order, remain probative in potential challenges, even if they are no longer memorialized in the Commission's rules. Nonetheless, given concerns raised by commenters, and for ease of future reference for parties seeking to rely on them as illustrative examples, the Commission moves the “functional equivalent” exemplary factors to the definition of CMRS in § 20.3 and slightly revise the rule to indicate that reliance on these examples is permissible but not required. Finally, nothing in this action alters the Commission's authority, independent of § 20.9, to take enforcement action against a licensee that tries to avoid CMRS regulation by misrepresenting that its service is or will be operated on a “non-common carrier” or “private, internal communications” basis.

    21. Elimination of § 20.7. Most commenters do not address the Commission's proposal to remove § 20.7, which lists certain services in various Commission rules parts that meet the statutory definition of “mobile services.” T-Mobile is the only party that raises a concern with removal of a specific subpart of the rule, § 20.7(h). Section 20.7(h) includes within the list of mobile services “[u]nlicensed services meeting the definition of [CMRS] in § 20.3, such as the resale of [CMRS], but excluding unlicensed radio frequency devices under part 15 of this chapter (including unlicensed personal communications service devices).” T-Mobile argues that this language represents an intentional decision by the Commission to exclude part 15 unlicensed services from the definition of “mobile service” in § 20.7. T-Mobile asks the Commission to either preserve § 20.7(h) or incorporate its wording into § 20.3.

    22. The Commission eliminates § 20.7, which provides an outdated and incomplete list of some, but not all, services that meet the definition of “mobile service” as used in the Act. This approach is consistent with the Commission's elimination of § 20.9, in favor of relying instead on the definition of CMRS in § 20.3. As is the case with respect to the definition of CMRS, § 20.3 clearly articulates the definition of “mobile service,” consistent with the statutory definition. Elimination of § 20.7 will thus not affect the Commission's understanding or application of the term “mobile service” in the Act or under the Commission's rules.

    23. Regarding the concern raised by T-Mobile about the regulatory categorization of part 15 unlicensed devices, the Commission found, in the CMRS Second Report and Order, that the definition of “mobile service” in the 1993 OBRA includes “service for which a license is required in a personal communications service,” and therefore concluded that “mobile service” does not include unlicensed PCS and part 15 devices. This action should in no way be construed as affecting the Commission's findings in the CMRS Second Report and Order. Nonetheless, to ensure that there is no confusion on this issue, the Commission revises § 20.3 to make clear that the term “mobile service” explicitly excludes unlicensed radio frequency devices under part 15 of the Commission's rules.

    24. Edits to parts 1, 4, and 9 of the Rules. Consistent with the Commission's proposal in the NPRM and its efforts to streamline its rules, the Commission makes corrective edits to rule parts that errantly cross-reference § 20.9 for the definition of CMRS, rather than cross-referencing the definition in § 20.3, the definitions section for part 20. Specifically, § 4.3(f) of the rules, which defines “wireless service providers” that are subject to outage reporting requirements, cross-references section 20.9 for a definition of CMRS. Section 9.3, related to the provision of interconnected VoIP services, similarly defines CMRS as “Commercial Mobile Radio Service, as defined in § 20.9 of this chapter.” The Commission amends both sections to remove the reference to § 20.9 and refer instead to the definition of CMRS in § 20.3.

    25. CTIA requested changes to § 1.907's definitions of Private Wireless Services and Wireless Telecommunications Services to remove cross-references to other CFR rule parts that appear in those definitions. The CMRS proceeding has focused on the treatment of services defined and regulated as PMRS and CMRS under part 20 of the Commission's rules and cross-referenced in several other related rules. While the definitions for which CTIA seeks modification are not coextensive with the definitions of PMRS and CMRS, the Commission sought broad comment in the CMRS proceeding on whether to eliminate the itemized, service-by-service approach to classifying wireless services that the Commission had superimposed over the statutory definitions, in favor of an approach that enabled applicants and licensees themselves to classify—under straightforward statutory definitions—what type of permitted flexible operations they had chosen to provide (rather than forcing them to proceed under a categorical framework that requires parties to seek an exception from the Commission when their choice of flexible operations will not line up with the correct statutorily-defined wireless classification that the rules are forcing them into). CTIA's proposal for eliminating the categorical list of services classified as Wireless Telecommunications Services under the § 1.907 definitions is virtually indistinguishable in these regards from the proposal the Commission made for CMRS, as the elimination of these categories from the Wireless Telecommunications Service definition will remove the needless inefficiency and reduce the rigidity of such a categorical approach, while leaving intact in the rule the critical classification benchmark—i.e., the definition of “telecommunications service” in section 3 of the Act—on which applicants and licensees can rely in choosing to provide Wireless Telecommunications Service. In contrast, the Commission does not, in the CMRS proceeding, modify the § 1.907 definition of Private Wireless Service because this aspect of CTIA's proposals addresses a definition in the rules that does not expressly invoke a statutory definition to provide a ready benchmark that can replace the categories of service that are listed categorically as comprising (and defining) the Private Wireless Services. Accordingly, CTIA's proposal for this definition, whatever the merits, is not part of the regulatory changes that the Commission envisioned in this proceeding, and the Commission therefore denies this aspect of CTIA's request without prejudice.

    26. Regulatory Status on FCC Forms. In the NPRM, the Commission requested comment on whether it would need to make changes to any of its forms if it were to eliminate § 20.9. For example, it noted that Form 603 (used for assignments and transfers of control) does not include an option for an assignee/transferee to indicate a different regulatory status for a license at issue in the proposed transaction, and suggested that, if the Commission eliminated § 20.9, it would need to revise Form 603 to permit such a designation. The Commission also sought comment on whether the regulatory status options provided on Form 601 and other forms—“common carrier,” “non-common-carrier,” and “private, internal communications”—were confusing, and asked whether they should be replaced with or altered to include the CMRS/PMRS terminology.

    27. Only one party addresses the NPRM questions about forms, recommending that the Commission retain the three regulatory status categories currently used on Form 601 and other forms—“common carrier,” “non-common carrier,” and “private/internal communications.” The Commission decides not to replace the current form designations of “common carrier,” “non-common carrier,” and “private, internal communications” with the alternatives of CMRS or PMRS. The Commission concludes that the change would create a less detailed description of regulatory status for certain licensees. Further, the current designations, in combination with a filer's responses to form questions regarding the type of radio service being provided, are used by the Commission to determine, among other things, regulatory fees and which filings may need to go on an accepted for filing public notice. The Commission also declines to revise Form 601 or other forms to add an additional question asking an entity to distinguish whether it is providing, or plans to provide, “CMRS” and/or “PMRS.” Adding this to the Commission's forms and to ULS would be costly, without providing the Commission with additional useful information beyond what it already obtains from the combination of questions about regulatory status and type of radio service being provided.

    28. The current ULS Form 601 permits an applicant to select the status of its radio service operation as “common carrier,” “non-common carrier,” or “private, internal communications,” or some combination, to the extent applicable. This status must be selected when an applicant first files for an authorization. Under this action, applicants in services previously covered by § 20.9 will have the same flexibility as other licensees that utilize ULS to select the appropriate status or statuses, without additional regulatory requirements. A licensee also can use Form 601 to modify its regulatory status to add an additional status or change the status under which it was originally licensed. Applications on Form 601 to modify regulatory status are processed as a minor modification to the subject authorization.

    29. The current Form 603 does not permit a proposed assignee or transferee to make any selection regarding regulatory status. Rather, the proposed assignee or transferee receives the license with the regulatory status as designated by the assignor or the pre-transfer licensee. Because a change to Form 603 would require corresponding changes to ULS, including costly reprogramming and additional time to implement, the Commission directs staff to explore an interim process for permitting a proposed assignee or transferee to modify the regulatory status for a license as part of the assignment or transfer of control application, perhaps by permitting the applicants to provide in an exhibit a request for change. In the interim and as can be done under the Commission's current processes, assignees or transferees will be able to file a modification on Form 601 to change the regulatory status of a license obtained pursuant to a transaction after the transaction is consummated.

    30. The current Form 608, Item 9, permits a proposed spectrum lessee to indicate at the time of filing an initial spectrum leasing application what regulatory status or statuses are applicable to its planned operations on the leased spectrum. Once a spectrum leasing arrangement is granted or accepted, as applicable, the spectrum lessee may file a lease modification on Form 608 to indicate a change in the regulatory status as application to its operations under the spectrum leasing arrangement.

    31. Other Issues. Several commenters raise issues that were not discussed in the NPRM. For example, MSI and NPPD highlight several part 22 rules that they argue are ripe for reform, and ask the Commission to initiate a separate rulemaking to review these and other part 22 rules. Those issues are beyond the scope of the CMRS proceeding and the Commission does not address them here.

    I. Procedural Matters A. Paperwork Reduction Act Analysis

    32. This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

    B. Congressional Review Act

    33. The Commission will send a copy of the Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act.

    C. Final Regulatory Flexibility Certification

    34. The Regulatory Flexibility Act of 1980, as amended (RFA), requires that an agency prepare a regulatory flexibility analysis for notice and comment rulemakings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” The Final Regulatory Flexibility Certification of the possible economic impact of the rule changes contained in the Report and Order was attached as Appendix B of the Order.

    D. Contact Information

    35. For further information regarding the Order, contact Kathy Harris at (202) 418-0609, [email protected], or Thomas Reed at (202) 418-0531, [email protected]

    II. Ordering Clauses

    36. Accordingly, it is ordered, pursuant to sections 1, 2, 4(i), 4(j), 7, 301, 303, 307, 308, 309, and 332 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 154(j), 157, 301, 303, 307, 308, 309, and 332, that this report and order in WT Docket No. 16-240 is adopted.

    37. It is further ordered that the report and order shall be effective 30 days after publication of a summary of the report and order in the Federal Register.

    38. It is further ordered that part 1 of the Commission's rules, 47 CFR part 1, part 4 of the Commission's rules, 47 CFR part 4, part 9 of the Commission's rules, 47 CFR part 9, and part 20 of the Commission's rules, 47 CFR part 20, are amended as specified in Appendix A of the Order, effective 30 days after publication in the Federal Register.

    39. It is further ordered that, pursuant to Section 801(a)(1)(A) of the Congressional Review Act, 5 U.S.C. 801(a)(1)(A), the Commission shall send a copy of the report and order to Congress and to the Government Accountability Office.

    40. It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of the report and order, including the Final Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the Small Business Administration.

    41. It is further ordered that, if no petitions for reconsideration or applications for review are timely filed, this proceeding shall be terminated and the docket closed.

    List of Subjects in 47 CFR Parts 1, 4, 9, and 20

    Commercial mobile services, Disruptions to communications, Interconnected voice over internet protocol services, Practice and procedure.

    Federal Communications Commission. Katura Jackson, Federal Register Liaison Officer, Office of the Secretary. Final rules

    For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 1, 4, 9, and 20 as follows:

    PART 1—PRACTICE AND PROCEDURE 1. The authority citation of part 1 is revised to read as follows: Authority:

    47 U.S.C. 151, 154(i), 155, 157, 160, 201, 225, 227, 303, 309, 332, 1403, 1404, 1451, 1452, and 1455, unless otherwise noted.

    2. In § 1.907, revise the definition for “Wireless Telecommunications Services” to read as follows:
    § 1.907 Definitions.

    Wireless Telecommunications Services. Wireless Radio Services, whether fixed or mobile, that meet the definition of “telecommunications service” as defined by 47 U.S.C. 153, as amended, and are therefore subject to regulation on a common carrier basis.

    PART 4—DISRUPTIONS TO COMMUNICATIONS 3. The authority citation of part 4 continues to read as follows: Authority:

    Sections 1, 4(i), 4(j), 4(o), 251(e)(3), 254, 301, 303(b), 303(g), 303(r), 307, 309(a), 309(j), 316, 332, 403, 615a-1, and 615c of Pub. L. 73-416, 48 Stat. 1064, as amended, and section 706 of Pub. L. 104-104, 110 Stat. 56; 47 U.S.C. 151, 154(i)-(j) & (o), 251(e)(3), 254, 301, 303(b), 303(g), 303(r), 307, 309(a), 309(j), 316, 332, 403, 615a-1, 615c, and 1302, unless otherwise noted.

    4. In § 4.3, revise paragraph (f) to read as follows:
    § 4.3 Communications providers covered by the requirements of this part.

    (f) Wireless service providers include Commercial Mobile Radio Service communications providers that use cellular architecture and CMRS paging providers. See § 20.3 of this chapter for the definition of Commercial Mobile Radio Service. Also included are affiliated and non-affiliated entities that maintain or provide communications networks or services used by the provider in offering such communications.

    PART 9—INTERCONNECTED VOICE OVER INTERNET PROTOCOL SERVICES 5. The authority citation of part 9 continues to read as follows: Authority:

    47 U.S.C. 151, 154(i)-(j), 251(e), 303(r), and 615a-1 unless otherwise noted.

    6. In § 9.3, revise the definition for “CMRS” to read as follows:
    § 9.3 Definitions.

    CMRS. Commercial Mobile Radio Service, as defined in § 20.3 of this chapter.

    PART 20—COMMERCIAL MOBILE SERVICES 7. The authority citation for of part 20 continues to read as follows: Authority:

    47 U.S.C. Sections 151, 152(a), 154(i), 157, 160, 201, 214, 222, 251(e), 301, 302, 303(b), 303(r), 307, 307(a), 309, 309(j)(3), 316, 316(a), 332, 610, 615, 615a, 615b, 615c unless otherwise noted.

    8. In § 20.3: a. In the definition for “Commercial mobile radio service”: i. In paragraph (b), remove “of this section” and add “of this definition” in its place; and ii. Add paragraphs (c) and (d); and b. Revise the introductory text of the definition for “Private Mobile Radio Service”.

    The additions and revision read as follows:

    § 20.3 Definitions.

    Commercial mobile radio service. * * *

    (c) A variety of factors may be evaluated to make a determination whether the mobile service in question is the functional equivalent of a commercial mobile radio service, including: Consumer demand for the service to determine whether the service is closely substitutable for a commercial mobile radio service; whether changes in price for the service under examination, or for the comparable commercial mobile radio service, would prompt customers to change from one service to the other; and market research information identifying the targeted market for the service under review.

    (d) Unlicensed radio frequency devices under part 15 of this chapter are excluded from this definition of Commercial mobile radio service.

    Private mobile radio service. A mobile service that meets neither the paragraph (a) nor paragraph (b) definitions of commercial mobile radio service set forth in this section. A mobile service that does not meet the paragraph (a) definition of commercial mobile radio service in this section is presumed to be a private mobile radio service. Private mobile radio service includes the following:

    § 20.7 [Removed and Reserved]
    9. Section 20.7 is removed and reserved.
    § 20.9 [Removed and Reserved]
    10. Section 20.9 is removed and reserved.
    [FR Doc. 2018-00919 Filed 2-20-18; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF VETERANS AFFAIRS 48 CFR Parts 816, 828, and 852 RIN 2900-AP82 Revise and Streamline VA Acquisition Regulation To Adhere to Federal Acquisition Regulation Principles (VAAR Case 2014-V002) AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of Veterans Affairs (VA) adopts as final the proposed amendments to VA regulations. This rulemaking prescribes five new Economic Price Adjustment clauses for firm-fixed-price contracts, identifies VA's task-order and delivery-order ombudsman, clarifies the nature and use of consignment agreements, adds policy coverage on bond premium adjustments and insurance under fixed-price contracts, and provides for indemnification of contractors for medical research or development contracts. This document adopts the proposed rule published on March 13, 2017, as a final rule with five technical non-substantive changes.

    DATES:

    This rule is effective on March 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Ricky Clark, Senior Procurement Analyst, Procurement Policy and Warrant Management Services, 003A2A, 425 I Street NW, Washington, DC 20001, (202) 632-5276 (this is not a toll-free telephone number).

    SUPPLEMENTARY INFORMATION:

    This document adopts as a final rule without change a proposed rule amending the VA Acquisition Regulation (VAAR). On March 13, 2017, VA published a proposed rule in the Federal Register (82 FR 13418) which announced VA`s intent to amend regulations for parts 816 and 828. On April 4, 2017, VA published in the Federal Register a correction to the proposed rule at 82 FR 16332.

    We provided a 60 day comment period for interested parties to submit comments to VA on or before May 12, 2017. Five respondents submitted comments to the proposed rule. A discussion of the comments is provided below.

    One commenter asserted that the restrictions imposed on VA regarding 38 U.S.C. 8127 can often impact the efficiency of using the combined synopsis/solicitation method. The commenter recommends: “Creating a policy and procedure for COs to utilize the commercial combo and still comply with the “purpose” of 38 U.S.C. 8127 but COs will need guidance and limitations.”

    The parts in this final rule do not address acquisition of commercial items or simplified acquisition procedures set forth in the Federal Acquisition Regulation (FAR) parts 12 and 13 or VAAR parts 812 and 813. However, in response to the comment, VA does not concur. In order to satisfy the requirements of 38 U.S.C. 8127, VA must ensure that preference is given for awards to service-disabled veteran-owned small businesses and veteran-owned small businesses, even for acquisition of commercial items under FAR part 13. Accordingly, VA has revised its market research process to facilitate the identification of verified and qualified veteran-owned firms for contract awards. VA's contracting officers will be able to perform the required market research and identify veteran-owned firms more quickly and efficiently as the learning curve diminishes. VA is committed to complying with 38 U.S.C. 8127, ensuring the mission is not compromised, and that contracting officers are making awards in a timely fashion. Additionally, implementation of 38 U.S.C. 8127, the Veterans Benefits, Healthcare, and Information Technology Act of 2006, does not prohibit the use of the combined synopsis/solicitation method set forth in FAR part 12.

    One commenter expressed general support for veterans programs and complimented the revisions made in the rule. VA appreciates the commenter's support of veterans.

    One commenter noted that the proposed rule does not require formal rulemaking. VA removed the term “formal” in the description of its rulemaking process. However, in accordance with 41 U.S.C. 1707 (the Office of Federal Procurement Policy Act), a procurement policy, regulation, procedure, or form (including an amendment or modification thereto) may not take effect until 60 days after it is published for public comment in the Federal Register. During this process where VA is examining its VA Acquisition Regulation, proposed rules will be published for public comment in accordance with the Federal rulemaking process.

    One commenter stated that this rule could benefit from further explanation as currently in VA there is confusion regarding how consignment agreements are entered into. The first sentence of section 816.770 has been changed from “A consignment agreement is not a contract” to “Consignment agreements shall only be established under a contract and by a contracting officer.”

    The final rule informs the public that consignment agreements are permitted to be used at VA. As stated in the proposed rule: “This Proposed Rule will streamline the VAAR to implement and supplement the FAR only when required, and remove internal agency guidance as noted above in keeping with the FAR principles concerning agency acquisition regulations.” Internal agency guidance and procedures relating to consignment agreements are included in M816, the corresponding VA Acquisition Manual (VAAM) part that will be issued within VA when the revised VAAR part 816 is published. The information included in the VAAM will address the concerns raised by the commenter.

    One commenter recommends that VA consider the use of cascading set-asides in FAR part 16 related acquisitions. The commenter also takes issue with VA's implementation of 38 U.S.C. 8127 in that it doesn't explicitly allow cascading set-asides and believes that this slows the procurement process. We are making no change to VAAR Part 816 at this time based on this comment.

    This comment was beyond the scope of the proposed rule. Guidance on cascading set-asides would more appropriately be placed in VAAR Part 819. VA will consider including guidance on cascading when VA proposes revisions to VAAR Part 819. VA is committed to complying with 38 U.S.C. 8127, ensuring the mission is not compromised, and that contracting officers are making awards in a timely fashion.

    Technical Non-Substantive Changes to the Proposed Rule

    This final rule removes the citation of 38 U.S.C. 501 from parts 828 and 852, 41 U.S.C 1121 and 41 U.S.C. 1702 to the authority of parts 816, 828, and 852 which address overall direction of procurement policy, acquisition planning and management responsibilities.

    This final rule revises subsection 816.203-4(f) to remove “or under a VA provider agreement.” This clarifies that the prescribed clause applies to VA contracts and should not be utilized for VA provider agreements that are not made under a contract. Clause 852.216-72, “Proportional Economic Price Adjustment of Contract Price(s) Based on a Price Index,” included in a footnote the sentence, “Selection of the wrong index may result in a claim and reformation of a contract.” This sentence has been removed. The deleted text represents internal VA guidance for VA contracting personnel and is not appropriate for inclusion in a regulation.

    This final rule revises section 828.306(b) by replacing “VA Manual MP-1, Part II, Chapter 3” with “VA Policy” in reference to the policy document for emergency or sporadic ambulance services. This change was made to avoid the need to amend the regulation should VA place this policy in a different document in the future.

    This final rule revises section 852.216-73(a) by including “by a contracting officer” at the end of the paragraph. This is to clarify that contract modifications must be performed by a contracting officer. Sections 852.216-73(a) and 852.216-74 are revised to remove the terms “ALT #1” and “ALT #2” from the titles of the clauses as well as from their prescriptions at section 816.203-4(e)(3) and (4).

    Based on the rationale set forth in the proposed rule and in this document, VA is adopting the provisions of the proposed rule as a final rule with the changes discussed above.

    Paperwork Reduction Act

    Although this action contains provisions constituting collections of information at 48 CFR 828.306 and 852.228-71, under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521), no new or proposed revised collections of information are associated with this final rule. The information collection requirements for 48 CFR 828.306 and 852.228-71 are currently approved by the Office of Management and Budget (OMB) and have been assigned OMB control number 2900-0590.

    Regulatory Flexibility Act

    This final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule will generally be small business neutral. The overall impact of the final rule will be of benefit to small businesses owned by veterans or service-disabled veterans as the VAAR is being updated to remove extraneous procedural information that applies only to VA's internal operating procedures. VA estimates no cost impact to individual business resulting from these rule updates. On this basis, the adoption of this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. Therefore, under 5 U.S.C. 605(b), this final rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

    Executive Orders 12866, 13563 and 13771

    Executive Orders (E.O.) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits of reducing costs, of harmonizing rules, and of promoting flexibility. E.O. 12866, Regulatory Planning and Review defines “significant regulatory action” to mean any regulatory action that is likely to result in a rule that may: “(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive order.”

    VA has examined the economic, interagency, budgetary, legal, and policy implications of this regulatory action, and it has been determined to be a significant regulatory action under E.O. 12866, because it raises novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive order. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/orpm by following the link for VA Regulations Published from FY 2004 Through Fiscal Year to Date. This rule is not expected to be subject to the requirements of E.O. 13771, Reducing Regulation and Controlling Regulatory Costs, because this rule is expected to result in no more than de minimis costs.

    Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal Governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal Governments or on the private sector.

    List of Subjects 48 CFR Part 816

    Government procurement.

    48 CFR Part 828

    Government procurement, Insurance, Surety bonds.

    48 CFR Part 852

    Government procurement, Reporting and recordkeeping requirements.

    Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on December 15, 2017, for publication.

    Dated: February 12, 2018. Consuela Benjamin, Regulations Development Coordinator, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.

    For the reasons set out in the preamble, VA amends 48 CFR, chapter 8, parts 816, 828, and 852 as follows:

    PART 816—TYPES OF CONTRACTS 1. The authority citation for part 816 is revised to read as follows: Authority:

    40 U.S.C. 121(c); 41 U.S.C. 1121; 41 U.S.C. 1702; and 48 CFR 1.301-1.304.

    Subpart 816.1 [Removed and Reserved] 2. Subpart 816.1 is removed and reserved. 3. Subpart 816.2, consisting of section 816.203, is added to read as follows: Subpart 816.2—Fixed-Price Contracts
    816.203 Fixed-price contracts with economic price adjustment.
    816.203-4 Contract clauses.

    (e) The contracting officer shall, when contracting by negotiation, use the following clauses.

    (1) The contracting officer shall insert the clause at 852.216-71, “Economic Price Adjustment of Contract Price(s) Based on a Price Index,” in solicitations and firm fixed price contracts, subject to FAR 16.203-4(d)(1) and when changes to a price index will be used to calculate corresponding changes to the total contract price or unit prices of the contract.

    (i) Exceptions:

    (A) Do not use this clause when changes to the price index will apply to only a component part of the contract price.

    (B) Do not publish or include the footnotes in the solicitation, they are only included herein to provide guidance to contracting officers.

    (2) The contracting officer shall insert the clause at 852.216-72, “Proportional Economic Price Adjustment of Contract Price(s) Based on a Price Index,” in solicitations and firm fixed price contracts, and subject to FAR 16.203-4(d)(1) when changes to an industry price index shall be used to calculate changes to only a portion of the contract price or the unit prices of the contract.

    (i) Exceptions:

    (A) The clause should not be used when a change in the index price will be applied directly and totally to the contract price or the unit prices, i.e., when the Consumer Price Index is used to calculate changes and a 5% increase in the CPI would result in a 5% increase in the total contract price of the unit prices.

    (B) Do not publish or include the footnotes in the solicitation, as they are only provided for guidance to the contracting officer.

    (3) The contracting officer shall insert the clause at 852.216-73, “Economic Price Adjustment—State Nursing Home Care for Veterans,” in solicitations and firm fixed price contracts subject to FAR 16.203-4(d)(1) and the following circumstance: When changes to the Medicaid rate, as authorized by the State Medicaid Agency (SMA), shall be used to calculate corresponding changes in the total contract price or the per diem prices of the agreement or contract.

    (4) The contracting officer shall insert the clause at 852.216-74, “Economic Price Adjustment—Medicaid Labor Rates,” in solicitations and firm fixed price contracts when the conditions specified in FAR 16.203-4(c)(1) apply. The clause is modifiable by increasing the 10-percent maximum limit on aggregate increases specified in paragraph (c)(4) of this section, upon the approval by the Head of the Contracting Activity (HCA) or designee.

    (5) The contracting officer shall insert the clause at 852.216-75, “Economic Price Adjustment—Fuel Surcharge,” in solicitations and firm fixed price contracts when contracting by negotiation is subject to changes in the cost of fuel increases. The clause is subject to the conditions at FAR 16.203-4(d)(1).

    (f) The contracting officer shall follow procedures as prescribed in FAR 16.203-4(c) and 38 CFR 51.41(b)(1) for EPA fixed price contracts based on Medicaid rates. These procedures shall be used when contracting by negotiation between the VA and the State Veteran Home for making payments under contracts for nursing home care for Veterans.

    816.504 [Removed]
    4. Section 816.504 is removed. 5. Section 816.505 is revised to read as follows:
    816.505 Ordering.

    (b)(8) Task-order and delivery-order ombudsman. The task-order contract and delivery-order ombudsman for VA is the Associate Deputy Assistant Secretary (ADAS) for Procurement Policy, Systems and Oversight. The VA Ombudsman shall review and resolve complaints from contractors concerning all task and delivery order actions. If any corrective action is needed after reviewing complaints from contractors, the VA Ombudsman shall provide a written determination of such action to the contracting officer. Contracting officers shall be notified of any complaints submitted to the VA Ombudsman.

    6. Subpart 816.7 is added to read as follows: Subpart 816.7—Agreements
    816.770 Consignment agreements.

    Consignment agreements shall only be established under a contract and by a contracting officer. A consignment agreement is defined as a delivery method for a specified period of time in which the contractor provides an item/s for Government use and the contractor receives reimbursement only if and when the item is used by the Government. Consignment agreements are allowable and shall be considered in those instances when the requirement for an item is immediate and on-going and when it is impossible to predetermine the type or model of a particular item until the need is established, and it is determined to be in the best interest of the VA.

    PART 828—BONDS AND INSURANCE 7. The authority citation for part 828 is amended to read as follows: Authority:

    38 8127-8128 and 8151-8153; 40 U.S.C. 121(c); 41 U.S.C 1121; 41 U.S.C. 1702; and 48 CFR 1.301-1.304.

    Subpart 828.1—Bonds and Other Financial Protections 828.101, 828.101-2, and 828.101-70 [Removed] 8. Sections 828.101, 828.101-2, and 828.101-70 are removed.
    828.106-6 [Removed]
    9. Section 828.106-6 is removed. 10. Section 828.106-70 is revised to read as follows:
    828.106-70 Bond premium adjustment.

    The contracting officer shall insert the clause at 852.228-70, Bond Premium Adjustment, in solicitations and contracts when performance and payment bonds or payment protection is required.

    Subpart 828.2 [Removed and Reserved] 11. Subpart 828.2 is removed and reserved. 12. Section 816.306 is amended by revising paragraph (a) to read as follows:
    828.306 Insurance under fixed-price contracts.

    (a) The contracting officer shall insert the provision at 852.228-71, Indemnification and Insurance, in solicitations when utilizing term contracts or contracts of a continuing nature for ambulance, automobile and aircraft service.

    Subpart 828.71 [Redesignated as Subpart 828.70] 13. Subpart 828.71 is redesignated as subpart 828.70 and revised to read as follows: Subpart 828.70—Indemnification of Contractors for Medical Research or Development Contracts 828.7000 Scope of subpart. 828.7001 Extent of indemnification. 828.7002 Financial protection. 828.7003 Indemnification clause.
    828.7000 Scope of subpart.

    (a) As used in this subpart, the term “contractor” includes subcontractors of any tier under a contract containing an indemnification provision under 38 U.S.C. 7317.

    (b) This subpart sets forth the policies and procedures concerning indemnification of contractors performing contracts involving medical research or research and development that involve risks of an unusually hazardous nature, as authorized by 38 U.S.C. 7317.

    (c) The authority to indemnify the contractor under this subpart does not create any rights to third parties that do not exist by law.

    828.7001 Extent of indemnification.

    (a) A contract for medical research or development authorized by 38 U.S.C. 7303, may provide that the Government will indemnify the contractor against losses or liability specified in paragraphs (b) and (c) of this section if all of the following apply:

    (1) The contract work involves a risk of an unusually hazardous nature.

    (2) The losses or liability arise out of the direct performance of the contract.

    (3) The losses or liability are not covered by the financial protection required under 828.7002.

    (b) The Government may indemnify a contractor for liability (including reasonable expenses of litigation or settlement) to third persons for death, bodily injury, or loss of or damage to property from a risk that the contract defines as unusually hazardous. The indemnification will not cover liability under State or Federal worker's injury compensation laws to employees of the contractor who are both:

    (1) Employed at the site of the contract work; and

    (2) Working on the contract for which indemnification is granted.

    (c) The Government may indemnify the contractor for loss of or damage to property of the contractor from a risk that the contract defines as unusually hazardous.

    (d) A contract that provides for indemnification in accordance with this subpart must also require that:

    (1) The contractor must notify the contracting officer of any claim or suit against the contractor for death, bodily injury, or loss of or damage to property; and

    (2) The Government may choose to control or assist in the defense of any suit or claim for which indemnification is provided in the contract. (38 U.S.C. 7317)

    828.7002 Financial protection.

    (a) A contractor shall have and maintain an amount of financial protection to cover liability to third persons and loss of or damage to the contractor's property that meets one of the following:

    (1) The maximum amount of insurance available from private sources; or

    (2) A lesser amount that the Secretary establishes after taking into consideration the cost and terms of private insurance.

    (b) Financial protection may include private insurance, private contractual indemnities, self-insurance, other proof of financial responsibility, or a combination that provides the maximum amount required. If a contractor elects to self-insure, the contractor must provide the contracting officer, before award, proof of financial responsibility up to the maximum amount required. (38 U.S.C. 7317)

    828.7003 Indemnification clause.

    The contracting officer shall include the clause, 852.228-72, “Indemnification of Contractor—Hazardous Research Projects” in contracts and solicitations that indemnify a contractor for liability (including reasonable expenses of litigation or settlement) to third person for death, bodily injury, or loss of or damage to property from a risk that the contract defines in the performance work statement, the statement of work, or the statement of objectives as unusually hazardous.

    PART 852—SOLICITATION PROVISIONS AND CONTRACT CLAUSES 14. The authority citation for 48 CFR part 852 is revised to read as follows: Authority:

    38 U.S.C. 8127-8128, and 8151-8153; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C 1702; and 48 CFR 1.301-1.304.

    852.216-70 [Removed and Reserved]
    15. Section 852.216-70 is removed and reserved. 16. Section 852.216-71 is added to read as follows:
    852.216-71 Economic price adjustment of contract price(s) based on a price index.

    As prescribed in 816.203-4(e)(1), insert the following clause:

    ECONOMIC PRICE ADJUSTMENT OF CONTRACT PRICE(S) BASED ON A PRICE INDEX (DATE)

    (a) To the extent that contract cost increases are provided for by this economic price adjustment clause, the Contractor warrants that the prices in this contract for the base period and any option periods do not include any amount to protect against such contingent cost increases.

    (b) The Base and Adjusting Indexes, for the purpose of price adjustment under this clause, shall be ___,1 as contained in ___,2 as published by ___.3 All adjustments authorized under this clause shall be made by using the Base Index and Adjusting Indexes, which are published ___.4

    1 The Contracting Officer shall conduct market research to determine a suitable Consumer Price Index or other independent broad-based index to use for the solicitation. For example, for medical services, an appropriate index may be the Consumer Price Index that tracks medical services.

    2 Specify where the Index can be found, such as in a solicitation for laboratory services, the Contracting Officer might enter “Table 1, CPI-U: U.S. City Average, by expenditure category and commodity and service group, found at http://www.bls.gov/news.release/cpi.t01.htm”.

    3 Provide the information on who publishes the applicable Index used, e.g., in the example for laboratory services, “the U.S. Department of Labor”.

    4 State how often the Index is published, such as “monthly, around the middle of the month”. Note that some Consumer Price Indexes are not published monthly. Ensure that the correct information is provided for the specific Index used.

    (1) The Base Index, for the purposes of price adjustment under this clause, shall be the most recent Index published prior to the date for receipt of offers, or the due date for receipt of best and final offers if discussions were held whichever is later. The Base Index shall remain constant for the entire term of the contract, including all option periods.

    (2) The Adjusting Index shall be the most recent Index published prior to the date of contract adjustment, as specified in paragraph (d) of this clause.

    (c) The percentage difference between the Base Index and the Adjusting Index, rounded to the nearest .01 percent (e.g., 4.57%), will be used in calculating all adjustments to the following line items: ___.5 The prices for these line items will be multiplied by the percentage increase or decrease and the resulting amount will be added to or deducted from the original line item price for that contract period (e.g., Base Year) to arrive at the new contract price for those line items from the effective date of the adjustment to the beginning of the next contract adjustment period, rounded to the same number of decimal points as the prices originally bid. Calculations for option year contract terms will be based on the prices in the schedule for those option years.

    5 Enter the line items that will be subject to adjustment or revise this paragraph to otherwise state what prices are subject to adjustment under this clause.

    (d) The dates of contract adjustment shall be ___ 6 and the starting dates of each option year, if not already included in these dates. The Contracting Officer shall retain a copy of the Base Index in the contract file and, on each date of adjustment specified in this paragraph (d), shall obtain a copy of the Adjusting Index. The Contracting Officer shall calculate the adjustment due and shall, within 5 business days, issue a modification to the contract adjusting the unit or contract prices, as specified in paragraph (c). The adjusted unit or contract prices shall be effective for all orders placed or services provided after the date of contract adjustment as specified in this paragraph (d) until the beginning of the next contract adjustment period. If the Contracting Officer fails to act, the Contractor shall request in writing a contract adjustment and any subsequent adjustment shall be retroactive to the applicable date of contract adjustment specified in this paragraph (d). The Contractor's entitlement to price increases for a prior contract period (base year or option year) is waived unless the Contractor's written request for an adjustment under this clause is received by the Contracting Officer no later than 30 days following the end of the base year for changes applicable to the base year, or 30 days following the end of each option year for changes applicable to that option year. The Government's right to contract decreases for prior contract periods (base year or option year) is waived unless the Contracting Officer processes a contract modification no later than 30 days following the end of the base year for changes applicable to the base year, or 30 days following the end of each option year for changes applicable to that option year.

    6 Establish time periods for when the Contracting Officer will process adjustments. This could be “the first day of every quarter, January, April, July, and October” or “Annually on October 1st” or some other similar time periods. Since the contracting officer is responsible for initiating the change, the Contracting Officer must establish a reminder mechanism to ensure that the adjustments are accomplished within the time period specified.

    (e) An example of an adjustment calculation is provided herein for informational purposes only.

    (1) The original contract price or line item prices for that contract term (e.g., base year) shall be used for all calculations during that particular contract term and new calculations shall be made for each and every contract adjustment period specified in paragraph (d) during that contract term.

    (2) For purposes of this example, the contract prices for the line items as specified in paragraph (c) will be adjusted by the percentage calculated as follows:

    Adjusting Index for the current period 196.6 Minus the Base Index −188.0 Equals the Index Point Change 8.6 Index Point Change Divided by the Base Index 8.6/188.0 = .0457 * Result Multiplied by 100 Equals the Percentage Change 4.57% (The Index Point Change Percentage) * This figure shall be rounded to the fourth decimal place. When the fifth decimal is 1 to 4, the figure shall be rounded down, 5 to 9, rounded up.

    (3) For a line item with an original bid price of $25.00 and a 4.57 percent Index Point Change increase as of the first contract adjustment period, as shown above, the calculations for a new contract price for the first contract adjustment period would be as follows: $25.00 × .0457 = $1.14, $25 + $1.14 = $26.14 **. The new contract price for this line item from the beginning of that first contract adjustment period until the start of the next contract adjustment period would be $26.14 and the Contracting Officer would issue a contract modification reflecting this price change. ** The unit price adjustment shall be rounded up or down, as in paragraph (e)(1) of this clause, to match the number of decimal places in the original bid.

    (4) If the Adjusting Index went down for the second adjustment period, reflecting only a 3 percent Index Point Change increase over the Base Index, the new price for this sample line item would be reduced for the second contract adjustment period from $26.14 to $25.75 as follows: $25 × .03 = $0.75, $25 + $0.75 = $25.75. Note that the calculations for the second contract adjustment period are based on the original contract price for that contract term of $25.00. The contract price for this line item is modified to reflect this new price for the second contract adjustment period.

    (5) At the start of the first option year and each subsequent option year period (as well as for each contract adjustment period specified in paragraph (d) during that option year, if different), the Contracting Officer shall recalculate the contract or unit prices for that first option year based on any changes between the Adjusting Index and the Base Index, from the original contract award date to the start of the first option period, and based on the Contractor's new option year prices. Assume the Contractor's bid price for the first option year for the above sample line item was $25.50 and the calculations shown in paragraph (e)(1) of this clause at the start of the first option period reflected a 6 percent Index Point Change. The new contract price for this sample line item at the start of the first option period would be calculated as follows: $25.50 × .06 = $1.53, $25.50 + $1.53 = $27.03. The Contracting Officer would process a contract modification reflecting a revised contract price of $27.03 for the first contract adjustment period in the first option year.

    (f) Price adjustments pursuant to this clause, shall be documented by a contract modification issued by the Contracting Officer, show the Base Index (see paragraph (b)(1)), the Adjusting Index, the adjusted contract prices (see paragraph (c)), the mathematical calculations used to arrive at the adjusted contract prices, and the effective date of the adjustment (see paragraph (d)).

    (g) At the start of each option year, the Contracting Officer shall, within 5 days of the start of the option year period, process a contract modification adjusting the option year prices by the then current Index Point Change percentage, if any, reflecting the new adjusted prices for that first contract adjustment period in that option year.

    (h) In the event that ___ 7 discontinues, or alters substantially, its method of calculating the Index cited herein, the parties shall mutually agree upon an appropriate substitute for determining the price adjustment described herein. If the Contracting Officer determines that the Index consistently and substantially fails to reflect market conditions, the Contracting Officer may modify the contract to specify the use of an appropriate substitute index, effective on the date the Index specified herein begins to consistently and substantially fail to reflect market conditions.

    7 Enter in the name of the entity whose index is used in the clause. In most cases when using this clause format, the index used would be a CPI-U Index and the Contracting Officer would enter “the U.S. Department of Labor”.

    (i) Any dispute arising under this clause shall be resolved subject to the “Disputes” clause of the contract.

    (End of clause)
    17. Section 852.216-72 is added to read as follows:
    852.216-72 Proportional economic price adjustment of contract price(s) based on a price index.

    As prescribed in 816.203-4(e)(2), insert the following clause:

    PROPORTIONAL ECONOMIC PRICE ADJUSTMENT OF CONTRACT PRICE(S) BASED ON A PRICE INDEX (DATE)

    (a) To the extent that contract cost increases are provided for by this economic price adjustment clause, the Contractor warrants that the prices in this contract for any option periods do not include any amount to protect against such contingent cost increases.

    (b) The cost index, for the purpose of price adjustment under this clause, shallbe ___ 1 as contained in ___ 2 as published by ___ .3 All adjustments authorized under this clause shall be made by using the Base Index and Adjusting Indexes, which are published ___ .4

    1 The Contracting Officer shall conduct market research to determine a suitable cost index for use in the solicitation. The index used is directly related to the type of commodity or service most likely to impact the Contractor and must approximately track the economic changes affecting the Contractor's costs. For transportation services, an appropriate index might be one that tracks the price of gasoline or diesel fuel. For example, in a solicitation for ambulance services, the Contracting Officer might enter into this block “the “Weekly U.S. Retail Gasoline Prices, Regular Grade” Index for New England” (or California or whichever index is the most appropriate).

    2 Specify where the index can be found, such as in an example for gasoline, “the Energy Information Administration website (see VAAM M816.203-70).

    3 Provide the information on who publishes the index, such as, in an example for gasoline, “the U.S. Department of Energy.”

    4 State how often the index used is published, such as, in an example for an index for gasoline, “weekly each Monday at 5:00 p.m. (Eastern time),” or “Tuesday if Monday is a holiday.”

    (1) The Base Index, for the purposes of price adjustment under this clause, shall be the most recent Index published prior to the closing date for receipt of offers, or the due date for receipt of best and final offers if discussions are held. This Base Index shall remain constant throughout the life of the contract, including all options.

    (2) The Adjusting Index shall be the most recent Index published prior to the date of contract adjustment, as specified in paragraph (f).

    (c) For purposes of this clause, it will be conclusively presumed that ___ percent (%) 5 of the price of ___ 6 represents the Base Cost of ___ 7 and the resulting Base Cost will be the basis upon which adjustment will be made under this clause. This Base Cost will be used in calculating all adjustments to the following line items: ___.8 A new Base Cost will be calculated for each option year period based on the new option year prices.

    5 Prior to issuing the solicitation, the Contracting Officer must conduct market research to determine an appropriate percentage to include in this paragraph. The percentage should reflect that portion of the unit price for the services or supplies being acquired that is applicable to the indexed commodity. For instance, in the case of an ambulance contract, research might indicate that, at the time the solicitation is being drafted and based on prior per-mile bid prices, the cost of gasoline accounts for 10% of the per mile cost of operating an ambulance. For example, if the prior bid price had been $1.60 per mile, ambulances average 10 miles per gallon, and the cost of gasoline had been $1.559 per gallon, 1 mile's worth of gasoline ($.16) would be approximately ten (10) percent of the prior per mile bid price of $1.60 per mile. This percent must be stated in the solicitation so that the same figure applies to all bidders. This figure remains constant throughout the life of the contract.

    6 Enter in this block the portion of the contract that will be subject to price adjustment, e.g., “each one-way mile of ambulance services,” or the line items that will be subject to price adjustment.

    7 Enter in this block the commodity applicable to the index being used, as in an example for an ambulance contract, “regular grade gasoline”.

    8 Enter the line items that will be subject to adjustment, as in an example for an ambulance contract, the line items that reflect the one-way cost per mile for ambulance services for the base year and for each option year.

    (d) The percentage of the price of the indexed commodity (see paragraph (c)) remains fixed throughout the life of the contract and is not subject to modification under this clause. Any pricing actions pursuant to the “Changes” clause or other clause or provision of the contract, except for this clause, will be priced as though there were no provisions for economic price adjustment.

    (e) All price adjustments shall be applicable only to the specific contract adjustment period to which the calculations are made. For every contract adjustment period, new calculations shall be made and new prices determined. Every adjustment during the Base Year shall be based on the original contract prices for that contract year and every adjustment during an option year shall be based on the original contract prices for that option year. The Contracting Officer must make new calculations for each and every contract adjustment period specified in paragraph (f) and at the beginning of each new option year, if different.

    (f) The dates of contract adjustment shall be ___ 9 and the starting dates of each option year, if not already included in these dates. The Contracting Officer shall retain a copy of the Base Index in the contract file and, on each date of adjustment specified herein, obtain a copy of the Adjusting Index. The Contracting Officer shall calculate the adjustment due and shall, within 5 business days, issue a modification to the contract adjusting the contract or unit price(s). The adjusted contract or unit price(s) shall be effective for all orders placed or services provided after the date of contract adjustment, as specified in this paragraph (f), until the date of the next contract adjustment. If the Contracting Officer fails to act, the Contractor shall request a contract adjustment in writing and any subsequent adjustment shall be retroactive to the applicable date of contract adjustment. The Contractor's entitlement to price increases for a prior contract period (base year or option year) shall be waived unless the Contractor's written request for an adjustment under this clause is received by the Contracting Officer no later than 30 days following the end of the base year for changes applicable to the base year, or 30 days following the end of each option year for changes applicable to that option year. The Government's right to contract decreases for prior contract periods (base year or option year) shall be waived unless the Contracting Officer processes a contract modification no later than 30 days following the end of the base year for changes applicable to the base year, or 30 days following the end of each option year for changes applicable to that option year.

    9 Establish time periods for when the Contracting Officer will process adjustments. This could be “the first day of each month” or “the first day of every quarter, January, April, July, and October” or “annually on October 1st” or some other similar time periods. Since the Contracting Officer is responsible for initiating the change, the Contracting Officer must establish a reminder mechanism to ensure that the adjustments are accomplished on time.

    (g) An example of an adjustment calculation is provided herein for informational purposes only.

    (1) For purposes of this example, assume that a contract is for ambulance services, that the contract price is $2.10 per mile one way, that price adjustments will be made on the basis of the cost of gasoline, that the cost of gasoline represents 10% of the total cost per mile (the Base Cost is 10% of $2.10 (the per mile one way price in Line Item X), or $0.21), and that contract adjustments will be made quarterly. If the Base Index (the price of gasoline the week prior to receipt of bids) is $1.559 per gallon and the price of gasoline at the first date of contract adjustment is $2.129 per gallon, the calculations for contract price adjustment would be as follows:

    Adjusting Index (most recent Index cost of gasoline as of the date of the first adjustment period) $2.129 per gallon. Minus the Base Index (Index cost of gasoline as of the date of receipt of offers) −$1.559 per gallon. Equals increase (or decrease) to the Base Index $0.570. Divide increase (or decrease) to the Base Index by the Base Index $0.570 + $1.559 = .3656 *
  • (36.56% increase).
  • Base Cost of $0.21 (10% of $2.10) multiplied by .3656 = $0.0768 unit price increase. New Unit price following the adjustment is $2.10 plus $0.0768 = $2.1768 per mile (rounded to $2.18) ** * This figure shall be rounded to the fourth decimal place. When the fifth decimal is 1 to 4, the figure shall be rounded down, 5 to 9, rounded up. ** The unit price adjustment shall be rounded up or down, as above, to match the number of decimal places in the original bid.

    (2) For the second contract adjustment period, all calculations would be based on the original contract bid price for that contract year, $2.10 per mile in this example. If the price of gasoline goes down during the second adjustment period to the original Base Index price of $1.559 per gallon, the adjusted contract price for that second period would return to $2.10 per mile (there would be a zero percent increase or decrease to the Base Cost and thus no change to the original bid price for that contract adjustment period). The Contracting Officer would then issue a contract modification returning the contract price from $2.18 to $2.10 per mile for that contract adjustment period. If, on the other hand, the price of gasoline actually went below the Base Index price, say to $1.449 per gallon, the calculations for the second economic price adjustment period would be as follows:

    Adjusting Index (most recent Index cost of gasoline as of the date of the second adjustment period) $1.449 per gallon. Minus the Base Index (Index cost of gasoline as of the date of receipt of offers) −$1.559 per gallon. Equals increase (or decrease) to Base Index ($0.110) (a negative $.11). Divide increase (or decrease) to the Base Index by the Base Index ($0.11) + $1.559 = (.0706) (7.06% decrease). Base Cost of $0.21 (10% of $2.10) multiplied by (.0706) = ($0.0148) unit price decrease New Unit price following the second economic price adjustment is $2.10 minus $0.0148 = $2.0852 per mile (rounded to $2.09)

    (3) At the start of the first option year, the Contracting Officer shall recalculate the price per mile based on any changes in the price of gasoline from the original contract award date and based on the Contractor's new first option year price per mile. Assuming the Contractor's bid price per mile for the first option year was $2.25 per mile, the new Base Cost for gasoline would be 10% of $2.25, or $0.225 (note that the original percent figure from paragraph (c) (10% in this sample) stays constant throughout the life of the contract), but the Base Cost would change if the option year contract price changes. If the Adjusting Index for gasoline at the start of the first option year was now up to $1.899 per gallon, the new first option year price for the first contract adjustment period would be calculated as follows:

    Adjusting Index (most recent Index cost of gasoline as of the first day of the first option period) $1.899 per gallon. Minus the Base Index (Index cost of gasoline as of the date of receipt of offers) −$1.559 per gallon. Equals increase (or decrease) to the Base Index $0.340. Divide the increase (or decrease) to the Base Index by the Base Index $0.34 + $1.559 = .2181 (21.81% increase). Base Cost of $0.225 (10%* of $2.25) multiplied by .2181 = $0.0491 unit price increase New Unit price for the first contract adjustment period in the first option year is $2.25 plus $0.0491 = $2.2991 per mile (rounded to $2.30 per mile). * Note that the percentage remains constant (10%) but that the Base Cost has been increased for the first contract adjustment period in the first option year, since the Base Cost is a percentage of the first option year unit cost per mile (in this sample), and the unit cost per mile has increased in this sample for the first option year from $2.10 to $2.25. Although the new unit price for the first contract adjustment period of the first option year following application of the economic price adjustment in this sample would be $2.30 per mile, all economic price adjustment calculations made during that first option year would be based on the original first option year bid price ($2.25 in this sample). If in the second contract adjustment period of the first option year, the calculations resulted in a unit price increase for gasoline of $0.0332, the adjusted price for that period would be $2.25 + $0.0332 = $2.2832, rounded to $2.28 per mile.

    (h) Price adjustments pursuant to this clause, which shall be made by contract modification issued by the Contracting Officer, shall show the Base Index (see paragraph (b)(1)), the Adjusting Index, the Base Cost (see paragraph (c)), the mathematical calculations used to arrive at the adjusted contract unit price, and the effective date of the adjustment.

    (i) In the event that ___10 discontinues, or alters substantially, its method of calculating the Index cited herein, the parties shall mutually agree upon an appropriate substitute for determining the price adjustment described herein. If the Contracting Officer determines that the Index consistently and substantially fails to reflect market conditions, the Contracting Officer may modify the contract to specify use of an appropriate substitute index, effective on the date the Index specified herein begins to consistently and substantially fail to reflect market conditions.

    10 Enter in the name of the entity whose index is used in the clause. In the example for ambulance services using the “Weekly U.S. Retail Gasoline Prices, Regular Grade” index; the Contracting Officer would enter the “Energy Information Administration, Department of Energy”.

    (j) Any dispute arising under this clause shall subject to the “Disputes” clause of the contract.

    (End of clause)
    18. Section 852.216-73 is added to read as follows:
    852.216-73 Economic price adjustment—state nursing home care for veterans.

    As prescribed in 816.203-4(e)(3), insert the following clause:

    ECONOMIC PRICE ADJUSTMENT—STATE NURSING HOME CARE FOR VETERANS (DATE)

    This clause does not apply to rates for non-Medicaid nursing homes.

    (a) Rate Determination. The per diem rate is established by the current Medicaid rate for Medicaid approved nursing home care plus a fair market amount (percentage) to cover the costs of supplies, services, and equipment above that provided under Medicaid established by the local State Medicaid Agency (SMA). Rates established after the effective date of this contract will require a modification to the contract by the Contacting Officer.

    (1) The Medicaid rate covers room, board, and routine nursing care services.

    (2) For all levels of nursing care a percentage is added for routine ancillary services/supplies, such as drugs, nursing supplies, oxygen (occasional use), x-ray, laboratory, physician visits, and rental equipment.

    (3) Special equipment, e.g. Clinitron bed, is not considered routine ancillary services (and may not be provided by the VA).

    (4) Drug costs which comprise more than eight and one-half percent (8.5%) of the per diem rate are generally not considered routine ancillary supplies (and may not be provided by the VA).

    (5) Rehabilitation therapies will be provided as distinct levels of care, i.e., skilled, intermediate, and custodial care. Hospice Care and Dialysis are not included in the rate. Payment for Hospices and Dialysis services is provided by the VA or other payers as determined by the Veteran with the VA's approval.

    (b) Economic Price Adjustment. This clause does not apply to ancillary services that may be added or deleted from the agreement.

    (1) The per diem rate(s) will apply throughout the term of this contract, including extension period(s). The rate(s) may be adjusted only to reflect a change in a Medicaid rate as authorized by the SMA. Normally, this will be on an annual basis. The negotiated percentage above the Medicaid rate, to cover the all-inclusive nature of the contract, will not be renegotiated; but will be applied and added to the new Medicaid rate for the adjusted per diem rate for each level of care item. In this regard, new rates will be negotiated requiring a modification to the contact. Each per diem price adjustment under this clause is subject to the following limitations:

    (2) Any adjustment shall be limited to the effect of increases or decreases in the approved SMA's patient care components within the affected Medicaid groups.

    (3) Adjustments will occur no more frequently than those issued by the SMA.

    (4) No adjustments are made until the Contracting Officer receives from the SMA an authenticated copy of the new rates signed and dated at the top right of the document by the authorized nursing home official. Within ten days after this occurs, the Contracting Officer will execute an approval signature and date at the approximate locations of the nursing home official's signature, the action of which will serve as the effective date of the adjusted rate. A copy of the fully executed document will be sent to the nursing home official for record keeping purposes.

    (End of clause)
    852.216-74 [Amended]
    19. Subsection 852.216-74 is added to read as follows:
    852.216-74 Economic price adjustment—medicaid labor rates.

    As prescribed in 816.203-4(e)(4), insert the following clause:

    ECONOMIC PRICE ADJUSTMENT—MEDICAID LABOR RATES (DATE)

    This clause does not apply to rates for non-Medicaid nursing homes.

    (a) The Contractor shall notify the Contracting Officer if, at any time during contract performance, the Medicaid rate set by the State Medicaid Agency (SMA) for contract line item increases or decreases in the Schedule. The Contractor shall furnish this notice within 60 days after the increase or decrease, or within any additional period that the Contracting Officer may approve in writing, but not later than the date of final payment under this contract. The notice shall include the Contractor's proposal for an adjustment in the contract unit prices to be negotiated under paragraph (b) of this clause, and shall include, in the form required by the Contracting Officer, supporting data explaining the cause, effective date, and the amount of the increase or decrease and the amount of the Contractor's adjustment proposal.

    (b) The Contracting Officer and the Contractor shall negotiate a price adjustment to the contract's unit prices and its effective date upon receipt of the notice and data under paragraph (a) of this clause. However, the Contracting Officer may postpone the negotiations until an accumulation of increases and decreases of the Medicaid labor rates (including fringe benefits) shown in the Schedule results in an adjustment allowable under paragraph (c)(3) of this clause. The Contracting Officer shall modify this contract as follows:

    (1) Include the price adjustment and its effective date;

    (2) Revise the Medicaid labor rates (including fringe benefits) as shown in the Schedule to reflect the increases or decreases resulting from the SMA adjustment. The Contractor shall continue performance pending agreement on, or determination of, any adjustment and its effective date.

    (c) Any price adjustment under this clause is subject to the following limitations:

    (1) Adjustment shall be limited to the effect on unit prices of the increases or decreases of the Medicaid rates of pay for labor (including fringe benefits) shown in the Schedule. There shall be no adjustment for changes in rates or unit prices other than those shown in the Schedule.

    (2) No upward adjustment shall apply to supplies or services that are required to be delivered or performed before the effective date of the adjustment, unless the Contractor's failure to deliver or perform according to the delivery schedule results from causes beyond the Contractor's control and without its fault or negligence, within the meaning of the Default clause.

    (3) There shall be no adjustment for any change in rates of pay for labor (including fringe benefits) or unit prices for material which would not result in a net change of at least three percent of the then-current total contract price. This limitation shall not apply, however, if, after final delivery of all contract line items, either party requests an adjustment under paragraph (b) of this clause.

    (4) The aggregate of the increases in any contract unit price made under this clause shall not exceed 10 percent of the original unit price. There is no percentage limitation on the amount of decreases made under this clause.

    (d) The Contracting Officer, precluding certified cost and pricing data may examine the Contractor's books, records, and other supporting data relevant to the cost of labor (including fringe benefits) and material during all reasonable times until the end of 3 years after the date of final payment under this contract or the time periods specified in Subpart 4.7 of the Federal Acquisition Regulation (FAR), whichever is earlier.

    (End of clause)
    852.216-75 [Amended]
    20. Section 852.216-75 is added to read as follows:
    852.216-75 Economic price adjustment clause—fuel surcharge.

    As prescribed in 816.203-4(e)(5), insert the following clause:

    ECONOMIC PRICE ADJUSTMENT CLAUSE—FUEL SURCHARGE (DATE)

    (a) To the extent that contract fuel cost increases are provided for by this economic price adjustment clause, the Contractor warrants that the prices in this contract for any option periods do not include any amount to protect against such contingent fuel cost increases.

    (b) The fuel cost index, for the purpose of price adjustment under this clause, shall be the “Weekly Retail On-Highway Diesel Prices Index.”

    The Base Fuel Cost, for the purpose of price adjustments under this clause, shall be the most recent Index Weekly Average Diesel Fuel Price per gallon published prior to the closing date for receipt of offers, or the due date for receipt of final proposal revisions if discussions are held.

    (c) For purposes of this clause, it will be conclusively presumed that x% increase or decrease of the Base Fuel Cost represents a reasonable fluctuation of diesel fuel prices. The Base Fuel Cost (+/−) x% price range will be determined for the base contract year and will remain constant throughout the life of the contract, including option years. Base Fuel Cost price range is documented at time of contract award.

    (d) Increases (or decreases) in the diesel fuel costs (Base Fuel Cost x%) as listed on the Index two weeks prior to the end of each calendar quarter can trigger a request from the Contractor to the Government (or from the Government to the Contractor) for cost adjustments. Notice must be in writing to the Subsistence Prime Vendor (SPV) Contracting Officer (or Contracting Officer's Representative) no less than ten days prior to the beginning of the next quarter.

    (e) Since fuel cost is only a part of the SPV Contracted distribution cost, the adjustment will be made as a penny per delivered case for every ten cent fuel price per gallon increase or decrease to the Base Fuel Cost x%. The difference is rounded down to the nearest whole cent and will be added to last line of each invoice noted as “Fuel Adjustment”.

    Example calculation of fuel price change: Price $2.50 Base (+ or −) 15% Average National Diesel Fuel $2.88−$2.13. 3rd QTR (3rd week June) first year. Fuel Price $3.05 Calculation: $3.05−2.88 = $.17 (rounded down to 10 cents) Add one cent per delivered case to each invoice, starting first Monday of July. 3rd QTR Diesel Fuel Price decrease $2.13−1.80 = $ .33 (rounded down to $.30 cents) Credit each invoice. $1.80 Calculation: $.03 cents per delivered case.

    (f) Once approved, the date for contract fuel price adjustment will be the first Monday of the first month of each quarter unless otherwise designated at time of contract award.

    (g) The Contracting Officer shall retain a copy of the Base Fuel Index establishing the Base Fuel Cost and the calculation of the price range incorporating the (+/−) x% adjustment in the contract file. All subsequent changes will be documented within the contract file and communicated to the Contractor and VA SPV customers via email one week prior to the fuel price adjustment implementation.

    (h) Any adjustments for fuel price changes will only be implemented if requested in writing, reviewed by both parties, and provided within the designated time frames. No retroactive cost adjustments will be made. A contract modification will be issued at inception of first increase or decrease detailing Base Fuel Cost, price range, and calculation of first fuel adjustment charge. Adjustment will remain in effect with quarterly calculation changes as needed until price falls within Base Fuel Cost price range. A contract modification will be issued to terminate the adjustment when price returns to Base Fuel Cost (+/−) x% price range.

    (i) In the event that “the Energy Information Administration, Department of Energy” discontinues, or substantially alters its method of calculating the national average diesel fuel prices cited herein, the parties shall mutually agree upon an appropriate substitute for determining the price adjustment described herein. If the Contracting Officer determines the Index consistently and substantially fails to reflect market conditions, the Contracting Officer may modify the contract to specify use of an appropriate substitute Index, effective on the date the Index specified herein begins to consistently and substantially fail to reflect market conditions.

    (j) Any dispute arising under this clause shall be determined in accordance with and subject to the “Disputes” clause of the contract.

    (End of clause)
    21. Section 852.228-71 is revised to read as follows:
    852.228-71 Indemnification and insurance.

    As prescribed in 828.306, insert the following clause:

    INDEMNIFICATION AND INSURANCE (DATE)

    (a) Indemnification. The Contractor expressly agrees to indemnify and save the Government, its officers, agents, servants, and employees harmless from and against any and all claims, loss, damage, injury, and liability, however caused, resulting from, arising out of, or in any way connected with the performance of work under this contract. Further, it is agreed that any negligence or alleged negligence of the Government, its officers, agents, servants, and employees, shall not be a bar to a claim for indemnification unless the act or omission of the Government, its officers, agents, servants, and employees is the sole, competent, and producing cause of such claims, loss, damage, injury, and liability. At the option of the Contractor, and subject to the approval by the Contracting Officer, insurance coverage may be employed as guaranty of indemnification.

    (b) Insurance. Satisfactory insurance coverage is a condition precedent to award of this contract. In general, a successful bidder must present satisfactory evidence of full compliance with State and local requirements, or those below stipulated, whichever are the greater. More specifically, workers' compensation and employer's liability coverage will conform to applicable State law requirements for the service defined, whereas general liability and automobile liability of comprehensive type shall, in the absence of higher statutory minimums, be required in the amounts per vehicle used of not less than $200,000 per person and $500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage. State-approved sources of insurance coverage ordinarily will be deemed acceptable to the Department of Veterans Affairs, subject to timely certifications by such sources of the types and limits of the coverages afforded by the sources to the bidder. [Contracting Officer's Note: In those instances where airplane service is to be used, substitute the word “aircraft” for “automobile” and “vehicle” and modify coverage to require aircraft public and passenger liability insurance of at least $200,000 per passenger and $500,000 per occurrence for bodily injury, other than passenger liability, and $200,000 per occurrence for property damage. Coverage for passenger liability bodily injury shall be at least $200,000 multiplied by the number of seats or passengers, whichever is greater.]

    (End of clause)
    22. Section 852.228-73 is added to read as follows:
    852.228-73 Indemnification of contractor—hazardous research projects.

    As prescribed in 828.7003, insert the following clause:

    INDEMNIFICATION OF CONTRACTOR—HAZARDOUS RESEARCH PROJECTS (DATE)

    (a) This contract involves work with a risk of an unusually hazardous nature as specifically defined in the contract. The government shall indemnify the Contractor, including subcontractors of any tier, against losses or liability specified in paragraphs (b) and (c) of this clause if—

    (1) The losses or liability arise out of or results from a risk defined in this contract as unusually hazardous; and

    (2) The losses or liability are not covered by the financial protection required by paragraph (c).

    (b) The Government shall indemnify a Contractor for—

    (1) Liability (including reasonable expenses of litigation or settlement) to third persons for death, bodily injury, or loss of or damage to property from a risk that the contract defines as unusually hazardous. This indemnification shall not cover liability under State or Federal worker's injury compensation laws to employees of the Contractor who are both:

    (i) Employed at the site of the contract work; and

    (ii) Working on the contract for which indemnification is granted.

    (2) The Government shall also indemnify the Contractor for loss of or damage to property of the Contractor from a risk that the contract defines as unusually hazardous.

    (c) A Contractor shall have and maintain an amount of financial protection to cover liability to third persons and loss of or damage to the Contractor's property. Financial protection may include private insurance, private contractual indemnities, self-insurance, other proof of financial responsibility, or a combination that provides the maximum amount required. The financial protection provided must meet one of the following—

    (1) The maximum amount of insurance available from private sources; or

    (2) A lesser amount that the Secretary establishes after taking into consideration the cost and terms of private insurance.

    (d) Actions in event of a claim—

    (1) The Contractor shall notify the Contracting Officer of any claim or suit against the Contractor for death, bodily injury, or loss of or damage to property; and

    (2) The Government may elect to control or assist in the defense of any suit or claim for which indemnification is provided in the contract.

    (End of clause)
    [FR Doc. 2018-03164 Filed 2-20-18; 8:45 am] BILLING CODE 8320-01-P
    83 35 Wednesday, February 21, 2018 Proposed Rules OFFICE OF PERSONNEL MANAGEMENT 5 CFR Part 890 RIN 3206-AN51 Federal Employees Health Benefits Program Regulations: Revised Guaranteed Issue Conversion Requirements and Technical Updates AGENCY:

    Office of Personnel Management.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Office of Personnel Management proposes to amend the guaranteed issue conversion requirements for the Federal Employees Health Benefits (FEHB) Program. Guaranteed issue insurance policies are available in all 50 states and the District of Columbia. These rules update the requirements and timeframes for FEHB Carriers to offer assistance to enrollees who may wish to enroll in guaranteed issue conversion contracts and ensure that terminating enrollees are able to receive assistance from FEHB Carriers if they choose to enroll in guaranteed issue non-group policies. This rule also updates the title of the Director for Retirement and Insurance.

    DATES:

    Comments are due on or before April 23, 2018.

    ADDRESSES:

    You may submit comments, identified by docket number and/or Regulatory Information Number (RIN) and title, by any of the following methods:

    Federal Rulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail: Delon Pinto, Senior Policy Analyst, Planning and Policy Analysis, U.S. Office of Personnel Management, Room 4312, 1900 E Street NW, Washington, DC 20415.

    All submissions received must include the agency name and docket number or RIN for this document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    Delon Pinto, Senior Policy Analyst, at [email protected] or (202) 606-0004.

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The Federal Employees Health Benefits (FEHB) Program is administered by the Office of Personnel Management (OPM) in accordance with Chapter 89 of Title 5 of the U.S. Code and our implementing regulations (title 5, part 890 and title 48, chapter 16). The statute establishes the basic rules for benefits, enrollment, and participation. OPM is authorized to contract with health insurance Carriers; approve health plans for participation in the program; negotiate with Carriers about benefit and premium levels; determine the times and conditions for an annual open enrollment period known as “open season” during which eligible individuals may elect coverage or change plans; make information available to employees concerning plan options; evaluate health plans on key parameters of clinical quality, customer service, resource use in comparison with national benchmarks and contract oversight requirements; apply administrative sanctions to health care providers that have committed certain violations; and administer the program's financing.

    OPM is also responsible for maintaining the funds that hold contingency reserves for the plans and the fund that receives premium payments from enrollees and Federal agencies, from which premiums are disbursed to participating plans. OPM determines whether retiring employees or survivor annuitants meet the requirements to continue health insurance coverage; takes the action necessary to terminate, accept, or continue enrollment; oversees the automatic deduction of premiums from monthly annuity checks and credits the premiums, along with the applicable Government contribution, to the proper account; processes all enrollment changes; notifies affected Carriers of enrollment changes; and keeps enrolled retirees advised of rate and benefit changes within their plan.

    Background

    Under Section 8902 of Title 5 of the U.S. Code, OPM may only contract with health insurance Carriers who offer terminating enrollees the opportunity to convert to a non-group policy without restrictions on pre-existing conditions. This was an additional protection to ensure that individuals could receive health insurance coverage if they no longer had access to group or non-group coverage. Currently, Carriers must offer a non-group policy to terminating enrollees. Subject to certain exceptions, all non-grandfathered health insurance policies offered in the individual market must be sold to individuals on a guaranteed issue basis.

    Discussion of Proposed Changes

    OPM has determined that the existing FEHB Program requirement that health insurance Carriers offer the option to convert to a non-group contract providing health benefits to FEHB enrollees and covered family members upon termination of their FEHB coverage can be revised to allow more flexibility to enrollees or covered family members and Carriers. As a result, in addition to or as an alternative to enrollment in a conversion plan offered by the Carrier when an enrollee's or covered family member's FEHB coverage is terminated, the enrollee or covered family member can enroll in a guaranteed issue non-group policy. OPM will continue to offer enrollees and covered family members a 31-day extension of coverage, which may be extended to 60 days if the enrollee or covered family member can prove that the 31-day extension did not provide sufficient opportunity to convert to a non-group contract.

    Additionally, the timeframe in which an agency must notify a terminating enrollee of his or her right to convert has been decreased from 60 days to 15 days to minimize the risk of a gap in coverage for the enrollee. OPM arrived at 15 days by reviewing the enrollment deadlines for non-group coverage options available to enrollees and calculating a reasonable time frame for notice that would allow terminating enrollees to subsequently enroll in coverage before the 30 day temporary extension of coverage expired.

    Expected Impact of Proposed Changes

    OPM expects the proposed deregulatory changes to increase the flexibility for Carriers to assist terminating enrollees in finding health insurance coverage and to reduce the costs for Carriers who will have additional options to assist enrollees with finding conversion coverage. Because are proposing to decrease the timeline for notification by employing agencies, we expect individuals to expedite their transition from FEHB coverage to a conversion plan should they choose to enroll in conversion coverage. This increased flexibility will reduce the administrative costs for Carriers. Currently, Carriers must contract with a third party or provide an internal organization to accept any enrollees who may elect conversion coverage offered by the plan. This is a sunk cost regardless of whether enrollees actually elect conversion coverage. This can be a significant expense, particularly if the FEHBP is the only program for which the Carrier must provide this service. If the Carrier has additional flexibility regarding conversion coverage, the Carrier will no longer bear this expense. Depending on how the plan is rated, a portion of this cost will be passed on to the Government and will proportionally reduce premiums. OPM expects these proposed changes to increase the flexibility for Carriers to assist terminating enrollees in finding appropriate health insurance coverage.

    OPM does not believe that this regulation will have a large impact on the broader health insurance market since FEHB generally constitutes a smaller percentage of the overall health insurance carrier's book of business. OPM also believes that employees and annuitants make their health care decisions based on a variety of factors, including networks, premiums, etc., so changes in plan enrollments will be determined by individual choice. However, because OPM does not have extensive data to determine the impact of this regulation, we are seeking comments on the following:

    1. How will the changes made by this regulation impact the non-group health insurance market?

    2. How will the changes made by this regulation impact the choices available to terminating FEHB enrollees?

    3. How will the changes made by this regulation impact the administration of conversion coverage by FEHB Carriers?

    Regulatory Impact Analysis

    OPM has examined the impact of this proposed rule as required by Executive Order 12866 and Executive Order 13563, which directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public, health, and safety effects, distributive impacts, and equity). A regulatory impact analysis must be prepared for major rules with economically significant effects of $100 million or more in any one year. This rule has been designated as a “significant regulatory action,” under Executive Order 12866.

    E.O. 13771: Reducing Regulation and Controlling Regulatory Costs

    This proposed rule is expected to be an E.O. 13771 deregulatory action. Details can be found in the “Expected Impact of the Proposed Changes” section of the rule.

    Regulatory Flexibility Act

    I certify that this regulation will not have a significant economic impact on a substantial number of small entities.

    Federalism

    We have examined this rule in accordance with Executive Order 13132, Federalism, and have determined that this rule will not have any negative impact on the rights, roles and responsibilities of State, local, or tribal governments.

    List of Subjects in 5 CFR Part 890

    Administration and general provisions, Administrative practice and procedure, Administrative sanctions imposed against health care providers, Benefits for former spouses, Benefits for United States hostages in Iraq and Kuwait and United States hostages captured in Lebanon, Benefits in medically underserved areas, Contributions and withholdings, Department of Defense Federal Employees Health Benefits Program demonstration project, Employee benefit plans, Enrollment, Government employees, Health benefits plans, Limit on inpatient hospital charges, physician charges, and FEHB benefit payments, Reporting and recordkeeping requirements, Retirement, Temporary continuation of coverage, Temporary extension of coverage and conversion, Transfers from retired FEHB Program.

    U.S. Office of Personnel Management. Kathleen M. McGettigan, Acting Director.

    Accordingly, OPM proposes to amend title 5, Code of Federal Regulations as follows:

    PART 890—FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM 1. The authority citation for part 890 continues to read as follows: Authority:

    5 U.S.C. 8913; Sec. 890.301 also issued under sec. 311 of Pub. L. 111-03, 123 Stat. 64; Sec. 890.111 also issued under section 1622(b) of Pub. L. 104-106, 110 Stat. 521; Sec. 890.112 also issued under section 1 of Pub. L. 110-279, 122 Stat. 2604; 5 U.S.C. 8913; Sec. 890.803 also issued under 50 U.S.C. 403p, 22 U.S.C. 4069c and 4069c-1; subpart L also issued under sec. 599C of Pub. L. 101-513, 104 Stat. 2064, as amended; Sec. 890.102 also issued under sections 11202(f), 11232(e), 11246 (b) and (c) of Pub. L. 105-33, 111 Stat. 251; and section 721 of Pub. L. 105-261, 112 Stat. 2061; Pub. L. 111-148, as amended by Pub. L. 111-152.

    2. Amend § 890.401 by revising paragraphs (a)(1), (b)(2), and (c) to read as follows:
    § 890.401 Temporary extension of coverage and conversion.

    (a) * * *

    (1) An enrollee whose enrollment is terminated other than by cancellation of the enrollment or discontinuance of the plan, in whole or part, and a covered family member whose coverage is terminated other than by cancellation of the enrollment or discontinuance of the plan, in whole or in part, is entitled to a 31-day extension of coverage for self only, self plus one, or self and family, as the case may be, without contributions by the enrollee or the Government, during which period he or she is entitled to exercise the right of conversion provided for by this part. The 31-day extension of coverage and the right of conversion for any person ends on the effective date of a new enrollment under this part covering the person. In the event this 31-day temporary extension period provides insufficient opportunity for the enrollee to exercise his or her right to convert to a non-group contract with an effective date commencing before or immediately upon the end of the 31-day temporary extension of coverage, the Carrier may, on a case-by-case basis, provide an additional extension of coverage not to exceed a total of 60 days as appropriate to avoid an interruption in coverage. The enrollee or covered family member must explain to the Carrier in writing the circumstances for seeking additional extension, and the Carrier must notify the OPM Contracting Officer of any extension granted, or obtain prior approval of any extension request that is proposed for denial.

    (b) * * *

    (2) Except when a plan is discontinued in whole or in part or the Director orders an enrollment change, a person whose enrollment has been changed from one plan to another, or from one option of a plan to the other option of that plan, and who is confined to a hospital or other institution for care or treatment on the last day of enrollment under the prior plan or option, is entitled to continuation of the benefits of the prior plan or option during the continuance of the confinement. Continuation of benefits shall not extend beyond the 91st day after the last day of enrollment in the prior plan or option. The plan or option to which enrollment has been changed shall not pay benefits with respect to that person while he or she is entitled to any inpatient benefits under the prior plan or option. The gaining plan or option shall begin coverage according to the limits of its FEHB Program contract on the day after the day all inpatient benefits have been exhausted under the prior plan or option or the 92nd day after the last day of enrollment in the prior plan or option, whichever is earlier. For the purposes of this paragraph (b)(2), “exhausted” means paid or provided to the maximum benefit available under the contract.

    (c)(1) The employing agency must notify the enrollee of the termination of the enrollment and of the right to convert to a non-group contract within 15 days after the date the enrollment terminates.

    (2) The individual whose enrollment terminates must request conversion information from the losing Carrier within 15 days of the date of the agency notice of the termination of the enrollment and of the right to convert. The losing Carrier must provide information to the individual that will assist the individual in enrolling in a non-group contract for which the individual is eligible.

    (3) When an agency fails to provide the notification required in paragraph (c)(1) of this section within 15 days of the date the enrollment terminates, or the individual fails for other reasons beyond his or her control to request conversion as required in paragraph (c)(2) of this section, he or she may request assistance with conversion to a non-group contract by writing directly to the Carrier. Such a request must be filed within 6 months after the individual became eligible to convert his or her group coverage and must be accompanied by verification of termination of the enrollment; e.g., an SF 50, showing the individual's separation from the service. In addition, the individual must show that he or she was not notified of the termination of the enrollment and of the right to convert, and was not otherwise aware of it, or that he or she was unable, for cause beyond his or her control, to convert. The Carrier will determine if the individual is eligible to convert; and when the determination is affirmative, the individual may convert within 31 days of the determination. If the determination by the Carrier is negative, the individual may request a review of the Carrier's determination from OPM.

    (4) When an individual converts his or her coverage any time after the group coverage has ended, the non-group plan coverage is effective on the date governed by the rules applicable to the non-group plan.

    (5) An individual who fails to exercise his or her rights to convert to non-group plan during the extension period is deemed to have declined the right to convert unless the Carrier, or, upon review, OPM determines the failure was for cause beyond his or her control.

    [FR Doc. 2018-03510 Filed 2-20-18; 8:45 am] BILLING CODE 6325-63-P
    DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency 12 CFR Part 45 [Docket No. OCC-2018-0003] RIN 1557-AE29 FEDERAL RESERVE SYSTEM 12 CFR Part 237 [Docket No. R-1596] RIN 7100-AE96 FEDERAL DEPOSIT INSURANCE CORPORATION 12 CFR Part 349 RIN 3064-AE70 FARM CREDIT ADMINISTRATION 12 CFR Part 624 RIN 3052-AD28 FEDERAL HOUSING FINANCE AGENCY 12 CFR Part 1221 RIN 2590-AA92 Margin and Capital Requirements for Covered Swap Entities; Proposed Rule AGENCY:

    Office of the Comptroller of the Currency, Treasury (OCC); Board of Governors of the Federal Reserve System (Board); Federal Deposit Insurance Corporation (FDIC); Farm Credit Administration (FCA); and the Federal Housing Finance Agency (FHFA).

    ACTION:

    Notice of proposed rulemaking and request for comment.

    SUMMARY:

    The Board, OCC, FDIC, FCA, and FHFA (each an Agency and, collectively, the Agencies) are seeking comment on proposed amendments to the minimum margin requirements for registered swap dealers, major swap participants, security-based swap dealers, and major security-based swap participants for which one of the Agencies is the prudential regulator (Swap Margin Rule). The Agencies are proposing these amendments in light of the rules recently adopted by the Board, the OCC, and the FDIC that impose restrictions on certain non-cleared swaps and non-cleared security-based swaps and other financial contracts (Covered QFCs) (the QFC Rules). The QFC Rules amend the definition of “Qualifying Master Netting Agreement” in the Federal banking agencies' regulatory capital and liquidity rules to ensure that a Covered QFC is not prevented from being part of a Qualifying Master Netting Agreement solely because the Covered QFC conforms to the new requirements in the QFC Rules. The FCA also plans to propose amendments to its capital rules, including potential revisions to its regulatory definition of “Qualifying Master Netter Agreement,” which is expected to be identical to the definition used in the Federal banking agencies' regulatory capital and liquidity rules.

    The Agencies are proposing to amend the definition of “Eligible Master Netting Agreement” in the Swap Margin Rule so that it remains harmonized with the amended definition of “Qualifying Master Netting Agreement” in the Federal banking agencies' regulatory capital and liquidity rules, and amendments to the capital rules that the FCA separately plans to propose. This proposed rule would also ensure that netting agreements of firms subject to the Swap Margin Rule are not excluded from the definition of “Eligible Master Netting Agreement” based solely on their compliance with the QFC Rules. The Agencies are also proposing that any legacy non-cleared swap or non-cleared security-based swap (i.e., a non-cleared swap or non-cleared security-based swap entered into before the applicable compliance date) that is not subject to the margin requirements of the Swap Margin Rule would not become subject to the provisions of the Swap Margin Rule if the non-cleared swap or non-cleared security-based swap is amended solely to comply with the requirements of the QFC Rules.

    DATES:

    Comments should be received by April 23, 2018.

    ADDRESSES:

    Interested parties are encouraged to submit written comments jointly to all of the Agencies. Commenters are encouraged to use the title “Margin and Capital Requirements for Covered Swap Entities” to facilitate the organization and distribution of comments among the Agencies. Commenters are also encouraged to identify the number of the specific question for comment to which they are responding. Comments should be directed to:

    OCC: You may submit comments to the OCC by any of the methods set forth below. Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments through the Federal eRulemaking Portal or email, if possible. Please use the title “Margin and Capital Requirements for Covered Swap Entities” to facilitate the organization and distribution of the comments. You may submit comments by any of the following methods:

    Federal eRulemaking Portal—“Regulations.gov”: Go to www.regulations.gov. Enter “Docket ID OCC-2018-0003” in the Search Box and click “Search.” Click on “Comment Now” to submit public comments.

    • Click on the “Help” tab on the Regulations.gov home page to get information on using Regulations.gov, including instructions for submitting public comments.

    Email: [email protected]

    Mail: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW, Suite 3E-218, Washington, DC 20219.

    Hand Delivery/Courier: 400 7th Street SW, Suite 3E-218, Washington, DC 20219.

    Fax: (571) 465-4326.

    Instructions: You must include “OCC” as the agency name and “Docket ID OCC-2018-0003” in your comment. In general, the OCC will enter all comments received into the docket and publish them on the Regulations.gov website without change, including any business or personal information that you provide such as name and address information, email addresses, or phone numbers. Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.

    You may review comments and other related materials that pertain to this rulemaking action by any of the following methods:

    Viewing Comments Electronically: Go to www.regulations.gov. Enter “Docket ID OCC-2018-003” in the Search box and click “Search.” Click on “Open Docket Folder” on the right side of the screen. Comments and supporting materials can be viewed and filtered by clicking on “View all documents and comments in this docket” and then using the filtering tools on the left side of the screen.

    • Click on the “Help” tab on the Regulations.gov home page to get information on using Regulations.gov. The docket may be viewed after the close of the comment period in the same manner as during the comment period.

    Viewing Comments Personally: You may personally inspect and photocopy comments at the OCC, 400 7th Street SW, Washington, DC 20219. For security reasons, the OCC requires that visitors make an appointment to inspect comments. You may do so by calling (202) 649-6700 or, for persons who are deaf or hearing impaired, TTY, (202) 649-5597. Upon arrival, visitors will be required to present valid government-issued photo identification and submit to security screening in order to inspect and photocopy comments.

    Board: You may submit comments, identified by Docket No. R-1596 and RIN 7100 AE-96, by any of the following methods:

    Agency website: http://www.federalreserve.gov. Follow the instructions for submitting comments at http://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm.

    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) 452-3819 or (202) 452-3102.

    Mail: Address to Ann E. Misback, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551.

    All public comments will be made available on the Board's website at http://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm as submitted, unless modified for technical reasons. Accordingly, comments will not be edited to remove any identifying or contact information. Public comments may also be viewed electronically or in paper form in Room 3515, 1801 K Street NW (between 18th and 19th Streets NW), between 9:00 a.m. and 5:00 p.m. on weekdays.

    FDIC: You may submit comments, identified by RIN 3064-AE70, by any of the following methods:

    Agency website: http://www.fdic.gov/regulations/laws/federal. Follow instructions for submitting comments on the Agency website.

    Email: [email protected] Include “RIN 3064-AE70” on the subject line of the message.

    Mail: Robert E. Feldman, Executive Secretary, Attention: Comments/RIN 3064-AE70, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429.

    Hand Delivery/Courier: Comments may be hand delivered to the guard station at the rear of the 550 17th Street Building (located on F Street) on business days between 7 a.m. and 5 p.m. All comments received must include the agency name (FDIC) and RIN 3064-AE70 and will be posted without change to http://www.fdic.gov/regulations/laws/federal, including any personal information provided.

    FCA: We offer a variety of methods for you to submit your comments. For accuracy and efficiency reasons, commenters are encouraged to submit comments by email or through the FCA's website. As facsimiles (fax) are difficult for us to process and achieve compliance with section 508 of the Rehabilitation Act, we are no longer accepting comments submitted by fax. Regardless of the method you use, please do not submit your comments multiple times via different methods. You may submit comments by any of the following methods:

    Email: Send us an email at [email protected]

    FCA website: http://www.fca.gov.

    Select “Public Commenters,” then “Public Comments,” and follow the directions for “Submitting a Comment.”

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

    Mail: Barry F. Mardock, Deputy Director, Office of Regulatory Policy, Farm Credit Administration, 1501 Farm Credit Drive, McLean, VA 22102-5090.

    You may review copies of all comments we receive at our office in McLean, Virginia or on our website at http://www.fca.gov. Once you are in the website, select “Public Commenters,” then “Public Comments,” and follow the directions for “Reading Submitted Public Comments.” We will show your comments as submitted, including any supporting data provided, but for technical reasons we may omit items such as logos and special characters. Identifying information that you provide, such as phone numbers and addresses, will be publicly available. However, we will attempt to remove email addresses to help reduce internet spam.

    FHFA: You may submit your written comments on the proposed rulemaking, identified by regulatory information number (RIN) 2590-AA92, by any of the following methods:

    Email: Comments to Alfred M. Pollard, General Counsel, may be sent by email at [email protected] Please include “RIN 2590-AA92” in the subject line of the message. Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. If you submit your comment to the Federal eRulemaking Portal, please also send it by email to FHFA at [email protected] to ensure timely receipt by the Agency. Please include “RIN 2590-AA92” in the subject line of the message.

    U.S. Mail, United Parcel Service, Federal Express, or Other Mail Service: The mailing address for comments is: Alfred M. Pollard, General Counsel, Attention: Comments/RIN 2590-AA45, Federal Housing Finance Agency, Eighth Floor, 400 7th St. SW, Washington, DC 20219.

    Hand Delivery/Courier: The hand delivery address is: Alfred M. Pollard, General Counsel, Attention: Comments/RIN 2590-AA45, Federal Housing Finance Agency, Eighth Floor, 400 7th St. SW, Washington, DC 20219. A hand-delivered package should be logged at the Guard Desk, First Floor, on business days between 9 a.m. and 5 p.m. All comments received by the deadline will be posted for public inspection without change, including any personal information you provide, such as your name and address, on the FHFA website at http://www.fhfa.gov. Copies of all comments timely received will be available for public inspection and copying at the address above on government-business days between the hours of 10 a.m. and 3 p.m. To make an appointment to inspect comments please call the Office of General Counsel at (202) 649-3804.

    FOR FURTHER INFORMATION CONTACT:

    OCC: Allison Hester-Haddad, Counsel, Legislative and Regulatory Activities Division, (202) 649-5490, for persons who are deaf or hearing impaired, TTY (202) 649-5597, Office of the Comptroller of the Currency, 400 7th Street SW, Washington, DC 20219.

    Board: Anna M. Harrington, Senior Supervisory Financial Analyst, (202) 452-6406, or Kelly Tomera, Financial Analyst, (202) 912-7861, Division of Supervision and Regulation; Adam Cohen, Counsel, (202) 912-4658, Victoria M. Szybillo, Counsel, (202) 475-6325, or Jason Shafer, Senior Attorney, (202) 728-5811, Legal Division, Board of Governors of the Federal Reserve System, 20th and C Streets NW, Washington, DC 20551.

    FDIC: Irina Leonova, Senior Policy Analyst, Capital Markets Branch, Division of Risk Management Supervision, (202) 898-3843, [email protected]; Phillip E. Sloan, Counsel, Legal Division, [email protected], (703) 562-6137, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429.

    FCA: J.C. Floyd, Associate Director, Finance & Capital Markets Team, Timothy T. Nerdahl, Senior Policy Analyst—Capital Markets, Jeremy R. Edelstein, Senior Policy Analyst, Office of Regulatory Policy, (703) 883-4414, TTY (703) 883-4056, or Richard A. Katz, Senior Counsel, Office of General Counsel, (703) 883-4020, TTY (703) 883-4056, Farm Credit Administration, 1501 Farm Credit Drive, McLean, VA 22102-5090.

    FHFA: Ron Sugarman, Principal Policy Analyst, Office of Policy Analysis and Research, (202) 649-3208, [email protected], or James Jordan, Assistant General Counsel, Office of General Counsel, (202) 649-3075, [email protected], Federal Housing Finance Agency, Constitution Center, 400 7th St. SW, Washington, DC 20219. The telephone number for the Telecommunications Device for the Hearing Impaired is (800) 877-8339.

    I. Background A. The Swap Margin Rule

    The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) was enacted on July 21, 2010.1 Title VII of the Dodd-Frank Act established a comprehensive new regulatory framework for derivatives, which the Dodd-Frank Act generally characterizes as “swaps” (swap is defined in section 721 of the Dodd-Frank Act to include, among other things, an interest rate swap, commodity swap, equity swap, and credit default swap) and “security-based swaps” (security-based swap is defined in section 761 of the Dodd-Frank Act to include a swap based on a single security or loan or on a narrow-based security index).2 For the remainder of this preamble, the term “swaps” refers to swaps and security-based swaps unless the context requires otherwise.

    1 Dodd-Frank Wall Street Reform and Consumer Protection Act, Public Law 111-203, 124 Stat. 1376 (2010).

    2See 7 U.S.C. 1a(47); 15 U.S.C. 78c(a)(68).

    Sections 731 and 764 of the Dodd-Frank Act required the Office of the Comptroller of the Currency (OCC); Board of Governors of the Federal Reserve System (Board); Federal Deposit Insurance Corporation (FDIC); Farm Credit Administration (FCA); and the Federal Housing Finance Agency (FHFA) (collectively, the Agencies) to adopt rules jointly that establish capital and margin requirements for swap entities 3 that are prudentially regulated by one of the Agencies (covered swap entities),4 to offset the greater risk to the covered swap entity and the financial system arising from swaps that are not cleared by a registered derivatives clearing organization or a registered clearing agency (non-cleared swaps).5 On November 30, 2015, the Agencies published a joint final rule (Swap Margin Rule) to establish minimum margin and capital requirements for covered swap entities.6

    3See 7 U.S.C. 6s; 15 U.S.C. 78o-10. Sections 731 and 764 of the Dodd-Frank Act add a new section 4s to the Commodity Exchange Act of 1936, as amended, and a new section, section 15F, to the Securities Exchange Act of 1934, as amended, respectively, which require registration with the Commodity Futures Trading Commission (CFTC) of swap dealers and major swap participants and the U.S. Securities and Exchange Commission (SEC) of security-based swap dealers and major security-based swap participants (each a swap entity and, collectively, swap entities). The CFTC is vested with primary responsibility for the oversight of the swaps market under Title VII of the Dodd-Frank Act. The SEC is vested with primary responsibility for the oversight of the security-based swaps market under Title VII of the Dodd-Frank Act. Section 712(d)(1) of the Dodd-Frank Act requires the CFTC and SEC to issue joint rules further defining the terms swap, security-based swap, swap dealer, major swap participant, security-based swap dealer, and major security-based swap participant. The CFTC and SEC issued final joint rulemakings with respect to these definitions in May 2012 and August 2012, respectively. See 77 FR 30596 (May 23, 2012); 77 FR 39626 (July 5, 2012) (correction of footnote in the Supplementary Information accompanying the rule); and 77 FR 48207 (August 13, 2012). 17 CFR part 1; 17 CFR parts 230, 240 and 241.

    4 Section 1a(39) of the Commodity Exchange Act of 1936, as amended, defines the term “prudential regulator” for purposes of the margin requirements applicable to swap dealers, major swap participants, security-based swap dealers and major security-based swap participants. The Board is the prudential regulator for any swap entity that is (i) a state-chartered bank that is a member of the Federal Reserve System, (ii) a state-chartered branch or agency of a foreign bank, (iii) a foreign bank which does not operate an insured branch, (iv) an organization operating under section 25A of the Federal Reserve Act of 1913, as amended, or having an agreement with the Board under section 25 of the Federal Reserve Act, or (v) a bank holding company, a foreign bank that is treated as a bank holding company under section 8(a) of the International Banking Act of 1978, as amended, or a savings and loan holding company (on or after the transfer date established under section 311 of the Dodd-Frank Act), or a subsidiary of such a company or foreign bank (other than a subsidiary for which the OCC or the FDIC is the prudential regulator or that is required to be registered with the CFTC or SEC as a swap dealer or major swap participant or a security-based swap dealer or major security-based swap participant, respectively). The OCC is the prudential regulator for any swap entity that is (i) a national bank, (ii) a federally chartered branch or agency of a foreign bank, or (iii) a Federal savings association. The FDIC is the prudential regulator for any swap entity that is (i) a State-chartered bank that is not a member of the Federal Reserve System, or (ii) a State savings association. The FCA is the prudential regulator for any swap entity that is an institution chartered under the Farm Credit Act of 1971, as amended. The FHFA is the prudential regulator for any swap entity that is a “regulated entity” under the Federal Housing Enterprises Financial Safety and Soundness Act of 1992, as amended (i.e., the Federal National Mortgage Association and its affiliates, the Federal Home Loan Mortgage Corporation and its affiliates, and the Federal Home Loan Banks). See 7 U.S.C. 1a(39).

    5See 7 U.S.C. 6s(e)(3)(A); 15 U.S.C. 78o-10(e)(3)(A).

    6 80 FR 74840 (November 30, 2015).

    In the Swap Margin Rule, the Agencies adopted a risk-based approach for initial and variation margin requirements for covered swap entities.7 To implement the risk-based approach, the Agencies established requirements for a covered swap entity to collect and post initial margin for non-cleared swaps with a counterparty that is either: (1) A financial end user with material swaps exposure,8 or (2) a swap entity.9 A covered swap entity must collect and post variation margin for non-cleared swaps with all swap entities and financial end user counterparties, even if such financial end users do not have material swaps exposure.10 Other counterparties, including nonfinancial end users, are not subject to specific, numerical minimum requirements for initial and variation margin.11

    7 80 FR 74843.

    8 “Material swaps exposure” for an entity means that the entity and its affiliates have an average daily aggregate notional amount of non-cleared swaps, non-cleared security-based swaps, foreign exchange forwards, and foreign exchange swaps with all counterparties for June, July, and August of the previous calendar year that exceeds $8 billion, where such amount is calculated only for business days. See § _.2 of the Swap Margin Rule.

    9See §§ _.3 and _.4 of the Swap Margin Rule.

    10Id.

    11Id.

    The effective date for the Swap Margin Rule was April 1, 2016, but the Agencies established a phase-in compliance schedule for the initial margin and variation margin requirements.12 On or after March 1, 2017, all covered swap entities are required to comply with the variation margin requirements for transactions with other swap entities and financial end user counterparties. By September 1, 2020, all covered swap entities will be required to comply with the initial margin requirements for non-cleared swaps with all financial end users with a material swaps exposure and all swap entities.

    12 The applicable compliance date for a covered swap entity is based on the average daily aggregate notional amount of non-cleared swaps, foreign exchange forwards and foreign exchange swaps of the covered swap entity and its counterparty (accounting for their respective affiliates) for each business day in March, April and May of that year. The applicable compliance dates for initial margin requirements, and the corresponding average daily notional thresholds, are: September 1, 2016, $3 trillion; September 1, 2017, $2.25 trillion; September 1, 2018, $1.5 trillion; September 1, 2019, $0.75 trillion; and September 1, 2020, all swap entities and counterparties. See § _.1(e) of the Swap Margin Rule.

    The Swap Margin Rule's requirements apply only to a non-cleared swap entered into on or after the applicable compliance date (covered swap); a non-cleared swap entered into prior to a covered swap entity's applicable compliance date (legacy swap) is generally not subject to the margin requirements in the Swap Margin Rule.13 However, a legacy swap that is later amended or novated on or after the applicable compliance date would be deemed to be a covered swap, and therefore would become subject to the requirements of the Swap Margin Rule.14

    13See § _.1(e) of the Swap Margin Rule.

    14 80 FR 74850-51.

    Whether a non-cleared swap is deemed to be a legacy swap or a covered swap also affects the treatment of a covered swap entity's netting portfolios. The Swap Margin Rule permits a covered swap entity to (1) calculate initial margin requirements for covered swaps under an eligible master netting agreement (EMNA) with a counterparty on a portfolio basis in certain circumstances, if it does so using an initial margin model; and (2) calculate variation margin on an aggregate net basis under an EMNA.15 In addition, the Swap Margin Rule permits swap counterparties to identify one or more separate netting portfolios under an EMNA, including netting sets of covered swaps and netting sets of non-cleared swaps that are not subject to margin requirements.16 Specifically, a netting portfolio that contains only legacy swaps is not subject to the margin requirements set out in the Swap Margin Rule.17 However, if a netting portfolio contains any covered swaps, the entire netting portfolio is subject to the margin requirements of the Swap Margin Rule.18

    15See §§ _.2 and .5 of the Swap Margin Rule.

    16 Typically, this is accomplished by using a separate Credit Support Annex for each netting set, subject to the terms of a single master netting agreement.

    17See §§ _.2 and _.5 of the Swap Margin Rule.

    18Id.

    B. The QFC Rules

    As part of the broader regulatory reform effort following the financial crisis to increase the resolvability and resiliency of U.S. global systemically important banking institutions 19 (U.S. GSIBs) and the U.S. operations of foreign GSIBs (together, GSIBs),20 the Board, the OCC, and the FDIC adopted final rules that establish restrictions on and requirements for certain non-cleared swaps and other financial contracts (collectively, Covered QFCs) of GSIBs and their subsidiaries (the QFC Rules).21

    19See 12 CFR 217.402 (defining global systemically important banking institution). The eight firms currently identified as U.S. GSIBs are Bank of America Corporation, The Bank of New York Mellon Corporation, Citigroup Inc., Goldman Sachs Group, Inc., JP Morgan Chase & Co., Morgan Stanley Inc., State Street Corporation, and Wells Fargo & Company.

    20 The U.S. operations of 20 foreign GSIBs are currently subject to the Board's QFC Rule.

    21See 12 CFR 252.82(c) (defining Covered QFC), 382.2(c) (same). See also 82 FR 56630 (November 29, 2017) (for OCC's QFC Rule). See also 82 FR 50228 (October 30, 2017) (for FDIC's QFC Rule). See also 82 FR 42882 (September 12, 2017) (for the Board's QFC Rule). The effective date of the Board's QFC Rule was November 13, 2017, and the effective date for the substance of the OCC's and FDIC's QFC Rules was January 1, 2018. The QFC Rules include a phased-in conformance period for a Covered QFC Entity that varies depending upon the counterparty type of the Covered QFC Entity. The first conformance date is January 1, 2019, and applies to Covered QFCs with GSIBs. The QFC Rules provide Covered QFC Entities an additional six months or one year to conform its Covered QFCs with other types of counterparties.

    Subject to certain exemptions, the QFC Rules require U.S. GSIBs, together with their subsidiaries, and the U.S. operations of foreign GSIBs (each a Covered QFC Entity and, collectively, Covered QFC Entities) to conform Covered QFCs to the requirements of the rules.22 The QFC Rules generally require the Covered QFCs of Covered QFC Entities to contain contractual provisions that opt into the “temporary stay-and-transfer treatment” of the Federal Deposit Insurance Act (FDI Act) 23 and Title II of the Dodd-Frank Act, thereby reducing the risk that the stay-and-transfer treatment would be challenged by a Covered QFC Entity's counterparty or a court in a foreign jurisdiction.24 The temporary stay-and-transfer treatment is part of the special resolution framework for failed financial firms created by the FDI Act and Title II of the Dodd-Frank Act. The stay-and-transfer treatment provides that the rights of a failed insured depository institution's or financial company's counterparties to terminate, liquidate, or net certain qualified financial contracts on account of the appointment of the FDIC as receiver for the entity (or the insolvency or financial condition of the entity for which the FDIC has been appointed receiver) are temporarily stayed when the entity enters a resolution proceeding to allow for the transfer of the failed firm's Covered QFCs to a solvent party.25 The QFC Rules also generally prohibit Covered QFCs from allowing the exercise of default rights related, directly or indirectly, to the entry into resolution of an affiliate of the Covered QFC Entity (cross-default rights).26

    22 To the extent a U.S. GSIB, any of its subsidiaries, or the U.S. operations of a foreign GSIB include a swap entity for which one of the Agencies is a prudential regulator, a Covered QFC Entity may be a covered swap entity.

    23 12 U.S.C. 1811 et. seq.

    24 82 FR 42882 (September 12, 2017); 82 FR 50228 (October 30, 2017); 82 FR 56630 (November 29, 2017).

    25 12 U.S.C. 1821(e)(10)(B), 5390(c)(10)(B). Title II of the Dodd-Frank Act also provides the FDIC with the power to enforce Covered QFCs (and other contracts) of subsidiaries and affiliates of the financial company for which the FDIC has been appointed receiver. 12 U.S.C. 5390(c)(16); 12 CFR 380.12.

    26 82 FR 42882 (September 12, 2017); 82 FR 50228 (October 30, 2017); 82 FR 56630 (November 29, 2017).

    The Board's QFC Rule applies to U.S. GSIBs and their subsidiaries, state branches, and state agencies, as well other U.S. operations of foreign GSIBs with the exception of banks regulated by the FDIC or OCC, Federal branches, or Federal agencies.27 The FDIC's QFC Rule applies to GSIB subsidiaries that are state savings associations and state-chartered banks that are not members of the Federal Reserve System.28 The OCC's QFC Rule applies to national bank subsidiaries and Federal savings association subsidiaries of GSIBs, and Federal branches and agencies of foreign GSIBs.29

    27 82 FR 42882 (September 12, 2017).

    28 82 FR 50228 (October 30, 2017).

    29 82 FR 56630 (November 29, 2017).

    C. The Definitions of Qualifying Master Netting Agreement

    As part of the QFC Rules, the Federal banking agencies amended the definition of qualifying master netting agreement (QMNA) in their capital and liquidity rules to prevent the QFC Rules from having disruptive effects on the treatment of netting sets of Board-regulated firms, OCC-regulated firms, and FDIC-regulated firms.30 The FCA plans to propose several technical and clarifying amendments to its capital regulations, including a possible revision to the definition of QMNA so it continues to be identical to the definition in the regulations of the Federal banking agencies' regulatory capital and liquidity rules.31

    30 82 FR 42882, 42915; 82 FR 50228, 50258; 82 FR 56630, 56659.

    31See FCA's Fall 2017 Unified Agenda (www.RegInfo.gov). The FCA's Tier 1/Tier 2 Capital Framework's existing definition of QMNA is identical to the previous definition of QMNA used in the Federal banking agencies' capital and liquidity rules.

    The amendments to the Federal banking agencies' capital and liquidity rules are necessary because the previous QMNA definition did not recognize some of the new close-out restrictions on Covered QFCs imposed by the QFC Rules.32 Pursuant to the previous definition of QMNA, a banking organization's rights under a QMNA generally could not be stayed or avoided in the event of its counterparty's default. However, the definition of QMNA permitted certain exceptions to this general prohibition to accommodate certain restrictions on the exercise of default rights that are important to the prudent resolution of a banking organization, including a limited stay under a special resolution regime, such as Title II of the Dodd-Frank Act, the FDI Act, and comparable foreign resolution regimes. The previous QMNA definition did not explicitly recognize all the restrictions on the exercise of cross-default rights.33 Therefore, a master netting agreement that complies with the QFC Rules by limiting the rights of a Covered QFC Entity's counterparty to close out against the Covered QFC Entity would not meet the previous QMNA definition. Thus, a failure to meet the definition of QMNA would result in a banking organization subject to one of the Federal banking agencies' capital and liquidity rules losing the ability to net offsetting exposures under its applicable capital and liquidity requirements when its counterparty is a Covered QFC Entity. If netting were not permitted, the banking organization would be required to calculate its capital and liquidity requirements relating to certain Covered QFCs on a gross basis rather than on a net basis, which would typically result in higher capital and liquidity requirements. The Federal banking agencies do not believe that such an outcome would accurately reflect the risks posed by the affected Covered QFCs.

    32 12 CFR 3.2 (2017); 12 CFR 50.3 (2017); 12 CFR 217.2 (2017); 12 CFR 249.3 (2017); 12 CFR 324.2; 12 CFR 329.3.

    33See, e.g., 12 CFR 252.84(b)(1).

    The amendments to the QMNA definition maintain the netting treatment for these contracts under the Federal banking agencies' capital and liquidity rules. The amendments permit a master netting agreement to meet the definition of QMNA even if it limits the banking organization's right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default of a counterparty that is a Covered QFC Entity to the extent necessary for the Covered QFC Entity to comply fully with the QFC Rules. The amended definition of QMNA continues to recognize that default rights may be stayed if the defaulting counterparty is in resolution under the Dodd-Frank Act, the FDI Act, a substantially similar law applicable to government-sponsored enterprises, or a substantially similar foreign law, or where the agreement is subject by its terms to, or incorporates, any of those laws. By recognizing these required restrictions on the ability of a banking organization to exercise close-out rights when its counterparty is a Covered QFC Entity, the amended definition allows a master netting agreement that includes such restrictions to continue to meet the definition of QMNA under the Federal banking agencies' capital and liquidity rules.

    II. Proposed Changes to the Swap Margin Rule A. Proposed Amendment to the Definition of Eligible Master Netting Agreement

    In the Swap Margin Rule, the Agencies explained that the current definition of EMNA was purposefully aligned with the Federal banking agencies' then-current definition of QMNA in the capital and liquidity rules. This was to “minimize operational burden for a covered swap entity, which otherwise would have to make a separate determination as to whether its netting agreements meet the requirements of this [Swap Margin Rule] as well as comply with the regulatory capital rules.” 34 In addition, the Agencies' rationale for recognizing netting of non-cleared swap exposures pursuant to the Swap Margin Rule is quite similar to the Federal banking agencies' rationale for recognizing netting of various asset and liability exposures pursuant to their capital and liquidity rules. Therefore, it is appropriate that the corresponding conditions for recognizing a robust netting set under all three rules be the same.

    34 80 FR 74861. The Swap Margin Rule used the term EMNA rather than QMNA to avoid confusion with, and to distinguish from, the term used under the Federal banking agencies' capital and liquidity rules.

    Like the definition of QMNA, the definition of EMNA recognizes that default rights of the covered swap entity may be stayed pursuant to a special resolution regime such as Title II of the Dodd-Frank Act, the FDI Act, the Federal Housing Enterprises Financial Safety and Soundness Act of 1992, the Farm Credit Act of 1971, and comparable foreign resolution regimes. However, as was the case with the previous definition of QMNA, the current EMNA definition does not explicitly recognize certain restrictions on the exercise of cross-default rights imposed under the QFC Rules. Therefore, a master netting agreement that is amended in order to address a Covered QFC Entity's compliance with the QFC Rules will not meet the current definition of EMNA from the standpoint of a Covered QFC Entity's counterparty that is a covered swap entity. Failure to meet the definition of EMNA would require that covered swap entity to measure its exposures from covered swaps on a gross, rather than net, basis for purposes of the Swap Margin Rule. This outcome would be an unintended consequence of the QFC Rules and would be contrary to the policy decisions expressed in the Swap Margin Rule to permit initial margin to be calculated on a net basis for covered swaps subject to netting agreements.

    Accordingly, the Agencies are proposing to add a new paragraph to the definition of “eligible master netting agreement” to make clear that a master netting agreement meets the definition under the Swap Margin Rule when the agreement limits “the right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default of the counterparty to the extent necessary for the counterparty to comply with the requirements of part 47, Subpart I of part 252 or part 382 of Title 12, as applicable.” This text is identical to the corresponding text used in the amended definition of QMNA in the Federal banking agencies' capital and liquidity rules.

    B. Proposed Amendment to the Meaning of “Swaps Entered Into”

    As discussed above, the Swap Margin Rule's requirements apply only to covered swaps.35 Legacy swaps will generally not be subject to the Swap Margin Rule's initial and variation margin requirements.36 However, in the preamble to the Swap Margin Rule, the Agencies declined to include language extending legacy swap treatment to a swap if it is subsequently novated or amended after the applicable compliance date.37 At the time, the Agencies did not contemplate that legacy swaps might be amended solely to meet other regulatory requirements imposed by one or more of the Agencies, such as the QFC Rules.

    35See supra note 13.

    36 However, a legacy swap may be subject to margin requirements if it is part of a netting set that includes non-cleared swaps that are entered into after the compliance date applicable to the covered swap entity.

    37 80 FR 74850-74851. The Agencies articulated concerns about potential evasion of the rule if legacy swaps could be materially amended and remain not subject to the requirements of the Swap Margin Rule, as well as the difficulty of administrating a more complex regulatory approach that attempted to draw distinctions among the materiality of, or the intended purpose of, amendments to legacy swaps.

    As discussed above, Covered QFC Entities must conform to the requirements of the QFC Rules Covered QFCs entered into on or after January 1, 2019 and, in some instances, Covered QFCs entered into before that date.38 To comply with the requirements governing the restrictions on Covered QFCs, a Covered QFC Entity may directly amend the contractual provisions of its Covered QFCs, or alternatively, cause its Covered QFCs to be subject to the International Swaps and Derivatives Association 2015 Resolution Stay Protocol (“Universal Protocol”) or a yet-to-be-developed protocol that is expected to be similar to the Universal Protocol.39 Therefore, in order to provide clarity to market participants as to the effects of an amendment that is required by the QFC Rules to a legacy QFC that is a legacy swap, the Agencies are proposing an amendment to the Swap Margin Rule that makes clear that a legacy swap will not be deemed a covered swap under the Swap Margin Rule if it is amended, either by a direct amendment or a modification causing the legacy swap to be governed by one of the aforementioned protocols, by either counterparty solely to conform to the QFC Rules.

    38 The QFC Rules require a Covered QFC Entity to conform Covered QFCs entered into, executed, or to which it otherwise became a party before January 1, 2019 (legacy QFCs), if the Covered QFC Entity or any affiliate that is a Covered QFC Entity also enters, executes, or otherwise becomes a party to a new Covered QFC with the counterparty to the preexisting Covered QFC or a consolidated affiliate of the counterparty on or after January 1, 2019. See, e.g., 12 CFR 252.82 (2017); 12 CFR 382.2 (2017).

    39 The QFC Rules set forth requirements for the yet-to-be developed protocol to be an acceptable alternative protocol for purposes of the QFC Rules, which would cause the new protocol to differ from the Universal Protocol. The QFC Rules also permit the new protocol to include certain other differences from the Universal Protocol. For example, the yet-to-be developed protocol is permitted to allow Covered QFC counterparties to adhere only with respect to Covered QFC Entities.

    This proposal is intended to provide certainty to a covered swap entity and its counterparties about the treatment of legacy swaps and any applicable netting arrangements in light of the QFC Rules. However, if in addition to amendments required to comply with the QFC Rules, any other amendments are contemporaneously entered into, the amended legacy swap will be treated as a covered swap in accordance with the application of the existing Swap Margin Rule.

    III. Regulatory Analysis A. Paperwork Reduction Act

    OCC: In accordance with 44 U.S.C. 3512, the OCC may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid OMB control number. The OCC reviewed the proposed rule and concluded that it contains no requirements subject to the PRA.

    Board: In accordance with section 3512 of the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), the Board may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The Board reviewed the proposed rule under the authority delegated to them by OMB. The proposed rule contains no requirements subject to the PRA.

    FDIC: In accordance with the requirements of the PRA, the FDIC may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid OMB control number. The FDIC reviewed the proposed rule and concludes that it contains no requirements subject to the PRA. Therefore, no submission will be made to OMB for review.

    FCA: The FCA has determined that the proposed rule does not involve a collection of information pursuant to the Paperwork Reduction Act for Farm Credit System institutions because Farm Credit System institutions are Federally chartered instrumentalities of the United States and instrumentalities of the United States are specifically excepted from the definition of “collection of information” contained in 44 U.S.C. 3502(3).

    FHFA: The proposed rule amendments do not contain any collections of information pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Therefore, FHFA has not submitted any information to the Office of Management and Budget for review.

    B. Initial Regulatory Flexibility Act Analysis

    OCC: In general, the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) requires that in connection with a rulemaking, an agency prepare and make available for public comment a regulatory flexibility analysis that describes the impact of the rule on small entities. Under section 605(b) of the RFA, this analysis is not required if an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities and publishes its certification and a brief explanatory statement in the Federal Register along with its rule.

    The OCC currently supervises approximately 956 small entities.40 None of these entities is a covered swap entity. Moreover, because the OCC assumes that this proposal will be implemented before any OCC-supervised entities are required to comply with the QFC Rules, the OCC believes that the proposal will not result in savings—or more than de minimis costs—for OCC-supervised entities. Therefore, the OCC certifies that the proposed rule will not have a significant economic impact on a substantial number of small OCC-regulated entities.

    40 The OCC bases its estimate of the number of small entities on the Small Business Association's size thresholds for commercial banks and savings institutions, and trust companies, which are $550 million and $38.5 million, respectively. Consistent with the General Principles of Affiliation 13 CFR 121.103(a), the OCC counts the assets of affiliated financial institutions when determining if we should classify an OCC-supervised institution a small entity. The OCC used December 31, 2016, to determine size because a “financial institution's assets are determined by averaging the assets reported on its four quarterly financial statements for the preceding year.” See footnote 8 of the U.S. Small Business Administration's Table of Size Standards.

    Board: In accordance with section 3(a) of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. (RFA), the Board is publishing an initial regulatory flexibility analysis for the proposed rule. The RFA requires an agency to provide an initial regulatory flexibility analysis with the proposed rule or to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. The Board welcomes comment on all aspects of the initial regulatory flexibility analysis. A final regulatory flexibility analysis will be conducted after consideration of comments received during the public comment period.

    1. Description of the reasons why action by the Board is being considered and statement of the objectives of the proposal. The Board is proposing to amend the definition of Eligible Master Netting Agreement in the Swap Margin Rule so that it remains harmonized with the amended definition of “Qualifying Master Netting Agreement” in the Federal banking agencies' regulatory capital and liquidity rules. The Board is also proposing an amendment that will make clear that a legacy swap (a non-cleared swap entered into before the applicable compliance date) that is not subject to the requirements of the Swap Margin Rule will not be deemed a covered swap under the Swap Margin Rule if it is amended solely to conform to the QFC Rules.

    2. Small entities affected by the proposal. This proposal would apply to financial institutions that are covered swap entities that are subject to the requirements of the Swap Margin Rule. Under Small Business Administration (SBA) regulations, the finance and insurance sector includes commercial banking, savings institutions, credit unions, other depository credit intermediation and credit card issuing entities (financial institutions). With respect to financial institutions that are covered swap entities under the Swap Margin Rule, a financial institution generally is considered small if it has assets of $550 million or less.41 Covered swap entities would be considered financial institutions for purposes of the RFA in accordance with SBA regulations. The Board does not expect that any covered swap entity is likely to be a small financial institution, because a small financial institution is unlikely to engage in the level of swap activity that would require it to register as a swap dealer or a major swap participant with the CFTC and SEC, respectively.42 None of the current covered swap entities are small entities.

    41See 13 CFR 121.201 (effective December 2, 2014); see also 13 CFR 121.103(a)(6) (noting factors that the SBA considers in determining whether an entity qualifies as a small business, including receipts, employees, and other measures of its domestic and foreign affiliates).

    42 The CFTC has published a list of provisionally registered swap dealers as of November 20, 2017 that does not include any small financial institutions. See http://www.cftc.gov/LawRegulation/DoddFrankAct/registerswapdealer. The SEC has not yet imposed a registration requirement on entities that meet the definition of security-based swap dealer or major security-based swap participant.

    3. Reporting, recordkeeping and compliance requirements. The proposed amendments apply to covered swap entities. As a result of the proposals, the economic impact on covered swap entities will be positive as they will continue to be able to enter into netting agreements that allow margin to be calculated on a net basis, rather than a gross basis. In addition, absent this proposal, legacy swaps that are not currently subject to the margin requirements of the Swap Margin Rule would be required to comply with the provisions of the Swap Margin Rule solely because of amendments made to conform to the requirements of the QFC Rules.

    4. Other Federal rules. Absent this proposal, the definition of EMNA would conflict with the definition of QMNA in the Federal banking agencies' regulatory capital and liquidity rules. This would result in additional compliance costs for firms that are subject to both definitions. In addition, absent these amendments, there would be a conflict between what the QFC Rules require in Covered QFCs and the policy determination previously made by the Board about the application of the Swap Margin Rule to legacy swaps.

    5. Significant alternatives to the proposed rule. As discussed above, the Agencies have requested comment on the scope of the proposed amendments and have solicited comment on any approaches that would reduce the burden on covered swap entities. The Board welcomes comment on any significant alternatives that would minimize the impact of the proposal on small entities.

    FDIC: The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., requires an agency to provide an initial regulatory flexibility analysis with a proposed rule, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities (defined by the Small Business Administration for purposes of the RFA to include banking entities with total assets of $550 million or less).

    According to the most recent data from the Consolidated Reports of Income and Condition (CALL Report), the FDIC supervised 3,674 institutions. Of those, 2,950 are considered “small,” according to the terms of the Regulatory Flexibility Act. The proposed rule primarily affects covered swap entities. The FDIC believes that FDIC-supervised small entities are unlikely to be a covered swap entity because such entities are unlikely to engage in the level of swap activity that would require them to register as a swap entity. The Swap Margin Rule implements sections 731 and 764 of the Dodd-Frank Act, as amended by the Terrorism Risk Insurance Program Reauthorization Act of 2015 (“TRIPRA”). Because TRIPRA excludes non-cleared swaps entered into for hedging purposes by a financial institution with total assets of $10 billion or less from the requirements of the Swap Margin Rule, when a covered swap entity transacts non-cleared swaps with a small entity supervised by the FDIC, and such swaps are used to hedge a commercial risk of the small entity, those swaps will not be subject to the Swap Margin Rule. The FDIC believes that it is unlikely that any small entity it supervises will engage in non-cleared swaps for purposes other than hedging. Therefore, it is unlikely that the amendments included in the proposed rule would result in a significant economic impact on a substantial number of small entities under its supervisory jurisdiction.

    For these reasons, the FDIC certifies that the Proposed Rule, if adopted in final form, would not have a significant economic impact on a substantial number of small entities, within the meaning of those terms as used in the RFA. Accordingly, a regulatory flexibility analysis is not required.

    FCA: Pursuant to section 605(b) of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., FCA hereby certifies that the proposed rule will not have a significant economic impact on a substantial number of small entities. Each of the banks in the Farm Credit System, considered together with its affiliated associations, has assets and annual income in excess of the amounts that would qualify them as small entities; nor does the Federal Agricultural Mortgage Corporation meet the definition of “small entity.” Therefore, System institutions are not “small entities” as defined in the Regulatory Flexibility Act.

    FHFA: 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. FHFA need not undertake such an analysis if the agency has certified the regulation will 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 the proposed rule under the Regulatory Flexibility Act, and certifies that the proposed rule, if adopted as a final rule, would not have a significant economic impact on a substantial number of small entities because the proposed rule is applicable only FHFA's regulated entities, which are not small entities for purposes of the Regulatory Flexibility Act.

    C. Solicitation of Comments on the Use of Plain Language

    Section 722 of the Gramm-Leach-Bliley Act requires the U.S. banking agencies to use plain language in proposed and final rulemakings.43 The Agencies have sought to present the proposed rule in a simple and straightforward manner, and invite comment on the use of plain language in this proposal.

    43 12 U.S.C. 4809(a).

    Question 1: Have the Agencies organized the proposal in a clear way? If not, how could the proposal be organized more clearly?

    Question 2: Are the requirements of the proposed rule clearly stated? If not, how could they be stated more clearly?

    Question 3: Does the proposal contain unclear technical language or jargon? If so, which language requires clarification?

    Question 4: Would a different format (such as a different grouping and ordering of sections, a different use of section headings, or a different organization of paragraphs) make the regulation easier to understand? If so, what changes would make the proposal clearer?

    Question 5: What else could the Agencies do to make the proposal clearer and easier to understand?

    D. OCC Unfunded Mandates Reform Act of 1995 Determination

    Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded Mandates Act) (2 U.S.C. 1532) requires that the OCC prepare a budgetary impact statement before promulgating a rule that includes any Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. If a budgetary impact statement is required, section 205 of the Unfunded Mandates Act also requires the OCC to identify and consider a reasonable number of regulatory alternatives before promulgating a rule. The OCC has determined that the proposed rule does not impose any new mandates and will not result in expenditures by State, local, and Tribal governments, or by the private sector of $100 million or more in any one year. Accordingly, the OCC has not prepared a budgetary impact statement or specifically addressed the regulatory alternatives considered.

    E. Riegle Community Development and Regulatory Improvement Act of 1994

    The Riegle Community Development and Regulatory Improvement Act of 1994 (RCDRIA) requires that each Federal banking agency, in determining the effective date and administrative compliance requirements for new regulations that impose additional reporting, disclosure, or other requirements on insured depository institutions, consider, consistent with principles of safety and soundness and the public interest, any administrative burdens that such regulations would place on depository institutions, including small depository institutions, and customers of depository institutions, as well as the benefits of such regulations. In addition, new regulations and amendments to regulations that impose additional reporting, disclosures, or other new requirements on insured depository institutions generally must take effect on the first day of a calendar quarter that begins on or after the date on which the regulations are published in final form.44 Each Federal banking agency has determined that the proposed rule would not impose additional reporting, disclosure, or other requirements; therefore the requirements of the RCDRIA do not apply.

    44 12 U.S.C. 4802.

    List of Subjects 12 CFR Part 45

    Administrative practice and procedure, Capital, Margin requirements, National banks, Federal savings associations, Reporting and recordkeeping requirements, Risk.

    12 CFR Part 237

    Administrative practice and procedure, Banks and banking, Capital, Foreign banking, Holding companies, Margin requirements, Reporting and recordkeeping requirements, Risk.

    12 CFR Part 349

    Administrative practice and procedure, Banks, Holding companies, Margin Requirements, Capital, Reporting and recordkeeping requirements, Savings associations, Risk.

    12 CFR Part 624

    Accounting, Agriculture, Banks, Banking, Capital, Cooperatives, Credit, Margin requirements, Reporting and recordkeeping requirements, Risk, Rural areas, Swaps.

    12 CFR Part 1221

    Government-sponsored enterprises, Mortgages, Securities.

    DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency 12 CFR Chapter I Authority and Issuance

    For the reasons stated in the preamble, the Office of the Comptroller of the Currency proposes to amend part 45 of chapter I of title 12, Code of Federal Regulations, as follows:

    PART 45—MARGIN AND CAPITAL REQUIREMENTS FOR COVERED SWAP ENTITIES 1. The authority citation for part 45 continues to read as follows: Authority:

    7 U.S.C. 6s(e), 12 U.S.C. 1 et seq., 12 U.S.C. 93a, 161, 481, 1818, 3907, 3909, 5412(b)(2)(B), and 15 U.S.C. 78o-10(e).

    2. Section 45.1 is amended by adding paragraph (e)(7) to read as follows:
    § 45.1 Authority, purpose, scope, exemptions and compliance dates.

    (e) * * *

    (7) For purposes of determining the date on which a non-cleared swap or a non-cleared security-based swap was entered into, a Covered Swap Entity will not take into account amendments to the non-cleared swap or the non-cleared security-based swap that were entered into solely to comply with the requirements of part 47, Subpart I of part 252 or part 382 of Title 12, as applicable.

    3. Section 45.2 is amended by revising paragraph (2) of the definition of Eligible master netting agreement to read as follows:
    § 45.2 Definitions.

    (2) The agreement provides the covered swap entity the right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default, including upon an event of receivership, conservatorship, insolvency, liquidation, or similar proceeding, of the counterparty, provided that, in any such case:

    (i) Any exercise of rights under the agreement will not be stayed or avoided under applicable law in the relevant jurisdictions, other than:

    (A) In receivership, conservatorship, or resolution under the Federal Deposit Insurance Act (12 U.S.C. 1811 et seq.), Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act (12 U.S.C. 5381 et seq.), the Federal Housing Enterprises Financial Safety and Soundness Act of 1992, as amended (12 U.S.C. 4617), or the Farm Credit Act of 1971, as amended (12 U.S.C. 2183 and 2279cc), or laws of foreign jurisdictions that are substantially similar to the U.S. laws referenced in this paragraph (2)(i)(A) in order to facilitate the orderly resolution of the defaulting counterparty; or

    (B) Where the agreement is subject by its terms to, or incorporates, any of the laws referenced in paragraph (2)(i)(A) of this definition; and

    (ii) The agreement may limit the right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default of the counterparty to the extent necessary for the counterparty to comply with the requirements of part 47, Subpart I of part 252 or part 382 of Title 12, as applicable;

    BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM 12 CFR Chapter II Authority and Issuance

    For the reasons set forth in the preamble, the Board of Governors of the Federal Reserve System proposes to amend 12 CFR part 237 to read as follows:

    PART 237—SWAPS MARGIN AND SWAPS PUSH-OUT 4. The authority citation for part 237 continues to read as follows: Authority:

    7 U.S.C. 6s(e), 15 U.S.C. 78o-10(e), 15 U.S.C. 8305, 12 U.S.C. 221 et seq., 12 U.S.C. 343-350, 12 U.S.C. 1818, 12 U.S.C. 1841 et seq., 12 U.S.C. 3101 et seq., and 12 U.S.C. 1461 et seq.

    5. Section 237.1 paragraph (e)(7) is added to read as follows: Subpart A—Margin and Capital Requirements for Covered Swap Entities (Regulation KK)
    § 237.1 Authority, purpose, scope, exemptions and compliance dates.

    (e) * * *

    (7) For purposes of determining the date on which a non-cleared swap or a non-cleared security-based swap was entered into, a Covered Swap Entity will not take into account amendments to the non-cleared swap or the non-cleared security-based swap that were entered into solely to comply with the requirements of part 47, Subpart I of part 252 or part 382 of Title 12, as applicable.

    6. Section 237.2 is amended by revising paragraph (2) of the definition of “Eligible master netting agreement” to read as follows:
    § 237.2 Definitions

    (2) The agreement provides the covered swap entity the right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default, including upon an event of receivership, conservatorship, insolvency, liquidation, or similar proceeding, of the counterparty, provided that, in any such case,

    (i) Any exercise of rights under the agreement will not be stayed or avoided under applicable law in the relevant jurisdictions, other than:

    (A) In receivership, conservatorship, or resolution under the Federal Deposit Insurance Act (12 U.S.C. 1811 et seq.), Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act (12 U.S.C. 5381 et seq.), the Federal Housing Enterprises Financial Safety and Soundness Act of 1992, as amended (12 U.S.C. 4617), or the Farm Credit Act of 1971, as amended (12 U.S.C. 2183 and 2279cc), or laws of foreign jurisdictions that are substantially similar to the U.S. laws referenced in this paragraph (2)(i)(A) in order to facilitate the orderly resolution of the defaulting counterparty; or

    (B) Where the agreement is subject by its terms to, or incorporates, any of the laws referenced in paragraph (2)(i)(A) of this definition; and

    (ii) The agreement may limit the right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default of the counterparty to the extent necessary for the counterparty to comply with the requirements of part 47, Subpart I of part 252 or part 382 of Title 12, as applicable;

    FEDERAL DEPOSIT INSURANCE CORPORATION 12 CFR Chapter III Authority and Issuance

    For the reasons set forth in the preamble, the Federal Deposit Insurance Corporation proposes to amend 12 CFR part 349 as follows:

    PART 349—DERIVATIVES Subpart A—Margin and Capital Requirements for Covered Swap Entities 7. The authority citation for Subpart A continues to read as follows: Authority:

    7 U.S.C. 6s(e), 15 U.S.C. 78o-10(e) and 12 U.S.C. 1818 and 12 U.S.C. 1819(a)(Tenth), 12 U.S.C. 1813(q), 1818, 1819, and 3108.

    8. Section 349.1 is amended by adding paragraph (e)(7) as follows:
    § 349.1 Authority, purpose, scope, exemptions and compliance dates.

    (e) * * *

    (7) For purposes of determining the date on which a non-cleared swap or a non-cleared security-based swap was entered into, a Covered Swap Entity will not take into account amendments to the non-cleared swap or the non-cleared security-based swap that were entered into solely to comply with the requirements of part 47, Subpart I of part 252 or part 382 of Title 12, as applicable.

    9. Section 349.2 is amended by revising of the definition of “Eligible master netting agreement” to read as follows:
    § 349.2 Definitions.

    Eligible master netting agreement means a written, legally enforceable agreement provided that:

    (1) The agreement creates a single legal obligation for all individual transactions covered by the agreement upon an event of default following any stay permitted by paragraph (2) of this definition, including upon an event of receivership, conservatorship, insolvency, liquidation, or similar proceeding, of the counterparty;

    (2) The agreement provides the covered swap entity the right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default, including upon an event of receivership, conservatorship, insolvency, liquidation, or similar proceeding, of the counterparty, provided that, in any such case,

    (i) Any exercise of rights under the agreement will not be stayed or avoided under applicable law in the relevant jurisdictions, other than:

    (A) In receivership, conservatorship, or resolution under the Federal Deposit Insurance Act (12 U.S.C. 1811 et seq.), Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act (12 U.S.C. 5381 et seq.), the Federal Housing Enterprises Financial Safety and Soundness Act of 1992, as amended (12 U.S.C. 4617), or the Farm Credit Act of 1971, as amended (12 U.S.C. 2183 and 2279cc), or laws of foreign jurisdictions that are substantially similar to the U.S. laws referenced in this paragraph (2)(i)(A) in order to facilitate the orderly resolution of the defaulting counterparty; or

    (B) Where the agreement is subject by its terms to, or incorporates, any of the laws referenced in paragraph (2)(i)(A) of this definition; and

    (ii) The agreement may limit the right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default of the counterparty to the extent necessary for the counterparty to comply with the requirements of part 47, Subpart I of part 252 or part 382 of Title 12, as applicable;

    (3) The agreement does not contain a walkaway clause (that is, a provision that permits a non-defaulting counterparty to make a lower payment than it otherwise would make under the agreement, or no payment at all, to a defaulter or the estate of a defaulter, even if the defaulter or the estate of the defaulter is a net creditor under the agreement); and

    (4) A covered swap entity that relies on the agreement for purposes of calculating the margin required by this part must:

    (i) Conduct sufficient legal review to conclude with a well-founded basis (and maintain sufficient written documentation of that legal review) that:

    (A) The agreement meets the requirements of paragraph (2) of this definition; and

    (B) In the event of a legal challenge (including one resulting from default or from receivership, conservatorship, insolvency, liquidation, or similar proceeding), the relevant court and administrative authorities would find the agreement to be legal, valid, binding, and enforceable under the law of the relevant jurisdictions; and

    (ii) Establish and maintain written procedures to monitor possible changes in relevant law and to ensure that the agreement continues to satisfy the requirements of this definition.

    FARM CREDIT ADMINISTRATION Authority and Issuance

    For the reasons set forth in the preamble, the Farm Credit Administration proposes to amend chapter VI of title 12, Code of Federal Regulations, as follows:

    PART 624—MARGIN AND CAPITAL REQUIREMENTS FOR COVERED SWAP ENTITIES 10. The authority citation for part 624 continues to read as follows: Authority:

    7 U.S.C 6s(e), 15 U.S.C. 78o-10(e), 12 U.S.C. 2154, 12 U.S.C. 2243, 12 U.S.C. 2252, 12 U.S.C. 2279bb-1.

    11. Section 624.1 is amended by adding paragraph (e)(7) to read as follow:
    § 624.1 Authority, purpose, scope, exemptions and compliance dates.

    (e) * * *

    (7) For purposes of determining the date on which a non-cleared swap or a non-cleared security-based swap was entered into, a Covered Swap Entity will not take into account amendments to the non-cleared swap or the non-cleared security-based swap that were entered into solely to comply with the requirements of part 47, Subpart I of part 252 or part 382 of Title 12, as applicable.

    12. Section 624.2 is amended by revising paragraph (2) of the definition of Eligible master netting agreement to read as follows:
    § 624.2 Definitions

    (2) The agreement provides the covered swap entity the right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default, including upon an event of receivership, conservatorship, insolvency, liquidation, or similar proceeding, of the counterparty, provided that, in any such case,

    (i) Any exercise of rights under the agreement will not be stayed or avoided under applicable law in the relevant jurisdictions, other than:

    (A) In receivership, conservatorship, or resolution under the Federal Deposit Insurance Act (12 U.S.C. 1811 et seq.), Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act (12 U.S.C. 5381 et seq.), the Federal Housing Enterprises Financial Safety and Soundness Act of 1992, as amended (12 U.S.C. 4617), or the Farm Credit Act of 1971, as amended (12 U.S.C. 2183 and 2279cc), or laws of foreign jurisdictions that are substantially similar to the U.S. laws referenced in this paragraph (2)(i)(A) in order to facilitate the orderly resolution of the defaulting counterparty; or

    (B) Where the agreement is subject by its terms to, or incorporates, any of the laws referenced in paragraph (2)(i)(A) of this definition; and

    (ii) The agreement may limit the right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default of the counterparty to the extent necessary for the counterparty to comply with the requirements of part 47, Subpart I of part 252 or part 382 of Title 12, as applicable;

    FEDERAL HOUSING FINANCE AGENCY Authority and Issuance

    For the reasons set forth in the preamble, the Federal Housing Finance Agency proposes to amend chapter XII of title 12, Code of Federal Regulations, as follows:

    PART 1221—MARGIN AND CAPITAL REQUIREMENTS FOR COVERED SWAP ENTITIES 13. The authority citation for part 1221 continues to read as follows: Authority:

    7 U.S.C. 6s(e), 15 U.S.C. 78o-10(e), 12 U.S.C. 4513, and 12 U.S.C. 4526(a).

    14. Section 1221.1 is amended by adding paragraph (e)(7) to read as follows:
    § 1221.1 Authority, purpose, and scope, exemptions and compliance dates.

    (e) * * *

    (7) For purposes of determining the date on which a non-cleared swap or a non-cleared security-based swap was entered into, a Covered Swap Entity will not take into account amendments to the non-cleared swap or the non-cleared security-based swap that were entered into solely to comply with the requirements of part 47, Subpart I of part 252 or part 382 of Title 12, as applicable.

    15. Section 1221.2 is amended by revising paragraph (2) of the definition of Eligible master netting agreement to read as follows:
    § 1221.2 Definitions.

    (2) The agreement provides the covered swap entity the right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default, including upon an event of receivership, conservatorship, insolvency, liquidation, or similar proceeding, of the counterparty, provided that, in any such case,

    (i) Any exercise of rights under the agreement will not be stayed or avoided under applicable law in the relevant jurisdictions, other than:

    (A) In receivership, conservatorship, or resolution under the Federal Deposit Insurance Act (12 U.S.C. 1811 et seq.), Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act (12 U.S.C. 5381 et seq.), the Federal Housing Enterprises Financial Safety and Soundness Act of 1992, as amended (12 U.S.C. 4617), or the Farm Credit Act of 1971, as amended (12 U.S.C. 2183 and 2279cc), or laws of foreign jurisdictions that are substantially similar to the U.S. laws referenced in this paragraph (2)(i)(A) in order to facilitate the orderly resolution of the defaulting counterparty; or

    (B) Where the agreement is subject by its terms to, or incorporates, any of the laws referenced in paragraph (2)(i)(A) of this definition; and

    (ii) The agreement may limit the right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default of the counterparty to the extent necessary for the counterparty to comply with the requirements of part 47, Subpart I of part 252 or part 382 of Title 12, as applicable;

    Dated: January 29, 2018. Joseph M. Otting, Comptroller of the Currency.

    By order of the Board of Governors of the Federal Reserve System, January 24, 2018.

    Ann E. Misback, Secretary of the Board. Dated at Washington, DC, this 25th day of January 2018. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary. Dated: January 26, 2018. Melvin L. Watt, Director, Federal Housing Finance Agency. Dated: January 25, 2018 Dale L. Aultman, Secretary, Farm Credit Administration Board.
    [FR Doc. 2018-02560 Filed 2-20-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-0619; Product Identifier 2016-SW-093-AD] RIN 2120-AA64 Airworthiness Directives; AgustaWestland S.p.A. Helicopters AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for AgustaWestland S.p.A. (AgustaWestland) Model AW189 helicopters. This proposed AD would require inspecting the tail gearbox (TGB) fitting for a crack. This proposed AD is prompted by a report of a crack on a TGB fitting that was found during a scheduled inspection. The actions of this proposed AD are intended to prevent an unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by April 23, 2018.

    ADDRESSES:

    You may send comments by any of the following methods:

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

    Fax: 202-493-2251.

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

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

    Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0619; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the European Aviation Safety Agency (EASA) AD, the economic evaluation, any comments received, and other information. The street address for Docket Operations (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    For service information identified in this proposed rule, contact Leonardo S.p.A. Helicopters, Matteo Ragazzi, Head of Airworthiness, Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone +39-0331-711756; fax +39-0331-229046; or at http://www.leonardocompany.com/-/bulletins. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

    FOR FURTHER INFORMATION CONTACT:

    Matt Fuller, Senior Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email [email protected]

    SUPPLEMENTARY INFORMATION:

    Comments Invited

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

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

    Discussion

    EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD No. 2016-0177, dated September 8, 2016, to correct an unsafe condition for Leonardo Helicopters (formerly Finmeccanica S.p.A. and AgustaWestland) Model AW189 helicopters with a tail assembly part number (P/N) 8G5350A00131.

    EASA advises that a crack was detected on the TGB fitting P/N 4F5350A04152 during a scheduled inspection of an AW189 helicopter. EASA advises that this condition, if not detected and corrected, could lead to crack propagation up to a critical length. This condition could reduce the assembly's ability to sustain loads from the TGB and tail rotor, possibly resulting to reduced helicopter control. The EASA AD consequently requires repetitive inspections of the fitting and replacing the fitting, depending on the inspections' outcome. EASA considers these actions to be interim and that further AD action may follow.

    The FAA is in the process of updating AgustaWestland's name changes to Finmeccanica S.p.A., and then to Leonardo Helicopters, on its FAA type certificate. Because this name change is not yet effective, this AD specifies AgustaWestland.

    FAA's Determination

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

    Related Service Information Under 1 CFR Part 51

    Leonardo Helicopters has issued Bollettino Tecnico No. 189-114, dated September 6, 2016 (BT), which specifies inspecting the TGB fitting within 30 flight hours or 1 month from the receipt of the BT, whichever comes first, and then at intervals not to exceed 150 flight hours. If a crack is found, the BT requires replacing the TGB fitting.

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

    Proposed AD Requirements

    This proposed AD would require within 30 hours time-in-service (TIS) and thereafter at intervals not to exceed 150 hours TIS, cleaning the areas around the Hi-lok holes and inspecting the TGB fitting for a crack. If a crack exists, this proposed AD would require replacing the part before the next flight.

    Differences Between This Proposed AD and the EASA AD

    The EASA AD requires you to provide a compliance record and return parts to Leonardo Helicopters if a crack is found on the fitting. This proposed AD would require no such actions.

    Interim Action

    We consider this proposed AD to be an interim action. The design approval holder is expected to develop a modification that will address the unsafe condition identified in this AD. Once this modification is developed, approved, and available, we might consider additional rulemaking.

    Costs of Compliance

    We estimate that this AD affects 4 helicopters of U.S. Registry and that labor costs average $85 per work-hour. Based on these estimates, we expect the following costs:

    • Inspecting the TGB fitting would require 4 work-hours and no parts for a cost per helicopter of $340 and $1,360 for the U.S. fleet each inspection cycle.

    • Replacing the TGB fitting would require 48 work-hours and parts would cost $30,000 for a cost of $34,080 per helicopter.

    According to Leonardo Helicopters' service information, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage by Leonardo Helicopters. Accordingly, we have included all costs in our cost estimate.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

    For the reasons discussed, I certify this proposed regulation:

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

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

    3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): AgustaWestland S.p.A.: Docket No. FAA-2017-0619; Product Identifier 2016-SW-093-AD. (a) Applicability

    This AD applies to AgustaWestland S.p.A. Model AW189 helicopters, certificated in any category, with tail assembly part number 8G5350A00131 installed.

    (b) Unsafe Condition

    This AD defines the unsafe condition as a crack on a tail gearbox fitting. This condition could reduce the tail assembly's ability to sustain loads from the tail rotor gearbox (TGB) and the tail rotor and result in loss of helicopter control.

    (c) Comments Due Date

    We must receive comments by April 23, 2018.

    (d) Compliance

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

    (e) Required Actions

    Within 30 hours time-in-service (TIS) and thereafter at intervals not to exceed 150 hours TIS, clean and inspect the TGB fitting for a crack in the areas depicted in Figure 1 of Leonardo Helicopters Bollettino Tecnico No. 189-114, dated September 6, 2016. If there is a crack, replace the TGB fitting before further flight.

    (f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards Branch, FAA, may approve AMOCs for this AD. Send your proposal to: Matt Fuller, Senior Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email [email protected]

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

    (g) Additional Information

    The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2016-0177, dated September 8, 2016. You may view the EASA AD on the internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2017-0619.

    (h) Subject

    Joint Aircraft Service Component (JASC) Code: 6520, Tail Rotor Gearbox. Issued in Fort Worth, Texas, on February 12, 2018.

    Scott A. Horn, Deputy Director for Regulatory Operations, Compliance & Airworthiness Division, Aircraft Certification Service.
    [FR Doc. 2018-03494 Filed 2-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0112; Product Identifier 2017-NM-161-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, -500 series airplanes. This proposed AD was prompted by reports of cracking in certain flanges, and the adjacent web, of the wing outboard flap track at certain positions. This proposed AD would require an inspection to determine the part number of the wing outboard flap track assembly; repetitive inspections of each affected wing outboard flap track for discrepancies, and applicable on-condition actions; and repetitive overhaul of each wing outboard flap track. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by April 9, 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, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0112.

    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-2018-0112; 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 NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations (phone: 800-647-5527) is listed above. 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-2018-0112; Product Identifier 2017-NM-161-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 during the tear down of a Model 737-300 airplane, cracking was found in the inboard lower flange and adjacent web near the forward attachment of the outboard flap track at position 8. The cracked flap track had accumulated 1,579 flight cycles since it was installed on the airplane after the most recent overhaul, and approximately 20,000 flight cycles since new. The metallurgical evaluation of the cracked flap track found that stress corrosion cracking originated from a fastener hole in the flap track web with missing cadmium plating. There was not sufficient evidence to conclude that the missing cadmium plating was the cause or the result of the cracking. Boeing has since received one more report of cracking in the outboard lower flange and the adjacent web of the outboard flap track at position 8 on a different Model 737-300 airplane. The crack was also found near the forward attachment, but did not originate from a fastener hole. The cracked flap track had accumulated 1,175 flight cycles since it was installed on the airplane. Boeing determined that the existing inspection programs are not sufficient to find such cracks before failure of a flap track could occur.

    Cracking in the area between the forward and rear spar attachments of the wing outboard flap tracks may lead to the inability of a principal structural element to sustain required flight load, such cracking could result in loss of the outboard trailing edge flap and consequent reduced controllability of the airplane.

    Related Rulemaking

    AD 2013-09-02, Amendment 39-17443 (78 FR 27010, May 9, 2013) (“AD 2013-09-02”), requires operators to use Boeing Service Bulletin (SB) 737-57A1271, Revision 3, dated February 13, 2012 (“SB 737-57A1271 R3”), to accomplish the inspections required by paragraph (p) of that AD. Boeing SB 737-57A1271 was issued to address more than 30 reports of stress corrosion cracks in the wing outboard flap tracks at positions 2 and 7, and provides instructions to do detailed and non-destructive test (NDT) inspections of the flap track flanges and webs, and detailed and NDT inspections of the flap track at the rear spar attachment. Boeing SB 737-57A1271 also gives instructions to repair, overhaul, and replace the wing outboard flap tracks at positions 2 and 7. Boeing SB 737-57A1271 does not include NDT inspections of the flap track flanges at the attachment of the flap transmission and the hinge support assembly, or NDT inspections of the flap track webs forward of the rear spar attachment nor repair, overhaul, and replacement of the wing outboard flap tracks at positions 1 and 8. As discussed above, Boeing reported information that indicates additional areas of stress corrosion cracks in other positions of the wing outboard flap tracks and the adjacent web of the outboard flap tracks. Therefore, the existing requirements of AD 2013-09-02 do not fully address the unsafe condition.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017. The service information describes procedures for repetitive inspections, repair, repetitive overhaul, and replacement of the wing outboard flap tracks, 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

    This proposed AD would require new NDT inspections of the flap track flanges and webs forward of the rear spar attachment, in areas not previously inspected using SB 737-57A1271 R3 (or previous revisions), to the existing requirements in AD 2013-09-02. The new and existing requirements would also apply to the wing outboard flap tracks at positions 1 and 8. Accomplishment of the inspections, repair, overhaul, and replacement of the wing outboard flap tracks specified in Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017, would replace the instruction in SB 737-57A1271 R3 (or previous revisions), and terminates the requirements of AD 2013-09-02.

    This proposed AD would require accomplishment of the actions identified in the Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 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-2018-0112.

    Explanation of Requirements Bulletin

    The FAA 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 of ADs and 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, which contains only the actions needed to address the unsafe condition (i.e., only the 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
  • Inspection (positions 1 and 8; Group 2 and Group 3, configuration 1) 78 work-hours × $85 per hour = $6,630 per inspection cycle $0 $6,630 per inspection cycle $1,060,800 per inspection cycle. Inspection (positions 1 and 8; Group 3, configuration 2) 89 work-hours × $85 per hour = $7,565 per inspection cycle 0 $7,565 per inspection cycle $1,210,400 per inspection cycle. Inspection (positions 2 and 7; Group 2 and Group 3, configuration 1) 83 work-hours × $85 per hour = $7,055 per inspection cycle 0 $7,055 per inspection cycle $1,128,800 per inspection cycle. Inspection (positions 2 and 7; Group 3, configuration 2) 86 work-hours × $85 per hour = $7,310 per inspection cycle 0 $7,310 per inspection cycle $1,169,600 per inspection cycle.

    We have received no definitive data that would enable us to provide cost estimates for the actions for Group 1 airplanes or 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-2018-0112; Product Identifier 2017-NM-161-AD. (a) Comments Due Date

    We must receive comments by April 9, 2018.

    (b) Affected ADs

    This AD affects AD 2013-09-02, Amendment 39-17443 (78 FR 27010, May 9, 2013) (“AD 2013-09-02”).

    (c) Applicability

    This AD applies to all The Boeing Company Model 737-100, -200, -200C, -300, -400, -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 cracking in certain flanges, and the adjacent web, of the wing outboard flap track at certain positions. We are issuing this AD to detect and correct cracking of the rear spar attachment, and cracking of the wing outboard flap tracks. Cracking in the area between the forward and rear spar attachments of the wing outboard flap tracks could lead to the inability of a principal structural element to sustain required flight load, and result in loss of the outboard trailing edge flap and consequent reduced controllability 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 as Group 1 in Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017: Within 120 days after the effective date of this AD, do actions to correct the unsafe condition using a method approved in accordance with the procedures specified in paragraph (l) of this AD.

    (h) Required Actions

    For airplanes not specified in paragraph (g) of this AD: Except as required by paragraph (i) of this AD, at the applicable times specified in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017, do all applicable actions identified in, and in accordance with, the Accomplishment Instructions of Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017.

    Note 1 to paragraph (h) of this AD:

    Guidance for accomplishing the actions required by this AD can be found in Boeing Alert Service Bulletin 737-57A1338, dated September 25, 2017, which is referred to in Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017.

    (i) Exceptions to Service Information Specifications

    For purposes of determining compliance with the requirements of this AD: Where Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017, uses the phrase “the original issue date of Requirements Bulletin 737-57A1338 RB,” this AD requires using “the effective date of this AD.”

    (j) Terminating Action for Requirements of AD 2013-09-02

    Accomplishment of the requirements specified in paragraph (h) of this AD terminates all of the requirements specified in AD 2013-09-02.

    (k) Parts Installation Limitation

    As of the effective date of this AD, no person may install, on any airplane, a wing outboard flap track having a part number listed in paragraph 1.B. of Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017, unless the inspections and corrective actions specified in the Accomplishment Instructions of Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017, are accomplished prior to the part's installation on the airplane.

    (l) 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 (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, 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.

    (m) 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, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    Issued in Renton, Washington, on February 12, 2018. Michael Kaszycki, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-03433 Filed 2-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-1034; Airspace Docket No. 17-ANM-23] Proposed Amendment of Class D and Class E Airspace; Aurora, OR AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend Class D airspace, Class E surface area airspace, and Class E airspace extending upward from 700 feet above the surface, at Aurora State Airport, Aurora, OR. After a biennial review the FAA found modification necessary to accommodate airspace redesign for the safety and management of instrument flight rules (IFR) operations at the airport. Additionally, an editorial change would be made removing the city associated with the airport name in the airspace designations. Also, this proposal would make an editorial change to the Class D airspace legal description replacing Airport/Facility Directory with the term Chart Supplement.

    DATES:

    Comments must be received on or before April 9, 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; telephone: 1-800-647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2017-1034; Airspace Docket No. 17-ANM-23, 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:

    Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW, Renton, WA 98057; telephone (425) 203-4511.

    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 Aurora State Airport, Aurora, OR to support IFR operations at the airport.

    Comments Invited

    Interested parties are invited to participate in 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 and be submitted in triplicate to the address listed above. Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2017-1034; Airspace Docket No. 17-ANM-23”. 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 notice may be changed in light of the comments received. 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 the 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 during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW, Renton, WA 98057.

    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 proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Class D airspace, Class E surface area airspace, and Class E airspace extending upward from 700 feet above the surface at Aurora State Airport, Aurora, OR.

    Class D airspace would be modified to a 4-mile radius of the airport and within 1.8 miles each side of the 007° bearing from the airport extending from the 4-mile radius to 5.1 miles north of the airport (from a 4.2-mile radius of the airport from the 64° bearing from the airport clockwise to the 142° bearing, extending to a 5-mile radius from the 142° bearing clockwise to the 64° bearing from the airport). Two excluded area cutouts for Lenhardt Airpark and McGee Airport, respectively, (both nearby satellite general aviation airports) would be modified by excluding that airspace below 1,500 feet MSL within the area bounded by lat. 45°11′51″ N, long. 122°45′45″ W; to lat. 45°12′50″ N, long. 122°44′34″ W; to the point where the 142° bearing from the airport intersects the 4-mile radius of the airport, thence clockwise along the airport 4-mile radius to the 174° bearing from the airport, thence to the point of beginning; and excluding that airspace below 1,500 feet MSL within the area bounded by lat. 45°15′37″ N, long. 122°51′14″ W; to the point where the 235° bearing from the airport intersects the 4-mile radius of the airport, thence clockwise along the airport 4-mile radius to the airport 281° bearing, thence to the point of beginning” (from “excluding that airspace below 1,200 feet beyond 3.3 miles from the airport from the 142° bearing clockwise to the 174° bearing, and that airspace below 1,200 feet beyond 3.3 miles from the airport from the 250° bearing clockwise to the 266° bearing from the airport.” The modification of the excluded areas within the Class D provides additional airspace for visual flight rules operations at the satellite airports while maintaining the required airspace to support IFR operations at Aurora State Airport. Also, an editorial change would be made to the Class D airspace legal description replacing Airport/Facility Directory with the term Chart Supplement.

    Class E surface area airspace would be modified to be coincident with the dimensions of the Class D airspace except no exclusion would be provided in the vicinity of Lenhardt Airpark (“excluding that airspace below 1,500 feet MSL within the area bounded by lat. 45°11′51″ N, long. 122°45′45″ W; to lat. 45°12′50″ N, long. 122°44′34″ W; to the point where the 142° bearing from the airport intersects the 4-mile radius of the airport, thence clockwise along the airport 4-mile radius to the 174° bearing from the airport, thence to the point of beginning”). Class E surface area airspace is required within this Class D cutout to ensure Class E weather requirements exist from the surface and protect IFR arrival operations to Aurora State Airport.

    Class E airspace extending upward from 700 feet would be modified to within a 6.5-mile radius (from a 7-mile radius) from the airport 043° bearing clockwise to the airport 350° bearing and within a 9-mile radius (from a 6.5-mile radius) from the airport 350° bearing clockwise to the airport 043° bearing, and within 1.6 miles each side of a 007° bearing from the airport extending from the 9-mile radius of the airport to 20.6 miles north of the airport (from within 1.6 miles either side of the 007° bearing from airport extending from the 7-mile radius to 20 miles northeast of the airport), and within 1.8 miles each side of a line extending from lat. 45°21′12″ N, long. 122°58′41″ W, to lat. 45°19′20″ N, long. 122°49′07″ W (from within 1.2 miles either side of the 306° bearing from airport extending from the 7-mile radius to 10.9 miles northwest of the airport).

    A graphic illustration of the proposed airspace will be entered into Docket No. FAA-2017-1034, and available for download under the “Supporting/Related Materials” section.

    The airport designations for the Class D and E airspace areas also would be amended by removing the name of the city associated with the airport to be in compliance with a recent change to FAA Order 7400.2L, Procedures for Handling Airspace Matters, effective October 12, 2017.

    Class D and Class E airspace designations are published in paragraph 5000, 6002, 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.

    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 will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would 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.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, 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 14 CFR 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. ANM OR D Aurora, OR [Amended] Aurora State Airport, OR (Lat. 45°14′50″ N, long. 122°46′12″ W)

    That airspace extending upward from the surface to and including 2,700 feet MSL within a 4-mile radius of Aurora State Airport and within 1.8 miles each side of the 007° bearing from the airport extending from the 4-mile radius to 5.1 miles north of the airport, excluding that airspace below 1,500 feet MSL within the area bounded by lat. 45°11′51″ N, long. 122°45′45″ W; to lat. 45°12′50″ N, long. 122°44′34″ W; to the point where the 142° bearing from the airport intersects the 4-mile radius of the airport, thence clockwise along the airport 4-mile radius to the 174° bearing from the airport, thence to the point of beginning, and excluding that airspace below 1,500 feet MSL within the area bounded by lat. 45°15′37″ N, long. 122°51′14″ W; to the point where the 235° bearing from the airport intersects the 4-mile radius of the airport, thence clockwise along the airport 4-mile radius to the airport 281° bearing, thence to the point of beginning. 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.

    Paragraph 6002 Class E Airspace Designated as Surface Areas. ANM OR E2 Aurora, OR [Amended] Aurora State Airport, OR (Lat. 45°14′50″ N, long. 122°46′12″ W)

    That airspace extending upward from the surface within a 4-mile radius of Aurora State Airport and within 1.8 miles each side of the 007° bearing from the airport extending from the 4-mile radius to 5.1 miles north of the airport, excluding that airspace below 1,500 feet MSL within the area bounded by lat. 45°15′37″ N, long. 122°51′14″ W; to the point where the 235° bearing from the airport intersects the 4-mile radius of the airport, thence clockwise along the airport 4-mile radius to the airport 281° bearing, thence to the point of beginning.

    Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ANM OR E5 Aurora, OR [Amended] Aurora State Airport, OR (Lat. 45°14′50″ N, long. 122°46′12″ W)

    That airspace extending upward from 700 feet above the surface within a 9-mile radius of the Aurora State Airport from a 350° bearing from the airport clockwise to a 043° bearing from the airport, and within a 6.5-mile radius of the airport from the airport 043° bearing clockwise to the airport 350° bearing, and within 1.6 miles each side of a 007° bearing from the airport extending from the 9-mile radius of the airport to 20.6 miles north of the airport, and within 1.8 miles each side of a line extending from lat. 45°21′12″ N, long. 122°58′41″ W; to lat. 45°19′20″ N, long. 122°49′07″ W.

    Issued in Seattle, Washington, on February 7, 2018. B.G. Chew, Acting Manager, Operations Support Group, Western Service Center.
    [FR Doc. 2018-03408 Filed 2-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-1148; Airspace Docket No. 17-AWP-30] Proposed Removal of Class E Airspace; Mercury, NV AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to remove Class E airspace extending upward from 700 feet above the surface at Desert Rock Airport, Mercury, NV. This airspace is not required, as there are no instrument flight rules (IFR) operations at the airport.

    DATES:

    Comments must be received on or before April 9, 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; telephone: 1 (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2017-1148; Airspace Docket No. 17-AWP-30, 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:

    Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW, Renton, WA 98057; telephone (425) 203-4511.

    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 support the removal of controlled airspace at Desert Rock Airport, Mercury, NV.

    Comments Invited

    Interested parties are invited to participate in 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-2017-1148; Airspace Docket No. 17-AWP-30) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for address and phone number).

    Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2017-1148, Airspace Docket No. 17-AWP-30”. The postcard will be date/time stamped and returned to the commenter.

    All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. 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 the 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 Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW, Renton, WA 98057.

    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 proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by removing Class E airspace extending upward from 700 feet above the surface at Desert Rock Airport, Mercury, NV. Controlled airspace is no longer needed as there are no standard instrument approach or departure procedures for IFR operations at the 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 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, 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 will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, would 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.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, 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 14 CFR 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. AWP CA E5 Mercury, NV [Removed] Issued in Seattle, Washington, on February 7, 2018. B.G. Chew, Acting Manager, Operations Support Group, Western Service Center.
    [FR Doc. 2018-03405 Filed 2-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-1147; Airspace Docket No. 17-AWP-29] Proposed Revocation of Class E Airspace; Sunol, CA AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to remove Class E airspace extending upward from 1,200 feet above the surface at Sunol, CA. This airspace is wholly contained within the Sacramento en route airspace area and duplication is not necessary.

    DATES:

    Comments must be received on or before April 9, 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; telephone: 1 (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2017-1147; Airspace Docket No. 17-AWP-29, 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:

    Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW, Renton, WA 98057; telephone (425) 203-4511.

    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 remove Class E airspace at Sunol, CA.

    Comments Invited

    Interested parties are invited to participate in 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-2017-1147; Airspace Docket No. 17-AWP-29) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for address and phone number).

    Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2017-1147, Airspace Docket No. 17-AWP-29”. The postcard will be date/time stamped and returned to the commenter.

    All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. 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 the 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 Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW, Renton, WA 98057.

    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.

    History

    The FAA published a final rule in the Federal Register (82 FR 27988; June 20, 2017) for Docket No. FAA-2016-9476 establishing Class E en route airspace extending upward from 1,200 feet above the surface centered near Sacramento, CA. The FAA found that this airspace encompasses the Class E 1,200-foot airspace for Sunol, CA.

    The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by removing Class E airspace extending upward from 1,200 feet above the surface at Sunol, CA. The existing airspace area designated for Sunol, CA, is wholly contained within the Sacramento en route airspace area, and duplication is not necessary.

    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.

    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, 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 will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, would 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.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, 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 14 CFR 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. AWP CA E5 Sunol, CA [Removed] Issued in Seattle, Washington, on February 7, 2018. B.G. Chew, Acting Manager, Operations Support Group, Western Service Center.
    [FR Doc. 2018-03406 Filed 2-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-1145; Airspace Docket No. 17-AWP-19] Proposed Amendment of Class E Airspace; Kamuela, HI AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend Class E surface area airspace and Class E airspace extending upward from 700 feet above the surface at Waimea-Kohala Airport, Kamuela, HI. The part-time Notice to Airmen (NOTAM) status would be removed from Class E surface area airspace, references to the Kamuela VOR/DME would be removed from all associated Class E airspace areas, and airspace boundaries would be modified to only that area necessary to contain instrument flight rules (IFR) operations at the airport. Airspace redesign is necessary as the FAA transitions from ground-based to satellite-based navigation for the safety and management of the national airspace system. Also, an editorial change would be made removing the airport name and replacing it with the city in the airspace designators for the above airspace areas.

    DATES:

    Comments must be received on or before April 9, 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; telephone: 1 (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2017-1145; Airspace Docket No. 17-AWP-19, 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:

    Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW, Renton, WA 98057; telephone (425) 203-4511.

    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 Waimea-Kohala Airport, Kamuela, HI, to accommodate airspace redesign in support of IFR operations at the airport.

    Comments Invited

    Interested parties are invited to participate in 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-2017-1145; Airspace Docket No. 17-AWP-19) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for address and phone number).

    Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2017-1145; Airspace Docket No. 17-AWP-19.” The postcard will be date/time stamped and returned to the commenter.

    All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. 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 the 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 Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW, Renton, WA 98057.

    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 proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by removing the part-time NOTAM status of Class E surface area airspace and defining its boundaries with reference to the Waimea-Kohala Airport, Kamuela, HI (instead of the Kamuela VOR/DME). Class E airspace would extend upward from the surface within the 4.3-mile radius of Waimea-Kohala Airport, and within 2.4 miles north and 1.8 miles south of the 069° bearing from the airport extending from the 4.3-mile radius to 7.3 miles east of the airport (from 1.8 miles northwest of and 2.6 miles southeast of the Kamuela VOR 063° radial, extending from the 4.3-mile radius to 7.8 miles northeast of the Kamuela VOR/DME).

    Class E airspace extending upward from 700 feet above the surface would be modified to within a 4.3-mile radius of Waimea-Kohala Airport (from a 6.4-mile radius) and within 4.1 miles each side of the 069° bearing from the airport extending from the 4.3-mile radius to 12.8 miles east of the airport, and within 1.3 miles each side of the 244° bearing from the airport extending from the 4.3-mile radius to 5.8 miles southwest of the airport (from 2 miles each side of the Kamuela VOR/DME 068° radial, extending from the 6.4-mile radius 12.6 miles northeast of the Kamuela VOR/DME, and within 2 miles each side of the Kamuela VOR/DME 246° extending from the 6.4-mile radius to 13.4 miles southwest of the Kamuela VOR/DME). This airspace redesign would expand the airspace areas slightly northeast and reduce the airspace from southeast clockwise to north to only that area necessary to contain IFR operations at the airport.

    Additionally, an editorial change would be made replacing Waimea-Kohala Airport, HI, with Kameula, HI, in the airspace designation of the above classes of airspace to comply with a recent change to FAA Order 7400.2L, Procedures for Handling Airspace Matters, dated October 12, 2017.

    Class E airspace designations are published in paragraph 6002, 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 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, 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 will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, would 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.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, 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 14 CFR 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 6002 Class E Airspace Areas Designated as Surface Areas. AWP HI E2 Kamuela, HI [Amended] Waimea-Kohala Airport, HI (Lat. 20°00′05″ N, long. 155°40′05″ W)

    That airspace extending upward from the surface within a 4.3-mile radius of Waimea-Kohala Airport, and within 2.4 miles north and 1.8 miles south of the 069° bearing from the airport extending from the 4.3-mile radius to 7.3 miles east of the airport.

    Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AWP HI E5 Kamuela, HI [Amended] Waimea-Kohala Airport, HI (Lat. 20°00′05″ N, long. 155°40′05″ W)

    That airspace extending upward from 700 feet above the surface within a 4.3-mile radius of Waimea-Kohala Airport, and within 4.1 miles each side of the 069° bearing from the airport extending from the 4.3-mile radius to 12.8 miles east of the airport, and within 1.3 miles each side of the 244° bearing from the airport extending from the 4.3-mile radius to 5.8 miles southwest of the airport.

    Issued in Seattle, Washington, on February 7, 2018. B.G. Chew, Acting Manager, Operations Support Group, Western Service Center.
    [FR Doc. 2018-03411 Filed 2-20-18; 8:45 a.m.] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-1146; Airspace Docket No. 17-AWP-16] Proposed Amendment of Class D and Class E Airspace, and Removal of Class E Airspace; Lompoc, CA AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend Class D airspace, Class E airspace extending upward from 700 feet above the surface, and remove Class E airspace designated as an extension at Vandenberg Air Force Base (AFB), Lompoc, CA. This action also proposes to modify Class E airspace extending upward from 700 feet above the surface at Lompoc Airport, Lompoc, CA, by enlarging the airspace and removing the part-time Notice to Airmen (NOTAM) status. This action would also amend the geographic coordinates of the airports to match the FAA's aeronautical database. This action is necessary for the safety and management of instrument flight rules (IFR) operations at these airports. An editorial change would be made removing the city associated with the airport name in the airspace designator for Vandenberg AFB, as well as removing exclusionary language from the description. Additionally, this action would replace the outdated term “Airport/Facility Directory” with the term “Chart Supplement”.

    DATES:

    Comments must be received on or before April 9, 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; telephone: 1(800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2017-1146; Airspace Docket No. 17-AWP-16, 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:

    Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW, Renton, WA 98057; telephone (425) 203-4511.

    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, Class E airspace, and remove Class E airspace designated as an extension at Lompoc, CA, in support of IFR operations at Vandenberg AFB and Lompoc Airport.

    Comments Invited

    Interested parties are invited to participate in 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-2017-1146; Airspace Docket No. 17-AWP-16) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for address and phone number).

    Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2017-1146; Airspace Docket No. 17-AWP-16.” The postcard will be date/time stamped and returned to the commenter.

    All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. 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 the 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 Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW, Renton, WA 98057.

    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 proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by enlarging Class D airspace, reducing Class E airspace extending upward from 700 feet above the surface, and removing Class E airspace designated as an extension at Vandenberg Air Force Base (AFB), Lompoc, CA, and also would amend Class E airspace extending upward from 700 feet above the surface and remove part-time NOTAM status at Lompoc Airport, Lompoc, CA.

    Class D airspace would be enlarged to within a 5-mile radius (from a 4.3-mile radius) of Vandenberg AFB. Additionally, an editorial change would remove the city associated with the airport name in the airspace designation to comply with a recent change to FAA Order 7400.2L, dated October 12, 2017. An editorial change also would be made to the Class D airspace legal description replacing “Airport/Facility Directory” with “Chart Supplement”.

    Class E airspace designated as an extension would be removed, as this airspace is not required to protect IFR arrival and departure aircraft at Vandenberg AFB.

    Class E airspace extending upward from 700 feet above the surface at Vandenberg AFB would be modified to a 7.3-mile radius of the airport with extensions to 11 miles north, 12.5-miles southeast, and 11 miles south of the airport (from a 7.8-mile radius of the airport and within 1.8 miles each side of the Vandenberg AFB ILS localizer southeast course, extending from 7.8 miles to 10.3 miles southeast 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.

    This action also would amend Class E airspace extending upward from 700 feet above the surface at Lompoc Airport, Lompoc, CA, by enlarging the airspace to within a 6.4-mile radius of the airport, and within 4 miles each side of the 090° bearing from the airport extending from the 6.4-mile radius to 12.8 miles east of the airport, and within 4 miles each side of the 113° bearing from the airport extending from the 6.4-mile radius to 20.4 miles southeast of the airport (from a 4.3-mile radius of the airport and within 4.3 miles each side of the Gaviota VORTAC 293° radial extending from the 4.3-mile radius to 10.9 miles west of the Gaviota VORTAC and within 4 miles each side of the 083° bearing from the Lompoc NDB to 8 miles east of the NDB. Also, the part-time NOTAM status would be removed, since this airspace is effective continuously.

    Finally, this action would update the geographic coordinates of these airports to match the FAA's aeronautical database.

    Class E airspace designations are published in paragraph 5000, 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 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, 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 will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, would 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.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, 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 14 CFR 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. AWP CA D Lompoc, CA [Amended] Vandenberg AFB, CA (Lat. 34°44′14″ N, long. 120°35′04″ W)

    That airspace extending upward from the surface to and including 2,900 feet MSL within a 5-mile radius of Vandenberg AFB. 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.

    Paragraph 6004 Class E Airspace Designated as an Extension to a Class D or Class E Surface Area. AWP CA E4 Lompoc, CA [Removed] Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AWP CA E5 Lompoc, CA [Amended] Vandenberg AFB, CA (Lat. 34°44′14″ N, long. 120°35′04″ W)

    That airspace extending upward from 700 feet above the surface within a 7.3-mile radius of Vandenberg AFB from the airport 007° bearing clockwise to the airport 143° bearing, and within a 12.5-mile radius of the airport from the airport 143° bearing clockwise to the airport 168° bearing, and within an 11-mile radius of the airport from the airport 168° bearing clockwise to the airport 190° bearing, and within a 7.3-mile radius of the airport from the airport 190° bearing clockwise to the airport 343° bearing, and within an 11-mile radius of the airport from the airport 343° bearing clockwise to the airport 007° bearing.

    AWP CA E5 Lompoc, CA [Amended] Lompoc Airport, CA (Lat. 34°39′56″ N, long. 120°28′03″ W)

    That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Lompoc Airport, and within 4 miles each side of the 090° bearing from the airport extending to 12.8 miles east of the airport, and within 4 miles each side of the 113° bearing from the airport extending to 20.4 miles southeast of the airport.

    Issued in Seattle, Washington, on February 7, 2018. B.G. Chew, Acting Manager, Operations Support Group, Western Service Center.
    [FR Doc. 2018-03415 Filed 2-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 54 [REG-133491-17] RIN 1545-BO41 DEPARTMENT OF LABOR Employee Benefits Security Administration 29 CFR Part 2590 RIN 1210-AB86 DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Parts 144, 146, and 148 [CMS-9924-P] RIN 0938-AT48 Short-Term, Limited-Duration Insurance AGENCY:

    Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Centers for Medicare & Medicaid Services, Department of Health and Human Services.

    ACTION:

    Proposed rule.

    SUMMARY:

    This rule contains proposals amending the definition of short-term, limited-duration insurance for purposes of its exclusion from the definition of individual health insurance coverage. This action is being taken to lengthen the maximum period of short-term, limited-duration insurance, which will provide more affordable consumer choice for health coverage.

    DATES:

    To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. EST on April 23, 2018.

    ADDRESSES:

    In commenting, please refer to file code CMS-9924-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

    You may submit comments in one of four ways (please choose only one of the ways listed):

    1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov. Follow the “Submit a comment” instructions.

    2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-9924-P, P.O. Box 8010, Baltimore, MD 21244-8010.

    Please allow sufficient time for mailed comments to be received before the close of the comment period.

    3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-9924-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses prior to the close of the comment period:

    a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201.

    (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

    b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

    For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

    FOR FURTHER INFORMATION CONTACT:

    Amber Rivers or Matthew Litton of the Department of Labor, at 202-693-8335; Karen Levin, Internal Revenue Service, Department of the Treasury, at (202) 317-5500; David Mlawsky, Centers for Medicare & Medicaid Services, Department of Health and Human Services, at 410-786-1565.

    Customer Service Information: Individuals interested in obtaining information from the Department of Labor concerning employment-based health coverage laws may call the Employee Benefits Security Administration (EBSA) Toll-Free Hotline, at 1-866-444-EBSA (3272) or visit the Department of Labor's website (http://www.dol.gov/ebsa). In addition, information from the Department of Health and Human Services (HHS) on private health insurance for consumers can be found on the Centers for Medicare & Medicaid Services (CMS) website (www.cms.gov/cciio) and information on health reform can be found at www.HealthCare.gov.

    SUPPLEMENTARY INFORMATION:

    Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments.

    I. Background

    This proposed rule contains amendments to the definition of “short-term, limited-duration insurance” for purposes of its exclusion from the definition of “individual health insurance coverage” in 26 CFR part 54, 29 CFR part 2590, and 45 CFR part 144.

    A. General Statutory Background and Enactment of PPACA

    The Health Insurance Portability and Accountability Act of 1996 (HIPAA),1 added title XXVII to the Public Health Service Act (PHS Act), part 7 to the Employee Retirement Income Security Act of 1974 (ERISA), and Chapter 100 to the Internal Revenue Code (the Code), providing portability and nondiscrimination rules with respect to health coverage. These provisions of the PHS Act, ERISA, and the Code were later augmented by other laws, including the Mental Health Parity Act of 1996,2 the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008,3 the Newborns' and Mothers' Health Protection Act,4 the Women's Health and Cancer Rights Act,5 the Genetic Information Nondiscrimination Act of 2008,6 the Children's Health Insurance Program Reauthorization Act of 2009,7 Michelle's Law,8 and the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (PPACA).9

    1 Public Law 104-191, 110 Stat. 1936 (August 21, 1996).

    2 Public Law 104-204, 110 Stat. 2944 (September 26, 1996).

    3 Public Law 110-343, 122 Stat. 3881 (October 3, 2008).

    4 Public Law 104-204, 110 Stat. 2935 (September 26, 1996).

    5 Public Law 105-277, 112 Stat. 2681-436 (October 21, 1998).

    6 Public Law 110-233, 122 Stat. 881 (May 21, 2008).

    7 Public Law 111-3, 123 Stat. 64 (February 4, 2009).

    8 Public Law 110-381, 122 Stat. 4081 (October 9, 2008).

    9 The Patient Protection and Affordable Care Act, Public Law 111-148, was enacted on March 23, 2010, and the Health Care and Education Reconciliation Act of 2010, Public Law 111-152, was enacted on March 30, 2010.

    PPACA reorganizes, amends, and adds to the provisions of Part A of title XXVII of the PHS Act relating to group health plans and health insurance issuers in the group and individual markets. PPACA added section 715 of ERISA and section 9815 of the Code to incorporate provisions of Part A of title XXVII of the PHS Act (generally, sections 2701 through 2728 of the PHS Act) into ERISA and the Code.

    B. President's Executive Order

    On October 12, 2017, President Trump issued Executive Order 13813 entitled “Promoting Healthcare Choice and Competition Across the United States”.10 This Executive Order states in relevant part: “Within 60 days of the date of this order, the Secretaries of the Treasury, Labor, and Health and Human Services shall consider proposing regulations or revising guidance, consistent with law, to expand the availability of [short-term, limited-duration insurance]. To the extent permitted by law and supported by sound policy, the Secretaries should consider allowing such insurance to cover longer periods and be renewed by the consumer.”

    10 82 FR 48385.

    C. 2017 Tax Legislation

    Section 5000A of the Code, added by PPACA, provides that all non-exempt applicable individuals must maintain minimum essential coverage or pay the individual shared responsibility payment.11 On December 22, 2017, the President signed tax reform legislation into law.12 This legislation includes a provision under which the individual shared responsibility payment included in section 5000A of the Code is reduced to $0, effective for months beginning after December 31, 2018.

    11 The eligibility standards for exemptions can be found at 45 CFR 155.605. Section 5000A of the Code and Treasury regulations at 26 CFR 1.5000A-3 provide exemptions from the requirement to maintain minimum essential coverage for the following individuals: (1) Members of recognized religious sects; (2) members of health care sharing ministries; (3) exempt noncitizens; (4) incarcerated individuals; (5) individuals with no affordable coverage; (6) individuals with household income below the income tax filing threshold; (7) members of federally recognized Indian tribes; (8) individuals who qualify for a hardship exemption certification; and (9) individuals with a short coverage gap of a continuous period of less than 3 months in which the individual is not covered under minimum essential coverage.

    12 Public Law 115-97, 131 Stat. 2054.

    D. Short-Term, Limited-Duration Insurance

    Short-term, limited-duration insurance is a type of health insurance coverage that was designed to fill temporary gaps in coverage that may occur when an individual is transitioning from one plan or coverage to another plan or coverage. Although short-term, limited-duration insurance is not an excepted benefit,13 it is exempt from the PHS Act's individual-market requirements because it is not individual health insurance coverage.14 Section 2791(b)(5) of the PHS Act provides “[t]he term `individual health insurance coverage' means health insurance coverage offered to individuals in the individual market, but does not include short-term limited duration insurance.” 15

    13 Sections 2722 and 2763 of the PHS Act, section 732 of ERISA, and section 9831 of the Code provide that the respective requirements of title XXVII of the PHS Act, part 7 of ERISA, and Chapter 100 of the Code generally do not apply to certain types of benefits, known as “excepted benefits.” Excepted benefits are described in section 2791(c) of the PHS Act, section 733(c) of ERISA, and section 9832(c) of the Code. See also 26 CFR 54.9831-1(c), 29 CFR 2590.732(c), 45 CFR 146.145(b), and 45 CFR 148.220.

    14 The definition of short-term, limited-duration insurance has some limited relevance with respect to group health plans and group health insurance issuers. For example, an individual who loses coverage due to moving out of an HMO service area in the individual market triggers a special enrollment right into a group health plan. See 26 CFR 54.9801-6(a)(3)(i)(B), 29 CFR 2590.701-6(a)(3)(i)(B) and 45 CFR 146.117(a)(3)(i)(B). Also, a group health plan that wraps around individual health insurance coverage is an excepted benefit if certain conditions are satisfied. See 26 CFR 54.9831-1(c)(3)(vii), 29 CFR 2590.732(c)(3)(vii), and 45 CFR 146.145(b)(3)(vii).

    15 Sections 733(b)(4) of ERISA and 2791(b)(4) of the PHS Act provide that group health insurance coverage means “in connection with a group health plan, health insurance coverage offered in connection with such plan.” Sections 733(a)(1) of ERISA and 2791(a)(1) of the PHS Act provide that a group health plan is generally any plan, fund, or program established or maintained by an employer (or employee organization or both) for the purpose of providing medical care to employees or their dependents (as defined under the terms of the plan) directly, or through insurance, reimbursement, or otherwise. There is no corresponding provision excluding short-term, limited-duration insurance from the definition of group health insurance coverage. Thus, any insurance that is sold in the group market and purports to be short-term, limited-duration insurance must comply with Part A of title XXVII of the PHS Act, part 7 of ERISA, and Chapter 100 of the Code.

    The PHS Act does not define short-term, limited-duration insurance. Under regulations implementing HIPAA, and that continued to apply through 2016, short-term, limited-duration insurance was defined as “health insurance coverage provided pursuant to a contract with an issuer that has an expiration date specified in the contract (taking into account any extensions that may be elected by the policyholder without the issuer's consent) that is less than 12 months after the original effective date of the contract.” 16

    16 62 FR 16894 at 16928, 16942, 16958 (April 8, 1997), 69 FR 78720 (December 30, 2004).

    To address the issue of short-term, limited-duration insurance being sold as a type of primary coverage, as well as concerns regarding possible adverse selection impacts on the risk pool for PPACA-compliant plans, the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (together, the Departments) 17 published a proposed rule on June 10, 2016 in the Federal Register entitled “Expatriate Health Plans, Expatriate Health Plan Issuers, and Qualified Expatriates; Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance.”18 The June 2016 proposed rule changed the definition of short-term, limited-duration insurance that had been in place for nearly 20 years by revising the definition to specify that short-term, limited-duration insurance could not provide coverage for 3 months or longer (including any renewal period(s)).19

    17 Note, however, that in section headings listing only 2 of the 3 Departments, the term “Departments” generally refers only to the 2 Departments listed in the heading.

    18 81 FR 38019.

    19 81 FR 38019, 38032-33.

    The June 2016 proposed rule also included a requirement that the following notice be prominently displayed in the contract and in any application materials provided in connection with enrollment in short-term, limited-duration insurance, in 14 point type:

    THIS IS NOT QUALIFYING HEALTH COVERAGE (“MINIMUM ESSENTIAL COVERAGE”) THAT SATISFIES THE HEALTH COVERAGE REQUIREMENT OF THE AFFORDABLE CARE ACT. IF YOU DON'T HAVE MINIMUM ESSENTIAL COVERAGE, YOU MAY OWE AN ADDITIONAL PAYMENT WITH YOUR TAXES.20

    20 82 FR 38032.

    Some stakeholders who submitted comments on the June 2016 proposed rule supported the rule and the Departments' stated goals. Several commenters agreed that the proposed rule would limit the number of consumers relying on short-term, limited-duration insurance as their primary form of coverage and improve the PPACA's individual market single risk pools. However, other commenters expressed concerns about restricting the use of short-term, limited-duration insurance (as originally defined under the HIPAA regulations) because it provides an additional, often much more affordable coverage option than an insurance policy that complies with all of the requirements of the PPACA. Some commenters explained that individuals who do not qualify for premium tax credits and need temporary coverage, or who cannot afford Consolidated Omnibus Budget Reconciliation Act 21 (COBRA) continuation coverage, or who missed an opportunity to sign up for coverage during open enrollment or special enrollment periods, might need to rely on short-term, limited-duration insurance coverage for 3 months or longer. Commenters highlighted how a person with just a less-than-3-month policy who develops a health condition might have no coverage options for the condition after their coverage expires until the beginning of the plan year that corresponds to the next individual market open enrollment period. Other commenters also expressed opposition to the proposed rule citing their belief that States are in the best position to regulate short-term, limited-duration insurance and that the proposed rule would limit State flexibility. Finally, several commenters observed that PPACA-compliant policies are often network-based but short-term, limited-duration insurance policies typically are not, thus offering consumers a greater choice of health care providers. This is particularly true in rural areas, one commenter stated.

    21 Public Law 99-272, 100 Stat. 82 (April 7, 1986).

    After reviewing public comments and feedback received from stakeholders, on October 31, 2016, the Departments finalized the June 2016 proposed rule without change in a final rule published in the Federal Register entitled “Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance”.22

    22 81 FR 75316.

    On June 12, 2017, HHS published a request for information in the Federal Register entitled “Reducing Regulatory Burdens Imposed by the Patient Protection and Affordable Care Act & Improving Healthcare Choices to Empower Patients”,23 which solicited public comments about potential changes to existing regulations and guidance that could promote consumer choice, enhance affordability of coverage for individual consumers, and affirm the traditional regulatory authority of the States in regulating the business of health insurance, among other goals. Several commenters stated that changes to the October 2016 final rule may provide an opportunity to achieve these goals. Consistent with many comments submitted on the June 2016 proposed rule, commenters stated that shortening the permitted length of short-term, limited-duration insurance policies had deprived individuals of affordable coverage options. One commenter explained that due to the increased costs of PPACA-compliant major medical coverage, many financially-stressed individuals may be faced with a choice between short-term, limited-duration insurance coverage and going without any coverage at all. One commenter highlighted the need for short-term, limited-duration insurance coverage among individuals who are in-between jobs. Another commenter explained that States have the primary responsibility to regulate short-term, limited-duration insurance and opined that the October 2016 final rule was overreaching on the part of the Federal government.

    23 82 FR 26885.

    The Departments are also aware that, while individuals who qualify for premium tax credits are largely insulated from significant premium increases (that is, the government, and thus federal taxpayers, largely bear the cost of the higher premiums), individuals who are not eligible for subsidies are particularly harmed by increased premiums in the individual market due to a lack of other, more affordable alternative coverage options. Based on CMS data on Exchange plan selections and data compiled from issuer regulatory filings at the State level, for the first quarters of 2016 and 2017, the number of off-Exchange and unsubsidized enrollees with individual market coverage fell by nearly 2 million, representing an almost 25 percent decrease.24 Further, in 2018, about 26 percent of enrollees (living in 52 percent of counties) have access to just one insurer in the Exchange.25 Short-term, limited-duration insurance has become increasingly attractive to some individuals as premiums have escalated for PPACA-compliant plans and affordable choices in the individual market have dwindled.

    24 See Mark Farrah and Associates, “A Brief Look at the Turbulent Individual Health Insurance Market,” July 19, 2017. Available at: http://www.markfarrah.com/healthcare-business-strategy-print/A-Brief-Look-at-the-Turbulent-Individual-Health-Insurance-Market.aspx. Also, see the Centers for Medicare and Medicaid Services, “2017 Effectuated Enrollment Snapshot,” June 12, 2017. Available at: https://downloads.cms.gov/files/effectuated-enrollment-snapshot-report-06-12-17.pdf.

    25 See Kaiser Family Foundation. “Insurer Participation on ACA Marketplaces, 2014-2018,” November 10, 2017. http://www.kff.org/health-reform/issue-brief/insurer-participation-on-aca-marketplaces/.

    II. Overview of the Proposed Regulations

    In light of Executive Order 13813 directing the Departments to consider proposing regulations or revising guidance to expand the availability of short-term, limited-duration insurance, as well as continued feedback from stakeholders expressing concerns about the October 2016 final rule, the Departments are proposing to amend the definition of short-term, limited-duration insurance so that it may offer a maximum coverage period of less than 12 months after the original effective date of the contract, consistent with the original definition in the 1997 HIPAA rule (that is, the proposed rule would expand the potential maximum coverage period by 9 months). This proposed definition states that the expiration date specified in the contract takes into account any extensions that may be elected by the policyholder without the issuer's consent.

    In addition, this proposed rule would revise the required notice that must appear in the contract and any application materials for short-term, limited-duration insurance. The Departments are concerned that short-term, limited-duration insurance policies that provide coverage lasting almost 12 months may be more difficult for some individuals to distinguish from PPACA-compliant coverage which is typically offered on a 12-month basis. Accordingly, under this proposed rule, one of two versions (as explained below) of the following notice would be required to be prominently displayed (in at least 14 point type) in the contract and in any application materials provided in connection with enrollment:

    THIS COVERAGE IS NOT REQUIRED TO COMPLY WITH FEDERAL REQUIREMENTS FOR HEALTH INSURANCE, PRINCIPALLY THOSE CONTAINED IN THE AFFORDABLE CARE ACT. BE SURE TO CHECK YOUR POLICY CAREFULLY TO MAKE SURE YOU UNDERSTAND WHAT THE POLICY DOES AND DOESN'T COVER. IF THIS COVERAGE EXPIRES OR YOU LOSE ELIGIBILITY FOR THIS COVERAGE, YOU MIGHT HAVE TO WAIT UNTIL AN OPEN ENROLLMENT PERIOD TO GET OTHER HEALTH INSURANCE COVERAGE. ALSO, THIS COVERAGE IS NOT “MINIMUM ESSENTIAL COVERAGE”. IF YOU DON'T HAVE MINIMUM ESSENTIAL COVERAGE FOR ANY MONTH IN 2018, YOU MAY HAVE TO MAKE A PAYMENT WHEN YOU FILE YOUR TAX RETURN UNLESS YOU QUALIFY FOR AN EXEMPTION FROM THE REQUIREMENT THAT YOU HAVE HEALTH COVERAGE FOR THAT MONTH.

    As stated below, the Departments are proposing that the applicability date for this proposed rule, if finalized, would be 60 days after the publication of the final rule, and that policies sold on or after that date would have to meet the requirements of the final rule in order to constitute short-term, limited-duration insurance. As previously discussed, the individual shared responsibility payment is reduced to $0 for months beginning after December 2018. Consequently, the Departments propose that the final two sentences of the notice must appear only with respect to policies sold on or after the applicability date of the rule, if finalized, that have a coverage start date before January 1, 2019. The Departments solicit comments on this revised notice, and whether its language or some other language would best ensure that it is understandable and sufficiently apprises individuals of the nature of the coverage.

    The current definition of short-term, limited-duration insurance applies for policy years beginning on or after January 1, 2017. In the October 2016 final rule, the Departments recognized that State regulators may have approved short-term, limited-duration insurance products for sale in 2017 that met the definition in effect prior to January 1, 2017.26 Accordingly, HHS noted it would not take enforcement action against an issuer with respect to its sale of a short-term, limited-duration insurance product before April 1, 2017, on the ground that the coverage period is 3 months or more, provided that the coverage ended on or before December 31, 2017, and otherwise complies with the definition of short-term, limited-duration insurance in effect under the final rule.27 As stated in the October 2016 final rule, States may also elect not to take enforcement actions against issuers with respect to such coverage sold before April 1, 2017. The current definition in the October 2016 final rule, and the non-enforcement policy as applied to policies sold before April 1, 2017, and that end on or before December 31, 2017, would continue to apply unless and until this rule is finalized.

    26 81 FR 75318 through 75319.

    27 This non-enforcement policy is limited to the requirement that short-term, limited-duration insurance must be less than 3 months. It does not relieve issuers of short-term, limited-duration insurance of the notice requirement, which applies for policy years beginning on or after January 1, 2017.

    Effective Date and Applicability Date

    The Departments propose that this rule, if finalized, would be effective 60 days after publication of the final rule. With respect to the applicability date, the Departments propose that insurance policies sold on or after the 60th day following publication of the final rule, if finalized, would have to meet the definition of short-term, limited-duration insurance in the final rule in order to be considered such insurance. The Departments propose that group health plans and group health insurance issuers, to the extent they must distinguish between short-term, limited-duration insurance and individual market health insurance (such as for purposes of determining whether an individual has moved out of a health maintenance organization (HMO) service area in the individual market, which would trigger a special enrollment right into a group health plan or for purposes of offering limited wraparound coverage (which wraps around individual health insurance or the Basic Health Plan as an excepted benefit 28 ), must apply the definition of short-term, limited-duration insurance in the final rule as of the 60th day following publication of the final rule. The current regulations specify the applicability date for the definition of short-term, limited-duration insurance at 26 CFR 54.9833-1; 29 CFR 2590.736, 45 CFR 146.125; and 45 CFR 148.102. Therefore, the Departments propose conforming amendments to those rules as part of this rulemaking. The Departments also propose a technical update in 26 CFR 54.9833-1; 29 CFR 2590.736; and 45 CFR 146.125 to delete the reference to the applicability date for amendments to 26 CFR 54.9831-1(c)(5)(i)(C); 29 CFR 2590.732(c)(5)(i)(C); and 45 CFR 146.145(c)(5)(i)(C) (regarding supplemental coverage excepted benefits).29 Given that the applicability date for the amendments to those sections has passed, it is no longer necessary to mention the “future” applicability date.30 HHS similarly proposes to amend § 148.102 to remove the reference to the applicability date for amendments to § 148.220(b)(7) (regarding supplemental coverage excepted benefits).31

    28 See footnote 14.

    29 The reference in current regulations at 45 CFR 146.125 to the applicability date of 45 CFR 146.145(c)(5)(i)(C) was a drafting error. It was intended to be a reference to 45 CFR 146.145(b)(5)(i)(C).

    30 The applicability date for these amendments (policy years and plan years beginning on or after January 1, 2017) remains unchanged.

    31 The applicability date for these amendments (policy years beginning on or after January 1, 2017) remains unchanged.

    Request for Comments

    The Departments seek comments on all aspects of this proposed rule, including whether the length of short-term, limited-duration insurance should be some other duration. The Departments seek comments on any regulations or other guidance or policy that limits issuers' flexibility in designing short-term, limited-duration insurance or poses barriers to entry into the short-term, limited-duration insurance market.

    In addition, the Departments seek comments on the conditions under which issuers should be able to allow short-term, limited-duration insurance to continue for 12 months or longer with the issuer's consent. Among other things, the Departments solicit comments on whether any processes for expedited or streamlined reapplication for short-term, limited-duration insurance that would simplify the reapplication process and minimize the burden on consumers may be appropriate; whether federal standards are appropriate for such processes; and whether any clarifications are needed regarding the application of the definition of short-term, limited-duration insurance in the proposed rule to such practices. For example, an expedited process could involve setting minimum federal standards for what must be considered as part of the streamlined reapplication process while allowing insurers to consider additional factors in accordance with contract terms. The Departments are also interested in information on any State approaches (including any approaches that States are considering adopting) to minimize the burden of the reapplication process for issuers and consumers.

    Because short-term, limited-duration insurance can be priced in an actuarially fair manner (by which the Departments mean that it is priced so that the premium paid by an individual reflects the risks associated with insuring the particular individual or individuals covered by that policy), subject to State law, individuals who are likely to purchase short-term, limited-duration insurance are likely to be relatively young or healthy. Allowing such individuals to purchase policies that are not in compliance with PPACA may impact the individual market single risk pools. As explained in section III., “Economic Impact and Paperwork Burden” of this proposed rule, the Departments estimate that in 2019, after the elimination of the individual shared responsibility payment, between 100,000 and 200,000 individuals previously enrolled in Exchange coverage would purchase short-term, limited-duration insurance policies instead. This would cause the average monthly individual market premiums and average monthly premium tax credits to increase, leading to an increase in total annual advance payments of the premium tax credit (APTC) 32 in the range of $96 million to $168 million. The Departments seek comments on these estimates, and welcome other estimates of the increase in enrollment in short-term, limited-duration insurance under this proposal, and the health status and age of individuals who would purchase these policies.

    32 The Departments are using data on APTC as an approximation of premium tax credits since this is the data that is available for 2017.

    The Departments also seek comments on the proposed effective and applicability dates of this rule, if finalized. The Departments seek comments on whether the proposed fixed applicability date, which would first impose the new definition of short-term, limited-duration insurance on group health plans and group health insurance issuers on a date that may occur in the middle of a plan year, would cause any special challenges for group health plans and group health insurance issuers.

    III. Economic Impact and Paperwork Burden A. Summary—Department of Labor and Department of Health and Human Services

    This rule proposes to amend the definition of short-term, limited-duration insurance coverage so that the coverage (taking into account extensions elected by the policyholder without the issuer's consent) has a maximum period of less than 12 months after the original effective date of the contract. This rule also seeks comments on all aspects of this proposed rule, including whether the maximum length of short-term, limited-duration insurance should be some other duration; under what conditions issuers should be able to allow short-term, limited-duration insurance to continue for 12 months or longer with the issuer's consent; and on the proposed revisions to the notice that must appear in the contract and any application materials.

    The Departments have examined the effects of this rule as required by Executive Order 13563 (76 FR 3821, January 18, 2011, Improving Regulation and Regulatory Review), Executive Order 12866 (58 FR 51735, September 30, 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995, Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)) and Executive Order 13771 (January 30, 2017, Reducing Regulation and Controlling Regulatory Costs).

    B. Executive Orders 12866 and 13563—Department of Labor and Department of Health and Human Services

    Executive Order 12866 (58 FR 51735) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 (76 FR 3821, January 21, 2011) is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866.

    Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a final rule—(1) having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

    A full regulatory impact analysis must be prepared for major rules with economically significant effects (for example, $100 million or more in any 1 year), and a “significant” regulatory action is subject to review by the Office of Management and Budget (OMB). The Departments anticipate that this regulatory action is likely to have economic impacts of $100 million or more in at least 1 year, and therefore meets the definition of “significant rule” under Executive Order 12866. Therefore, the Departments have provided an assessment of the potential costs, benefits, and transfers associated with this proposed rule. In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by OMB.

    1. Need for Regulatory Action

    This rule contains proposed amendments to the definition of short-term, limited-duration insurance for purposes of the exclusion from the definition of individual health insurance coverage. This regulatory action is taken in light of Executive Order 13813 directing the Departments to consider proposing regulations or revising guidance to expand the availability of short-term, limited-duration insurance, as well as continued feedback from stakeholders expressing concerns about the October 2016 final rule. While individuals who qualify for premium tax credits are largely insulated from significant premium increases, individuals who are not eligible for subsidies are harmed by increased premiums in the individual market due to a lack of other, more affordable alternative coverage options. The proposed rule would increase insurance options for individuals unable or unwilling to purchase PPACA-compliant plans.

    2. Summary of Impacts

    In accordance with OMB Circular A-4, Table 1 depicts an accounting statement summarizing the Departments' assessment of the benefits, costs, and transfers associated with this regulatory action.

    Table 1—Accounting Table Benefits: Qualitative: • Increased access to affordable health insurance for consumers unable or unwilling to purchase PPACA-compliant plans, potentially resulting in improved health outcomes for them. • Increased choice at lower cost and increased protection (for consumers who are currently uninsured) from catastrophic health care expenses for consumers purchasing short-term, limited-duration insurance. • Potentially broader access to health care providers compared to PPACA-compliant plans for some consumers. Costs: Qualitative: • Reduced access to some services and providers for some consumers who switch from PPACA-compliant plans. • Increased out-of-pocket costs for some consumers, possibly leading to financial hardship. • Worsening of States' individual market single risk pools and potential reduced choice for some other individuals remaining in those risk pools. Transfers Low
  • estimate
  • (million)
  • High
  • estimate
  • (million)
  • Year dollar Discount
  • rate
  • (percent)
  • Period
  • covered
  • Annualized Monetized ($/year) $96 $168 2017 7 2019 96 168 2017 3 2019 Quantitative: • Transfer from the Federal government to enrollees in individual market plans in the form of increased APTC payments. Qualitative: • Transfer from enrollees in individual market plans who experience increase in premiums to individuals who switch to lower premium short-term, limited-duration insurance. • Tax liability for consumers who replace PPACA-compliant plans and will thus no longer maintain minimum essential coverage in 2018.

    Short-term, limited-duration insurance represents a small fraction of the health insurance market. Based on data from the National Association of Insurance Commissioners (NAIC), in 2016, before the October 2016 final rule became effective, total premiums earned for policies designated short-term, limited-duration by carriers were approximately $146 million for approximately 1,279,500 member months and with approximately 160,600 covered lives at the end of the year. During the same period, total premiums for individual market (comprehensive major medical) coverage were approximately $63.25 billion for approximately 175,689,900 member months with approximately 13.6 million covered lives at the end of the year.33

    33 National Association of Insurance Commissioners, 2016 Accident and Health Policy Experience Report, July 2017, available at http://www.naic.org/prod_serv/AHP-LR-17.pdf.

    Some public comments received in response to the June 2016 proposed rule stated that the majority of the short-term, limited-duration insurance policies were sold as transitional coverage, particularly for individuals seeking to cover periods of unemployment or other gaps between employer-sponsored coverage, and that the policies typically provided coverage for less than 3 months. Accordingly, this proposed rule would have no effect on the consumers who purchase such coverage for less than 3 months and perhaps some issuers of those policies. While it is not clear how the October 2016 final rule affected the sales of short-term, limited-duration insurance, the sales of such coverage were increasing prior to the issuance of that rule. Given the prior trend and the recent increases in premiums in the individual market, the Departments anticipate that the rule, if finalized, would encourage more consumers to purchase short-term, limited-duration insurance for longer durations, including individuals who were previously uninsured and some who are currently enrolled in individual market plans, especially in 2019 and beyond, when the individual shared responsibility payment included in section 5000A of the Code is reduced to $0, as provided under Public Law 115-97.

    Benefits

    Consumers who would be likely to purchase short-term, limited-duration insurance for longer periods would benefit from increased insurance options at lower premiums, as the average monthly premium in the fourth quarter of 2016 for a short-term, limited-duration policy was approximately $124 compared to $393 for an unsubsidized PPACA-compliant plan.34 This proposed rule would also benefit individuals who need coverage for longer periods for reasons previously discussed in the preamble, such as needing more than 3 months to find new employment, or finding PPACA-compliant plans to be unaffordable. Individuals who purchase short-term, limited-duration insurance as opposed to being uninsured would potentially experience improved health outcomes and have greater protection from catastrophic health care expenses. Individuals purchasing short-term, limited-duration policies could obtain broader access to health care providers compared to those PPACA-compliant plans that have narrow provider networks.35 The Departments seek comments on how many consumers may purchase short-term, limited-duration insurance, rather than being uninsured or purchasing PPACA-compliant plans, and the benefits to them from having short-term, limited-duration insurance, as well as any impacts on the PPACA individual market single risk pools.

    34http://www.npr.org/sections/health-shots/2017/01/31/512518502/sales-of-short-term-insurance-plans-could-surge-if-health-law-is-relaxed.

    35 The ability of short-term limited-duration plans to provide broad provider networks has been touted by some in the insurance community. https://www.wsj.com/articles/sales-of-short-term-health-policies-surge-1460328539.

    Issuers of short-term, limited-duration insurance would benefit from higher enrollment. They are likely to experience an increase in premium revenues and profits because such policies can be priced in an actuarially fair manner (by which the Departments mean that it is priced so that the premium paid by an individual reflects the risks associated with insuring the particular individual or individuals covered by that policy) and are not required to comply with PPACA medical loss ratio requirements for group and individual health insurance coverage.

    Costs and Transfers

    Short-term, limited-duration insurance policies would be unlikely to include all the elements of PPACA-compliant plans, such as the preexisting condition exclusion prohibition, coverage of essential health benefits without annual or lifetime dollar limits, preventive care, maternity and prescription drug coverage, rating restrictions, and guaranteed renewability. Therefore, consumers who switch to such policies from PPACA-compliant plans would experience loss of access to some services and providers and an increase in out-of-pocket expenditures related to such excluded services, benefits that in many cases consumers do not believe are worth their cost (which could be one reason why many consumers, even those receiving subsidies for PPACA-compliant plans, may switch to short-term, limited-duration policies rather than remain in PPACA-compliant plans). The Departments seek comments on the value of such excluded services to individuals who switch coverage. Depending on plan design, consumers who purchase short-term, limited-duration insurance policies and then develop chronic conditions could face financial hardship as a result, until they are able to enroll in PPACA-compliant plans that would provide coverage for such conditions. Additionally, since short-term, limited-duration insurance does not qualify as minimum essential coverage, any individual enrolled in a short-term, limited-duration plan that lasts 3 months or longer in 2018 would potentially incur a tax liability for not having minimum essential coverage during that year. Starting in 2019, the individual shared responsibility payment included in section 5000A of the Code is reduced to $0, as provided under Public Law 115-97.

    Because short-term, limited-duration insurance policies can be priced in an actuarially fair manner, subject to State law, individuals who are likely to purchase such coverage are likely to be relatively young or healthy. Allowing such individuals to purchase policies that do not comply with PPACA, but with term lengths that may be similar to those of PPACA-compliant plans with 12-month terms, could potentially weaken States' individual market single risk pools. As a result, individual market issuers could experience higher than expected costs of care and suffer financial losses, which might prompt them to leave the individual market. Although choices of plans available in the individual market have already been reduced to plans from a single insurer in roughly half of all counties, this proposed rule may further reduce choices for individuals remaining in those individual market single risk pools. The Departments seek comments on these and any other potential costs.

    The Departments anticipate that most of the individuals who switch from individual market plans to short-term, limited-duration insurance would be relatively young or healthy and would also not be eligible to receive APTC. If individual market single risk pools change as a result, it would result in an increase in premiums for the individuals remaining in those risk pools. An increase in premiums for individual market single risk pool coverage would result in an increase in Federal outlays for APTC.

    Beginning in 2019, the individual shared responsibility payment included in section 5000A of the Code is reduced to $0, as provided under Public Law 115-97. This would compound the effects of the provisions of this proposed rule (one potential exception being the impact on APTC payments). In order to estimate the impact on the individual market and APTC payments, the Departments used enrollment, premium and APTC data for 2017, observed rate increases for 2018, and assumed that 2019 rates will increase in line with medical expenditures and assumed the relative morbidities of the individuals leaving the individual market single risk pool to those remaining in the risk pool to be 75 percent. The Congressional Budget Office estimates that 3 million people will drop coverage in 2019 from the individual market and premiums will increase 10 percent on average, as a result of the change to the individual shared responsibility payment.36 The Departments seek comments on how many of these individuals may purchase short-term, limited-duration insurance instead. Based on enrollment trends prior to the October 2016 final rule, the Departments project that approximately 100,000 to 200,000 additional individuals would shift from the individual market to short-term, limited-duration insurance in 2019. Most of these individuals would be young or healthy and only about 10 percent of them would have been subsidized by eligibility for APTC if they maintained their Exchange coverage. While the reduction in the number of subsidized enrollees would tend to reduce total APTC payments, increases in premiums would tend to increase them. The proposed rule's net effect on total APTC payments is uncertain, but federal outlays for APTC are estimated to increase by between $96 million ($54,948 million−$54,852 million) and $168 million ($55,020 million−$54,852 million) annually. Table 2 depicts the effects on average premiums 37 and APTC payments.

    36 See Congressional Budget Office, Repealing the Individual Health Insurance Mandate: An Updated Estimate, November 2017, available at https://www.cbo.gov/system/files/115th-congress-2017-2018/reports/53300-individualmandate.pdf.

    37 Percent Premium Increase = (Total Enrollment−(Morbidity(75%) * Number Switching)) / (Total Enrollment−Number Switching).

    Table 2—Estimated Effect on Individual Market Exchanges in 2019 Estimated
  • number of
  • subsidized
  • enrollees in
  • exchanges
  • Estimated
  • number of
  • unsubsidized
  • enrollees in
  • exchanges
  • Estimated
  • average
  • monthly
  • premium
  • Estimated
  • average
  • monthly
  • APTC
  • Estimated
  • total monthly
  • APTC
  • Estimated
  • total annual
  • APTC
  • No change in policy 8,459,000 4,671,000 $649 $512 $4,331,000,000 $51,972,000,000 $0 individual shared responsibility payment 8,122,000 1,608,000 714 563 4,573,000,000 54,852,000,000 100,000 People switching to short-term, limited-duration insurance 8,112,000 1,518,000 716 564 4,579,000,000 54,948,000,000 200,000 People switching to short-term, limited-duration insurance 8,102,000 1,428,000 718 566 4,585,000,000 55,020,000,000

    There is significant uncertainly regarding these estimates, because changes in enrollment and premiums would depend on a variety of economic factors and it is difficult to predict how consumers and issuers would react to the proposed policy changes.

    C. Regulatory Alternatives

    One regulatory alternative would be to set the maximum duration for short-term, limited-duration insurance to a 6 month or 9 month period. However, this alternative would not adequately increase choices for individuals unable or unwilling to purchase PPACA-compliant plans.

    D. Paperwork Reduction Act—Department of Health and Human Services

    This proposed rule would revise the required notice that must be prominently displayed in the contract and in any application materials for short-term, limited-duration insurance. The Departments have proposed the exact text for this notice requirement and the language would not need to be customized. The burden associated with these notices is not subject to the Paperwork Reduction Act of 1995 in accordance with 5 CFR 1320.3(c)(2) because they do not contain a “collection of information” as defined in 44 U.S.C. 3502(3). Consequently, this document need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    E. Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) imposes certain requirements with respect to Federal rules that are subject to the notice and comment requirements of section 553(b) of the Administrative Procedure Act (5 U.S.C. 551 et seq.) and that are likely to have a significant economic impact on a substantial number of small entities. Unless an agency certifies that a proposed rule is not likely to have a significant economic impact on a substantial number of small entities, section 603 of RFA requires that the agency present an initial regulatory flexibility analysis at the time of the publication of the notice of proposed rulemaking describing the impact of the rule on small entities and seeking public comment on such impact. Small entities include small businesses, organizations and governmental jurisdictions.

    The RFA generally defines a “small entity” as—(1) a proprietary firm meeting the size standards of the Small Business Administration (13 CFR 121.201); (2) a nonprofit organization that is not dominant in its field; or (3) a small government jurisdiction with a population of less than 50,000. (States and individuals are not included in the definition of “small entity”). The Departments use as their measure of significant economic impact on a substantial number of small entities a change in revenues of more than 3 to 5 percent.

    This proposed rule would impact health insurance issuers, especially those in the individual market. The Departments believe that health insurance issuers would be classified under the North American Industry Classification System code 524114 (Direct Health and Medical Insurance Carriers). According to SBA size standards, entities with average annual receipts of $38.5 million or less are considered small entities for these North American Industry Classification System codes. Issuers could possibly be classified in 621491 (Health Maintenance Organization Medical Centers) and, if this is the case, the SBA size standard is $32.5 million or less.38 The Departments believe that few, if any, insurance companies selling comprehensive health insurance policies (in contrast, for example, to travel insurance policies or dental discount policies) fall below these size thresholds. Based on data from Medical Loss Ratio (MLR) annual report submissions for the 2015 MLR reporting year,39 approximately 92 out of over 530 issuers of health insurance coverage nationwide had total premium revenue of $38.5 million or less, of which 64 issuers offer plans in the individual market. This estimate may overstate the actual number of small health insurance companies that may be affected, since almost 50 percent of these small companies belong to larger holding groups, and many if not all of these small companies are likely to have non-health lines of business that would result in their revenues exceeding $38.5 million. Therefore, the Departments certify that this proposed rule would not have a significant impact on a substantial number of small entities.

    38 “Table of Small Business Size Standards Matched to North American Industry Classification System Codes”, effective October 1, 2017, U.S. Small Business Administration, available at https://www.sba.gov/sites/default/files/files/Size_Standards_Table_2017.pdf.

    39 Available at https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.html.

    In addition, section 1102(b) of the Social Security Act requires agencies to prepare a regulatory impact analysis if a rule may have a significant economic impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. This proposed rule will not affect small rural hospitals. Therefore, the Departments have determined that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals.

    F. Special Analysis—Department of the Treasury

    Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. Pursuant to Executive Order 13789, the Treasury Department and OMB are currently reviewing the scope and implementation of the existing exemption. Pursuant to section 7805(f) of the Code, this proposed rule has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

    G. Unfunded Mandates Reform Act

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a proposed rule that includes any Federal mandate that may result in expenditures in any 1 year by a State, local, or Tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. Currently, that threshold is approximately $148 million. This proposed rule does not include any Federal mandate that may result in expenditures by State, local, or tribal governments, or the private sector, that may impose an annual burden that exceeds that threshold.

    H. Federalism—Department of Labor and Department of Health and Human Services

    Executive Order 13132 outlines fundamental principles of federalism. It requires adherence to specific criteria by Federal agencies in formulating and implementing policies that have “substantial direct effects” on the States, the relationship between the national government and States, or on the distribution of power and responsibilities among the various levels of government. Federal agencies promulgating regulations that have these federalism implications must consult with State and local officials, and describe the extent of their consultation and the nature of the concerns of State and local officials in the preamble to the final regulation.

    Federal officials have discussed the issue of the term length of short-term, limited-duration insurance with State regulatory officials. This proposed rule has no federalism implications to the extent that current State law requirements for short-term, limited-duration insurance are the same as or more restrictive than the Federal standard proposed in this proposed rule. States may continue to apply such State law requirements.

    I. Congressional Review Act

    This proposed rule is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.) and will be transmitted to the Congress and to the Comptroller General for review in accordance with such provisions.

    J. Reducing Regulation and Controlling Regulatory Costs

    Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. This proposed rule, if finalized as proposed, is expected to be an Executive Order 13771 deregulatory action.

    IV. Statutory Authority

    The Department of the Treasury regulations are proposed to be adopted pursuant to the authority contained in sections 7805 and 9833 of the Code.

    The Department of Labor regulations are proposed to be adopted pursuant to the authority contained in 29 U.S.C. 1135 and 1191c; and Secretary of Labor's Order 1-2011, 77 FR 1088 (Jan. 9, 2012).

    The Department of Health and Human Services regulations are proposed to be adopted pursuant to the authority contained in sections 2701 through 2763, 2791, 2792 and 2794 of the PHS Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, 300gg-92 and 300gg-94), as amended.

    List of Subjects 26 CFR Part 54

    Pension excise taxes.

    29 CFR Part 2590

    Continuation coverage, Disclosure, Employee benefit plans, Group health plans, Health care, Health insurance, Medical child support, Reporting and recordkeeping requirements.

    45 CFR Parts 144 and 146

    Health care, Health insurance, Reporting and recordkeeping requirements.

    45 CFR Part 148

    Administrative practice and procedure, Health care, Health insurance, Penalties, Reporting and recordkeeping requirements.

    Kirsten B. Wielobob, Deputy Commissioner for Services and Enforcement, Internal Revenue Service. Signed this 8th day of February 2018. Preston Rutledge, Assistant Secretary, Employee Benefits Security Administration, Department of Labor. Dated: February 1, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. Dated: February 9, 2018. Alex M. Azar II, Secretary, Department of Health and Human Services. DEPARTMENT OF THE TREASURY Internal Revenue Service

    For the reasons stated in the preamble, 26 CFR part 54 is proposed to be amended as follows:

    PART 54—PENSION AND EXCISE TAX Par. 1. The authority citation for part 54 continues to read in part as follows: Authority:

    26 U.S.C. 7805 * * *

    Par. 2. Section 54.9801-2 is amended by revising the definition of “Short-term, limited-duration insurance” to read as follows:
    § 54.9801-2 Definitions.

    Short-term, limited-duration insurance means health insurance coverage provided pursuant to a contract with an issuer that:

    (1) Has an expiration date specified in the contract (taking into account any extensions that may be elected by the policyholder without the issuer's consent) that is less than 12 months after the original effective date of the contract;

    (2) With respect to policies having a coverage start date before January 1, 2019, displays prominently in the contract and in any application materials provided in connection with enrollment in such coverage in at least 14 point type the following:

    THIS COVERAGE IS NOT REQUIRED TO COMPLY WITH FEDERAL REQUIREMENTS FOR HEALTH INSURANCE, PRINCIPALLY THOSE CONTAINED IN THE AFFORDABLE CARE ACT. BE SURE TO CHECK YOUR POLICY CAREFULLY TO MAKE SURE YOU UNDERSTAND WHAT THE POLICY DOES AND DOESN'T COVER. IF THIS COVERAGE EXPIRES OR YOU LOSE ELIGIBILITY FOR THIS COVERAGE, YOU MIGHT HAVE TO WAIT UNTIL AN OPEN ENROLLMENT PERIOD TO GET OTHER HEALTH INSURANCE COVERAGE. ALSO, THIS COVERAGE IS NOT “MINIMUM ESSENTIAL COVERAGE”. IF YOU DON'T HAVE MINIMUM ESSENTIAL COVERAGE FOR ANY MONTH IN 2018, YOU MAY HAVE TO MAKE A PAYMENT WHEN YOU FILE YOUR TAX RETURN UNLESS YOU QUALIFY FOR AN EXEMPTION FROM THE REQUIREMENT THAT YOU HAVE HEALTH COVERAGE FOR THAT MONTH.; and

    (3) With respect to policies having a coverage start date on or after January 1, 2019, displays prominently in the contract and in any application materials provided in connection with enrollment in such coverage in at least 14 point type the following:

    THIS COVERAGE IS NOT REQUIRED TO COMPLY WITH FEDERAL REQUIREMENTS FOR HEALTH INSURANCE, PRINCIPALLY THOSE CONTAINED IN THE AFFORDABLE CARE ACT. BE SURE TO CHECK YOUR POLICY CAREFULLY TO MAKE SURE YOU UNDERSTAND WHAT THE POLICY DOES AND DOESN'T COVER. IF THIS COVERAGE EXPIRES OR YOU LOSE ELIGIBILITY FOR THIS COVERAGE, YOU MIGHT HAVE TO WAIT UNTIL AN OPEN ENROLLMENT PERIOD TO GET OTHER HEALTH INSURANCE COVERAGE.
    Par. 3. Section 54.9833-1 is amended by revising the section heading and the last sentence to read as follows:
    § 54.9833-1 Applicability dates.

    * * * Notwithstanding the previous sentence, the definition of “short-term, limited-duration insurance” in § 54.9801-2 applies [DATE 60 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER].

    DEPARTMENT OF LABOR Employee Benefits Security Administration 29 CFR Chapter XXV

    For the reasons stated in the preamble, the Department of Labor proposes to amend 29 CFR part 2590 as set forth below:

    PART 2590—RULES AND REGULATIONS FOR GROUP HEALTH PLANS 4. The authority citation for part 2590 continues to read as follows: Authority:

    29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 1181-1183, 1181 note, 1185, 1185a, 1185b, 1191, 1191a, 1191b, and 1191c; sec. 101(g), Pub. L. 104-191, 110 Stat. 1936; sec. 401(b), Pub. L. 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. 110-343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Pub. L. 111-148, 124 Stat. 119, as amended by Pub. L. 111-152, 124 Stat. 1029; Division M, Pub. L. 113-235, 128 Stat. 2130; Secretary of Labor's Order 1-2011, 77 FR 1088 (Jan. 9, 2012).

    5. Section 2590.701-2 is amended by revising the definition of “Short-term, limited-duration insurance” to read as follows:
    § 2590.701-2 Definitions.

    Short-term, limited-duration insurance means health insurance coverage provided pursuant to a contract with an issuer that:

    (1) Has an expiration date specified in the contract (taking into account any extensions that may be elected by the policyholder without the issuer's consent) that is less than 12 months after the original effective date of the contract;

    (2) With respect to policies having a coverage start date before January 1, 2019, displays prominently in the contract and in any application materials provided in connection with enrollment in such coverage in at least 14 point type the following:

    THIS COVERAGE IS NOT REQUIRED TO COMPLY WITH FEDERAL REQUIREMENTS FOR HEALTH INSURANCE, PRINCIPALLY THOSE CONTAINED IN THE AFFORDABLE CARE ACT. BE SURE TO CHECK YOUR POLICY CAREFULLY TO MAKE SURE YOU UNDERSTAND WHAT THE POLICY DOES AND DOESN'T COVER. IF THIS COVERAGE EXPIRES OR YOU LOSE ELIGIBILITY FOR THIS COVERAGE, YOU MIGHT HAVE TO WAIT UNTIL AN OPEN ENROLLMENT PERIOD TO GET OTHER HEALTH INSURANCE COVERAGE. ALSO, THIS COVERAGE IS NOT “MINIMUM ESSENTIAL COVERAGE”. IF YOU DON'T HAVE MINIMUM ESSENTIAL COVERAGE FOR ANY MONTH IN 2018, YOU MAY HAVE TO MAKE A PAYMENT WHEN YOU FILE YOUR TAX RETURN UNLESS YOU QUALIFY FOR AN EXEMPTION FROM THE REQUIREMENT THAT YOU HAVE HEALTH COVERAGE FOR THAT MONTH.; and

    (3) With respect to policies having a coverage start date on or after January 1, 2019, displays prominently in the contract and in any application materials provided in connection with enrollment in such coverage in at least 14 point type the following:

    THIS COVERAGE IS NOT REQUIRED TO COMPLY WITH FEDERAL REQUIREMENTS FOR HEALTH INSURANCE, PRINCIPALLY THOSE CONTAINED IN THE AFFORDABLE CARE ACT. BE SURE TO CHECK YOUR POLICY CAREFULLY TO MAKE SURE YOU UNDERSTAND WHAT THE POLICY DOES AND DOESN'T COVER. IF THIS COVERAGE EXPIRES OR YOU LOSE ELIGIBILITY FOR THIS COVERAGE, YOU MIGHT HAVE TO WAIT UNTIL AN OPEN ENROLLMENT PERIOD TO GET OTHER HEALTH INSURANCE COVERAGE.
    6. Section 2590.736 is amended by revising the last sentence to read as follows:
    § 2590.736 Applicability dates.

    * * * Notwithstanding the previous sentence, the definition of “short-term, limited-duration insurance” in § 2590.701-2 applies [DATE 60 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER].

    DEPARTMENT OF HEALTH AND HUMAN SERVICES

    For the reasons stated in the preamble, the Department of Health and Human Services proposes to amend 45 CFR parts 144, 146, and 148 as set forth below:

    PART 144—REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE 7. The authority citation for part 144 continues to read as follows: Authority:

    Secs. 2701 through 2763, 2791, and 2792 of the Public Health Service Act, 42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92.

    8. Section 144.103 is amended by revising the definition of “Short-term, limited-duration insurance” to read as follows:
    § 144.103 Definitions.

    Short-term, limited-duration insurance means health insurance coverage provided pursuant to a contract with an issuer that:

    (1) Has an expiration date specified in the contract (taking into account any extensions that may be elected by the policyholder without the issuer's consent) that is less than 12 months after the original effective date of the contract;

    (2) With respect to policies having a coverage start date before January 1, 2019, displays prominently in the contract and in any application materials provided in connection with enrollment in such coverage in at least 14 point type the following:

    THIS COVERAGE IS NOT REQUIRED TO COMPLY WITH FEDERAL REQUIREMENTS FOR HEALTH INSURANCE, PRINCIPALLY THOSE CONTAINED IN THE AFFORDABLE CARE ACT. BE SURE TO CHECK YOUR POLICY CAREFULLY TO MAKE SURE YOU UNDERSTAND WHAT THE POLICY DOES AND DOESN'T COVER. IF THIS COVERAGE EXPIRES OR YOU LOSE ELIGIBILITY FOR THIS COVERAGE, YOU MIGHT HAVE TO WAIT UNTIL AN OPEN ENROLLMENT PERIOD TO GET OTHER HEALTH INSURANCE COVERAGE. ALSO, THIS COVERAGE IS NOT “MINIMUM ESSENTIAL COVERAGE”. IF YOU DON'T HAVE MINIMUM ESSENTIAL COVERAGE FOR ANY MONTH IN 2018, YOU MAY HAVE TO MAKE A PAYMENT WHEN YOU FILE YOUR TAX RETURN UNLESS YOU QUALIFY FOR AN EXEMPTION FROM THE REQUIREMENT THAT YOU HAVE HEALTH COVERAGE FOR THAT MONTH.; and

    (3) With respect to policies having a coverage start date on or after January 1, 2019, displays prominently in the contract and in any application materials provided in connection with enrollment in such coverage in at least 14 point type the following:

    THIS COVERAGE IS NOT REQUIRED TO COMPLY WITH FEDERAL REQUIREMENTS FOR HEALTH INSURANCE, PRINCIPALLY THOSE CONTAINED IN THE AFFORDABLE CARE ACT. BE SURE TO CHECK YOUR POLICY CAREFULLY TO MAKE SURE YOU UNDERSTAND WHAT THE POLICY DOES AND DOESN'T COVER. IF THIS COVERAGE EXPIRES OR YOU LOSE ELIGIBILITY FOR THIS COVERAGE, YOU MIGHT HAVE TO WAIT UNTIL AN OPEN ENROLLMENT PERIOD TO GET OTHER HEALTH INSURANCE COVERAGE.
    PART 146—REQUIREMENTS FOR THE GROUP HEALTH INSURANCE MARKET 9. The authority citation for part 146 is revised to read as follows: Authority:

    Secs. 2702 through 2705, 2711 through 2723, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg-1 through 300gg-5, 300gg-11 through 300gg-23, 300gg-91, and 300gg-92).

    10. Section 146.125 is amended by revising the last sentence to read as follows.
    § 146.125 Applicability dates.

    * * * Notwithstanding the previous sentence, the definition of “short-term, limited-duration insurance” in § 144.103 of this subchapter applies [DATE 60 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER].

    PART 148—REQUIREMENTS FOR THE INDIVIDUAL HEALTH INSURANCE MARKET 11. The authority citation for part 148 continues to read as follows: Authority:

    Secs. 2701 through 2763, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92), as amended.

    12. Section 148.102 is amended by revising the section heading and the last sentence of paragraph (b) to read as follows:
    § 148.102 Scope and applicability date.

    (b) * * * Notwithstanding the previous sentence, the definition of “short-term, limited-duration insurance” in § 144.103 of this subchapter is applicable [DATE 60 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER].

    [FR Doc. 2018-03208 Filed 2-20-18; 8:45 am] BILLING CODE 4150-28-P; 4510-29-P; 6325-64-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 RIN 0648-BG83 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Amendment 36A AGENCY:

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

    ACTION:

    Notification of availability; request for comments.

    SUMMARY:

    The Gulf of Mexico (Gulf) Fishery Management Council (Council) has submitted Amendment 36A to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (Reef Fish FMP) for review, approval, and implementation by NMFS. Amendment 36A would require owners or operators of federally permitted commercial Gulf reef fish vessels landing any commercially caught, federally managed reef fish from the Gulf to provide notification prior to landing and to land at approved locations; require shares of red snapper individual fishing quota (IFQ) (RS-IFQ) program and groupers and tilefishes IFQ (GT-IFQ) program from non-activated accounts to be returned to NMFS for redistribution; and allow NMFS to hold back a portion of IFQ allocation at the start of the fishing year in anticipation of a commercial quota reduction. The purpose of Amendment 36A is to improve compliance and increase management flexibility in the RS-IFQ and GT-IFQ programs, and increase the likelihood of achieving optimum yield (OY) for reef fish stocks managed under these programs.

    DATES:

    Written comments on Amendment 36A must be received by April 23, 2018.

    ADDRESSES:

    You may submit comments on the amendment identified by “NOAA-NMFS-2017-0060” by either of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0060, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Peter Hood, NMFS Southeast Regional Office, 263 13th Avenue South, St. Petersburg, FL 33701.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    Electronic copies of Amendment 36A may be obtained from www.regulations.gov or the Southeast Regional Office website at http://sero.nmfs.noaa.gov/sustainable_fisheries/gulf_fisheries/reef_fish/2017/A36A_comm_IFQ/am36Aindex.html. Amendment 36A includes an environmental assessment, fishery impact statement, regulatory impact review, and Regulatory Flexibility Act analysis.

    FOR FURTHER INFORMATION CONTACT:

    Peter Hood, NMFS Southeast Regional Office, telephone: 727-824-5305, or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) requires each regional fishery management council to submit any FMP or amendment to NMFS for review and approval, partial approval, or disapproval. The Magnuson-Stevens Act also requires that NMFS, upon receiving a plan or amendment, publish an announcement in the Federal Register notifying the public that the FMP or amendment is available for review and comment.

    Amendment 36A to the Reef Fish FMP was prepared by the Council and, if approved, would be implemented by NMFS through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Act.

    Background

    There are two commercial IFQ programs in the Gulf. Amendment 26 to the Reef Fish FMP established the RS-IFQ program, and Amendment 29 to the Reef Fish FMP established the GT-IFQ program. The RS-IFQ program manages commercial harvest of red snapper and was implemented on January 1, 2007 (71 FR 67447, November 22, 2006). The GT-IFQ program manages commercial harvest of multiple species of groupers and tilefishes, and was implemented on January 1, 2010 (74 FR 44732, August 31, 2009). Both IFQ programs share a single Web-based accounting and reporting system.

    The Council began the development of Amendment 36 to the Reef Fish FMP in response to a 5-year review of the RS-IFQ Program completed in 2013. This review evaluated the progress of the RS-IFQ program towards achieving the stated goals of reducing overcapacity in the fishery and eliminating problems associated with race-to-fish (derby) fishing. The Council also received input on the program from some of their advisory panels as well as from the public. As a result, the suggested modifications to the RS-IFQ program became complex, and the Council split the numerous potential actions into two FMP amendments, Amendments 36A and 36B. The scope of the actions was also expanded to include revisions to the GT-IFQ program because management, as well as the goals and objectives, of this program are similar to the RS-IFQ program. Amendment 36A addresses compliance and program flexibility issues, while Amendment 36B addresses program participation and the distribution of IFQ shares and allocation in the programs.

    Actions Contained in Amendment 36A

    Amendment 36A includes actions to expand the requirement for vessels with a commercial Gulf reef fish permit to notify NMFS in advance of landing any reef fish species not managed under the IFQ programs and to land at approved locations, and addresses IFQ shares held in shareholder accounts that have not been activated, since the current Web-based system was put in place on January 1, 2010. Amendment 36A would return shares held in non-activated accounts to NMFS for future redistribution. In addition, Amendment 36A provides NMFS the authority to withhold annual allocation before distribution at the beginning of a year in which a commercial quota reduction is expected to occur.

    Landing Notification

    Currently, to improve compliance with the IFQ programs, vessel owners or operators with commercial Gulf reef fish permits are required to notify NMFS between 3 and 24 hours in advance of landing any commercially harvested reef fish species managed under the IFQ programs (IFQ species). In addition, vessels must land IFQ species at an approved landing location. Although the advance landing notifications help with the enforcement of the IFQ programs, one of the conclusions from a 5-year review of the RS-IFQ Program was additional enforcement efforts may be necessary to deter IFQ landing violations.

    Amendment 36A would expand the requirement for an advance landing notification to all commercial trips that land Gulf reef fish species or Florida Keys/East Florida hogfish harvested in the Gulf even if no IFQ species are on board. Note that the single hogfish stock in the Gulf was recently split into a West Florida stock and a Florida Keys/East Florida stock, separated at 25°09′ N lat. in Gulf Federal waters off the west coast of Florida (82 FR 34574 and 82 FR 34584, July 25, 2017). The management measures for the Florida Keys/East Florida stock are developed by the South Atlantic Fishery Management Council, but commercial vessels fishing for this stock in Gulf Federal waters are required to have a Federal commercial permit for Gulf reef fish and are required to follow the reporting requirements associated with this permit.

    The vessel owner or operator would notify NMFS at least 3 hours, but no more than 24 hours, in advance of landing on each trip. Amendment 36A would also require owners and operators on such trips to land at approved landing locations. Requiring notification in advance of landing any federally managed reef fish from the Gulf and requiring landings at approved locations is expected to help deter fishermen from illegally landing IFQ species or reporting IFQ species as another species (e.g., red snapper reported as vermilion snapper), because law enforcement and port agents would be informed in advance of all reef fish trips returning to port and can meet vessels to inspect landings. If any IFQ species are to be landed, all regulations under the applicable IFQ program must be followed, including the more extensive advance notice of landing. Only one IFQ landing notification covering both IFQ and non-IFQ Gulf reef fish species or Florida Keys/East Florida hogfish harvested in the Gulf would be required on such a trip.

    Non-Activated IFQ Shareholder Accounts

    Amendment 36A also addresses RS-IFQ and GT-IFQ shareholder accounts that received shares through the initial apportionment when each IFQ program began, but the accounts have never been accessed by the shareholder since January 1, 2010, the initiation of the current IFQ system. NMFS and the Council have attempted to notify account holders with these non-activated IFQ accounts through phone calls, certified letters, and discussion at public meetings. Although shares in the non-activated accounts represent a small fraction of the total shares, annual allocation assigned to these non-activated IFQ accounts is not landed, and therefore, may prevent achieving OY if not made available for use. Amendment 36A would return RS-IFQ and GT-IFQ shares in these non-activated accounts to NMFS for redistribution. The Council intends to redistribute these shares to IFQ program participants through a mechanism determined in Amendment 36B.

    Allocation

    Amendment 36A also addresses how to distribute allocation to IFQ shareholders in a fishing year where there is an anticipated reduction of the commercial quota. Under the IFQ programs, annual allocation is distributed to IFQ shareholders on January 1, and most IFQ program participants begin to use or transfer their allocation early in the fishing year. After shareholders begin transferring or landing allocation, NMFS cannot retroactively withdraw allocation from shareholder accounts if a quota decrease became effective after the beginning of the fishing year. Amendment 36A would allow NMFS to anticipate a decrease in the quota of any IFQ species or multi-species share categories after the start of a fishing year and withhold distribution of quota equal to the amount of the expected decrease in commercial quota. NMFS would distribute the remaining portion of the annual allocation to shareholders on January 1. If the rulemaking associated with the commercial quota reduction is not effective by June 1 in the same fishing year, then NMFS would distribute the withheld quota back to the current shareholders.

    Proposed Rule for Amendment 36A

    A proposed rule that would implement Amendment 36A has been drafted. In accordance with the Magnuson-Stevens Act, NMFS is evaluating the proposed rule to determine whether it is consistent with the Reef Fish FMP, the Magnuson-Stevens Act, and other applicable laws. If that determination is affirmative, NMFS will publish the proposed rule in the Federal Register for public review and comment.

    Consideration of Public Comments

    The Council has submitted Amendment 36A for Secretarial review, approval, and implementation. Comments on Amendment 36A must be received by April 23, 2018. Comments received during the respective comment periods, whether specifically directed to Amendment 36A or the proposed rule, will be considered by NMFS in its decision to approve, partially approve, or disapprove Amendment 36A. Comments received after the comment periods will not be considered by NMFS in this decision. All comments received by NMFS on Amendment 36A or the proposed rule during their respective comment periods will be addressed in the final rule.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: February 15, 2018. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-03463 Filed 2-20-18; 8:45 am] BILLING CODE 3510-22-P
    83 35 Wednesday, February 21, 2018 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request February 15, 2018.

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

    Comments regarding this information collection received by March 23, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW, Washington, DC 20502. 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. Copies of the submission(s) may be obtained by calling (202) 720-8958.

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

    Animal Plant and Health Inspection Service

    Title: Self Certification Medical Statement.

    OMB Control Number: 0579-0196.

    Summary of Collection: The United States Department of Agriculture is responsible for ensuring consumers that food and farm products are moved from producer to consumer in the most efficient, dependable, economical, and equitable system possible. Each year, the United States Department of Agriculture's Marketing and Regulatory Programs (MRP) agency hires individuals for commodity grading and inspection positions to ensure this process is efficient and effective. These positions often involve arduous conditions and require direct contact with meat, dairy, fresh or processed fruits and vegetables, and poultry intended for human consumption; and cotton and tobacco products intended for consumer use. 5 CFR part 339 authorizes an agency to request medical information from an applicant that may assist management with employment decisions concerning covered positions that have specific medical or physical fitness requirements. APHIS will collect the applicant's medical information using MRP Form 5 (Self-Certification Medical Statement).

    Need and Use of the Information: The information collected from prospective employees assists MRP officials, administrative personnel, and servicing Human Resources Offices in determining an applicant's physical fitness and suitability for employment in positions with approved medical standards and physical requirements. If the information was not collected, APHIS would not be able to accurately determine the applicant's fitness to safely perform the duties of the covered positions.

    Description of Respondents: Individuals or households.

    Number of Respondents: 606.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 102.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2018-03522 Filed 2-20-18; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2018-0002] Codex Alimentarius Commission: Codex Committee on Pesticide Residues (CCPR) AGENCY:

    Office of the Deputy Under Secretary for Food Safety, USDA.

    ACTION:

    Notice of public meeting and request for comments.

    SUMMARY:

    The Office of the Deputy Under Secretary for Food Safety, U.S. Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS), and the U.S. Environmental Protection Agency (EPA) are sponsoring a public meeting on March 15, 2018. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 50th Session of the Codex Committee on Pesticide Residues (CCPR) of the Codex Alimentarius Commission (Codex), taking place in Haikou, China between April 9 and 14, 2018. The Acting Deputy Under Secretary for Food Safety and the EPA recognize the importance of providing interested parties the opportunity to obtain background information on the 50th Session of the CCPR and to address items on the agenda.

    DATES:

    The public meeting is scheduled for Thursday, March 15, 2018, 1:00 p.m.-4:00 p.m.

    ADDRESSES:

    The public meeting will take place at the EPA, Room PYS-4350, One Potomac Yard South, 2777 South Crystal Drive, Arlington, VA 22202.

    Documents related to the 50th Session of the CCPR are accessible via the internet at the following address: http://www.fao.org/fao-who-codexalimentarius/meetings/en/.

    Captain David Miller, U.S. Delegate to the 50th Session of the CCPR, and the USDA invite interested U.S. parties to submit their comments electronically to the following email address: [email protected].

    Call-In-Number

    If you wish to participate in the public meeting for the 50th Session of the CCPR by conference call, please use the call-in-number and participant code listed below:

    Call-in-Number: 1-888-844-9904 Participant Code: 5126092

    For Further Information About the 50th Session of the CCPR Contact: Captain David Miller, Chief, Chemistry & Exposure Branch and Acting Chief, Toxicology & Epidemiology Branch, Health Effects Division, Ariel Rios Building, 1200 Pennsylvania Avenue NW, Washington, DC 20460. Telephone: (703) 305-5352, Fax: (703) 305-5147, Email: [email protected]

    For Further Information About the Public Meeting Contact: Marie Maratos, U.S. Codex Office, 1400 Independence Avenue SW, South Agriculture Building, Room 4861, Washington, DC 20250. Telephone: (202) 205-7760, Fax: (202) 720-3157, Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization and the World Health Organization (FAO/WHO). Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices are used in trade.

    The CCPR is responsible for establishing maximum limits for pesticide residues in specific food items or in groups of food; establishing maximum limits for pesticide residues in certain animal feeding stuffs moving in international trade where this is justified for reasons of protection of human health; preparing priority lists of pesticides for evaluation by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR); considering methods of sampling and analysis for the determination of pesticide residues in food and feed; considering other matters in relation to the safety of food and feed containing pesticide residues; and establishing maximum limits for environmental and industrial contaminants showing chemical or other similarity to pesticides, in specific food items or groups of food.

    The CCPR is hosted by China. The U.S. attends this committee as a member country of the Codex Alimentarius.

    Issues To Be Discussed at the Public Meeting

    The following items on the Agenda for the 50th Session of the CCPR will be discussed during the public meeting:

    • Proposed draft and draft revision of the Classification of Food and Feed for selected commodity groups (including seeds for beverages and sweets);

    • Proposed draft tables on examples of representative commodities (including seeds for beverages and sweets);

    • Electronic Working Group Outcomes on the Proposed New Work on the Possible Revision of the International Estimated Short-Term Intake (IESTI) equations;

    • Establishment of Codex Schedules and Priority Lists of Pesticides for evaluation by JMPR;

    • Electronic Working Group Outcomes on the possible establishment of a Codex database of national registration of pesticides; and

    • Other Business and Future Work.

    Each issue listed will be fully described in documents distributed, or to be distributed, by the Secretariat before to the Meeting. Members of the public may access or request copies of these documents (see ADDRESSES).

    Public Meeting

    At the March 15, 2018, public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to Captain David Miller, U.S. Delegate for the 50th Session of the CCPR (see ADDRESSES). Written comments should state that they relate to activities of the 50th Session of the CCPR.

    Additional Public Notification

    Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS web page located at: http://www.fsis.usda.gov/federal-register.

    FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Update is available on the FSIS web page. Through the web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

    USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.

    How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative.

    Send your completed complaint form or letter to USDA by mail, fax, or email:

    Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410, Fax: (202) 690-7442, Email: [email protected].

    Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

    Done at Washington, DC, on February 14, 2018. Marie Maratos, Acting U.S. Manager for Codex Alimentarius.
    [FR Doc. 2018-03465 Filed 2-20-18; 8:45 am] BILLING CODE 3410-DM-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-12-2018] Foreign-Trade Zone 135—Palm Beach, Florida; Application for Reorganization and Expansion Under Alternative Site Framework

    An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Port of Palm Beach District, grantee of FTZ 135, requesting authority to reorganize and expand 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 9, 2018.

    FTZ 135 was approved by the FTZ Board on March 16, 1987 (Board Order 348, 52 FR 9903, March 27, 1987) and expanded on November 8, 2002 (Board Order 1258, 67 FR 70046, November 20, 2002). The current zone includes the following sites: Site 1 (25 acres)—Located at Port of Beach Miami Terminal, 1 mile from the Lake Worth Inlet to the Atlantic Ocean, Riviera Beach; Site 2 (37 acres)—industrial site located 2 miles due west of the terminal at I-95 and Highway 710, Riviera Beach; Site 3 (11 acres)—TravelPro USA, 700 Banyan Trail, Boca Raton; Site 4 (66 acres)—Martin County Airport, 1801 SE Airport Road, Stuart; Site 5 (24 acres total, three parcels)—Palm Beach International Airport, 1300 N. Perimeter Road, West Palm Beach; Site 6 (286 acres, three parcels)—North Beach County Airport, located adjacent to Beeline Highway (SR 710), North Palm Beach; Site 7 (3.56 acres, 155,000 sq. ft.)—warehouse, 1440 West Indiantown Road, Jupiter; Site 8 (170 acres)—within the Palm Beach Park of Commerce, located on the Beeline Highway (SR 710) near Pratt Whitney Road, south of Indiantown Road, Palm Beach; Site 9 (1.44 acres)—Team International Corporation, 6643 42nd Terrace, Riviera Beach; Site 10 (11.63 acres)—Viking Sport Cruisers, Inc., Palm Harbor Marina, 400 North Flagler Drive, West Palm Beach; Site 11 (31.56 acres)—Rybovich, 4200 North Flagler Drive, West Palm Beach; and Site 12 (1.66 acres)—Berth One International, 1 East 11th Street, Riviera Beach. Sites 9 through 12 were designated through minor boundary modifications pending the grantee's submission of its application to reorganize and expand the zone (including Sites 9 through 12) under the ASF.

    The grantee's proposed service area under the ASF would be Palm Beach County, Martin County and St. Lucie County (with the exception of Sites 1 through 4 of FTZ 218, which are located in St. Lucie County), 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 West Palm Beach Customs and Border Protection port of entry.

    The applicant is requesting authority to reorganize its existing zone to include Sites 1, 4, 5, 6 and 8 as “magnet” sites and Sites 2, 3, 7, 9, 10, 11 and 12 as “usage-driven” sites. 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.

    In accordance with the FTZ Board's regulations, Qahira El-Amin 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 23, 2018. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to May 7, 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 Qahira El-Amin at [email protected] or (202) 482-5928.

    Dated: February 14, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-03517 Filed 2-20-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security Proposed Information Collection; Comment Request; Request for Investigation Under Section 232 of the Trade Expansion Act AGENCY:

    Bureau of Industry and Security, U.S. Department of 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 23, 2018.

    ADDRESSES:

    Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the internet at [email protected]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Mark Crace, BIS ICB Liaison, Regulatory Policy Division, (202) 482-8093 or at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    Upon request, BIS will initiate an investigation to determine the effects of imports of specific commodities on the national security, and within 270 days report to the President the findings and a recommendation for action or in-action. Within 90 days after receiving the report, the President shall determine whether to concur or not concur with the findings and recommendations. No later than 30 days after a decision, the determination will be published in the Federal Register and reported to Congress. The purpose of this collection is to account for the public burden associated with the surveys distributed to determine the effect of imports of specific commodities on the national security.

    II. Method of Collection

    Submitted electronically or in paper form.

    III. Data

    OMB Control Number: 0694-0120.

    Form Number(s): None.

    Type of Review: Regular submission.

    Affected Public: Business or other for-profit organizations.

    Estimated Number of Respondents: 800.

    Estimated Time per Response: 7.5 hours.

    Estimated Total Annual Burden Hours: 6,000.

    Estimated Total Annual Cost to Public: $0.

    Respondent's Obligation: Voluntary.

    Legal Authority: U.S. Code: 19 U.S.C. 1862.

    Name of Law: Trade Expansion Act of 1962.

    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. 2018-03523 Filed 2-20-18; 8:45 am] BILLING CODE 3510-07-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-412-824] Certain Cold-Rolled Steel Flat Products From the United Kingdom: Rescission of Antidumping Duty Administrative Review; 2016-2017 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 cold-rolled steel flat products from the United Kingdom (U.K.) for the period March 7, 2016, through August 31, 2017.

    DATES:

    Effective February 21, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Joshua Poole or Thomas Schauer, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1293 or (202) 482-0410, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On September 1, 2017, Commerce published a notice of opportunity to request an administrative review of the antidumping duty order on certain cold-rolled steel flat products (CR Steel) from the U.K. for the period of review (POR) March 7, 2016, through August 31, 2017.1 On October 2, 2017, the petitioners, AK Steel Corporation, Steel Dynamics Inc., ArcelorMittal USA LLC, Nucor Corporation, and United States Steel Corporation, requested an administrative review of the order with respect to Caparo Precision Strip, Ltd., and Liberty Performance Steels Ltd.2 On November 13, 2017, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.221(c)(1)(i), we initiated an administrative review of the order on CR Steel from the U.K. with respect to Caparo Precision Strip, Ltd., and Liberty Performance Steels Ltd.3 On February 6, 2018, the petitioners timely withdrew their request for an administrative review of Caparo Precision Strip, Ltd., and Liberty Performance Steels Ltd.4 No other party requested a review.

    1See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 82 FR 41595 (September 1, 2017).

    2See the petitioners' Letter, “Re: Cold-Rolled Steel Flat Products from the United Kingdom: Request for Administrative Review,” dated October 2, 2017.

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 82 FR 52268 (November 13, 2017) (Initiation Notice). In the Initiation Notice, Commerce stated that it had previously determined that Liberty Performance Steels Ltd. is the successor-in-interest to Caparo Precision Strip, Ltd. See Initiation Notice at footnote 5.

    4See the petitioners' Letter, “Re Cold-Rolled Steel Flat Products from the United Kingdom: Withdrawal of Request for Administrative Review,” dated February 6, 2018.

    Rescission of Review

    Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review “in whole or in part, if a party that requested a review withdraws the request within 90 days of the date of publication of notice of initiation of the requested review.” The petitioners withdrew their request for review within the 90-day time limit. Because we received no other requests for review of Caparo Precision Strip, Ltd., and Liberty Performance Steels Ltd., and no other requests for the review of the order on CR Steel from the U.K. with respect to other companies subject to the order, we are rescinding the administrative review of the order in full, in accordance with 19 CFR 351.213(d)(1).

    Assessment

    Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries of CR Steel products from the U.K. during the POR at rates equal to the cash deposit rate 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 publication of this notice in the Federal Register.

    Notification to Importers

    This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

    Notification Regarding Administrative Protective Order

    This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or 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.

    This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(d)(4).

    Dated: February 14, 2018. James Maeder, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2018-03516 Filed 2-20-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG029 Marine Mammals; File No. 21419 AGENCY:

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

    ACTION:

    Notice; receipt of application.

    SUMMARY:

    Notice is hereby given that Shannon Atkinson, Ph.D., University of Alaska Fairbanks, 17101 Point Lena Loop Road, Juneau, AK 99801 has applied in due form for a permit to import, export, and receive marine mammal parts for scientific research.

    DATES:

    Written, telefaxed, or email comments must be received on or before March 23, 2018.

    ADDRESSES:

    The application and related documents are available for review by selecting “Records Open for Public Comment” from the Features box on the Applications and Permits for Protected Species (APPS) home page, https://apps.nmfs.noaa.gov, and then selecting File No. 21419 from the list of available applications.

    These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to [email protected] Please include the File No. 21419 in the subject line of the email comment.

    Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on these applications would be appropriate.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Skidmore or Shasta McClenahan, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), and the Fur Seal Act of 1966, as amended (16 U.S.C. 1151 et seq.).

    The applicant proposes to receive, import, and export biological samples from pinnipeds and cetaceans annually for scientific research. Marine mammal parts will not exceed 1,000 animals per year within order Cetacea (dolphins, porpoises, and whales) and 1,000 animals per year within order Pinnipedia (seals and sea lions, excluding walrus) with unlimited samples per individual. Secondary to research, marine mammal parts may also be used for educational purposes. Import/export activities would occur worldwide. Sources of samples include U.S. subsistence harvests and stranded animals in foreign countries. Samples may also be obtained within the United States or abroad from animals held in captivity, authorized researchers or collections, and soft or hard parts that sloughed, excreted, or naturally discharged. No live animals would be harassed or taken, lethally or otherwise, under the requested permit. The requested duration of the permit is 5 years.

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    Concurrent with the publication of this notice in the Federal Register, NMFS is forwarding a copy of the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

    Dated: February 15, 2018. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-03540 Filed 2-20-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG032 Pacific Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of public meeting (webinar).

    SUMMARY:

    The Pacific Fishery Management Council's (Pacific Council) Ad hoc Community Advisory Board (CAB) will hold a one-day meeting in Rohnert Park, CA. The meeting is open to the public.

    DATES:

    The meeting will be held on Friday, March 9, 2018, from 1 p.m. until business for the day has been completed.

    ADDRESSES:

    The meeting will be held at the Oxford Suites Sonoma County, Redwood Ballroom, 67 Golf Course Drive West, Rohnert Park, CA 94928; telephone: (707) 584-0333.

    Council address: Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Jim Seger, Pacific Council; telephone: (503) 820-2416.

    SUPPLEMENTARY INFORMATION:

    The primary purpose of the CAB meeting is to continue to work on ranges of alternatives for modifying the trawl catch share program pursuant to the results from the catch share program review (alternatives for follow-on actions). The CAB may also comment on purpose and need statements, priorities, and other matters related to the Council's consideration of follow-on actions. The meeting will result in a report to be presented for Pacific Council consideration at the March 2018 Pacific Council meeting under Agenda Item H.6.

    Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (503) 820-2411 at least 10 business days prior to the meeting date.

    Dated: February 14, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-03435 Filed 2-20-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG039 Marine Mammals; File No. 21251 AGENCY:

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

    ACTION:

    Notice; receipt of application.

    SUMMARY:

    Notice is hereby given that Waikiki Aquarium, 2777 Kalakaua Avenue, Honolulu, HI 96815 (Dr. Andrew Rossiter, Responsible Party), has applied in due form for a permit to conduct research on and enhancement of captive Hawaiian monk seals.

    DATES:

    Written, telefaxed, or email comments must be received on or before March 23, 2018.

    ADDRESSES:

    The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page, https://apps.nmfs.noaa.gov, and then selecting File No. 21251 from the list of available applications.

    These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to [email protected] Please include the File No. 21251 in the subject line of the email comment.

    Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Skidmore or Sara Young, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

    The Waikiki Aquarium is requesting a 5-year permit to continue to maintain in captivity up to three male Hawaiian monk seals (Neomonachus schauinslandi) for research and enhancement purposes. The aquarium currently maintains two non-releasable seals. Research proposed includes continuation of a long-term diet study using voluntary behaviors to monitor changes in body mass. The Aquarium will continue its collaboration with the University of California Santa Cruz investigating underwater feeding behavior. The Aquarium will begin a new project with Dr. Christin Murphy of the Department of Defense and Woods Hole Oceanographic Institute studying ventral vibrissae. All activities will occur at the Waikiki Aquarium.

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    Concurrent with the publication of this notice in the Federal Register, NMFS is forwarding copies of the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

    Dated: February 15, 2018. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-03541 Filed 2-20-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Marine Mammals and Endangered Species AGENCY:

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

    ACTION:

    Notice; issuance of permits and permit modifications.

    SUMMARY:

    Notice is hereby given that permits or permit amendments have been issued to the following entities under the Marine Mammal Protection Act (MMPA) and the Endangered Species Act (ESA), as applicable.

    ADDRESSES:

    The permits and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    FOR FURTHER INFORMATION CONTACT:

    Carrie Hubard (File No. 20626), Shasta McClenahan (File No. 21431), Jennifer Skidmore (File No. 21315), and Amy Hapeman (File No. 18688); at (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    Notices were published in the Federal Register on the dates listed below that requests for a permit or permit modification had been submitted by the below-named applicants. To locate the Federal Register notice that announced our receipt of the application and a complete description of the research, go to www.federalregister.gov and search on the permit number provided in the table below.

    Permit No. RIN Applicant Previous Federal Register notice Permit or modification issuance date 18688-01 0648-XD505 NMFS Pacific Islands Regional Office (Responsible Party: Michael Tosatto), 1601 Kapiolani Boulevard, Suite 1110, Honolulu, HI 96814 0648-XD505; November 21, 2017 January 31, 2018. 20626 0648-XF734 James H.W. Hain, Ph.D., Box 721, Woods Hole, MA 02543 82 FR 51397; November 6, 2017 December 22, 2017. 21315 0648-XF746 Alaska Department of Fish and Game, (Responsible Party: Lori Quakenbush), 1300 College Road, Fairbanks, AK 99701 82 FR 48488; October 18, 2017 January 19, 2018. 21431 0648-XF787 Gregory Bossart, V.M.D., Ph.D., Georgia Aquarium, 225 Baker Street Northwest, Atlanta, GA 30313 82 FR 50121; October 30, 2017 January 19, 2018.

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), a final determination has been made that the activities proposed are categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    As required by the ESA, as applicable, issuance of these permit was based on a finding that such permits: (1) Were applied for in good faith; (2) will not operate to the disadvantage of such endangered species; and (3) are consistent with the purposes and policies set forth in Section 2 of the ESA.

    Authority:

    The requested permits have been issued under the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), as applicable.

    Dated: February 15, 2018. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-03509 Filed 2-20-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Socio-Economic Survey of Hired Captains and Crew in New England and Mid-Atlantic Commercial Fisheries AGENCY:

    National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

    DATES:

    Written comments must be submitted on or before April 23, 2018.

    ADDRESSES:

    Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the internet at [email protected]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Lisa L. Colburn, (401) 782-3252 or [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    This request is for a reinstatement with change of a previously approved collection.

    The NOAA Fisheries, Northeast Fisheries Science Center, Social Science Branch (SSB) seeks to conduct surveys to provide for the ongoing collection of social and economic data related to the fishing industry in the New England and Mid-Atlantic States. The purpose of this survey is to assess the current social and economic conditions of commercial fishing crews for which little is known. The proposed survey is as a follow-up to a baseline study conducted in 2011/2012. The intent of the proposed study is to assess how and why commercial crew working conditions may have changed since the initial 2011/2012 assessment. Data needed for this assessment support fishery performance measures developed by the SSB, which include information on financial viability, distributional outcomes, stewardship, governance, and well-being. Data to be collected include demographic information on crew, wage calculations systems, individual and community well-being, fishing practices, job satisfaction, job opportunities, and attitudes toward fisheries management. The National Environmental Policy Act (NEPA) and Magnuson-Stevens Conservation and Management Act (MSA) both contain requirements for considering the social and economic impacts of fishery management decisions. There is a need to understand how such fishery management policies and programs will affect the social and economic characteristics of those involved in the commercial fishing industry. To help meet these requirements of NEPA and MSA, the SSB will collect data on an ongoing basis to track how socio-economic characteristics of fisheries are changing over time and the impact of fishery management policies and programs implemented in New England and the Mid-Atlantic regions.

    II. Method of Collection

    This information will be collected though in-person intercept surveys.

    III. Data

    OMB Control Number: 0648-0636.

    Form Number(s): None.

    Type of Review: Regular submission (reinstatement with change of a previously approved collection).

    Affected Public: Individuals or households; Business or other for-profit organizations.

    Estimated Number of Respondents: 500.

    Estimated Time per Response: 20 minutes.

    Estimated Total Annual Burden Hours: 167.

    Estimated Total Annual Cost to Public: $0.

    IV. Request for Comments

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

    Dated: February 15, 2018. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2018-03542 Filed 2-20-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG031 Pacific Fishery Management Council; Public Meetings AGENCY:

    National Marine Fisheries Service, National Oceanic and Atmospheric Administration, Commerce.

    ACTION:

    Notice of public meetings.

    SUMMARY:

    The Pacific Fishery Management Council (Pacific Council) and its advisory entities will hold public meetings.

    DATES:

    The Pacific Council and its advisory entities will meet March 8-14, 2018. The Pacific Council meeting will begin on Friday, March 9, 2018 at 9 a.m. Pacific Standard Time (PST), reconvening at 8 a.m. each day through Wednesday, March 14, 2018. All meetings are open to the public, except a closed session will be held from 8 a.m. to 9 a.m., Friday, March 9 to address litigation and personnel matters. The Pacific Council will meet as late as necessary each day to complete its scheduled business.

    ADDRESSES:

    Meetings of the Pacific Council and its advisory entities will be held at the Doubletree by Hilton Sonoma Wine Country, One Doubletree Drive, Rohnert Park, CA; telephone: (707) 584-5466.

    Council address: Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220. Instructions for attending the meeting via live stream broadcast are given under SUPPLEMENTARY INFORMATION, below.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Chuck Tracy, Executive Director; telephone: (503) 820-2280 or (866) 806-7204 toll-free; or access the Pacific Council website, http://www.pcouncil.org for the current meeting location, proposed agenda, and meeting briefing materials.

    SUPPLEMENTARY INFORMATION:

    The March 9-14, 2018 meeting of the Pacific Council will be streamed live on the internet. The broadcasts begin initially at 9 a.m. PST Friday, March 9, 2018 and continue at 8 a.m. daily through Wednesday, March 14, 2018. Broadcasts end daily at 5 p.m. PST or when business for the day is complete. Only the audio portion and presentations displayed on the screen at the Pacific Council meeting will be broadcast. The audio portion is listen-only; you will be unable to speak to the Pacific Council via the broadcast. To access the meeting online, please use the following link: http://www.gotomeeting.com/online/webinar/join-webinar and enter the November Webinar ID, 530-089-227, and your email address. You can attend the webinar online using a computer, tablet, or smart phone, using the GoToMeeting application. It is recommended that you use a computer headset to listen to the meeting, but you may use your telephone for the audio-only portion of the meeting. The audio portion may be attended using a telephone by dialing the toll number 1-562-247-8321 (not a toll-free number), audio access code 240-052-611, and entering the audio pin shown after joining the webinar.

    The following items are on the Pacific Council agenda, but not necessarily in this order. Agenda items noted as “Final Action” refer to actions requiring the Council to transmit a proposed fishery management plan, proposed plan amendment, or proposed regulations to the U.S. Secretary of Commerce, under Sections 304 or 305 of the Magnuson-Stevens Fishery Conservation and Management Act. Additional detail on agenda items, Council action, advisory entity meeting times, and meeting rooms are described in Agenda Item A.4, Proposed Council Meeting Agenda, and will be in the advance March 2018 briefing materials and posted on the Pacific Council website at www.pcouncil.org no later than February 16, 2018.

    A. Call to Order 1. Opening Remarks 2. Roll Call 3. Executive Director's Report 4. Approve Agenda B. Open Comment Period 1. Comments on Non-Agenda Items C. Administrative Matters 1. Council Coordination Committee (CCC) Update 2. Marine Planning Update 3. National Marine Sanctuary Coordination Report 4. Legislative Matters 5. Approval of Council Meeting Record 6. Membership Appointments and Council Operating Procedures 7. Future Council Meeting Agenda and Workload Planning D. Habitat 1. Current Habitat Issues E. Salmon Management 1. National Marine Fisheries Service Report 2. Review of 2017 Fisheries and Summary of 2018 Stock Forecasts 3. Identification of Management Objectives and Preliminary Definition of 2018 Salmon Management Alternatives 4. Recommendations for 2018 Management Alternative Analysis 5. Further Council Direction for 2018 Management Alternatives 6. Adoption of 2018 Management Alternatives for Public Review 7. Appoint Salmon Hearings Officers F. Ecosystem 1. California Current Ecosystem and Integrated Ecosystem Assessment Report and Science Review Topics 2. Fishery Ecosystem Plan Climate and Communities Initiative Update 3. Sablefish Ecosystem Indicators: Management Strategy Evaluation G. Pacific Halibut Management 1. Annual International Pacific Halibut Commission Meeting Report 2. Incidental Catch Recommendations: Options for the Salmon Troll and Final Recommendations for Fixed Gear Sablefish Fisheries—Final Action H. Groundfish Management 1. National Marine Fisheries Service Report 2. Trawl Catch Shares—Gear Switching and Trawl Sablefish Area Management 3. Implementation of the 2018 Pacific Whiting Fishery Under the U.S./Canada Agreement 4. Initial Stock Assessment Plan and Terms of Reference 5. Endangered Species Act Biological Opinion on the Take of Listed Salmon in Groundfish Fisheries 6. Trawl Catch Share—Final Range of Alternatives (ROA) for Follow-On Actions 7. Update on 2019-2020 Harvest Specifications and Management Measures 8. Final Inseason Management, Including Shorebased Carryover and Exempted Fishing Permits (EFPs)—Final Action I. Highly Migratory Species Management 1. National Marine Fisheries Service Report 2. Deep-Set Buoy Gear Authorization—Final Range of Alternatives/Preliminary Preferred Alternative 3. Proposed Deep-Set Buoy Gear Exempted Fishing Permits Advisory Body Agendas

    Advisory body agendas will include discussions of relevant issues that are on the Pacific Council agenda for this meeting, and may also include issues that may be relevant to future Council meetings. Proposed advisory body agendas for this meeting will be available on the Pacific Council website http://www.pcouncil.org/council-operations/council-meetings/current-briefing-book/ no later than Friday, February 16, 2018.

    Schedule of Ancillary Meetings Day 1—Thursday, March 8, 2018 Ecosystem Advisory Subpanel—8 a.m. Ecosystem Workgroup—8 a.m. Habitat Committee—8 a.m. Scientific and Statistical Committee—8 a.m. Legislative Committee—1 p.m. Tribal Policy Group—Ad Hoc Tribal and Washington Technical Group—Ad Hoc Day 2—Friday, March 9, 2018 California State Delegation—7 a.m. Oregon State Delegation—7 a.m. Washington State Delegation—7 a.m. Ecosystem Advisory Subpanel—8 a.m. Ecosystem Workgroup—8 a.m. Groundfish Management Team—8 a.m. Salmon Advisory Subpanel—8 a.m. Salmon Technical Team—8 a.m. Scientific and Statistical Committee—8 a.m. Ad Hoc Community Advisory Board (Offsite: Oxford Suites)—1 p.m. Enforcement Consultants—3 p.m. Tribal Policy Group—Ad Hoc Tribal and Washington Technical Group—Ad Hoc Day 3—Saturday, March 10, 2018 California State Delegation—7 a.m. Oregon State Delegation—7 a.m. Washington State Delegation—7 a.m. Groundfish Advisory Subpanel—8 a.m. Groundfish Management Team—8 a.m. Salmon Advisory Subpanel—8 a.m. Salmon Technical Team—8 a.m. Tribal Policy Group—Ad Hoc Tribal and Washington Technical Group—Ad Hoc Enforcement Consultants—Ad Hoc EFH/RCA Informational Meeting—7 p.m. Day 4—Sunday, March 11, 2018 California State Delegation—7 a.m. Oregon State Delegation—7 a.m. Washington State Delegation—7 a.m. Groundfish Advisory Subpanel—8 a.m. Groundfish Management Team—8 a.m. Highly Migratory Species Advisory Subpanel—8 a.m. Highly Migratory Species Management Team—8 a.m. Salmon Advisory Subpanel—8 a.m. Salmon Technical Team—8 a.m. Tribal Policy Group—Ad Hoc Tribal and Washington Technical Group—Ad Hoc Enforcement Consultants—Ad Hoc Day 5—Monday, March 12, 2018 California State Delegation—7 a.m. Oregon State Delegation—7 a.m. Washington State Delegation—7 a.m. Groundfish Advisory Subpanel—8 a.m. Groundfish Management Team—8 a.m. Highly Migratory Species Advisory Subpanel—8 a.m. Highly Migratory Species Management Team—8 a.m. Salmon Advisory Subpanel—8 a.m. Salmon Technical Team—8 a.m. Tribal Policy Group—Ad Hoc Tribal and Washington Technical Group—Ad Hoc Enforcement Consultants—Ad Hoc Day 6—Tuesday, March 13, 2018 California State Delegation—7a.m. Oregon State Delegation—7a.m. Washington State Delegation—7 a.m. Highly Migratory Species Advisory Subpanel—8 a.m. Highly Migratory Species Management Team—8 a.m. Salmon Advisory Subpanel—8 a.m. Salmon Technical Team—8 a.m. Tribal Policy Group—Ad Hoc Tribal and Washington Technical Group—Ad Hoc Enforcement Consultants—Ad Hoc Day 7—Wednesday, March 14, 2018 California State Delegation—7 a.m. Oregon State Delegation—7 a.m. Washington State Delegation—7 a.m. Salmon Technical Team—8 a.m. Tribal Policy Group—Ad Hoc Tribal and Washington Technical Group—Ad Hoc

    Although non-emergency issues not contained in this agenda may come before the Pacific Council for discussion, those issues may not be the subject of formal Council action during these meetings. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Pacific Council's intent to take final action to address the emergency.

    Special Accommodations

    These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2280, ext. 411 at least 10 business days prior to the meeting date.

    Dated: February 14, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-03436 Filed 2-20-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Office of the Secretary Charter Renewal of Department of Defense Federal Advisory Committees AGENCY:

    Department of Defense.

    ACTION:

    Renewal of Federal Advisory Committee.

    SUMMARY:

    The Department of Defense (DoD) is publishing this notice to announce that it is renewing the charter for the Department of Defense Advisory Committee on Women in the Services (“the Committee”).

    FOR FURTHER INFORMATION CONTACT:

    Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.

    SUPPLEMENTARY INFORMATION:

    The Committee's charter is being renewed 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). The Committee's charter and contact information for the Committee's Designated Federal Officer (DFO) can be found at http://www.facadatabase.gov/. The Committee provides the Secretary of Defense and the Deputy Secretary of Defense, through the Under Secretary of Defense for Personnel and Readiness, independent advice and recommendations on matters and policies relating to women in the Armed Forces of the United States.

    The Committee is composed of no more than 20 members who have experience with military or with women's workforce issues. All members of the Committee are appointed to provide advice on behalf of the Government on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Except for reimbursement of official Committee-related travel and per diem, Committee members serve without compensation.

    The public or interested organizations may submit written statements to the Committee membership about the Committee's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Committee. All written statements shall be submitted to the DFO for the Committee, and this individual will ensure that the written statements are provided to the membership for their consideration.

    Dated: February 15, 2018. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-03520 Filed 2-20-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Charter Establishment of Department of Defense Federal Advisory Committees AGENCY:

    Department of Defense.

    ACTION:

    Establishment of Federal Advisory Committee.

    SUMMARY:

    The Department of Defense (DoD) is publishing this notice to announce that it is establishing the charter for the Government-Industry Advisory Panel (“the Panel”).

    FOR FURTHER INFORMATION CONTACT:

    Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.

    SUPPLEMENTARY INFORMATION:

    This committee's charter is being established 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). The charter, once filed, along with contact information for the Panel's Designated Federal Officer (DFO) can be obtained at http://www.facadatabase.gov/. The Panel, previously established as a non-discretionary advisory committee, is being reestablished as a discretionary advisory committee due to the lapse in legislative authority so it can complete its work. The Panel shall provide to the Secretary of Defense and the Deputy Secretary of Defense, through the Under Secretary of Defense for Acquisition and Sustainment (USD(A&S)), a review of 10 U.S.C. 2320 and 2321, regarding rights in technical data and the validation of proprietary data restrictions and the regulations implementing such sections, for the purpose of ensuring that such statutory and regulatory requirements are best structured to serve the interests of the taxpayers and the national defense. The Panel shall develop recommendations for changes to 10 U.S.C. 2320 and 2321 and the regulations implementing such sections.

    Dated: February 15, 2018. Aaron Siegel, Alternate OSD Liaison Officer, Department of Defense.
    [FR Doc. 2018-03503 Filed 2-20-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Charter Renewal of Department of Defense Federal Advisory Committees AGENCY:

    Department of Defense.

    ACTION:

    Renewal of Federal Advisory Committee.

    SUMMARY:

    The Department of Defense (DoD) is publishing this notice to announce that it is renewing the charter for the Department of Defense Advisory Committee on Military Personnel Testing (“the Committee”).

    FOR FURTHER INFORMATION CONTACT:

    Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.

    SUPPLEMENTARY INFORMATION:

    The Committee's charter is being renewed 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). The Committee's charter and contact information for the Committee's Designated Federal Officer (DFO) can be found at http://www.facadatabase.gov/.

    The Committee provides the Secretary of Defense and the Deputy Secretary of Defense, through the Under Secretary of Defense for Personnel and Readiness, independent advice and recommendations on matters pertaining to military personnel testing for enlisted selection and classification.

    The Committee is composed of no more than seven members who are eminent authorities in the fields of educational and psychological testing. All members of the Committee are appointed to provide advice on behalf of the Government on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Except for reimbursement of official Committee-related travel and per diem, Committee members serve without compensation.

    The public or interested organizations may submit written statements to the Committee membership about the Committee's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Committee. All written statements shall be submitted to the DFO for the Committee, and this individual will ensure that the written statements are provided to the membership for their consideration.

    Dated: February 15, 2018. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-03497 Filed 2-20-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Defense Advisory Committee on Women in the Services; Notice of Federal Advisory Committee Meeting AGENCY:

    Under Secretary of Defense for Personnel and Readiness, Department of Defense (DoD).

    ACTION:

    Notice of Federal Advisory Committee meeting.

    SUMMARY:

    The Department of Defense (DoD) is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Advisory Committee on Women in the Services (DACOWITS) will take place.

    DATES:

    Day 1—Open to the public Tuesday, March 20, 2018 from 8:30 a.m. to 12:00 p.m. Day 2—Open to the public Wednesday, March 21, 2018 from 8:30 a.m. to 11:30 a.m.

    ADDRESSES:

    The address of the open meeting is the Hilton Alexandria-Mark Center, 5000 Seminary Road, Alexandria, VA 22311.

    FOR FURTHER INFORMATION CONTACT:

    Colonel Toya J. Davis, U.S. Army, (703) 697-2122 (Voice), 703-614-6233 (Facsimile), [email protected] (Email). Mailing address is 4800 Mark Center Drive, Suite 04J25-01, Alexandria, VA 22350. Website: http://dacowits.defense.gov. The most up-to-date changes to the meeting agenda can be found on the website.

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150.

    Purpose of the Meeting: The purpose of the meeting is for the Committee to receive briefings and updates relating to their current work. The meeting will open with the Designated Federal Officer (DFO) giving a status update on the Committee's requests for information. This will be followed with a briefing on Marketing Strategies. Then the Committee will have two panel discussions on the following topics: Healthy Unit Climate, and Women's Mental Health. The second day of the meeting will open with a panel discussion on Personal Protective Equipment/Gear for Women. This will be followed by an update briefing on Marine Corps Recruit Training. Day two will end with a public comment period.

    Agenda: Tuesday, March 20, 2018, from 8:30 a.m. to 12:00 p.m.—Welcome, Introductions, and Announcements; Request for Information Status Update; Briefing: Marketing Strategies; Panel Discussion: Healthy Unit Climate; Panel Discussion: Women's Mental Health; Public Dismissed. Wednesday, March 21, 2018, from 8:30 a.m. to 11:30 a.m.—Welcome and Announcements; Panel Discussion: Personal Protective Equipment/Gear for Women; Briefing: Marine Corps Recruit Training Update; Public Comment Period; Public Dismissed.

    Meeting Accessibility: Pursuant to 5 U.S.C. 552b, as amended, and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public, subject to the availability of space.

    Written Statements: Pursuant to 41 CFR 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, interested persons may submit a written statement for consideration by the DACOWITS. Individuals submitting a written statement must submit their statement to the point of contact listed at the address in FOR FURTHER INFORMATION CONTACT no later than 5:00 p.m., Monday, March 12, 2018. If a written statement is not received by Monday, March 12, 2018, prior to the meeting, which is the subject of this notice, then it may not be provided to or considered by the DACOWITS until its next open meeting. The DFO will review all timely submissions with the DACOWITS Chair and ensure they are provided to the members of the Committee. If members of the public are interested in making an oral statement, a written statement should be submitted. After reviewing the written comments, the Chair and the DFO will determine who of the requesting persons will be able to make an oral presentation of their issue during an open portion of this meeting or at a future meeting. Pursuant to 41 CFR 102-3.140(d), determination of who will be making an oral presentation is at the sole discretion of the Committee Chair and the DFO, and will depend on time available and if the topics are relevant to the Committee's activities. Five minutes will be allotted to persons desiring to make an oral presentation. Oral presentations by members of the public will be permitted only on Wednesday, March 21, 2018 from 11:00 a.m. to 11:30 a.m. in front of the full Committee. The number of oral presentations to be made will depend on the number of requests received from members of the public.

    Dated: February 15, 2018. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-03485 Filed 2-20-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Navy Notice of Availability of Government-Owned Inventions; Available for Licensing AGENCY:

    Department of the Navy, DoD.

    ACTION:

    Notice.

    SUMMARY:

    The Department of the Navy (DoN) announces the availability of the inventions listed below, assigned to the United States Government, as represented by the Secretary of the Navy, for domestic and foreign licensing by the Department of the Navy.

    ADDRESSES:

    Requests for copies of the patents cited should be directed to Naval Surface Warfare Center, Crane Div, Code OOL, Bldg 2, 300 Highway 361, Crane, IN 47522-5001.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Christopher Monsey, Naval Surface Warfare Center, Crane Div, Code OOL, Bldg 2, 300 Highway 361, Crane, IN 47522-5001, Email [email protected]

    SUPPLEMENTARY INFORMATION:

    The following patents are available for licensing: Patent No. 8,857,157 (Navy Case No. 200273): STAND-OFF CHARGE SYSTEM INCLUDING AN ATTACHMENT BRACKET AND RELATED METHODS//Patent No. 9,860,694 (Navy Case No. 200352): COMPUTING PLATFORM METHOD AND APPARATUS FOR TRANSMITTING DATA COMMUNICATION VIA RADIO ACCESS POINT//Patent No. 9,874,625 (Navy Case No. 102054): ELECTROMAGNETIC RADIATION SOURCE LOCATING SYSTEM//Patent No. 9,874,858 (Navy Case No. 103103): AUTOMATION CONTROL SYSTEM AND A METHOD IN AN AUTOMATION CONTROL SYSTEM//Patent No. 9,876,969 (Navy Case No. 200347): ELECTROMAGNETIC (EM) POWER DENSITY AND FIELD CHARACTERIZATION TECHNIQUE//and Patent No. 9,877,208 (Navy Case No. 200240): SYSTEM AND METHODS FOR UNOBTRUSIVELY AND RELOCATEABLY EXTENDING COMMUNICATION COVERAGE AND SUPPORTING UNMANNED AERIAL VEHICLE (UAV) ACTIVITIES.

    Authority:

    35 U.S.C. 207, 37 CFR part 404.

    Dated: February 13, 2018. E.K. Baldini, Lieutenant Commander, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer.
    [FR Doc. 2018-03442 Filed 2-20-18; 8:45 am] BILLING CODE 3810-FF-P
    DEPARTMENT OF EDUCATION [Docket ID ED-2017-OPE-0085] Request for Information on Evaluating Undue Hardship Claims in Adversary Actions Seeking Student Loan Discharge in Bankruptcy Proceedings AGENCY:

    Office of Postsecondary Education, U.S. Department of Education.

    ACTION:

    Request for information.

    SUMMARY:

    The U.S. Department of Education (Department) seeks to ensure that the congressional mandate to except student loans from bankruptcy discharge except in cases of undue hardship is appropriately implemented while also ensuring that borrowers for whom repayment of their student loans would be an undue hardship are not inadvertently discouraged from filing an adversary proceeding in their bankruptcy case. Accordingly, the Department is requesting public comment on factors to be considered in evaluating undue hardship claims asserted by student loan borrowers in adversary proceedings filed in bankruptcy cases, the weight to be given to such factors, whether the existence of two tests for evaluation of undue hardship claims results in inequities among borrowers seeking undue hardship discharge, and how all of these, and potentially additional, considerations should weigh into whether an undue hardship claim should be conceded by the loan holder.

    DATES:

    Responses must be received by May 22, 2018.

    ADDRESSES:

    Submit your comments through the Federal eRulemaking Portal or via U.S. mail, commercial delivery, or hand delivery. We will not accept comments by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID and the term “Evaluating Undue Hardship Claims in Bankruptcy” at the top of your comments.

    Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under the “Help” tab.

    U.S. Mail, Commercial Delivery, or Hand Delivery: If you mail or deliver your comments, address them to Jean-Didier Gaina, U.S. Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, Washington, DC 20202-6110. Though this Request for Information (RFI) is not regulatory in nature, the Department has elected to use the Federal eRulemaking Portal for submissions to ensure the process is transparent to all interested parties.

    Privacy Note:

    The Department's policy for comments received from members of the public (including comments submitted by mail, commercial delivery, or hand delivery) is to make these submissions available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available on the internet.

    Note:

    This RFI is issued solely for information and planning purposes and is not a request for proposal (RFP), a notice inviting applications (NIA), or a promise to issue an RFP or NIA. This RFI does not commit the Department to provide a response to any of the comments or take any action proposed in any comment. The Department will not pay for any information or administrative costs that you may incur in responding to this RFI. The documents and information submitted in response to this RFI become the property of the U.S. Government and will not be returned.

    FOR FURTHER INFORMATION CONTACT:

    Jean-Didier Gaina, U.S. Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, Washington, DC 20202-6110. Telephone: 202-453-7551.

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

    SUPPLEMENTARY INFORMATION:

    Background A. Statutory Authority

    The U.S. Bankruptcy Code, 11 U.S.C. 523(a)(8), currently provides that student loans can be discharged in bankruptcy only if excepting the debt from discharge would impose an “undue hardship” on the borrower and the borrower's dependents:

    Section 523 Exceptions to Discharge

    (a) A discharge under . . . this title does not discharge an individual debtor from any debt—

    (8) unless excepting such debt from discharge under this paragraph would impose an undue hardship on the debtor and the debtor's dependents, for—

    (A)(i) an educational benefit overpayment or loan made, insured, or guaranteed by a governmental unit, or made under any program funded in whole or in part by a governmental unit or nonprofit institution; or

    (ii) an obligation to repay funds received as an educational benefit, scholarship, or stipend; or

    (B) any other educational loan that is a qualified education loan, as defined in section 221(d)(1) of the Internal Revenue Code of 1986, incurred by a debtor who is an individual.

    11 U.S.C. 523(a)(8).

    Congress has amended the student loan bankruptcy discharge provision several times, tightening the restrictions on discharge with each amendment.

    B. “Undue Hardship” Case Law

    Congress has never defined the term “undue hardship” in the Bankruptcy Code and has not delegated to the Department the authority to do so. Federal courts have established the legal standard for a student loan debtor to prove “undue hardship” as authorized by Congress. In general, the courts have used one of two tests to analyze whether undue hardship is proven: The Brunner test (named after the case in which that test was first articulated, Brunner v. New York State Higher Educ. Serv. Corp., 831 F.2d 395 (2d Cir. 1987)) or the Totality of the Circumstances test (Long v. Educ. Credit Mgmt. Corp., 322 F.3d 549 (8th Cir. 2003).

    Under the Brunner test, the debtor must show that: (1) He or she cannot maintain, based on current income and expenses, a minimal standard of living for himself or herself and any dependents if forced to repay the loans; (2) additional circumstances exist indicating that this state of affairs is likely to persist for a significant portion of the repayment period of the student loans; and (3) he or she has made good faith efforts to repay the loans. Under the Totality of the Circumstances test, the court examines: (1) The debtor's past, present, and likely future financial resources; (2) his or her reasonably necessary living expenses; and (3) any other relevant facts and circumstances. Regardless of which test is used, the burden of proof is on the debtor to meet the standard and prove undue hardship.

    C. Regulatory Requirements: Direct 34 CFR 685.212(c), FFELP 34 CFR 682.402(i)(1) & Perkins 34 CFR 674.49(c)

    Department regulations currently require holders to evaluate each undue hardship claim to determine whether requiring repayment would constitute an undue hardship. If a holder determines that requiring repayment would impose an undue hardship, the holder must concede an undue hardship claim by the borrower in an adversary proceeding. The Department's current guidance to guarantors and educational institutions in defending bankruptcy proceedings is summarized in a July 7, 2015, Dear Colleague Letter (GEN-15-13 https://ifap.ed.gov/dpcletters/GEN1513.html) and provides for a two-step analysis when evaluating whether or not to object to a borrower's claim of undue hardship. The Department follows the same two-step analysis when defending bankruptcy proceedings for Direct loans. After receiving input from this notice, we will consider whether that analysis is still appropriate.

    Context for Responses and Information Requested: The undue hardship standard established under either test requires a variety of factors to be evaluated when determining whether repaying a debt will cause a debtor and his or her dependents an undue hardship, such as, but not limited to, the debtor's: Medical, work, or family history; history of mental illness; level of educational attainment; future employment prospects; payment history, including a borrower's willingness to avail himself or herself of all available repayment plans, including income-driven repayment plans; and necessary expenses in excess of ordinary unique to the debtor.

    The Assistant Secretary for Postsecondary Education invites the public, including individuals, advocacy groups, and professional organizations, as well as other State or Federal agencies or components, to provide comment on, and offer information regarding: (1) Factors to be considered in evaluating undue hardship claims; (2) weight to be given to any such factors; (3) whether the use of two tests results in inequities among borrowers; (4) circumstances under which loan holders should concede an undue hardship claim by the borrower; and (5) whether and how the 2015 Dear Colleague Letter should be amended. The Department will review the data collected to determine whether there is any need to modify how undue hardship claims by student loan borrowers in bankruptcy are evaluated.

    You may provide comments in any convenient format (i.e., bullet points, charts, graphs, paragraphs, etc.) and may also provide relevant information that is not responsive to a particular question but may nevertheless be helpful.

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

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

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

    Program Authority:

    20 U.S.C. 1082(a).

    Dated: February 15, 2018. Frank T. Brogan, Principal Deputy Assistant Secretary and Delegated the duties of the Assistant Secretary, Office of Planning, Evaluation and Policy Development, Delegated the duties of the Assistant Secretary, Office of Postsecondary Education.
    [FR Doc. 2018-03537 Filed 2-20-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2017-ICCD-0133] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Consolidated State Performance Report Part I and Part II AGENCY:

    Office of Elementary and Secondary Education (OESE), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 23, 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-0133. 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 216-42, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Sarah Newman, 202-453-6956.

    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: Consolidated State Performance Report Part I and Part II.

    OMB Control Number: 1810-0724.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 14,653.

    Total Estimated Number of Annual Burden Hours: 16,447.

    Abstract: The Consolidated State Performance Report (CSPR) is the required annual reporting tool for each State, the Bureau of Indian Education, District of Columbia, and Puerto Rico as authorized under Section 8303 of the Elementary and Secondary Education Act (ESEA), as amended by the Every Student Succeeds Act (ESSA). The CSPR collects data on programs authorized by:

    • Title I, Part A;

    • Title I, Part C;

    • Title I, Part D;

    • Title II, Part A;

    • Title III, Part A;

    • Title V, Part A;

    • Title V, Part B, Subparts 1 and 2; and

    • The McKinney-Vento Act.

    The information in this collection relate to the performance and monitoring activities of the aforementioned programs under ESSA and the McKinney-Vento Act. These data are needed for reporting on GPRA as well as other reporting requirements under ESSA. There are significant changes between this collection and the SY2016-17 collection. The SY2016-17 collection represented the reporting requirements under the No Child Left Behind Act while the SY2017-18 aligns with the reporting requirements of the Every Student Succeeds Act.

    Dated: February 15, 2018. Tomakie Washington, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-03521 Filed 2-20-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2018-ICCD-0018] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 2008/18 Baccalaureate and Beyond (B&B: 08/18) Full-Scale AGENCY:

    National Center for Education Statistics (NCES), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 23, 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-0018. 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 Kashka Kubzdela, 202-245-7377.

    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: 2008/18 Baccalaureate and Beyond (B&B: 08/18) Full-Scale.

    OMB Control Number: 1850-0729.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 15,336.

    Total Estimated Number of Annual Burden Hours: 7,202.

    Abstract: The Baccalaureate and Beyond Longitudinal Study (B&B), conducted by the National Center for Education Statistics (NCES), part of the U.S. Department of Education, examines students' education and work experiences after they complete a bachelor's degree, with a special emphasis on the experiences of K-12 school teachers. The B&B-eligible cohort is initially identified in the National Postsecondary Study Aid Study (NPSAS). The first cohort (B&B:93) was identified in NPSAS:93, and consisted of students who received their bachelor's degree in the 1992-93 academic year. The second cohort (B&B:2000) was selected from the NPSAS:2000, and the third cohort (B&B:08) was selected from NPSAS:2008, which became the base year for follow-up interviews in 2009 and 2012. The B&B:08/18 data collection will be the third and final follow-up for the third cohort of the B&B series (OMB# 1850-0729). The fourth cohort of baccalaureate recipients (B&B:16/17), identified in NPSAS:2016, entered full-scale data collection in 2017 (OMB# 1850-0926). The request to conduct the B&B:08/18 field test in 2017, which collected data from B&B:08 sample members after they were first surveyed 10 years earlier, was approved in May 2017 (OMB# 1850-0729 v.11-12). This request is to conduct the full-scale B&B:08/18 from July 2018 through March 2019.

    Dated: February 15, 2018. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-03519 Filed 2-20-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Basic Energy Sciences Advisory Committee AGENCY:

    Office of Science, Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Basic Energy Sciences Advisory Committee (BESAC). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

    DATES:

    Thursday, March 22, 2018 9:00 a.m. to 5:00 p.m.

    Friday, March 23, 2018 8:00 a.m. to 12:00 noon.

    ADDRESSES:

    DoubleTree by Hilton Hotel Bethesda—Washington, DC, 8120 Wisconsin Avenue, Bethesda, MD 20814.

    FOR FURTHER INFORMATION CONTACT:

    Katie Runkles; Office of Basic Energy Sciences; U.S. Department of Energy; Germantown Building, 1000 Independence Avenue SW, Washington, DC 20585; Telephone: (301) 903-6529.

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of this Board is to make recommendation to DOE-SC with respect to the basic energy sciences research program.

    Tentative Agenda:

    • Call to Order, Introductions, Review of the Agenda • News from the Office of Science • News from the Office of Basic Energy Sciences • Discussion of the BES 40th Report Preparation • Materials Sciences and Engineering Division COV meeting announcement • Public Comments • Adjourn Breaks Taken as Appropriate

    Public Participation: The meeting is open to the public. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of the items on the agenda, you should contact Katie Runkles at (301) 903-6594 (fax) or [email protected] (email). Reasonable provision will be made to include the scheduled oral statements on the agenda. The Chairperson of the Committee will conduct the meeting to facilitate the orderly conduct of business. Public comment will follow the 10-minute rule.

    Minutes: The minutes of this meeting will be available for public review and copying within 30 days at by contacting Ms. Runkles at the address or email above.

    Issued in Washington, DC on February 14, 2018. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2018-03483 Filed 2-20-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Notice of Intent To Prepare a Supplemental Environmental Impact Statement for Decommissioning and/or Long-Term Stewardship at the West Valley Demonstration Project and Western New York Nuclear Service Center, Notice of Floodplain and Wetlands Involvement, and Draft Scope AGENCY:

    New York State Energy Research and Development Authority, Department of Energy.

    ACTION:

    Notice of intent and draft scope.

    SUMMARY:

    The U.S. Department of Energy (DOE) and the New York State Energy Research and Development Authority (NYSERDA) announce their intent to jointly prepare a Supplemental Environmental Impact Statement for Decommissioning and/or Long-Term Stewardship at the West Valley Demonstration Project and Western New York Nuclear Service Center (DOE/EIS-0226-S1), hereinafter referred to as the Supplemental Environmental Impact Statement (SEIS) for the West Valley Site, and to conduct a public scoping process. The West Valley Site, for the purposes of this SEIS and associated documents, includes the DOE West Valley Demonstration Project (WVDP) or Project Premises, and the retained premises, which includes the Western New York Nuclear Service Center (WNYNSC), and the State-Licensed Disposal Area (SDA). In 2010, DOE and NYSERDA decided to implement the Phased Decision-making Alternative, which was the preferred alternative in the Final Environmental Impact Statement for Decommissioning and/or Long-Term Stewardship at the West Valley Demonstration Project and Western New York Nuclear Service Center (DOE/EIS-0226) (2010 Final EIS). With this Notice of intent and draft scope, DOE and NYSERDA are initiating the public scoping process for the SEIS and requesting comments to help define the environmental issues and the range of reasonable alternatives to be analyzed.

    DATES:

    DOE and NYSERDA are inviting public comments on the scope and content of the SEIS for the West Valley Site during a public scoping period starting with the date of publication of this Notice and ending on April 23, 2018. Comments must be submitted during this time period to ensure consideration; late comments will be considered to the extent practicable. DOE and NYSERDA will hold public scoping meetings on the SEIS in West Valley, NY (March 19, 2018), in Buffalo, NY (March 20, 2018), and in Irving, NY (March 21, 2018). Further information about the public scoping meetings is contained under SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    Written comments on the scope of the SEIS, requests to be placed on the SEIS mailing list, and requests for information may be submitted by U.S. mail to the DOE Document Manager, Mr. Martin Krentz, West Valley Demonstration Project, U.S. Department of Energy, 10282 Rock Springs Road, AC-DOE, West Valley, New York 14171-9799, by email to [email protected], or via the SEIS website at www.SEISWestValleySite.com. Before including your address, phone number, email address, or other personal identifying information in your comment, please be advised that your entire comment—including your personal identifying information—may be made publicly available. If you wish for DOE to withhold your name and/or other personally identifiable information, please state this prominently at the beginning of your comment. You may also submit comments anonymously. The “Public Reading Room” section under SUPPLEMENTARY INFORMATION lists the address of the reading room where documents referenced herein are available. Documents and information about the SEIS process are also available online at the SEIS website at www.SEISWestValleySite.com.

    FOR FURTHER INFORMATION CONTACT:

    For information regarding the West Valley Demonstration Project or the SEIS, contact Mr. Martin Krentz at the address given above; telephone: (716) 942-4007; or email: [email protected] For general information on DOE's NEPA process, contact Mr. Brian Costner (GC-54), Acting Director, Office of NEPA Policy and Compliance, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585; telephone: (202) 586-4600; facsimile: (202) 586-7031; or leave a message at 1-800-472-2756, toll-free. Questions for NYSERDA should be directed to Dr. Lee Gordon, New York State Energy Research and Development Authority, 9030-B Route 219, West Valley, New York 14171; telephone: (716) 942-9960, ext. 4963; facsimile: (716) 942-9961; or email: [email protected] Those seeking general information on the SEQRA process should contact Ms. Janice Dean, Deputy Counsel, New York State Energy Research and Development Authority, 17 Columbia Circle, Albany, New York 12203-6399; telephone: (518) 862-1090, ext. 3117; facsimile: (518) 862-1091; or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    In 2010, DOE and NYSERDA decided to implement the Phased Decision-making Alternative, which was the preferred alternative in the Final Environmental Impact Statement for Decommissioning and/or Long-Term Stewardship at the West Valley Demonstration Project and Western New York Nuclear Service Center (DOE/EIS-0226) (2010 Final EIS). The Phased Decision-making Alternative is described in the 2010 Final EIS, DOE's associated Record of Decision (ROD) (75 FR 20582; April 20, 2010), and NYSERDA's associated Findings Statement (May 12, 2010). During implementation of Phase 1 of the Phased Decision-making Alternative, which is ongoing, a number of highly contaminated facilities at the West Valley Site are being removed via decontamination and demolition and off-site disposal. The Phased Decision-making Alternative deferred decisions (known as Phase 2 decisions) on several facilities for 10 years (the expected time frame to complete Phase 1 decommissioning activities) while DOE and NYSERDA gather additional information and perform additional analyses (Phase 1 Studies) to foster inter-agency consensus and inform the decisions. DOE and NYSERDA intend to make Phase 2 decisions in 2022 on the disposition of the facilities and areas that would remain after completion of Phase 1 decommissioning. The remaining facilities include the Waste Tank Farm, U.S. Nuclear Regulatory Commission (NRC)-Licensed Disposal Area (NDA), non-source area of the North Plateau Groundwater Plume, Construction and Demolition Debris Landfill, Cesium Prong, contaminated stream sediments, balance of the WNYNSC property, and SDA.

    DOE and NYSERDA intend to jointly prepare an SEIS to inform Phase 2 decision-making for the West Valley Site. The SEIS process will be structured to meet DOE and NYSERDA's respective environmental review responsibilities under the National Environmental Policy Act (NEPA, 42 U.S.C. 4321 et seq.) and the New York State Environmental Quality Review Act (SEQRA, N.Y. Env. Conserv. Law § 8-0101 et seq.), the West Valley Demonstration Project Act of 1980 (Pub. L. 96-368) (WVDP Act), the Atomic Energy Act of 1954 (as amended) (AEA), and other applicable Federal and state requirements. The SEIS will be prepared in accordance with regulations of the Council on Environmental Quality for implementing NEPA (40 CFR parts 1500-1508), DOE's NEPA Implementing Procedures (10 CFR part 1021), and State of New York regulations for implementing SEQRA (6 NYCRR Part 617).

    The WNYNSC is a 1,351-hectare (3,338-acre) site located 48 kilometers (30 miles) south of Buffalo, NY, and owned by NYSERDA. In 1962, Nuclear Fuel Services, Inc. (“NFS”) entered into Agreements with the Atomic Energy Commission and New York State to construct the first commercial reprocessing plant of nuclear fuel in the United States. NFS, a private company, built and operated the fuel reprocessing plant and burial grounds, processing 640 metric tons of spent nuclear fuel at the WNYNSC from 1966 to 1972 under an Atomic Energy Commission license. Fuel reprocessing ended in 1972, when the plant was shut down for modifications. In 1976, in view of increased costs and regulatory requirements, NFS decided to exercise its contractual right to yield responsibility for the WNYNSC to the State of New York. NFS withdrew without removing any of the in-process nuclear wastes. NYSERDA now holds title to and manages the WNYNSC.

    In 1980, Congress passed the WVDP Act, Public Law 96-368. The WVDP Act requires DOE to demonstrate that the liquid high-level radioactive waste from reprocessing could be safely managed by solidifying it at the WNYNSC and transporting it to a Federal repository for permanent disposal. Specifically, Section 2(a) of the WVDP Act directs DOE to take the following actions:

    1. Solidify, in a form suitable for transportation and disposal, the high-level radioactive waste at the WNYNSC;

    2. Develop containers suitable for the high-level radioactive waste's permanent disposal;

    3. As soon as feasible, transport the solidified waste to a Federal repository for permanent disposal;

    4. Dispose of low-level radioactive waste and transuranic waste produced by the solidification of the high-level radioactive waste; and

    5. Decontaminate and decommission the tanks and other facilities used at the WNYNSC in which the high-level radioactive waste was solidified, the facilities used in the waste's solidification, and any material and hardware used in connection with the West Valley Demonstration Project.

    Pursuant to the WVDP Act, on October 1, 1980, DOE and NYSERDA entered into a Cooperative Agreement (amended September 18, 1981) that established a framework for the implementation of the WVDP. Under the agreement, NYSERDA has made available to DOE, without transfer of title, a 68-hectare (167-acre) area known as the Project Premises, which includes the formerly operated spent nuclear fuel reprocessing plant, spent nuclear fuel receiving and storage area, underground liquid high-level waste storage tanks, and a liquid low-level waste treatment facility with associated lagoons, as well as other facilities. Most of the facilities on the Project Premises were radioactively contaminated from reprocessing operations and are located on a geographic area known as the North Plateau. Among the other facilities located within the Project Premises is a radioactive waste disposal area known as the NRC-licensed disposal area (NDA). Adjacent to the Project Premises is a radioactive waste disposal area known as the State-Licensed Disposal Area (SDA), for which NYSERDA has operational responsibility. Both the NDA and SDA are located on a geographic area known as the South Plateau.

    In 1982, DOE assumed control, but not ownership, of the Project Premises to conduct the WVDP, as required under the WVDP Act. As part of the WVDP Act, NRC was charged with developing decommissioning criteria. In the “Decommissioning Criteria for the WVDP at the West Valley Site; Final Policy Statement” (NRC Policy Statement) (67 FR 5003; February 1, 2002), NRC prescribed the requirements for decommissioning the WVDP. NRC prescribed its License Termination Rule as the decommissioning goal for the WVDP and all NRC-licensed portions of the WNYNSC. The decommissioning criteria define the conditions that would allow the Project Premises to be used with specified restrictions or without restrictions on future use. If those conditions cannot be met, the NRC Policy Statement also defines the circumstances under which sections of the Project Premises could remain under long-term management or stewardship. NRC intends to use the SEIS to evaluate the environmental impacts of the various alternatives before deciding whether to accept the preferred alternative as meeting the criteria permitted by the License Termination Rule. NRC has placed the Technical Specifications of NYSERDA's license under the NRC regulations at Title 10 of the Code of Federal Regulations Part 50 in abeyance during DOE's fulfillment of its WVDP Act requirements.

    A 1987 Stipulation of Compromise between the Coalition on West Valley Nuclear Wastes and DOE specified that a closure environmental impact statement (EIS) be prepared that also addresses the disposal of those Class B and C low-level radioactive wastes generated as a result of DOE's activities at the WVDP. In 1990, DOE and NYSERDA entered into a supplemental agreement to prepare an EIS to address both the completion of the WVDP and closure or long-term management of the WNYNSC.

    After issuance of a draft EIS in 1996, DOE and NYSERDA in 2001 announced a revised EIS strategy. Under the revised strategy, DOE and NYSERDA, as co-lead preparers, issued a draft EIS in 2008 and, in 2010, issued the Final Environmental Impact Statement for Decommissioning and/or Long-Term Stewardship at the West Valley Demonstration Project and Western New York Nuclear Service Center (DOE/EIS-0226) (2010 FEIS). As described in DOE's 2010 ROD and NYSERDA's 2010 Findings Statement, DOE and NYSERDA decided to implement the Phased Decision-making Alternative based on information and analyses contained in the 2010 FEIS. During implementation of Phase 1 of the Phased Decision-making Alternative, which is ongoing, a number of highly contaminated facilities at the West Valley Site are being removed via decontamination and demolition and off-site disposal. The Phased Decision-making Alternative deferred decisions (known as Phase 2 decisions) on several facilities for up to 10 years (the expected time frame to complete Phase 1 decommissioning activities) while DOE and NYSERDA gather additional information and perform additional analyses (Phase 1 Studies) to foster interagency consensus and better inform the Phase 2 decisions. DOE and NYSERDA plan to make Phase 2 decisions in 2022 on the disposition of the facilities and areas that would remain after completion of Phase 1 decommissioning. The remaining facilities and areas include the Waste Tank Farm, NDA, non-source area of the North Plateau Groundwater Plume, Construction and Demolition Debris Landfill, Cesium Prong, contaminated stream sediments, balance of the WNYNSC property, and SDA.

    DOE and NYSERDA have determined that the preparation of an SEIS would further the purposes of NEPA by including new information and changes since issuance of the 2010 Final EIS, and is consistent with the commitment in the 2010 ROD and Findings Statement to providing robust and meaningful opportunities for public participation during decommissioning. Preparation of an SEIS for the West Valley Site would also further the purposes of SEQRA, the WVDP Act, the AEA, and other applicable Federal and state requirements. Phase 2 decisions will be informed by the Phase 1 and other scientific studies being performed at the West Valley Site, a long-term probabilistic performance assessment, and an SEIS that will incorporate the above analyses as part of the evaluation of the potential environmental impacts of the range of reasonable Phase 2 alternatives proposed for the West Valley Site. The SEIS will “tier” (40 CFR 1502.20) from the 2010 FEIS, and, where appropriate, information and analyses from the 2010 Final EIS will be summarized and incorporated by reference in the SEIS. The SEIS will contain new information and analyses to ensure its adequacy for Phase 2 decision-making.

    Following the 2010 FEIS, DOE and NYSERDA established a process for conducting scientific studies (the Phase 1 Studies) in order to facilitate interagency consensus to complete decommissioning of the remaining facilities. Subject-matter expert working groups were established and studies conducted on topics such as erosion modeling, the geomorphic history of the site, geologic material properties, site radiological inventory, and precedent waste exhumation projects/technologies. The new information produced by these Phase 1 Studies will inform the Phase 2 decisions.

    Additionally, in order to further evaluate and potentially reduce uncertainty in the long-term performance assessment, DOE and NYSERDA decided to perform a long-term probabilistic performance assessment (PPA) for the West Valley Site. The PPA model is currently being developed in the GoldSim probabilistic modeling platform and will be supported by several process-level models, including a surface water/sediment transport model, a three-dimensional groundwater flow model, and an erosion model. The PPA will be used to evaluate the range of alternatives in the SEIS. As such, the new information developed by the PPA and component models will inform the Phase 2 decisions.

    The Supplemental Environmental Impact Statement for the West Valley Site (DOE/EIS-0226-S1) (SEIS) will further the purposes of NEPA by incorporating the new information produced by the Phase 1 Studies, other scientific studies being performed at the West Valley Site, and the PPA as part of the evaluation of the potential environmental impacts of the Phase 2 alternatives.

    Purpose and Need for Agency Action

    DOE is required by the WVDP Act to decontaminate and decommission the tanks and facilities used in the solidification of the high-level waste, and any material and hardware used in connection with the WVDP, in accordance with such requirements as NRC may prescribe. NRC has prescribed its License Termination Rule as the decommissioning criteria for the WVDP. Therefore, DOE needs to determine the manner that facilities, materials, and hardware for which the Department is responsible are managed or decommissioned, in accordance with NRC's License Termination Rule and applicable Federal and state requirements. To this end, DOE needs to determine what, if any, material or structures for which it is responsible that were not addressed in Phase 1 (i.e., Phase 2 facilities) will remain on site, and what, if any, institutional controls, engineered barriers, or stewardship provisions would be needed. That is, DOE needs to determine what it needs to do to complete the WVDP and return the Project Premises to NYSERDA.

    NYSERDA needs to determine the manner that Phase 2 facilities and property for which NYSERDA is responsible, including the SDA, will be managed or decommissioned, in accordance with applicable Federal and state requirements. To this end, NYSERDA needs to determine what, if any, material or structures for which it is responsible will remain on site, and what, if any, institutional controls, engineered barriers, or stewardship provisions would be needed. It is NYSERDA's intent to pursue termination of the existing 10 CFR part 50 license for the WNYNSC upon DOE's completion of decontamination and decommissioning under the WVDP Act in accordance with criteria prescribed by NRC. NYSERDA plans to use the analysis of alternatives in the SEIS for the West Valley Site to support any necessary NRC or New York State Department of Environmental Conservation (NYSDEC) license or permit applications.

    Proposed Action

    The Proposed Action is the WVDP's completion and the decommissioning and/or long-term management or stewardship of the WNYNSC and SDA. This includes the decontamination and decommissioning of the facilities remaining at the West Valley Site after completion of Phase 1 decommissioning.

    Alternatives

    The SEIS will examine the range of reasonable Phase 2 alternatives (i.e., the alternatives that meet DOE's and NYSERDA's respective purpose and need for action) and their potential environmental impacts. The SEIS will also analyze the No Action Alternative, as required by NEPA and SEQRA.

    As specified in NRC's Final Policy Statement, DOE and NYSERDA intend to use NRC's License Termination Rule as the framework to evaluate alternatives for decommissioning and/or long-term stewardship actions involving West Valley Site facilities.

    The range of reasonable alternatives encompasses those involving release of West Valley Site facilities and areas for re-use under unrestricted and restricted conditions as allowed under the License Termination Rule. Accordingly, the SEIS will evaluate whether the alternatives would meet the NRC decommissioning criteria and other applicable requirements. This evaluation will include analysis of the long-term radiological dose impacts of the Phase 2 alternatives for the facilities and areas on the West Valley Site. DOE and NYSERDA will consider this information as it is being developed in determining details of the alternatives to be analyzed in the SEIS. This process for alternatives development will help ensure that the range of alternatives is adequate and provides a sound basis for informed decision-making.

    Specific action alternatives proposed for analysis in the SEIS include the Sitewide Close-in-Place Alternative and the Sitewide Removal Alternative (described below). Conceptually, these alternatives represent the ends of the spectrum of action alternatives from the perspective of onsite and offsite management of facilities and contaminants, and the associated amount of area for which unrestricted versus restricted future land use would be appropriate. In developing these primary alternatives, DOE and NYSERDA will explore alternative ways to implement them, which would be presented under the primary alternatives as implementing options. In addition, DOE and NYSERDA will explore mitigation measures to avoid or reduce potential environmental impacts of the alternatives and implementing options. These mitigation measures could include institutional controls, license and or permit terms/controls and other administrative controls (e.g. deed restrictions), robust engineered closure controls (e.g. multi-layer caps, grouts, etc.), robust erosion control structures, and/or additional removal of radiological inventory.

    In addition to these primary alternatives and their associated implementing options, analysis of at least two “hybrid” alternatives is planned. Conceptually, the hybrid alternatives would represent points along the middle of the alternatives spectrum between the Sitewide Close-in-Place Alternative and the Sitewide Removal Alternative, with elements of each. To that end, DOE and NYSERDA will consider preliminary information from the PPA as it is developed to inform the development of these alternatives.

    The alternatives and associated environmental analyses will be structured so that decisions based on the SEIS need not be limited only to a specific set of elements that happen to define a particular alternative. Rather, decision-makers could ultimately select an alternative comprised of elements of one or more of the primary (including hybrid) alternatives and their associated implementing options.

    DOE and NYSERDA invite comments on this approach. Comments are also invited on the potential scope of the hybrid alternatives, including the specific elements, facilities, and areas that should be included.

    Preliminary Description of Alternatives Sitewide Close-in-Place Alternative

    Under this alternative, most Phase 2 facilities would be closed in place. Major facilities and sources of contamination such as the Waste Tank Farm, NDA, and SDA would be managed at their current locations. Residual radioactivity in facilities with larger inventories of long-lived radionuclides would be isolated by specially engineered designed structures and barriers. These structures and barriers would be designed to meet regulatory requirements to retain hazardous and radioactive constituents to ensure they would be resistant to long-term degradation and include features to discourage inadvertent intrusion into the material left on site. Structures that would interfere with the construction of these barriers would be removed (e.g., the Supernatant Treatment System Support Building). Facilities with lesser amounts of contamination (e.g., the North Plateau Groundwater Plume, the Cesium Prong) would be allowed to naturally attenuate. This approach would allow large areas of the WNYNSC to be released for unrestricted use. Facilities that are closed in place, and any buffer areas around them, as well as facilities that are allowed to naturally attenuate, would require long-term stewardship.

    Sitewide Removal Alternative

    Under this alternative, site facilities, contaminated soil, sediment, and groundwater would be removed to meet criteria that would allow unrestricted release of the WNYNSC. Radioactive, hazardous, and mixed waste would be characterized, packaged, and shipped off site for disposal. Immediate implementation of this alternative would require the disposition of waste for which there is currently no offsite disposal location (e.g., potential non-defense transuranic waste and Greater-Than-Class C low-level radioactive waste). Any such “orphan waste” would be stored on site until an appropriate offsite facility is available. Completion of these activities would allow unrestricted use of the site (i.e., the site could be made available for any public or private use).

    Hybrid Alternatives

    Analysis of at least two hybrid alternatives is planned. The hybrid alternatives could contain elements of any or all of the other alternatives. For example, a hybrid alternative might include complete or partial removal of certain facilities and close-in-place for the remaining facilities. Additionally, these actions could occur immediately or after a safe-storage period. The results of the PPA will be used to determine which facilities should be removed and which to close-in-place. For example, if the PPA shows that a particular radionuclide from a particular facility dominates the long-term dose/risk estimate, then one hybrid alternative might be the removal of the material containing that radionuclide from that facility and closure in place of the remaining facilities. Depending on the facility and the amount of material to be removed, the approach for implementing the partial removal of material from a facility under the hybrid alternative may differ from the approach presented for the Sitewide Removal Alternative.

    No Action Alternative

    Under the No Action Alternative, Phase 1 decommissioning actions would be completed, but no further actions toward decommissioning the West Valley Site would be taken. The No Action Alternative would involve the continued management and oversight of West Valley Site facilities. The site would continue to be monitored and maintained for the foreseeable future, as required by Federal and state regulations, to protect the health and safety of workers, the public, and the environment. Additionally, periodic maintenance activities (e.g., replacing permeable treatment wall media, replacing landfill geomembranes) would continue during an assumed period of active institutional controls until, for purposes of analysis only, controls are assumed to become ineffective. The No Action Alternative would not meet the purpose and need for agency action, but analysis of the No Action Alternative is required under NEPA and SEQRA to provide a baseline against which the environmental impacts from the other analyzed alternatives can be compared.

    DOE and NYSERDA plan to identify a preferred alternative in the Draft SEIS.

    Potential Environmental Issues for Analysis and Potentially Significant Adverse Impacts

    DOE and NYSERDA have tentatively identified the following potential environmental issues and potentially significant adverse impacts that will be analyzed in the SEIS. The list is presented to facilitate early comment on the scope of the SEIS. It is not intended to be all-inclusive nor to predetermine the alternatives to be analyzed or their potential impacts.

    Potential Environmental Issues for Analysis

    • Issues associated with long-term site stewardship, including duration and costs of stewardship, regulatory and engineering considerations, institutional controls, and land use restrictions, including the need for buffer areas.

    • Ability of alternatives to satisfy the NRC LTR decommissioning criteria for the WVDP.

    • Ability of alternatives to meet the Comprehensive Environmental Response, Compensation and Liability Act risk range.

    • Compliance with applicable Federal, state, and local requirements.

    • Identification of Derived Concentration Guideline Limits and other relevant clean-up concentrations, where appropriate.

    • The influence of, and potential interactions of, any wastes remaining at the West Valley Site after decommissioning.

    • Long-term site stability, including seismicity and erosion, based upon available data on the likelihood of future weather events.

    • Issues associated with Waste Incidental to Reprocessing.

    • Irretrievable and irreversible commitment of resources.

    Potentially Significant Adverse Impacts

    • Impacts to the general population and onsite workers from radiological and non-radiological releases from decommissioning and/or long-term stewardship activities. Transportation impacts from shipments of radioactive, hazardous, mixed, and clean waste generated during decommissioning activities.

    • Impacts to the general population and onsite workers from radiological and non-radiological releases at radiological and non-radiological waste disposal sites receiving waste generated during site decommissioning and/or long-term stewardship activities.

    • Impacts from postulated accidents.

    • Disproportionately high and adverse effects on low-income and minority populations (environmental justice).

    • Socioeconomic impacts to local communities.

    • Areas of concern to the Seneca Nation of Indians related to culturally-specific considerations.

    • Short-term and long-term land use impacts.

    • Short-term and long-term environmental impacts, including air and water quality, from decommissioning and/or long-term stewardship activities.

    • Impacts to floodplains and wetlands (the SEIS will contain an assessment of potential floodplain and wetland impacts in accordance with DOE requirements (10 CFR part 1022)).

    • Impacts to groundwater quality.

    • Impacts on threatened and endangered species.

    Other Agency Involvement

    DOE and NYSERDA invite Federal, state, and local agencies with jurisdiction by law or special expertise to participate in the SEIS as cooperating or involved agencies. At this time, the U.S. Environmental Protection Agency (EPA), NRC, and NYSDEC will participate as cooperating agencies under NEPA. NYSDEC and NYSDOH will also participate as involved agencies under SEQRA with respect to NYSERDA's proposed actions.

    Public Scoping Process

    The purpose of scoping is to encourage public involvement and to solicit public comments on the proposed scope of the SEIS. DOE and NYSERDA invite interested parties to participate in the scoping process to help identify the range of reasonable alternatives and the environmental issues to be analyzed. Written comments may be provided by any of the means described under ADDRESSES, or orally at public scoping meetings. Both oral and written comments will be considered and given equal weight by DOE and NYSERDA regardless of how submitted. Comments must be provided by April 23, 2018, to ensure consideration in preparation of the Draft SEIS. DOE and NYSERDA will consider late comments to the extent practicable.

    DOE and NYSERDA will hold three public scoping meetings on the West Valley SEIS on the following dates:

    • Monday, March 19, 2018, from 6:00 p.m. to 9:30 p.m. at the West Valley Volunteer Hose Company, Inc., Firemen's Memorial Hall and Training, 9091 Route 240, West Valley, NY 14171, in the Main Hall.

    • Tuesday, March 20, 2018, from 6:00 p.m. to 9:30 p.m. at Erie Community College, City Campus, Post Office Building, 121 Ellicott Street, Buffalo, NY 14203, in the Minnie Gillette Auditorium.

    • Wednesday, March 21, 2018, from 6:00 p.m. to 9:30 p.m. at the Cattaraugus Council Chambers, 12837 Route 438, Irving, NY 14081.

    Further information about these meetings is available on the SEIS website at www.SEISWestValleySite.com and will be announced in the local media.

    Requests to speak at the public meeting should be made to the DOE Document Manager (see ADDRESSES).

    Speakers will be scheduled on a first-come, first-served basis. Individuals may sign up at the door to speak and will be accommodated as time permits. Written comments will also be accepted at the meeting. Speakers are encouraged to provide written versions of their oral comments for the record.

    The meetings will be facilitated by a moderator. Time will be provided for meeting attendees to ask clarifying questions. Individuals requesting to speak on behalf of an organization must identify the organization. Each speaker will be allowed five minutes to present comments unless more time is requested and available. Comments will be recorded by a court reporter and will become part of the scoping meeting record.

    SEIS Process and Schedule

    DOE and NYSERDA will consider comments received during the public scoping period in defining the alternatives and issues to be analyzed in detail in the Draft SEIS, which is planned for issuance by the end of 2020. After the document is distributed to the public, EPA will publish a notice of availability of the Draft SEIS in the Federal Register, and NYSERDA will publish notice of availability in the State Environmental Notice Bulletin, which will begin a 6-month public comment period. DOE and NYSERDA will announce how to comment on the Draft SEIS and will hold at least three public hearings during the public comment period, but no sooner than 15 days after EPA's notice of availability and NYSERDA's notice are published. In preparing the Final SEIS, which is planned for issuance in 2022, DOE and NYSERDA will respond to comments received on the Draft SEIS. DOE may issue its ROD no sooner than 30 days after EPA publishes a notice of availability of the Final SEIS. NYSERDA Findings and Decisions can be made no sooner than 10 days after the Notice of Completion of the Final SEIS is published. DOE and NYSERDA intend to complete the SEIS process to inform Phase 2 decisions in 2022.

    Notice of Floodplain and Wetland Involvement: Because the proposed project may involve actions in floodplains and wetlands, in accordance with DOE's 10 CFR part 1022, the Draft SEIS will include a floodplain and wetland assessment, and, as appropriate, the Final SEIS or ROD will include a floodplain statement of findings.

    Public Reading Room

    Documents referenced in this Notice of Intent and Draft Scope and related information are available online at www.SEISWestValleySite.com and at the Ashford Community and Training Center, 9377 NY-240, West Valley, New York 14171, (716) 942-6016.

    Signed in Washington, DC, this 14th day of February, 2018. James M. Owendoff, Acting Assistant Secretary for Environmental Management, Department of Energy.
    [FR Doc. 2018-03493 Filed 2-20-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY DOE/NSF Nuclear Science Advisory Committee AGENCY:

    Office of Science, Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the DOE/NSF Nuclear Science Advisory Committee (NSAC). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

    DATES:

    Monday, March 12, 2018 8:30 a.m.-4:30 p.m.

    ADDRESSES:

    Crystal City Marriott at Reagan National Airport, 1999 Jefferson Davis Highway, Potomac Ballroom, Arlington, Virginia 22202, 703-413-5500.

    FOR FURTHER INFORMATION CONTACT:

    Brenda L. May, U.S. Department of Energy; SC-26/Germantown Building, 1000 Independence Avenue SW, Washington, DC 20585; Telephone: (301) 903-0536 or email: [email protected]

    The most current information concerning this meeting can be found on the website: http://science.gov/np/nsac/meetings/.

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to provide advice and guidance on a continuing basis to the Department of Energy and the National Science Foundation on scientific priorities within the field of basic nuclear science research.

    Tentative Agenda: Agenda will include discussions of the following:

    Monday, March 12, 2018 • Perspectives from Department of Energy and National Science Foundation • Update from the Department of Energy and National Science Foundation's Nuclear Physics Offices • Presentation of the Mo-99 Subcommittee Report • Discussion of the Mo-99 Subcommittee Report Note:

    The NSAC Meeting will be broadcast live on the internet. You may find out how to access this broadcast by going to the following site prior to the start of the meeting. A video record of the meeting, including the presentations that are made, will be archived at this site after the meeting ends: http://www.tvworldwide.com/events/DOE/180312/.

    Public Participation: The meeting is open to the public. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of these items on the agenda, you should contact Brenda L. May, (301) 903-0536 or [email protected] (email). You must make your request for an oral statement at least five business days before the meeting. Reasonable provisions will be made to include the scheduled oral statements on the agenda. The Chairperson of the Committee will conduct the meeting to facilitate the orderly conduct of business. Public comment will follow the 10-minute rule.

    The minutes of the meeting will be available for review on the U.S. Department of Energy's Office of Nuclear Physics website at: http://science.gov/np/nsac/meetings/.

    Issued in Washington, DC, on February 14, 2018. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2018-03484 Filed 2-20-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. IC18-1-000] Commission Information Collection Activities (FERC-598); Comment Request; Extension AGENCY:

    Federal Energy Regulatory Commission, Department of Energy.

    ACTION:

    Notice of information collection and request for comments.

    SUMMARY:

    In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC-598 (Self-Certification for Entities Seeking Exempt Wholesale Generator Status or Foreign Utility Company Status) and submitting the information collection to the Office of Management and Budget (OMB) for review. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below. The Commission published a Notice in the Federal Register in Docket No. IC18-1-000 on December 11, 2017 requesting public comments. FERC received no comments in response to the Notice and is indicating that in its submittal to the OMB.

    DATES:

    Comments on the collection of information are due March 23, 2018.

    ADDRESSES:

    Comments filed with OMB, identified by OMB Control No. 1902-0166, should be sent via email to the Office of Information and Regulatory Affairs: [email protected] Attention: Federal Energy Regulatory Commission Desk Officer. The Desk Officer may also be reached via telephone at 202-395-0710.

    A copy of the comments should also be sent to the Commission, in Docket No. IC18-1, by either of the following methods:

    eFiling at Commission's website: http://www.ferc.gov/docs-filing/efiling.asp.

    Mail/Hand Delivery/Courier: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street NE, Washington, DC 20426.

    Instructions: All submissions must be formatted and filed in accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance, contact FERC Online Support by email at [email protected], or by phone at: (866) 208-3676 (toll-free), or (202) 502-8659 for TTY.

    Docket: Users interested in receiving automatic notification of activity in this docket or in viewing/downloading comments and issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

    FOR FURTHER INFORMATION CONTACT:

    Ellen Brown may be reached by email at [email protected], telephone at (202) 502-8663, and fax at (202) 273-0873.

    SUPPLEMENTARY INFORMATION:

    Title: FERC-598, Self-Certification for Entities Seeking Exempt Wholesale Generator Status or Foreign Utility Company Status.

    OMB Control No.: 1902-0166.

    Type of Request: Three-year extension of the FERC-598 information collection requirements with no changes to the current reporting requirements.

    Abstract: The Commission uses the data in the FERC-598 information collection to implement the statutory provisions of Title XII, subtitle F of the Energy Policy Act of 2005 (EPAct 2005).1

    1 Energy Policy Act of 2005, Public Law 109-58, 119 Stat. 594, 972 et seq. (2005) (codified at 42 U.S.C. 16451 et seq.).

    EPAct 2005 repealed the Public Utility Holding Company Act of 1935 (PUHCA 1935),2 and adopted in its place the Public Utility Holding Company Act of 2005 (PUHCA 2005).3 While providing for the Commission's regulation of holding companies, PUHCA 2005 also provided an exemption from such regulation for those holding companies that are subject to Commission regulation as holding companies solely due to their holding exempt wholesale generators (EWG) and foreign utility companies (FUCO).4 To carry out this statutory directive, the Commission amended its regulations (in Order No. 667) 5 to, among other things, add procedures for not only defining what entities would qualify as EWGs and FUCOs, but also the self-certification by entities seeking EWG and FUCO status, coupled with the self-certification of the exemption of their holding companies, in turn, from Commission regulation.6 This self-certification for EWGs and FUCOs is similar to the process available to entities that seek qualifying facility status.7

    2Id. § 1263, 119 Stat. 594, 974.

    3Id. § 1261, 119 Stat. 594, 972.

    4Id. § 1266(a), 119 Stat. 594, 975 (codified at 42 U.S.C. 16454(a)).

    5Repeal of the Public Utility Holding Company Act of 1935 and Enactment of the Public Utility Holding Company Act of 2005, 70 FR 75592, FERC Stats. & Regs. ¶ 31,197 (2005), order on rehearing, Order 667-A, 71 FR 28446, FERC Stats. & Regs. ¶ 31,213 (2006), order on rehearing, Order 667-B, 71 FR 42750, FERC Stats. & Regs. ¶ 31,244 (2006), order on rehearing, Order 667-C, 118 FERC ¶ 61,133 (2007).

    6 18 CFR 366.1, 366.3(a), 366.4, 366.7.

    7 18 CFR 292.207.

    An EWG is defined as “any person engaged directly, or indirectly through one or more affiliates . . . and exclusively in the business of owning or operating, or both owning and operating, all or part of one or more eligible facilities and selling electric energy at wholesale.” 8 A FUCO is defined as “any company that owns or operates facilities that are not located in any state and that are used for the generation, transmission, or distribution of electric energy for sale or the distribution at retail of natural or manufactured gas for heat, light, or power, if such company: (1) Derives no part of its income, directly or indirectly, from the generation, transmission, or distribution of electric energy for sale or the distribution at retail of natural or manufactured gas for heat, light, or power, within the United States; and (2) [n]either the company nor any of its subsidiary companies is a public-utility company operating in the United States.” 9

    8 18 CFR 366.1.

    9Id.

    An EWG, FUCO, or its representative seeking to self-certify its status as an EWG or FUCO must file with the Commission a notice of self-certification (FERC-598) demonstrating that it satisfies the definition of EWG or FUCO. In the case of EWGs, the person filing a notice of self-certification must also file a copy of the notice of self-certification with the state regulatory authority of the state in which the facility is located and that person must also represent to the Commission in its submission that it has filed a copy of the notice with the appropriate state regulatory authority.10

    10 18 CFR 366.7.

    Submission of the information collected by FERC-598 is necessary for the Commission to carry out its responsibilities under section 1266(a) of EPAct 2005.11 The Commission implements its responsibilities through the Code of Federal Regulations (CFR), Title 18, Part 366. These filing requirements are mandatory for entities seeking to self-certify their EWG or FUCO status, in order to, in turn, exempt their holding companies from Commission regulation.

    11 42 U.S.C. 16454(a).

    Type of Respondents: EWGs and FUCOs.

    Estimate of Annual Burden:12 The Commission estimates the total annual burden and cost 13 for this information collection as follows.

    12 “Burden” is the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For further explanation of what is included in the information collection burden, refer to Title 5 Code of Federal Regulations 1320.3.

    13 Subject matter experts found that industry employment costs (for salary plus benefits) for the FERC-598 information collection closely resemble the Commission's. FERC's 2017 average annual salary plus benefits per FTE (full-time equivalent) is $158,754 (or $76.50 per hour).

    FERC-598 [Self-certification for entities seeking exempt wholesale generator status or foreign utility company status] Number of respondents
  • (EWGs and FUCOs)
  • Annual
  • number of
  • responses per
  • respondent
  • Total
  • number of
  • responses
  • Average
  • burden hrs.
  • & cost ($)
  • per response
  • Total annual
  • burden hours
  • & total
  • annual cost
  • Average
  • cost per
  • respondent
  • ($)
  • (1) (2) (1) * (2) = (3) (4) (3) * (4) = (5) (5) ÷ (1) 147 1 147 6 hrs.; $459 882 hrs.; $67,473 $459

    Comments: Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

    Dated: February 13, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-03458 Filed 2-20-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 3011-016] Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving Use of the Traditional Licensing Process; Natco Products Corporation

    a. Type of Filing: Notice of Intent to File License Application and Request to Use the Traditional Licensing Process.

    b. Project No.: 3011-016.

    c. Date Filed: December 29, 2017.

    d. Submitted By: Natco Products Corporation (Natco).

    e. Name of Project: Arctic Project.

    f. Location: On the South Branch Pawtuxet River in West Warwick, Kent County, Rhode Island. No federal lands are occupied by the project works or located within the project boundary.

    g. Filed Pursuant to: 18 CFR 5.3 and 5.5 of the Commission's regulations.

    h. Potential Applicant Contact: Steve Burke, Natco Products Corporation, 155 Brookside Avenue, West Warwick, RI 02893; (401) 828-0300; email at [email protected].

    i. FERC Contact: John Ramer at (202) 502-8969; or email at [email protected].

    j. Natco filed its request to use the Traditional Licensing Process on December 29, 2017, and provided public notice of the request on the same date. In a letter dated February 13, 2018, the Director of the Division of Hydropower Licensing approved Natco's request to use the Traditional Licensing Process.

    k. With this notice, we are initiating informal consultation with the U.S. Fish and Wildlife Service and NOAA Fisheries under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR part 402; and NOAA Fisheries under section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act and implementing regulations at 50 CFR 600.920. We are also initiating consultation with the Rhode Island State Historic Preservation Officer, as required by section 106 of the National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.

    l. Natco filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.

    m. A copy of the PAD is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website (http://www.ferc.gov), using the “eLibrary” link. Enter the docket number, excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). A copy is also available for inspection and reproduction at the address in paragraph h.

    n. The licensee states its unequivocal intent to submit an application for a subsequent license for Project No. 3011. Pursuant to 18 CFR 16.20, each application for a subsequent license and any competing license applications must be filed with the Commission at least 24 months prior to the expiration of the existing license. All applications for license for this project must be filed by December 31, 2020.

    o. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    Dated: February 13, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-03460 Filed 2-20-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER18-855-000] Panoche Valley Solar, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding Panoche Valley Solar, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 6, 2018.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 14, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-03507 Filed 2-20-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Docket Nos. Panda Hummel Station LLC EG18-14-000 Wildwood Lessee, LLC EG18-15-000 Red Dirt Wind Project, LLC EG18-16-000 ORNI 39 LLC EG18-17-000 ORNI 41 LLC EG18-18-000 Hamakua Energy, LLC EG18-19-000

    Take notice that during the month of January 2018, the status of the above-captioned entities as Exempt Wholesale Generators became effective by operation of the Commission's regulations. 18 CFR 366.7(a) (2017).

    Dated: February 14, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-03506 Filed 2-20-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Number: PR18-15-001.

    Applicants: SCOOP Express, LLC.

    Description: Tariff filing per 284.123(b),(e)+(g): SCOOP Express Amended SOC filing Feb 12 2018 to be effective 12/22/2017.

    Filed Date: 2/12/18.

    Accession Number: 201802125088.

    Comments Due: 5 p.m. ET 3/5/18.

    284.123(g) Protests Due: 5 p.m. ET 3/5/18.

    Docket Number: PR18-29-000.

    Applicants: National Fuel Gas Distribution Corporation.

    Description: Tariff filing per 284.123(b)(2)+(: Application of National Fuel Gas Distribution Corporation to Amend Rates to be effective 2/12/2018.

    Filed Date: 2/12/18.

    Accession Number: 201802125178.

    Comments/Protests Due: 5 p.m. ET 3/5/18.

    Docket Numbers: RP18-438-000.

    Applicants: Guardian Pipeline, L.L.C.

    Description: § 4(d) Rate Filing: Negotiated Rate PAL Agreements—Wisc. Electric Power Company to be effective 3/1/2018.

    Filed Date: 2/13/18.

    Accession Number: 20180213-5184.

    Comments Due: 5 p.m. ET 2/26/18.

    Docket Numbers: RP18-439-000.

    Applicants: Northern Natural Gas Company.

    Description: Northern Natural Gas submits report of the penalty and daily delivery variance charge (DDVC) revenues that have been credited to shippers.

    Filed Date: 2/13/18.

    Accession Number: 20180213-5217.

    Comments Due: 5 p.m. ET 2/26/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified date(s). Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 14, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-03505 Filed 2-20-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following exempt wholesale generator filings:

    Docket Numbers: EG18-46-000.

    Applicants: Panoche Valley Solar, LLC.

    Description: Self-Certification of EG of Panoche Valley Solar, LLC.

    Filed Date: 2/13/18.

    Accession Number: 20180213-5379.

    Comments Due: 5 p.m. ET 3/6/18.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER17-2291-002.

    Applicants: PJM Interconnection, L.L.C.

    Description: Compliance filing: Compliance Filing in ER17-2291 re: February 5, 2018 Order re: Dyanmic Transfers to be effective 11/9/2017.

    Filed Date: 2/14/18.

    Accession Number: 20180214-5117.

    Comments Due: 5 p.m. ET 3/7/18.

    Docket Numbers: ER18-856-000.

    Applicants: Southern California Edison Company.

    Description: Tariff Cancellation: Notice of Cancellation Letter Agreement Casa Diablo 4 Project SA No. 377 to be effective 12/28/2017.

    Filed Date: 2/14/18.

    Accession Number: 20180214-5066.

    Comments Due: 5 p.m. ET 3/7/18.

    Docket Numbers: ER18-857-000.

    Applicants: California Independent System Operator Corporation.

    Description: Compliance filing: 2018-02-14 Petition for Limited Tariff Waiver Tardy Requests Acquired Resources to be effective N/A.

    Filed Date: 2/14/18.

    Accession Number: 20180214-5144.

    Comments Due: 5 p.m. ET 3/7/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 14, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-03504 Filed 2-20-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2100-185] California Department of Water Resources; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:

    a. Type of Application: Request for license amendment.

    b. Project No.: 2100-185.

    c. Dates Filed: January 29 and February 13, 2018.

    d. Applicant: California Department of Water Resources.

    e. Name of Project: Feather River Project.

    f. Location: The project is located on the Feather River in Butte County, California, and occupies lands of the United States administered by the U.S. Forest Service and the U.S. Bureau of Land Management.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.

    h. Applicant Contact: Mr. Ted Craddock, California Department of Water Resources, 1416 Ninth Street, P.O. Box 942836, Sacramento, CA 94236-0001, (916) 502-2067.

    i. FERC Contact: Mr. John Aedo, (415) 369-3335, [email protected]

    j. Deadline for filing comments, motions to intervene, and protests is 30 days from the issuance date of this notice by the Commission (March 15, 2018).

    All documents may be filed electronically via the internet. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's website at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be filed electronically, documents may be paper-filed. To paper-file, an original and seven copies should be mailed to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments.

    Please include the project number (P-2100-185) on any comments, motions, or recommendations filed.

    k. Description of Request: California Department of Water Resources (licensee) requests Commission approval for an amendment to its current project license to enhance the existing emergency spillway at Oroville Dam to prevent erosion, and to incorporate these enhancements into its project license. The licensee also requests Commission approval to relocate a portion of a project transmission line connecting the Hyatt Powerplant Switchyard and the Thermalito Diversion Dam Powerhouse. In addition, the licensee proposes to reconstruct the Oroville main spillway to similar dimensions as the original design. Finally, the licensee proposes various protective or mitigative measures to minimize impacts to environmental resources during these activities. The above activities are being proposed as a result of the February 2017 failure of the main spillway and extensive erosion caused by the use of the emergency spillway. The Commission will be analyzing the environmental effects of the above activities, also known as the response and recovery phases of the spillway failure. Consequently, any comments, motions to intervene, or protests should concern only the environmental aspects of the response and recovery efforts. Any comments relating to project relicensing are not within the scope of this public notice and subsequent analysis.

    l. Locations of the Application: A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street NE, Room 2A, Washington, DC 20426, or by calling (202) 502-8371. This filing may also be viewed on the Commission's website at http://www.ferc.gov/docs-filing/efiling.asp. Enter the docket number excluding the last three digits in the docket number field to access the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, call 1-866-208-3676 or email [email protected], for TTY, call (202) 502-8659. A copy is also available for inspection and reproduction at the address in item (h) above.

    m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.

    n. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

    o. Filing and Service of Responsive Documents: All filings must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). All comments, motions to intervene, or protests should relate to project works which are the subject of the license amendment. Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. If an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 18 CFR 385.2010.

    Dated: February 13, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-03459 Filed 2-20-18; 8:45 am] BILLING CODE 6717-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of Intent To Terminate Receiverships

    Notice is hereby given that the Federal Deposit Insurance Corporation (FDIC or Receiver), as Receiver for the institutions listed below, intends to terminate its receivership for said institutions.

    Receivership name Date of
  • appointment
  • of receiver
  • 10092 Community First Bank, Prineville, Oregon August 7, 2009. 10252 High Desert State Bank, Albuquerque, New Mexico June 25, 2010.

    The liquidation of the assets for each receivership has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receiverships will serve no useful purpose. Consequently, notice is given that the receiverships shall be terminated, to be effective no sooner than thirty days after the date of this notice. If any person wishes to comment concerning the termination of any of the receiverships, such comment must be made in writing, identify the receivership to which the comment pertains, and be sent within thirty days of the date of this notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.

    No comments concerning the termination of the above-mentioned receiverships will be considered which are not sent within this time frame.

    Dated: February 15, 2018. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2018-03492 Filed 2-20-18; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL MINE SAFETY AND HEALTH REVIEW COMMISSION Sunshine Act Notice February 16, 2018. TIME AND DATE:

    10:00 a.m., Friday, March 23, 2018.

    PLACE:

    The Richard V. Backley Hearing Room, Room 511N, 1331 Pennsylvania Avenue NW, Washington, DC 20004 (enter from F Street entrance).

    STATUS:

    Open.

    MATTERS TO BE CONSIDERED:

    The Commission will consider and act upon the following in open session: Secretary of Labor v. Consol Pennsylvania Coal Co., Docket No. PENN 2014-816 (Issues include whether the Judge erred in concluding that the operator violated a reporting requirement that applies when an accident has a “reasonable potential to cause death.”)

    Any person attending this meeting who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d).

    CONTACT PERSON FOR MORE INFO:

    Emogene Johnson (202) 434-9935/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free.

    PHONE NUMBER FOR LISTENING TO ARGUMENT:

    1 (866) 867-4769, Passcode: 678-100.

    Sarah L. Stewart, Deputy General Counsel.
    [FR Doc. 2018-03641 Filed 2-16-18; 4:15 pm] BILLING CODE 6735-01-P
    FEDERAL MINE SAFETY AND HEALTH REVIEW COMMISSION Sunshine Act Notice February 16, 2018. TIME AND DATE:

    2:00 p.m., Thursday, March 22, 2018.

    PLACE:

    The Department of Labor Auditorium, Frances Perkins Building, 200 Constitution Avenue NW, Washington, DC 20210.

    STATUS:

    Open.

    MATTERS TO BE CONSIDERED:

    The Commission will hear oral argument in the matter Secretary of Labor v. Consol Pennsylvania Coal Co., Docket No. PENN 2014-816 (Issues include whether the Judge erred in concluding that the operator violated a reporting requirement that applies when an accident has a “reasonable potential to cause death.”)

    Any person attending this oral argument who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d).

    CONTACT PERSON FOR MORE INFO:

    Emogene Johnson (202) 434-9935/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free.

    PHONE NUMBER FOR LISTENING TO ARGUMENT:

    1 (866) 867-4769, Passcode: 678-100.

    Sarah L. Stewart, Deputy General Counsel.
    [FR Doc. 2018-03640 Filed 2-16-18; 4:15 pm] BILLING CODE 6735-01-P
    FEDERAL RESERVE SYSTEM Proposed Agency Information Collection Activities; Comment Request AGENCY:

    Board of Governors of the Federal Reserve System.

    ACTION:

    Notice, request for comment.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, with revision, the Reports of Deposits (FR 2900; OMB No. 7100-0087).

    DATES:

    Comments must be submitted on or before April 23, 2018.

    ADDRESSES:

    You may submit comments, identified by FR 2900, FR 2910a, FR 2915, or FR 2930, by any of the following methods:

    Agency Website: http://www.federalreserve.gov. Follow the instructions for submitting comments at http://www.federalreserve.gov/apps/foia/proposedregs.aspx .

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

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

    Fax: (202) 452-3819 or (202) 452-3102.

    Mail: Ann E. Misback, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551.

    All public comments are available from the Board's website at http://www.federalreserve.gov/apps/foia/proposedregs.aspx as submitted, unless modified for technical reasons. Accordingly, your comments will not be edited to remove any identifying or contact information. Public comments may also be viewed electronically or in paper form in Room 3515, 1801 K Street (between 18th and 19th Streets NW), Washington, DC 20006 between 9:00 a.m. and 5:00 p.m. on weekdays.

    Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.

    FOR FURTHER INFORMATION CONTACT:

    A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public website at: http://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears below.

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

    Request for Comment on Information Collection Proposal

    The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:

    a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;

    b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

    c. Ways to enhance the quality, utility, and clarity of the information to be collected;

    d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and

    e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.

    At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Federal Reserve should modify the proposal prior to giving final approval.

    Proposal To Approve Under OMB Delegated Authority the Extension for Three Years, With Revision, of the Following Report

    Report title: Report of Transaction Accounts, Other Deposits, and Vault Cash (FR 2900); Annual Report of Deposits and Reservable Liabilities (FR 2910a); Report of Foreign (Non-U.S.) Currency Deposits (FR 2915); and Allocation of Low Reserve Tranche and Reservable Liabilities Exemption (FR 2930).

    Agency form number: FR 2900; FR 2910a; FR 2915; and FR 2930.

    OMB control number: 7100-0087.

    Frequency: Weekly, quarterly, annually, and on occasion.

    Respondents: Depository institutions.

    Estimated number of respondents: FR 2900 (Weekly), 2,007; FR 2900 (Quarterly), 4,395; FR 2910a, 2,941; FR 2915, 122; and FR 2930, 93.

    Estimated average hours per response: FR 2900 (Weekly), 1.25; FR 2900 (Quarterly), 3; FR 2910a, 0.75; FR 2915, 0.5; and FR 2930, 0.25.

    Estimated annual burden hours: FR 2900 (Weekly), 130,455; FR 2900 (Quarterly), 52,740; FR 2910a, 2,206; FR 2915, 244; FR 2930, 23.

    General description of reports: Data from these mandatory reports are used by the Board for administering Regulation D (Reserve Requirements of Depository Institutions) and for constructing, analyzing, and monitoring the monetary and reserve aggregates. The FR 2900 is the primary source of data used for the calculation of required reserves and applied vault cash, and for the construction and analysis of the monetary aggregates. Data are also used for indexing the exemption amount and low reserve tranche amount each year, as required by statute and for indexing the nonexempt deposit cutoff and reduced reporting limit each year, as determined by the Board, amounts which determine whether depository institutions file the FR 2900 either weekly or quarterly. The FR 2910a is generally submitted by exempt institutions whose total deposits (as shown on their December Call Report) 1 are greater than the exemption amount. All FR 2900 respondents, both weekly and quarterly, that offer deposits denominated in foreign currencies at their U.S. offices file the FR 2915 quarterly on the same reporting schedule as quarterly FR 2900 respondents. Foreign currency deposits are subject to reserve requirements and, therefore, are included in the FR 2900 data. However, because foreign currency deposits are not included in the monetary aggregates, the FR 2915 data are used to net foreign currency-denominated deposits from the FR 2900 data to exclude them from measures of the monetary aggregates. The FR 2930 data are collected when the low reserve tranche and reservable liabilities exemption thresholds are adjusted toward the end of each calendar year or upon the establishment of an office outside the home state or Federal Reserve District.

    1 In this document, the term Call Report refers to the Consolidated Reports of Condition and Income (FFIEC 031, FFIEC 041, and FFIEC 051; OMB No. 7100-0036) filed by commercial banks, Report of Assets and Liabilities of U.S. Branches and Agencies of Foreign Banks (FFIEC 002; OMB No. 7100-0032), Statement of Financial Condition (NCUA 5300; OMB No. 3133-0004) filed by credit unions, and Consolidated Report of Condition and Income for Edge and Agreement Corporations (FR 2886b; OMB No. 7100-0086).

    Proposed revisions: The Board proposes raising the nonexempt deposit cutoff to $1 billion, substantially increasing the cutoff from its indexed amount of $457.5 million that is set to take effect in September 2018. This proposed increase in the nonexempt deposit cutoff would reduce reporting burden on depository institutions while maintaining accurate measurements of the money and reserves aggregates. With this increase, the Board estimates that approximately 1,000 depository institutions would become newly eligible to elect to shift from weekly to quarterly FR 2900 reporting. However, consistent with current policy, newly eligible institutions for quarterly reporting may elect to continue reporting weekly. There are no changes proposed for the FR 2910a, FR 2915, or FR 2930.

    Legal authorization and confidentiality: The information collected on these reports is authorized under sections 11, 25(7), and 25A(17) of the Federal Reserve Act (FRA), and section 7 of the International Banking Act (IBA). Section 11 of the FRA (12 U.S.C. 248(a)) authorizes the Board to require reports from each member bank as it may deem necessary and authorizes the Board to prescribe reports of liabilities and assets from insured depository institutions to enable the Board to discharge its responsibility to monitor and control monetary and credit aggregates. Sections 25(7) and 25A(17) of the FRA (12 U.S.C. 604a and 625) authorize the Board to require Edge and agreement corporations to make reports to the Board. Section 7 of the IBA (12 U.S.C. 3105(c)(2)) authorizes the Board to require reports from U.S. branches and agencies of foreign banks. The FR 2900, FR 2910a, FR 2915, and FR 2930 are all mandatory. The release of data collected on these forms would likely cause substantial harm to the competitive position of the respondent if made publicly available. The data collected on these forms, therefore, may be kept confidential under exemption 4 of the Freedom of Information Act, which protects from disclosure trade secrets and commercial or financial information (5 U.S.C. 552(b)(4)).

    Board of Governors of the Federal Reserve System, February 15, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-03544 Filed 2-20-18; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Proposed Agency Information Collection Activities; Comment Request AGENCY:

    Board of Governors of the Federal Reserve System.

    ACTION:

    Notice, request for comment.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, without revision, the voluntary Quarterly Report of Interest Rates on Selected Direct Consumer Installment Loans and the Quarterly Report of Credit Card Plans (FR 2835; FR 2835a; OMB No. 7100-0085).

    DATES:

    Comments must be submitted on or before April 23, 2018.

    ADDRESSES:

    You may submit comments, identified by FR 2835 or FR 2835a, by any of the following methods:

    Agency Website: http://www.federalreserve.gov. Follow the instructions for submitting comments at http://www.federalreserve.gov/apps/foia/proposedregs.aspx.

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

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

    FAX: (202) 452-3819 or (202) 452-3102.

    Mail: Ann E. Misback, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551.

    All public comments are available from the Board's website at http://www.federalreserve.gov/apps/foia/proposedregs.aspx as submitted, unless modified for technical reasons. Accordingly, your comments will not be edited to remove any identifying or contact information. Public comments may also be viewed electronically or in paper form in Room 3515, 1801 K Street (between 18th and 19th Streets NW), Washington, DC 20006 between 9:00 a.m. and 5:00 p.m. on weekdays.

    Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.

    FOR FURTHER INFORMATION CONTACT:

    A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public website at: http://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears below.

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

    Request for Comment on Information Collection Proposal

    The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:

    a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;

    b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

    c. Ways to enhance the quality, utility, and clarity of the information to be collected;

    d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and

    e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.

    At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Federal Reserve should modify the proposal prior to giving final approval.

    Proposal To Approve Under OMB Delegated Authority the Extension for Three Years, Without Revision, of the Following Report

    Report title: Quarterly Report of Interest Rates on Selected Direct Consumer Installment Loans and Quarterly Report of Credit Card Plans.

    Agency form number: FR 2835; FR 2835a.

    OMB control number: 7100-0085.

    Frequency: Quarterly.

    Respondents: Commercial banks.

    Estimated number of respondents: FR 2835: 150; FR 2835a: 50.

    Estimated average hours per response: FR 2835: .29 hours; FR 2835a: .50 hours.

    Estimated annual burden hours: FR 2835: 176 hours; FR 2835a: 100 hours.

    General description of report: The FR 2835 collects information from a sample of commercial banks on interest rates charged on loans for new vehicles and loans for other consumer goods and personal expenses. The data are used for the analysis of household financial conditions. The FR 2835a collects information on two measures of credit card interest rates from a sample of commercial banks with $1 billion or more in credit card receivables and a representative group of smaller issuers. The data are used to analyze the credit card market and draw implications for the household sector.

    Legal authorization and confidentiality: The Board is authorized to collect the information on the FR 2835 and FR 2835a by sections 2A and 11 of the Federal Reserve Act (“FRA”). Section 2A of the FRA (12 U.S.C. 225a) requires that the Board and the Federal Open Market Committee (“FOMC”) maintain long-run growth of the monetary and credit aggregates commensurate with the economy's long run potential to increase production, so as to promote effectively the goals of maximum employment, stable prices, and moderate long-term interest rates. Section 11 of the FRA (12 U.S.C. 248(a)) authorizes the Board to require reports from each member bank as it may deem necessary and authorizes the Board to prescribe reports of liabilities and assets from insured depository institutions to enable the Board to discharge its responsibility to monitor and control monetary and credit aggregates. The information collected on the FR 2835 and FR 2835a assist the Board and the FOMC with fulfilling these obligations. Both the 2835 and 2835a are voluntary. With respect to the FR 2835, only the narrative information to explain large fluctuations in reported data is considered confidential. With respect to the 2835a, the individual respondent data is considered confidential. Such treatment is appropriate because the data is not publicly available and the public release of this data is likely to impair the Board's ability to collect necessary information in the future and cause substantial harm to the competitive position of the respondent. Thus, this information may be kept confidential under exemption (b)(4) of the Freedom of Information Act, which exempts from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential.” (5 U.S.C. 552(b)(4)).

    Board of Governors of the Federal Reserve System, February 15, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-03543 Filed 2-20-18; 8:45 am] BILLING CODE 6210-01-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 15, 2018.

    A. Federal Reserve Bank of San Francisco (Gerald C. Tsai, Director, Applications and Enforcement) 101 Market Street, San Francisco, California 94105-1579:

    1. Allegiant United Holdings, LLC and Nano Financial Holdings, Inc., both of Irvine, California; to become bank holding companies through Nano Financial Holdings, Inc. by acquiring 100 percent of the outstanding shares of Commerce Bank of Temecula Valley, Murrieta, California.

    Board of Governors of the Federal Reserve System, February 15, 2018. Ann Misback, Secretary of the Board.
    [FR Doc. 2018-03468 Filed 2-20-18; 8:45 am] BILLING CODE 6210-01-P12
    FEDERAL RESERVE SYSTEM Proposed Agency Information Collection Activities; Comment Request AGENCY:

    Board of Governors of the Federal Reserve System.

    ACTION:

    Notice, request for comment.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, without revision, the Senior Loan Officer Opinion Survey on Bank Lending Practices (FR 2018; OMB No. 7100-0058).

    DATES:

    Comments must be submitted on or before April 23, 2018.

    ADDRESSES:

    You may submit comments, identified by FR 2018, by any of the following methods:

    Agency Website: http://www.federalreserve.gov. Follow the instructions for submitting comments at http://www.federalreserve.gov/apps/foia/proposedregs.aspx.

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

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

    Fax: (202) 452-3819 or (202) 452-3102.

    Mail: Ann E. Misback, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551.

    All public comments are available from the Board's website at http://www.federalreserve.gov/apps/foia/proposedregs.aspx as submitted, unless modified for technical reasons. Accordingly, your comments will not be edited to remove any identifying or contact information. Public comments may also be viewed electronically or in paper form in Room 3515, 1801 K Street (between 18th and 19th Streets NW), Washington, DC 20006 between 9:00 a.m. and 5:00 p.m. on weekdays.

    Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.

    FOR FURTHER INFORMATION CONTACT:

    A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public website at: http://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears below.

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

    Request for Comment on Information Collection Proposal

    The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:

    a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;

    b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

    c. Ways to enhance the quality, utility, and clarity of the information to be collected;

    d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and

    e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.

    At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Federal Reserve should modify the proposal prior to giving final approval.

    Proposal to approve under OMB delegated authority the extension for three years, without revision, of the following report(s):

    Report title: Senior Loan Officer Opinion Survey on Bank Lending Practices.

    Agency form number: FR 2018.

    OMB control number: 7100-0058.

    Frequency: Up to six times a year.

    Respondents: Domestically chartered large commercial banks and large U.S. branches and agencies of foreign banks.

    Estimated number of respondents: 104.

    Estimated average hours per response: 2 hours.

    Estimated annual burden hours: 1,248 hours.

    General description of report: The FR 2018 is conducted with a senior loan officer at each respondent bank, generally through electronic submission, up to six times a year. The purpose of the survey is to provide qualitative and limited quantitative information on credit availability and demand, as well as evolving developments and lending practices in the U.S. loan markets. A portion of each survey typically covers special topics of timely interest. There is the option to survey other types of respondents (such as other depository institutions, bank holding companies, or other financial entities) should the need arise. The FR 2018 survey provides crucial information for monitoring and understanding the evolution of lending practices at banks and developments in credit markets.

    Legal authorization and confidentiality: The Board's Legal Division has determined that the Senior Loan Officer Opinion Survey on Bank Lending Practices is authorized by Sections 2A, 11, and 12A of the Federal Reserve Act (12 U.S.C. 225a, 248(a), and 263) and Section 7 of the International Banking Act (12 U.S.C. 3105(c)(2)) and is voluntary. Individual survey responses from each respondent can be held confidential under section (b)(4) of the Freedom of Information Act (5 U.S.C. 552(b)(4)). However, certain data from the survey is reported in aggregate form and the information in aggregate form is made publicly available and not considered confidential.

    Board of Governors of the Federal Reserve System, February 15, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-03532 Filed 2-20-18; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Solicitation of Nominations for Appointment to the Lead Exposure and Prevention Advisory Committee ACTION:

    Notice.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC) is soliciting nominations for membership on the LEPAC. The LEPAC consists of 15 Federal and non-Federal experts in fields associated with lead screening, the prevention of lead exposure, and services for individuals and communities affected by lead exposure. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishment of the committee's objectives. Nominees will be selected based on expertise in the fields of epidemiology, toxicology, mental health, pediatrics, early childhood education, special education, diet and nutrition, and environmental health. Members may be invited to serve for three-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of LEPAC objectives.

    DATES:

    Nominations for membership on the LEPAC must be received no later than April 15, 2018. Packages received after this time will not be considered for the current membership cycle.

    ADDRESSES:

    All nominations should be mailed to Ms. Perri Ruckart, MPH, Centers for Disease Control and Prevention, 4770 Buford Highway, MS F-58, Atlanta, GA 30341, emailed (recommended) to [email protected], or faxed to 770-488-3635.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Perri Ruckart, MPH, Designated Federal Officer, National Center for Environmental Health, Centers for Disease Control and Prevention, 4770 Buford Hwy. NE, Mailstop F-58, Atlanta, GA 30341, 770-488-3808, [email protected]

    SUPPLEMENTARY INFORMATION:

    The members of this committee are selected by the Secretary of the U.S. Department of Health and Human Services (HHS). The committee advises the Secretary, HHS and the Director, Centers for Disease Control and Prevention/Administrator, Agency for Toxic Substances and Disease Registry on a range of activities to include: (1) Review of the Federal programs and services available to individuals and communities exposed to lead; (2) review of the current research on lead exposure to identify additional research needs; (3) review of and identification of best practices, or the need for best practices regarding lead screening and the prevention of lead exposure; (4) identification of effective services, including services relating to healthcare, education, and nutrition for individuals and communities affected by lead exposure and lead poisoning, including in consultation with, as appropriate, the lead exposure registry as established in Public Law 114-322 Section 2203(b) (42 U.S.C. 300j-27); and (5) undertaking of any other review or activities that the Secretary determines to be appropriate.

    Annually as determined necessary by the Secretary or as required by Congress, the committee shall submit a report to include: (1) An evaluation of the effectiveness of the Federal programs and services available to individuals and communities exposed to lead; (2) an evaluation of additional lead exposure research needs; (3) an assessment of any effective screening methods or best practices used or developed to prevent or screen for lead exposure; (4) input and recommendations for improved access to effective services relating to health care, education, or nutrition for individuals and communities impacted by lead exposure; and (5) any other recommendations for communities affected by lead exposure, as appropriate.

    At least half of the committee will consist of Federal representatives from a range of agencies that may include the Department of Housing and Urban Development; the Environmental Protection Agency; the Consumer Product Safety Commission; the Centers for Medicare and Medicaid Services; the Health Resources and Services Administration; the Food and Drug Administration; the U.S. Department of Agriculture; the Occupational Safety and Health Administration; the National Institute of Environmental Health Sciences; the U.S. Geological Survey; and such additional federal, state, tribal, and local public and private officials as the Secretary deems necessary for the committee to carry out its function. The rest of the committee will consist of non-Federal members. Only non-Federal members are being solicited with this announcement.

    The U.S. Department of Health and Human Services policy stipulates that committee membership be balanced in terms of points of view represented and the committee's function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Committee members are Special Government Employees, requiring the filing of financial disclosure reports at the beginning and annually during their terms. CDC reviews potential candidates for LEPAC membership each year, and provides a slate of nominees for consideration to the Secretary of HHS for final selection. HHS notifies selected candidates of their appointment as soon as the HHS selection process is completed. Note that the need for different expertise varies from year to year and a candidate who is not selected in one year may be reconsidered in a subsequent year. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Candidates should submit the following items:

    • Current curriculum vitae, including complete contact information (telephone numbers, mailing address, email address).

    • A least one letter of recommendation from person(s) not employed by the U.S. Department of Health and Human Services. (Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by an HHS agency (e.g., CDC, NIH, FDA, etc.).

    Nominations may be submitted by the candidate him- or herself or by the person/organization recommending the candidate.

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both the Centers for Disease Control and Prevention, and the Agency for Toxic Substances and Disease Registry.

    Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2018-03462 Filed 2-20-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10656 and CMS-10277] 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 23, 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 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: New collection of information request; Title of Information Collection: Evaluation of the Partnership for Patients (PfP) 3.0; Use: In the summer of 2015, the Centers for Medicare & Medicaid Services (CMS) Administrator approved the plans for integration of the Partnership for Patients (PfP) Hospital Engagement Network (HEN) model test with the Quality Improvement Network-Quality Improvement Organization (QIN-QIO) program. This is consistent with the Agency's intention for further integration to maximize the strengths of the QIO program and PfP HENs to sustain and expand current national reductions in in-patient harm and 30-day readmissions. The alignment of the two programs permits the systematic use of innovative patient safety practices at a national scale.

    Under this initiative, CMS has awarded multiple contracts to Hospital Improvement Innovation Networks (HIINs), formerly known as HENs, to engage the hospital, provider, and broader caregiver communities to implement well-tested and measured best practices. The end result of the overall initiative is the anticipated reduction in preventable hospital-based harm and readmissions for patients.

    The PfP initiative is a public-private partnership dedicated to the improvement of health care quality, safety, and affordability. CMS, working with hospitals, providers, and the broader caregiver community, aims to implement and disseminate best practices on a national scale to reduce hospital acquired conditions (HACs) and all-cause readmissions. Through the PfP model, which was initiated in April 2011, CMS fostered rapid learning among a nationwide community of practice, resulting in major strides in patient safety and engagement by patients and families.

    A mixed methods approach to answering the PfP HIIN evaluation questions includes three primary data collection activities, as follows: Hospital Survey on Prevention of Adverse Events and Reduction of Readmissions, HIIN Data Quality Assurance (QA) Survey and Qualitative Discussions with HIIN leaders and Other Support Contractors. The data collected will provide us feedback to focus efforts to improve the effectiveness and efficiency of the HIIN initiative. As we draft future HIIN and QIO contracts, information from hospitals about HIIN influence on their care processes will be used together with follow-up input from stakeholders about the survey results. Subsequent to the 60-day Federal Register notice (82 FR 51360), the collection instrument was revised to include pre-testing results. There has been a slight decrease in the burden hours. Form Number: CMS-10656 (OMB Control Number: 0938-NEW); Frequency: Annually; Affected Public: Private Sector: Business or other for-profits and Not-for-profit institutions; Number of Respondents: 819; Total Annual Responses: 838; Total Annual Hours: 380. (For policy questions regarding this collection contact Israel Cross at 410-786-0619.)

    2. Type of Information Collection Request: Reinstatement of a previously approved collection; Title of Information Collection: Hospice Conditions of Participation; Use: The Conditions of Participation and accompanying requirements are used by Federal or State surveyors as a basis for determining whether a hospice qualifies for approval or re-approval under Medicare. The healthcare industry and CMS believe that the availability to the hospice of the type of records and general content of records, which the final rule (72 FR 32088) specifies, is standard medical practice, and is necessary in order to ensure the well-being and safety of patients and professional treatment accountability. Form Number: CMS-10277 (OMB control number: 0938-1067); Frequency: Reporting and Recordkeeping—Yearly; Affected Public: Private sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 4,473; Total Annual Responses: 19,769,931; Total Annual Hours: 6,074,745. (For policy questions regarding this collection contact Mary Rossi-Coajou at 410-786-6051.)

    Dated: February 15, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2018-03518 Filed 2-20-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [OMB NO.: 0970-0151] Submission for OMB Review; Comment Request; Head Start Child and Family Experiences Survey (FACES)

    Description: The Office of Planning, Research and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new round of the Head Start Family and Child Experiences Survey (FACES). Similar to FACES 2014-2018, in 2019, two parallel studies will commence. Each study will provide data on a set of key indicators for Head Start programs. FACES 2019 focuses on Head Start Regions I through X (which are geographically based); AI/AN (American Indian and Alaska Native) FACES 2019 focuses on Region XI (which funds Head Start programs that serve federally recognized American Indian and Alaska Native tribes). In fall 2019 and spring 2020, FACES will assess the school readiness skills of 2,400 Head Start children in Regions I-X (FACES 2019) and 800 children in Region XI (AI/AN FACES 2019), survey their parents, and ask their Head Start teachers to rate children's social and emotional skills. This sample will be drawn from 60 programs in Regions I-X and 22 programs in Region XI. In spring 2020 classroom observations of sampled programs will occur. In Regions I-X, the number of programs will increase from the 60 that are used to collect data on children's school readiness outcomes to 180 for the purpose of conducting observations in 720 Head Start classrooms. In Region XI, the program sample will remain at 22, and approximately 80 Head Start classroom observations will take place. Program director, center director, and teacher surveys will also be conducted in spring 2020 in Regions I-XI. In spring 2022, program level data collection will be repeated in Regions I-X only. FACES 2019 also features a “Core Plus” design, with the above activities reflecting the Core data, with the potential of “Plus” studies to inform emerging programmatic questions. If any Plus studies are conducted, they will be conducted within the Core sample.

    This notice is specific to the data collection activities needed to recruit Head Start programs and centers into FACES. A future notice will provide information about data collection for the study. A nationally representative sample of Head Start programs and centers from Regions I-X (FACES 2019) and a representative sample of Head Start programs and centers from Region XI (AI/AN FACES 2019) will be selected to participate in FACES 2019. From Regions I-X, the programs participating in the Core child-level data collection will be contacted and recruited for the study in spring 2019. In fall 2019, the remaining programs participating in classroom-level data collection will be contacted. All programs will be contacted a second time in fall 2021 to confirm their continued participation in the Core spring 2022 data collection. The programs from Region XI would be recruited a year before data collection (i.e., fall 2018) given the increased amount of time to recruit programs in tribal communities and to obtain tribal council and/or tribal leadership approval.

    The method of data collection for recruitment of all programs will include telephone conversations with program directors and on-site coordinators who serve as liaisons between the FACES study team and the Head Start centers. All of these calls will inform program staff about the purpose of the study and will gather lists of centers in each program in order to compile the center sampling frame. The purpose of this data collection is to support the 2007 reauthorization of the Head Start program (Pub. L.110-134), which calls for periodic assessments of Head Start's quality and effectiveness.

    Respondents: Head Start Program Directors and Staff.

    Annual Burden Estimates Instrument Total
  • number of
  • respondents
  • Annual
  • number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Annual
  • burden hours
  • Telephone script and recruitment information collection for program directors, Regions I-X 230 77 2 1 154 Telephone script and recruitment information collection for program directors, Region XI 30 10 1 1 10 Telephone script and recruitment information collection for on-site coordinators, Regions I-X 230 77 2 .75 116 Telephone script and recruitment information collection for on-site coordinators, Regions XI 30 10 1 .75 8

    Estimated Total Annual Burden Hours: 288.

    Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]

    OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected], Attn: Desk Officer for the Administration for Children and Families.

    Mary Jones, ACF/OPRE Certifying Officer.
    [FR Doc. 2018-03431 Filed 2-20-18; 8:45 am] BILLING CODE 4184-22-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 Quarterly Data Collection, OMB Number: 0906-0016—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 23, 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 pap[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 Quarterly Data Collection, OMB Number: 0906-0016—Revision.

    Abstract: This clearance request is for continued approval of the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program Quarterly Data Collection. The MIECHV Program, administered by HRSA in partnership with the Administration for Children and Families (ACF), supports voluntary, evidence-based home visiting services during pregnancy 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 4, Due date: Revise the due date to be 15 days after the end of each reporting period.

    • Form 4, Section A: Renumber all tables.

    • Form 4, Table A.2: Revise the columns to reflect counties served, communities served, and number of families served by zip code.

    • Form 4, Table A.4: Expand to include a measure of staff retention.

    • Form 4, Section A—Notes: Revise to include page-specific notes.

    • Form 4, Definition of Key Terms: Update definitions for Tables A.1, A.2, A.3, and A.4.

    • Form 4, Section B: Delete.

    HRSA is also requesting an extension of this information collection request through November 30, 2021.

    Need and Proposed Use of the Information: HRSA uses quarterly performance information to demonstrate program accountability 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 service utilization, place-based services, and staffing indicators for home visiting programs. 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 State/Territory awardees (n = 56) and MIECHV Program Tribal awardees (n = 25).

    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 4: Quarterly Performance Report—State/Territory Awardees 56 4 224 24 5,376 Form 4: Quarterly Performance Report—Tribal Awardees 25 4 100 24 2,400 Total 81 324 7,776

    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. 2018-03457 Filed 2-20-18; 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: Family-to-Family Health Information Center Feedback Surveys, OMB No.: 0906-xxxx—New AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the requirement for opportunity for public comment on proposed data collection 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 Information Collection Request must be received no later than April 23, 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: Family-to-Family Health Information Center Feedback Surveys, OMB Control Number: 0906-xxxx—New.

    Abstract: The Family-to-Family Health Information Center (F2F HIC) program is authorized by the Social Security Act, Title V, § 501(c) (42 U.S.C. 701(c)), as amended by the Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10), § 216. The goal of the F2F HIC program is to promote optimal health for children and youth with special health care needs (CYSHCN) by facilitating their access to an effective health delivery system and by meeting the health information and support needs of families of CYSHCN and the professionals who serve them. HRSA's Maternal and Child Health Bureau (MCHB) funds 51 F2F HICs in each of the 50 United States and the District of Columbia. On average, these Centers provide information, education, technical assistance, and peer support to approximately 160,000 families of CYSHCN and approximately 68,000 health professionals each year. F2F HICs are staffed by families of CYSHCN who are uniquely positioned to provide such services, and by health professionals. F2F HIC staff also assist in ensuring families and health professionals are partners in decision making at all levels of care and service delivery.

    HRSA has developed feedback surveys to determine the extent to which F2F HICs provide service to families of CYSHCN and health professionals who serve such families. Each F2F HIC will administer the surveys and report data back to HRSA. Survey respondents will be asked to answer questions about how useful they found the information, assistance, or resources received from the F2F HICs. The purpose of this notice is to solicit comments regarding the proposed feedback surveys.

    Need and Proposed Use of the Information: Data from the feedback surveys will support the HHS Secretary's priorities of engagement and performance and will provide mechanisms to capture consistent performance data from F2F HIC grant recipients. The data will also allow F2F HICs to evaluate the effectiveness of their interventions and improve services provided to families and the providers who serve CYSHCN families. 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 collection can be completed in a timely manner.

    Likely Respondents: Likely respondents are users of F2F HIC services, which include family members of CYSHCN and health professionals who serve such families.

    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; to process and to maintain, information; and to disclose and provide information; to train personnel 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 Information Collection Request are summarized in the table below.

    The estimated respondent count per year is approximately 3,000 families and 1,000 professionals.

    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
  • F2F HIC Feedback Survey 4,000 1 4,000 0.15 600 F2F HIC Grant Recipient Activity 51 1 51 89 4,539 Total 4,051 4,051 5,139

    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. 2018-03455 Filed 2-20-18; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; 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 Eye Institute Special Emphasis Panel; NEI Mentored Career Development Award and Pathways to Independence Applications (K).

    Date: March 13, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

    Contact Person: Jeanette M. Hosseini, Ph.D., Scientific Review Officer, Division of Extramural Research, National Eye Institute, National Institutes of Health, 5635 Fishers Lane, Suite 1300, Bethesda, MD 20892, 301-451-2020, [email protected].

    Name of Committee: National Eye Institute Special Emphasis Panel; NEI Clinical, Epidemiological and Secondary Data Analysis Applications.

    Date: March 22, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate cooperative agreement applications.

    Place: Hilton Garden Inn Bethesda, 7301 Waverly Street, Bethesda, MD 20814.

    Contact Person: Brian Hoshaw, Ph.D., Scientific Review Officer, Division of Extramural Research, National Eye Institute, National Institutes of Health, 5635 Fishers Lane, Suite 1300, Rockville, MD 20892, 301-451-2020, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS)
    Dated: February 15, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-03473 Filed 2-20-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Nursing Research; Notice to Close Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Nursing Research Special Emphasis Panel; NINR Centers Meeting.

    Date: March 5-6, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

    Contact Person: Weiqun Li, MD, Scientific Review Officer, National Institute of Nursing Research, National Institutes of Health, 6701 Democracy Blvd., Suite 710, Bethesda, MD 20892, (301) 594-5966, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.361, Nursing Research, National Institutes of Health, HHS)
    Dated: February 15, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-03475 Filed 2-20-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; CTEP Branch and Support Contracts Forms and Surveys (National Cancer Institute) AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

    DATES:

    Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

    FOR FURTHER INFORMATION CONTACT:

    To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Michael Montello, Pharm. D., Shanda Finnigan, MPH, RN, CCRC, or Jacquelyn Goldberg, JD, Cancer Therapy Evaluation Program (CTEP), 9609 Medical Center Drive, MSC 9742, Rockville, MD 20850 or call non-toll-free number 240-276-6080 or Email your request, including your address to: [email protected] Formal requests for additional plans and instruments must be requested in writing.

    SUPPLEMENTARY INFORMATION:

    Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Proposed Collection Title: CTEP Support Contract Forms and Surveys 0925-0753 Expiration Date 06/30/2020 ICR Type: Revision, National Cancer Institute (NCI), National Institutes of Health (NIH).

    Need and Use of Information Collection: The National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) and the Division of Cancer Prevention (DCP) fund an extensive national program of cancer research, sponsoring clinical trials in cancer prevention, symptom management and treatment for qualified clinical investigators. As part of this effort, CTEP implements programs to register clinical site investigators and clinical site staff, and to oversee the conduct of research at the clinical sites. CTEP and DCP also oversee two support programs, the NCI Central Institutional Review Board (CIRB) and the Cancer Trial Support Unit (CTSU). The combined systems and processes for initiating and managing clinical trials is termed the Clinical Oncology Research Enterprise (CORE) and represents an integrated set of information systems and processes which support investigator registration, trial oversight, patient enrollment, and clinical data collection. The information collected is required to ensure compliance with applicable federal regulations governing the conduct of human subjects research (45 CFR 46 and 21 CRF 50), and when CTEP acts as the Investigational New Drug (IND) holder, FDA regulations pertaining to the sponsor of clinical trials and the selection of qualified investigators under 21 CRF 312.53). Information is also collected through surveys to assess satisfaction, provide feedback to guide improvements with processes and technology, and assess health professional's interests in clinical trials.

    To increase efficiencies, reduce administrative burden and cost, CTEP has requested consolidation of their current OMB submission. Consolidation is justified because although the various branches and contracts are responsible for distinct services, the processes that support the NCI and participating clinical sites efforts are intertwined. This revision of the previous submission includes changes to the NCI CIRB and CTSU form collections and integrates the Clinical Trials Monitoring Branch (CTMB) and Pharmaceutical Management Branch (PMB) form collections related to site audit and clinical investigator and key clinical site staff registration.

    OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 68,855.

    Estimated Annualized Burden Hours Form name Type of respondent Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total annual
  • burden hours
  • CTSU IRB/Regulatory Approval Transmittal Form (Attachment A01) Health Care Practitioner 2,444 12 2/60 978 CTSU IRB Certification Form (Attachment A02) Health Care Practitioner 2,444 12 10/60 4,888 Withdrawal from Protocol Participation Form (Attachment A03) Health Care Practitioner 279 1 10/60 47 Site Addition Form (Attachment A04) Health Care Practitioner 80 12 10/60 160 CTSU Roster Update Form (Attachment A05) Health Care Practitioner 600 1 5/60 50 CTSU Request for Clinical Brochure (Attachment A06) Health Care Practitioner 360 1 10/60 60 CTSU Supply Request Form (Attachment A07) Health Care Practitioner 90 12 10/60 180 Site Initiated Data Update Form (Attachment A08) Health Care Practitioner 2 12 10/60 4 Data Clarification Form (A